South Carolina              
Administrative Law Court
Edgar A. Brown building 1205 Pendleton St., Suite 224 Columbia, SC 29201 Voice: (803) 734-0550

SC Administrative Law Court Decisions

CAPTION:
Greenville Metro Treatment Center vs. SCDHEC et al.

AGENCY:
South Carolina Department of Health and Environmental Control

PARTIES:
Petitioner:
Greenville Metro Treatment Center

Respondent:
South Carolina Department of Health and Environmental Control and Piedmont Treatment Center
 
DOCKET NUMBER:
97-ALJ-07-0143-CC

APPEARANCES:
John Adams Hodge, Esquire
E. Wade Mullins, III, Esquire
For Petitioner

Nancy S. Layman, Esquire
William A. Ready, III, Esquire
For Respondent Department of Health and Environmental Control

J. Richard Kelly, Esquire
For Respondent Piedmont Treatment Center
 

ORDERS:

ORDER AND DECISION

STATEMENT OF THE CASE


This matter comes before this tribunal pursuant to Petitioner's Request for Administrative Review. Petitioner Greenville Metro Treatment Center challenges the issuance of a license for the operation of Piedmont Treatment Center located in Greenville, South Carolina. The South Carolina Department of Health and Environmental Control issued Piedmont a license as an outpatient facility for chemically dependent or addicted persons on March 19, 1997, pursuant to S.C. Code Ann. Regs. 61-93 (Supp. 1996) and the provisions of S.C. Code Ann. § 44-7-260, et seq. (Supp. 1996). On March 26, 1997, Greenville Metro Treatment Center requested a hearing contesting the Department's licensure of Piedmont as an outpatient treatment facility for chemically dependent or addicted persons. This request was transmitted to the Administrative Law Judge Division by the Department on April 4, 1997. A second request was filed by Greenville Metro on May 6, 1997, appealing the issuance of Controlled Substance Registration #79-0014 on April 21, 1997. This registration granted Piedmont the authority to dispense methadone. Greenville Metro asserts that the Department acted improperly in issuing the health license and registration certificate because of alleged deficiencies in the Policies and Procedures Manual of Piedmont.

In accordance with S.C. Code Ann. Regs. 61-72 and ALJD Rule 34, Piedmont's operations were automatically stayed during the pendency of this appeal. However, Piedmont continued to operate because the Department did not enforce the stay. On May 23, 1997, Greenville Metro filed a Motion for a Temporary Restraining Order and a Motion to Enforce an Automatic Stay during the pendency of this case. Prior to this tribunal ruling on Greenville Metro's motions, Piedmont filed a Motion to Lift the Stay which this tribunal granted by Order dated May 30, 1997. Subsequently, Piedmont and the Department each filed a Motion to Dismiss Greenville Metro's Petition for Administrative Review of the issuance of the health license and drug control registration. A hearing on these motions was held at the Administrative Law Judge Division, at which time oral arguments were presented. Respondents' Motions to Dismiss were denied by Order dated June 26, 1997. In the same order, Greenville Metro's petitions to review Piedmont's health license and drug control registration were consolidated into one case. After timely notice to all parties, a hearing was conducted October 15 - 17, 1997 at the Administrative Law Judge Division, 1205 Pendleton Street, Columbia, South Carolina.

Based upon the following Findings of Fact and Conclusions of Law, this tribunal concludes that Petitioner Greenville Metro has failed to establish that the Department acted improperly or exceeded its authority in granting Piedmont a license from the Department's Health Licensing Division and a registration by the Bureau of Drug Control to operate a methadone clinic, despite finding certain deficiencies in the drug control registration.

FINDINGS OF FACT

Having considered all pleadings, motions, testimony, exhibits, and arguments presented at the hearing of this matter, and taking into account the credibility of witnesses and accuracy of evidence, I make the following Findings of Fact by a preponderance of the evidence:

