PROPOSED RULEMAKING
DEPARTMENT OF DRUG AND ALCOHOL PROGRAMS
[ 28 PA. CODE CH. 709 ]
Standards for Licensure of Freestanding Treatment Facilities
[44 Pa.B. 1317]
[Saturday, March 8, 2014]The Department of Drug and Alcohol Programs (Department) proposes to amend §§ 709.21—709.26 and 709.28—709.32 and add § 709.34 (relating to reporting of unusual incidents) to read as set forth in Annex A.
This proposed rulemaking reduces redundant and outdated requirements but maintains the elements regarding quality and safety. Under proposed § 709.34, the Department will require that all drug and alcohol facilities develop and implement policies and procedures to respond to and report specific unusual incidents. Some facilities are currently required under § 715.28 (relating to unusual incidents) to report unusual incidents and most other facilities are also providing these reports on a voluntary basis.
The preliminary proposed regulation was presented and discussed with the Department's stakeholders at a meeting held on June 28, 2013, which was followed by a 30-day comment period. This proposed rulemaking is a result of comments and suggestions made at the stakeholder meeting and the comment period.
A. Effective Date
This proposed rulemaking will be effective upon final-form publication in the Pennsylvania Bulletin.
B. Contact Persons
For further information, contact Ronald G. Young, Director, Division of Program Licensure, 132 Kline Plaza, Harrisburg, PA 17104, (717) 783-8675; or Tawny K. Mummah, Deputy General Counsel, Counsel, Department of Drug and Alcohol Programs, 333 Market Street, 17th Floor, Harrisburg, PA 17101, (717) 787-9354. This proposed rulemaking is available on the Department's web site at www.ddap.pa.gov.
C. Statutory Authority
This proposed rulemaking is authorized under the act of July 9, 2010 (P. L. 348, No. 50) (Act 50), which created the Department. Specifically, Act 50 added section 2301-A of The Administrative Code of 1929 (71 P. S. § 613.1) and provided the Department with the power to promulgate rules and regulations necessary to carry out the provisions in paragraph (9) of this section.
D. Background and Purpose
Act 50 transferred the powers, duties and functions of the Department of Health concerning drug or alcohol abuse to the Department. The goal of this proposed rulemaking is to eliminate redundant and outdated requirements and maintain or strengthen the elements regarding quality and safety.
E. Summary of Regulatory Requirements
Except for proposed § 709.34, this proposed rulemaking reduces the burden on the regulated community currently imposed by Chapter 709 (relating to standards for licensure of freestanding treatment facilities). For instance, the Department is proposing to delete requirements that specifically provide how the facility should be governed and how the facility should manage its personnel policies, procedures and records.
In most instances when it appears that the Department is increasing requirements, it is instead incorporating or restating Department of Health interpretive guidelines that did not have the force and effect of law but were used by the Department of Health to explain or augment the regulatory requirements.
Under proposed § 709.34, the Department is requiring that drug and alcohol facilities develop and implement policies and procedures to respond to and report specific unusual incidents. This requirement is not overly burdensome as some treatment facilities are already required under § 715.28 to report unusual incidents and most other facilities are also providing these reports on a voluntary basis under a Department of Health-issued Licensing Alert, which, similar to interpretive guidelines, does not have the force and effect of law.
F. Benefits, Cost and Compliance
Benefits
This proposed rulemaking will benefit drug and alcohol facilities by reducing the Department's inspection time at a facility. Specifically, the Division of Program Licensing will no longer be reviewing the policies, procedures and records that are reviewed under the current regulation.
Compliance Costs
There are no compliance costs for the drug and alcohol facilities associated with this proposed rulemaking.
Paperwork Requirements
There are no additional paperwork requirements associated with this proposed rulemaking as the unusual incident reports required under proposed § 709.34 are currently being submitted by the regulated community.
G. Regulatory Review
Under section 5(a) of the Regulatory Review Act (71 P. S. § 745.5(a)), on February 26, 2014, the Department submitted a copy of this proposed rulemaking and a copy of a Regulatory Analysis Form to the Independent Regulatory Review Commission (IRRC) and to the Chairpersons of the Senate Committee on Public Health and Welfare and the House Committee on Human Services. A copy of this material is available to the public upon request.
Under section 5(g) of the Regulatory Review Act, IRRC may convey any comments, recommendations or objections to the proposed rulemaking within 30 days of the close of the public comment period. The comments, recommendations or objections must specify the regulatory review criteria which have not been met. The Regulatory Review Act specifies detailed procedures for review, prior to final publication of the rulemaking, by the Department, the General Assembly and the Governor of comments, recommendations or objections raised.
