Sapphiros Laboratories, Llc

Summary Statement of Deficiencies D0000 A CLIA recertification survey was conducted for the Orig3n, Inc laboratory pursuant to the Clinical Laboratory Improvement Amendments (CLIA) of 1988 and CLIA regulations at 42 CFR 493. . 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) review and interview with the Technical Supervisor (TS) on 3/23/21, the laboratory failed to document and maintain a copy of all PT records as evidenced by the following: The surveyors reviewed College of American Pathologists (CAP) PT records for calendar years 2019 and 2020 on 3/23 /21. The review revealed that attestation statements provided by the PT program were not signed by analyst for the following events: 1. APOE-B 2019 Event 2 2. APOE-B 2020 Event 2 3. MGL1-B 2020 Event 2 The TS confirmed in an interview on 3/23/21 at 11:25 AM that not all attestation statements were signed by the analyst. . D5805 TEST REPORT CFR(s): 493.1291(c) 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 -- 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 record review and interview with the Technical Supervisor (TS) and Laboratory Director (LD) on 3/23/2021, the laboratory failed to indicate the name and address of the laboratory where the test was performed on the final test report as evidenced by the following: Surveyors reviewed eleven (11) laboratory final reports for testing performed between 4/10/19 and 3/5/21 on 3/23/21. The review revealed that the name and address of the laboratory where testing was performed was not present on three (3) out of (11) reports reviewed. 1. The laboratory performed 23,614 COVID-19 tests between March 2020 when the test was implemented through August 2020. Final reports during this time period did not indicate the address of the laboratory where testing was performed. 2. a) The laboratory utilized Clinical Research Sequencing Platform as a reference laboratory. Final reports from August 2020 through December 2020 did not include the full name of the laboratory where testing was performed. The final report indicates "Broad Institute CRSP Laboratory." The name of the laboratory is Clinical Research Sequencing Platform. b) 18,959 COVID-19 specimens were sent to the reference laboratory and were reported without the full name of the laboratory where testing was performed. 3. The TS and LD confirmed in an interview on 3/23/2021 at 5:45 PM that final test reports did not all contain the full name and address of the laboratory where the test was performed. This is a repeat deficiency from a complaint survey performed on 1/31/2018. . D6127 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) The technical supervisor is responsible for evaluating and documenting the performance of individuals responsible for high complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: . Based on record review and interview with the technical supervisor (TS) on 3/23/21, the TS failed to evaluate and document the performance of individuals responsible for high complexity testing at least semiannually during the first year the individual tested patient specimens as evidenced by the following: 1. Surveyors reviewed the CMS 209 Laboratory Personnel Report on 3/23/21. The review revealed that there were three (3) new testing persons (TP) hired since the last CLIA recertification survey on 10/11 /17. 2. Surveyors reviewed personnel competency assessments on 3/23/21. The review revealed that there was no documentation of semiannual competency evaluations for TP1 who had been working for over a year. 3. The TS confirmed in an interview on 3 /23/21 at 10:50 AM that no semiannual competency evaluations had been performed on TP1. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An onsite complaint investigation of the Orig3n, Inc laboratory was performed on 8/7 /2020 and 8/21/2020. Please refer to Conditions of Participation for Clinical Laboratories 42 CFR Part 493. D5010 VIROLOGY CFR(s): 493.1205 If the laboratory provides services in the subspecialty of Virology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1265, and 493. 