The Issue Whether Petitioner's renewal application for an assisted living facility (ALF) license should be denied based upon Petitioner's failure of the biennial re-licensure survey conducted on June 10 and 11, 2013, and because Petitioner has a controlling interest in another ALF that has an unpaid fine of $5,000.00 from 2012 after its license was revoked.
Findings Of Fact AHCA is the state agency responsible for regulating home health agencies in Florida. In this capacity, AHCA determines whether to approve applications for renewal of licensure as an ALF, and it has administrative jurisdiction to enforce the laws governing such licensees, including the authority to take disciplinary measures against licensees who violate the applicable statutes and rules. Petitioner is a corporation which operates a 62-bed ALF in the Cannon Point neighborhood of Lauderhill, Florida. The ALF has both a standard ALF license and a specialty limited mental health (LMH) license. Petitioner has been owned and operated for approximately 13 years by Susan and William Spaw. Mrs. Spaw serves as president, administrator, and chief financial officer of Petitioner and owns a 51 percent interest in Petitioner. As such, she is "a controlling interest" of Petitioner as defined by section 408.803(7), Florida Statutes. Mrs. Spaw also was a controlling interest of Serenity Gardens, an ALF which had its license revoked by AHCA by Final Order dated March 30, 2012 (Final Order). By the same Final Order, Serenity Gardens also had a $5,000.00 fine imposed against it by AHCA that remained unpaid as of the date of the final hearing in this proceeding. Florida ALF licenses must be renewed every two years. Petitioner filed an application for license renewal with AHCA which was received on March 20, 2013. When Petitioner's application was received by AHCA, it was referred to Jim Alfred (Alfred), senior management analyst in the ALF licensing unit. Alfred reviewed the application to determine whether any items were missing or anything needed to be added or corrected. On April 12, 2013, AHCA issued an Omissions Letter (Omissions Letter) drafted by Alfred to Mrs. Spaw advising that Petitioner's renewal application was determined to be incomplete and specifying the errors and omissions to be addressed within 21 days to deem the application complete. Among other things, the Omissions Letter states that pursuant to section 408.831, if there are any outstanding fines, liens, or overpayments that have been assessed by final order of AHCA against the licensee or a common controlling interest, they must be paid prior to license/registration issuance. The Omissions Letter indicates that AHCA's records show that, in addition to having a controlling ownership interest in Petitioner, Mrs. Shaw also had a controlling ownership interest in Serenity Gardens which had an outstanding fine in Final Order status for the amount of $5,000.00. The Omissions Letter also notified Petitioner that section 429.14(3), Florida Statutes, gives AHCA the authority to deny the renewal application based upon the revocation of license number 10176, which was issued to Serenity Gardens. As part of the ALF license renewal process, AHCA conducts a biennial "survey." The survey is a comprehensive inspection of an ALF facility and its records to determine compliance with applicable statutes and rules. The survey must be completed before the renewal is issued. During the survey, AHCA surveyors observe staff in their interactions with residents and the dispensing of medications. The surveyors also examine the physical plant and review resident records. When Alfred reviewed Petitioner's application, Petitioner's license was "red flagged" in AHCA's computer system because of the revocation of the license for Serenity Gardens and the outstanding $5,000.00 fine. Alfred brought this to the attention of his supervisor, Shaddrick Haston (Haston), AHCA's unit manager for ALFs. Although either the revocation of the license for Serenity Gardens, a facility in which Mrs. Shaw had a controlling interest, or the outstanding $5,000.00 fine would be a sufficient basis for denial of the renewal application, Haston directed Alfred to wait until receipt of the biennial survey results for Petitioner's ALF before moving forward with a possible denial of the renewal application. The biennial re-licensure survey was conducted at Petitioner's facility on June 10 and 11, 2013, by AHCA surveyors Michael Forrester (Forrester) and Nicolas Frias (Frias). At the time of the survey, both Forrester and Frias were experienced surveyors, each with over approximately 100 inspections, including renewal application biennial surveys. Working together, Forrester and Frias determined there were ten deficiencies, commonly cited as "tags," in reference to applicable regulatory standards. Tag A 010 Tag A 010 cited Petitioner with a violation of Florida Administrative Code Rule 58A-5.0181(4) regarding "Continued Residency." This rule requires that the patient must have a face-to-face medical examination by a licensed health care provider at least every three years after the initial assessment, or after a significant change, whichever comes first. The results of the examination must be recorded on AHCA Form 1823 (Form 1823). A resident observation log revealed that on May 7, 2013, a resident was taken by ambulance to the hospital because she was disoriented, stumbling, drooling, and had slurred speech. Petitioner's staff checked her blood sugar and found it very high. The resident also expressed that she wanted to commit suicide. Although the resident was not diagnosed with diabetes at that time, the resident was determined to have high blood sugar which needed to be monitored by home health services. Neither the change in mental status or physical status was documented on a Form 1823 although each qualifies as a "significant change." Tag A 030 Tag A 030 cited Petitioner with a violation of rule 58A-5.0182(6) and section 429.28 regarding "Resident Care-Rights & Facility Procedures." This deficiency was based upon the observation that the ALF had a pet cat that had no documentation of vaccination since 2009. This was considered to be potentially harmful to the residents. This violation was admitted by Petitioner. Tag A 052 Tag A 052 cited Petitioner with violating rule 58A- 5.0185(3) regarding "Medication-Assistance with Self- Administration." Forrester observed staff assisting residents in the self-administration of medications and saw that the required procedures for unlicensed staff were not followed properly with four residents. A staff member was observed assisting one resident with the application of a medication patch on the resident's abdomen. The staff member did not wear gloves, nor did she wash her hands after providing assistance. Two residents received medication without the staff member first reading the label in the presence of