Transcript DPH`s PowerPoints

Proposed Amendments to 105 CMR 130.000:
Hospital Licensure
Sherman Lohnes, JD
Director of the Division of Health Care Facility Licensure and Certification
Bureau of Health Care Safety and Quality
Lauren B. Nelson, Esq.
Director of Policy and Quality Improvement
Bureau of Health Care Safety and Quality
Public Health Council
September 14, 2016
Slide 1
Background
• This regulation, 105 CMR 130.000, Hospital Licensure, sets
forth standards for the maintenance and operation of
hospitals, pursuant to M.G.L. c. 111, §§51 and 51G.
• This regulation ensures a high quality of care, industry
standardization, and strong consumer protection for
individuals receiving care in hospitals.
• These amendments are proposed as part of the regulatory
review process, mandated by Executive Order 562, which
requires all state agencies to undertake a review of each
regulation under its jurisdiction currently published in the
Code of Massachusetts Regulations.
Slide 2
Proposed Revision Highlights
The proposed revisions will achieve the following:
• Eliminate outdated or unnecessary requirements;
• Clarify requirements for licensure;
• Require notice to employees and state agencies before the closure of essential
services;
• Update the nurse to patient ratio to comply with M.G.L. c. 111 §231;
• Align reporting of serious complaints and incidents with other state and federal
requirements;
• Incorporate birth center provisions from the proposed rescinded birth center
regulation (105 CMR 142.000);
• Update and consolidate the sections relative to Stem Cell Transplantation,
Maternal and Newborn Services, and Cardiac Surgery and Cardiac Catheterization
Services; and
• Update terminology, centralize generally applicable definitions and use plain
language to make the regulation easier to read and understand.
Slide 3
Proposed Revision Highlights:
Outdated and Unnecessary Sections
The proposed revisions remove several sections which are no longer
required or are otherwise unnecessary, including:
• Eliminating references to the Advocacy Office established pursuant to 105
CMR 131.000, as this regulation is proposed for rescission;
• Removing language requiring DPH to establish advisory committees where
there is no statutory requirement for an advisory committee:
– The committees have not met on a regular basis, and
– DPH can request input from stakeholders when needed;
• Eliminating bed count reporting requirements, which were removed from
M.G.L. c. 111 §51 by chapter 402 of the acts of 2014;
• Removing outdated language for deadlines that have already passed; and
• Eliminating visitation provisions for county hospitals, as such hospitals no
longer exist.
Slide 4
Proposed Revision Highlights:
Licensure Requirements
Current Regulation:
• There is currently no timeline for submission of an application for initial
licensure or transfer of ownership.
Proposed Revision:
• Requires applications for initial licensure or transfer of ownership to be
submitted at least 60 days in advance.
• Inserts a new section outlining the requirements for the transfer of
ownership of a hospital.
Rationale:
• Provides specific timelines, eliminating delays in application review.
• Provides regulatory support for the transfer of ownership or location
process required by DPH and eliminates current confusion around the
process.
• Aligns with newly proposed amendments to 105 CMR 100: Determination
of Need.
Slide 5
Proposed Revision Highlights:
Additional Licensing Updates
Additional proposed licensing revisions include the following:
• Updating evidence of responsibility and suitability requirements to more
closely track the statutory requirements in M.G.L. c. 111 §51;
• Eliminating the provisional licensure category, as M.G.L. c. 111 §51 does
not provide for such a license; and
• Eliminating duplicative licensure review for hospitals offering substance
abuse services if they have already been approved by the Bureau of
Substance Abuse Services, thereby reducing delay in opening new and
expanded services.
• Ensuring submission of a community benefits plan, as required by M.G.L.
c. 111 §51G;
– DPH will work to create consistency and eliminate duplication across overlapping
regulatory and statutory provisions in this area.
Slide 6
Proposed Revision Highlights:
Closure of Essential Services
Current Regulation:
• Requires notice only to DPH at least 90 days in advance of closing an essential service.
