Macomb Medical Clinic Pc

Summary Statement of Deficiencies D0000 An unannounced revisit survey was performed on July 22, 2024 as a follow-up to the May 21, 2024 recertification survey. The Department of Licensing and Regulatory Affairs has evaluated this facility and determined it remains out of compliance with the following Conditions: 493.1250 Condition: Analytic systems 493.1441 Condition: Laboratories performing high complexity testing; laboratory director 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. This STANDARD is not met as evidenced by: . Based on observation, review of the laboratory's policies and procedures, record review, and interviews, the laboratory failed to provide evidence that they follow manufacturer's instructions for the use of its Drummond pipettes with reusable tips used to perform high complexity routine chemistry testing for two (July 2022 to July 2024) of two years reviewed. Findings include: 1. The surveyor requested the manufacturer's instructions for the use of the Drummond pipettes with reusable tips on 7/22/24 at 1:43 pm and none were made available. 2. Refer to D5403 and D5435 D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) 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: (i) Define a function check protocol that ensures equipment, instrument, and test system 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 -- performance that is necessary for accurate and reliable test results and test result reporting. (ii) Perform and document the function checks, including background or baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks must be within the laboratory's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: . Based on observation, record review, and interview with the Technical Consultant, the laboratory failed to establish function check protocol for the use of Drummond pipettes when pipetting patient serum for its Pointe Scientific 180 and Med Test chemistry testing for two (July 2022 to July 2024) of two years reviewed. Findings include: 1. An interview on 7/22/24 at 1:06 pm with the Technical Consultant confirmed the laboratory had not established a protocol for function checks of the resusable pipette tips prior to conducting patient testing. 2. Refer to D5403 and D5411. -- 2 of 2 --

Summary Statement of Deficiencies D5200 GENERAL LABORATORY SYSTEMS CFR(s): 493.1230 Each laboratory that performs nonwaived testing must meet the applicable general laboratory systems requirements in 493.1231 through 493.1236, 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 general laboratory systems and correct identified problems specified in 493.1239 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: . Based on record review and interviews, the laboratory failed to ensure positive patient identification through the testing process (refer to D5203) and the laboratory failed to follow its competency assessment policy (refer to D5209). D5203 SPECIMEN IDENTIFICATION AND INTEGRITY CFR(s): 493.1232 The laboratory must establish and follow written policies and procedures that ensure positive identification and optimum integrity of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results. This STANDARD is not met as evidenced by: . Based on record review and interview with the Technical Consultant, the laboratory failed to ensure positive patient identification through the testing process for 1 (Patient #4) of 7 patient test records reviewed. Findings include: 1. A review of the laboratory's patient test records revealed Patient #4 had Free T4 testing ordered on 3 /17/23, performed on 3/20/23, and was assigned the sample number of "97493." 2. A Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 9 -- review of the laboratory's FREND immunoassay instrument data from 3/20/23 revealed a lack of results for the sample number 97493. Results for sample number 97456, a sample number not on the testing log, were present with a Free T4 result of "1.06 ng/dL." 3. A review of the Patient #4's test report showed Free T4 results from 3 /20/24 reported on 3/21/24 as "1.0 ng/dL." 4. An interview on 5/21/24 at 2:51 pm revealed the Technical Consultant acknowledged the sample number discrepancy listed above. 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: . Based on record review and interviews, the laboratory failed to follow its competency assessment policy for 1 (Coverage Testing Personnel) of 3 laboratory testing personnel. Findings include: 1. A review of the laboratory's records revealed a lack of quality control results for Total Iron Binding Capacity (TIBC) documentation on 7/17/23. 2. When asked on 5/21/24 at 3:05 pm about the missing quality controls from 7/17/23, Testing Personnel #1 revealed they were on vacation during this timeframe and had another person cover for them. 3. An interview on 5/21/24 at 3:08 pm with the Technical Consultant revealed they were unaware the Coverage Testing Personnel was performing testing during this time and that testing performed by the Coverage Testing Personnel was against the competency assessment policy of the laboratory. 