Bay Area Heart Surgery Center

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Bay Area Heart Surgery Center on 01/14/2026. The laboratory was surveyed under 42 CFR Part 493 CLIA requirements. Standard deficiencies cited are as follows: D6020 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) (e)(5) Ensure that the quality control and quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur; This STANDARD is not met as evidenced by: Based on record review and interview, the Laboratory Director failed to identify, via monthly quality assessement reviews, an electronic simulator check (internal control check) was not performed and documented for one (20th) of four days (13th, 20th, 26th and 29th) patient testing was performed in August 2024 for the test - Actived Clotting Factor (ACT) in the specialty of Hematology. Findings include: 1. The Laboratory Specimen Log for 08/2024 was reviewed. ACT patient tests were performed on the 13th, 20th, 26th, and 29th. 2. The August 2024 Maintenance and System Check Log, was reviewed. The form was signed by the Laboratory Director on 08/31/2024. The electronic simulator check was not documented as completed and acceptable on 08/20/2024. The form indicated no patient testing was performed. 3. The Laboratory Monthly Quality Assurance and QC review form was reviewed for 08 /2024. The form was signed by the Laboratory Director on 08/31/2024. The section titled "Preventative maintenance and systems checks completed and documented" was filled out indicating the electronic simulator checks were completed and documented each day patient testing was performed. 4. Electronic correspondence (interview) dated 01/14/2026 from the Laboratory Director, confirmed the above data. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Bay Area Heart Surgery Center on 07/12/22. The laboratory is not in compliance with 42 CFR Part 493, Requirement for Laboratories. The following Condition was cited: D6033 - 42 CFR 493.1409: Laboratories performing moderate complexity testing; technical consultant D6033 TECHNICAL CONSULTANT-MODERATE COMPEXITY CFR(s): 493.1409 The laboratory must have a technical consultant who meets the qualification requirements of 493.1411 of this subpart and provides technical oversight in accordance with 493.1413 of this subpart. This CONDITION is not met as evidenced by: Based on record review and interview, the laboratory failed to have a qualified Technical Consultant in the Specialty of Hematology and Subspecialty of Routine Chemistry from 04/26/22 to 07/12/22 with an annual estimated test volume of 1380 (See D6034). D6034 TECHNICAL CONSULTANT QUALIFICATIONS CFR(s): 493.1411 The laboratory must employ one or more individuals who are qualified by education and either training or experience to provide technical consultation for each of the specialties and subspecialties of service in which the laboratory performs moderate complexity tests or procedures. The director of a laboratory performing moderate complexity testing may function as the technical consultant provided he or she meets the qualifications specified in this section. 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 record review and staff interview, the laboratory failed to have a qualified Technical Consultant to provide technical oversight of the testing process which commenced on 04/26/22 to 07/12/22. Findings Included: Record review of the CMS 209, Laboratory Personnel Report, signed by the Laboratory Director on 07/08/2022 revealed the Laboratory Director also functioned as the Technical Consultant for moderate complexity testing in the Specialty of Hematology and Subspecialty of Routine Chemistry. Review of the CMS-116, Clinical Laboratory Improvement Amendments (CLIA) Application for Certification, signed by the Laboratory Director on 7/12/22 revealed the estimated annual test volume for Hematology was 1248, and Routine Chemistry was 132 for a total estimated test volume of 1380. Review of the Laboratory Director's personnel records revealed he became the Laboratory Director on 10/04/21. Review of the Laboratory Director's Curriculum Vitae (CV) and additional education/training records revealed no evidence of 1 year of laboratory training. Record review of the laboratory's policy titled "LAB 101 Laboratory Director's Responsibilities" revealed "The Laboratory Director, if qualified, may perform the duties of the technical consultant... or delegate these responsibilities to personnel meeting the qualification of 493.1409, 493.1415, and 493.1421. On 07/12 /22 at 10:25 AM, the Surgery Center Director stated she did not know that the Laboratory Director needed 1 year of laboratory training to become the Technical Consultant. She did not know additional training was required beyond the 20 hour Continuing Medical Education (CME) course required to be qualified as the Laboratory Director. -- 2 of 2 --