Unity Health Wcmc

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 review of the 2025 CMS Casper Reports 0153D, 096D, and the College of American Pathologists (CAP) proficiency testing results, it was determined the laboratory failed to have initial successful participation in proficiency testing for the analyte Troponin. 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 as cited at D2096. 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 review of the 2025 CMS Casper Reports 0153D, 096D, and CAP proficiency testing results, it was determined the laboratory failed to have satisfactory participation in proficiency testing for the analyte Troponin. Survey Findings follow: A. A review of the proficiency testing results revealed the laboratory received a score of 0% for the analyte Troponin in the second proficiency testing event of 2025. B. A review of the proficiency testing results revealed the laboratory received a score of 0% for the analyte Troponin in the third proficiency testing event of 2025. 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 review of 2025 proficiency testing results, the laboratory director failed to ensure that the proficiency testing samples are tested as required under Subpart H of this part. 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 the 2025 proficiency testing event results, the laboratory director failed to ensure the laboratory successfully participated in proficiency testing for the Chemistry test Troponin. Refer to D2096. -- 2 of 2 --

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 review of the 2025 CMS Casper Reports 0153D, and the College of American Pathologists (CAP) proficiency testing results, it was determined the laboratory failed to have initial successful participation in proficiency testing for the analyte Aspartate Amino Transferase (AST). 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 as cited at D2096. 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 review of the 2025 CMS Casper Reports 0153D and CAP proficiency testing results, it was determined the laboratory failed to have satisfactory participation in proficiency testing for the analyte AST. Survey Findings follow: A. A review of the proficiency testing results revealed the laboratory received a score of 40% for the analyte AST in the first proficiency testing event of 2025. B. A review of the proficiency testing results revealed the laboratory received a score of 40% for the analyte AST in the second proficiency testing event of 2025. 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 review of 2025 proficiency testing results, the laboratory director failed to ensure that the proficiency testing samples are tested as required under Subpart H of this part. 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 the 2025 proficiency testing event results, the laboratory director failed to ensure the laboratory successfully participated in proficiency testing for the Chemistry test AST. Refer to D2096. -- 2 of 2 --

Summary Statement of Deficiencies D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) (b) The procedure manual must include the following when applicable to the test procedure: (b)(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. (b)(2) Microscopic examination, including the detection of inadequately prepared slides. (b)(3) Step-by- step performance of the procedure, including test calculations and interpretation of results. (b)(4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (b)(5) Calibration and calibration verification procedures. (b)(6) The reportable range for test results for the test system as established or verified in 493.1253. (b)(7) Control procedures. (b)(8)

Summary Statement of Deficiencies D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Through a review of the blood gas laboratory policy and procedure manual, co- oximetry quality control for 2022 and 2023, review of proficiency testing results, instrument service records, review of patient activity report for 2023, and through interviews with laboratory personnel, it was determined the laboratory failed to monitor Methemoglobin quality control accuracy over time from January through May 2023. Survey findings follow: A. Through a review of quality control policies and procedures in the blood gas laboratory policy and procedure manual it was determined the procedure manual failed to include policies or procedures for monitoring quality control, over time, for accuracy and precision. B. A review of January 2023 co-oximetry quality control revealed three of three levels of Methemoglobin quality control were shifted above the mean the entire month. Thirty- three of thirty-three consecutive results for Quality Control (QC) lot #S7335 were 1 Standard Deviation (SD) above the mean during the month of January 2023. Thirty- three of thirty-four consecutive results for QC lot #S7345 were 1 SD above the mean during the month of January 2023. Thirty-seven of thirty-seven results for QC lot 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 -- #S7355 were above the mean up to 1 SD during the month of January 2023. C. A review of February 2023 co-oximetry quality control revealed three of three levels of Methemoglobin quality control were shifted