Proposed Revision:
• Expands 90-day notice of essential services closures to:
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The Health Policy Commission;
The Center for Health Information and Analysis;
The Attorney General’s Office;
The Executive Office of Labor and Workforce Development; and
The health care coalitions and community groups identified by the hospital in its notice.
Provides additional notice to the following groups 30 days prior to notifying DPH:
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The hospital’s patient and family council;
Each staff member of the hospital;
Every labor organization that represents the hospital’s workforce;
Members of the General Court who represent the hospital district; and
A representative of the city or town in which the hospital is located.
Rationale:
• Enhances communication and notice of closures to interested parties in line with ongoing
Public Health Council and stakeholder discussion.
Slide 7
Proposed Revision Highlights:
ICU Nurse Staffing
Current Regulation:
• Requires a ratio of 1 nurse for every 4 patients in Intensive Care Units.
Proposed Revision:
• Requires a nurse to patient ratio of either 1:1 or 1:2, depending on the
acuity of the patient.
Rationale:
• Updated to comply with M.G.L c. 111 §231.
• Aligns with CMS conditions of participation, which require a 1:2 ratio.
Slide 8
Proposed Revision Highlights:
Reporting Requirements
Current Regulation:
• Requires reporting of serious incidents, serious reportable events and
healthcare acquired infections to DPH.
Proposed Revision:
• Adds reporting requirement for serious adverse drug events to DPH, and
defines the term according to statute.
– Sub-regulatory guidance will be crafted to ensure that implementation in accordance with
statute is managed efficiently, using existing reporting mechanisms when possible.
• Updates the reporting requirements for serious incidents, serious reportable
events and healthcare associated infections to comply with statutory
requirements.
Rationale:
• Ensures compliance with federal and state reporting requirements.
• Aligns with the reporting requirements of other health care facilities.
Slide 9
Proposed Revision Highlights:
Maternal and Newborn Services
The proposed revisions to the maternal and newborn services sections
include the following:
• Updates definitions to reflect changes in current practice;
• Reorganizes and consolidates duplicative sections;
• Removes overly prescriptive language that could limit a hospital’s ability
to develop new and innovative approaches to patient care based upon
current standards of practice;
• Reduces prescriptive data collection and reporting requirements while
providing DPH flexibility to request more data, pursuant to guidelines; and
• Restructures the requirements of each level of maternal and newborn
service to build off the level below.
• For example, a Level II service which includes special care nurseries must
comply with the requirements of the baseline Level I service, well baby and
continuing care nurseries, plus additional mandates.
Slide 10
Proposed Revision Highlights:
Maternal and Newborn Services: Patient Services
Current Regulation:
• Includes specific requirements for patient and family services.
Proposed Revision:
• Removes specific requirements for patient and family services while
retaining the requirement that hospitals develop policies and procedures
for such services.
Rationale:
• Allows hospitals to develop policies for patient and family services that
reflect the needs of their community.
– For example, strict language relating to family relationships, like “mother and father”
have been replaced with broad terms like “family”, thereby allowing recognition of
varied family systems.
Slide 11
Proposed Revision Highlights:
Maternal and Newborn Services: Physical Plant
Requirements
Current Regulation:
• Includes specific physical plant requirements for maternal and newborn
services.
Proposed Revision:
• Aligns physical plant requirements with the nationally recognized,
evidence-based, industry standards of the Facility Guidelines Institute
requirements for maternal and newborn services.
• Removes the requirement to have the number of bassinets in the
newborn nursery be one more than the number of maternity beds.
Rationale:
• Provides consistency with other health care facility licensure regulations.
• Provides flexible, streamlined development using contemporary standards
to reduce regulatory burden.
Slide 12
Proposed Revision Highlights:
Birth Center Services
Current Regulation:
• References 105 CMR 142 for regulation of birth center services.
Proposed Revision:
• Incorporates the requirements for free-standing birth centers operated by
hospitals that are included in 105 CMR 142.000, which DPH recommends for
rescission.
