The Issue Whether Respondent committed the offenses described in the Administrative Complaint? If so, what disciplinary action should be taken against him?
Findings Of Fact Based upon the record evidence, the following Findings of Fact are made: Respondent is now, and has been since October 18, 1977, a physician authorized to practice medicine in the State of Florida under license number ME 0013979. He is a board certified dermatologist and dermapathologist. Respondent's practice is located in St. Lucie County. He is the only dermapatholgist in the county. E.M. is a former patient of Respondent. He is a fair complected retiree with red hair who has lived his entire life in areas that have warm and sunny climates. Fair complected individuals are more prone to develop skin cancers as a result of exposure to the sun than are their darker complected counterparts. E.M. had been treated for skin cancer on several occasions, dating back to some time between 1954 and 1960, before becoming Respondent's patient. In June of 1988, E.M. became concerned about two lesions that he had in a dime-sized area on his left forearm below the elbow. The lesions were scaly and crusted in texture, pea-sized in diameter, irregularly shaped, reddish in color and sensitive to the touch. E.M.'s concern led him to make an appointment to see Respondent. His initial visit to Respondent's office was on June 29, 1988. Because he was a new patient, E.M. filled out a medical history form before going into the examining room. Respondent did not give E.M. a complete physical examination. He examined only E.M.'s left forearm. His examination revealed the lesions about which E.M. was concerned. These were not the only lesions Respondent discovered on E.M.'s left forearm, however. By all appearances, the lesions on E.M.'s left forearm were pre- cancerous growths. There was no evidence of any ulceration, discharge, bleeding or other indication that these lesions were malignant. Having no reason to suspect that these lesions were cancerous, Respondent determined that they were solar keratoses, which are pre-malignant growths that appear on the superficial layers of sun damaged skin. E.M. had told Respondent before the examination that he had previously used Efudex, which is a chemotherapeutic drug used in the treatment of solar keratoses. Accordingly, at the time he made his diagnosis, Respondent knew that E.M. had a history of pre-cancerous growths. As a general rule, Respondent treats growths of the type he found on E.M.'s left forearm with cryosurgery1 and cauterization.2 If, after two or three such treatments, sufficient progress has not been made, he will then perform a biopsy to determine if there are cancerous cells in the deeper layers of the skin. In accordance with his usual practice, Respondent, during E.M.'s first visit on June 29, 1988, treated the lesions on E.M.'s left forearm, which Respondent reasonably believed to be pre-cancerous growths, with cryosurgery and cauterization. He then gave E.M. a cortisone cream to apply to the treated areas to aid the healing process. An appointment for a follow-up visit was made for July 13, 1988. Respondent next saw E.M. on July 13, 1988. His examination of E.M.'s left forearm on July 13, 1988, did not reveal any evidence of a malignancy, however, he did determine that there was a need to, and therefore he did, perform additional cryosurgery. Respondent sent E.M. home with a cream that contained not only cortisone to aid in healing, but an antibiotic as well to prevent against infection. An appointment for a second follow-up visit was made for July 27, 1988. E.M.'s next visit to Respondent was on July 27, 1988. Respondent's examination of E.M.'s left forearm on July 27, 1988, revealed that the treated areas were slowly healing. Based upon his examination, he had no reason to suspect a malignancy. Nor was there any indication that further cryosurgery was necessary. Respondent noted a flat, pigmented lesion in close proximity to the areas on E.M.'s left forearm that had been treated during his two previous visits. Respondent was not particularly concerned about this lesion,3 but he nonetheless mentioned to E.M. that it might be a good idea to have it biopsied to be on the safe side. E.M. responded that he preferred that such a biopsy not be performed. Respondent did not pursue the matter any further during the visit. Once again, Respondent gave E.M. a different cream to apply to the areas that had been treated. This time it was a pure antibiotic ointment. An appointment for a third follow-up visit was made for the morning of Wednesday, August 10, 1988. Respondent typically schedules biopsies and excisions on Wednesday mornings. E.M. cancelled his August 10, 1988, appointment with Respondent. He did not make another appointment. Accordingly, Respondent did not see E.M. as a patient again. In failing to biopsy the lesions on E.M.'s left forearm, which he had no reason to suspect were cancerous, Respondent did not act in a manner that was inconsistent with what a reasonably prudent physician with his training and experience would have done under like circumstances. More than a year later, in September, 1989, E.M. noticed that a lesion on his left forearm had opened and was draining. E.M. went to see Dr. Gary Marder, an osteopathic physician who specializes in dermatology. Marder suspected a malignancy. Accordingly, he performed a biopsy and scheduled E.M. for surgery. The initial biopsy report indicated an "invasive moderately differentiated squamous cell carcinoma." After Marder surgically excised the area, the pathologist revisited the matter and changed his diagnosis to an amelanotic melanoma, which is a rare type of melanoma4 that is characterized by an absence of pigmented cells. Pigmented lesions, like the one Respondent noticed on E.M.'s left forearm during E.M.'s July 27, 1988, visit, are not precursors of amelonotic melanomas. It was subsequently determined that the cancer had spread. Cancerous lymph nodes were removed from E.M.'s axilla in April, 1990, and from his elbow in November, 1990.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is hereby RECOMMENDED that the Board of Medicine enter a final order dismissing the instant Administrative Complaint against Respondent in its entirety. DONE AND ENTERED in Tallahassee, Leon County, Florida, this 23rd day of January, 1992. STUART M. LERNER Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 23rd day of January, 1992. 1/ Respondent uses liquid nitrogen to freeze and destroy the unwanted tissue. 2/ The cautery device that Respondent uses is battery-operated and produces a low current. It is particularly effective in removing rough, hard-crusted areas of skin. 3/ It did not even appear to be a pre-cancerous condition. 4/ Melanomas are one of the three types of skin cancers. Basal cell carcinomas and squamous cell carcinomas, which together account for 98% of all cancers, are the two other types. Of these three types of cancers, melanomas are the most destructive and the most likely to metastasize. 5/ Respondent has not been charged with failing to keep adequate medical records. 6/ Precisely what information E.M. provided on this form is unclear. 7/ The issue is not whether the practice described in this proposed finding is common, but whether it is acceptable. 8/ As noted above, the adequacy of Respondent's medical records are not at issue in the instant case. 9/ The Department did not advance this theory in the Administrative Complaint. APPENDIX TO RECOMMENDED ORDER IN CASE NO. 91-3696 The following are the Hearing Officer's specific rulings on the findings of fact proposed by the Department: Accepted and incorporated in substance, although not necessarily repeated verbatim, in this Recommended Order First sentence: Accepted and incorporated in substance; Second and fourth sentences: Rejected because they are more in the nature of summaries of testimony than findings of fact; Third sentence: To the extent that this proposed finding suggests that there was also a "pigmented lesion" on E.M.'s left forearm that Respondent observed during E.M.'s first visit to his office, it has been rejected because it is not supported by persuasive competent substantial evidence. Rejected because it would add only unnecessary detail to the factual findings made by the Hearing Officer.5 First sentence: Accepted and incorporated in substance;6 Second sentence: Rejected because, even if true, it would have no bearing on the outcome of the instant case. Rejected because, even if true, it would have no bearing on the outcome of the instant case. First sentence: Accepted and incorporated in substance; Second sentence: Rejected because it would add only unnecessary detail to the factual findings made by the Hearing Officer. Rejected because, even if true, it would have no bearing on the outcome of the instant case. Rejected because it would add only unnecessary detail to the factual findings made by the Hearing Officer. Rejected because, even if true, it would have no bearing on the outcome of the instant case. First sentence: Accepted and incorporated in substance; Second sentence, fragment before comma: Accepted and incorporated in substance; Second sentence, fragment after comma: Rejected because, even if true, it would have no bearing on the outcome of the instant case. 11-12. Accepted and incorporated in substance. 13. Rejected because, even if true, it would have no bearing on the outcome of the instant case. 14-17. Accepted and incorporated in substance. Rejected because, even if true, it would have no bearing on the outcome of the instant case.7 First sentence: Rejected because it would add only unnecessary detail to the factual findings made by the Hearing Officer; Second sentence: Accepted and incorporated in substance. First sentence: Accepted and incorporated in substance; Second sentence: Rejected because it is more in the nature of a summary of testimony than a finding of fact; Third sentence: To the extent that this proposed finding suggests that Respondent believed that the pigmented lesion was a squamous cell carcinoma, it is rejected because it is not supported by persuasive competent substantial evidence. First sentence: Rejected because it is more in the nature of a summary of testimony than a finding of fact; Second sentence: Accepted and incorporated in substance; Third sentence: Rejected because it constitutes argument regarding the credibility of testimony rather than a finding of fact. Rejected because it would add only unnecessary detail to the factual findings made by the Hearing Officer.8 First sentence: Rejected because it is more in the nature of a summary of testimony than a finding of fact; Second sentence: To the extent that this proposed finding states that "E.M. had had several prior biopsies . . . [and therefore] was aware of the reasons for a biopsy," it has been accepted and incorporated in substance. To the extent that it suggests that Respondent never recommended to E.M. that a biopsy be performed on the pigmented lesion that Respondent observed on E.M.'s left forearm during the July 27, 1988, visit and that, if such a recommendation had been made, E.M. "would have willingly submitted," it has been rejected because it is contrary to the greater weight of the evidence. Rejected because, even if true, it would have no bearing on the outcome of the instant case. Accepted and incorporated in substance. First sentence: Rejected because it is not supported by persuasive competent substantial evidence; Second and third sentences: Rejected because they would add only unnecessary detail to the factual findings made by the Hearing Officer. First sentence: Rejected because it is more in the nature of a recitation of testimony than a finding of fact; Second sentence: Rejected because it would add only unnecessary detail to the factual findings made by the Hearing Officer. 28-29. Rejected because they would add only unnecessary detail to the factual findings made by the Hearing Officer. 30-34. Accepted and incorporated in substance. Rejected because it would add only unnecessary detail to the factual findings made by the Hearing Officer. Third sentence: Accepted and incorporated in subst ance; Remaining sentences: Rejected because they would add only unnecessary detail to the factual findings made by the Hearing Officer. Rejected because it would add only unnecessary detail to the factual findings made by the Hearing Officer. Rejected because, even if true, it would have no bearing on the outcome of the instant case. Rejected because it is contrary to the greater weight of the evidence. Rejected because, even if true, it would have no bearing on the outcome of the instant case.9 COPIES FURNISHED: Mary B. Radkins, Esquire Department of Professional Regulation 1940 North Monroe Street, Suite 60 Tallahassee, Florida 32399-0792 Shamsher Singh, M.D. 1701 Hillmoor Drive, #A-3 Port St. Lucie, Florida 34952 Dorothy Faircloth, Executive Director Board of Medicine Department of Professional Regulation 1940 North Monroe Street Tallahassee, Florida 32399-0792 Jack McRay, General Counsel Department of Professional Regulation 1940 North Monroe Street Tallahassee, Florida 32399-0792
The Issue Petitioner Department of Professional Regulation seeks to suspend, revoke, or otherwise discipline respondent's license to practice medicine on charges of professional misconduct violative of Chapter 458 Florida Statutes (1979). The issues for determination are: Whether respondent is guilty of gross or repeated malpractice or the failure to practice medicine with that level of care, skill, and treatment recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances, in his treatment of Verdi Hammond Burroughs ("Burroughs") and Charles Kirk ("Kirk") in violation of Section 458.331(1)(t), Florida Statutes (1979); Whether respondent's treatment of Burroughs and Kirk was fraudulent and constituted misrepresentation, and whether the treatment was medically beneficial to the exclusion of other forms of proper medical treatment and was, therefore, harmful to the patient in violation of Section 458.331(1)(1), Florida Statutes (1979); Whether respondent violated Sections 458.331(1)(1), 458.331(1)(h), Florida Statutes (1979) by failing to fully inform Burroughs and Kirk (in his prescribing and administering Amygdalin [Laetrile]) of alternative methods of treatment for their cancer, and the potential of these methods for cure; whether each patient failed to sign a written release releasing respondent from liability; and whether respondent informed each patient, in writing, that Laetrile has not been approved as a treatment or cure by the Food and Drug Administration of the United States Department of Health and Human Services; Whether respondent's treatment of Burroughs and Kirk, when measured by the prevailing standards of medical practice in the community, would constitute experimentation on a human subject without first obtaining full, informed, and written consent, in violation of Section 458.331(1)(u), Florida Statutes (1979); Whether respondent failed to comply with Sections 458.333 and 458.335, Florida Statutes (1979); Whether metabolic therapy is recognized by a respectable minority of the medical profession as a treatment for cancer. Background By an eight-count administrative complaint dated March 31, 1982, petitioner Department of Professional Regulation, Board of Medical Examiners (Department), charged respondent Daniel J. Clark with multiple violations of Chapter 458, Florida Statutes (1979), the "Medical Practice Act." Respondent disputed the charges and requested a Section 120.57(1) hearing. On April 29, 1982, the Department forwarded this case to the Division of Administrative Hearings for assignment of a hearing officer. Hearing was then set for September 22 and 23, 1982. At hearing, the Department presented the testimony of Evelyn Kuhn, Daniel Clark, Alvin Edward Smith, Tammy Thompson, Brenda Kempton, and Lois Ann White. Petitioner's Exhibit Nos. 1/ 1-5 were received into evidence. The respondent testified in his own behalf and presented the testimony of Rodrigo Rodriquez, Rebecca Scholz, and Allen Bernsten. Respondent's Exhibit Nos. 1-5 were proffered but not received into evidence. The parties filed proposed findings of fact and post- hearing briefs by December 1, 1982. Those proposed findings which are incorporated herein are adopted; otherwise they are rejected as unsupported by the evidence or unnecessary to resolution of the issues. Based on the evidence presented at hearing, the following findings of fact are determined:
Findings Of Fact I. Respondent Since 1976, respondent has been licensed to practice medicine in the State of Florida, holding license number ME0026861. (Tr. 269; Prehearing Stipulation) He received a bachelor of science degree from Georgia Southwestern College and a medical degree from Medical College of Georgia. In 1975, he trained for five months with a gynecological oncologist in Americus, Georgia. In 1978, he completed a three year residency program at University Hospital in Jacksonville, Florida. (Tr. 266-268). Since 1979, he has practiced medicine in Ormond Beach, Florida. Initially, his practice included gynecology, family practice, and general nutrition. He then began to treat cancer patients with metabolic (nutritional) therapy. The purpose of such therapy is to enhance the immunological and biological capacities of a patient--nutritionally, immunologically, and physiologically--in order to improve the patients performance in combating cancer. This cancer treatment includes the administration of Amygadalin (Laetrile), vitamins, herbal teas and detoxifiers, and the application of salves and packs to cause localized hyperthermia. It is not a conventional, orthodox, or widely practiced form of cancer treatment. No other physician in Volusia County uses it. Most accredited medical schools in the United States do not teach it. The American Medical Association (AMA) considers it to be experimental. Eventually, respondent's metabolic treatment of cancer patients began to account for 15 percent to 20 percent of his practice. (Testimony of Clark, Rodriquez; P-3) II. Respondent's Treatment of Verdi Hammond Burroughs In October or November 1979, Nelson Murray, a chiropractor, asked respondent to examine Verdi Hammond Burroughs, a patient who had complained to Dr. Murray about a lump in her right breast. (The offices of Dr. Murray and respondent were close together in the same building. And, in the past, Dr. Murray had referred patients to respondent for medical treatment.) (Testimony of Clark, P-3). Respondent, who considered it an "across-the-hall consult," agreed. He went to Dr. Murray's office, examined Ms. Burroughs' right breast, and noted a small lump. He recommended that she have a biopsy or that she see a surgeon for a second opinion, to make sure that the lump was not malignant. (Subsequently, she failed to follow this recommendation.) Although he did not refer her to a particular surgeon, he looked up the names of several who might be willing to operate on her, as she was a Jehovah's Witness. (Since Jehovah's Witnesses object to blood transfusions, many surgeons refuse to operate on them.) (Testimony of Clark, P-3) During this brief examination, respondent did not perform any diagnostic tests other than to manually examine the breast. Although he kept meticulous patient medical records, he did not open a patient record on Ms. Burroughs or have her complete a patient history form. He took no progress notes during the examination. He did not consider her his patient, did not assume responsibility for her treatment, and did not charge her a fee. (Testimony of Clark; P-1, P-3). Respondent had no contact with Ms. Burroughs until Dr. Murray asked him to reexamine her in February, 1980. The circumstances were similar. Respondent examined her in Dr. Murray's office, noted the breast lump was unchanged, made no medical reports, and charged no fee. He recommended that she undergo a laboratory test, including complete blood chemistry, SMAC 22, CBC, and sedimentation rate. For this purpose, he specifically referred her to Dr. Nelson A. Murray, a medical doctor and pathologist in Jacksonville, Florida. (At that time, she lived in Jacksonville, Florida.) He also recommended, again, that she have a biopsy performed--a