The Issue Whether Respondent violated section 429.26(7), Florida Statutes, and Florida Administrative Code Rule 58A-5.0182(1) by failing to appropriately supervise one of its residents, and, if so, the penalty that should be imposed. Whether Respondent failed to follow its own elopement policy, in violation of Florida Administrative Code Rule 58A- 5.0182(8), and, if so, the penalty that should be imposed.
Findings Of Fact The Parties Petitioner, Agency for Health Care Administration, is the state agency statutorily charged with regulating assisted living facilities ("ALFs") in the state of Florida. Respondent, Flamingo Park Manor, LLC, is a 72-bed limited mental health2/ ALF licensed pursuant to License No. AL7308 and subject to regulation by Petitioner pursuant to chapter 429, Florida Statutes, and Florida Administrative Code Chapter 58A-5. It is located at 3051 East 4th Avenue, Hialeah, Florida 33013. The Administrative Complaint As the result of a complaint survey conducted on or about February 3, 2015, Petitioner served an Administrative Complaint on Respondent on April 14, 2015. The Administrative Complaint charged Respondent with a Class I violation of section 429.26(7) and rule 58A-5.0182(1) for failing to appropriately supervise one of its facility residents, R.R., resulting in Respondent not knowing R.R.'s whereabouts for five days. The Administrative Complaint also charged Respondent with a Class II violation of rule 58A-5.0182(8) for failing to follow its own elopement policy and procedures during the time that R.R. was absent from Respondent's facility. The Administrative Complaint seeks to impose administrative penalties of $5,000 for the alleged Class I violation and $2,500 for the alleged Class II violation.3/ The Events Giving Rise to this Proceeding R.R., a 38-year-old male, admitted himself to, and became a resident of, Respondent's ALF on May 15, 2014. He was classified as a mental health resident.4/ He had been diagnosed with schizophrenia and had been prescribed medications to address this condition. On the day he was admitted to the ALF, Respondent's administrator completed an Elopement Risk Assessment Form, which evaluated R.R.'s risk for elopement5/ from the facility. At that time, R.R. was determined not to constitute an elopement risk.6/ On June 1, 2014, by Joyce Gonzalez, a doctor of osteopathic medicine, performed a health assessment of R.R. She completed the Resident Health Assessment for Assisted Living Facilities, AHCA Recommended Form 1823 ("Form 1823"), as required by rule. Gonzalez noted on Form 1823 that R.R. had been diagnosed with schizophrenia and asthma, and that he heard voices and exhibited poor judgment. R.R. was evaluated as "independent" for the following activities of daily living: ambulation, bathing, eating, toileting, and transferring. She evaluated him as "needs supervision" for dressing, and "needs assistance" for self-care (grooming). Gonzalez answered "yes" in response to the question "[i]n your professional opinion, can this individual's needs be met in an assisted living facility, which is not a medical or psychiatric facility?" R.R. was evaluated as "independent" for the self-care tasks of shopping, making phone calls, handling personal affairs, and handling financial affairs. In the "General Oversight" section of Form 1823, which constitutes an evaluation of the frequency with which R.R. needed general oversight by Respondent's staff, R.R. was determined to need the following services on a daily basis: observing wellbeing, observing whereabouts, and reminders for daily tasks.7/ On the "Self-Care and General Oversight—Medications" section of R.R.'s Form 1823, Gonzalez listed three medications that R.R. was to receive, some twice daily. Gonzalez indicated on Form 1823 that R.R. needed the assistance of Respondent's staff to self-administer his medications. The Form 1823 completed for R.R. states that he did not constitute an elopement risk. R.R. was involuntarily admitted to a mental health treatment facility (i.e., "Baker-Acted") from May 16 through May 20 and September 29 through October 3, 2014. Both times, after being discharged, he resumed living at Respondent's ALF. When R.R. was discharged from the mental health treatment facility on October 3, 2014, he was taking an anti- psychotic medication to treat his schizophrenia and medications to alleviate the side effects of his anti-psychotic medication. The written patient discharge instructions he received, which were included in Respondent's medical information files for R.R., included descriptions of the medications he had been prescribed. These instructions stated that these medications needed to be taken as directed. The evidence establishes that despite his mental health condition, R.R. was an independent resident who was lucid, alert, self-aware, and oriented regarding time and place. As was the case for the other residents at Respondent's ALF, R.R. received his meals when he was present in the facility. He also received assistance from Respondent's staff in self- administering his medications, which he was free to refuse to take, and he received supervision and guidance in grooming and dressing himself. In other respects, consistent with the evaluation recorded on Form 1823, R.R. functioned independently. When R.R. was present in the ALF, his wellbeing and whereabouts were observed on a daily basis, as documented by the room censuses, medication logs, shift reports, and resident observation logs that Respondent kept on R.R. During his residency at the ALF, R.R. left the facility at various times of the day, on an almost daily basis. He often would be gone for many hours and would return to the facility. According to Respondent's staff, R.R. told them that he took long walks in the community and that at times, he visited his parents at their home. The credible evidence establishes that during R.R.'s five-month residency at the ALF, although he requently left and often was gone for many hours at a time, he had been absent more than 48 hours only twice,8/ and absent between 24 hours and 48 hours three times,9/ prior to his departure on October 15, 2014. If R.R. was not in the facility at the time he was to take his medications, he did not receive them. The medication observation records for R.R. show numerous days throughout his residency on which he did not receive some or all of his medications. Sometime during the day on October 15, 2014, R.R. left the ALF. R.R. received the morning doses of his medications and attended a mental health counseling session before he left that day. Alaine Dominguez, Respondent's shift supervisor on duty that day, and George Hernandez, the psychological counselor who conducted the mental health counseling sessions at the facility, both testified, credibly, that R.R. told them he was leaving for approximately a week to visit his parents at their home.10/ Dominguez credibly testified that he told R.R. to take his medications with him, but R.R. refused. Respondent's staff did not contact R.R.'s parents to verify that he was going to visit, or was visiting, them. Tragically, R.R. was struck by an automobile late on the evening of October 15, 2014, while walking in the travel lanes of Northwest 79th Street. He was seriously injured and was taken to Jackson Memorial Hospital, where he died on the morning of October 16, 2014. R.R.'s parents were notified by the hospital on October 16, 2014, that R.R. had been injured and died. On October 20, 2014, R.R.'s mother and sister visited Respondent's facility and questioned staff regarding R.R.'s whereabouts. Respondent's staff told them that R.R. had left the facility a few days ago to visit his parents. At that point, R.R.'s mother informed Respondent's staff that R.R. had been killed almost five days ago. By the time R.R.'s mother informed Respondent's staff of his death, R.R. had been absent from the ALF for approximately five days. Until R.R.'s mother informed Respondent's staff that he had been killed, they did not know R.R.'s specific whereabouts during the period in which he was absent from the ALF. The evidence establishes that Respondent's staff assumed that, consistent with R.R.'s statements to Dominguez and Hernandez, he had gone to visit his parents at their home. Consequently, Respondent did not report to R.R.'s parents, law enforcement, or any other entity, that R.R. was absent or missing from the ALF. Petitioner presented the testimony of its health care evaluator, James Byrd Williams, who performed the February 3, 2015, complaint survey on Respondent's ALF. Williams testified that R.R.'s mother told him that R.R. did not know the location of his parents' home, so he could not have gone to visit them.11/ Regardless of whether R.R. knew or did not know the location of his parents' home, the evidence establishes that Respondent's staff believed that R.R. knew the location of his parents' home. Accordingly, it was reasonable for them to accept as true R.R.'s statement that he was leaving the facility to visit his parents at their home. Respondent's staff completed shift reports for October 15 through October 20, 2014. Most of the reports noted that R.R. was "on pass," meaning that he was not present in the ALF. None of the reports contained notations specifically stating that R.R. was visiting his parents or when he was expected to return. Williams testified that in his opinion, Respondent did not adequately supervise R.R., based on the fact that R.R. was a mental health resident, that he frequently left the ALF and was gone for extended periods of time without Respondent knowing his specific whereabouts, that R.R. did not receive his medications when he was out of the ALF, and that Respondent did not contact his parents at their home to verify that R.R. was, in fact, at their home. As required by rule, Respondent has prepared and implemented an elopement policy,12/ which states: Policy: It is the policy of this facility to permit and encourage residents to retain their independence and not to infringe upon their right to come and go from the facility as they please. Procedure: Residents are informed upon admission and during their stay to notify staff members when they leave the facility and when they will be expected to return. Each new admission and yearly thereafter, will have an "Elopement Risk Assessment Form" completed. If elopement risk is determined, the following actions will be taken: an i.d. bracelet will be placed with his/her name and facility contact information; a picture will be placed in the "Elopement Risk Binder" where pertinent resident information will be easily available if reporting is needed; and all staff members will be informed of "at risk" residents and the "Elopement Risk Binder" and its contents. Each case will be evaluated independently when implementing this policy taking into consideration the resident's usual outing habits. For "At-Risk" identified residents, the following will take place immediately if facility staff determines that the whereabouts of such resident is unknown: a complete grounds search will be conducted by all staff members present at the time, directed by the Shift Supervisor; a complete neighborhood search will be conducted by all staff at the time, directed by the Shift Supervisor; if resident is not located and it has not been determined that he/she left without notifying staff, Shift Supervisor or Administrative staff will be responsible for notifying law enforcement, resident's family, guardian, health care surrogate, attending physician and case manager that the resident's whereabouts are not known. an adverse incident report in the AHCA website will be done. Once the resident has been reported "missing" with the local authorities, a case number will be obtained and placed on the resident's chart. A "Quality Improvement/Missing Person Report Form" will be used to evaluate events and keep track of all daily calls to hospitals, shelters, jails etc[.] made to locate resident. If resident is located by facility staff prior to law enforcement, then the Shift Supervisor or Administrative staff will notify law enforcement, resident's family, guardian, health care surrogate, attending physician and case manager that the resident has been located. Residents who are considered to be "not at risk," from the elopement risk assessment form complete [sic] upon admission, are to be reported missing if ou[t] of the facility more than 48 hours. If