CDPH is revising the GACH Clinical Laboratory Service regulations. In April 2011, CDPH held a public meeting to notify stakeholders that the Department intends to revise the GACH regulations, Articles 3 and 6, which includes the Clinical Laboratory Service regulations. At that time, CDPH received and carefully reviewed the comments and feedback that stakeholders provided. CDPH is now seeking additional stakeholder input on specific areas of the regulations.

Interested stakeholders are encouraged to provide input and comments related to revising the GACH Clinical Laboratory Service regulations through an online survey at: General Acute Care Hospital Clinical Laboratory Service Survey (https://www.surveymonkey.com/r/8MPM3NN), or by emailing responses to the following survey questions to CDPH_CHCQRegulationsUnit@cdph.ca.gov by September 29, 2017.

The GACH Clinical Laboratory Service Survey

1. Organization Name
2. Organization Type
   a. Hospital Provider
   b. Advocacy Group
   c. Other (please specify)
3. What costs (if any) would be imposed by requiring approvals to be made in writing if the approval of various policies, procedures, and/or other documents is already required in the existing regulations?
4. Are you aware of a hospital experiencing delays receiving test results from outside contractors? If so, how have such delays impacted patient care?
5. Do hospitals have different lab procedures for outpatients than those used for inpatients? If so, what are the differences and why are different procedures used?
6. According to current regulations, the pathologists who examine tissue and oral specimens must be certified by a specified medical board, or possess qualifications equivalent to those required for certification. Currently, who determines if a pathologist candidate’s qualifications are equivalent to those required for certification?
   a. The clinical lab director
   b. A committee described in the medical by-laws
   c. The governing body, acting under 22 CCR 70701(a)(1)(B)
   d. Other (please specify)
7. The lab director must be certified in either anatomic or clinical pathology by a specified board, or possess qualifications equivalent to those required for certification. Who determines that a lab director candidate’s qualifications are equivalent to those required for certification?
   a. The governing body, acting under 22 CCR 70701(a)(1)(B)
   b. A committee described by the medical by-laws
   c. Other (please specify)

Additional information or comments may be emailed to Karen Halbo at CDPH_CHCQRegulationsUnit@cdph.ca.gov by September 29, 2017. You may also submit documents by U.S. Mail to:

California Department of Public Health
Center for Health Care Quality
Attn: Karen Halbo, Regulations Unit
P.O. Box 99737
Sacramento, CA 95899-7377

Sincerely,

Original signed by Jean Iacino

Jean Iacino
Deputy Director