Westchester Medical Group Pllc

Summary Statement of Deficiencies 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 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 record review and staff interview the laboratory failed to ensure proficiency testing (PT) samples were tested in the same manner and number of times as routine patient samples were tested prior to reporting to the PT program. Findings include: 1. Record review on 4/7/22 of the PT samples instrument printouts revealed the following: a. Event 1 of 2021 for Hematology was performed by Testing Personnel (TP) #1 on 3/12/2021 at 1:59 PM. b. Event 1 of 2021 for Hematology was repeated by TP #1 on 3/15/2021 at 4:06 PM. 2. Record review on 4/7/2022 of the American Proficiency Institute (API) PT comparative evaluation report revealed the results submitted to API were from testing performed on 3/15/2021. 3. Staff interview with technical consultant on 4/7/2022 at 12:05 PM confirmed the above findings. 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 4 -- This STANDARD is not met as evidenced by: Based on record review and staff interview the laboratory failed to rotate proficiency testing (PT) samples amongst all routine testing personnel (TP) in the specialty of Hematology and Chemistry. Findings include: 1. Record review on 4/7/22 of the American Proficiency Institute PT testing records revealed the following: a. All three Chemistry PT events of 2021 were performed by TP# 1. b. Events 1 and 2 of three Hematology PT events of 2021 were performed by TP# 1. c. Events 1 and 2 of three Hematology PT events of 2020 were performed by TP# 2. d. Events 1 and 3 of three Chemistry PT events of 2020 were performed by TP# 2. e. Events 2 and 3 of three Chemistry PT events of 2019 were performed by TP# 1. f. All three Hematology PT events of 2019 were performed by TP# 2. 2. Staff interview with TP#1 on 4/7/2022 at 12:15 PM confirmed the above findings. D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to attest that proficiency testing (PT) samples were tested in the same manner as routine patient specimens. Findings include: 1. Record review on 4/7/22 of the American Proficiency Institute PT evaluation and

Summary Statement of Deficiencies D5781