[32 Pa.B. 5638]
[Continued from previous Web Page] Section 715.20. Patient transfers.
This section requires each narcotic treatment program to develop policies regarding the transfer of patients to another narcotic treatment program or another treatment environment upon the request of the patient.
Comment
This proposed section requires each narcotic treatment program to develop policies and procedures for transferring patients from one treatment program to another, but makes no mention of whether patient records are to be kept confidential in the event of transfer. Proposed § 715.11 (relating to confidentiality of patient records) sets forth the importance of the confidentiality of patients records in complying with Federal and State statutes and regulations. The Department should consider cross-referencing § 715.11 in this section to impress upon narcotic treatment programs that patient records will continue to be confidential even if the patient is transferred to another narcotic treatment program.
Response
The Department agrees. The Department has incorporated § 715.11 in this section.
Comment
The 7-day time frame proposed in this section for a narcotic treatment program to transfer patients upon request is without adequate support. The Department should explain how the 7-day time frame was derived, why the time period is necessary and whether the ''request'' must be submitted by a patient in writing to the narcotic treatment program.
Response
The Department has elected to impose 7-day time period in which a narcotic treatment program must transfer a patient upon request because some programs may wish to retain patients when it would not be appropriate to do so for a variety of reasons. Imposing this specific time requirement will provide efficiency in the transfer because it is a suitable time period for the program to prepare the appropriate paperwork for transfer. Additionally, the Department does not require a patient to submit a request for transfer in writing because it would likely result in undue delays in the transfer process. The Department has not changed the section in response to the comment.
Section 715.21. Patient termination.
This section states that narcotic treatment programs must establish policies regarding termination of clients from the program.
Comment
Proposed paragraph (1) defines in what instances a narcotic treatment program may involuntarily terminate a patient from the program. That list does not include involuntary termination due to nonpayment. ''Nonpayment of fees'' should be specifically included as a justification for termination. Providers work hard to assist patients to access available funding to support their services and to assist patients, as part of rehabilitation, to work to support themselves. Narcotic treatment programs would not be able to remain in business if they were not able to require payment from those deemed liable for their services.
Response
The Department has not added nonpayment to the list of causes for involuntary termination. The Department believes that the medication these patients are receiving is a life-sustaining medication, as determined by the Department of Public Welfare, and termination because of inability to pay may be detrimental to the health and well being of the patient. Further, a program may conduct a financial intake assessment prior to admission to verify that each individual has the means to pay.
Comment
Proposed paragraph (1)(iii) includes the phrase ''excessively absent.'' This phrase is unclear. The Department should include in this paragraph the standards for determining when absences become excessive.
Response
The Department agrees and has changed the regulation. Paragraph (1)(iii) has been revised to include absences of 3 consecutive days or longer without cause as a cause for termination.
Section 715.22. Patient grievance procedures.
This section establishes the procedures for reviewing and resolving patient grievances.
Comment
Proposed subsection (a) requires a narcotic treatment program to develop and utilize a patient grievance procedure. Proposed subsection (b) states ''if the grievance is filed against the program director, the review of the case shall be conducted by the governing body.'' The arrangement may not be in the best interests of the patient. A multi-representative group of the narcotic treatment program may be better suited to render judgment in these cases. The Department should consider allowing grievances against the program director to be heard by either a multi-representative group or a subcommittee of the governing body instituted for the express purposes of grievance adjudication. Additionally, it is unclear whether grievances can be appealed directly to the Department.
Response
The Department accepts this recommendation in part. The Department has revised subsection (b) to permit grievances against the program director to be heard by either a multi-representative group or a subcommittee of the governing body instituted for the express purposes of grievance adjudication. The Department does not wish for grievances to be appealed directly to the Department. Permitting this would add another adjudicative layer and the Department already has a complaint process in existence as a recourse for patient grievances.
Subsection (c) has been revised for clarification.
Section 715.23. Patient records.
This section sets out the time period which records must be kept after a patient leaves the program.
Comment
This proposed section contains the phrase ''within the provisions of State and Federal confidentiality regulations.'' This section should provide citations to the specific section of the confidentiality requirements. Further, the Department should consider incorporating a provision by which a patient can authorize a provider to disclose any confidential information as the patient deems in the patient's interest.
Response
The Department agrees in part with this recommendation. The Department has provided citations to 42 CFR 2.16 (relating to security for written records) and 42 CFR 2.22 to avoid confusion and ambiguity in the interpretation of the regulation. State law does not permit incorporation of a provision permitting a patient to authorize the patient's provider to disclose confidential information as the patient deems in the patient's interest.
Comment
Proposed subsection (b)(15) provides for ''psychiatric, psychological or psychosocial evaluations of the patient.'' The drafting of the language of this subsection implies that psychiatric and psychological evaluations can replace the psychosocial evaluation requirement. This provision should be redrafted to include psychosocial evaluations as a separate and distinct requirement of this subsection.
Response
The Department agrees. Subsection (b)(15) has been revised to allow for psychosocial evaluations as a separate requirement. The Department has added a new subsection (b)(16) which will provide for any psychiatric, psychological or other evaluations if available.
Comment
Proposed subsection (e) requires all patient records, information and documentation to be ''maintained on standardized forms.'' It is unclear from the language of this subsection whether the Department will develop and distribute these forms and whether the Department will permit patient records to be maintained electronically.
Response
The Department does not develop or provide forms to be used for patient records and information. The narcotic treatment programs will develop and utilize these forms. In keeping with current trends in technology, the Department will permit patient records to be maintained electronically.
Section 715.24. Narcotic detoxification.
This section requires that minimum procedures for detoxification be developed and implemented by narcotic treatment programs.
Comment
Proposed paragraph (4)(i) requires that take home medication not be dispensed during a 30-day detoxification treatment. Also, narcotic treatment programs are required to observe the patient ingesting the medication 7 days per week. It is suggested that the 7-day-per-week clause be changed to the phrase ''daily'' to accommodate for a 6 day opening week.
Response
It is medically necessary during the detoxification phase of narcotic treatment programs to observe patients ingesting their medication 7 days per week. The Department has not changed the regulation.
Section 715.25. Prohibition of medication units.
This section prohibits medication units from operating in this Commonwealth.
Comment
Because the number of narcotic treatment programs is so few, it is difficult for patients to continue treatment at the program, as well as employment. The Department should explain the rationale behind prohibiting medication units within the Commonwealth. Also, the exact meaning of the term ''medication unit'' is unclear. In the interest of clarity, the Department should cite the specific Federal regulation which defines medication units.
Response
The Department prohibits medication units within this Commonwealth because these sites can be hundreds of miles from the main narcotic treatment program facility site. Further, only medication is dispensed at these sites. There is no counseling, no support services and no supervision at these medication units. Dispensing medication without clinical or support services is not in the best interests of patients. The Department has not changed the regulation in response to this comment. The Department does agree, however, that the definition of ''medication units'' should be included in § 701.1. That definition reads as follows:
Medication unit--A facility established as part of, but geographically separate from, the narcotic treatment program site, from which a retail pharmacist or a practitioner, who is licensed under state law and registered under federal law to administer or dispense a narcotic drug, may dispense or administer a narcotic drug or collect samples for drug testing or analysis for narcotic drugs.Section 715.26. Security.
This section establishes the requirements for security in narcotic treatment programs and the requirements of narcotic treatment programs to address community concerns.
Comment
The proposed rulemaking refers to Federal and State statutes and regulations. This phrase needs to be clarified to reference specific citations to the requirements.
Response
The Department agrees. The Department has provided a citation to 21 CFR 1301.72 and 1301.74. This addition should remove confusion and ambiguity in the interpretation of the regulation.
Section 715.27. Readmission.
The Department received no comments on this section, however, it has been revised for clarity.
Section 715.28. Unusual incidents.
This section requires a narcotic treatment program to develop a procedure to document and respond to unusual incidents.
Comment
Proposed subsection (c) requires a narcotic treatment program to file ''Unusual Incidence Reports.'' An ''unusual incident'' under proposed subsection (c)(1) includes ''complaints of patient abuse (physical, verbal, sexual, emotional and financial).'' The phrase ''financial abuse'' is unclear. The Department should clarify what constitutes financial abuse. Additionally, there are a number of terms and phrases that are unclear in this proposed section: subsections (a)(1) ''inappropriate behavior;'' (a)(5) and (c)(2) ''unusual circumstances;'' (a)(6) and (c)(3) ''significant disruption''; and (a)(9) and (b)(1) ''unusual incident.'' The Department should clarify each of the terms indicated.
Response
The Department has deleted the term ''financial abuse.'' The other terms are consistent with established Joint Commission for Accreditation of Health Organizations (JCAHO) Guidelines for Sentinel Events. The narcotic treatment regulations need to be consistent with these commonly accepted industry terms.
Section 715.29. Exceptions.
The Department received no comments on this section.
Section 715.30. Applicability.
The Department received no comments on this section.
C. Fiscal Impact
It is anticipated that the amendments to the narcotics addiction treatment program regulations will have no fiscal impact. In fact, it is anticipated that facilities, once in compliance, will experience savings as a result of these amendments. There will be no measurable costs imposed upon local or State government.
