Kansas Medical Clinic Pa- Dermatology

Summary Statement of Deficiencies D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on the lack of competency documentation for TP #2 (see D6079); presence of expired reagents, review of temperature logs with missing data and a lack of thermometer accuracy documents (see D6082); lack of proficiency testing (PT) attestation documents (see D6089); lack of evaluation of failed PT results (see D6091); lack of

Summary Statement of Deficiencies D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on the review of the laboratory's 2020, 2021 and to date of survey 2022 AAFP proficiency testing evaluations, and interview, the laboratory failed to document proficiency testing evaluation for three of five events the specialty of microbiology. Findings: 1. Review of the laboratory's AAFP proficiency testing evaluations documentation forms from 9/10/20 to 6/15/22 for microbiology had no documentation of the laboratory director's (LD) signature or designee on: a. AAFP PT 2021-A Clinical Microscopy b. AAFP PT 2021-B Clinical Microscopy c. AAFP PT 2022-A Clinical Microscopy 2. The laboratory manager stated she did not know that acceptable results required documentation of the review. 3. The only documentation on the reports was a highlighting of the results. 3. Interview with the laboratory manager on 6/15/22 at 9:40 a.m. confirmed, the laboratory failed to document proficiency testing evaluation activities for three of five events from 9/10/20 to 6/15 /22 in the specialty of microbiology. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --