Linda Laboratory

Summary Statement of Deficiencies D5300 PREANALYTIC SYSTEMS CFR(s): 493.1240 Each laboratory that performs nonwaived testing must meet the applicable preanalytic system(s) requirements in 493.1241 and 493.1242, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the preanalytic systems and correct identified problems as specified in 493. 1249 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on deficiencies cited for preanalytic systems, the laboratory failed to meet the applicable preanalytic systems requirements at 493.1241 and 493.1242 or monitor and evaluate the overall quality of the preanalytic systems and correct identified problems as specified in 493.1249 for each specialty and subspecialty of testing performed. Refer to D5311 (Failure to establish policies and procedures for specimen collection, labeling, storage, preservation, transportation, processing, acceptability, rejection). 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 rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 15 -- I. Based on review of manufacturer's instructions for the Co-Diagnostics Inc. Logix Smart COVID-19 polymerase chain reaction (PCR) test and the RayBiotech RayBio COVID-19 Rapid Isothermal PCR Kit and interview with the testing personnel on 8/26 /21 at 11:15 a.m., the laboratory failed to establish and follow written policies and procedures for specimen collection, specimen storage and preservation, conditions for specimen transportation, specimen processing, and specimen acceptability and rejection for the Co-Diagnostics Inc. Logix Smart COVID-19 PCR test and the RayBiotech RayBio COVID-19 Rapid Isothermal PCR Kit. Findings include: A. Review of manufacturer's instructions for the Co-Diagnostics Inc. Logix Smart COVID-19 PCR test revealed the Instructions for Use state, "For nasopharyngeal swab and oropharyngeal swabs, use only synthetic fiber swabs with plastic shafts. Do not use calcium alginate swabs or swabs with wooden shafts, as they may contain substances that inactivate some viruses and inhibit PCR testing. Place swabs immediately into sterile tubes containing 2 -3 milliliters of viral transport media. Refrigerate specimens at 2 - 8 degrees Celsius and ship overnight to the testing laboratory on an ice pack." There were no written procedures for specimen collection, specimen storage and preservation, conditions for specimen transportation, specimen processing, or for specimen acceptability and rejection available for review on 8/26 /21, the day of the survey. In an interview with the testing personnel on 8/26/21 at 11: 15 a.m., the testing personnel stated the specimens for Coronavirus Disease 2019 (COVID-19) testing with the Co-Diagnostics Inc. Logix Smart COVID-19 PCR test were collected at other sites and transported to the laboratory for testing. B. Review of manufacturer's instructions for the RayBiotech RayBio COVID-19 Rapid Isothermal PCR Kit revealed the User Manual states, "This product is intended for research only and is not to be used for clinical diagnosis." There were no written policies and procedures establishing acceptable specimens for performing COVID-19 testing with the RayBiotech RayBio COVID-19 Rapid Isothermal PCR Kit. II. Based on review of patient test logs, interview with the testing personnel on 8/26/21 at 11:15 a.m., and lack of written policies and procedures, the laboratory failed to establish a written specimen labeling policy, to include patient name or unique patient identifier, and, when appropriate, specimen source, in order to ensure positive identification of seventy-eight patient specimens tested with the Co-Diagnostics Inc. Logix Smart COVID-19 PCR test from 12/6/20 through 2/11/21 and of nine patient specimens tested from 3/12/21 through 3/28/21 with the RayBiotech RayBio COVID-19 Rapid Isothermal PCR Kit. Findings include: There was no written policy for specimen labeling to include patient name or unique patient identifier, and, when appropriate, specimen source, available for review on 8/26/21, the day of the survey. In an interview with the testing personnel on 8/26/21 at 11:15 a.m., the testing personnel confirmed there were no written policies and procedures. Review of patient test logs revealed seventy-eight patient specimens were tested with the Co-Diagnostics Inc. Logix Smart COVID-19 PCR test from 12/6/20 through 2/11/21 and nine patient specimens were tested with the RayBiotech RayBio COVID-19 Rapid Isothermal PCR Kit from 3/12/21 through 3/28/21. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. -- 2 of 15 -- This CONDITION is not met as evidenced by: Based on deficiencies cited for analytic systems, the laboratory failed to meet the applicable analytic systems requirements in 493.1251 through 493.1283 or monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. Refer to D5401 (Failure to establish a written procedure manual). Refer to D5411 (Failure to follow manufacturer's instructions for test reagent storage). Refer to D5421 (Failure to verify performance specifications for Co-Diagnostics Logix Smart COVID-19 PCR test). Refer to D5423 (Failure to establish performance specifications for RayBiotech COVID-19 Rapid Isothermal PCR Kit). Refer to D5455 (Failure to perform control testing each day of high-complexity testing). Refer to D5791 (Failure to establish quality assessment plan). 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. This STANDARD is not met as evidenced by: Based on review of patient test logs, interview with the testing personnel on 8/26/21 at 11:15 a.m., and lack of a written procedure manual, the laboratory failed to establish a written procedure manual for performing COVID-19 testing with the Co-Diagnostics Inc. Logix Smart COVID-19 PCR test, in use for patient testing from 12/6/20 through 2/11/21 when a total of seventy-eight patient specimens were tested, and for performing COVID-19 testing with the RayBiotech RayBio COVID-19 Rapid Isothermal PCR Kit, in use for patient testing from 3/12/21 through 3/28/21, when a total of nine patient specimens were tested. Findings include: In an interview with the testing personnel on 8/26/21 at 11:15 a.m., the testing personnel stated the Co- Diagnostics Inc. Logix Smart COVID-19 PCR test was used by the laboratory for patient COVID-19 testing from December 2020 through February 2021, and the RayBiotech RayBio COVID-19 Rapid Isothermal PCR Kit was used for patient COVID-19 testing in March 2021. Review of patient test logs revealed seventy-eight patient specimens were tested from 12/6/20 through 2/11/21 and nine patient specimens were tested in March 2021. There was no procedure manual available for review on the day of the survey, 8/26/21, for performing patient COVID-19 testing with the the Co-Diagnostics Inc. Logix Smart COVID-19 PCR test and the RayBiotech RayBio COVID-19 Rapid Isothermal PCR Kit. D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. -- 3 of 15 -- This STANDARD is not met as evidenced by: Based on review of the manufacturer's instructions for the Co-Diagnostics Inc. Logix Smart COVID-19 PCR test and RayBiotech RayBio COVID-19 Rapid Isothermal PCR Kit, patient test logs, observation of the laboratory freezer on 8/26/21 at 10:00 a. m., and interview with the testing personnel on 8/26/21 at 11:15 a.m., the laboratory failed to store, according to manufacturers' instructions, the Co-Diagnostics Inc. Logix Smart COVID-19 PCR test, used for patient COVID-19 testing from 12/6/20 though 2 /11/21 for seventy-eight patients, and the RayBiotech RayBio COVID-19 Rapid Isothermal PCR Kit, used for patient COVID-19 testing from 3/12/21 through 3/28/21 for nine patients. Findings include: The manufacturer's Instructions For Use for the Co-Diagnostics Inc. Logix Smart COVID-19 PCR test state, "The Logix Smart COVID-19 kit is shipped on dry ice. The components should arrive frozen. All components should be stored immediately at or below minus 20 degrees Celsius to prevent degradation of reagents." The manufacturer's instructions for the RayBiotech RayBio COVID-19 Rapid Isothermal PCR Kit state, "Kit ships on dry ice. Upon receipt, all components of the RayBio COVID-19 Rapid Isothermal PCR Kit should be stored at minus 20 degrees Celsius." Observation of the laboratory freezer on 8/26 /21 at 10:00 a.m. revealed no thermometer for monitoring freezer temperature. There were no temperature records available for review on the day of the survey, 8/26/21, documenting the freezer temperatures for 12/6/20 through 2/11/21, the time frame in which patient testing was performed with the Co-Diagnostics Inc. Logix Smart COVID-19 PCR test, or for 3/12/21 through 3/28/21, the time frame in which patient testing was performed with the RayBiotech RayBio COVID-19 Rapid Isothermal PCR Kit. In an interview with the testing personnel on 8/26/21 at 11:15 a.m., the testing personnel stated the Co-Diagnostics Inc. Logix Smart COVID-19 PCR test was used by the laboratory for patient COVID-19 testing from December 2020 through February 2021, and the RayBiotech RayBio COVID-19 Rapid Isothermal PCR Kit was used for patient COVID-19 testing in March 2021. Review of patient test logs revealed the following patient specimens were tested for COVID-19 on the following dates: 12/6/20--Specimens tested: L1, L2, L3, L4, L5, L8, L9, L10, L11, L12, L13, L14, L15, L16, L17, L18, L20. 