recommendation which she, again, failed to follow. (Testimony of Clark; P-3). On September 22, 1980, almost eight months later, chiropractor Murray again asked respondent to come to his office and examine Ms. Burroughs right breast. Respondent's subsequent examination revealed that the entire breast was severely inflamed and the nipple was inverted or sloping downward. The breast had the appearance of an inflamed carcinoma. Respondent strongly suggested that she have laboratory tests (the same tests which he had recommended earlier) done as soon as possible and that she arrange to see him immediately thereafter. He, again, told her that she needed a biopsy and gave a preliminary diagnosis of breast cancer. This time, she followed his recommendation. Two days later, she had the complete lab tests done by Dr. Murray, the Jacksonville pathologist. (Testimony of Clark; P-3). Respondent still did not consider Ms. Burroughs his patient or assume any responsibility for her treatment. During this September 22, 1980, examination, he did not open a patient file, take notes, or charge a fee. There is no evidence that Ms. Burroughs-- at that time--believed that she was his patient--or he, her doctor. Nor is there evidence that either party misunderstood or was confused about their relationship or their respective responsibilities. (Testimony of Clark; P-3). Between the February, ,1980 and September 22, 1980, examinations, respondent did not contact Ms. Burroughs and did not discuss her condition with chiropractor Murray. Between the November, 1979 and the September, 1980, examinations, respondent did not order or perform any further diagnostic tests on Ms. Burroughs and did not attempt to check with her to see if she had followed his recommendations. Neither did he expressly inform her that he was not her doctor. The Department contends that his failure to take these actions violates a generally accepted standard of medical care. (Testimony of Clark; P- 3) This contention, however, is unsubstantiated. The evidence does not demonstrate that the generally accepted standard of medical care required respondent to take such actions. Conversely, it has not been specifically shown how, and in what ways, respondent's treatment of Ms. Burroughs between November, 1979 and September, 1980, fell below an acceptable standard of medical care. 2/ Ms. Burroughs became respondent's patient on October 7, 1980, when she came to his office for medical treatment. He performed a complete work up, physical examination, and medical history, and reviewed the results of the lab blood tests. He concluded that her condition was essentially normal except for her right breast, which was severely inflamed and the nipple retracted. In addition, the lymph nodes under her right armpit' were palpable and enlarged. His initial impression was that she had inflammatory carcinoma (cancer) of the right breast with lymph gland involvement. He then scheduled her for a biopsy, which was necessary before he could determine the type of cancer involved. (Testimony of Clark; P-3) The biopsy was performed on October 9, 1980 by Dr. Kluger, a St. Augustine physician. It indicated an inflamatory intraductal adenocarcinoma of the breast, primary. Dr. Kluger, who felt that surgery was inadvisable because of the lymph node involvement, subsequently recommended to respondent that Ms. Burroughs undergo radiation and chemotherapy. (Testimony of Clark; P-1, P-3). During the October 7, 1980, office visit, respondent explained to Ms. Burroughs the alternative methods of cancer treatment, including their potential for cure. The methods discussed included surgery, radiation, chemotherapy, and metabolic therapy. She refused to undergo radiation or surgical treatment, explaining that her husband died of lung cancer after receiving surgery, radiation, and chemotherapy. She agreed however, to consider chemotherapy in conjunction with metabolic therapy. He explained to her that metabolic therapy was not a treatment against the cancer, per se, but that it would help "build up her body to where her own immune system would help her fight the cancer." (P-1). She agreed to accept this treatment--chemotherapy with metabolic therapy--then signed four separate affidavits on forms provided by respondent. The affidavits acknowledged her consent to the ordering and administration of Laetrile. Respondent, however, did not inform Ms. Burroughs in writing (by these affidavits or any other documents), that Laetrile has not been approved as a treatment or cure by the Food and Drug Administration of the United States Department of Health and Human Services. She also did not sign a written release, releasing him from any liability from the administration of Laetrile. (Testimony of Clark; P-1, P-3) During the October 7, 1980, visitation--after the affidavits were signed--respondent began treating her with metabolic therapy, consisting of Laetrile I.V., Vitamin C, B Vitamins, B-15, B-12, and crude liver injections. Metabolic therapy was commenced without obtaining her prior written consent. (Testimony of Clark; P-1). Several days later, on October 13, 1980, respondent began treating her with small doses of chemotherapy in conjunction with the metabolic therapy. The chemotherapy treatment plan was based on a phone call to Dr. Donald Cole, a New York oncologist. Respondent described the type and extent of Ms. Burroughs cancer and Dr. Cole recommended small 100 milligram doses of 5-FU twice weekly, two to five milligrams of Laetrile twice weekly, and 50 milligrams of Cytoxin PO orally. Respondent administered this regimen until he discontinued chemotherapy at the end of November, 1980. (Testimony of Clark; P-3). These doses and intervals of chemotherapy did not conform to the manufacturers' recommended doses contained in the Physicians Desk Reference, a standard reference used by practicing physicians. The doses administered by respondent were lower than those normally used in chemotherapy and are considered to be in the research or experimental stage. (Testimony of Clark, Smith). Chemotherapy and metabolic therapy are incompatible-- they work at cross-purposes. Chemotherapy drugs are strong immunosuppressants. They are toxic and intended to poison cancer cells; 3/ their effect is to suppress the body's immunological system. In contrast, the purpose of metabolic therapy is to enhance that same immunological system. (Tr. 215-216). For this reason, the use of chemotherapy is not included within the protocols for metabolic therapy found in International Protocols in Cancer Management. 4/ Respondent concedes that this publication is authoritative and contains the standard protocols for metabolic therapy. (Testimony of Rodriquez, Clark). Ms. Burroughs chemotherapy stopped at the end of November, 1980, but her metabolic therapy continued. By March, 1981, her right arm was beginning to swell because of enlarging lymph nodes. On the March 2, 1981, office visit, respondent told her that Laetrile was not stopping the cancer, and discussed restarting chemotherapy. He increased her Vitamin C, and began administering herbal cleaners and botanical medicines containing red clover, chapparral, myrr, goldenseal, yellow dot, juniper berries, yuva, ursaberries, conch grass, and dandelion. Respondent categorizes these medicines as blood purifiers, lymph purifiers, liver cleaners, and kidney cleaners. (P-3). By June, 1981, respondent believed the cancer had metastasized to Ms. Burroughs' right lung. During office visits in early June, he rubbed herbal ointment or liniment, Vitamins E and F, into her rib cage area. He also prescribed herbal packs and poultices to cause localized hyperthermia (heat increase). He prescribed dark and yellow herbal salves and instructed her to apply them to her right breast and underarm area, explaining that they would draw out and break down the cancer tumor. (Testimony of Clark, Kuhn; P-3). These salves--strong and painful--caused pieces of gray tissue to fall off her breast and underarm area. Respondent reacted by encouraging her, telling her that the salves were breaking down the cancerous tumor. (He now admits, however, that the herbal ointments and salves would have been ineffective in treating the cancer which had metastasized to her lungs.) He also prescribed a tea which tasted like black pepper. She forced herself to swallow it because he had told her that it would break up the cancer in her body. This representation was also untrue. (Testimony of Clark, Kuhn, Smith.) In administering metabolic therapy to Ms. Burroughs, respondent also prescribed whole-body hyperthermia for the purpose of stimulating her immune system. This required her to totally submerge herself in bath water which was as hot as she could tolerate. According to the standardized protocols for metabolic therapy, as stated in International Protocols in Cancer Management, such "whole-body hyperthermia, while successful in some cases, is dangerous and considered experimental." (Tr. 320, Testimony of Clark). Respondent's metabolic and chemotherapeutic treatment of Ms. Burroughs failed to conform to the standard of care recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances. It fell below the prevailing and generally accepted standard of care recognized by his peers in the medical community: a.) After the diagnosis, respondent made an improper and incomplete staging 5/ of the disease by failing to take a liver scan, which would have revealed the existence (or nonexistence) of liver lesion. Cancer of the liver is deadly and must be dealt with immediately. (Tr. 89-92). b.) After he diagnosed Ms. Burroughs breast cancer, he failed to prescribe surgery or a combination of surgery and radiation therapy, treatment methods which likely would have been beneficial and controlled the disease. (Surgery, such as a radical mastectomy, does not cause a significant loss of blood, so blood transfusions--something Ms. Burroughs opposed--could have been avoided.) If necessary, chemotherapy--using conventional doses--could also have been administered. The chemotherapy and metabolic therapy which respondent provided Ms. Burroughs was probably worthless. The herbal salves and teas which he prescribed were incapable of drawing out or breaking up the cancerous tumor. c.) When Ms. Burroughs' cancer was diagnosed, it was in an advanced and complicated stage. Under such circumstances, a general practitioner (such as respondent) should have referred her to or obtained a consult from an oncologist, a specialist in the treatment of cancer. Respondent did neither. (Testimony of Smith). Metabolic therapy is not approved or recognized as acceptable for cancer treatment by a respectable minority of the medical profession. This finding is based on the opinion of Alvin Edward Smith, MD., board certified in oncology and internal medicine, and a Fellow of the American College of Physicians. He has treated cancer patients since 1978. His opinion on this issue is considered more credible than the contrary opinion of Rodrigo Rodriquez, M.D., who practices medicine in Tijuana, Mexico, who is not licensed to practice medicine in the United States, and who--other than acting as a guest resident at Kings County Hospital in Brooklyn, New York--has never practiced medicine in the United States. (Testimony of Smith, Rodriquez). III. Respondent's Treatment of Charles Kirk Charles Kirk became respondent's patient on August 13, 1980, and died shortly thereafter on September 9, 1980. Mr. Kirk, a 77-year-old male, was having great difficulty swallowing food and had a history of recurring choriocarcinoma of the larynx or throat. Surgery had been performed on him several times, and his larynx (voice-box) had been removed. Respondent explained to him the alternative methods of treatment, including surgery, chemotherapy, radiation, and metabolic therapy. Mr. Kirk opposed further surgery and objected to chemotherapy and radiation. He requested Laetrile. After he signed an affidavit provided by respondent (the same form which had been provided Ms. Burroughs), respondent ordered Laetrile. (Testimony of Clark; P-2). Respondent then referred him to a general surgeon for the placing of a gastrostomy feeding tube, a device which would enable him to swallow food and liquids. The tube was successfully placed surgically, after which respondent began administering Laetrile to him as part of metabolic therapy. The treatment was brief, only nine or ten days. On September 26, 1980, Mr. Kirk died. (Testimony of Clark; P-2). Mr. Kirk's condition, when he first became respondent's patient, was essentially irreversible; he was in the final stages of a fatal cancer. (Testimony of Clark, Smith; P-2). Respondent administered Laetrile to Mr. Kirk without first obtaining from him a release of liability and without informing him, in writing, that Laetrile has not been approved as a treatment or cure by the Food and Drug Administration of the United States Department of Health and Human Services. (Testimony of Clark.)
Recommendation Based on the foregoing, it is RECOMMENDED: That respondent's license to practice medicine be suspended for one year, for violating Section 458.331(1)(h), (1), (t), (u), Florida Statutes (1979). DONE AND RECOMMENDED this 9th day of March, 1983, in Tallahassee, Florida. R. L. CALEEN, JR. Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32301 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 9th day of March, 1983.
Findings Of Fact Upon consideration of the oral and documentary evidence presented at the hearing, the following relevant facts are found: At all times pertinent to the matters considered here, the Respondent was a medical doctor licensed by the State of Florida under license number ME1472. He has been engaged in the practice of medicine for 50 years. While in practice in Orlando, Florida, during the period March 14, 1980, through August 8, 1980, Respondent had as a patient, and acted as treating physician for, Mary Walsh, who was at the time suffering from cancer of the lung. Respondent's treatment of Mary Walsh during the entire period she was his patient included the administering to her of laetrile, dimethylsulfoxide (DMSO) intravenously, enzymes, and megavitamins. Dr. James M. Johnstone (D.O.) had been a physician to Mrs. Walsh over a period of several years for a variety of complaints. (Her lung cancer was detected in December, 1979, however, when she went into his office on a routine visit.) Over the period of time he had treated her, she had suffered from such things as seizures, thyroid problems, and the like, but on this particular December 1979 visit, she complained of a sore throat. Dr. Johnstone referred her for consultation with a Dr. Porth, who ultimately opined she might have cancer of the epiglottis. As a result, in January, 1980, she was admitted to the hospital, where she was diagnosed as having cancer of the left lung. Exploratory surgery conducted during a second period of hospitalization in February, 1980, revealed that the cancer was inoperable and terminal, and the procedure was terminated without any surgical excision. Dr. Johnstone and several other physicians advised Mrs. Walsh and her daughter, Vicki L. Chapman, that conventional-treatments such as radiation therapy were available for, if not a cure, at least palliative treatment to reduce pain and perhaps extend life somewhat, but Mrs. Walsh was afraid of radiation therapy and refused it repeatedly. During this period of diagnoses and tests, Mrs. Walsh and her daughter, Vicki, were told by an acquaintance named Elmer Boener, of the Fairfield Medical Center in Jamaica, which offered the organic approach to cancer control, including the use of diet and vitamins. While Mrs. Walsh and her daughter were deciding whether to go to Jamaica, Mr. Boener informed them that a Dr. Wedel would be working at Respondent's clinic offering the same treatment as available in Jamaica, and they would not have to have the stress of going out of the country. They decided to go to Jamaica, however, because of the stress in this course of treatment on diet and, in March, 1980, went to the Fairfield Clinic for ten days, returning during the first week in April, 1980, at which time Mrs. Walsh took up treatment of her condition with Dr. Wedel and Respondent at the latter's clinic in Orlando. Mrs. Chapman went with her mother on almost every visit to Respondent's office and was present when Mrs. Walsh talked with either doctor or got her treatment. On one occasion, after looking at some X rays taken of Mrs. Walsh's lungs, in the presence of Mrs. Chapman, Dr. Lynn allegedly told Mrs. Walsh that her cancer was shrinking and getting better. This was not true. Dr. Lynn denies telling her this, saying he told her the amount of fluid in the lungs had reduced, but not the size of the cancer. Considering all the evidence and weighing all the factors, I find that Dr. Lynn did make the statement alleged. However, Mrs. Walsh still had pain, and Respondent would not prescribe medication for her. Because of that, she had to go to another doctor for a prescription for whatever she needed to relieve pain. During the time that Respondent treated Mrs. Walsh, he was assisted by a "Dr." Wedel, who held himself out to be a nutritionist. However, search of the records of the various licensing agencies for the medical disciplines within this state reveals that he is not licensed as a medical doctor, osteopath, naturopath, physical therapist, podiatrist, chiropractor, pharmacist, registered nurse, or licensed practical nurse. His service to Mrs. Walsh consisted of nutritional counselling as to diet, vitamins, etc., and writing prescriptions for vitamins that were subsequently signed by Respondent. Respondent's supervision of Wedel was not regular, but periodic. Wedel was recommended to Respondent by a friend in Oregon and intended to apply for a Florida license as a medical doctor. Dr. Lynn states that before offering Wedel employment, he cleared taking him on with the Orange County Medical Association, which agency interposed no objection. When Mrs. Walsh returned to Respondent's care from Jamaica, she requested that he continue the course of treatment she had been undergoing there, which included diet control and the use of vitamins, enzymes, laetrile, and DMSO. Though Dr. Lynn's medical notes were not introduced at the hearing, he indicated that they fail to reveal he counseled Mrs. Walsh on other, conventional forms of treatment for her condition, such as X-ray therapy or chemotherapy. He is satisfied, however, that she was aware of them. Respondent, due to Mrs. Walsh's request to him that he continue the use of laetrile and DMSO, had her oral consent to do so. However, he did not have, nor did he insure that, his staff secure for him her informed, written consent to treat her with either drug. Further, he did not, prior to utilizing either drug, inform her in writing that neither was approved for use in the treatment of cancer by the Federal Food and Drug Administration of the United States Department of Health and Human Services (FDA). Laetrile, DMSO, enzymes, and megavitamins, either singly or taken together, are unconventional treatments for cancer, as accepted by the medical community, and are generally recognized by that community as being experimental.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED: That Respondent's license to practice medicine in the State of Florida be suspended for a period of one year. RECOMMENDED this 11th day of April, 1983, in Tallahassee, Florida. ARNOLD H. POLLOCK, Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32301 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 11th day of April, 10983. COPIES FURNISHED: Charlie L. Adams, Esquire Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 William Trickel, Jr., Esquire 35 West Pine Street Orlando, Florida 32801 Ms. Dorothy Faircloth Executive Director Board of Medical Examiners Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Mr. Fred Roche Secretary Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301
The Issue Whether the Certificate of Need (“CON”) Application No. 10490 submitted by Baptist Hospital of Miami, Inc. (“Baptist Hospital” or “Baptist”), to establish a new adult autologous and allogeneic bone marrow transplant program in Florida’s Organ Transplant Service Area 4 (“TSA 4”) should be approved.
