Troy Pediatrics, Llp

Summary Statement of Deficiencies D1002 REPORTING OF SARS-CoV-2 TEST RESULTS During the Public Health Emergency, as defined in 400.200 of this chapter, each laboratory that performs a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (hereinafter referred to as a "SARS-CoV-2 test") must report SARS-CoV-2 test results to the Secretary in such form and manner, and at such timing and frequency, as the Secretary may prescribe. This CONDITION is not met as evidenced by: Based on surveyor's review of the laboratory's form used to record the patient test results for SARS-CoV-2 performed on the Quidel Sofia analyzer, Quality Control (QC) results, the lot numbers, expiration date and an interview with the laboratory director, the laboratory failed to establish a written procedure for reporting the patient's tests results to the New York Bureau of Surveillance and Data systems, via the Electronic Clinical Laboratory Reporting System (ECLRS) from 10/21/20 through survey date. FINDINGS 1. The laboratory director confirmed on December 14, 2021 at approximately 10:30 AM, the surveyor's findings that the laboratory failed to establish a written procedure for reporting the patient's tests results for the SARS- CoV-2 to the New York Bureau of Surveillance and Data Systems from 10/21/20 through survey date. 2. The written procedure for reporting the required data must include: Test ordered using Logical Observation Identifiers Names Codes (LOINC) from Center for Diseases Control (CDC) Device identifier Test result and result date Accession number/specimen number Patient age, race, ethnicity's, zip code and county Ordering provider name, National Provider Identifier (NPI) number, address, and zip code Performing facility name and/or Clia number and zip code Specimen source, date ordered, and date collected Patient name (last, first, middle initial) and date of birth Patient address and phone number with area code 3. The laboratory personnel would add a check mark in the column when the data entry was entered into the NYS BSDS systems. 4. Approximately 106 patients were tested and reported during the above time. 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 -- D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on surveyor's review of 2020, 2021 American Proficiency Institute (API) Proficiency testing (PT) attestation statements and an interview with the laboratory director, the laboratory failed to rotate the testing of PT samples among five laboratory personnel, who routinely perform hematology automated Complete Blood Count (CBC) tests. Two out of three laboratory personnel performed the 2020 and 2021 events, as indicated by the signed attestation statements. FINDINGS. The laboratory director confirmed on December 14, 2021 at approximately 11:00 AM, the surveyor's findings that two of three laboratory personnel performed the 2020 and 2021 PT events, as indicated by the signed attestation statements. 2. The laboratory did not rotate the testing of the PT samples for the three out of five testing personnel, who routinely perform hematology CBC testing. 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 surveyor's review of the Beckman Coulter AcT Diff hematology analyzer's QC records from June 1, 2019 through survey date and an interview with the laboratory director, the laboratory failed to retain the daily startup/background check printouts for the hematology analyzer from June 1, 2019 through survey date. FINDINGS: The laboratory director confirmed on December 14, 2021, at approximately 11;00 AM, the surveyor's findings that the laboratory did not retain the daily startup/background check printouts for the of the hematology analyzer from June 1, 2019 through survey date. a. The laboratory did retain the daily startup /background check printouts only when performing API PT testing for 2020 and 2021. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on surveyor's review of the laboratory's Quality Assessment (QA) policy, QA review records for the calendar year 2019, 2020, 2021 and an interview with the laboratory director, the laboratory failed to follow their established QA policy for an -- 2 of 5 -- ongoing mechanism to monitor, assess and correct problems identified in the general laboratory systems. FINDINGS: 1. The laboratory director confirmed on December 14, 2021 at approximately 9:45 AM, that the laboratory failed to follow their established QA policy for an ongoing mechanism to monitor, assess and correct problems identified in the general laboratory systems. The laboratory failed to: a. identify, take

Summary Statement of Deficiencies D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on the surveyor's review of the American Proficiency Institute (API) Proficiency Testing (PT) records and confirmed in an interview with the laboratory director on May 23, 2019 at 10:00 AM, the laboratory failed to retain copies of the signed attestation forms for the third events of 2017 and 2018 and the first event of 2019. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on surveyor's review of American Proficiency Institute (API) 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 2 -- Testing (PT) records and confirmed in an interview with the laboratory director, the laboratory failed to evaluate and document the review of the laboratory's scored PT results. FINDINGS: On the date of survey, at approximately 10:15 AM, the laboratory director confirmed that there was no evidence of PT review of the scored results for the second events of 2017 and 2018, the third events of 2017 and 2018, and the first event of 2019. D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(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-- Establish or verify the criteria for acceptability of all control materials. (i) When control materials providing quantitative results are used, statistical parameters (for example, mean and standard deviation) for each batch and lot number of control materials must be defined and available. (ii) The laboratory may use the stated value of a commercially assayed control material provided the stated value is for the methodology and instrumentation employed by the laboratory and is verified by the laboratory. (iii) Statistical parameters for unassayed control materials must be established over time by the laboratory through concurrent testing of control materials having previously determined statistical parameters. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on surveyor's review of the laboratory's Quality Control (QC) records for hematology and confirmed in an interview with the laboratory director, the laboratory failed to perform a lot to lot comparison of assayed hematology controls used with the Coulter AcT Diff analyzer prior to use. FINDINGS: The laboratory director confirmed at approximately 9:30 AM on May 23, 2019 that the laboratory does not test new lots of controls against the current lot before using the new lot as primary QC. -- 2 of 2 --