RULES AND REGULATIONS
Title 55--PUBLIC WELFARE
DEPARTMENT OF PUBLIC WELFARE
[55 PA. CODE CH. 5320]
Long-Term Structured Residences
[26 Pa.B. 867]
The Department of Public Welfare (Department), by this order adopts Chapter 5320 (relating to long-term structured residences) as set forth in Annex A under the authority of section 1021 of the Public Welfare Code (62 P. S. § 1021).
Notice of proposed rulemaking was published at 23 Pa.B. 5806 (December 11, 1993).
Purpose of the Regulations
The purpose of these final regulations is to adopt licensure requirements for long-term structured residences (LTSRs) which are highly structured therapeutic residential mental health treatment facilities of no more than 16 beds. They are designed to serve persons 18 years of age or older who are eligible for hospitalization but who can receive adequate care in an LTSR. Admission is limited to individuals who require the services described in Chapter 5320. Admission may occur voluntarily under section 201 of the Mental Health Procedures Act (50 P. S. § 7201) or involuntarily under section 304, 305 or 306 of the Mental Health Procedures Act (50 P. S. §§ 7304--7306). LTSRs are required to provide services and treatment in accordance with Departmental regulations at 55 Pa. Code Chapter 5100 (relating to mental health procedures).
Need for the Regulations
The establishment and licensing of LTSRs furthers the Department's goal of establishing a comprehensive array of community-based mental health services, including alternatives to inpatient hospitalization, that are administered by the county mental health offices. LTSRs have been established as an alternative to hospital services in those county mental health service systems affected by the closure or consolidation of a State hospital. Additional programs have been proposed under county/State hospital integrated project plans that have been submitted for approval by the Department. Regulations are needed to assure appropriate care, service delivery and safety of residents in these programs.
The requirements in § 5320.11(2) (relating to prerequisites to licensure), that an LTSR may be licensed only if it is identified in the officially submitted county plan, as well as the requirement in § 5320.32(1) (relating to admission authorization), that the County Administrator's Office (CAO) approve all admissions, identify the CAO as the single point of accountability for provider participation, client services and financial decision making. The responsibilities of the area offices of mental health, which are a part of the Department, include the oversight and monitoring of all mental health services within their jurisdiction which are publicly and privately funded. Their responsibilities include licensing and service utilization review.
These final regulations contain the licensing requirements that must be met to obtain a certificate of compliance to operate an LTSR. These final regulations are intended to safeguard and promote the health and mental health, safety, well-being, rights and dignity of each LTSR resident.
Affected Organizations and Individuals
The primary beneficiaries of LTSR services are individuals 18 years of age or older and over who do not need hospitalization but who require mental health treatment and supervision on an ongoing 24-hour per day basis. LTSRs are new and distinct community-based residential treatment services that affect persons who require these services, their families, service providers and the CAOs that provide funding for LTSRs.
Accomplishments and Benefits
LTSRs provide a 24-hour therapeutic environment which employs active psychiatric treatment and psychosocial rehabilitation skills training in a structured residential milieu. LTSR services provide a less restrictive and less costly alternative to inpatient hospitalization. The operational policies and procedures empower residents to take an active role in their treatment and other decisions which affect their lives, and create an environment which reduces stigma, promotes independence and fosters self-esteem. The policies and procedures should be flexible enough to accommodate cultural diversity among the residents and their individual and changing needs. They are designed to gain maximum benefit from community mental health providers and other available resources while ensuring that public funds are expended efficiently.
The LTSR regulations were published as proposed at 23 Pa.B. 5806. Written comments, suggestions and objections were solicited within a 30-day period after the publication date. As a result of extensive comments received after the publication of the proposed regulations, and actual experience with the currently operating programs, numerous revisions were made to the proposed regulations. The final regulations now apply to additional geographical areas (see § 5320.1). The final regulations also differ from the proposed regulations in format and include language revisions to clarify the meaning of various sections. The revisions do not, however, enlarge the original purpose of proposed rulemaking.