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 observation, record review, and interviews, the laboratory failed to ensure diluent for the Medonic M-Series Complete Blood Count (CBC) analyzer was labeled with expiration dates (refer to D5415), failed to ensure reagents were not used beyond the expiration date (refer to D5417 A), failed to ensure blood collection tubes were not used beyond expiration dates (refer to D5417 B), failed to verify performance specifications for Vitamin D and Thyroid Stimulating Hormone (TSH) testing using the NanoEnTek Frend Immunoassay analyzer prior to testing patient specimens (refer to D5421), failed to conduct a risk assessment supporting the number and frequency of control procedures in the laboratory's Quality Control Plan (refer to D5425), failed to ensure the electronic quality control laser check for the NanoEnTek Frend -- 2 of 9 -- Immunoassay analyzer was within limits before reporting patient results (refer to D5431), and failed to perform at least two levels of control materials for glucose testing (refer to D5447). D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: . Based on observation and interview with Testing Personnel #1, the laboratory failed to ensure diluent for the Medonic M-Series Complete Blood Count (CBC) analyzer was labeled with expiration dates for seven urine collection cups observed. Findings include: 1. The surveyor observed seven urine cups in the laboratory with "Diluent" written on the top of the orange cap on 5/21/24 at 9:35 am. 2. An interview on 5/21/24 at 9:35 am with Testing Personnel #1 revealed they did not know how often the diluent in the cups are changed and confirmed expiration dates were not listed on the cups containing the diluent. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: . A. Based on observation and interview with the Technical Consultant, the laboratory failed to ensure reagents were not used beyond the expiration date for 3 bottles of reagent observed. Findings include: 1. The surveyor observed expired reagents in the laboratory on 5/21/24 at 9:45 am: a. 1 bottle of Acetone with the expiration date of 11 /04/2021. b. 1 bottle of Cholesterol Reagent with the expiration date of 12/31/2023. c. 1 bottle of Iron Buffer Reagent with expiration date of 04/30/2024. 2. An interview with Techincal Consultant at 9:45 am confirmed the bottles listed above were expired. B. Based on observation and interview with the Technical Consultant, the laboratory failed to ensure blood collection tubes were not used beyond expiration dates for 5 lavender top vacutainer tubes observed. Findings include: 1. The surveyor observed 5 expired lavender top tubes at 10:07 am in a phlebotomy draw tray with an expiration date of 10/31/2019 for 1 tube and 12/31/2019 for 4 tubes. 2. An interview with the Technical Consultant on 5/21/24 at 10:08 am confirmed the expiration date of the lavender top tubes. 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 -- 3 of 9 -- 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: . Based on record review and interview with the Technical Consultant, the laboratory failed to verify performance specifications for Vitamin D and Thyroid Stimulating Hormone (TSH) testing using the NanoEnTek Frend Immunoassay analyzer prior to testing patient specimens for 6 (November 2023 to May 2024) of 6 months since the test systems were introduced. Findings include: 1. A record review of the Vitamin D verification of performance specification data from 11/7/23 to 11/15/23 revealed "QC failed" for laser check on on instrument tape indicating the test system was not performing correctly. 2. A record review of the TSH verification of performance specification data from 11/15/23 to 12/7/23 revealed "QC failed" for laser check indicating the test system was not performing correctly. 3. A review of the laboratory's "Frend Vitamin D" and "Frend TSH" manufacturer's instructions for use revealed a section titled "Quality Control" stating, "The FREND QC Cartridge contains multiple controls that check the optics of the system. By testing the QC Cartridge, the integrity of the laser power, alignment and mechanical components of the system are confirmed." 4. An interview on 5/21/24 at 11:30 am with the Technical Consultant confirmed the laser checks had failed during runs used to verify the performance specifications of Vitamin D and TSH testing and