residents, [sic] behavior is to leave the facility for long periods of time and always returns, this is to be considered to also be "not at risk" and will be reported missing after 48 hours. Respondent's administrator testified that paragraph 1 of Respondent's elopement policy superseded all of the other paragraphs of the policy, so that if a resident told a member of Respondent's staff that he or she was leaving the ALF, that resident would not be considered to have eloped, even if he or she were absent longer than the time period specified in paragraphs 5 and 9 for residents considered "at risk" and "not at risk" for elopement. Only if the resident did not follow the procedure set forth in paragraph 1 when leaving the facility would the other provisions of the elopement policy apply, depending on whether the resident was "at risk" or "not at risk" for elopement. As noted above, none of the documents prepared by Respondent to keep track of which residents were present or absent from the facility, including the shift reports or room census reports, contained notations regarding where R.R. had told staff he was going when he left on October 15, 2014, or when he anticipated returning. However, Respondent's administrator testified that, based on verbal communications from Dominguez, "we were all aware of how long it was going to be." She further testified that if R.R. had told them he was going to be gone a week and then was gone for a longer period, the elopement policy would have been triggered and Respondent would have contacted R.R.'s family and law enforcement and filed a missing person report pursuant to the applicable policy provisions. Findings of Ultimate Fact Florida courts consistently hold that the issue of whether an individual's or entity's actions violate a statute or deviate from an established standard of conduct is an issue of ultimate fact to be determined based on the evidence in the record. See Gross v. Dep't of Health, 819 So. 2d 997, 1003 (Fla. 1st DCA 2002); Goin v. Comm'n on Ethics, 658 So. 2d 1131, 1138 (Fla. 1st DCA 1995); Langston v. Jamerson, 653 So. 2d 489, 491 (Fla. 1st DCA 1995). Failure to Provide Appropriate Supervision Petitioner did not prove, by clear and convincing evidence, that Respondent failed to provide appropriate supervision to R.R., in violation of section 429.26(7) or rule 58A-5.0182(1). Section 429.26(7) states: The facility must notify a licensed physician when a resident exhibits signs of dementia or cognitive impairment or has a change of condition in order to rule out the presence of an underlying physiological condition that may be contributing to such dementia or impairment. The notification must occur within 30 days after the acknowledgment of such signs by facility staff. If an underlying condition is determined to exist, the facility shall arrange, with the appropriate health care provider, the necessary care and services to treat the condition. R.R. was diagnosed with schizophrenia before becoming a resident at Respondent's ALF. However, the evidence does not establish that R.R. suffered from dementia or cognitive impairment. To that point, when R.R. was admitted to the facility, the evaluating doctor determined that his needs could be met in an ALF, rather than a medical facility. There are no notations in the resident observation logs or in any other records that Respondent kept on R.R. indicating that he suffered from dementia or cognitive impairment. Additionally, although R.R. would not receive his medications on many occasions, Petitioner failed to establish that R.R.'s refusal or failure to take his medication somehow constituted a "changed condition" that required Respondent to notify a physician of his condition. Further, even if the evidence had shown that R.R. exhibited dementia, cognitive impairment, or a changed condition, Petitioner failed to present evidence establishing when Respondent's staff acknowledged these conditions for purposes of commencing the 30-day statutory notification period. Accordingly, it cannot be discerned when the notification period ended for purposes of determining whether Respondent violated the notification requirement. For these reasons, it is determined that Petitioner failed to prove that Respondent violated section 429.26(7), as charged in the Administrative Complaint. Rule 58A-5.0182(1), which establishes the standard of care for supervision of ALF residents, states in pertinent part: (1) SUPERVISION. Facilities must offer personal supervision as appropriate for each resident, including the following: * * * Daily observation by designated staff of the activities of the resident while on the premises, and awareness of the general health, safety, and physical and emotional well-being of the resident. Maintaining a general awareness of the resident's whereabouts. The resident may travel independently in the community. Contacting the resident's health care provider and other appropriate party such as the resident's family, guardian, health care surrogate, or case manager if the resident exhibits a significant change; contacting the resident's family, guardian, health care surrogate, or case manager if the resident is discharged or moves out. Maintaining a written record, updated as needed, of any significant changes, any illnesses that resulted in medical attention, changes in the method of medication administration, or other changes that resulted in the provision of additional services. Fla. Admin. Code R. 58A-5.0182(1)(emphasis added). The evidence establishes that Respondent appropriately supervised R.R. under his specific personal circumstances. As discussed above, when R.R. was present in the facility, Respondent's staff observed and documented his wellbeing and whereabouts. The evidence shows that in most respects, R.R. was an independent resident who only required assistance with a limited number of tasks. Although R.R. frequently left the facility for long periods of time, Respondent's staff generally were aware, based on R.R.'s statements to them, that he was walking around in the community——which he clearly was entitled to do without being supervised, pursuant to the plain language of rule 58A- 5.0182(1)(c).13/ With respect to the specific event giving rise to this proceeding, the persuasive evidence establishes that when R.R. left the ALF on October 15, 2014, he told Respondent's staff that he was going to be gone for approximately a week to visit his parents at their home, and that Respondent's staff had no reason to question the truth of this statement. The evidence establishes that Respondent's staff believed R.R. was at his parents' home. This is sufficient to meet the rule requirement that Respondent maintain a general awareness of R.R.'s whereabouts——particularly given that there is no statute or rule that would require Respondent to "check up on" or verify that a resident was at the specific location that he or she purported to be going when leaving the facility. Petitioner also failed to present evidence showing that R.R. exhibited a "significant change" in condition14/ or that he had been discharged or moved out of the facility, any of which would have triggered the requirement to notify his health care provider or family. The evidence also fails to establish that Respondent failed to maintain adequate written records of significant changes in R.R.'s condition, illnesses that R.R. suffered resulting in medical attention, changes in the method of R.R.'s medication administration, or other changes resulting in the provision of additional services. To the contrary, the written records Respondent kept regarding R.R.'s condition and medication administration specifically noted when he had been Baker-Acted and when he took or did not take his medications. Petitioner did not present any evidence showing that these records were inaccurate or incomplete. For these reasons, Petitioner failed to prove, by clear and convincing evidence, that Respondent violated rule 58A-5.0182(1), as charged in the Administrative Complaint. Failure to Follow Elopement Policy Petitioner also failed to prove, by clear and convincing evidence, that Respondent violated rule 58A-5.0182(8) by failing to follow its own elopement policy with respect to reporting R.R. missing. Rule 58A-5.0182(8) requires ALFs to develop written rights and facility procedures for responding to a resident elopement. The rule states in pertinent part: (b) Facility Resident Elopement Response Policies and Procedures. The facility must develop detailed written policies and procedures for responding to a resident elopement. At a minimum, the policies and procedures must provide for: An immediate search of the facility and premises; The identification of staff responsible for implementing each part of the elopement response policies and procedures, including specific duties and responsibilities; The identification of staff responsible for contacting law enforcement, the resident's family, guardian, health care surrogate, and case manager if the resident is not located pursuant to subparagraph (8)(b)1.; and The continued care of all residents within the facility in the event of an elopement. "Elopement" is defined as "an occurrence in which a resident leaves a facility without following facility policies and procedures." Fla. Admin. Code R. 58A-5.0131(14)(emphasis added). As noted above, Respondent has developed an elopement policy pursuant to rule 58A-5.0182(8), and the sufficiency of this policy is not at issue in this proceeding. As a threshold matter, Respondent's elopement policy requires residents to notify staff members when they leave the facility and when they will be expected to return. If a resident complies with this requirement, he or she has followed the "facility's policies and procedures," so has not eloped under rule 58A-5.0313(14). Here, the persuasive evidence establishes that when R.R. left the facility on October 15, 2014, he informed Respondent's staff that he was leaving the facility and that he expected to return in approximately one week, in compliance with Respondent's policies and procedures regarding notification when the resident leaves the facility. Therefore, R.R.'s departure from the facility that day did not constitute "elopement" as defined in rule 58A-5.0131(14). Because R.R. did not elope from the facility on October 15, 2014, he was not considered "missing" for purposes of triggering paragraph 9 of Respondent's elopement policy, which would have required Respondent to report him missing after being out of the facility for 48 hours. For these reasons, Petitioner failed to prove, by clear and convincing evidence, that Respondent violated rule 58A-5.0182(8), as charged in the Administrative Complaint.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that Petitioner, Agency for Health Care Administration, enter a final order dismissing the Administrative Complaint against Respondent, Flamingo Park Manor, LLC. DONE AND ENTERED this 9th day of May, 2016, in Tallahassee, Leon County, Florida. S CATHY M. SELLERS 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 9th day of May, 2016.
