Stat Laboratory Inc

Summary Statement of Deficiencies D0000 Based on a desk review of proficiency testing records from the Certification and Survey Provider Enhanced Reporting (CASPER) database and verified with the proficiency testing provider the laboratory was found to be out of compliance with the following CONDITION level deficiencies: D2016 - 42 C.F.R. 493.803 Condition: Successful participation [proficiency testing] D6000 - 42 C.F.R. 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director; D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on a desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D Individual Laboratory Profile and American Association of 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 -- Bioanalysts Medical Laboratory Evaluation (AAB-MLE) Proficiency Testing (PT) records, the laboratory failed to achieve satisfactory performance for the hematology analyte White Blood Cell Differential for two consecutive PT events in 2025 (events 2 and 3) resulting in the initial unsuccessful PT performance. Refer to D2130. D2130 HEMATOLOGY CFR(s): 493.851(f) (f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D Individual Laboratory Profile and American Association of Bioanalysts Medical Laboratory Evaluation (AAB-MLE) Proficiency Testing (PT) records, the laboratory failed to achieve satisfactory performance for the hematology analyte White Blood Cell Differential for two consecutive PT events in 2025 (events 2 and 3) resulting in the initial unsuccessful PT performance. Findings include: 1. Review of the CASPER Report 0155D, generated on 12-01-2025, the laboratory received the following unsatisfactory scores for the hematology analyte White Blood Cell Differential. White Blood Cell Differential Initial Unsuccessful PT Performance EVENT 2, 2025 - 64% Unsatisfactory EVENT 3, 2025 - 48% Unsatisfactory 2. Review of AAB-MLE PT evaluation reports (AAB-MLE M2 & M3 2025) confirmed the above unsatisfactory scores that resulted in the initial unsuccessful PT performance for the hematology analyte White Blood Cell Differential. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on a desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D Individual Laboratory Profile and American Association of Bioanalysts Medical Laboratory Evaluation (AAB-MLE) Proficiency Testing (PT) records, the laboratory director failed to ensure successful participation in a Health and Human Services (HHS) approved PT program for the hematology analyte White Blood Cell Differential resulting in the laboratory's initial unsuccessful PT performance. Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) (e)(4)(i) The proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on a desk review of the Certification and Survey Provider Enhanced Reporting -- 2 of 3 -- (CASPER) Report 0155D Individual Laboratory Profile and American Association of Bioanalysts Medical Laboratory Evaluation (AAB-MLE) Proficiency Testing (PT) records, the laboratory director failed to ensure successful participation in a Health and Human Services (HHS) approved PT program for the hematology analyte White Blood Cell Differential resulting in the laboratory's initial unsuccessful PT performance. Refer to D2130. -- 3 of 3 --

Summary Statement of Deficiencies D0000 Based on a desk review of proficiency testing records from the Certification and Survey Provider Enhanced Reporting (CASPER) database and verified with the proficiency testing provider, the laboratory was found to be out of compliance with the following CONDITION level deficiencies: D2016 - 42 C.F.R. 493.803 Condition: Successful participation [proficiency testing] D6000 - 42 C.F.R. 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on a desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D Individual Laboratory Profile and Medical Laboratory 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 -- Evaluation (MLE) Proficiency Testing (PT) records, the laboratory failed to successfully participate in a proficiency testing program approved by Health & Human Services (HHS), for each specialty, subspecialty, and analyte or test in which the laboratory is certified under the Clinical Laboratory Approvement Amendments (CLIA). The laboratory failed to successfully participate in PT for the routine chemistry analyte albumin for two consecutive PT events in 2025 (event 1 and event 2 of 2025) resulting in the initial unsuccessful PT performance (See D2096). D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) (f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D Individual Laboratory Profile and Medical Laboratory Evaluation (MLE) Proficiency Testing (PT) records, the laboratory failed to achieve satisfactory performance for the routine chemistry analyte albumin for two consecutive PT events in 2025 (event 1 and event 2 of 2025) resulting in the initial unsuccessful PT performance for albumin. Findings include: 1. Review of the CASPER Report 0155D, generated on 08-01-2025, the laboratory received the following unsatisfactory scores for the routine chemistry analyte albumin. Albumin EVENT 1, 2025 - 0% Unsatisfactory EVENT 2, 2025 - 20% Unsatisfactory 2. Review of MLE PT evaluation reports for the chemistry events M1 2025 and M2 2025 confirmed the above unsatisfactory scores that resulted in the initial unsuccessful PT performance for the routine chemistry analyte albumin. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on a desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D Individual Laboratory Profile and Medical Laboratory Evaluation (MLE) Proficiency Testing (PT) records, the laboratory director failed to ensure successful participation in a Health and Human Services (HHS) approved PT program for the routine chemistry analyte albumin resulting in the laboratory's initial unsuccessful PT performance (See D6016). D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) (e)(4)(i) The proficiency testing samples are tested as required under Subpart H of this part; -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on a desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D Individual Laboratory Profile and Medical Laboratory Evaluation (MLE) Proficiency Testing (PT) records, the laboratory director failed to ensure successful participation in a Health and Human Services (HHS) approved PT program for the routine chemistry analyte albumin resulting in the laboratory's initial unsuccessful PT performance (See D2096). -- 3 of 3 --

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on an off-site desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D Individual Laboratory Profile and Medical Laboratory Evaluation (MLE) Proficiency Testing (PT) records confirmed the initial unsuccessful PT performance for the routine chemistry analyte iron, total (See D2096) for two of three PT events in 2024 through 2025 (event two of 2024 and event one of 2025). D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) 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 -- (f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on an off-site desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D Individual Laboratory Profile and Medical Laboratory Evaluation (MLE) Proficiency Testing (PT) records the laboratory failed to achieve satisfactory performance for the routine chemistry analyte iron, total for two of three PT events in 2024 through 2025 (event two of 2024 and event one of 2025) resulting in the initial unsuccessful PT performance for iron, total. Findings include: 1. Review of the CASPER Report 0155D, generated on 05-01-2025, the laboratory received the following unsatisfactory scores for the routine chemistry analyte iron, total. Iron, total EVENT 2, 2024 - 60% Unsatisfactory EVENT 1, 2025 - 0% Unsatisfactory 2. Review of MLE PT evaluation reports for the chemistry events M2 2024 and M1 2025 confirmed the initial unsuccessful performance for the routine chemistry analyte iron, total. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on an off-site desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D Individual Laboratory Profile and Medical Laboratory Evaluation (MLE) Proficiency Testing (PT) records the laboratory director failed to ensure successful participation in a Health and Human Services (HHS) approved PT program for the routine chemistry analyte iron, total resulting in the laboratory's initial unsuccessful PT performance (see D6016). D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) (e)(4)(i) The proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on an off-site desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D Individual Laboratory Profile and Medical Laboratory Evaluation (MLE) Proficiency Testing (PT) records the laboratory director failed to ensure successful participation in a Health and Human Services (HHS) approved PT program for the routine chemistry analyte iron, total (see D2096) resulting in the laboratory's initial unsuccessful PT performance. -- 2 of 2 --

Summary Statement of Deficiencies D3000 FACILITY ADMINISTRATION CFR(s): 493.1100 Each laboratory that performs nonwaived testing must meet the applicable requirements under 493.1101 through 493.1105, unless HHS approves a procedure that provides equivalent quality testing as specified in Appendix C of the State Operations Manual (CMS Pub. 7). (a) Reporting of SARS-CoV-2 test results During the Public Health Emergency, as defined in 400.200 of this chapter, each laboratory that performs a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (hereinafter referred to as a "SARS-CoV-2 test") must report SARS-CoV-2 test results to the Secretary in such form and manner, and at such timing and frequency, as the Secretary may prescribe. This CONDITION is not met as evidenced by: Based on review of the laboratory's application for CLIA Certification (116); testing menu; policies and procedures manuals; test results; and interview with the laboratory director (LD), the laboratory failed to report SARS CpV-2 test results to the Secretary during the Public Health Emergency as specified. Findings: 1. Review of the 116 revealed, under section "VIII. NON-WAIVED TESTING", the laboratory listed Sars- cov-2 IgG and IgM analytes tested using Beckman DXI 6000. 