[39 Pa.B. 6958]
[Saturday, December 12, 2009]
[Continued from previous Web Page] § 611.56. (health screening)
Commentators almost unanimously objected to the proposed regulation requiring a health screening prior to referral or assignment of a direct care worker. The regulation as proposed would have required a ''screening assessment'' to establish that the individual had been screened for tuberculosis, and for five other communicable diseases or conditions which were listed in the proposed regulation. Commentators have inquired regarding the meaning of the term ''screening assessment'' and expressed concern that direct care workers would need to undergo more onerous scrutiny as to their health status than other workers in the health care field.
IRRC commented that Representatives Mundy and Hennessey, Senator Corman and several other commentators question how the ''screening assessment'' required by the proposed regulation would be accomplished. IRRC inquired whether a laboratory test would be required or whether a physical examination by a doctor would be sufficient. Many commentators expressed concern that the Department was proposing an invasive procedure necessitating the use of blood and stool samples to detect communicable disease. Several commentators inquired whether the screening assessment could consist of a questionnaire. IRRC recommended that the Department amend this section to clearly state how the ''screening assessment'' must be completed.
IRRC also pointed out that commentators asserted that the list of conditions which must be screened for, far exceed the screening required for employees of other licensed health care facilities. IRRC inquired how the Department determined that the health screenings in the proposed regulation are appropriate for use with agency or registry direct care workers.
One commentator said that prospective direct care workers do not have access to clinics that would provide the necessary health evaluation, and that home care agencies and registries do not have qualified health professionals on staff to perform the evaluation. The commentator said that lack of access to a qualified health professional would further exacerbate the growing shortage of direct care workers.
The act requires that ''prior to referral to consumers, all individuals and any other office staff or contractors with direct consumer contact must obtain documentation from a physician or other appropriate health care professional that the individual is free from communicable disease, including, at a minimum, a tuberculosis screening as outlined by the screening guidelines of the department.'' 35 P. S. § 448.806(d.1)(5). Thus, in the draft regulations, circulated prior to publication of proposed regulations, the Department suggested that the direct care worker should be screened for tuberculosis, in accordance with guidelines issued by the Federal Centers for Disease Control and Prevention (since these are the guidelines routinely used by the Department), and tested as necessary, and screened for ''other communicable diseases.'' Although the draft regulation did not provoke a great number of questions during the stakeholder process, the Department anticipated that once the regulations were in effect, the Department would receive questions about the kind of communicable diseases for which the individual must be screened, and the kind of communicable diseases for which the direct care worker must be screened.
In the process of revising the draft regulation dealing with health evaluations prior to publication of the regulation as proposed, the Department considered incorporating by reference a regulation included with the Department's communicable disease regulations in 28 Pa. Code Chapter 27, such as § 27.155 (relating to restrictions on health care practitioners) or § 27.71 (relating to exclusion of children, and staff having contact with children, for specified diseases and infectious conditions). The Department ultimately rejected incorporating by reference one of its communicable disease regulations. Ruling out infectious conjunctivitis, for example, listed in 28 Pa. Code § 27.71 during a physical examination conducted prior to the individual's start date would not provide any assurance regarding the individual's actual condition on the start date. Requiring a complete physical and potential testing of blood and stool samples to rule out all of the conditions listed in 28 Pa. Code § 27.155 would be cost prohibitive.
Ultimately, the Department included in the proposed regulation a list of communicable diseases for which the individual would be screened at the same time the individual was screened for tuberculosis risk factors. These diseases and conditions put the consumer at significant risk, and screening for these diseases and conditions sometime prior to the direct care worker's start date, in the Department's view, constituted a valuable and useful exercise.
As stated previously, stakeholders were consistent in their criticism of the proposed regulation, although much of the criticism stemmed from the confusion over the meaning of the term ''screening assessment.'' The County Commissioner Association of Pennsylvania supported the Department's attempt to protect consumers from workers with communicable diseases or conditions but believed that the proposed rulemaking applicable to annual screenings was excessive, intrusive and too expensive to implement. They pointed out, as did many other commentators, that the proposed screening far exceeded the kind of screenings required in other health care facilities licensed under the act. The Association requested that the Department adopt a more broadly based regulation that would require home care agencies or home care registries to assure that employees do not have communicable disease or conditions but would not prescribe the process for doing so.
The Department also received many comments regarding the 180-day time frame in the proposed regulation. Several commented that achieving compliance was going to be challenging. Several commented that the health evaluation should be obtained in the one year prior to the start date.
As requested, the Department has revised the regulation. The final regulation has been titled ''Health screening'' and states that the home care agency or home care registry shall insure that each direct care worker and other office staff or contractors with direct consumer contact, prior to consumer contact, provide documentation that the individual is free from active mycobacterium tuberculosis. The regulation instructs that the determination regarding the individual's status for tuberculosis should be made using the current CDC Guidelines for Preventing the Transmission of Mycobacteriuium Tuberculosis in Health Care Settings. The documentation must be dated not more than 1 year prior to the individual's start date. The requirement that the direct care worker must obtain the documentation every 12 months has been deleted.
One commentator inquired whether a registered nurse could perform the health evaluation. A ''health evaluation'' is no longer required. The regulation now merely requires a health screening for tuberculosis. CDC guidelines do not require a physician, physician's assistant, or certified registered nurse practitioner to conduct the screening for tuberculosis. Therefore, the Department has deleted the requirement that a ''qualified health professional'' provide the documentation regarding the direct care worker's health status and deleted the definition of ''qualified health professional'' from the definitional section in § 611.5.
One commentator inquired whether the Commonwealth has a standard form that should be completed for the direct care worker. The Department will not be supplying a standard form or requiring a standard format. As long as the documentation establishes that the individual was screened for and is free from active tuberculosis, the documentation will suffice.