  1. The South Carolina Department of Health and Environmental Control is the state agency charged with the administration of health licensing procedures and oversight for all facilities specifically designated by S.C. Code Ann. section 44-7-110, et seq. (1976) (as amended).
  2. The Department is also the agency of the State of South Carolina, authorized through its Bureau of Drug Control, to issue controlled substances registrations to those persons who manufacture, distribute or dispense any controlled substances, or, who propose to engage in the manufacture, distribution or dispensing of any controlled substance as defined by law.
  3. Piedmont Treatment Center, located at 109 Poinsett Highway, Greenville, South Carolina, and managed by Larry Worley, made application to the Department for a license to operate an outpatient facility for chemically dependent or addicted persons on March 7, 1997. This application included the facility's name, address, and owner. It also stated that Larry Worley would act as the facility's program director. The application contained the appropriate signatures and was notarized. The application was forwarded to the Department's Division of Health Licensing for review and decision.
  4. The particular type of facility Piedmont sought to establish was a methadone treatment facility. Methadone is a substance used in the 1960s and 1970s to treat opiate-addicted individuals and, more recently, heroin-addicted individuals. The intent of a methadone treatment program is to stabilize the patient medically, psychologically replace the drug dependent lifestyle, and reacclimate the patient into society. The methadone is used to suppress cravings for further narcotics and to establish a blockade effect in the patient's brain against continued narcotics use.
  5. The operation of a methadone treatment facility requires two separate applications to the Department, one to the Division of Health Licensing Regulations and one to the Bureau of Drug Control. Therefore, contemporaneous with its health license application, Piedmont applied for a registration from the Department to dispense two Schedule II narcotic substances, methadone and LAAM.
  6. As part of its review of Piedmont's application, Mr. George Moore, the Coordinator of Policy Development within the Division of Health Licensing, and Ms. Myra Taylor, an inspector with the Division of Health Licensing, made an initial licensing inspection of Piedmont on March 14, 1997, which lasted approximately three hours.
  7. Before conducting the Piedmont inspection, Ms. Taylor had been employed at the Department since 1994, and had inspected between fifty and sixty residential care facilities, including seven to ten residential facilities for individuals with alcohol and chemical dependencies. She had reviewed over one hundred policies and procedures Manuals of other facilities. Ms. Taylor became involved in initial licensing of facilities in 1996. Piedmont was the first methadone treatment facility Ms. Taylor had inspected.
  8. While Mr. Moore and Mr. Worley made a "walk-through" of the facility, examining aspects of the facility related to general safety, cleanliness, and maintenance, Ms. Taylor reviewed Piedmont's Policy and Procedures Manual. Additionally, Mr. Moore reviewed personnel files.
  9. Ms. Taylor recorded her progress using a standardized checklist promulgated by the Department. Resp. Ex. 1, Vol. I, p. 21-23. This checklist consisted of one sentence summaries of each section of S.C. Code Ann. Regs. 61-93. Ms. Taylor placed a check mark on each section if she determined that Piedmont complied with that provision. She did not place check marks beside the sections relating to S.C. Code Ann. Regs. 61-93, section 203(B), Fee Collection Policy and Fiscal Management Policies and Procedures and S.C. Code Ann. Regs. 61-93, section 203(A) concerning annual budgets.
  10. Piedmont's Policy and Procedures Manual contained the following information regarding the requirements of Regulation 61-93:

(a) personnel policies concerning employment, evaluation, grievances, separation and employee mistreatment;

(b) a plan for evaluating its progress in attaining goals and objectives including procedures for assessing utilization of resources;

(c) a program utilization review plan that included procedures for maintaining up-to-date program utilization records;

(d) a quality assurance program plan with objectives, the scope of the plan, monitoring mechanisms, evaluation and problem-solving activities;

(e) policies and procedures covering all aspects of care and treatment;

(f) a description of the facility's treatment philosophy as a framework for its written policies;

(g) policies that included,

(1) outreach procedures including the program's specific goals;

(2) the relationship between the needs of the client population and the program's treatment approach;

(3 ) a description of the correlation between the community's needs and the program's treatment approach;

(4) a description of the serviced geographic region; and

(5) a description of the facility's cooperative efforts with state or community service organizations and providers;.

(h) standard operating procedures addressing medical emergencies, fire safety or any other calamity that has the potential to jeopardize safety;

(i) service policies which included procedures related to admissions, intake, assessment, testing, pre-treatment referral, treatment planning, counseling, discharge, post treatment referral, follow-up, aftercare, dropouts and readmission criteria;

(j) policies and procedures that protected the confidentiality of client records and governed disclosure of information in the records; and

(k) policies and procedures related to serving minors.

