Dr Karelys Rivera And Associates Pa

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) (b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on review of the laboratory's proficiency testing policy, review of the laboratory's Wisconsin State Hygiene Laboratory's proficiency testing records from 2025 and 2026, and staff interview, the laboratory failed to have documentation of testing personnel signing 4 of 5 attestation statements. The findings included: 1. The laboratory's proficiency testing policy stated: "The attestation statement shall be signed and dated by testing personnel and the Laboratory Director at the time of testing." 2. A review of the laboratory's Wisconsin State Hygiene Laboratory's proficiency testing records from 2025 (events 1, 2, and 3) and 2026 (events 1 and 2) determined the laboratory failed to have documentation of each testing personnel signing the attestation statement for 4 of 5 events. They were: 2025 Event 2 2025 Event 3 2026 Event 1 2026 Event 2 3. The technical consultant confirmed the findings in an interview conducted on 09/15/2026 at 900 hours in the break room. D2010 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(2) (b)(2) The laboratory must test samples the same number of times that it routinely tests patient samples. This STANDARD is not met as evidenced by: Based on review of the laboratory's proficiency testing policy, 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 5 -- laboratory's Wisconsin State Laboratory of Hygiene proficiency testing records from 2025 and 2026, and staff interview, the laboratory failed to test proficiency samples the same number of times it routinely tests patient samples for 4 of 5 events. The findings included: 1. The laboratory's Proficiency Testing policy (signed 10/30/2018) stated: "PT specimens are to be treated the same as patient samples." 2. A review of the laboratory's Wisconsin State Laboratory of Hygiene proficiency testing records from 2025 (Events 1, 2 and 3) and 2026 (Events 1 and ) determined the laboratory tested proficiency testing samples more times than it would routinely test patient samples for 4 of 5 events. They were: a) 2025 event 1 Sample: AT 1 Tested: 2/5/2025 2:19 pm Tested: 2.5.2025 2:20 pm No flagged or critical results Sample: AT 2 Tested: 2/5/2026 2:23 pm Tested 2/5/2025 2:24 pm Flagged results on 2nd test b) 2025 event 3 Sample: AT 13 Tested: 9/23/2025 10:45 am Tested: 9/23/2025 10:46 am Sample: AT 15 Tested: 9/23/2026 10:56 am Tested: 9/23/2026 10:59 am No flagged or critical results c) 2026 Event 1 Sample: AT 1 Tested: 02/12/2026 3:53 pm Tested: 02/12/2026 3:55 pm No flagged or critical results d) 2026 Event 2 Sample: AT 7 Tested: 06/10 /2026 10:33 am Tested: 06/10/2026 10:35 Flagged results on 2nd test Sample: AT 10 Tested: 06/10/2026 11:00 am Tested: 06/10/2026 11:10 am No flagged or critical results 3. The technical consultant confirmed the findings after her review of the records during an interview conducted on 09/15/2026 at 900 hours in the break room. D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on review of the laboratory's policies, review of the laboratory's Wisconsin State Laboratory of Hygiene proficiency testing records from 2025 and 2026, and staff interview, the laboratory failed to have documentation of evaluating ungraded proficiency testing records on 2 of 5 events. The findings included: 1. The laboratory's Policy titled "Proficiency Testing

Summary Statement of Deficiencies D0000 Noted deficiencies and plans of correction were discussed with the laboratory representative(s) at the exit conference. The facility representative(s) were given an opportunity to provide evidence of compliance with the noted deficiencies, and no such evidence was provided prior to survey exit. The facility was found to be in compliance with applicable Conditions of Participation in the CLIA program, and recertification is recommended. D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) Laboratories eligible for a certificate of waiver must-- (1) Follow manufacturers' instructions for performing the test; and (2) Meet the requirements in subpart B, Certificate of Waiver, of this part. This STANDARD is not met as evidenced by: Based on review of manufacturer's instructions, review of patient test records from October 2020 to March 2021, and confirmed in interview of facility personnel, the laboratory failed to provide documentation of following the manufacturer's instructions when performing Quidel Sofia SARS Antigen testing. The findings were: 1. Review of the manufacturer's instructions for the QUIDEL Sofia SARS Antigen stated, "All operators using your product must be appropriately trained in performing and interpreting the results of your product in accordance with the authorized labeling." 2. Review of patient test records October 2021 to March 2021 (see patient alias list) found the laboratory tested the patients when the laboratory failed to provide documentation of training operators. 3. The laboratory was asked to provide documentation of following the manufacturer's instructions to train operators in performing and interpreting results for Sofia SARS Antigen testing. No documentation was provided. 4. The results were confirmed in interview with the technical consultant on March 10, 2021 at 09:30 hours in the break room. 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 The laboratory was found to be out of compliance based on the following CONDITION LEVEL DEFICIENCY: D5400 - 42 C.F.R. 493.1250 Condition: Analytic systems; D6000 - 42 C.F.R. 493.1403 Condition: Lab Director, moderate complexity D6033 - 42 C.F.R. 493.1409 Condition: Technical Consultant; moderate complexity D6063 - 42 C.F.R. 493.1412 Condition: Testing Personnel; moderate complexity Noted deficiencies and plans of correction were discussed with the laboratory representative at the exit conference. The facility representative was given an opportunity to provide evidence of compliance with noted deficiencies and no such evidence was provided prior to survey exit. Note: The CMS-2567 (Statement of Deficiencies) is an official, legal document. All information must remain unchanged except for entering the