Power County Hospital District

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: Based on a review of the Centers for Medicare and Medicaid Services (CMS) 209 personnel form, laboratory procedures, training and competency assessment records and an interview with the laboratory manager on 9/12/2024, the laboratory failed to follow written policies and procedures to assess testing personnel competency in 2023 and 2024. The findings include: 1. The CMS 209 identified 11 testing personnel (TP) performing moderate complexity and high testing of which six (6) were new since the last inspection on 10/18/2022. 2. A review of laboratory procedures identified that the laboratory established policies and procedures to assess TP initial training, semiannual and annual competency. 3. A review of training and competency assessment records identified that the laboratory failed to have six month competency assessments for three (3) TP performing i-STAT testing in 2023. 4. A review of training and competency assessment records identified that the laboratory failed to have annual competency assessments for three (3) TP performing i-STAT testing in 2024. 5. An interview with the laboratory manager on 9/12/2024 at 10:25 am confirmed the above findings. 6. The laboratory reports performing 24 i-STAT tests annually. 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. 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 laboratory maintenance logs and an interview with the laboratory manager on 9/12/2024, the laboratory failed to perform maintenance as required by their instrument manufacturers in 2023 and 2024. The findings include: 1. A review of the laboratory maintenance logs identified that the laboratory failed to have documentation of daily maintenance for the Sysmex CA 600 and the Dimension EXL200 as required by the manufacturers. The laboratory failed to document Turning the Power OFF and on, Check/Replace Distilled Water, Check/Empty Waste Container, Check/Discard Pneumatic Trap Chamber Fluid, Check & Replenish Reaction Tubes, Empty/Clean Reaction Tube Trash Box, Load CA Clean II in Rinse Position, Run "Rinse Probe",Load Fresh CA Clean I in Rinse Position, Run "Rinse Probe",Wipe Sample Probe with Alcohol Swab and Check Temperatures daily on the Sysmex CA 600 daily in 2023 and 2024. The laboratory failed to document performing the daily system check on the Dimension EXL200 in 2023 and 2024 2. A review of the laboratory maintenance logs identified that the laboratory failed to have documentation of monthly maintenance for the bioMrieux Vidas 3 and the Dimension EXL200 as required by the manufacturers. The laboratory failed to clean the SPR block on the bioMrieux Vidas 3 in 2024. The laboratory failed to clean the R1 drain and clean the clot check drain on the IMT port on the Dimension EXL200 in 2023 and 2024. 3. A review of the laboratory maintenance logs identified that the laboratory failed to have documentation of semi annual maintenance for the bioMrieux Vidas 3 as required by the manufacturer. The laboratory failed to clean the housing, front cover, vials, tubes, disposables rack, reagent strip sections and touch screen in 2023 and 2024. 4. An interview with the laboratory manager on 9/12/2024 at 11:40 am confirmed that the above findings. 5. The laboratory reports performing 57,698 tests annually. 6. This is a repeat deficiency from the previous inspection on 3/10/2021. 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: Based on a review of instrument manuals, a lack of maintenance logs and an interview with the laboratory manager on 9/12/2024, the laboratory failed to perform function checks as required by the Abbott i-STAT 1 manufacturer. The findings include: 1. A review of the Abbott i-STAT 1 user manual identified that the electronic stimulator is to be performed daily to verify the performance of the analyzer. 2. A lack of maintenance logs for the Abbott i-STAT 1 identified that the laboratory failed to perform the required performance verification using the electronic simulator in 2023 and 2024. 3. An interview with the laboratory manager on 9/12/2024 at 2:44 pm confirmed the above finding. 4. The laboratory reports performing 24 tests annually on the Abbott i-STAT 1. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) -- 2 of 4 -- 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 calibration records, linearities, instrument documents for the Biomerieux Vidas 3 and i-STAT 1 and an interview with the laboratory manager on 9 /12/2024, the laboratory failed to verify the reportable range at least once every six months for procalcitonin and blood gas analytes in 2023 and 2024. The findings include: 1. A review of calibration records, linearities and documents for the Biomerieux Vidas 3 identified that the laboratory failed to perform verifications of the reportable range for the analyte procalcitonin at least every six months in 2023 and 2024. 