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 on record review and interview with the Office Manager, the laboratory failed to perform competency evaluations on 2 out of 2 Clinical Consultants (#B and #C) and 2 (#B and #C) out of 3 (#A-#C) Testing Personnel reviewed. Findings included: Review of CMS 209 revealed that Clinical Consultant #B and #C and Testing Personnel #B and #C are the same people. No competency evaluations were performed for #B or #C for being the Clinical Consultant or Testing Personnel. During an interview on 11/08/18 at 10:00 AM the Office Manager confirmed that competency evaluations were not performed on #B or #C. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on record review and interview with the Laboratory Director the laboratory failed to verify the accuracy of testing at least twice a year for 1 (2017) out of 2 years (2016-2018) reviewed in Histopathology. Findings Included: Review of peer review for Histopathology revealed it performed 11/08/18, 11/07/18, 08/03/17, 09/08/16, and 03/21/16. During an interview on 11/08/18 at 11:00 AM the Laboratory Director Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- confirmed that even though it was performed there was no other documentation of peer reviews being conducted in 2017. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on record review and interview with the Office Manager the laboratory failed to perform Quality Assurance (QA) check lists per their policy for 2 out of 2 years (2016-2018) reviewed. Findings Included: Review of policies and procedures (last signed by the Laboratory Director on 09/12/2014 revealed that the laboratory should be performing a QA checklist monthly. No documentation of the QA checklist were provided. During an interview on 11/08/18 at 11:30 AM the Office Manager confirmed that the QA checklist has not been documented monthly. -- 2 of 2 --