Summary of Changes
The final regulations have also had considerable public review and input beyond the publication and response period. A workgroup consisting of representatives from the Statewide Mental Health Consumers Association, Alliance for the Mentally Ill, Community Providers Association, Philadelphia City Mental Health Office and the Office of Mental Health Area Offices and Headquarters staff met as needed in a collaborative effort to respond to the comments and revise the proposed regulations.
Over 30 comments were received from interested persons or organizations throughout this Commonwealth. The principal comments received were related to: changes in the rulemaking that may affect established LTSRs; the availability of LTSRs; staffing requirements; pharmaceutical arrangements, medication administration and seclusion and restraint. A summary of the comments received, and the Department's response to those comments, follows. Several general comments are listed under the relevant regulatory heading.
The Independent Regulatory Review Commission (IRRC) questioned how the changes proposed in this final rulemaking would affect LTSRs which were established and have been operating under the original proposed regulations as published at 21 Pa.B. 2020 (May 4, 1991) which proposed a significantly different set of rules.
IRRC recommended expanding and revising the waiver of standards in § 5320.101 (relating to waiver of standards). This would enable providers an opportunity to seek a waiver from a new requirement for good cause as long as the health and safety of residents is not jeopardized.
Although the final regulations differ from the originally proposed regulations in regard to Statewide expansion, format and language clarifications, the Department does not believe the revisions enlarge the original purpose of proposed rulemaking or represent a significantly different set of rules. The Department, however, agrees with IRRC's recommendation and has revised § 5320.101 to establish a more generalized waiver of standards so that providers which have been operating under the original proposed regulations would have opportunity to seek a waiver from a new requirement for good cause.
One provider commented that there are and will be LTSR programs in areas that are still being serviced by a State hospital. In many instances, the populations of these programs may not be as severely ill as those where there is no State hospital. In cases where the population is fairly stable the provider suggested that staffing patterns and psychiatric time be adjusted to reflect the nature of the population. In instances when there would be a need for more supervision of psychiatric time, adjustments could be made to provide needed services.
Despite closings and consolidations, all areas of the State are served by State mental hospitals. Residents who do not require mental health treatment and supervision on a 24-hour per day basis are not the appropriate population for LTSRs. These residents would be more appropriately served in Community Residential Rehabilitation programs (CRRs) or less intensive residential/housing programs. Since LTSRs were designed for individuals who would otherwise be hospitalized, any adjustments to the requirements set forth in this chapter will have to occur through the waiver of standards process described in § 5320.101.
Section 5320.1. Scope.
In §§ 5320.1 and 5320.2 (relating to scope; and policy), it is not clear whether an individual can seek admission to an LTSR or whether LTSRs can be established in all counties Statewide. IRRC believed that the sections should not preclude a county from requesting approval to establish an LTSR through its county plan, and recommended that the language under this section be expanded to read ''This chapter is applicable to counties affected by the closure or consolidation of a State mental hospital, or where a County/State hospital integrated project has been approved by the Department or where operation of LTSRs are included in a county plan.''
In response to these comments, the Department has revised § 5320.1 to include references to §§ 5320.31 and 5320.32(1) and (2) (relating to admission criteria; and admission authorization). The referenced sections provide clarification on the LTSR admission criteria and admission authorization process under IRRC's recommendation. The Department also revised § 5320.1 by inserting the phrase ''or where operation of LTSRs are included in an approved county plan.''
Section 5320.3. Definitions.
In several sections, references are made to the resident's designated person, guardian, next of kin or family member. It is unclear whether the references are intended to be interchangeable with ''designated person'' or whether the reference is to another person acting on the resident's behalf.
IRRC recommended the term ''designated person'' be used consistently throughout the chapter. The term ''guardian'' should be defined and references to family, next of kin, executor, appropriate other persons and agency should be deleted from §§ 5320.33(a), 5320.51(4)(i) and 5320.64(c)(1)(v) (relating to resident provider contract; information on resident rights; treatment plan; and resident records).
The Department agrees with this recommendation and has revised the chapter to replace the terms ''family,'' ''next of kin,'' ''executor,'' ''appropriate other persons'' and ''agency'' with the term ''designated person'' in §§ 5320.33(a) and 5320.51. In addition, use of the term guardian (personal or legal) throughout the chapter has been deleted and the phrase ''act on behalf of the resident'' has been added to the definition in § 5320.3 (relating to definitions).
