STATE OF FLORIDA

DIVISION OF ADMINISTRATIVE HEARINGS

DEPARTMENT OF HEALTH AND )

REHABILITATIVE SERVICES )

)

Petitioner, )

)

vs. ) CASE NO. 88-5518

) RAINBOW TREATMENT CENTER, INC.,)

)

Respondent. )

)

RECOMMENDED ORDER

Pursuant to notice, the Division of Administrative Hearings, by its duly designated Hearing Officer, James E. Bradwell held a public hearing in this case on April 17, 1989 in Tampa, Florida.

APPEARANCES

For Petitioner: Jack Farley, Esquire

Department of Health and Rehabilitative Services

400 W. Buffalo Avenue 5th Floor, Room 500 Tampa, Florida 33614

For Respondent: Amelia M. Park, Esquire and

William M. Park, Esquire

8001 North Dale Mabry Highway Building 601, Suite B

Tampa, Florida 33614 STATEMENT OF THE ISSUE

Whether Respondent's probationary license to operate a methadone clinic should be revoked pursuant to Section 397.095, Florida Statutes (1987).

PRELIMINARY STATEMENT

By copy of an emergency final order filed October 4, 1988, Petitioner revoked the probationary license of Respondent, Rainbow Treatment Center, Inc., effective at 5:00 p.m. on October 10, 1988 pursuant to Section 397.092 Florida Statutes (1987). Petitioner also further ordered Respondent to cease and desist all operations of its methadone treatment program pursuant to Section 397.091(1) Florida Statutes effective at 5:00 p.m. on October 10, 1988 based on Petitioner's determination that Respondent's facility and the circumstances found at the facility on September 29, 1988 created a serious and immediate danger to public health, safety or welfare and that less restrictive alternatives would not sufficiently protect the public and Respondent's clients. Thereafter, on the following day, October 5, 1988, Petitioner filed an

administrative complaint alleging in summary fashion that during an unannounced inspection on September 29, 1988, Petitioner's investigators observed that while Respondent's facility was open for business to dispense and administer methadone, there were no medical personnel present at the center, that access to methadone was not secured as required, and that investigators observed liquid methadone being administered by an unauthorized employee in violation of Florida Administrative Code Rules 10E-7.034(1)(a)2 and 10E-7.03(2)(f)3; Section 21

1. 1301.71 and Section 893.05(1) Florida Statutes (1987) .

   
   

   Respondent timely filed a request for hearing on October 25, 1988. On October 31, 1988, the matter was referred to the Division of Administrative Hearings for assignment of a hearing officer. Neither party requested an expedited hearing to contest the emergency final order, however, Respondent appealed the emergency revocation to the District Court of Appeal. Following the completion of discovery, the matter was set for hearing on February 9, 1989. It was continued based on Respondent's motion for a continuance and thereafter rescheduled for hearing on March 17, 1989 and was again continued. It was thereafter rescheduled for hearing on April 17, 1989 and was heard at that time. Petitioner presented the testimony of its employees Gail Potter, Phillip Emenheiser and Harry Moffett. Respondent presented the testimony of its administrator/owner/president, Angela Duncan and Petitioner recalled Gail Potter as a rebuttal witness. Petitioner introduced Exhibits 1 through 3 which were received in evidence and Respondent presented the deposition of Clifford Frost which was received in lieu of live testimony.

   
   

   The undersigned took official recognition of Chapters 120 and 397, Florida Statutes and Florida Administrative Code Rules 10E-7.029 through 10E-7.039.

   
   

   STIPULATED FACTS

   
   

   1. On May 15, 1988, the Department issued to Rainbow a 90-day probationary license to operate a methadone treatment center pursuant to Chapter 397, Florida Statutes (1987), Florida Administrative Code Rules 10E-7.029 through 10E-7.039, and 21 Code of Federal Regulations, Parts 291 and 1300.

