Thedacare Medical Center Wild Rose

Summary Statement of Deficiencies 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: Item One: Based on surveyor review of procedures and competence evaluation records and interview with the General Supervisor, the laboratory did not follow their policies and procedures for documentation of competence evaluations for four of six testing personnel. Findings include: 1. Review of the 'Lab Orientation, Training, and Competency Policy' showed competency "must be assessed at least annually" for non- waived testing personnel. 2. Review of testing personnel 'Competency Assessment' logs from 2023 showed four of six testing personnel did not complete competence assessment for all test systems identified on the list as current test systems in the laboratory. The form includes boxes to confirm use of each of the six elements in the evaluation and spaces for the evaluator to date and initial when the test system evaluation was completed. The forms showed the six elements for the following test systems (as identified on the forms) were not documented, and the items listed were not dated or initialed as completed. Staff A: Post Vasectomy / Wet Prep / Gram Staining - Sputum for Acceptability / Triage Staff B: ABL 80 / Post Vasectomy Staff C: Manual Cell Counts - WBC, Platelet / Fluids - General, CSF, Differentials / Gram Staining - Sputum for Acceptability Staff D: EPOC The forms for Staff D showed evaluation of the six required elements for only one of the thirty-two tests evaluated. 3. Interview with the General Supervisor on May 21, 2024, at 11:00 AM confirmed testing personnel did not ensure completion of competence evaluations for all tests and confirmed personnel evaluating competence did not complete documentation as required in 2023. Item two: Based on surveyor review of the Centers for Medicare and Medicaid Services (CMS) Form CMS-209, procedures, and records, and interview Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 8 -- with the General Supervisor, the laboratory did not document competency assessment in the last year for five of five testing personnel that functioned as technical consultants and / or technical supervisors. Findings include: 1. Review of the Form CMS-209 submitted for this survey showed five testing personnel (Staff A, B, D, E, and F) who also functioned as technical consultants and / or technical supervisors. 2. The 'Competency Assessment for Leaders Fulfilling CLIA Roles (i.e., Technical Supervisors, Technical Consultants, and General Supervisors)' procedure stated, "Leaders fulfilling a CLIA defined role as technical supervisor, technical consultant, or general supervisor and performing competency assessment for testing personnel are to be competency assessed annually as part of the annual performance review process for leaders. This competency assessment for leaders performing competency assessment for testing personnel will be completed by their manager/director and documented within Workday as competent (yes/no)." 3. Review of competence records showed no evidence of evaluation of the performance of the technical consultant and technical supervisor responsibilities by the five identified testing personnel. 4. Interview with the General Supervisor on May 22, 2024, at 11:00 AM confirmed the laboratory did not evaluate the competence of the five testing personnel in meeting the additional responsibilities of technical consultant and / or technical supervisor in the past year. 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 surveyor review of the manufacturer's instructions and laboratory procedures, observation in the laboratory, and interview with the General Supervisor, the laboratory did not follow the manufacturer's instructions for one of four Gram stain reagents. Findings include: 1. Review of the manufacturer's instructions for Remel Gram Iodine reagent showed the reagent required reconstitution prior to use and the instructions directed, "Use Gram Iodine within 3 months after reconstitution." 2. Review of the "Gram Stain Procedure" showed no requirement for use of the stain within 3 months of reconstitution. The effective date of the procedure was May 6, 2022. 3. Observation of the four Gram stain reagents in the laboratory on May 22, 2024, at 2:00 PM revealed the Gram Iodine reagent in use was lot 134761, expiration date April 26, 2025. 4. Interview with the General Supervisor on May 22, 2024, at 2: 15 PM confirmed the laboratory was not following the manufacturer's instructions for the reduced expiration date of the Gram Iodine reagent after reconstitution. 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. -- 2 of 8 -- This STANDARD is not met as evidenced by: Based on surveyor observation in the laboratory and interview with the General Supervisor, the laboratory did not label the reconstituted Gram Iodine reagent with the three-month reconstituted expiration date. Findings include: 1. Observation of the current gram stain reagents in the laboratory on May 22, 2024, at 2:00 PM revealed the Gram Iodine reagent in use was lot 134761, expiration date April 26, 2025. The three-month reconstituted expiration date was not evident on the bottle. 2. Interview with the General Supervisor on May 22, 2024, at 2:15 PM confirmed personnel had not labeled the Gram Iodine bottle with the expiration date to reflect the three-month expiration after reconstitution of the reagent. 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: Item One: Based on surveyor review of laboratory procedures and records, and interview with the General Supervisor, the laboratory did not perform function checks on two of two centrifuges used for coagulation sample preparation every six months to ensure the use of platelet poor plasma for coagulation testing in 2022, 2023, and 2024. Findings include: 1. The 'Platelet Poor Plasma' procedure stated, "Centrifuges used for coagulation specimens need to be validated semi-annually". The procedure section required personnel to test five samples per centrifuge every six months. 