The Issue The issue for consideration in this case is whether Respondent's license as a physician in Florida should be disciplined because of the matters alleged in the Administrative Complaint.
Findings Of Fact At all times pertinent to the issues herein, the Petitioner, Board of Medicine, through the Agency For Health Care Administration, and formerly the Department of Business and Professional Regulation, has been the state agency in Florida responsible for the regulation of the practice of medicine and the licensing of physicians in this state. Respondent has been a physician licensed in Florida under license number ME 003824. Starting on January 12, 1988 and continuing thereafter until on or about March 16, 1988, Respondent treated Patient #1 for a condition known as Dupuytren's Contracture of the left hand. This conditions results in the thickening of scar tissues and contracture of fibrous bands in the palm and fingers which pulls the fingers into the palm and constricts their ability to flex or straighten out. Patient #1 had suffered from this condition since 1982. In 1984, a surgeon in New Jersey performed Dupuytren's Contracture release surgery on the patient's right hand, but the results were not altogether satisfactory. Respondent first saw Patient #1 on January 12, 1988. At this initial visit, Respondent discussed the implications of the proposed surgical procedure and advised the patient of the possible adverse consequences thereof. He noted that because the patient had delayed seeking treatment for the left hand, there was a strong possibility of complications as a result of surgery which could involve nerve damage and infection in addition to a possibility of vascular damage and necrosis of the tissue of the hand. On February 10, 1988, Respondent performed a Dupuytren's Contracture release on the patient's left hand at the Gulf Coast Orthopedic Center, (GCOC). This surgery is a complicated, delicate and difficult procedure which in the instant case, was made even more difficult by the extent of the existing contracture of the patient's hand. After the completion of the surgery, Respondent placed Patient #1 on Keflex, an antibiotic, and also prescribed Darvocet for pain. Respondent saw Patient #1 again on February 11, 1988. At this time, the patient was complaining of pain in the hand and of the tightness of the bandage. Respondent examined the wound at this time, cleaned it, placed a plastic platform splint on the hand and re-bandaged it. The patient was also prescribed Percodan for pain and advised to continue the Keflex at a 1,500 mg/day dosage. Patient #1 returned to Respondent again on February 12, 1988, still complaining of pain and that the bandage was too tight. After again examining the hand, Respondent re-bandaged it, placing gauze between the patient's fingers and the splint. He also gave the patient another prescription for Percodan for the pain. On February 17, 1988, the patient again came to the Respondent's office for his third postoperative checkup. When Respondent removed the bandage, he noticed a small greenish area on the palm which was exuding what appeared to be white pus. Respondent thoroughly cleaned the wound by placing the hand in a whirlpool bath of water and Betadine solution for approximately 45 minutes. He did not culture the green area or the white exudation. When he released the patient that day, however, he increased the Keflex dosage to 2,000 mg/day but refused to give him a prescription for additional Percodan for the pain. Instead, he told him to take extra strength Tylenol. He also told the patient to keep the hand elevated but did not suggest the patient call in the event of pain. Respondent did not see Patient #1 again until February 24, 1988 even though the pain had increased during that period. The patient, however, did not call the Respondent to complain, believing the increase in pain was the result of the removal of the prescription for Percodan and the substitution of a lesser strength substance, Tylenol, therefor. The patient assumed, from the Respondent's prior comments, that the pain was normal and to be expected. When Respondent saw Patient #1's hand again on February 24, 1988, he became excited because it appeared there was infection in the left palm which had spread to the PIP joint of the middle finger at which point there was some necrosis. Respondent appeared upset because the Patient had not called him when the pain continued or increased. Patient #1's wife had asked that the patient do so, but the patient decided to wait until the next scheduled appointment on February 24, 1988. At this time, Respondent removed the sutures from the patient's hand and irrigated the wound with a mixture of saline solution and an antibiotic, Kepsol. A culture was also taken at this time. Since Respondent did not have hospital admitting privileges in the area, he arranged through Dr. Alea, an associate in his clinic who did have such privileges, to have Patient #1 admitted to Bayonet Point Hospital for treatment of the infection. The treating physician there was Dr. K. Sundaresh, an infectious disease specialist. The admission was on February 24, 1988. Dr. Sundaresh placed Patient #1 on prolonged antibiotic treatment, obtained a bone scan to document any infection, and directed debridement, incision and drainage of the wound. The bone scan report indicated that Patient #1 "most likely" had developed osteomyelitis, a bone infection, at the base of the middle finger on the left hand. X-rays taken around the same time, on March 1, 1988, revealed findings consistent with osteomyelitis. Following the hospital admission, Respondent departed for Arizona for three days to attend a previously scheduled medical seminar, returning on February 27, 1988. While he was gone, however, Respondent spoke daily with Patient #1 by telephone and consulted with the physicians who were treating him. Dr. Alea suggested that Patient #1 be examined by another orthopedic physician, Dr. Moss, but when Dr. Moss came to see Patient #1 in the hospital, he was told the patient had already seen Respondent. The consult report prepared by Dr. Moss reflects no consult was had because the patient "wants treatment as now arranged under Dr. Bonati." Records of GCOC indicate that on March 1, 1988, Respondent spoke with patient #1's daughter by telephone indicating that if the patient did not come to the clinic that day, he would be released from Respondent's care. In fact, the patient did go to see Respondent on March 1 and 2, 1988 on pass from the hospital, but claims he did not refuse treatment by Dr. Moss. When Respondent saw Patient #1 in his office on March 1, 1988, after noticing a greenish material on the patient's left palm which he thought might be pseudomonas, he elected to continue the antibiotic treatment that was initiated in the hospital. When the patient was released from the hospital on March 4, 1988, the wound was healing well. Dr. Sundaresh arranged for the patient to continue the intravenous antibiotic treatments through a home nursing services. The final diagnosis at the time of discharge was osteomeleyitis of the middle finger of the PIP joint on the left hand due to pseudomonas aeruginosa infection. Respondent saw Patient #1 in his office on March 7, 9, and 16, 1988, after the patient's discharge from the hospital. The patient was scheduled for another visit on March 22, 1988, but cancelled that appointment and also elected to discontinue the physical therapy Respondent had prescribed for him at GCOC. The hospital records show that while there, Patient #1 received daily physical therapy treatments consisting of whirlpool treatments to the hand and sterile dressings, starting on his admission on February 24, 1988, but no range of motion exercises. The physical therapy prescribed at GCOC by Respondent starting on March 8, 1988 included range of motion exercises which he continued until March 15, 1988. At the time of the last visit, on March 16, 1988, Respondent noted that the patient's wounds were healing well, but there was some limited range of motion. One of Petitioner's experts, Dr. Nadler, a board certified orthopedic surgeon with over 17 years experience, who is in practice with Dr. Angelides, to whom he refers all his hand surgery cases, opined that the standard of care for orthopedic surgery such as performed here by Respondent would be for the surgeon to have the ability to admit and follow the patient in a hospital if complications should arise. At very least, the surgeon should have the ability to make arrangements for another orthopedic surgeon to follow the patient in his absence. According to Dr. Nadler, it is not at all unusual for infection to occur in Dupuytren's Contracture release surgery. He concluded that Respondent fell below the standard of care when he performed a complicated surgical procedure on Patient #1 without having the personal ability to admit his patient to a hospital or to follow his patient's progress in the hospital in the event complications, such as an infection, should occur. He also concluded that Respondent's failure to have another orthopedic surgeon available to follow the patient while in the hospital was below standards as well. This opinion was shared by Petitioner's other expert, Dr. Visconti, a board certified orthopedic surgeon who, by his own admission, however, is not a hand surgeon specialist. Respondent's expert, Dr. Angelides, a board certified orthopedic surgeon who specializes exclusively in surgery to the hand and upper extremity, indicated that the presence of a green wound which exudes pus is consistent with infection. The standard of care for treating such an infection consists of cleaning the wound, obtaining cultures of the suspected infection, and seeing the patient again within a day or two for follow-up examination. In Angelides' opinion, Respondent's leaving the bandage on Patient #1's hand from the time of surgery on February 17 through February 24, without taking it off to check on the course of infection was not the way he would have handled the situation. However, he did not go so far as to state the Respondent's failure to do so was inappropriate, and he could find no impropriety in the way Respondent managed this case. Recognizing that the case presented here was about as severe an example of Dupuytren's Contracture as can be seen, Dr. Angiledes opined that the result achieved by Respondent was quite good considering the severity of the problem. He was not put off by the development of necrosis here, accepting that as a common complication in cases of this nature. He was satisfied by Respondent's calling in an infectious disease specialist and with the continuation of antibiotics administration after discharge through home health care. In his opinion, the surgery was appropriate and the ensuing complications common. The admission of the patient through an intermediary was not, to him, inappropriate so long as, as here, the patient continued to be seen by an infectious disease specialist. In substance, Dr. Angelides could see no problems with this case that were not properly handled and nothing that could have been done that was not done.