City Of Gary Department Of Health

Summary Statement of Deficiencies D0000 A recertification survey was completed on 4/11/2024. It was determined that the following condition-level deficiencies existed: 42 C.F.R. 493.1409 Laboratories performing moderate complexity testing; technical consultant. D6021 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) 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. (e) The laboratory director must-- (e)(5) Ensure that quality assessment programs are established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on record review, lack of documentation, and interview, the laboratory director failed to ensure the quality assessment program was maintained from July 2, 2021, until April 11, 2024. Findings Included: 1. Upon request for a policy on how and when quality assessments were performed, on 4/03/24 at 11:56 am, SP-2 (testing person) indicated quality assessments activities were performed quarterly and provided the policy titled "Syphilis Health Check" and "Laboratory Quality Assurance Problems" sheets. 2. Review of the policy "Syphilis Health Check", with no approval or effective date, indicated there were no requirements for how or when quality assessments would be performed. 3. Review of documents titled, "Laboratory Quality Assurance Problems", with dates ranging from 2/04/21 to 07/02/21, indicated the last documentation of a problem was on 7/2/2021. There was no documentation of quarterly meetings or assessments. 4. Review of document, "City of Gary Job Description", for SP-2, signed by the Department/ Division Head on 05/16/02, under: Principle Functions, stated the following regarding test performance specifications: a) Identifies problems that may adversely affect test performance or reporting of test Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- results and either correct the problem or immediately notify the Technical Consultant (TC), Clinical Consultant (CC), or the Deputy Director. b) Documents all

Summary Statement of Deficiencies D2071 SYPHILIS SEROLOGY CFR(s): 493.835(c) Failure to return proficiency testing results to the proficiency testing program within the time frame specified by the program is unsatisfactory performance and results in a score of 0 for the testing event. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to return its proficiency testing (PT) results to the College of American Pathologists (CAP) before the submission deadline for one of one test (rapid plasma reagin (RPR)) performed in one of three (Event 3) PT events in 2021 for the subspecialty of Syphilis Serology. Findings: 1. "Policy and Procedure Proficiency Testing City of Gary Department of Health Laboratory", signed January 17, 2017, stated that 'Survey Results must be reported before [the] deadline via. (sic) fax, mail or internet." 2. CAP's "Syphilis Serology Survey Result Form" for the third event of 2021 stated that "Results are due no later than midnight, Central Time: January 04, 2022". 3. A fax transaction report indicated that the laboratory reported its results for the third PT event of 2021 to CAP on January 6, 2022 at 5:26 pm, after the deadline. 4. On 02/22/2022 at 1:15 pm, SP3 (testing person) confirmed that the laboratory faxed its results to CAP after the deadline for the third PT event of 2021. 5. The lab's CASPER Report 0155D indicated that the laboratory received a 0 score for the third syphilis serology PT event of 2021. 6. The annual test volume for Syphilis Serology is approximately 687. 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 --