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 record review and an interview with the Laboratory Director (LD), the laboratory failed to blindly verify the accuracy of the slide interpretation procedures at least twice annually for 2019 and 2020. This deficient practice had the potential to affect all patients tested in the specialty of histopathology for 2019 and 2020. Findings Include: 1. An offsite review of the laboratory's 'Quality Improvement Plan' policy and procedure provided via email on 02/02/2021 at 11:37 AM found the following statement: "3.) At least twelve cases will be submitted for QC annually, including a variety of benign and malignant diagnosis." 2. An offsite review of the laboratory's 'Peer Review' documentation for 2019 and 2020 provided via email on 02/02/2021 at 11:37 AM found an "Initial Diagnosis" column. 3. An interview with the LD via phone call, on 02/10/2021 at 10:15 AM, confirmed the laboratory provided all initial diagnosis documents with the slides sent and the test accuracy verification was not performed blindly in 2019 and 2020. D5891 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess and, when indicated, correct problems identified in the postanalytic systems specified in 493.1291. 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 -- Based on record review and an interview with the Laboratory Director (LD), the laboratory failed to establish and follow written policies and procedures and document all assessment activities of the ongoing mechanism to monitor, assess, and correct problems identified in the post analytic systems. All patients tested under the specialty of histopathology in 2019 had the potential to be affected by this deficient practice. Findings Include: 1. An offsite review of the laboratory's "Midvalley GI Pathology QA report for year 2019" provided 02/02/2021 at 11:37 AM via email found the following statement: "No major systemic problems were identified, and occasional issues were quickly resolved." 2. During a phone interview with the LD on 02/10 /2021 at 10:30 AM, the inspector requested the policy and procedure including documentation for all issues and