12/12/20--Specimens tested: H1, H2, H3, H4, H5, H6, H8, H9, H10, H11, H12, H13, H14, H19, H7, H21, H22, H23, H28, H29. 1/3/21--Specimens tested: H25, H26. 1/6/21--Specimens tested: H15, H16, H17, H18. 1/16/21--Specimens tested: E1, E2, E3, E4. 1/17/21--Specimens tested: P1, P2, P3, P4, P5, P6, P7, G7, G8, G9, G10, G11, G12, G13. 1/29/21--Specimens tested: W1. 1 /31/21--Specimens tested: W2, W3, W4, W5, W6, W7, W8, W9, W10, W11, W12, W13, W14, H24. 2/11/21--Specimens tested: G1, H31. 3/12/21--Specimens tested: G2, G3, G4, G5, G6. 3/14/21--Specimens tested: A1, A2. 3/22/21--Specimens tested: H30. 3/28/21--Specimens tested: A3. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: -- 4 of 15 -- Based on interview with the testing personnel on 8/26/21 at 11:15 a.m. and review of the laboratory's patient test logs, the laboratory failed to perform and document verification of performance specifications, including accuracy and precision, for the Co-Diagnostics Inc. Logix Smart COVID-19 PCR test, in use for patient COVID-19 testing from 12/6/20 through 2/11/21, when a total of seventy-eight patient specimens were tested. Findings include: In an interview with the testing personnel on 8/26/21 at 11:15 a.m., the testing personnel stated the Co-Diagnostics Inc. Logix Smart COVID- 19 PCR test was used by the laboratory for patient COVID-19 testing from December 2020 through February 2021. There was no documentation of the verification of performance specifications, including accuracy and precision, performed by the laboratory for the Co-Diagnostics Inc. Logix Smart COVID-19 PCR test. Review of the patient test logs revealed the following patient specimens were tested for COVID- 19 on the following dates: 12/6/20--Specimens tested: L1, L2, L3, L4, L5, L8, L9, L10, L11, L12, L13, L14, L15, L16, L17, L18, L20. 12/12/20--Specimens tested: H1, H2, H3, H4, H5, H6, H8, H9, H10, H11, H12, H13, H14, H19, H7, H21, H22, H23, H28, H29. 1/3/21--Specimens tested: H25, H26. 1/6/21--Specimens tested: H15, H16, H17, H18. 1/16/21--Specimens tested: E1, E2, E3, E4. 1/17/21--Specimens tested: P1, P2, P3, P4, P5, P6, P7, G7, G8, G9, G10, G11, G12, G13. 1/29/21--Specimens tested: W1 1/31/21--Specimens tested: W2, W3, W4, W5, W6, W7, W8, W9, W10, W11, W12, W13, W14, H24. 2/11/21--Specimens tested: G1, H31. D5423 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(2) Each laboratory that modifies an FDA-cleared or approved test system, or introduces a test system not subject to FDA clearance or approval (including methods developed in-house and standardized methods such as text book procedures), or uses a test system in which performance specifications are not provided by the manufacturer must, before reporting patient test results, establish for each test system the performance specifications for the following performance characteristics, as applicable: (2)(i) Accuracy. (2)(ii) Precision. (2)(iii) Analytical sensitivity. (2)(iv) Analytical specificity to include interfering substances. (2)(v) Reportable range of test results for the test system. (2)(vi) Reference intervals (normal values). (2)(vii) Any other performance characteristic required for test performance. This STANDARD is not met as evidenced by: Based on review of manufacturer's instructions for the RayBiotech RayBio COVID- 19 Rapid Isothermal PCR Kit, patient test logs, and interview with the testing personnel on 8/26/21 at 11:15 a.m., the laboratory failed to establish performance specifications for the RayBio COVID-19 Rapid Isothermal PCR Kit used to perform COVID-19 testing on nine patient specimens from 3/12/21 through 3/28/21. Findings include: Review of manufacturer's instructions for the RayBiotech RayBio COVID-19 Rapid Isothermal PCR Kit revealed the manufacturer states in the User Manual, "This product is intended for research only and is not to be used for clinical diagnosis." In an interview with the testing personnel on 8/26/21 at 11:15 a.m., the testing personnel stated the RayBiotech RayBio COVID-19 Rapid Isothermal PCR Kit was used for testing patient COVID-19 specimens in March 2021. There was no documentation of the establishment of performance specifications for the RayBio COVID-19 Rapid Isothermal PCR Kit, including accuracy, precision, analytical sensitivity, and analytical specificity, to include interfering substances. Review of the patient test logs -- 5 of 15 -- revealed the following patient specimens were tested for COVID-19 on the following dates: 3/12/21--Specimens tested: G2, G3, G4, G5, G6. 