One commentator suggested the regulation should require agencies and registries to have a policy that workers should not present themselves for work if they have symptoms of acute illnesses such as fever, jaundice or diarrhea. The Department considered the suggestion and determined not to impose the requirement for a policy as suggested by the commentator. The Department will not require the policy; however, the Department is in favor of such a policy and would encourage agencies and registries to put such policies in place.
One commentator said that if the agency must bear the cost of ''testing,'' the administrative costs for the agency will increase which will raise the hourly rate to the client. Other commentators also commented on the cost to the agency or registry. The regulation does not assign the cost of the health screening to the agency or registry. The regulation merely prohibits the agency or registry from assigning or referring a direct care worker to provide services until the documentation that the screening has been conducted has been obtained. If, in the interest of having the direct care worker prepared to begin providing services in a more prompt fashion, the agency or registry wishes to arrange and pay for the health screening, that is within the discretion of the agency or registry. The agency or registry also can choose to impose the obligation on the direct care worker to obtain and supply the necessary documentation to the agency or registry, as a condition of employment or roster.
Several commentators inquired whether the regulation will address the agency's or registry's obligations with regard to existing employees. After December 12, 2009, the home care agency or home care registry cannot assign or refer a direct care worker to provide home care services unless documentation of the health screening meeting the requirements of the regulation is part of the individual's file. In accordance with the recommendation of one or more commentators, the regulation gives the agency or registry 180 days to obtain the necessary documentation for direct care workers employed or rostered as of December 12, 2009.
A commentator requested the Department delete references to ''personnel.'' The Department made the changes as requested. The commentator also suggested that the Department replace ''180 days'' with ''one year'' prior to the individual's start date. The time frame, if not the exact wording, has been inserted in the final regulation. The commentator suggested the Department delete the five communicable diseases, in addition to tuberculosis, listed in the proposed regulation. The Department accepted this recommendation. The commentator suggested that the Department replace the reference in subsection (c) to ''individual employed or rostered by the agency or registry'' with ''direct care worker.'' The Department accepted this recommendation.
§ 611.57. (consumer protections)
IRRC pointed out that commentators stated that there are situations when there is not time to get an information packet to the consumer or the consumer's family member prior to the start of services, when, for example, the consumer is being discharged from the hospital and is in immediate need of services and the family member requesting the services lives out of town. IRRC inquired whether the family member could give verbal permission for services to begin without having first received the required information, and asked that this be clarified in the final form regulation.
The act requires that ''each consumer or the consumer's legal representative or responsible family member shall receive an information packet from the home care agency or home care registry prior to the commencement of services. . . '' 35 P. S. § 448.806c(b). The information packet is to include a listing of available services that will be provided to the consumer, the hours when the services will be provided, fees and costs for the services on an hourly or weekly basis, Department contact information for agency and registry licensure requirements and for compliance information, information regarding the Department's 24-hour hotline and the local ombudsman program, and information about the direct care worker who will be providing home care services, including information about the hiring process and training or testing to ensure competency. The information packet, per the statute, also must include a disclosure whether the direct care worker is an employee or an independent contractor and information regarding the respective employment and tax obligations of the consumer and the agency or registry.
The Department has no authority to alter the statutory requirement for written notice of the requisite items prior to the commencement of services.
One commentator suggested that the language in subsection (c)(6) of the proposed regulation requiring an agency or registry to provide, in advance of services, information regarding hiring and competency requirements applicable to direct care workers, a description of the manner and frequency of periodic reassessment of direct care worker competency, and information regarding documentation maintained by the home care agency or home care registry to confirm compliance with hiring and training requirements was not likely to be helpful to the consumer. The commentator suggested that the regulation should require the agency or registry to provide information specific to the skills and abilities of the direct care worker and to list the services the direct care worker can and cannot provide.
Another commentator also commented on the awkward language in proposed subsection (c)(6), and suggested that the Department merely require the agency or registry to confirm for the consumer, prior to commencement of services, that all direct care workers referred have: (1) successfully completed a competency examination approved by the Department of Health; (2) acceptable reference checks; (3) a face-to-face interview; (4) a health screen completed by a licensed health care professional; and (5) a criminal background review conducted by the Pennsylvania State Police or the Federal Bureau of Investigation.
The Department agreed with the comments and has revised the proposed regulation to require general information regarding hiring and competency requirements applicable to direct care workers, and information about the specific services the direct care worker assigned to the consumer will provide. While the Department did not add language to the regulation requiring the agency or registry to include information about services the direct care worker will not provide, it is certainly with the discretion of the agency or registry to include this information in the packet to be given to the consumer or the consumer's family member or legal representative.
The same commentator also suggested that the Department clarify subsection (c)(2) which requires the agency or registry to provide information, in advance of the service start date, regarding the hours when direct care services would be provided. The commentator suggested that the Department add the following language to the subsection: ''Such hours that are requested by and agreed to by the consumer.''
The final-form regulation now requires the agency or registry to provide the consumer or the consumer's family member or legal representative a listing of the actual home care services to be provided to the consumer and the hours during which the services will be provided. The hours identified when services will be provided are those mutually agreed upon by the consumer and the agency or registry. The notice will serve as confirmation for the consumer.
One commentator suggested that the home care agency or registry, prior to commencement of services, must provide a full disclosure statement acknowledging the responsibilities of the agency or registry. The commentator went on to list the items the commentator believed should be included in the disclosure statement: the employment status of the direct care worker, specifically, an explanation of which party is responsible for payment the wages or salary of the direct care worker, paying Federal social security taxes and state and Federal unemployment taxes for the direct care worker, and procuring worker's compensation or liability insurance covering injury to the direct care worker. The commentator also suggested that the disclosure statement should identify which party is responsible for supervising the direct care worker, assigning duties to the direct care worker, and for hiring, firing and discipline of the direct care worker. The commentator stated that the disclosure statement should identify the party responsible and liable if a direct care worker is hurt on the job.
