Braxton County Memorial Hospital

Summary Statement of Deficiencies D0000 A routine recertification survey was conducted at Braxton County Memorial Hospital, March 26 through March 27, 2024. The laboratory was assessed for compliance with the Federal Clinical Laboratory Improvement Amendments (CLIA) regulations under 42 CFR 493. Specific deficiencies cited are explained below. D2087 ROUTINE CHEMISTRY CFR(s): 493.841(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on record review and interview the laboratory failed to achieve a satisfactory score for analytes #0325 PO2 Blood Gas and #0335 PCO2 Blood Gas in the 2nd American Proficiency Institute (API) routine chemistry testing event of 2023. Findings: 1. Review of API proficiency testing (PT) records revealed the following scores for 2023 2nd event: 60% PO2 Blood Gas 60% PCO2 Blood Gas 2. An interview with the testing personnel, 3/26/24 at 10:00 AM, confirmed the findings. 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: Review of policies and procedures (P&P), lack of documentation, and interview the laboratory failed to assess the competency of testing personnel (TP) for DAT 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 -- Immunohematology testing in 2023. Findings: 1. Review of P&P revealed a process for assessing TP competency for all test methodologies at prescribed intervals. 2. No documentation of the competency assessment for DAT testing in Immunohematology for 8 of 8 Immunohematology TP could be located. 3. An interview with the general supervisor, 3/26/24 at 9:30 AM, confirmed no competency assessment for DAT had been performed for the 8 TP involved with Immunohematology testing in 2023. 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 observation, lack of documentation, and interview the laboratory failed to establish and monitor the environmental conditions required for the storage of the GEM Premier 5000 blood gas analyzer reagent packs. Findings: 1. A tour of the storage area for the reagent packs, 3/27/24 at 12:30 PM, identified no established environmental conditions. 2. GEM Premier 5000 reagent packs were observed to have a storage temperature range of 15-25 degrees Celsius on the boxes. No documentation of the monitoring of the storage temperature for the reagent packs could be located for 2023. 3. An interview with the testing personnel, 3/27/24 at 12:30 PM, confirmed no environmental monitoring of the storage area occurred. 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 observation, record review, and interview the laboratory failed to ensure the calibration results for 2 of 10 analytes met the acceptability criteria before reporting patient results from the Alinity chemistry analyzer. Findings: 1. During a tour of the laboratory, 3/27/24 at 10:00 AM, the Alinity chemistry analyzer was observed as having current calibrations for analytes direct dilirubin (Bili D) and total bilirubin (Bili Total). 2. Review of reagent management logs for Chemistry identified reagent lot 24909FD01 put into use on the analyzer 11/8/23. 3. Review of the analyzer -- 2 of 3 -- programmed calibration data identified the following calibration factors for lot 24909FD01 expiry 12/31/24: Bili D 0.84 cal 1, 7.86 cal 2 Bili Total 1.42 cal 1, 14.53 cal 2 4. Review of the product insert for lot 24909FD01 identified the following calibration factors: Bili D 0.78 cal 1, 8.5 cal 2 Bili Total 1.30 cal 1, 15.47 cal 2 5. An interview with the technical consultant, 3/27/24 at 10:15 AM, confirmed the calibration factors programmed on the analyzer were not the correct calibration factors for the lot of reagent in use for Bili D and Bili Total testing. D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. (c) The laboratory must document all test result comparison activities. This STANDARD is not met as evidenced by: Based on policies and procedures (P&P), record review, and interview the laboratory failed to have established criteria for the evaluation of the comparisons of test results between the two Alinity chemistry analyzers, two hematology analyzers (Coulter DxH 600 and AcT diff), two GEM Premier 5000 blood gas analyzers, and the two methodologies used in Immunohematology testing (Echo and manual tube testing). Findings: 1. Review of P&P identified a "Semiannual Correlation of Instruments" stating: a. "The DxH and AcT analyzers are compared twice a year. Anytime a comparison does not match, the samples are reviewed and the study is repeated with fresh or additional samples." No specific acceptability criteria for the evaluation of the comparison between the results of the DxH and AcT analyzers could be located. b. "The lab will semi-annually compare between the two Alinity analyzers. Anytime a comparison does not match, the samples are reviewed and the study is repeated with fresh or additional samples." No specific acceptability criteria for the evaluation of the comparison of the Alinity results could be located. c. No process for the performance and evaluation of comparison between the Echo automated method and the manual tube testing utilized in Immunohematology testing could be located. d. No process for the performance and evaluation of comparison between the two GEM Premier 5000 blood gas analyzers could be located. 2. Review of 2022 and 2023 records revealed comparisons were being performed between the hematology, chemistry, and blood gas analyzers and between the Immunohematology testing methods. No evaluation of the results could be located. 3. An exit interview with the technical consultant, 3/27/24 at 4:45 PM, confirmed the findings. -- 3 of 3 --

Summary Statement of Deficiencies D0000 An unannounced, off site, proficiency testing (PT) desk review was conducted for Braxton County Memorial Hospital on April 2, 2023, by the West Virginia Office of Laboratory Services. The laboratory PT evaluations with the American Proficiency Institute (API) were reviewed for compliance with the Federal Clinical Laboratory Improvement Amendment (CLIA) regulations under 42 CFR 493. Specific deficiencies are explained below. D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on record review, the laboratory failed to successfully participate in proficiency testing (PT) for the analyte #0895 Compatibility Testing (immunohematology) for 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 -- two consecutive American Proficiency Institute (API) testing events in 2022 and 2023. Findings: 1. Review of CASPER 155D Individual Laboratory Profile Report identified the following consecutive, unsatisfactory scores for analyte #0895 Compatibility Testing (immunohematology): 80% event 3 2022 80% event 1 2023 2. Review of PT evaluation reports from API for the 3rd event of 2022 and the 1st event of 2023 confirmed the unsuccessful participation for analyte #0895 Compatibility Testing (Immunohematology). D2181 COMPATIBILITY TESTING CFR(s): 493.863(e) Failure to achieve an overall testing event score of satisfactory for two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to perform successfully in proficiency testing (PT) for the analyte #0895 Compatibility Testing (Immunohematology) for two consecutive American Proficiency Institute (API) testing events in 2022 and 2023. Findings: 1. Review of CASPER 155D Individual Laboratory Profile Report identified the following unsatisfactory scores for analyte #0895 Compatibility Testing (Immunohematology): 80% event 3 2022 80% event 1 2023 2. Review of PT evaluation reports from API for the 3rd event of 2022 and the 1st event of 2023 confirmed the two consecutive unsatisfactory performance scores for analyte #0895 Compatibility Testing (Immunohematology). 3. An interview with the clinical laboratory director, on 5/2/23 at approximately 1:40 PM, confirmed the cumulative unsuccessful performance for analyte #0845 Compatibility Testing (Immunohematology). -- 2 of 2 --

Summary Statement of Deficiencies D0000 A routine, on site, recertification survey was conducted at Braxton County Memorial Hospital on March 15 and March 16, 2022. The laboratory was assessed for compliance with the Federal Clinical Laboratory Improvement Amendment (CLIA) regulations under 42 CFR 493. Specific deficiencies are explained below. D2173 COMPATIBILITY TESTING CFR(s): 493.863(a) Failure to attain an overall testing event score of at least 100 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on record review and interview the laboratory failed to achieve a satisfactory performance score for Compatibility Testing in 1 of 3 Immunohematology proficiency testing events of 2021. Findings: 1. Review of American Proficiency Institute (API) PT records revealed an unsatisfactory performance of 80% for the analyte #0895 Compatibility Testing in the 3rd PT event of 2021. 2. An interview with the general supervisor, on 3/15/22 at approximately 11:00 AM, confirmed the findings. 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: Based on review of written policies and procedures (P&P), lack of documentation , Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- and interview the facility failed to: 1) Define the specific criteria parameters to be observed and monitored to identify a possible transfusion reaction in 2 of 2 P&P reviewed 2) Establish a uniform process for the laboratory to perform the investigation of transfusion reactions in 2 of 2 P&P reviewed Findings: 1) A. Review of facility P&P "Blood Administration" revealed a chart containing a column for vital signs to be monitored for each blood or blood product administered, referring to "Blood Administration Step #18" for RBCs, RBCs frozen and washed, WBCs, Plateletpheresis, FFP, and Platelets. "Blood Administration Step #18" states the required time intervals for monitoring the BP and Temperature of the recipient. No definition of the criteria for abnormal vital signs or specific changes in temperature or blood pressure that could identify a possible transfusion reaction could be located. B. Review of the facility "Transfusion Reaction Report" worksheet contains an area to document the recipient Temperature, BP, and Pulse. No definition of the criteria for abnormal vital signs or specific changes in temperature, blood pressure, or pulse that could identify a possible transfusion reaction could be located. 