Summary:
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 procedures and an interview with the laboratory director, the laboratory failed to establish and follow a written policy and procedure for an ongoing mechanism to monitor, assess, and when indicated correct problem that may occur in the laboratory testing. This is a repeat deficiency from the last survey of August 4, 2016. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on a lack of a procedure manual and an interview with the laboratory director, the laboratory did not have a procedure manual available for review. Finding: It was confirmed with the laboratory director on June 28, 2018 at approximately 1:45 pm, that the laboratory director failed to have a signed and dated procedure manual available for review. 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 -- 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 on a review of calibration records and an interview with the laboratory director, the laboratory failed to calibrate the Coulter AcT Diff 2 hematology analyzer every six months. Calibration was last performed on August 6, 2017. The manufacturer of the Coulter AcT Diff hematology analyzer requires the instrument to be calibrated every six months. Findings Include: 1. It was confirmed with the laboratory director at on June 28, 2018 at approximately 12:45 pm that the Coulter AcT Diff 2 has not been calibrated since August 6, 2017. 2. The Coulter AcT Diff 2 analyzer has been out of calibration since February 6, 2018 to the date of this survey. 3. Approximately 250 patient specimens were tested and reported for hematology testing when the laboratory was out of calibration. This is a repeat deficiency from the survey of September 25, 2014 and August 4, 2016 . 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 findings and confirmed in an interview with the laboratory director at the time of the survey, the director failed to provide overall management and direction for the laboratory. Findings Include: The director failed to ensure that: 1.