The commentator stated that it is critical that the disclosure form include a place for the consumer's signature and that the regulation require the consumer's signature on the disclosure form as a mechanism for acknowledging receipt and understanding of the information on the disclosure statement. The commentator stated that the home care agency or registry should be required to keep a copy of the signed disclosure statement in agency or registry files. Another commentator suggested that the regulation should require documentation of when consumer information was provided as well as dates informational packets were mailed.
The regulation states that information provided to the consumer must include a disclosure addressing the employee or independent contractor status of the direct care worker providing services to the consumer, and the resultant respective tax and insurance obligations and other responsibilities of the consumer and the home care agency and home care registry. The regulation states that the disclosure must be in the format as published by the Department in the Pennsylvania Bulletin by February 10, 2010. As indicated by the outline of information required to be included in the disclosure statement, the Department fully intends that the disclosure statement will address the points listed by the commentator.
As for the suggestion that the Department should require the agency or registry to obtain the consumer's signature on the disclosure form, the Department will take into consideration the suggestion when drafting the disclosure form to be published in the Pennsylvania Bulletin following publication of the final-form regulations. As for the suggestion that the regulation should require the agency or registry to maintain documentation to establish compliance with the requirements applicable to consumer protections, the Department has added a subsection (e) to the regulation to require the agency or registry to maintain documentation on file at the agency or registry for verification by the Department of compliance with the requirements in the regulation.
One commentator requested that disclosure form to be drafted by the Department should be made available for public comment prior to publication in the Pennsylvania Bulletin. The Department will make every effort to obtain stakeholder input on the disclosure form prior to publication. The comment process will be brief, however, in light of the Department's obligation, per the language of the regulation, to publish the form by February 10, 2010. The regulations are effective December 12, 2009.
One commentator inquired whether the requirement that consumers be informed of tax obligations and employment responsibilities was pertinent only to registries and consumer employers. The responsibility to provide information listed above applies to home care agencies and registries. If a home care agency will assume all employment responsibilities and tax obligations associated with employment, this is information that should be provided to the consumer. The regulations do not apply to ''consumer employers.'' ''Consumer employer'' is a term used in the Medicaid waiver and other publicly funded programs to refer to the individual receiving services who has elected to serve as employer of the individual providing the services to the consumer. A ''consumer employer,'' most likely, does not meet the definition of a ''home care agency'' or ''home care registry'' as set forth in the act and in the definitional section in these regulations. Only those entities who meet the definition, and are not excluded under the terms of the act or these regulations (see § 611.3, need to obtain a license and comply with the requirements set forth in the act and these regulations.
Another commentator inquired whether the requirement that information be provided to consumers concerning the services to be provided, the hours when services will be provided, and fees and costs for services applies only to private pay clients and not to clients whose services are paid by the Medicaid waiver or other publicly funded program. The requirement applies to all home care agencies and registries, regardless of the payment source for the services. For those clients or consumers whose services are paid by a Medicaid waiver or other publicly funded program, the information about specific fees and costs for the specific services to be provided to the client or consumer should reference the Medicaid waiver or other publicly funded program.
The Disability Rights Network commented that when a publicly funded program, such as the Medicaid Home and Community Based Waiver or the Act 150 Attendant Care Program, is involved, the home care agency or home care registry already is required to provide certain types of information and notices prior to the commencement of services. The commentator suggested that the regulation, therefore, also should require the home care agency or home care registry receiving public funds to comply with all information and notice requirements of the publicly-funded program.
The Disability Rights Network also commented that the Medicaid waiver and other publicly funded programs include due process requirements for reduction or termination of services. The commentator suggested that, to avoid confusion, the Department should revise the regulation to require agencies and registries providing services to the publicly funded program recipients to follow the publicly funded program's due process requirements for termination of services. The commentator suggested that the requirements applicable to termination of services in the proposed regulation should apply only to agencies and registries with private-pay clients.
The Department cannot impose through regulations, having the force and effect of law, the requirements imposed by the Medicaid waiver or other publicly funded program through contract with the provider. Further, the Department can only promulgate regulations authorized by the statute. The Legislature has determined that all recipients of services provided by a licensed home care agency or home care registry are entitled to at least 10 days notice of termination of services, unless lack of payment or an immediate threat to the health or safety of the consumer or provider warrants less notice. If the home care agency or home care registry provides services to individuals who are beneficiaries of a publicly funded program, there may be additional or other requirements connected with termination or reduction of services to these individuals. A publicly funded program, subject to laws requiring due process in the event of termination or reduction of a public benefit, may require a participating provider to offer certain due process to the client or consumer as a condition of the provider's participation in the program. The Department has no authority to impose those requirements. Thus, an entity meeting the definition of a ''home care agency'' or ''home care registry'' that provides services to individuals and receives payment through the Medicaid waiver or other publicly funded program will need to be aware of and comply with licensure requirements in the act and in these regulations, and they will need to be aware of and comply with any requirements imposed by the Medicaid waiver or other publicly funded program as a condition of participation as a provider in the program.
Fiscal Impact
State Government.
The licensure program for home care agencies and home care registries will cost approximately $1,060,000 for the first full year of the program. This projection is based on the approximate cost to survey a home care agency or registry and the projected number of home care agencies and home care registries (650).
