CLIA requires all entities perform even one test, including waived tests on "materials derived from the human body for the purpose of providing information for the diagnosis, prevention or treatment of any disease or impairment of, or the assessment of the health of, human beings" to meet certain Federal requirements. If an entity performs tests for these purposes, it is considered under CLIA to be a laboratory and must register with the CLIA program.
POLS will be obtaining information needed to complete the application: check sheet,lab director information, state requirements etc. The technical consultant will be reviewing validation studies if needed for the application, which is based on state requirements. POLS will obtain the correct mailing address and will prepare a completed application, converting it into a PDF file which will be emailed to the desired personnel.
The Client will be providing documentation from personal information/ documentation,testing details, ownership disclosure, and other documentation as needed for CLIA application, in a timely manner to complete application. The desired personnel will mail it to the address POLS provides. The lab will be billed for an interim Certificate of Registration. This serves as a valid CLIA certificate until the lab has successfully passed an onsite inspection. Staff will need to make a copy and post this Certification in the lab and pay the bill in a timely manner.
There will also be Government inspection fees which is based on estimated annual test volume and a validation fee. This will be mailed to the lab. Staff will need to make sure this is paid in a timely manner as well. This may occur before or after the laboratory has successfully completed the inspection process.
To maintain a valid and current CLIA certificate the client must renew every two years.
If your lab will be or is located outside of Washington or New York States, CLIA requires nonwaived labs to enroll in an evaluation agency. COLA is the premier clinical laboratory education, and accreditation organization for POLS. They are an independent accreditor whose practical, educational standards have a positive and immediate impact. Their services enable clinical laboratories and staff to meet CLIA and other regulatory requirements, act in accordance with Quality Systems, and provide the best possible patient care.
POLS will complete the application and apply to CAP or COLA for the Client. POLS will see to the initial completion of CAP or COLA requirements and insure all the CAP or COLA required documents for staff are completed. POLS will email documents to the Lab Director as initially needed. The Lab Director will need to sign these documents and email them back in a timely manner. POLS will upload these documents to the CAP or COLA site. It is the Client's responsibility to keep the records on the CAP or COLA site up to date. The Client should delegate this reasonability to one staff member.
Proficiency testing determines the performance of individual laboratories for specific tests or measurements and is used to monitor laboratories’ continuing performance.
POLS will provide a list of the CLIA approved Proficiency Testing programs along with prices and benefits of each program. POLS will give a suggestion of which PT program to use. Once the desired PT program has been selected POLS will proceed with the setup and ordering.
The Client is responsible to pay for the PT program in a timely manner. Staff will abide by the CLIA requirement for testing of PT samples. See post below.
Section 353(d)(1)(E) of the Public Health Service Act requires the laboratory to “treat proficiency testing samples in the same manner as it treats materials derived from the human body referred to it for laboratory examinations or other procedures in the ordinary course of business, except that no proficiency testing sample shall be referred to another laboratory for analysis as prohibited under subsection (i)(4)”. Additionally, this requirement is emphasized in the CLIA regulations at §493.801(b). A laboratory is not to test PT samples on more than one instrument/method unless that is how they test patient specimens. Repeated analysis of PT samples is not appropriate unless patient specimens are similarly tested.
Federal regulation are ever changing. Each year there new requirements. POLS has allocated time to keep up-to-date on these changes to insure we can provided the best consulting lab services.