2. The laboratory listed Sars-cov-2 IgG and Sars- cov-2 IgM as analytes it tests. 3. Review of manufactures instructions for use revealed that the laboratory uses the ACCESS Immunoassay System (ACCESS SARS-CoV-2 IgG and ACCESS SARS- CoV-IgM) for use under the Emergency Use Authorization (EUA). The instructions state, "Laboratories within the United States and its territories are required to report all positive results to the appropriate public health authorities." Instructions also state, "Authorized laboratories using your product will have a process in place for reporting test results to healthcare providers and relevant public health authorities, as appropriate." 4. On December 15, 2020 at 2:30 PM, the surveyor requested a list of all Sars-cov -2 IgG and IgM test results from the date of initial testing (August 2020) through December 14, 2020. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 11 -- From the list the surveyor selected test results reported from November 4, 2020 through December 14, 2020; for a total of 145 test results reported. There was no documentation or record to show that test results were reported to public health authorities and/or the "Secretary", as required. 5. On December 15, 2020 at 3:00 PM, in an interview with the LD, the surveyor asked the LD how the lab reports its Sars- cov-2 results to public health. The LD stated that she did not know she was supposed to report Sars-cov- 2 tests results to Public Health. Thus, confirming the surveyor's findings. 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 review of laboratory policies and procedures manuals; patients' test requisitions; patients' test reports; and interview with the laboratory director (LD), the laboratory failed to monitor and evaluate the overall quality of the pre-analytic systems and correct identified problems as specified in 493.1249 for each specialty and subspecialty of testing performed. Findings: Review of the laboratory's procedures manual revealed, patients' tests are ordered from facilities using a written requisition form or electronic request. The following information must be entered on the requisition: A. Date B. Patient Name C. Date of Birth D. Sex E. Date and Time of Collection F. Test Order G. Ordering Physician Name 2. Review of patient's' test requisitions and corresponding patients' test reports revealed that tests were performed without proper authorization. See tag D5301 3. The surveyor could not determine that test requisition information was entered and / or transcribed into its LIS correctly. See tag D5309. 4. On December 16, 2020 at 11:30 AM, the LD confirmed the surveyor's findings. 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 review of the laboratory's policies and procedures manuals; patients' test requisitions; patients' test results; and interview with the laboratory director (LD), the laboratory failed to have a written or electronic request for patient testing from an authorized person. Findings: 1. Review of the laboratory's procedures manual revealed, patients' tests are ordered from facilities using a written requisition form or electronic request. The following information must be entered on the requisition: A. Date B. Patient Name C. Date of Birth D. Sex E. Date and Time of Collection F. Test Order G. Ordering Physician Name 2. On December 15, 2020 at 2:30 PM, the surveyor selected a total of 25 test requisitions along with their corresponding test -- 2 of 11 -- results. There was no documentation to show who ordered tests for 2 of 25 test requisitions reviewed. The only information recorded on 2 0f 25 patients' test requisitions was patient name; date of birth; and test ordered. The words "weekly", every two weeks were written on 2 of 25 test requests reviewed. There were no written procedures for standing orders. 3. On December 15, 2020 at 2:45 PM, in an interview with the LD, they surveyor asked the LD why tests were analyzed and reported when the requisition was missing required information. The LD told the surveyor that because those patients were "walk-ins" requesting their own tests, the lab only enters the patient's name, Date of Birth, and the tests ordered. 4. On December 15, 2020 at 2: 45 PM, review of 25 patients test results revealed 2 of 25 patients test results were reported when there was no order from an authorized person. 