Kaiser Interstate Medical Office Lab

Summary Statement of Deficiencies D6063 LABORATORY TESTING PERSONNEL CFR(s): 493.1421 The laboratory must have a sufficient number of individuals who meet the qualification requirements of 493.1423, to perform the functions specified in 493. 1425 for the volume and complexity of tests performed. This CONDITION is not met as evidenced by: Based on review of the CMS 209 form, testing personnel (TP) educational and competency records and interview with the Point of Care (PoC) Coordinator, the laboratory failed to ensure all TP in the PoC area performing moderate complexity testing had diplomas on file and competencies assigned were completed. Findings include: 1. See D6065, D6066 D6065 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(b)(1)(2)(3)(4)(i) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located or have earned a doctoral, master's, or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution; or (b)(2) Have earned an associate degree in a chemical, physical or biological science or medical laboratory technology from an accredited institution; or (b)(3) Be a high school graduate or equivalent and have successfully completed an official military medical laboratory procedures course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); or (b)(4)(i) Have earned a high school diploma or equivalent; and 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 -- This STANDARD is not met as evidenced by: Based on review of the personnel documents submitted for my review during survey and interview with the Point of Care (PoC) supervisor, the laboratory failed to ensure that all testing personnel (TP) performing whole blood Human Chorionic Gonadotropin (HCG) assays for pregnancy with the Adexus, had educational documents on site for review during survey. Findings include: 1. Upon review of TP records for personnel performing moderate complexity pregnancy testing in the PoC area since last survey 11/28/2022, and listed on the current CMS 209 form, four (4) new TP did not have any record of education to qualify them to perform moderate complexity assays. 2. Interview with the PoC supervisor at 12:30 pm confirmed that these four (4) individuals did not have documentation on site to verify a minimum of a high school diploma, required to perform moderate complexity testing. 3. The laboratory reports performing 552 whole blood HCG assays annually in the PoC area, using the Adexus instrument. D6066 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(b)(4)(ii) Have documentation of training appropriate for the testing performed prior to analyzing patient specimens. This STANDARD is not met as evidenced by: Based on review of the testing personnel (TP) competency assessments presented for review during survey and interview with the Point of Care (PoC) supervisor, the laboratory failed to ensure that those TP performing Human Chorionic Gonadotropin (HCG) testing for pregnancy in the PoC area, had comptency assessment since the last CLIA survey 11/28/2022. Findings include: 1. Of the TP reviewed for the PoC area, performing whole blood HCG testing for pregnancy, three (3) of four (4) TP were lacking competency assessment as assigned by the PoC supervisor. TP #1 Failure to complete 6 month competency assessment for HCG, was due 09/2024. TP #3 No competncy assessment for HCG in 2022 or 2023 TP #4 No competency assessment for 2022 and failure to complete competency assessment for 2024, was due 09/2024. 2. Interview with the PoC supervisor at 1230 pm confirmed that there was no record of these three (3) TP completing the assigned competencies for HCG assay for pregnancy. 3. The laboratory reports performing 552 HCG assays for pregnancy annually. -- 2 of 2 --

Summary Statement of Deficiencies D5655 CYTOLOGY CFR(s): 493.1274(e)(4) (e) Slide examination and reporting. The laboratory must establish and follow written policies and procedures that ensure the following: (e)(4) Unsatisfactory specimens or slide preparations are identified and reported as unsatisfactory. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures and interview with the Laboratory Director the laboratory failed to establish written policies and procedures to ensure unsatisfactory nongynecologic slide preparations are identified and reported as unsatisfactory. Findings include: 1. The Survey Team requested and the laboratory failed to provide written policies and procedures to ensure that unsatisfactory nongynecologic slide preparations are identified and reported as unsatisfactory for evaluation. 2. During a phone interview on February 8, 2023 at 10:15 AM the Laboratory Director confirmed these findings. D6115 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(2) The technical supervisor is responsible for verification of the test procedures performed and establishment of the laboratory's test performance characteristics, including the precision and accuracy of each test and test system. This STANDARD is not met as evidenced by: A. Based on the microscopic review of 3 unsatisfactory nongynecologic cytology cases/7 slides from January 2021 through December 2022 and confirmation by Technical Supervisor on February 13, 2023 the Technical Supervisor failed to verify the accuracy of one nongynecologic cytology test. 1. N21-1147-C 03/12/2021 Left 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 -- Ureter Wash LABORATORY DIAGNOSIS: Unsatisfactory due to cellularity SURVEY TEAM DIAGNOSIS: Negative for High Grade Urothelial Carcinoma- abundant cellular material TECHNICAL SUPERVISOR DIAGNOSIS: Part C: Negative for High Grade Urothelial Carcinoma B. Based on the microscopic review of 99 negative and unsatisfactory gynecologic cytology cases/110 slides from January 2021 through December 2022 and confirmation by Technical Supervisor on February 13, 2023 the Technical Supervisor failed to verify the accuracy of two gynecologic cytology tests. 1. G21-27926 08/19/2021 ThinPrep Pap Test (TPPT) LABORATORY DIAGNOSIS: Negative for Intraepithelial Lesion SURVEY TEAM DIAGNOSIS: Low Grade Squamous Intraepithelial Lesion TECHNICAL SUPERVISOR DIAGNOSIS: Low Grade Squamous Intraepithelial Lesion 2. G21-41358 12/02/2021 ThinPrep Pap Test (TPPT) LABORATORY DIAGNOSIS: Negative for Intraepithelial Lesion SURVEY TEAM DIAGNOSIS: Unsatisfactory for Interpretation; scant cellularity TECHNICAL SUPERVISOR DIAGNOSIS: Unsatisfactory D9999 By agreement between ASCT Services, Inc. and CMS, information provided for CMS's completion of CMS Form 670 are ASCT Services, Inc. averages only. This information is confidential and proprietary to ASCT Services, Inc., is exempt under the Freedom of Information Act (5 U.S.C. 552 et seq.), and shall be used for federal government purposes only. -- 2 of 2 --