1281 through 493.1299. This CONDITION is not met as evidenced by: This Condition is not met as evidenced by: Based on surveyor record review and staff interviews, the laboratory failed to document the daily sanitizing of the laboratory benches and equipment utilized for the COVID-19 test (refer to D5433); failed to ensure control materials included one that is capable of detecting errors in the extraction phase of testing (refer to D5453); failed to establish a quality control monitoring system capable of identifying contamination during the extraction phase of testing and failed to follow quality assessment policies and procedures for COVID-19 positivity rates (refer to D5791); and failed to maintain a suitable copy of corrected reports when errors in the reported patient test results were detected (refer to D5821). D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must establish a maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result 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 -- reporting. The laboratory must perform and document the maintenance activities specified in paragraph (b)(1)(i) of this section. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to document daily sanitizing of the laboratory benches and equipment. This Standard is not met as evidenced by: 1. On 8/7/2020 surveyors reviewed standard operating procedure (SOP) SOP CV2020.02.MA COVID-19 RNA Extraction and Purification - Omega Bio-Tek Protocol, Section 5.1.1.2 and SOP 300.004 Safety Manual, Section 7.6. Each SOP stated that the laboratory benches and equipment were to be sanitized daily with 70% v /v Ethanol. The review revealed that the laboratory failed to document the daily sanitizing of the laboratory benches and equipment from 4/27/2020 to 8/6/2020. 2. The laboratory director confirmed in an interview on 8/7/2020 at 2:55 P.M. that the laboratory performed daily sanitization of the laboratory benches and equipment but failed to maintain written documentation. D5453 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(iv)(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 test system that has an extraction phase, include two control materials, including one that is capable of detecting errors in the extraction process; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to ensure control materials included one that is capable of detecting errors in the extraction process. This Standard is not met as evidenced by: 1. On 8/21/2020 surveyors reviewed COVID-19 quality control (QC) records from calendar months April, May, June, July, and August 2020, Standard Operating Procedure (SOP) titled SOP.CV2020.02.MA COVID-19 RNA Extraction and Purification - Omega Bio-Tek Protocol, COVID-19, Master Count Tracking logs from April 27, 2020 to August 5, 2020, the laboratory's spreadsheet of positive COVID-19 counts per state and institution from 7/30/2020 to 8 /2/2020, and the laboratory's spreadsheet of all positive COVID-19 results from 7/30 /2020 to 8/2/2020. 2. The review revealed that the laboratory failed to include a negative extraction control during the extraction phase of testing that is capable of detecting contamination in the extraction process. 3. The laboratory director stated on 8/21/2020 at 11:15 AM that at least two controls were included in the extraction phase but were not included in the extraction reagent pipetting step and would not detect contamination of these reagents. 4. Surveyors reviewed the laboratory's COVID-19 Master Count Tracking logs on 8/21/2020. According to the logs, 3,761 specimens were run from 7/30/2020-8/2/2020. 5. On 8/21/2020, surveyors reviewed the laboratory's spreadsheet of positive COVID-19 counts per state and institution resulted from 7/30/2020 to 8/2/2020 which indicated that 406 samples tested positive for COVID-19. 6. On 8/21/2020, surveyors reviewed the laboratory's spreadsheet of all positive COVID-19 results from 7/30/2020 to 8/2/2020 including retested results. 337 positive specimens were rerun at the laboratory and subsequently were reported as negative for COVID-19. 46 of these specimens were rerun at a reference laboratory and were reported as negative for COVID-19. 7. The laboratory reported 383 false -- 2 of 6 -- positive results for COVID-19. 8. The laboratory director confirmed through interview on 8/21/2020 at 11:15 AM that the QC utilized in the extraction step was not adequate to detect contamination in the extraction process. 9. The laboratory began testing for COVID-19 4/27/2020 and reported 23,513 COVID-19 results. 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 record review and interview, the laboratory failed to establish and follow procedures for an ongoing mechanism to monitor and ensure reliable and accurate COVID-19 test results. This Standard is not met as evidenced by: 1. On 8/7/2020, surveyors reviewed the Standard Operating Procedure (SOP) 500.001 Quality Assurance Policies, Section 3.4 and the COVID-19 Master Count Tracking logs from April 27, 2020 to August 5, 2020. The review revealed that the laboratory tracked daily COVID-19 positivity rates but the daily positivity rates were not "objectively assessed" per Section 3.4 of the SOP. 2. The laboratory director and CEO confirmed in an interview on 8/7/2020 at 2:30 P.M. that the laboratory tracked daily COVID-19 positivity rates but failed to assess and correct any problems that arose due to higher than normal positivity rates. 