  1. However, during her review of the Policies and Procedures Manual, Ms. Taylor shared some concerns about the manual with Mr. Moore. She specifically noted that the facility's medical director, Dr. Sid Noor, had not submitted a signed contract as part of the application package.
  2. In his "walk through" of the facility, Mr. Moore found deficiencies involving insufficient data on personnel records, inadequate credentialing of counselors and the absence of a signed contract with a licensed physician. He also found that the bottom step of a ramp at the front of the building was missing; there was no posted evacuation plan; and an exit sign was absent.
  3. Within fifteen days after the inspection, Piedmont responded that the noted regulatory inadequacies had been addressed and furnished a signed contract with a licensed physician, Dr. Sid Noor. The Department determined that all other deficiencies had been corrected.
  4. Mr. Moore recommended to his supervisor, Mr. Alan Samuels, Director of Health Licensing, that Piedmont be licensed by the Health Licensing Division. Pursuant to S.C. Code Ann. Regs. 61-93, the Department issued an initial license to Piedmont on March 19, 1997, to operate an outpatient facility for chemically dependent or addicted persons, effective on that date.
  5. Piedmont applied for a registration for maintenance and detoxification at the facility by submitting an application dated January 31, 1997. See Resp. Ex. 1 Vol. II p. 182.
  6. Pursuant to Regs. 61-4, the Department's Bureau of Drug Control inspected the facility on March 19, 1997, through its methadone clinics inspector, Ray Trotter. Mr. Trotter inspected the facility, its records and Policy and Procedures Manual.
  7. An agent from the Drug Enforcement Administration accompanied Mr. Trotter to Piedmont Treatment Center and also completed an inspection and pre-registration report for Piedmont's DEA controlled substances registration. Subsequent to the inspection, DEA issued its federal registration to Piedmont.
  8. Mr. Trotter prepared a pre-registration report and took notes during the inspection. See Resp. Ex. 1 Vol. II at 14-19. By letter dated April 3, 1997, Mr. Trotter advised Mr. Worley of several deficiencies at Piedmont that would have to be corrected prior to issuance of a controlled substances registration. See Resp. Ex. 1 Vol. II at 14.
  9. On April 10, 1997, the Department received a letter from Mr. Worley stating that the noted deficiencies would be or had been corrected and that the facility would operate pursuant to applicable law. See Resp. Ex. 1 Vol. II at 13, 122-130.
  10. Mr. Trotter found that the noted deficiencies had been corrected and recommended to the Director of the Bureau of Drug Control, Wilbur Harling, that a controlled substances registration be approved and issued to Piedmont.
  11. On April 21, 1997, the Bureau of Drug Control approved Piedmont's application and issued Controlled Substances Registration No. 79-0014 to the facility. Resp. Ex. 1 Vol. II at 10-12.

CONCLUSIONS OF LAW AND DISCUSSION

Based upon the foregoing Findings of Fact and the testimony put forth in this case, I make the following Conclusions of Law:

A. HEALTH LICENSURE

  1. This matter is an administrative review of an agency decision and is governed by the provisions of the Administrative Procedures Act. S.C. Const. Art I, § 22, See League of Women Voters of Georgetown County v. Lichfield by the Sea, 305 S.C. 424, 409 S.E.2d 378 (1991).
  2. The Administrative Law Judge Division has jurisdiction over this matter pursuant to S.C. Const. Art. I, Section 22; S.C. Code Ann. sections 1-23-500 through 1-23-600 (Supp. 1996), and S.C. Code Ann. section 44- 7-210(E) (Supp. 1996).
  3. In the adjudication of this matter, this tribunal must (1) ascertain the applicable legal standards in the licensure and drug control registration of a methadone treatment facility; and (2) determine whether the Department properly applied those standards in licensing Piedmont as an outpatient treatment facility and in granting Piedmont a drug control registration certificate.
  4. This case does not require an inquiry into the Department's enforcement of Piedmont after licensure. From the outset of this matter, this tribunal has drawn a clear distinction between the Department's activities in licensing a facility and its enforcement actions subsequent to licensure.(1)

    At the beginning of the hearing, this tribunal addressed Piedmont's Motion in Limine to restrict testimony during the hearing to information that was available to the Department and relied upon at the time of licensure. This tribunal ruled that "only evidence which is relevant to the licensure procedure will be admissible at this hearing." R. 1 at 16. Furthermore, S.C. Code Ann. Regs. 61-93 , section 102(B) clearly states that:

[t]he issuance of a license does not guarantee adequacy of individual care, treatment, personal safety, fire safety or the well-being of any occupant of a facility."

Proper licensure does not ensure that mishaps will not occur or that a facility will comply with the applicable standards once licensed. Additionally, the subsequent occurrence of such mishaps does not equate to improper licensure.

