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:
- 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).
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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
- 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).
- 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).
- 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.
- 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.
- 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.
- 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.
- 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)).
- 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).
- 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.
- 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).
- 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).
- "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).
- 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).
- 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.
- 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).
- 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.
- 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).
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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).
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- "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).
- 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
- 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.
- 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.
- The Department promulgated Regulation 61-4 to regulate the licensing and
control of the manufacture, distribution, and dispensing of controlled substances.
- 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.
- 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).
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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. |