M & M Pediatrics Pllc

Summary Statement of Deficiencies D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) (b) The procedure manual must include the following when applicable to the test procedure: (b)(1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (b)(2) Microscopic examination, including the detection of inadequately prepared slides. (b)(3) Step-by- step performance of the procedure, including test calculations and interpretation of results. (b)(4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (b)(5) Calibration and calibration verification procedures. (b)(6) The reportable range for test results for the test system as established or verified in 493.1253. (b)(7) Control procedures. (b)(8)

Summary Statement of Deficiencies D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on review of the laboratory's quality control records, patient records, and confirmed in interview of laboratory personnel, the laboratory failed to retain patient and quality control records for Rotavirus from June 2, 2021 to October 31, 2021. The findings included: 1. Review of the laboratory's Rotavirus quality control records from June 2, 2021 to June 30, 2022 found no records could be recovered to ensure the laboratory performed quality control according to its IQCP from June 2, 2021 to October 31, 2021. a. The laboratory failed to retain Rotavirus quality control records from June 2, 2021 to October 31, 2021 for a minimum of two years. 2. Review of the laboratory's patient test records from June 2, 2021 to June 30, 2022 found no records could be recovered from June 2, 2021 to October 31, 2021. The laboratory failed to retain patient test records for a minimum of two years. 3. The laboratory was asked to provide documentation of retaining patient and quality control records for a minimum of two years. No documentation was provided. 4. The findings were confirmed in interview with the technical consultant on July 13, 2022 at 11:00 hours in the break room. Key: IQCP - Individualized Quality Control Plan 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 Noted deficiencies and plans of correction were discussed with the laboratory representatives at the entrance and exit conferences. The facility representatives were given an opportunity to provide evidence of compliance with the noted deficiency, 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 certification is recommended. Note: The CMS-2567 (Statement of Deficiencies) is an official, legal document. All information must remain unchanged except for entering the