      
      

   2. On September 23, 1988 the Department sent Rainbow a letter further extending Rainbow's second probationary period for a full 90 days and enclosed a probationary license No. 06 29 D 175, effective through November 11, 1988, all of which Rainbow received.

      
      

   3. On Thursday, September 29, 1988, Department representatives, Phillip W. Emenheiser and Harry Moffett, made an inspection visit to Rainbow.

      
      

   4. On Wednesday, October 5, 1988, Angela Duncan, President of Rainbow, was served with a copy of the Department's administrative complaint.

      
      

   5. In 1988, September 29 was a Thursday, October 5, was a Wednesday and October 10 was a Monday.

      
      

   6. Based upon my observation of the witnesses and their demeanor while testifying, documentary evidence received and the entire record compiled herein, the following relevant factual findings are found:

      
      

      FINDINGS OF FACT

      
      

   7. Rainbow (herein sometimes Respondent) began operations as a methadone treatment center (outpatient methadone program) on May 15, 1988, with a

      probationary license for 90 days granted by the Petitioner, Department of Health and Rehabilitative Services. All methadone treatment programs begin operations with a probationary license.

      
      

   8. Methadone is a classified Schedule II narcotic drug, a synthetic opiate, manufactured in a pharmaceutical laboratory. It is highly addictive and for that reason, it is closely monitored and controlled by the Federal Drug Enforcement Administration, can only be dispensed and administered by authorized medical personnel and the authorized dispensers of methadone are required to maintain strict security of access to methadone.

      
      

   9. Respondent's operation is a drug abuse treatment and prevention program (DATAP) and is defined as such and governed by Chapter 397, Florida Statutes.

      
      

   10. Respondent's program is designed to assist its clients, particularly the heroin addict or someone who is taking the synthetic opiate Dilaudid, a popular street drug, to take the client "off the street," and give them a stabilizing dose of methadone so that they can return to a more fully functional and responsible life style. That is accomplished by first stabilizing the client on a dose of methadone which is acceptable to them physically and provide treatment planning and auxillary services to assist them in restructuring their life style. The goal of the program is to reduce the methadone a client receives with the ultimate idea of making the addict drug free.

       
       

   11. On July 13-14, 1988, Petitioner dispatched a technical team to inspect Respondent's program. The inspection team consisted of Phil Highman, Sr., Human Services Program Specialist, Anton Krone, M. D., Mark Engelhardt, Program Supervisor - HRS District VI, and Gail Potter, Senior Human Services Program Analyst. Respondent's President, Angela Duncan, was present along with Lois Knoffler, R. N., Nursing Supervisor and Barbara Reszac, L. P. N. Following the inspection, an exit conference was held on July 14, at which time the inspection team advised Duncan of numerous clinical and medical standard deficiencies which were not being complied with. The inspection team found that Respondent's problems were due principally to a lack of knowledge regarding addiction and methadone treatment and a general laxness in implementing and documenting service provisions. On the clinical side there was no evidence to suggest that charts were being reviewed on a consistent, regular basis to ensure that specific treatment activities were in compliance with Chapter 10E-7, Florida Administrative Code, and on the medical side, the Medical Director exhibited little experience in the addiction field and the services provided were minimal at best. Also, the Medical Director was not spending adequate time at the clinic.

       
       

   12. The following programmatic elements were in noncompliance with regulations and required corrective action. In the clinical area these were:

       
       

       1. An absence of a psycho-social assessment including a clinical summary of each record within 10 days of admission to out-patient maintenance treatment as required by Section 10E-7.039 (a)(g), Florida Administrative Code.

       2. Respondent's failure to provide signed credentialed and dated, psycho-social assessments for each client as required by Section 10E-7.032(18)(g), Florida Administrative Code.

       3. An absence of individualized treatment

          plans developed for each patient within 30 days of admission to include measurable goals and objectives and the type and frequency of services required and properly signed, credentialed and dated. Sections 10E- 7.032(28)(b) and 10E-7.039(3)(j)2., Florida

          Administrative Code.