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is, therefore: RECOMMENDED that a Final Order be entered in this case finding Respondent not guilty of the offenses alleged in the Administrative Complaint and ordering it dismissed. RECOMMENDED this 22nd day of August, 1994, in Tallahassee, Florida. ARNOLD H. POLLOCK 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 22nd day of August, 1994. APPENDIX TO RECOMMENDED ORDER The following constitutes my specific rulings pursuant to Section 120.59(2), Florida Statutes, on all of the Proposed Findings of Fact submitted by the parties to this case. FOR THE PETITIONER: Accepted and incorporated herein. - 4. Accepted and incorporated herein. 5. - 7. Accepted and incorporated herein. 8. - 10. Accepted and incorporated herein. 11. - 13. Accepted and incorporated herein. - 19. Accepted and incorporated herein. Accepted and incorporated herein. - 23. Accepted and incorporated herein. 24. & 25. Accepted and incorporated herein. 26. & 27. Accepted and incorporated herein. 28. & 29. Accepted and incorporated herein. 30. & 31. Accepted. 32. - 35. Accepted and incorporated herein. 36. - 38. Accepted and incorporated herein. 39. & 40. Accepted and incorporated herein. 41. & 42. Accepted. 43. Accepted and incorporated herein. 44. & 45. No more than recitations of evidence. & 47. Accepted and incorporated herein. Rejected as a classification of Respondent's treatment as "inappropriate." The deposition cited as authority for that comment does not support it. However, the action described and the time frame in question are accurately noted. Accepted. Accepted as a recitation of the witness' testimony. Rejected as to the description "well supported." & 52. Accepted as restatements of testimony. Accepted. See "50" above. Rejected as not supported by clear and convincing evidence. FOR THE RESPONDENT: Accepted and incorporated herein. Accepted. & 4. Accepted and incorporated herein. - 9. Accepted and incorporated herein. Accepted and incorporated herein. Not an evidentiary Finding of Fact. - 14. Accepted as restatements of testimony. 15. - 18. Accepted as restatements of testimony. 19. & 20. Accepted as restatements of testimony. 21A. - O. Not proper Findings of Fact. These are more Proposed Conclusions of Law which are drawn by the Hearing Officer independently in that portion of the Recommended Order. COPIES FURNISHED: Hugh R. Brown, Esquire Agency for Health Care Administration 1940 North Monroe Street Tallahassee, Florida 32399-0792 Steven A. Rothenberg, Esquire Agency for Health Care Administration 9325 Bay Plaza Boulevard Tampa, Florida 33610 Paul B. Johnson, Esquire Johnson & Johnson, Post Office Box 3416 Tampa, Florida 33601 Sam Power Agency Clerk Agency for Health Care Administration The Atrium, Suite 301 325 John Knox Road Tallahassee, Florida 32303 Harold D. Lewis, Esquire Agency for Health care Administration The Atrium, Suite 301 325 John Knox Road Tallahassee, Florida 32303 Dr. Marm Harris Executive Director Board of Medicine 1940 North Monroe Street Tallahassee, Florida 32399-0792
The Issue The issues are whether Respondent is guilty of failing to meet the applicable standard of care with respect to acts and omissions involving two patients, in violation of Section 464.018(1)(n), Florida Statutes, and, if so, what penalty should be imposed.
Findings Of Fact At all material times, Respondent has been a licensed registered nursing in Florida, holding license number RN 2732432. At all material times, he was employed as a registered nurse at Integrated Health Services in Vero Beach, Florida. In June and July 2002, R. F. was a resident of Integrated Health Services. She had wounds to both buttocks. On June 7, 2002, her physician ordered the application of duo derms to each wound and ordered that the dressing be changed at least every three days, or more frequently, if needed. The wound treatment and progress records for both wounds are identical forms that require the nurse tending the wound to describe it, by abbreviations, in terms of drainage, general appearance, and surrounding skin and then to initial the notes. The initialing of the form signifies that the nurse also has changed the dressing, not just described the wound, as it would be impossible to view the wound without removing the old dressing. The form on which this information is recorded is divided into days, so that the date of the activity is clear on the completed form. The forms in this case for the June treatments of these wounds show that licensed practical nurse Kathleen Ertle described each wound on June 7. The only difference between them was that the wound on the right buttock was dry and pink, and the wound on the left buttock was moist and red. Three days later, on June 10, Respondent changed each dressing, and described each wound appropriately--by now, both wounds were moist, red, and macerated. Two days later, Nurse Ertle changed the dressings and described the wounds as unchanged from two days earlier. The following day, June 13, Respondent changed the dressings and described the wounds as unchanged. Three days later, on June 16, Respondent changed the dressings and described the wounds as unchanged. On June 18, he changed the dressings, and this time described the left wound as dry, but the right wound as moist. Three days later, on June 21, Respondent changed the dressings and described both wounds as dry and pink, not red. The June 24 entry on wound treatment and progress record for both wounds is a little confusing, but the confusion does not appear to have contributed to the violations in this case. Respondent entered a description of each wound--again, dry, pink, and macerated--but overwritten on this entry are: "healed" and "ERROR." It is unclear who wrote these entries or what is identified as erroneous--Respondent's initial description or that the wounds are healed. The next entry for either wound is by Nurse Ertle who, on June 27, described the left wound as macerated, red, and reddened. On June 28, Nurse Ertle made entries for both wounds, describing each as macerated, red, and reddened. There are no more entries for June. The next entry is July 1 and is made by Respondent, who described the wounds as dry, pink, and macerated. On July 3, each wound bears two entries. At the top is an entry by Respondent, describing each wound as dry, pink, and macerated. Beneath these entries are entries by Nurse Ertle, describing each wound as dry, red, and reddened. The next entry for each wound is July 5, on which Respondent described each wound as unchanged from his preceding description. The last entry for each wound is July 8, at which time Respondent described each wound as still unchanged. The wound treatment and progress record for the left wound bears an additional notation to discontinue wound treatment. Neither record, though, bears additional entries as to wound care, and both wounds were subsequently treated by a special air-pressure mattress. The problems as to R. F. arose when, on July 3, Nurse Ertle examined the wounds and the dressings. Nurses routinely mark the date of application on the exterior of the dressing. Instead of finding "July 1" on the dressing on the right-buttock wound, Nurse Ertle found the date, "June 28." This finding was inconsistent with the above-described entries in the records. Petitioner proved that Respondent failed to change the right-buttock dressing on July 1. As evidenced by his notation on the record, Respondent had undertaken the duty to change the dressing on July 1, and the evidence is clear that he failed to do so, at least as to the right buttock. Petitioner also proved that Respondent made the July 1 entry in an attempt to falsify or alter the records. Initially, it seemed at least as likely that Respondent made the entry in advance of changing the dressing, intending to do so, and merely forgot to do so. (Even if such advance recording of nursing activity is improper, it is not an act with which Respondent is charged.) However, Petitioner's nursing expert, Katherine Johnson, pointed out that the charting could not have been an innocent mistake, such as by charting before changing the dressing, because Respondent charted the condition of the wound, which he could not have seen without removing the dressing. Although Petitioner charged Respondent with falsification of the records that he changed the dressing, not that he falsely described the wound, evidence of fraudulent intent in describing the wound tends to establish fraudulent intent in recording that he had changed the dressing. However, Petitioner failed to prove that Respondent's act and omission caused significant harm to R. F. Nurse Ertle testified on direct that the wound deteriorated from Stage I to Stage II between June 28 and July 3, but later testified, on cross-examination, that the deterioration had taken place before June 27. Shortly after the introduction of the special mattresses, both wounds healed. At 3:00 p.m. on October 24, 2002, an advanced registered nurse practitioner (ARNP) ordered the intravenous administration of potassium to J. R., who was a patient at Integrated Health Services. The purpose of the order was to treat hypernatremia. This order was received by a nurse working the 3:00 p.m. to 11:00 p.m. shift. However, neither she nor any other nurse on this shift attempted to start the IV, which was only started at 6:45 a.m. on October 25. Respondent arrived at Integrated Health Services at 11:00 p.m., at which time he served as the shift supervisor. The record fails to establish that any nurse on the preceding shift had documented the ARNP's order, such as in the nurse's notes, in such a way that Respondent reasonably could have found it and taken appropriate action on the order, either starting the IV or calling the ARNP and explaining what had happened and stating when the IV could be started. Furthermore, Petitioner's nursing expert, Katherine Johnson, testified that the duty of ensuring that the IV had been started or the ARNP informed of the failure fell to the nurse who took the orders and her shift supervisor, and the duty of auditing the records to ensure that orders were carried out by the preceding shift belonged to the nurse assigned to the patient. In no instance did Ms. Johnson assign the duty of auditing as belonging to the subsequent shift supervisor, Respondent.
Recommendation It is RECOMMENDED that the Board of Nursing enter a final order finding Respondent guilty of two violations of Florida Administrative Code Rule 64B9-8.006(2) and imposing an administrative fine of $1000. DONE AND ENTERED this 19th day of September, 2006, in Tallahassee, Leon County, Florida. S ROBERT E. MEALE 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 19th day of September, 2006. COPIES FURNISHED: Dan Coble, RN, Ph.D., CNAA, C, BC Executive Director Board of Nursing Department of Health 4052 Bald Cypress Way Tallahassee, Florida 32399-1701 Ellen M. Simon Assistant General Counsel Department of Health Prosecution Services Unit 4052 Bald Cypress Way--Bin C-65 Tallahassee, Florida 32399-3265 Timothy M. Cerio, General Counsel Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701 David Carpenter 419 Sandpiper Drive Satellite Beach, Florida 32937
The Issue The issues in this case are whether Respondent, SA-PG Sun City Center, LLC, d/b/a Palm Garden of Sun City (hereinafter "Palm Garden" or the "Facility") failed to follow established and recognized practice standards regarding care to its residents; and whether Respondent failed to comply with the rules governing skilled nursing facilities adopted by Petitioner, Agency for Health Care Administration (hereinafter "AHCA" or the "Agency"). If the answer to those questions is in the affirmative, then there is an issue as to what penalty should be imposed on Respondent. HOLDING: There is no competent and substantial evidence that Palm Garden failed to follow established practice standards that resulted in harm to its residents and failed to comply with rules governing skilled nursing facilities, or that otherwise warrants a fine or Conditional rating. Palm Garden was marginally deficient in two minor areas concerning their own policies, but neither violation is a Class II deficiency, nor warrants imposition of a sanction.
Findings Of Fact AHCA is the state agency responsible for licensing and monitoring skilled nursing facilities in Florida. Part and parcel of its duties is the inspection of all facilities on an approximately annual basis. Further, AHCA may conduct a survey of a facility upon receipt of a complaint from a third party about operations or conditions at a specific facility. Palm Garden is a 120-bed skilled nursing facility located in Sun City, Florida. The Facility provides services to private pay residents and is also certified to provide services for residents under the Medicaid and Medicare reimbursement programs. At all times relevant hereto, Palm Garden was operating under a Standard nursing home license. On April 26 through 30, 2010, AHCA conducted an annual survey at the Facility. During the course of the survey, AHCA surveyors made findings concerning two allegedly deficient practices by the Facility. The deficiencies are identified as follows: (1) One resident, identified herein as Resident 68, complained of burning on urination and said no treatment was offered to relieve the pain; and (2) One resident, identified herein as Resident 138, had wounds on his skin that his family believes were not properly treated. During the survey, Resident 68 purportedly complained to a surveyor that she was currently having pain when she urinated and was not being treated for the condition. The surveyor reviewed the resident's chart and determined that Resident 68 had previously complained of urination pain on April 10, 2010. In response to her complaint, a Diascreen test was performed on that same date. The test came back negative for urine infection. The test was normal in all regards, except for glucose level. The resident was at 250 mg/dL (milligrams per deciliter) of glucose when the normal range is between 50 and 150 mg/dL. The Agency expert opined that the glucose level discrepancy renders the test result less reliable. In her opinion, the report would be inconclusive as to whether a urinary tract infection ("URI") existed. There are, as the Facility's expert opined, other conditions, including diabetes, which can cause a high glucose rating. Resident 68 suffered from diabetes at the time the test was done. On balance, it appears that the test was viable. On the date the Diascreen test was performed, a checklist for potential URI was placed in the resident's medication administration record. That checklist set forth a protocol to follow over the next 72 hours in order to better assess the resident's condition. There is no evidence the protocol was followed. The Facility's infection control nurse, Sue Fuller, admitted that sometimes it is difficult to get all nurses to strictly follow established procedures. However, Resident 68 was receiving 24-hour care by the Facility and was monitored regularly as part of that care. The resident's chart does not indicate any further problems concerning urination pain until April 27, 2010, i.e., day two of the annual survey. On that date, there is a doctor's note indicating dysuria, i.e., painful urination condition. The doctor prescribed Pyridium, a urinary antiseptic (not an antibiotic) for treatments. The physician did not order any additional tests or other treatment. It is apparent a physician was involved in Resident 68's care, but he did not diagnose a UTI. AHCA concluded from its investigation that Resident 68 suffered actual harm between April 10 and April 27, 2010, because there is no documentation that the resident's pain was being addressed. However, Palm Garden charts by exception, meaning that they only place into the chart events which are abnormal or negative. Ignoring the issue of whether that is the best way to chart a resident's care, the absence of chart notations relating to URI or painful urination means, from the Facility's perspective, that there was no complaint of pain on the days it was not mentioned. The resident was visited by a physician on April 16 and 22, 2010, but the doctor's notes do not indicate a complaint concerning pain when urinating. The resident's chart does indicate that Resident 68's activities of daily living, meal consumption, and therapy records reflect normal activity without any notable exceptions. It is unlikely an elderly person with an untreated UTI would be able to pursue normal activities. AHCA did not independently ascertain whether Resident 68 experienced pain during the period between April 10 and April 27, 2010. The Agency's conclusion in that regard is based on pure speculation by the surveyor. There is no competent evidence that there was harm to the resident.2 The resident purportedly told the surveyor that she (resident) had experienced pain during that time, but the clinical records do not support that claim.3 During the survey, Resident 138 was noted to have two skin wounds on his buttocks. The resident's wife had complained to surveyors about the wounds because she did not believe appropriate treatment was being provided by the Facility. A surveyor contacted the Facility's wound nurse to inquire about the wounds, which the surveyor believed to be pressure sores. No measurements had been taken of the wounds, a deficient practice from the surveyor's perspective. The surveyor stated, "And they were Stage II pressure ulcers. I mean, she was saying they were excoriations, but they were on the bony prominence. It was a Stage II. It wasn't very deep when I saw it. The one on the left buttocks was irregular, and the one on the right buttocks was smaller. I didn't see any drainage and there was no odor and it was actually superficial. It would be a Stage II pressure ulcer." (See Transcript, page 84.) In fact, the wounds were considered excoriations, rather than pressure sores by the Facility. The Facility's director of nursing, who was very familiar with Resident 138 and had examined him prior to and during the survey, described the wounds as excoriations based on the way they were healing. Excoriations are not normally measured because they change rapidly and tend to heal quickly. Conversely, pressure sores must be measured as a part of their on-going treatment because they heal slowly and must be monitored. The surveyors found the wounds to be very small and superficial. If they were pressure sores, they would have been Stage I sores. Stage I pressure sores do not blanch. To blanch means that if pressure is applied to the area, blood would rush back after the pressure is released. The wounds on Resident 138 were personally blanched by the Facility's director of nursing.4 There are other wounds that look like pressure sores, but actually come about due to other causes. For example, a sore may occur when a person lies in urine, thus, agitating the skin. Sores may be caused by frequent contact with liquids and by residents being moved in their beds. There is no mention in Resident 138's medical chart of pressure sores. Rather, the doctor's notes refer to the resident's wounds as open sores or excoriation. At one point the Wound Treatment Evaluation Record for the resident listed a Type I and a Type II for wound type and pressure ulcer stage. However, that notation was later indicated as an error by the wound nurse. There is no competent medical evidence that Resident 138's wounds on his buttocks were pressure sores. Nonetheless, the surveyors observed nursing staff treating Resident 138's wounds and found some deficient practices. A treating nurse put on gloves after setting up her treatment table. The nurse then reached back and closed the curtain around the resident's bed (a proper practice), but did so with her gloved hand. That action would desterilize the glove. She then began treating the resident without re-washing her hands or re-gloving. The nurse then discarded the wound dressing and changed gloves. However, she did not wash her hands before changing gloves. She then poured saline on the wounds as required. The surveyor at this point noted what she believed