Signify Laboratory, Llc

Summary Statement of Deficiencies D0000 An Initial survey was performed at Signify Laboratory, LLC, CLIA ID 19D2169206, on October 7, 2020. Signify Laboratory, LLC was found not in compliance with the following CONDITION LEVEL DEFICIENCIES: 42 CFR 493.1210 CONDITION: Routine Chemistry 42 CFR 493.1441 CONDITION: Laboratories performing high complexity testing, Laboratory Director 42 CFR 493.1447 CONDITION: Laboratories performing high complexity testing; Technical Supervisor D5016 ROUTINE CHEMISTRY CFR(s): 493.1210 If the laboratory provides services in the subspecialty of Routine Chemistry, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493. 1267, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on record review and interview with personnel, the laboratory failed to ensure the quality of testing in the specialty of Chemistry. Findings: 1. The laboratory failed to verify the accuracy of the performance of Hereditary Cancer screening testing at least twice annually. Refer to D5217. 2. The laboratory failed to have a system for ensuring specimens for Hereditary Cancer screening maintained the manufacturer's temperature requirements during transport. Refer to D5311. 3. The laboratory failed to ensure their client services manual reflected manufacturer's stability claims per their policy. Refer to D5317. 4. The laboratory failed to have a complete proficiency testing policy. Refer to D5401. 5. The laboratory failed to have complete quality control policies for Hereditary Cancer screening testing. Refer to D5403. 6. The laboratory failed to ensure the acceptable temperature range for refrigerators reflected the manufacturer's temperature requirements for the reagents stored in the refrigerators. Refer to D5413. 7. The laboratory failed to ensure reagents and supplies had not exceeded their expiration dates. Refer to D5417. 8. The laboratory failed to establish complete performance specifications for accuracy and specificity for Hereditary Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 21 -- Cancer screening testing. Refer to D5423. 9. The laboratory failed to include on the report for non-FDA approved tests a disclaimer stating "The performance characteristics of this test were determined by Signify Laboratory, LLC. It has not been cleared or approved by the U.S. Food and Drug Administration." Refer to D5805. 10. The laboratory failed to notify clients of testing delays per laboratory policy. Refer to D5815. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: I. Based on review of personnel records, policies, and interview with personnel, the laboratory failed to have documentation of initial training for testing personnel per laboratory policy for five (5) of ten (10) testing personnel reviewed. Findings: 1. Review of the laboratory's "Personnel Training and Competency" policy (effective September 1, 2019) revealed "It is the responsibility of the Technical Supervisor to ensure that staff are trained accordingly and to perform the initial six-month competency reviews and all following annual reviews. It is the responsibility of the Laboratory Director to review initial hire and annual competency reviews of all staff on an annual basis." 2. Review of the laboratory's competency records revealed the following document signed on "5/19/2020" by Technical Supervisor 1: " Signify personnel record were reviewed for completeness. Training policy was in place however training records were not. Since assuming the technical supervisor role on 2 /26/2020, I have implemented forms for training and competency for laboratory personnel. These forms are completed for all applicable personnel." 3. Review of the laboratory's CMS 209 form (Laboratory Personnel Report) and competency records revealed the following current and previous testing personnel did not have initial training documentation: Current Testing Personnel: a) Technical Supervisor 1: no training documentation for data analysis b) General Supervisor: no training documentation for library preparation procedure Previous Testing Personnel: a) Technical Supervisor 2 ( previously served as Testing Personnel): no training documentation for extraction and library enrichment preparation procedures b) Technical Supervisor 3: no training documentation for data analysis (terminated February 26, 2020) c) Technical Supervisor 4: no training documentation for data analysis (terminated February 26, 2020) 4. In interview on October 7, 2020 at 11:00 am, the General Supervisor confirmed the laboratory did not have an initial training document for her performing library preparation procedure. 5. In interview on October 7, 2020 at 11:00 am, Technical Supervisor 2 stated she performed the extraction and library preparation procedures for the patient samples tested in March. Technical Supervisor 2 further stated Testing Personnel 4 left before he signed off her training. 6. In interview on October 7, 2020 at 11:22 am, Technical Supervisor 2 stated she did not know anything about Technical Supervisor 3 and Technical Supervisor 4. Technical Supervisor 2 confirmed the laboratory did not have the identified documents for Technical Supervisor 3 and Technical Supervisor 4. 7. In interview on October 7, 2020 at 1:29 pm, Technical Supervisor 1 stated Technical Supervisor 3 and Technical Supervisor 4 were previously hired to perform data analysis. Technical Supervisor 1 stated she would perform data analysis in house. 