PROVISION OF SERVICES
Section 5320.22. Governing body.
One provider believed § 5320.22(4) (relating to governing body) regarding the development of measurable anticipated outcomes in an LTSR is problematic. LTSRs do not have enough historical data to derive accurate predictive outcomes as the LTSR has only been operational since April 1992. Additionally, predicting therapeutic outcomes with a chronic schizophrenic population is in itself very inaccurate as regression is frequently difficult to predict.
The Department disagrees with these comments. Measurable outcome indicators are essential components of a quality improvement program and can, in fact, be developed for the program and individuals with serious mental illness. For example, changes in the frequency of symptoms or behaviors are measurable outcomes.
Section 5320.23. Access.
This section authorizes access to the facility by community service organizations, community legal services, advocacy groups, consumer and family organizations and authorized Federal, State or local government agents. Although there is strong support for the inclusion of access by legal services, advocacy groups, consumer and family organizations and government agents, IRRC questioned the unlimited right to access by community service organizations. IRRC suggested the Department delete this reference and allow the provider to review requests by community service organizations to access the facility on a case-by-case basis.
The Department agrees with this recommendation and has deleted the phrase ''access by community service organizations'' and added the following sentence: ''The provider will review requests by generic community service organizations to access the facility on a case-by-case basis.''
Section 5320.25. Provider records.
IRRC recommended that the Department clarify what it believes are appropriate allowable charges in order to assure that costs are standardized as much as possible in letters of agreement entered into by county administrators.
The Department agrees that clarification of this section (as well as § 5320.33) is needed. Section 5320.11 and § 5320.25 (relating to provider records) have been revised to clarify that the County Administrator/Provider Letter of Agreement delineate the services and items included in the per diem cost of care, including room and board, treatment, rehabilitation and personal care services, personal hygiene items and laundry services. Section 5320.33(c) (relating to resident/provider contract; information on resident rights) has been revised to clarify that residents may be responsible for the cost of services or items that are not included in the per diem cost of care if the items are furnished at the request of the resident.
Section 5320.26. Confidentiality.
IRRC recommended the Department add language to ensure that confidentiality of individual records is maintained by inserting the word ''individual'' before the words ''mental health records.''
The Department agrees with this recommendation and has inserted the word ''individual'' before the words ''mental health records.''
ADMISSION AND RESIDENT/PROVIDER CONTRACT
Section 5320.31. Admission criteria.
This section was titled ''Admission, Initial Assessment Procedures and Reassessment'' in the proposal. IRRC believed that § 5320.32 should be limited to the admission process and the resident/provider contract provisions and that § 5320.32(3) and (4) were repetitive of the requirements contained in § 5320.51 (relating to the treatment plan), and would be more appropriately placed in § 5320.51. IRRC further recommended that this title be amended to read ''Admission and Resident/Provider Contract.''
The Department agrees with these recommendations. The section has been retitled and limited to the admission process and the resident/provider contract provisions. Also, § 5320.32(3) and (4) were placed in § 5320.51.
Section 5320.32. Admission authorization.
This subsection was titled ''Assessment and Admission Authorization.'' IRRC recommended the title of this section be amended to read ''Admission Authorization.'' Also, under this section, the Department should define ''referring entity'' in § 5320.3.
The Department agrees with these recommendations and has amended this section to read ''Admission authorization'' and has defined ''referring entity'' in § 5320.3.
Section 5320.33. Resident/provider contract; information on resident rights.
Under subsection (a), the provider must explain the contents of the contract to the resident or the resident's guardian. IRRC questioned whether the provider could explain the contents of the contract to the resident's designated person if the guardian and designated person are not the same individual. IRRC suggested the Department add a reference to ''designated person'' within subsection (a). Additionally, the word ''or'' in subsection (a) should be replaced with the word ''and'' to ensure that both the resident and the legal guardian or the designated person are aware of the terms of the contract.
In response to these comments, the Department added a reference to ''designated person'' within subsection (a) and replaced the word ''or'' with the word ''and'' to ensure that both the resident and the Department designated person are aware of the terms of the contract. The Department also clarified the definition of ''designated person'' in § 5320.3.
