Logan Health Conrad

Summary Statement of Deficiencies D0000 Based on a remote complaint survey conducted on January 26, 2024, deficiencies were cited for Logan Health Conrad located in Conrad, MT. D5301 TEST REQUEST CFR(s): 493.1241(a) The laboratory must have a written or electronic request for patient testing from an authorized person. This STANDARD is not met as evidenced by: Based on record review, laboratory policies, and an interview with technical supervisor (TS) #1, the laboratory failed to provide a written or electronic request for patient testing from an authorized person for ten out of eleven patients tested on the GeneXpert and two out of two patients tested on the i-STAT from December 30, 2023, through January 02, 2024. Findings: 1. An interview with TS#1, February 8, 2024, at 7:42 AM, confirmed the "Lab Specimen Log For Collection 12/27/23 Thru 01 /03/24" (an electronic health report (Meditech) query which contains patients demographics, test orders and test results) "included all orders regardless of status" for patients tested from December 27, 2023, through January 03, 2024. 2. A review of GeneXpert patient data tested from December 28, 2023, to January 02, 2024 revealed ten out of eleven patients failed to be listed on the "Lab Specimen Log For Collection 12/27/23 Thru 01/03/24". 3. A review of i-STAT patient data tested from December 30, 2023, to December 31, 2023, revealed two out of two patients failed to be listed on the "Lab Specimen Log For Collection 12/27/23 Thru 01/03/24". 4. A review of "Specimen Ordering and Collection" revealed laboratory staff failed to ensure an order for the laboratory tests performed on the i-STAT and GeneXpert was provided and to enter all laboratory requests into the computer from December 30, 2023, through January 02, 2024. . D5445 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 4 -- 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 record review, laboratory policies, and an interview with technical supervisor (TS) #1, the laboratory failed to perform quality control at the frequency dictated by the policies for i-STAT Troponin I and B-Type Natriuretic Peptide cartridges used to perform patient testing on two out of two patients tested on December 30, 2023, and December 31, 2023. Findings: 1. A review of "i-STAT Troponin I (cTnI)" and "i-STAT BNP (B-Type Natriuretic Peptide)" policies revealed laboratory staff failed to follow their policies to perform and document "Two levels of external liquid controls (Level 1 and 3) to be run monthly" for two out of two patients (MD2642 and MD0326) tested on December 30, 2023, and December 31, 2023. 2. A review of QC records lacked monthly external QC (Level 1 and 3) for i-STAT CTNI and BNP cartridges for the month of December 2023. 3. An interview with TS #1 on January 26, 2024, at 1:05 PM confirmed the laboratory staff failed to perform quality control at the frequency dictated by the policies for i-STAT CTNI and BNP cartridges used to perform patient testing on December 30, 2023, and December 31, 2023. . D5537 ROUTINE CHEMISTRY CFR(s): 493.1267(b)(d) For blood gas analyses, the laboratory must perform the following: (b) Test one sample of control material each 8 hours of testing using a combination of control materials that include both low and high values on each day of testing. (d) Document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on record review, laboratory policies, i-STAT Individualized Quality Control Plans (IQCP), and an interview with technical supervisor (TS) #1, the laboratory failed to perform and document a low and high quality control (QC) for each day i- STAT CG8+ and CG4+ cartridges were used to perform patient testing on two of two patients tested on December 30, 2023, and December 31, 2023. Findings: 1. A review of "i-Stat CG8+ Cartridge (Blood Gas)" and "i-Stat CG4+ Cartridge" policies revealed laboratory staff failed to perform and document external control levels 1 and 3 "every 24 hours when running patient samples". 2. A review of QC records lacked two levels of external QC for each day i-STAT CG8+ and CG4+ cartridges were used to test two of two patients (MD2642 and MD0326) on December 30, 2023, and December 31, 2023. 3. A review of i-STAT QC records from January 13, 2023, to December 31, 2023, lacked identification of which i-STAT cartridge was used, cartridge lot number, QC lot number, date prepared, expiration date, and the actual test measurements or reaction. 4. An interview with TS #1 on January 26, 2024, at 1:05 PM confirmed the laboratory staff failed to perform quality control at the frequency dictated by the -- 2 of 4 -- policies for the i-STAT CG8+ and CG4+ cartridges used to perform patient testing on December 30, 2023, and December 31, 2023. . D6115 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(2) The technical supervisor is responsible for verification of the test procedures performed and establishment of the laboratory's test performance characteristics, including the precision and accuracy of each test and test system. This STANDARD is not met as evidenced by: Based on review of the i-STAT verification records, and an interview with technical supervisor (TS) #1, the technical supervisor failed to verify the performance of CG8+, the precision of CG4+, and the reference intervals (normal values) for the laboratory's patient population for analytes: Glucose, Sodium, Potassium, Ionized Calcium, Hemoglobin, Hematocrit, pH, PO2, PCO2, TCO2, HCO3, Base Excess, O2 saturation, Lactate, cardiac troponin I and B-type Natriuretic Peptide performed on the i-STAT prior to approval by the laboratory director from September 28, 2023, to January 26, 2024 Findings: 1. A review of the i-STAT CG4+ precision study lacked more than two days of data to assess the repeatability of day-to-day and run-to-run variance prior to starting patient testing. 