Associated Pathologists, Llc

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on February 16, 2023. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: D3011 FACILITIES CFR(s): 493.1101(d) Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. This STANDARD is not met as evidenced by: Based on review of the Standard Operating Procedure (SOP) and staff interview, the laboratory failed to establish a safety procedure for the Eyewash. The Findings include: 1. SOP document review revealed that the laboratory failed to establish a safety procedure for the sink eyewash in the laboratory. 2. No maintenance was being performed on the Eyewash for 2021, 2022, and thus far 2023 (January-December). 3. During an interview with the Director of Operations on February 16, 2023, at 12:50 PM, in the conference room, confirmed that the laboratory failed to establish a safety procedure for the Eyewash and no maintenance was performed on the Eyewash for 2021, 2022, and thus far 2023. 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 D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on January 21, 2021. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on surveyor review of laboratory records and an interview with the Laboratory Manager (LM), the laboratory failed to enroll in a CMS-approved proficiency test (PT) as required by Clinical Laboratory Improvement Amendments (CLIA) for the specialty of Histopathology for 2019 and 2020. The findings include: 1. Review of laboratory records revealed the laboratory was not enrolled in a PT program for the specialty of Histopathology for 2019 and 2020. 2. The LM confirmed on January 21, 2021 at 1:30 P.M. in an office, inside of the laboratory, that the facility was not enrolled in a CMS-approved PT as required by CLIA for the specialty of Histopathology for 2019 and 2020. D5781