Summary:
Summary Statement of Deficiencies D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years. This STANDARD is not met as evidenced by: Based on review of proficiency testing records and interview with the laboratory director, the laboratory failed to retain all proficiency testing (PT) records for at least 2 years. Findings: 1. On May 5, 2021, at 10:00 AM, the surveyor reviewed PT records. PT records show the laboratory performed PT twice a year. 2. There was no documentation made available to the surveyor for the following PT records: a. 1st and 2nd PT events of 2019 and 1st PT event of 2020- there was no Attestation Statement and testing record (bubble form) included with the PT records b. 2nd PT event of 2020, no PT record of the PT event was made available to the surveyor. 3. On May 5, 2021, at 10:30 AM, the laboratory director confirmed the surveyor's findings. 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 review of proficiency testing (PT) records and interview with the laboratory director, the laboratory failed to verify the accuracy of its histopathology procedures at least twice annually. Findings: 1. On May 5, 2021 at 10:00 AM, surveyor review of PT records revealed that there was no documentation to show that PT was performed 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 -- twice in 2020 for its histopathology procedures. There were no PT records for the 2nd PT event in 2020. 2. On May 5, 2021 at 10:30 AM, the laboratory director confirmed the surveyor's findings. D8100 INSPECTION REQUIREMENTS CFR(s): 493.1771 Each laboratory issued a CLIA certificate must meet the requirements in 493.1773 and the specific requirements for its certificate type, as specified in 493.1775 through 493.1780. All CLIA-exempt laboratories must comply with the inspection requirements in 493.1773 and 493.1780, when applicable. This CONDITION is not met as evidenced by: Based on review of proficiency testing records and interview the laboratory director, the laboratory failed to comply with the inspection requirements in 493.1773. Findings: 1. The laboratory failed to provide the CLIA surveyor exact duplicates of proficiency testing records requested during the laboratory's survey on May 5, 2021. See tag D8103 D8103 BASIC INSPECTION REQUIREMENTS CFR(s): 493.1773(b)(c)(d) (b) General Requirements. As part of the inspection process, CMS or a CMS agent may require the laboratory to do the following: (b)(1) Test samples, including proficiency testing samples, or perform procedures. (b)(2) Permit interviews of all personnel concerning the laboratory's compliance with the applicable requirements of this part. (b)(3) Permit laboratory personnel to be observed performing all phases of the total testing process preanalytic, analytic, and postanalytic). (b)(4) Permit CMS or a CMS agent access to all areas encompassed under the certificate including, but not limited to, the following: (b)(4)(i) Specimen procurement and processing areas. (b)(4) (ii) Storage facilities for specimens, reagents, supplies, records, and reports. (b)(4)(iii) Testing and reporting areas. (b)(5) Provide CMS or a CMS agent with copies or exact duplicates of all records and data it requires. (c) Accessible records and data. A laboratory must have all records and data accessible and retrievable within a reasonable time frame during the course of the inspection. (d) Requirement to provide information and data. A laboratory must provide, upon request, all information and data needed by CMS or a CMS agent to make a determination of the laboratory's compliance with the applicable requirements of this part. This STANDARD is not met as evidenced by: Based on review of proficiency test (PT) records; observation; and interview with the laboratory director, the laboratory failed to provide the surveyor with exact duplicates of PT records the surveyor requested. Findings: 1. On May 5, 2021 at 10:00 AM, the surveyor reviewed PT records. All PT records were not made available to the surveyor. Some of the PT records were missing. See tags D3037 and D5217. 2. On May 5, 2021 at 10:30 AM, the surveyor requested that the laboratory provide her with copies of the PT records as evidence of her findings. 3. On May 5, 2021 at 11:45 AM, the laboratory director provided copies of the requested PT documentation but upon review the documents had been modified by the laboratory and now included false /erroneous information. The LD refused to provide copies of the original documents as requested. -- 2 of 2 --