Findings Of Fact Bone Marrow Transplants Bone marrow transplantation is performed after a patient has received very high doses of chemotherapy in order to eradicate cancer. High doses of chemotherapy can cure cancerous cells or cause remission, but chemotherapy can also damage healthy cells. Damage may be done to progenitor cells that create the components for blood, including white blood cells. If progenitor cells are damaged by chemotherapy, the patient may succumb to infection and bleeding. To avoid this problem, physicians remove blood-producing progenitor cells from the patient's blood and bone marrow, and store them while the patient receives chemotherapy. The patient is then reinfused with progenitor blood cells, allowing the patient to make normal blood and recover. This infusion of progenitor cells is commonly referred to as bone marrow transplantation ("BMT"). BMT has become an essential method of fighting blood cancers. BMT is offered in hospital settings, and most transplants are performed on an inpatient basis. However, certain types of BMT services are more frequently being offered on an outpatient basis. BMTs are categorized as either autologous or allogeneic. In autologous BMTs, the patient's own blood and bone marrow cells are removed and then reinfused after chemotherapy. The process begins with apheresis to collect the patient's bone marrow and blood cells. The patient's blood is processed through a machine that separates progenitor cells and stores them. The process of apheresis may take up to five hours. The cells are frozen for later use. The process of freezing blood product is referred to as cryopreservation. The patient then receives chemotherapy and is then reinfused with the patient's own blood and bone marrow cells. Some cancer patients, such as acute leukemia patients, have malignant or compromised blood progenitor cells. In those cases, autologous transplantation is not an option. Instead, progenitor cells must be obtained from an alternative donor, such as a family member or a compatible nonrelative. Allogeneic transplants carry a higher risk of complications, primarily because the introduction of another person's progenitor cells may cause "graft vs. host" disease, which involves the patient’s rejection of the infused cells. Histocompatibility tests help determine whether donated progenitor cells will successfully match with the patient and reduce the chances of graft vs. host disease. BMT is a relatively rare procedure. In 2014, there were 17,303 BMT procedures in the United States involving patients over the age of 21. In 2016, there were 1,026 cases in Florida involving patients over the age of 15. The Regulatory Framework Section 408.032(17), Florida Statutes (2018),1/ defines a “tertiary health service” as a health service which, due to its high level of intensity, complexity, specialized or limited applicability, and cost, should be limited to, and concentrated in, a limited number of hospitals to ensure the quality, availability, and cost-effectiveness of such service. Examples of such service include, but are not limited to, pediatric cardiac catheterization, pediatric open-heart surgery, organ transplantation, neonatal intensive care units, comprehensive rehabilitation, and medical or surgical services which are experimental or developmental in nature to the extent that the provision of such services is not yet contemplated within the commonly accepted course of diagnosis or treatment for the condition addressed by a given service. As a tertiary health service, inpatient BMT may only be offered once a hospital has obtained a CON. See §§ 408.032(17), 408.036(1)(f), Fla. Stat.; Fla. Admin. Code R. 59C-1.044. The statutory review criteria for CONs are set forth in section 408.035. The criteria include factors such as: (a) the need for the health service proposed; (b) the applicant’s ability to provide quality care; (c) the extent to which the proposed service will enhance access to healthcare for residents in the applicable service district; and (d) the immediate and long-term financial feasibility of the proposal. AHCA has published Florida Administrative Code Rule 59C-1.044 governing CON review for transplantation services. Subsections (3), (4), (5) set forth criteria that applicants for several different types of transplant programs must satisfy. Subsections (9) and (10) set forth criteria that BMT applicants must "normally" meet before a new transplant program will be approved. AHCA may approve a CON for BMT services when an applicant demonstrates that not-normal circumstances are present. For many CON-regulated services, AHCA predicts the future need for additional beds or services by announcing a "fixed need pool," establishing a numerical need for new programs around the state. See, e.g., Fla. Admin. Code R. 59C-1.0355 (establishing fixed need pool methodology for hospices); 59C-1.036 (pertaining to nursing facility beds), 59C-1.039 (pertaining to comprehensive medical rehabilitation beds). The establishment of a fixed need pool creates a rebuttable presumption that a new service is or is not needed. Balsam v. Dep’t. of HRS, 486 So. 2d 1341 (Fla. 1st DCA 1986); Humhosco, Inc. v. Dep’t. of HRS, 476 So. 2d 258 (Fla. 1st DCA 1985). However, there is no fixed need pool for organ transplantation services such as BMT. With regard to need, a BMT CON applicant must reliably project that it will annually perform 10 autologous and 10 allogeneic transplants. See Fla. Admin. Code R. 59C-1.044(9)(b)1. (pertaining to adult allogeneic BMT programs and stating such applicants “shall be able to project that at least 10 adult allogeneic transplants will be performed each year. New units shall be able to project the minimum volume for the third year of operation.”); Fla. Admin. Code R. 59C-1.044(9)(c)1. (pertaining to adult autologous BMT programs and stating that such applicants “shall be able to project that at least 10 adult autologous transplants will be performed each year. New units shall be able to project the minimum volume for the third year of operation.”). Rule 59C-1.044(2)(f) provides that “[p]lanning for organ transplantation programs shall be done on a regionalized basis.” Accordingly, the rule establishes four transplant service areas (“TSA”), and each one corresponds to an area containing approximately 25 percent of Florida’s population. The TSA relevant to the instant case is TSA 4, which consists of Broward, Miami-Dade, Monroe, Collier, and Palm Beach Counties. The Parties Baptist Hospital Baptist Health South Florida (“BHSF”) is a not-for- profit, faith-based community healthcare organization that operates nine hospitals, approximately 50 outpatient centers, and a medical group serving South Florida, from the Keys to the Palm Beaches. Though each is separately incorporated, all of BHSF's hospitals report to BHSF leadership and represent an integrated hospital system. BHSF has traditionally offered cancer treatment throughout its hospitals. BHSF sought to create a comprehensive cancer institute to serve South Florida, the Caribbean, and Latin America. The cancer institute would offer complete cancer care, from screening and diagnosis, to treatment, and psychosocial support, all the way to palliative care. BHSF created the Miami Cancer Institute (“MCI”) to consolidate the cancer services it offered at many of its hospitals into a single location at Baptist Hospital. The goal was to offer integrated care, so that everything a cancer patient might need could be offered at one location. Though separately incorporated, MCI is an outpatient department of Baptist Hospital in Miami-Dade County, Florida.2/ All of MCI's services are billed through Baptist Hospital, and MCI’s management reports to Baptist Hospital’s administration.3/ MCI sees between 800 and 1,000 cancer patients a day. Because BMT is required to cure most hematological malignancies, including leukemia, myelodysplastic syndrome, pyelolymphatic disorders, myeloma, and lymphoma, BMT services are essential to MCI becoming a comprehensive cancer care center. Consultants and leaders at MCI also concluded that MCI must offer inpatient BMT in order for MCI to offer the full range of care needed by cancer patients. Therefore, Baptist applied to obtain the CON at issue in this proceeding. Baptist recently completed the process of becoming an affiliate of the Memorial Sloan Kettering (“MSK”) Cancer Center in New York. That alliance has now been formed and is operational. MSK is the United States’ leading center for cancer treatment and BMT. The alliance between Baptist and MSK is a strong, integrated linkage between the clinical and research efforts of both organizations. The alliance provides Baptist’s patients with the latest BMT protocols and techniques. MSK and its cancer research will now be able to add a genomic database of Hispanic cancer patients that may result in improved treatment for patients not of European descent. The University of Miami The University of Miami (“UM”) was established in 1925 and is one of Florida’s preeminent universities. The University of Miami Hospital and Clinics (“UMHC”), the Sylvester Comprehensive Cancer Center (“Sylvester”), and the Miller School of Medicine are all part of UM and are all located in Miami-Dade County, Florida. UM’s medical facilities (the Miller School of Medicine, the University of Miami Hospital, Sylvester, and Anne Bates Leach Eye Center) are located on a medical campus shared with Jackson Memorial Hospital in Miami. Sylvester is a 40-bed specialty care center hospital, and the care offered to the residents of South Florida has achieved significant statewide and national prominence. UM is recognized as a Prospective Payment System (“PPS”) exempt institute, which allows it special reimbursement treatment from Medicare for purposes of reimbursement for cancer care provided at Sylvester. There are only 11 such centers in the country. According to AHCA’s discharge database, 147 residents of TSA 4 received BMT treatment in calendar year 2016 at UM.4/ In 2016, UM performed the second highest number of BMTs in Florida.5/ AHCA AHCA is the state agency charged with administering Florida’s CON program. A CON is required before a hospital may offer inpatient BMT. A CON is not required to establish and operate an outpatient BMT program because outpatient services are exempt from CON review. The Non-Parties H. Lee Moffitt Cancer Center (“Moffitt”) is located in Hillsborough County, Florida. Moffitt is the largest BMT program in Florida, performing more than 400 BMT procedures annually. Moffitt is a recognized cancer hospital, and its physicians are recognized cancer researchers. Fifty to 60 residents of TSA 4 travel outside of South Florida each year in order to receive BMT, and the majority receive that treatment at Moffitt. Because the distance from Miami to Moffitt is 250 to 280 miles and a course of treatment can take two to three months, it is a substantial burden for patients in TSA 4 with limited resources to receive BMT treatment at Moffitt. Memorial Hospital West (“Memorial West”) is located in Broward County. Memorial West and UM are the only operational CON-approved adult service providers of BMT services in TSA 4. Memorial West has been a low volume provider of BMT. According to AHCA’s State Agency Action Report(“SAAR”), Memorial West performed nine inpatient BMT procedures in 2012, 15 in 2013, 20 in 2014, 15 in 2015, and four in 2016. Shortly before the final hearing in this matter, Memorial West affiliated with Moffitt in hopes of reinvigorating its largely inactive program. Moffitt has fully staffed and assumed all clinical operations in the Memorial West program. Under Moffitt leadership and clinical management, the Memorial West program performed eight allogeneic and 19 autologous BMTs between July 1, 2017, and January 26, 2018. Good Samaritan Hospital (“Good Samaritan”) is located in Palm Beach County. For many years, Good Samaritan reported to AHCA that it provided a moderately large volume of inpatient BMT. For instance, Good Samaritan reported doing 42 BMTs in 2016. However, it was recently discovered that Good Samaritan had been incorrectly reporting bone marrow biopsies as bone marrow transplants. All parties now acknowledge that Good Samaritan does not have a BMT program. The Prior Proceeding During the October 2015 Other Beds and Programs CON Batching Cycle, Baptist Hospital filed an application to establish a new adult inpatient autologous and allogeneic BMT program in TSA 4. On February 19, 2016, AHCA issued a SAAR preliminarily approving the application. On March 11, 2016, UM filed a petition challenging AHCA’s preliminary decision, and the petition was assigned DOAH Case No. 16-1698CON. After a nine-day hearing in September 2016, Administrative Law Judge (“ALJ”) James H. Peterson, III, issued a Recommended Order on March 30, 2017, recommending that AHCA deny Baptist’s CON application. AHCA rendered a Final Order on June 13, 2017, adopting ALJ Peterson’s recommendation.6/ The Current CON Application Baptist’s current application seeks to establish an adult inpatient autologous and allogeneic bone marrow transplant program located in TSA 4. On August 18, 2017, AHCA issued a SAAR preliminarily approving Baptist's CON application. Baptist has self-imposed three conditions on its application. The first condition is that the proposed BMT program will be located at Baptist Hospital. The second condition is that 12 acute-care beds will be delicensed so as to convert an 18-bed unit to a 6-bed inpatient BMT unit. The third condition is that Baptist will provide at least 10 percent of its inpatient BMT case volume on an annual basis to Medicaid (including managed Medicaid), charity, or self-pay payments. AHCA is requiring that Baptist establish an on-site cryopreservation lab as a condition of approval for its CON. Outpatient BMT has already begun at Baptist because a CON is not required for outpatient services. It is assumed that Baptist will achieve accreditation from the Foundation for the Accreditation of Cellular Therapy (“FACT”) for autologous BMT before the first inpatient procedures are performed. FACT accreditation is the key to receiving reimbursement from federal payors and private insurers. Baptist does not plan to perform any inpatient BMTs until it has completed a year of outpatient autologous procedures. AHCA received letters from several Florida state legislators and local government officials expressing support for Baptist’s application. The Statutory Review Criteria Section 408.035(1)(a) – The Need for BMT in TSA 4 Because the rule governing applicants for autologous and allogeneic BMT programs requires applicants to demonstrate the ability to perform 10 autologous and 10 allogeneic BMTs a year, a forecast of the future need for BMT by TSA 4 residents is necessary in order to evaluate whether Baptist can satisfy that requirement. AHCA’s discharge database includes inpatient treatments and excludes outpatient treatments because outpatients are not admitted. That database indicates that 215 TSA 4 residents received BMTs at a CON-approved hospital in Florida for the 12 months ending September 2016. Sixty-two TSA 4 residents received their treatment at a facility outside TSA 4 during the 12 months ending in December 2016. The number of outmigration cases has remained relatively constant over the last 10 years despite the fact that UM has entered the BMT market and steadily increased the number of BMTs it performs. Baptist’s current application projects the increase in TSA 4's adult inpatient BMT case volume for 2019 (year one of operation) and 2020 (year two of operation) using three different annual growth rates (five percent, seven percent, and nine percent). This analysis forecasts increases of 34 to 63 BMT cases in 2019 and 46 to 88 cases in 2020, depending on the growth rate applied. In other words, Baptist projects that inpatient BMT need in 2019 for TSA 4 will be between 249 and 278 cases, and Baptist projects that inpatient BMT need for TSA 4 in 2020 will be between 261 and 303 cases. UM predicts that the need for adult inpatient BMT in TSA 4 in 2020 will be 277 cases. Both parties’ need projections are reasonable. Even if the demand for BMT by TSA 4 residents only grows by five percent a year, the resulting number of BMT cases will be higher than Baptist's projected volumes of 22 cases in year one and 30 cases in year two. This indicates that there will be adequate growth to support Baptist's BMT program and the existing providers. With regard to the need for BMT in TSA 4, Baptist’s health planning expert testified that: the number of adult inpatient bone marrow transplant cases that will be performed on residents of TSA 4 will grow by more than the 22 and 30 cases that are forecasted for Baptist Hospital. In other words, the market is growing enough that Baptist can achieve its volume and existing providers can maintain at least their current level of service. There are circumstances indicating that a five percent annual growth rate for inpatient BMT is conservative and likely to underestimate the actual need among TSA 4 residents. For instance, national volume data for BMT from the Center for International Blood and Marrow Transplant Research (“the CIBMTR”) shows that there has been strong and continuous growth in autologous and allogeneic BMT over the last 10 years in the United States. In 2010, there were 16,668 BMTs in the United States. By 2014, that number had grown to 19,862, which represents a five percent average annual growth rate. More recent data from the CIBMTR indicates that there were 21,292 BMTs performed in the United States during 2015, which represents a seven percent growth rate from 2014 to 2015. The number of BMT procedures is reliably growing every year, and that is partially due to slight increases in population. This increase is also due to the fact that additional types of patients might benefit from BMT. There has also been an increase in the number of BMTs performed in Florida. Total adult inpatient BMT cases performed in all Florida hospitals have grown from 671 procedures for the 12 months ending September 2012, to 917 procedures for the 12 months ending September 2016. That amounts to an increase of 246 inpatient cases over a four-year period, or an average annual increase of 62 cases each year. In percentage terms, that is a 37 percent increase from 2012 to 2016 and an annual average percentage growth of nine percent per year. A review of the most recent yearly increase, from 2015 to 2016, demonstrates there were 68 new cases and a percentage growth of eight percent. As for circumstances specific to TSA 4, the total population in South Florida is increasing at a rate of approximately one percent per year. The segment of the population over the age of 15 is growing at a slightly higher rate than the total population. People over the age of 61 are receiving more BMTs than in the past. Because the elderly (65+) show the highest percentage population growth in TSA 4, the increased volume for this population will impact the overall volume growth forecasted for TSA 4. There is additional room for BMT use to increase in TSA 4 because that area’s utilization of BMT is low in comparison to other geographic areas. AHCA discharge data shows an overall adult BMT use rate for TSA 4 residents of 4.12 cases per 100,000 people, and the use rate for all of Florida is 5.07 cases per 100,000 people. The greater weight of the evidence demonstrates that the number of inpatient BMT cases in TSA 4 will increase to at least 249 cases in 2019 and to at least 261 cases in 2020. The greater weight of the evidence also demonstrates that the aforementioned forecasts are conservative and that the actual increases are likely to be higher. Section 408.035(1)(b) – The Existing Health Services in the Service District of the Applicant Section 408.035(1)(b) requires AHCA to evaluate “[t]he availability, quality