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BOARD OF MEDICAL EXAMINERS vs. VALARIA A. ALSINA, 83-002965 (1983)
Division of Administrative Hearings, Florida Number: 83-002965 Latest Update: Mar. 14, 1984

Findings Of Fact Valaria Alsina has been licensed as a medical physician in Florida since 1976 and was so licensed at all times here relevant. On August 19, 1980, Elsa Trujillo and her daughter Nancy, age 12, visited the office of Respondent for treatment. This was the initial visit to Respondent by these patients. Patient histories in Exhibit 3 for Elsa show the first entry to be October 7, 1980; however, the language used in this history clearly shows this to be not Elsa's first visit. Respondent's testimony and reports submitted by Respondent to Petitioner, Exhibit 3, reveal initial complaints by this patient to be dizziness, urinary tract infection, vomiting, vaginal discharge, headache, depression, burning sensation while voiding, and dark urine. Respondent did a urinalysis, took blood for testing, did a PAP smear and vaginal irrigation. Other treatment rendered this patient was not disclosed. The skin and blood tests performed constitute the gravamen of the charges here involved. In Exhibit 1 Respondent billed the insurance carrier for Elsa $359.50 for this visit of August 19, 1980. Those blood tests, the necessity for some of which is questioned by Petitioner, are for glucose, BUN, creatinine, calcium, phosphorus, uric acid, electrolytes (including sodium, potassium, chlorides, and carbon dioxide) total protein, bilirubin, and albumin. The reason the need for these tests is questioned is because they were billed to Prudential Insurance Company as individual tests for each of which Respondent billed from $10.00 to $20.00. These tests are normally performed by medical laboratories in groups, automatically, in which testing machines are programmed to do certain tests on one blood sample introduced into the testing machine. These automatic testing procedures are generically designated "SMA" and are known as SMAC-6, SMAC-16, SMAC-26, etc., with the number denoting the number of tests performed. Those blood tests performed on the Trujillos are all included in the SMAC-22 program for which a laboratory normally charges the doctor $10-$12. Had these tests been charged as SMAC-22, the fact that several were unnecessary would have been accepted because, as a SMAC-22 neither physical nor financial harm resulted to the patient from the unnecessary blood tests conducted. The SMAC-22 could have been performed as cheaply as or cheaper than two manual and individual tests. Since Petitioner's expert witnesses both agreed that some of the tests conducted on this patient were indicated from the symptoms presented, the only fault they found was in Respondent's performing, and charging the patient for, individual and manual blood tests for which there was no medical justification. Nancy Trujillo was seen by Respondent on August 19, 1980. For this visit Respondent billed Prudential Insurance Company $262.50. Clinical data prepared by Respondent for Nancy shows usual childhood diseases, tonsillectomy, adenoid-ectomy, fever, sore throat accompanied by ear pains and swelling, patient complaining of weakness, history of anemia, poor appetite, burning sensation when voiding, dark urine, and a skin rash on right leg. Patient's weight was recorded as 70 pounds, but neither height nor temperature was recorded. In addition to a complete physical examination, a urinalysis, skin culture, and sensitivity test were done, and blood chemistry tests included complete blood count, calcium, glucose, BUN, creatinine, albumin, bilirubin, total protein, and SGPT. These blood tests, all of which (except the cbc) are included in a SMAC-22, were billed as having been performed as individual tests at costs ranging from $10.00 to $17.50 each. Treatment prescribed for Nancy consisted of aspirin suppositories. Respondent testified that Nancy was under weight, although her height was not measured, and that she took Nancy's temperature but failed to record it. Jose Trujillo was seen by Respondent on February 4, 1981, as a patient. Clinical data recorded by Respondent on this visit (Exhibit 3) include ". . . history of diverticulitis of colon, states that have diet but feels like some abdominal discomfort accompanied by diarrhea and feels weak. Patient with history of admission in the hospital, admission Palmetto General Hospital. Some lower discomfort abdomen and dark urine." For this visit prudential Insurance Company was billed $340 for complete physical examination (genital exam omitted) complete blood count; urinalysis; blood tests including