• Includes the necessary protocols for health and safety policies, staffing
requirements, necessary specialized equipment, and specialized requirements
for medical records, off-hour coverage, and a referral system for necessary
transfers to the parent hospital.
Rationale:
• Birth centers operated by hospitals were required to comply with all applicable
provisions of both 105 CMR 130.000 and 105 CMR 142.000, creating duplicative
and confusing regulations.
• Incorporation of the birth center regulations will eliminate confusion for
hospitals operating birth centers.
Slide 13
Proposed Revision Highlights:
Cardiac Catheterization Services
Current Regulation:
• Limits approval of cardiac catheterization services through department guidance.
Proposed revisions:
• Update the regulations to reflect medical advances and changing national standards for
the provision of service; and
• Remove all references to mobile cardiac catheterization, as there are currently no
mobile cardiac catheterization programs in Massachusetts, and DPH does not anticipate
the need to add any new mobile services.
Rationale:
• Streamlines multiple application and approval methods into a single, predictable
method.
• Standardizes confusing and outdated processes to bring cardiac catheterization services
in line with other hospital services.
• Modernizes the approval and oversight of cardiac catheterization to ensure minimum
requirements for the safety and quality of a long-standing service type.
Slide 14
Proposed Revision Highlights:
Cardiac Catheterization Services: Licensure
Current Regulation:
• Limits approval of cardiac catheterization services through department guidance
Proposed Revision:
• Establishes a licensing process to provide cardiac catheterization services.
• Provides application review to determine whether hospitals meet regulatory standards
and quality and access requirements necessary to operate a service.
• Permits hospitals to seek approval to operate each of the following services, regardless
whether they perform cardiac surgery on site:
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diagnostic catheterization;
diagnostic and interventional catheterization;
pediatric catheterization; and
electrophysiology
Rationale:
• Comprehensive guidance, with data-driven approach to patient safety will replace all
current circular letters to remove the moratorium on new cardiac catheterization
programs within a 30-minute ambulance ride of another program.
• Allowing any hospital to apply for approval of a service will provide consistent,
predictable rules for operation and may increase geographic access.
Slide 15
Proposed Revision Highlights:
Cardiac Catheterization Services: Service Volumes
Current Regulation:
• Hospitals that perform diagnostic and/or interventional catheterizations
must annually perform a stated number of procedures.
Proposed Revision:
• Requires hospitals to meet service volume minimums, which are based on
the evidence-based guidelines and standards issued by the American
College of Cardiology, American Heart Association and Society for Cardiac
Angiography and Interventions.
• Retains condition to submit Quality Assessment and Performance
Improvement (QAPI) quarterly reports if minimums are not met.
Rationale:
• Enables efficient responsiveness to changes in nationally recognized
consensus documents, which are updated approximately every 2 years,
while maintaining safety and quality care for patients.
Slide 16
Proposed Revision Highlights:
Cardiac Catheterization Services: Physician Volumes
Current Regulation:
• Physicians who perform percutaneous coronary intervention (PCI) must
meet a minimum volume of 75 PCI procedures annually.
Proposed Revision:
• Eliminates physician/operator volume minimum requirement;
• Directs the hospital to establish criteria for granting privileges; and
• Requires the hospital to ensure that its staff is appropriately trained and
competent to perform the service.
Rationale:
• Reflects changing national standards for the provision of such services.
• Current consensus documents have moved away from strict volume
minimums as the prevailing indicator of safe practice.
• Physicians with higher than expected mortality outcomes are identified
annually through MassDAC and the Department follows up appropriately.
Slide 17
• The Department will conduct a public hearing to solicit
comments on the proposed revision.
• Following the public comment period, the Department will
return to the Public Health Council to report on testimony
and any recommended changes to this revision, and seek
final promulgation.
Slide 18
• Thank you for the opportunity to present this information today.
