Most Frequent Reasons For Laboratory Citations, As Cited By Lab Accreditation And Hospital Accredita

By Author: Erica Ronchetti
Total Articles: 739
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A lab self-assessment test provided by a lab accreditation or hospital accreditation organization can provide lab facilities with the guidance and tools necessary to adhere to all CLIA requirements, quality systems, and avoid future citations. Provided by lab accreditation and hospital accreditation organizations, this article offers an easy lab self-assessment to help improve lab performance and meet CLIA requirements.

Based on clinical lab accreditation surveys taken between the years of 2008-2010, hospital accreditation organizations list the following as the most frequently cited reasons for laboratory citations (as cited by surveyors):

Lack of procedure for adverse event reporting (or FDA voluntary reporting).
Lab specimens are improperly labeled—this can happen when not labeled with a unique patient identifier, or when a specimen’s source isn’t included.
Lack of repeated testing procedures—control materials were not verified by repeated testing.
A lab’s failure to follow manufacturer instructions (with regard to controls, kits, reagents, etc…).
Personnel ...
... records do not contain proper documentation of experience, education, or job history that qualify a lab employee for his or her position.
An employee is unable to complete his or her job requirements/responsibilities.
A lab directory (or responsible designee) fails to review quality control data with other lab personnel.

Should a hospital accreditation organization or lab accreditation organization find fault with your organization, you may be subjected to additional CLIA inspection. CLIA inspections (also referred to as “surveys”) are key in determining whether a laboratory is compliant with lab best practices. Should a hospital accreditation organization or lab accreditation organization CLIA certify your lab, your organization must observe all mandatory requirements, as enforced by the Social Security Act, current CLIA regulations, and Public Health Service Acts. Adherence to these requirements does not mean you will be subjected from inspection, which could be preformed at any time.

During a CLIA inspection performed by a hospital accreditation organization or lab accreditation organization, your compliance with CLIA regulations will be determined. Surveyors will carefully consider how your lab’s best practices compare to those specific requirements, and whether or not a deficiency exists.

A hospital accreditation organization/lab accreditation organization considers the following factors:

General adequacy of facilities, including equipment, supplies, etc…
Accuracy of lab results, timeliness of results, specimen integrity, general accuracy, reliability.
Personnel skill and expertise. Ability to delegate responsibilities, problem solving abilities, test results, and training are all considered in a CLIA inspection.

Erica Ronchetti is a freelance writer for COLA.org. COLA accredits almost 8,000 medical laboratories and provides the clinical laboratory with a program of education, consultation, and accreditation. The organization is an independent, non-profit accreditor whose education and standards enable clinical laboratories and staff to meet U.S. CLIA and other regulatory requirements. For more information about Lab Accreditation Organizations, Hospital Accreditation Organizations,and CLIA Compliance visit Cola.org.