The Issue Whether Sandra Ann Lindstrom (“Ms. Lindstrom” or “Respondent”), a licensed physician assistant, prescribed Lorcet, a medication containing a controlled substance (hydrocodone), in violation of the Florida Statutes and the Florida Administrative Code as charged in the Amended Administrative Complaint filed at the Department of Health in DOH Case No. 2006-36542 on October 27, 2014. If so, what is the appropriate discipline?
Findings Of Fact The Parties The Department of Health is the state agency responsible for regulating the practice of physician assistants in the State of Florida. The regulation is pursuant to both chapter 456 (“Health Professions and Occupations, General Provisions”) and chapter 458 (“Medical Practice”), Florida Statutes. Respondent is licensed as a physician assistant by the Board of Medicine. Her license number is PA 9103823. The license was effective on August 3, 2006, with an expiration date of March 31, 2008. Her license has been continuously renewed since its effective date. See Pet’r’s Ex. A. Ms. Lindstrom is not licensed to practice medicine as a physician. Id. Physician Assistants Physician assistants are governed by section 458.347, a section within the chapter of the Florida Statutes that governs Medical Practice. Physician assistant licensure is provided for in section 458.347(7), and the Board of Medicine is authorized to “impose any of the penalties authorized under ss. 456.072 and 458.331(2) upon a physician assistant if the physician assistant or the supervising physician has been found guilty of or is being investigated for any act that constitutes a violation of this chapter [Ch. 458] or chapter 456.” § 456.347(7)(g), Fla. Stat. A physician assistant’s supervisory physician may delegate authority to conduct aspects of medical practice to a physician assistant under circumstances expressed in the statutes. The limited medical practice that may be delegated to a physician assistant includes certain practices at county health departments. Whether conducting the delegated practice of medicine at a county health department, or not, physician assistants may be delegated authority to prescribe medications provided they are not listed on a formulary created pursuant to section 458.347(7)(f). See § 458.347(7)(d) and (e), Fla. Stat. The formulary must include “controlled substances as defined in chapter 893.” § 458.347(7)(f)1., Fla. Stat. In sum, physicians may not delegate to physician assistants the prescription of medications which are controlled substances as defined in chapter 893, Florida Statutes. The Department’s Investigative Office The Department has an investigative office charged with looking into regulatory complaints. In a typical regulatory investigation, the investigator discloses his identity to any party interviewed, whether the party is the source of the complaint, a witness, or, if amenable to an interview, the licensee who is the subject of the complaint. Aside from interviews, the investigations include record reviews, the obtaining of evidence, and the preparation of an investigative report. In addition to investigating complaints of regulatory violations by licensed health care practitioners, the investigative office looks into cases of unauthorized practice by unlicensed individuals. Investigations of unlicensed activity are conducted by what is known as the “ULA” section of the office. Commonly, ULA investigations are done by investigators who are “undercover,” that is, the investigators hide their identity as investigators and use pseudonyms rather than their actual names. Typically, undercover ULA investigators present at the offices of the subjects of investigation. If the unlicensed subject of the investigation offers to perform services that require a license or engages in practice that requires a license, the Department pursues remedies, including an order that the subject cease and desist from the unlawful, unlicensed activity. Investigations of a licensee for practicing outside the scope of the licensed activity may be viewed as something of a hybrid of a typical regulatory investigation and a ULA investigation. It is regulatory since the subject is a licensee, but it is usually done undercover in the same manner in which a ULA investigation is conducted. One such investigation was conducted by Ryan Heal, an employee of the Department between August and December of 2006. Mr. Heal conducted the investigation undercover using a pseudonym referred to in Department documents as “RJ.” RJ and the 2006 Investigation of JHS Mr. Heal has been a medical malpractice investigator for