were two wounds, neither of which was draining or had an odor. The wounds were superficial, not deep, according to the surveyor. At that point, the nurse cleaned both wounds using the same piece of gauze. She then applied dressing to the wounds, completing her treatment. The surveyor found that touching the curtain with a gloved hand was an infection control violation. So too was the cleaning of two wounds using the same piece of gauze. The Facility opines that the treatment process was not a sterile situation, until such time as the wound had been cleaned and dressed. Touching the curtain before that process and changing gloves without washing would not necessarily be deemed infection control issues, although transferring germs from the curtain to the wound area was a possibility. The wound area was not a pressure sore, thus did not contain infection. It was, therefore, proper to wash the wound area with the same gauze without violating infection control procedures. It is the opinion of the AHCA surveyor that Resident 138 had two wounds. She believed one wound was smaller than the other and that neither of them were open or had odor, but that each of them was a Stage II decubitus ulcer. It is the opinion of the Facility that there were no decubitus ulcers on the resident. Rather, the resident had an area of excoriation that was treated pursuant to the doctor's orders. Based on the greater degree of personal involvement with the resident and the confirmation of their opinion by the treating physician, the Facility's perception is given greater weight. A number of treatments were used to address Resident 138's wounds. An order for hydrocolloid was entered, followed by elimination of the hydrocolloid in favor of optase jell, then discontinuance of the optase jell in favor of methylex. The Facility properly followed the physician's prescribed treatment for this resident. No persuasive, non- hearsay evidence was presented as to the status of Resident 138's wounds as of the date of the final hearing, so there can be no finding as to whether the wounds healed (an indication of excoriation, rather than decubitus) or not (a contrary indication).
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a final order be entered by Petitioner, Agency for Health Care Administration, denying the imposition of a fine or a Conditional license against Respondent, SA-PG Sun City Center, LLC, d/b/a Palm Garden of Sun City, and dismissing the Administrative Complaint. DONE AND ENTERED this 21st day of December, 2010, in Tallahassee, Leon County, Florida. S R. BRUCE MCKIBBEN 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 21st day of December, 2010.
Findings Of Fact On or about December 13, 1984, Petitioner applied to Respondent for a CON for an ambulatory surgical center (ASC). Respondent assigned CON number 3677 to Petitioner's application. Petitioner seeks to construct a two operating room, free standing ASC at 1710 West Colonial Drive in Orlando, Orange County, Florida. The primary area to be served by this application is Orange County, and the facility as proposed is reasonably accessible to Orange County residents. Orange County is located within Respondent's District VII, which is also comprised of Osceola, Brevard and Seminole Counties. Stuart and Joseph Yachnowitz are owners of Y and S Management and are partners in the application here at issue. Y and S Management will provide medical management services at this facility, as it provides at nine other facilities throughout the country which performed approximately 17,500 outpatient surgical procedures in 1985, primarily gynecological. Two of the facilities managed by Y and S Management are licensed as ASCs under the laws of the states in which they are located. The chief operating officer of Y and S Management, Susan Hill, prepared the CON application which is here at issue. Financing for this project will be provided from the personal funds of Stuart and Joseph Yachnowitz. No funds will be borrowed for this purpose. They have sufficient liquid personal funds to fully finance the project cost of $473,000, as well as operating costs. Petitioner will lease 6,500 square feet on the first floor of a professional building to be constructed at 1710 West Colonial Drive in Orlando from West Colonial Properties, Ltd., at $12 per square foot. This property is owned by Stuart and Joseph Yachnowitz. An abortion clinic known as Orlando Women's Health Center, which they also own, is located next door at 1700 West Colonial Drive. The facility as proposed can reasonably be expected to meet licensure requirements for an ASC. Ambulatory surgical procedures to be performed at Petitioner's facility will include, but not be limited to abortions, tubal ligations, hernia repairs, diagnostic laproscopies, eye surgery for cataracts, hand surgery, plastic surgery, tonsillectomies, and dilatation and curettage. Equipment cost estimates for this project of $161,158 are realistic and complete. Staffing requirement estimates of 11.54 F.T.E., and salary requirements of approximately $182,000 annually are also realistic and complete. Petitioner estimates that for 1987 and 1988, 20% of all cases will be paid by Medicaid, 5% by Medicare, and 75% will be insurance and private pay, with 4% of this figure ultimately being bad debt or indigent care. With total cases estimated for 1987 and 1988 to be 1700 and 2100, respectively, total net revenues for 1987 and 1988 are estimated to be $732,000 and $903,000, respectively. Providing services to Medicaid patients in 20% of its cases would be beneficial to the community since this is a high level of service to patients who are typically underserved. Assuming that 20% of the cases handled at Petitioner's facility have multiple procedures, the projected charge rates for 1987 are $326 per case for Medicare and Medicaid, and $489 per case for private pay and insurance. These are reasonable and competitive charges. The projected charge rate for private pay and insurance is simply 150% of the Medicare and Medicaid rate, which in turn is based on the projected case mix considering the various levels of reimbursement. Petitioner will pay Y and S Management a fee of $50 per case for management services. The financial pro forma prepared for Petitioner demonstrates that using a conservative approach that somewhat overestimates expenses, Petitioner will reach the break-even point at 1400 cases, after allowing for management fees, depreciation and amortization. Using a less conservative, but more typical approach to estimating expenses, Petitioner will break-even at 1100 cases. Need in the service area exceeds the conservative break-even point and Petitioner estimates it will handle 1700 cases in its first year of operation and 2100 in its second. These are reasonable estimates. Respondent has not promulgated a rule setting forth a methodology for determining need for an ASC. However, Respondent has utilized an evolving non-rule policy in evaluating the need for such facilities. Reid Jaffe, Respondent's expert in health care planning, explained the methodology used in this case which resulted in his determining that in July, 1987, there will be a need for additional ambulatory surgical facilities in Orange County sufficient to recommend approval of Petitioner's CON application. Specifically, Jaffe's methodology is as follows: Acquire data from the local health council regarding the number of inpatient and outpatient procedures performed by existing providers, as reported for the current calendar year (1985) by hospitals in the appropriate service district (District VII). Acquire data from the Governor's Office of the population estimate for the appropriate service area (Orange County) for the current and planning horizon years. Using this data, calculate the current overall surgical and outpatient surgical use rates per 1000 population for hospitals in the service area. Using the projected population for the planning horizon year (1987) and the current use rates calculated in (c) above, calculate the projection of overall surgical procedures in the planning horizon year. Multiply projected overall surgeries by 40% to establish total number of out-patient surgeries to be performed in the planning horizon year. Subtract from (e) all outpatient surgical procedures to be performed in hospitals, other ASCs in the service area, as well as the financial break-evens of all CON approved free-standing outpatient surgery centers in the service area. After performing these calculations and subtractions, the number of outpatient surgical procedures remaining are compared to the break-even of the CON applicant at issue. If the remaining number is larger than the applicant's break even, a quantitative need is demonstrated. Applying Jaffe's methodology to this case and applying data he obtained from the Local Health Council of East Central Florida, as reported to it by hospitals in District VII for calendar year 1985, as well as population data for Orange County he obtained from the Governor's Office, it appears that a total of 83,054 surgical procedures were performed in District VII in 1985, with 21,084 of these being outpatient procedures performed in a hospital. Using a July, 1985, population estimate for Orange County of 556,384, the overall surgical use rate for Orange County is 83,054 divided by 556,384 over 1000, or 149.27 surgical procedures per 1000 population; the use rate for outpatient procedures performed in hospitals is 21,084 divided by 556,384 over 1000, or 37.89 outpatient procedures performed in hospitals per 1000 population. Multiplying the overall surgical use rate of 149.27 by 574,599 (projected Orange County population for July 1987) over 1000 and applying a factor of 40% yields a projection of 34,308 outpatient surgical procedures to be performed in 1987. The use rate of 37.89 for