H. Public Comments
Written comments. Interested persons are invited to submit comments, suggestions or objections regarding the proposed rulemaking within 30 days following publication in the Pennsylvania Bulletin. Comments should be mailed to Ronald G. Young, Director, Division of Program Licensure, 132 Kline Plaza, Harrisburg, PA, 17104. Comments submitted by facsimile will not be accepted. Comments are public documents that will be posted on the IRRC web site.
Electronic comments. Comments may be submitted electronically to the Department at RA-licensuredivision@pa.gov and must be received by the Department within 30 days following publication in the Pennsylvania Bulletin. A subject heading of proposed rulemaking and a return name and address must be included in each transmission. If the sender does not receive an acknowledgement of electronic comments within 2 working days, the comments should be retransmitted to ensure receipt.
GAROLD E. TENNIS,
SecretaryFiscal Note: 74-1. No fiscal impact; (8) recommends adoption.
Annex A
TITLE 28. HEALTH AND SAFETY
PART V. DRUG AND ALCOHOL FACILITIES AND SERVICES
CHAPTER 709. STANDARDS FOR LICENSURE OF FREESTANDING TREATMENT FACILITIES
Subchapter C. GENERAL STANDARDS FOR FREESTANDING TREATMENT ACTIVITIES § 709.21. Applicability.
* * * * * (b) A facility in which freestanding treatment activities are provided that has a valid full license from the Department of Public Welfare under 55 Pa. Code Chapters 5300 and 5310 (relating to private psychiatric hospitals; and community residential rehabilitation services for the mentally ill) is deemed to be in compliance with [the following standards: Sections] §§ 709.22—709.27, 709.29 and 709.32. This subsection shall remain in effect as long as the Department finds the standards in 55 Pa. Code Chapters 5300 and 5310 to be consistent with the requirements of this subchapter.
§ 709.22. Governing body.
(a) A project shall have a governing body and legal responsibility for the project rests in the governing body.
[(b) If a project is publicly funded, not more than one staff member of the project may sit on the governing body at a designated time.
(c) If the governing body consists of a board, it shall adopt written policies which shall include, but not be limited to:
(1) A method of selection for membership.
(2) Qualifications for membership.
(3) Criteria for continued membership.
(4) Frequency of meetings.
(d)] (b) The duties of the governing body include, but are not limited to, the following:
(1) [Selecting a] Designating the position to serve as project director as the person officially responsible to the governing body either directly or indirectly.
(2) Identifying the project's purpose and philosophy directly related to drug and alcohol services.
(3) [Describing] Documenting the project's organizational structure.
[(e)] (c) If a facility is publicly funded, the governing body shall make available to the public an annual report which includes, but is not limited to[:], a statement disclosing the names of officers, directors and principal shareholders, when applicable.
[(1) Activities and accomplishments of the preceding year.
(2) A financial statement of income and expenses.
(3) A statement disclosing the names of officers, directors and principal shareholders, where applicable.]
§ 709.23. Project director.
[(a) The project director] Project directors shall prepare [and], annually update and sign a written manual delineating project policies and procedures.
[(b) The project director shall assist the governing body in formulating policy and present the following to the governing body at least annually:
(1) Project goals and objectives which include time frames and available resources.
(2) Written reports of project operations.
(3) A performance report summarizing the progress towards meeting goals and objectives.]
§ 709.24. Treatment/rehabilitation management.
(a) The governing body shall adopt a written plan for the coordination of client treatment and rehabilitation services which includes, but is not limited to:
(1) [Defined target population.] Definition of the target population toward whom facility services are directed.
(2) [Treatment] Identification of the treatment models and practices utilized by the project.
(3) Written procedures for the management of treatment/rehabilitation services for clients.
(4) Written procedures for referral outlining cooperation with other service providers including, but not limited to, provisions for access to emergency services.
[(b) The project shall obtain written letters of agreement or understanding with primary referral sources.
(c)] (b) The project shall maintain a current community resource listing of other health and social service agencies.
[(d) Provisions shall be made, through written agreement with a licensed hospital or physician, for 24-hour emergency psychiatric and medical coverage.]
§ 709.25. Fiscal management.
[(a)] The project shall obtain the services of an independent certified public accountant for an annual financial audit of [financial] activities associated with the project's drug/alcohol abuse services, in accordance with generally accepted accounting principles which include reference to the drug and alcohol treatment activities.
[(b) Projects shall develop a service fee schedule which shall be posted in a prominent place.]
§ 709.26. Personnel management.
(a) The governing body shall adopt and have implemented written project personnel policies and procedures [which] in compliance with State and Federal employment laws. These laws include, but are not limited to:
[(1) Recruitment, selection, promotion and termination of staff.
(2) Utilization of volunteers.
(3) Wage and salary administration.
(4) Employe benefits.
