Washington County Hospital

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the national database and verified with the laboratory's proficiency testing provider, American Proficiency Institute (API). The laboratory was found to be out of compliance with CONDITION LEVEL DEFICIENCIES, as follows: D2016 - 42 C.F.R. 493.803 Condition: Successful participation [proficiency testing] D6000 - 42 C.F.R. 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director . 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 proficiency testing (PT) desk reviews of the CASPER Reports 0153D and 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 -- 0155D (Individual Laboratory Profiles from the Centers of Medicare and Medicaid Services [CMS]), and PT evaluation reports from the American Proficiency Institute (API), the laboratory failed to successfully participate (achieve scores of 100%) in proficiency testing for Compatibility Testing, an analyte in the specialty of Immunohematology. The laboratory failed two out of three PT events in 2024-2025, resulting in initial unsuccessful proficiency testing performance. Refer to D2181. . D2181 COMPATIBILITY TESTING CFR(s): 493.863(e) (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 proficiency testing (PT) desk reviews of the CASPER Reports 0153D and 0155D (Individual Laboratory Profiles from the Centers of Medicare and Medicaid Services [CMS]), and PT evaluation reports from the American Proficiency Institute (API), the laboratory failed to successfully participate (achieve scores of 100%) in proficiency testing for Compatibility Testing. The laboratory failed two out of three PT events in 2024-2025, resulting in initial unsuccessful proficiency testing performance. The findings include: 1. A review of the CASPER Reports revealed the laboratory received failing scores for Compatibility Testing in two out of three API PT events, as follows: A) 2024 Immunology / Immunohematology Event #2: 80 % B) 2025 Immunology / Immunohematology Event #1: 80 % 2. A review of the laboratory's proficiency testing evaluation reports from API confirmed these findings. . D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on proficiency testing (PT) desk reviews of the CASPER Reports 0153D and 0155D (Individual Laboratory Profiles from the Centers of Medicare and Medicaid Services [CMS]), and proficiency testing evaluation reports from the American Proficiency Institute (API), the laboratory director failed to ensure successful participation in an HHS approved proficiency testing program. Refer to D6089. . D6089 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(i) (e)(4)(i) The proficiency testing samples are tested as required under subpart H of this part; This STANDARD is not met as evidenced by: Based on proficiency testing (PT) desk reviews of the CASPER Reports 0153D and -- 2 of 3 -- 0155D (Individual Laboratory Profiles from the Centers of Medicare and Medicaid Services [CMS]), and PT evaluation reports from the American Proficiency Institute (API), the laboratory director failed to ensure the laboratory had successful participation in an HHS approved proficiency testing program for Compatibility Testing in two out of three 2024-2025 API PT events. Refer to D2181. -- 3 of 3 --

Summary Statement of Deficiencies D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) (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: (b)(1) Water quality. (b)(2) Temperature. (b)(3) Humidity. (b)(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 review of the 2024 Room Temperature (RT) and Humidity Charts, and an interview with the Testing Personnel 1 (TP1), the laboratory failed to ensure RT and Humidity were recorded each day of patient testing. The surveyor noted no RT and Humidity were recorded for 3 out of the 30 days in September 2024. The findings include: 1) A review of the RT and Humidity Chart revealed the laboratory failed to monitor and record the RT and Humidity of the laboratory from 09-24-2024 thru 09- 26-2024 when patient testing was performed. 2. A further review of the RT and Humidity Chart indicated the following specified ranges: A) RT of 18-30 degrees Celsius B) Humidity of 5-40 Percent 3) During Day 2 exit conference on 04-09-2025 at 3:30 PM, TP1 confirmed the above findings. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) (c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (c)(1) Identity and when significant, titer, strength or concentration. (c)(2) Storage 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 -- requirements. (c)(3) Preparation and expiration dates. (c)(4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on observations during the laboratory tour, reviews of the package inserts for the Coulter 6C Plus Cell Hematology Controls, Triage test cartridges, and an interview with the Testing Personnel 1 (TP1), the laboratory staff failed to: (1) write the new expiration dates on the three levels of the Hematology Quality Control (QC) vials currently in use; and (2) record the new expiration for Triage D-Dimer and Cardiac Panel cartridges when transferred from the refrigerator to room temperature for patient testing. The findings include: 1. During the laboratory tour on 04-08-2025 at approximately 8:59 AM the surveyor observed the three levels of Hematology Controls in use had "04/06" on the vials, however there was no indication of when the Controls expired upon opening. 