3/14/21--Specimens tested: A1, A2. 3/22/21--Specimens tested: H30. 3/28/21--Specimens tested: A3. D5455 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(v)(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-- At least once a day patient specimens are assayed or examined perform the following for-- Each molecular amplification procedure, include two control materials and, if reaction inhibition is a significant source of false negative results, a control material capable of detecting the inhibition. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: 1. Based on review of manufacturer's instructions for the Co-Diagnostics Inc. Logix Smart COVID-19 PCR test, interview with the testing personnel on 8/26/21 at 11:15 a. m., and review of the laboratory's patient test logs, the laboratory failed to include two control materials at least once each day of patient testing with the Co-Diagnostics Inc. Logix Smart COVID-19 PCR test for nine days when a total of seventy-eight patient specimens were tested for COVID-19. Findings include: In an interview with the testing personnel on 8/26/21 at 11:15 a.m., the testing personnel stated the Co- Diagnostics Inc. Logix Smart COVID-19 PCR test was used by the laboratory for patient Coronavirus Disease-19 testing from December 2020 through February 2021. The manufacturer's instructions for the Co-Diagnostics Inc. Logix Smart COVID-19 PCR test state, "Each positive control should show an amplification curve for the COVID-19 marker in the FAM channel and amplification of the internal positive control for RNaseP in the CF610 channel. A positive amplification curve should have a cycle threshold below 45 cycles. The results of the negative control should show no amplification. If controls pass, interpret the sample results." There was no documentation of the testing of control materials on the following days when the Co- Diagnostics Inc. Logix Smart COVID-19 PCR test was used for patient Coronavirus Disease-19 testing: 12/6/20--Specimens tested: L1, L2, L3, L4, L5, L8, L9, L10, L11, L12, L13, L14, L15, L16, L17, L18, L20. 12/12/20--Specimens tested: H1, H2, H3, H4, H5, H6, H8, H9, H10, H11, H12, H13, H14, H19, H7, H21, H22, H23, H28, H29. 1/3/21--Specimens tested: H25, H26. 1/6/21--Specimens tested: H15, H16, H17, H18. 1/16/21--Specimens tested: E1, E2, E3, E4. 1/17/21--Specimens tested: P1, P2, P3, P4, P5, P6, P7, G7, G8, G9, G10, G11, G12, G13. 1/29/21--Specimens tested: W1 1 /31/21--Specimens tested: W2, W3, W4, W5, W6, W7, W8, W9, W10, W11, W12, W13, W14, H24. 2/11/21--Specimens tested: G1, H31. 2. Based on interview with the testing personnel on 8/26/21 at 11:15 a.m. and review of the laboratory's patient test logs, the laboratory failed to include two control materials at least once each day of patient testing with the RayBiotech RayBio COVID-19 Rapid Isothermal PCR Kit for four days, when a total of nine patient specimens were tested for Coronavirus Disease- 19. Findings include: In an interview with the testing personnel on 8/26/21 at 11:15 a. m., the testing personnel stated the RayBiotech RayBio COVID-19 Rapid Isothermal PCR Kit was used by the laboratory for patient COVID-19 testing in March 2021. There was no documentation of the testing of control materials on the following days when the RayBiotech RayBio COVID-19 Rapid Isothermal PCR Kit was used for -- 6 of 15 -- patient COVID-19 testing: 3/12/21--Specimens tested: G2, G3, G4, G5, G6. 3/14/21-- Specimens tested: A1, A2. 3/22/21--Specimens tested: H30. 3/28/21--Specimens tested: A3. 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. This STANDARD is not met as evidenced by: Based on review of manufacturers' instructions for the Co-Diagnostics Inc. Logix Smart COVID-19 PCR test and RayBiotech RayBio COVID-19 Rapid Isothermal PCR Kit, patient test logs, and interview with the testing personnel on 8/26/21 at 11: 15 a.m., the laboratory failed to establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems. Findings include: There was no written policy for quality assessment of analytic systems available for review on 8/26/21, the day of the survey, to include assessing test procedures; accurate and reliable test systems, equipment, instruments, reagents, materials, and supplies; specimen and reagent storage conditions; equipment/instrument/test/system maintenance and function checks; establishment and verification of method performance specifications; control procedures; comparison of test results;