outpatient services performed in a hospital is then multiplied by 574,599 over 1000 to obtain 21,722 which is the projected number of outpatient procedures which will be performed in a hospital in 1987. By subtracting this number (21,722) from the projection of total outpatient surgical procedures to be performed in 1987 (34,308) you identify 12,536 procedures which could be performed in ASCs in 1987. The reported number of outpatient procedures being performed in existing ASCs and the break-evens of CON approved facilities are calculated to be 5,488 (Surgical Services 2,693; MediVision 903; AMI Single Day Surgery 1,832; Surgical Associates 60) which is then subtracted from 12,536 to leave a need of 7,048 outpatient procedures which could be performed in ASCs which are not now approved for this service area. Since Petitioner has a conservative break-even point of 1400 cases, and a more typical break-even point of 1100 cases, a quantitative need has been identified which far exceeds Petitioner's break-even point. Jaffe testified that in his experience this is the largest margin between break-even and available procedures he has seen in reviewing CON applications. A need analysis conducted by Howard E. Fagin, Ph.D., who was accepted as an expert in health care planning, facility planning and operations analysis, also confirms that there is a quantitative need for the ASC proposed by Petitioner. The methodology used by Dr. Fagin starts by calculating a target utilization for ambulatory surgical operating rooms. Assuming that a facility operates 250 days/year, 6 hours/day, it takes 1.25 hours/case and that there are 1.2 procedures/case with a utilization rate of 75%, a target utilization of 1,080 procedures/year for an ambulatory surgical room is thereby determined. In 1985 there were 10 approved hospital "dedicated" ambulatory surgical rooms in Orange County, and 9 approved rooms in free-standing ASCs (Surgical Services-5, AMI Single Day Surgery-2, MediVision-2) not counting the 2 rooms approved in CON 3313 for Surgical Associates which are used for no more than 60 cases per year. Multiplying these 19 rooms by the target utilization of 1,080 procedures/year results in a calculation of 20,520 total utilization in available dedicated and free-standing ASC rooms. Data from the Local Health Council of East Central Florida for 1985 indicates that 11,413 outpatient procedures were performed in hospital, non-dedicated, operating rooms. Therefore if we take Jaffe's projection of 34,308 outpatient surgical procedures to be performed in 1987, and subtract 20,520 (total utilization in available dedicated and free-standing ASC rooms) and also subtract 11,413 (outpatient procedures performed in hospital, non-dedicated, rooms), we arrive at a need of 2,375 procedures in 1987 and 3,770 procedures in 1989. Since Petitioner's break-even is conservatively 1400 cases, and again assuming 1.2 procedures per case, Petitioner's conservative break-even is 1680 procedures, which is within the need which will exist in 1987, and well within the need in 1989. The need methodology and opinion of Intervenor's expert, Dr. Deborah Kolb, is rejected because she incorrectly: (a) considered Orange and Seminole Counties as comprising a two county service area; (b) included all existing inpatient hospital based operating rooms, regardless of whether they are dedicated to outpatient surgery, in arriving at her conclusion that there is excess capacity; and (c) assumed all hospital operating rooms are available for outpatient surgery without modification. Ambulatory surgery is typically performed in three types of facilities: hospitals which utilize their operating rooms for both inpatient and outpatient surgery; hospitals which maintain separate "dedicated" outpatient operating rooms, sometimes even in separate facilities adjacent to the main hospital; and free-standing ASCs which are not associated with a hospital. There are definite disadvantages to serving outpatients in hospitals without "dedicated" outpatient operating rooms, including the "bumping" of outpatients in emergencies and increased costs to the patient for services. On the other hand there are advantages and disadvantages to the other two modes of delivering ambulatory surgical services. Hospital based "dedicated" rooms are obviously closer to a hospital in case an emergency develops, and some patients may prefer this proximity to additional equipment and emergency medical staff. On the other hand, costs at a free-standing ASC are generally lower, and some patients prefer to avoid a hospital atmosphere altogether. Surgical procedures performed at ASCs have grown from 10% of all procedures in the early 1970s to 40% currently, and are projected to grow to 50% in the near future. This growth is somewhat the result of a change in Medicaid/Medicare reimbursement policies which now pay 80% for procedures performed in a hospital and require a 20% co-payment by the patient, but which pay 100% for procedures performed in an ASC and require no patient co-payment. The decision to have outpatient surgery performed at one or the other of these types of facilities is primarily the result of patient preference. However, it is clear that the increasing utilization of ASCs is a market force that is driving the cost of hospital outpatient services down. Respondent issued its original notice of intent to deny Petitioner's application on or about May 17, 1985, and on June 14, 1985, Petitioner filed its Petition for Formal Hearing. Thereafter, Respondent reconsidered its position and on March 6, 1986, notified the parties that it intended to grant Petitioner's application. The reason for this reconsideration was that when the initial denial was made, Respondent's projections of procedures were premised on the use of a 30% outpatient surgical factor. Subsequently, the Respondent began using 40% in its projection of the total volume of surgical procedures which might be performed on an outpatient basis. Given the fact that the reason Petitioner was initially denied was due to insufficient procedures, and utilization of the new projection of outpatient volume indicated there would be sufficient volume to support the facility, Respondent determined to support Petitioner's application. The notice of change of position was prepared by Reid Jaffe, who based his testimony at hearing on the 40% factor, and was approved by Robert E. Maryanski, Administrator of Community Medical Facilities, and Marta V. Hardy, Deputy Assistant Secretary for Health Planning and Development. Since Respondent has not adopted a need methodology rule for ambulatory surgical centers, the increase in the factor used to calculate outpatient surgeries from overall surgeries performed was not accomplished through rule-making proceedings. In 1985 Respondent used a factor of 30%, but in early 1986 increased this to the 40% applied in this case.. Intervenor provides services similar to those which Petitioner will perform, and has four free-standing, "dedicated" operating rooms which are used for ambulatory surgery. It also has 17 operating rooms that are used for both in and out-patient surgery. The Intervenor opposes Petitioner's application. In 1985, Intervenor made a profit of $10.9 million on total revenues collected of $184 million; it had an actual total of $37.4 million in uncompensated care which includes partial or no payments, charity, bad debt, and contractual patients. For 1986, it projects an $18.9 million profit on collected revenues of $211 million, with projections of actual uncompensated care of approximately $52 million. In 1985, 2% of Intervenor's costs were for providing indigent care, and this totaled approximately $6 million. Petitioner projects net revenues of approximately $900,000, and it has not been established if this will have any impact on Intervenor's revenues. According to Billie June, Assistant Director of Operating Rooms at Florida Hospital who was accepted as an expert in surgical nursing, and the management and operation of surgical units from a nursing standpoint, Intervenor has had considerable difficulty attracting qualified nursing staff for its operating rooms, and has had to develop its own qualified staff through an internship program. However, Petitioner's facility will not contribute to this difficulty or result in higher salaries. Susan Hill testified based on her experience since 1973 of managing and hiring staff in the Orlando area of the type needed to operate an ASC, that she has had no difficulty obtaining the cooperation of physicians in the area and in attracting fully qualified staff. Based on Hill's experience with other ASCs managed by Y and S Management throughout the country as well as her experience in Orange County, it is found that the staffing needs of Petitioner's proposed facility can be met with nursing and medical staff available in the area. It is found as a matter of fact that there is a need in Orange County for the two operating room ASC proposed by Petitioner, that Petitioner has the ability and will provide quality care, the project is financially feasible, Petitioner will work with and help to meet the needs of health maintenance organizations and will promote cost effectiveness in Orange County. Petitioner's proposal is consistent with the goals, objectives and recommended actions in the 1985-87 Florida State Health Plan and the local health plan. The State Plan encourages the existence of ASCs and the removal of obstacles to the use of outpatient surgery; the local plan provides that applicants for an ASC must demonstrate a willingness to provide services to underserved patient groups and considers the provision of ambulatory surgery to the underserved population to be a desirable objective. In this case Petitioner intends to provide 20% of its cases to Medicaid patients, and another 4% to indigents.