Findings Of Fact Regulation of those practicing acupuncture first became law in Florida with the passage of Chapter 80-375, Laws of Florida (1980). Therein it was declared unlawful for any person to practice acupuncture in this state unless such person has been certified by the Department of Professional Regulation. This statute, as amended, and now contained in Section 468.323, Florida Statutes (1981), requires an applicant for certification to practice acupuncture in this state to pass an examination which tests the applicant's competence and knowledge of the practice of acupuncture and "includes a practical examination of the skills required to practice acupuncture, covering diagnostic techniques and procedures, point/meridian selection, needle insertion, manipulation and removal, patient care, sanitation and antiseptic application." The technique of point/meridian selection, needle insertion, manipulation and removal, which Section 468.323 requires a successful applicant to demonstrate are techniques basic to traditional Chinese acupuncture. All of these Petitioners failed the clinical practical portion of the examination given in August, 1982. The August, 1982, examination was the second examination given in this state to applicants for certification to practice acupuncture. The first examination was given in December, 1981. Due to the lack of known-to-be qualified examiners in Florida, Respondent contacted the State of California, who has licensed acupuncture practitioners since 1976, and arranged to have acupuncturists who have served as examiners in California, serve as examiners for the practical part of the Florida examination for the examinations given in December, 1981, and August, 1982. All of the examiners who administered and graded the practical portion of the August, 1982, examination have practiced acupuncture for at least five years and have served as examiners in California for at least three years. Most of these examiners hold degrees in medicine or oriental medicine and all are highly qualified acupuncturists. All of these examiners were assembled before the commencement of the examination and instructed for twelve to eighteen hours to assure that all were grading on the same scale and their grades would be as consistent as practicable. They were provided with Acupuncture Examiner Manual (Exhibit 14) which contains grading criteria for each task on the practical examination. Petitioners contend that this examiner manual established grading criteria for procedures that are unnecessary and/or not practiced by many acupuncturists, thereby taking from the examiners the initiative to grade the examinees on their overall demonstration of acupuncture techniques. A careful review of Exhibit 14 does not compel this conclusion. To the contrary, Exhibit provides the examiners with examples of techniques that demonstrate competence as well as techniques demonstrating superior performance. As noted below, the areas in which the greatest number failed was in location of acupuncture point and length of needle/angle of insertion/manipulation. In the former a passing grade was given if the candidate needled on the proper meridian. A superior grade resulted if the candidate was less than one-half inch off point and on the meridian. In the latter the candidate received a passing score if he got two of the three, viz, angle of insertion, length of needle and/or manipulation, correct. Either twisting and twirling or lifting and thrusting of the needle was accepted for manipulation for either tonification or sedation. Instructions were mailed to all applicants advising of the time and place of their examination; the format of the examination; the bibliography of books to study for Part II of the examination, Theory and Practice of Acupuncture; how Part IV of the practical examination will be graded and that it will consist of: (1) Needle Insertion, Manipulation and Removal and (2) Patient Care, Sanitation and Antiseptic Application (Exhibit 4). Also forwarded to the applicants were the rules governing acupuncture clinics, Chapter 10D-81, Florida Administrative Code, and Chapter 21-12, Florida Administrative Code, covering licensing procedures for acupuncturists, including scope of the examination. Every examinee's scores for items 6, 11, and 16 on Part IV.1 of the August, 1982, examination intended to test examinees' performance in needle inspection prior to insertion were invalidated by Respondent at the examination because: Candidates did not adhere to this criteria, it would appear that while this is a vital precautionary measure to be utilized in the practice of acupuncture, candidates, however, consistently failed this criteria. The contention is that since applicants used newly purchased pre-packaged needles, disposable needles, and their personal needles, the assumption is that candidates were confident of the "good" condition of needles, and with the exception of one candidate this appears to be true. Prior to the August, 1982, acupuncture licensure examination, Respondent did not specify to Petitioners any text as reference for the clinical practical portion (Part IV) of the examination, nor did Respondent expressly notify Petitioners that they would be tested on points/meridian location in Part IV.1 of the examination. Respondent did not instruct examiners for the August, 1982, examination that they had to determine the accuracy of Petitioners' point/meridian location through the examinees' use of the proportional measurement method, including the comparison of the size of their hand to Petitioners' hands, and then palpation, and the examiners did not use this method of determining the accuracy with which Petitioners located acupuncture points on the clinical practical examination. Respondent did not notify Petitioners expressly in writing prior to the examination that they were required to insert the needle at an angle, either with or against the flow of energy along the meridian, in order to receive a score for "correct angle" on the August, 1982, acupuncture licensure clinical practical examination. Respondent did not notify Petitioners expressly in writing prior to the examination that they had to demonstrate one of the needle manipulation techniques known as "twisting and twirling" or "lifting and thrusting" in order to receive a score for "correct manipulation" on the August, 1982, acupuncture licensure clinical examination. Respondent did not notify Petitioners by rule or otherwise that "needle manipulation" would be graded in two separate items on the grade sheet for each acupuncture point on the examination. Nor did Respondent notify Petitioners expressly in writing prior to the examination that they had to close the hole for tonification and leave the hole open for sedation in order to receive a score for "proper removal" of the needle on this examination. Respondent did not notify Petitioners expressly in writing prior to the examination that they had to cleanse hands by washing with soap or scrubbing with alcohol or an antiseptic solution prior to handling needles and that they had to maintain "sterile hands" when handling any of the needles in order to receive a "pass" score for item 2 of Part IV.2 of the examination. Nor did Respondent so notify Petitioners that they had to use an antiseptic agent, such as betadine solution, hydrogen peroxide, or alcohol, to cleanse the skin area in which needle insertion was to be performed in order to receive a pass score for item 3 of Part IV.2 of this examination. Nor did Respondent so notify Petitioners that once their hands had been cleansed the cleansed hands could not be used to adjust their clothing or in any other manner that would not maintain sterility in order to receive a "pass" score for item 4 of Part IV.2 of the examination. Respondent did not adopt a rule specifying the criteria by which examiners were to be selected prior to the August, 1982, acupuncture examination, nor did Respondent adopt a rule specifying point/meridian location as a grading criterion for the August, 1982, examination. "Superior manipulation" and "extreme care exercised" are not terms of art in the practice of acupuncture. Acupuncture is defined in the statutes and rules to mean "the insertion of needles into the human body, or the treatment of specific skin areas by means of mechanical, thermal, or the electrical stimulation, for the purpose of controlling and regulating the flow and balance of energy in the body." There are numerous "schools" of acupuncture throughout the world where "masters" teach different techniques. However, all of these schools teach the traditional Chinese theory of acupuncture which is to balance the energy in the body by "tonifying" those areas where there is insufficient energy and "sedating" those areas with too much energy. No evidence was presented that different acupuncture "points" are used at the differing schools of acupuncture or that proper results can be obtained if the needle is not inserted accurately on the point to he needled. These "points" are where needles are inserted and manipulated to increase or decrease the flow of energy on that meridian. The differences in these schools of acupuncture, including the western or scientific, consists mainly of techniques used to attain the desired end. Of these techniques, depth of needle, angle of insertion, and how a needle is manipulated to stimulate the point are perhaps the most significant. Of the three texts referred to the applicants for study, two describe the traditional Chinese art of acupuncture, while the third, by Felix Mann, tests the Chinese art of acupuncture against western scientific bases to demonstrate the efficacy or lack thereof of some of these procedures. While a scientific basis for certain of the traditional Chinese theories cannot be demonstrated, Mann, and others in the scientific world, contend these theories to be without merit. Pursuant to the Chinese school of acupuncture, both depth and angle of insertion of the needle are important. For tonification this school teaches that the needle be angled with the flow of energy, and stimulation of the point is attained by: (1) Repeatedly lift the needle gently subtaneously, then thrust it back with force; (2) Twist and twirl the needle back and forth with small amplitudes and slowly; (3) Insert the needle slowly, twirl it gently. When withdrawing, rest the needle just beneath the skin for a short interval, then withdraw it swiftly; and (4) After withdrawing the needle, close the acupuncture hole by applying slight pressure over it, preventing the vital energy from the channel from escaping. For sedation the needle is inserted against the flow and the manipulations above-noted for tonification are, insofar as practicable, reversed and the hole is left open for the excess energy to escape (Exhibit 6). Traditional Chinese acupuncture emphasizes the importance of point location, angle of insertion, depth of penetration of the needle, the type manipulation used and opening or closing of the hole. All schools emphasize the importance of point location. Some schools, finding little scientific basis for angle and depth of insertion, de-emphasize the importance of these techniques. Many contend that there is no basis for angled insertions solely for tonification or sedation, that with adequate stimulation, depth of needle is unimportant and that almost any type of stimulation is adequate for either tonification or sedation. Little scientific basis for leaving the hole open or closing the hole for sedation and tonification, respectively, has been demonstrated. Since many acupuncture practitioners in the western world, particularly medical doctors, attain stimulation by the use of electricity, and electricity will pass through body tissue easier than manually transmitted vibrations of the needle, the depth of penetration for these practitioners using electrical stimulation is not particularly important. Accordingly, those practitioners give little weight to depth of penetration. Manipulation of the needle during and after insertion consists principally of lifting and thrusting or twisting and twirling. The needle can be moved only in three dimensions, but the speed and amplitude of those movements can be varied. Variations of the speed, amplitude and direction of the movement of the needle are obtained by "plucking" the needle, "scraping" the needle, "shaking" the needle, "flying" the needle, and "trembling" the needle. (Exhibit 28) Movements in certain directions with emphasis are specified for tonification and other movements for sedation are important in the practice of traditional Chinese acupuncture. In the instructions given to the applicants, including all of these Petitioners, they were directed to bring acupuncture needles of various sizes they would use in their practice and all material needed for sanitation and antiseptic application. For Part IV of the examination, each applicant was advised prior to the examination (Exhibit 5) that he/she would be required to perform needle insertion, manipulation and removal on themselves for three different acupuncture points, that the examiner will designate the points on which needle insertion, manipulation and removal are to be performed; that they were to demonstrate for the examiners how they would treat a patient in their clinic when performing needle insertion, manipulation and removal; that they are required to demonstrate only the proper sterilization and sanitation procedures and proper needling techniques for the designated acupuncture points; and that minutes is allotted for this portion of the test. The examination was conducted in a motel room having a sink for the applicant to wash his hands, a straight chair and coffee