Hood Memorial Hospital

Summary Statement of Deficiencies D0000 A Recertification survey was performed at Hood Memorial Hospital, CLIA ID 19D0048403, on July 15, 2024 through July 18, 2024. Hood Memorial Hospital was found not in compliance with the following CONDITION LEVEL DEFICIENCIES: 42 CFR 493.1250 CONDITION: Analytic systems 42 CFR 493.1403 CONDITION: Laboratories performing moderate complexity testing; Laboratory Director 42 CFR 493.1409: CONDITION: Laboratories performing moderate complexity testing; Technical Consultant 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 activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: ***Repeat deficiency from previous survey performed on November 14, 2022 through November 17, 2022 *** Based on observation by surveyor, review of coagulation quality control (QC) records, and interview with personnel, the laboratory failed to maintain instrument printouts in a manner to ensure visibility of data for at least two (2) years. Findings: 1. Observation by surveyor during the laboratory tour on July 15, 2024 at 10:28 am revealed the laboratory utilizes the Siemens CA 600 for coagulation testing (Prothrombin time (PT) and Partial thromboplastin time (PTT)). 2. Observation by surveyor on July 17, 2024 at 11:19 am revealed the laboratory taped the thermal paper printout of coagulation QC results to copier paper and photocopied each. 3. Review of the laboratory's coagulation QC records revealed the QC results for the following dates were not visible on the thermal paper printouts or photocopies: June 1, 2024 at 19:36 QC 03 for PT and PTT June 8, 2024 time not visible QC 03 for PT 4. In interview on July 17, 2024 at 1:24 pm, the Lab Manager stated the non- visible coagulation QC was not able to be retrieved. The Lab Manager confirmed the Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 14 -- laboratory did not ensure visibility of coagulation QC results for the identified two dates in June 2024. 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 by surveyor, record review, and interview with personnel, the laboratory failed to ensure quality of testing within the analytic systems. Findings: 1. The laboratory failed to document the open expiration date of the saline utilized for blood bank testing as required. Refer to D5415. 2. The laboratory failed to ensure laboratory supplies and reagents did not exceed their expiration dates. Refer to D5417. 3. The laboratory failed to perform reportable range studies for erythrocyte sedimentation rate (ESR) testing. Refer to D5421 I. 4. The laboratory failed to perform performance specification verification studies for the OSOM serum human chorionic gonadotropin (hCG) test. Refer to D5421 II. 5. The laboratory failed to perform external quality controls (QC) each day of patient testing for qualitative serum human chorionic gonadotropin (hCG) testing for three (3) of thirteen (13) days in 2024 reviewed. Refer to D5449. 6. The laboratory failed to establish their own means and ranges for QC material utilized for microscopic Urinalysis testing. Refer to D5469. 7. The laboratory failed to document quality control for blood bank testing prior to patient testing for two (2) of 194 days in 2024 reviewed. Refer to D5559. 8. The laboratory failed to have documentation of complete

Summary Statement of Deficiencies D0000 A Certification survey was performed at Hood Memorial Hospital, CLIA # 19D0048403, on November 14, 2022 through November 17, 2022. Hood Memorial Hospital was found not in compliance with the following CONDITION LEVEL DEFICIENCIES: 42 CFR 493.801 CONDITION: Enrollment and testing of samples 42 CFR 493.1403 CONDITION: Laboratories performing moderate complexity testing; Laboratory Director D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on review of the laboratory's proficiency test records, test menu, and interview with personnel, the laboratory failed to enroll in an HHS approved proficiency testing program for lactate dehydrogenase (LDH). Findings: 1. Review of the laboratory's 2021 and 2022 proficiency test records revealed the laboratory was not enrolled in an HSS approved proficiency testing program for LDH. 2. Review of the laboratory's records revealed LDH testing was added in 2021. 3. In interview on November 17, 2022 at 3:45 pm , the newly hired Lab Manager confirmed the laboratory was not enrolled in proficiency testing for LDH. 4. Review of the laboratory's test menu revealed the laboratory performs twenty three (23) LDH tests annually. 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 -- 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 activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on observation by surveyor, review of coagulation quality control (QC) records, and interview with personnel, the laboratory failed to maintain instrument printouts in a manner to ensure visibility of data for at least two (2) years. Findings: 1. Observation by surveyor on November 16, 2022 at 2:32 pm and review of the laboratory's coagulation quality control records revealed the laboratory maintains the quality control thermal paper printouts in a notebook. Further observation and review of the thermal paper printouts revealed instances of faded results, clear scotch tape in location that removed the printed results, as well as, results blacked out with sharpie marker. The laboratory did not ensure the unacceptable results was still visible. 2. In interview on November 17, 2022 at 11:10 am Testing Personnel 1 stated unacceptable QC results are blacked out and acceptable results left visible. Testing Personnel 1 confirmed the laboratory's current way of maintaining the raw data for coagulation QC did not preserve the visibility of the data for at least two (2) years. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on review of proficiency testing records, validation records, and interview with personnel, the laboratory failed to verify the accuracy of erythrocyte sedimentation rate (ESR) and potassium hydroxide preparations (KOH) testing at least twice annually. Findings: 1. Review of the laboratory's test menu revealed the laboratory performs ESR (utilizing the Excyte Mini) and KOH prep testing. 2. Review of the laboratory's validation records for the Excyte Mini for ESR testing revealed the laboratory began patient testing in August 2022. 