of care, accessibility, and extent of utilization of existing health care facilities and health services in the service district of the applicant.” (emphasis added). Section 408.032(5) divides Florida into 11 health service planning districts. District 11 consists of Miami-Dade and Monroe Counties. UM is the only BMT provider in District 11. Memorial West is located in District 10, which encompasses Broward County. Therefore, section 408.032(5) excludes Memorial West from this analysis. Good Samaritan does not have a BMT program. While UM is the only authorized and operational provider of inpatient BMT services in Miami-Dade County, UM did not provide BMT to a single charity care patient between 2014 and 2016, despite committing to do so. UM's lack of service to charity BMT patients is consistent with its financial reports to the state. UM has the ability to provide charity care. In 2016, UMHC reported a net income of approximately $175 million. As the only existing local BMT provider in the community, UM's failure to provide any charity care presents an access limitation for charity patients. The lack of outpatient BMT presents another access issue. UM does not plan to perform any outpatient BMT procedures even though the medical trend is that more and more of the less complicated autologous BMT procedures are being performed on an outpatient basis. Some countries in Europe are even experimenting with autologous transplantation performed in the patient's home. For some patients that live in the Miami area, outpatient BMT presents a more convenient alternative than a long hospital stay. The inability to access a BMT provider willing to perform outpatient BMT is an access issue. Another access issue involves the utilization of UM’s BMT capacity. The number of BMT procedures performed at UM has steadily increased over time and jumped by more than 70 procedures in 2017 alone. UM's physicians predicted that the number of BMT procedures would grow by 65 in the current year, allowing UM to reach volumes it has never achieved before. Those volumes have allowed UM to conduct research and educational activities. As a result of increasing volumes, UM's BMT program has used a progressively higher number of beds within the hospital. UM's BMT program is on track to treat 240 patients and will have to utilize other beds in addition to the 12 beds originally set aside for BMT. Another access issue pertains to the types of cases that outmigrate from TSA 4. Baptist’s application contained data indicating that a disproportionate amount of the outmigration cases are complex in nature, and the SAAR states the following: the applicant notes that the highest level of outmigration was observed in allogeneic BMT patients which accounted for 41 percent of outmigration cases. [Baptist] states that these patients require the longest post-discharge treatment regimen and for this reason high levels of outmigration are evidence of a significant problem. Autologous cases with complications account for 23 percent of outmigration cases and autologous patients without complications account for four percent of outmigration cases. The applicant reiterates that the proposed project is expected to target these patients as a local alternative to care outside of OTSA 4. The fact that Good Samaritan does not have a BMT program may be the most significant access issue in this particular service district, and that amounts to a substantial change in circumstances since the prior proceeding. ALJ Peterson’s Recommended Order indicates that he evaluated the existing provision of BMT in District 11 based on the premise that Good Samaritan had an operational BMT program. The greater weight of the evidence demonstrates that access to BMT in District 11 is less than optimal, especially given that all parties now accept that Good Samaritan does not have a BMT program. Section 408.035(1)(c) – The Applicant’s Ability and History Regarding Quality of Care Baptist offers high quality healthcare. Evidence of past quality is demonstrated by Baptist's numerous accreditations and quality awards. U.S. News and World Report studied patient safety and mortality rates in U.S. hospitals and surveyed 30,000 physicians in 5,000 hospitals across the country. The publication ranked BHSF as the highest performing healthcare organization in South Florida, and eighth best in Florida. Since the CON application was filed, BHSF has risen to sixth best in the state. Baptist is one of only eight hospitals in the world, and the first hospital in Florida, to receive the Magnet Award, an award for nursing practice from the American Nursing Association. The American Nursing Association reviews quality metrics and nursing performance in all departments of the hospital to determine merit for the Magnet Award. Baptist has achieved high marks for patient satisfaction. Consumer Reports ranked Baptist highly for patient safety and quality. Consumer Reports rated Baptist Hospital the safest hospital in Miami-Dade County. Baptist assures that a high quality of care is maintained by implementing robust performance improvement plans. Baptist has a board-level quality committee that reviews outcome data on a bi-monthly basis. Baptist also has a medical executive committee where performance improvement peer review results are presented on a monthly basis. Baptist also has a number of collaborative teams over particular areas such as surgery, stroke, and tumors. These teams review outcomes in their particular areas and present them to the performance improvement steering council. Baptist's performance improvement plan will be applied to a BMT program. There will be a BMT group to monitor outcomes in the same way as other groups. Baptist has already developed extensive policies and procedures for its BMT program. These policies and procedures were developed by the recruited staff and will be reviewed for final approval by the BMT program’s new director, Dr. Gunther Koehne. Baptist expects Dr. Koehne to implement standards of care consistent with MSK's in order for Baptist's patients to participate in MSK's clinical trials. Baptist’s outpatient BMT unit is brand new and is equipped for patient needs. The outpatient and apheresis BMT units had already been constructed, equipped, and staffed by the time of the final hearing in this matter. Dr. Koehne testified that the facilities are both attractive and highly functional. Baptist has provided the space and equipment necessary to operate a BMT program. Baptist's CON application included plans for the renovation of a portion of the hospital where inpatient BMT patients will be served. The parties stipulated that the costs and methods of that construction were reasonable. Baptist has an age-appropriate intensive critical care unit which includes facilities for prolonged reverse isolation. Evidence was presented regarding the correlation of low volume BMT hospitals or doctors and their outcomes. The studies suggest that higher volumes and experience for physicians and their teams lead to better outcomes for patients. However, Dr. Hugo Fernandez, the Chair of the Department of Malignant Hematology and Cellular Therapies at Moffitt, testified that a volume of 10 allogeneic transplants and 10 autologous transplants is above the volume at which research shows lower volumes may affect quality. Dr. Fernandez testified that Memorial West began safely performing allogeneic transplants one year after receiving its CON. Dr. Claudio Anasetti, the Chair of the Blood and Marrow Transplantation Department at Moffitt, agreed that 20 transplants is a sufficient volume to ensure good outcomes. The aforementioned findings, and those yet to be discussed, demonstrate that Baptist will be able to offer high quality care to patients of an adult inpatient BMT program. Section 408.035(1)(d) – The Availability of Resources Section 408.035(1)(d) pertains to a review of the applicant’s resources for project accomplishment and operation. The statute expressly mentions “health personnel, management personnel, and funds for capital and operating expenditures.” Findings regarding Baptist’s current ability to provide the health and management personnel necessary for autologous and allogeneic BMT will be discussed below in relation to Baptist’s ability to satisfy the criteria of rule 59C-1.044 applicable to BMT centers. Baptist’s ability to fund the proposal will be discussed below in relation to the immediate and long-term financial feasibility of the proposal. Section 408.035(1)(e) – The Extent to Which the Proposed Services Will Enhance Access to Health Care for Residents of the Service District Baptist has a history of providing health care services to Medicaid and indigent/charity patients. Baptist Health System hospitals, including Baptist Hospital, provide 4.3 percent of its services to charity care patients, which is well above the average of 3.4 percent for hospitals in Miami- Dade County. Baptist Hospital also exceeds the county average. As noted in a previous section, the access to care in District 11 is less than optimal given: (1) UM’s lack of inpatient charity care; (2) the fact that UM performs no outpatient BMT; (3) the fact that Good Samaritan does not have a BMT program; and (4) the fact that a very high percentage of the outmigration cases are complex in nature, i.e., allogeneic and autologous with complications. The greater weight of the evidence indicates that a BMT program at Baptist is likely to alleviate issues pertaining to access to care in the service district. However, given that Baptist will likely be a relatively small program for the foreseeable future, those issues will not be resolved in their entirety in the short-term. Section 408.035(1)(f) – The Immediate and Long-Term Financial Feasibility of the Proposal Section 408.035(1)(f) refers to “financial feasibility” rather than “profitability.” The cost for Baptist's proposed BMT program is $7,624,433, and the greater weight of the evidence demonstrates that Baptist will be able to finance the completion of the BMT program along with its other planned capital projects. Baptist has a capital budget of $20,414,000 to finance routine items such as the replacement of outdated equipment and renovations of nursing units. This budget also covers additional clinical equipment that might be needed to begin a new service line. Baptist identified other capital commitments that it had planned or were underway at the time of application. Along with the BMT program, Baptist’s other significant capital projects include construction of a new medical tower at a cost of $125 million and relocation of a helipad at a cost of $5 million. In total, Baptist disclosed $195.8 million in capital projects in its application. Rather than using debt to finance the initiation of the BMT program, Baptist will use cash on hand. The application included a letter from BHSF's Chief Financial Officer committing to pay for the project’s start-up costs and to cover any operational losses that may be incurred as the BMT program ramps up: BHSF intends to make available the required funds to Baptist Hospital of Miami, Inc. for the purpose of establishment of the project described in CON Application No. 10490, through startup and project stabilization, including but not limited to the project costs identified on Schedule 1 of CON Application No. 10490. BHSF intends to fund this project from internal sources. BHSF’s ability to fund the project is documented in the attached BHSF audited financial statements. Baptist provided audited financial statements which demonstrate the wherewithal to afford this project. BHSF’s net income for 2016 was $162,640,710. BHSF had $263 million in cash flow in 2016 and possesses over $2.4 billion in cash and investments. While the audited financial statements state that the cash and other investments are “limited,” the explanatory notes to those statements state that “[a]ssets whose use is limited include assets set aside by the Board of Trustees for future capital improvements and education, over which the Board retains control and may at its discretion subsequently use for other purposes . . . .” This supports Baptist’s assertion that the unrestricted cash and investments can be used for any purpose. BHSF’s financial statements indicate that its current liabilities exceed its current assets by $100,470,725. While this is cause for concern, that is substantially ameliorated by the fact that BHSF’s total assets exceeded its total liabilities by $3,165,081,911 in 2016. Even if BHSF’s application understated (or even omitted) some expenses associated with initiating the BMT unit, those expenses are insignificant for an entity with the financial resources available to Baptist through BHSF. In short, the greater weight of the evidence demonstrates that Baptist can afford to initiate the proposed project and cover any operational losses during the first years of operation. With regard to long-term financial feasibility, Baptist expects to get little or no revenue from allogeneic transplants in year one because it plans to perform 10 cases in order to become FACT accredited. None of the managed payors such as Medicare HMO and Medicaid HMO will pay until there is FACT accreditation. Accordingly, the per case revenue is expected to be $88,000 in year one, but that amount is expected to increase to $175,000 in year two. After accounting for anticipated expenses, Baptist forecasts a $2.9 million loss in year one of the application and a $577,000 loss in year two of the application. During the final hearing, Baptist’s financial expert testified that the BMT program was projected to turn a small profit of $25,000 in year three of the application. Given how substantially the net loss from the BMT program narrowed from year one to year two by adding only eight patients, it is reasonable to infer that the program will come close to breaking even by adding an additional 10 patients at some point after year two of the application. Baptist’s projected expenses differ from its previous application because Baptist previously estimated both inpatient and outpatient revenues and expenses. The current application is for inpatient services only. Outpatient BMT services have already been established at Baptist, and the expenses for those facilities and staff are considered sunk costs when compared to the project at issue, inpatient BMT services. Those sunk costs include research facilities, staffing, nurses, and doctors, and they were appropriately excluded from the pro forma financial statements associated with this application. Existing hospital staff can absorb the additional demand for dietary and other services. Even if it were to be assumed that this project will never be a positive contributor to Baptist’s net income, that would not be a basis, by itself, for finding that the BMT program is not financially feasible over the long-term. UM’s healthcare planning expert testified that BMT programs are not profit centers, but healthcare institutions operate such programs in order to fulfill a “mission” and to help people. That testimony was convincing and is accepted. The evidence clearly and convincingly demonstrates that Baptist and BHSF are committed to having a BMT program. As noted above, Baptist considers a BMT program to be an integral component of its goal to have MCI be a full service cancer treatment center. Baptist and BHSF’s commitment to the project is further demonstrated by the fact that MCI has already begun treating patients via an outpatient BMT program. Baptist has incurred substantial expenses (such as construction and staffing) in preparing to have a BMT program at MCI. In short, the preponderance of the evidence demonstrates that this project is financially feasible in the long-term. Even if it is not ultimately profitable, Baptist is committed to funding the program's losses, and Baptist demonstrated the ability to cover operational losses indefinitely.7/ Section 408.035(1)(g) – The Extent to Which the Proposal Will Foster Competition that Promotes Quality and Cost-Effectiveness AHCA concluded in the SAAR that “[t]his project is not likely to have a material impact on competition to promote quality and cost-effectiveness.” Nevertheless, the SAAR presented the following regarding the implications of UM’s PPS-exempt status: In addition, the reviewer notes that the applicant will not be a PPS-exempt cancer hospital, as UMHC is designated, and therefore reimbursement to the two proposed Miami-Dade providers from Medicare will be different. The reviewer notes that according to the U.S. Government Accountability Office (GAO), in 2012, Medicare payments received by the 11 PPS- exempt cancer hospitals were, on average, 42 percent more per discharge than what Medicare would have paid a local PPS teaching hospital to treat cancer beneficiaries with the same level of complexity. The GAO also found that the PPS-exempt cancer hospital’s payment methodology lacks strong incentives for cost containment and has the potential to result in substantially higher total Medicare expenditures. The GAO concludes that until Medicare pays PPS-exempt cancer hospitals to encourage efficiency, Medicare remains at risk for overspending. According to FloridaHealthFinder.gov, based on data submitted to the Agency through the inpatient database, UMHC had 160 bone marrow transplants with charges ranging from (on average) $403,740 (25th percentile) to $662,662 (75th percentile) with an ALOS of 25.0 days for CY 2016 for all adults 18+. The statewide total charges, for the same time period, ranged (on average) from $188,363 to $458,097 with an ALOS of 22.8 days. While a BMT program at Baptist is unlikely to promote competition that will increase quality and cost-effectiveness, it appears that a BMT program at Baptist serving Medicare recipients would be less costly than the same service at UM, a PPS-exempt provider. However, given the relatively small size of the program at Baptist, it would probably be many years before any substantial savings could be achieved by shifting Medicare BMT patients from UM to Baptist. Section 408.035(1)(h) – The Costs and Methods of the Proposed Construction The parties stipulated that the costs and methods of construction were reasonable. Section 408.035(1)(i) – Baptist’s Past and Proposed Provision of Health Care Services to Medicaid Patients and the Medically Indigent As found above, Baptist Hospital has a significant record of providing more than the average level of service to Medicaid recipients and the indigent. Rule Review Criteria General Requirements for Organ Transplantation Programs Rule 59C-1.044 is entitled “Organ Transplantation” and sets forth additional criteria by which AHCA reviews applications for organ transplantation programs such as a BMT program. Subsection (1) of the rule provides that “[a]pplicants for each type of transplantation program shall meet the requirements specified in subsections (3), (4) and (5).” Rule 59C-1.044(3)(a) requires applicants to have staff and other resources necessary to care for the patient’s chronic illness before, during, and after transplantation. The rule also requires that “[s]ervices and facilities for inpatient and outpatient care shall be available on a 24-hour basis.” Findings regarding Baptist’s physician staff are set forth below during the discussion of requirements pertaining specifically to allogeneic BMT programs. Nevertheless, it is found here that Baptist can provide a comprehensive range of physician specialty support services on a 24-hour basis. These include (but are not limited to) services such as intensive care physicians, cardiologists, infectious disease specialists familiar with the care of severely immune-compromised patients, and interventional radiologists. Rule 59C-1.044(3)(c) requires a transplant services applicant to have “[a]n age-appropriate (adult or pediatric) intensive care unit which includes facilities for prolonged