• For more information on 105 CMR 130.000, Hospital Licensure, please find
the relevant statutory language (M.G.L. c. 111, § 3, 51 through 56, and
70) and the full current regulation here:
https://malegislature.gov/Laws/GeneralLaws/PartI/TitleXVI/Chapter111
http://www.mass.gov/courts/docs/lawlib/104-105cmr/105cmr130.pdf
Slide 19
Proposed Amendments to 105 CMR 140.000:
Licensure of Clinics
Sherman Lohnes, JD
Director of the Division of Health Care Facility Licensure and Certification
Bureau of Health Care Safety and Quality
Lauren B. Nelson, Esq.
Director of Policy and Quality Improvement
Bureau of Health Care Safety and Quality
Public Health Council
September 14, 2016
Slide 20
Background
• This regulation, 105 CMR 140.000, Licensure of Clinics, sets
forth standards for the maintenance and operation of
clinics.
• The regulation ensures a high quality of care, industry
standardization, and strong consumer protection for
individuals receiving care at clinics.
• These amendments are proposed as part of the regulatory
review process, mandated by Executive Order 562, which
requires all state agencies to undertake a review of each
regulation under its jurisdiction currently published in the
Code of Massachusetts Regulations.
Slide 21
Proposed Revision
The proposed revisions will achieve the following:
• Improve readability by updating language;
• Update definitions where necessary;
• Reduce regulatory burdens on regulated parties operating a
limited services clinic or small clinic with no more than 2 exam
rooms, while maintaining high safety and quality standards;
• Align reporting of serious complaints and incidents with other
state and federal requirements;
• Add flexibility for clinics providing mental health services; and
• Incorporate birth center provisions from the proposed
rescinded birth center regulation (105 CMR 142.000).
Slide 22
Proposed Revision Highlights:
Urgent Care
Current Regulation:
• The urgent care practice model is not addressed.
Proposed Revision:
• Adds a definition for urgent care to clarify that such a practice model
requires licensure as a clinic.
• Inserts a requirement that urgent care clinics provide a copy of the medical
record of a visit to a patient at the end of that visit, and with the patient’s
consent, provide a copy to the patient’s primary care provider.
Rationale:
• Requiring licensure reduces confusion to operators of urgent care centers
and the public.
• Providing medical records to the patient’s primary care provider ensures
patients have continuity of care.
Slide 23
Proposed Revision Highlights:
Licensing Requirements
Current Regulation:
• Requires a clinic to notify DPH of any proposed change in name or location.
Proposed Revision:
• Adds specific timelines for submitting applications for renewal (90 days prior to
the expiration of the license) and for notifying DPH of a proposed change in name
or location (30 days prior to the proposed change).
• Inserts language to prevent clinics from having misleading names and requires
clinics to seek approval from DPH prior to changing the clinic name.
Rationale:
• Specific timelines provide DPH with adequate time to review changes.
• Restrictions on misleading names will protect the public from confusion.
Slide 24
Proposed Revision Highlights:
Clinic Facilities
Current Regulation:
• Exempts clinics providing only mental health services from physical plant
requirements for clean storage and soiled workroom areas.
Proposed Regulation:
• Includes small clinics with no more than 2 examination rooms in the clean
storage and soiled workroom area exemption.
• Allows limited service clinics and mobile or portable units that are located
at or on the premises of another entity to share toilet facilities with that
entity as long as the facilities meet other sanitary requirements.
Rationale:
• Reduces regulatory burden of regulated parties, while maintaining high
quality and safety standards.
Slide 25
Proposed Revision Highlights:
Reporting Requirements
Current Regulation:
• Requires reporting of serious incidents, serious reportable events (by
ambulatory surgical centers) and healthcare associated infections to DPH.
Proposed Revision:
• Requires reporting of serious adverse drug events (SADE) to DPH.
• Updates the reporting requirements for serious incidents, serious
reportable events and healthcare associated infections to comply with
statutory requirements.
Rationale:
• Ensures compliance with federal and state reporting requirements,
including SADE requirements, as required by statute.