The Department also will incur certain start-up costs associated with hiring and training of surveyors or inspectors and updating the Department's electronic Survey Agency Information System (SAIS) through which the Department coordinates and manages its licensure functions. Through SAIS, the Department schedules and tracks surveys or inspections of all facilities, tracks surveyor time and efforts, and tracks complaints about facilities. The SAIS system also includes a function through which a statement of deficiencies, in the event of regulatory violations identified during an inspection, can be generated. The system also allows the facilities to submit its plan of correction electronically. The SAIS system will need to be revised to include the home care agency and home care registry licensing function.
Local Government.
There would be no cost to local government.
Public.
There may be a cost to the public in the form of higher charges for care because the home care agency or home care registry would need to recoup start-up and ongoing costs of compliance with licensure criteria.
Regulated Entity.
Home care agencies and home care registries would incur costs as a result of these regulations. To the extent an agency or registry currently does not have hiring policies and procedures in place equal to or more stringent than the hiring prerequisites contained in the proposed rulemaking, the agency or registry would incur the one-time cost of establishing systems and procedures that comply with the proposed regulation and the on-going cost of doing business in the manner dictated by the regulation. The proposed rulemaking would permit choices, however, and the choice made by an agency or registry would have an impact on overall costs. Establishing competency of a direct care worker through a competency examination, for example, might cost less than establishing competency through a training program. The agency or registry also would be required to pay the annual licensing fee of $100.
Paperwork Requirements
State Government.
The Department will have additional paperwork responsibilities connected with its role as the licensing agency. Much of the licensing paperwork is handled electronically through the Department's SAIS system. The Department will issue a hard copy license to the agency or registry. The Department also will issue a hard copy statement of deficiencies.
Local Government.
There would be no additional paperwork requirements for local government.
Public.
Consumers of home care services will receive paperwork as a result of these regulations. Consumers will receive written notice of termination of services. Consumers also will receive written notice of services to be provided, the hours when those services will be provided, fees and costs associated with the services, and who to contact with complaints. Consumers also will receive a written description of the hiring and training requirements applicable to direct care workers and a written disclosure of the worker's status as an employee or independent contractor and the resultant respective tax and insurance obligations of the consumer and the agency or registry.
Regulated Entity.
Home care agencies and home care registries will be required to submit paperwork to receive or renew a license. Home care agencies and home care registries would need to respond to any identified regulatory deficiencies in the form of a plan of correction. They will need to create and maintain files for direct care workers containing documentation of a face-to-face interview, references, a criminal history report and ChildLine verification, if necessary, and documentation of satisfactory completion of the competency prerequisites and the annual competency review. The files also will be required to contain documentation of a health evaluation obtained prior to employment or roster.
Home care agencies and home care registries will be required to provide written notice to the consumer of the intent to terminate services. Finally, home care agencies and home care registries will be required to provide written documentation to the consumer listing services to be provided, the hours when those services would be provided, fees and costs associated with the services, and who to contact with complaints. The written documentation also must describe the hiring and training requirements applicable to the direct care worker being sent to the consumer's home or other independent living environment and disclose the worker's status as an employee or independent contractor and the resultant respective tax and insurance obligations of the consumer and the agency or registry.
Effective Date
These regulations will take effect immediately upon publication as final-form rulemaking.
Sunset Date
These regulations will be continually monitored for their effectiveness and updated as needed. Therefore, no sunset date has been established.
Regulatory Review
Under section 5(a) of the Regulatory Review Act (71 P. S. § 745.5(a), the Department submitted a copy of a notice of proposed rulemaking, published at 37 Pa.B. 4431 to IRRC and to the House Committee on Health and Human Services, the Senate Committee on Public Health and Welfare, the House Older Adult Services Committee, and the Senate Aging and Youth Committee (Committees). In compliance with section 5(c) of the Regulatory Review Act, the Department also provided IRRC and the Committees with copies of all comments received during the formal comment period, as well as other documentation.
In compliance with section 5.1(a) of the Regulatory Review Act (71 P. S. § 745.5a(a)), 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 these final-form regulations, the Department has considered all comments received from IRRC, the Committees and the public.
This final-form regulations were deemed approved by the Committees on September 30, 2009. IRRC met on October 1, 2009, and approved the regulations in accordance with section 5.1(e) of the Regulatory Review Act.
Contact Person
Questions regarding these regulations should be submitted to Janice Staloski, Director, Bureau of Community Program Licensure and Certification, 132 Kline Plaza, Suite A, Harrisburg, PA 17104-1579, (717) 783-8665. Persons with a disability may submit questions in alternative format such as by audio tape, Braille, or by using V/TT (717) 783-6514, or the Pennsylvania AT&T Relay Service at (800) 654-5984 [TT]. Persons who require an alternative format of this document may contact Janice Staloski at the previous address or telephone number so that necessary arrangements may be made.
Findings
The Department, after consultation with the Health Policy Board, finds that:
(1) Public notice of intention to adopt the 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 (relating to notice of proposed rulemaking required; and adoption of regulations).
(2) A public comment period was provided as required by law and all comments were considered.
(3) The adoption of regulations in the manner provided by this order is necessary and appropriate for the administration of the authorizing statutue.
Order
The Department, after consultation with the Health Policy Board, acting under the authorizing statute, orders that:
(1) The regulations of the Department, 28 Pa. Code, are amended by adding §§ 611.1—611.5 and 611.51—611.57 to read as set forth in Annex A.
(2) 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.
(3) The Secretary of Health shall submit this order, Annex A and a Regulatory Analysis Form to IRRC, the Committees for their review and action as required by law.
(4) The Secretary of Health shall certify this order and Annex A and deposit them with the Legislative Reference Bureau as required by law.
(5) This order shall take effect immediately upon publication in the Pennsylvania Bulletin.
(Editor's Note: The proposal to add §§ 611.11—611.21, included in the proposed rulemaking at 37 Pa.B. 4198 (August 4, 2007) has been withdrawn. For a notice relating to this rulemaking, see 39 Pa.B. 7064 (December 12, 2009).)