reverse isolation when required.” Baptist’s application satisfies this requirement. Baptist proposes utilizing its existing adult critical care resources when necessary for BMT patients. Baptist plans to transfer BMT patients from the six-bed adult BMT unit to the intensive care unit (“ICU”) when the ICU team determines the patient needs additional critical care support. Examples include patients who become hemodynamically unstable or those who need mechanical ventilation. Baptist’s application notes that it is developing a “Protective Environment” room to support BMT patients who may require critical care services. Rule 59C-1.044(3)(d) requires a transplant services applicant to have “[a] clinical review committee for evaluation and decision-making regarding the suitability of a transplant candidate.” Baptist satisfies this requirement in that Baptist has specifically identified eight physicians to serve on its clinical review committee and will place subsequently recruited BMT physicians on the committee. Baptist has also identified 17 other medical professionals (including many from the BMT Team Support staff) who will be placed on its clinical review committee. Rule 59C-1.044(3)(e) requires an applicant to have: [w]ritten protocols for patient care for each type of organ transplantation program including, at a minimum, patient selection criteria for patient management and evaluation during the pre-hospital, in- hospital, and immediate post-discharge phases of the program. Rule 59C-1.044(3)(f) requires an applicant to have “[d]etailed therapeutic and evaluative procedures for the acute and long term management of each transplant program patient, including the management of commonly encountered complications.” Baptist’s application states that: [t]he protocols, policies, treatment plans and guidelines for selection, evaluation, treatment and management of the BMT patients are currently being finalized under the direction of the BMT Medical Director, Lyle Feinstein, MD. Drafts of these [] protocols, policies, treatment plans and guidelines are presented in Appendix 5. The draft documents received in evidence and other information presented in Baptist’s application are sufficient to satisfy the required patient selection criteria established by rule. As for the evaluative procedures, the application states “[w]ritten protocols/policies defining therapeutic and evaluative procedures for the acute and long term management of each BMT patient are being finalized for the Fall 2017 initiation of the outpatient BMT program and for the development of this proposed inpatient BMT program.” The application includes examples of those final drafts. The draft documents received in evidence are sufficient to meet the required therapeutic and evaluative procedures established by rule. Rules 59C-1.044(3)(h), (i), and (j) require an applicant to have: (a) an onsite tissue-typing laboratory or a contractual arrangement with an outside laboratory within Florida meeting the requirements of the American Society of Histocompatibility; (b) pathology services; and (c) blood banking facilities. In the current application, Baptist states that it has contracted with the Laboratory Corporation of America (“LabCorp”) for tissue typing services. The application includes a certificate from the American Society of Histocompatibility and Immunogenetics indicating that LabCorp is accredited in the area of “Histocompatibility Testing for Other Clinical Purposes.” The application also demonstrates that LabCorp is licensed to operate within the State of Florida. The contract with LabCorp is sufficient to meet the criteria in rule 59C-1.044(3)(h). As for pathology services, Baptist explains in its application that its laboratory department has the technical resources and expertise necessary to fully support the proposed BMT program and provide the necessary information to best manage[] each BMT patient’s care. This in-house expertise and infrastructure, combined with the OneBlood and LabCorp external resources, will ensure that all BMT patients will have the required laboratory support to optimally meet their medical needs. The application specifies that Baptist’s laboratory department can provide the following services: chemistry, coagulation, cytology, flow cytometry, hematology, histology, microbiology, phlebotomy, serology, transfusion service, and urinalysis. The aforementioned services are available 24 hours a day, seven days a week. In addition, laboratory tests can be completed in approximately one hour on a STAT basis. The application states that the laboratory department has seven pathologists who are board certified in anatomic and clinical pathology and that those pathologists: are eminently qualified and [] can diagnose the spectrum of complications that may occur in the immunocompromised bone marrow transplant patient population. They are able to diagnose the different pathogens that may effect this population. Similarly, they are able to identify and diagnose the histologic features of graft vs. host disease. The record evidence is sufficient to meet the criteria for pathology services in rule 59C-1.044(3)(i). The application also states that: [t]he existing blood banking and transfusion facilities and services currently in existence at Baptist Hospital are appropriate for supporting the blood requirements associated with the proposed new BMT program. Combining these existing Hospital capacities with the support of OneBlood, acting as the area’s centralized blood collection, storage and distribution hub, all necessary blood banking services are available and supported. Further, with OneBlood providing the specialty BMT blood/marrow processing and storage services, the blood and blood banking needs of the BMT patients will be fully met. The application contains a June 6, 2017, letter from a OneBlood representative to Marisol Fitch of AHCA describing OneBlood’s capabilities and indicating OneBlood will be servicing Baptist’s BMT program. The record evidence is sufficient to meet the criteria for blood banking facilities and services in rule 59C-1.044(3)(j). Rule 59C-1.044(3)(k) calls for an applicant to have a “program for the education and training of staff regarding the special care of transplantation patients,” and Baptist’s current application demonstrates it has such a program. Rule 59C-1.044(3)(l) refers to “[e]ducation programs for patients, their families and the patient’s primary care physician regarding after-care for transplantation patients.” UM does not challenge Baptist’s ability to satisfy this criterion. Rules 59C-1.044(4)(a) and (b) set forth general requirements for the physician staff and the program director. These topics will be addressed in the discussion pertaining to the specific rule-based requirements for an adult allogeneic BMT program. Rule 59C-1.044(4)(d) sets forth general requirements for nurses and nurse practitioners. This topic will be addressed in the discussion pertaining to the specific rule-based requirements for an adult allogeneic BMT program. Rule 59C-1.044(4)(e) calls for an applicant to have “[c]ontractual agreements with consultants who have expertise in blood banking and are capable of meeting the unique needs of transplant patients on a long term basis.” Baptist’s current application demonstrates that OneBlood, as its provider of “specialty BMT blood/marrow processing and storage services,” meets the criteria established in that rule. Rules 59C-1.044(4)(f), (g), and (h) call for an applicant to have appropriately trained nutritionists, respiratory therapists, social workers, psychologists, and psychiatrists. Baptist has “clinical registered dieticians who are Certified Specialists in Oncology Nutrition, having the expertise of meeting the needs of patients with immunocompromised patients.” As for respiratory therapists, the application states that Baptist’s respiratory therapists “are experienced in providing respiratory support to BMT patients who develop pulmonary complications post-transplant such as pulmonary edema, bronchiolitis obliterans with organizing pneumonia and other complications seen post-transplant.” The application also states that Baptist’s respiratory therapists “will receive structured education about current standards of respiratory and pulmonary care for bone marrow patients by an expert in the field.” As for the requirements pertaining to social workers, psychologists, and psychiatrists, Baptist’s application states that it has a full complement of such professionals and four social workers assigned to the inpatient oncology unit. Baptist plans to have social workers “specifically trained and assigned to support bone marrow transplant patients and families.” Those “BMT social workers will be knowledgeable in the spectrum of community services and assets available to support bone marrow transplant patients and their families throughout the full continuum of bone marrow care, including pre- and post-transplant care.” Moreover, MCI is building a “Cancer Patient Support Center” that will be staffed by multidisciplinary teams of specialists and clinicians who will provide a wide array of support services such as Psycho-Oncology, Psychosocial Services, Integrative Medicine, Exercise Physiology, and Oncology Rehabilitation. Baptist’s application and the evidence of record is sufficient to meet the criteria established in rules 59C- 1.044(4)(f), (g), and (h). Rule 59C-1.044(5) pertains to data reporting requirements for facilities with organ transplant programs and is not at issue in this proceeding. As discussed above and in subsequent findings set forth below, Baptist’s application satisfies the requirements set forth in rules 59C-1.044(3) and (4). Requirements Specific to Bone Marrow Transplant Applicants Rule 59C-1.044 sets forth requirements specific to bone marrow transplant applicants. For instance, subsection (1) states that a bone marrow transplant applicant must be a teaching or research hospital. See Fla. Admin. Code R. 59C-1.044(1) (mandating in pertinent part that “[t]he following organ transplantation programs shall be restricted to teaching or research hospitals: liver, adult allogeneic bone marrow, pediatric allogeneic and autologous bone marrow ”). See also Fla. Admin. Code R. 59C-1.044(9)(b)(mandating that “[a]dult allogeneic bone marrow transplantation programs shall be limited to teaching and research hospitals.”); Fla. Admin. Code R. 59C-1.044(9)(c)(providing that “[a]dult autologous bone marrow transplantation programs can be established at teaching hospitals or research hospitals; or at community hospitals having a research program, or who are affiliated with a research program, as defined in this rule.”). Rule 59C-1.044(9)(b)9. pertains specifically to adult allogeneic BMT programs and requires an applicant to have “[a]n ongoing research program that is integrated either within the hospital or by written agreement with a bone marrow transplantation center operated by a teaching hospital. The program must include monitoring and long-term patient follow-up.” Rule 59C-1.044(9)(b)10. requires “[a]n established research-oriented oncology program.” The Research Criteria Rule 59C-1.044(2)(d) defines a “research hospital” as “[a] hospital which devotes clearly defined space, staff, equipment, and other resources for research purposes, and has documented teaching affiliations with an accredited school of medicine in Florida or another state.” Rule 59C-1.044(2)(d) defines a “research program” as “[a]n organized program that conducts clinical trial research, collects treatment data, assesses outcome data, and publishes statistical reports showing research activity and findings.” The evidence presented at final hearing demonstrated that Baptist Hospital has a robust research program and a good research team. Dr. Miguel Villalona-Calero was recognized as an expert in medical oncology and clinical and translational research. Dr. Villalona-Calero has been involved with cancer research his entire career. Dr. Villalona-Calero has served as principal investigator on numerous clinical trials, including National Cancer Institute ("NCI") clinical trials. In 1999, Dr. Villalona-Calero moved to Ohio State University where he became a full tenured professor and conducted many clinical trials with early therapeutics. By the time Dr. Villalona-Calero left Ohio State, the research he was conducting had become nationally and internationally known. Dr. Villalona-Calero has approximately 111 original publications resulting from his research. Dr. Villalona-Calero has been involved in approximately 21 grants from NCI related to translational research work. Dr. Villalona-Calero left Ohio State to join Baptist in September of 2015. Dr. Villalona-Calero was one of the first physicians Baptist recruited toward the goal of building the research component of Baptist's comprehensive cancer center. Dr. Villalona-Calero leads Baptist's research program with Dr. Jeffrey Boyd, Dr. Minesha Mehta, and Dr. Michael Zinner. Among the other clinical trials personnel on the fourth floor of MCI are coordinators, research nurses, and data managers. Dr. Villalona-Calero has recruited infusion nurses with the experience to respond to any emergencies that may occur during the clinical trials on the fourth floor. In addition to Dr. Villalona-Calero, Dr. Zinner, Dr. Boyd and Dr. Minesh Mehta, there are other investigators at Baptist who conduct research, including a radiation oncologist and a neuro-oncologist. Baptist's application contained the biographies of 13 additional investigators conducting research at Baptist. Dr. Koehne will also conduct research at Baptist, similar to the research he conducted at MSK. Dr. Koehne is well recognized in the bone marrow transplant field, specifically in the area of T-cell immunology and T-cell immunotherapy. The clinical trials office at Baptist is almost fully staffed. The only area for which Dr. Villalona-Calero is still recruiting is in the expanding area of early therapeutics. Staffing is complete for clinical research services, regulatory quality assurance, clinical trials administration, and finance. Dr. Villalona-Calero formed the clinical scientific review committee to review the scientific merit of all the cancer clinical trials to be performed at MCI. The clinical scientific review committee works in conjunction with the Institutional Review Board ("IRB"). The IRB rules on ethical issues such as informed consent. While the clinical scientific review committee is composed of MCI faculty, the IRB is an independent higher authority that must approve clinical trials before they may commence. Since the 2015 CON application, Baptist has constructed MCI, and it includes a research wing. Baptist now has its clinical trials personnel on the fourth floor of the research wing. The new research wing also houses the Center for Genomic Medicine and a Phase One Therapeutics Unit. Dr. Villalona-Calero designed the therapeutics unit that contains advanced cardiology equipment that permits printing of EKGs directly from the equipment. The unit also contains ten infusion areas, a centralized nursing station, and a centralized investigational pharmacy. Adjacent to the unit are the facilities to house the clinical trials personnel. Near the clinical trials personnel are a protocols support lab and a biorepository. The fourth floor of the research wing also contains treatment rooms. These rooms have monitoring capabilities not available in normal hospital rooms. Because a patient's condition can change quickly and unexpectedly during clinical trials, these rooms are also designed so that emergency procedures can be activated more quickly than in a normal hospital room. The fourth floor rooms are similar to ICU rooms. The clinical treatment rooms and their equipment are fully operational and open to patients. Dr. Villalona-Calero and Dr. Boyd also have laboratories at Florida International University (“FIU”). The labs at FIU allow for trials not suitable in a hospital, such as trials involving animals. BHSF funded the labs at FIU. Baptist has outcome monitoring and long-term patient follow-up as part of its research program. Additionally, Baptist's Center for Genomic Medicine is conducting cutting edge research at Baptist. Dr. Boyd was accepted as an expert in translational research and genomic medicine. Dr. Boyd is the Vice-President for Translational Research and Genomic Medicine, as well as the Deputy Director at MCI. Dr. Boyd is also employed by FIU as a tenured professor and chair of the Department of Human and Molecular Genetics, and associate dean for basic research and graduate programs. He has held both positions since July 2015. As founding director of the Center for Genomic Medicine at MCI, Dr. Boyd has created three operation units within MCI. First is the division of clinical genetics, a group of medical professionals whose function is to counsel and advise appropriate genetic testing – and in some cases treatment – for individuals at substantially increased risk for inherited cancer susceptibility. Second is a biobanking operation consisting of two discrete entities: the biospecimen repository facility ("BRF") and the protocol support lab ("PSL"). The BRF is charged with acquiring the consent of MCI patients for permission to bank excess tissue, blood and other fluids, annotate them, store them and ultimately distribute them for generic research purposes, as they may arise in the translational cancer research universe. The PSL obtains these biospecimens, processes them, and distributes them to laboratories that may be conducting a test associated with the clinical trial. Third is the molecular diagnostics laboratory ("MDL"), which is the clinical testing facility. The MDL performs targeted therapy, precision therapy, and precision medicine by obtaining DNA from patient tumors and manipulating that DNA with the goal of finding "druggable targets." The MDL contains a research and development division that carries out translational cancer research, primarily genetic and genomic type research using existing technology, and research to develop new types of testing that may become appropriate as the field evolves. The Center for Genomic Medicine at MCI conducts significant clinical research. This clinical research is specifically focused on cancer research. Baptist and FIU share a very close and expanding relationship related to medical school research and clinical care. FIU's medical school has 480 students (120 students per class). Most of these students' clinical experience during their four-year education period takes place at Baptist. Baptist has funded research laboratories for numerous faculty on the college of medicine staff. Baptist's research program has changed substantially since the 2015 CON application. For example, Baptist has ramped up its clinical trials program through its association with MSK, and the completion of the construction of the physical plant has allowed the opening of the Center for Genomic Medicine, where the above mentioned genomic research takes place. Baptist also conducts investigator-initiated trials that were not yet begun during the last CON application. The Teaching Criteria Rule 59C-1.044(2)(g) provides that a “teaching hospital” means “[a]ny hospital which meets the conditions specified in Section 408.07(45), F.S.” The statute defines teaching hospitals as hospitals that are officially affiliated with an accredited Florida medical school with at least seven accredited, graduate medical educational programs and the presence of at least 100 full time resident physicians. Baptist does not offer seven accredited graduate medical educational programs to at least 100 residents, and therefore does not meet the definition of a teaching hospital as set forth in section 408.07. However, Baptist engages in teaching activities. BHSF coordinates all of the clinical rotations for FIU medical students across the Baptist