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Summary Statement of Deficiencies D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) (b) The procedure manual must include the following when applicable to the test procedure: (b)(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. (b)(2) Microscopic examination, including the detection of inadequately prepared slides. (b)(3) Step-by- step performance of the procedure, including test calculations and interpretation of results. (b)(4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (b)(5) Calibration and calibration verification procedures. (b)(6) The reportable range for test results for the test system as established or verified in 493.1253. (b)(7) Control procedures. (b)(8)

Summary Statement of Deficiencies 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. (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: D5413 Based on review of the laboratory's, humidity logs for year 2021 and lack of calibration records for both the room temperature/humidity thermometers and an interview with the general supervisor, the laboratory failed to maintain the humidity as required by Sysmex XN 450 for calendar year 2021 and the certification for the thermometers, as required by the manufacturer. FINDINGS: 1.The laboratory failed to maintain the required certification and calibration on room temperature and humidity thermometer in 2021 through survey date. 2.The laboratory failed to ensure that the humidity was within manufacturer requirement range of 20-80% of Sysmex XN 450 for the following days: 2021 March - 10 days April - 5 days May - 10 days June - 4 days 3.The general supervisor confirmed on 3/10/2022 at approximately 2:30pm, the laboratory failed to maintain the humidity requirements and certified calibrated thermometer. D6021 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) The laboratory director is responsible for the overall operation and administration of 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 -- the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(5) Ensure that quality assessment programs are established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on review of humidity log for year 2021 and lack of certification and calibration of thermometer used for room temperature and humidity, it was determined that the laboratory director failed to implement and maintain the laboratory's quality assessment program. It was confirmed on an interview with general supervisor on 3/10/2022 about 2:30pm. Refer 5413 -- 2 of 2 --

Summary Statement of Deficiencies D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on a lack of Quality Assessment (QA) policy and confirmed in an interview with the practice manager, the laboratory supervisor and the technical consultant, the laboratory failed to establish a written QA policy and procedure for an ongoing mechanism to monitor, assess, and when indicated correct problems that may occur in the laboratory testing to include frequency of the QA reviews and to indicate the individual responsible for the QA reviews. On April 30, 2019 at approximately 11:00 AM the practice manager confirmed surveyor findings that the laboratory's written QA policy is kept at their Core laboratory which is a CLEP Certified laboratory. D6029 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(11) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(11) Ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. 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 -- This STANDARD is not met as evidenced by: Based on a surveyor review of personnel records and an interview with the practice manager, laboratory supervisor and the technical consultant, on April 30, 2019, at approximately 11:00 am, the laboratory director failed to ensure that appropriate training was documented for the two testing personnel performing moderate complexity test for hematology. D6032 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(14) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(14) Specify, in writing, the responsibilities and duties of each consultant and each person, engaged in the performance of the preanalytic, analytic, and postanalytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or results reporting, and whether consultant or director review is required prior to reporting patient test results. This STANDARD is not met as evidenced by: Based on the surveyor's review of personnel records and confirmed in an interview with the practice manager, laboratory supervisor and the technical consultant, the laboratory director failed to specify, in writing, the duties and responsibilities of the staff involved in all phases of the hematology laboratory. -- 2 of 2 --