INSTRUCTIONS FORM CMS-209 This form will be completed by the laboratory. It will be used by the surveyor to review the qualifications of technical personnel in the laboratory.
You have the right to review the laboratory file which is maintained by Chief, Laboratory Field Services Section, Department of Public Health, 850 Marina Bay Parkway, Bldg. P, 1st Floor, Richmond, California 94804-6403, (510) 620-3800.
Documented competency assessment is required for individuals fulfilling the following personnel responsibilities outlined in Subpart M of the CLIA regulations: clinical consultant (CC), technical consultant (TC), technical supervisor (TS), general supervisor (GS) and testing personnel (TP).
Attestation by Laboratory Director: The current CLIA/CLIP/CAP Laboratory Director must print his or her name, sign and date the certification statement of the completed Personnel Roster form attesting that all individuals listed on the roster are qualified to function in the positions listed.
Associate degree in medical laboratory technology (or pulmonary function) and 2 years laboratory (or blood gas analysis) training or experience, or both, in high complexity testing
Explore the latest updates in laboratory personnel qualifications and competency requirements under the new CMS regulations. Delve into insights from a seasoned CAP inspector, Darryl E. Elzie, as he navigates common questions and nuances surrounding competency assessment, addressing key elements, handling critical specimens, using proficiency ...
An individual employed in a clinical laboratory as director, general supervisor, technical supervisor, technologist, cytotechnologist, cytotechnologist supervisor, or technician, must establish his/her qualifications under N.J.S.A. 45:9-42.34.
enter Laboratory Testing Personnel and Non-laboratory Testing Personnel 2. Complete the CLIA Roles section – CLIA roles must be fulfilled by qualified personnel and match the test complexity performed in the laboratory. Click the help symbol, “?”, next to a CLIA role for the qualifications of a particular role.
CLIA has regulatory requirements for quality that all laboratories must meet. guide helps laboratories seeking to apply CLIA cert ation from CMS. More information can be found on the CMS CLIA website. Download this fillable form and type your responses in each section. Make sure you save it as a PDF on your computer.