Health system. There are approximately 500 students participating in rotations at BHSF. Approximately 3,000 physicians are credentialed at BHSF. More than 500 of those physicians have faculty appointments at FIU. They serve as precepting physicians for the medical students who participate in clinical rotations. Baptist offers training to first and second year medical school students, including rotations in emergency medicine. After moving into their third and fourth years, students move into their core elective rotations which occur across the entire BHSF system. There are approximately two dozen elective rotations available to third and fourth year medical school students at Baptist, including general surgery and internal medicine. There are approximately 500 medical students rotating in a typical year at Baptist. Baptist provides accredited graduate medical education programs in family medicine, family sports medicine, and orthopedic sports medicine. Baptist also offers fellowships in radiology and minimally invasive surgery. Baptist offers a robust clinical training program in nursing and allied health. Baptist has between 3,500 and 4,000 nursing allied health students credentialed to rotate through all of BHSF. Despite the fact that Baptist does not meet the technical requirements to be a teaching hospital, it does satisfy the standards associated with a research hospital. Therefore, Baptist satisfies rules 59C-1.044(1) and (9). Volume Requirements When considered together, rules 59C-1.044(9)(b)1. and (c)1. require that an applicant for an adult autologous and allogeneic BMT program be able to project that at least 10 autologous and 10 allogeneic transplants will be performed each year.8/ As found in a previous section, a conservative estimate indicates that the number of BMT procedures should grow by at least five percent a year in TSA 4. Given the forecasted growth in BMT and the fact that Baptist refers approximately 70 patients a year to other facilities for BMT treatment, Baptist should have no difficulty satisfying the volume requirement. It is reasonable to expect that a substantial number of patients who begin their cancer treatment at Baptist will elect to stay with Baptist if their course of treatment leads to BMT. The greater weight of the evidence demonstrates that Baptist satisfies the volume requirements. Program Director Requirements 253. Rules 59C-1.044(9)(b)2. and (c)2. have virtually identical requirements for a program director. Rule 59C-1.044(9)(b)2. requires an applicant to have program director who is a board certified hematologist or oncologist with experience in the treatment and management of adult acute oncological cases involving high dose chemotherapy or high dose radiation therapy. The program director must have formal training in bone marrow transplantation. Baptist has recruited Dr. Koehne to serve as the program director for its BMT program. After obtaining his medical degree and PhD in Germany, Dr. Koehne worked at MSK. MSK is one of the leading institutions for cancer and bone marrow transplant in the world. While at MSK, Dr. Koehne focused his research on post-transplant complications following allogeneic BMTs, including the reactivation of certain viruses. After undergoing clinical trials, a method developed by Dr. Koehne to treat such viral reactivations became the nationally recognized standard for treatment and has been licensed by biopharmaceutical companies. In addition to his appointment as a member at MSK, Dr. Koehne was a professor of medicine at Weill Cornell Medical College. Prior to coming to MCI, Dr. Koehne was the medical director of the BMT laboratory and associate attending physician at MSK. As medical director, Dr. Koehne oversaw the processing of bone marrow and gained familiarity with the equipment and processes for blood processing. Dr. Koehne has done extensive work in the field of BMT research. Before leaving MSK, Dr. Koehne served as principal investigator of three clinical research trials and co-investigator on three or four more trials. Dr. Koehne plans to continue these clinical trials at MCI, the results of some of which have already been published. Dr. Koehne has personally performed many BMTs throughout his career. MSK Cancer Center does 450 transplants a year. Approximately 250 of those cases are autologous and the rest are allogeneic. The greater weight of the evidence demonstrates that Baptist has satisfied the program director requirement. Nursing Requirements Rule 59C-1.044(4)(d) requires all transplant applicants to have a staff of nurses and nurse practitioners “with experience in the care of chronically ill patients and their families.” Rule 59C-1.044(9)(b)3., which specifically pertains to adult allogeneic BMT programs, requires an applicant to have “[c]linical nurses with experience in the care of critically ill immune-suppressed patients. Nursing staff shall be dedicated full time to the program.” UM does not contest the fact that Baptist has a nursing staff experienced in the care of chronically ill patients and their families. As for the requirements of rule 59C-1.044(9)(b)3., Baptist has approximately 130 critical care, clinical nurses experienced in the care of critically ill immunosuppressed patients within the critical care unit. Baptist has a history of effectively staffing specialty areas that require specialty education. Baptist's ICU is also appropriately staffed. This nursing expertise will be available to the BMT program. Baptist has developed a program for the education and training of staff regarding special care of BMT patients. Baptist included the 306-page plan in its CON application. This plan addresses the care requirements for providing bone marrow transplant care. The greater weight of the evidence demonstrates that Baptist satisfies the nursing requirements. Interdisciplinary Transplant Team Rule 59C-1.044(4)(a) pertains to all transplant applicants and requires them to have a “staff of physicians with expertise in caring for patients with end-stage disease requiring transplantation.” Furthermore, that staff “shall have medical specialties or sub-specialties appropriate for the type of transplantation program to be established.” Rule 59C-1.044(9)(b)4. applies specifically to adult allogeneic BMT programs and requires an applicant to have: [a]n interdisciplinary transplantation team with expertise in hematology, oncology, immunologic diseases, neoplastic diseases, including hematopoetic and lymphopoietic malignancies, and non-neoplastic disorders. The team shall direct permanent follow-up care of the bone marrow transplantation patients, including the maintenance of immunosuppressive therapy and treatment of complications. Baptist has substantially augmented its existing physician staff through the hiring of Dr. Koehne. Baptist will also rely on Dr. Feinstein to provide BMT services. Dr. Feinstein has experience starting a new BMT program and in achieving FACT accreditation. Dr. Feinstein has experience with both autologous and allogeneic transplantations. Dr. Feinstein has a strong background in BMT. MCI was also successful in recruiting Dr. Paba-Prada, who is experienced in autologous transplantation and treating patients with myeloma and lymphoma from Dana-Farber Cancer Center. Baptist’s application states the following regarding its physician staffing: Essential to the success of the proposed BMT program is the experienced team of 27 board certified hematologists and oncologists currently on staff at the Hospital, with three of these physicians currently trained and experienced to care for the adult BMT patients. With this large group of hematologists and oncologists currently on staff, providing patient care in the inpatient and outpatient settings, these physicians create a strong and experienced medical team to support the existing 9 multidisciplinary tumor site teams, including a team for Hematological Malignancies and BMT. To whatever extent that Baptist needs to recruit additional physicians in order to satisfy the rule-based requirements, it is noted that the program will not heavily taxed at the outset. There will probably never be more than two to three patients in the BMT unit at any one time during the first two years of operation. The greater weight of the evidence demonstrates that Baptist satisfies the physician staffing requirements. Laboratory Requirements Rule 59C-1.044(9)(b)7. calls for an applicant to have: [a] laboratory equipped to handle studies including the use of monoclonal antibodies, if this procedure is employed by the hospital, or T-cell depletion, separation of lymphocyte and hematological cell subpopulations and their removal for prevention of graft versus host disease. This requirement may be met through contractual arrangements. Rule 59C-1.044(9)(b)8. calls for an applicant to have “[a]n onsite laboratory equipped for the evaluation and cryopreservation of bone marrow. Baptist proposed to contract with OneBlood for laboratory services required to offer BMT. The application also indicated that Baptist would establish an onsite lab if required by AHCA. When AHCA approved Baptist's application, the approval was conditioned upon the establishment of an onsite laboratory for cryopreservation at Baptist. Since that requirement was announced, Baptist identified space, budgeted, and has now equipped a cryopreservation lab at the hospital. OneBlood offers services used in BMT at hospitals. OneBlood provides processing for allogeneic and autologous transplants. OneBlood provides blood processing services for other BMT programs in Florida. OneBlood provides services for both Miami Children's Hospital's BMT program and Memorial West's BMT program. Neither hospital has its own cryopreservation lab. OneBlood provides all processing required of – and has all the equipment needed for – an autologous BMT procedure including cryopreservation. OneBlood also provides all the processing required for an allogeneic BMT procedure. OneBlood has agreed to provide the processing required for Baptist's BMT program, as it does for Miami Children's Hospital and Memorial West. OneBlood offers cryopreservation and storage, thawing of stem cell collections, and CD 34 cell counts. OneBlood will offer T-Cell subset characterization (also referred to as "T-cell depletion") in 2018. To begin offering T-cell depletion, OneBlood only needs to acquire a cell separator. The cell separator is an automatic machine. OneBlood will have little difficulty gaining the additional accreditation to perform T-cell depletion because performing T-cell depletion only requires the acquisition of the cell separator. The OneBlood contract accommodates requests for services after hours and on weekends because OneBlood is available on call if products arrive during off hours. UM has used OneBlood for stem cell processing in the past. UM has successfully transferred blood product from OneBlood to UM for use in transplantation. UM has also successfully shipped blood products that were harvested at UM from UM to OneBlood. UM has successfully transferred blood product to OneBlood for use in a transplantation in Broward County. The greater weight of the evidence demonstrates that Baptist satisfies the laboratory requirements. Other Criteria Baptist satisfies the requirements in rules 59C- 1.044(9)(b)5. and 6. pertaining to inpatient transplantation units and a radiation therapy division. Rule 59C-1.044(9)(b)11. calls for an applicant to have a “patient convalescent facility to provide a temporary residence setting for transplant patients during the prolonged convalescence.” Baptist’s application notes that it “works cooperatively with a number of local hotels to ensure that patients and their families have accessible housing resources during extended hospital stays or extended recuperative stays." Baptist also has several apartments that can be used by patients, caregivers and/or family members. The application states that Baptist is in the process of constructing a new hotel facility that will be located on the northwest corner of the Baptist Hospital campus. This hotel will have 184 rooms and will house BMT patients and their families during post-transplant monitoring and evaluation. Rule 59C-1.044(9)(b)12. calls for an applicant to have an “outpatient unit for close supervision of discharged patients.” The application states that Baptist anticipated completing an outpatient unit on the third floor of MCI by the Fall of 2017. The greater weight of the evidence demonstrates that Baptist satisfies standards for convalescent housing and outpatient facilities. Not Normal Circumstances A prospective provider of a tertiary health service such as BMT can apply by satisfying all of the statutory and rule requirements or by demonstrating that not-normal circumstances exist. Ms. Fitch, the CON and commercial managed care unit manager for AHCA, explained the not-normal circumstances AHCA relied on to preliminarily approve Baptist’s CON: Q: What abnormal circumstances were presented within this application? A: Well, there were a couple of them. There was the utilization of the existing programs. Essentially the – there are three programs in OTSA 4. The first one, Good Sam, is essentially defunct. We had condition compliance reports; we noted it in the SAAR, that, through condition compliance reports, we found out that what Good Sam had been reporting were biopsies, because they reported zero inpatient or outpatient bone marrow transplants in calendar year 2016. So that program is essentially defunct. We also had Memorial West, which is significantly underutilized and not producing enough bone marrow transplants to be considered much of a viable program in the latter half of 2015 and certainly in 2016. We also have the overutilization of the one program at University of Miami Hospital and Clinics. They applied for a 12-bed unit. They advertised on their website for a 12-bed unit. They’re obviously doing more than what an average daily census of 12 beds would be. So that program seemed to be overutilized. So the utilization patterns that we were seeing [were] one not-normal circumstance for the population. Another not-normal circumstance is the charity care or lack of charity care within this OTSA 4, not seeing that charity care is being provided by the existing program, and so there [are] questions as to financial accessibility to the residents of OTSA 4. In addition to that, looking at the cost- effectiveness criteria under 408.035, looking at the data that is at Florida Health Line for charges amongst the – statewide for the exact same procedure, and then looking at the charges at University of Miami Hospital and Clinics, the charges at University of Miami Hospital and Clinics are significantly higher than the charges for the statewide average. And by “significantly higher,” it’s approximately $200,000 plus, both in the charges low category, which is the 25th quartile; and in the charges high category, which is the 75 quartile. So that cost- effectiveness issue is concerning. In addition to that, on the cost- effectiveness, University of Miami pointed out in their opposition statement that they are a PPS-exempt facility. And kind of exploring what that means, they’re one of only 11 PPS-exempt facilities in the nation, and how they get reimbursed by Medicare – of course Medicare is the bar in which all rates are set – and so how that affects cost-effectiveness within the OTSA 3 – 4, sorry. Q: Were previous programs approved by the agency applying this rule under not normally approved? A: Yes. The last two bone marrow transplant programs in OTSA 4 that were approved, both the University of Miami Hospital and Clinics and Memorial West, were approved under not-normal circumstances, because they did not meet all the rule criteria; specifically, both of those facilities were not statutory teaching hospitals. The fact that Good Samaritan does not have a BMT program, despite the previous reports to AHCA that it performed 42 BMTs in 2016, by itself, is significant enough to justify Baptist not strictly complying with the requirements of rules 59C-1.044(9)(b) and (c). The greater weight of the evidence demonstrates that not-normal circumstances are present in TSA 4. Adverse Impact If the CON at issue is granted, there is no persuasive evidence demonstrating that UM’s ability to conduct research or to maintain the proficiency of its physicians will be adversely impacted. However, it is very likely that patients who would have received their BMT treatment at UM will instead receive that treatment at Baptist. While the greater weight of the evidence demonstrates that UM should not experience any meaningful decline in volume, UM is very likely to be adversely impacted by the fact that its patient volumes (and the resulting increase in revenues) will not be growing as quickly if the CON at issue were not granted. As Baptist moves to recruit additional staff with experience with BMT and/or allogeneic procedures, it is possible that Baptist may hire UM employees. In sum, the greater weight of the evidence demonstrates that UM will be adversely impacted to a minor degree if the CON at issue is granted. Changed Circumstances To the extent the outcome of DOAH Case No. 16-1698CON is determined to have any relevance in this de novo proceeding, the evidence establishes that conditions have sufficiently changed such that conclusions regarding issuance of a CON to Baptist for an adult autologous and allogeneic BMT program in TSA 4 in DOAH Case No. 16-1698CON have no applicability to the new application at issue herein. Such changed circumstances include, but are not limited to, the following. Ms. Fitch testified that it was unknown during the prior proceeding that Good Samaritan was a defunct program. Multiple findings in ALJ Peterson’s Recommended Order corroborate Ms. Fitch’s testimony. The alliance between Baptist and MSK is another changed circumstance. Mr. Richardson described the significance of that alliance as follows: The Memorial Sloan Kettering alliance linkage is just not marketing and branding and saying you are a part of us. It actually appears to be a much stronger integrated linkage between Memorial Sloan Kettering and the Baptist Hospital Miami Cancer Institute operation. Basically the last go around, Baptist was in a six- to nine-month evaluation process, where they were providing policies, procedures, outcomes, just a huge amount of information to Sloan Kettering to basically see whether they would be accepted as part of the alliance. That all went through, and now as described here, it’s a real linkage; they basically, in terms of the – you have linkage between the clinical side and you have linkage between the research sides. So you have the ability for Baptist to tap into the expertise that is available at Sloan Kettering. So it’s not just a marketing name, Baptist Hospital linked with somebody else. It’s a true integrated operational linkage. Another changed circumstance is that MCI is now operational, and Baptist is performing outpatient autologous procedures. At the time of the 2015 CON application, MCI was aspirational and was being constructed. The current Baptist application is substantially better than the prior one. Baptist has gone to great lengths to improve its research capacity, and all of the available evidence indicates that Dr. Koehne is exceptionally well-qualified to be Baptist’s program director.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Agency for Health Care Administration enter a final order approving the Certificate of Need Application No. 10490 submitted by Baptist Hospital of Miami, Inc. to establish a new adult autologous and allogeneic bone marrow transplant program in Florida’s Organ Transplant Service Area 4. DONE AND ENTERED this 15th day of August, 2018, in Tallahassee, Leon County, Florida. S G. W. CHISENHALL Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 15th day of August, 2018.