2. The technical supervisor failed verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population for analytes tested on the i-STAT: Glucose, Sodium, Potassium, Ionized Calcium, Hemoglobin, Hematocrit, pH, PO2, PCO2, TCO2, HCO3, Base Excess, O2 saturation, Lactate, cardiac troponin I and B-type Natriuretic Peptide. 3. The technical supervisor failed to verify the performance specifications of the i-STAT CG8+ cartridge. 4. Interview with TS #1 on January 26, 2024, at 1:30 PM, confirmed the technical supervisor failed to verify the performance specifications for the CG8+ cartridge, lacked multiple days of precisions studies for CG4+ and verify the reference ranges for four of four i-STAT cartridges prior to approval by the laboratory director from September 28, 2023, to January 26, 2024. . D6120 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(7)(8) (7) The technical supervisor is responsible for 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; (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. This STANDARD is not met as evidenced by: Based on record review, the CMS-209 Laboratory Personnel Report (CLIA) form, policies, and interview with technical supervisor (TS) #1, two out of ten testing personnel lacked orientation, training, and competency assessment with the six required procedures and were unqualified to perform moderate-level diagnostic testing on the i-STAT for two out of two patients tested on December 30, 2023, and December 31, 2023. Findings: 1. A review of laboratory training records for TP09 and TP10 lacked an orientation checklist and training records signed off by the "Hi Line Supervisor" per their "Orientation and Training" policy. 2. A review of laboratory -- 3 of 4 -- training records for the i-STAT revealed TP09 and TP10 lacked competency assessments to include the six required procedures per their "Competency Assessment" policy. 3. An interview with TS #1 on January 26, 2024, at 1:00 PM confirmed the lack of orientation, training, and i-STAT competency assessment for two out of ten testing personnel prior to performing patient testing on December 30, 2023, and December 31, 2023. -- 4 of 4 --

Summary Statement of Deficiencies D0000 Based on an unannounced complaint survey conducted on November 14, 2023, deficiencies were cited for Logan Health Conrad, in Conrad, MT. D5016 ROUTINE CHEMISTRY CFR(s): 493.1210 If the laboratory provides services in the subspecialty of Routine Chemistry, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493. 1267, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on a review of chemistry records, patient results reports, product inserts and procedures, the laboratory failed to verify the precision overtime for the VITROS Chemistry Analyzer and the reference intervals (normal values) for analytes high- density lipoprotein and C-reactive protein (Cross refer D5421); failed to establish a procedure for the Ortho VITROS signed by the laboratory director (Cross Refer D5403); failed to establish acceptable QC statistical parameters for each analyte tested on the Ortho VITROS chemistry analyzer prior to patient testing (Cross Refer D5469); and failed to meet the chemistry quality control (QC) acceptability criteria for triglyceride and amylase assays prior to reporting patient test results (Cross Refer D5481). 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 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 -- 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 D3021 REQUIREMENTS FOR TRANSFUSION SERVICES CFR(s): 493.1103(c)(1) Blood and blood products storage and distribution. If a facility stores or maintains blood or blood products for transfusion outside of a monitored refrigerator, the facility must ensure the storage conditions, including temperature, are appropriate to prevent deterioration of the blood or blood product. This STANDARD is not met as evidenced by: Based on review of Immunohematology records, policies, and interview with technical supervisor (TS) #1, the laboratory failed to ensure the temperature is documented upon receipt of new shipments of blood or blood products and on units reissued from May 17, 2021, to May 17, 2023. Findings: 1. A review of Immunohematology records revealed the laboratory failed to take and document the temperatures of blood or blood products upon receipt of new shipments from May 17, 2021, to May 17, 2023. 2. A review of "Transfusion Service Testing Record" lacked a temperature record for one blood unit not used for transfusion and returned to inventory on 12/01/22. 3. An interview with TS #1 on May 17, 2023 at 11:40 AM, confirmed laboratory staff failed to take the temperature upon receipt of new shipments of blood or blood products and units reissued from May 17, 2021, to May 17, 2023. 