Idaho National Laboratory - Cfa

Summary Statement of Deficiencies D2010 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(2) The laboratory must test samples the same number of times that it routinely tests patient samples. This STANDARD is not met as evidenced by: Based on an observation, a proficiency testing (PT) review, and an interview with the technical consultant, the laboratory failed to test 5 out 5 complete blood counts (CBC) proficiency samples from the College of American Pathologists (CAP) in the same manner as it tests patient samples for the 2019 event 1 and 2 programs. Findings: 1. An observation on June 24, 2019 at 1:30 PM of the Emerald Cell-Dyn revealed the laboratory had 7 testing personnel perform the tests on the 5 samples 3 times on February 7, 2019, 2 times on February 8, 2019, and 2 times on February 9, 2019. 2. A review of the Cell-Dyn analyzer PT results reports revealed the laboratory failed to test the 5 samples in the same manner as the laboratory tests patient samples by performing the tests by different personnel on 3 consecutive days. 3. An interview with the technical consultant on June 24, 2019 at 1:30 PM, confirmed the laboratory had multiple testing personnel test the 5 samples over 3 days. 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 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 -- 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: D2015 Based on a proficiency testing (PT) record review and an interview with the technical consultant, the laboratory director and the testing personnel failed to sign the College of American Pathologists (CAP) attestation statements for the complete blood counts (CBCs) performed during 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 during events 1 and 2 in 2019. 2. An interview with the technical consultant on June 24, 2019 at 2:05 PM, confirmed the laboratory director and testing person failed to sign the CAP attestation statements in 2019. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(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 instrument quality control record reviews, patient reviews, and an interview with the technical consultant, the laboratory failed to retain the Emerald Cell-Dyn complete blood count (CBC) manufacturer's quality control assay reference sheets prior to June 2019 and failed to retain the CBC quality control data from March 7, 2019 through June 3, 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 the current lot number 9070 in use on June 3, 2019. 2. A review of the quality control test results from the Emerald Cell- Dyn analyzer revealed the laboratory failed to retain quality control test results from March 7, 2019 through June 3, 2019. 3. The laboratory performed approximately 250 CBC between March and June 2019. 4. An interview with the technical consultant on June 24, 2019 at 2:30 PM, confirmed the laboratory failed to retain the quality control assay reference sheets and the quality control test records. D5203 SPECIMEN IDENTIFICATION AND INTEGRITY CFR(s): 493.1232 The laboratory must establish and follow written policies and procedures that ensure positive identification and optimum integrity of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results. This STANDARD is not met as evidenced by: Based on an observation, a procedure review, and an interview with the technical consultant, the laboratory failed to follow the written policy to ensure positive identification of patient's blood and urine specimens on June 24, 2019. Findings: 1. An observation on June 24, 2019 at 12:45 PM, of the laboratory, revealed 4 out of 4 -- 2 of 6 -- patient complete blood count specimens failed to be labeled with the patient's name, 'S' number, date, time, and the collector's initials on the label. 2. An observation on June 24, 2019 at 12:45 PM, of the laboratory, revealed 1 out of 1 patient's urine specimen failed to be labeled. 3. A review of the procedure manual revealed the laboratory failed to follow the written procedure to label the patient's specimens with the patient's name, 'S' number, date, time, and the collector's initials on the label. 4. An interview with the technical consultant on June 24, 2019 at 2:10 PM, confirmed the laboratory failed to follow their procedure for labeling specimens. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on a record review and an interview with the technical consultant, the laboratory failed to verify the accuracy of microscopic urine sediment examinations at least twice annually since June 2018. Findings: 1. A record review of proficiency testing from the College of American Pathologists and laboratory documents, revealed the laboratory failed to document the accuracy of microscopic urine sediment analysis at least semiannually since the start of patient testing in June 2018. 2. The laboratory performed approximately 200 urine sediment examinations since June 2018. 3. An interview with the technical consultant on June 24, 2019 at 11:45 AM, confirmed the laboratory failed to document the accuracy of urine sediment exams at least semiannually. 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 refrigerator and room temperature ranges on the laboratory worksheet and failed to record the daily temperature for the refrigerator and the laboratory room where quality control material for the Emerald Cell-Dyn complete blood counts (CBCs) were stored and patient specimens 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 where CBC quality control material was stored and the room temperature where patient specimens were tested. 2. A review of the temperature log worksheet revealed the laboratory failed to record the daily temperatures for the refrigerator for 15 out of 24 days in February 2019. 3. A review of the temperature log worksheet revealed the laboratory failed to monitor and record -- 3 of 6 -- the daily room temperature of the laboratory since the start of patient testing on June 29, 2018. 4. An interview with the technical consultant on June 24, 2019 at 1:45 PM, confirmed the laboratory failed to state the acceptable temperature ranges on the worksheet and record the temperatures. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of quality control records, a review of patient test reports, and an interview with the technical consultant, the laboratory failed to test at least 2 levels of quality control materials for complete blood counts (CBC) performed on the Emerald Cell-Dyn for each day of patient testing between February 19, 2019 and February 28, 2019. Findings: 1. A review of the quality control records for the Emerald Cell-Dyn hematology analyzer revealed the laboratory failed to test at least 2 levels of quality control materials each day of patient testing between February 19 and February 28, 2019. 2. A review of patient CBC reports between February 19, 2019 and February 28, 2019, revealed 30 patients were reported. 3. An interview with the technical consultant on June 24, 2019 at 2:30 PM, confirmed the laboratory failed to test at least 2 levels of quality control materials prior to performing tests on patient specimens. D5785