D. Paperwork Estimate
There will be no measurable increase in paperwork since a paperwork system for the license and approval of narcotic addiction treatment programs is already in place. The current licensure forms might require slight modification to account for the regulatory changes.
E. Effective Date/Sunset Date
This rulemaking will become effective immediately upon publication as final-form rulemaking. No sunset date is necessary. The Department will monitor the appropriateness of these regulations on a continuing basis.
F. Statutory Authority
The Department was authorized by the General Assembly under Reorganization Plan No. 2 of 1977 (71 P. S. § 751-25); Reorganization Plan No. 4 of 1981 (71 P. S. § 751-31); and the Pennsylvania Drug and Alcohol Abuse Control Act (71 P. S. §§ 1690.101--1690.114) (Act 63), to assume the function and responsibilities of the Governor's Council on Drug and Alcohol Abuse (Council). The Council's authority to regulate and promulgate rules and regulations was transferred to the Department through those reorganization plans. See Reorganization Plan No. 2 of 1977 (transferring duties under the Public Welfare Code with regard to regulation, supervision and licensing of drug and alcohol facilities to the Council), Reorganization Plan No. 4 of 1981 (transferring the functions of the Council to the Department and establishing the Council as an advisory council) and Act 63, as amended by the act of December 20, 1985 (P. L. 529, No. 119), (amending Act 63 to reference the Pennsylvania Advisory Council on Drug and Alcohol Abuse). This final-form rulemaking was promulgated under these provisions and is being deleted, amended and added under these provisions. This final-form rulemaking is also required by Federal regulations, 42 CFR 8.1--8.34 (relating to certification of opioid treatment programs).
G. Regulatory Review
Under section 5(a) of the Regulatory Review Act (71 P. S. § 745.5(a)), on July 17, 2000, the Department submitted a copy of the proposed rulemaking, published at 30 Pa.B. 3795 (July 29, 2000), to the Independent Regulatory Review Commission (IRRC) and to the Chairpersons of the House Committee on Health and Human Services and the Senate Committee on Public Health and Welfare for review and comment. In addition, in compliance with section 5(c) of the Regulatory Review Act, the Department provided IRRC and the Committees with copies of the comments received.
The Department submitted a copy of the final-form rulemaking to IRRC and the Chairpersons of the House Health and Human Services Committee and the Senate Public Health and Welfare Committees on August 26, 2002. In addition, the Department provided IRRC and the Committees with a copy of a Regulatory Analysis Form prepared by the Department in compliance with Executive Order 1996-1, ''Regulatory Review and Promulgation.'' A copy of this material is available to the public upon request.
In preparing this final-form rulemaking the Department has considered all comments received from IRRC, the Committees and the public.
Under section 5.1(d) of the Regulatory Review Act (71 P. S. § 745.5a(d)), this final-form rulemaking was deemed approved by the House and Senate Committees on September 16, 2002. IRRC met on September 26, 2002, and approved the final-form rulemaking in accordance with section 5.1 (e) of the Regulatory Review Act. The Office of Attorney General approved the regulations on October 28, 2002.
H. Contact Person
Questions regarding this final-form rulemaking may be submitted to John C. Hair, Director, Bureau of Community Program Licensure and Certification, 132 Kline Plaza, Suite A, Harrisburg, PA 17104, (717) 783-8665. Persons with a disability may also submit questions regarding the final-form rulemaking by using V/TT (717) 783-6514 for speech and/or hearing impaired persons or the Pennsylvania AT&T Relay Service at (800) 654-4984[TT]). Persons with a disability who would like to obtain this document in an alternative format (that is, large print, audio tape or Braille) may contact John Hair so that necessary arrangements may be made.
Findings
The Department finds that:
(1) Public notice of intention to adopt regulations adopted by this order has been given under sections 201 and 202 of the act of July 31, 1968 (P. L. 769, No. 240) (45 P. S. §§ 1201 and 1202), and the regulations thereunder, 1 Pa. Code §§ 7.1 and 7.2.
(2) A public comment period was provided as required by law and the comments received were considered.
(3) The adoption of the final-form rulemaking in the manner provided by this order is necessary and appropriate.
Order
The Department, acting under the authorizing statutes, orders that:
(a) The regulations of the Department, 4 Pa. Code Chapter 263, are amended by deleting §§ 263.1--263.26; 28 Pa. Code Chapters 701 and 705, are amended by amending § 701.1 and by adding §§ 715.1--715.30 to read as set forth in Annex A, with ellipses referring to the existing text of the regulations.
(b) The Secretary of Health shall submit this order and Annex A to the Office of General Counsel and the Office of Attorney General for approval as required by law.
(c) The Secretary of Health shall submit this order, Annex A and a Regulatory Analysis Form to IRRC and the House and Senate Committees for their review and action as required by law.