table for applicant to sit on and set up his equipment and two chairs for the two examiners. Upon entry into the room, each applicant was given the information contained in Exhibit 10. Several Petitioners testified Exhibit 10 was not read to them, while all examiners testified that Exhibit 10 was read to each applicant. All Petitioners who testified prepared a lower leg for acupuncture, all acknowledged that they used a different needle for each insertion, and each acknowledged that he/she was directed to tonify or sedate three specific points. Exhibit 10 directs the procedures each Petitioner testified he followed with the possible exception of the words "using correct angle and needle manipulation" following the directions to "tonify spleen 6" or "sedate liver 4." While a few of the Petitioners attributed their failure to use correct needle angle prescribed by traditional Chinese acupuncture to the failure of the examiners to so instruct them, most of the Petitioners who didn't angle the needle testified that they used a perpendicular needle angle of insertion of the needle because they didn't believe in the efficacy of angling the needle; or to the instruction to insert the needle as they would on a patient in their clinic. Since they didn't use angled insertions on their patients or "close the hole" or "leave the hole open" when treating their patients, they didn't demonstrate the use of those techniques on the examination. Petitioners' primary complaints about the examination concern the failure of Respondent to more specifically tell them exactly what they would be required to do on the practical part of the examination to obtain a passing grade. Su Liang Ku was a successful applicant for licensure on the August, 1982, examination and testified as an expert witness in these proceedings. He acknowledged that the instructions that he was given were not all-encompassing and that he did not always "close the hole" when applying tonification procedures to patients in his office; however, he clearly recognized the need to demonstrate to the examiners all of the appropriate techniques when taking an examination. Ku had taken exams in Burma, China and California before taking the Florida examination and was not surprised by the tests he was asked to perform on the practical examination or uncertain whether the needle should be angled, the hole closed or left open, or whether he should demonstrate more than one technique used to stimulate the point. Had some of these Petitioners recognized and kept in mind this innate distinction between adequate clinical procedures and examination procedures, they, too, would have passed this examination. Petitioner William Skelton failed Part IV of the examination largely because he was graded zero by both examiners for "needle manipulation and removal" for two of the three points. He was also given a below average by both examiners on needle length for one point. Skelton understood he would be examined on traditional Chinese acupuncture, and to tonify a point, he angled the needle in the direction of flow. He also understood point location was very important and that when told to tonify Spleen 6 he was expected to insert the needle at the correct point. Despite his acknowledgment that he understood he was being examined in traditional Chinese acupuncture, Skelton closed the hole on one point traditional Chinese acupuncture indicates should be left open. Petitioner Anna Alvarez failed Part IV of the August, 1982, examination largely as a result of the marks she received from both examiners on length of needle/angle of insertion/manipulation. These marks were 2 for both examiners for points 2 and 3 while for point 1 examiner A scored her performance zero and examiner B scored it 2. Had a passing mark from each examiner been awarded for all three points on this item of the examination, she would easily have passed Part IV of the examination. Ms. Alvarez testified that she did not understand she was being graded on point selection; however, she received passing marks in accuracy of location of acupuncture points from both examiners for all three points. Ms. Alvarez also testified that she achieved chi at two points and after receiving chi it is not necessary to manipulate the needle. While this procedure may well be appropriate in practice, the examiner can hardly determine that the applicant is competent as an acupuncturist unless acupuncture techniques are demonstrated. Simply announcing the arrival of "chi" after which additional stimulation may not be necessary, does not demonstrate manipulation. On the third point, Liver 4, she testified that she did not want sedation so she did not try to get chi. She also testified that the needle was inserted perpendicular to the skin for each point. One of the criteria tested on this part of the practical examination is angle of insertion. While the efficacy of angle of insertion is disputed by many, it is entrenched in traditional Chinese acupuncture and all candidates were aware that the examination would be in this field. Applicants were not given a failing score if needle was not angled, but received a higher score if this technique was demonstrated. Petitioner Paul Gonzalez failed Part IV of the August, 1982, examination largely because of the grades he received in accuracy of location of acupuncture point and in length of needle/angle of insertion/manipulation. For point one, Gonzalez was marked zero by both examiners. He testified that he was told to do Liver 8 and he got mixed up and inserted the needle at Kidney 8. He also testified that he had brought only 1-1/2 inch needles to the examination despite instructions received in Exhibit 4. On cross examination he testified that he had other needles with him but used only 1-1/2 inch needles in the examination. Gonzalez expected to he tested on traditional Chinese acupuncture procedures and attempted to demonstrate those techniques and needle insertion and manipulation. However, of the six grades received for each of the four sections on which the candidates were graded (two examiners x three points) Gonzalez received 2 - 3's and 4 - 2's for length of needle/angle of insertion/manipulation. Only on point 3 did his total score for a point reach the passing level of 3. Gonzalez angled the needle against the flow when he was told to sedate Gall Bladder 41. He also testified he was not told to tonify or sedate the other two points; however, this is contrary to the testimony of the examiners that they read Exhibit 5 to all applicants and to the testimony of other witnesses that they were told to tonify or sedate each point to be needled. Petitioner Edward Rumsey failed Part IV of the August, 1982, examination after receiving zeros from both examiners on point selection for point 1, a 3 and a 0 for point selection for point 2, and 2 - 2's for point selection for point 3. For needle manipulation and removal he received zeros from both examiners for points 1 and 2. In each of the 4 techniques tested for the three points, Rumsey received a total score less than 12 which reduces to an average score of less than 3 needed for passing. Rumsey testified he studied the books on Chinese acupuncture listed on Exhibit 4. When told to tonify Stomach 36, he inserted needle perpendicular to the skin. When told to tonify Spleen 10, he inserted the needle at an angle to the flow. When told to sedate Gall Bladder 41, he again inserted needle perpendicular to the skin. Rumsey further testified the only manipulation technique he used was twisting the needle and he didn't demonstrate closing the hole or leaving the hole open. As with other applicants, the examiners who tested Rumsey were seated in chairs facing Rumsey and could observe him clearly. Rumsey, as did several other witnesses, contended the examiners could not ascertain the needle was inserted more than 1/2 inch from the correct point unless they actually measured. The various acupuncture points are located a certain number of "cuns" from an anatomical landmark and there are a specified number of cuns between two anatomical landmarks. For example, Exhibit 9, p 91, shows there are 8 cuns between the nipples on a man's chest. An experienced acupuncturist should be able to locate a point with considerable accuracy by viewing the anatomical landmark and, by eye, selecting the point 3/8, 1/4, etc. of the distance between these landmarks. Petitioner, David Bole, failed part IV of the August, 1982, examination because he received an average score high enough to pass only one of the four criteria graded by the examiners, viz, "condition of needle - handle comes in contact with skin." On needle manipulation and removal, he received for point 1 a 0 and a 3; for point 2 - 3 zeros; and for point 3 - 2 fours. On accuracy of point location, Bole received 2 - 3's for point 1; a zero and a 3 for point 2; and a 4 and a 3 for point 3. For length of needle/angle of insertion/manipulation, he received scores of 3 and 2 for point 1; 2 and 3 for point 2; and 3 and 4 for point 3. Bole also received a mark of at least one fail by both examiners in the sanitation part of Part IV. Any grade of fail in the sanitation portion of the examination results in a final grade of fail. Bole testified he holds a Ph.D. in psychology and has been practicing acupuncture under the supervision of a medical doctor. He studied the recommended texts to prepare for the examination, but relied on his experience, past training and instruction to proceed as he would with a patient in his own clinic, in demonstrating his proficiency in traditional Chinese acupuncture. Bole testified he inserted the needle at an angle with the flow when directed to tonify and against the flow when directed to sedate. He also demonstrated closing the hole or leaving the hole open as appropriate. He used the same swab to clean all points as well as to seal the hole and he used 1-1/2 inch needles for all points. Bole acknowledged that knowing length of needle used allows the examiner to determine the depth the needle is inserted. His principal objection is that insufficient directions were given to applicants for the applicants to understand exactly what they were expected to demonstrate. Harvey J. Kaltsas failed Part IV of the August, 1982, examination by reason of the low scores he received in accuracy of locating acupuncture point and length of needle/angle of insertion/manipulation. On point location Kaltsas received passing grades of 3 by each examiner for points 1 and 2, but for point 3, received grades of 0 and 2. For length of needle/angle of insertion/manipulation he received a 2 from each examiner for point 1, a 3 from each examiner for point 3, and one 2 and one 3 for point 2. Kaltsas testified that in his training, the angle of insertion of the needle is the most important factor in needling. To prepare for the examination Kaltsas studied the texts recommended in Exhibit 10 and assumed the examiners would be looking for methods of tonification and sedation discussed in the books on traditional Chinese acupuncture. For each of the three points he was told to tonify or sedate, he inserted the needle perpendicular to the skin. Kaltsas also testified he didn't think the examiners were looking for point location because they didn't take physical measurements to check the accuracy of each point he needled. Petitioner Marie Burleson failed Part IV of the August, 1982, examination partly as a result of running out of time before point 3 was needled. However, even if the score on point 3 could be ignored, Burleson would have failed all of the criteria except "needle manipulation and removal." For the accuracy of location of the two points needled, Ms. Burleson received two 2's for point 1 and one 2 and one 3 for point 1. Zeros were given for point 3. For length of needle/angle of insertion/ manipulation, Burleson received a score of 3 from one examiner for points 1 and 2, but a score of 1 from the other examiner. For a "condition of needle" Petitioner received a score of 4 from one examiner for points 1 and 2, but received a score of 0 and 3 from the other examiner. Both the examiners scored Burleson zero on point 3. Burleson attributed her difficulty in not completing point 3 to the fact that she had no comfortable place to put her foot while she was needling the leg. She testified that when she started to insert the needle in point 3, her foot slipped off the chair and the needle was