Under subsection (b)(1), the resident/provider contract must include the actual amount of allowable resident charged for services and items. IRRC believes the regulation should be amended to clearly require the contract to identify the actual amount for each service or item, or both, for which the provider is authorized to charge the resident, not only a total amount. Thus, the contract would clearly identify each charge for which the resident would be responsible.
As noted in response to comments regarding § 5320.25, the Department agrees that clarification of this section was needed and the suggested changes were made. See response at §§ 5320.11 and 5320.25. The Department has also revised the language in § 5320.33(c) to clarify the types of charges for which the resident could be responsible.
REQUIREMENTS FOR DIRECT-CARE AND SUPPORT STAFF
The preplacement and biennial physical examinations for direct care and dietary support staff are under §§ 5320.22(9) and 5320.25(5). However, there is no specific section which requires the direct-care staff and dietary support staff to have a preplacement or biennial physical examination. In addition, the proposed rulemaking required a tuberculosis and hepatitis screening. It is unclear whether the Department intends physical examinations under this rulemaking to also include the screenings. IRRC recommended the Department incorporate the requirements for physical examinations and a description of what the examinations must include in this section.
The Department agrees with these comments and has deleted the language in § 5320.22(9) and revised § 5320.25(5) to require direct-care and dietary staff to have preemployment and biennial examinations, including screening for tuberculosis and hepatitis. The Department began renumbering this section to create a specific section, § 5320.41 (relating to physical examinations), requiring staff to have physical examinations with screenings for tuberculosis and hepatitis. The Department has also changed the word ''preplacement'' to ''preemployment.''
Section 5320.42. Staffing levels.
Section 5320.42(3) (relating to staffing level) requires a minimum of three staff persons to be awake and on duty when 10 to 16 residents are on the premises, and paragraph (4) requires two staff persons to be awake and on duty when fewer than 10 residents are on the premises. The Department does not identify which staff is required to be on duty (that is, direct care staff, support staff or either). IRRC suggested the final-form regulation specifically identify the types of staff required to meet the staffing levels.
In response to these comments, the Department has specified in § 5320.42(3) and (4) that direct-care staff are required to be awake and on duty when residents are on the premise. The Department also inserted ''direct-care'' at § 5320.42(8) and (9).
IRRC suggested allowing just two staff on duty as long as another direct-care staff person is on call. Or, if the Department continues to believe that three staff persons are essential, IRRC suggested considering allowing the three staff persons to be comprised of at least two direct- care staff and one support staff during the evening hours.
Staff at one provider agency have expressed concerns that utilizing three staff persons on a midnight shift (11 p.m. to 7 a.m.) is not necessary since most of the residents are asleep. They indicated that there is very little resident contact during the night shift. They believe that requiring three staff members to be present and awake would deplete staff from other shifts where there is a greater need for direct resident care.
The Department agrees with these recommendations and has revised the regulation to allow two direct-care staff awake and on duty as long as there is another direct-care staff on call and able to respond onsite within 30 minutes or less.
Section 5320.43. Program director and direct-care staff qualifications.
IRRC and several staff from one provider agency questioned whether the level of education proposed is necessary. Both believe that only allowing a person with a Master's degree to qualify for these positions reduces the provider's ability to recruit and retain staff. In order to provide some flexibility for hiring practices, while at the same time ensuring that qualified staff are employed, both IRRC and the provider agency strongly suggested the Department consider also allowing individuals with a Bachelor's degree and a number of years of clinical experience (that is, 5 or 6 years) to also qualify for these positions.
In response to this comment, the Department recognizes the concerns regarding recruitment and retention; however, the Department disagrees with the suggested change. LTSRs are 24-hour treatment facilities designed for persons who are seriously mentally ill and who otherwise would be hospitalized. As such, the Department must ensure that program direction is provided by persons with graduate level clinical training for which experience is not a sufficient substitute. Furthermore, § 5320.101 allows for a waiver to address staffing variations.
A second concern expressed by IRRC with the provisions under § 5320.43 (relating to program director and direct-care staff qualifications) related to the requirements for the program director and mental health professionals to be licensed, certified or registered by a professional licensure board. Since there are several State licensure boards, many of which are not relevant to the mental health field, IRRC suggested the Department specifically incorporate the appropriate state boards and the applicable terms (that is, licensed, registered or certified).