the Department since November 2000. During the course of his more than 15 years as a Department investigator, Mr. Heal has investigated both regulatory violations and unauthorized practice violations. In 2006, allegations reached the Department that prescriptions were being written at Jacksonville Health Systems (“JHS”), a clinic located on Baymeadows Road in Jacksonville, Florida, by a physician assistant without the supervision of a physician. In response, the Department launched an investigation. The investigation was conducted undercover by Mr. Heal using his pseudonym RJ. Commenced in August of 2006, the investigation lasted until the following December. August 10, 2006 On August 10, 2006, Mr. Heal, using his fictitious name, presented at JHS. A woman behind the counter in the reception area accepted a cash payment for the visit. She took RJ’s blood pressure and requested the name of the pharmacy for any medicine prescribed. To the best of Mr. Heal’s recollection, the receptionist recorded some of the information. After the interaction with staff in the reception room, Mr. Heal took a seat and waited to be called back to the examination room. Shortly thereafter, Ms. Lindstrom emerged and asked for RJ. Mr. Heal “stood up and went over to her.” Hr’g Tr. 19. Ms. Lindstrom identified herself by her first name and said, “I’m the provider here.” Id. Ms. Lindstrom accompanied Mr. Heal to the examination room where only she and Mr. Heal were present. After Mr. Heal complained of back pain, Ms. Lindstrom asked where in his back the pain was located and what caused it, but she did not conduct a physical examination. As Mr. Heal testified at hearing, “[t]here was no examination. She never touched my back. Never took vitals or anything.” Hr’g Tr. 20. Ms. Lindstrom suggested that Mr. Heal use a chair with lumbar support, try stretching, lose weight, and have an MRI. Ms. Lindstrom then stated that she would prescribe medication to treat the pain: Lorcet, Flexeril, and Motrin. With the visit in the examination room concluded, Ms. Lindstrom took Mr. Heal back to the receptionist. The meeting in the examination room and his first visit to the JHS offices being over, Mr. Heal departed the JHS facility. He did not return until the following October. October 31, 2006 Mr. Heal returned to the JHS facility on October 31, 2006. The process during the second visit was similar to the one followed during the visit the previous August. He presented as “RJ.” A staff member took his blood pressure in the reception area and he paid her $90 in cash. Mr. Heal sat down and waited to be called. Again, Ms. Lindstrom appeared in the reception area and took him to the examination room in the back. The visit was shorter than it had been in August. Ms. Lindstrom asked if his pain had improved and if an MRI had been done. With the intention of calling in his prescriptions, Ms. Lindstrom showed Mr. Heal a list of five pharmacies from which to choose. Mr. Heal, however, took a tack that was different from Ms. Lindstrom’s intention and from his first visit: I explained to her that I did not have reliable transportation and asked [for] . . . handwritten prescriptions . . . so that I could take them to whatever pharmacy was convenient . . . . She agreed that she could write them that time, but that on the next visit, I would have to arrange for proper transportation to get to the pharmacy or wherever they needed to be called into. Hr’g Tr. 23. Ms. Lindstrom wrote out three prescriptions: Two of them were for “Flexeril 10mg (ten) #30 (thirty)” and “Ibprofen (sic) [Ibuprofen] 800mg #120 (one twenty).” Pet’r’s Ex. B. The third prescription was for “Lorcet 10/650 #90 (Ninety).” Id. Ms. Lindstrom explained to Mr. Heal that he should use one of the five pharmacies on her list because “several [of the Clinic’s patients] had been kicked out of pharmacies . . . [that] were refusing to fill the prescriptions.” Hr’g Tr. 25. Ms. Lindstrom also “mentioned that a couple of her patients had been arrested for forging prescriptions.” Hr’g Tr. 25-6. At no time during his visit to JHS on October 31, 2006, did Mr. Heal see a physician. No one entered the examination room where Ms. Lindstrom met with Mr. Heal that day. Nor did Ms. Lindstrom leave the examination room while Mr. Heal was present in the room. Like the first visit the previous August, Ms. Lindstrom recommended that Mr. Heal have an MRI. She explained that results from an MRI were needed “in case the DEA wanted to look at the file, to show that [she and JHS] were actually treating [Mr. Heal] for something.” Hr’g Tr. 28. December 1, 2006 