       4. An absence of recorded progress notes in the case records in accordance with the frequency of counseling. Sections 10E- 7.039(3)(j)1 and 3, Florida Administrative Code.

       5. A failure to place on phase one, all persons admitted, readmitted or transferred to maintenance treatment absent an authorized exception. Sections 10E-7.039(3)(d)6. and 10E-7.039(3)(e), Florida Administrative Code.

       6. Failure to document that clients who violated clinical rules such as illicit drug use and absenteeism had received disciplinary actions appropriate to the nature of the violation. Section 10E-7.039(3)(h), Florida Administrative Code and Sections 291.505 (d)(8)(v), (b) and (1), Code of Federal Regulations.

          
          

   13. In the medical area the following deficiencies were noted:

       
       

       1. A failure to document that the program physician conducted a physical exam prior to administration of the initial dose of methadone absent a documentable emergency. Section 10E-7.039(2)(f)2., Florida Administrative Code.

       2. A failure to document that all physical exams con formed to the medical services requirements prescribed under Sections 10E- 7.034(1)(a) and 10E-7.039(2)(F), Florida Administrative Code.

       3. A failure to provide results of a laboratory test which is required on each patient at the time of admission. Section

          10E-7.039 (f)(1), Florida Administrative Code.

       4. Failure to document that the program physician thoroughly documented each patient's current addiction and history of addiction before administering the initial dose of methadone. Sections 10E-7.039(2)(f) 5.A. and 10E-7.039(3)(a)1.-3., Florida Administrative Code.

       5. Failure to document that each patient had signed the "consent to methadone treatment" form prior to being administered the initial methadone dose. Section 291.505(d)(1)(ii), Code of Federal Regulations.

       6. A failure to document that the program

       physician signed or countersigned, within 72 hours, all orders relative to medication and take-home privileges. Sections 10E- 7.039(2)(f)5.d-f, Florida Administrative Code.

       
       

   14. On August 15, 1988, Petitioner advised Respondent of the non- compliance of the above-referred clinical and medical standards and by that notification, extended Respondent's first probationary license 45 days through September 27, 1988 to allow Respondent an opportunity to correct the deficiencies; placed a moratorium on admissions of new clients beginning August 14, 1988, and advised of its serious concern with the deficiencies with Petitioner's then consideration of denying Respondent a regular license. Respondent was further advised that Petitioner would continue to monitor Respondent's activities during the probationary period. Petitioner's moratorium limited Respondent to 49 clients.

       
       

   15. On August 30, 1988, Petitioner again dispatched an inspection team to Respondent's facility to monitor compliance. Petitioner's attendees were the same attendees who made up the earlier inspection on July 13-14, 1988. Administrator Duncan was present along with clinical supervisor, Bob Brouck and Clifford Frost, counselor. On the day of inspection there were 49 clients in treatment in keeping with the moratorium and current staff/client ratio was within acceptable standards. In the clinical area, the team reviewed 14 clinical records and while there were psycho-social assessments available in all case records, in 11 of 14 cases assessments had not been completed within the required 10 days of admission. In the area of treatment plans, plans were available in 13 of 14 cases. In two cases, plans were not completed within the required 30 days of admission and in none of the cases reviewed, was the information provided delineating the type and frequency of services to be provided. In the area of progress notes, improvement was shown in terms of content but in 12 of 14 cases, notes were not recorded with the proper frequency according to client phase level. Also, in 5 of 14 cases, urine drug screens indicated that the clients in question were involved in illicit drug use and no reference to these incidents were made in the progress notes.

