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 review of the laboratory's submitted Form CMS 209, review of the laboratory's policies and procedures, review of the laboratory's competency assessment records, and interview with both technical consultants, it was determined that the laboratory failed to have documentation of policy to perform competency assessments on the technical supervisor and general supervisor. Findings include: 1. Review of the laboratory's submitted Form CMS 209 revealed the laboratory identified 1 technical supervisor and 1 general supervisor. 2. Review of the laboratory's policies and procedures revealed the facility failed to have documentation of a policy addressing performing competency assessments on supervisors. 3. Review of 2020, 2021 and 2022 competency assessments revealed no documentation of competency for technical supervisor and general supervisor. 4. Interview at 1:15 P.M. on May 11, 2022 in the break room with both technical consultants confirmed the above findings. =================================== D5213 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(1) The laboratory must verify the accuracy of any analyte or subspecialty without analytes listed in subpart I of this part that is not evaluated or scored by a CMS- approved proficiency testing program. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- This STANDARD is not met as evidenced by: ================================== Based on review of the American Proficiency Institute (API) proficiency testing survey results evaluation, the laboratory policy titled "Proficiency Testing", and interview with technical consultant #1, determined the laboratory failed to verify the accuracy of analytes not evaluated or scored by a CMS-approved proficiency testing program for sperm classification for 2 of 7 events (2020 Event 3 and 2022 Event 1). The findings include: 1. Review of the API proficiency testing survey results evaluation revealed the following events with ungraded performance: a. Hematology 2020 Event 3 Sperm classification Sample SCL-12 Reported result: Abnormal Expected result: See commentary Performance: Not graded Sample SCL-14 Reported result: Borderline Expected result: Normal Performance: Not graded Sample SCL-15 Reported result: Immature germinal cell Expected result: See commentary Performance: Not graded Sample SCL-19 Reported result: Abnormal Expected result: See commentary Performance: Not graded Further review of the API "Performance Review and