Little more than a month later on December 1, Mr. Heal made a third visit to JHS. The reception process was the same. The receptionist took his blood pressure, he paid $90 in cash, and waited in the reception area for Ms. Lindstrom to call him back. While waiting, he was informed that the number of pharmacies that would accept JHS prescriptions had been drastically reduced. Only one pharmacy would now accept JHS prescriptions: a pharmacy called New Horizon. Subsequent to the third visit, Mr. Heal presented to the pharmacy identified as New Horizon. In the company of law enforcement and with its supervision, Mr. Heal had the prescriptions filled for three medications: Flexeril, Ibuprofen at a prescription-strength dosage, and Lorcet. Supervising Physician and Other Claims At hearing under oath, Ms. Lindstrom admitted that she treated Mr. Heal once at the JHS facility and admitted that she prescribed Flexeril and Ibuprofen for him. She claimed under oath that the supervising physician for the 2006 visit in which she prescribed the two medications was James Hendrick, M.D. The Department produced documentation in the Department’s official business records that shows that Dr. Hendrick cancelled his Professional Liability Insurance Policy effective October 1, 2005, the year before Ms. Lindstrom claims to have seen Mr. Heal at the JHS facility under Dr. Hendrick’s supervision. The reason for the cancellation of the policy is listed on the letter from the insurer to the Department as “Retired.” Pet’r’s Ex. F, letter dated October 17, 2005, from FPIC, First Professionals Insurance Company. Department records also include an “Address Change” form that contains a section entitled “Financial Responsibility” dated November 21, 2005, the year before the incidents in this case. No boxes are checked in the section that shows “Financial Responsibility Coverage.” Under a section on the form entitled, “Category II: Financial Responsibility Exemptions,” Dr. Hendrick checked a box that indicated he was “retired or maintain[ed] part-time practice,” id., at least as of late November 2005, 11 months or more before the October 31, 2006, visit by Mr. Heal. Ms. Lindstrom made other claims with regard to RJ’s visit that she asserted occurred on October 3, 2006, rather than October 31, 2006, as charged. Among them was that she left the examination room after completing the prescriptions for Flexeril and Ibuprofen and partially completing a third prescription by inserting all the information, including her signature, except for the medicine to be prescribed and how often it should be taken. Ms. Lindstrom claimed that she intended to write a prescription for Lodine, but failed to write down “Lodine” on the third prescription form because she was distracted by a discussion with Mr. Heal about the need for RJ to have an MRI. She says she left the room to make arrangements for an MRI and when she returned, RJ was gone, together with the two filled out prescriptions, the third incomplete prescription, and her prescription pad. Ms. Lindstrom’s testimony about the theft of the pad and other details about the event, including when it occurred, is not credible. In contrast, Mr. Heal’s testimony about the visits he made to the JHS facility, seeing Ms. Lindstrom, and her prescription of Lorcet, is credited as truthful. Lorcet Lorcet contains hydrocodone, which is a controlled substance.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Board of Medicine enter a final order: Finding that Respondent Sandra A. Lindstrom, P.A., violated section 458.331(1)(nn), Florida Statutes (2006), by violating Florida Administrative Code Rule 64B8-30.008 (2006), as charged in the Amended Administrative Complaint; Imposing a $2,500 fine; and Revoking Respondent’s license as a physician assistant. DONE AND ENTERED this 30th day of March, 2016, in Tallahassee, Leon County, Florida. S DAVID M. MALONEY Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 30th day of March, 2016. COPIES FURNISHED: Sandra Ann Lindstrom 6726 Pomeroy Circle Orlando, Florida 32810 Yolonda Y. Green, Esquire Maciej Lewandowski, Esquire Department of Health 4052 Bald Cypress Way, Bin C65 Tallahassee, Florida 32399-3265 (eServed) Andre Ourso, Executive Director Board of Medicine Department of Health 4052 Bald Cypress Way, Bin C03 Tallahassee, Florida 32399-3253 (eServed) Nichole C. Geary, General Counsel Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701 (eServed)
The Issue Whether Respondent committed the violations alleged in the Administrative Complaint. If so, what punitive action should be taken against Respondent.
