Avoid These 7 Common Reasons For Laboratory Citations

If your facility or lab should receive a complaint, your organization may be subjected to an additional CLIA inspection. CLIA inspections (also referred to as "surveys" by the Health Care Financing Administration are key in determining whether laboratories are compliant with CLIA requirements.Laboratories certified under CLIA must adhere to requirements—mandatory requirements for laboratories are enforced by the Public Health Service Acts, Social Security Act, and CLIA regulations as well.Your laboratory may be up for immediate inspection at any time:





1.Labs should anticipate a biannual survey conducted by the HCFA or by lab accreditation organization that has been granted authority by the HCFA.



2.CLIA inspections are also necessary for gathering general information.



3.Another common reason for CLIA inspections is complaint investigation.CLIA Inspections are also conducted when a public health hazard is believed to exist. Under circumstances such as these, a lab accreditation agency may not provide more than 3 days of notice in advance before the CLIA inspection is conducted—in other instances, no notice is given and investigations are unannounced. Lab accusations typically arise from users of the laboratory, employees, inspectors (from federal programs), or even the general public.





During CLIA inspection, the laboratory accreditation/compliance organization will make determinations regarding your lab’s compliance to the CLIA regulations. Lab surveyors carefully consider how the practices of a laboratory compare to specific requirements and then determine if a deficiency exists. They consider the following factors:





1.Accuracy of lab results, specifically reliability, timeliness of results, specimen integrity, accuracy, etc…



2.The general adequacy of lab facilities, including supplies, equipment, etc…



3.Personnel skill/expertise. A CLIA inspection will take into account training, test results, ability to resolve problems, ability to delegate responsibilities.





Based on clinical laboratory accreditation surveys between 2008-2010, here are a few most frequently cited reasons for laboratory citations, as cited by surveyors:





1.There’s no procedure for adverse event reporting (FDA voluntary reporting).



2.The materials used as controls were not verified by repeated testing procedures.



3.Improperly labeled specimens. This can occur when not labeled with a unique patient identifier or the source of the specimen is not included when appropriate.



4.A failure to follow manufacturer instructions (regarding reagents, controls, kits, etc…)



5.An employee of the laboratory failing to fulfill his or her job responsibilities.



6.A laboratory’s personnel records do not contain the proper documentation of employee education and experience that qualify an employee for his or her position.



7.The directory of the laboratory (or designee) does not review quality control data with lab personnel.