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 record review, lack of documentation, and interview with the Laboratory Director, Office Administrator, and the Office Manager, the laboratory failed to report SARS-CoV-2 test results every day of patient testing for 99 of 99 days reviewed from June 19, 2020 to January 18, 2021. Findings include: 1. SARS-CoV-2 "Accession Log" documentation was reviewed from June 19, 2020 to January 18, 2021. 2. No documentation of SARS-CoV-2 test result reporting from June 19, 2020 to January 18, 2021. 3. No documentation of test reporting revealed for 1403 SARS-CoV-2 tests, 701 IgG and 702 IgM, were reported as required. 4. The Laboratory Director, Office Administrator, and the Office Manager confirmed the findings on 1/21/2021 at 4:57 pm. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: . Based on lack of documentation and interview with the Office Manager (OM), the laboratory failed to retain documentation for the reporting activity of the COVID-19 IgG/IgM results to the healthcare provider for 99 (6/18/20 to 1/18/21) of 99 days of testing. Findings include: 1. No documentation was available on the day of the survey to show positive and negative COVID-19 IgG/IgM results had been transmitted to the healthcare provider for 99 (6/19/20 to 1/18/21) of 99 days of testing. 2. A interview on 1/21/21 at 9:23 am, the OM confirmed the laboratory did not retain documentation of the COVID-19 test results that were faxed to the healthcare provider. D5014 GENERAL IMMUNOLOGY CFR(s): 493.1208 If the laboratory provides services in the subspecialty of General immunology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: . Based on document review and interview, the laboratory failed to meet Immunology requirements. Findings include: 1. The laboratory failed to establish a policy and procedure for reporting patient results for the COVID IgG/IgM Rapid Test Cassette testing to the healthcare provider. Refer to D5403. 2. The laboratory failed to establish performance specifications for COVID-19 IgG/IgM Rapid Test Cassette testing before reporting patient test results. Refer to D5421. 3. The laboratory failed to perform control procedures for the Covid-19 IgG/IgM testing each day of patient testing. Refer to D5445. 4. The laboratory failed to establish a system to routinely check the transmission of COVID-19 IgG/IgM testing to the healthcare provider. Refer to D5801. 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: The laboratory failed to meet applicable analytic system requirements and correct identified problems. Findings include: 1. The laboratory failed to perform control procedures each day of patient testing for the endocrinology prostate specific antigen (PSA). Refer to D5445. 2. The laboratory failed to run the "FREND System Quality Control (QC) Cartridge" every day of patient testing. Refer to D5445. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) -- 2 of 5 -- 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 record review, lack of documentation, and interview with the Laboratory Director, Office Administrator, and the Office Manager, the laboratory failed to report SARS-CoV-2 test results every day of patient testing for 99 of 99 days reviewed from June 19, 2020 to January 18, 2021. Findings include: 1. SARS-CoV-2 "Accession Log" documentation was reviewed from June 19, 2020 to January 18, 2021. 2. No documentation of SARS-CoV-2 test result reporting from June 19, 2020 to January 18, 2021. 3. No documentation of test reporting revealed for 1403 SARS-CoV-2 tests, 701 IgG and 702 IgM, were reported as required. 4. The Laboratory Director, Office Administrator, and the Office Manager confirmed the findings on 1/21/2021 at 4:57 pm. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: . Based on lack of documentation and interview with the Office Manager (OM), the laboratory failed to retain documentation for the reporting activity of the COVID-19 IgG/IgM results to the healthcare provider for 99 (6/18/20 to 1/18/21) of 99 days of testing. Findings include: 1. No documentation was available on the day of the survey to show positive and negative COVID-19 IgG/IgM results had been transmitted to the healthcare provider for 99 (6/19/20 to 1/18/21) of 99 days of testing. 2. A interview on 1/21/21 at 9:23 am, the OM confirmed the laboratory did not retain documentation of the COVID-19 test results that were faxed to the healthcare provider. D5014 GENERAL IMMUNOLOGY CFR(s): 493.1208 If the laboratory provides services in the subspecialty of General immunology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: . Based on document review and interview, the laboratory failed to meet Immunology requirements. Findings include: 1. The laboratory failed to establish a policy and procedure for reporting patient results for the COVID IgG/IgM Rapid Test Cassette testing to the healthcare provider. Refer to D5403. 2. The laboratory failed to establish performance specifications for COVID-19 IgG/IgM Rapid Test Cassette testing before reporting patient test results. Refer to D5421. 3. The laboratory failed to perform control procedures for the Covid-19 IgG/IgM testing each day of patient testing. Refer to D5445. 