Summary:
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 the review of Abbott Cell Dyn Emerald systems startup records and an interview with the technical consultant, the laboratory failed to retain background records for the year of 2020. Findings: 1. The laboratory was not able to retrieve the startups from a backup file for the year of 2020. 2. The technical consultant and testing person confirmed on 2/18/2022 about 10:30am, The laboratory was not able to retrieve the startups from a backup file for the year of 2020. 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 review of training and competency procedure, training, and competency records 2019, 2020 and 2021, the laboratory failed to perform and document the six- month competency evaluation for the #2 testing person, as required by the laboratory's competency procedure. Findings: 1. The #2 testing person hired on 10/22/2019, training was completed on 12/17/2019, however, the laboratory director failed to perform and document the six-month evaluation which was due on 6/2020. 2. The 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 -- technical consultant and testing person #2 confirmed on 2/18/2022 at approximately 10am, that the laboratory director failed to perform and document the six-month evaluation which was due on 6/2020. D5219 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(2) At least twice annually, the laboratory must verify the accuracy of any test or procedure listed in subpart I of this part for which compatible proficiency testing samples are not offered by a CMS-approved proficiency testing program. This STANDARD is not met as evidenced by: Based on the review of the laboratory's Quality Assessment (QA) procedure, the QA documentation for 2020 and 2021 and an interview with the technical consultant and #2 testing person, the laboratory failed to maintain the written QA policy, to identify the failure to include a monthly review for the refrigerator temperatures and take remedial action when the temperatures fall outside the establish refrigerator temperatures. Refer to D5413 Findings: 1. The laboratory failed to ensure that the refrigerator temperatures were within the establish ranges. 2. The technical consultant and #2 testing person confirmed on 2/18/2022 about 10:45am. 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 the review of the laboratory's, refrigerator temperature logs for 2020 and 2021 and an interview with the technical consultant and #2 testing person, the laboratory failed to maintain the laboratory's temperature procedure for the calendar years 2020 and 2021. Findings: 1.The laboratory failed to ensure that the refrigerator temperatures were within the establish range 35-46F for the following days: a. 2020 March - 2 days April - 18 days May - 16 days June - 20 days July - 12 days August - 1 day September - 1 day December - 1 day b. 2021 April - 2 days May - 1 day July - 1 day October - 1 day D6019 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iv) 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)(iv) Ensure that an approved