  1. At the hearing of this matter, Greenville Metro questioned the sufficiency of Myra Taylor's experience with methadone treatment facilities. Greenville Metro also questioned the appropriateness of the Department's reliance on Ms. Taylor's review when making its licensing determination. However, the inexperience of a Department employee, standing alone, does not necessarily evince improper licensure. Furthermore, the issue in this case is not the propriety of a supervisor's reliance on the investigation and opinion of subordinates. The issue is whether such inexperience resulted in an inappropriate application of the legal standards in this case. If Piedmont met the standards set forth in the applicable statutes and regulations at the time of licensure, the Department did not act improperly in licensing Piedmont.
  2. Greenville Metro contests the issuance of a license by Piedmont to operate an outpatient facility for chemically dependent or addicted persons pursuant to S.C. Code Ann. section 44-7-260, et seq. (Supp. 1996). Greenville Metro contends that the Department failed to follow applicable authority in issuing both a health license and a drug control registration to the facility.
  3. As the moving party, Greenville Metro bears the burden of proving by a preponderance of the evidence that the Department improperly issued a health license and drug control registration to Piedmont. In civil cases, generally, the burden of proof rests upon the party who asserts the affirmative of an issue. 29 Am. Jur. 2d Evidence § 127 (1994); Alex Sanders, et al., South Carolina Trial Handbook § 9:3 Party With Burden, Civil Cases (1994). Greenville Metro is the party asserting the affirmative in this case; therefore, Greenville Metro must prove by a preponderance of the evidence that the Department acted improperly in licensing Piedmont and granting the facility a drug control registration. "The preponderance of the evidence means such evidence as, when considered and compared with that opposed to it, has more convincing force and produces in the mind the belief that what is sought to be proved is more likely true than not true." Sanders, supra, § 9:5 Quantum of Evidence in Civil Cases (1994), (citing Frazier v. Frazier, 228 S.C. 149, 89 S.E.2d 225 (1955)).
  4. Evidence of allegations must be sufficient and probative of the matter to be proven. See Coleman v. Palmetto State Life Ins. Co., 241 S.C. 384, 128 S.E.2d 699 (1962). The test for the sufficiency of a proffer of evidence to warrant a finding is as follows:

A . . . finding must be based on the evidence and . . . on the facts proved . . . . [A]lthough difficulty of proof does not prevent the assertion of a legal right, the . . . finding cannot rest on surmise nor can it rest on mere speculation. Likewise, . . . a . . . finding cannot rest on conjecture. . . guesswork . . . or rest on supposition, assumption, imagination, suspicion, arbitrary action, whim, caprice, illogical and unsound reasoning, innuendo, percentage, likelihood, mere theory, or conclusions that are in conflict with undisputed fact . . . The evidence on which the . . . finding is based must be competent, legal evidence received in the course of the trial, credible, and of probative force, and must support every material fact. The decision should be against the party having the burden of proof where there is no evidence, or the evidence as to the material issue is insufficient. . . . (emphasis added).

