Cdc Arctic Investigations Program

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on a surveyor's review of the CMS-209 laboratory personnel form and interview with the technical supervisor on June 30, 2022 the laboratory failed to establish and follow written policies and procedures to assess competency for the technical and general supervisor duties annually. Findings include: 1. Review of CMS 209 and personnel competency records revealed that one technical supervisor, and two general supervisors, did not have annual competencies performed to assess their ability to perform the duties and responsibilities as Technical Supervisor or General Supervisors as delegated by the laboratory director for 2022. 2. A interview conducted on June 30, 2022 at approximately 9:00 AM with the technical supervisor confirmed the lack of competency assessments. It was stated that she believed the delegation of duties documentation was a competency assessment. D5219 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(2) At least twice annually, the laboratory must verify the accuracy of any test or procedure listed in subpart I of this part for which compatible proficiency testing samples are not offered by a CMS-approved proficiency testing program. This STANDARD is not met as evidenced by: Based on a surveyor's review of the Proficiency Testing(PT) policy, competency 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 -- assessment records and an interview with the technical supervisor, the laboratory failed to have a system for verifying the accuracy of the testing for H.pylori in gastric biopsy at least twice yearly for the last two years. Findings: 1.A review of the PT policy revealed that the laboratory performed an internal assessment for accuracy of testing due to lack of availability of a suitable PT product. 2. A review of personnel competency records, revealed the laboratory did not perform their internal method for assessing the accuracy of culture results for H. pylori and susceptibility testing twice annually. Assessments were performed once annually as follows: a. Identification of Helicobacter pylori- 12/20/21 & 11/4/20 b. H.pylori susceptibility testing- 11/22/21 & 10/21/20 c. H.pylori Levofloxacin susceptibility- 7/2/21 & 12/10/20 3. An interview conducted on June 30, 2022 at approximately 10:00 AM with the technical supervisor, confirmed that the laboratory does not assess the accuracy of testing twice annually. D5807 TEST REPORT CFR(s): 493.1291(d) Pertinent "reference intervals" or "normal" values, as determined by the laboratory performing the tests, must be available to the authorized person who ordered the tests and, if applicable, the individual responsible for using the test results. This STANDARD is not met as evidenced by: Based on a surveyor's review of the patient test reports and an interview with the technical supervisor, the laboratory failed to include pertinent reference intervals, normal or expected values on the final test reports. Findings: 1. A review of final test reports for cultures on gastric biopsies revealed that no normal or expected values were available on the final test reports. 2. The laboratory test menu changes according to the needs of the research team and other specialties/analytes are added and removed to the CLIA certificate that also would not contain reference intervals, normal or expected values on the final test reports. 3. An interview conducted on June 30, 2022 at approximately 9:30 AM with the technical supervisor, confirmed that the final reports for all analytes do not include reference intervals, normal or expected values or any comments. 4. The laboratory reports performing approximately 17 patient samples in 2022. -- 2 of 2 --

Summary Statement of Deficiencies D3007 FACILITIES CFR(s): 493.1101(b) The laboratory must have appropriate and sufficient equipment, instruments, reagents, materials, and supplies for the type and volume of testing it performs. This STANDARD is not met as evidenced by: Based on record review of patient testing, proficiency testing records from the College of American Pathologists (CAP) and interview with the laboratory technical supervisor (TS) on 02/10/2021, the laboratory failed to have appropriate and sufficient reagents, materials, and supplies for the Hepatitis testing performed. The findings include: 1. The laboratory performs Hepatitis B core antibody testing for research projects, in which the individual test reports are provided to the research participants. 2. The laboratory has not been able to perform proficiency testing (PT) for 3/3 testing events in 2020, 2/3 testing events in 2019, and 3/3 testing events in 2018 due to no reagents available for testing. 3. The laboratory has not been able to evaluate 2/2 testing personnel for annual competency for 2018, 2019 and 2020 assigned to Hepatitis B testing due to lack of reagents. 4. The laboratory technical supervisor confirmed by interview on 02/10/2021 at 11:00 a.m. that the laboratory only purchases the Hepatitis reagents when there is a research study being performed and does not maintain the reagents in house to perform PT or annual personnel competency evaluations. 5. The laboratory reports performing no patient testing since January of 2019 (30), and no patient testing in 2018. D6120 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(7)(8) (7) The technical supervisor is responsible for identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed; (8) 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 -- Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on employee record review, the CMS-209 personnel report, and interview with the laboratory technical supervisor (TS) on 02/10/2021, the laboratory failed to evaluate the competency of 2/2 testing personnel performing Hepatitis B antibody testing and assuring that the testing personnel maintain their competency to perform Hepatitis B antibody testing. Findings include: 1. The laboratory CMS-209 personnel form lists two testing personnel for Hepatitis B testing. The laboratory has no documentation of annual competency for 2 of 2 testing personnel for 2020, 2019 and 2018. 2. The laboratory is enrolled in the College of American Pathologists (CAP) proficiency testing (PT), but has not performed 3/3 PT events for 2020, 2/3 PT events in 2019, 3/3 PT events in 2018, resulting in inability to evaluate testing personnel annual competency. 3. The laboratory technical supervisor confirmed by interview on 02/10/2021 at 11:00 a.m., that the laboratory does not have annual competency for the two personnel assigned to perform Hepatitis B antibody testing due to lack of reagent. 4. The laboratory reported performing 30 Hepatitis B antibody tests in 2019. -- 2 of 2 --