Summary:
Summary Statement of Deficiencies D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) Laboratories eligible for a certificate of waiver must-- (1) Follow manufacturers' instructions for performing the test; and (2) Meet the requirements in subpart B, Certificate of Waiver, of this part. This STANDARD is not met as evidenced by: Based on surveyor's review of the laboratory's procedure manual and an interview with the site administrator, the laboratory failed to retain the current copies of the manufacturers package inserts. FINDINGS The site administrator confirmed on 01/29 /2018 at approximately 2:00 PM, that the laboratory did not retain copies of the following manufactures package inserts for these test kits: a. Henry Schein One Step + Rapid Strep A, Henry Schein One Step + Influenza A & B , Henry Schein One Step + Respiratory Syncytial Virus and the Alere Uhcg. b. The laboratory changed to these current test kits in 01/2016. D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years. This STANDARD is not met as evidenced by: Based on surveyor's review of Medical Laboratory Evaluation (MLE) Proficiency Testing (PT) policy and lack of 3rd event 2017 MLE PT 2017 records and confirmed in an interview with the site administrator, the laboratory failed to retain copies of the MLE records and documentation to include signed attestation forms, test result forms, insturment printouts and PT summary reports for the 2017 third event. FINDINGS The site administrator confirmed on 1/29/2018 at approximately 3:00 PM that 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 6 -- laboratory failed to retain copies of the MLE records and documentation to include signed attestation forms, test result forms, insturment printouts and PT summary reports for the 2017 third event. 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 a surveyor's review of the laboratory's policies and procedure manual and confirmed in an interview with the site administrator, the laboratory failed to establish a comprehensive written policy and procedure that includes the six required components to assess testing personnel's competency. FINDINGS The site administrator confirmed on 1/29/2018 at approximately 2:00 PM, that the laboratory failed to retain a copy of their competency assessment policy for all testing personnel, clinical consultants and the laboratory director, therefore there was no policy available at survey. The laboratory failed to include the following six criteria: 1. Direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing and testing; 2. Monitoring the recording and reporting of test results; 3. Review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records; 4. Direct observations of performance of instrument maintenance and function checks; 5. Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples; and 6. Assessment of problem solving skills. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on the surveyor's review of MLE PT reports and confirmed in an interview with the site administrator, the laboratory director failed to review and evaluate the PT summary reports for all three events in 2016 and 1st & 2nd events of 2017. 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 the surveyor's review of the laboratory's Quality Assessment (QA) polices -- 2 of 6 -- /procedures and confirmed in an interview with the site administrator, the laboratory failed to follow the laboratory's written QA policy and perform QA reviews for the general laboratory systems for hematology testing in calendar years 2016 and 2017. 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 of surveyor's review of the hematology calibration records and confirmed in an interview with the site administrator, the laboratory failed to perform the required six- month calibration for the hematology analyzer. FINDINGS 1. The site administrator confirmed on 1/29/2018 at approximately 3:30 PM, that the laboratory failed to calibrate the Coulter Act Diff hematology analyzer at the required six-month period. The last recorded date of calibration was 2/18/16 therefore, the analyzer was out of calibration in 2016 until the laboratory performed a calibration on 2/9/17. 2. The laboratory's calibration policy and the manufacturer of the hematology analyzer requires calibration every six months. 3. Approximately 104 patient specimens were tested and reported for CBC, when analyzer was out of calibration. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on surveyor's findings and confirmed in an interview with the site administrator, the laboratory director failed to provide overall management of the laboratory. The laboratory director failed to ensure that the: 1. MLE PT reports were reviewed and evaluated, refer to D6018; 2. QC program for hematology was maintained, refer to D6020; 3. laboratory's QA program maintained, refer to D6021; 4.