(Editor's Note: For the text of the order of the Independent Regulatory Review Commission relating to this document, see 39 Pa.B. 6204 (October 17, 2009).)
Fiscal Note: 10-184. (1) General Fund; (2) Implementing Year 2008-09 is $1.060 M; (3) 1st Succeeding Year 2009-10 is $1.114 M; 2nd Succeeding Year 2010-11 is $1.171 M; 3rd Succeeding Year 2011-12 is $1.232 M; 4th Succeeding Year 2012-13 is $1.297 M; 5th Succeeding Year 2013-14 is $1.366 M; (4) 2007-08 Program—$17.308 M; 2006-07 Program—$15.557 M; 2005-06 Program—$16.057 M; (7) Quality Assurance; (8) recommends adoption. Funds have been included in the budget to cover this increase.
Annex A
TITLE 28. HEALTH AND SAFETY
PART IV. HEALTH FACILITIES
Subpart H. HOME CARE AGENCIES AND HOME CARE REGISTRIES
CHAPTER 611. HOME CARE AGENCIES AND HOME CARE REGISTRIES
GENERAL § 611.1. Legal base.
(a) This chapter is promulgated by the Department under the powers granted and the duties mandated under sections 803 and 809.1 of the act (35 P. S. §§ 448.803 and 448.804a).
(b) The Department has the power and its duty is to promulgate the regulations necessary to implement the provisions of Chapter 8 of the act (35 P. S. §§ 448.801a—448.820) and to assure that its regulations and the act are enforced.
(c) The purpose of this chapter is to protect and promote the public health and welfare through the establishment and enforcement of regulations setting minimum standards for the operation of home care agencies and home care registries. The standards are intended by the Department to assure safe, adequate and efficient home care agencies and home care registries, and to promote the health, safety and adequate care of the consumers of services provided by home care agencies and home care registries.
§ 611.2. License required.
(a) Except as set forth in subsection (c), no entity or organization may operate, maintain, or hold itself out as operating or maintaining a home care agency or home care registry without first having obtained a license from the Department in accordance with this chapter. Each physical location of the home care agency or home care registry must be separately licensed. The Department will conduct an inspection prior to issuing an initial license or a license renewal.
(b) The license will specify whether the entity is licensed as a home care agency, a home care registry, or both, the term of the license, and any conditions or limitations imposed on the license.
(c) An entity operating a home care agency or home care registry, or both, as of December 12, 2009, may continue to operate after December 12, 2009, provided it submits an application for a license to the Department in accordance with instructions published in the Pennsylvania Bulletin and posted on the Department's web site by February 10, 2010. An entity that has submitted an application for licensure in accordance with the requirements of this subsection may continue to operate the home care agency or home care registry until a date that the Department may refuse the application for licensure. If the Department grants the application for licensure, the home care agency or home care registry may continue operation of the agency or registry in accordance with this chapter.
(d) The applicant shall obtain the application for a license to operate a home care agency or home care registry from the Department of Health, Division of Home Health.
(e) The applicant shall submit an application or renewal form to the Department with the fee of $100. The applicant shall submit a renewal form at least 60 days prior to the expiration date on the license. There will be no rebate, refund, or prorating of the application fee. The applicant shall complete a separate application and pay a separate application fee for each separately licensed home care agency or home care registry that it intends to operate.
(f) The applicant shall specify on its application the type of facility for which it is seeking a license.
§ 611.3. Affected home care agencies and home care registries.
(a) This chapter applies to home care agencies, home care registries and to entities that meet both definitions, profit or nonprofit, operated in this Commonwealth, as defined in this chapter. This chapter does not apply to a home health care agency, a durable medical equipment provider, a volunteer provider, or an organization or business entity designated under section 3504 of the Internal Revenue Code (26 U.S.C.A. § 3504) regarding acts to be performed by agents and either IRS revenue procedure 70-6 or IRS revenue procedure 80-4, that provides financial management services or supports coordination services, or both, to consumers of home and community-based services through Medicaid Waiver or other publicly funded programs.
(b) Existing home care agencies and home care registries which were home care agencies or home care registries prior to December 12, 2009, shall be required to meet the same standards as home care agencies and home care registries created after December 12, 2009.
§ 611.4. Requirements for home care agencies and home care registries.
(a) A current copy of this chapter shall be maintained at the home care agency or home care registry.
(b) Chapter 51 (relating to general information), applicable to all entities licensed as health care facitilies under the act, applies to home care agencies and home care registries licensed under this chapter.
(c) Home care agencies and home care registries licensed under this chapter shall comply with applicable environmental, health, sanitation and professional licensure standards which are required by Federal, State and local authorities.
(d) If there is a difference in applicable State or local standards, the standards established under State statutes apply for the purpose of compliance with this chapter.
§ 611.5. Definitions.
The following words and terms, when used in this chapter, have the following meanings, unless the context clearly indicates otherwise:
Act—The Health Care Facilities Act (35 P. S. §§ 448.101—448.904b).
ChildLine—An organizational unit of the Department of Public Welfare which operates a State-wide toll-free system for receiving reports of suspected child abuse established under 23 Pa.C.S. 6332 (relating to establishment of Statewide toll-free telephone number), refers the reports for investigation and maintains the reports in the appropriate file.
ChildLine verification—Confirmation regarding whether an applicant for employment or referral by a home care agency or home care registry is named in the Department of Public Welfare's Statewide Central Register as the perpetrator of a founded or indicated report of child abuse (as defined in 55 Pa. Code § 3490.4 (relating to definitions)).
Companionship services—Socialization, support and assistance with instrumental activities of daily living.
Consumer—An individual to whom services are provided.
Consumer control—Control and direction by the consumer in identifying, exercising choice of, and managing home care services in accordance with the consumer's needs and personal preferences.