32 C.J.S. Evidence § 1042 (1964); see also S.C. Code Ann. § 1-23-320(i) (Supp. 1996).

  1. Evidence has probative value "if it tends to prove an issue." Black's Law Dictionary 1203 (6th ed. 1990). In reviewing the record of this case, this tribunal considered Greenville Metro's assertions of deficiencies in Piedmont's licensure. While this tribunal found certain deficiencies as noted herein, most of the assertions of Greenville Metro were unsubstantiated. Further, the established deficiencies do not rise to the level of improper licensure. In considering the record as a whole, the Department presented substantial evidence to support its initial licensing of Piedmont.
  2. The statutes and regulatory provisions dispositive of the issues in this case are S.C. Code Ann. section 44-7-110, et seq. (Supp. 1996), S.C. Code Ann. section 44-53-300, S.C. Code Ann. Regs. 61-4 (Supp. 1996), and S.C. Code Ann. Regs. 61-93 (Supp. 1996).
  3. Regulations promulgated by an agency to clarify statutory provisions that the agency is charged with enforcing have the force and effect of law. See Young v. South Carolina Dep't of Highways and Pub. Trans., 287 S.C. 108, 336 S.E.2d 879 (1985); Faile v. South Carolina Employment Sec. Comm'n, 267 S.C. 536, 230 S.E.2d 219 (1976).
  4. "Construction of a statute by an agency charged with its administration will be accorded the most respectful consideration and will not be overruled absent compelling reasons." Captain's Quarters v. South Carolina Coastal Council. 306 S.C. 488, 413 S.E.2d 13 (1992); Lloyd v. South Carolina Dep't. of Health and Envt'l Control, 491 S.E.2d 592 (Ct. App. 1997).
  5. In order to receive initial licensure, a facility must demonstrate "to the satisfaction of the Department" that the facility is in compliance with the standards set forth in the regulation. S.C. Code Ann. Regs. 61-93, § 102(G) (emphasis added).
  6. Regulation 61-93 requires that persons seeking licensure submit an application upon the forms prescribed by the Department and pay an annual licensing fee. The application must contain (1) the facility's name and address; (2) the appropriate signatures; and (3) any additional information the Department requires. S.C. Code Ann. Regs. 61-93, § 102(D). Piedmont submitted a completed application on the prescribed form containing all of the requested information. Resp. Ex. 1 Vol. I at 1-4. Additionally, Piedmont paid the licensing fee. Resp. Ex. 1 Vol. I at 53.
  7. In order to receive a health license from the Department, a facility must present affirmative evidence of its ability to comply with reasonable rules, regulations and standards the Department may require. S.C. Code Ann. Regs. 61-93, § 102(D). Affirmative is defined as "[t]hat which declares positively; that which avers a fact to be true; that which establishes; the opposite of a negative." Black's Law Dictionary 59 (6th ed. 1990).
  8. The regulation does not require written evidence of Piedmont's ability to comply with the applicable statutes and regulations at the time of licensure, and this tribunal will not construe the phrase "affirmative evidence" so narrowly as to necessitate written proof. It is within the Department's discretion to determine what constitutes affirmative evidence of Piedmont's ability to comply with the Department's rules and regulations. Further, this tribunal found no evidence that the Department abused this discretionary authority.
  9. Regulation 61-93 enumerates specific instances where written policies and procedures are necessary. A policy is defined as "a statement of the principles which guide and govern the activities, procedures and operations of a program." S.C. Code Ann. Regs. 61-93, § 101(T). A procedure is defined as "a series of activities designed to implement program goals or policy." S.C. Code Ann. Regs. 61-93, § 101(U).
  10. A policies and procedures manual is a tool used by a facility's management to outline the responsibilities, functions, goals, rules, and procedures the facility's employees are expected to know. R. at 2-209.
  11. A facility must have written personnel policies which include procedures concerning employment, evaluation, grievances, separation and employee mistreatment of clients to comply with Regulation 61-93. Regs. 61-93, § 204(D). Piedmont had written personnel policies in place at initial licensure which included the necessary procedures. See Resp. Ex. 1 Vol. II at 40 - 46.
  12. Section 206(A) of Regulation 61-93 requires that a facility have a written plan for evaluating its progress in attaining goals and objectives. This plan must include procedures for assessing utilization of resources to meet the facility's goals and objectives. Piedmont's Policies and Procedures Manual contains a progress evaluation plan with the necessary procedures. See Resp. Ex. 1 Vol. II at 30.
  13. Section 207(B) of Regulation 61-93 requires a program utilization review plan that includes procedures for maintaining up-to-date program utilization records. The utilization review plan, along with the necessary procedures, is set forth in the Piedmont's Policies and Procedures Manual. See Resp. Ex. 1 Vol. II at 64.
  14. Under S.C. Code Ann. Regs., section 208(A)(1), a facility must have a written quality assurance program plan with objectives, the scope of the plan, monitoring mechanisms, evaluation and problem-solving activities set forth. Piedmont's quality assurance program plan is set forth in Article 13 of the Policies and Procedures Manual. See Resp. Ex. 1 Vol. II at 29.
  15. Section 300 of Regulation 61-93 states that:

[e]ach outpatient facility for treatment of chemical dependency will publish policies and procedures covering all aspects of care and treatment provided.

Petitioner alleges that Piedmont's Policies and Procedures Manual did not adequately address (1) minimization of falsification in urinalysis testing; (2) information concerning linkages with law enforcement or the criminal justice system; and (3) procedures to verify that patients are not being dosed elsewhere simultaneously.