3. Review of the laboratory's proficiency test records revealed the laboratory did not verify the accuracy of the ESR and KOH prep testing at least twice a year for 2022. 4. In interview on November 17, 2022 at 3:45 pm, the newly hired Laboratory Manager confirmed the laboratory did not verify the accuracy of the ESR and KOH prep testing at least twice annually. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on review of the laboratory's proficiency testing (PT) records and interview with personnel, the laboratory failed to ensure complete documentation of review of PT results for Gentamicin in 2022. Findings: 1. Review of the laboratory's PT records -- 2 of 11 -- for 2022 Event 2 revealed a score of 40% for Gentamicin. 2. Further review of the laboratory's PT records for the 2022 Event 2 for Gentamicin revealed the laboratory had raw data; however, did not include detailed documentation of steps taken for the assessment. 3. In interview on November 14, 2022 at 2:31 pm, the Diagnostic Services Director stated the laboratory repeated the proficiency samples. The Diagnostic Services Director confirmed the laboratory's documentation did not include specific steps/tasks performed for the unsatisfactory Gentamicin score. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: I. Based on review of the laboratory's policies, SARS COV-2 test logs, and interview with personnel, the laboratory failed to report SARS COV-2 results from the BioFire Film Array to the state of Louisiana as required per laboratory policy. Findings: 1. In interview on November 14, 2021 at 9:27 am, the Diagnostic Services Director stated the laboratory added the BioFire Film Array Torch for testing of respiratory pathogens including SARS COV-2 on June 2021. 2. Review of the laboratory's "Covid Reporting Results" policy revealed "All positive and negative COVID results will be reported to the state within 24 hours of being resulted." The policy had a review date of "3/15/2022." 3. In interview on November 17, 2022 at 3:30 pm Testing Personnel 3 stated on December 21, 2021 the BioFire SARS COV-2 results were no longer being reported to the state. Testing Personnel 3 further stated they were told that the BioFire COVID results did not have to be reported. 4. Review of the laboratory's BioFire test logs for SARS COV-2 revealed the laboratory tested 477 patient samples from January 3, 2022 through November 16, 2022 without reporting results to the state. II. Based on review of the laboratory's policy and procedure manual and interview with personnel, the laboratory failed to establish a complete policy and procedure manual. Findings: 1. Review of the laboratory's policy and procedure manual revealed the laboratory did not include the following: a) Written quality control procedure for blood culture bottles that included visual inspections b) Updated blood bank refrigerator alarm check policy to include frequency that matched what was in practice 2. In interview on November 16, 2022 at 1:58 pm the Diagnostic Services Director confirmed the laboratory did not have a procedure for visual inspections of blood culture bottles. 3. In interview on November 17, 2022 at 11:18 am, Testing Personnel 2 stated she began performing the blood bank high/low temperature refrigerator alarm checks monthly in September/October of 2021. Testing Personnel 2 confirmed the blood bank refrigerator alarm checks were not performed quarterly as stated in their policy. III. Based on review of the laboratory's policies and battery check logs for 2022 revealed, the laboratory failed to perform the blood bank refrigerator battery checks quarterly per laboratory policy. Findings: 1. Review of the laboratory's policies revealed the laboratory will perform blood bank refrigerator battery checks quarterly. 2. Review of the laboratory's battery check logs for 2022 revealed the laboratory performed on the following dates, not quarterly: March 28, 2022 April 15, 2022 September 1, 2022 October 3, 2022 3. In interview on November 17, 2022 at 11:18 am, Testing Personnel 2 confirmed the battery checks were not performed quarterly per policy. -- 3 of 11 -- D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies and interview with personnel, the laboratory failed to ensure policies and procedures were updated to current practices. Findings: 1. Review of the laboratory's policies revealed the laboratory did not include the following: a) Ammonia to include the manufacturer's sample stability requirements 2. In interview on November 15, 2022 at 11:47 am, the newly hired Laboratory Manager confirmed the laboratory's ammonia policy was not updated to current practices. 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 by surveyor, review of the manufacturer's package insert, and interview with personnel, the laboratory failed to document the visual inspection of blood culture bottles prior to use per manufacturer's requirements. Findings: 1. Observation by surveyor during the laboratory tour on November 14, 2022 at 10:41 am revealed the laboratory utilizes BacT/ALERT Adult and Pediatric Blood Culture Collection Kits. 2. Review of the manufacturer's package insert revealed "Inspect each blood culture bottle before use to ensure integrity of bottle and sensor on bottom of bottle is intact. The sensor is normally a uniform grayish-green color and a yellow color would indicate contamination of the broth. Discard any bottle found to be damaged or with a sensor that is yellow." 3. In interview on November 16, 2022 at 1: 58 pm the Diagnostic Services Director confirmed the laboratory does not document visual inspections of the blood culture bottles received. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on observation by surveyor, review of the laboratory's performance verification -- 4 of 11 -- records, and interview with personnel, the laboratory failed to have complete performance verification studies for erythrocyte sedimentation rate (ESR) testing. Findings: 1. Observation by surveyor during laboratory tour on November 14, 2022 at 10:41 am revealed the laboratory utilizes the Excyte Mini analyzer for ESR testing. 