glucose, BUN, creatinine, calcium, phosphorus, uric acid, electrolytes (including calcium, potassium, chlorides, and carbon dioxide) total protein, cholesterol, triglycerides, SGOT, SGPT, and alkaline phosphates; urine culture; sensitivity test; and collection and handling. The blood tests were all included in a SMAC- 22 but were billed as individual and manually performed tests with costs ranging from $10.00 to $20.00 each. Petitioner's expert witnesses both testified that some of the tests performed on these three patients were indicated by the symptoms and complaints described. Other tests conducted were not appropriate for the symptoms given. They also agreed that had these tests been conducted and billed as a SMAC-22 they would not consider that that could be a violation of the Medical Practices Act because, even though some of these tests were not medically indicated, they "come with the package" and would not increase the cost to the patient. However, when conducted manually and individually and so billed, the practice of conducting blood tests for which there is no medical justification does not conform to the generally prevailing standards in the medical community. Because of the findings below, it is unnecessary to denote those tests performed on each of the Trujillos for which there was no medical justification. Although billed to Prudential Insurance Company as manually and individually performed, the blood tests on the three patients above-named were conducted as a SMAC-22 and were not performed manually and individually as testified to by Respondent. This determination is based on the following facts, circumstances, and rationalizations: Respondent sent the blood samples from these three patients to Central Medical Laboratory, Inc., for a SMAC-22 test. Respondent testified that she performed each of the series of 10 to 15 tests on the blood samples of these patients in 20 to 30 minutes; however, other medical witnesses testified it took a trained technician 20 minutes to perform one of these blood tests manually. The latter testimony is deemed more credible. Many of these tests have subjective characteristics, such as color comparisons, and identical results from the same blood sample tested by two technicians or run through the same automated process would be rare. The odds against a technician performing individual and manual tests on 16 blood samples and obtaining the identical result on all tests that is obtained from a commercial laboratory SMA test is astronomical. Yet, the one report obtained from Central Medical Laboratory for the SMAC-22 conducted on the blood sample from Jose Trujillo (Exhibit 7) is identical to the "manual and individual" test report maintained by Respondent for the same blood sample in Exhibit 3--with one exception. The laboratory found the triglyceride test to be 254 MG/DL, well outside the 30-175 range for this test. On Exhibit 3 Respondent recorded 175 for this test. She testified she sent blood samples from the three Trujillos to the laboratory to have a check on her tests but did not ask the laboratory to do a recheck on the triglycerides test on Jose or recheck her test for triglycerides after receiving the laboratory report. Only a small amount of blood (5 or 10 cc) is required for an automated procedure for up to 40 different tests, whereas at least three times this amount of serum would be required for 10 tests conducted manually or individually. Accordingly, manual testing would require the drawing of a lot more blood than would be required for automated testing in a commercial lab. Respondent testified that she sent one-half of the blood sample taken on each Trujillo to the laboratory and kept the other one-half to test in her office. Commercial medical laboratories are licensed by the state; are checked for compliance with proper procedures; equipment used is checked for proper calibration at frequent intervals; reagents used in the testing is frequently replaced; and, when compared to the equipment, procedures, calibration, and reagents used in a physician's office which are subject to no regulation, the former should provide the more reliable test in a much shorter time. The equipment in Respondent's office is capable of being used to conduct all of the tests on these three patients for which Respondent billed Prudential Insurance Company. No rational explanation was provided to justify having a SMAC-22 performed and duplicating these tests manually. Respondent's testimony that the SMAC-22 was ordered to check the results of the manual tests she performed is not credible. If a check on the manual tests conducted on blood samples of Nancy and Elsa Trujillo for the August 