bent. Burleson is a graduate of an acupuncture school in California from which she took most of her studies by correspondence. She spent only one month full-time in classrooms before graduation. At the examination, Burleson used a one-inch needle inserted perpendicular to the skin for both points 1 and 2. She demonstrated closing the hole for the two points tonified. Petitioner Henry Meritt failed Part IV of the August, 1982, examination as the result of failing all of the criteria except "condition of needle" for which he was graded a 3 by each examiner for each of the 3 points. He also failed the sanitary part of Part IV with respect to his handling of needles. For accuracy of location of acupuncture point Meritt scored 3's for points 1 and 2 and zero for point 3 by both examiners. For length of needle/angle of insertion/manipulation, Meritt scored a zero and 2 for point 1, two 2's for point 2, and a zero and a 3 for point 3. For "needle manipulation and removal" both examiners scored Meritt zero for points 1 and 2 and he received a 2 and a 4 for point 3. Meritt contends he was not instructed to demonstrate how he located the points to be needled and that he thought, as did others, that point location was to be graded only in Parts II and III of the examination. In view of Finding of Fact 5 above, that point location is the most important element in acupuncture, such contentions are simply not credible. Without inserting the needle on the point or at least on the meridian on which this point is located, the desired results are not obtainable. This Petitioner testified tonification is obtained simply by leaving the needle inserted and without manipulation, that he used 1-1/2 inch needles for all points, that it was immaterial what length needle he used because they were inserted only 1/4 inch and that his two examiners were unprofessional during the time he was in the room taking his practical examination. He graduated from Doctor Dale's Institute in New York and refers to himself as Dr. Meritt although he has no doctoral degree in medicine or anything else. Petitioner Charles McWilliams failed Part IV of the August, 1982, examination by reason of obtaining a total score from both examiners below that required for passing in all of the criteria tested except "condition of needle - handle comes in contact with skin" on which he received a score of 3 from each examiner for each of the 3 points. For accuracy of location of acupuncture points, examiner A gave him a 4 for each of the 3 points, while examiner B awarded him scores of 3, 2 and 0 for points 1, 2 and 3, respectively. For length of needle/angle of insertion/manipulation for point 1 he received scores of 1 and 2; for point 2 scores of 2 and 3; and for point 3 scores of 2 and 2. For "needle manipulation and removal" for point 1 he received scores 2 and 0; for point 2 scores of 2 and 0; and for point 3 scores of 0 and 3. McWilliams testified he understood the practical part of the examination would be based on the texts to which he had been referred in Exhibit 4; that he angled his needle; that a 1-1/2 inch needle was used to tonify Stomach 36 (point 1) and Spleen 10 (point 2) and a 1-inch needle was used to sedate Gall Bladder 41 (point 3); that when he withdrew the needle from point 3, a drop of blood appeared and he put a swab on the hole; and if the latter motion constituted closing the hole, he closed the hole at point 3. McWilliams does not adhere to the theory that closing the hole or leaving the hole open is effective in tonification or sedation. Petitioner James Bissland failed Part IV of the August, 1982, examination because of failing scores received in accuracy of location of acupuncture point and length of needle/angle of insertion/manipulation and because he received a fail score from examiner A on the use of antiseptic solution on the skin prior to needle insertion on all three points needled. Bissland's scores for accuracy of point location were 2's for points 1 and 2 and 3's for point 3. For length of needle/angle of insertion/manipulation he scored a 1 and a 2 for point 1; a 1 and a 2 for point 2; and 2's for point 3. Bissland contends he did not know he would be graded on accuracy of point location but, had he known, he would have done nothing different than he did on the examination. Bissland studied the texts referred to in Exhibit 4 and expected Part IV of the examination to be a demonstration of the knowledge presented in Parts II and III. When told (by Exhibit 5) that he should demonstrate to the examiners the procedures he used in his own clinic, Bissland testified that is what he did. For each point Bissland used a 1-inch needle and a Japanese shallow needle technique with each needle penetrating 1/4 to 1/2 inch. No angling of the needles was performed. Bissland normally provides stimulation by electricity and does not angle the needles unless anatomically necessary. Since he was advised that electrical stimulation would not be allowed on the examination, he demonstrated slow and rapid insertion of the needle, slow and rapid rotation of the needle, and what he considered proper removal of the needle. Petitioners' expert witness, Peter Lu, took and passed the acupuncture examination in August, 1982. His father and grandfather were both Chinese medical doctors and Lu graduated from Hong Kong Western Pacific College where he studied acupuncture and Chinese medicine for four years. He considers point location and depth of needle insertion very important in acupuncture and an examiner can judge the depth of insertion by the length of the needle used. He was taught for tonification to angle the needle with the flow and to close the hole to prevent the escape of energy. For sedation he was taught to angle the needle against the flow and to leave the hole open to release the undesirable energy. Lu would consider a demonstration unsatisfactory if an examinee bent a needle while needling himself. Petitioners presented an expert witness who opined that test results on a practical examination were unreliable when two examiners on a scale of 0 to 4 gave scores 3 or more points apart. Here, the examiners were directed to give the applicant being tested a passing score if they could not clearly see what the applicant was demonstrating. This expert also testified the grades are unreliable where one examiner awards a pass and the other a fail. On the sanitation and antiseptic application part of the examination, the only grades authorized are pass and fail. At one point on the scale on which such performance is weighed there must be a equipoise between pass and fail. Thereafter, whichever way the scale is tilted determines the grade assigned. In this examination, the two examiners agreed on the grade to be assigned for 81 percent of the applicants. Part of the 19 percent on which they disagreed can be attributed to the instructions to award a pass score if the demonstration couldn't be clearly seen by the examiner. Even without this instruction, a difference of only 19 percent is a reasonable deviation in scores assigned by two examiners.
The Issue The issues are whether proposed Florida Administrative Code Rule 58A-5.024(1)(p)1.a., a proposed amendment to Florida Administrative Code Rule 58A-5.024(3)(c), and, as recently amended or created, Florida Administrative Code Rules 58A-5.0131(41), 58A-5.0181(2)(b) (amending AHCA1 Form 1823 (Form 1823)), 58A-5.0182(8)(a) and (8)(a)1., 58A-5.0185(3)(g), 58A-5.0191(3)(a), and 58A-5.031(2)(d)2 are invalid exercises of delegated legislative authority, pursuant to section 120.52(8), Florida Statutes, on the grounds set forth in the Joint Pre-hearing Stipulation filed on May 30, 2018 (Prehearing Stipulation) or such other grounds that were tried by consent.
Findings Of Fact By "Notice of Proposed Rule" published on March 5, 2018, Respondent proposed amendments to 11 rules: rules 58A-5.0131, 58A-5.014, 58A-5.0181, 58A-5.0182, 58A-5.0185, 58A-5.019, 58A-5.0191, 58A-5.024, 58A-5.029, 58A-5.030, and 58A-5.031. For rulemaking authority, Respondent cited sections 429.07, 429.17, 429.178, 429.24, 429.255, 429.256, 429.27, 429.275, 429.31, 429.41, 429.42, 429.44, 429.52, 429.54, and 429.929. For the law implemented, Respondent cited sections 429.01 through 429.55 and 429.905 and chapter 2015-126, Laws of Florida.14 The proposed amendments to rule 58A-5.024 state15: The facility must maintain required records in a manner that makes such records readily available at the licensee’s physical address for review by a legally authorized entity. . . . For purposes of this section, “readily available” means the ability to immediately produce documents, records, or other such data, either in electronic or paper format, upon request.16 FACILITY RECORDS. Facility records must include: * * * The facility's infection control policies and procedures. The facility's infection control policy must include: A hand hygiene program which includes sanitation of the hands through the use of alcohol-based hand rubs or soap and water before and after each resident contact. Use of gloves during each resident contact where contact with blood, potentially infectious materials, mucous membranes, and non-intact skin could occur. The safe use of blood glucometers to ensure finger stick devices and glucometers are restricted to a single resident. Lancets should be disposed in an approved sharps container and never reused. Glucometers should be cleaned and disinfected after every use, per manufacturer's instructions, to prevent carry-over of blood and infectious agents. Medication practices including adherence to standard precautions to prevent the transmission of infections in a residential setting. Staff identification, reporting, and prevention of pest infestations such as bed bugs, lice, and fleas. * * * (3) RESIDENT RECORDS. Resident records must be maintained on the premises and include: * * * (c) . . . Records of residents receiving nursing services from a third party must contain all orders for nursing services, all nursing assessments, and all nursing progress notes for services provided by the third party nursing services provider. Facilities that do not have such documentation but that can demonstrate that they have made a good faith effort to obtain such documentation may not be cited for violating this paragraph. A documented request for such missing documentation made by the facility administrator within the previous 30 days will be considered a good faith effort. The documented request must include the name, title, and phone number of the person to whom the request was made and must be kept in the resident's file. The challenge to rule 58A-5.024(1)(p)1.a. is to the unconditional requirement of hand sanitizing "before and after each resident contact."17 Resident contact is unqualified, so the challenged provision does not exclude casual or incidental contact between a staffperson and a resident. One of Respondent's witnesses assured that Respondent does not intend for "each residential contact" to include casual contact by staff, such as "high fives" during a bingo game or the brushing of shoulders in the hall, but this assurance cannot displace the unconditional language of the rule, as well as the fact that enforcement of the rule is left to the Agency for Health Care Administration (AHCA), not Respondent.18 In its present form, the rule requires hand sanitizing before exchanging "high fives" or, somehow, even a pat on a staffperson's clothed shoulder initiated by a resident, so as to discourage such casual contact. Requiring hand sanitizing before and after each and every resident contact will encompass many contacts for which hand sanitizing will have no effect on the control of infections and deter or abbreviate interactions between residents and staff, who would repeatedly be washing their hands during time that they otherwise might spend with residents. Generally, a hand hygiene program is neither capricious nor arbitrary because it responds to a well-recognized means by which disease is transmitted——human to human--with sanitation as a well-recognized means to interrupt this transmission process. However, the proposed rule irrationally requires hand sanitation before incidental residential contact that, by its nature, is unplanned, and after residential contact with another part of a staffperson's body, such as an elbow or clothed back, rather than the staffperson's hand, where hand washing would