Golisano Children's Health Center

Summary Statement of Deficiencies D0000 A recertification survey was conducted from January 08, 2025 to January 14, 2025. GOLISANO CHILDREN'S HEALTH CENTER clinical laboratory was not in compliance with 42 CFR 493, requirements for clinical laboratories. D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) (b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to have one out of two testing personnel (TP) rotate through the testing of Proficiency Testing (PT) for Hematology and Chemistry specialties in 2 out of 2 years reviewed. Findings included: Review of FORM CMS-209 signed and dated by the Laboratory Director (LD) on 12/31/2024 revealed the laboratory had two TP listed (TP#1 and TP# 2). - Review of personnel records revealed that TP#1 and TP#2 had competencies during 2023 and 2024. -Review of American Proficiency Institute (API) PT records for 2023 (first, second and third event), 2024 (first, second and third event) in the specialties of Chemistry and Hematology, revealed that TP#1 had no PT participation during 2023 for Hematology and for 2024 TP#1 failed to participate in PT during 2024. During an interview on 01/08/2025 at 12:30 PM, the Technical Consultant confirmed that the laboratory failed to rotate the PT between all TP for the period of reference. 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, 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 -- consultant competency. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to have the annual competency assessment for 1 out of 2 Technical Consultant (TC) signed by the laboratory director for 2024. Findings include: 1)Review of CMS 209 Laboratory Personnel Report dated and signed by the Laboratory Director (LD) on 12/31/2024 revealed that: The Laboratory Director and Clinical Consultant was the same person, there was two technical Consultant (TC) (TC#1 and TC#2), and had two Testing Person (TP) (TP#1) and TP#2. 2) Review of TC#1 annual competency assessment on 02/15/2024 revealed that a person not listed in the 209 signed the competency of reference. During an interview on 01/08/2025 at 11:00 AM, with TC#1, she confirmed that a person not listed in the 209 signed her annual competency for 2024. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Golisano Children's Health Center on 1/24/23 - 1/26/23, a clinical laboratory in Fort Myers, Florida. The Golisano Children's Health Center laboratory is not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level deficiencies: D6006 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(d) 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, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (d) Each individual may direct no more than five laboratories. This STANDARD is not met as evidenced by: Based on record review of the CMS Laboratory Personnel Report (CMS 209) and the Clinical Laboratory Improvement Amendment (CLIA) Application (CMS 116) and interview with the Urgent Care Manager and CLIA Program Manager, the laboratory failed to ensure the laboratory director did not direct more than five laboratories at the time of survey, 1/24/23 - 1/26/23. The findings included: Record review of the CMS 209, signed and dated 1/26/23, included the name of a laboratory director that CMS listed as the current laboratory director. Record review of the CMS 116, signed and dated 1/19/23 revealed on page 5, "X. Director Affiliation with other Laboratories" listed five other laboratories that the laboratory director was directing. On 1/24/23 at 1: 10 p.m., the Urgent Care Manager confirmed the laboratory director was directing more than five laboratories. She stated that one of the laboratories said they had submitted an application to remove the laboratory director from their CLIA certificate. In a phone interview on 1/25/2023 at 11:20 a.m., the CLIA program manager stated that her office had not received an application to remove this laboratory director from 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 -- one of the five laboratories listed on the CMS 116 and confirmed the laboratory director was directing more than five laboratories. -- 2 of 2 --