17, 1980, visit was desired, it would appear appropriate to check the office procedures by doing a SMAC-22 on only one of those blood samples, rather than have both of these samples checked as was done here. Repeating this "check" on the sample taken from Jose Trujillo on February 4, 1981, does not make sense. Either the laboratory test is trusted or it is not. The same applies to the individual tests conducted manually in the office. If confident of the procedures, there would be no reason for Respondent to check the manual tests conducted in the office by sending one-half of the serum to a commercial laboratory. Respondent testified that Central Medical Laboratory picks up blood samples at her office daily. This suggests that some tests are routinely ordered by Respondent and conducted by the laboratory, and no evidence was presented to rebut such a conclusion. On the other hand, Petitioner presented no evidence of the volume of tests conducted by Central Medical Laboratory for Respondent which would solidify this conclusion. Nor did Petitioner submit the SMAC-22 results obtained by Central Medical Laboratory for the blood test conducted on the serum taken from Elsa and Nancy Trujillo on August 17, 1980, to see if they too were identical to the results shown in Exhibit 3. The only rational explanation for having SMAC-22 tests performed in a commercial laboratory and reporting these tests as done individually and manually in Respondent's office is the amount the insurance company will pay for the latter is nearly ten times what they will pay for the former. Laboratory tests billed for Jose Trujillo for the February 4, 1981, visit amount to nearly $250. Charges submitted for these tests reported on the SMAC-22 (Exhibit 7) amount to $187. Respondent testified she paid for the SMAC-22 tests she ordered and did not bill the insurance company for these tests because "they won't pay for both" SMAC and manual tests performed on the same sample. Since the lab charged Respondent only $10-$12 for the SMAC-22 tests conducted, the insurance company would not pay $187 if these tests were charged as automated tests. Considerable evidence was submitted that there was no medical justification for certain of the tests performed on Nancy, Elsa, and Jose Trujillo. For Nancy, these unnecessary tests included tests for calcium, glucose, BUN, creatinine, albumin, bilirubin, total protein, and SGPT. For Elsa, these unnecessary tests were calcium, phosphorus, uric acid, total protein, bilirubin, with either BUN or creatinine justified, but not both. For Jose, no medical justification was shown for manually performed tests for glucose, calcium, phosphorus, electrolytes, SGDT and SGNT. In view of the finding above, that these tests were not manually done but were performed as a SMAC-22, the fact that they are not medically justified if done manually becomes immaterial.

Florida Laws (1) 458.331
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DEPARTMENT OF HEALTH, BOARD OF MEDICINE vs KAMBAM R. REDDY, M.D., 11-003488PL (2011)
Division of Administrative Hearings, Florida Filed:West Palm Beach, Florida Jul. 19, 2011 Number: 11-003488PL Latest Update: Mar. 06, 2025
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DEPARTMENT OF HEALTH, BOARD OF MEDICINE vs AJAZ AFZAL, M.D., 13-003344PL (2013)
Division of Administrative Hearings, Florida Filed:Orlando, Florida Sep. 06, 2013 Number: 13-003344PL Latest Update: Mar. 06, 2025
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DEPARTMENT OF HEALTH, BOARD OF CHIROPRACTIC vs PETER ANTHONY KENT, D.C., 01-000327PL (2001)
Division of Administrative Hearings, Florida Filed:West Palm Beach, Florida Jan. 25, 2001 Number: 01-000327PL Latest Update: Mar. 06, 2025
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DEPARTMENT OF HEALTH, BOARD OF MEDICINE vs JOSEPH CHI, M.D., 07-002310PL (2007)
Division of Administrative Hearings, Florida Filed:Miami, Florida May 22, 2007 Number: 07-002310PL Latest Update: Mar. 06, 2025
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DEPARTMENT OF HEALTH, BOARD OF MEDICINE vs ADIB A. CHIDIAC, M.D., 11-001725PL (2011)
Division of Administrative Hearings, Florida Filed:Fort Lauderdale, Florida Apr. 11, 2011 Number: 11-001725PL Latest Update: Mar. 06, 2025
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FRANK W. FENDER vs DEPARTMENT OF HEALTH, 97-004811 (1997)
Division of Administrative Hearings, Florida Filed:Jacksonville, Florida Oct. 16, 1997 Number: 97-004811 Latest Update: Jul. 06, 2004

The Issue The issue in this case is whether Petitioner, Frank W. Fender, should have received a passing grade on the March 1997 Clinical Chemistry Technologist examination.