3. On 8/21/2020, surveyors reviewed quality control (QC) records from calendar months April, May, June, July, and August 2020 and policy SOP.CV2020.02.MA COVID-19 RNA Extraction and Purification - Omega Bio-Tek Protocol revealed that the QC in the extraction phase was not adequate enough to detect contamination. 4. The laboratory director confirmed through interview on 8/21/2020 at 11:15 AM that the QC utilized in the extraction step was not adequate to detect contamination in the extraction process and there was no other method for detecting contamination through the entire extraction phase of testing. D5821 TEST REPORT CFR(s): 493.1291(k) When errors in the reported patient test results are detected, the laboratory must do the following: (k)(1) Promptly notify the authorized person ordering the test and, if applicable, the individual using the test results of reporting errors. (k)(2) Issue corrected reports promptly to the authorized person ordering the test and, if applicable, the individual using the test results. (k)(3) Maintain duplicates of the original report, as well as the corrected report. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to maintain duplicate copies of the original and the corrected reports. This Standard is not met as evidenced by: 1. The surveyors reviewed two corrected reports on 8/21/2020 for false positive COVID-19 results from test dates 7/31/2020 and 8/1/2020. The review revealed that the laboratory's corrected reports failed to indicate the fact that the report is a corrected report. 2. The laboratory director and the CEO and president of the laboratory confirmed in an interview on 8/21/2020 at 10:30 AM that all the corrected -- 3 of 6 -- reports issued did not indicate that they were corrected reports. The CEO stated that corrected reports were submitted to the ordering providers in folders labeled as corrected. 3. The laboratory issued 337 corrected reports for COVID-19. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: This Condition is not met as evidenced by: Based on record review and staff interview, the laboratory director (LD) failed to provide overall management and direction in accordance with 493.1445. The cumulative effect of this lack of oversight resulted in the laboratory director's inability to ensure the accuracy and reliability of patient test results in the sub-specialty of Virology. The LD failed to indicate the fact that the report is a corrected report on 337 corrected reports, this is a repeat deficiency (refer to D6082); failed to ensure the daily sanitizing of the laboratory benches and equipment were documented (refer to D6087); failed to ensure that the quality control programs established assure the quality of laboratory services provided and to identify failures in quality as they occur (refer to D6093); and failed to ensure that the quality assessment programs were established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur (refer to 6094). D6082 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(1) The laboratory director must ensure that testing systems developed and used for each of the tests performed in the laboratory provide quality laboratory services for all aspects of test performance, which includes the preanalytic, analytic, and postanalytic phases of testing. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory director (LD) failed to ensure quality laboratory services specifically the postanalytic phase of testing. This Standard is not met as evidenced by: 1. The surveyors reviewed two corrected reports for false positive COVID-19 results from test dates 7/31/2020 and 8/1/2020. The review revealed that the laboratory's corrected reports failed to indicate the fact that the report is a corrected report. 2. The LD confirmed in an interview on 8/21/2020 at 10:30 A.M. that the laboratory failed to maintain a suitable copy of corrected reports. 