above the mean the entire month. Thirty- one of thirty-one consecutive results for Quality Control (QC) lot #S7335 were between 1 SD and 2 SD above the mean during the month of February 2023. Twenty- eight of twenty-eight consecutive results for QC lot #S7345 were between 1 SD and 2 SD above the mean during the month of February 2023. Forty-one of forty-one results for QC lot #S7355 were 1 SD above the mean during the month of February 2023. D. A review of March 2023 co-oximetry quality control revealed three of three levels of Methemoglobin quality control were shifted above the mean. Thirty-four of thirty- four consecutive results for Quality Control (QC) lot #S7335 were between 1 SD and 2 SD above the mean during the month of March 2023. Thirty-two of thirty-three consecutive results for QC lot #S7345 were between 1 SD and 2 SD above the mean during the month of March 2023. Thirty-three of thirty-three results for QC lot #S7355 were 1 SD above the mean during the month of March 2023. E. A review of April 2023 co-oximetry quality control revealed three of three levels of Methemoglobin quality control were shifted above the mean. Thirty-one of thirty-one consecutive results for Quality Control (QC) lot #S7335 were between 1 SD and 2 SD above the mean during the month of April 2023. Thirty of thirty consecutive results for QC lot #S7345 were between 1 SD and 2 SD above the mean during the month of April 2023. Twenty-nine of thirty results for QC lot #S7355 were between 1 SD and 2 SD above the mean during the month of April 2023. F. A review of May 2023 co- oximetry quality control revealed three of three levels of Methemoglobin quality control were shifted above the mean through 5/10/2023.. Thirty-three of thirty-three consecutive results for Quality Control (QC) lot #S7335 were 2 SD or more above the mean between 5/1/2023 and 5/10/2023 with twenty-five results documented outside of acceptable 2 SD range. Ten of ten consecutive results for QC lot #S7345 were 2 SD above the mean during from 5/1/2023 through 5/10/2023. Eleven of eleven results for QC lot #S7355 were between 1 SD and 2 SD above the mean from 5/1/2023 through 5 /10/2023. G. A review of proficiency testing results for the first event of 2023 revealed all five sample results were above the expected target value. H. Quality control records for May 2023 include documentation that service was called on 5/10 /2023 due to the failure of lot #S7335 and inability to get the result within the 2 SD range. Instrument service records from that date show that the co-oximetry module was replaced as well as other parts of the instrument. I. A review of "Procedure Activity Report" revealed 1,123 patients had blood gas testing in January, February, and March of 2023. During this time period, co-oximetry results were reported (including Methemoglobin) on every patient blood gas report (1,123 of 1,123). J. In an interview, on 6/22/2023 at 1:05 p.m., laboratory employee #??????? (as listed on the form CMS-209) stated that she didn't know to be looking for shifts and confirmed that there is no policy for evaluating quality control over time for shifts or trends in results. D5553 IMMUNOHEMATOLOGY CFR(s): 493.1271(b)(f) (b) Immunohematological testing and distribution of blood and blood products. Blood and blood product testing and distribution must comply with 21 CFR 606.100(b)(12); 606.160(b)(3)(ii) and (b)(3)(v); 610.40; 640.5(a), (b), (c), and (e); and 640.11(b). (f) Documentation. The laboratory must document all control procedures performed, as specified in this section. -- 2 of 4 -- This STANDARD is not met as evidenced by: Through review of laboratory policy for "Emergency Transfusion Request", Emergency Requests for Uncrossmatched Blood for September and December of 2022 and for May 2023 and interview with laboratory staff it was determined that the request for release of uncrossmatched blood in two of thirty-two requests to release blood on an uncrossmatched basis during the three months reviewed were not signed by the requesting physician as required at 21 CFR 606.160(b)(3)(v). Findings follow: A) Review of the laboratory policy and procedure for "Emergency Transfusion Request" revealed, "a RN may sign the request with a verbal order of the physician; however, at some point the physician must sign the request". B) Review of Emergency Requests Transfusion Requests for September and December 2022 and May of 2023 revealed that thirty-two requests for the emergency release of uncrossmatched blood products were received and that two of the requests were not signed or counter signed by the requesting physician. C) In an interview on 6/23/2023 at 2:10 p.m., laboratory employee #???????? (as listed on the CMS 209 form) confirmed that the requests for emergency release of uncrossmatched blood forms had been not been signed by the physician. This is a repeat deficiency from the survey conducted on 6/23/2021. D5783