2. Review of the laboratory's "Excyte ESR Analyzer Verification Protocol", approved by the Laboratory Director on August 26, 2022, revealed the laboratory did not include the following: a) Reportable range b) Reference range 3. In interview on November 14, 2022 at 2:31 pm, the Diagnostic Services Director confirmed the laboratory did not address reportable and reference ranges, to include,but not limited to the clinical source utilized if applicable. D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- Establish or verify the criteria for acceptability of all control materials. (i) When control materials providing quantitative results are used, statistical parameters (for example, mean and standard deviation) for each batch and lot number of control materials must be defined and available. (ii) The laboratory may use the stated value of a commercially assayed control material provided the stated value is for the methodology and instrumentation employed by the laboratory and is verified by the laboratory. (iii) Statistical parameters for unassayed control materials must be established over time by the laboratory through concurrent testing of control materials having previously determined statistical parameters. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: I. Based on observation by surveyor, review of manufacturer's package insert, quality control (QC) records, test menu, and interview with personnel, the laboratory failed to establish their own means and ranges for QC material utilized for Urine Drug Screen (UDS) testing. Findings: 1. Observation by surveyor during laboratory tour on November 14, 2022 at 10:41 am revealed the laboratory utilizes the Beckman Coulter DxC 700 AU for urine drug screen testing with Bio-Rad Liquichek Qualitative Urine Toxicology controls. 2. Review of the "Bio-Rad Liquichek Qualitative Urine Toxicology Control" package insert under "Assignment of Values" section revealed " Each laboratory should use the results provided only as a reference and establish its own parameters of precision." 3. Review of the laboratory's quality control records revealed the laboratory did not have documentation of establishing their own QC means and ranges for lot # 74710. 4. In interview on November 15, 2022 at 3:40 pm, the newly hired Laboratory Manager stated per the previous Laboratory Manager the laboratory did not establish their own means and ranges due to the control being assayed. 5. Review of the laboratory's test menu revealed the laboratory performs 3,451 UDS tests annually. II. Based on observation by surveyor, review of manufacturer's package insert, quality control (QC) records, test menu, and interview with personnel, the laboratory failed to establish their own means and ranges for QC material utilized for Hemoglobin A1C testing. Findings: 1. Observation by surveyor during laboratory tour on November 14, 2022 at 10:41 am revealed the laboratory utilizes the Beckman Coulter DxC 700 AU for Hemoglobin A1C testing with extendSURE controls. 2. Review of the manufacturer's package insert under "Value Assignment, Traceability Statement and Assay Values" section revealed "Since the assay values are dependent upon assay procedures as well as several other factors and -- 5 of 11 -- because other assay systems may produce different values it is recommended that each laboratory should establish its own control limits form day-to-day use of the test." 3. Review of the laboratory's quality control records revealed the laboratory did not have documentation of establishing their own QC means and ranges. 4. In interview on November 15, 2022 at 3:40 pm, the newly hired Laboratory Manager stated per the previous Laboratory Manager the laboratory did not establish their own means and ranges due to the control being assayed. 5. Review of the laboratory's test menu revealed the laboratory performs 2,867 Hemoglobin A1C tests annually. D5555 IMMUNOHEMATOLOGY CFR(s): 493.1271(c)(f) (c) Blood and blood products storage. Blood and Blood products must be stored under appropriate conditions that include an adequate temperature alarm system that is regularly inspected. (c)(1) An audible alarm system must monitor proper blood and blood product storage temperature over a 24-hour period. (c)(2) Inspections of the alarm system must be documented. (f) Documentation. The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on review of the laboratory's blood bank refrigerator circular charts, alarm check logs, and interview with personnel, the laboratory failed to ensure the high/low temperature alarm checks were visible on the blood bank refrigerator's circular charts in 2021 (June through December) and 2022 (January through December). Findings: 1. Review of the laboratory's policies revealed the laboratory will perform blood bank high/low temperature alarm checks quarterly. 2. Review of the laboratory's alarm check logs for 2021 and 2022 revealed the laboratory performed alarm checks more frequently than quarterly. The alarm checks were documented on the log for the following dates: a) 2022: January 20, 2022 February 28, 2022 March 28, 2022 April 5, 2022 June 1, 2022 July 12, 2022 September 1, 2022 October 3, 2022 b) 2021: June 2, 2021 September 3, 2021 October 12, 2021 December 1, 2021 3. Review of the laboratory's blood bank refrigerator circular charts for 2021 and 2022 revealed the high /low temperature alarm checks were not visible on the charts. 4. In interview on November 17, 2022 at 11:18 am, Testing Personnel 2 stated she started performing the blood bank refrigerator's high/low alarm checks monthly in September/October 2021. Testing Personnel 2 further stated a button is pushed to initiate the alarm check. Testing Personnel 2 confirmed the alarm checks are not visible on the blood bank refrigerator's circular charts. 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 observation by surveyor, record review, and interview with personnel, the Laboratory Director failed to provide overall management and direction for the laboratory. Findings: 1. The Laboratory Director failed to ensure performance verification studies were complete. Refer to D6013. 2. The Laboratory Director failed -- 6 of 11 -- to ensure the laboratory personnel performed test methods as required. Refer to D6014. 3. The Laboratory Director failed to ensure that the laboratory is enrolled in an HHS approved proficiency testing program for the testing performed. Refer to D6015. 4. The Laboratory Director failed to ensure the laboratory documented complete