3. The laboratory issued 337 corrected reports for COVID-19 testing that did not indicate that the reports were corrected. (Refer to D5821) This is a repeat deficiency from a complaint investigation conducted on 1/31/2018. D6087 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(3)(iii) The laboratory director must ensure that laboratory personnel are performing the test methods as required for accurate and reliable results. -- 4 of 6 -- This STANDARD is not met as evidenced by: Based on record review and confirmed through interview, the laboratory director failed to ensure that laboratory personnel were performing the test methods as required for accurate and reliable results. This Standard is not met as evidenced by: 1. On 8/7/2020 the surveyors reviewed standard operating procedures (SOP) SOP CV2020.02.MA COVID-19 RNA Extraction and Purification - Omega Bio-Tek Protocol, Section 5.1.1.2 and SOP 300.004 Safety Manual, Section 7.6. Each SOP stated that the laboratory benches and equipment were to be sanitized daily with 70% v /v Ethanol. The review revealed that the laboratory director failed to ensure the daily sanitizing of the laboratory benches and equipment were documented. 2. The laboratory director confirmed in an interview on 8/7/2020 at 2:55 P.M. that the laboratory performed daily sanitization of the laboratory benches and equipment but failed to maintain written documentation. (Refer to D5433) D6093 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality control programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory director failed to ensure that quality control (QC) programs assured quality laboratory services and identified failures in quality as they occurred. This Standard is not met as evidenced by: 1. The laboratory director failed to include a negative extraction control during the extraction phase of testing that is capable of detecting contamination in the extraction process. The laboratory director stated that at least two controls were included in the extraction phase but were not included in the extraction reagent pipetting step. 2. The laboratory reported 383 false positive results for COVID-19 due to contamination in the reagent set up prior to extraction. 3. The laboratory director confirmed through interview on 8 /21/2020 at 11:15 AM that the QC utilized in the extraction step was not adequate enough to detect contamination in the extraction process. (Refer to D5453) D6094 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory director (LD) did not ensure that quality assessment programs assured the quality of laboratory services or identified failures in quality. This Standard is not met as evidenced by: 1. On 8/7/2020, surveyors reviewed the Standard Operating Procedure (SOP) 500.001 Quality Assurance Policies, Section 3.4 and the COVID-19 Master Count Tracking logs from April 27, 2020 to August 5, 2020. The review revealed that the laboratory tracked daily COVID-19 positivity rates but the daily positivity rates were not "objectively -- 5 of 6 -- assessed" per Section 3.4 of the SOP. 2. The LD and CEO confirmed in an interview on 8/7/2020 at 2:30 P.M. that the laboratory tracked daily COVID-19 positivity rates but failed to assess and correct any problems that arose due to higher than normal positivity rates. 3. On 8/21/2020, surveyors reviewed of quality control (QC) records from calendar months April, May, June, July, and August 2020 and policy SOP. CV2020.02.MA COVID-19 RNA Extraction and Purification - Omega Bio-Tek Protocol revealed that the QC in the extraction phase was not adequate to detect contamination. 4. The laboratory director confirmed through interview on 8/21/2020 at 11:15 AM that the QC utilized in the extraction step was not adequate to detect contamination in the extraction process and there was no other method for detecting contamination through the entire extraction phase of testing. (Refer to D5791) -- 6 of 6 --

Summary Statement of Deficiencies D0000 A complaint investigation of the Orig3n, Inc. laboratory was performed on 1/31/18. Please refer to Conditions of Participation for Clinical Laboratories 42 CFR Part 493. . D5301 TEST REQUEST CFR(s): 493.1241(a) The laboratory must have a written or electronic request for patient testing from an authorized person. This STANDARD is not met as evidenced by: Based on record review and staff interview the laboratory failed to provide documentation of a written or electronic request for patient testing from an authorized person as evidenced by the following: a) Record review was conducted on 1/31/18 of five (5) genetic final test reports (customer IDs: f2121b73-a4d9-4f38-9cb2- 099fc7df99db, f90a8afc-7b85-40dd-8c1 4-59bdbl e8a556, 8d7ab99e-f83b-45ce-ba47- f4cf582bf573, 9lafd7e9-5353-4260-81ci-ccf0b5d066ic, and 6817d9b5-102c-42c7- a564-b7f3747b67ec). b) During the survey, the surveyor requested proof that the tests ordered were from an authorized person. c) The chief operating officer interviewed on 1/31/18 at 12:41 PM