Qmc Punchbowl Nuclear Medicine Department

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 laboratory record review and an interview with the testing personnel and technical consultant on 01/27/2023 at 9:15 AM, it was determined that the laboratory failed to follow its written policies and procedures to assess the competency of one of five Daxor BVA-100 blood volume testing personnel in 2022. The laboratory performed an annual volume of 200 hematology analyses with this test system. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on laboratory record review and an interview with the testing personnel and technical consultant on 01/27/2023 at 9:30 AM, it was determined that the laboratory failed to at least twice annually verify the accuracy of the Daxor BVA-100 blood volume testing it performed in 2022. The laboratory performed an annual volume of 200 blood volume analyses. D6021 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) 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 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)(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 laboratory record review and an interview with the testing personnel and technical consultant on 01/27/2023 at 9:30 AM, it was determined that the laboratory director failed to ensure its quality assessment program was maintained for the Daxor BVA-100 blood volume testing services it provided. Biannual accuracy verification of this test system was performed once in 2022. See D5217. D6030 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(12) 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)(12) Ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills; This STANDARD is not met as evidenced by: Based on laboratory record review and an interview with the testing personnel and technical consultant on 01/27/2023 at 9:15 AM, it was determined that the laboratory director failed to ensure that laboratory policies and procedures for monitoring the individuals conducting preanalytical, analytical and post analytical phases of hematology analyses were followed. See D5209. -- 2 of 2 --

Summary Statement of Deficiencies D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least annually, after the first year. This STANDARD is not met as evidenced by: Based on a 02/10/2021 review of testing personnel competency assesments, and an interview with testing personnel at 3:30pm, it was determined that the laboratory failed to document the annual evalutation of testing personnel. The findings include: 1. Annual employee evaluation was documented on 05/23/2018, but was not again documented until 01/10/2020. At the time of survey, testing personnel evaluation documentation was not available for the the time period from 05/24/2019 - 01/10 /2020. 2. Approximately 189 patient tests were performed from 05/24/2019 - 01/10 /2020. 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 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: Based on a 04/17/2019 review of laboratory manuals and quality control records, direct observation and an interview with testing personnel at 2:00 p.m., it was determined that the laboratory failed to define temperature criteria for the proper storage of reagents and for accurate and reliable test system operation. The findings include: 1. Three separate timed samples are collected from each patient for BVA 100 Daxor blood volume testing. These samples are collected into 6 mL K3E K3 EDTA tubes. Manufacturer labeling on each tray of these tubes, lot# B18113DU, expiration date 05/14/2020, stated store at 4-25 degrees Centigrade or 40-77 degrees Fahrenheit. 2. The Queen's Medical Center Blood Volume Manual, Exhibit 1. Flowchart of actions to address QC test failures, stated the operating temperature range for the BVA 100 Daxor blood volume test system was 65-85 degrees Fahrenheit. If the temperature is not within range, testing personnel are to "correct temperature variance" and "wait 2 hours". 3. Testing personnel stated that the temperature of the room where the EDTA tubes are stored and where BVA 100 Daxor blood volume testing is also performed is not monitored. 4. The laboratory performs an estimated annual volume of 500 blood volume tests. D6010 LABORATORY DIRECTOR RESPONSIBILITIES 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 -- CFR(s): 493.1407(e)(2) 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)(2) Ensure that the physical plant and environmental conditions of the laboratory are appropriate for the testing performed. This STANDARD is not met as evidenced by: Based on a 04/17/2019 review of laboratory manuals and quality control records, direct observation and an interview with testing personnel at 2:00 p.m., it was determined that the laboratory failed to ensure that the environmental conditions of the laboratory are appropriate for the blood volume testing it performs. Refer to D tag 5413. D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) 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)(4)(iii) Ensure that all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require