Summary Statement of Deficiencies D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: . 1. Through a review of the monthly documentation titled, "Temperature Reviews and Eyewash Station Checks", and interviews with laboratory staff, it was determined the laboratory failed to document Temperature and Humidity on three of thirty days in November 2020. Survey findings include: A. The "Temperature Reviews and Eyewash Station Checks" is the document the laboratory uses to document temperatures of seven refrigerators, three freezers, laboratory room temperature, storage room temperature, and laboratory humidity as well as weekly eyewash checks. B. On three of thirty days in November 2020 (11/11, 11/12, and 11/30), the laboratory failed to document temperatures or humidity of any of the areas monitored. C. In an interview at 2:45 p.m. on 6/22/2021, laboratory employee #2 (as listed on the form CMS-209) confirmed the lack of temperature documentation on the three days listed. 35451 . 2. Through observations, lack of documentation and interviews with staff, it was determined the laboratory failed to monitor and document room temperature in Phlebotomy drawing room separated from main laboratory. Survey Findings follow: A. During a tour of the Phlebotomy drawing room on 06/22/2021 at 0930, the following supplies were observed stored at room temperature: One box of BD Vacutainer Purple Top Tubes Lot #1074760 (storage requirements 4-25 degrees Celsius); one box of BD Yellow Top Tubes Lot #106822 (storage requirements 4-25 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 -- degrees Celsius) one box of BD Vacutainer Dark Blue Top Tubes (storage requirements 4-25 degrees Celsius); one box of BD Vacutainer Plain Red Blue Top Tubes Lot #1137557 (storage requirements 4-25 degrees Celsius); one box BD Vacutainer Green Top Tubes Lot #1040964 (storage requirements 4-25 degrees Celsius); two Blood Culture Bottles Lot #0004100106 (storage requirements 15-30 degrees Celsius); four MRSA Nasal swabs lot #201722100 (storage requirements 15- 30 degrees Celsius) and four COVID-19 collection swabs Lot #B003308 (storage requirements 15-30 degrees Celsius). B. The surveyor requested room temperatures documentation for the Phlebotomy drawing room. None was provided. C. In an interview on 6/22/2021 at 10:30, laboratory personnel #1 (as listed on CMS form 209) confirmed the laboratory failed to monitor and document room temperatures of the Phlebotomy drawing room. 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: Through a review of July 2020, November 2020, and March 2021 Levey-Jennings Reports for twenty different chemistry tests performed on the two Architect Chemistry Analyzers, and through interviews with laboratory staff, it was determined the laboratory used expired chemistry control material for three of twenty tests reviewed. Survey findings include: A. A review of the Levey-Jennings Reports for BHB (beta-hydroxybutyrate) tests performed in July 2020 and November 2020 revealed that Level 1 and Level 2 quality controls in use were documented as Lot #09581 with an expiration documented as 3/31/2020. Lot #09581 control material was documented in use eight months after the expiration date. B. A review of the Levey- Jennings Reports for iPTH (intact Parathyroid Hormone) tests performed in July 2020, November 2020, and March 2021 revealed that, in July 2020, Low, Medium, and High quality controls in use were documented as Lot #05919F000 with an expiration documented as 3/27/2020. Lot #05919F000 control material was documented in use four months after the expiration date. In March 2021 the laboratory documented using, until 3/6/2021, Low, Medium, and High quality control material with Lot #00320E000 and an expiration date of 2/7/2021. Lot #00320E000 was documented in use twenty-seven days after the expiration date. C. A review of the Levey-Jennings Reports for D-dimer tests performed in November 2020 revealed that from 11/1/2020 through 11/13/2020, Level 1 and Level 2 quality controls in use were documented as Lot #070K with an expiration documented as 11/10/2020. Lot #070K control material was documented in use three days after the expiration date. D. During an interview, at 2:31 p.m. on 6/21/2021, laboratory employee #11 (as listed on the form CMS-209) confirmed that the only documentation available shows that the controls were used after the expiration date. 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 -- 2 of 4 -- function check protocol that ensures equipment, instrument, and test system 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: Through a review of periodic maintenance documentation provided by the biomedical engineering department, a review of documentation on stickers attached to the centrifuges, and through interviews with laboratory staff, it was determined the laboratory failed to document that centrifuge speeds were within established limits. Survey findings include: A. The surveyor requested documentation that the laboratory had checked the speed of all laboratory centrifuges and was provided periodic maintenance (PM) documentation, by the biomedical engineering department. The PM documentation included a separate document for each centrifuge that listed the dates that PM was performed on each centrifuge. The PM was documented every 6 months. The documentation did not include the speed that was verified by tachometer, to insure the centrifuges were spinning at the appropriate speeds for the specific use of each centrifuge. B. In an interview, at 9:41 a.m. on 6/23/2021, laboratory employee #3 (as