  1. The applicable regulatory provision does not delineate specific methods which must be employed in minimizing falsification of urine samples. However, Piedmont's Policies and Procedures Manual clearly states that "[u]rine will be collected in a way that minimizes falsification of urine samples." Resp. Ex. 1 Vol. II at 92. It further states that the urine samples will be collected randomly. Id. Furthermore, Articles 2 and 3 of the Policies and Procedures Manual deal specifically with Piedmont's relationship to the criminal justice system, law enforcement organizations and community based organizations. Resp. Ex. 1 Vol. II at 50-52. Further, Piedmont demonstrated to the satisfaction of the Department that the facility employed procedures to prevent double dosing.
  2. Petitioner also asserts that Piedmont's licensure was inappropriate because Piedmont offered no evidence of its ability to comply with federal standards concerning HIV and TB testing and education or OSHA standards regarding the handling of blood borne pathogens. Mr. Alan Samuels, who served as the Department's Director of Health Licensing at the time of Piedmont's licensure, testified that the language is standard language demonstrating the Department's intent to refuse licensing to any facility that has been denied a license by a federal or local agency. R. at 2-207 - 208. This section does not impose a duty to conduct federal inspections upon the Department as a state agency. Jasper County Tax Assessor v. Westvaco Corp., 305 S.C. 346, 409 S.E.2d 333 (1991) (reasonable construction of a statute by agency will be accorded most respectful consideration and will not be overruled absent compelling reasons).
  3. S.C. Code Ann. Regs. 61-93, section 301(A) requires a written description of the facility's treatment philosophy as a framework for its written policies. Piedmont complied with this requirement. See Resp. Ex. 1 Vol. II at 36.
  4. S.C. Code Ann. Regs. 61-93, section 302(B) requires written policies including, at a minimum (1) outreach procedures to include the program's specific goals; (2) the relationship between the needs of the client population and the program's treatment approach; (3) a description of the correlation between the community's need and the program's treatment approach; (4) a description of the serviced geographic region; and (4) a description of the facility's cooperative efforts with state or community service organizations and providers. All of this information is contained in Piedmont's Introduction to the manual and its Article on Accessibility. See Resp. Ex. 1 Vol. II at 36, 53.
  5. An outpatient treatment facility must have written standard operating procedures addressing medical emergencies, fire safety or any other calamity that potentially could jeopardize safety. Additionally, the facility must outline plans for measures to be taken if and when an incident results in injury or death at the facility. S.C. Code Ann. Regs. 61-93, § 302. Piedmont has satisfied this requirement. See Resp. Ex. 1 Vol. II at 45, 59, 69 - 70.
  6. A treatment facility must develop service policies which include procedures related to admissions, intake, assessment, testing, pre-treatment referral, treatment planning, counseling, discharge, post treatment referral, follow-up, aftercare, dropouts and readmission criteria. S.C. Code Ann. Regs. 61-93, §§ 303(A), 401, 402, 405, 406. Piedmont's manual contained sufficient information on all of these areas. See Resp. Ex. 1 Vol. II at 54, 55, 66, 67, 72-76, 84, 100, 111-113.
  7. In order to receive licensure, a facility must have written policies and procedures that protect the confidentiality of client records and govern disclosure of information in the records. These policies and procedures must specifically state when information on applicants or patients may be disclosed and outline procedures for the information's release. S.C. Code Ann. Regs. 61-93, § 304(B). Piedmont's manual addressed confidentiality. See Resp. Ex. 1 Vol. II at 48-49, 115-121.
  8. A treatment facility must have policies and procedures related to serving minors. S.C. Code Ann. Regs. 61-93, § 305(C). In accordance with federal law, Piedmont does not serve minors. See Resp. Ex. 1 Vol. II at 67 -68.
  9. Policies and procedures must be promulgated ensuring the protection of the rights and dignity of the facility's clients. S.C. Code Ann. Regs. 61-93, § 306(A). Piedmont's Policies and Procedures Manual satisfies this regulatory requirement.
  10. Petitioner alleged that some of Piedmont's policies and procedures did not meet professional standards and good medical practice. Specifically, Petitioner questioned (1) the frequency and nature of counseling; (2) the policies allowing patients to perform services to pay the facility for treatment; (3) the manner in which the initial dose protocol was set; (4) the policies regarding pregnant patients; and (5) the take-out procedures. Larry Worley, Piedmont's director, testified that the Policies and Procedures Manual minimally addresses these issues because of the constant availability of certified staff members to perform such functions. Further, Greenville Metro did not introduce concrete evidence that any of Piedmont's policies and procedures constitute facial violations of professional standards or good medical practice. Although Petitioner's expert witnesses testified that some of the procedures that Piedmont included in its Policies and Procedures Manual did not meet their personal standards, Petitioner's expert testimony did not conclusively enunciate prevailing medical standards or establish any deviation from them by Piedmont.
  11. "The qualification of a witness as an expert in a particular field is within the sound discretion of the trial judge." Smoak v. Liebherr-Am., Inc., 281 S.C. 420, 422, 315 S.E.2d 116, 118 (1984); South Carolina Dept. of Highways and Pub. Transit v. Manning, 283 S.C. 394, 323 S.E.2d 775 (1984). However, where the expert's testimony is based upon facts sufficient to form the basis for an opinion, the trier of fact determines its probative weight. Berkeley Elec. Coop. v. South Carolina Pub. Serv. Comm'n, 304 S.C. 15, 402 S.E.2d 674 (1991); Smoak, supra. Further, a trier of fact is not compelled to accept an expert's testimony, but may give it the weight and credibility he determines it deserves. Florence County Dept. of Social Serv. v. Ward, 310 S.C. 69, 425 S.E.2d 61 (1992); Greyhound Lines v. South Carolina Pub. Serv. Comm'n, 274 S.C. 161, 262 S.E.2d 18 (1980). He also may accept one expert's testimony over that of another. S.C. Cable Tel. Assn. v. Southern Bell Tel. and Tel. Co., 308 S.C. 216, 417 S.E.2d 586 (1992).
  12. Because Piedmont applied for a license using the proper form with the necessary information, paid the licensing fee, and produced affirmative evidence of its ability to comply with the applicable statutes and regulations, the initial licensure of Piedmont was appropriate.

