Valley Physician Services, Inc

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 D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on the lack of Competency Assessment (CA) records and interview with the Office Manager (OM), the laboratory failed to perform a CA on one out of one testing personnel for the calendar years 2020 and 2021. The OM confirmed on 11/30/22 at 10: 30 am that the CA was not performed as stated above. D5309 TEST REQUEST CFR(s): 493.1241(e) If the laboratory transcribes or enters test requisition or authorization information into a record system or a laboratory information system, the laboratory must ensure the information is transcribed or entered accurately. This STANDARD is not met as evidenced by: Based on review of Electronic Medical Records (EMR), Accession Log (AL), Work Records (WR) and interview with the Office Manager (OM), the laboratory failed to ensure that WR were entered accurately into the EMR system for all tests from 11/14 /19 to the date of the survey. The OM confirmed on 11/30/22 at 11:00 am that the laboratory did not ensure that WR were entered accurately into the EMR system. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) 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 -- Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on surveyor observation of the Quality Control (QC) reagents and interview with the Office Manager (OM), the laboratory failed to put a new expiration date on the ABX Micros QC reagents in use on the Horiba analyzer on the date of the survey. The findings include: 1. The Manufacturers Package Insert (MPI) stated "open vial stability is 16 days after opening." 2. The laboratory did not put new expiration dates on the ABX Micros QC reagents after opening. 3. The OM confirmed on 11/30/22 at 11:10 am the laboratory failed to put new expiration date on the QC reagents. D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (2)(i) Using calibration materials appropriate for the test system and, if possible, traceable to a reference method or reference material of known value; and (2)(ii) Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and (3) Whenever calibration verification fails to meet the laboratory's acceptable limits for calibration verification. This STANDARD is not met as evidenced by: Based on surveyor review of Calibration (C) records, User Manual (UM) and interview with the Office Manager (OM), the laboratory failed to perform, document and meet acceptable limits for all Calibration results and procedures at least once every six months for Hematology Tests performed on the Horiba analyzer in the calendar year 2022. The findings include: 1. A review of C records revealed that the laboratory failed to correctly perform and document "repeatability" a) The UM states in the "Preparation for Calibration" procedure to "perform a repeatability study by running one normal patient sample ten times mixing well before each run. Ensure repeatability is acceptable" 2. Calibration material was run on 8/25/22 repeatability was performed on 9/29/2022. 3. The OM confirmed on 11/30/2022 at 11:32 am that the laboratory failed to correctly perform, document and meet acceptable limits for C once every six months. D5803 TEST REPORT CFR(s): 493.1291(b) Test report information maintained as part of the patient's chart or medical record must be readily available to the laboratory and to CMS or a CMS agent upon request. -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on surveyor review of the Electronic Medical Records (EMR), Test Results (TR) and interview with the Office Manager (OM), the laboratory failed to have all tests performed in the EMR on the date of survey. The finding includes: 1. One out of five EMR reviewed did not have a TR. 2. The OM confirmed on 11/30/22 at 11:40 am that all TR were not in the EMR. -- 3 of 3 --

Summary Statement of Deficiencies 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: Based on surveyor review of the Performance Specification (PS) records and interview with the Testing Personnel (TP), the laboratory failed to ensure that all PS procedures were performed on the Horiba Micros 60 analyzer were adequate from 4 /15/19 to the date of survey. The finding includes: 1. There was no documented evidence Method Verification was performed. 2. The TP #1 listed on the CMS form 209 confirmed on 11/14/19 at 11:15 am that PS records were not adequate. 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 --