Summary:
Summary Statement of Deficiencies D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on proficiency testing (PT) record review and an interview with the technical consultant, the laboratory director and the testing person failed to sign the College of American Pathologists (CAP) attestation statements and failed to maintain instrument copies for 5 out of 5 complete blood counts (CBCs)sample test results performed during the 2019 events 1 and 2. Findings: 1. A review of PT documents revealed the laboratory director and the testing person failed to sign the CAP attestation statements for the CBCs performed for events 1 and 2 in 2019. 2. A review of PT documents revealed the laboratory failed to maintain the Emerald Cell-Dyn instrument test results for 5 out of 5 PT samples. 3. An interview with the technical consultant on June 24, 2019 at 4:05 PM, confirmed the laboratory director and testing person failed to sign the CAP attestation statements in 2019 and failed to maintain instrument test results. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) 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 -- 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 quality control record reviews and an interview with the technical consultant, the laboratory failed to retain the Emerald Cell-Dyn complete blood count (CBC) quality control test results and the manufacturer's quality control assay reference sheets from January 2019 through April 2019. Findings: 1. A review of quality control records from the Emerald Cell-Dyn analyzer revealed the laboratory failed to retain the manufacturer's quality control assay reference sheets prior to May 2019. 2. A review of the quality control test results from the Emerald Cell-Dyn analyzer revealed the laboratory failed to retain the quality control test results from the analyzer between January 2019 and April 2019. 3. The laboratory performed approximately 830 CBC since June 29, 2018. 4. An interview with the technical consultant on June 24, 2019 at 4:30 PM, confirmed the laboratory failed to retain the quality control assay reference sheets and the quality control test records. 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 record review and an interview with the technical consultant, the laboratory failed to state the acceptable temperature range for the refrigerator on the laboratory worksheet for the where the quality control material for the Emerald Cell- Dyn complete blood counts (CBCs) were stored, as well as the room temperature where patient specimens were tested since the start of patient testing on June 29, 2018. Findings: 1. A review of the temperature log worksheet revealed the laboratory failed to state the acceptable temperature ranges on the chart for the refrigerator and the room temperature where patient specimens were tested. 2. A review of the temperature log worksheet revealed the laboratory failed to monitor and record the daily room temperature of the laboratory since the start of patient testing on June 29, 2018. 3. An interview with the technical consultant on June 24, 2019 at 4:45 PM, confirmed the laboratory failed to indicate the acceptable temperature ranges on the worksheet and record the temperatures. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (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 analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on record reviews and an interview with the technical consultant, the laboratory failed to establish and follow a written procedure or policy for a system to monitor, identify, and correct problems in the hematology test system since June 29, 2018. Findings: 1. A review of quality control test results for the Emerald Cell-Dyn revealed the laboratory staff failed to document