2. Review of laboratory records showed testing personnel completed the function checks for two centrifuges, StatSpin 3 and StatSpin 4, on the following dates. StatSpin 3: June 14, 2022 February 17, 2023 September 20, 2023 April 28, 2024 StatSpin 4: March 11, 2023 September 20, 2023 April 28, 2024 3. Interview with the General Supervisor on May 21, 2024, at 1:05 PM confirmed the validation was due for StatSpin 3 in December 2022, August 2023, and March 2024, and the validation was due for StatSpin 4 in March 2024. Further interview confirmed the laboratory did not complete the platelet poor plasma validation procedures as required in 2022, 2023, and 2024. This is a repeat deficiency cited at D6175 on June 30, 2022. Item Two: Based on surveyor review of maintenance records and interview with the General Supervisor, the laboratory did not document the required MAGNEHELIC Gauge Reading for the Biological Safety Cabinet for twenty-two of the last twenty-two months. Findings include: 1. Review of the 'Microbiology Quality Control and Maintenance Log' from July 2022 to April 2024 showed one of the monthly maintenance requirements was documentation of the reading of the MAGNEHELIC Gauge. Review of the logs showed testing personnel did not record the MAGNEHELIC Gauge reading on any of the logs. 2. Interview with the General Supervisor on May 22, 2024, at 11:15 AM confirmed testing personnel did not document the MAGNEHELIC Gauge function check in the last twenty two months. D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) Unless otherwise specified in this subpart, for each applicable test system the -- 3 of 8 -- laboratory must perform and document calibration procedures-- (1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (2)(i) Using calibration materials appropriate for the test system and, if possible, traceable to a reference method or reference material of known value; and (2)(ii) Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and (3) Whenever calibration verification fails to meet the laboratory's acceptable limits for calibration verification. This STANDARD is not met as evidenced by: Based on surveyor review of procedures and records and interview with the General Supervisor, the laboratory did not perform two of the last four calibrations of the fibrinogen test on the ACL TOP analyzer every six months as required by the laboratory procedures. Findings include: 1. Review of the calibration section of the 'Fibrinogen - ACL TOP' procedure showed the procedure required a new reference curve every six months. 2. Review of calibration records for the ACL TOP showed the laboratory performed fibrinogen calibrations on April 13, 2022, February 2, 2023, June 29, 2023, and May 13, 2024. 3. Interview with the General Supervisor on May 22, 2023, at 1:05 PM confirmed fibrinogen calibrations were due in October 2022 and December 2023. Further interview confirmed the laboratory did not meet the six- month calibration requirement for the fibrinogen test. This is a repeat deficiency previously cited on November 4, 2020. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on surveyor review of laboratory records and interview with the General Supervisor, the laboratory did not perform calibration verification on the ABL80 Flex CO-OX every six months as required. The laboratory did not perform one of two -- 4 of 8 -- verifications due in 2023. Findings include: 1. Review of the calibration verification records for the ABL80 Flex CO-OX analyzer showed testing personnel performed calibration verification testing on April 17, 2023, and on April 20, 2024. No other records were available for calibration verification in 2023 or 2024. 2. Interview with the General Supervisor on May 22, 2024, at 11:36 AM confirmed the laboratory did not complete the calibration verification for the ABL80 Flex CO-OX analyzer that was due in November 2023. D5481 CONTROL PROCEDURES CFR(s): 493.1256(f)(g) (f) Results of control materials must meet the laboratory's and, as applicable, the manufacturer's test system criteria for acceptability before reporting patient test results. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on surveyor review of blood bank quality control records and manufacturer's product insert and interview with the General Supervisor, testing personnel did not identify that the control results for Anti-D testing did not match the manufacturer's criteria for acceptability on three of three days in May 2024. Findings include: 1. Review of Quality Control (QC) worksheets completed on May 4, 5, and 6, 2024 showed personnel recorded the Anti-D result as 4+ for QC samples 1 - 4. The worksheets showed no evidence testing personnel did not accept the results. 2. Review of the QC manufacturer's product insert showed the expected result for Anti-D with QC sample 1 was negative, the expected result for QC samples 2, 3, and 4 was positive. 3. Interview with the General Supervisor on May 22, 2024, at 12:30 PM confirmed the results for Anti-D testing with QC sample 1 did not meet the manufacturer's criteria for acceptability and confirmed testing personnel did not identify the QC was not acceptable. 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 surveyor review of laboratory records and interview with the General Supervisor, the laboratory did not perform inspections or verify proper functioning of the audible alarm system on two of two blood storage units in the last two years. Findings include: 1. Review of laboratory transfusion services records showed no evidence of inspections of the alarm system for the blood bank refrigerator or freezer. 2. Interview with the General Supervisor on May 22, 2024, at 3:30 PM confirmed procedures required the alarm system inspections and verifications quarterly and confirmed testing personnel had not completed the inspections and verification of the alarms in the last two years. -- 5 of 8 -- D5781

