Summary:
Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Fort Norfolk Plaza Medical Associates on October 10, 2018 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. Specific deficiencies cited are as follows: 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 review of policies and procedures, temperature logs, manufacturer's user guide and package insert, and an interview, the laboratory failed to record and monitor temperature and humidity according to their quality assurance (QA) policy for fourteen (14) of one hundred eighty-eight (188) days reviewed in calendar year 2018. Findings include: 1. Review of the policy and procedure manual revealed a Reagent, Materials, and Supplies QA Policy that stated: "Maintain temperature logs of room, refrigerator, freezer, and humidity. Ensure that refrigerator and freezer are in acceptable working condition. Record daily the temperature of the room, refrigerator, freezer, and room humidity in the appropriate temperature chart." 2. Review of the daily temperature logs from February 1, 2018 up to the date of survey on October 10, 2018 revealed no documentation of temperature monitoring for refrigerator, freezer, laboratory room temperature or humidity on the following 14 dates: 2/16/18, 4/16/18, 4/17/18, 5/14/18, 5/15/18, 5/16/18, 5/22/18, 6/4/18, 6/11/18, 7/9/18, 7/10/18, 8/22/18, 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 -- 9/6/18, and 9/28/18. The inspector requested to review documentation that the laboratory temperatures were monitored for the dates listed above. No documentation was available for review. 3. Review of the Horiba ABX Micros 60 user guide revealed the hematology instrument's operating temperature and humidity requirement range as 16 - 30 Celsius (C) with maximum humidity at 80% for patient complete blood count (CBC) testing. The Horiba Minitrol package insert for hematology quality control (QC) materials revealed stability and storage instructions to "store the quality control tubes at 2 - 4 C when not in use". The QC package insert's instructions for day of use as: "remove control blood from refrigerator and allow to warm at room temperature (18 - 30 C) for 15 minutes before mixing". 4. In an interview with the technical consultant at approximately 12:00 PM, it was confirmed that the laboratory failed to record and monitor the laboratory temperatures and room humidity according to their policy to ensure that Horiba manufacturer's instructions for patient CBC testing were followed on the dates outlined above. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on a review of the policies and procedure manual, two (2) randomly selected patient complete blood count (CBC) reports from the electronic medical record (EMR), and an interview, the laboratory's hematology report failed to include the unit of measurement (UOM) for ten (10) of sixteen (16) CBC patient test parameters resulted. Findings include: 1. Review of the laboratory's policy and procedure manual revealed a Post Analytical Quality Assurance Results Reporting policy that stated "review annually patient reports to verify reports contain the following information: name of test, results, units of measure, normal ranges, testing person identified, patient name, laboratory name, and address. 2. Review of 2 randomly selected patient CBC reports from the MicroMD EMR revealed no UOM for the following 10 reported parameters: White Blood Count (WBC), Red Blood Count (RBC), Hemoglobin (HGB), Hematocrit (HCT), Mean Corpuscular Volume (MCV), Mean Corpuscular Hemoglobin (MCH), Mean Corpuscular Hemoglobin Concentration (MCHC), Red Cell Distribution Width (RDW), Platelet (PLT), and Mean Platelet Volume (MPV). 3. In an interview with the technical consultant at approximately 12: 00 PM, it was confirmed that the laboratory's patient hematology report failed to include the UOM for the 10 test parameters outlined above. -- 2 of 2 --