the residents. Staff was also observed leaving a resident before the resident took her medication, in violation of the rule. These violations were admitted by Petitioner, but Petitioner attributed these deficiencies to the staff being nervous due to the presence of the surveyors. Tag A 053 Tag A 053 cited Petitioner with violating rule 58A- 5.0185(4) regarding "Medication-Administration." This deficiency was based upon a review of resident records that reflect an unlicensed staff member performed blood glucose testing on a resident. Upon questioning, the surveyors learned that this was not the only time this occurred because Mrs. Spaw and the staff were unaware that a licensed medical professional is required by the rule to perform this type of procedure. Tag A 054 Tag A 054 cited Petitioner with violating rule 58A- 5.0185(5) regarding "Medication – Records." This deficiency was based on the finding that five out of 28 sampled residents' medication observation records (MORs) were not appropriately maintained. Forrester observed a staff member assist resident 18 with two medications. However that resident's MOR revealed that resident 18 should have been provided with three medications. The staff member noted on the MOR that one of the medications, Risperidone, an antipsychotic medication, was not available. After the surveyor questioned why the resident was not receiving the medication, another staff member found the missing medication. Forrester observed a staff member take a package of medications from a filing cabinet and a pill from one of the packages fell on the floor. None of the same pill type was missing from future doses for resident 13. A review of the MOR for resident 13 showed that one capsule by mouth daily was initialed as being given to the resident from June 1 through June 11, 2013. Because one pill was lying on the floor, it is not possible for the resident to have received all of the prior doses. The MOR for resident 16 showed that this resident was to be given one 800mg tablet of ibuprofen three times a day and had in fact received the ibuprofen as ordered from June 1 through June 10, 2013. However, when staff was questioned by the surveyor regarding why no ibuprofen was available for this resident on June 11, the surveyor was told that the physician had discontinued this order in September 2012. According to staff, the pharmacy erroneously printed the order for ibuprofen on the MOR in June. The deficiency was based upon the fact that staff indicated on the resident's MOR for the first ten days of June that they were assisting the resident with this medication when, in fact, no medication was available. A review of the MORs for residents 21 and 22 indicated that unlicensed staff initialed for providing injections. According to staff, the injections were actually provided by licensed health care providers who came to the facility. At some point later, staff wrote "error." Only the individual who actually provides the injection is to initial the MOR. Tag A 056 Tag A 056 cited Petitioner with violating rule 58A- 5.0185(7) regarding "Medication–Labeling and Orders." This deficiency was based, in part, on the finding that Petitioner failed to ensure that medication orders were followed as directed for 12 out of 28 sampled residents. These 12 residents received their 8:00 a.m. medications after 9:00 a.m. on June 11, 2013. According to the facility's pharmacy, the ideal window for providing medications to a resident would be no more than an hour before and an hour after the required medication dosage time as noted on the MORs. The resident is supposed to take the medications at the time intervals given. The timing issue becomes worse when a resident takes a medication more than once a day. The delay of assistance with self-administered medications for sampled residents by staff is not within the recommended pharmacy time intervals for providing medication assistance at dosage times. The facility's failure to provide physician- ordered medication at prescribed dosage times directly affects the well-being of the sampled residents. On June 11, 2013, Mrs. Spaw acknowledged exceeding the recommended time frame for medication distribution and indicated that it might be due to people coming in late. However, the staff individual who was observed distributing medications late stated that she starts the morning medications at 8:00 a.m. Mrs. Spaw indicated during the survey that she thought the medication distribution was beginning at 7:00 a.m. but she is not at the facility at that time.2/ Tag A 056 was also based upon the observation of a resident who did not receive all doses of medication, despite records indicating that all doses had been dispensed when, in fact, one dose was found on the floor. This deficiency was noted under this tag because it represented a failure to follow the doctor's order of prescribing one dosage per day. Tag A 093 Tag A 093 cited Petitioner with violating rule 58A- 5.020(2) regarding "Food Service-Dietary Standards." This deficiency was based upon Petitioner's failure to follow its own prepared menus. This rule requires that menus are to be dated and planned at least one week in advance for both regular and therapeutic diets. Any substitutions are to be noted before or when the meal is served. A three-day supply of nonperishable food, based on the number of weekly meals the facility has contracted with residents to serve, shall be on hand at all times. The surveyors found that the facility was not providing fruit juice despite fruit juice being on the menu, the menus were not showing a substitution, and the facility did not have a stock of fruit juice available. Petitioner provided no explanation or evidence to rebut this deficiency. Tag A 152 Tag A 152 cited Petitioner with violating rule 58A- 5.023(3) regarding "Physical Plant–Safe Living Environment/Other." In accordance with this rule, residents are supposed to be able to decorate their rooms with their own belongings as space permits. This rule also requires that residents are provided with a safe living environment. This deficiency was based upon the observation that a resident's magazine pictures, which he had taped to the wall of his room, were torn down. This left the walls with missing paint, and they were unsightly. A drain cover for a shower was missing in another resident's bathroom leaving an open hole in the floor which could result in injury to the resident. Petitioner did not dispute this deficiency. Tag A 167 Tag A 167 cited Petitioner with violating rule 58A- 5.025(1) regarding "Resident Contracts." Petitioner is required by this rule to maintain resident contracts that have an accurate monthly rental rate. For two of the 28 residents sampled, the surveyors found that one contract had a rate left blank and another had an incorrect rate. Tag AL 241 Tag AL 241 cited Petitioner with violating rule 58A- 5.029(2) regarding "LMH–Records." This rule requires that a facility with a LMH license maintain an up-to-date admission and discharge log identifying all mental health residents. Review of the facility's records showed that Petitioner had only one admission and discharge log which did not identify mental health residents. This rule also requires that each mental health resident shall have a Community Living Support Plan (CLSP) prepared by the facility administrator and the individual's mental health care provider which identified the specific needs of the resident and a plan for how those needs will be met. The CLSP is to be updated annually. A review of resident 1's records showed that Petitioner only had a CLSP that had been last updated in February 2008. Although the resident had an Interim Mental Health Assessment dated February 18, 2013, it did not reference the CLSP or contain any of its mandatory components. The Exit Interview On June 11, 2013, at the completion of the inspection, Forrester and Frias met briefly for an exit interview with Mrs. Spaw, Assistant Administrator Holli Raven (Raven), and Resident Assistant Marcia Gray (Gray). The purpose of the meeting was to provide a summary of the surveyors' findings and to discuss the Petitioner's responses, if any, to the concerns.3/ Forrestor represented at the meeting that he and Frias believed the deficiencies were all Class III violations but that the determination of classifications was subject to review by their supervisor. Statement of Deficiencies On June 20, 2013, Forrestor hand-delivered to Petitioner a copy of Form 3020, the Statement of Deficiencies, which included a detailed summary of the applicable rules violated and facts supporting the finding of deficiencies. The cover letter indicated that two tags, A 054 and A 056, regarding medication records, labeling and orders, were considered Class II deficiencies. As such, AHCA directed Petitioner to comply with a designated corrective action plan within five days. When delivering the Statement of Deficiencies, Forrestor explained to Mrs. Spaw that the medication-related deficiencies were upgraded by his supervisor from Level III to Level II. Forrestor's supervisor was not physically present at the survey but reviewed the results reported by Forrestor and Frias and upgraded the classifications based upon her training and familiarity as a licensed practical nurse with medication issues. The corrective action plan required Petitioner to provide a medication training course, approved by the Department of Elder Affairs, to staff. It also required Petitioner to ensure all unlicensed staff maintains a minimum of two hours of continuing education training on providing assistance with self- administered medication. The plan also directed Petitioner to obtain the consultation of a pharmacist to ensure all staff providing assistance with self-administered medication is following the guidelines of section 429.256 and that such consultation must be no less than three months in length. Petitioner immediately hired a pharmacy consultant and implemented training for staff. The consultant also reviewed the resident's medical records to make sure they were in compliance with applicable rules. However, Petitioner did not notify AHCA of its compliance efforts nor did AHCA conduct a re-inspection to determine whether the plan was being followed. Mrs. Spaw was very surprised to receive the extensive statement of deficiencies. In particular, she was dismayed that the facility was cited with two Class II violations when the surveyors had indicated at the exit interview that the purported deficiencies were Class III violations. According to Mrs. Spaw, she is not aware of any other facility in her vicinity which has received Class II designations for the types of deficiencies for which her facility is cited.4/ Mrs. Spaw and Forrester had no conversation regarding the findings when he hand-delivered the June 20, 2013, correspondence from AHCA. Mrs. Spaw felt that the survey findings reflected a bias or animus against her facility. However, there was absolutely no evidence of this presented at the final hearing. Both Forrester and Frias testified that they had no prior instruction with regard to how to conduct the survey other than when it was scheduled. They also testified that they conducted the survey at Petitioner's facility in the same fashion that they have conducted numerous other re-licensure surveys. Petitioner did not contest the underlying facts which supported the deficiencies. However, Petitioner suggests that these are relatively minor errors which occurred because a staff member was very nervous due to the surveyors being present and following them while dispensing medications. Notably, the staff person who was involved in the majority of the MOR errors and medication delays did not testify. Petitioner also argues that many of the deficiencies cited are based upon the same facts. For example, there are several deficiencies related to the incident of a pill being found on the floor. However, as explained by Forrester, factual observations may be listed repeatedly because they demonstrate different areas of non-compliance with laws or rules. The same incident may be referenced in support of different tag numbers because there are a variety of laws and rules involved. Notice of Intent to Deny After reviewing the results of Petitioner's re- licensure survey, Alfred met with Haston to discuss Petitioner's re-licensure application. Haston reviewed the results and saw there were two Class II and eight Class III violations. Although Haston wanted Petitioner's facility to remain open because he believes Mrs. Spaw "takes care of patients no one else wants" and there is a need for LMH beds in Petitioner's area, Haston decided to deny re-licensure based upon the failed survey, the outstanding fine from Serenity Gardens, and the fact that the license of Serenity Gardens was revoked. AHCA issued a Notice of Intent to Deny on October 2, 2013, and explained that the denial was based upon the failed biennial re-licensure survey, the outstanding fine imposed by Final Order on March 30, 2012, and that the applicant (Mrs. Spaw on behalf of Petitioner) had a controlling interest in Serenity Gardens, a facility which had its license revoked by Final Order.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Agency for Health Care Administration enter a final order upholding the denial of Petitioner's licensure renewal application. DONE AND ENTERED this 23rd day of May, 2014, in Tallahassee, Leon County, Florida. S MARY LI CREASY 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 23rd day of May, 2014.
The Issue The issue in this case is whether the Board of Osteopathic Medicine (the Board) should discipline the Respondent's license on charges alleged in an Administrative Complaint, AHCA Case No. 94-09207, filed against him on August 17, 1994.
