Summary:
Summary Statement of Deficiencies D0000 A Validation Survey was performed at Acadian Medical Center a Campus of Mercy Regional Medical Center, CLIA ID # 19D1018705 on December 16, 2019 through December 20, 2019. Acadian Medical Center a Campus of Mercy Regional Medical Center was found not in compliance with the following CONDITION LEVEL DEFICIENCIES: 42 CFR 493.1250 CONDITION: Analytic systems 42 CFR 493.1403 CONDITION: Laboratories performing moderate complexity testing; Laboratory Director 42 CFR 493.1409 CONDITION: Laboratories performing moderate complexity testing; Technical Consultant 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: I. Based on record review and interview with personnel, the laboratory failed to establish written policy to assess competency for the Technical Consultant and General Supervisor. Findings: 1. Review of the laboratory's CMS-209 form (Laboratory Personnel Report) revealed the Technical Consultant also serves as the General Supervisor. 2. Review of the laboratory's "Personnel Competency" policy revealed the laboratory did not include competency assessment for duties of Technical Consultant and General Supervisor including frequency. 3. Review of the Technical Consultant's personnel records revealed a "Laboratory Competency of Supervisory Personnel" form completed December 10, 2018; however, the Laboratory Director did not perform the assessment. 4. In interview on December 17, 2019 at 10:55 am, the Technical Consultant confirmed the Laboratory Director did not perform her competency assessment for supervisory duties. II. Based on record review and interview with personnel, the laboratory failed to follow written policy for Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 31 -- competency assessments for testing personnel who perform Histopathology testing. Findings: 1. Review of the laboratory's CMS-209 form (Laboratory Personnel Report) revealed the Laboratory Director and two (2) Pathologists perform Histopathology testing. 2. Review of the laboratory's "Personnel Competency" policy revealed "Competency testing is carried out on all procedures starting at orientation, at 6 months, and each annual review." 3. Review of personnel records revealed the Laboratory Director and two (2) Pathologists did not have competency assessments performed. 4. In interview on December 19, 2019, the Technical Consultant confirmed the laboratory did not perform competency assessments for the two (2) Pathologists and Laboratory Director that perform Histopathology testing. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: I. Based on record review and interview with personnel, the laboratory failed to ensure the Laboratory Director or designee reviewed the proficiency testing performance evaluation results for the 3rd event for Microbiology and Chemistry. Findings: 1. Review of the American Proficiency Institute (API) proficiency testing records for 2019 revealed the laboratory did not have documentation of review of the results by the Laboratory Director or designee for the following events: 2019 Microbiology 3rd Event: no signature by Laboratory Director or designee 2019 Chemistry Core 3rd Event: no signature by Laboratory Director or designee 2. In interview on December 16, 2019 the Technical Consultant confirmed the laboratory did not document review of the proficiency testing results for the identified events. II. Based on record review and interview with personnel, the laboratory failed to ensure the Laboratory Director reviewed