Summary Statement of Deficiencies D0000 A Recertification survey was performed on May 3, 2021 through May 6, 2021 at Hood Memorial Hospital, CLIA ID # 19D0048403. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) Laboratories eligible for a certificate of waiver must-- (1) Follow manufacturers' instructions for performing the test; and (2) Meet the requirements in subpart B, Certificate of Waiver, of this part. This STANDARD is not met as evidenced by: I. Based on observation by surveyor, review of manufacturer's instructions, test menu, and interview with personnel, the laboratory failed to include "Fact Sheets" to providers or patients for Emergency Use Authorization (EUA) SARS COV-2 testing. Findings: 1. Observation during laboratory tour on May 3, 2021 at 10:29 am revealed the laboratory performs SARS COV-2 testing utilizing the BD Veritor . 2. Review of the manufacturer's instructions for use under "Conditions of Authorization of the Laboratory" section revealed "Authorized laboratories using your product must include with test result reports, all authorized Fact Sheets. Under exigent circumstances, other appropriate methods for disseminating these Fact Sheets may be used, which may include mass media." 3. In interview on May 3, 2021 at 9:40 am, General Supervisor 2 stated the laboratory does not provide the "fact sheets" for the COVID test to patients. 4. Review of the laboratory's test menu revealed the laboratory performs 481 SARS COV-2 tests annually. II. Based on review of manufacturer's instructions, patient final test reports, test menu, and interview with personnel, the laboratory failed to include the Food and Drug Administration (FDA) Emergency Use Authorization statement on SARS COV-2 patient final reports. Findings: 1. Review of the manufacturer's instructions for the BD Veritor revealed the Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 10 -- following statement: "In the USA, this product has not been FDA cleared or approved; but has been authorized by FDA under an EUA for use by authorized laboratories." 2. Review of random selection of patient final reports for SARS COV-2 revealed the laboratory did not include the identified Emergency Use Authorization statement on patient final reports. 3. In interview on May 4, 2021 at 2:22 pm, General Supervisor 2 confirmed the laboratory's patient final reports for SARS COV-2 did not include the identified statement. 4. Review of the laboratory's test menu revealed the laboratory performs 481 SARS COV-2 tests annually. D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on review of the laboratory's proficiency testing records and interview with personnel, the laboratory failed to ensure the Laboratory Director or qualified designee (if applicable) signed the attestation forms and/or performance evaluation forms for five (5) of seven (7) proficiency testing (PT) events reviewed. Findings: 1. Review of the laboratory's American Proficiency Institute (API) PT records for 2019, 2020, and 2021 first event revealed the Laboratory Director and/or qualified designee did not sign the attestation statements and/or performance evaluation forms for the following five (5) events: a) 2019: Immunology/Immunohematology 1st event; Laboratory Director did not sign the performance evaluation form b) 2019: Immunology/Immunohematology 2nd event; Laboratory Director did not sign the performance evaluation form c) 2020: Immunology/Immunohematology 3rd event; Laboratory Director did not sign the attestation statement form d) 2020: Chemistry- Miscellaneous 2nd event; Laboratory Director or qualified designee did not sign the performance evaluation form e) 2021: Hematology/Coagulation 1st event; Laboratory Director or qualified designee did not sign the performance evaluation form 2. In interview on May 3, 2021 at 1:13 pm, General Supervisor 2 confirmed the Laboratory Director and/or qualified designee, if applicable, did not sign the identified PT events. D3025 REQUIREMENTS FOR TRANSFUSION SERVICES CFR(s): 493.1103(d) Investigation of transfusion reactions. The facility must have procedures for preventing transfusion reactions and when necessary, promptly identify, investigate, and report blood and blood product transfusion reactions to the laboratory and, as appropriate, to Federal and State authorities. This STANDARD is not met as evidenced by: -- 2 of 10 -- Based on review of the laboratory's policies, nursing policies, and interview with personnel, the laboratory failed to ensure criteria for suspected transfusion reactions were defined in nursing policies. Findings: 1. Review of the laboratory's "Transfusion Reaction Investigation" policy indicated the following signs/symptoms: a) Fever (2 degree F increase) with or without chills associated with transfusion. Fever is the most common symptom of hemolytic transfusion reaction, but more frequently it has other causes. b) Shaking shills with or without fever c) Pain at the infusion site or in the chest, abdomen, or flanks d) Blood pressure changes, usually acute, either hypertension or hypotension. The laboratory did not define/specify the amount of change that would initiate a transfusion reaction procedure. e) Respiratory distress, including dyspnea, tachypnea, wheezing, or hypoxemia f) Skin changes, including urticaria, pruritis (itching), flushing, or localized edema (angioedema) g) Nausea with or without vomiting h) Darkened urine or jaundice i) Bleeding or other manifestations of a consumptive coagulopathy 2. Review of the "Blood /Blood Components Transfusion Reactions" for the "Medical Surgical Unit" policy revealed the following: "Notification of the physician must take place for the following types of transfusion reactions: hemolytic, allergic, febrile, bacterial, circulatory overload. In the event of a suspected transfusion reaction the nursing staff attending the patient shall notify the responsible physician. In the the event that the reaction involves a rise in the patient's temperature of 2 degrees C or higher the following protocol must be followed." 3. Further review of the "Blood/Blood Components Transfusion Reactions" for the "Medical Surgical Unit" policy revealed the policy did not include the same criteria as the laboratory's policy, such as blood pressure changes. 4. In interview on May 6, 2021 at 11:10 am, the General Supervisor 2 confirmed the criteria utilized by nursing for suspected transfusion reactions did not match the laboratory's criteria. 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 review of laboratory policies, personnel records, and interview with personnel, the laboratory failed to ensure procedures to assess competency for one (1) of two (2) General Supervisors reviewed were complete . Findings: 1. Review of the laboratory's "Evaluation & Competency" policy revealed "Each employee is evaluated by supervisor annually. Each new employee is evaluated after 90 days. Competency will be done one time on Technical Supervisor as long as they hold that position. These requirements will be reviewed by the Lab Director in order to maintain competency of employees." 2. In interview on May 3, 2021 at 1:13 pm, General Supervisor 2 stated he became a General Supervisor in 2020. 3. Review of personnel records for General Supervisor 2 revealed a competency assessment for the duties of General Supervisor was not performed. 4. In further interview on May 3, 2021 at 1:13 pm, General Supervisor 2 confirmed the Laboratory Director did not perform a competency assessment for his duties as General Supervisor prior to the laboratory's on-site survey. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) -- 3 of 10 -- A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: I. Based on review of the laboratory's policies and procedures, the laboratory failed to have a complete policy and procedure manual. Findings: 1. Review of the laboratory's policies and procedures revealed the laboratory did not include the following: a) Manual INR calculation check to include procedure and frequency of performance b) Reporting of SARS COV-2 test results to state public health agency, to include but not limited to frequency and who is responsible 2. In interview on May 5, 2021 at 1: 37 pm, General Supervisor 2 confirmed the laboratory's policies did not include the identified procedures. II. Based on review of blood administration policies, blood transfusion patient records, and interview with personnel, the laboratory failed to ensure blood administration policies were complete and followed for two (2) of four (4) patients reviewed. Findings: 1. Review of the "BLOOD/BLOOD COMPONENTS - TRANSFUSION: WHOLE BLOOD AND PACKED CELLS" policy for the "Medical Surgical Unit" revealed the following: "Vital signs shall be measured prior to and after procedure. Vital signs will be taken at the start of the infusion, then every five (5) minutes x 3, then every fifteen (15) minutes x 2, then every thirty (30) minutes til infusion complete and upon completion of transfusion." 2. Further review of the identified policy revealed the specific vital signs required to be taken were not defined in the policy. 3. Review of random selection of blood transfusion patient records revealed the vital signs are documented during blood administration blood pressure, O2 Sat, respiration, pulse, and temperature. 4. Further review of random selection of blood transfusion patient records revealed the vital signs were not documented per policy for the following two (2) of four (4) patients: a) June 26, 2020: Patient 54629, no vital signs documented after completion of transfusion b) December 24, 2020: Patient 05214, no vital signs documented after completion of transfusion 5. In interview on May 5, 2021 at 1:40 pm, the Manager of the Medicine Unit confirmed the vitals were not documented after completion of transfusion for the identified patients. 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: Based on observation by surveyor and interview with personnel, the laboratory failed to ensure laboratory supplies had not exceeded their expiration dates. Findings: 1. Observation by surveyor during the laboratory tour on May 3, 2021 at 10:29 revealed the following expired items: a) Aptima Multitest Swab Specimen Collection Kit, Lot 265718, Expiration date: 2021-04-30, Quantity: one (1) box b) BD Veritor System SARS COV-2 Control Swab, Lot 0293028, Expiration date: 2021-04-22, Quantity: one (1) pack c) Viral Negative Control Swab, Lot 103466, Expiration date: 2020-21, Quantity: one (1) pack d) Alere RSV Positive Control Swab, Lot 102097, Expiration date: 2020-11, Quantity: one (1) pack e) BD Veritor System SARS COV-2 Negative -- 4 of 10 -- Control Swab, Lot 0287647, Expiration date: 2021-04-20, Quantity: One (1) pack f) Copan ClassiQ swabs tip wrapped with traditional fiber, Lot, PS10323, Expiration date: 11/2020; Quantity: six (6) swabs 2. In interview on May 3, 2021 at 10:37 am, General Supervisor 2 confirmed the identified items were expired. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on observation by surveyor, review of the laboratory's performance verification studies, test menu, and interview with personnel, the laboratory failed to have complete reference range studies for Lactate Dehydrogenase (LDH), amylase, and lipase. Findings: 1. Observation by surveyor during the laboratory tour on May 3, 2021 at 10:29 am revealed the laboratory utilizes the Beckman Coulter DxC 700 AU for Chemistry testing of the following analytes: albumin, alkaline phosphatase, alanine aminotransferase, amylase, aspartate aminotransferase, total bilirubin, calcium, CO2, chloride, cholesterol, ethanol, glucose, HDL cholesterol, iron, lactate, lipase, magnesium, phosphorus, potassium, total protein, sodium, triglycerides, uric acid, blood urea nitrogen (BUN), creatine kinase, acetaminophen, salicylate, digoxin, phenobarbital, phenytoin, valproic acid, vancomycin, gentamycin, transferrin, prealbumin, HGB A1C, ammonia, D-dimer, urine creatinine, urine protein, urine microalbumin, urine sodium, urine potassium, urine chloride, amphetamine, barbiturate, benzodiazepine, cocaine, methadone, opiate, THC, C-reactive protein, and lactate dehydrogenase. 2. Review of the laboratory's performance verification (validation) studies revealed the laboratory did not complete the reference range studies for LDH, amylase, and lipase. 3. In interview on May 4, 2021 at 11:01 am, General Supervisor 2 stated the laboratory is using the manufacturer's reference ranges. General Supervisor 2 further stated the laboratory did not have enough patients to verify the manufacturer's reference ranges. General Supervisor 2 stated the Beckman Coulter DxC 700 AU was put into use on March 9, 2021. 4. Review of the laboratory's test menu revealed the laboratory performs 360 amylase, 480 lipase, and zero (0) LDH tests annually. D5555 IMMUNOHEMATOLOGY CFR(s): 493.1271(c)(f) (c) Blood and blood products storage. Blood and Blood products must be stored under appropriate conditions that include an adequate temperature alarm system that is regularly inspected. (c)(1) An audible alarm system must monitor proper blood and blood product storage temperature over a 24-hour period. (c)(2) Inspections of the alarm system must be documented. (f) Documentation. The laboratory must document all control procedures performed, as specified in this section. -- 5 of 10 -- This STANDARD is not met as evidenced by: Based on review of the laboratory's blood bank temperature charts and interview with personnel, the laboratory failed to monitor the back-up refrigerator's temperature for the storage of blood products for one (1) of thirty one (31) days in March 2021. Findings: 1. Review of the laboratory's circular temperature charts for March 2021 revealed the following comment for March 26, 2021: "See Temp Sheet. Refrigerator wouldn't stay on units moved." Fluctuations in the temperature were recorded on the circular chart from 2:00-4:00 pm and 10:00 pm -11:00 pm. 2. Review of the laboratory's "Blood Bank Temp." log for March 2021 revealed the laboratory did not have documentation of comments or

Summary Statement of Deficiencies D0000 A Certification survey was performed at Hood Memorial Hospital-CLIA ID # 19D0048403 on July 16, 2018 through July 18, 2018. Hood Memorial Hospital was not in compliance with the following CONDITION LEVEL DEFICIENCIES: 42 CFR 493.1215 CONDITION: Hematology 42 CFR 493.1403 CONDITION: Laboratories performing moderate complexity testing, Laboratory Director D5024 HEMATOLOGY CFR(s): 493.1215 If the laboratory provides services in the specialty of Hematology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1269, and 493. 1281 through 493.1299. This CONDITION is not met as evidenced by: Based on observation, record review, and interview with personnel, the laboratory failed to ensure the quality of testing for the specialty of Hematology. Findings: 1. The laboratory failed to ensure patient donors for Mean Prothrombin Time studies met manufacturer requirements of normal donors. Refer to D5411. 2. The laboratory failed to have complete performance specification verification studies. Refer to D5421. 3. The laboratory failed to ensure quarterly maintenance for the Beckman Coulter AU 680 was performed and documented as required. Refer to D5429. 4. The laboratory failed to perform two levels of control materials each eight (8) hours of patient testing for D-dimer testing. Refer to D5545. 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. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 12 -- This STANDARD is not met as evidenced by: Based on record review and interview with personnel, the laboratory failed to establish written policies and procedures to assess personnel competency semi- annually. Findings: 1. Review of the laboratory's "Evaluation & Competency" policy revealed the following: a) "Each new employee is evaluated semi-annually for the first year." 2. Review of personnel records revealed the laboratory utilized the "Merit Evaluation Tool" form to assess testing personnel semi-annually during the first year of employment; however, tasks were non laboratory specific. 3. Further review of the "Merit Evaluation Tool" form revealed the following tasks were assessed: a) "Quality /accuracy of work" b) "Quantity of work" c) "Dependability" d) "Attendance /Punctuality" e) "Professional communication skills with co-workers/supervisors" f) "Customer-focused communication skills" g) "Ability to work as a member of a team; teamwork" h) "Ability to work independently" i) "Open to feedback" j) "Willingness to take on additional responsibilities" k) "Complies with company policies and procedures" l) "Exhibits effective problem solving skills" m) "Eagerness to learn new job-related skills" n) "Asks questions and seeks guidance as needed" o) "Makes progress toward professional development goals N/A" p) "Complies with hospital's annual requirements (e.g., SWANK, TB, CPR, SAFETY STORM)" q) "Actively participates in hospital activities N/A" 4. In interview on July 16, 2018 at 11:50 am, Personnel 2 confirmed she uses the "Merit Evaluation Tool" form for semi-annual competency assessments. Personnel 2 confirmed the form is not specialty or laboratory testing specific. Personnel 2 stated the laboratory uses the minimal six (6) procedures required by CLIA for annual competency assessments. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: *** REPEAT DEFICIENCY from survey date February 6, 2017 through February 9, 2017. *** Based on record review and interview with personnel, the laboratory failed to follow their policy for documentation of Quality Control (QC) for Blood Bank testing. Findings: 1. Review of the laboratory's "Blood Bank QC" records from March 9, 2017 through July 17, 2018 revealed the following items are to be documented: a) Results for Ortho Confidence reagents: Anti-A, Anti-B, Anti-AB, Anti-D, Rh control material b) Results for Ortho Confidence Reagent Red Blood Cells: A1, B, Screen cells 1, and Screen cells 2 c) Results for DAT and Coombs d) Lot number and expiration dates for Reagents e) Visual inspection check for Diluent 2 and Saline f) RPM speed check, Timer and Incubator Checks 2. Further review of the laboratory's "Blood Band QC" records from March 9, 2017 through July 17, 2018 revealed information was not documented for the following three (3) dates: a) December 9, 2017: "QC Reagent" Lot # and Expiration Date b) May 2, 2018: RPM Check and Timer Check c) May 30, 2018: DAT Reagent Lot #s and Expiration Dates 3. In interview on July 18, 2018 at 11:40 am, Personnel 2 confirmed the identified dates did not have all QC tasks documented. -- 2 of 12 -- 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, record review, and interview with personnel, the laboratory failed to ensure patient donors for Mean Prothrombin Time studies met manufacturer requirements of normal donors. Findings: 1. Observation by surveyor during laboratory tour on July 16, 2018 revealed the laboratory utilizes the Stago Satellite for Prothrombin Time (PT) and International Normalized Ratio (INR) testing. 