indicated that the data to review was in a database and there was no means of obtaining the data during the time of the survey to review and confirm that the requests for testing came from an authorized person. Also refer to D8103. . D5305 TEST REQUEST CFR(s): 493.1241(c) The laboratory must ensure the test requisition solicits the following information: (1) The name and address or other suitable identifiers of the authorized person requesting the test and, if appropriate, the individual responsible for using the test results, or the name and address of the laboratory submitting the specimen, including, as applicable, Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- a contact person to enable the reporting of imminently life threatening laboratory results or panic or alert values. (2) The patient's name or unique patient identifier. (3) The sex and age or date of birth of the patient. (4) The test(s) to be performed. (5) The source of the specimen, when appropriate. (6) The date and, if appropriate, time of specimen collection. (7) For Pap smears, the patient's last menstrual period, and indication of whether the patient had a previous abnormal report, treatment, or biopsy. (8) Any additional information relevant and necessary for a specific test to ensure accurate and timely testing and reporting of results, including interpretation, if applicable. This STANDARD is not met as evidenced by: Based on record review and staff interview the laboratory failed to solicit the date of collection on the test requisition. a) Record review conducted on 01/31/18 of a blank patient test request form revealed that the date of specimen collection was not on the test requisition. b) Interview with the with the laboratory technical supervisor on 1/31 /18 at 9:42 AM confirmed this finding. D5801 TEST REPORT CFR(s): 493.1291(a) The laboratory must have an adequate manual or electronic system(s) in place to ensure test results and other patient-specific data are accurately and reliably sent from the point of data entry (whether interfaced or entered manually) to final report destination, in a timely manner. This includes the following: (a)(1) Results reported from calculated data. (a)(2) Results and patient-specific data electronically reported to network or interfaced systems. (a)(3) Manually transcribed or electronically transmitted results and patient-specific information reported directly or upon receipt from outside referral laboratories, satellite or point-of-care testing locations. This STANDARD is not met as evidenced by: Based on record review and staff interview conducted on 01/31/2018, the laboratory failed to have a system in place to ensure that test results and other patient-specific data are accurately and reliably sent from the point of data entry (whether interfaced or entered manually) to final report destination, in a timely manner as evidenced by the following: a) During the time of the survey, laboratory personnel were requested to show all patient-specific data that led up to the final report of five (5) patient specimens tested (customer IDs: f2121b73-a4d9-4f38-9cb2-099fc7df99db, f90a8afc- 7b85-40dd-8c1 4-59bdbl e8a556, 8d7ab99e-f83b-45ce-ba47-f4cf582bf573, 9lafd7e9- 5353-4260-81ci-ccf0b5d066ic, and 6817d9b5-102c-42c7-a564-b7f3747b67ec). b) Interview with laboratory personnel on 01/31/2018 at 12:30 PM revealed that they were unable to provide and demonstrate that patient-specific data was being transmitted electronically in an accurate and reliable manner and that the final report included all of the necessary required information for reporting c) Interview with the technical supervisor on 1/31/18 at 12:41 PM confirmed that neither she nor the laboratory director had access to the post analytic portion of the reporting system to ensure compliance with the regulatory requirements for the test report and that all necessary information regarding test results were accurate. D5805 TEST REPORT CFR(s): 493.1291(c) -- 2 of 4 -- 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 record review and staff interview, the laboratory failed to ensure that the final report contained all required information for interpretation as evidenced by the following: a) Record review conducted on 01/31/2017 of five (5) final patient genetic test reports (customer IDs: f2121b73-a4d9-4f38-9cb2-099fc7df99db, f90a8afc-7b85- 40dd-8c1 4-59bdbl e8a556, 8d7ab99e-f83b-45ce-ba47-f4cf582bf573, 9lafd7e9-5353- 4260-81ci-ccf0b5d066ic, and 6817d9b5-102c-42c7-a564-b7f3747b67ec) revealed that five (5) of five (5) of the final reports did not include the following: 1. A second