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: Based on surveyor observation of the chemistry freezer, review of the manufacturer's requirements and chemistry freezer temperature log, and interview with the general supervisor, the laboratory did not define an acceptable temperature range that was consistent with the manufacturer's acceptable range for the Bio-Rad chemistry quality control material stored in the freezer. Findings include: 1. Review of the manufacturer's package requirements for the Bio-Rad chemistry quality control showed the manufacturer's required storage at -20 to -70 Celsius (C). 2. Observation of BioRad chemistry quality control in the chemistry freezer on June 30, 2022 at 10: 13 AM showed the manufacturer required storage at -20 to -70 Celsius (C). 3. Review of the temperature logs for 2021 showed the defined acceptable temperature range for the chemistry freezer was -18 to -25 C. Forty-eight of three hundred sixty-five days showed recorded temperatures were warmer than -20 C. 4. Interview with the general supervisor on June 30, 2022 at 10:25 AM confirmed the laboratory's acceptable range for the chemistry freezer was not consistent with the manufacturer's acceptable range for the Bio-Rad chemistry quality control material stored. This is a repeat deficiency from April 30, 2014. D5429 MAINTENANCE AND FUNCTION CHECKS Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory 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: Item 1: Based on surveyor review of maintenance logs for the Hematek 3000 slide stainer and interview with the general supervisor, the laboratory did not document routine weekly maintenance for three of fifty-two weeks in 2021. Findings include: 1. Review of "Hematek 3000 Slide Stainer Maintenance" log showed weekly cleaning of the drain troughs is required. Further review showed the laboratory did not document the weekly maintenance for three of fifty-two weeks in 2021. 2. Interview with the general supervisor on Jun 29, 2022 at 1:52 PM confirmed the laboratory did not document routine weekly maintenance on the Hematek 3000 slide stainer for three of fifty-two weeks in 2021. Item 2: Based on surveyor review of maintenance logs for the BioFire Film Array stainer and interview with the general supervisor, the laboratory did not document routine weekly maintenance for three of thirty-nine weeks between April 2021 and February 2022. Findings include: 1. Review of "BioFire FilmArray Preventative Maintenance Record" showed weekly cleaning and restart of the analyzer is required. Further review showed the laboratory did not document the weekly maintenance for three of thirty-nine weeks between April 2021 and February 2022. 2. Interview with the general supervisor on Jun 29, 2022 at 2:05 PM confirmed the laboratory did not document routine weekly maintenance on the BioFire FilmArray for three of thirty-nine weeks between April 2021 and February 2022. This is a repeat deficiency from November 4, 2020. D6175 TESTING PERSONNEL RESPONSIBILITIES CFR(s): 493.1495(b)(1) Each individual performing high complexity testing must follow the laboratory's procedures for specimen handling and processing, test analyses, reporting and maintaining records of patient test results. This STANDARD is not met as evidenced by: Item 1: Based on surveyor review of laboratory procedures and blood bank temperature logs and interview with the general supervisor, testing personnel did not follow the procedure to perform and document temperature checks for the Grifols gel card incubator for 635 of 635 days between October 6, 2020 and June 29, 2022. Findings include: 1. Review of the "Blood Bank Quality Assurance" procedure revealed "heating blocks must have temperature checks performed every day". Further review revealed testing personnel must "record on the temp log". 2. Review of the "Blood Bank Daily Checks" log showed a blood bank dry block range of 36-38 Celsius (C). Further review showed no documentation on the log for the blood bank dry block temperature. 3. Interview with the general supervisor on June 29, 2022 at 11: 55 AM confirmed testing personnel did not follow the procedure to perform and document temperature checks for the Grifols gel card incubator for 635 of 635 days between October 6, 2020 and June 29, 2022. Item 2 Based on surveyor review of patient records, blood bank temperature logs and laboratory procedures and interview with the general supervisor, testing personnel did not follow the procedure to perform and document temperature checks on the water bath used to thaw fresh frozen plasma -- 2 of 3 -- for transfusion for one of one patients. Findings include: 1. Review of transfusion records showed patient 1 received thawed fresh frozen plasma on October 27, 2021. 2. Review of temperature logs in the laboratory showed no log in place to track the temperature of the water bath used to thaw fresh frozen plasma. 3. Review of the "Blood Bank Quality Assurance" procedure revealed "water baths must have temperature checks performed every day". Further review revealed testing personnel must "record in the temperature log". 