(d) The Secretary of Health shall certify this order and Annex A and deposit them with the Legislative Reference Bureau as required by law.
(e) This order shall take effect upon publication in the Pennsylvania Bulletin.
ROBERT S. ZIMMERMAN, Jr.,
Secretary(Editor's Note: For the text of the order of the Independent Regulatory Review Commission, relating to this document, see 32 Pa.B. 5145 (October 12, 2002).)
Fiscal Note: Fiscal Note 10-159 remains valid for the final adoption of the subject regulations.
Annex A
TITLE 4. ADMINISTRATION
PART XI. GOVERNOR'S COUNCIL ON DRUG AND ALCOHOL ABUSE
CHAPTER 263. (Reserved) §§ 263.1--263.26. (Reserved).
TITLE 28. HEALTH AND SAFETY
PART V. DRUG AND ALCOHOL FACILITIES AND SERVICES
CHAPTER 701. GENERAL PROVISIONS
Subchapter A. DEFINITIONS § 701.1. General definitions.
The following words and terms, when used in this part, have the following meanings, unless the context clearly indicates otherwise:
* * * * * Agent--A Commonwealth approved opioid pharmaco- therapy substance.
CSAT--Center for substance abuse treatment.
* * * * * Commonwealth approved opioid pharmacotherapy substance--Methadone, LAAM or other controlled drug approved by the Department for the detoxification or maintenance of opiate addiction.
Controlled substance--A drug, substance or an immediate precursor included in Schedules I through V of the Pennsylvania Controlled Substance, Drug, Device, and Cosmetic Act (35 P. S. §§ 780-101--780-149).
* * * * * DEA--The Federal Drug Enforcement Administration.
Detoxification of a narcotic dependent person utilizing an agent--Dispensing of an agent in decreasing doses to an individual to alleviate adverse physiological or psychological effects incident to withdrawal from the continuous or sustained use of an opiate and for assisting patients in reaching and maintaining a narcotic drug-free state of detoxification.
* * * * * Long-term detoxification treatment--Detoxification treatment for more than 30 days but not in excess of 180 days.
Long-term residential facilities--Facilities where the average length of stay exceeds 90 days.
MH/MR administrator--The person appointed by the local authority to carry out duties, as provided in the Mental Health and Mental Retardation Act of 1966 (50 P. S. §§ 4101--4704), within a county MH/MR program.
Maintenance treatment--Dispensing of an agent in sufficient doses to an individual on a continuing basis in conjunction with assessment, rehabilitation, treatment and ancillary services, to achieve stabilization or prevent withdrawal symptoms for treatment of an individual with an opiate dependency.
Medical director--A narcotic treatment physician who assumes responsibility for the administration of all medical services performed in the narcotic treatment program, including ensuring that the program is in compliance with all Federal, State and local laws and regulations regarding the medical treatment of narcotic addiction with a an agent.
Medication--A prescription drug ordered by a licensed physician.
Medication unit--A facility established as part of, but geographically separate from, the narcotic treatment program site, from which a retail pharmacist or a practitioner, who is licensed under State law and registered under Federal law to administer or dispense a narcotic drug, may dispense or administer a narcotic drug or collect samples for drug testing or analysis for narcotic drugs.
Narcotic or opioid dependent person--An individual who physiologically needs heroin or an opiate to prevent the onset of signs of withdrawal and who meets the accepted diagnostic criteria for opioid dependence.
Narcotic treatment physician--A physician who meets the qualifying criteria in § 715.6(a)(1)(i)--(iii) who is employed or contracted by a narcotic treatment program to provide medical services to patients.
Narcotic treatment program--A program for chronic opiate drug users that administers or dispenses agents under a narcotic treatment physician's order either for detoxification purposes or for maintenance and when appropriate or necessary provides a comprehensive range of medical and rehabilitative services.
* * * * * Physician--An individual who has a currently registered license to practice medicine or osteopathic medicine in this Commonwealth.
* * * * * Psychotherapy--Treatment of problems of an emotional nature by psychological means in which a trained person deliberately establishes a professional relationship with the patient with the objective of removing, modifying or retarding existing symptoms, mediating disturbed patterns of behavior and promoting positive personality growth and development.
* * * * * Short-term detoxification treatment--Detoxification treatment for 30 days or less.
State authority--The agency designated by the Governor or other appropriate official to exercise the responsibility and authority for the treatment of narcotic addiction with an agent.
* * * * *
CHAPTER 715. STANDARDS FOR APPROVAL OF NARCOTIC TREATMENT PROGRAM Sec.