2. A review of instrument documents and a lack of linearities for the i-STAT 1 identified that the laboratory failed to perform verifications of the reportable range for the blood gas analytes pH, PO2, PCO2, TCO2, HCO3, SO2 and lactate at least every six months in 2023 and 2024. 3. An interview with the laboratory manager on 9/12 /2024 at 3:10 pm confirmed that the laboratory had not verified the reportable range of procalcitonin and blood gas analytes at least once every six months in 2023 and 2024. 4. The laboratory reports performing 17 procalcitonin tests and 24 blood gas tests annually. D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(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-- At least once a day patient specimens are assayed or examined perform the following for-- Each quantitative procedure, include two control materials of different concentrations; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a lack of Quality Control (QC) records and an interview with the laboratory manager on 9/12/2024, the laboratory failed to successfully perform two levels of QC each day of use on the Abbot i-STAT 1. The findings include: 1. A lack of QC documents for the Abbot i-STAT 1 for 2023 and 2024 identified that the laboratory -- 3 of 4 -- failed to perform at least two levels of QC for each analyte everyday of testing in 2023 and 2024. 2. An interview with the laboratory manager on 9/12/2024 at 2:44 pm confirmed the above finding. 3. The laboratory reports performing 24 i-STAT tests annually. D5555 IMMUNOHEMATOLOGY CFR(s): 493.1271(c)(f) (c) Blood and blood products storage. Blood and Blood products must be stored under appropriate conditions that include an adequate temperature alarm system that is regularly inspected. (c)(1) An audible alarm system must monitor proper blood and blood product storage temperature over a 24-hour period. (c)(2) Inspections of the alarm system must be documented. (f) Documentation. The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on a review of temperature logs and an interview with the laboratory manager on 9/12/2024, the laboratory failed to perform alarm checks on the immunohematology refrigerator in 2024. The findings include: 1. A review of laboratory temperature logs identified that the laboratory failed to perform alarm checks on the immunohematology refrigerator used to store blood units for emergency release in 2024. 2. An interview with the laboratory manager on 9/12/2024 at 1:24 pm confirmed the above finding. 3. This a repeat deficiency from previous inspections on 10/22/2018 and 3/102021. -- 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 Centers for Medicare and Medicaid (CMS) proficiency testing (PT) data report (Report 155D), graded results from the American Proficiency Institute (API) and an interview with the laboratory manager on 10/18/2022, the laboratory failed to successfully participate and achieve an overall satisfactory score for two (2) of three (3) testing events in 2022 for the subspecialty of toxicology. See D2118 D2118 TOXICOLOGY CFR(s): 493.845(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 3 -- 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 Centers for Medicare and Medicaid (CMS) Proficiency Testing (PT) data report (Report 155D), graded PT results from the American Proficiency Institute (API) and an interview with the laboratory manager on 10/18 /2022, the laboratory failed to achieve satisfactory performance for two (2) consecutive PT events for the analyte phenytoin. The findings include: 1. A review of Report 155D and graded PT results from API identified that the laboratory failed to achieve satisfactory performance for events one (1) in 2022 and two (2) in 2022 for the subspecialty of toxicology for the analyte phenytoin. Analyte Year Event Score Phenytoin 2022 1 0% Phenytoin 2022 2 0% 2. An interview with the laboratory manager on 10/18/2022 at 3:40 pm confirmed the above findings. 3. The laboratory reports performing 4 phenytoin tests annually. 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 record review of Sysmex CA 620 coagulation quality control (QC) documentation, patient results, and an interview with the laboratory manager on 10/18 /2022, the laboratory failed to include two levels of QC material every eight hours of patient testing. The findings include: 1. A random record review of prothrombin time (PT) and partial thromboplastin time (PTT) QC identified that the laboratory failed to document two levels of QC every eight hours when patient testing occurred one day in January 2022, one day in March 2022 and one day in April 2022. 2. A review of the laboratory's patient results identified one patient PTT reported on 1/30/2022, four patient PT/INR's and one PTT reported on 3/7/2022 and one patient PT/INR reported on 4/16/2022 without two levels of QC. 3. An interview with the laboratory manager on 10/18/2022 at 12:03 pm confirmed the above findings. 