Summary:
Summary Statement of Deficiencies D0000 An initial Clinical Laboratory Improvement Amendments (CLIA) survey was completed on December 17, 2018. The laboratory was not in compliance with all applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on review of event 3 of 2018 proficiency testing (PT) records and staff interview, the laboratory failed to have a statement signed by the laboratory director attesting that PT samples were tested in the same manner as patient specimens. Findings include: 1. Review of the PT attestation statement for event 3 of 2018 revealed it is not signed by the laboratory director. 2. Interview with the testing personnel and office manager on December 17, 2018 at approximately 12:30 pm in the office assigned to the surveyor confirmed the attestation statement is not signed by the laboratory director. 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. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 7 -- This STANDARD is not met as evidenced by: Based on review of laboratory policy and procedures, review of laboratory records and staff interview, the laboratory failed to follow its written quality assessment (QA) policy. Findings include: 1. Review of the laboratory's policy and procedures in use at the time of the survey revealed no instructions for performing QA and no documentation of QA activity between September 2018 and the date of the survey. 2. Review of policies and procedure manuals stored with records of testing performed in 2017 revealed the laboratory has a comprehensive QA policy which includes instructions, charts and checklist. 3. Interview with the testing personnel and office manager on December 17, 2018 at approximately 12:30 pm in the office assigned to the surveyor revealed neither were aware of the QA policy and confirmed there is no documentation of QA activity from September 2018 to the present. 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 review of operating specifications for the Sysmex XP 300 Hematology analyzer (Sysmex), review of laboratory records, lack of records to review and staff interview, the laboratory failed to document the temperature and humidity of the room where the Sysmex is operated. Findings include: 1. Review of operating specifications for the Sysmex revealed the room temperature where the instrument is operated should be between 15-30 degrees centigrade and the relative humidity of the area should be between 30-85 percent. 2. Review of the laboratory's records revealed no documentation or evidence that the temperature and humidity of the area where the Sysmex is located is monitored and recorded. 2. Interview with the testing personnel and office manager on December 17, 2018 at approximately 12:30 pm in the office assigned to the surveyor confirmed the temperature and humidity is not monitored. D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. (g) The laboratory must document all control procedures performed. -- 2 of 7 -- This STANDARD is not met as evidenced by: Based on review of the laboratory's quality control (QC) records for testing performed on the Sysmex XP 300 Hematology analyzer and staff interview, the laboratory failed to monitor over time, the accuracy and precision of test performance. Findings include: 1. Review of QC records revealed no evidence of Levey-Jennings (LJ) charts, calculation of means and standard deviations or other means for reviewing control values to determine shifts or trends and monitoring over time the accuracy and precision of test performance . 2. Interview with the office manager and testing personnel on December 17, 2018 at approximately 12:30 pm in the office assigned to the surveyor, confirmed LJ charts have not been printed for any testing performed, statistical parameters have not been calculated and the laboratory is not reviewing QC values for shifts and trends. D5783