Findings Of Fact Based upon the evidence adduced at hearing and the record as a whole, the following findings of fact are made: Petitioner is a state government licensing and regulatory agency. Respondent is now, and has been since August 5, 1981, a dentist licensed to practice dentistry in the State of Florida. His license number is DN 0009016. In 1982, Respondent formed Dade Family Dental Facilities, Inc. (DFDF), a multidentist, multioffice dental practice in Dade County. He and Todd Smith, D.M.D., are currently co-owners of DDF. At all times material to the instant case, C.A., who is presently 40 years of age, was a patient at DFDF under the primary care of Respondent. C.A. was not just a patient of Respondent's. He was also someone whom Respondent considered to be a friend. Nonetheless, C.A. proved to be an uncooperative and difficult patient. It was not uncommon for C.A. to miss scheduled appointments. Oftentimes, C.A. would show up at one of DFDF's three Miami offices without an appointment claiming that he had a dental emergency and needed to be seen. Whenever his schedule permitted, Respondent accommodated C.A. and provided him with treatment, even though C.A. did not have a scheduled appointment. C.A. failed to take proper care of his teeth and gums. Furthermore, he was a heavy smoker. (Smoking can exacerbate periodontal problems.) By Respondent's own admission (made at the final hearing in this case), he "could have been a lot more extensive in [the] notes [he maintained on C.A.], but because [C.A.] was a friend, he . . . neglected to [provide such additional detail.]" His handwritten notes (and those made by his assistants pursuant to his instructions and directives) concerning his care and treatment of C.A. are sketchy and incomplete.1 They do not provide sufficient information to give neutral third parties a reasonably clear understanding of the full extent of the services he provided C.A. and the circumstances that led him to follow such a course of treatment. C.A. first presented to Respondent on May 19, 1988. It was an emergency visit. C.A. complained to Respondent of pain in tooth number 18. Respondent began a root canal in an attempt to alleviate the pain C.A. was experiencing. Thereafter, full-mouth x-rays were taken, and a complete examination was given. Based upon his review of the x-rays and the results of his examination, Respondent devised a treatment plan for C.A., which he reduced to writing and included in C.A.'s chart. Respondent's written treatment plan did not contain any mention of tooth number 18. It was merely a partial listing of work that needed to be done on C.A. At no time did Respondent subsequently update, supplement or otherwise modify this written treatment plan. The root canal that Respondent began on May 19, 1988, was completed by him on or about May 29, 1988. C.A. next visited Respondent on June 15, 1988. He came in without an appointment complaining of pain in tooth number 21. Respondent performed root canal therapy on the tooth. Although Respondent had determined that C.A. had periodontal disease, he did not specifically so state in the dental records that he maintained on C.A. Respondent initially treated C.A.'s periodontal disease by having his dental hygienist, Glenda Garvin, perform root planning (scraping the roots below the gums) and curettage (detoxifying the root surfaces from plaque). These procedures were performed on December 13, 1988, and again on February 2, 1989. Root planning and curettage are generally accepted methods of initially treating periodontal disease. Respondent subsequently determined that C.A. required the services of a periodontal specialist. He therefore referred C.A. to Ronald Cohen, D.D.S. Dr. Cohen is a Florida-licensed dentist. At the time he had an arrangement with Respondent whereby he performed periodontal services for Respondent's patients at Respondent's Northwest 18th Avenue and 183rd Street (Miami) office. He performed these services, not under the direction or supervision of Respondent, but as an independent contractor. Respondent billed the patients (or their insurance companies) for the periodontal services Dr. Cohen performed and he paid Dr. Cohen a percentage of the fees he received. Dr. Cohen first saw C.A. on October 5, 1989. He confirmed Respondent's diagnosis of periodontal disease. Unlike Respondent, however, Dr. Cohen made mention of this diagnosis in the notes that he made concerning his care and treatment of C.A. and which he left with Respondent. Among the other things that he mentioned in his notes was that tooth number 3 "[m]ay need distal root application." Dr. Cohen determined that C.A. required osseous (referring to the bone supporting the teeth) surgery. 