715.1. General provisions. 715.2. Relationship of Federal and State regulations. 715.3. Approval of narcotic treatment programs. 715.4. Denial, revocation, or suspension of approval. 715.5. Patient capacity. 715.6. Physician staffing. 715.7. Dispensing or administering staffing. 715.8. Psychosocial staffing. 715.9. Intake. 715.10. Pregnant patients. 715.11. Confidentiality of patient records. 715.12. Informed patient consent. 715.13. Patient identification. 715.14. Urine testing. 715.15. Medication dosage. 715.16. Take-home privileges. 715.17. Medication control. 715.18. Rehabilitative services. 715.19. Psychotherapy services. 715.20. Patient transfers. 715.21. Patient termination. 715.22. Patient grievance procedures. 715.23. Patient records. 715.24. Narcotic detoxification. 715.25. Prohibition of medication units. 715.26. Security. 715.27. Readmission. 715.28. Unusual incidents. 715.29. Exceptions. 715.30. Applicability. § 715.1. General provisions.
(a) An entity within this Commonwealth which uses agents for maintenance or detoxification of persons shall obtain the approval of the Department to operate a narcotic treatment program.
(b) The Department's approval of a narcotic treatment program shall be contingent upon the narcotic treatment program's compliance with the standards and conditions in this part. In addition, the program shall comply with applicable Federal laws and regulations.
§ 715.2. Relationship of Federal and State regulations.
(a) A narcotic treatment program shall comply with Federal regulations and requirements governing the administration, dispensing and storage of agents.
(b) This chapter is intended to supplement the Federal regulations governing narcotic treatment programs in 21 CFR Chapter II, 1300--1399 (relating to Drug Enforcement Administration, Department of Justice).
§ 715.3. Approval of narcotic treatment programs.
(a) An entity shall apply for and receive approval as required from the Department, DEA and CSAT or an organization designated by the Substance Abuse and Mental Health Services Administration (SAMHSA), under the authority of section 303 of the Controlled Substances Act (21 U.S.C.A. § 823) and sections 501(d), 509(a), 543, 1923, 1927(a) and 1976 of the Public Health Service Act (42 U.S.C.A. §§ 290aa(d), 290bb-2(a), 290dd-2, 300x-23, 300x-27(a) and 300y-11), prior to offering services within this Commonwealth as a narcotic treatment program. Application for approval shall be made simultaneously to the Department, DEA and CSAT or SAMHSA designee.
(1) The Department will forward a recommendation for approval to the Federal officials after a review of policies and procedures and an onsite inspection by an authorized representative of the Department and after a determination has been made that the requirements for approval under this chapter have been met.
(2) The decision of the Federal officials set forth in 21 CFR Chapter II (relating to Drug Enforcement Administration, Department of Justice) or other Federal statutes shall constitute the final determination on the application for approval by DEA and CSAT or SAMHSA designee.
(b) A narcotic treatment program shall be licensed under the Department's regulations for drug and alcohol facilities in Chapter 157, 704, 705, 709 or 711. When a licensee applies to operate a narcotic treatment program, the history component of the application of the licensee shall include the licensee's record of operation of any facility regulated by any State or Federal entity. A narcotic treatment program may not be recommended for approval unless licensure has been obtained under Chapters 157, 704, 705, 709 or 711.
(c) The Department will grant approval as a narcotic treatment program after an onsite inspection and review of narcotic treatment program policies, procedures and other material, when the Department determines that the requirements for approval have been met.
(d) The Department will inspect a narcotic treatment program at least annually to determine compliance with State narcotic treatment program regulations. This inspection shall consist of an onsite visit and shall include an examination of patient records, reports, files, policies and procedures, and other similar items to enable the Department to make an evaluation of the status of the narcotic treatment program. The Department may inspect the narcotic treatment program without notice during any regular business hours of the narcotic treatment program.
(e) During the inspection process, a narcotic treatment program shall make available to the authorized staff of the Department full and free access to its premises, facilities, records, reports, files and other similar items necessary for a full and complete evaluation. The Department may make copies of materials it deems necessary under 42 CFR 2.53 (relating to audit and evaluation activities) and §§ 709.15 and 711.15 (relating to right to enter and inspect; and right to enter and inspect).
(f) The authorized Department representative may interview patients and staff as part of the inspection process.
(g) The Department may grant approval as a narcotic treatment program after an onsite inspection when the Department determines that a narcotic treatment program satisfies the following:
(1) It has substantially complied with applicable requirements for approval.
(2) It is complying with a plan of correction approved by the Department with regard to any outstanding deficiencies.
(3) Its existing deficiencies will not adversely alter the health, welfare or safety of the facility's patients.
(h) Notification of deficiencies involves the following:
(1) The authorized Department representative will provide the program director with a record of deficiencies with instructions to submit a plan of correction.