Findings Of Fact On March 31, 1986, the Respondent's license to practice osteopathic medicine was revoked. The Respondent reapplied for licensure, and the Board issued an Order on April 5, 1993, approving the application and relicensing the Respondent subject to a period of probation. One of the conditions of the Respondent's probation was: "Respondent shall not examine or treat any female patients without a female employee who is a health care practitioner licensed by the Department of Professional Regulation present in the room during the examination." On various occasions since April 5, 1993, while on probation, the Respondent examined female patients while just one of the following female employees was present in the room during the examination: Jacqueline Mehle, a licensed practical nurse who worked for him from approximately July through October, 1993; Teresa Patrick, a medical lab technician licensed by the Department of Business and Professional Regulation (formerly the Department of Professional Regulation, now the ACHA), who worked for the Respondent in 1994; Lynn Gongre, either a licensed practical nurse or a licensed registered nurse who worked for the Respondent starting in June, 1994; Susan Almgreen, a certified nurse assistant; and Lynn Sanford, a licensed X-ray technician. During times when Mehle worked for the Respondent, usually she would be present, but sometimes Almgreen or Sanford would take her place when she stepped out of the room. While Gongre worked for him, usually she would be present, but sometimes Patrick would be and sometimes one of the others took their place when Gongre or Patrick stepped out of the room. In 1994, before Gongre started working for him, Patrick usually would be present, but sometimes one of the others took her place when she stepped out of the room. The Respondent did not see patients during the time period after Mehle left but before Patrick started working for him. On other occasions, Almgreen or Carmen McGrew were present in the examination room with female patients to take information concerning insurance and payment for services, but those interviews generally occurred before the Respondent entered the examination room with Mehle, Patrick or Gongre. It was not proven whether either Patrick, Almgreen or Sanford is a "health care practitioner licensed by the Department of Professional Regulation" under the terms of the Respondent's probation conditions. It was not proven that the Respondent believed that either Patrick, Almgreen or Sanford was not a "health care practitioner licensed by the Department of Professional Regulation" under the terms of the Respondent's probation conditions. There is no evidence that any female patient has complained about anything the Respondent has said or done during an examination since his relicensure. After his relicensure, the Respondent reapplied for Drug Enforcement Agency (DEA) certification to prescribe and dispense controlled substances. When the Respondent filled out the DEA application, he correctly checked the box on the form to indicate that he was applying as a "Practitioner," not as a "Teaching Institution" or one of the other categories. But he misread the form and mistakenly checked the "no" box in answer to the following question, which was single-spaced in very small print on the form: Has the applicant ever been convicted of a crime in connection with controlled substances under State or Federal law, or ever surrendered or had a Federal controlled substance registration revoked, suspended, restricted or denied, or ever had a State professional license or controlled substances registration revoked, suspended, denied, restricted or placed on probation? The evidence on the DEA application process is confusing. This finding reflects what is believed to be what transpired. It is believed that the Respondent's initial application was returned for failure to include an osteopathic medicine license number. The Respondent telephoned the DEA to resolve the problem and fully discussed his prior revocation and relicensure under probation. (In addition, copies of the documentation of the prior revocation were contained in DEA files under the Respondent's name both in the DEA's Florida office and in Washington, D.C.) After his discussions with the DEA, the Respondent contacted the Board to obtain a license number. After being told that it takes time, the Respondent resubmitted the DEA application, together with copies of both the Final Order revoking his previous license and the April 5, 1993, Order relicensing him under probation conditions. When the Respondent received his DEA certificate, it mistakenly indicated that the Respondent was a "Teaching Institution," instead of a "Practitioner." The Respondent again telephoned the DEA to have the error corrected. While the Respondent was waiting for his certificate to be corrected, a DEA investigator noticed the mistaken reference to the Respondent's being a "Teaching Institution" and investigated. While investigating, she also noticed the false statement in the Respondent's application. She notified the AHCA, which dispatched an investigator to accompany the DEA investigator to the Respondent's office. The charges in the Order of Emergency Restriction of License and the Administrative Complaint followed.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is recommended that the Board of Osteopathic Medicine enter a final order dismissing the Administrative Complaint. RECOMMENDED this 3rd day of October, 1994, in Tallahassee, Florida. J. LAWRENCE JOHNSTON Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 3rd day of October, 1994. APPENDIX TO RECOMMENDED ORDER, CASE NO. 94-4595 To comply with the requirements of Section 120.59(2), Fla. Stat. (1993), the following rulings are made on the parties' proposed findings of fact: Petitioner's Proposed Findings of Fact. 1.-3. Accepted but subordinate and unnecessary. 4.-7. Accepted and incorporated to the extent not subordinate or unnecessary. 8. Rejected as not proven. 9.-10. Accepted, but whether either was a "health care licensee" is not the issue. Rejected as not proven. Also, whether she was a "health care licensee" is not the issue. Accepted, but whether she was a "health care licensee" is not the issue. Rejected as not proven. Also, whether he had a "health care licensee in the room" is not the issue. Rejected as not proven. Rejected as largely not proven. Accepted and incorporated that his license was revoked and that his application for relicensure was granted with probation conditions. 16.-17. Rejected as not proven. Accepted and incorporated. Rejected as not proven. Respondent's Proposed Findings of Fact. Rejected as unclear. His license was revoked; he applied for relicensure; he was relicensed with probation conditions. Rejected as contrary to the greater weight of the evidence. It is believed that he applied, that the application was returned for failure to include a license number, and that then he spoke to DEA about the probation conditions. Accepted and incorporated. Second sentence, rejected as contrary to the greater weight of the evidence. See 2., above. Third sentence, also rejected as contrary to the greater weight of the evidence. (It is believed that the conversation related here took place after the surrender of the Respondent's DEA certificate on June 2, 1994.) Otherwise, accepted and incorporated. Accepted and incorporated. Generally accepted but largely argument, and subordinate and unnecessary. Accepted and incorporated. Rejected as contrary to the greater weight of the evidence that the Respondent always "keeps the Torah." Otherwise, accepted but subordinate and unnecessary. Rejected as contrary to the greater weight of the evidence. Sometimes Almgreen or Sanford replaced them for periods of time. 10.-14. Accepted and incorporated. 15.-16. Accepted; subordinate to facts found. 17. Accepted and incorporated. COPIES FURNISHED: Francesca Plendl, Esquire Agency for Health Care Administration Northwood Centre, Suite 60 1940 North Monroe Street Tallahassee, Florida 32399-0792 Salvatore Carpino, Esquire 8001 North Dale Mabry, Suite 301-A Tampa, Florida 33614 Henry Dover Executive Director Northwood Centre 1940 North Monroe Street Tallahassee, Florida 32399-0792 Harold D. Lewis, Esquire Agency for Health Care Administration The Atrium, Suite 301 325 John Knox Road Tallahassee, Florida 32303