not have any sanitizing effect. The rule is also unsupported by logic or the necessary facts. On its face, rule 58A-5.024(1)(p)1.a. is not vague: a staffperson must sanitize her hands after every contact with a resident and before every contact with a resident, even, somehow, unplanned contacts that may be initiated by the resident. Respondent's promise that AHCA will apply this proposed rule reasonably--i.e., the inspector will know a violation when she sees one--makes the point that, to be spared findings of capriciousness and arbitrariness, rule 58A-5.024(1)(p)1.a. must be construed so as to fail to establish adequate standards for agency decisions. "Sanitary" means "of or relating to health[, as in] sanitary measure."19 The challenge to rule 58A-5.024(3)(c) is to the requirement that an ALF obtain and maintain the records of third party providers of nursing services. This requirement is supported by logic and the necessary facts and is not irrational. Maintaining a set of these records at the residence of an ALF resident promotes resident welfare. Applicable only to a facility that intends to offer limited nursing services, rule 58A-5.031(2)(d) provides: Facilities licensed to provide limited nursing services must employ or contract with a nurse(s) who must be available to provide such services as needed by residents. The facility's employed or contracted nurse must coordinate with third party nursing services providers to ensure resident care is provided in a safe and consistent manner. The facility must maintain documentation of the qualifications of nurses providing limited nursing services in the facility's personnel files. Coordinating a facility's nursing services with the nursing services of a third party to ensure that resident care is provided in a safe and consistent manner is neither capricious nor arbitrary. Resident welfare is served by a rule requiring coordination between any nurse employed or contracting with a facility and a provider of third party nursing services, so this requirement is rationally related to resident care and supported by logic and the necessary facts. "Coordination" means "the process of organizing people or groups so that they work together properly and well."20 "Quality assurance" means "a program for the systematic monitoring and evaluation of the various aspects of a project, service, or facility to ensure that standards of quality are being met." "Ensure" means "to make sure, certain, or safe: guarantee."21 In addition to proposed rule 58A-5.024(1)(p)1., two rules pertain to a facility's infection control program (ICP). Rule 58A-5.0185(3)(g) provides: "All trained staff must adhere to the facility's [ICP] and procedures when assisting with the self——administration of medication." Rule 58A-5.0191(3)(a) adds: Staff who provide direct care to residents . . . must receive a minimum of 1 hour in- service training in infection control including universal precautions and facility sanitation procedures, before providing personal care to residents. The facility must use its [ICP] and procedures when offering this training. . . . Requiring the use of a facility's ICP in training or when assisting with the self-administration of medication is neither capricious nor arbitrary. These requirements are supported by logic and the necessary facts and are rational. 13. Rule 58A-5.0131(41) provides: An "Unscheduled Service Need" means a need for a personal service, nursing service, or mental health intervention that generally cannot be predicted in advance of the need for the service, and that must be met promptly to ensure within a time frame that provides reasonable assurance that the health, safety, and welfare of residents is preserved. On its face and based on its placement within a rule devoted to definitions, rule 58A-5.0131(41) is a definition. If so, an "Unscheduled Service Need" occurs: 1) when a need for a covered service arises unexpectedly and 2) the need must be met promptly to ensure the preservation of resident welfare. If the rule is a definition, an amendment making the second condition more rigorous would inure to the benefit of ALFs because fewer situations would rise to the level of an Unscheduled Service Need. For instance, there would be even fewer Unscheduled Service Needs if the second condition stated, "and that must be met promptly to save the life of a resident." Two factors suggest that rule 58A-5.0131(41) is not merely a definition. A definition is normally incorporated in another provision of law that creates rights or enforces duties. However, "Unscheduled Service Need" occurs nowhere in the Florida Statutes and nowhere else in the Florida Administrative Code. "Unscheduled Service Need" might trigger action in a resident's care plan, but few residents are required to have a care plan. The parties have treated rule 58A-5.0131(41) as though it were a definitional rule that enforces a duty. FALA has challenged rule 58A-5.0131(41) as though the initial condition-- the occurrence of an unexpected, covered need--is the definition and the duty is for the ALF to meet the need to ensure the resident's welfare. Agreeing, Respondent stated in its proposed final order: "A plain reading of the entire rule makes it clear that the rule requires a facility to respond to an unscheduled service need in a manner that does not delay addressing the residents' needs."22 Although nearly all23 of the other subsections of rule 58A-5.0131 seem to provide conventional definitions, under the circumstances, this final order will follow the parties' reading of this definitional rule, so as to include the imposition of a duty on the ALF to take prompt action to ensure the resident's welfare. Rule 58A-5.0131(41) is neither arbitrary nor capricious. It is not irrational, illogical, or unsupported by the facts to define an unscheduled service need in the manner set forth in the rule and to require an ALF promptly to meet the need to ensure that the welfare of the resident. Rule 58A-5.0131(41) is vague. On its face, it is a merely definitional rule with two conditions, but, in reality, it is a rule that encompasses a definition with but one condition and an enforceable duty imposed upon an ALF. This fact, alone, establishes vagueness. Construed as a definition with a single condition and an enforceable duty imposed on an ALF, rule 58A-5.0131(41) achieves greater vagueness. The condition, which is a condition precedent, is invariably clear, but the enforceable duty is contingent on a condition subsequent that is entirely independent from the condition precedent: i.e., the duty of the ALF arises only if its prompt discharge ensures the resident's welfare. This means that, even though the condition precedent is satisfied, the duty of the ALF is not imposed if prompt action is not required to ensure the resident's welfare--as in a minor problem that does not jeopardize the resident's welfare--or if prompt action will not ensure the resident's welfare--as in a catastrophic event, such as a massive cardiovascular event, that precludes the possibility of any action that would "ensure" the resident's welfare. The fatal ambiguity arises because the final 17 words of the rule announced, simultaneously, the mandated action by the ALF and a condition precedent to the duty to take this action. Rule 58A-5.019(3) requires that an ALF maintain a specified number of minimum staff hours per week based on a specified "Number of Residents, Day Care Participants, and Respite Care Residents" in the facility. For instance, 6 to 15 such persons require a minimum of 212 staff hours weekly, and 16 to 25 such persons require a minimum of 253 staff hours weekly. Unchallenged, rule 58A-5.0131(12) defines "Day Care Participant" as "an individual who receives services at a facility for less than 24 hours per day." The inclusion of "Day Care Participants" among the persons on whom minimum staff hours are calculated is not capricious or arbitrary. An ALF accepting Day Care Participants has assumed responsibility for the care of these persons, and the imposition of minimum staffing standards based on residents and Day Care Facilities is supported by logic and the necessary facts and is rational. 22. Rule 58A-5.0182(8)(a) and (8)(a)1. provides: Residents Assessed at Risk for Elopement. All residents assessed at risk for elopement or with any history of elopement must be identified so staff can be alerted to their needs for support and supervision. All residents must be assessed for risk of elopement by a health care provider or mental health care provider within 30 calendar days of being admitted to a facility. If the resident has had a health assessment performed prior to admission pursuant to Rule 58A-5.0181(2)(a), F.A.C., this requirement is satisfied. . . . Staff trained pursuant toRule 58A-5.0191(10)(a) or (c), F.A.C., mustbe generally aware of the location of all residents assessed at high risk for elopement at all times. Rule 58A-5.0191(10) applies to ALFs that advertise that they provide special care for persons with Alzheimer's Disease and Related Disorders (ADRD) or that maintain certain secured areas (ADRD ALFs); the rule requires that ADRD ALFs must ensure that their staff receive specialized training. Rule 58A-5.0191(10)(a) and (c) specifies the training for staff who provide direct care to, or interact with, residents with ADRD. By addressing the training received by staff, rather than whether the supervised residents suffer ADRD or whether an ALF employing the staffperson is an ADRD ALF, rule 58A-5.0182(8)(a)1. imposes higher supervisory duties strictly on the basis of the training received, at some point, when the staffperson may have been employed by an ADRD ALF. Thus, the level of supervision at an ALF that is not an ADRF ALF may vary from shift to shift and unit to unit, as the staffpersons who, at some point, received the additional training are distributed through the facility's workplace. Perhaps it is not irrational to impose a higher supervisory duty on more highly trained staffpersons, but, on these facts, rule 58A-5.0182(8)(a)1. is not supported by logic or the necessary facts. Rule 58A-5.0182(8)(a)1. is vague. A "high risk" of elopement lacks meaning. As discussed below, in Form 1823, Respondent asks in a yes-or-no format the question of whether the resident is an "elopement risk," which seems to suggest an elevated risk from the general population. A "high risk" of elopement seems to suggest an even more elevated risk, but the rule provides no means to determine the threshold, even though, with each elevation of risk from the general population, the prescribed threshold becomes less discernible. Rule 58A-5.0182(8)(a)1. is also vague because of the phrase, "generally aware of the location" of all residents at high risk of elopement. "Generally" means "in disregard of specific instances and with regard to an overall picture generally speaking."24 Treating "awareness" as synonymous with "knowledge," it is difficult to understand what is meant by general, not specific, knowledge of the location of a resident.25 The troublesome qualifier modifies the knowledge of the staff person, not the location of the resident, which raises an obvious problem as to meaning, as well as proof. By inserting "generally," the rule rejects "knowledge" or "specific knowledge" in favor of knowledge of "an overall picture generally speaking" and introduces an unworkable level of ambiguity into the requirement. Rule 58A-5.0182(8)(a) is not capricious. A rule requiring a timely assessment of elopement risk by a health care provider or mental health care provider26 is not irrational; such an exercise is not utterly senseless. But a closer question is whether this rule is supported by logic or the necessary facts. A commonly used elopement risk tool, which was included in the exhibits of FSLA and Respondent, assigns numerical values on a scale of 0 to 4 to various resident behaviors or conditions. The predictive utility of each behavior or condition is a function of the value assigned to it: a 4 has the greatest predictive value. The only behavior or condition assigned a 4 is the resident's believing that he is late for work or needs to pick up the children, thus creating an urgency to leave the ALF. Four behaviors or conditions bear a 3: the resident's becoming lost outside of the facility, thus necessitating the intervention of staff to return him to the ALF; emphatically proclaiming that