(2) The narcotic treatment program shall complete the plan of correction and submit it to the Department within 21 days after the last day of the onsite inspection.
(3) The Department will not grant approval as narcotic treatment program until the Department receives and approves a plan of correction.
§ 715.4. Denial, revocation or suspension of approval.
(a) The Department will deny, suspend or revoke approval of a narcotic treatment program if the applicant or program fails to comply with this chapter. Procedures for the revocation, suspension or denial of Department approval, and appeals from these actions, shall be the same as procedures in §§ 709.17, 709.18, 711.17 and 711.18.
(b) The Department may recommend to the DEA or CSAT or SAMHSA's designee to initiate proceedings to revoke or deny Federal approval.
(c) The Department may seek an injunction for the closure of a narcotic treatment program in a court of competent jurisdiction.
§ 715.5. Patient capacity.
The Department may increase or decrease the number of patients a narcotic treatment program may treat. The Department may raise the patient capacity, upon the written request of the narcotic treatment program, based upon the Department's review of the narcotic treatment program. The factors the Department will consider include:
(1) Safety. Considerations include dispensing time, internal patient flow and external traffic patterns.
(2) Physical facility. Considerations include the number and size of counseling offices, waiting areas, restrooms, and dispensing and nursing windows.
(3) Staff size and composition. Considerations include the number of narcotic treatment physicians, dispensing and counseling staff.
(4) Ability to provide required services. Considerations include compliance with licensing and narcotic treatment program regulations as determined during licensing, monitoring and special visits to the narcotic treatment program.
(5) Availability and accessibility of service. Considerations include the location of the narcotic treatment program and the hours of operation.
§ 715.6. Physician staffing.
(a) A narcotic treatment program shall designate a medical director to assume responsibility for administering all medical services performed by the narcotic treatment program.
(1) A medical director shall be a physician and shall have obtained one of the following:
(i) Three years documented experience in the provision of services to persons who are addicted to alcohol or other drugs, including at least 1 year of experience in the treatment of narcotic addiction with a narcotic drug.
(ii) Certification in addiction medicine by the American Society of Addiction Medicine.
(iii) A certificate of added qualifications in addiction psychiatry by the American Board of Psychiatry and Neurology, Inc.
(2) When a narcotic treatment program is unable to hire a medical director who meets the qualifications in paragraph (1), the narcotic treatment program may hire an interim medical director. The narcotic treatment program shall develop and submit to the Department for approval a training plan for the interim medical director, addressing the measures to be taken for the interim medical director to achieve minimal competencies and proficiencies until the interim medical director meets qualifications identified in paragraph (1)(i), (ii) or (iii). The interim medical director shall meet the qualifications within 36 months of being hired.
(3) The medical director's responsibilities include the following:
(i) Supervision of narcotic treatment physicians.
(ii) Supervision of licensed practical nurses if the narcotic treatment program does not employ a registered nurse to supervise the nursing staff. In addition, the medical director in these instances shall ensure that licensed practical nurses adhere to written protocols for dispensing and administration of medication.
(b) A narcotic treatment program may employ narcotic treatment physicians to assist the medical director. A narcotic treatment physician's responsibilities include:
(1) Performing a medical history and physical exam.
(2) Determining diagnosis and determining narcotic dependence.
(3) Reviewing treatment plans.
(4) Determining dosage and all changes in doses.
(5) Ordering take-home privileges.
(6) Discussing cases with the treatment team.
(7) Issuing verbal orders pertaining to patient care.
(8) Assessing coexisting medical and psychiatric disorders.
(9) Treating or making appropriate referrals for treatment of these disorders.
(c) A narcotic treatment physician shall be otherwise available for consultation and verbal medication orders at all times when a narcotic treatment program is open and a narcotic treatment physician is not present.
(d) A narcotic treatment program shall provide narcotic treatment physician services at least 1 hour per week onsite for every ten patients.
(e) A physician assistant or certified registered nurse practitioner may perform functions of a narcotic treatment physician in a narcotic treatment program if authorized by Federal, State and local laws and regulations, and if these functions are delegated to the physician assistant or certified registered nurse practitioner by the medical director, and records are properly countersigned by the medical director or a narcotic treatment physician. One-third of all required narcotic treatment physician time shall be provided by a narcotic treatment physician. Time provided by a physician assistant or certified registered nurse practitioner may not exceed two-thirds of the required narcotic treatment physician time.
§ 715.7. Dispensing or administering staffing.
(a) A narcotic treatment program shall be staffed as follows:
(1) If it operates an automated dispensing system, one full-time nurse or other person authorized by law to administer or dispense a controlled substance shall be available for every 200 patients.
