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Hello Readers!

I hope everyone is having a great spring. If you are like me, you are glad to see spring and would like to forget the nasty winter we just experienced. Since spring is all about fresh starts and new things blossoming, let’s look at some new things that are out there on the lab horizon.

The final regulation change has taken place for a new required policy for all CLIA laboratories. It has to do with a patient’s rights to receive a copy of their completed lab results.

This final rule changes the Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations to specify that, upon the request of a patient (or the patient's personal representative), laboratories subject to CLIA may provide the patient, the patient's personal representative, or a person designated by the patient, as applicable, with copies of completed test reports that, using the laboratory's authentication process, can be identified as belonging to that patient.

This means that a patient (or approved representative) can request a copy of their completed lab results.

Our responsibilities are:

  • To properly identify the patient or representative before releasing the report

  • To provide it to them within 30 days of the request

  • To not interpret the results for the patient in any way. If the patient has questions about the results, they are to be directed to the individual that ordered the tests.

This is in effect now and inspectors are looking for a defined policy in the lab policy manuals now.

Here are some links to additional information on this new policy:

http://www.healthlawpolicymatters.com/2014/02/04/cms-finalizes-hipaa-and-clia-amendments-intended-to-increase-patient-access-to-test-results/

http://www.hhs.gov/news/press/2014pres/02/20140203a.html

 

Next, a new replacement for EQC (Equivalency Quality Control) is here. It falls under mandate EP23 and is called IQCP (Individualized Quality Control Plan).

The CLIA Individualized Quality Control Plan (IQCP) is a risk-based, approach to performing quality control testing. The IQCP is based on assessment of the laboratory testing in use, patient populations, and other aspects. The use of IQCPs will be implemented under the CMS regulation 42 CFR 493.1256 Standard: Control Procedures, and applies to most CMS-certified current and new non-waived tests. It does not apply to waived tests. 

PLEASE NOTE!  IQCP is voluntary, but it will replace the current Equivalent Quality Control (EQC) procedure, which was intended to minimize the amount of external QC required and laboratory costs.  CLIA concepts and regulations will not change, and laboratories may elect to follow current CLIA QC regulations directly in order to demonstrate compliance. Pathology, histopathology, oral pathology, and cytology tests (and a few others) are not eligible for use of IQCP.

The IQCP draws from the CLSI EP23: Laboratory Quality Control Based on Risk Management; Approved Guideline. The concepts include (1) Risk Assessment, (2) the Quality Control Plan, and (3) Quality Assessments (surveillance).

Bottom line, if you want to continue with your lab the way it is, no problem. This is a voluntary process, not required. If your lab wants to adopt this new program for quality control, there are training courses available online to help facilitate this. WARNING, you may be solicited by email for some of these courses. The wording in these solicitations may have you believe this is required and that the sky is falling. The sky is not falling and this is not required for your QC program to continue on, business as usual.

If your lab currently uses EQC for its QC activities then make note of the implementation timeline below

CMS is providing training, information and guidance prior to the January 1, 2016, IQCP implementation date. The IQCP Education and Transition period began on January 1, 2014, and will conclude on January 1, 2016. Between now and the implementation date, laboratories may: 1) follow CLIA QA requirements as written; 2) continue to use EQC; or 3) implement IQCP. After 01/01/16, EQC will no longer be acceptable. Your lab can be cited for non-compliance if EQC is still in use.

 Here are links related to IQCP:

http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Individualized_Quality_Control_Plan_IQCP.html

http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/CLIAbrochure11.pdf