Findings Of Fact Petitioner, Frank W. Fender, took the Clinical Chemistry Technologist examination in March 1997 (hereinafter referred to as the "Examination"). The Examination consists of fifty multiple choice questions. The instructions for the Examination specifically informed persons taking the examination that they were to "[a]lways choose the BEST answer." It was determined that Mr. Fender had answered twenty- seven of the Examination questions correctly. Mr. Fender was, therefore, awarded a score of 349. A score of 350 or more was required for a passing score. If Mr. Fender were determined to have answered one more question correctly, he would receive a passing score. Mr. Fender was informed that he had not passed the Examination. By letter dated July 25, 1997, Mr. Fender requested a formal administrative hearing to contest his failing score. In particular, Mr. Fender challenged the determination that he did not answer questions 3, 9, 16, and 21 correctly. Question 3: Question 3 involved obtaining "true serum triglyceride results." Mr. Fender selected answer "D" which was: "measure a blank in which the dye-coupling is omitted." The answer considered correct was "B." The evidence failed to prove that answer "D" was the best answer. While the use of blanks in triglyceride methodologies is correct, "dye-coupling" is not. Therefore, answer "D" is not a correct response. The evidence failed to prove that answer "D" was the best answer for question 3. Question 9: Question 9 asks which enzyme listed in the answers is found to be elevated in the majority of alcoholics. Mr. Fender selected "B," ALT, as the correct response. The evidence failed to prove that answer "B" was the best answer. While ALT may be raised in an alcoholic, it also may not be. GGT is the most sensitive indicator of alcoholism. Even if ALT is normal, GGT will be raised in an alcoholic. The best answer to question 9 was, therefore, "C," GGT. The evidence failed to prove that answer "B" was the best answer to question 9. Question 16: Question 16 asks why one must wait approximately 8 hours to draw a blood sample after administering an oral dose of digoxin. Mr. Fender selected "D" as the correct response. This answer indicates that the reason one must wait is because "all" of the digoxin "will be in the cellular fraction." Mr. Fender's response was not the best response because of the use of the work "all" in the answer he selected. The most digoxin that could be in the cellular fraction is approximately twenty-five percent, because approximately seventy-five percent is excreted through the kidneys. The evidence failed to prove that answer "D" was the best answer to question 16. Question 21: Question 21 asks the best way to test for suspected genetic abnormalities in an unborn fetus. Mr. Fender selected answer "B," "performing L/S ratios" as the best answer. While the evidence proved that L/S ratios will measure immature fetal lungs, this condition results in respiratory distress syndrome. Respiratory distress syndrome is an "acquired" disorder and not a "genetic" abnormality. While an L/S ratio can be used to test for acquired disorders, a "chromosome analysis," answer "C," is used to test for genetic abnormalities. The evidence failed to prove that answer "B" was the best answer to question 21. The evidence failed to prove that Mr. Fender should have received a score higher than 349 on the Examination.

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 Health dismissing Frank W. Fender's challenge to the grade awarded to him on the March 1997 Clinical Chemistry Technologist examination. DONE AND ORDERED this * day of March, 1998, in Tallahassee, Leon County, Florida. LARRY J. SARTIN 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 Filed with the Clerk of the Division of Administrative Hearings this * day of March, 1998. * Mailed 3/2/98 undated. -ac COPIES FURNISHED: Frank W. Fender 7603 North Laura Street Jacksonville, Florida 32208 Anne Marie Williamson, Esquire Department of Health Office of the General Counsel 1317 Winewood Boulevard Building 6, Room 106 Tallahassee, Florida 32399-0700 Dr. James Howell, Secretary Department of Health 1317 Winewood Boulevard Building 6, Room 306 Tallahassee, Florida 32399-0700 Pete Peterson Department of Health 1317 Winewood Boulevard Building 6, Room 102-E Tallahassee, Florida 32399-0700 Angela T. Hall, Agency Clerk Department of Health 1317 Winewood Boulevard Building 6 Tallahassee, Florida 32399-0700

Florida Laws (2) 120.57483.809
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BOARD OF CHIROPRACTIC EXAMINERS vs. R. H. GRANT, 76-001355 (1976)
Division of Administrative Hearings, Florida Number: 76-001355 Latest Update: Jun. 01, 1977

Findings Of Fact Respondent is a licensed chiropractor in the State of Florida and was so licensed at the time of the alleged violations. He holds License No 2167 issued by the State Board of Chiropractic Examiners. On December 24, 1975, pursuant to a request of Randy Spector for a blood test, Respondent extracted a blood sample from Spector. At this time, Respondent informed Spector that he would send the blood sample to MET-PATH laboratories for testing and that the results would be back in approximately a week or ten days. A few days later Spector visited Respondent's office and was informed by him that the tests were fine and that he was in good health, but he did not have the results back from the laboratory. Respondent's wife, who was present, told Spector that the laboratories do not always send the test back unless they are asked for or unless something was wrong. This sounded like "double talk" to Spector and he asked Respondent for the test results. Respondent