The Commonwealth of Massachusetts
Executive Office of Health and Human Services
Department of Public Health
250 Washington Street, Boston, MA 02108-4619
To: Commissioner Monica Bharel, MD and Members of the Public Health Council
From: Eric Sheehan, Director, Bureau of Health Care Safety and Quality
Date: 9/14/16
RE: Informational Briefing on Proposed Amendments to 105 CMR 145.000, Licensing of Out-of-Hospital Dialysis Units in Massachusetts
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I. Introduction
The purpose of this memorandum is to provide the Public Health Council (PHC) with information about proposed amendments to 105 CMR 145.000, Licensing of Out-of-Hospital Dialysis Units in Massachusetts. The Bureau of Health Care Safety and Quality (BHCSQ), within DPH, drafted these amendments to update the regulations as part of the regulatory review process, mandated by Executive Order 562, which requires the Department of Public Health (DPH), and all other state agencies, to undertake a review of each and every regulation currently published in the Code of Massachusetts Regulations under its jurisdiction.
The proposed amendments to this regulation improve readability by updating the language, clarify and update staffing requirements to reflect appropriate practice in units and to be consistent with federal law, make emergency planning consistent with clinics, streamline medical records requirements for clarity and consistency with federal law, and clarify reporting requirements.
II. Proposed Regulation
Updates For Clarity and Consistency
Throughout the regulations we propose updating language and clarifying requirements. In addition, we have added sections to comply with statutory requirements and to create consistency with state and federal laws, regulations and procedures.
We propose adding sections to permit applications for special projects and to request waivers of regulations. These sections exist in the other health facility licensure regulations and provide a means to innovate in the delivery of service.
The Admission procedures requirement has changed to allow admission or transfer without prior initiation of dialysis in an affiliated hospital which has a chronic dialysis service that agrees to accept the patient for in-patient care and other services as needed. This change reflects the current, lower-cost practice and eliminates or reduces a potentially unnecessary hospitalization.
The proposed regulations also streamline requirements for medical records to align retention periods with federal regulations at 42 CFR 494.710.
We propose making emergency planning consistent with clinic requirements at 105 CMR 140.305.
We propose removing 105 CMR 145.840, Agency Responsible for Supervision of Dialysis because the primary care provider or physician of the patient’s choice is responsible for supervising the patient’s care as described in 105 CMR 145.410.
Professional Staff Changes
We propose updating the regulation requiring the unit to have a governing body that sets the policies of the unit, to allow the option for an individual or small group of individuals to be designated with the legal authority to provide governance to the dialysis unit. In addition, we have added, at 105 CMR 145.124 and 145.125, regulations requiring the medical staff director to work with the governing body to grant privileges to staff, and requiring that the unit have medical staff bylaws approved by the governing body. These changes make the regulations consistent with federal law regarding out-of-hospital dialysis units and more consistent with other health facility licensure regulations.
We propose updating language to reflect that a patient’s primary care provider may be a nurse practitioner or a physician.
In addition, the proposed regulations clarify that the administrator responsible for the unit and the medical director must be physically present sufficiently to perform their duties.
The proposed amendments also update the nursing personnel regulations to more accurately reflect the duties of nursing personnel and other staff. We have added Licensed Professional Nurses to the requirement at 105 CMR 145.150 that the unit have sufficient direct care nursing personnel on duty to provide nursing care, because this care can be provided by either RNs or LPNs.
We have also updated the title of dialysis staff to “Clinical Hemodialysis Technicians” and have updated 105 CMR 145.153 to reflect that these technicians, after training, may conduct such direct care work as starting and ending dialysis, maintenance and use of dialysis equipment, surveillance of the patient’s condition during dialysis, and administration of agents prescribed for regulation of blood clotting mechanisms as part of the dialysis process.
Physical Plant Requirements
The proposed amendments update the physical plant requirements to provide flexibility and consistency with other standards, while still ensuring patient health and safety. We have removed specific square footage requirements where it is more appropriate to require that there be sufficient space for specific equipment and access, and added space requirements where necessary for safety. These changes all comply with federal requirements as well.
We have added requirements for the physical space necessary if units provide a room for home training. In addition, the requirements for dialysis unit support space have been updated to reflect the necessary health and safety standards without unnecessarily prescriptive specifications. We have also added a requirement for mechanical ventilation for all rooms without direct access to the outside, to protect the health and safety of everyone in the unit.
Affiliation Agreements
The affiliation agreements have been updated and consolidated. Affiliation agreements for emergency services have been removed because units should call 911 and rely on the EMS system in emergencies. In addition, we have consolidated separate and duplicative affiliation agreements into 105 CMR 145.300, requiring affiliation agreements that consider inpatient care, routine and emergency dialysis, other hospital services, and emergency care.
Reporting Requirements
The proposed amendments require facilities to share health care associated infection (HAI) data with DPH, develop and implement complaint procedures, and report serious incidents. Facilities must grant DPH access to reports concerning HAIs which are presently reported to the Centers for Medicare and Medicaid Services through the Centers for Disease Control and Prevention’s National Healthcare Safety Network, consistent with other health care facilities including hospitals which also provide dialysis.
We have also added requirements for procedures to ensure facilities respond promptly and completely to serious complaints and requirements for providers to report the death of a patient, fires, evacuation or other serious incidents to the Department and allegations of abuse, neglect, misappropriation or mistreatment. These added requirements foster patient safety and standardize serious incident reporting and serious complaint procedures across all health care facilities.
Evaluation of Quality
We propose adding 105 CMR 145.460, Evaluation of Quality, to require all units to establish an active program to ensure care is delivered in a safe and reliable manner, and that any identified care issues are promptly addressed.
Pharmaceutical Services
We also propose adding a regulation to clarify already existing obligations if a unit stores and administers controlled substances. 105 CMR 145.470 specifies that the facility must register with the Department pursuant to M.G.L. c. 94C, §7 and must comply with the provisions for storage and administration of controlled substances pursuant to the Federal Food, Drug and Cosmetics Act, M.G.L. c. 94C, and 105 CMR 700.000.
V. Summary
Staff intends to conduct the public comment hearing in September and hopes to return to the PHC shortly after that to report on testimony and any recommended changes to the proposed amendments. Following final action by the PHC, the Department will be able to file the final amendment with the Secretary of the Commonwealth.
The proposed amendments to 105 CMR 145.000 are attached to this memorandum.
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