       
       

   16. In the medical area, a total of 7 medical charts were reviewed. In the area of physical exams, in only 2 of 7 cases were physicals completed prior to administering the initial dose of methadone. In the remaining cases, physicals were either unavailable, undated or not completed within the required time frame. Laboratory tests were available in 6 of 7 cases. However, in only one of the six cases was the test completed upon admission. In one case the lab was unable to draw blood from the client because of difficulty in locating a vein. In all cases reviewed, there was adequate documentation of the client's current addiction. In the phasing and take-out privileges area, it was difficult to determine each client's phase level from the clinical records; however, an examination of dosing records indicated that patients were participating on the proper phase level according to time and treatment. Respondent's program was out of compliance in the following clinical areas:

       
       

       1. Psycho-social assessments were not completed within 10 days of admission as required.

       2. Individualized treatment plans were not developed within 30 days of admission and no reference was made to the type and frequency of services to be provided.

       3. Progress notes were not recorded in case records with proper frequency according to phase level and,

       4. Illicit drug use had not been addressed relative to appropriate disciplinary action.

          
          

   17. In the medical area, the following deficiencies were noted:

       
       

       1. Physical exams had not been conducted prior to the administration of the initial dose of methadone.

       2. Physical exams did not conform to the medical service requirements prescribed under Sections 10E-7.034(1)(a) and 10E-7.039(2)(f)1 Florida Administrative Code.

       3. Laboratory tests had not been conducted at the time of admission. See Section 10E- 7.039(2)(f)1, Florida Administrative Code.

       
       

   18. At that time, Petitioner extended Respondent's second probationary period for a full 90 days, i.e. from August 14, to November 11, 1988, to allow Respondent time to correct the noted program deficiencies and items of non- compliance with rules and regulations which were cited by the inspection team.

       
       

   19. On September 29, 1988, Petitioner's agents Emenheiser and Moffett again inspected Respondent's program to determine compliance with the moratorium on new clients.

       
       

   20. At approximately 9:30 a.m. on September 29, Emenheiser and Moffett went to Rainbow, knocked on the door and were admitted by Respondent's counselor, Clifford Frost whom Emenheiser met at the previous inspection visit. Respondent's operating hours were 6 o'clock a.m. to 2 o'clock p.m., seven days a week. Rainbow was open for business to administer and dispense methadone. At the time of their arrival, there was a client in Respondent's waiting area talking with Frost.

       
       

   21. Inspectors Emenheiser and Moffett asked Frost for entry into the methadone dispensing area and inquired as to the whereabouts of Administrator Duncan and the dispensing nurse. Neither were at the clinic. Frost left the area and obtained the key to the dispensing area and unlocked the dispensing room. At the time, there were no medical personnel in the facility. Counselor Frost is not a medical person nor is he authorized to enter the dispensing room or to dispense methadone. The inspectors, after gaining entry to the dispensing area by Frost, found the dispensing room safe open with a telephone cord draped between the safe door and the body of the safe. In the open safe they found a full bottle of methadone and a box with 4 full bottles next to it.

       
       

   22. On the dispensing room counter, the inspectors found a bottle with about two inches of methadone in it and a pipette dispenser in its top and a take-out bottle with a small amount of methadone. Emenheiser and Moffett observed the medication record which contained signed entries initial led in advance.

       
       

   23. While in the dispensing room, Inspectors Emenheiser and Moffett observed another client come into the facility and Frost administered the take- out bottle of methadone to the client in the dispensing room. The take-out bottle was prepared in advance by Frost. In this regard, Frost stated that he

       did not do that sort of thing very often. Based on the inspectors observance of the access by an unauthorized person to obtain entry into the storage area where the liquid methadone was stored, the absence of medical personnel at Respondent's premises during the period of time when the facility was open for business to dispense and administer methadone, the dispensing and administration of methadone to a patient by an unauthorized employee, and the general lack of security in the area where the methadone was stored, Petitioner's agents called the Federal Drug Enforcement Administration (DEA) to report their findings and the events they had witnessed. After confirming that these were security violations, the inspectors left the facility immediately to consult with their superiors. The inspectors later provided affidavits detailing their findings and provided assistance in drafting the administrative complaint and the emergency final order. Respondent was ordered to cease and desist all operations of its DATAP program effective at 5 o'clock p.m. on October 10, 1988.

