Baton Rouge General Bluebonnet Lab

Summary Statement of Deficiencies D5645 CYTOLOGY CFR(s): 493.1274(d)(3) (d)(3) The laboratory must maintain records of the total number of slides examined by each individual during each 24-hour period and the number of hours spent examining slides in the 24-hour period irrespective of the site or laboratory. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, laboratory workload records and interview with Technical Supervisor B, the laboratory failed to follow written policies and procedures to ensure the laboratory maintained records of the total number of slides examined and the hours spent examining slides during each 24-hour period. The laboratory failed to provide records of the total number of slides examined and the hours spent examining slides for three of seven Technical Supervisors in 2024 and January 1, 2025 to the date of the survey in 2025. Findings include: 1. The laboratory failed to follow the written procedure NON-GYNECOLOGIC CYTOLOGY WORKLOAD which stated: "The pathologist is responsible for documenting the following information on the non-gynecologic workload reporting form: Number of Non-Gyn slides screened manually per day; Total hours spent screening per day." 2. The Survey Team requested and the laboratory failed to provide records for three of seven Technical Supervisors who performed primary screening. (See D6133) Technical Supervisors include: -Laboratory Director/Technical Supervisor A -Technical Supervisor B -Technical Supervisor C 3. During an interview on February 25, 2025 at 3:15 PM, Technical Supervisor B confirmed these findings. D6133 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(c)(6) (c)(6) If responsible for screening cytology slide preparations, must document the number of cytology slides screened in 24 hours and the number of hours devoted 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 -- during each 24-hour period to screening cytology slides. This STANDARD is not met as evidenced by: Based on review of laboratory workload records and interview with Technical Supervisor B, two of seven Technical Supervisors failed to document the total number of slides examined and hours spent examining slides during each 24-hour period and one of seven Technical Supervisors failed to document the number of hours spent examining slides during each 24-hour period from January 2024 to January 2025. Findings include: 1. Three of seven Technical Supervisors failed to document the following on the laboratory record PATHOLOGIST NON-GYNECOLOGIC CYTOLOGY MONTHLY WORKLOAD REPORTING FORM from January 2024 to January 2025. a. Laboratory Director/Technical Supervisor A failed to document the total number of slides examined and hours spent examining slides for January 2024 and September 2024. b. Technical Supervisor C failed to document the total number of slides examined and the total number of hours spent examining slides for December 2024 and January 2025. c. Technical Supervisor B failed to document the total number of hours spent examining slides for April 22-27, 2024. 2. During an interview on February 25, 2025 at 3:15 PM, Technical Supervisor B confirmed these findings. D9999 -- 2 of 2 --

Summary Statement of Deficiencies D0000 A recertification survey was conducted at Baton Rouge General Bluebonnet - CLIA ID # 19D0955389 on December 10, 2019. The laboratory was found in compliance with 42 CFR 493 Requirement for Laboratories; however, standard level deficiencies were identified. 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 record review and interview with personnel, the laboratory failed to follow their established competency assessment policy for testing personnel. Findings: 1. Review of the laboratory's personnel competency policy revealed all testing personnel competency to be evaluated prior to patient testing. 2. Review of the laboratory's CMS 209 (Laboratory Personnel Report) revealed the Personnel 13 was listed as testing personnel. 3. Review of personnel records revealed competency assessment for Personnel 13 was not documented prior to patient testing. 4. In interview on December 10, 2019, the Personnel 15 confirmed an initial competency assessment was not documented for Personnel 13. D6102 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(12) The laboratory director must ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate 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 -- results. This STANDARD is not met as evidenced by: Based on record review and interview with personnel, the Laboratory Director failed to ensure Testing Personnel met training requirements prior to patient testing. Refer to D5209. -- 2 of 2 --