Clinical Pathology Associates Ne Baptist Hospital

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 January 2023 and March 2023, and staff interview, the laboratory failed to have documentation of assessing stain quality on 3 of 3 days. The findings include: 1. A random sampling of histology stain quality records from January 2023 and March 2023 identified 3 of 3 days where the laboratory failed to have documentation of acceptable stain quality. The days were: January 5, 2023 January 23, 2023 March 17, 2023 2. The laboratory was asked to provide documentation of acceptable histology stain quality on the identified days. No documentation was provided. 3. The Clinical Service Manager confirmed the findings after her review of the records on 02/06/2023 at 1424 hours in the office. D6127 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 semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: 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 -- Based on review of the laboratory's personnel records, and staff interview, the laboratory failed to have documentation of competency assessments being performed twice within the first year of employment for 1 of 1 personnel requiring them. The findings include: 1. A review of the laboratory's personnel records identified 1 testing personnel who required semiannual competency assessments within the first year of testing during the record review period. They were (as listed on Form CMS 209): Testing personnel number 2 2. Further review of the personnel records revealed: Testing personnel number 2 Hired: 04/2022 One competency assessment performed: 2023 3. The laboratory was asked to provide documentation of 2 competency assessments being performed within the first year of employment for the identified personnel. No documentation was provided. 4. The Clinical Service Manager confirmed the findings during an interview conducted 02/06/2024 at 0915 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, 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 personnel records and staff interview, the laboratory failed to have documentation of annual competency assessments for 4 of 4 testing personnel requiring them in 2022. The findings include: 1. A review of the laboratory's personnel records identified 3 testing personnel who required annual competency assessments in 2022. They were (as listed on Form CMS 209): Testing personnel number 3 Testing personnel number 4 Testing personnel number 5 Testing personnel number 6 2. Competency assessments for 2022 were not available for 4 of the 4 identified personnel. 3. The laboratory was asked to provide documentation of annual competency assessments being performed in 2022 for each of the 4 identified personnel. No documentation was provided. 4. The Clinical Service Manager confirmed the findings during an interview conducted 02/06/2024 at 0915 hours in the office. -- 2 of 2 --

Summary Statement of Deficiencies D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on the review of laboratory records and interviews it was determined that the Facility A laboratory (CLIA #45D2007457) failed to enroll in an approved cytology proficiency testing (PT) program for gynecologic examination (refer to D2001). The cumulative effect of this systemic problem resulted in the laboratory's failure to meet certification requirements to accurately and reliably evaluate patients gynecologic cytology specimen slides for 2016, 2017 and to the date of the survey in 2018. D2001 ENROLLMENT CFR(s): 493.801(a)(1)(2)(i) The laboratory must-- (1) Notify HHS of the approved program or programs in which it chooses to participate to meet proficiency testing requirements of this subpart. (2)(i) Designate the program(s) to be used for each specialty, subspecialty, and analyte or test to determine compliance with this subpart if the laboratory participates in more than one proficiency testing program approved by CMS; Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 12 -- This STANDARD is not met as evidenced by: Based on the lack of cytology PT enrollment records and interviews it was determined that the Facility A laboratory failed to enroll in an approved cytology PT program for the years 2016, 2017 and to the date of the survey in 2018. Findings include: 1. The Survey Team requested and the Facility A laboratory failed to provide records of enrollment in an approved cytology PT program for 2016, 2017 and to the date of the survey in 2018. 2. During an interview on 2/28/18 at 9:00 AM, the Facility B (CLIA #45D0505003) Laboratory Manager stated that the Facility A laboratory was not enrolled in an approved cytology PT program for 2016, 2017 and to the date of the survey in 2018. The Facility B Laboratory Manager further stated that Facility A staff participated in the PT at Facility B. 3. The Facility A Laboratory Director/Technical Supervisor #1 confirmed these findings during an interview on 2/28/18 at 1:45 PM . 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 the review of written laboratory policies and procedures, laboratory records, and interview, it was determined that the Facility A laboratory failed to establish written policies and procedures to assess the competency of seven of seven Technical Supervisors who performed the microscopic evaluation of cytology specimens in 2016 and 2017. Findings include: 1. The written procedure titled PROFESSIONAL COMPETENCY OF PATHOLOGISTS (not signed or dated by the Facility A Laboratory Director/Technical Supervisor #1) stated that the "pathologists participate in quality assurance activities as required by institutional policies to assure competency." The written procedure did not detail how these quality assurance activities were performed and documented for seven of seven Technical Supervisors in 2016 and 2017. 2. The Survey Team requested and the Facility A laboratory failed to provide records of competency assessment for seven of seven Technical Supervisors that performed the microscopic examination and reporting of cytology test results in 2016 and 2017. Laboratory Director/Technical Supervisor #1 Technical Supervisor #2 Technical Supervisor #5 Technical Supervisor #7 Technical Supervisor #8 Technical Supervisor #9 Technical Supervisor #10 3. During an interview on 2/28 /18 at 1:45 PM the Facility A Laboratory Director/Technical Supervisor #1 confirmed these findings. D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: -- 2 of 12 -- Based on the review of written laboratory policies and procedures and interview it was determined that the Facility A laboratory failed to establish written policies or procedures to document the conditions required for the transportation of cytology specimen slides from Facility A to Facility B for the years 2016, 2017 and to the date of the survey in 2018. Findings include: 1. The Survey Team requested and the Facility A laboratory failed to provide written policies and procedures for the documentation of the conditions required for the transport of cytology slides between Facility A and Facility B. 2. All cytology specimen slides were accessioned, processed, stained and examined by cytotechnologists at Facility B. Slides that required a Technical Supervisor review were then transported from Facility B to Facility A for final microscopic examination and reporting by a Technical Supervisor. All slides were transported back to Facility B for storage. 3. The Facility B Laboratory Manager and the Facility A Laboratory Director/Technical Supervisor #1 confirmed these findings during an interview on 2/28/18 at 1:45 PM. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (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. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)