1. The Evolving Regulatory Landscape
CCLA 2014 Annual Conference
The Evolving Regulatory Landscape
Bea O’ Keefe, Chief, Lab Field Services, California Department of Public Health
Gary Yamamoto, Laboratory Consultant, US DHHS CMS
Amy Daniels, MT (ASCP), Senior Manager, Investigations, College of American Pathologists

2. Telepathology Given that
1. Laboratory patient data is commonly stored and manipulated electronically and
2. Laboratory Directors have electronic and remote access to these data using LIMS programs:
Can Laboratory Directors review patient data and release reports from locations that are remote to the laboratory within existing regulations?
How do regulations and the CAP checklist need to change to accommodate this activity?

3. Ebola
Will regulations for laboratories regarding blood borne pathogen exposure and waste disposal evolve as a result of the Ebola epidemic in West Africa and potential transmission in the developed world?

4. (Notes provided for clarification)
LCD/NCD conflicts
Given that LCDs are not harmonized with NCDs, please describe the protocol for CMS to assure uniformity in access to Medicare services regardless of the MAC administering the patient plan. 
(Notes provided for clarification)
Regarding access:  Can HHS address the conflictive nature and contradictions in the CMS guidelines for test coverage between Medicare and Medicaid and in many instances between Medicare MAC’s.  Specifically the variances between LCD and NCD among the various MAC’s. Can you describe the protocol for CMS to assure uniformity in access to Medicare services regardless of the MAC administering the patient plan. 

5. CMS and Reimbursement Rates
Can CMS obtain reimbursement rates directly from private payers, rather than from the laboratories?
(Notes provided for clarification)
Private Insurance companies issue reimbursement rates.  Both the State of California Medi-Cal Procurement Division and now CMS for the Federal Medicare Program have initiated mandates for laboratories to submit private insurance reimbursement rates through a “Stakeholder” process.  This requirement was written into California law via a trailer bill in the 11th hour.  Stakeholders met numerous times and submissions were made almost two years ago now and still the California Medi-Cal offices has had such difficulty deciphering the information due the   Private Insurers lack transparency usually do not print a fee schedule and write into the contract terminology stating reimbursement in percents of Medicare.   Due to co-pays, deductibles that vary with every policy the billing software usually does not break out into policies.   Can CMS tell us why they do not attempt to obtain the information they need directly from the private insurance providers?

6. FDA Oversight of LDTs
Please comment on the FDA oversight of LDTs with respect to the California business codes, CLIA and the CAP accreditation process.
What changes to the CA business codes and the CAP checklist are anticipated?

7. (Notes provided for clarification)
CAP Inspections
CAP custom checklists arrive approximately one month prior to the 3-month inspection window. Can these be provided earlier?
Can CAP also provide custom checklist for the interim inspection?
Regarding unannounced CAP inspections: would it be possible to have one day notification  rather than one hour notification, or a smaller window of inspection opportunity to minimize disruption to the laboratory and to patient care? 
(Notes provided for clarification)
CAP Accreditation Checklists and inspections:  Interim checklist frequently is not the same as the final version received for the actual inspection.  The CAP Inspection application with the large generic check list for inspection arrives so late and close to the window of opportunity for inspection it does not leave time for the section leaders to start over with an entirely new list.  The customized list arrives barely one month prior to the “window”.  Would it be possible to A) have the live inspection and the interim inspection be on the same Check List Version? 2) have CAP send out the inspection application earlier than one and two months prior to the “window” period. 

8. Regarding RNs in the Laboratory…
What is the CA/CMS/CAP position on requiring transcripts/diplomas for nursing staff that perform point of care moderate complexity testing?   What is the State/CMS/CAP position on this for nursing staff that perform only waived complexity testing?   What the nurse is from a nursing registry?
Is color blindness testing required for nurses performing moderate complexity testing if color discrimination is required for test interpretation?  If the nurse is only performing waived testing and color discrimination is required for test interpretation, is color blindness testing required?
Can you describe any successful programs for obtaining transcripts/diplomas for nurses?

9. Delegation to General Supervisors
Can a general supervisor perform the following:
Regarding Proficiency Testing (PT):
Sign proficiency testing attestation statements on behalf of the laboratory director?
Review and sign proficiency testing evaluation reports?
Perform “self-grading” of proficiency testing results as applicable?
Approve corrective action for proficiency testing failures?
Approve new method verification studies on behalf of the laboratory director?
Monthly review of quality control results?

10. (Notes provided for clarification)
CA CLS License Renewal
Is there an audit method to identify if the State actually collected double fees from the laboratory personnel?
Please address how CA LFS evaluates CMEs for CLSs. If CMEs are denied, can a grace period be extended to the applicant?
(Notes provided for clarification)
Issue 1: LFS personnel license renewals:  Four cytotechnologists had difficulty with license renewals.  Most of the problem stems from the confusion surrounding the CME unites.  Completed renewal with CME were submitted with a check for the license fee. The check was cashed immediately however, the CME were challenged, disallowed for various reasons.  In all cases the cytologists had plenty of CME but the State representative disallowed, rejected the renewal and forced the employees to submit additional documentation and another check.
Issue 2: CLS Medical Technologists, some have the same problem with the CME being denied.  Request clarification on the renewal as to the time frame the CME must be obtained in.  One person had well over 100 hours of CME within the correct timeframe and considered the LFS evaluator ill equipped to make the proper evaluation, resulting in initial rejection, resubmission and now delay in renewal.  Although CLS Med Techs have 90 day grace period.  Would it be possible to extend a grace period to Cytotechnologists and Phlebotomists?

11. Equivalent Quality Control (EQC)
Please discuss the conflict between CLIA and the CA Business codes regarding EQC and provide suggestions for resolution.
(Notes provided for clarification)
Equivalent quality control (EQC) is permitted under CLIA with certain CLIA EQC came into existence in 2004 as a CMS (formerly HCFA) equivalent procedure specified in appendix C of the State Operations Manual and is widely used throughout the nation.
CA LFS unlawful, because it is not CLIA regulation; it appears only in appendix C.  
CLIA inspectors accept the use of IQC or IQCP, while State examiners cite it as a deficiency.
It has been estimated that in at least one large hospital POCT program, not only would it be nearly impossible to re-train hundreds of nurses to perform regular QC (in some situations QC once every 8 hours), but also that reagent expenses alone may increase more than $6,000 per day or approximately $2.25 million per year.

12. Points and Methods of Contact
Please provide the best points of contact for urgent questions- and telephone numbers for representatives from your organization. 
California Department of Public Health, Laboratory Field Services, Bea O’Keefe, Chief or (510)
CMS Point of Contact: CMS’ San Francisco Regional Office – CLIA Program (415)
CAP Accreditation and Checklist Interpretation- or Phone: , Ext. 6065
Amy Daniels MT(ASCP) Senior Manager, Investigations, CAP Accreditation Programs College of American- Pathologists 325 Waukegan Road, Northfield, IL Tel: ext Dir: Fax: Web: cap.org