Recommendation Based on the foregoing, it is recommended that the Department of Health and Rehabilitative Services issue a Final Order granting Petitioner's application for CON number 3677. DONE and ENTERED this 23rd day of October, 1986, at Tallahassee, Florida. DONALD D. CONN, Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32399 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 23rd day of October, 1986. COPIES FURNISHED: William Page, Jr., Secretary Department of Health and Rehabilitative Services 1323 Winewood Boulevard Tallahassee, Florida 32301 Chris H. Bentley, Esquire Post Office Box 1739 Tallahassee, Florida 32302 Douglas Mannheimer, Esquire Post Office Drawer 11300 Tallahassee, Florida 32302 E. G. Boone, Esquire Jeffrey Boone, Esquire Gregory Roberts, Esquire Post Office Box 1596 Venice, Florida 34284. APPENDIX Rulings on Petitioner's Proposed Findings of Fact: 1. Adopted in Findings of Fact 1, 2. 2,3. Adopted in Finding of Fact 3. Adopted in Finding of Fact 6. Adopted in Finding of Fact 5. Adopted in Finding of Fact 7. Adopted in Finding of Fact 11. Adopted in Findings of Fact 11, 22. Adopted in Finding of Fact 9. Adopted in Finding of Fact 2. Adopted in Findings of Fact 2, 14. 12,13. Adopted in Finding of Fact 20. Adopted in Finding of Fact 7. Adopted in Finding of Fact 20. Adopted in Finding of Fact 8. Adopted in Findings of Fact 3, 8. Adopted in Findings of Fact 4, 7. Adopted in Finding of Fact 4. Adopted in Finding of Fact 2. Adopted in part in Finding of Fact 15 but otherwise rejected as cumulative and unnecessary. Adopted in Finding of Fact 19. 23-25. Rejected in Finding of Fact 18 and otherwise rejected as irrelevant and not based on competent substantial evidence. Rejected as cumulative and unnecessary. Rejected in Finding of Fact 18. Adopted in Findings of Fact 12-14. Adopted in Findings of Fact 12, 13. Adopted in Findings of Fact 13, 14. 31-35. Adopted in Finding of Fact 15. 36,37. Rejected as irrelevant and unnecessary. 38. Adopted in Finding of Fact 22. 39,40. Adopted in Finding of Fact 23. 41. Rejected as a Finding of Fact since this is a request for further ruling on Petitioner's Motion to Limine which was granted at hearing. Petitioner filed a Motion in Limine on June 11, 1986 to exclude depositions taken of John Hutchens on April 23, 1986 and June 5, 1986. This is the motion dealt with at the prehearing conference on June 23, 1986. The only deposition of John Hutchens offered by Intervenor and admitted was one taken on June 20, 1986 (I-2). Therefore, Petitioner's motion and the prior ruling is moot since the depositions to which the motion was directed were not offered at hearing. 42-45. Adopted in Finding of Fact 22. Rulings on Intervenor's Proposed Findings of Fact, as set forth beginning on page 3: 1. Adopted in Finding of Fact 12. 2-16. Rejected in Finding of Fact 15, and otherwise irrelevant and cumulative. 17,18. Rejected in Findings of Fact 12-14, 22. 19-26. Adopted in part in Finding of Fact 14, but otherwise rejected as contrary to competent substantial evidence. 27,28. Adopted in part in Findings of Fact 12, 13, but otherwise rejected as contrary to competent substantial evidence. 29. Rejected in Findings of Fact 12-15 and otherwise as argument rather than proposed findings of fact. 30-34. Adopted and rejected in part in Finding of Fact 16 and otherwise rejected as contrary to competent substantial evidence. Adopted in part in Finding of Fact 19, but otherwise rejected as irrelevant. Adopted in Findings of Fact 13, 14. 37,38. Rejected as irrelevant. 39,40. Adopted in part in Finding of Fact 16. Adopted in part in Findings of Fact 2, 3 but otherwise rejected as contrary to competent substantial evidence. Adopted in part in Finding of Fact 6, but otherwise rejected as irrelevant. 43,44. Rejected in Finding of Fact 22. 45-47. Rejected in Finding of Fact 7. Adopted in Finding of Fact 7. Rejected in Finding of Fact 7. Rejected in Findings of Fact 3, 5, 7 and 22. Adopted in part in Finding of Fact 3. Rejected as contrary to competent substantial evidence. 53,54. Adopted and rejected in part in Finding of Fact 21. Adopted in part in Findings of Fact 11, 22 but otherwise rejected as irrelevant. Rejected as cumulative and unnecessary. 57-59. Rejected as simply a summation of testimony, irrelevant and contrary to competent substantial evidence. Adopted in part in Findings of Fact 13, 14 and 16 but otherwise rejected as contrary to competent substantial evidence. Rejected as irrelevant. 62,63. Rejected in Finding of Fact 21 and otherwise irrelevant and contrary to competent substantial evidence. Rejected in Findings of Fact 4, 7. Adopted and rejected in part in Finding of Fact 8. Rejected in Findings of Fact 11, 22. Rejected in Finding of Fact 22 and otherwise irrelevant and contrary to competent substantial evidence. Adopted in part in Finding of Fact 20, but otherwise rejected as irrelevant. Rejected as irrelevant. Adopted in Finding of Fact 16; rejected in Finding of Fact 21 and otherwise rejected as contrary to competent substantial evidence. Rejected in Findings of Fact 4, 5 and otherwise rejected as irrelevant. 72-75. Adopted in part in Findings of Fact 19-21, but otherwise rejected in Findings of Fact 21, 22 and as irrelevant. 76-79. Rejected as irrelevant, cumulative argument which does not provide citations to the record contrary to Rule 221-6.31(3), Florida Administrative Code.
The Issue The issue is whether Respondent properly denied Petitioner's application for approval as an office surgery accrediting organization pursuant to Section 459.309(3), Florida Statutes, and Florida Administrative Code Rule 64B8-9.0092.
