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CLTAC Updates |
June 13, 2008
Tim Hamill welcomed everyone and initiated introductions. A quorum was present.
The minutes of the March 7, 2008 meeting were approved as presented.
DEPARTMENT NEWS KATHLEEN BILLINGSLEY
(Deputy Director of Center for Health Care Quality in Dept. Public Health)
Public Health Advisory Committee has met over last 2 months and is finalizing strategic plan for Dept. of Public Health.
Budget hearing process has gone forward will soon learn the outcome.
Working on the 5th complaint at UCLA because of breach of confidentiality, hospitals taking it seriously.
Working with hospitals regarding reporting adverse events and administrative penalties. Heparin recall completed review of dialysis units and hospitals
LABORATORY FIELD SERVICES UPDATE KAREN NICKEL
(Chief Laboratory Field Services)
Items to be discussed during the meeting today:
New website: go to www.cdph.ca.gov Then click on programs then click on Laboratory Field Services
Compliance in phlebotomy (5 years out now)
BSA audit report to legislature in August
Genetic testing concerns
Approval to give civil service exam again, bulletin going out soon, will be given on a continuous basis
Certification exams continuing to review and approve certification exams, will phase out state exams have added toxicology BS, PhD and chemistry BS, PhD
Department concerns:
Slow start to MLT licensing program, legislation in 2002, regs 2005, started 2008 licensed only 27 people in last 6 months.
Only 40% renewal rate for phlebotomy
People are passing certification exams who didnt pass state exam
CLIA 2003 SUBCOMMITTEE ROBERT FOOTLIK
Meetings have been suspended because department cannot provide support.
MEDICARE COMPETITIVE BIDDING UPDATE DONNA MCCALLUM
The roll out was planned to be 4/11/08. An injunction was issued and the project is on hold.
LEGISLATION IMPACTING CLINICAL LABORATORIES, 2008
SB 1184 (KUEHL) REPORTING CD4 RESULTS California does not have CD4 reporting needs to get more Ryan White funds
AB 2658 (HORTON) ELECTRONIC LAB TEST REPORTING
Note: Reuters says better counting responsible for 25% increase in HIV/AIDS cases.
REGULATIONS IMPACTING CLINICAL LABORATORIES
DPH-07-10: HIV Screening Testing (CCR 1230) will be sent soon
DPH-08-01: Clinical Lab Personnel Standards (CCR 1030-1061) - much has been done to make more efficient but they are not ready for review
DPH-08-02: Clinical Laboratory Standards (CCR 1050) working on repealing CCR 1050 this summer
DPH-08-XX: Sperm Donor Standards (SB 443, Migden) sperm donor standards are due by 2010 (rendering sperm infection free)
LFS WEBSITE UPDATE
There was a demonstration of the new website. The link is: www.cdph.ca.gov Click on programs then click on Laboratory Field Services.
BSA AUDIT OF LAB FIELD SERVICES BEA OKEEFE
This audit was mandated by legislature. The audit is looking at 2007-2008, viewing the extent and effectiveness of policies and procedures. How is the Department investigating non-compliance? Are they imposing appropriate sanctions? Looking at the extent of the Departments ability to impose sanctions. They will make recommendations for improvements. The report will be completed in August of 2008. The Department will be able to review prior to submission. The Department has some preliminary information, but it is confidential until report. The Department is making changes.
LABORATORY LICENSURE PROJECT BEA OKEEFE
Enforcement of licensing of laboratory requirements. The Department worked with MediCal for waived and PPM laboratories. Since 2004, 6,500+ labs registered. Next on the list is to identify labs with CLIA certificates issued after 1996 that are not state licensed. The approach is to notify, educate, and bring in to compliance. Non-accredited labs will be next (inspected, but not yet determined to be licensed.)
PHLEBOTOMY COMPLAINTS AND COMPLIANCE ISSUES TOM TEMPSKE
29,000 phlebotomy certificates were issued over a 3 year period. The first phase is over. In the second phase the Department is in to renewals. They are finding compliance issues. 6 areas: Scope of practice (doing lab duties not authorized); false phlebotomy applications; false proof of experience (after 2/1/07 cant have experience without a certificate) civil money penalties; problems with renewals people renewing without being in data base (forged certificates); live scan if self identified of being convicted; and problems with training schools.
Business and Professions Code (B&P) 1269 describes what phlebotomists can and cannot do (esp. B and D)
B&P 1285 hiring unqualified personnel
INCREASE IN HEALTHCARE PROVIDERS USING TISSUE PRODUCTS
There are 560 Tissue Banks in California now.
GENETIC TESTING CONCERNS KAREN NICKEL
There was a review of genetic testing with the conclusion that there is no good definition. The bottom line is genetic tests may NOT be self-ordered in California. Labs who perform genetic testing are subject to the same laws and regulations as any other clinical laboratory.
NEW BUSINESS
When does a private physician report MRSA to Public Health Department? Only the most severe cases.
There is a severe shortage of cytogeneticists. There are only two levels. PhD level individuals have gone through a fellowship and passed boards may be employed in interpretation of genetic studies. For non PhD level individuals CA requires 2 additional years of post training experience prior to getting a license as a Clinical cytogeneticist. What can be done to eliminate the roadblocks to licensure?
The next meeting will be September 5th.
Kathleen Doty
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