Summary:
Summary Statement of Deficiencies 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. This STANDARD is not met as evidenced by: Based on review of competency assessment records and interview with testing personnel #1 (TP1) and Laboratory Director, the laboratory did not evaluate the annual personnel competency for ALL testing personnel for 2017 and 2018 as referenced in 493.1413 (b) (8) (i-vi) and b(9) Findings include: 1. The laboratory had a policy and system in place to document seminanual and annual competency of testing personnel. However, there were no records to support TP2 was evaluated for competency for the CBC ACT2 Diff and Affirm testing. TP1 had been evaluated properly according to policy 2. The Director and TP1 stated that TP2 conducted testing only if TP1 was unavailable, such as during vacations. 3. Bluefield Women's Center, PC Laboratory personnel list included both TP1 and TP2 as testing personnel. D6051 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8)(v) The procedures for evaluation of the competency of the staff must include, but are not limited to assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples. This STANDARD is not met as evidenced by: Based on proficiency testing record review and interview with testing personnel #1 (TP1) and Laboratory Director, the laboratory was not evaluating test performance 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 -- through proficiency testing for ALL testing personnel. Findings include: 1. The laboratory was enrolled with American Proficiency Testing Institute (API) as their Proficiency Testing (PT) provider. Records from the third event 2016 through 2018 support PT participation for Counter Act 2 Difff CBC and BD Affirm methods for TP1 but not TP2. 2. Documentation of the testing personnel on the PT record attestation statement page show TP1 participated in all PT events. No attestation pages were signed by TP2 as testing personnel. 3. The Director and TP1 stated that TP1 was the primary laboratory testing person and TP2 only filled in when TP1 was ill or on vacation. Testing records for Hematology show TP 2 conducted testing on 7/7 /18 through 7/11/18. There were no records that TP2 conducted any of the Affirm testing but she is listed as laboratory testing personnel on the Bluefield Women's Center laboratory personnel list. -- 2 of 2 --