2. Review of the laboratory's"Establishing Patient Normal Range" policy revealed the following: "The donors should be screened using the following guidelines: a) A minimum of 20 donors should be used b) The donors should be healthy and have no known pathological conditions c) The donors should not be on medication, including oral contraceptives and estrogen therapy d) Donors should span the adult age range. (Employees are used when available). e) The study should include a fairly even number of males and females. Reference: NCCLS H21-A3 December 1998" 3. Review of the laboratory's donor questionnaires from October 23, 2017 through November 1, 2017 for Thromboplastin lot # 251655 revealed the laboratory utilized two (2) questionnaires. 4. Further review of the laboratory's donor questionnaires revealed on October 24, 2017 through November 1, 2017 the laboratory utilized the "Prothrombin Time Normal Mean Study Questionnaire." The laboratory documented responses from twenty one (21) donors (Patients 54-73) for the following questions: "Are you currently taking any of the following? a) Alcohol b) Antibiotics c) Anti- coagulants d) Vitamin K e) Aspirin 5. Review of the laboratory's donor questionnaires revealed the laboratory did not include the following criteria: a) Healthy and have no known pathological conditions donors b) Not be on medication, including oral contraceptives and estrogen therapy 6. In interview on July 18, 2018 at 11:40 am, Personnel 2 stated the questionnaire was changed after she spoke to the manufacturer and was told oral contraceptives should not interfere with PT results. Personnel 2 further stated it was unknown if donors (Patients 54-73) were on birth control (oral contraceptives). 7. Review of the laboratory's Task 1 and 3 forms revealed the laboratory performs 1,002 PT/INR tests annually. 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: Based on observation, record review, and interview with personnel, the laboratory failed to ensure Blood Bank reagents were not used beyond their expiration date. Findings: 1. Observation by surveyor during laboratory tour on July 16, 2018 revealed the laboratory utilizes Micro Typing Systems Gel cards for Antibody Screen and Crossmatch testing. 2. Review of the laboratory's Blood Bank Quality Control and -- 3 of 12 -- patient test records from March 9, 2017 through July 17, 2018 revealed the following expired reagent: On January 28, 2018 Gel Card Lot # 032717001-05, Documented Expiration Date: 1-19-18 3. Further review of the laboratory's patient test records revealed the following patient was reported on January 28, 2018: Patient 48 4. Review of the laboratory's Blood Bank Quality Control form for January 28, 2018 revealed the form was reviewed on January 29, 2018 5. In interview on July 18, 2018 at 11:40 am, Personnel 3 stated the testing personnel transcribed the expiration date of the gel cards incorrectly. Personnel further stated that he was unable to find a packing slip or insert from the manufacturer verifying the identified gel cards expiration date. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on observation, record review, and interview with personnel, the laboratory failed to have complete performance specification verification studies. Findings: 1. Observation by surveyor during the laboratory tour on July 16, 2018 revealed the laboratory utilizes the Sysmex XN 550 for Complete Blood Count (CBC) and Reticulocyte (Retic) testing. 2. In interview on July 16, 2018 at 9:05 am, Personnel 2 stated the laboratory began patient testing on the new hematology analyzer in February 2018. 3. Review of the laboratory's "Validating New Methodologies" policy under section "IV. Reference Range Studies" revealed the following: "The laboratory may begin patient testing using the manufacturer suggested reference ranges or published reference ranges from a textbook or a journal publication. The Reference ranges may vary based on the type of patient (e.g. pediatric, male, female). Be sure to verify that the manufacturer's reference ranges (normal values) are appropriate for your laboratory's patient population by performing the study below. In addition, Reference ranges will be monitored as part of the quality assessment program. If published ranges are used, document published 'source' with method validation studies." 4. Further review of the laboratory's "Validating New Methodologies" policy under section "SUMMARY OF TEST METHOD VALIDATION" revealed "All documented data must be reviewed and approved by the lab director prior to initiating patient testing." 5. Review of the laboratory's performance verification studies revealed the following information was not included: a) Reference Range b) Laboratory Director approval/signature 6. In interview on July 16, 2018 at 3:20 pm, Personnel 2 stated the Laboratory Director reviewed the performance studies but did not sign. Personnel 2 further stated she could not locate data for reference range study. 7. Review of the laboratory's Task 1 and 3 forms revealed the laboratory performed 43,953 CBC and forty (48) Retic tests on the Sysmex XN 550 analyzer. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory -- 4 of 12 -- must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on observation, record review and interview with personnel, the laboratory failed to ensure quarterly maintenance for the Beckman Coulter AU 680 was performed and documented as required. Findings: 1. Observation by surveyor during laboratory tour on July 16, 2018 revealed the laboratory utilizes the Beckman Coulter AU 680 for Chemistry and D-dimer testing. 2. Review of the "AU680 ANALYZER QUARTERLY & AS NEEDED MAINTENANCE LOG" indicated the following quarterly maintenance tasks: a) "Clean Air Filters" b) "Replace Detergent Rolling Tube" c) "Replace Roller Tubes for MID soln Depense & Mixture Aspiration" d) " Replace Pinch Valve Tubing" 3. Further review of the "AU680 ANALYZER QUARTERLY & AS NEEDED MAINTENANCE LOG" for 2017 and 2018 revealed the laboratory did not document quarterly maintenance for the following four (4) quarters: 2017: 3rd Quarter, due September 2017 2017: 4th Quarter, due December 2017 2018: 1st Quarter, due March 2018 2018: 2nd Quarter, due June 2018 4. In interview on July 16, 2018 at 2:40 pm Personnel 2 stated the laboratory did not document quarterly maintenance for the identified dates. 