Palo Alto Medical Foundation

Summary Statement of Deficiencies D6127 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) The technical supervisor is responsible for evaluating and documenting the performance of individuals responsible for high complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on reviews of laboratory documents for personnel competency assessment and interview with the General supervisor (GS) on 12/18/19 and 12/19/19, it was determined that the Technical Supervisor failed to evaluate and document the performance of individuals responsible for high complexity testing at least semiannually during the first year. The findings included: a. The laboratory identified eight (8) testing personnel (TP) and one General Supervisor (GS) on the form CMS- 209. b. The General Supervisor's start date was March of 2019. c. Although the laboratory maintained a policy for competency assessment of all lab personnel within its quality manual titled 'Quality Manual Policy, 'PAMF-QA-POL-4.4,' version 3,' the laboratory was unable to provide for review documents evaluating the competency of the General Supervisor at least semiannually during the first year for high complexity testing. d. The failure to evaluate and document the competency of the General Supervisor at least semiannually during the first year for high complexity testing, was confirmed by interview with the General Supervisor and Quality Assurance management personnel on 12/19/19 at 12.40 p.m. e. The laboratory reports performing approximately 300,000 patient tests annually. 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 --

Summary Statement of Deficiencies D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on review of the first quarter (Q1-2017) Sperm count, second quarter (Q2- 2017) Sperm motility of the American Association of Bioanalyts (AAB) proficiency testing records and interview with the technical supervisor, it was determined that the laboratory failed to verify the accuracy of the above analytes with an artificial score of 100%. The findings included: Q1-2017 a. AAB reported the following artificial score of 100% proficiency testing scores. Analyte: Value Acceptable Sperm Reported: Range: Count Spec#1 21 4-18 Q2-2017 Analyte: Value Acceptable Sperm Reported: Range: Motility Spec#1 21 34-58 b. Based on the laboratory's annual testing volume declaration submitted for 2016-2017, the laboratory analyzed and reported 568 Sperm analysis even though the laboratory's proficiency testing scores were unsatisfactory for sperm count and sperm motility. c. The testing personnel affirmed (2/21/2018, 1400), that the laboratory received the above artificial 100% for the above analytes without any