Findings Of Fact Patient D.R., was born in 1958. She first presented to Respondent's group practice in 1987. D.R. had a history of a bleeding disorder and wanted one of Respondent's associates to follow her Coumadin treatment. The bleeding disorder was related to a rare condition, Klippel-Trenaunay Weber Syndrome, which is characterized by an abnormality of the bones and muscles in the extremities resulting in multiple deep vein thrombosis. An orthopedic physician in a separate practice followed her treatment for severe scoliosis. D.R. also suffered from secondary tension headaches and depression along with her multiple medical problems. She was in constant pain. D.R.'s husband was in the Navy. From the beginning, Respondent's associate worked with a psychologist in an attempt to get the Navy Family Service Center to accept D.R. as a client for family and marital counseling. In April, 1987, D.R. complained of tendonitis of the lower bicep region in the left arm. D.R.'s treating physician referred her to Respondent for consultation as to whether D.R. was suffering from a deep vein thrombosis. In May of 1987, D.R. was referred to a vascular surgeon. In September of 1987, a surgeon at the Naval base performed a hysterectomy on D.R. because her anticoagulant therapy resulted in dysfunctional uterine bleeding. In November of 1987 D.R. underwent orthopedic surgery to stablize her scoliosis. Depending on D.R.'s complaint on each office visit, Respondent's associates prescribed Xanax, Valium, Tylox, Demerol, Darvocet, Vistaril, Motrin, Persantin, Phenergan, Flexoril, Septra, and Coumadin. D.R. continued to receive services from the group practice until March, 1988, when she requested that Respondent serve as her primary attending physician. When Respondent began his care of D.R., she was already taking Vicodin two to three times per week, and Coumadin for hypercoagulaopathy. In April, 1988, D.R. complained of increasing pain in her back and head. She had increased her use of Vicodin with no relief. Respondent switched her medications to 5 mg of Methadone every twelve (12) hours for pain. D.R. also received office injections of Demerol and Phenergan for immediate relief of her pain. The Methadone seemed to work "very well" in relieving D.R.'s back pain. Respondent continued to prescribe this medication for the next several months. For a period of time in June of 1988, Respondent terminated D.R.'s use of Amitriptyline. Other physicians had prescribed this drug for D.R. for four years and she was showing some side affects. Respondent changed D.R.'s medication to another antidepressant, Prozac, and the depression subsided. Respondent prescribed several different medications, including Elavil, Motrin, Imipramine, Vistaril and Demerol, to relieve the patient's recurrent headache pain, through the summer of 1988. At one point, Respondent appropriately recognized the signs of dependency and refused to give D.R. a two month refill of Dolophine to take with her on an alleged two (2) month vacation. Toward the end of July, 1988, D.R. overdosed on Xanax and experienced hallucinatory feelings. In August, 1988, Respondent discussed the increased use of medications with D.R. and referred her to a psychologist for counseling. Respondent also informed D.R. that she needed to enter an inpatient setting such as Charter-by- the-Sea. He also changed the time that D.R. could receive any medications to every other week to control her intake. D.R. subsequently entered Charter-by-the-Sea for inpatient treatment. Upon her discharge, D.R. left Respondent's care to move to California. At the time she left, Respondent provided D.R. with a one (1) month supply of Demerol and Motrin for pain. D.R. was already taking opioids when Respondent agreed to be her physician. He immediately began a program of controlling her intake of pain medication. Although Respondent only treated D.R. for six (6) months, he made appropriate referrals to a psychologist and to an inpatient detoxification program. There was no need for Respondent to refer D.R. to an addictionologist until such time as she appeared intoxicated and hallucinating in July of 1988. At that point, Respondent properly hospitalized D.R., transferring her to the care of experts. There is no persuasive record evidence that a referral to a psychiatrist was appropriate for D.R. Respondent made the appropriate assessment, diagnosis, and referrals for D.R. Additional consultations or referrals were not required. Respondent's treatment of D.R. met the level of care and skill which is recognized as acceptable under similar conditions and circumstances. CHRONIC PAIN MANAGEMENT Respondent did not use narcotics to treat the above referenced patients in an unorthodox, illegal, non-indicated, substandard manner. Methadone is often used for detoxification purposes. However, it is also indicated for "relief of severe pain." Physicians may dispense Methadone from any licensed pharmacy for analgesic purposes. C.A., C.B. C.M., and D.R. were suffering from chronic severe pain when Respondent began treating them. Therefore, Methadone was an appropriate part of their treatment program. There is no persuasive evidence that Respondent used Methadone with his patients for detoxification purposes. Certain chronic pain patients respond satisfactorily to long-term opioid therapy, especially when no other treatment works for them. With the opioid treatment, these patients are able to function socially and participate in other modes of recommended treatment. Respondent's patients in this case fit this profile. They were in the one percent of the most difficult patients that one encounters. Additionally, these four patients represented only a fraction of a percent of Respondent's practice. There is no persuasive evidence that Respondent engaged in a pattern of improper chronic pain treatment. Some physicians prefer to routinely use a multi-disciplinary approach to chronic pain treatment regardless of the severity and complexity of their patients' medical problems. They refer their chronic pain patients to neurologists, psychiatrists, psychologists, and occupational and physical therapists for extensive, expensive long-term care. However, a considerable percentage of patients treated under the multi-disciplinary approach still require long-term opioid treatment because it is the only way to keep the patient sufficiently functional to participate in the multi-disciplinary treatment. All four of Respondent's patients improved for various periods of time while under Respondent's care. They were able to cope with serious episodes of pain and able to expand their function. Unfortunately, there was no cure for any of the conditions from which these four patients suffered. Family physicians can manage such patients expertly if they: (a) are well informed about the use of opioids for analgesic purposes; (b) know their patients' medical history; (c) determine that the benefits of the treatment outweigh the risks; (d) establish a therapeutic relationship