Criminal history report—A State Police criminal history record or a Department of Aging letter of determination of eligibility for hire or roster based on a review of a Federal criminal history record.
Department—The Department of Health of the Commonwealth.
Department of Aging letter of determination—A written decision supplied by the Department of Aging regarding whether, based on the criminal history report from the Federal Bureau of Investigation, the applicant for employment by a home care agency or referral by a home care registry may be employed or rostered.
Direct care worker—The individual employed by a home care agency or referred by a home care registry to provide home care services to a consumer.
Direct consumer contact—Face-to-face interaction with the consumer in the consumer's place of residence or other independent living environment.
Financial management services—One or more of the following services:
(i) Managing payroll including Federal, State and local employment taxes for direct care workers recruited and retained by the consumer.
(ii) Processing the payment of workers' compensation, health and other insurance benefits for the direct care worker.
(iii) Assisting consumers in calculating and managing individual budgets for Medicaid Waiver and other publicly funded home and community based services.
(iv) Monitoring the consumer's spending of public funds and any underage or overage in accordance with the consumer's approved budget.
(v) Collecting, processing and maintaining time sheets for direct care workers.
(vi) Providing training to consumers related to employer-related tasks (for example, recruiting, hiring, training, managing and discharging direct care workers and managing payroll and bill paying).
Home care agency—An organization that supplies, arranges or schedules employees to provide home care services, as directed by the consumer or the consumer's representative, in the consumer's place of residence or other independent living environment for which the organization receives a fee, consideration or compensation of any kind.
Home care registry—An organization or business entity or part of an organization or business entity that supplies, arranges or refers independent contractors to provide home care services, as directed by the consumer or the consumer's representative, in the consumer's place of residence or other independent living environment for which the registry receives a fee, consideration or compensation of any kind.
Home care services—The term encompasses the following activities:
(i) Personal care.
(ii) Assistance with instrumental activities of daily living.
(iii) Companionship services.
(iv) Respite care.
(v) Specialized care.
Independent living philosophy—A system of beliefs, concepts and attitudes that emphasize self-direction, control, peer support and community integration for individuals with disabilities.
Inspection—A scheduled or unscheduled examination or assessment of a home care agency or home care registry during regular business hours, to determine compliance with requirements for licensure using one or more of the following means: inspection of records, interviews with office staff, consumers and direct care workers, and observation of the provision of services to consumers who have consented in advance to observation.
Instrumental activities of daily living—As defined in section 802.1 of the act (35 P. S. § 448.802a).
Nurse—A registered nurse or a licensed practical nurse.
Personal care—The term includes, but is not limited to, assistance with self-administered medications, feeding, oral, skin and mouth care, shaving, assistance with ambulation, bathing, hair care and grooming, dressing, toileting and transfer activities.
Respite care—Personal care and assistance with instrumental activities of daily living provided on a short term basis because of the absence or need for relief for those persons normally providing the services.
Roster—To place an individual on a list of individuals eligible to be referred by a home care registry to provide home care services to an individual in the individual's place of residence or other independent living environment; or the list of individuals eligible to be referred by a home care registry to provide home care services to an individual in the individual's place of residence or other independent living environment.
Specialized care—Nonskilled services unique to the consumer's care needs that facilitate the consumer's health, safety and welfare, and ability to live independently.
Statewide central register—A register of child abuse established in the Department of Public Welfare, which consists of founded and indicated reports of child abuse.
Supports coordination services—Services to consumers of home and community-based services through Medicaid Waiver or other publicly funded programs including intake services, needs assessment, and advocacy to ensure coordination of medical, social, educational and other services and maximum consumer independence.
GOVERNANCE AND MANAGEMENT § 611.51. Hiring or rostering of direct care workers.
(a) Hiring or rostering prerequisites. Prior to hiring or rostering a direct care worker, the home care agency or home care registry shall:
(1) Conduct a face-to-face interview with the individual.
(2) Obtain at least two satisfactory references for the individual. A satisfactory reference is a positive, verifiable reference, either verbal or written, from a former employer or other person not related to the individual that affirms the ability of the individual to provide home care services.
(3) Require the individual to submit a criminal history report, in accordance with § 611.52 (relating to criminal background checks), and a ChildLine verification, if applicable, in accordance with the requirements of § 611.53 (relating to child abuse clearance).
(b) Direct care worker files. Files for direct care workers employed or rostered must include documentation of the date of the face-to-face interview with the individual and of references obtained. Direct care worker files must also include other information as required under § 611.52, § 611.53, and if applicable, §§ 611.54, 611.55 and 611.56 (relating to provisional hiring; competency requirements; and health screening).
§ 611.52. Criminal background checks.
(a) General rule. The home care agency or home care registry shall require each applicant for employment or referral as a direct care worker to submit a criminal history report obtained at the time of application or within 1 year immediately preceding the date of application. An applicant for employment as a member of the office staff for the home care agency or home care registry and the owner or owners of the home care agency or home care registry also are required to obtain a criminal history report in accordance with requirements contained in this section.
(b) State Police criminal history record. If the individual required to submit or obtain a criminal history report has been a resident of this Commonwealth for 2 years preceding the date of the request for a criminal history report, the individual shall request a State Police criminal history record.
(c) Federal criminal history record. If the individual required to submit or obtain a criminal history report has not been a resident of this Commonwealth for the 2 years immediately preceding the date of the the request for a criminal history report, the individual shall obtain a Federal criminal history record and a letter of determination from the Department of Aging, based on the individual's Federal criminal history record, in accordance with 6 Pa. Code § 15.144(b) (relating to procedure).
