M & M Pediatrics

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 D0000 Noted deficiencies and plans of correction were discussed with the laboratory representative(s) at the exit conference. The facility was found to be in compliance with applicable Conditions 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 the Instructions for Use for the BinaxNOW RSV card, a review of patient test records from October 2022 to February 2023, and staff interview, it was revealed that the laboratory failed to follow the manufacturer's instructions by ensuring the BinaxNOW RSV (Respiratory Syncytial Virus) test was run on patients five years of age or older for five of twenty patient test reports reviewed. Findings include: 1. A review of the Instructions for Use for the BinaxNOW RSV card test revealed the following: "ATTENTION Do not use the RSV test in patients 5 years or older." 2. A review of the laboratory's patient test records from October 2022 to February 2023 revealed the following 5 patient's samples were run using the BinaxNOW RSV card: Patient date of birth: 4/19/11 Patient age: 11 years Date tested: 10/10/22 Patient date of birth: 4/25/15 Patient age: 8 years Date tested: 10/14/22 Patient date of birth: 8/3/10 Patient age: 13 years Date tested: 12/9/22 Patient date of birth: 4/4/02 Patient age: 20 years Date tested: 1/21/23 Patient date of birth: 3/28/12 Patient age: 10 years Date tested: 2/11/23 3. An interview with the technical consultant (as indicated on the CMS 209 form) on 4/26/23 at 10:44 a.m. in the upstairs break room, after review of the records, confirmed the above findings. 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 -- 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 a review of the laboratory's Rotavirus Log Sheets for the SAS Rotavirus test and staff interview, it was revealed that the laboratory failed to retain the Rotavirus Log Sheets, containing quality control and patient test results, for 38 of 59 days from January 1, 2022 to February 28, 2022. Findings include: 1. A review of the laboratory's Rotavirus Log Sheets for the SAS Rotavirus test revealed the laboratory failed to retain the Rotavirus Log Sheets, containing quality control and patient test results, for 38 days from January 14, 2022 to February 22, 2022. 2. An interview with the technical consultant (as indicated on the CMS 209 form) on 4/26/23 at 10:05 a.m. in the upstairs break room, after review of the records, confirmed the above findings. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of the laboratory's IQCP (Individualized Quality Control Plan) for the SAS Rotavirus test, the laboratory's quality control records from 2022, the laboratory's patient test records, and staff interview, it was revealed that the laboratory failed to have documentation of running quality controls for the SAS Rotavirus test at the frequency established by the IQCP for one of twelve months from January to December 2022. Findings include: 1. A review of the laboratory's IQCP for the SAS Rotavirus test revealed the following: "QC for the SAS Rotavirus will consist of: Testing of Positive and Negative External Controls per each lot & shipment before placing these materials into service and monthly thereafter." 2. A review of the laboratory's quality control (QC) records from January to December 2022 revealed the laboratory failed to have documentation of running positive and negative controls in the month of July. 3. A review of the laboratory's patient test records revealed the laboratory ran the following SAS Rotavirus test in July: Patient: HG040621 Tested on: 7/6/22 4. An interview with the technical consultant (as indicated on the CMS 209 form) on 4/26/23 at 9:45 a.m. in the upstairs break room, after review of the records, confirmed the above findings. -- 2 of 2 --

Summary Statement of Deficiencies D0000 Based on a proficiency testing desk review survey performed on December 20, 2021, the laboratory was found to be out of compliance based on the following CONDITION LEVEL DEFICIENCIES: D2016 - 42 C.F.R. 493.803 Condition: Successful participation D6000 - 42 C.F.R. 493.1403 Condition: Laboratory Director, moderate complexity D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and American Proficiency Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- Institute (API) proficiency testing records, the laboratory failed to achieve successful performance in two of three testing events for Rotavirus antigen, resulting in unsuccessful performance in the specialty of Virology (refer to D2061, D2062, and D2064). D2056 VIROLOGY CFR(s): 493.831(a) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and American Proficiency Institute (API) proficiency testing records, the laboratory failed to attain an overal testing score of at least 80% for the specialty of Virology. The findings included: 1. 2021 (2nd event) - laboratory received an overall score of 0%. 2. 2021 (3rd event) - laboratory received an overall score of 0%. 3. This failures resulted in unsuccessful proficiency testing performance. D2057 VIROLOGY CFR(s): 493.831(b) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3) The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: Based on review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and American Proficiency Institute (API) proficiency testing records, the laboratory failed to participate in 2 consecutive PT (proficiency testing) events for Virology. The findings included: 1. 2021 (2nd event) - failure to participate (0%) 2. 2021 (3rd event) - failure to participate (0%) 3. These failures to participate resulted in unsatisfactory performance for the specialty of Virology. D2064 VIROLOGY CFR(s): 493.831(e) Failure to achieve an overall testing event score of satisfactory performance for two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: -- 2 of 3 -- Based on desk review of proficiency testing records, it was determined the laboratory failed to achieve satisfactory performance (80 % or greater) for the specialty of Virology in two consecutive testing events. Two out of three unsatisfactory scores results in unsuccessful PT performance. 1. API 2021 - 2nd event: laboratory received a score of 0% resulting in unsatisfactory performance. 2. API 2021 - 3rd event: laboratory received a score of 0% resulting in unsatisfactory performance. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and American Proficiency Institute proficiency testing records, the laboratory director failed to provide overall management and direction of the laboratory services. The findings included: Based on desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and American Proficiency Institute (API) proficiency testing records, the laboratory director failed to ensure successful participation in an HHS approved proficiency testing program for Virology (refer to D6016). D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) 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)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and American Proficiency Institute (API) proficiency testing records, the laboratory director failed to ensure successful participation in a HHS approved proficiency testing program for Virology (refer to D2056, D2057, and D2064). -- 3 of 3 --

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 in compliance with applicable Conditions of Participation in the CLIA program, and recertification is recommended. Note: The CMS-2567 (Statement of Deficiencies) is an official, legal document. All information must remain unchanged except for entering the

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. Note: The CMS-2567 (Statement of Deficiencies) is an official, legal document. All information must remain unchanged except for entering the