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 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 -- 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) records, laboratory policies, and an interview with technical supervisor (TS) #1, the laboratory failed to establish, follow, and perform two levels of external quality control each day of patient testing or develop an Individualized Quality Control Plan (IQCP) to perform external controls at the manufacturer's recommended frequency for mononucleosis (Mono), clostridium difficile (C. diff) toxin A and B, and Helicobacter pylorifrom (H. Pylori) from May 17, 2021, to May 17, 2023. Findings: 1. A review of QC records revealed the laboratory was performing external QC at the frequency of once per lot/shipment for Cardinal Health Mono II rapid test, Tech lab C. DIFFICILE TOX A/B II, and Tech lab H. PYLORI CHEK. 2. No IQCP evaluation containing a risk assessment, a quality control plan, and a quality assessment plan was available for review to support QC practices less stringent than the regulatory control procedure. 3. An interview with the TS #1 on May 17, 2023, at 3:30 PM confirmed the laboratory failed to perform two levels of external QC each day of testing or develop an IQCP for alternative QC practices from May 17, 2021, to May 17, 2023 4. A review of the test volume sheet revealed the laboratory performed 20 H. pylori, 11 Mono(serum) and 20 C. diff toxin A and B tests, from May 17, 2022 to May 17, 2023 (12-month period). D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- Establish or verify the criteria for acceptability of all control materials. (i) When control materials providing quantitative results are used, statistical parameters (for example, mean and standard deviation) for each batch and lot number of control materials must be defined and available. (ii) The laboratory may use the stated value of a commercially assayed control material provided the stated value is for the methodology and instrumentation employed by the laboratory and is verified by the laboratory. (iii) Statistical parameters for unassayed control materials must be established over time by the laboratory through concurrent testing of control materials having previously determined statistical parameters. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of chemistry quality control (QC) records and procedures and an interview with the technical supervisor (TS) #1, the laboratory failed to establish acceptable criteria (mean and standard deviation) for new lots of Bio-Rad liquid unassayed Multiqual controls performed on the Siemens Dimension EXL chemistry analyzer from May 17, 2021, to May 17, 2023. Findings: 1. No correlation studies of new lots of Bio-Rad liquid unassayed Multiqual controls were available for review that showed an established mean and standard deviation for each analyte performed on the Siemens Dimension EXL chemistry. 2. The laboratory failed to establish a step- by-step procedure on how to perform and determine the statistical parameters for new lots of unassayed control material. 3. An interview with (TS) #1 on May 17, 2023, at 1:10 PM confirmed the laboratory failed to establish and document acceptable -- 2 of 4 -- statistical parameters for new lots of Bio-Rad liquid unassayed Multiqual controls performed on the Siemens Dimension EXL chemistry analyzer from May 17, 2021, to May 17, 2023 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 observation, review of policies, blood bank alarm records, and interview with the technical supervisor (TS) #1, the laboratory failed to monitor the alarm for one of one freezer and failed to follow their procedure for documentation of one of one alarm check for the blood bank refrigerator from May 17, 2021, to May 17, 2023. Findings: 1. Observed one of one refrigerator and freezer containing blood or blood products stored by the laboratory. 2. No records of alarm checks for the freezer were available for review from May 17, 2021, to May 17, 2023. 3. A review of the alarm check logs for the refrigerator revealed no records were available for year 2021 and the alarm check record in 2022 failed to include the high and low temperature records per the laboratory policy. 4. An interview with TS #1 on May 17, 2023, at 10:45 AM. confirmed the laboratory failed to perform alarm checks for the freezer and failed to follow their procedure for documentation of the refrigerator alarm check from May 17, 2021, to May 17, 2023. D5793 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(b)(c) (b) The analytic systems quality assessment must include a review of the effectiveness of

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 record review of American Proficiency Institute (API) proficiency testing scores and interview with the Technical Supervisor (TS) #1, the laboratory failed to achieve satisfactory performance for specialties mycology and immunohematology for 2 out of 3 events in 2019 and 2020 and failed to undertake appropriate training and employ the technical assistance necessary to correct problems associated with immunohematology proficiency testing failures. (See D2028, D2188 and D2190) D2046 MYCOLOGY CFR(s): 493.827(e) 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 -- Failure to achieve an overall testing event score of satisfactory performance 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 of American Proficiency Institute (API) proficiency testing scores and interview with the Technical Supervisor (TS) #1, the laboratory failed to achieve a satisfactory performance score of 80% or better for KOH preparation (glass slide) for two of three events (2019 Event 3 and 2020 Event 2), resulting in unsuccessful proficiency testing performance. Findings: 1. Review of American Proficiency Institute (API) proficiency testing scores revealed the laboratory scored 50% for 2019 Event 3 and 2020 Event 2. 