The Issue Whether the Petitioner, Floretta Allen, is entitled to payment for medical services by the State of Florida Employees' Group Health Self Insurance Plan?
Findings Of Fact The Parties. The Petitioner, Floretta Allen, is the wife of an employee of the State of Florida. Ms. Allen is a participant in the State of Florida Employees' Group Health Self Insurance Plan (hereinafter referred to as the "Insurance Plan"). The Respondent, the Division of State Employees' Insurance, Department of Management Services (hereinafter referred to as the "Department"), is an agency of the State of Florida. Among other things, the Department is administrator of the Insurance Plan. Ms. Allen's Illness. In April of 1992, Ms. Allen was diagnosed as suffering from multiple myeloma. Multiple myeloma is a form of cancer which affects the bone marrow and blood. Ms. Allen was diagnosed by Dr. Mary Alpin. Dr. Alpin specializes in hematology and oncology, disorders of the blood and cancer. Ms. Allen was diagnosed by Dr. Alpin as having Stage III-A Myeloma: "She had a very high total protein in her blood. She already had extensive involvement of her bone marrow. And although a large percentage of people respond to treatment, their prognosis is not very good with that stage of disease. In other words they tend to respond to treatment for a while and then relapse. They may respond to a second treatment, but they eventually succumb to their disease pretty rapidly." Page 42, lines 20-25 and page 43, lines 1-3 of the transcript of the final hearing. Treatment and Referral of Ms. Allen by Dr. Alpin. Because of the stage of Ms. Allen's disease, Dr. Alpin "mentioned to her that there was some evidence suggesting that there were long-term disease remissions and possibly even cures of myeloma with bone marrow transplant." Page 42, lines 2-5 of the transcript of the final hearing. Therefore, Dr. Alpin referred Ms. Allen to the University of Florida medical facility, Shands, because there was a bone marrow transplant unit there. Shands did not perform bone marrow transplants for multiple myeloma. Dr. Alpin then referred Ms. Allen to the H. Lee Moffitt Cancer Center (hereinafter referred to as the "Cancer Center"), at the University of South Florida in Tampa, Florida. Ms. Allen's Treatment at the Cancer Center. Ms. Allen was under the care of Oscar Ballester, M.D. at the Cancer Center. Ms. Allen first saw Dr. Ballester in July or August of 1992. Dr. Ballester confirmed Dr. Alpin's diagnosis of Ms. Allen's illness. At the time of Ms. Allen's referral to the Cancer Center, the Cancer Center was carrying on a Phase I-II Study, Protocol Number 10461 (hereinafter referred to as the "Phase I-II Study"), involving the treatment of multiple myeloma with high dosage chemotherapy and bone marrow transplantation. Dr. Ballester recommended that Ms. Allen agree to participate in the Phase I-II Study to treat her illness. Ms. Allen agreed to the recommended treatment. Initially Ms. Allen underwent approximately six months of chemotherapy. She underwent a short course of intensive chemotherapy after which her peripheral blood stem cells were harvested and then she was admitted for high-dose therapy with busulfan and cyclophosphamide. While undergoing chemotherapy during the end of 1992, a bone marrow donor, one of Ms. Allen's sisters, was found. In August of 1993 Ms. Allen underwent the bone marrow transplant. Denial of Insurance Coverage. Petitioner's exhibits 1 and 2 are examples of booklets provided to employees of the State of Florida. Pursuant to Petitioner's exhibit 1, employees are informed on pages 5 and 6 of certain "exclusions" from coverage under the Insurance Plan. Among other things, "experimental or investigative procedures" are listed as excluded from coverage. Pursuant to Petitioner's exhibit 2, employees are informed on pages 10 through 12 of "exclusions" from coverage. Among other things, the following is listed as excluded: "Any service or procedures which are determined by the Administrator to be experimental or investigative " The Benefit Document for the Insurance Plan also provides that "experimental" procedures or services are excluded from coverage. The Benefit Document defines the terms "experimental or investigative" as follows: W(b) "Experimental or Investigative" means any evaluation, treatment, therapy, or device which involves the application, administration or use, of procedures, techniques, equipment, supplies, products, remedies, vaccines, biological products, drugs, pharmaceuticals, or chemical compounds if, as recommended by the Servicing Agent and determined by the Administrator: such evaluation, treatment, therapy, or device cannot be lawfully marketed without approval of the United States Food and Drug Administration or the Florida Department of Health and Rehabilitative Services and approval for marketing has not, in fact, been given at the time such is furnished to the Insured; reliable evidence shows that such evaluation, treatment, therapy, or device is the subject of an ongoing Phase I, II, or III clinical investigation or under study to determine: maximum tolerated dosage(s), toxicity, safety, efficacy, or efficacy as compared with the standard means for treatment or diagnosis of the condition in question; reliable evidence shows that the consensus of opinion among experts is that further studies, research, or clinical investigations are necessary to determine: maximum tolerated dosage(s), toxicity, safety, efficacy, or efficacy as compared with the standard means for treatment or diagnosis of the Condition question; reliable evidence shows that such evaluation, treatment, therapy, or device has not been proven safe and effective for treatment of the condition in question, as evidenced in the most recently published medical literature in the United States, Canada, or Great Britain, using generally accepted scientific, medical, or public health methodologies or statistical practices; there is no consensus among practicing Physicians that the treatment, therapy, or device is safe and effective for the condition in question; or such evaluation, treatment, therapy, or device is not the standard treatment, therapy or device utilized by practicing Physicians in treating other patients with the same or similar condition. NOTE: "Reliable evidence" is determined by the Administrator to mean: . . . . the written protocol or protocols relied upon by the treating physician or institution or the protocols of another physician or institution studying substantially the same evaluation, treatment, therapy, or device; or the written informed consent used by the treating physician or institution or by another physician or institution studying substantial the same evaluation, treatment, therapy, or device; or . . . . Respondent's exhibit 3-C. Ms. Allen was informed in August of 1992 that her Insurance Plan would not cover the treatment recommended by the Cancer Center because it was considered to be "experimental." By letter dated March 24, 1993, the Cancer Center was informed that treatment pursuant to the Phase I-II Study was not covered by the Insurance Plan because it was considered to be "experimental." Even though aware that the Insurance Plan had taken the position that treatment pursuant to the Phase I-II Study was not covered by the Insurance Plan, Ms. Allen and the Cancer Center proceeded with Ms. Allen's treatment. By letter dated April 23, 1993, Ms. Allen requested that the Department pay for the medical services she had received at the Cancer Center. In a letter dated May 28, 1993, the Department informed Ms. Allen that her request was denied. The Department informed Ms. Allen that Subsection G.28 of the Insurance Plan's Benefit Document excludes "any services or procedures which are experimental or investigative . . . ." The Department informed Ms. Allen that the Cancer Center's treatment of her was under a Phase I-II Study Program of the University of South Florida Health Science Center and was "experimental." Was the Cancer Center's Treatment "Experimental." Dr. Ballester is a member of the Cancer Center's bone marrow transplant division. Dr. Ballester is involved in cancer research at the Cancer Center. Dr. Ballester was a co-investigator for the Phase I-II Study of the Cancer Center. The rationale, purpose and nature of the Phase I-II Study is described in a Protocol, Respondent's exhibit 3F and Respondent's exhibits A and C (Respondent's exhibit C was not effective until December 7, 1993, after Ms. Allen's treatment). The rationale and purpose of the Phase I-II Study contained in the Protocol is hereby incorporated by reference into this Recommended Order. The Phase I-II Study and the Protocol were approved by the Cancer Center on December 2, 1991, and by the University of South Florida on January 6, 1992. The objectives of the Phase I-II Study are described as follows in the Protocol: To confirm the value of the combination of busulfan and cyclophosphamide and allogeneic bone marrow transportation in the treatment of standard risk leukemias, high risk leukemias, lymphomas not eligible for autologous bone marrow transplant, myelodysplasia, and multiple myeloma. To evaluate this combination of chemotherapy with the addition of total lymphoid irradiation for patients undergoing matched unrelated donor transplants for leukemia or lymphoma. To evaluate this combination of chemotherapy for patients with leukemia or myeloma not candidates for allogeneic bone marrow transplants but eligible for autologous peripheral stem cell transplantation. To determine response rates and long term remission rates as measured by disease free survival. To determine the toxicities of this drug combination with and without total lymphoid irraditation. The number of patients that may be treated in the Phase I-II Study is limited to 60. The procedures followed in the Phase I-II Study pursuant to the Protocol are consistent with guidelines for Phase I-II Studies established by the United States Food and Drug Administration. The Protocol provides that all patients participating in the Phase I- II Study pursuant to the Protocol are to sign an informed consent form. See Respondent's exhibit 3E and Respondent's exhibit B. The informed consent form explains in some detail the purpose of the "research study," the procedures involved, the risks, discomforts or side effects that may be expected, possible benefits and alternative procedures or treatment. The Protocol also contains the following: PARTICIPATION AS A RESEARCH SUBJECT: My participation in this study is voluntary and I am free to withdraw consent and stop participation in the study at any time without this decision affecting my medical care. . . . Ms. Allen executed an informed consent form as required by the Protocol. Dr. Ballester explained why he does not believe that the treatment that Ms. Allen received is "experimental." Dr. Ballester, however, did not indicate that he was aware of or took into account the definition of "experimental" for purposes of the Insurance Plan contained in the Benefits Document. Dr. Ballester did not dispute that the services provided to Ms. Allen were part of a Phase I-II Study, that a consent form was required of Ms. Allen to participate in the Phase I-II Study and that the Phase I-II Study was intended to determine the "efficacy and safety" of the drugs involved in the study. The definition of "experimental" contained in the Benefits Document includes evaluations, treatments, therapies and devices which are "subject of an ongoing Phase I, II or III clinical investigation" to determine ". safety, efficacy " Although the treatment received by Ms. Allen may not be considered by some physicians to be experimental, the treatment received by Ms. Allen which is at issue in this case comes with the definition of "experimental" contained in the Benefits Document for purposes of the Insurance Plan.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Department of Management Services, Division of State Employees' Insurance, enter a Final Order denying payment for the services received by Ms. Allen pursuant to the Phase I-II Study and dismissing Floretta Allen's petition. DONE AND ENTERED this 3rd day of June, 1994, in Tallahassee, Florida. LARRY J. SARTIN Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 3rd day of June, 1994. APPENDIX Case Number 93-3728 The Department has submitted proposed findings of fact. It has been noted below which proposed findings of fact have been generally accepted and the paragraph number(s) in the Recommended Order where they have been accepted, if any. Those proposed findings of fact which have been rejected and the reason for their rejection have also been noted. Ms. Allen did not file a proposed recommended order. The Department's Proposed Findings of Fact Accepted in 1-2. Hereby accepted. Accepted in 3 and 5. See 4. The specific findings contained in this paragraph are based upon what purports to be an article published in a periodical. It constitutes unsubstantiated hearsay and the article was not properly identified or authenticated for the purpose for which the Department has relied upon it to support the proposed findings of fact contained in this paragraph. Accepted in 6. Accepted in 6. Accepted in 7-8. 8-9 Hereby accepted. Not supported by the weight of the evidence. The specific findings contained in this paragraph are based upon what purports to be an article published in a periodical. It constitutes unsubstantiated hearsay and the article was not properly identified or authenticated for the purpose for which the Department has relied upon it to support the proposed findings of fact contained in this paragraph. Accepted in 9. Accepted in 14. Accepted in 13 and hereby accepted. Accepted in 28 and hereby accepted. 15-16 See 27. Accepted in 29. Accepted in 26. 19-22 Hereby accepted. Not supported by the weight of the evidence. The specific findings contained in this paragraph are based upon what purports to be an articles published in periodicals. They constitute unsubstantiated hearsay and the articles were not properly identified or authenticated for the purpose for which the Department has relied upon them to support the proposed findings of fact contained in this paragraph. Accepted in 34 and hereby accepted. 25-27 Hereby accepted. Accepted in 30 and 32. Hereby accepted. Accepted in 20 and hereby accepted. Hereby accepted. Accepted in 20. Accepted in 21. Accepted in 22. Hereby accepted. COPIES FURNISHED: Arthur R. Shell, Jr., Esquire 502 Northwest 75th Street, Suite 10 Gainesville, Florida 32607 Augustus D. Aikens, Jr. Chief of Bureau of Benefits and Legal Services Division of State Employees' Insurance Department of Management Services 2002 Old St. Augustine Road, B-12 Tallahassee, Florida 32301-4876 William H. Lindner, Secretary Department of Management Services Knight Building, Suite 307 Koger Executive Center 2737 Centerview Drive Tallahassee, Florida 32399-0950 Paul A. Rowell, General Counsel Department of Management Services Knight Building, Suite 312 Koger Executive Center 2737 Centerview Drive Tallahassee, Florida 32399-0950 Alecia Runyon, Director Department of Management Services Division of State Employees' Insurance 2002 Old St. Augustine Road, B-12 Tallahassee, Florida 32301-4876
The Issue This case is a bid protest filed by Petitioner, Laboratory Corporation of America Holdings ("LabCorp"), to contest the award of a contract by Respondent, Department of Revenue ("Department"), to Intervenor, Orchid Cellmark, Inc ("Orchid" or sometimes "OCI"). The issues are whether the Orchid bid was responsive to the bid criteria, whether Orchid is a responsible bidder, and whether the Department's award of the bid to Orchid should be deemed clearly erroneous, contrary to competition, arbitrary or capricious.