4. The laboratory failed to establish a system to routinely check the transmission of COVID-19 IgG/IgM testing to the healthcare provider. Refer to D5801. 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: The laboratory failed to meet applicable analytic system requirements and correct identified problems. Findings include: 1. The laboratory failed to perform control procedures each day of patient testing for the endocrinology prostate specific antigen (PSA). Refer to D5445. 2. The laboratory failed to run the "FREND System Quality Control (QC) Cartridge" every day of patient testing. Refer to D5445. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) -- 2 of 5 -- 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 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 record review of the CMS database and the American Association of Bioanalysts (AAB) proficiency testing reports, it was determined the laboratory failed to successfully participate in a CMS-approved proficiency testing program for the specialty of endocrinology. Findings include: A review of the CMS database and the AAB proficiency testing reports revealed the laboratory failed to achieve satisfactory performance for the specialty of endocrinology. Refer to D2099 and D2108. D2099 ENDOCRINOLOGY CFR(s): 493.843(b) 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 -- Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: . Based on record review of the CMS database and the American Association of Bioanalysts (AAB) final proficiency testing reports, the laboratory failed to achieve satisfactory performance for the specialty of endocrinology analyte triiodothyronine for 2 (3rd event of 2019 and 1st event of 2020) of 3 testing events. Findings include: A review of the CMS database and AAB final proficiency testing reports revealed unsatisfactory performance resulting in a score of 0 for the endocrinology analyte triiodothyronine for the following testing events: Triiodothyronine PT event Score 3rd event 2019 0% 1st event 2020 0% D2108 ENDOCRINOLOGY CFR(s): 493.843(g) Failure to achieve an overall testing event score of satisfactory performance for 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 record review of the CMS database and the American Association of Bioanalysts (AAB) final proficiency testing reports, the laboratory failed to achieve an overall satisfactory performance for the specialty of endocrinology for 2 (3rd event of 2019 and 1st event of 2020) of 3 testing events. Findings include: A review of the CMS database and AAB final proficiency testing reports revealed unsatisfactory performance for the specialty of endocrinology for the following testing events: Endocrinology PT event Score 3rd event 2019 66% 1st event 2020 66% -- 2 of 2 --

Summary Statement of Deficiencies D5431 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(2) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document function checks as defined by the manufacturer and with at least the frequency specified by the manufacturer. Function checks must be within the manufacturer's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: . Based on record review and interview, the laboratory failed to document for four (#1, #2, #4, and #6) of 11 patient charts audited the daily background count for the Medonic hematology instrument as defined by the manufacturer. Findings include: 1. On April 16, 2018 at 1:18 p.m., record review for four of 11 patient charts audited revealed there was no documentation of the instrument background count on the day of testing. 2. On April 16, 2018 at 1:18 p.m. when queried, the technical consultant as listed on the CMS-209 was unable to provide the surveyor the documentation requested. 3. During the interview on April 16, 2018 at 1:18 p.m., the technical consultant confirmed acceptable background counts were not documented before patient testing. 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 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 -- from outside referral laboratories, satellite or point-of-care testing locations. This STANDARD is not met as evidenced by: . Based on record review and interview, the laboratory failed to establish a system to ensure the Laboratory Information System (LIS) calculated glomerular filtration rate (GFR) was monitored for accuracy from the point of entry to the final patient's electronic medical record (EMR) for two (April 12, 2016 to April 12, 2018) of two year. Findings include: 1. On April 16, 2018 at 1:20 p.m., record review for two of two years revealed the laboratory had no documentation to show the LIS calculated chemistry GFR test was monitored for accuracy from the point of entry to the final patient's EMR. 2. During the interview on April 16, 2018 at 1:20 p.m., the technical supervisor as listed on the CMS-209 confirmed the LIS glomerular filtration calculation was not checked for accuracy. -- 2 of 2 --