Summary:
Summary Statement of Deficiencies D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on standard operating procedure manual and quality assurance (QA) review and interview with the laboratory staff, the laboratory did not ensure that proficiency testing (PT) was performed at least twice annually. Findings: 1. The procedure, "Quality Control Program" states that "The Laboratory Director will randomly select five (5) processed cases every six (6) months each calendar year to forward to a third party laboratory for comparative diagnosis." 2. A review of QA records showed that "Doctor #1" began reading slides at the laboratory in August, 2017. 5 cases from this doctor were sent out and reviewed 6/11/18; and 3. For "Doctor #2," 10 cases from 2017 and 5 cases from 2018 were sent out and reviewed 6/11/18; and 4. During an interview at 1:40 PM, when laboratory staff was asked about the delay in sending out PT, they stated that "We forgot." 3. During an interview on 6/12/18 at 2:15 PM, the LD confirmed that PT slides were not sent out at least twice annually. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: 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 -- Note: This is a repeat deficiency. The laboratory was cited during the re-certification survey on 6/29/2016 for not recording the lot numbers and expiration dates of stains used for staining tissue samples prior to slide preparation. The