2) A. Review of laboratory P&P "Transfusion Reaction Investigation" and the "Transfusion Reaction Report" worksheet identified discrepancies in the step by step procedures regarding the specific tests that must be completed, the timeframe to complete the transfusion reaction investigation testing, and the documentation of the testing. i. P&P Step 4 instructs to check centrifuged samples for hemolysis and icterus. The worksheet has no area to document the presence or absence of icterus. ii. P&P Step 5 instructs to perform pre- and post- transfusion DATs using both gel and tube methods. The worksheet has no area to document the results of the gel DAT testing. iii. P&P Step 6 instructs to perform Bacteriologic Testing on the blood bag or segments if the bag is not available. The worksheet has no instructions for when to perform Bacteriologic testing in the process. iv. P&P states that a ABO/Rh, crossmatch, and antibody screen on the pre- and post- transfusion specimens (Steps 7 thru 10) are performed if "there is hemolysis, DAT is positive, or a transfusion reaction other than an allergic reaction is suspected." The worksheet states that the ABO/Rh, crossmatch, and antibody screen (Steps 4-6) be performed on a routine basis if there is no hemolysis, DAT is negative, and the suspected transfusion reaction is other than an allergic reaction. An interview with the general supervisor, 3/15/22 at approximately 11:35 AM, confirmed all the findings. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on record review, lack of documentation, policies and procedures (P&P), and interview the laboratory failed to document the competency assessment concerning the secondary Immunohematology testing method for 7 of 7 testing personnel (TP) in 2020 and 8 of 8 TP in 2021. Findings: 1. Review of 2020 TP competency assessment documents revealed no evaluation of the secondary tube test methodology for Immunohematology for all 7 TP. 2. Review of 2021 TP competency assessment documents revealed no evaluation of the secondary tube test methodology for Immunohematology for all 8 TP. 3. Review of P&P identified a procedure for the tube -- 2 of 5 -- testing method for Immunohematology. 4. An interview with the general supervisor, on 3/15/22 at approximately 8:40 AM, confirmed the lack of documentation for all TP competency with the tube testing method in 2020 and 2021. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

Summary Statement of Deficiencies D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on a review of the written laboratory policies and procedures, laboratory quality assessment (QA) records, and an interview with technical supervisor 1 (TS1), the laboratory failed to establish a written policy or procedure for Quality Assessment (QA) of the general laboratory systems. Findings: 1. No written policy or procedure for QA of the general laboratory systems could be located. This includes the monitoring and assessment of confidentiality, specimen identification and integrity, complaint investigations, communications, personnel competency, and proficiency testing evaluation. 2. A review of laboratory 2018 and 2019 QA records identified the laboratory is performing QA monitoring of general laboratory systems documented on monthly and quarterly QA forms. 3. An interview with TS1, on 12/12/19 at approximately 12:45 PM, confirmed there is no written policy or procedure for the QA of general laboratory systems. D5391 PREANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1249(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the preanalytic systems specified at 493.1241 through 493.1242. 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 -- This STANDARD is not met as evidenced by: Based on a review of the written laboratory policies and procedures, laboratory quality assessment (QA) records, and an interview with technical supervisor 1 (TS1), the laboratory failed to establish a written policy or procedure for the quality assessment (QA) of the preanalytic systems. Findings: 1. No written policy or procedure could be located for QA of the preanalytic system, which includes the following: test request and specimen submission, handling, and referral. 2. A review of QA records for 2018 and 2019 identified the laboratory is performing QA monitoring of the preanalytic systems documented on monthly and quarterly QA forms. 3. An interview with TS1, on 12/12/19 at approximately 12:45 PM, confirmed there is no written policy or procedure for the QA of the preanalytic system. 