unique patient identifier or identification number; 2. The address of the laboratory location where the test was performed; and, 3) The test report date. b) The laboratory technical supervisor confirmed in an interview on 1/31/18 at 11:10 AM that the final report did not include the above information. . D6082 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(1) The laboratory director must ensure that testing systems developed and used for each of the tests performed in the laboratory provide quality laboratory services for all aspects of test performance, which includes the preanalytic, analytic, and postanalytic phases of testing. This STANDARD is not met as evidenced by: Based on observation and record review, the laboratory director failed to ensure that the testing systems developed and used for each of the tests performed in the laboratory provide quality laboratory services for all aspects of test performance, specifically the postanalytic phase of testing as evidenced by the following: a) During the time of the survey laboratory personnel were requested to show all patient-specific data that led up to the final test report for five (5) patient specimens tested (customer IDs: f2121b73-a4d9-4f38-9cb2-099fc7df99db, f90a8afc-7b85-40dd-8c1 4-59bdbl e8a556, 8d7ab99e-f83b-45ce-ba47-f4cf582bf573, 9lafd7e9-5353-4260-81ci- ccf0b5d066ic, and 6817d9b5-102c-42c7-a564-b7f3747b67ec). b) Observation of laboratory personnel revealed that they were unable to provide patient-specific data to demonstrate that test results were being transmitted electronically in an accurate and reliable manner and that the final report included all of the necessary required information for reporting (refer to D5801 and D5805). c) The technical supervisor interviewed on 1/31/18 at 12:41 PM confirmed that neither she nor the laboratory director had access to the post analytic portion of the reporting system in order to ensure compliance with the regulatory requirements for the test report and ensure that all necessary information regarding test results were accurate. D8103 BASIC INSPECTION REQUIREMENTS CFR(s): 493.1773(b)(c)(d) -- 3 of 4 -- (b) General Requirements. As part of the inspection process, CMS or a CMS agent may require the laboratory to do the following: (b)(1) Test samples, including proficiency testing samples, or perform procedures. (b)(2) Permit interviews of all personnel concerning the laboratory's compliance with the applicable requirements of this part. (b)(3) Permit laboratory personnel to be observed performing all phases of the total testing process preanalytic, analytic, and postanalytic). (b)(4) Permit CMS or a CMS agent access to all areas encompassed under the certificate including, but not limited to, the following: (b)(4)(i) Specimen procurement and processing areas. (b)(4) (ii) Storage facilities for specimens, reagents, supplies, records, and reports. (b)(4)(iii) Testing and reporting areas. (b)(5) Provide CMS or a CMS agent with copies or exact duplicates of all records and data it requires. (c) Accessible records and data. A laboratory must have all records and data accessible and retrievable within a reasonable time frame during the course of the inspection. (d) Requirement to provide information and data. A laboratory must provide, upon request, all information and data needed by CMS or a CMS agent to make a determination of the laboratory's compliance with the applicable requirements of this part. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to have all records and data accessible and retrievable within a reasonable time frame during the course of the inspection. The laboratory did not provide, upon request, all information and data needed by the CMS agent to make a determination of the laboratory's compliance with the applicable requirements of this part as evidenced by the following: a) Record review was conducted on 01/31/18 of five (5) genetic testing final test reports (customer IDs: f2121b73-a4d9-4f38-9cb2-099fc7df99db, f90a8afc-7b85-40dd-8c1 4- 59bdbl e8a556, 8d7ab99e-f83b-45ce-ba47-f4cf582bf573, 9lafd7e9-5353-4260-81ci- ccf0b5d066ic, and 6817d9b5-102c-42c7-a564-b7f3747b67ec). b) At the time of the survey, a request was made by the surveyor to provide all patient-specific data that led up to the final reports. The data was not able to be provided to the surveyor for review during the time of the survey. c) The chief operating officer stated in an interview on 1 /31/18 at 12:41 PM that the data was stored in a database off site and was not retrievable in order to be reviewed during the time of the survey. -- 4 of 4 --