Red Hook Family Practice

Summary Statement of Deficiencies D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on review of patient test records, manufacturers package insert, and laboratory director interview, the laboratory failed to meet the analytic system requirements in 42 CFR 493.1251 through 42 CFR 493.1283. Findings include: 1) Failure to perform performance specifications. See D5421. 2) Failure to perform two different concentrations of control material. See D5447. 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: 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 -- Based on review of the manufacturers package insert, patient test results and interview, the laboratory failed to demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for IgG/IgM qSARS-CoV-2 antibody testing. One of one patient test result and one of one manufacturers package insert was reviewed. Findings include: 1) Patient test results obtained on July 13, 2021 shows the following test results: a) Cellex q Sars Cov-2 IgM Antibody test- Negative b) Cellex q Sars Cov-2 IgG Antibody test- Positive 2) Review of the manufacturer's package insert for Cellex qSARS-CoV-2 IgG/IgM Rapid Test contains the following verbiage: a) Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. 263a, to perform moderate and high complexity tests. 3) The surveyor requested data demonstrating that the laboratory could obtain performance specifications comparable to those established by manufacturer for Cellex qSARS- CoV-2 IgG/IgM Rapid Test. No performance specification data was provided. 4) The laboratory director confirmed in an e-mail communication dated September 9, 2021 at 11:29 AM, the following: a) "Did not perform verification of performance specifications" D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(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-- At least once a day patient specimens are assayed or examined perform the following for-- Each quantitative procedure, include two control materials of different concentrations; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of patient test results and laboratory director interview, the laboratory director failed to perform two control materials of different concetrations at least once a day patients are assayed for Cellex q Sars Cov-2 IgM/IgG Antibody test. One of one patient test result was reviewed. Findings include: 1) Patient test results obtained on July 13, 2021 shows the following test results: a) Cellex q Sars Cov-2 IgM Antibody test- Negative b) Cellex q Sars Cov-2 IgG Antibody test- Positive 2) Review of the manufacturer's package insert for Cellex qSARS-CoV-2 IgG/IgM Rapid Test contains the following verbiage: a) Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. 263a, to perform moderate and high complexity tests. 3) The surveyor requested two control materials of different concentrations that were assayed for the patient test results obtained on July 13, 2021 for Cellex q Sars Cov-2 IgM/IgG antibody testing. No quality control (QC) or control material data was provided. 4) The laboratory director confirmed in an e-mail communication dated September 9, 2021 at 1:59 PM, the following: a) No QC testing was performed for batch or shipments on the test cards. Per manufacturer-comes with internal control. Internal control present on each test card. No QC was performed for patient test report on 07 /13/21. -- 2 of 2 --

Summary Statement of Deficiencies 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 interview with the laboratory director and technical consultant, and review of records, the laboratory failed to follow manufacturer's instruction to perform external quality control procedures prior to use of Icon 25 hCG urine pregnancy test kit and Urispec 10SG urine chemistry testing. The findings included: a. The laboratory started testing pregnancy test using urine sample, upon discontinuance of serum sample in 2018. No qulaity control records were seen. b. No quality control records presented for Urispec 10SG chem strip test system for lot #76239, expiration date 4/18/2020. D2121 HEMATOLOGY CFR(s): 493.851(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on interview with the laboratory director, technical consultant and testing personnel, the laboratory failed to evaluate the unsatisfactory score (47%) for white blood cell (WBC) differential in the first event FY 2019. The findings included: a. 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 -- Although a review was affixed, there was no documentation of evaluation of the failure and subsequent