       
       

   24. Clifford Frost, Respondent's counselor, gave testimony and maintained, via deposition, that he allowed Petitioner's agents access to the storage area where methadone was kept based on prior conversations that he had with Emenheiser to the effect that if he (Frost) would help him close down Respondent's program, he (Emenheiser) would help Frost get another job. Frost maintains that he was being led by Emenheiser to shut down Respondent's facility and that he did so in an effort to go along with Emenheiser's wishes.

       Emenheiser denied having any motivation to shut down Respondent's program and as a long term career veteran with Petitioner's DATAP programs, the absence of any bias having been shown by Respondent, Emenheiser's testimony is credited.

       Frost's testimony is not credited to the extent that his testimony differs from the versions of events found herein and as testified to by employees Phillip Emenheiser, Harry Moffett and Gail Potter.

       
       

       CONCLUSIONS OF LAW

       
       

   25. The Division of Administrative Hearings has jurisdiction over the subject matter of and the parties to this action pursuant to Section 120.57(1), Florida Statutes.

       
       

   26. The parties were duly noticed pursuant to the notice provisions of Chapter 120, Florida Statutes.

       
       

   27. The authority of the Petitioner is derived from Chapter 397, Florida Statutes.

       
       

   28. Rainbow Treatment Center, Inc., is a DATAP program as defined and governed by Chapter 397, Florida Statutes (1987), Florida Administrative Code Rules 10E-7.029 through 10E-7.039 and 21 Code of Federal Regulations, Part 291 and is subject to the jurisdiction of Petitioner pursuant to these statutes and regulations.

       
       

   29. Petitioner has established that its agents made a routine inspection of Respondent's facility on September 29, 1988, which revealed the following violations:

1. Rainbow was open for business to dispense and administer methadone and there were no medical personnel present at the center in violation of Florida Administrative Code Rule 10E-7.034(1)(a)(2).

2. The only Rainbow staff person present was

   a counselor who was not licensed to dispense or administer methadone and who had possession of the keys to the methadone dispensing room and access to Rainbow's supply of methadone in violation of Florida Administrative Code Rule 10E-7.039(2)(f)3. and Section 893.05(1), Florida Statutes (1987).

3. The counselor, who was present unlocked the door to the dispensing room and dispensed methadone from the room which contained a safe with five full bottles and one case of liquid methadone was not licensed to dispense or administer methadone, and the safe door was ajar in violation of security requirements respecting access to methadone within the purview of Section 21, Code of Federal Regulation 13.01.71. The dispensing of methadone by an unauthorized person is a violation of Section 893.05(1), Florida Statutes and Rule 10E-7.039(2)(f)(3), Florida Administrative Code. The open safe containing methadone presented a clear and present danger to the health and safety of Respondent's clients and the general public. This is so in view of the fact that an unauthorized staff member had access to the dispensing room.

4. The unlicensed counselor administered the contents of a take-out bottle of liquid methadone to a Rainbow Client in violation of Florida Administrative Code Rule 10E- 7.039(2)(f)3. and Section 893.05(1) Florida Statutes (1987).

5. Petitioner is authorized to revoke a DATAP program license for cause pursuant to Section 397.092, Florida Statutes. Petitioner has established sufficient cause to revoke Respondent's DATAP license herein based on the above-referenced violations which show a continued pattern of non- compliance, by Respondent, with applicable rules, regulations and statutes. Moreover, based on the clear and present danger classification of the violations found,

emergency action was warranted in the form of a cease and desist order. See, Section 397.091(1), Florida Statutes (1987).

RECOMMENDATION

Based on the foregoing findings of fact and conclusions of law, it is RECOMMENDED that Petitioner enter a final order revoking Petitioner's

probationary license to operate a methadone treatment center.