21, Dr. Cohen performed such surgery approximately one week after C.A.'s October 5, 1989, visit. Thereafter, Dr. Cohen referred C.A. back to Respondent for restorative procedures. Respondent saw C.A. on December 5, 1989. Respondent's notes of C.A.'s December 5, 1989, visit read simply as follows: "Bridge Prep. #s 3-6. Imp. for Temp." No other information is given. The pontics and abutments of the bridge referenced in the notes are not identified. Furthermore, the notes do not indicate, nor does a review of the other materials in the records maintained by Respondent reveal, any reason why a bridge was needed for teeth numbers 3 through 6. Respondent's records do not contain any x-rays or notations indicating that any of these teeth were missing at the time of C.A.'s December 5, 1989, visit. In March of 1990, after C.A.'s gums had healed sufficiently from the surgery Dr. Cohen had performed,2 Respondent prepared a bridge for C.A. for teeth numbers 18 through 30. He used bridge work made by Budget Labs. Respondent was not satisfied with the appearance or the fit of the bridge. He therefore told C.A., on March 27, 1990, that he would have the bridge replaced, at no cost to C.A. The replacement bridge was for teeth numbers 19 through 31 (rather than 18 through 30). It was made by Mel Simkins. Simkins has been a dental technician for the past 48 years. Respondent wanted to make absolutely sure that there were not any problems with the bridge, so he asked Simkins to be present when the bridge was fitted and tested. The bridge was put in on or about May 26, 1990. At the time, it fit well and C.A. had no complaints. The margins were adequately sealed.3 There were sufficient embrasure spaces. The abutment-to-pontic ratio was adequate. Respondent saw C.A. again on September 18, 1990. At the time the bridge (that he had put in on or about May 26, 1990) appeared to still be intact and fit well. C.A., however, complained of pain in the area of tooth number 27, one of the teeth used as an abutment for the bridge. (On a previous visit on March 24, 1990, Respondent had performed root canal therapy on this tooth.) Respondent consulted with Dr. Cohen about the matter. He asked Dr. Cohen "how efficient he was at doing an apicoectomy" (which involves removal of the root tip). Dr. Cohen indicated that he was capable of performing such a procedure. Respondent subsequently referred C.A. to Dr. Cohen to perform an apicoectomy on tooth number 27. Before seeing Dr. Cohen again, C.A. returned to the DFDF on September 25, 1990. On this visit, he was seen by Dr. Smith, who did composite restoration work on teeth numbers 6 and 11 (located on the upper arch).4 Although he performed work on the upper arch, Dr. Smith visually examined C.A.'s entire mouth, and he noticed the bridge on the lower arch. The bridge did not appear to be ill-fitted. Dr. Smith commented to C.A. that the bridge looked good. In response to this comment, C.A. indicated to Dr. Smith that he was pleased with the bridge. C.A. saw Dr. Cohen on January 3, 1991, at which time Dr. Cohen performed an apicoectomy on C.A.'s tooth number 27. Approximately a week later C.A. saw Respondent. For the first time, C.A. expressed to Respondent dissatisfaction with the aesthetics of C.A.'s lower bridge. Respondent examined C.A. He observed that "the tissue was resorbed, so that the gums pulled back from the bridge." Respondent told C.A. that he would replace the bridge at no cost to C.A. C.A. declined the offer stating that he "wanted to move on." He asked Respondent to give him back his money (that he paid Respondent for the lower bridge). Respondent refused. As he said he would, C.A. "moved on" to another dentist. On February 12, 1991, he went to see Frederick Knoll, D.D.S. Dr. Knoll examined C.A. He then discussed his findings and available treatment options with C.A. During the discussion, C.A. advised Dr. Knoll that he was not "going to do anything about [his condition]." C.A. left Dr. Knoll's office without receiving any treatment or making a return appointment. Several months later, Dr. Knoll was asked by attorneys that C.A. had retained to provide them with a written assessment of C.A.'s condition based upon his February 12, 1991, examination of C.A. In response, Dr. Knoll wrote the following letter, dated August 20, 1991, to C.A.'s attorneys, in which he described what his February 12, 1991, examination had revealed: [C.A.] presented himself to me for a complete dental examination on 2/12/91. His chief complaint was of pain in the lower right area, and a general discomfort. A full series of radiographs were taken by [C.A.'s] periodontist and were made available for me to examine. [C.A.] has class III periodontitis with the sequela of alveolar bone loss and tooth mobility. He has the additional problem of multiple endodontic problems, some of which may need to be solved by surgery. The existing restorative