B. BUREAU OF DRUG CONTROL

  1. The Department is the agency authorized to register an applicant to manufacture, distribute, or dispense controlled substances if it determines that such registration would be consistent with the public interest. S.C. Code Ann. § 44-53-300(a). In determining the public interest, the Department must consider whether:

a. the facility has effective controls against the diversion of controlled substances into improper channels;

b. the facility has complied with the applicable state or federal laws;

c. there are promotions and technical advances in the art of manufacturing the substances or new substances have been developed;

d. the applicant has a prior conviction record under federal or state law regarding controlled substance manufacture, distribution or dispensing;

e. the applicant has past experience in drug control, manufacture, distribution, and dispensing;

f. licensing by a federal agency; and

g. other factors relevant to and consistent with public health and safety.

Id.

  1. The Department is authorized to promulgate regulations relating to the license and control of the manufacture, distribution, and dispensing of controlled substances. S.C. Code Ann. § 44-53-280.
  2. The Department promulgated Regulation 61-4 to regulate the licensing and control of the manufacture, distribution, and dispensing of controlled substances.
  3. The Department's Bureau of Drug Control enforces S.C. Code Ann. Regs. 61-4 and S.C. Code Ann. section 44-53-110, et seq. (Supp. 1996) applying to the issuance of controlled substance registrations. See S.C. Code Ann. Regs. 61-4, §§ 115-125.
  4. Because Piedmont Treatment Center proposed to engage in the dispensing of methadone, a controlled substance, it was required to obtain a registration from the Bureau according to applicable rules and regulations. S.C. Code Ann. §§ 44-53-200 and 44-53-290(i) (Supp. 1986).
  5. Piedmont properly applied for a registration for its methadone facility from the Bureau pursuant to S.C. Code Ann. Regs. 61-4, sections 115 - 121.
  6. In accordance with S.C. Code Ann. Regs. 61-4, section 122, the Bureau of Drug Control investigated the application from Piedmont and followed Department policies, procedures and all applicable law in its decision to issue the registration to Piedmont.
  7. The Bureau took reasonable steps to insure that Piedmont complied with all federal laws by inspecting Piedmont at the same time as an agent from the Drug Enforcement Administration. Subsequent to the inspection, the DEA issued its federal registration to Piedmont. As previously stated, the statutes and regulations stating that the Department will not grant a registration to a facility that has not complied with federal law do not impose a duty of federal inspection on state agencies. See infra p. 15 at ¶24.
  8. Any change in dosage, whether it be the substituting of a placebo or a decision not to medicate a patient, must be made by a doctor. S.C. Code Ann. Regs. 61-4 § 503(b). Piedmont's Policies and Procedures Manual initially gave nurses the authority to make a decision to reduce a dose, withhold a dose, or dispense a placebo under certain emergency circumstances. The Department notified Mr. Worley of this deficiency in the letter dated April 3, 1997. Resp. Ex.1, Vol. II at 14. However, prior to licensure, Mr. Worley informed the Department that a physician would be on the premises at all times and that the nurses would prepare the dosage in the doctor's presence as allowed by S.C. Code Ann. Regs. 61-4 section 143(I). Resp. Ex. 1 Vol. II at 13. Furthermore, at the time of licensure, Piedmont had an on-site pharmacist. In emergency situations, a pharmacist may dispense medication without a doctor being present if the practitioner has given oral authorization. See S.C. Code Ann. Regs. 61-4, § 503(b) and 508.
  9. Methadone detoxification is not permitted in an out-patient setting. S.C. Code Ann. Regs. 61-4 § 507.2. As defined in S.C. Code Ann. Regs. 61-4, "detoxification treatment" means the dispensing for a period not in excess of twenty-one days, of a narcotic drug or narcotic drugs and decreasing dosages to an individual in order to alleviate adverse physiological or psychological effects incidental to the withdrawal from the continuous or sustained use of a narcotic drug and as a method of bringing the individual to a narcotic drug free state within such period of time. . . ." S.C. Code Ann. Regs. 61-4 § 101(ad). Furthermore, withdrawal of drug dependent persons by use of methadone must be performed in an in-patient setting and not to exceed 21 days pursuant to S.C. Code Ann. Regs. 61-4 § 507.2.
  10. When Piedmont applied for its drug control registration, Mr. Worley confused the term methadone detoxification treatment with dose reduction during methadone maintenance treatment. In seeking permission to perform dose reduction during methadone maintenance, which is permissible, Mr. Worley applied for permission to perform methadone detoxification. Although Piedmont's intent at the time of registration was dose reduction during methadone maintenance treatment, the Department's allowance of "methadone detoxification" was improper, technically speaking, because detoxification is not permitted in an out-patient setting. Therefore, Piedmont's request for permission to perform methadone detoxification was superfluous and the Department's granting of such permission was improper.