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 a tour of the laboratory, a review of laboratory temperature and humidity documentation logs, and an interview with technical supervisor 1 (TS1), the laboratory failed to monitor and document the (2) temperature and (3) humidity for reliable test system operation and proper storage of reagents utilizing a NIST certified calibrated thermometer and hydrometer. Findings: 1. A review of the temperature and humidity log for the laboratory identifies acceptable temperature and humidity ranges for the laboratory and provides a form for the documentation of the daily temperature and humidity monitoring. a. Humidity 75 to 85 percent b. Room Temperature 0 to 75 degrees Fahrenheit 2. A review of the laboratory temperature and humidity logs showed the daily documentation of laboratory temperature and humidity conditions. The temperature range established for the laboratory environment was identified as 0 to 75 degrees Fahrenheit. The lower end of the monitored ,acceptable temperature range should not exceed the requirements for storage temperatures of reagents. The laboratory reagent storage area contained Microscan GI Panel Film Array (storage reference range 15 to 25 degrees Celcius), MicroScan Blood Culture ID Panel (storage reference range 2 to 25 degrees Celcius), and Beckman Coulter DXH reagent (storage reference range 2 to 40 degrees Celcius). 3. An examination of the thermometer/hydrometer revealed the laboratory was utilizing a SP (SN#51096858) thermometer/hydrometer and the NIST certified calibration had expired 5/2/2017. No documentation of a current calibration or traceability validation could be located. 4. An interview with TS1, on 12/12/19 at approximately 1:00 PM, confirmed the findings. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems -- 2 of 4 -- identified in the analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on a review of the written laboratory policies and procedures, laboratory quality assessment (QA) records, and an interview with technical supervisor 1 (TS1), the laboratory failed to establish a written policy or procedure for Quality Assessment (QA) of the analytic systems. Findings: 1. No written policy or procedure could be located for QA of the analytic systems, which includes the following: procedure manual, test systems/equipment/supplies, establishment and verification of performance specifications, maintenance and function checks, calibration and calibration verification procedures, control procedures, comparison of test results,

Summary Statement of Deficiencies 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 review of the laboratory's policy and procedure manual, Instrumentation Laboratories ACL 1000 reagent and quality control (QC) records, and interview with Technical Supervisor #1(TS1), the laboratory failed to periodically verify the International Normalized Ratio (INR) calculation for 2 of 2 lot changes of HemosIL PT-Fibrinogen Reagent. Record review was for 2016 and 2017. The findings include: 1. Review of the laboratory's policy and procedure manual identified a lack of a policy outlining the procedure for periodically verifying the INR calculation. 2. Review of the Instrumentation Laboratories ACL 1000 reagent and quality control (QC) records identified no documentation of the laboratory periodically verifying the INR calculation when the laboratory changed the lot of HemosIL PT-Fibrinogen Reagent on 8/15/16 and 7/3/17. 3. On 1/9/18 at approximately 3:00 PM, TS1 confirmed that the laboratory has never periodically verified the INR calculation. D5477 CONTROL PROCEDURES CFR(s): 493.1256(e)(4)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (4) Before, or concurrent with the initial use-- (e)(4)(i) Check each batch of media for sterility if sterility is required for testing; (e)(4)(ii) Check each batch of media for its ability to support growth and, as appropriate, select or inhibit specific organisms or produce a biochemical response; and (e)(4)(iii) Document the physical characteristics 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 -- of the media when compromised and report any deterioration in the media to the manufacturer. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: A. Based on review of the laboratory's policy and procedure manuals and interview with Technical Supervisor #1(TS1), the laboratory failed to check each lot number and shipment of Bac T/Alert BPA Bottles for sterility and ability to support growth from January 2016 to current. The findings include: 1. Review of the laboratory's policy and procedure manual identified a policy, "Media Quality Control", which stated "1. Record the lot number, expiration date, received date and initial of tech unpacking on the Microbiology Media Record for each medium type; 2. Remove package label from one package of each lot received and attach to Microbiology Media Record for each medium type; 3. Notify the microbiology tech of receipt of chocolate (or any nonexempt as defined by CLSI) media so growth properties can proceed ASAP. Procedure for microbiology tech: For chocolate agar (or any nonexempt medias as defined by CLSI) verify acceptable growth properties as follows: Growth properties-Inoculate one plate with the control organisms listed on the Chocolate Agar Media Growth Support Record...." 