5. On December 15, 2020 at 3:00 PM, the LD confirmed the surveyor's findings. D5309 TEST REQUEST CFR(s): 493.1241(e) If the laboratory transcribes or enters test requisition or authorization information into a record system or a laboratory information system, the laboratory must ensure the information is transcribed or entered accurately. This STANDARD is not met as evidenced by: Based on review of test requisitions and interview with the laboratory director (LD), the laboratory failed to ensure the information is transcribed or entered accurately. Findings: 1. On December 16, 2020 at 11:00 AM, the surveyor selected 20 test requisitions for review. Review of the 20 requisitions revealed the following information: A. A date was hand written over the "DATE" and "DRAW ON." with permanent marker for 20 0f 20 requisitions reviewed. B. Due to the permanent marker covering information on the hard copy of the requisition, the surveyor could not determine if the "DATE" and DRAW ON" were entered into the LIS correctly when she compared the hard copy of the requisition to the LIS entry for 20 of 20 requisitions reviewed. 2. On December 16, 2020 at 11:30 AM, the LD confirmed the surveyor's findings. 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. This CONDITION is not met as evidenced by: Based on review of laboratory policies and procedures manuals; verification records; control procedure; and interview with the laboratory director, the laboratory failed to meet analytic systems requirements for each test; and monitor and evaluate the overall quality of the analytic systems for each specialty and subspecialty of testing it performs. Findings: 1. There is no documentation to show that the laboratory has a written procedure, that describes, specifically, the laboratory's pre-analytic, analytic, and post analytic activities from the test order through result reporting for each test it -- 3 of 11 -- performs. See tag D5403 2. There is no documentation to show that laboratory could demonstrate the Accuracy, Precision, Reportable Range, and Normal Values for all its test systems for each specialty and /or subspecialty. See tag D5421 3. There is no documentation to show that the laboratory established the number, type, and frequency it performed testing on quality control materials. See tag D5441 4. On December 16, 2020 at 11:30 AM, the laboratory confirmed the surveyor's findings. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

Summary Statement of Deficiencies D3000 FACILITY ADMINISTRATION CFR(s): 493.1100 Each laboratory that performs nonwaived testing must meet the applicable requirements under 493.1101 through 493.1105, unless HHS approves a procedure that provides equivalent quality testing as specified in Appendix C of the State Operations Manual (CMS Pub. 7). (a) Reporting of SARS-CoV-2 test results During the Public Health Emergency, as defined in 400.200 of this chapter, each laboratory that performs a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (hereinafter referred to as a "SARS-CoV-2 test") must report SARS-CoV-2 test results to the Secretary in such form and manner, and at such timing and frequency, as the Secretary may prescribe. This CONDITION is not met as evidenced by: Based on review of the laboratory's application for CLIA Certification (116); testing menu; policies and procedures manuals; test results; and interview with the laboratory director (LD), the laboratory failed to report SARS CpV-2 test results to the Secretary during the Public Health Emergency as specified. Findings: 1. Review of the 116 revealed, under section "VIII. NON-WAIVED TESTING", the laboratory listed Sars- cov-2 IgG and IgM analytes tested using Beckman DXI 6000. 2. The laboratory listed Sars-cov-2 IgG and Sars- cov-2 IgM as analytes it tests. 3. Review of manufactures instructions for use revealed that the laboratory uses the ACCESS Immunoassay System (ACCESS SARS-CoV-2 IgG and ACCESS SARS- CoV-IgM) for use under the Emergency Use Authorization (EUA). The instructions state, "Laboratories within the United States and its territories are required to report all positive results to the appropriate public health authorities." Instructions also state, "Authorized laboratories using your product will have a process in place for reporting test results to healthcare providers and relevant public health authorities, as appropriate." 4. On December 15, 2020 at 2:30 PM, the surveyor requested a list of all Sars-cov -2 IgG and IgM test results from the date of initial testing (August 2020) through December 14, 2020. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 11 -- From the list the surveyor selected test results reported from November 4, 2020 through December 14, 2020; for a total of 145 test results reported. There was no documentation or record to show that test results were reported to public health authorities and/or the "Secretary", as required. 5. On December 15, 2020 at 3:00 PM, in an interview with the LD, the surveyor asked the LD how the lab reports its Sars- cov-2 results to public health. The LD stated that she did not know she was supposed to report Sars-cov- 2 tests results to Public Health. Thus, confirming the surveyor's findings. 