Findings Of Fact Based on the oral and documentary evidence presented at the final hearing and on the entire record of the proceeding, including the Joint Pre-Hearing Stipulation of the parties, the following Findings of Fact are made: Petitioner, Laboratory Corporation of America Holdings, is a national testing laboratory with over 1,700 company-owned Patient Service Centers in the United States, including 176 in Florida. LabCorp has an existing contract with the State of Florida to provide Child Support Enforcement Genetic Testing Services in Department Regions 2, 3, 4 and 5, as well as Manatee County. These regions comprise the majority of the state. LabCorp has a longer history of providing paternity testing services using buccal swab collections (see discussion below) than any other party bidding on the RFP. Intervenor, Orchid Cellmark, Inc., is also a long-time provider of genetic testing and has been providing genetic parentage testing services since 1979. Orchid currently has a contract with the Department to provide such services in two areas of the state: Department Region 1 (comprising essentially all of Florida panhandle) and Dade County. Orchid has experience providing parentage services to governmental entities, including the states of Ohio, Georgia and Michigan. In its services to the State of Florida, Orchid has tested over 20,000 cases involving over 53,000 samples; it had zero misreported results to the Department related to those cases. Respondent, Department of Revenue, is the state agency responsible for the CSE program. CSE is one of six programs within the Department that interacts with clients on a one-to- one basis. The Department, unlike many state agencies, is organized using a business process model similar to the structure used in commercial and industrial sectors. Tasks and activities within the Department are aggregated from the bottom to the top, where the executive director is found. CSE became a function of the Department in 1994, moving from the Department of Children and Families. The purpose of the move was to emphasize collection of funds and to change from a caseworker model to a business process model. As a result, cases within CSE are handled by different offices or persons depending on the nature of the activity being addressed within that particular case, as opposed to having the entire case handled by a single assigned caseworker. CSE has five core processes: Case Management, Payment Processing and Fund Distribution, Child Support Aid, Establishment, and Compliance. CSE is organized into five geographic regions, each of which has service sites where CSE provides client services. One of the important services provided in these regions is genetic testing which is used to establish paternity. Inasmuch as the Department does not have the personnel or wherewithal to perform genetic testing internally, that function is contracted out to established providers of such services. CSE handles the establishment of the paternity process up to the point of genetic testing before allowing its contracted providers to perform the test. Once the test is completed, CSE continues with its duties concerning CSE. Each contracted provider of testing is responsible for the entire testing process: collecting specimens, transfer of specimens to a lab, maintaining chain of custody, conducting tests and reporting results to the Department. Further, each testing provider is responsible for seeing that a licensed phlebotomist is present to take the sample from the Department's client. Providers will not be paid if there are any failures during the testing process. On or about August 31, 2007, the Department put out the RFP soliciting bids for genetic testing of clients and associated persons within the CSE program. The contract period runs from the contract execution date (or January 1, 2008, whichever is later) until June 30, 2011, plus three optional one-year renewals. Bids from the following entities were received in response to the RFP: Orchid, Labcorp, Paternity Testing Corporation, and ReliaGene Technologies.1/ Each of the four bids was reviewed upon submission to determine whether they were responsive to the bid criteria. Each was found to be responsive. Thereafter, four Department employees designated as "evaluators," each reviewed the four bids (or proposals). The evaluators were: William Branch, Carey Abney, Mayra Levenson, and Scott Edmonds. The bids were scored pursuant to points assessed for each section of the RFP, as indicated in the table below: Technical Response Maximum Raw Score Weight Factor Maximum Points Possible Understanding the Required Services 5 20 100 Methodology Used for Providing the Services 5 25 125 Management Plan for Providing the Services 5 15 75 Experience and Qualifications 5 20 100 Cost Response 5 50 250 Based upon these evaluation criteria, the four proposals were scored by the evaluators as follows: LabCorp: Technical--306.25; Cost--250.00; Total--556.25 Orchid: Technical--368.75; Cost--241.94; Total--610.69 PTC: Technical--301.25; Cost--187.50; Total--488.75 ReliaGene: Technical--217.50; Cost--157.34; Total--374.84 LabCorp, whose cost proposal segment2/ was deemed superior to the other applicants, contests the total point assignment to Orchid on several bases. Each of those will be discussed below, but first a brief discussion of the underlying service in the contract: DNA testing. DNA Testing Versus Genetic Testing DNA testing for human identity first became available in the mid-to-late 1980s. DNA paternity testing began in approximately 1990. Early DNA paternity testing contracts bidded out by various states required DNA testing to be performed on blood drawn from the putative parents and the child for whom paternity was to be established. However, as the science in this area improved, other testing methods became available. At the present time, Florida requires paternity testing to be done by way of polymerase chain reaction (PCR) technology. PCR technology allows laboratories to perform DNA testing on a very small sample. This technology is utilized to evaluate human epithelial or "buccal" cells drawn from the inside of a person's cheek by use of buccal swabs. This process eliminates the need to draw venous blood from the subjects, expediting and easing the specimen collection process. The purpose section of the RFP includes this language: [CSE] is soliciting proposals for genetic testing services through this Request for Proposal for the purpose of conducting genetic testing services for the Department Program in child support cases throughout Florida. The Genetic Testing provided by the Provider is to conclusively determine the paternity of a child when paternity has not already been established. In certain circumstances in which paternity may have already been established, the court may order genetic tests in order to assist with its decision in a contested case. The general instructions to the RFP include language relating to misstatements made by vendors. The RFP states: All information provided by, and representations made by, the respondent are material and important and will be relied upon by the Buyer in awarding the Contract. Any misstatement shall be treated as fraudulent concealment from the Buyer of the true facts relating to submission of the bid. A misrepresentation shall be punished under law, including, but not limited to Chapter 817 of the Florida Statutes. Chapter 817, Florida Statutes, relates to Fraudulent Practices, including issuing statements under false pretenses and fraud. Relating to action that can be taken by the Department if a vendor submits a proposal with misstatements, Section 1.4.18 of the RFP states: FDOR will reject all proposals that FDOR deems to have a material defect. A material defect is any part of the proposed solution that violates a mandatory requirement and results in an unacceptable system or unacceptable risk. FDOR will reject proposals that fail to pass the Selected Mandatory Items Compliance Evaluation. Further, Paragraph 16 of the General Instructions to the RFP states: Minor Irregularities/Right to Reject. The Buyer reserves the right to accept or reject any and all bids, or separable potions thereof, and to waive any minor irregularity, technicality, or omission if the Buyer determines that doing so will serve the State's best interests. The Buyer may reject any response not submitted in the manner specified by the solicitation documents. With that backdrop, LabCorp maintains that Orchid provided false information in its bid proposal, thereby making the proposal non-responsive to the RFP. LabCorp's position is based on certain statements by Orchid concerning Orchid's history in the field of genetic testing. Orchid's History of DNA Testing Orchid, in its proposal, states, "Orchid Cellmark, Inc. (OCI), has been a leading provider of parentage and other family relationship DNA analysis since 1979, and is one of the largest providers of identity testing services in the world." It also states, "OCI has a history of providing the highest quality and most reliable DNA testing services identical to those outlined in this [RFP] for over 27 years." In actuality, DNA testing has not been in existence since 1979, a fact Orchid freely conceded at final hearing.3/ Orchid actually intended its statement to suggest that Orchid had been involved in "genetic" testing since 1979; that is also a true fact and more accurately reflects Orchid's history. None of the evaluators made any distinction between DNA testing versus genetic testing when reviewing the competing proposals. The phrase "DNA testing," in and of itself, does not appear to have been material or relevant to the assignment of scores by the evaluators under the scoring criteria. LabCorp also contends that Orchid provided misleading information by claiming to own a large number of testing sites when, in fact, Orchid generally does not own testing sites that it utilizes. Orchid's Network of Approved Sites In its proposal, Orchid stated several times that it had a network of over 5,000 established, approved sites for specimen collections. That network has been developed by Orchid as it performed services under various contracts around the United States (and Great Britain). Orchid does not own or lease any of the sites. Nonetheless, Orchid's proposal states, "Currently, OCI provides secure and convenient specimen collection services at 127 of its own sites in addition to many Service Centers designated by the State." Orchid distinguishes the phrases "own sites" from "owned sites" by saying that the former means a site used by them on a regular basis. This definition is supported by the attachment to Orchid's proposal which lists the various sites. That list includes not only state office buildings, but also hospitals and other health facilities. (In fact, Orchid lists as part of its 5,000 sites some sites actually owned by LabCorp.) It is clear Orchid is not claiming ownership of those places. Orchid's witnesses' testimony concerning this issue is credible. There was no representation by Orchid that it had obtained state or other government approval for its intended collection sites. Rather, the sites were "approved" internally by Orchid, representing the fact that such sites had been used by Orchid previously and found to be sufficient for their purposes. None of the evaluators based their scoring on whether Orchid owned or leased a collection site versus simply having access to them based on past relationships, nor did calling the sites "approved" sway the evaluators. Failure of Orchid to Identify Subcontracted Phlebotomists LabCorp also contends that Orchid failed to properly identify and provide information for all of its intended subcontract-phlebotomists. The RFP, at section 2.5, states: Subcontractors may be used to perform work under this Contract. If a proposer intends to use subcontractors, the proposer must identify in the proposal the following: complete name of the subcontractor, complete address of the subcontractor, type of work the subcontractor will be performing, percentage of work the subcontractor will be performing, evidence that the subcontractor holds a valid business license, a written statement, signed by each proposed subcontractor, that clearly verifies that the subcontractor is committed to render the services required by the Contract. A proposer's failure to provide this information may cause the FDOR to consider their proposal non-responsive and reject it. The substitution of one subcontractor for another may be made only at the direction and prior written approval of the Contract Manager for the FDOR. Subcontractors of the Provider must adhere to the same level of qualifications and standards as required of the Provider. LabCorp maintains that Orchid violated this provision of the RFP by failing to identify its phlebotomists as subcontractors and failing to provide all the required information about such subcontractors. LabCorp does most of its collections and testing using its own employees. The company occasionally subcontracts with other vendors to provide some services. LabCorp, in its proposal, identified a subcontractor with whom it intended to do business under the contract with the State of Florida. All required information concerning that subcontractor was supplied to the Department in LabCorp's response. Conversely, Orchid has no employees who do actual collecting of samples. Rather, Orchid relies on the services of persons and entities which operate independently of Orchid. Some of these independent collectors are located within the network of 5,000 sites addressed by Orchid in its proposal. The collectors for the contract at issue are yet to be named or will be contracted once the award has become final. This arrangement (using independent collectors for doing collections) has worked well for Orchid during its historical operations and particularly during its current contract with the State of Florida in Region 1 and Dade County. Orchid intends to use the same arrangement for collections under the contract currently in dispute. Orchid has an agreement it utilizes when hiring third-party sample collectors. The agreement is part of the Collector Manual employed by Orchid and distributed to many of its collector sites. In response to emails from the Department concerning its current contract with Orchid, Orchid was asked whether a certain collector was a subcontractor and, if so, to provide certain required information about that collector. In response, Orchid emailed the Department a list of collectors designated either as a "Business" or as an "Independent Contractor." Apparently Orchid's distinction between independent contractors and businesses is that individuals (real persons as opposed to business entities) are independent contractors. Since Orchid does not employ subcontractors, this list was submitted in response to the inquiry instead of a list of subcontractors (which it does not have). The term "subcontractor" is not defined in the RFP. It is defined in Black's Law Dictionary as: One who takes portion of a contract from principal contractor or another subcontractor. . . One who has entered into a contract, express or implied, for the performance of an act with the person who has already contracted for the performance. . . One who takes from the principal or prime contractor a specific part of the work undertaken by the principal contractor. Clearly, Orchid intends to allow some non-affiliated persons to perform some portions of the contracted work under the RFP. However, Orchid has always referred to such persons as independent contractors, as evidenced by its response to a Department email in March 2007. In its email, the Department has asked Orchid whether a certain business entity (Accurate DNA of Northeast Florida) was Orchid's subcontractor. In response, Orchid provided a list of active specimen collectors that it utilized at that time. The list contained the requisite information (Federal ID number, address, name, etc.), but identified the entities as either businesses or independent contractors. The Department then thanked Orchid for providing "your list of subcontractors." The RFP addresses phlebotomists a number of times. However, in only one section (5.1.2.2.5) does the RFP specifically address "sub-contracted phlebotomists." In that section, providers are directed to insure that both its phlebotomists and subcontracted phlebotomists maintain a professional appearance and demeanor while at a collection site. It is impossible to distinguish the semantics in the discussion between Orchid and the Department on this issue to ascertain whether each was contemplating the same thing. Nonetheless, in the RFP at issue, Orchid did not provide a list of subcontractors, but the Department exercised its discretion and deemed the proposal responsive nonetheless.4/ The Department intended to designate specific collection sites upon final award of the contract. Thereafter, the winning bidder would be expected to propose additional sites as necessary to provide services to meet the needs of the Department. It is reasonable to presume that a bidder would not be able to list all of its intended phlebotomists at the time of the initial bid. And, the Department's deputy director for the CSE program testified that the Department did not presume or expect a vendor to list its intended phlebotomists. In its review of proposals, the Department made a determination as to each bidder's qualifications and experience. It did not attempt to determine if one bidder was more qualified and experienced than another. Rather, it simply determined that a bidder had enough experience to carry out the terms of the contract. Both Orchid and LabCorp were found to meet the necessary experience threshold. A side-by-side comparison of the relative experience and qualifications of Orchid versus LabCorp was irrelevant to the award of the contract.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a final order be entered by the Department of Revenue upholding its award of the contract to Orchid. DONE AND ENTERED this 13th day of June, 2008, in Tallahassee, Leon County, Florida. R. BRUCE MCKIBBEN Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 13th day of June, 2008.