2. Review of the laboratory's policy and procedure manual identified no quality control plan for the Bac T/Alert BPA bottles. 3. Review of the laboratory's quality control records identified a lack of documentation demonstrating the laboratory checked each lot number and shipment of BacT/Alert BPA (platelet) Bottles for sterility and ability to support growth from January 2016 to current. 4. On 1/9/18 at approximately 2:00 PM, TS1 stated that they were keeping the certificates and not checking for sterility or the ability to support growth and they did not have an IQCP plan that included the BacT/Alert BPA bottles. B. Based on review of the laboratory's policy and procedure manuals and interview with Technical Supervisor #1(TS1), the laboratory failed to check each lot number and shipment of BBL Fluid Thioglycolate Medium for sterility and ability to support growth for 1 of 1 shipments in 2017. The findings include: 1. Review of the laboratory's policy and procedure manual identified a policy, "Media Quality Control", which stated "1. Record the lot number, expiration date, received date and initial of tech unpacking on the Microbiology Media Record for each medium type; 2. Remove package label from one package of each lot received and attach to Microbiology Media Record for each medium type; 3. Notify the microbiology tech of receipt of chocolate (or any nonexempt as defined by CLSI) media so growth properties can proceed ASAP. Procedure for microbiology tech: For chocolate agar (or any nonexempt medias as defined by CLSI) verify acceptable growth properties as follows: Growth properties-Inoculate one plate with the control organisms listed on the Chocolate Agar Media Growth Support Record...." 2. Review of the laboratory's policy and procedure manual identified no quality control plan for the Thioglycolate broth. 3. Review of the laboratory's quality control records identified a lack of documentation demonstrating the laboratory checked the 3/7/17 shipment of BBL Fluid Thioglycolate Medium for sterility and ability to support growth. 4. On 1/9/18 at approximately 2:00 PM, TS1 stated that they were keeping the certificates and not checking for sterility or the ability to support growth and they did not have an IQCP plan that included the BBL Fluid Thioglycolate Medium. C. Based on review of the laboratory's policy and procedure manuals and interview with Technical Supervisor #1 (TS1), the laboratory failed to check each lot number and shipment of MacConkey II Agar for sterility and ability to support growth for 20 of 20 shipments in 2016 and 19 of 19 shipments in 2017. The findings include: 1. Review of the laboratory's policy and procedure manual identified a policy, "Media Quality Control", which stated "1. Record the lot number, expiration date, received date and initial of tech unpacking on -- 2 of 4 -- the Microbiology Media Record for each medium type; 2. Remove package label from one package of each lot received and attach to Microbiology Media Record for each medium type; 3. Notify the microbiology tech of receipt of chocolate (or any nonexempt as defined by CLSI) media so growth properties can proceed ASAP. Procedure for microbiology tech: For chocolate agar (or any nonexempt medias as defined by CLSI) verify acceptable growth properties as follows: Growth properties- Inoculate one plate with the control organisms listed on the Chocolate Agar Media Growth Support Record...." 2. Review of the laboratory's policy and procedure manual identified no quality control plan for the MacConkey II Agar. 3. Review of the laboratory's quality control records identified a lack of documentation demonstrating the laboratory checked the 1/8/16, 1/26/16, 2/9/16, 2/24/16, 3/23/16, 4/8/16, 4/22/16 (2 lot numbers in shipment), 5/17/16, 6/7/16(2 lot numbers in shipment), 6/21/16, 7/8 /16, 7/22/16, 8/12/16, 8/30/16, 9/16/16, 9/27/16, 10/21/16, 11/8/16, 12/6/16, and 12/23 /16 shipments of MacConkey II Agar for sterility and ability to support growth. 4. Review of the laboratory's quality control records identified a lack of documentation demonstrating the laboratory checked the 1/13/17, 2/3/17, 2/21/17, 3/10/17, 4/4/17, 4 /21/17, 5/2/17, 5/16/17, 6/2/17, 6/27/17, 6/30/17, 7/11/17, 8/1/17, 9/22/17, 10/10/17, 10/31/17, 11/14/17, 11/28/17, and 12/26/17 shipments of MacConkey II Agar for sterility and ability to support growth. 