Cpa-Baptist North Central

Summary Statement of Deficiencies D5032 CYTOLOGY CFR(s): 493.1221 If the laboratory provides services in the subspecialty of Cytology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1274, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on review of laboratory policies and procedures, laboratory records and interviews the laboratory failed to establish written policies and procedures for an annual statistical evaluation of the required laboratory statistics (refer to D5629); failed to establish and follow written policies and procedures for the establishment, reassessment and documentation of individual workload limits (refer to D5633, D5637 and D5647); failed to establish written policies and procedures to ensure that workload limits would be prorated when examining slides in less than eight hours (refer to D5641); failed to establish and follow written policies and procedures to ensure the laboratory maintained records of the total number of slides examined and the total number of hours spent examining slides per 24-hour period (refer to D5645); failed to establish written policies and procedures to ensure unsatisfactory nongynecologic cytology slide preparations were identified and reported as unsatisfactory (refer to D5655); failed to establish and follow written policies and procedures for the system of narrative descriptive nomenclature used by the laboratory to report nongynecologic cytology test results (refer to D5657); failed to establish and follow written policies and procedures for an ongoing mechanism to monitor, assess and correct problems identified in the analytic cytology systems (refer to D5791); and failed to establish and follow written policies and procedures for an ongoing mechanism to monitor, assess and correct problems identified in the postanalytic cytology systems (refer to D5891). D5401 PROCEDURE MANUAL Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 9 -- CFR(s): 493.1251(a) (a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on review of 15 laboratory policies and procedures, laboratory records and interview with Technical Supervisor B the laboratory failed to follow one written policy and procedure. Findings include: 1. The laboratory failed to follow the procedure MICROSCOPIC EXAMINATION OF ANATOMIC PATHOLOGY SPECIMENS, which stated: "The pathologist will review the staining and slide quality each day as well as the quality of the gross. The results of this review are recorded on the CPA Daily Histology and Cytology QA Log." 2. The Survey Team reviewed records titled SURGICAL AND CYTOLOGY STAIN QUALITY LOG from January 2024 through December 2024. The laboratory failed to document the stain quality for 19 of 26 days. Dates include: -01/16/24 -01/19/24 -02/05/24 -02/19 /24 -02/25/24 -02/28/24 -02/29/24 -03/04/24 -03/07/24 -03/11/24 -03/19/24 -04/01/24 -04/15/24 -04/18/24 -05/06/24 -05/13/24 -05/23/24 -07/02/24 -11/20/24 3. During an interview on February 24, 2025 at 1:15 PM, these findings were confirmed with Technical Supervisor B. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) (b) The procedure manual must include the following when applicable to the test procedure: (b)(1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (b)(2) Microscopic examination, including the detection of inadequately prepared slides. (b)(3) Step-by- step performance of the procedure, including test calculations and interpretation of results. (b)(4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (b)(5) Calibration and calibration verification procedures. (b)(6) The reportable range for test results for the test system as established or verified in 493.1253. (b)(7) Control procedures. (b)(8)

Summary Statement of Deficiencies D5473 CONTROL PROCEDURES CFR(s): 493.1256(e)(2)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (2) Each day of use (unless otherwise specified in this subpart), test staining materials for intended reactivity to ensure predictable staining characteristics. Control materials for both positive and negative reactivity must be included, as appropriate. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of the laboratory's daily histology stain quality records from August 2023, review of patient test records from August 1913 and staff interview, the laboratory failed to have documentation of assessing stain quality on 3 of 21 days. The findings include: 1. A random sampling of histology stain quality records from August 2023 identified 3 of 21 days where the laboratory failed to have documentation of acceptable stain quality. The days were: August 22 August 23 August 24 2. The laboratory was asked to provide documentation of acceptable histology stain quality on the identified days. No documentation was provided. 3. A review of the patient test records from August 2023 identified the following patient slides read on days without stain quality being assessed: a) August 22 ID: 900016004 ID: 900016007 b) August 23 ID: 900016002 ID: 900016008 ID: 900016001 c) August 24 ID: 900016021 ID: 900016022 4. The Clinical Service Manager confirmed the findings after her review of the records on 05/08/2024 at 1210 hours in the office. D6128 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) The technical supervisor is responsible for evaluating and documenting the performance of individuals responsible for high complexity testing at least annually after the first year, unless test methodology or instrumentation changes, in which case, 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 -- prior to reporting patient test results, the individual's performance must be reevaluated to include the use of the new test methodology or instrumentation. This STANDARD is not met as evidenced by: Based on review of the laboratory's submitted Form CMS 209, review of the laboratory's personnel records, and staff interview, the laboratory failed to have documentation of the technical supervisor performing annual competency assessments on 12 of 12 testing personnel in 2022. The findings included: 1. A review of the laboratory's submitted Form CMS 209 determined the laboratory identified 12 testing personnel. 2. A review of the laboratory's personnel records determined the laboratory failed to have documentation of the technical supervisor performing 12 of 12 competency assessments in 2022. 3. The laboratory was asked to provide documentation of the missing competency assessments. No documentation was provided. 4. The clinical service manager confirmed the findings in an interview conducted 05/08/2024 at 1030 hours in the office. -- 2 of 2 --