Quality Pathology Group Inc

Summary Statement of Deficiencies D0000 A recertification survey was conducted on June 16, 2021. Quality Pathology Group Inc of Gulfstream Eye clinical laboratory was not in compliance with 42 CFR 493, requirements for clinical laboratories. 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: Based on observation and interview, the laboratory failed to ensure the Gill 3 Hematoxylin stain was not expired prior to patient testing from 04/02/2020 to 06/16 /2021. Findings: Observations made during a tour of the laboratory on 06/16/2021 at 9: 20 AM, showed the bottle of Gill 3 Hematoxylin stain expired on 04/01/2020. According to the Clinical Laboratory Improvement Amendments (CLIA) Application for Certification signed and dated by the Laboratory Director on 06/09/2021, the laboratory had an estimated annual test volume of 50 tests per year. On 06/16/2021 at 9:22 AM, the Laboratory Director said the expired Hematoxylin stain was an oversight and would be replaced with a new bottle of stain. 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 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 record review and interview, the laboratory failed to verify the accuracy of the reading and interpretation of the Hematoxylin and Eosin (H&E) stain in 2018 at least twice annually for two testing personnel (A & C). Findings: The laboratory uses peer review to verify the accuracy of the reading and interpretation H&E stain. Review of the laboratory's records showed that peer review was performed in only once in December of 2018 for testing person A and C. The procedure titled "Quality Assurance Plan" noted that proficiency testing will be sent out twice a year. During an interview on 4/05/19 at 9:33 AM, the Laboratory Director acknowledged that peer review was sent out only once in 2018. 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 --