said that he would call the lab on the phone and obtain the results. On January 2, 1976, Spector again visited Respondent's office and was provided the report of blood analysis. Respondent explained some of the entries on the report and after so doing, Spector asked him to sign the report. Respondent did so. Thereupon Spector gave him a check for $15.00 in payment for the test and was provided a receipt. (Testimony of Spector, Petitioner's Exhibits 1,2 & 3) Spector was now convinced that the analysis of his blood had not been made by MET-PATH laboratories and therefore called that company several times during the next week or so. Each time he was informed by that concern that they had not received any of his blood for testing from Respondent. On January 5, 1976, Spector's legal counsel wrote a letter to Respondent advising him that Spector believed that the test results were fabricated and asserted a claim for malpractice and fraud. Respondent's counsel responded by letter of January 19 denying the allegations and stating that "if there was any error, it was simply an error in transposition of any test results and there was no resulting damage of any nature whatsoever to your client". (Testimony of Spector, Respondent's Exhibits 1 & 2). Spector contacted Dr. George Fica, a chiropractor who had been treating him and his wife. He told him of his complaint against Respondent and indicated that the matter was going "to be blown sky high" and that the press would be involved. However, Spector told Fica that if Respondent apologized, he would drop the matter. He showed Fica the blood test results and Fica told him that they were in normal limits but that some of the tests would have required the use of a laboratory. Fica talked to the Respondent about Spector's complaints and his claim that MET-PATH Laboratories had not done the work. Respondent stated that he had done it with a machine in his office. Fica then questioned him about certain tests such as triglycerides, which required laboratory analysis. Respondent then informed him that he didn't do the work in his office, but that he was using many labs for blood work and that his secretary had typed the wrong information on Spector's report. (Testimony of Fica) About January 12th or 13th, Spector went to Respondent's office and told him that the matter had gotten out of hand and that he wanted to straighten it out. Spector checked Respondent's tape recorder to make sure it was not running and also looked up and down the hallway outside his office and then closed the door. During the course of the conversation, Respondent apologized for not sending Spector's blood sample to MET-PATH and told him that he had run the tests in his own office and that they had been transposed in error. Spector told Respondent it would cost him a lot of money to go to court and indicated that the matter should be settled. (Testimony of Spector; Respondent) It was stipulated that Respondent had not sent Spector's blood sample to any laboratory for analysis. Respondent testified that he had originally planned to send Spector's blood to MET-PATH but due to a previous fire that destroyed much of his office, he had no usable mailing cartons for this purpose. Therefore, he did those tests that he could perform on a machine in his office. A number of the tests could not be done on the machine and he was unaware that his secretary had typed entries for such tests on the report given to Spector. Respondent speculated that the secretary must have mistakenly used figures from another patient's blood test when preparing the report. This explanation is not deemed credible in view of Respondent's contradictory statements in this regard to Spector and Fica as set forth in the foregoing findings. The laboratory cost for preparing a blood analysis is approximately $10.00. (Testimony of Resp., Pet.'s Exh. 4) Respondent has been a chiropractor for approximately 13 years and enjoys an excellent reputation for competence in his field. An associate, who has been in his office for the past several months, has never observed him engage in an unethical practice. (Testimony of Respondent, Fica, Gordon)

Recommendation That the Florida Board of Chiropractic Examiners issue a reprimand to Respondent, R.H. Grant, for violation of Section 460.13(3)(h), Florida Statutes. DONE and ENTERED this 25th day of October, 1976, in Tallahassee, Florida. THOMAS C. OLDHAM Hearing Officer Division of Administrative Hearings Room 530, Carlton Building Tallahassee, Florida 32304 COPIES FURNISHED: Ronald C. LaFace, Esquire Post Office Box 1752 Tallahassee, Florida Charles A. Sullivan 1245 20th Street Post Office Box 3 Vero Beach, Florida 32960

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DEPARTMENT OF HEALTH, BOARD OF NURSING vs ALEJANDRO PEREZ, A.P.R.N., 20-003057PL (2020)
Division of Administrative Hearings, Florida Filed:Tallahassee, Florida Jul. 08, 2020 Number: 20-003057PL Latest Update: Mar. 06, 2025

The Issue The issues are whether, during 2015, Respondent held himself out as a “doctor of medicine,” even though he did not hold a license to practice medicine in Florida, in violation of section 456.072(1)(m), Florida Statutes (2014); whether, during 2015, Respondent exceeded the scope of his advanced practice registered nursing (APRN)1 license modifier by removing adipose tissue from a patient’s abdomen, performing intravitreous injections of the processed tissue into both eyes of a patient, and failing to have a protocol in place for the removal of abdominal adipose tissue and the intravitreous injection of any material into a living person, in violation of section 456.072(1)(o); and, if so, the penalty that should be imposed.

Findings Of Fact The Parties Petitioner is the state agency charged with regulating the practice of nursing pursuant to section 20.43, and chapters 456 and 464, Florida Statutes. Respondent was born and raised in Cuba, where he obtained a licensed practical nurse degree and, in 1995, Respondent earned a Doctor of Medicine degree and moved to Florida. On two occasions, Respondent failed to pass the examinations in Florida for licensure as a medical doctor. Respondent obtained a Florida license as a registered nurse in 2005 and, in March 2015, a license modifier as an APRN. Respondent’s highest relevant education in the United States is a Master of Science degree in nursing awarded in December 2014 from the south Florida campus of the University of Turabo. A couple of months later, the American Academy of Nurse Practitioners certified Respondent as a Family Nurse Practitioner. The transfer of processed fat tissue into the eye is thought, by some, to treat conditions of the eye, such as dry macular degeneration, to be part of regenerative medicine. This so-called “stem cell injection procedure” (“procedure”) comprises three steps: (1) removing the fat tissue, usually from the abdomen; (2) processing the fat tissue to prepare it for injection; and (3) injecting the processed fat tissue into the vitreous cavity at the back of the eye. Following the completion of his medical education in Cuba, Respondent obtained varying degrees of training and experience in the each of the three steps of the procedure. Respondent testified that he trained with a “specialist,” possibly an ophthalmologist, in intravitreal injections. This covered such topics as the choice of syringe, the preparation of the patient, maintaining an open eye, the choice of a substance to stabilize the inside and outside eye, and the angle of the needle to the surface of the eye at the point of injection. Respondent also obtained training in intranasal and intraarterial injections, the latter of which is the more complicated. Respondent obtained a certificate in Mexico for completing the training in the removal of tissue from bone marrow. Respondent did not detail his training or experience in processing removed fat tissue. Through much of Latin America, Respondent has injected processed fat tissue, at the rate of about ten patients over one week, and has trained other healthcare providers to perform these procedures. Respondent also testified that he had performed a dozen intravitreal injections of processed fat tissue in Mexico and Chile prior to the three injections at issue in this case, so it seems that most of his experience did not involve intravitreal injections. Respondent’s only evidence of purported “stem cell” experience was assisting in bone marrow aspiration, not surgical adipose tissue removal or intravitreal injections. Respondent admitted that he had never performed intravitreal injections under the supervision of an ophthalmologist, a medical doctor of any type, or in a supervised training program prior to performing intravitreal injections on Patients E.K., E.N., and P.B. in May and June of 2015. Respondent failed to provide any evidence that he was educated or supervised by a licensed physician in the performance of these procedures prior to performing them on Patients E.K., E.N., and P.B. Performance of the Procedure by Respondent at the Clinic Respondent’s first intravitreal injection of fat tissue at the Clinic took place in April 2015, about one month after he had completed the educational requirement for this APRN license modifier. Having retained Respondent as an independent contractor, the Clinic called him a few days before an upcoming intravitreal stem cell injection to confirm his availability. The Clinic paid Respondent $500 per procedure, for which it charged each patient $5000. Although the Clinic operated this program as an FDA- registered clinical trial, all procedures were “patient funded treatment,” and the Clinic was not affiliated with any educational or research institution investigating stem-cell treatment of eye diseases or disorders. The three patients involved in this case are, or were, E.K., P.B., and E.N. E.K.’s procedure took place on May 15, 2015, and P.B. and E.N.’s procedures took place on June 16, 2015. Each patient suffered from dry macular