In response to these comments, the Department has revised § 5320.43(a)(2) and (b)(2) to clarify the requirements. The Department's reference to licensure, certification or registration is only relevant if the profession is governed by a registration, certification or licensing board in this Commonwealth.
Subsection (c) contains qualifications for mental health workers. A mental health worker shall be a person without a graduate degree who by training and experience has achieved recognition as a mental health worker. Absent any degree requirements, the phrase ''without a graduate degree'' should be eliminated. IRRC questioned how one achieves recognition as a mental health worker. IRRC strongly recommended that the Department establish specific minimum training and experience criteria and delete the phrase ''has achieved recognition as a mental health worker.''
The Department agrees with this recommendation and has revised this section to include minimum training and experience criteria for a mental health worker. The phrase ''has achieved recognition as a mental health worker'' has been deleted as suggested.
Section 5320.45. Staff orientation and training.
IRRC believed this section should be divided into two sections since they are two separate and distinct requirements.
Under the training provisions, the regulation incorporates a number of topics to be included in the orientation and training program. In order to provide greater clarity, IRRC suggested the Department establish separate sections identifying topics to be included in the orientation program for direct care and support staff as well as another section identifying the types of topics required to be incorporated in the ongoing training program.
The Department agrees with these recommendations and has revised the regulation accordingly. Section 5320.45(3) (relating to staff orientation and training) (new section) now describes topics included in the orientation program for direct-care and support staff while § 5320.45(4) identifies the topics included in the ongoing training program.
Section 5320.51. Treatment plan.
IRRC suggested that the provisions in § 5320.32 which relate to the assessment process and the responsibilities of the interdisciplinary team would be more appropriately placed in this section.
IRRC also believed the language in § 5320.51(1) (relating to treatment plan) should be replaced with the language currently proposed in § 5320.32(3) which more clearly explains what the initial assessment should entail. Additionally, the Department should ensure that the reassessment provisions proposed in § 5320.32(4) are moved to the therapeutic program sections.
The Department agrees with these recommendations and has revised the sections accordingly.
One provider suggested changing § 5320.51(2) to require that the comprehensive treatment plan be developed within 30 days rather than 10 days of admission.
The Department disagrees with this suggestion. The treatment needs of residents and practical experience with existing LTSRs demonstrate that the treatment plan can and should be completed within 10 days of admission.
Section 5320.53. Medication.
Subsection (a)(3) states that medication administration policies and procedures shall address how medication and treatments shall be administered by the licensed staff who prepared the dose for administration and shall be given as soon as possible after the dose is prepared. The latter portion of this provision which requires administration of a dosage as soon as possible after preparation would be more appropriate if placed under a new subsection regarding medication administration. Therefore, IRRC recommended subsection (a)(3) be revised to read ''How medication and treatments shall be administered by the licensed medical staff who prepared the dose for administration.''
In response to this suggestion, the Department has revised this section by deleting the phrase ''and must be given as soon as possible after the dose is prepared.'' With this change, the Department does not believe there is need for a new subsection.
Section 5320.53(b) sets forth the circumstances under which the provider stores medication for residents. IRRC suggested subsection (b)(3) and (4) be combined to read, ''Each prescription medication ordered for a resident is kept in the original prescription container labeled by the dispensing pharmacist for the sole use of the resident.''
The Department agrees with this suggestion. Paragraphs (3) and (4) of subsection (b) have been combined using the recommended language.
One provider agency suggested that § 5320.53(c)(1) and (2) under pharmaceutical services was unnecessary, redundant and increased the cost of an already expensive program. At present LTSR residents have their medication regime reviewed at least every 30 days by the treatment team.
This provider agency believed the quarterly review by a pharmacist can only determine if the medications being prescribed are in the therapeutic range or contraindicated. This should be done by the LTSR's nurse who sees the resident on a daily basis and is familiar with the individual's background and medication history.
This provider also believed an annual review of the provider's medication policies and procedures is already being conducted during the annual licensing review. In addition, in-service recommendations are already incorporated as part of the regulations under staff training.
