Summary:
Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based upon a review of the CMS 209 form, review of laboratory documentation of competency assessment, lack of documentation and interview with laboratory staff the laboratory failed to assess testing personnel competency on an annual basis for two of two testing personnel listed on the CMS 209 form. Findings follow: A) Review of the CMS 209 form revealed that two testing personnel (numbers 2 and 3 on the form CMS 209) were employed by the laboratory. B) Review of competency assessment records revealed that the testing personnel (numbers 2 and 3 on the CMS 209 form) had no record of competency evaluation. C) Upon request, the laboratory was unable to provide competency assessments for testing personnel (numbers 2 and 3 on the CMS 209 form). D) In an interview on 7/10/25 at 9: 15 a.m., the laboratory staff member (# 1 on the separate employee identification list) confirmed that competency assessments for the testing personnel identified above were not performed and the employees had performed testing in the laboratory since the laboratory applied for a certificate of compliance.. D5317 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(d) (d) If the laboratory accepts a referral specimen, written instructions must be available to the laboratory's clients and must include, as appropriate, the information specified in paragraphs (a)(1) through (a)(7) of this section. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- This STANDARD is not met as evidenced by: Based upon interview and lack of documentation the laboratory did not provide clients with written instructions for specimen submission, handling, and referral as specified in CFR 493.1242 paragraphs (a)(1) through (a)(7). A) In an interview on 7/10/25 at 10: 40 a.m.the laboratory staff member (number 2 on the CMS 209 form) stated that all specimens tested in the laboratory are referred from outside clients. B) Upon request, the laboratory could not provide a copy of a client services manual or evidence of instructions for specimen collection and handling that is provided to clients . C) In an interview on 7/10/25 at 10:40 a.m. the laboratory staff member (number 2 on the CMS 209 form) said that the laboratory has been accepting patient samples from outside clients since 6/10/25, has tested thirty patients to date, and they are working on a client specimen manual but haven't completed and distributed one at this time D5467 CONTROL PROCEDURES CFR(s): 493.1256(d)(9)(g) (d)(9) When using calibration material as a control material, use calibration material from a different lot number than that used to establish a cut-off value or to calibrate the test system. This STANDARD is not met as evidenced by: Based upon review of policy and procedure for "Analysis of Metabolites in Human Urine by LC/MS/MS", and interview with laboratory staff, the laboratory used the same lot number of certified analytical reference materials to prepare both standards and quality control materials for test performance. Findings follow: A) Review of procedures for "Analysis of Metabolites in Human Urine by LC/MS/MS, a "mixed analyte stock solution is prepared by spiking known concentrations of NIST traceable, certified analytical reference materials" from which standards and quality controls are prepared. B) In an interview on 7/10/25 at 09:25 a.m., the laboratory staff member ( number 2 on the form CMS 209) confirmed that standards and quality controls are prepared from the same stock solution at the same time. D5779