degeneration. Each patient was sighted at the time of the procedure, at the end of which, each patient was substantially blind. At the time of each patient’s procedure, E.K., who died five years after her procedure, was 89 years old and resided in Oklahoma. P.B. was 77 years old and resided in southwest Florida, and E.N. was 72 years old and resided in Missouri, where she had taught research methods to graduate students at the University of Missouri. At the time of the subject procedures, the Clinic was affiliated with Bioheart, Inc., a publicly traded corporation. Key employees of the Clinic included Kristin Comella, who served as the chief scientist of the Clinic and chief scientific officer of Bioheart and holds bachelor’s and master’s degrees in chemical engineering, and Dr. Antonio Blanco, who is an internist in Hollywood, Florida, with 26 years of practice and the medical director of the Clinic and holds a medical degree from Georgetown University. The Clinic’s website adds that Ms. Comella is in the top 50 of global stem-cell influencers. E.K. and E.N. testified that they learned about or confirmed their interest in the Clinic by an online search of clinical trials of stem-cell treatment for dry macular degeneration. Neither patient differentiated between patient-funded clinical trials, such as these, and clinical trials whose treatment costs were subsidized by research centers, universities, hospitals, and pharmaceutical manufacturers. E.K.’s medical records do not include any representations as to Respondent’s status as a healthcare provider. E.K. and her niece, who accompanied her, arrived in Fort Lauderdale in sufficient time for E.K.’s pre-operative appointment with Dr. Greenbaum, an ophthalmologist employed with the Hollywood Eye Clinic. Until she spoke with Dr. Greenbaum, E.K. believed that Dr. Greenbaum would perform the procedure, based on what she had been told by Clinic staff. At the pre-operative exam conducted by Dr. Greenbaum, E.K. and her niece learned that Dr. Greenbaum would not be performing the procedure on the following day. Dr. Greenbaum mentioned Respondent’s name, so the niece had her husband research Respondent that night, but his research revealed nothing. The next day, E.K. and her niece were introduced to Respondent by a Clinic employee, likely Ms. Comella. The niece does not recall if the employee referred to Respondent as a physician, but she assumed that he was. She recalled only that the clinic employee introduced him by saying that he was very experienced and had performed lots of stem cell injections of this type. The niece recalled distinctly that Respondent introduced himself as a “medical doctor.” Respondent denies doing so. The niece’s testimony is credited based on the totality of the evidence. P.B.’s medical records do not include any representations as to Respondent’s status as a healthcare provider except for the operative report, which bears Respondent’s signature above “Physician Signature.” Well prior to the date of the procedure, P.B. called the Clinic, spoke with Dr. Greenbaum and Ms. Comella, who informed her that Dr. Greenbaum would perform the procedure. P.B. later arrived in Fort Lauderdale in time for her pre-operative exam by Dr. Greenbaum, whose office told P.B. that Dr. Greenbaum was no longer performing the procedure. P.B. assumed that another ophthalmologist would perform the procedure. The next day, P.B. and a friend or family member, who had accompanied her on the trip, met Ms. Comella and Respondent, whom Ms. Comella introduced as “Doctor Perez,” and he did not correct her. P.B. asked him if he was an ophthalmologist, and Respondent replied, “no, but I’m well-trained in this procedure.” He never mentioned that, in terms of Florida licensing, he was only a registered nurse or APRN and was not a physician. E.N.’s medical records include the most references to Respondent’s status as a healthcare provider. These records include a page from the Clinic’s website that was initialed and dated by E.N., and prominently identifies Respondent as a “DM, NP-C,” meaning “doctor of medicine” and “nurse practitioner--certified.” The accompanying text discloses that “Dr. Alejandro Perez” graduated from the University of Havana Medical School in 1993 as a “Doctor in Medicine”; since 2007, he has conducted