(5) Working hours.
(6) Vacation and sick leave.
(7) Rules of conduct.
(8) Disciplinary actions.
(9) Supervision of staff.
(10) Work performance evaluations.
(11) Employe accidents and safety.
(12) Employe grievances.]
(1) Utilization of volunteers.
(2) Rules of conduct.
(3) Supervision of staff.
(4) Orientation of new employees.
[(b) The governing body shall adopt a written policy to implement and coordinate personnel management, which includes, but is not limited to:
(1) Confidential maintenance of personnel records.
(2) The dissemination of employment information to project staff.
(3) The orientation of new employes.
(4) The implementation of Federal, State and local statutes concerning fair employment practices.
(c) The project director shall develop written policies and procedures to provide for ongoing staff training and staff evaluation. Documentation shall include, but is not limited to:
(1) An assessment of staff training needs.
(2) Plans for addressing these needs.
(3) A mechanism to collect feedback on training completed.
(4) An annual evaluation of the overall training program.
(d)] (b) The personnel records [shall] must include, but are not [be] limited to:
[(1) The application for employment.
(2) The results of reference investigations.
(3) The verification of training experience and professional licensure or registration, where applicable.
(4) Salary information.
(5) Work performance evaluation including the following:
(i) Individual staff performance shall be evaluated at least annually.
(ii) The individual shall be informed, by written copy, of the annual evaluation.
(6) Disciplinary actions.]
(1) Application or resume for employment.
(2) Written verification of qualifying professional credentials.
(3) Annual written individual staff performance evaluations, copies of which shall be reviewed and signed by the employee.
(4) Disciplinary actions.
[(e) The project director shall develop written policies on employe rights and demonstrate the project's efforts toward informing staff of the following:
(1) The employe's right to inspect his own records.
(2) The employe's right to request the correction or removal of inaccurate, irrelevant, outdated or incomplete information from the records.
(3) The employe's right to submit rebuttal data or memoranda to his own records.
(f)] (c) There shall be written job descriptions for project positions [which include, but are not limited to:].
[(1) Job title.
(2) Tasks and responsibilities of the job.
(3) The requisite skills, knowledge and experience.]
§ 709.28. Confidentiality.
(a) A written procedure shall be developed by the project director which shall comply with 4 Pa. Code § 255.5 (relating to projects and coordinating bodies: disclosure of client-oriented information). The procedure [shall] must include, but not be limited to:
(1) Confidentiality of client identity and records. Procedures must include a description of how the project plans to address security and release of electronic and paper records and identification of the person responsible for maintenance of client records.
(2) [Staff access to client records.] Identification of project staff having access to records, and the methods by which staff gain access.
(b) The project shall secure hard copy client records within locked storage containers. Electronic records must be stored on secure, password protected data bases.
(c) The project shall obtain an informed and voluntary consent from the client for the disclosure of information contained in the client record. The consent shall be in writing and include, but not be limited to:
* * * * * (4) Dated signature of client or guardian as provided for under 42 CFR 2.14(a) and (b) and 2.15 (relating to minor patients; and incompetent and deceased patients).
(5) Dated signature of witness.
(6) [Expiration date of the consent.] Date, event, or condition upon which the consent will expire.
(d) A copy of a client consent shall be offered to the client and a copy maintained in the client [records] record.
* * * * * § 709.29. Retention of client records.
(a) Client records, [whether original, reproductions or microfilm, shall be kept on file] regardless of format, shall be readily accessible for a minimum of 4 years following the discharge of a client.
* * * * * § 709.30. Client rights.
The project [director] shall develop written policies and procedures on client rights and [shall demonstrate efforts toward informing clients of the following:] document written acknowledgement by clients that they have been notified of those rights.
(1) A [person] client receiving care or treatment under section 7 of the act (71 P. S. § 1690.107)[,] shall retain civil rights and liberties except as provided by statute. No client may be deprived of a civil right solely by reason of treatment.
(2) The project may not discriminate in the provision of services on the basis of age, race, creed, sex, ethnicity, color, national origin, marital status, sexual orientation, handicap or religion.
(3) [A client has the right to inspect his own records.] Clients have the right to inspect their own records. The project, facility or clinical director may temporarily remove portions of the records prior to the inspection by the client if the director determines that the information may be detrimental if presented to the client. Reasons for removing sections shall be documented [and kept on file] in the record.
(4) [The client has] Clients have the right to appeal a decision limiting access to [his] their records to the [project] director.
(5) [The client has] Clients have the right to request the correction of inaccurate, irrelevant, outdated or incomplete information [from his] in their records.
(6) [The client has] Clients have the right to submit rebuttal data or memoranda to [his] their own records.
§ 709.31. [Uniform] Data Collection System.
