Summary:
Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on July 17, 2018. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: 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: A review of laboratory records and an interview with the laboratory's lead Testing Personnel (TP # 2 CMS 209), it was determined that the laboratory director failed to provide annual Competency Assessment for its testing personnel. Findings include: 1. A review of testing personnel records revealed there was no competency evaluations for testing personnel (TP# 2, 3 CMS 209) for 2016, 2017 and 2018. 2. The laboratory failed to have current written policy for semi-annual and annual competencies for testing personnel. 3. An interview with the laboratory's lead TP # 2 (CMS 209) on July 17, 2018 at 01:36 PM in the review room confirmed that there was no current written policy in place and annual competencies were not performed for testing personnel. D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. 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 -- This STANDARD is not met as evidenced by: Based on review of personnel competency assessment records and an interview with the laboratory's lead (TP# 2 CMS 209), the laboratory failed to include the six required competency assessment criteria when evaluating annual competency on testing personnel for the Coulter AcT Diff 2 Hematology analyzer and ACE Alera Chemistry analyzer. The findings include: 1. Review of testing personnel (TP # 2, 3, CMS 209) competency assessment records for 2016, 2017 and 2018 revealed the assessment did not include the six competency assessment criteria required by CLIA. 2. An interview with the laboratory's lead TP (#2 CMS 209) in the conference room on July 17, 2018 at approximately 01:45 PM confirmed that annual competency assessment for testing personnel (TP# 2, 3 CMS 209) did not contain the six required criteria by CLIA. -- 2 of 2 --