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Laboratory Field Services - California Clinical Laboratory ...

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Laboratory Field Services
Presented by:Robert J. Thomas, Chief
LFS Organization
Under the Office of the State Public Health Laboratory DirectorPaul Kimsey, Deputy DirectorTina Kruthoff, Assistant ChiefLaboratory Field ServicesRobert Thomas, ChiefLaboratory Licensing and RegistrationMartha Obeso, Section ChiefTissue and Blood Banks, Biologics, and CytologyRon Harkey, Section ChiefOn-site Licensing SectionElsa Eleco, Section ChiefCLIA Survey SectionDonna McCallum, Section ChiefPersonnel Licensing Section
Changes at LFS
On-site Licensing SectionElsa Eleco, Section ChiefGilberto Wilson, ComplaintsFacility Licensing and RegistrationMartha Obeso, Section ChiefEdward Campos, Program Technician II SupervisorNai Saechao, Staff Services Analyst, Out-of-State LicensingLFS Recruitment and RetentionPriorities
California State Auditors 2015 Report
CSA report and recommendations can be found at: should inspect all in-state and out-of-state licensed laboratories every two years (#2 Pending)Implement a procedure to identify out-of-state laboratories that fail proficiency testing (#3 Fully Implemented)
California State Auditors 2015 Report
Improve complaints procedures and establish policies for on-site visits to verify corrective actions (#4 Fully Implemented)Update sanctioning procedures (#5 Fully Implemented)Develop a process to assess the Budget Act annually and adjust fees accordingly (#6 Pending)Partner with accrediting organizations for laboratory oversight (#7 Fully Implemented)
California State Auditors 2015 Report
Develop a succession plan for staff recruitment and retention (#8 Partially Implemented)Update information technology data systems (#9 Pending)Update and develop regulations as necessary (#10 Pending)
Accrediting Organizations
The following federally approved accrediting organizations (AO) have been approved by LFS for deeming authorityCOLA approved September 2013The Joint Commission (JC) approved May 2016College of American Pathologists (CAP) approved May 2016Full information and updates available on the LFS website at:
All Clinical Laboratories Letter (ACLL)
ACLLAll ACLLs are posted on the LFS websiteThis mechanism can only be used for AOsAn ACLL is a letter from LFS that has the force of regulations
ACLLs explain the requirements for private non-profit AOs to inspect clinical laboratories and the requirements for laboratories choosing deemed statusACLL 16-01 (May 14, 2016): Laboratory requirements to qualify for deemed statusACLL 16-02 (August 20, 2016): AO requirements for deeming authorityLFS may issue future ACLLs
What does this mean for your lab?
If you choose LFS oversight:On-site inspections performed by LFS examinersFees paid to LFSInspection records subject to Public Records Act (PRA) requestsComplaints referred to LFSIf you choose deemed status under an AO:On-site inspections performed by AOValidation surveys may be performed by LFSFees paid to LFS and AOInspection records not subject to PRA requests*Complaints primarily under AO, LFS retains jurisdiction*Records supplied to LFS by the AO may be subject to PRA request
How to choose deemed status
If a laboratory is affiliated with an LFS-approved AO, the laboratory will be under AO oversight until the time of annual state renewalApplying for deemed statusSubmit an application to LFSLaboratories must now select LFS oversight or AO oversightHave a current, valid CLIA certificateBe enrolled with an LFS-approved AOSubmit a written request to the AO to be considered for deemed statusPay the LFS application or renewal feeLaboratories must meet the requirements found in ACLL 16-01
Online Application Systems
Phase I, PERL system activated for initial personnel license and certificatePhase II, PERL system in development for renewal of personnel licenses and certificatesPERL IIPERsonnelLicensingOnline renewal of personnel licenses and certificatesContinuing Education submitted onlineTraining school approval applications submitted online
Online Application Systems
ECMElectronicContentManagementHigh speed scanning and automatic document appendingELLFSElectronicLaboratoryLicensing and Registration forFacilitiesSystemWill bring facilities licensing onlineApply for licenses and registrations onlineOnline renewalOption to pay onlineApplicants can track application process
AACRAO (American Association of Collegiate Registrars and Admissions Officers) educational transcript evaluation service informed LFS that it would cease review of foreign transcripts effective August 15, 2016.Interim solution: LFS will accept transcript evaluations from:Current members of NACESEndorsed members of AICELFS working with the CDPH Office of Legal Services on a permanent solution
Regulations Update
Repeal of Title17 of the California Code of Regulations §1050Effective May 25, 2016.This action repeals all subsections of §1050 except old item (d), which pertains to facility requirements.Due to publication of the crosswalk, the Department is pursuing the repeal of the remaining §1050 item (d) regarding facilities to update CA law.
CLIA 2003 Crosswalk
The CLIA 2003 Crosswalk was published October 7, 2016, in the California Notice Register,Cal. Reg. Notice Register 2016, No. 41-Z, p. 1825.The Crosswalk lists provisions of CLIA 2003 deemed equivalent to or more stringent than California law.Those provisions deemed equivalent to or more stringent than California law are adopted into California law.
Regulations Update
DPH-11-012, Personnel Licensing RegulationsThis regulation package updates personnel licensing standards to facilitate licensure of qualified persons for various categories of laboratory professionals.Personnel license and certificate requirementsMLTs, CLS, director categories, trainees, cytotechnologists, phlebotomistsTraining program requirementsMLT, CLS, post-doc, phlebotomyContinuing educationUnlicensed personnelChanges to conform with new application and renewal formsCurrent draft is being finalized by LFS working with assigned attorneys from the Office of Regulations.
LFS Website Department website comingMore user friendlyADA accessibleIncreased interactive capacityEnhanced search functions





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Laboratory Field Services - California Clinical Laboratory ...