Western Connecticut Medical Group

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 D2010 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(2) The laboratory must test samples the same number of times that it routinely tests patient samples. This STANDARD is not met as evidenced by: Based on record review and staff interview the laboratory failed to test proficiency testing (PT) samples the same number of times that it routinely tests patient samples. Findings include: 1. Record review on 4/25/19 of the laboratory's PT records from American Proficiency Institute (API) revealed the following complete blood count (CBC) samples were tested twice by two testing personnel (TP) before submission to API for evaluation. a. 2017 Event 1: Tested by TP# 1 & 2 b. 2017 Event 2: Tested by TP# 3 & 4 c. 2017 Event 3: Tested by TP# 5 & 6 d. 2018 Event 1: Tested by TP# 4 & 7 e. 2018 Event 2: Tested by TP# 8 & 9 f. 2018 Event 3: Tested by TP# 3 & 2 g. 2019 Event 1: Tested by TP# 10 & 11 2. Record review on 4/25/19 of laboratory's CBC procedure manual revealed patient samples are routinely tested once. 3. Staff interview with the technical consultant on 4/25/19 at 10:15 AM confirmed the above findings. 4. The laboratory performs 18,650 CBC's annually. D6051 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8)(v) The procedures for evaluation of the competency of the staff must include, but are not limited to assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to ensure all testing 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 -- personnel (TP) have tested unknown samples to demonstrate competency in performing laboratory tests in the specialty of hematology. Findings Include: 1. Record review of the American Proficiency Institute's (API) complete blood count (CBC) attestation sheets on 4/25/19 revealed 8 of 14 TP did not examine proficiency testing material to accurately assess their skills in 2017 and 2018. 2. Record review of employee competency records on 4/25/19 revealed 8 of 14 TP did not examine previously analyzed specimens, internal blind testing samples or external proficiency testing samples to accurately assess their skills in 2017 and 2018. 3. Staff interview with the technical consultant on 4/25/19 at 11:00 AM confirmed the above findings. -- 2 of 2 --