4. The laboratory reports performing 120 PT/INR and 80 PTT tests annually. D6013 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(ii) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(3) Ensure that-- (e)(3)(ii) Verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method; -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on a record review of the Sysmex CA620 instrument verification, the Alcor miniiSED instrument verification and an interview with the laboratory manager on 10 /18/2022, the laboratory director failed to ensure that the instrument verifications were adequate before patient tests were reported. The findings include: 1. A record review of verifications for prothrombin time (PT) and partial thromboplastin time (PTT), performed on the Sysmex CA620, identified that the laboratory director failed to review and approve the verification results to ensure that they were adequate before beginning patient testing in June of 2021. 2. A record review of verifications for sedimentation rates, performed on the Alcor miniiSED, identified that the laboratory director failed to review and approve the verification results to ensure that they were adequate before beginning patient testing in June of 2022. 3. Interviews with the laboratory manager on 10/18/2022 at 12:16 pm and 1:56 pm confirmed the above findings. 4. The laboratory reports performing 120 PT, 80 PTT and 171 sedimentation rate tests annually. -- 3 of 3 --

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 Proficiency Testing (PT) desk review of the Centers for Medicare and Medicaid (CMS) PT data report (Report 155D), graded results from the American Association of Bioanalysts (AAB) and a telephone interview with the laboratory manger on 3/9/2022, the laboratory failed to successfully participate and achieve an overall satisfactory score for two (2) of three (3) consecutive testing events in 2021 for the subspecialty of routine chemistry for the analyte creatinine. See 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 Proficiency Testing (PT) desk review of the Centers for Medicare and Medicaid (CMS) PT data report (Report 155D), graded PT results from the American Association of Bioanalysts (AAB) and an interview with the laboratory manager on 3 /9/2022, the laboratory failed to successfully participate and achieve an overall satisfactory score for two (2) of three (3) consecutive testing events in 2021 for the subspecialty of routine chemistry. The findings include: 1. A PT desk review of Report 155D and graded PT results from AAB identified that the laboratory failed to achieve satisfactory scores for the subspecialty of routine chemistry for the analyte creatinine. Analyte Year Event Score Creatinine 2021 2 60% Creatinine 2021 3 0% 2. A telephone interview with the laboratory manager on 3/9/2022 at 9:48 am confirmed the above findings. -- 2 of 2 --

Summary Statement of Deficiencies 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 a random review of the maintenance log, laboratory policies and procedures and an interview with the laboratory manager on 3/10/2021, the laboratory failed to perform and document maintenance with the frequency defined by the manufacturer. The findings include: 1. A random review of the laboratory maintenance log identified the laboratory failed to perform and document maintenance as required by instrument manufacturers and laboratory policies and procedures. Microscope cleaning not documented on weeks 1 and 2 of September 2020 Siemens Dimension weekly maintenance: Clean HM probe not documented on week 1 of September and weeks 1 and 2 of December 2020 Clean R2 reagent probe not documented on week 1 of September and weeks 1 and 2 of December 2020 Siemens Dimension monthly maintenance: Clean R2 drain not documented in September and December of 2020 Stylet HM wash probes not documented in September and December of 2020 Siemens CA 500 monthly maintenance: Clean rinse bottle not documented in September and December of 2020 Replace reagent bottles not documented in September and December of 2020 Clinifuge cleaning not documented weeks 1 and 2 of December 2020 Serofuge 200 cleaning not documented weeks 1 and 2 of December 2020 2. An interview with the laboratory manager on 3/10/2021 at 11:55 am confirmed that the laboratory is not document maintenance as required by instrument manufacturers and laboratory policies and procedures. 3. The laboratory reports performing 62,325 tests annually. D5477 CONTROL PROCEDURES 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 -- 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 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: Based on a record review and an interview with the laboratory manager on 3/10/2021, the laboratory failed to check each lot of media for its ability to support growth and/or inhibit growth. The findings include: 1. A review of media invoices that came with media received from Portneuf Medical Center identified that the laboratory failed to perform and document quality control (QC) to show the ability of the media to support growth on MacConkey Agar lot number 225065 (Remel), Columbia CNA w /5% Sheep Blood Agar lot number 231732 (Remel), Blood Agar, 5% Sheep Blood Agar lot number 225037 (Remel) and Chocolate Agar lot number 222041 (Remel). 