Findings Of Fact In Florida, physicians who perform certain surgical procedures in their offices are required to register the office with DOH. Additionally, DOH must inspect such offices unless a nationally recognized accrediting agency or an accrediting organization approved by the Board inspects and accredits the offices every three years. See § 458.309(3), Fla. Stat. and Fla. Admin. Code R. 64B8-0.0091. Florida Administrative Code Rule 64B8-9.0092, entitled "Approval of Physician Office Accrediting Organizations," purports to establish requirements that FLACS must meet in order to achieve the Board's approval to operate as an accrediting organization. FLACS is a not-for-profit corporation, organized for the following purposes: (a) to promote office safety through its accreditation activities; (b) to promote cosmetic surgery; and (c) to provide continuing education courses related to office surgery. FLACS was formed in 1999 and, since that time, has participated actively in office surgery issues considered by the Board. The Board approved FLACS as an accrediting organization early in 2001. In January 2003 FLACS filed a complete renewal application, seeking the Board's approval to continue operating as an office surgery accrediting organization. The Board denied the application and, after a formal administrative hearing, entered a Final Order denying FLACS's application. See Florida Academy of Cosmetic Surgery, Inc. v. Board of Medicine, Case No. DOH-04-0661-FOF-MQA (Final Order, June 18, 2004)(adopting Recommended Order in DOAH Case No. 03-3349, April 15, 2004.) FLACS filed a new application for approval as an office surgery accrediting organization on July 12, 2004. The Board never advised FLACS whether its application was complete or incomplete. There is evidence that a member of the Board's staff, Melinda Grey, reviewed the application, finding it incomplete in many respects. On August 5, 2004, Ms. Grey prepared a spreadsheet entitled "Board of Medicine Staff Issues Regarding FLACS Application." The spreadsheet compared the application with the requirements of the applicable provisions of the Florida Administrative Code, including Florida Administrative Code Rule 64B8-9.0092. Larry McPherson, the Board's Executive Director, was aware that Ms. Grey was reviewing FLACS's application. She did not tell Mr. McPherson that the application was incomplete. Instead, she informed the Board's legal counsel that FLACS had filed the application. Subsequently, Ms. Grey placed the application on the agenda for the Board's next scheduled meeting. On August 7, 2004, the Board voted to deny the new application. On August 23, 2004, the Board entered an Notice of Intent to Deny FLACS's new application on the following grounds: When participating in accrediting activities in the past, the applicant violated Section 458.331(1)(nn), Florida Statutes, by failing to comply with rules of the Board in the following manner: The applicant failed to provide copies of accreditation reports and corrective action plans to the Board office within 30 days of completion of accrediting activities in violation of Rule 64B8- 9.0092(4)(e), Florida Administrative Code. The applicant failed to immediately report to the Department conditions in physicians' offices that posed a potential immediate threat to patients in violation of Rule 64B8-9.0092(4)(f), Florida Administrative Code. When inspecting and accrediting facilities the applicant ignored its written accreditation standards and failed to provide the Board office with accreditation standards under which it was actually operating. Such facts reveal that the applicant operated in violation of Rule 64B8-9.0092(4)(g), Florida Administrative Code. When inspecting the facilities, the applicant operated with inadequate or applied inconsistently its quality assurance program in violation of Rule 64B8- 9.0092(4)(a), Florida Administrative Code. The applicant failed to provide evidence of an adequate quality assurance program as required by Rule 64B8- 9.0092(4)(a), Florida Administrative Code. The applicant failed to provide evidence of an adequate ongoing anesthesia related accreditation and quality assurance processes as required by Rule 64B8- 9.0092(4)(c), Florida Administrative Code. The applicant failed to submit copies of all incident reports filed with the state that originated at FLACS accredited facilities as required by Rule 64B8-9.0092(4)(f), Florida Administrative Code. Uncorrected "Prior Errors" After FLACS submitted its January 2003 "renewal" application, the Board's staff met several times with FLACS to discuss and "work out" problems that the Board had with FLACS's office surgery accrediting procedures. These meetings, which took place between January 2003 (when FLACS filed its renewal application) and August 2003 (when the Board denied the renewal application,) were supposed to result in changes to FLACS's inspection procedures and to alleviate the Board's concerns about FLACS' renewal application. Apparently FLACS successfully implemented some changes between the time that the Board denied FLACS's renewal application in August 2003 and the time that the Board issued the June 2004 Final Order in DOAH Case No. 03-3349. There is no evidence in the instant case that FLACS committed the following prior violations: (a) failed to provide DOH with accreditation reports and corrective action plans required by Florida Administrative Code Rule 64B8-9.0092(4)(e); and (b) awarded accreditation retroactive to the inspection date. Despite FLACS's effort to make needed changes in its inspection processes, it failed to do so on several occasions. First, on May 23, 2004, FLACS inspected the office of Anthony Rogers, M.D. Even though Dr. Rogers had one crash cart deficiency (missing the drug isuprel), FLACS's facility inspection form indicates that Dr. Rogers passed the inspection. FLACS did not receive confirmation that Dr. Rogers was in 100 percent compliance with the Board's rules regarding the mandated crash cart medications until May 27, 2004. FLACS accredited Dr. Rogers on that date based on a packing slip/boxed content list, showing receipt of the isuprel. Second, FLACS inspected the office of Rodolfo Binker, M.D., on May 22, 2004. FLACS's facility inspection form indicates that Dr. Binker passed the inspection even though he was missing intubation forceps (McGill). FLACS did not receive confirmation that Dr. Binker's monitoring and emergency equipment included intubation forceps (McGill) until May 24, 2004. FLACS accredited Dr. Binker that same day based on an invoice, showing that the forceps had been ordered and shipped to Dr. Rogers. The invoice does not indicate the date that Dr. Rogers received the forceps. Third, FLACS prefers for physicians who fail an inspection to verify compliance with the Board's rules by providing FLACS with a packing slip, showing receipt of the missing drugs or equipment. However, the evidence indicates that one of FLACS's inspectors sometimes accepts purchase orders/invoices, which do not show actual receipt of the missing items. Fourth, there is no evidence that FLACS failed to advise DOH about conditions in any physician's office that posed potential immediate jeopardy to patients as required by Florida Administrative Code Rule 64B8-9.0092(4)(f). FLACS's application states that "[a]ll deficiencies, including those which pose potential immediate jeopardy, will be immediately reported to the Department of Health and the Board." However, as a practical matter, FLACS does not believe it is necessary to make such a report as long as it notifies the Board by telephone for any circumstance that it believes constitutes an "immediate threat" to a patient and provides the Board with copies of all inspection materials, facility surveys, and compliance materials on all FLACS accreditations. In other words, unless a patient is in immediate danger, FLACS will leave it to DOH and the Board to review all documentation and determine whether a physician's office poses a "potential immediate threat." Finally, Bruce Hirshman, D.O, is an anesthesiologist who participates in FLACS's ongoing anesthesia-related accreditation and quality assurance processes. At some point in time, FLACS accredited Dr. Hirshman's office surgery facility. As of June 3, 2003, FLACS was aware that Dr. Hirshman had not registered with the Board of Osteopathic Medicine and advised him to do so. FLACS took no further action regarding Dr. Hirshman's failure to register until May 2005. FLACS's May 5, 2005, letter to Dr. Hirshman, stated as follows in relevant part: As of April 28, 2004, the Florida Academy of Cosmetic Surgery was informed by Ms. Rina Palladino at the Florida Board of Osteopathic Medicine that you had not registered with the Florida Board of Osteopathic Medicine to perform office surgery. The Florida Academy of Cosmetic Surgery is withdrawing your accreditation . . . . Rule 64B8-9.0092(2)(f)--Adverse Incident Reports Florida Administrative Code Rule 64B8-9.0092(2)(f) requires an application for approval as an office surgery accrediting organization to include copies of all incident reports that accredited physicians file with the state. The incident reports are defined by Section 458.351(4), Florida Statutes, which reads as follows: (4) For purposes of notification to the department pursuant to this section, the term "adverse incident" means an event over which the physician or licensee could exercise control and which is associated in whole or in part with a medical intervention, rather than the condition for which such intervention occurred, and which results in the following patient injuries: The death of a patient. Brain or spinal damage to a patient. The performance of a surgical procedure on the wrong patient. 