4. Interview with the general supervisor on June 30, 2022 at 2:38 PM confirmed testing personnel did not follow the procedure to perform and document temperature checks on the water bath used to thaw fresh frozen plasma for transfusion for one of one patients. Item 3: Based on surveyor review of laboratory procedures and centrifuge logs and interview with the general supervisor, testing personnel did not follow the procedure to perform platelet-poor plasma checks on the StatSpin Express centrifuges every six months as required for one of two checks in 2021. Findings include: 1. Review of the "Platelet Poor Plasma" procedure revealed "five samples per centrifuge are required to be tested every six months". 2. Review of the "Centrifuge Checks" log showed the platelet-poor plasma checks were performed on May 15, 2021 and June 14, 2022. Further review showed no documentation of additional platelet-poor plasma checks due November 2021. 3. Interview with the general supervisor on June 30, 2022 at 1:48 PM confirmed testing personnel did not follow the procedure to perform platelet-poor plasma checks on the StatSpin Express centrifuges every six month as required for one of two checks in 2021. -- 3 of 3 --

Summary Statement of Deficiencies 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 surveyor review of quality assurance records and interview with the laboratory manager, the laboratory did not perform twice-annual accuracy verification in 2019 and 2020 for the Potassium Hydroxide (KOH) test for dermatology samples. Findings include: 1. Review of quality assurance records showed no evidence the laboratory performed accuracy verification for KOH testing of dermatology samples in 2019 or 2020. 2. Interview with the laboratory manager, staff A, on November 4, 2020 at 9:30 AM confirmed the laboratory did not complete twice-annual accuracy verification of the KOH test for dermatology samples in 2019 or 2020. This is a repeat deficiency previously cited on May 21, 2008 and June 28, 2012. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory 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 surveyor review of maintenance logs for the Hematek 3000 stainer and interview with the laboratory manager, the laboratory did not document routine weekly cleaning and pump tubing replacement as required in 2019 and 2020. Findings include: 1. Review of the October 2019 through October 2020 Hematek 3000 stainer 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 -- maintenance logs showed weekly cleaning of the drain troughs is required. The logs show the laboratory documented this cleaning daily from January 1 through January 9 and January 11, 2020; the laboratory did not document any other weekly cleaning. The logs also showed the following maintenance was required: After three stain packs have been used - replace pump tubing, and after ten stain packs have been used, replace underplaten tubing. Review of the logs from July 2019 through October 2020 showed the laboratory did not document replacement of the tubing. 2. Interview with the laboratory manager, staff A, on November 3, 2020 at 2:15 PM confirmed the laboratory did not document the required cleaning and maintenance for the Hematek 3000 stainer. D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (2)(i) Using calibration materials appropriate for the test system and, if possible, traceable to a reference method or reference material of known value; and (2)(ii) Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and (3) Whenever calibration verification fails to meet the laboratory's acceptable limits for calibration verification. This STANDARD is not met as evidenced by: Based on surveyor review of laboratory records and procedures, and interview with the laboratory manager, the laboratory did not calibrate the fibrinogen test every six months in 2019 and 2020 as required by their procedures. Findings include: 1. Review of calibration records for the ACL Top coagulation analyzer show the laboratory calibrated the fibrinogen test on January 19, 2019 and February 19, 2020. 2. Review of the laboratory procedure, "Fibrinogen - ACL Top", COAG 201, showed the calibration section of the procedure required calibration every six months. 3. Interview with the laboratory manager, staff A, on November 4, 2020 at 10:30 AM confirmed the laboratory did not calibrate the fibrinogen assay every six months in 2019 and 2020 as required. -- 2 of 2 --

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on surveyor review of proficiency testing (PT) records and interview with the technical consultant, the laboratory's testing personnel have not signed six of six attestation statements for three chemistry and three hematology PT events for 2017. Findings include: 1. Review of chemistry PT records from 2017 show that testing personnel did not sign the attestation statement for the first, second, and third events in 2017. Review of hematology PT records from 2017 show that testing personnel did not sign the attestation statement for the first, second, and third events in 2017. 2. Interview with the technical consultant on August 8, 2018 at 12:45 PM confirmed that the laboratory's testing personnel did not sign the attestation statement for any of the chemistry or hematology PT events in 2017. 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 surveyor observation of blood collection supplies and interview with the technical consultant, the laboratory had an expired blood culture collection tube 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 -- available for use in the patient drawing area. Findings include: 1. Observation of blood collection tubes in the patient drawing area on August 8, 2018 at 9:15 AM revealed that one of one PF Plus BacT/ALERT anaerobic blood culture tubes had expired June 10, 2018. 2. Interview with technical consultant on August 8, 2018 at 9: 15 AM confirmed that one of one anaerobic blood culture tubes expired in June 2018 and was available for use in the patient drawing area. -- 2 of 2 --