Section He-P 802.39 - Cardiac Catheterization Services(a) If cardiac catheterization services have not been provided by the hospital previously, no licensee shall offer cardiac catheterization services without a special health care service license.(b) In accordance with RSA 151:2-e, all licensees shall comply with this section if they provide cardiac catheterization services, regardless of whether the licensee holds a special health care license. (c) Cardiac catheterization laboratory services shall only be provided on the campus of a licensed hospital. (d) Licensed hospitals providing interventional cardiac catheterization laboratory services without on-site open-heart surgery shall secure and maintain a formal transfer agreement with a hospital performing open heart surgery. (e) Licensed hospitals providing elective interventional cardiac catheterization laboratories shall also provide primary interventional cardiac catheterization laboratory services within 12 months of commencement of elective interventional cardiac catheterization laboratory services.(f) Licensed hospitals providing primary interventional cardiac catheterization services shall meet the procedure volume requirements of 150 cardiac catheterization procedures of any kind at the licensed location on an annual basis by the end of the third year of operation. This may be demonstrated by the number of claims the licensee files in any twelve-month period.(g) Cardiac catheterization laboratories performing only diagnostic catheterization procedures and not interventional catheterization procedures shall not have any minimum volume requirements.(h) Hospitals providing cardiac catheterization laboratory services shall include cardiac catheterization laboratory services in the hospital's quality assurance plan to objectively and systematically monitor patient care. (i) The quality assurance plan referenced in (h) above shall:(1) Contain patient selection criteria by procedures; (2) Contain formal transfer agreements and emergency protocols for transfer to another facility which: a. Specify the protocol for transfer to another facility; and b. Include the signature of both hospitals and be dated within the past 12 months of submission with the application; (3) Describe the mentoring program for licensed physicians, which shall include operator volume requirements; and(4) Describe the process of review and outcomes analysis for patients who have been transferred without compromising the statutory confidentiality protection of the hospital's quality assurance program.(j) All licensees performing cardiac catheterization laboratory services shall be accredited by a recognized accrediting agency for the provision of cardiac catheterization laboratory services.(k) If the licensee is newly providing cardiac catheterization services, the licensee shall have 3 years, from the date of receiving a special health care license, to obtain accreditation required in (j) above.(l) Staffing for cardiac catheterization laboratory services shall be in accordance with the accrediting agency's accepted staffing requirements.(m) Cardiac catheterization laboratory services shall be directed and staffed by a board certified cardiologist with training and experience, which meets or exceeds the requirements of "ACCF/AHA/SCAI's "2013 Update of the Clinical Competence Statement on Coronary Artery Interventional Procedures" (July 2013), available as noted in Appendix A.N.H. Admin. Code § He-P 802.39
Derived From Volume XLI Number 6, Filed February 11, 2021, Proposed by #13166, Effective 1/28/2021, Expires 1/28/2031.