• Aligns with the reporting requirements of other health care facilities.
Slide 26
Proposed Revision Highlights:
Dental Surgery
Current Regulation:
• Requirements for the performance of dental surgery by clinics is not
addressed in current regulation.
Proposed Revision:
• Inserts a new section requiring a clinic that performs dental surgical
procedure to be licensed to provide surgical services.
Rationale:
• Ensures patient safety by allowing only those clinics that are appropriately
licensed to provide surgical services to perform dental surgery.
• Protects access to dental services by underserved communities.
Slide 27
Proposed Revision Highlights:
Mobile Health Services
Current Regulation:
• Includes detailed physical plant requirements of host sites for mobile services.
Proposed Revision:
• Removes prescriptive physical plant requirements of host sites for mobile
services, and outlines examples of appropriate sites, including long-term care
facilities, assisted living facilities, business locations, community centers, social
service agencies and churches.
• Clarifies that space leased by a clinic requires licensure as a satellite.
• Prohibits clinics from storing medications at any host site or overnight in a
mobile or portable unit.
Rationale:
• Allowing flexible siting of mobile services for clinics seeking to reach out to
rural, isolated and underserved communities.
• Regulating the storage of medication ensures the safety of patients and
prevents medication diversion.
Slide 28
Proposed Revision Highlights:
Mental Health Services
Current Regulation:
• Caps mental health outreach visits and limits outreach clients to less than
a majority of the clinic’s patients.
Proposed Revision:
• Removes the cap on mental health outreach visits and eliminates the
percentage limit on a clinic’s outreach clients.
• Recognizes that the appropriate evaluation and diagnostic services vary
depending on the patient’s chief complaint or problem.
• Adds provisions for patients requiring brief treatment of 4 sessions or less.
Rationale:
• Removes a barrier to mental health treatment by allowing clinics to
deliver services at sites in the community, without limitations on the
number of patients and percentage of clients that can be served.
• Provides greater flexibility for clinics providing mental health services.
Slide 29
Proposed Revision Highlights:
Birth Center Services
Current Regulation:
• Referenced 105 CMR 142 for regulation of birth center services.
Proposed Revision:
• Incorporates the requirements for free-standing birth centers operated by
clinics, included in 105 CMR 142.000, which DPH recommends for rescission.
• Includes the necessary protocols for health and safety policies, staffing
requirements, necessary specialized equipment, and specialized requirements
for medical records, off-hour coverage, and a referral system for necessary
transfers to hospitals.
Rationale:
• Birth centers operated by clinics were required to comply with all applicable
provisions of 105 CMR 140.000 and 105 CMR 142.000, creating duplicative and
confusing regulations.
• Incorporation of the birth center regulations will eliminate redundancy for
clinics operating birth centers.
Slide 30
Proposed Revision Highlights:
Additional Updates
Additional proposed revisions include the following:
• Includes definitions for mobile and portable care to expand
authority for clinics to operate vehicles to serve patients in
underserved and geographically isolated areas;
• Updates emergency transfer protocols by requiring clinics to
have a written policy for calling 911 for patients in need of
emergency treatment; and
• Requires the clinic administrator and professional services
director to be physically present in the clinic as necessary to
perform their duties and ensure patient safety.
Slide 31
• The Department will conduct a public hearing to solicit
comments on the proposed revision.
• Following the public comment period, the Department will
return to the Public Health Council to report on testimony
and any recommended changes to this revision, and seek
final promulgation.
Slide 32
• Thank you for the opportunity to present this information today.
• For more information on 105 CMR 140.000, Licensure of Clinics, please
find the relevant statutory language (M.G.L. c. 111, §3, 51 through 56)
and the full current regulation here:
https://malegislature.gov/Laws/GeneralLaws/PartI/TitleXVI/Chapter111
http://www.mass.gov/courts/docs/lawlib/104-105cmr/105cmr140.pdf
Slide 33