with the patient; (d) develop a treatment plan, (e) prescribe the drugs in a prudent manner, and (f) monitor their patients closely. Respondent met these criteria for each of the four patients discussed above. Respondent accepted an provided comprehensive treatment for each of the four (4) patients for comprehensive treatment with the following understandings: (1) no other physician would prescribe opioids; (2) Respondent would determine the appropriate dosage; (3) the patient would keep appointments at regular intervals; and (4) the patient would seek consultations with other professionals when appropriate. Throughout the treatment periods, Respondent appropriately considered whether the drugs were relieving his patients' pain and whether their level of function was improving. Respondent's treatment plans were flexible enough to prevent damage if a patient became noncompliant. Without this flexibility, Respondent or the patient might have abruptly terminated the therapeutic relationship compounding the patient's problems. Respondent closely monitored each patient to ensure that the treatment plan did not create addiction. He took appropriate corrective measures when a patient: (a) began to spend excessive time and energy to obtain the drug; (b) became intoxicated frequently; (c) gave up important social, occupational and recreational activities because of drug use and not because of chronic pain; (d) continued to use a drug even though the patient knew it caused or exacerbated psychological or physical problems. In the 1980's, Respondent's referral and consultation resources were limited. Inpatient substance abuse programs were available but very expensive. The first outpatient addiction recovery programs focused on alcoholism. Pain treatment centers, mental health centers, and addictionologists became more available in the 1990's. Changes in insurance and state and federal pharmacological reporting requirements have also changed physicians' referral and consultation patterns in the last five years. In the 1980's, Respondent's peers knew he was interested in chronic pain management. Because he was willing to treat patients with complex medical problems who were sometimes non-compliant, other local physicians routinely referred their difficult patients to Respondent. Respondent's opioid prescriptions were all legal and within the allowable requirements relating to dosage and number prescribed. He controlled the amount of narcotics the patients received by writing prescriptions for low dosages and for short periods of time, sometimes even on a weekly rather than a monthly basis. The evidence indicates that all four patients experienced severe long-term pain. These patients were incurable and did not respond to standard pain therapy or treatment. Respondent's care, treatment and careful monitoring provided these patients with pain relief sufficient for them to function in society and carry on with their lives. Referral to or consultations with psychiatrists and addictionologists were not required. Respondent's care and skill in managing his patient's chronic pain met the professional standard of care of a family practitioner in the state of Florida.
The Issue Whether Petitioner is entitled to temporary licensure as a physician assistant pending her successful completion of the licensure examination.
Findings Of Fact Petitioner is an applicant to sit for the examination for licensure as a physician assistant in Florida. Petitioner was found by Respondent to be eligible to sit for the licensure examination. Petitioner also requested a temporary certificate as a physician assistant, which request was denied by the Respondent. In requesting temporary certification, Petitioner relies on the provisions of Section 458.347(7)(b), Florida Statutes, which provide, in pertinent part, as follows: (b)1. . . . [T]he department shall examine each applicant who the board certifies: Has completed the application form ... Is an unlicensed physician who graduated from a foreign medical school listed with the World Health Organization .. Has applied for certification as a physician assistant in this state between July 1, 1990, and June 30, 1991. Was a resident of this state on July 1, 1990. . . The board may grant temporary certification to an applicant who meets the requirements of subparagraph 1. Petitioner's application to sit for the examination for licensure as a physician assistant was granted by an Order entered by the Board of Medicine on March 12, 1992. The Order also denied her request for temporary certification because she had not recently worked in the field of medicine and because she had not received significant continuing education in the interim. The Board determined that Petitioner had not established her ability to currently practice as a physician assistant with reasonable skill and safety to the public. The Board determined that Petitioner could establish that ability by passing the licensure examination. Petitioner graduated from medical school in Ecuador in December 1975. Between March 1976 and April 1980, she was in medical residency in Ecuador. She has not practiced medicine since April 30, 1980, when she moved from Ecuador to the United States. Physician assistants in Florida work under the supervision of a supervising physician. A physician assistant is permitted to examine patients, to diagnose conditions, and to prescribe treatment plans. Because of the rapid changes that occur in the field of medicine, the current ability to practice as a physician assistant should be demonstrated. The applicant can demonstrate that current ability through recent practice, through recent education, or through examination. Petitioner's testimony and the documentary evidence she presented at the formal hearing fail to establish that she is currently able to practice as a physician assistant with reasonable skill and safety to the public. She has not practiced medicine since 1980. Her participation in a program at the University of Miami School of Medicine in December 1991 and her volunteer work for Dr. Rodolfo Binker from August 1991 to November 1991, do not establish her current ability. The evidence offered by Petitioner as to continuing medical education likewise fail to establish her current ability. Both the quality and the quantity of her continuing education fail to meet the level of continuing education required of physician assistants.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that Respondent enter a Final Order denying Petitioner's application for temporary certification as a physician assistant. DONE AND ORDERED this 28th day of July, 1993, in Tallahassee, Leon County, Florida. CLAUDE B. ARRINGTON 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 28th day of July, 1993. COPIES FURNISHED: John H. Duhig, Esquire 702 National Bank Building 25 West Flagler Street Miami, Florida 33130-1770 Allen R. Grossman, Esquire Office of the Attorney General Plaza Level 01, The Capitol Tallahassee, Florida 32399-1050 Dorothy Faircloth, Executive Director Department of Professional Regulation Board of Medicine 1940 North Monroe Street Tallahassee, Florida 32399-0792 Jack McRay, General Counsel Department of Professional Regulation 1940 North Monroe Street Tallahassee, Florida 32399-0792
The Issue Whether Sandra Ann Lindstrom (“Ms. Lindstrom” or “Respondent”), a licensed physician assistant, prescribed Lorcet, a medication containing a controlled substance (hydrocodone), in violation of the Florida Statutes and the Florida Administrative Code as charged in the Amended Administrative Complaint filed at the Department of Health in DOH Case No. 2006-36542 on October 27, 2014. If so, what is the appropriate discipline?