[(a) If a project utilizes Department funds, it shall comply with the Department's UDCS.
(b)] (a) A data collection and recordkeeping system shall be developed that allows for the efficient retrieval of data needed to measure the project's performance in relationship to its stated goals and objectives.
(b) The recordkeeping system must allow for the identification of clients' admissions and discharges within a specific time period.
§ 709.32. Medication control.
(a) [Projects which furnish pharmaceutical services shall comply with applicable Federal, State and local ordinances, statutes and regulations regarding the storing, compounding, administering or dispensing of medication.] Projects furnishing pharmaceutical services shall present a license from the Department of Health's Board of Examiners or the Department of State's State Board of Pharmacy and a DEA registration to Department employees. Other notices of review or inspection, or both, shall be made available upon request.
(b) [Verbal medication orders may be accepted but shall be put in writing and signed within 24 hours thereafter by the prescribing physician.] Verbal orders for medication can be given only by a physician or other medical professional authorized by State and Federal law to prescribe medication and verbal orders may be received only by another physician, pharmacist or nurse, or medical professional authorized by State and Federal law to receive verbal orders. When a verbal or telephone order is given, it has to be authenticated in writing by a physician or other medical professional authorized by State and Federal law to prescribe medication. In detoxification levels of care, written authentication shall occur no later than 24 hours from the time the order was given. Otherwise, written authentication shall occur within 3 business days from the time the order was given.
(c) The project shall have and implement a written policy and procedures regarding all medications used by clients which shall include, but not be limited to:
(1) Administration of medication[.], including the documentation of the administration of medication:
(i) By individuals permitted to administer by Pennsylvania law.
(ii) When self administered by the client.
(2) Drug storage areas including, but not limited to, the secure storage of controlled substances and other abusable drugs in accordance with State and Federal regulations and program requirements.
(3) Inspection of storage areas that ensures compliance with State and Federal laws and program policy. The policy must include, but not be limited to:
(i) What is to be verified through the inspection, who inspects, how often, but not less than quarterly, and in what manner it is to be recorded.
(ii) Disinfectants and drugs for external use are stored separately from oral and injectable drugs.
(iii) Drugs requiring special conditions for storage to insure stability are properly stored.
(iv) Outdated drugs are removed.
(v) Copies of drug-related regulations are available in appropriate areas.
(4) Methods for control and accountability of drugs[.], including, but not limited to:
(i) Who is authorized to remove drug.
(ii) The program's system for recording drugs, which includes the name of the drug, the dosage, the staff person, the time and the date.
(5) Security of drugs, including, but not limited to, the loss, theft or misuse of drugs.
[(6) Inventories.
(7)] (6) Medication errors and drug reactions shall be recorded in the client record. This may be the medical record if a separate medical record is maintained for all clients.
(Editor's Note: The following section is new and printed in regular type to enhance readability.)
§ 709.34. Reporting of unusual incidents.
(a) The project shall develop and implement policies and procedures to respond to the following unusual incidents:
(1) Physical assault or sexual assault by staff or a client.
(2) Selling or use of illicit drugs on the premises.
(3) Death or serious injury due to trauma, suicide, medication error or unusual circumstances while in residential treatment or, when known by facility, for ambulatory services.
(4) Significant disruption of services due to disaster such as fire, storm, flood or other occurrence which closes the facility for more than 1 day.
(5) Theft, burglary, break-in or similar incident at the facility.
(6) Event at the facility requiring the presence of police, fire or ambulance personnel.
(7) Fire or structural damage to the facility.
(8) Outbreak of a contagious disease requiring Centers for Disease Control (CDC) notification.
(b) Policies and procedures must include the following:
(1) Documentation of the unusual incident.
(2) Prompt review and identification of the causes directly or indirectly responsible for the unusual incident.
(3) Implementation of a timely and appropriate corrective action plan, when indicated.
(4) Ongoing monitoring of the corrective action plan.
(5) Reporting mechanism to ensure that reporting of an unusual incident to an entity is in compliance with State and Federal confidentiality laws.
(c) To the extent permitted by State and Federal confidentiality laws, the project shall file a written unusual incident report with the Department within 3 business days following an unusual incident involving:
(1) Physical or sexual assault by staff or a client.
(2) Death or serious injury due to trauma, suicide, medication error or unusual circumstances.
(3) Significant disruption of services due to a disaster such as a fire, storm, flood or other occurrence that results in the closure of a facility for more than 1 day.
(4) Event at the facility requiring the presence of police, fire or ambulance personnel.
(5) Outbreak of a contagious disease requiring CDC notification.
[Pa.B. Doc. No. 14-466. Filed for public inspection March 7, 2014, 9:00 a.m.]
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