The Department disagrees with these comments. The proposed standards are intended to meet quality program management requirements. The preparation and involvement of a pharmacist in the review of medication is essential to the proper management of the psychiatric and physical conditions and illnesses of LTSR residents.
Section 5320.54. Seclusion and restraints.
This section sets forth the prohibition of the use of seclusion and restraints for behavior management. Under subsection (c), IRRC recommended that it is not clear whether the Department intended providers to meet the requirements of both paragraphs (1) and (2). In order to provide greater clarity, IRRC suggested the phrase ''all of the following'' be inserted after the word ''meets'' in subsection (c).
The Department requires providers to meet both paragraphs (1) and (2) and has revised this section reversing the order of (1) and (2) and using the phrase ''when the following conditions are met'' at subsection (c).
Under § 5320.54(c)(1), IRRC questioned what State and local standards the Department is requiring providers to meet. IRRC recommended the Department specifically cite the standards intended so that providers have a clearer understanding of what is required by this section.
The Department agrees with this comment and has revised the subsection to include references to the following standards: 28 Pa. Code Part IV (relating to health facilities); 55 Pa. Code Chapter 5300 (relating to private psychiatric hospitals); 34 Pa. Code Chapters 49--59, National Fire Protection Agency related to Institutional Occupancy (current applicable standards of Life Safety Code); and equivalent standards of cities with 1st class status.
IRRC commended that § 5320.54(c)(2) provides no indication of the volume, code or statute where this section appears. IRRC suggested this provision be further clarified by deleting the word ''section'' and specifically adding a reference to Chapter 13 (relating to use of restraints in treating patients/residents).
The Department agrees with this comment and has revised the subsection to correctly reference this citation as § 13.4 (relating to use of restraints to control involuntary movement due to organic cause or conditions). This paragraph was renumbered as (1).
PERSONAL CARE SERVICES/RESIDENT RECORDS
Section 5320.63. Resident's funds.
Under § 5320.63(4)(iii) (relating to resident funds), the provider must assist the resident with financial arrangements if a resident's accumulated cash assets, after room and board and daily spending allowance exceeds $200. IRRC believed this section needs further clarification regarding what is included in the room and board charge, who determines it and what is the level of the daily spending allowance and whether it is contained in the resident/provider agreement.
In response to this comment, the Department references the revisions in §§ 5320.11(3), 5320.25(12) and 5320.33(b)(6) that further clarify what items are included in the per diem cost of care as well as the resident liability. The Department has also clarified the minimum monthly amount of funds retained by the resident. The reference to ''daily spending allowance'' has been deleted from this subsection and § 5320.33(b)(6) has been added to require that procedures for resident access to funds be included in the provider/resident agreement.
Section 5320.64. Resident records.
Under subsection (c), IRRC questioned the need for the inclusion of race and ethnicity in the clinical record of a resident. IRRC has found no legal basis which would allow for the collection of this information. If the Department continues to believe the collection of this information is authorized, it should provide the legal basis and the rationale. Additionally, IRRC believed the information should be collected on a voluntary, anonymous basis.
The Department disagrees with this recommendation. The inclusion of race and ethnicity in the resident record is clinically appropriate and the Department knows of no legal basis for excluding these factors. Appropriate treatment and treatment planning must include consideration of race/ethnicity. For example, utilization and peer review cannot be appropriately conducted without consideration of these factors.
The legal basis is as follows: § 20.36 (relating to licensure or approval of facilities and agencies) cites Title VI of the Civil Rights Act of 1964, CFR 80.6--10; which incorporates by reference section 504 of the Rehabilitation Act of 1973, and the Pennsylvania Human Relations Act (43 P. S. §§ 951--963). These Federal regulations clearly require collection of this data as part of compliance reporting. In addition, the collection of race and ethnicity is required by the DPW/OMH Consolidated Community Reporting System (CCRS) as specified in the reporting manual revised: July 1, 1992.
Under § 5320.64(c)(1)(viii), the clinical record shall contain ''the most recent annual physician's examination.'' IRRC recommended the word ''physician's'' be deleted and replaced with the word ''physical.''
The Department agrees with this recommendation and has revised the language accordingly.
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