8. Review of final patient test reports revealed Technical Supervisor 1 reviewed and -- 2 of 21 -- approved the test results for the following three (3) patients: Patient 200306101003 Patient 200306101004 Patient 200306101002 II. Based on review of personnel records, policies, and interview with personnel, the laboratory failed to ensure two (2) of four (4) Technical Supervisors had documentation of competency assessment performed by Laboratory Director for their duties as Technical Supervisor. Findings: 1. Review of the laboratory's CMS 209 form (Laboratory Personnel Report) and competency records revealed the following previously employed Technical Supervisors did not have documentation of competency assessment for their duties as Technical Supervisor. a)Technical Supervisor 3: terminated February 26, 2020 b) Technical Supervisor 4: terminated February 26, 2020 2. In interview on October 7, 2020 at 11:22 am, Technical Supervisor 2 stated she did not know anything about Technical Supervisor 3 and Technical Supervisor 4. Technical Supervisor 2 confirmed the laboratory did not have the identified documents for Technical Supervisor 3 and Technical Supervisor 4. 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 record review and interview with personnel, the laboratory failed to verify the accuracy of the performance of Hereditary Cancer screening testing at least twice annually. Findings: 1. Review of the laboratory's test menu revealed the laboratory performs hereditary cancer screening for the following genetic markers: ATM, BRCA 1, BRCA 2, CDH 1, MLH 1, MSH 2, MSH 6, and PTN 2. Review of the laboratory's revised "Proficiency Testing Policy" revealed "Assays for which no commercial proficiency testing program is available require alternate methods as deemed appropriate by the Laboratory Director. These methods may include: a) Blinded Samples analysis b) Split Sample Analysis with other laboratories performing this or similar assay c) Split sample analysis with an alternate in-house method d) Alternative PT programs are described (with acceptable criteria) in the individual test that use them" 3. Review of the laboratory's records revealed the laboratory did not have documentation of verification of the accuracy of the performance of hereditary cancer screening testing at least twice annually. 4. In interview on October 7, 2020 at 9:55 am, Technical Supervisor 1 stated the laboratory tried to do split sample testing with another laboratory; however, the other lab did not test or return the samples. Technical Supervisor 1 stated the laboratory did not verify the accuracy of performance of hereditary cancer screening. 5. Review of the laboratory's test menu revealed the laboratory performs 600 hereditary cancer screens annually. 6. In interview on October 7, 2020 at 9:36 am, Technical Supervisor 1 stated the laboratory has tested three (3) patient samples since opening. D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and -- 3 of 21 -- rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies and procedures, manufacturer's package insert, and interview with personnel, the laboratory failed to have a system for ensuring specimens for Hereditary Cancer screening maintained the manufacturer's temperature requirements during transport. Findings: 1. Review of the ORAcollect- DX OCD-100 package insert revealed a 15 degrees Celsius to 25 degrees Celsius storage requirement. 2. Review of the laboratory's policies and procedures revealed the laboratory did not establish a system to ensure specimens during transport did not exceed the manufacturer's storage requirement. 3. In interview on October 7, 2020 at 11:30 am, Technical Supervisor 1 confirmed the laboratory did not monitor specimen temperature requirements during transport or upon receipt. 4. In interview on October 7, 2020 at 9:36 am, Technical Supervisor 1 stated the laboratory has tested three (3) patient samples since opening. 5. Review of patient final test reports revealed the laboratory received and tested the following three (3) patients : Patient 200306101003 Patient 200306101004 Patient 200306101002 D5317 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(d) If the laboratory accepts a referral specimen, written instructions must be available to the laboratory's clients and must include, as appropriate, the information specified in paragraphs (a)(1) through (a)(7) of this section. This STANDARD is not met as evidenced by: Based on review of the laboratory's Client Services Manual, , policies and procedure manual, manufacturer's package insert, and interview with personnel, the laboratory failed to ensure their client services manual reflected manufacturer's stability claims per their policy. Findings: 1. Review of the laboratory's "NEXTSEQ VERIFICATION REPORT November 6, 2019" under "Interfering Species, Sample Stability, and LOD" section revealed "Currently, Signify Laboratory adheres to all manufacturer's recommendations regarding sample collection, as well as reagent and patient sample storage expiration." 2. Review of the laboratory's "NEXTSEQ OCD-100 GENOTEK VALIDATION ADDENDUM May 10, 2020" revealed the laboratory did not include sample stability requirements. 3. In interview on October 7, 2020 at 11:22 am, Technical Supervisor 2 stated the laboratory's stability requirements for samples are the same as the manufacturer's. 4. Review of the "ORAcollect-Dx OCD-100" package insert revealed the following storage requirement 15-25 degrees Celsius. 5. Review of the laboratory's client service manual effective "9/24/2020" revealed the following " Storage: 15 C-30 C (normal room temperature) for up to 30 days." 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. -- 4 of 21 -- This STANDARD is not met as evidenced by: Based on record review and interview with personnel, the laboratory failed to have a complete proficiency testing policy. Findings: 1. In interview on October 7, 2020 at 9: 55 am, Technical Supervisor 1 stated the laboratory had a policy in place for proficiency testing for Hereditary Cancer Screening testing. 2. Review of the laboratory's "Proficiency Testing Policy QA.01.014" revealed the laboratory did not include the following information: a) Frequency of performance of split sample testing b) Acceptability criteria and