dentistry needs to be changed. It is currently contributing to the periodontal problem, and additional splinting will be necessary for stability. Extensive caries are also present. I have recommended to [C.A.] that his problem requires a multi-disciplined approach to achieve a satisfactory result. I asked him to continue with his periodontist and to get the necessary help from an endodontist. I would coordinate the treatment and do all the restorative dentistry. I have enclosed a proposed treatment plan with the current costs involved. This treatment plan does not include the cost and treatment Dr. August will incur from the periodontist or the endodontist. If you need any further information on this matter, please feel free to contact me. "[T]he existing restorative dentistry" to which Dr. Knoll referred in his letter was upper and lower crown and bridge work. Upon examining C.A. on February 12, 1991, Dr. Knoll had observed crowns with "wide open margins." On October 28, 1992, C.A. filed a malpractice lawsuit against Respondent alleging that Respondent had failed to properly diagnose his periodontal disease and, as a result, his crown and bridge work failed and he suffered bone loss. Respondent had never before, nor has he subsequently, been a defendant in a malpractice lawsuit. The lawsuit was settled on May 18, 1994. The settlement agreement provided for a payment of $55,000.00 to C.A. The payment was made on behalf of Respondent by his insurer. Upon being notified of the settlement, AHCA commenced an investigation to determine if the initiation of a disciplinary proceeding against Respondent was warranted. The AHCA investigator assigned the case, Kathy Redfearn, invited Respondent to submit a written statement for consideration. Respondent submitted such a statement. It read as follows: This case [C.A.] vs Webb was originally [C.A] vs Webb/Cohen. [C.A.'s] attorney later dropped Ron Cohen from the suit because, as I was told, they were unable to obtain a mailing address on Dr. Cohen and subsequently pursued me for vicarious liability. [C.A.] went through a regimental Perio program which included root planning/curettage and full mouth flap and osseous performed by Dr. Ron Cohen. After perio surgery a bridge #18-305 was completed on 6-26-90. [C.A.] was very pleased with the bridge and indicated so to the lab technician and his friend a periodontist. On 9-18-90, [C.A.] complained of pain on #27 and was referred to Dr. Cohen for a second opinion on a possible Apicoectomy on #27. Dr. Cohen performed [an] apicoectomy [on] #27, on 1-3-91, for [C.A.] and following this procedure [C.A.] complained of a "botched job" on the apicioectomy, #27, and dissatisfaction with the esthetics of the placed bridge. The bridge I placed was compromised after the apicoectomy procedure because of resorption in areas #25, 26, and 27 where the flap had been extended possibl[y] due to no buccal bone and extreme cyst. (see Dr. Cohen's notes.) Prior to the apicoectomy there w[ere] no signs of resorption under the bridge and no signs of a compromised or inferior bridge. This case went to mediation and both parties negotiated in certain areas including the fact that I was ultimately responsible for Dr. Cohen's work because I had employed him, hence vicarious liability. AHCA sought C.A.'s assistance in the investigation, but he refused to cooperate. He was asked to sign and return an Authorization for Release of Patient Information, but he failed to do so. After AHCA completed its investigation, the matter was presented to a probable cause panel. Thereafter, the Administrative Complaint which is the subject of the instant case was issued
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Department issue a final order (1) dismissing Count I of the Administrative Complaint; (2) finding Respondent guilty of violating Section 466.028(1)(m), Florida Statutes, as alleged in Count II of the Administrative Complaint (except to the extent that Count II charges Respondent with violating Section 466.028(1)(m), Florida Statutes, by not keeping records "correctly indicat[ing] amounts owed to [him] in relation to amounts paid by Patient C.A.," which allegation should be dismissed); and (3) as punishment for Respondent's violation of Section 466.028(1)(m), Florida Statutes, issuing him a reprimand, fining him $1,000.00, and placing him on probation for a period of one year subject to such conditions as the Board may specify. DONE AND ENTERED this 31st day of October, 1997, in Tallahassee, Leon County, Florida. STUART M. LERNER Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (904) 488-9675 SUNCOM 278-9675 Fax Filing (904) 921-6847 Filed with the Clerk of the Division of Administrative Hearings this 31st day of October, 1997.
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."
