Sant P Chawla Md Inc

Summary Statement of Deficiencies 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 the surveyor's review of the laboratory's American Proficiency Institute (API) proficiency testing (PT) records, five (5) random patients sampling, and interview with the technical consultant (TC); it was determined that the laboratory failed to attain a score of at least 80 percent of acceptable responses for Hematology on the first event of 2022 (Q1-2022). The findings included: 1. The API proficiency program gave an overall unsatisfactory score of 40 % for Hematology for Q1-2022 which included: Sample Analyte Performance ABT-01 Lymphocyte Acceptable ABT- 2 Lymphocyte Unacceptable ABT-3 Lymphocyte Unacceptable ABT-4 Lymphocyte Acceptable ABT-5 Lymphocyte Unacceptable 2. Based on the laboratory's annual testing declaration submitted on the day of the survey December 7, 2022; the laboratory analyzed and reported approximately 47,040 Hematology samples which included Lymphocytes counts during the time the laboratory had unsatisfactory proficiency testing results. 3. The TC confirmed on December 72022, at approximately 11:30 a.m. that the laboratory received the above proficiency score of 40% for Hematology as described in 1. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (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. (2) Microscopic 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 -- examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

Summary Statement of Deficiencies D2006 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b) The laboratory must examine or test, as applicable, the proficiency testing samples it receives from the proficiency testing program in the same manner as it tests patient specimens. This testing must be conducted in conformance with paragraph (b)(4) of this section. If the laboratory's patient specimen testing procedures would normally require reflex, distributive, or confirmatory testing at another laboratory, the laboratory should test the proficiency testing sample as it would a patient specimen up until the point it would refer a patient specimen to a second laboratory for any form of further testing. This STANDARD is not met as evidenced by: Based on the review of patient reports and interview with the technical consultant (September 24, 2018; 11:30 A.M.), the laboratory failed to test a proficiency sample in the same manner as a patient sample. Findings include: a. The laboratory tested 2018 American Proficiency Institute (API) Complete Blood Count (CBC) sample #1 on March 13, 2018 at 4:30 P.M. The sample had a low hemoglobin (Hgb) level (5.6 g /dL). The sample was later re-tested on March 14, 2018 at 8:32 A.M. b. The technical consultant affirmed that the above proficiency sample should have been repeat tested the same day, not the following day, and that the proficiency sample was not tested in the same manner as patient samples are handled. 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 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 -- This STANDARD is not met as evidenced by: Based on review of 2017 and 2018 API proficiency testing records and an interview with the technical consultant, the laboratory failed to have all routine testing personnel participate in the proficiency testing process. Findings include: a. The technical consultant stated (September 24, 2018, 11:30 A.M.) that four individuals routinely perform patient CBC tests. b. 2017 and 2018 API proficiency documents revealed only two individuals performed the CBC proficiency test. c. The technical consultant affirmed (September 24, 2018; 11:30 A.M.) that not all persons that perform the CBC tests participated in proficiency testing program. -- 2 of 2 --