listed on the form CMS-209) stated that the only documentation of centrifuge speed checks is the sticker on the side of the centrifuge that has the last documented verification of speed using a tachometer. She further confirmed the previous speed verifications using a tachometer are not available for the PM performed every six months. C. The surveyor observed thirteen centrifuges within the laboratory. Thirteen out of thirteen centrifuges had stickers that recorded speed checks in December 2020 but did not have stickers to document other speed checks performed every six months. D5553 IMMUNOHEMATOLOGY CFR(s): 493.1271(b)(f) (b) Immunohematological testing and distribution of blood and blood products. Blood and blood product testing and distribution must comply with 21 CFR 606.100(b)(12); 606.160(b)(3)(ii) and (b)(3)(v); 610.40; 640.5(a), (b), (c), and (e); and 640.11(b). (f) Documentation. The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Through review of laboratory policy for "Emergency Transfusion Request", Emergency Requests for Uncrossmatched Blood for the first quarter of 2021 and interview with laboratory staff it was determined that the request for release of uncrossmatched blood in five of twenty-three requests to release blood on an uncrossmatched basis from January through March of 2021 were not signed by the requesting physician as required at 21 CFR 606.160(b)(3)(v). Findings follow: A) Review of the laboratory policy and procedure for "Emergency Transfusion Request" revealed " a RN may sign the request with a verbal order of the physician; however, at some point the physician must sign the request". B) Review of Emergency Requests for Uncrossmatched Blood for January, February and March of 2021 revealed that twenty-three requests for the emergency release of uncrossmatched blood products were received and that five of the requests were not signed or counter signed by the requesting physician but were only signed by nursing personnel. C) In an interview on 6/22/21 at 10:43 a.m., laboratory employee #9 (as listed on the CMS 209 form) -- 3 of 4 -- confirmed that the requests for emergency release of uncrossmatched blood forms had been signed by nursing staff and not by the physician. D5783

Summary Statement of Deficiencies D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Through review of manufacturer's instrument user manual, lack of documentation, and interview it was determined that the laboratory failed to monitor humidity level in the Blood Bank laboratory for the entirety of 2018. Survey findings follow: A. Review of the Ortho Vision Blood Bank instrument manufacturer's user manual revealed the following warning; "In extreme laboratory conditions such as 15% relative humidity and a temperature of 30 degrees C. excessive evaporation of Ortho reagent red cells maybe observed with errors in results". B. Upon request, the laboratory could not provide records of relative humidity in the Blood Bank laboratory for 2018. C. In an interview on 12/13/18 at approximately 09:15 AM the testing personnel identified as number six on the CMS 209 form confirmed that the relative humidity in the Blood Bank laboratory had not been documented. D5545 HEMATOLOGY CFR(s): 493.1269(b)(d) (b) For all nonmanual coagulation test systems, the laboratory must include two levels of control material each 8 hours of operation and each time a reagent is changed. (d) The laboratory must document all control procedures performed, as specified in this 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 -- section. This STANDARD is not met as evidenced by: Through a review of quality control documentation on Levey - Jennings Reports for D- Dimer performed in March, July, and November 2018, a review of patient test records in November 2018, and interviews with laboratory staff, it was determined the laboratory failed to perform two levels of quality control for D-Dimer each 8 hours of testing in 92 of 92 days reviewed. Survey findings include: A. A review of Levey - Jennings Reports for March, July, and November 2018 revealed that quality control was documented once each day of testing (instead of each 8 hours of testing) in three of three months. B. A review of patient test records revealed the following examples of patients tested greater than 8 hours after quality control was performed: Patient #1868549 tested at 10:49 p.m. on 11/2/2018 (last quality control at 9:47 a.m.); Patient #1868785 tested at 6:35 p.m. on 11/4/2018 and Patient #1868806 tested at 10:25 p.m. on 11/4/2018 (last quality control at 10:12 a.m.); Patient #1869115 tested at 8:07 p.m. on 11/5/2018, Patient #1869119 tested at 8:52 p.m. on 11/5/2018, Patient #1869072 tested at 10:19 p.m. on 11/5/2018 and Patient #1869141 tested at 11:45 p.m. on 11/5 /2018 (last quality control at 11:05 a.m.); Patient #1869449 tested at 8:39 p.m. on 11/6 /2018 (last quality control at 9:55 a.m.); and Patient #1869708 tested at 6:24 p.m. on 11/7/2018 and Patient #1869729 tested at 8:49 p.m. on 11/7/2018 (last quality control at 10:21 a.m.). C. During an interview at 10:44 on 12/12/2018 the employee #14 (as listed on the form CMS-209) confirmed that the laboratory failed to perform D-Dimer quality control each eight hours of patient testing. D5783