Hirsch Clinic-Vmh

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 D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(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-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on surveyor review of laboratory records and interview with the technical consultant, the laboratory did not perform two levels of quality control (QC) on the serum human chorionic gonadotropin (HCG) test on twenty-one of twenty-seven patient testing days and did not have evidence of an individualized quality control plan (IQCP). Findings include: 1. Review of "Patient results-Serum Pregnancy Test" log showed two levels of QC run on: a. January 5, 2021, Lot# HCG0042017 b. February 2, 2021, Lot# HCG0042017; February 2 and 4, 2021, Lot#0042098 c. March 2, 2021, Lot#0042098 d. April 14, 2021, Lot#0082128 e. May 13, 2021, Lot#0092129 2. Further review of the "Patient results-Serum Pregnancy Test" log showed patient or proficiency testing (PT) on: a. January 5, 25 and 28, 2021 b. February 2, 3, 4, 8, 9, 10, 11, 12, 16, 17, 18, 19, 25 and 27, 2021 c. March 2 and 29, 2021 d. April 14, 15, 27 and 29, 2021 e. May 13, 14, 17 and 18, 2021 3. Interview with the technical consultant on June 23, 2021 at 11:25 AM confirmed the laboratory did not perform two levels of QC on the serum HCG test on twenty-one of twenty-seven patient testing days and did not have evidence of an IQCP. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on surveyor observation of the urinalysis testing area and interview with testing personnel (staff A), handwritten results of urinalysis microscopic testing were not retained after entry in the laboratory information system (LIS). Findings include: 1. Observation of the urinalysis testing section in the laboratory on February 4, 2019 at 10:45 AM revealed no computer for data entry near the microscope. No written records of microscopic urinalysis results were present. 2. Interview with testing personnel, staff A, on February 4, 2019 at 10:45 AM revealed test results may be written down until the results are entered in the LIS. Further interview confirmed the laboratory did not retain the written test results after entry in the LIS. 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 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 -- 493.1253. (7) Control procedures. (8)