(2) If it operates a manual or nonautomatic dispensing system, one full-time nurse or other person authorized by law to administer or dispense a controlled substance shall be available for every 150 patients.
(b) Dispensing time shall be prorated for patient census. There shall be sufficient dispensing staff to ensure that all patients are medicated within 15 minutes of arrival at the dispensing area.
§ 715.8. Psychosocial staffing.
A narcotic treatment program shall comply with the following staffing ratios as established in Chapter 704 (relating to staffing requirements for drug and alcohol treatment activities.):
(1) General requirements. A narcotic treatment program shall comply with the patient/staff and patient/counselor ratios in subparagraphs (i)--(vi) during primary care hours. These ratios refer to the total number of patients being treated, including patients with diagnoses other than drug and alcohol addiction served in other facets of the project. Family units may be counted as one patient.
(i) Inpatient nonhospital detoxification (residential detoxification).
(A) There shall be one full-time equivalent (FTE) primary care staff person available for every seven patients during primary care hours.
(B) There shall be a narcotic treatment physician on-call at all times.
(ii) Inpatient hospital detoxification. There shall be one FTE primary care staff person available for every five patients during primary care hours.
(iii) Inpatient nonhospital treatment and rehabilitation (residential treatment and rehabilitation). A narcotic treatment program serving adult patients shall have one FTE counselor for every eight patients.
(iv) Inpatient hospital treatment and rehabilitation (general, psychiatric or specialty hospital). A narcotic treatment program serving adult patients shall have one FTE counselor for every five patients.
(v) Partial hospitalization. A partial hospitalization narcotic treatment program shall have a minimum of one FTE counselor who provides direct counseling services to every ten patients.
(vi) Outpatients. The counseling caseload for one FTE counselor in an outpatient narcotic treatment program may not exceed 35 active patients.
(2) Counselor assistants. A counselor assistant eligible for a counseling caseload may be included in determining FTE ratios.
§ 715.9. Intake.
(a) Prior to administration of an agent, a narcotic treatment program shall screen each individual to determine eligibility for admission. The narcotic treatment program shall:
(1) Verify that the individual has reached 18 years of age.
(2) Verify the individual's identity, including name, address, date of birth, emergency contact and other identifying data.
(3) Obtain a drug use history and current drug use status of the individual.
(4) Have a narcotic treatment physician make a face- to-face determination of whether an individual is currently physiologically dependent upon a narcotic drug and has been physiologically dependent for at least 1 year prior to admission for maintenance treatment. The narcotic treatment physician shall document in the patient's record the basis for the determination of current dependency and evidence of a 1 year history of addiction.
(b) Exceptions to the requirements in subsection (a) are:
(1) A 1 year history of physiologic dependency is not required for detoxification or for pregnant patients.
(2) Upon readmitting a patient who has been out of a narcotic treatment program for 6 months or less after a voluntary termination, the narcotic treatment program shall update the information in and review the patient's file to show current opiate narcotic dependency, but need not conduct a physical examination and applicable laboratory tests. Privileges earned during the previous treatment may be reinstated at the discretion of the narcotic treatment physician.
(3) A patient who has been treated and later detoxified from comprehensive maintenance treatment may be readmitted to maintenance treatment, without evidence to support findings of current physiologic dependence, up to 2 years after discharge, if the following conditions are met:
(i) The narcotic treatment program attended is able to document prior narcotic drug comprehensive maintenance treatment of 6 months or more.
(ii) The admitting narcotic treatment physician, exercising reasonable clinical judgment, finds readmission to comprehensive maintenance treatment to be medically justified.
(c) If a patient was previously discharged from treatment at another narcotic treatment program, the admitting narcotic treatment program, with patient consent, shall contact the previous facility for the treatment history.
(d) A narcotic treatment program shall explain to each patient treatment options; pharmacology of methadone, LAAM and other agents, including signs and symptoms of overdose and when to seek emergency assistance; detoxification rights; grievance procedures; and clinic charges, including the fee agreement signed by the patient.
(e) A narcotic treatment program shall secure a personal history from the patient within the first week of admission. The personal history shall be made a part of the patient record.
§ 715.10. Pregnant patients.
(a) A narcotic treatment program may place a pregnant patient, regardless of age, who has had a documented narcotic dependency in the past and who may return to narcotic dependency, on a comprehensive maintenance regime.
(1) For these patients, evidence of current physiological dependence on narcotic drugs is not needed if a narcotic treatment physician certifies the pregnancy and, exercising reasonable clinical judgment, finds treatment to be medically justified.
(2) Evidence of all findings and the criteria used to determine the findings shall be recorded in the patient's record by the admitting narcotic treatment physician before the initial dose is administered to the patient.
