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: Through review of the CMS 209 form, personnel records and confirmed by interview it was determined that the competency of one of ten testing personnel reviewed was not performed at least on an annual basis and competency evaluations did not contain documentation that competency evaluations were performed utilizing the six required elements of competency evaluations , i.e. through direct observation of test performance, reveiw of test results, review of maintenance and quality control files, direct observation of maintenance procedures, review of intermediate test results and assessment of test performance through proficiency testing or blind samples. Findings follow: 1. Competency evaluations were not performed on an annual basis. A) Review of personnel files for the testing personnel, identified as number sixteen on the CMS 116 form, revealed that the employees date of hire was 12/18/18.. B) Review of personnel files revealed documentation of annual evaluation of the competency of the testing personnel, identified as number sixteen on the CMS 209 form, were dated 12 /23/18 and the last competency evaluation was dated 7/19/19 and no other competency evaluations were present . C) Upon request, the laboratory was unable to provide an additional competency evaluation of the testing personnel, identified as number sixteen on the CMS 209 form, since 7/19/19 . D) In an interview on 5/4/21 at 01:45 PM, the laboratory staff member, identified as number six on the CMS 209 form. stated the the date of hire of the testing personnel, identified as number two on the CMS 209 form, was in December of 2018 and competency evaluation had not been performed for the testing personnel since 7/19/19. 2. Competency evaluations were not performed utilizing the required elements of assessing testing personnel Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- competency. A) Review of the competency evaluation of the testing personnel, identified as number sixteen on the CMS 209 form, revealed that competency was assessed as " 1- below standard, 2- meets standard. 3-above standard" but does not confirm the methods used in determining the assessment. B) In an interview on 5/4/21 at 01:45 PM, the laboratory staff member, identified as number six on the CMS 209 form, confirmed that documentation does not specify the required elements of competency evaluation. D5317 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(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. This STANDARD is not met as evidenced by: Through interview and lack of documentation and review of specimen logs it was determined that 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 5/4/21 at 11:03, AM the laboratory staff member, identified as number six on the CMS 209 form, said that the laboratory received and tested specimens referred from "two or three" outside home health agencies. 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 5/4/21 at 11:03 the laboratory staff member identified as number six on the CMS 209 form confirmed that the laboratory did not provide instruction manuals for specimen submission, handling and referral to outside clients . D) Review of the laboratory's "Sign-In Log For Specimens Brought" revealed that sixteen spcimens were received from three outside agencies for testing between the dates of 4/26/21 to 5/5/21. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Through observation, review of the manufacturer's instrument user's manual and package inserts, the laboratory's