innovative research on regenerative medicine with a focus on adult stem cells from bone marrow and adipose tissue; “Dr. Perez” has worked on adult stem cells to treat multiple chronic diseases; “Dr. Perez” trains national and foreign “Medical Doctors” on the use of adult stem cells; and that “[h]e currently holds a National Board Certification as a Family Nurse Practitioner.” In three out of five references, the document refers to Respondent as a “doctor,” never disclosing that he was not a licensed physician in Florida. This website page may have come into existence after Respondent’s first patient encounter in this case in May 2015. Ms. Comella introduced Respondent to E.N. and her sister, who had accompanied her on the trip, as “Dr. Alex Perez.” Without stating his specialization, Respondent told E.N. that he was a “medical doctor” and was proud of his “profession,” which, in context, meant the practice of medicine, not nursing. Respondent wore a white jacket with a printed name tag, “Alex Perez, M.D.” At no time did Respondent reveal that his Florida licensure was as a registered nurse or APRN and not a physician. Lack of a Written Protocol As a licensed APRN, Respondent was required by section 464.012 and Florida Administrative Code Rule 64B9-4.002 to practice under an APRN protocol filed with the Board of Nursing. At all times material, the scope of practice of a certified family nurse practitioner licensed in Florida as an APRN did not include performing any invasive procedures, including surgical removal of adipose tissue or intravitreal injections, without an APRN Protocol on file that ensured physician supervision. By letter dated March 12, 2015, the Board of Nursing notified Respondent that he was required to have an approved APRN protocol on file with the Department “within 30 days of employment.” Respondent was employed in March 2015 at the time of receipt of the above-referenced letter. In May and June 2015, Respondent was aware of the protocol requirement and the scope of practice as an APRN. He admitted that he received the March 12, 2015, letter and failed to provide a protocol as instructed. At no time did Respondent ever obtain or file with the Board of Nursing a written protocol between him and a supervising licensed physician authorizing Respondent to perform the subject procedure. Respondent claimed, alternatively, that Drs. Greenbaum and Blanco served as his supervising physicians, but admitted that they served remotely and without a signed written protocol. Harm to the Patients The impact on the three patients of this unauthorized procedure performed by Respondent was blindness and its incumbent, incalculable damages, including, but not limited to, loss of independence, loss of mobility, and loss of enjoyment of life. Respondent admitted that, if not for the procedure, the three patients would likely not have been blind.2

Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Board of Nursing enter a final order finding that Respondent has violated sections 456.072(1)(o) and 456.072(1)(m) and revoking Respondent’s license to practice as an advanced practice registered nurse. DONE AND ENTERED this 3rd day of May, 2021, in Tallahassee, Leon County, Florida. S MARY LI CREASY Administrative Law Judge 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 3rd day of May, 2021. COPIES FURNISHED: Dirlie Anna McDonald, Esquire Department of Health 4052 Bald Cypress Way, Bin C-65 Tallahassee, Florida 32399 Nicole M. DiBartolomeo, Esquire Department of Health Office of the General Counsel 4052 Bald Cypress Way, Bin C-65 Tallahassee, Florida 32399 Louise St. Laurent, General Counsel Department of Health 4052 Bald Cypress Way, Bin C-65 Tallahassee, Florida 32399 Dwight Oneal Slater, Esquire Cohn Slater, P.A. 3689 Coolidge Court, Unit 3 Tallahassee, Florida 32311 Joe Baker, Jr., Executive Director Board of Nursing Department of Health 4052 Bald Cypress Way, Bin C-02 Tallahassee, Florida 32399 Deborah McKeen, BS, CD-LPN Board of Nursing Department of Health 4052 Bald Cypress Way, Bin D-02 Tallahassee, Florida 32399

Florida Laws (7) 120.569120.5720.43456.072464.003464.012464.018 Florida Administrative Code (3) 64B9-4.00264B9-4.01064B9-8.006 DOAH Case (4) 11-0546PL20-3057PL20-3062PL20-3066PL
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