Dr Karelys Rivera And Associates Pa

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