(d) Proof of residency. The home care agency or home care registry may request an individual required to submit or obtain a criminal history record to furnish proof of residency through submission of any one of the following documents:
(1) Motor vehicle records, such as a valid driver's license or a State-issued identification.
(2) Housing records, such as mortgage records or rent receipts.
(3) Public utility records and receipts, such as electric bills.
(4) Local tax records.
(5) A completed and signed, Federal, State or local income tax return with the applicant's name and address preprinted on it.
(6) Employment records, including records of unemployment compensation.
(e) Prohibition. The home care agency or home care registry may not hire, roster or retain an individual if the State Police criminal history record reveals a prohibited conviction listed in 6 Pa. Code § 15.143 (relating to facility responsibilities), or if the Department of Aging letter of determination states that the individual is not eligible for hire or roster.
(f) Records maintained. The home care agency or home care registry shall maintain files for direct care workers and members of the office staff which include copies of State Police criminal history records or Department of Aging letters of determination regarding Federal criminal history records. The files shall be available for Department inspection. The agency or registry shall maintain copies of the criminal history report for the agency or registry owners, which shall be available for Department inspection.
(g) Confidentiality. The home care agency or home care registry shall keep the information obtained from State Police criminal history records and Department of Aging letters of determination regarding Federal criminal history records confidential and use it solely to determine an applicant's eligibility to be hired, rostered or retained.
(h) Opportunity to appeal. If the decision not to hire, roster or retain an individual is based in whole or in part on State Police criminal history records, Department of Aging letters of determination regarding Federal criminal history records, or both, the home care agency or home care registry shall provide an affected individual with information on how to appeal to the sources of criminal history records if the individual believes the records are in error.
(i) Exceptions. A direct care worker who has complied with this section and who transfers to another agency or registry owned and operated by same entity is not required to obtain another criminal history report. A direct care worker employed or rostered by an entity that undergoes a change of ownership is not required to obtain another criminal history report to submit to the new owner.
(j) Individuals currently employed or rostered. A direct care worker and each member of the agency or registry office staff who is employed by or rostered by a home care agency or home care registry as of December 12, 2009, shall obtain and submit a State Police criminal history record or Department of Aging letter of determination, as applicable, to the home care agency or home care registry by April 12, 2010. This subsection does not apply if the home care agency or home care registry obtained a criminal history report meeting the requirements of this subsection when the direct care worker or office staff member was hired or rostered and a copy of the report is included in the individual's file.
§ 611.53. Child abuse clearance.
(a) General rule. A home care agency or home care registry that serves persons under 18 years of age shall require each applicant for employment or referral as a direct care worker, each applicant for employment as a member of the agency or registry office staff to request a ChildLine verification regarding whether the applicant is named in the Statewide Central Register as the perpetrator of a founded or indicated report of child abuse as defined in 55 Pa. Code § 3490.4 (relating to definitions).
(b) Prohibition. A home care agency or home care registry may not employ, roster or retain an individual where ChildLine has verified that the individual is named in the Statewide Central Register as the perpetrator of a founded or indicated report of child abuse.
(c) Records maintained. The files maintained by the home care agency or home care registry for each individual employed or rostered and for each member of the office staff must include copies of the ChildLine verification. The agency or registry shall maintain copies of the ChildLine verification for the agency or registry owners, which shall be available for Department inspection.
(d) Individuals currently employed or rostered. A person who is employed by or rostered by the home care agency or home care registry, including each member of the agency or registry office staff, as of December 12, 2009, shall obtain and submit a ChildLine verification to the home care agency or home care registry by April 12, 2010. This subsection does not apply if the home care agency or home care registry obtained a ChildLine verification when the individual was hired or rostered and a copy of the verification is included in the individual's file.
§ 611.54. Provisional hiring.
(a) General rule. The home care agency or home care registry may hire an applicant for employment or referral on a provisional basis, pending receipt of a criminal history report or a ChildLine verification, as applicable, if the following conditions are met:
(1) The applicant shall have applied for a criminal history report and ChildLine verification, as applicable, and provided the home care agency or home care registry with a copy of the completed request forms.
(2) The home care agency or home care registry shall have no knowledge about the applicant that would disqualify the applicant under 18 Pa.C.S. § 4911 (relating to tampering with public record information).
(3) The applicant shall swear or affirm in writing that the applicant is not disqualified from employment or referral under this chapter.
(4) The home care agency or home care registry may not assign or refer the provisionally hired applicant until that person has met the requirements of § 611.55 (relating to competency requirements).
(5) The home care agency or home care registry shall monitor the provisionally hired applicant awaiting a criminal background check through random, direct observation and consumer feedback. The results of monitoring shall be documented in the individual's file.
(6) The home care agency or home care registry shall directly supervise, or assign another direct care worker to accompany, a provisionally hired applicant awaiting a child abuse clearance who will provide home care services to a consumer less than 18 years of age.
(7) The period of provisional hire of an individual who is and has been, for a period of 2 years or more, a resident of this Commonwealth, may not exceed 30 days. The period of provisional hire of an individual who has not been a resident of this Commonwealth for 2 years or more may not exceed 90 days.
(b) Termination. If the information obtained from the criminal history report or ChildLine verification, or both, reveals that the individual is disqualified from employment or referral under § 611.52 (relating to criminal background checks) or under § 611.53 (relating to child abuse clearance), the individual shall be terminated by the home care agency or removed from the home care registry's roster immediately. If the individual fails to provide the ChildLine verification or criminal history report, or both, within the time period permitted for provisional hire, the individual shall be terminated by the home care agency or removed from the home care registry's roster immediately.
§ 611.55. Competency requirements.
(a) Prior to assigning or referring a direct care worker to provide services to a consumer, the home care agency or home care registry shall ensure that the direct care worker has done one of the following:
(1) Obtained a valid nurse's license in this Commonwealth.
