Northwest Women's Clinic

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 American Proficiency Institute (API) proficiency testing (PT) records and interview with the technical consultant (TC), the laboratory failed to sign and date the attestation page of the PT form. Findings include: 1. Review of the API PT records from 2022 to 2023 shows the following attestation pages of the PT form were not signed and dated by the TP performing the test. API Events 2023. a) 3rd Event 2023 Microbiology b) 2nd Event 2023 Hematology/Coagulation c) 2nd Event 2023 Microbiology d) 1st Event 2023 Hematology/Coagulation e) 1st Event 2023 Microbiology API Events 2022 a) 2nd Event 2022 Microbiology b) 3rd Event 2022 Hematology/Coagulation c) 2nd Event 2022 Hematology/Coagulation 2. Interview with the TC on 12/19/2023 at 11:00 AM confirmed these findings. 3. The laboratory performed 1089 microbiological specimens and 40 Hematology/Coagulation specimens from 01/01/2023 to 12/19/2023. 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 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 records and discussion with staff on 12/12/2019 at 1100, there was only one written documentation of bi-annual verification for the ten (10) providers performing vaginal wet mounts. Findings include: 1. The documennt used to record bi-annual verification for the first part of 2018 could not be produced. 2. Staff verified that there was no writtenn documentation of bi-annual verification for the ten (10) providers for the first half of 2018. 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 the procedure manual, no Quality Assuance (QA) plan could be produced. Findings include: 1. There was no written procedure for Quality Assurance for the general laboratory system. 2. There was no written documentation of of QA acttivities for 2018 and 2019. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT 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 -- CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on review of records and discussion with staff, room temperature outliers were not responded to. Findings include: 1. For the month of May 2019, room temperature was out established range seven (7) out of twenty two (22) days of the month. 2. For the month of September 2019, room temperature was out of established range six (6) out of twenty (20) days of the month. -- 2 of 2 --