2. A review of media invoices that came with media received from Portneuf Medical Center identified that the laboratory failed to perform and document QC to show the ability of the media to inhibit growth of gram positive organisms on MacConkey Agar lot number 225065 (Remel), 3. An interview with the laboratory manager on 3/10 /2021 at 4:40 pm confirmed that the laboratory failed to perform and document QC on media since discontinuing the performance of gram stains in June 2020. 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 a review of the laboratory maintenance log, policies and procedure and an interview with the laboratory manager on 3/10/2021, the laboratory failed to document inspection of the audible alarm system for the blood product storage refrigerator. The findings include: 1. A random review of maintenance logs from 2019 and 2020 identified that the laboratory failed to document inspection of the audible alarm for the blood product storage refrigerator monthly as required by laboratory policy in September 2020 and December of 2020. 2. An interview with the laboratory manager on 3/10/2021 at 12:00 pm confirmed that the laboratory failed to document inspection of the audible alarm system for the blood product storage refrigerator monthly. 3. This is a repeat deficiency from the 10/22/2018 survey. -- 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 proficiency testing (PT) record reviews and an interview with the laboratory manager, the laboratory director failed to sign the attestation statements from the American Association of Bioanalysts (AAB) for the specialty of Hematology, Chemistry, Immunology, Endocrinology, Toxicology, and Bacteriology since March 31, 2017. Findings: 1. An AAB PT record review from 2017 and 2018 revealed the laboratory director failed to sign the attestation statements for the specialty of Hematology, Chemistry, Immunology, Endocrinology, Toxicology, and Bacteriology. 2. An interview on October 22, 2018 at 9:40 AM, with the laboratory manager, confirmed the laboratory director failed to sign the attestation statements from AAB and failed to delegate the responsibility of signing the attestation forms to the technical supervisor. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on a records review and an interview with the laboratory manager, the Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- laboratory failed to retain instrument print-outs for patient test results, normal patient Prothrombin time mean and external quality control tests Sysmex CA-500 coagulation analyzer and the Beckman Coulter Act Diff 5 analyzer since the last survey on March 31, 2017. Findings: 1. A review of patient records and instrument data print-outs from the coagulation analyzer revealed the laboratory failed to retain instrument data print- outs for patient test results, normal patient Prothrombin time mean, and quality control test, as well as failed to retain quality control data for the hematology analyzer. 2. An interview on October 22, 2018 at 12:30 PM, with the laboratory manager, confirmed the laboratory failed to retain all patient and quality control data print-outs from the analyzers. 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 a record review of personnel documents and the procedure manual, and an interview with the laboratory manager, the laboratory failed to follow the written policy to evaluate the competency of testing personnel performing tests on patient's specimens in the specialties of Hematology, Chemistry, Immunology, Endocrinology, Bacteriology, Toxicology, and microscopic examinations since the last survey on March 31, 2017. Findings: 1. A review of competency assessment documents for the testing personnel revealed the laboratory manager failed to have documented competency evaluations for testing performed on patient's specimen since the last survey. 2. An interview on October 22, 2018 at 9:30 AM, with the laboratory manager, confirmed the laboratory manager failed to follow written policy to assess the competency for the tests performed in the laboratory. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on a proficiency testing (PT) record review and an interview with the laboratory manager, the laboratory failed to document the evaluation and review of unacceptable PT results for gram stains from the American Association of Bioanalysts (AAB) since the last survey on March 31, 2017. Findings: 1. A review of bacteriology PT results from AAB 2017 event 2 through 2018 event 2, revealed the laboratory failed to document the evaluation and