(2) Demonstrated competency by passing a competency examination developed by the home care agency or home care registry which meets the requirements of subsections (b) and (c).
(3) Successfully completed one of the following:
(i) A training program developed by a home care agency, home care registry, or other entity which meets the requirements of subsections (b) and (c).
(ii) A home health aide training program meeting the requirements of 42 CFR 484.36 (relating to the conditions of participation; home health aide services).
(iii) The nurse aid certification and training program sponsored by the Department of Education and located at www.pde.state.pa.us.
(iv) A training program meeting the training standards imposed on the agency or registry by virtue of the agency's or registry's participation as a provider in a Medicaid Waiver or other publicly funded program providing home and community based services to qualifying consumers.
(v) Another program identified by the Department by subsequent publication in the Pennsylvania Bulletin or on the Department's web site.
(b) A competency examination or training program developed by an agency or registry for a direct care worker must address, at a minimum, the following subject areas:
(1) Confidentiality.
(2) Consumer control and the independent living philosophy.
(3) Instrumental activities of daily living.
(4) Recognizing changes in the consumer that need to be addressed.
(5) Basic infection control.
(6) Universal precautions.
(7) Handling of emergencies.
(8) Documentation.
(9) Recognizing and reporting abuse or neglect.
(10) Dealing with difficult behaviors.
(c) A competency examination or training program developed by an agency or registry for a direct care worker who will provide personal care must address the following additional subject areas:
(1) Bathing, shaving, grooming and dressing.
(2) Hair, skin and mouth care.
(3) Assistance with ambulation and transferring.
(4) Meal preparation and feeding.
(5) Toileting.
(6) Assistance with self-administered medications.
(d) The home care agency or home care registry shall include documentation of the direct care worker's satisfactory completion of competency requirements in the direct care worker's file. If the direct care worker has a nurse's license or other licensure or certification as a health professional, the individual's file shall include a copy of the current license or certification. Documentation of satisfactory completion of competency requirements is transferable from one home care agency or registry to another home care agency or registry, provided the break in the individual's employment or roster status does not exceed 12 months.
(e) The home care agency or home care registry also shall include documentation in the direct care worker's file that the agency or registry has reviewed the individual's competency to perform assigned duties through direct observation, testing, training, consumer feedback or other method approved by the Department or through a combination of methods. The competency review must occur at least once per year after initial competency is established, and more frequently when discipline or other sanction, including, for example, a verbal warning or suspension, is imposed because of a quality of care infraction.
(f) A direct care worker employed by a home care agency or rostered by the home care registry on December 12, 2009, shall achieve compliance with the competency requirements imposed by this chapter by December 12, 2011.
§ 611.56. Health screening.
(a) A home care agency or home care registry shall insure that each direct care worker and other office staff or contractors with direct consumer contact, prior to consumer contact, provide documentation that the individual has been screened for and is free from active mycobacterium tuberculosis. The screening shall be conducted in accordance with CDC guidelines for preventing the transmission of mycobacterium tuberculosis in health care settings. The documentation must indicate the date of the screening which may not be more than 1 year prior to the individual's start date.
(b) A home care agency or home care registry shall require each direct care worker, and other office staff or contractors with direct consumer contact, to update the documentation required under subsection (a) at least every 12 months and provide the documentation to the agency or registry. The 12 months must run from the date of the last evaluation. The documentation required under subsection (a) shall be included in the individual's file.
(c) A direct care worker employed by a home care agency or rostered by the home care registry on December 12, 2009, shall achieve compliance with the health evaluation requirements imposed by this chapter by June 10, 2010.
§ 611.57. Consumer protections.
(a) Consumer rights. The consumer of home care services provided by a home care agency or through a home care registry shall have the following rights:
(1) To be involved in the service planning process and to receive services with reasonable accommodation of individual needs and preferences, except where the health and safety of the direct care worker is at risk.
(2) To receive at least 10 calendar days advance written notice of the intent of the home care agency or home care registry to terminate services. Less than 10 days advance written notice may be provided in the event the consumer has failed to pay for services, despite notice, and the consumer is more than 14 days in arrears, or if the health and welfare of the direct care worker is at risk.
(b) Prohibitions. No individual as a result of the individual's affiliation with a home care agency or home care registry may assume power of attorney or guardianship over a consumer utilizing the services of that home care agency or home care registry. The home care agency or home care registry may not require a consumer to endorse checks over to the home care agency or home care registry.
(c) Information to be provided. Prior to the commencement of services, the home care agency or home care registry shall provide to the consumer, the consumer's legal representative or responsible family member an information packet containing the following information in a form that is easily read and understood:
(1) A listing of the available home care services that will be provided to the consumer by the direct care worker and the identity of the direct care worker who will provide the services.
(2) The hours when those services will be provided.
(3) Fees and total costs for those services on an hourly or weekly basis.
(4) Who to contact at the Department for information about licensure requirements for a home care agency or home care registry and for compliance information about a particular home care agency or home care registry.
(5) The Department's complaint Hot Line (1-866-826-3644) and the telephone number of the Ombudsman Program located with the local Area Agency on Aging (AAA).
(6) The hiring and competency requirements applicable to direct care workers employed by the home care agency or referred by the home care registry.
(7) A disclosure, in a format to be published by the Department in the Pennsylvania Bulletin by February 10, 2010, addressing the employee or independent contractor status of the direct care worker providing services to the consumer, and the resultant respective tax and insurance obligations and other responsibilities of the consumer and the home care agency or home care registry.
(d) Documentation. The home care agency or home care registry shall maintain documentation on file at the agency or registry of compliance with the requirements of this section which shall be available for Department inspection.
[Pa.B. Doc. No. 09-2273. Filed for public inspection December 11, 2009, 9:00 a.m.]
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