Notice of public hearings on proposed amendments to regulations entitled hospital licensure regulations (105 CMR 130.000) and licensure of clinics (105 CMR 140.000)
Note from Mary:
Ch 305 is the big health quality and cost reform legislation signed into law last fall. There are lots of details to be worked out re reporting of SREs (serious reportable events), hospital reimbursement (or not) for these, establishment of rapid response teams, reporting of HAIs (hospital acquired infections) and DON, chiefly.
Notice is hereby given pursuant to M.G.L. c. 30A, §2, that the Department of Public Health will hold public hearings on proposed amendments to105 CMR 140.000 Licensure of Clinics and 105 CMR 130.000 Hospital Licensure. The proposed amendments implement certain provisions of chapter 305 of the Acts of 2008.
The proposed amendments to 105 CMR 140.000 Licensure of Clinics: (1) require all Medicare-certified Ambulatory Surgery Centers (ASC’s) to be licensed as clinics and allows the Department to “deem” a Medicare-certified ASC that is accredited by one of three nationally-recognized accrediting bodies to meet state licensing requirements; (2) require ASC’s to report serious reportable events (SRE’s) to the Department and prohibits ASC’s from charging or seeking reimbursement for SRE-related services; (3) require ASC’s to report healthcare-associated infections (HAI’s) to the Department; and (4) amend requirements for retention of clinic records to allow creation and maintenance of records in electronic format, shorten the retention period from 30 to 20 years, and require notification of the Department before records may be destroyed. In addition, the proposed amendments make technical changes to 105 CMR 140.000 to implement new Determination of Need requirements for ASC’s and require notification of the Department of clinic closures and temporary interruption of service.
The Proposed Amendments to 105 CMR 130.000 Hospital Licensure: (1) require hospitals licensed by the Department to report serious reportable events (SRE’s) to the Department and prohibit hospitals from charging or seeking reimbursement for SRE-related services; (2) require hospitals to report healthcare associated infections (HAI’s) to the Department; (3) require hospitals to establish a patient and family advisory council (PFAC); (4) require hospitals to develop a patient rapid response method (PRRM); and (5) amend requirements for retention of hospital records to allow creation and maintenance of records in electronic format, shorten the retention period from 30 to 20 years, and require notification of DPH before records may be destroyed. In addition, the proposed amendments to 105 CMR 130.000 update requirements for (6) licensed cardiac catheterization services, and (7) make technical corrections to the newborn and maternal services section of the regulation.
The Department is interested in all public comments regarding the proposed amendments. In addition, the Department is interested in comments regarding: (1) what information relating to hospital and ASC reporting of SRE’s and HAI’s should be made available to the public on the Department’s website; and (2) what factors should hospitals consider in determining the membership of Patient and Family Advisory Councils.
The first hearing will be held at the Department of Public Health, 250 Washington Street, Public Health Council Room, 2nd Floor, Boston, MA on Monday, March 23, 2009 @ 9:00 a.m.. The second hearing will be held at Springfield City Hall, 36 Court Street, Springfield, MA on Monday, March 30, 2009 @ 11:00 a.m.
Speakers are requested to provide a copy of their oral testimony. The Department encourages all interested parties to submit testimony electronically to the following address: Reg.Testimony@state.ma.us Please submit electronic testimony as an attached Word document or as text within the body of an email and type either “Hospital” or “Clinic” in the subject line. All submissions must include the sender’s full name and address. The Department will post all electronic testimony that complies with these instructions on its website. Parties who are unable to submit electronic testimony should mail submissions to LouAnn Stanton, Office of the General Counsel, Department of Public Health, 250Washington Street, Boston, MA 02108. All testimony must be submitted by 5:00p.m.on April 6, 2009.
A copy of the proposed amendments may be viewed on the Department’s website or obtained from LouAnn Stanton, Office of the General Counsel, at 617-624-5220.
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John Auerbach
Commissioner
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