(b) A narcotic treatment program shall give pregnant patients the opportunity for prenatal care either by the narcotic treatment program or by referral to appropriate health-care providers.
(c) Counseling records and other appropriate patients records shall reflect the nature of prenatal support provided by the narcotic treatment program.
(d) Within 3 months after termination of pregnancy, the narcotic treatment physician shall enter an evaluation of the patient's treatment status into her record and state whether she should remain in comprehensive maintenance treatment or receive detoxification treatment.
(e) A patient who is or becomes pregnant may not be started or continued on LAAM, except by the written order of a narcotic treatment physician who determines that LAAM is the best therapy for that patient.
(1) An initial pregnancy test shall be performed for each prospective female patient of childbearing potential before admission to LAAM comprehensive maintenance treatment.
(2) A monthly pregnancy test shall be performed thereafter on female patients on LAAM.
(f) The narcotic treatment program shall ensure that each female patient is fully informed of the possible risk to her or her unborn child from continued use of illicit drugs and from use of, or withdrawal from a narcotic drug administered or dispensed by the program in comprehensive maintenance or detoxification treatment.
§ 715.11. Confidentiality of patient records.
A narcotic treatment program shall physically secure and maintain the confidentiality of all patient records in accordance with 42 CFR 2.22 (relating to notice to patients of Federal confidentiality requirements) and § 709.28 (relating to confidentiality).
§ 715.12. Informed patient consent.
A narcotic treatment program shall obtain an informed, voluntary, written consent before an agent may be administered to the patient for either maintenance or detoxification treatment. The following shall appear on the patient consent form:
(1) That methadone and LAAM are narcotic drugs which can be harmful if taken without medical supervision.
(2) That methadone and LAAM are addictive medications and may, like other drugs used in medical practices, produce adverse results.
(3) That alternative methods of treatment exist.
(4) That the possible risks and complications of treatment have been explained to the patient.
(5) That methadone is transmitted to the unborn child and will cause physical dependence.
§ 715.13. Patient identification.
(a) A narcotic treatment program shall use a system for patient identification for the purpose of verifying the correct identity of a patient prior to administration of an agent.
(b) A narcotic treatment program shall maintain onsite a photograph of each patient which includes the patient's name and birth date. The narcotic treatment program shall update the photograph every 3 years.
§ 715.14. Urine testing.
(a) A narcotic treatment program shall complete an initial drug-screening urinalysis for each prospective patient and a random urinalysis at least monthly thereafter.
(1) Each test shall be for opiates, methadone, amphetamines, barbiturates, cocaine and benzodiazepines.
(2) If the narcotic treatment program determines that other drugs are abused in that narcotic treatment program's locality or have been identified in the patient's drug and alcohol history as being a drug of abuse or use, a narcotic treatment program may conduct a test or analysis for other drugs as well.
(b) A narcotic treatment program shall develop and implement policies and procedures to ensure that urine collected from patients is unadulterated. These policies and procedures shall include random observation which shall be conducted professionally, ethically and in a manner which respects patient privacy.
(c) A narcotic treatment program shall develop and implement policies and procedures to minimize misidentification of urine specimens and to ensure that the tested specimens can be traced to the donor.
(d) A narcotic treatment program shall ensure that a laboratory that performs the testing required under this section shall be in compliance with applicable Federal requirements, specifically the Clinical Laboratory Improvement Amendments of 1998 (42 U.S.C.A. §§ 201 note, 263 and 263a notes), and State requirements, specifically the Pennsylvania Clinical Laboratory Act (35 P. S. §§ 2151--2165) and Chapter 5 (relating to clinical laboratories).
§ 715.15. Medication dosage.
(a) The narcotic treatment physician shall review the dosage levels at least twice a year, with each review occurring at least 2 months apart, to determine a patient's therapeutic dosage.
(b) The narcotic treatment physician shall determine the proper dosage level for a patient, except as otherwise provided in this section. If the narcotic treatment physician determining the initial dose is not the narcotic treatment physician who conducted the patient examination, the narcotic treatment physician shall consult with the narcotic treatment physician who performed the examination before determining the patient's initial dose and schedule.
(c) Methadone shall be administered or dispensed only in oral form and shall be formulated to reduce its potential for parenteral abuse.
(d) A narcotic treatment program shall label all take-home medication with the patient's name and the narcotic treatment program's name, address and telephone number and shall package all take-home medication as required by Federal regulation.
(e) LAAM shall be administered or dispensed only in oral form and shall be formulated to reduce its potential for parenteral abuse.
(f) The narcotic treatment program shall develop written policies and procedures relating to narcotic treatment medication dosage which includes the requirements of subsections (a)--(e).
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