  11. Petitioner asserts that Piedmont's proposal to dispense methadone off-site violated S.C. Code Ann. Regs. 61-4, section 107 and S.C. Code Ann. section 44-53-360. However, Piedmont's intent in this provision was to service patients who were physically unable to enter the facility. For example, Mr. Worley testified that this provision was meant to accommodate patients who become incarcerated or incapacitated while undergoing treatment. The regulation mandates that "each principal place of business" have a separate registration. S.C. Code Ann. Regs. 61-4, § 108. The emergency situations Piedmont envisioned when drafting this provision do not equal the establishment of unregistered principal places of business for dispensing. Therefore, it is within the Department's discretion to grant a drug control registration to a facility with this provision.
  12. Methadone may be dispensed for analgesic purposes by a hospital pharmacy under three conditions set forth in S.C. Code Ann. Regs. 61-4 § 507.5(a). Therefore, to the extent that the drug control registration permits the usage of methadone for analgesic purposes, such permission is improper and exceeds regulatory authority. However, the Department's oversight, standing alone, does not negate the fact that Piedmont met the threshold requirements for drug control registration to dispense methadone for other permissible purposes.
  13. Petitioner asserted that the labeling proposed by Piedmont did not comply with S.C. Code Ann. Regs. 61-4, § 207, Labeling for Controlled Substances Dispensed Directly to Ultimate Users. However, section 207 outlines the appropriate format for individualizing labels. It requires that the labels state the dispenser's name and address, patient's name, directions for use, and the date of dispensing. A facility cannot produce individualized labels until there are individuals receiving medication. Individuals cannot receive the medication until the facility is granted a drug control registration. Because the issue of inappropriate labeling under section 207 can only arise subsequent to licensure, it is an enforcement issue rather than a prerequisite for licensure. Furthermore, prior to licensure, Piedmont hired an on-site pharmacist who was responsible for dispensing all medications in compliance with the applicable law.
  14. Petitioner also alleges that granting Piedmont a drug control registration was improper because Piedmont's Policies and Procedures Manual did not comply with the employee screening provisions mandated by S.C. Code Ann. Regs. 61-4 sections 148 and 149. However, this concern was noted in the Department's pre-registration report and corrected by Piedmont prior to licensure. Resp. Ex. 1 Vol. II at 13, 18.
  15. Piedmont also proposed the use of buprenorphine, a Schedule V substance. Petitioner alleges that this procedure is improper because Piedmont did not obtain a registration for buprenorphine. A facility is only authorized to distribute the controlled substances specified in its registration. S.C. Code Ann. § 44-53-300(b) (Supp. 1996). However, there is no evidence showing that the failure to receive a registration for a Schedule V substance is proof of improper initial registration with respect to a Schedule II substance. Schedule V substances are less addictive and less prone to abuse than Schedule II narcotics. S.C. Code Ann. § 44-53-270 (Supp. 1996). If Piedmont distributes buprenorphine which is not allowed for the treating of narcotic addictions and is not a Schedule II narcotic for which Piedmont had applied to utilize, Piedmont has exceeded its drug control registration. However, whether Piedmont's actions have exceeded its registration is an enforcement issue. It does not indicate that the initial drug control registration for the Schedule II substances was inappropriate.
  16. Petitioner also alleges that Piedmont's drug control registration was improper because no evidence was presented at licensure showing Piedmont's ability to comply with S.C. Code Ann. section 44-53-750, addressing patient consent to autopsy. However, Mr. Worley testified that the Department was shown a copy of its intake documents prior to licensure. These documents included a consent to autopsy. R. at 3-188.
  17. Although the Department improperly included methadone detoxification and allowed the usage of methadone as an analgesic when granting Piedmont a drug control registration for methadone and LAAM, there is sufficient evidence that Piedmont met the threshold requirements of S.C. Code Ann. § 44-53-300 and S.C. Code Ann. Regs. 61-4. Therefore, the Department has not acted improperly in granting a drug control registration to Piedmont Treatment Center.

ORDER

Based upon the above Findings of Fact and Conclusions of Law, it is hereby ORDERED that the Department's decision to issue Piedmont Treatment Center a health license to operate an outpatient facility for chemically dependent or addicted persons and a controlled substances registration certificate is hereby sustained.

AND IT IS SO ORDERED.

___________________

John D. Geathers

Administrative Law Judge



March 27, 1998

Columbia, South Carolina





1. This tribunal is not insensitive to the emotion surrounding this proceeding because of the death of Timothy Fricks, while a patient at Piedmont. However, this tribunal must limit its analysis to the appropriateness of the Department's initial licensure of Piedmont.


Brown Bldg.

 

 

 

 

 

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