2. Interview with the TS #1 on July 26, 2021 at 3:06 PM confirmed the laboratory failed to achieve a satisfactory performance for two of three events for KOH preparation (glass slide) for 2019 and 2020. D2188 ANTIBODY IDENTIFICATION CFR(s): 493.865(d) (1) For any unsatisfactory testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unsatisfactory testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: . Based on record review of American Proficiency Institute (API) proficiency testing scores for Immunohematology and interview with the Technical Supervisor (TS) #1, the laboratory failed to undertake appropriate training and employ the technical assistance necessary to correct problems associated with the unsuccessful proficiency testing for 2020. Findings: 1. Review of American Proficiency Institute (API) proficiency testing scores for 2020 Immunology/Immunohematology revealed unsuccessful proficiency testing for Compatibility Testing; Event 3, DAT-Anti-IgG; Event 2 and Event 3. 2. The laboratory failed to perform and document remedial training of personnel and to employ the technical assistance necessary to correct problems associated with repeat proficiency testing failure. 3. Interview with the TS #1 on July 26, 2021 at 3:30 PM confirmed the laboratory failed to perform and document remedial training and employ the technical assistance necessary to correct problems associated with the unsuccessful proficiency testing. D2190 ANTIBODY IDENTIFICATION CFR(s): 493.865(e) Failure to identify the same antibody in two consecutive or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on record review of American Proficiency Institute (API) proficiency testing scores and interview with the Technical Supervisor (TS) #1, the laboratory failed to -- 2 of 4 -- achieve a satisfactory performance score of 80% or better for DAT-Anti-IgG for two of three events (2020 Event 2 and 2020 Event 3), resulting in unsuccessful proficiency testing performance. Findings: 1. Review of American Proficiency Institute (API) proficiency testing scores for DAT-Anti-IgG revealed the laboratory scored a 50% for 2020 Event 2 and Event 3. 2. Interview with the TS #1 on July 26, 2021 at 3:10 PM confirmed the laboratory failed to achieve a satisfactory performance for two of three events for DAT-Anti-IgG for 2020. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: . Based on review of the calibration records for the Siemens Dimension EXL 200 chemistry analyzer for the analytes of sodium, potassium, and chloride, and interview with the Technical Supervisor (TS) #1, the laboratory failed to perform at least a three point (a minimal, mid-point, and maximum) calibration verification every six months. Findings: 1. Review of 2019 and 2020 calibration records for the Siemens Dimension EXL 200 chemistry analyzer for the analytes: sodium, potassium, and chloride, revealed the laboratory failed to perform a calibration including, at least, a minimal, midpoint, and maximum value for each analyte, every six months. 2. Interview with the TS #1 on July 26, 2021 at 11:52 AM confirmed the laboratory failed to perform at least a three-point calibration for sodium, potassium, and chloride on the Siemens Dimension EXL 200 chemistry analyzer every six months. D5471 CONTROL PROCEDURES CFR(s): 493.1256(e)(1)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e)(i) Check each batch (prepared in-house), lot number (commercially prepared) and shipment of reagents, disks, stains, antisera, (except those specifically referenced in 493.1261 (a)(3)) and identification systems (systems using two or more substrates or two or more reagents, or a combination) when prepared or opened for positive and -- 3 of 4 -- negative reactivity, as well as graded reactivity, if applicable. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on record review and interview with the Technical Supervisor (TS) #1, the laboratory failed to document the quality check of each new lot number, and shipment for positive and negative reactivity for bacitracin, catalase, Cefinase, oxidase, PYR disks, staphylococcal latex for year 2020. Findings: 1. Review of Bacteriology QC Log sheet lacked documentation for quality check for positive and negative reactivity for new lot number and shipment of bacitracin, catalase, Cefinase, oxidase, PYR disks, staphylococcal latex for year 2020. 2. Pondera Medical Center Laboratory procedure states " The following tests are used in this laboratory and QC are performed as noted: gram stain-weekly, bacitracin-each new lot# and shipment, catalase-each new lot# and shipment, Cefinase- each new lot# and shipment, staph latex- each new lot# and shipment, oxidase- each new lot# and shipment, PYR- each new lot# and shipment" 3. Interview on July 26, 2021 at 11:15 AM with TS #1 confirmed the laboratory failed to document the quality check for positive and negative reactivity for new lot number and shipment of bacitracin, catalase, Cefinase, oxidase, PYR disks, staphylococcal latex for year 2020. -- 4 of 4 --