2. As the laboratory tour continued, the surveyor observed room temperature Cardiac/D-Dimer test cartridge pouches with "04/06/25", the date when the packages were removed from the refrigerator. The testing personnel failed to record the new expiration date for test cartridges stored at room temperature. 3. A review of package inserts for the Coulter 6C Plus Cell Hematology Controls, and the Triage D-Dimer/Cardiac Panel test cartridges revealed the following: A) Hematology Controls - stability for 16 open vial days B) Triage Test Cartridges: Storage and Handling Requirements, "Once removed from refrigeration, the pouched Test Device is stable up to 14 days at room temperature..." 3. TP1 confirmed the above findings during Day 1 exit conference on 04-08-2025 at 4:30 PM. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) (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 direct observations during the laboratory tour, a review of the Blood Bank (BB) Quality Control (QC) records, and an interview with the Testing Personnel 1 (TP1), the surveyor determined the laboratory had utilized reagents/materials after expiration dates for patient testing. The expired dates were noted on the reagent bottles to the current date of the survey on 04-08-2025. The surveyor determined three of the four laboratory specialties had utilized expired reagents/materials from 2023- 2025. The findings include: 1. During the Chemistry laboratory tour with TP1 at approximately 8:37 AM, the surveyor observed the Vitros CKMB2 calibrators, Levels 1,2,3, Lot 0120 with an Expiration date of 03-20-2025. No open date was written on the vials. Calibrators were utilized from the expiration date of 03-20-2025 to the date of the survey, 04-08-2025. 2. During the Hematology laboratory tour with TP1 at approximately 8:59 AM, the surveyor observed the Epredia Resolve Immersion Oil, Lot 114622 with an Expiration date of 12/2023. No open date was written on the bottle. 3. A review of the BB QC records revealed the following materials had expired on 04-21-2023 but were utilized to run controls and one patient testing on 04-28-2025. A) Screen Cells I Lot 198690 B) Screen Cells II Lot 298690 C) Screen Cells III Lot 398690 D) Check Cells Lot 07447 4. TP1 confirmed the above findings during Day 2 exit conference on 04-09-2025 at 3:30 PM. -- 2 of 4 -- D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) (a)(1) 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 a review of the Hematology and Coagulation maintenance records, a review of the manufacturers' maintenance logs, and an interview with the Testing Personnel 1 (TP1), the laboratory failed to perform and document weekly, monthly, and quarterly maintenance for two analyzers. The surveyor noted no documentation of the weekly maintenance for the Beckman Coulter DxH 690T, and no documentation of the monthly and quarterly maintenance for the Stago Satellite from 2023-2025. The findings include: 1. A review of the 2023-2025 Hematology Beckman Coulter DxH 690T records revealed no documentation of weekly maintenance. 2. A review of the 2023-2025 Coagulation Stago Satellite logs revealed no documentation of monthly or quarterly maintenance 3. During an interview on 04-09-2025 at 1210 PM, TP1 stated TP had refused to follow Laboratory Policies and Procedures even after disciplinary enforcements. D6013 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(ii) (e)(3)(ii) Verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method; and This STANDARD is not met as evidenced by: Based on a lack the Quidel Triage Cardiac Panel installation and validation records, and an interview with the Testing Personnel 1 (TP1), the surveyor determined the Laboratory Director failed to document review and approval of the initial verification procedures for Troponin and CKMB before patient testing began. The surveyor noted no documentation was available for review from the last survey, 1-12-2023, to the current survey, 04-08-2025. The findings include: 1. A review of the Quidel Triage records revealed no documentation of installation and validation studies were performed before starting Troponin and CKMB patient testing on the Triage as an alternate analyzer when the Vitros XT 7600 was not operational. 2. An interview with TP1 revealed Quidel Triage Troponin and CKMB patient testing began May 2021 but were not reported on the CMS 116 form from the last survey of 1-12-2023. 