Summary:
Summary Statement of Deficiencies D0000 A Certification Survey was performed on March 8, 2019 at Lake Providence Medical Clinic, CLIA ID # 19D0901787. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on record review and interview with personnel, the laboratory failed to ensure that proficieny testing (PT) documents were signed by the appropriate personnel. Findings: 1. Review of the laboratory's policy for Proficiency Testing (PT) revealed "Attestations must be signed by testing personnel and the medical director. Testing personnel must indicate which sample sets they performed and sign the attestation for those samples". 2. Review of the laboratory's PT records revealed the attestation statements for the 2018 Hematology/Coagulation - 1st, 2nd, and 3rd Events were signed by the Laboratory Director only. The Testing Personnel did not sign all PT attestation documents. 3. In interview on March 8, 2019 at 10:30 am, the Technical Consultant stated she that she had put a note for the testing personnel to sign the 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 -- attestation statement on the folder but the testing personnel did not sign the documents. The Technical Consultant confirmed the attestation statementes were not signed by the testing personnel for all three (3) PT events in 2018. 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 on record review and interview with personnel, the laboratory failed to establish complete written policies and procedures to assess competency for testing personnel. Findings: 1. Review of the laboratory's policy and procedure manual revealed the laboratory did not include the following six (6) procedures as a minimal requirement for assessing the competency of all personnel performing laboratory testing: a) Direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing and testing. b) Monitoring the recording and reporting or test results. c) Review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventative maintenance records. d) Direct observation of performance of instrument maintenance and function checks. e) Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples. f) Assessment of problem solving skills. 2. In interview on March 8, 2019 at 10:50 am, the Technical Consultant stated that she updated the competency assessment forms but did not update the policy manual to reflect the changes. The Technical Consultant confirmed the laboratory's current competency policy did not include the identified six (6) procedures. D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(iii) Ensure that all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require