she is leaving the facility or saying that she is going somewhere, coupled with an attempt to leave; suffering paranoia or anxiety about where she is, disbelieving that she lives where she lives, or attempting to leave the ALF; and repeatedly trying to open the doors of the facility. Ten27 behaviors or conditions bear a 2: the resident's having a diagnosis of dementia; becoming confused outside of the community; wandering, looking for an exit from the ALF, or attempting to leave the ALF; getting up at night and leaving the room; suffering from disorientation as to place without any anxiety or effort to leave; dressing and presenting oneself in an appropriate manner, but requiring staff supervision outside of the building; ambulating, but unsafe outside without supervision; using assistive devices, but unsafe outside without supervision; presenting as unsafe when outside alone; and taking walks, but requiring redirection to the entrance of the building or back to the property. Five behaviors or conditions bear a 1: the resident's displaying evidence of early dementia; wandering at times, but not expressing a desire to leave the ALF or trying to leave the ALF; verbalizing the desire to be elsewhere; suffering occasional disorientation as to time and place, but reorienting easily; and presenting a disheveled and disorganized appearance, so as not to be confused for a visitor or staffperson. Nine behaviors or conditions bear a 0: the resident's having no diagnosis of dementia; having no history of elopement; not wandering; not verbalizing a need to leave the ALF; sleeping all night or getting up occasionally and not leaving the room; displaying orientation to time and place; dressing and presenting self in an appropriate manner and not requiring staff supervision outside of the building; ambulating or propelling self in wheelchair safely; and presenting no other behaviors associated with memory impairment. The elopement risk tool is completed by an ALF employee who is neither a health care provider nor or a mental health care provider. Of the 30 predictive factors, essentially only one, involving dementia, requires a medical or psychiatric diagnosis. It is, of course, not necessary to solicit from the health care provider an elopement risk assessment in order to obtain her opinion as to dementia. More importantly, overshadowing the dementia predictors to the point of near elimination are high- value predictors involving current behaviors, historic behaviors, and, most importantly, the perceived need to leave the facility to get to work or discharge domestic duties. Of these, the health care provider would have no direct knowledge, so her assessment of elopement risk would either be based on insufficient information or hearsay whose precise accuracy would be doubtful. On these facts, the requirement in rule 58A-5.0182 (8)(a) for a health care provider or mental health provider to assess a resident's elopement risk is unsupported by logic and the necessary facts. Rule 58A-5.0181(2)(b) incorporates Form 1823, which is divided into four sections. Sections 1, 2-A, and 2-B must be completed by a licensed health care provider. Section 3 must be completed by the ALF. The end of the form provides lines for the signatures of the resident and ALF. Under the signature of the resident, but not the ALF, the form states: "By signing this form, I agree to the services identified above to be provided by the [ALF] to meet identified needs." Section 1 is a "Health Assessment" that elicits information about allergies, medical history, height and weight, physical or sensory limitations, cognitive or behavioral status, nursing, treatment or therapy recommendations, special precautions, and "elopement risk." For all items except elopement risk, the form provides a block for comments; for elopement risk, the form provides only two boxes: one marked "yes" and one marked "no." Section 1.A asks: "To what extent does the individual need supervision or assistance with the following?" Seven activities of daily living (ADLs) are listed: ambulation, bathing, dressing, eating, self care (grooming), toileting, and transferring. Boxes allow the health care provider to pick one of four levels from independent to total care. The form also provides a block for comments beside each ADL. Section 1.B is: "Special Diet Restrictions." Four boxes are listed: regular, calorie controlled, no added salt, and low fat/low cholesterol. There are two lines for other dietary restrictions. Section 1.C asks: "Does the individual have any of the following conditions/requirements? If yes, please include an explanation in the comments column." Five items are listed: communicable disease, bedridden, pressure sores other than stage 1, "Pose a danger to self or others? (Consider any significant history of physically or sexually aggressive behavior.)," and 24 hour nursing or psychiatric care. The form provides a box for "yes/no" and a block for comments. Section 1.D asks: "In your professional opinion, can this individual's needs be met in an [ALF], which is not a medical, nursing, or psychiatric facility?" The form provides a box for "yes" and a box for "no," as well as a line for additional comments. Section 2-A is "Self-Care and General Oversight Assessment." Section 2-A.A is "Ability to perform Self-Care Tasks" and lists five tasks: preparing meals, shopping, making phone calls, handling personal affairs, handling financial affairs, and other. Boxes allow the health care provider to select one of three levels from independent to needs assistance. The form also provides a block for comments beside each task. Section 2-A.B is "General Oversight" and lists three tasks: "observing wellbeing," "observing whereabouts," "reminders for important tasks," and four spaces for "other." Boxes allow the health care provider to select one of four levels: independent, weekly, daily, and other. The form also provides a block for comments beside each task. Section 2-A.C is three lines for additional comments or observations. Section 2-B is "Self-Care and General Oversight Assessment--Medications." Section 2-B.A provides blocks for listing individual medications, dosages, directions for use, and route of administration. Section 2-B.B asks: "Does the individual need help with taking his or her medications (meds)?" The form provides a box for "yes" and a box for "no" with a direction, if yes is marked, to check one of the following three boxes: able to administer without assistance, needs assistance with self-administration, and needs medication administration. Section 2-B.C provides two lines for additional comments or observations. Immediately following Section 2-B is a section that requires identifying information about the health care provider and the date of the examination. Section 3 requires the ALF to identify the needs set forth in Sections 1 and 2 and provide the following information in blocks: identified needs, services needed, service frequency and duration, service provider name, and initial date of service. Form 1823 is mentioned in rule 58A-5.0181(2)(b) through (d), which describes the required medical examination based on when it takes place relative to admission or whether it follows a placement by Respondent, Department of Children and Families (DCF), or one of their private contractors. The rule states: HEALTH ASSESSMENT. As part of the admission criteria, an individual must undergo a face-to-face medical examination completed by a health care provider as specified in either paragraph (a) or (b) of this subsection. A medical examination completed within 60 calendar days before the individual’s admission to a facility pursuant to section 429.26(4), F.S. The examination must address the following: The physical and mental status of the resident, including the identification of any health-related problems and functional limitations, An evaluation of whether the individual will require supervision or assistance with the activities of daily living, Any nursing or therapy services required by the individual, * * * 7. A statement on the day of the examination that, in the opinion of the examining health care provider, the individual’s needs can be met in an assisted living facility[.] * * * A medical examination completed after the resident’s admission to the facility within 30 calendar days of the admission date. The examination must be recorded on AHCA Form 1823, Resident Health Assessment for Assisted Living Facilities, March 2017 October 2010 . . . . The form must be completed as instructed. Items on the form that have been omitted by the health care provider during the examination may be obtained by the facility either orally or in writing from the health care provider. Omitted information must be documented in the resident’s record. Information received orally must include the name of the health care provider, the name of the facility staff recording the information, and the date the information was provided. Electronic documentation may be used in place of completing the section on AHCA Form 1823 referencing Services Offered or Arranged by the Facility for the Resident. The electronic documentation must include all of the elements described in this section of AHCA Form 1823. Any information required by paragraph (a), that is not contained in the medical examination report conducted before the individual’s admission to the facility must be obtained by the administrator using AHCA Form 1823 within 30 days after admission. Medical examinations of residents placed by the department, by the Department of Children and Families, or by an agency under contract with either department must be conducted within 30 days before placement in the facility and recorded on AHCA Form 1823 described in paragraph (b). For the same reasons that rule 58A-5.0182(8)(a) is arbitrary, but not capricious, the yes-or-no question as to elopement risk in section 1 is arbitrary, but not capricious. The record lacks counterparts to the elopement assessment tool for the remaining items under challenge from the Form 1823, so it is necessary to obtain from the CMS Documentary Guidelines the scope of a typical medical examination to address whether the challenged items in the Form 1823 are supported by logic and the necessary facts. A medical examination may cover any of ten organ systems or areas: cardiovascular; ears, nose, mouth, and throat; eyes; genitourinary; hematologic/lymphatic/immunologic; musculoskeletal; neurological; psychiatric; respiratory; and skin. Each organ system or area comprises several elements. Medical examinations may vary as to their scope. Between the two types of general multi-system medical examinations that are not focused on a particular problem, the less exhaustive examination, which is "detailed," typically requires an examination of at least a dozen elements spanning two to six organ systems or areas. If a multi-system medical examination includes a psychiatric examination, the examination typically involves no more than a "description of patient's judgment and insight" and "brief assessment of mental status including: orientation to time, place and person[;] recent and remote memory[; and] mood and affect (eg, depression, anxiety, agitation)[.]" Even a full psychiatric examination encompasses only the following elements: Description of speech including: rate; volume; articulation; coherence; and spontaneity with notation of abnormalities (eg, perseveration, paucity of language) Description of thought processes including: rate of thoughts; content of thoughts (eg, logical vs. illogical, tangential); abstract reasoning; and computation Description of associations (eg, loose, tangential, circumstantial, intact) Description of abnormal or psychotic thoughts including: hallucinations; delusions; preoccupation with violence; homicidal or suicidal ideation; and obsessions Description of the patient's judgment (eg, concerning everyday activities and social situations) and insight (eg, concerning psychiatric condition) Complete mental status examination including Orientation to time, place and person Recent and remote memory Attention span and concentration Language (eg, naming objects, repeating phrases) Fund of knowledge (eg, awareness of current events, past history, vocabulary) Mood and affect (eg, depression, anxiety, agitation, hypomania, lability) However, a full psychiatric examination would unlikely meet the reasonable expectations of