1. The performance of a wrong- site surgical procedure; The performance of a wrong surgical procedure; or The surgical repair of damage to a patient resulting from a planned surgical procedure where the damage is not a recognized specific risk as disclosed to the patient and documented through the informed- consent process if it results in: death; brain or spinal damage; permanent disfigurement not to include the incision scar; fracture or dislocation of bones or joints; a limitation of neurological, physical or sensory function; or any condition that required transfer of the patient. A procedure to remove unplanned foreign objects remaining from a surgical procedure. Any condition that required transfer of a patient to a hospital licensed under Chapter 395, Florida Statutes, from any facility or any office maintained by a physician for the practice of medicine which is not licensed under Chapter 395, Florida Statutes. The incident reports are further defined by Florida Administrative Code Rule 64B8-9.001(1)(a), which states as follows in relevant part: . . . an event over which the physician or other licensee could exercise control and which is associated in whole or in part with a medical intervention, rather than the condition for which such intervention occurred, and which results in the following patient injuries: The death of a patient. Brain or spinal damage to a patient. The performance of a surgical procedure on the wrong patient. The performance of a wrong-site surgical procedure, the performance of a wrong surgical procedure; or the surgical repair of damage to a patient resulting from a planned surgical procedure where the damage is not a recognized specific risk as disclosed to the patient and documented through the informed-consent process and if one of the listed procedures in the paragraph results in: death; brain or spinal damage; permanent disfigurement not to include the incision scar; fracture or dislocation of bones or joints; a limitation of neurological, physical or sensory function; or any condition that required transfer of the patient. A procedure to remove unplanned foreign objects remaining from a surgical procedure. Any condition that required transfer of a patient to a hospital licensed under Chapter 395, Florida Statutes, from any facility or any office maintained by a physician for the practice of medicine which is not licensed under Chapter 395, Florida Statutes. FLACS understood that the "incident reports" referenced in Florida Administrative Code Rule 64B8-9.0092(2)(f) are the same as the "reports on adverse incident" defined by Section 458.351, Florida Statutes, and Florida Administrative Code Rule 64B8-9.001(1)(a). FLACS's application specifically references adverse incident reports as defined by Section 458.351, Florida Statutes. FLACS provided two such adverse incident reports with its new application: (a) one filed by Fabio Arturo Castro, M.D., from an incident that occurred on November 24, 2003; and (b) one filed by Kurt S. Dangl, M.D., from an incident that occurred on September 25, 2003. The new application did not include the following incident reports that FLACS included with its January 2003 renewal application: (a) one filed by Robert Gregory Smith, M.D., from an incident that occurred on August 16, 2001; and (b) one filed by Rafael A. Fleites, M.D., from an incident that occurred on March 9, 2002. As of July 12, 2004, DOH had received a total of nine (9) office incident reports from doctors' offices that are, or were at the time the incidents occurred, accredited by FLACS. FLACS's accredited physicians did not provide it with the following incident reports: (a) one filed by Michael Patipa, M.D., from and incident that occurred on March 29, 2004; (b) one filed by Constantino F. Mendieta, M.D., from an incident that occurred on February 2, 2004; (c) one filed by Edward J. Gross, M.D., from an incident that occurred on July 22, 2003; (d) one filed by Timothy Fee, M.D., from an incident that occurred on November 11, 2003; and (e) one filed by Ramiro Morales, Jr., M.D., from an incident that occurred on April 9, 2002. The Board's staff discovered that FLACS's application did not provide copies of these five incident reports by reviewing individual physician office registration files. FLACS has several methods to use in collecting incident reports. First, FLACS requires its accredited physicians and office surgery facilities to attest and acknowledge that they are required to provide FLACS with any and all adverse incident reports related to or following surgery in the accredited offices. Second, FLACS requires the staff of accredited offices to perform self-evaluation surveys after the first and second year of accreditation, said surveys to include such incident reports. Third, FLACS watches for information about adverse incidents as reported by news media or complaints from the public. Most important, FLACS can make quarterly public record requests for the reports even though the state system of record keeping for adverse incident reports is not computerized. There is no persuasive evidence that FLACS ever made an oral or written public records request for copies of incident reports related to its accredited physicians and office surgery facilities. There is no statutory or rule requirement for physicians to file copies of incident reports with their accrediting organization. However, at least two of the nationally recognized accrediting agencies, Joint Commission on Accreditation of Healthcare Organization (JACHO) and American Association for Accreditation of Ambulatory Surgical Facilities (AAAASF), have provisions in their accreditation manuals related to adverse incidents. JACHO's "Accreditation Manual for Office-Based Surgery Practices," Second Edition (2005), defines a "sentinel event" as follows: A sentinel event is an unexpected occurrence involving death or serious physical or psychological injury, or the risk thereof. Serious injury specifically includes loss of limb or function. The phrase "or risk thereof" includes any process variation for which a recurrence would carry a significant chance of a serious adverse outcome. Such events are called "sentinel" because they signal the need for immediate investigation and response. The terms "sentinel event" and "medical error" are not synonymous; not all sentinel events occur because of an error, and not all errors result in sentinel events. JACHO requires each accredited practice to define "sentinel event" for its own purposes in establishing mechanisms to identify, report, and manage these events. JACHO encourages, but does not require, its clients to report "sentinel events" to the accrediting agency within 45 days of the event or of becoming aware of the event. The report should include a root cause analysis and an action plan. If JACHO becomes aware of an unreported "sentinel event," JACHO will advise the accredited practice to prepare and submit the report within a certain timeframe. If the accredited practice fails to file an appropriate report within that time frame, JACHO will not revoke accreditation, but will place the accredited practice on an "Accreditation Watch" list. AAAASF's "Standards and Checklist for Accreditaion of Ambulatory Surgery Facilities" contains forms for accredited surgery facilities to use in reporting "unanticipated sequela." The forms refer one to AAAASF's "Quality Assurance and Peer Review Manual" for questions relative to their completion. The record indicates that "unanticipated sequela" are the equivalent of adverse incident reports, including but not limited to, events that result in unplanned hospital admissions. In Florida, physicians are required to file adverse incident reports with DOH's Consumer Services Unit (CSU), which is part of DOH's Medical Quality Assurance Program. On at least a quarterly basis, the Board's staff requests CSU to provide it with copies of adverse incident reports filed during a certain timeframe. The staff of the CSU has access to medical consultants who review the incident reports to determine whether there might have been a violation of law or a violation of a standard of care. If so, the matter is referred for further investigation, determination of probable cause, and possible disciplinary prosecution by the Board. The Board's staff places the incident reports in physician registration files and in office surgery inspection/accreditation files. The Board's staff also places copies of incident reports involving physicians or facilities in the respective file of their accrediting agency or accrediting organization. The Board's staff provides copies of adverse incident reports to DOH's state inspectors before they make office inspections of non-accredited facilities or facilities formerly accredited by a national agency or FLACS. The state inspector/risk manager uses the incident reports during inspections to recommend improvements so that such incidents can be avoided in the future. The Board's Surgical Care Committee, uses the incident reports for statistical purposes. The Surgical Care Committee reviews the reports to determine whether changes need to be made in administrative rules, including but not limited to, rules related to standard of care or physician registration. It is important for FLACS to be aware of adverse incident reports filed by its accredited physicians and office- surgery facilities. Such reports are an essential part of any accreditation program. Without such knowledge, FLACS cannot be assured that its accredited physicians and offices are taking steps to prevent such incidents in the future. Moreover, if FLACS is not aware of the adverse incidents occurring in the offices it inspects, FLACS cannot implement changes in its own policies to improve the accreditation process. The Board has no policy or practice for routinely sharing incident reports with accrediting organizations. Nevertheless, requiring FLACS to file copies of incident reports with the Board could alert the Board to incidents that were known to FLACS but never reported to the state and vice versa. As stated above, FLACS could make routine public records requests for copies of reports filed with the Board but not reported directly to FLACS. Rules 64B8-9.0092(4)(a) and 64B8-9.0092(4)(c) Florida Administrative Code Rules 64B8-9.0092(4)(a) and 64B8-9.0092(4)(c) were declared invalid in Florida Academy of Cosmetic Surgery, Inc. v. Department of Health, Board of Medicine, DOAH Case No. 05-0402RX (Final Order, August 8, 2005). For the reasons set forth below in the Conclusions of Law, it is unnecessary to report facts related to a mandatory quality assurance program or the ongoing anesthesia-related accreditation and quality assurance processes involving the active participation of anesthesiologists.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED: That the Board issue a Final Order denying FLACS's application for approval as an office surgery accrediting organization. DONE AND ENTERED this 9th day of August, 2005, in Tallahassee, Leon County, Florida. S SUZANNE F. HOOD 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 9th day of August, 2005.
