Great Neck Pediatric Associates Pc

Summary Statement of Deficiencies 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 the review of the American Proficiency Institute (API) Proficiency Test (PT) records, the laboratory failed to rotate proficiency testing for hematology between the three testing persons in calendar year 2020. Findings: 1. API attestation form for hematology PT for calendar year 2020 had same testing person signature. 2. Confirmed on an interview with technical consultant on 5/18/2022 about 11am. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on the review of November 2020 Quality Control (QC) records of hematology analyzer Coulter AcT Diff, the laboratory failed to maintain expiration dates of QC materials. Finding 1. Lot# 068300 Expiration date 11/23/2020 was used between 11/12 /2020-11/30/2020. 2. Approximately 50 patients were tested. 3. Confirmed on an interview with technical consultant on 5/18/2022 about 10:45am. PLEASE NOTE: THIS IS RECITED FROM THE SURVEY CONDUCTED ON 1/4/2017 AND 6/13 /2018 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 -- D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on the review of calibration record, the laboratory failed to perform calibration at least every six months. Findings: 1. Calibration performed only once for calendar year 2021 on 2/15/2021. 2. Confirmed on an interview with technical consultant on 5 /18/2022 about 11:30am PLEASE NOTE: THIS IS RECITED FROM THE SURVEY CONDUCTED ON 6/13/2018 D6021 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) 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)(5) Ensure that quality assessment programs are established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on the review of quarterly Quality Assurance (QA) records, the laboratory director failed to maintain overall QA program to maintain quality service provided. Refer to D5439, D2007 D6042 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(4) (b) The technical consultant is responsible for-- (b)(4) Establishing a quality control program appropriate for the testing performed and establishing the parameters for acceptable levels of analytic performance and ensuring that these levels are -- 2 of 3 -- maintained throughout the entire testing process from the initial receipt of the specimen, through sample analysis and reporting of test results; This STANDARD is not met as evidenced by: Based on the review of November 2020 QC records of hematology analyzer, the technical consultant failed to maintain Quality Control program appropriate for hematology testing. Refer to D5417 -- 3 of 3 --

Summary Statement of Deficiencies 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 the surveyor's review of American Proficiency Institute (API) Proficiency Testing (PT) reports and an interview with the technical consultant, the laboratory failed to evaluate, perform and document remedial action for the PT scores of less than 100% for the following analytes: 2018 first event: Hematocrit = 80% Red Blood Cell (RBC) = 60% Influenza A & B = 50% 2017 third event Influenza A & B = 50% D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on a surveyor's review of the hematology quality Control (QC) records and an interview with the technical consultant, the laboratory failed to discontinue the use of the expired quality control materials. FINDINGS: 1. On June 13, 2018 at approximately 3:30 PM the technical consultant confirmed surveyor's findings that the laboratory used 3 levels of expired QC for hematology testing for lot numbers low QC 068400, normal QC 078400, high QC 088400, expiration date 2/26/18 from 2/27/18 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 -- through 2/28/18. 2. Approximately 20 patients were tested for hematology using the expired quality control materials during the above time frame. PLEASE NOTE: THIS IS A RECITE FROM THE SURVEY CONDUCTED ON 1/4/2017. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on a surveyor's review of the validation records and an interview with the technical consultant, the laboratory failed to perform and document a complete method validation for the new Coulter AcT Diff analyzer prior to patient testing in September 2017. Findings: 1. On June 13, 2018 at approximately 3:30 PM the technical consultant confirmed that Correlation study was not performed for the hematology analytes as part of a complete validation of the Coulter AcT Diff analyzer prior to patient testing using the new analyzer in September 2017. 2. Approximately 500 patient specimens were tested and reported for hematology during above time frame. D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (2)(i) Using calibration materials appropriate for the test system and, if possible, traceable to a reference method or reference material of known value; and (2)(ii) Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and (3) Whenever calibration verification fails to meet the laboratory's acceptable limits for calibration verification. This STANDARD is not met as evidenced by: Based on a surveyor's review of hematology calibration records and interview with the technical consultant, calibration of the hematology analyzer was not performed at the frequencies required by the laboratory's calibration protocol and by the manufacturer of the analyzer. FINDINGS: 1. The laboratory is using the Coulter AcT Diff analyzer. The laboratory's calibration policy and the manufacturer of the hematology analyzer require analyzer calibration every six months. 2. On June 13, 2018 at approximately 3:30 PM the technical consultant confirmed that the documentation of the AcT Diff analyzer calibration available for review was for calibration performed on 3/21/17, 9/20/17 and 4/9/18. The hematology analyzer was therefore out of calibration from 3/21/18 through 4/8/18. 3. The reproducibility -- 2 of 5 -- summary was not available for the calibration performed on 4/9/18. 4. The RBC analyte calibration failed on 4/9/18. No records of re-calibration or