3. TP1 confirmed the above findings during Day 2 exit conference on 04-09-2025 at 3:30 PM. D6120 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(7)(8) (b)(7) Identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed; (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. -- 3 of 4 -- This STANDARD is not met as evidenced by: Based on a review of personnel competency records and an interview with Testing Personnel 1 (TP1), the Technical Consultant/Technical Supervisor (TC/TS), failed to assess and document the annual competency of individuals responsible for moderate and high complexity testing. This was noted on ten out of ten Testing Personnel (TP) from the date of the last survey, 1-12-2023 to the date of the current survey, 04-09- 2025. The findings include: 1. A review of personnel records listed on the CMS 209 (Laboratory Personnel Report- CLIA) revealed the TC/TS failed to perform and document the annual competency assessments for all ten Testing Personnel from 2023- 2025. Personnel records revealed TP1 had performed and signed the competency assessments. 2. During Day 1 exit conference on 04-08-2025 at 4:30 PM, the TP1 confirmed the above findings. -- 4 of 4 --

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on a review of the CMS (Centers for Medicare and Medicaid Services) CASPER report and API (American Proficiency Institute) proficiency testing evaluations, the laboratory failed to successfully participate in proficiency testing for Total Bilirubin (Chemistry), for two of three consecutive testing events, Event #2, 2022 and Event #1, 2023. These failures result in initial unsuccessful participation. The findings include. Refer to D2096. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a review of the CMS (Centers for Medicare and Medicaid Services) CASPER report and API (American Proficiency Institute) proficiency testing (PT) evaluations, the laboratory failed to satisfactorily perform in PT for Total Bilirubin (Chemistry), for two of three consecutive testing events, Event #2, 2022 and Event #1, 2023. The findings include. 1. A review of the CMS CASPER report revealed the laboratory scored the following: a) Event #2, 2022 Total Bilirubin = 20 % b) Event #1, 2023 Total Bilirubin = 60 % 2. A review of the API PT evaluations confirmed the above noted findings. -- 2 of 2 --

Summary Statement of Deficiencies 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 a review of the Ortho Diagnostics Vitros XT 7600 Chemistry Calibration Verification records, a review of the Audit MicroControls Vitamin D Linearity package insert, and an interview with Testing Personnel #1, the laboratory failed to perform and document calibration verification procedures at least once every six months as specified by CLIA requirements. The surveyor noted the laboratory failed to perform and document one out of two Vitamin D calibration verifications due in 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 -- 2022 on the Vitros XT 7600 chemistry analyzer. The findings include: 1. A review of Chemistry records for the Ortho Diagnostics Vitros XT 7600 revealed the laboratory performed Vitamin D calibration verifications on 10/27/2021 and 11/17/2022. There was no documentation of calibration verification on Vitamin D performed the first half of 2022. 2. A review of the Audit MicroControls Vitamin D Linearity package insert revealed the following under "Procedure", "...Calibration verification linearity material should be run every six months..." 3. During an interview on 1/11/2023 at 12: 50 PM, Testing Personnel #1 confirmed the above findings. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(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-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of quality control (QC)/patient test records, a review of the IQCP (Individualized Quality Control Plan) documents, and an interview with Testing Personnel #1, the laboratory failed to ensure two levels of controls were run each day of patient testing or at the interval specified by the laboratory's IQCP for D-Dimer, C. diff (Clostridium difficile), and Serum hCG. This was noted 27 times from January 2022 - December 2022. The findings include: 1. A review of IQCP documents, QC and patient records revealed the following: (I) Serum hCG (Human Chorionic Gonadotropin) 1) A review if the IQCP revealed QC should be performed every 30 days and with each new lot or shipment. 2) A review of the quality control/patient test records revealed the last QC was performed on 9/6/2022, however, patient tests were performed on 10/13/2022, 10/14/2022, 10/21/2022, and 12/4/2022. There was no documentation of QC in October or December 2022. (II) C. diff 1) A review of the IQCP revealed QC should be performed every 30 days and with each new lot or shipment. 