5. On 1/9/18 at approximately 2:00 PM, TS1 stated that they were not checking for sterility or the ability to support growth and they did not have an IQCP plan that included the MacConkey II Agar. D. Based on review of the laboratory's policy and procedure manuals and interview with Technical Supervisor #1(TS1), the laboratory failed to check each lot number and shipment of PEA media for sterility and ability to support growth for 15 of 15 shipments in 2016 and 9 of 9 shipments in 2017. The findings include: 1. Review of the laboratory's policy and procedure manual identified a policy, "Media Quality Control", which stated "1. Record the lot number, expiration date, received date and initial of tech unpacking on the Microbiology Media Record for each medium type; 2. Remove package label from one package of each lot received and attach to Microbiology Media Record for each medium type; 3. Notify the microbiology tech of receipt of chocolate (or any nonexempt as defined by CLSI) media so growth properties can proceed ASAP. Procedure for microbiology tech: For chocolate agar (or any nonexempt medias as defined by CLSI) verify acceptable growth properties as follows: Growth properties-Inoculate one plate with the control organisms listed on the Chocolate Agar Media Growth Support Record...." 2. Review of the laboratory's policy and procedure manual identified no quality control plan for the PEA media. 3. Review of the laboratory's quality control records identified a lack of documentation demonstrating the laboratory checked the 1/8/16, 2/9/16, 3/9/16, 3/25/16, 4/15/16, 4/22 /16, 5/17/16, 6/7/16, 6/21/16, 7/22/16, 8/16/16, 8/19/16, 10/21/16, 11/29/16, and 12/30 /16 shipments of PEA media for sterility and ability to support growth. 4. Review of the laboratory's quality control records identified a lack of documentation demonstrating the laboratory checked the 1/24/17, 3/24/17, 4/28/17, 6/2/17(2 lot numbers in shipment), 7/7/17, 8/1/17, 8/29/17, 10/3/17, 10/31/17, and 11/28/17 shipments of PEA media for sterility and ability to support growth. 5. On 1/9/18 at approximately 2:00 PM, TS1 stated that they were not checking for sterility or the ability to support growth and they did not have an IQCP plan that included the PEA media. E. Based on review of the laboratory's policy and procedure manuals and interview with Technical Supervisor #1(TS1), the laboratory failed to check each lot number and shipment of TSA II 5% Sheep Blood Agar media for sterility and ability to support growth for 30 of 30 shipments in 2016 and 28 of 28 shipments in 2017. The findings include: 1. Review of the laboratory's policy and procedure manual identified a policy, "Media Quality Control", which stated "1. Record the lot number, expiration date, received date and initial of tech unpacking on the Microbiology Media Record -- 3 of 4 -- for each medium type; 2. Remove package label from one package of each lot received and attach to Microbiology Media Record for each medium type; 3. Notify the microbiology tech of receipt of chocolate (or any nonexempt as defined by CLSI) media so growth properties can proceed ASAP. Procedure for microbiology tech: For chocolate agar (or any nonexempt medias as defined by CLSI) verify acceptable growth properties as follows: Growth properties-Inoculate one plate with the control organisms listed on the Chocolate Agar Media Growth Support Record...." 2. Review of the laboratory's policy and procedure manual identified no quality control plan for the TSA II 5% Sheep Blood Agar. 3. Review of the laboratory's quality control records identified a lack of documentation demonstrating the laboratory checked the 1 /8/16, 1/26/16, 1/29/16, 2/9/16, 2/22/16, 3/15/16(2 lot numbers in shipment), 3/25/16, 4/8/16, 4/15/16, 4/22/16, 4/29/16, 5/10/16(3 lot numbers in shipment), 5/27/16, 6/21 /16, 7/1/16(2 lot numbers in shipment), 7/12/16(2 lot numbers in shipment),7/22/16(2 lot numbers in shipment), 8/5/16, 8/12/16, 8/30/16(2 lot numbers in shipment), 9/9/16, 9/20/16(2 lot numbers in shipment), 9/27/16, 10/4/16, 10/7/16(2 lot numbers in shipment), 11/8/16, 11/29/16(2 lot numbers in shipment), 12/9/16, 12/13/16, and 12/23 /16(3 lot numbers in shipment)shipments of TSA II 5% Sheep Blood Agar for sterility and ability to support growth. 4. Review of the laboratory's quality control records identified a lack of documentation demonstrating the laboratory checked the 1/6/17, 1 /13/17, 1/24/17, 2/3/17, 2/21/17, 3/3/17, 3/14/17, 3/24/17, 4/4/17, 4/21/17, 5/4/17, 5/12 /17, 5/23/17, 6/2/17(2 lot numbers in shipment), 6/20/17(2 lot numbers in shipment), 7 /7/17, 8/1/17, 8/22/17, 9/15/17, 9/22/17, 10/3/17, 10/10/17(3 lot numbers in shipment), 10/31/17, 11/10/17, 11/21/17, 11/28/17, 12/13/17 and 12/26/17 shipments of TSA II 5% Sheep Blood Agar for sterility and ability to support growth. 5. On 1/9 /18 at approximately 2:00 PM, TS1 stated that they were not checking for sterility or the ability to support growth and they did not have an IQCP plan that included the TSA II 5% Sheep Blood Agar. -- 4 of 4 --