Findings Of Fact The Parties The Department of Health is the state agency responsible for regulating the practice of physician assistants in the State of Florida. The regulation is pursuant to both chapter 456 (“Health Professions and Occupations, General Provisions”) and chapter 458 (“Medical Practice”), Florida Statutes. Respondent is licensed as a physician assistant by the Board of Medicine. Her license number is PA 9103823. The license was effective on August 3, 2006, with an expiration date of March 31, 2008. Her license has been continuously renewed since its effective date. See Pet’r’s Ex. A. Ms. Lindstrom is not licensed to practice medicine as a physician. Id. Physician Assistants Physician assistants are governed by section 458.347, a section within the chapter of the Florida Statutes that governs Medical Practice. Physician assistant licensure is provided for in section 458.347(7), and the Board of Medicine is authorized to “impose any of the penalties authorized under ss. 456.072 and 458.331(2) upon a physician assistant if the physician assistant or the supervising physician has been found guilty of or is being investigated for any act that constitutes a violation of this chapter [Ch. 458] or chapter 456.” § 456.347(7)(g), Fla. Stat. A physician assistant’s supervisory physician may delegate authority to conduct aspects of medical practice to a physician assistant under circumstances expressed in the statutes. The limited medical practice that may be delegated to a physician assistant includes certain practices at county health departments. Whether conducting the delegated practice of medicine at a county health department, or not, physician assistants may be delegated authority to prescribe medications provided they are not listed on a formulary created pursuant to section 458.347(7)(f). See § 458.347(7)(d) and (e), Fla. Stat. The formulary must include “controlled substances as defined in chapter 893.” § 458.347(7)(f)1., Fla. Stat. In sum, physicians may not delegate to physician assistants the prescription of medications which are controlled substances as defined in chapter 893, Florida Statutes. The Department’s Investigative Office The Department has an investigative office charged with looking into regulatory complaints. In a typical regulatory investigation, the investigator discloses his identity to any party interviewed, whether the party is the source of the complaint, a witness, or, if amenable to an interview, the licensee who is the subject of the complaint. Aside from interviews, the investigations include record reviews, the obtaining of evidence, and the preparation of an investigative report. In addition to investigating complaints of regulatory violations by licensed health care practitioners, the investigative office looks into cases of unauthorized practice by unlicensed individuals. Investigations of unlicensed activity are conducted by what is known as the “ULA” section of the office. Commonly, ULA investigations are done by investigators who are “undercover,” that is, the investigators hide their identity as investigators and use pseudonyms rather than their actual names. Typically, undercover ULA investigators present at the offices of the subjects of investigation. If the unlicensed subject of the investigation offers to perform services that require a license or engages in practice that requires a license, the Department pursues remedies, including an order that the subject cease and desist from the unlawful, unlicensed activity. Investigations of a licensee for practicing outside the scope of the licensed activity may be viewed as something of a hybrid of a typical regulatory investigation and a ULA investigation. It is regulatory since the subject is a licensee, but it is usually done undercover in the same manner in which a ULA investigation is conducted. One such investigation was conducted by Ryan Heal, an employee of the Department between August and December of 2006. Mr. Heal conducted the investigation undercover using a pseudonym referred to in Department documents as “RJ.” RJ and the 2006 Investigation of JHS Mr. Heal has been a medical malpractice investigator for the Department since November 2000. During the course of his more than 15 years as a Department investigator, Mr. Heal has investigated both regulatory violations and unauthorized practice violations. In 2006, allegations reached the Department that prescriptions were being written at Jacksonville Health Systems (“JHS”), a clinic located on Baymeadows Road in Jacksonville, Florida, by a physician assistant without the supervision of a physician. In response, the Department launched an investigation. The investigation was conducted undercover by Mr. Heal using his pseudonym RJ. Commenced in August of 2006, the investigation lasted until the following December. August 10, 2006 On August 10, 2006, Mr. Heal, using his fictitious name, presented at JHS. A woman behind the counter in the reception area accepted a cash payment for the visit. She took RJ’s blood pressure and requested the name of the pharmacy for any medicine prescribed. To the best of Mr. Heal’s recollection, the receptionist recorded some of the information. After the interaction with staff in the reception room, Mr. Heal took a seat and waited to be called back to the examination room. Shortly thereafter, Ms. Lindstrom emerged and asked for RJ. Mr. Heal “stood up and went over to her.” Hr’g Tr. 19. Ms. Lindstrom identified herself by her first name and said, “I’m the provider here.” Id. Ms. Lindstrom accompanied Mr. Heal to the examination room where only she and Mr. Heal were present. After Mr. Heal complained of back pain, Ms. Lindstrom asked where in his back the pain was located and what caused it, but she did not conduct a physical examination. As Mr. Heal testified at hearing, “[t]here was no examination. She never touched my back. Never took vitals or anything.” Hr’g Tr. 20. Ms. Lindstrom suggested that Mr. Heal use a chair with lumbar support, try stretching, lose weight, and have an MRI. Ms. Lindstrom then stated that she would prescribe medication to treat the pain: Lorcet, Flexeril, and Motrin. With the visit in the examination room concluded, Ms. Lindstrom took Mr. Heal back to the receptionist. The meeting in the examination room and his first visit to the JHS offices being over, Mr. Heal departed the JHS facility. He did not return until the following October. October 31, 2006 Mr. Heal returned to the JHS facility on October 31, 2006. The process during the second visit was similar to the one followed during the visit the previous