Canyon View Medical Group Mapleton

Summary Statement of Deficiencies 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 This STANDARD is not met as evidenced by: Based on a review of the attestation statements for the American Academy of Family Physicians (AAFP) Proficiency Testing (PT) and for the Wisconsin State Laboratory of Hygiene (WSLH) PT, and an interview with the Laboratory Supervisor, the laboratory failed to have PT samples for the Complete Blood Count (CBC) tested by personnel who routinely perform the testing in the laboratory for 7 of 7 events reviewed. Finding include: 1. A review of the PT attestation statements at approximately 11:10 AM on 6/12/23, revealed that Testing Personnel (TP) 1, had performed all PT testing for the following events: AAFP-PT 2021-A, AAFP-PT 2021- B, AAFP-PT 2021-C, AAFP-PT 2022-A, AAFP-PT 2022-B, AAFP-PT 2022-C, and WSLH PT 2023-HemeReg1. 2. TP2 - TP11 as listed on the CMS-209, Laboratory Personnel Report, had not participated in any of the PT events as listing in Finding #1. 3. An interview with the Laboratory Supervisor at approximately 11:15 AM on 6/12 /23, confirmed that only TP1 had performed PT testing and that other personnel who routinely perform CBC testing had not participated in any of the PT events listed in Finding #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 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 -- 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 D5405 PROCEDURE MANUAL CFR(s): 493.1251(c) Manufacturer's test system instructions or operator manuals may be used, when applicable, to meet the requirements of paragraphs (b)(1) through (b)(12) of this section. Any of the items under paragraphs (b)(1) through (b)(12) of this section not provided by the manufacturer must be provided by the laboratory. This STANDARD is not met as evidenced by: Based on Standard Operating Procedure (SOP) manual review, lack of documentation, and interview with laboratory supervisor, the laboratory failed to provide specific instructions for reporting hematology patient results, or actions to take if a the Sysmex instrument system becomes inoperable. Findings include: 1. SOP manual review included a manufacturer's operator manual signed by the laboratory director and laboratory supervisor is in place of a laboratory developed SOP for operating the Sysmex hematology analyzer. 2. Manufacturer's operator manual does not provide laboratory specific instructions for reporting patient results, or actions to take if the Sysmex hematology analyzer becomes inoperable. 3. In an interview conducted on 3/9 /2021 at approximately 11:30 am the laboratory supervisor confirmed there is no laboratory specific SOP for the Sysmex instrument other than the manufacturer's operator manual. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. 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 -- (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on temperature and humidity log review, lack of a Standard Operating Procedure (SOP), and interview with laboratory supervisor, the laboratory failed to establish criteria for monitoring and documenting temperature and humidity readings as required for 1 of 1 tests performed. The laboratory performed approximately 5 complete blood counts per day. Findings include: 1. Laboratory procedure manual (SOP) review failed to include instruction for monitoring and documenting temperature and humidity, and the