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 review of laboratory policies and procedures manuals; patients' test requisitions; patients' test reports; and interview with the laboratory director (LD), the laboratory failed to monitor and evaluate the overall quality of the pre-analytic systems and correct identified problems as specified in 493.1249 for each specialty and subspecialty of testing performed. Findings: Review of the laboratory's procedures manual revealed, patients' tests are ordered from facilities using a written requisition form or electronic request. The following information must be entered on the requisition: A. Date B. Patient Name C. Date of Birth D. Sex E. Date and Time of Collection F. Test Order G. Ordering Physician Name 2. Review of patient's' test requisitions and corresponding patients' test reports revealed that tests were performed without proper authorization. See tag D5301 3. The surveyor could not determine that test requisition information was entered and / or transcribed into its LIS correctly. See tag D5309. 4. On December 16, 2020 at 11:30 AM, the LD confirmed the surveyor's findings. 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 review of the laboratory's policies and procedures manuals; patients' test requisitions; patients' test results; and interview with the laboratory director (LD), the laboratory failed to have a written or electronic request for patient testing from an authorized person. Findings: 1. Review of the laboratory's procedures manual revealed, patients' tests are ordered from facilities using a written requisition form or electronic request. The following information must be entered on the requisition: A. Date B. Patient Name C. Date of Birth D. Sex E. Date and Time of Collection F. Test Order G. Ordering Physician Name 2. On December 15, 2020 at 2:30 PM, the surveyor selected a total of 25 test requisitions along with their corresponding test -- 2 of 11 -- results. There was no documentation to show who ordered tests for 2 of 25 test requisitions reviewed. The only information recorded on 2 0f 25 patients' test requisitions was patient name; date of birth; and test ordered. The words "weekly", every two weeks were written on 2 of 25 test requests reviewed. There were no written procedures for standing orders. 3. On December 15, 2020 at 2:45 PM, in an interview with the LD, they surveyor asked the LD why tests were analyzed and reported when the requisition was missing required information. The LD told the surveyor that because those patients were "walk-ins" requesting their own tests, the lab only enters the patient's name, Date of Birth, and the tests ordered. 4. On December 15, 2020 at 2: 45 PM, review of 25 patients test results revealed 2 of 25 patients test results were reported when there was no order from an authorized person. 5. On December 15, 2020 at 3:00 PM, the LD confirmed the surveyor's findings. D5309 TEST REQUEST CFR(s): 493.1241(e) If the laboratory transcribes or enters test requisition or authorization information into a record system or a laboratory information system, the laboratory must ensure the information is transcribed or entered accurately. This STANDARD is not met as evidenced by: Based on review of test requisitions and interview with the laboratory director (LD), the laboratory failed to ensure the information is transcribed or entered accurately. Findings: 1. On December 16, 2020 at 11:00 AM, the surveyor selected 20 test requisitions for review. Review of the 20 requisitions revealed the following information: A. A date was hand written over the "DATE" and "DRAW ON." with permanent marker for 20 0f 20 requisitions reviewed. B. Due to the permanent marker covering information on the hard copy of the requisition, the surveyor could not determine if the "DATE" and DRAW ON" were entered into the LIS correctly when she compared the hard copy of the requisition to the LIS entry for 20 of 20 requisitions reviewed. 2. On December 16, 2020 at 11:30 AM, the LD confirmed the surveyor's findings. 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. This CONDITION is not met as evidenced by: Based on review of laboratory policies and procedures manuals; verification records; control procedure; and interview with the laboratory director, the laboratory failed to meet analytic systems requirements for each test; and monitor and evaluate the overall quality of the analytic systems for each specialty and subspecialty of testing it performs. Findings: 1. There is no documentation to show that the laboratory has a written procedure, that describes, specifically, the laboratory's pre-analytic, analytic, and post analytic activities from the test order through result reporting for each test it -- 3 of 11 -- performs. See tag D5403 2. There is no documentation to show that laboratory could demonstrate the Accuracy, Precision, Reportable Range, and Normal Values for all its test systems for each specialty and /or subspecialty. See tag D5421 3. There is no documentation to show that the laboratory established the number, type, and frequency it performed testing on quality control materials. See tag D5441 4. On December 16, 2020 at 11:30 AM, the laboratory confirmed the surveyor's findings. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)