DONE and ENTERED this 26th day of July, 1989, in Tallahassee, Leon County, Florida.

JAMES E. BRADWELL

Hearing Officer

Division of Administrative Hearings The DeSoto Building

1230 Apalachee Parkway

Tallahassee, Florida 32399-1550

(904) 488-9675

Filed with the Clerk of the Division of Administrative Hearings this 26th day of July, 1989.

APPENDIX TO RECOMMENDED ORDER CASE NO. 88-5518

Rulings on Petitioner's Proposed Findings of Fact Paragraph 9, rejected as conclusionary.

Paragraphs 10 and 11, adopted as modified, last sentence in paragraph 23, Recommended Order.

Paragraph 12, adopted as modified, paragraphs 11 and 15, Recommended Order. Paragraph 13, adopted as modified, paragraph 23, Recommended Order.

Paragraph 14, adopted as modified, paragraph 10, Recommended Order.

Paragraphs 15, 16, 17 and 18, adopted as relevant, paragraphs 11-14 and 24, Recommended Order. The remainder rejected as irrelevant and/or unnecessary.

Paragraph 19, adopted as modified, paragraph 14, Recommended Order. Paragraph 20, adopted as relevant, paragraphs 15-17, Recommended Order. Paragraph 21, rejected, irrelevant.

Paragraph 22, adopted as modified, paragraphs 19 and 20, Recommended Order. Paragraph 28, rejected, irrelevant.

Paragraph 29, adopted as modified, paragraph 23, lines 16-21, Recommended Order.

Rulings on Respondent's Proposed Findings of Fact

Paragraph 1, adopted, paragraph 1, stipulated facts and paragraphs 1 and 18, Recommended Order.

Paragraph 2, adopted, paragraph 4, stipulated facts.

Paragraph 3, adopted as modified, paragraph 19, Recommended Order.

Paragraph 4, first sentence, adopted and second sentence rejected based on contrary findings in paragraph 20, Recommended Order.

Paragraph 5, rejected based on contrary findings in paragraph 24, Recommended Order.

Paragraph 6, rejected as unnecessary to resolve the issues posed.

Paragraphs 8-12, rejected based on contrary credibility resolutions stated in paragraph 24, Recommended Order.

Paragraph 13, adopted as modified, paragraph 23, Recommended Order.

Paragraph 14, rejected based on contrary findings in paragraph 23 to the effect that Frost was unauthorized to dispense and administer methadone.

Paragraph 15, rejected as argument.

Paragraph 16, rejected as irrelevant based on the determination in paragraph 23 to the extent there was a general lack of security in the storage of methadone and that such lack of security was in violation of the security requirements of a scheduled, highly addictive drug.

Paragraph 17, rejected as argument.

Paragraph 18, rejected based on contrary findings in paragraph 23 and the general lack of security by Respondent at the treatment center.

Paragraph 19, rejected as irrelevant.

Paragraphs 21 through 23, rejected, irrelevant and not probative of the issues posed.

COPIES FURNISHED:

Jack Farley, Esquire Department of Health and

Rehabilitative Services

400 W. Buffalo Avenue 5th Floor, Room 500 Tampa, Florida 3361

Amelia M. Park, Esquire and William M. Park, Esquire

8001 North Dale Mabry Highway Building 601, Suite B

Tampa, Florida 33614

Sam Power, Clerk Department of Health and

Rehabilitative Services 1323 Winewood Boulevard Building One, Suite 407

Tallahassee, Florida 32399-0700

John Miller, Esquire Department of Health and

Rehabilitative Services 1323 Winewood Boulevard

Tallahassee, Florida 32399-0700

Gregory L. Coler, Secretary Department of Health and

Rehabilitative Services 1323 Winewood Boulevard

Tallahassee, Florida 32399-0700

Docket for Case No: 88-005518

Orders for Case No: 88-005518