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 section. This STANDARD is not met as evidenced by: Based on observation, record review, and interview with personnel, the laboratory failed to perform two levels of control materials each eight (8) hours of patient testing for D-dimer testing. Findings: 1. Observation by surveyor during laboratory tour on July 16, 2018 revealed the laboratory utilizes the Beckman Coulter AU 680 for D- dimer testing. 2. Review of the laboratory's "D-dimer" procedure under the "Quality Control" section revealed "Bio-Rad D-Dimer Controls Level 1 & Level 3 should be tested a minimum of once a day. In addition, these controls should be tested after calibration, with each new lot of reagent and after specific maintenance or troubleshooting steps described in the appropriate User's Guide." 3. Review of the manufacturer's package insert under the "Quality Control" section revealed "During operation of the Beckman Coulter AU analyzer at least two levels of appropriate control material, such as D-Dimer Control ODC0029, should be tested a minimum of once a day. In addition, these controls should be tested after calibration, with each new lot of reagent and after specific maintenance or troubleshooting steps described in the appropriate Beckman Coulter AU analyzer User Guide/Instructions For Use (IFU). Quality control testing should be performed in accordance with regulatory requirements and each laboratory's standard procedure." 4. In interview on July 17, 2018 at 10:39 am, Personnel 2 stated D-Dimer controls are tested once a day since the AU has been in use. 5. In further interview on July 17, 2018 at 11:30 am, Personnel 2 stated the laboratory did not perform an Individualized Quality Control Plan (IQCP). Personnel 2 further stated she thought they could go by the manufacturer requirements. 6. Review of D-dimer Quality Control (QC) and patient test records for -- 5 of 12 -- July 2017 and June 2018 revealed the laboratory did not perform two (2) levels of QC each eight (8) hours of patient testing for the following forty-seven (47) patients: Patient 1 reported on July 5, 2017 at 20:39, QC reported on July 5, 2017 at 06:30 Patient 2 reported on July 20, 2017 at 19:07, QC reported on July 20, 2017 at 05:26 Patient 3 reported on July 4, 2017 at 01:23, QC reported on July 4, 2017 at 05:37 Patient 4 reported on July 4, 2017 at 14:25, QC reported on July 4, 2017 at 05:37 Patient 5 reported on July 5, 2017 at 19:08, QC reported on July 5, 2017 at 06:30 Patient 6 reported on July 8, 2017 at 14:09, QC reported on July 8, 2017 at 05:12 Patient 7 reported on July 8, 2017 at 15:33, QC reported on July 8, 2017 at 05:12 Patient 8 reported on July 8, 2017 at 18:38, QC reported on July 8, 2017 at 05:12 Patient 9 reported on July 9, 2017 at 21:47, QC reported on July 9, 2017 at 05:35 Patient 10 reported on July 12, 2017 at 04:43, QC reported on July 12, 2017 at 06:24 and 09:10 Patient 11 reported on July 12, 2017 at 19:49, QC reported on July 12, 2017 at 06:24 and 09:10 Patient 12 reported on July 13, 2017 at 23:30, QC reported on July 13, 2017 at 05:39 Patient 13 reported on July 15, 2017 at 12:52, QC reported on July 15, 2017 at 04:07 Patient 14 reported on July 16, 2017 at 08:09, QC reported on July 16, 2017 at 12:11 Patient 15 reported on July 17, 2017 at 22:56, QC reported on July 17, 2017 at 04:54 Patient 16 reported on July 18, 2017 at 02:51, QC reported on July 18, 2017 at 05:51 Patient 17 reported on July 18, 2017 at 16:08, QC reported on July 18, 2017 at 05:51 Patient 18 reported on July 20, 2017 at 19:18, QC reported on July 20, 2017 at 05:26 Patient 19 reported on July 21, 2017 at 22:04, QC reported on July 21, 2017 at 05:26 Patient 20 reported on July 21, 2017 at 22:56, QC reported on July 21, 2017 at 05:26 Patient 21 reported on July 22, 2017 at 20:00, QC reported on July 22, 2017 at 04:13 Patient 22 reported on July 22, 2017 at 19:33, QC reported on July 22, 2017 at 04:13 Patient 23 reported on July 24, 2017 at 17:36, QC reported on July 24, 2017 at 05:34 and 06:57 Patient 24 reported on July 26, 2017 at 16:10, QC reported on July 26, 2017 at 06:56 Patient 25 reported on July 28, 2017 at 14:23, QC reported on July 28, 2017 at 05:40 Patient 26 reported on July 28, 2017 at 14:43, QC reported on July 28, 2017 at 05:40 Patient 27 reported on July 29, 2017 at 14:31, QC reported on July 29, 2017 at 05:51 Patient 28 reported on July 29, 2017 at 21:00, QC reported on July 29, 2017 at 05:51 Patient 29 reported on July 29, 2017 at 22:12, QC reported on July 29, 2017 at 05:51 Patient 30 reported on July 31, 2017 at 02:34, QC reported on July 31, 2017 at 02:34 Patient 31 reported on June 3, 2018 at 22:24, QC reported on June 3, 2018 at 04:09 Patient 32 reported on June 7, 2018 at 23:40, QC reported on June 7, 2018 at 03:33 Patient 33 reported on June 1, 2018 at 14:00, QC reported on June 1, 2018 at 04:05 Patient 34 reported on June 3, 2018 at 13:37, QC reported on June 3, 2018 at 04:09 Patient 35 reported on June 3, 2018 at 13:36, QC reported on June 3, 2018 at 04:09 Patient 36 reported on June 4, 2018 at 00:18, QC reported on June 4, 2018 at 03:45 Patient 37 reported on June 4, 2018 at 17:58, QC reported on June 4, 2018 at 03:45 Patient 38 reported on June 6, 2018 at 22:01, QC reported on June 6, 2018 at 03:31 Patient 39 reported on June 8, 2018 at 19:37, QC reported on June 8, 2018 at 03:31 Patient 40 reported on June 8, 2018 at 19:36, QC reported on June 8, 2018 at 03:31 Patient 41 reported on June 10, 2018 at 23:26, QC reported on June 10, 2018 at 03:44 Patient 42 reported on June 14, 2018 at 23:06, QC reported on June 14, 2018 at 03:57 Patient 43 reported on June 15, 2018 at 22:58, QC reported on June 15, 2018 at 04:07 Patient 44 reported on June 19, 2018 at 20:46, QC reported on June 19, 2018 at 03:39 Patient 45 reported on June 26, 2018 at 20:22, QC reported on June 26, 2018 at 04:03 Patient 46 reported on June 26, 2018 at 21:51, QC reported on June 26, 2018 at 04:03 Patient 47 reported on June 29, 2018 at 19:58, QC reported on June 29, 2018 at 07:09 7. Review of the laboratory's Task 1 and 3 forms revealed the laboratory performs three hundred eighty nine (389) D-dimer tests annually. -- 6 of 12 -- D5783