We notified you of the CDPH June of 2016 notice to hospitals that recalled a number of program flexibility notices on several regulations. One of the regulations impacted was Title 22 section 70223(g) regarding pathologist examination of surgical specimens. A letter was issued by DHCS in 1985 that allowed hospital medical staff to adopt modified policy allowing for direct disposal of certain surgical specimens without pathologist examination that included bone fragments, foreign bodies and other specimens.

 

A facility seeking to obtain program flexibility for Title 22 of the California Code of Regulations section 70223(g) would need to submit a written request and provide substantiating evidence. The request must include a list of specimens that will not be reviewed by pathology and an explanation as to why each specimen will not be reviewed. The supporting evidence could be in the form of an adopted written policy and procedure approved by the medical staff and governing body, which describes how the specimens will be handled and assures that an alternative method of meeting the requirements of Section 70223(g) is provided. This policy will be reviewed and approved by the facility's licensing district office and a California Department of Public Health's Licensing and Certification Program medical consultant.

 

The impact of this new notice is that all tissues and objects removed during surgery must be sent for pathologist review with no exceptions.  In an effort to assist members who want to request regulatory flexibility we have attached a sample policy that relies upon the CAP policy statement on the subject. Here is a link to the sample text.

The decision as to what specific specimens should be exempted is up to each pathology department and medical staff. You should be aware that CAP lab accreditation standards must reflect state law and therefore the current inspection standard states that all specimens removed during surgery must be reviewed by a pathologist. In order to have exemptions a regulatory flexibility request must be submitted by the hospital.

Read the notice here

   

Last year the Senate passed SB 562 (Lara) that would have created a single payer health care system for California eliminating the role of insurers in favor of a new state program. The bill crafted by its sponsor the Ca. Nurses Assoc. would have required broad coverage of services, including long term care, for all services ordered by a physician or other authorized practitioner without any patient co-insurance or deductibles. Though estimated to cost some $400 Billion it was passed to the Assembly without any funding source. In the Assembly the Speaker determined that the bill should not move without a select committee looking at a variety of issues related to such an approach.  Those hearings juts concluded last week looked at systems in other countries, need for federal approval or waivers to use such a process to cover Medi-Cal patients and a myriad of other concerns. The Select Committee is set to deliver a report this spring.

 

The CLTAC is a multidisciplinary committee. It is composed of 21 voting members and one non-voting member who represent the various interest groups related to clinical laboratories. The CLTAC meets three times per year and allows members to participate in person or via conference line. There is currently a vacancy for a pathologist and if you have an interest in serving please contact the CSP Executive Director Bob Achermann at bacheramann@amgroup.us.