August. He presented as “RJ.” A staff member took his blood pressure in the reception area and he paid her $90 in cash. Mr. Heal sat down and waited to be called. Again, Ms. Lindstrom appeared in the reception area and took him to the examination room in the back. The visit was shorter than it had been in August. Ms. Lindstrom asked if his pain had improved and if an MRI had been done. With the intention of calling in his prescriptions, Ms. Lindstrom showed Mr. Heal a list of five pharmacies from which to choose. Mr. Heal, however, took a tack that was different from Ms. Lindstrom’s intention and from his first visit: I explained to her that I did not have reliable transportation and asked [for] . . . handwritten prescriptions . . . so that I could take them to whatever pharmacy was convenient . . . . She agreed that she could write them that time, but that on the next visit, I would have to arrange for proper transportation to get to the pharmacy or wherever they needed to be called into. Hr’g Tr. 23. Ms. Lindstrom wrote out three prescriptions: Two of them were for “Flexeril 10mg (ten) #30 (thirty)” and “Ibprofen (sic) [Ibuprofen] 800mg #120 (one twenty).” Pet’r’s Ex. B. The third prescription was for “Lorcet 10/650 #90 (Ninety).” Id. Ms. Lindstrom explained to Mr. Heal that he should use one of the five pharmacies on her list because “several [of the Clinic’s patients] had been kicked out of pharmacies . . . [that] were refusing to fill the prescriptions.” Hr’g Tr. 25. Ms. Lindstrom also “mentioned that a couple of her patients had been arrested for forging prescriptions.” Hr’g Tr. 25-6. At no time during his visit to JHS on October 31, 2006, did Mr. Heal see a physician. No one entered the examination room where Ms. Lindstrom met with Mr. Heal that day. Nor did Ms. Lindstrom leave the examination room while Mr. Heal was present in the room. Like the first visit the previous August, Ms. Lindstrom recommended that Mr. Heal have an MRI. She explained that results from an MRI were needed “in case the DEA wanted to look at the file, to show that [she and JHS] were actually treating [Mr. Heal] for something.” Hr’g Tr. 28. December 1, 2006 Little more than a month later on December 1, Mr. Heal made a third visit to JHS. The reception process was the same. The receptionist took his blood pressure, he paid $90 in cash, and waited in the reception area for Ms. Lindstrom to call him back. While waiting, he was informed that the number of pharmacies that would accept JHS prescriptions had been drastically reduced. Only one pharmacy would now accept JHS prescriptions: a pharmacy called New Horizon. Subsequent to the third visit, Mr. Heal presented to the pharmacy identified as New Horizon. In the company of law enforcement and with its supervision, Mr. Heal had the prescriptions filled for three medications: Flexeril, Ibuprofen at a prescription-strength dosage, and Lorcet. Supervising Physician and Other Claims At hearing under oath, Ms. Lindstrom admitted that she treated Mr. Heal once at the JHS facility and admitted that she prescribed Flexeril and Ibuprofen for him. She claimed under oath that the supervising physician for the 2006 visit in which she prescribed the two medications was James Hendrick, M.D. The Department produced documentation in the Department’s official business records that shows that Dr. Hendrick cancelled his Professional Liability Insurance Policy effective October 1, 2005, the year before Ms. Lindstrom claims to have seen Mr. Heal at the JHS facility under Dr. Hendrick’s supervision. The reason for the cancellation of the policy is listed on the letter from the insurer to the Department as “Retired.” Pet’r’s Ex. F, letter dated October 17, 2005, from FPIC, First Professionals Insurance Company. Department records also include an “Address Change” form that contains a section entitled “Financial Responsibility” dated November 21, 2005, the year before the incidents in this case. No boxes are checked in the section that shows “Financial Responsibility Coverage.” Under a section on the form entitled, “Category II: Financial Responsibility Exemptions,” Dr. Hendrick checked a box that indicated he was “retired or maintain[ed] part-time practice,” id., at least as of late November 2005, 11 months or more before the October 31, 2006, visit by Mr. Heal. Ms. Lindstrom made other claims with regard to RJ’s visit that she asserted occurred on October 3, 2006, rather than October 31, 2006, as charged. Among them was that she left the examination room after completing the prescriptions for Flexeril and Ibuprofen and partially completing a third prescription by inserting all the information, including her signature, except for the medicine to be prescribed and how often it should be taken. Ms. Lindstrom claimed that she intended to write a prescription for Lodine, but failed to write down “Lodine” on the third prescription form because she was distracted by a discussion with Mr. Heal about the need for RJ to have an MRI. She says she left the room to make arrangements for an MRI and when she returned, RJ was gone, together with the two filled out prescriptions, the third incomplete prescription, and her prescription pad. Ms. Lindstrom’s testimony about the theft of the pad and other details about the event, including when it occurred, is not credible. In contrast, Mr. Heal’s testimony about the visits he made to the JHS facility, seeing Ms. Lindstrom, and her prescription of Lorcet, is credited as truthful. Lorcet Lorcet contains hydrocodone, which is a controlled substance.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Board of Medicine enter a final order: Finding that Respondent Sandra A. Lindstrom, P.A., violated section 458.331(1)(nn), Florida Statutes (2006), by violating Florida Administrative Code Rule 64B8-30.008 (2006), as charged in the Amended Administrative Complaint; Imposing a $2,500 fine; and Revoking Respondent’s license as a physician assistant. DONE AND ENTERED this 30th day of March, 2016, in Tallahassee, Leon County, Florida. S DAVID M. MALONEY 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 30th day of March, 2016. COPIES FURNISHED: Sandra Ann Lindstrom 6726 Pomeroy Circle Orlando, Florida 32810 Yolonda Y. Green, Esquire Maciej Lewandowski, Esquire Department of Health 4052 Bald Cypress Way, Bin C65 Tallahassee, Florida 32399-3265 (eServed) Andre Ourso, Executive Director Board of Medicine Department of Health 4052 Bald Cypress Way, Bin C03 Tallahassee, Florida 32399-3253 (eServed) Nichole C. Geary, General Counsel Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701 (eServed)
