Summary:
Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on review of the College of American Pathologists (CAP) Proficency Testing (PT) results for 2022 to date and interview with the General Supervisor (GS) during survey 10/11/2022, the laboratory failed to ensure the attestation forms for CAP PT for 2022 to date were reviewed, signed and dated by the Laboratory Director (LD). Findings include: 1. Review of the CAP PT documentation for 2022 to date revealed that six (6) out of eleven (11) attestations for CAP PT were not reviewed, signed and /or dated by the LD. 2. The attestations without LD review, signature or date for 2022 include: Immunology 2nd event Chemistry 2nd and 3rd events Hematology 2nd event Microbiology 2nd and 3rd events D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(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 general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on review of written Quality Assurance/Assessment (QA) policies and procedures and interview with the General Supervisor (GS), the laboratory failed to 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 -- ensure that QA policies and activities were being conducted and documented (written) at least twice a year. Findings include: 1. QA activities and written documentation thereof are required at a minimum of twice a year. During survey October 11, 2022, upon request, the GS was not able to present any written evidence of QA activities or written documentation for the Summit Health Bend Memorial Clinic Redmond (BMC Redmond) location for 2021 or 2022. 2. The GS confirmed that there was no written documentation regarding QA activities and/or documentation on site during interview and survey on 10/11/2022 at approximately 1130 am. 3. Evidence of QA activities and written documentation during survey 10/11/2022 was zero (0) out of four (4) for the years 2021 and 2022, with a minimum being two (2) events a year. -- 2 of 2 --