2) A review of the quality control/patient test records revealed the following: a) QC was performed on 2/18/2022, however, patient tests were performed on 3/10/2022, 3/23/2022, 4/19/2022, and 5/20/2022. There was no documentation of QC performed in March, April or May 2022. b) QC was performed on 6/7/2022, however, patient tests were performed on 7/15/2022, 7/27/2022, 7/30/2022, 7/31 /2022, 8/9/2022, 9/7/2022, and 10/12/2022. There was no documentation of QC performed in July, August, September or October 2022. (III) D-Dimer 1) A review of the IQCP revealed D-Dimer QC should be performed every 30 days and with each new lot or shipment. 2) A review of the quality control/patient test records revealed QC was performed each month of patient testing, however, the laboratory failed to follow the IQCP as written. 2. During an interview on 1/11/2023 at 4:00 PM, Testing Personnel #1 confirmed the above findings. -- 2 of 2 --

Summary Statement of Deficiencies 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 a review of Prothrombin Time (PT) reagent validation documents for the Stago STA Satellite and an interview with the previous Laboratory Manager, the laboratory failed to include documentation of the manual check of the INR (International Normalized Ratio) calculation on the instrument when new STA Neoplastine (PT) reagent was validated for use for patient testing in November 2020. This was noted on one of one lot numbers of PT reagent in use. The findings include: 1. A review of the Stago STA Satellite Neoplastine (PT) reagent validation records for Lot number 256760 revealed the laboratory established a normal patient mean, and performed parallel patient testing in November 2020, however there was no evidence the studies included a manual check of the INR calculation on the instrument using the new reagent. 2. During an interview on 11/9/2021 at 1:30 PM, the surveyor asked if the laboratory manually checked the INR calculation as a control to ensure numerical data was correctly entered for new lot numbers of PT reagent; the Manager confirmed the lab had not, because they did not realize this was a CLIA requirement. SURVEYOR #32558 Licensure and Certification Surveyor Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

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 observations, a review of the 2016-2018 environmental logs, a review of storage requirements for the Chemistry QC (quality controls) and an interview with the Laboratory Manager (also the General Supervisor), the laboratory failed to: (1) define appropriate acceptable temperature ranges for the freezer (as defined by the manufacturer of the items therein), (2) ensure QC was stored at temperatures as specified by the manufacturer, and (3) ensure room temperature and humidity was monitored and documented in the room where Arterial Blood Gas (ABG) testing was performed in 2016 thru July 2018. The findings include: 1. A review of the September 2016 thru August 2018 temperature records for the "Big White" Refrigerator/Freezer revealed the laboratory specified an acceptable range of -10 to -20 degrees C (Celsius) on the logs. Temperatures were documented in the specified range, with temperatures generally in the range of -12 to -18 degrees C. The freezer had temperatures documented at -20 degrees C (or colder) 97 times, or approximately thirteen percent of the two year review period. 2. A review of the Blood Bank area temperature logs (where ABG's are performed on the OPTI CCA-TS analyzer) revealed no documentation of room temperature and humidity monitoring until 7/26/2018. 3. A review of the OPTI CCA-TS Operator's Manual on page 2-1 revealed, "...2.2. Choosing a Location ... Room temperature within 10-32 degrees C (Celsius) (50-90 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 -- degrees Fahrenheit) [and] Maximum relative humidity of 95% ...". 4. During an interview with the Laboratory Manager on 8/9/2018 at 1:20 PM, freezer temperatures were reviewed on the charts, and on the inside thermometer (observed to be -17 degrees C). The surveyor and the Manager then reviewed the contents of the freezer which contained approximately twenty-five boxes (six vials each) of Biorad Chemistry and Endocrinology QC. An icon on the QC package inserts specified storage requirements of -20 to -70 degrees C. 5. As the interview continued, the Laboratory Manager confirmed the freezers were not consistently maintaining temperatures in the range required for the long-term storage of the Biorad QC. The surveyor also discussed the concern of the "acceptable ranges" on the freezer logs not reflecting the manufacturer's storage requirements for the items the freezer contained, and the CLIA requirement of following Biorad's QC storage and handling instructions. When asked about documentation of room temperature and humidity in the room where ABG testing was performed, the Manager confirmed the laboratory had not monitored these parameters until July 2018. Thus, the above noted findings were substantiated. SURVEYOR:Laura T. Williams, BS, MT (ASCP) Licensure and Certification Surveyor -- 2 of 2 --