Laboratorio Clets Ponce

Summary Statement of Deficiencies D0000 The Centers for Medicare & Medicaid Services (CMS) New York CLIA Branch Location federal surveyors conducted an announced CLIA recertification survey at Laboratorio EST/VIH/SIDA Ponce on August 24, 2022. The laboratory was surveyed under 42 CFR part 493 CLIA requirements. The following deficiency was found during the announced routine CLIA recertification survey performed on August 24, 2022. 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 the review of the he ASI Rapid Plasma Reagin (RPR) Card Test kit for syphilis quality control (QC) records, review of the quality assessment (QA) records and interview with the laboratory director (LD), the LD failed to maintain, review and sign QA and RPR QC documents from 2021 to 2022. Findings Include: 1. On the day of survey, 08/24/2022 review of the RPR QC records and QA records revealed, The LD did not sign the yearly QA records and monthly RPR QC records when reviewed from 2021 to 2022. 2. The LD confirmed on 08/24/2022 around 11:00 am, they reviewed the QA and QC records periodically but did not sign and date the document when the review was 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 D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on observation and confirmation by the technical supervisor, the laboratory failed to ensure that one Acetone and one 100% Ethanol container were each labeled with the appropriate preparation and expiration dates. D5431 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(2) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document function checks as defined by the manufacturer and with at least the frequency specified by the manufacturer. Function checks must be within the manufacturer's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on lack of documentation and confirmation by the technical supervisor, the laboratory failed to perform the required annual centrifuge calibration for the Rotina 420 centrifuge. The last centrifuge calibration occurred May 19, 2016 and expired on 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 -- May 19, 2017. The technical supervisor confirmed that during the period of May 20, 2017 to July 31, 2017, 114 patient specimens were processed using an uncalibrated centrifuge. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on reviewing patient test reports and confirmation by the technical supervisor, the laboratory failed to include the name and address of the laboratory location where the testing was performed. Eight of eight test reports identified the name and address of the Puerto Rico Department of Health laboratory located in Rio Piedras, Puerto Rico rather than Ponce, Puerto Rico. D5809 TEST REPORT CFR(s): 493.1291(e) The laboratory must, upon request, make available to clients a list of test methods employed by the laboratory and, as applicable, the performance specifications established or verified as specified in 493.1253. In addition, information that may affect the interpretation of test results, for example test interferences, must be provided upon request. Pertinent updates on testing information must be provided to clients whenever changes occur that affect the test results or interpretation of test results. This STANDARD is not met as evidenced by: Based on reviewing two test reports and confirmation by the technical supervisor, the laboratory failed to provide information that may affect the interpretation of test results. VDRL test reports failed to indicate the method used for the testing. The technical supervisor confirmed that all VDRL test reports fail to indicate the testing method. -- 2 of 2 --