Respondent or ALFs of a medical examination because it excludes consideration of any nearly all other organ systems or areas. The inquiry in Section 1.A about ADLs is not capricious, but is arbitrary as to some items. The scope of a typical medical examination will yield no information about a patient's ability to bathe, dress, groom, or toilet. The scope of a typical medical examination may yield some information about a patient's ability to ambulate, eat (as to swallowing), and transfer between a bed, chair, wheelchair, scooter, and car, and the health care provider should be able to rate the extent of the ability of the patient to perform each of these ADLs. Requiring the health care provider to rate the extent of the ability of the patient to perform any of the other ADLs is therefore not supported by logic or the necessary facts. The inquiry in Section 1.C about whether the patient poses a danger to self or others and directive to consider any significant history of physically or sexually aggressive behavior is arbitrary, but not capricious. Although a psychiatric examination would include a determination of whether the patient suffers from homicidal or suicidal ideations, a psychiatric examination is unlikely to take the place of a conventional medical examination, whose inclusion of limited psychiatric elements would not yield a reasonable basis for opining whether the patient poses a danger to self or others. Nor does the record suggest that the medical examinations of the type conducted for the admission of the patient to an ALF are conducted by psychiatrists, physician assistants specializing in psychiatry, or advanced registered nurse practitioners specializing in psychiatry. This finding necessitates the invalidation of the directive to consider significant history of physically or sexually aggressive behavior in responding to the question--a directive that is meaningless without the question of whether the patient poses a danger to self or others. The inquiry in Section 1.D about whether, in the "professional opinion" of the health care provider, the patient's needs can be met in an ALF that is not a medical, nursing, or psychiatric facility is arbitrary, but not capricious. No ALF is a medical facility, which likely means a hospital; nursing facility, which likely means a skilled nursing facility; or psychiatric facility, which likely means a psychiatric hospital. The addition of this information, which is superfluous to anyone who understands the nature of ALFs, reveals the concern of AHCA or Respondent that the health care providers lack even this basic knowledge of the nature of ALFs. Due, in fact, to their lack of knowledge of the specific features of an ALF, health care providers lack the foundation to answer this question intelligently. The request in section 2-A.A about the ability of the patient to perform self-care tasks and the request in section 2-A.B about the need of the patient for general oversight, are arbitrary, but not capricious, for the same reasons as set forth concerning the ADLs of bathing, dressing, grooming, and toileting. Section 3 is neither arbitrary nor capricious. The collection of needs identified in the preceding sections and identification of services to meet these needs, as well as the additional information, are not irrational and are supported by logic and the necessary facts. Due to section 3, the requirement that the resident and ALF sign the Form 1823 is neither arbitrary nor capricious. By signing, the resident explicitly agrees to receive the identified services, and the ALF implicitly agrees to provide the identified services; so it is not irrational or unsupported by logic or the necessary facts to require both parties to sign the Form 1823. However, if section 3 were invalidated, as it is below, the requirement of the signatures of the patient and ALF would be irrational and unsupported by logic and the necessary facts because there is no reason for the patient or ALF to sign a medical examination form, that does not also contain a statement of the services to be provided by the ALF. The only signature on a medical examination form that might rationally be required would be that of the health care professional in order to authenticate the completed form. A "form" is "the shape and structure of something as distinguished from its material--the building's massive form"; or "a printed or typed document with blank spaces for insertion of required or requested information tax forms."
Findings Of Fact Petitioner William Huang received training in acupuncture at the Chinese Acupuncture Science Research Foundation in Taiwan, China, and has practiced acupuncture for ten years, seven and a half of which have been in Florida. In August of 1981, petitioner submitted to the Department of Professional Regulation his Application for Acupuncture Examination. The Application form requests the applicant to check one of two alternative methods of qualifying for the examination: by education or by Florida apprenticeship or experience. Petitioner checked the box for "by Florida apprenticeship or experience." As of the dates of the hearing in this proceeding, petitioner had not been notified by the DPR as to whether or not he had been approved as qualified to take the examination. The examination is tentatively scheduled to occur on December 18 and 19, 1981. It was the opinion of Mr. Huang that only ten percent of the practicing acupuncturists today utilize the traditional Oriental method of diagnosis. One of the challenged rules, Rule 21-12.06(4)(a), assigns a thirty-five percent weight to the diagnostic techniques and procedures portion of the practical examination. Prior to 1980, there were no statutes or promulgated rules specifically relating to or governing the practice of acupuncture in Florida. While a rule had never been promulgated with respect to the field of acupuncture, the Florida Board of Medical Examiners had taken the official position that acupuncture is the practice of medicine. Prior to October of 1974, it was this Board's position that the performance of acupuncture should only be done by licensed medical doctors and doctors of osteopathy. Believing that legislation was imminent to allow nonlicensed persons skilled in acupuncture to perform under the direct and responsible supervision of licensed M.D.'s and D.O.'s, the Board of Medical Examiners altered its policy to reflect the same. By memorandum dated October 8,1 974, the Board issued its "Statement on Acupuncture" to be as follows: . . . to allow skilled unlicensed persons to perform acupuncture provided this is done under the responsible and direct supervision of licensed M.D.'s. This means that the non-licensed person who performs acupuncture is employed in the office of the licensed M.D. and is working in the office of the licensed M.D. and the licensed M.D. should be on the premises when acupuncture is performed. This is analogous to the Physician's Assistant who only functions under the responsible supervision of his employing physician. This does not mean that a licensed M.D. should put nonlicensed personnel out in satellite offices away from his main office performing acupuncture. A licensed M.D. should be in each office in which acupuncture is being performed. It must be remembered that the licensed M.D. is responsible for the acts and performances of any unlicensed persons within his office and in his employ regardless of the tasks or procedures performed by the unlicensed person and; therefore, this Board holds the licensed M.D. responsible for seeing that the intent of this ruling on the performance of acupuncture is carried out. . . . Effective October 1, 1980, the practice of acupuncture became specifically regulated by the enactment of Chapter 80-375, Laws of Florida. This was codified as Chapter 468, Part VIII, Florida Statutes (1980), and was amended by Chapter 81-227, Laws of Florida, effective July 2, 1981. In order to become certified to practice acupuncture under the new statutes, the applicant must furnish satisfactory evidence to the DPR that he has either: Completed a two-year program of education in acupuncture in a school or college approved by the Department; or Completed two years in an apprenticeship program . . .; provided that prior to July 1, 1981, a full-time and continuous practice of acupuncture under Chapters 458 or 459 may be substituted on an equivalent basis for all or part of the two-year apprenticeship program approved by the Department. and he must past an examination administered by the Department. Section 468.323(2), Laws of Florida. There being no Board of Acupuncturists established yet, the administration and implementation of Chapter 468 relating to acupuncture is presently being performed by the respondent's Division of Professions. Currently, that office conducts an initial review of the applications to qualify for the acupuncture examination and then the respondent's Office of Investigative Services verifies the information submitted on the application regarding the supervision of the applicant by a licensed physician and the duration thereof. This function was performed by the Office of Investigative Services by requesting the physician named on the application to sign a sworn affidavit that he or she holds a current active Florida license and that From 19 through 1981, the doctor personally knows that the applicant rendered acupuncture treatments to patients and all of these acupuncture treatments were administered under the direct supervision and control of the above-named licensed doctor. Noting that there had been confusion on the part of supervising physicians concerning the term "direct supervision," the investigators performing the function of obtaining affidavits and verifying signatures were instructed by memorandum dated September 24, 1981, as follows: It is necessary that the supervising physician for the purpose of clarification and understanding be informed that as a minimum, direct supervision means that the non-licensed person who performs acupuncture is employed by the licensed M.D. and is working in the office of the licensed M.D. and the licensed M.D. should be on the premises when acupuncture is performed. A licensed M.D. should be in each office in which acupuncture is performed. For the December 1981 acupuncture examination, the respondent received approximately 210 applications. About 125 applicants were determined to have not met the qualifications. At the time of review of these applicants and as of the time of the hearing in this matter, DPR had not yet approved any schools or colleges with programs of education in acupuncture, nor had the Department made a determination that any specific school or college met the criteria for approval of schools listed in its Rule 21-12.08, Florida Administrative Code. Of the some 41 applicants who attempted to qualify by two-years of experience under the supervision of a licensed physician, some 22 applicants have been approved as qualified to take the examination. Those were approved by the respondent on the basis of a completed, verified application form and the affidavit from the licensed Florida physician.
Recommendation Based on the findings of fact and conclusions of law recited herein, it is ORDERED that the petitioner has failed to demonstrate that Rules 21-12.02(2)(b), 21-12.05 or 21.12.06, Florida Administrative Code, constitute the invalid exercises of delegated authority or that the challenged affidavit constitutes a "rule" within the meaning of the Administrative Procedure Act. Accordingly, the petition seeking an administrative determination of those rules and affidavit is DISMISSED. DONE AND ENTERED this 11th day of December 1981, in Tallahassee, Florida. DIANE D. TREMOR Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32301 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 11th day of December 1981. COPIES FURNISHED: R. Jeremy Solomon, Esquire Booth & Conner Building A 325 John Knox Road Tallahassee, Florida 32303 Salvatore Carpino, Esquire Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Samuel Shorstein, Secretary Department of Professional Regulation Old Courthouse Squire Building 130 North Monroe Street Tallahassee, Florida 32301 Liz Cloud, Bureau Chief Administrative Code Section Department of State 1802 The Capitol Tallahassee, Florida 32301 Michael A. Glean Box 3666 St. Augustine, Florida 32084 and Box 28306 Atlanta, Georgia 30328