Sgpa - Hematology And Oncology 6450 (B)

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) Recertification Survey was completed on March 17, 2026. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: D6079 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(a)(b) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, record and report test results promptly, accurately and proficiently, and for assuring compliance with the applicable regulations. (a) The laboratory director, if qualified, may perform the duties of the technical supervisor, clinical consultant, general supervisor, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications under 493.1447, 493.1453, 493.1459, and 493.1487 respectively. (b) If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed. This STANDARD is not met as evidenced by: A review of the current Laboratory Procedure Manual, 2024 - 2026 Maintenance Records, 2024 - 2026 Personnel Records, 2024 - 2026 Proficiency Testing Records, 2024 - 2026 Quality Assurance Records, 2024 - 2026 Quality Control Records, and 2024 - 2026 Temperature Records confirmed that the Laboratory Director failed to provide proper oversight of the overall operations and administrations of the facility to assure accurate and quality results. THE FINDINGS INCLUDE: 1. A review of the 2024 - 2026 Personnel Records revealed that Testing Personnel 1 (TP1) (identified on CMS-Form 209) performed the competencies on Testing Personnel 2 (TP2) ( identified on CMS-Form 209.) 2. A review of 2024 - 2026 Quality Assurance Records confirmed that quality assurance oversight was performed by TP1. 3. A review of the 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 -- 2024 - 2026 Personnel Records revealed that a written Letter of Delegation, from the Laboratory Director, assigning duties performed by TP1, was not available on the day of survey. 4. An exit interview, with Testing Personnel 1, on March 17, 2026, at 2: 30pm, confirmed that the Laboratory Director failed to provide proper oversight of the overall operations of the laboratory to assure accurate and quality clinical laboratory results. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on November 19, 2019. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least annually, after the first year. This STANDARD is not met as evidenced by: Based on review of testing personnel (TP) documents and staff interview , the technical consultant (lab director) failed to perform annual competency on testing personnel. Findings include: 1. Review of testing personnel (TP) competency documents reveals the technical consultant (lab director) failed to perform annual competency on 2 of 2 testing personnel during the year of 2018. 2. Interview with staff #1 (CMS 209 form) on 11/19/19 at approximately 12:30 PM in the front side office, confirmed the annual competencies were not performed. 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 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on January 17, 2018. The laboratory was not in compliance with all applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiency was cited: D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on observation by the surveyor during a tour of the laboratory and staff interview, the laboratory failed to perform function checks on the Quest Horizon centrifuge used to prepare specimens for testing. Findings include: 1. Observation by the surveyor during a tour of the laboratory revealed the rotations per minute (RPM) check was last performed on 8/24/16. 2. Interview with testing personnel # 1 on January 17, 2018 at 12 pm in the break room confirmed the last time centrifuge maintenance and RPM check were performed is 8/24/16 and it is not performed yearly as required. 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 --