Aspirus Stanley Hospital Laboratory

Summary Statement of Deficiencies D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on surveyor review of laboratory records and interview with the technical consultant, the laboratory did not test the American Proficiency Institute (API) proficiency testing (PT) samples using the laboratory's routine methods for five of five gram stain samples in June 2024. Findings include: 1. Review of the "Microbiology Log" worksheets showed API PT samples were tested on June 6, 12, 19, 21 and 22, 2024. 2. Review of the "Micro Maintenance Log" stated "Gram Stain QC must be performed WEEKLY and PER DAY of PATIENT TESTING". Further review showed QC testing was performed June 2, 6, and 16, 2024, while QC was not performed on June 12, 19, 21 and 22, 2024, while performing the API PT samples. 3. Interview with the technical consultant on September 4, 2024, at 12:55 PM confirmed the laboratory did not test PT samples using the laboratory's routine methods for gram stains. 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: 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 -- Based on surveyor review of the submitted Centers for Medicare and Medicaid Services (CMS) Form CMS-209 (Laboratory Personnel Report), procedures, laboratory records and competency evaluation records and interview with a technical supervisor, staff A, the laboratory did not follow written policies and procedures to assess the competence for two of two personnel designated as technical consultant, technical supervisor and general supervisor. Findings include: 1. Review of the Form CMS-209 submitted for survey showed one technical consultant, two technical supervisors (the laboratory director is the technical supervisor for immunohematology) and two general supervisors. 2. Review of laboratory procedures related to competency assessment showed the evaluation of the competence of staff A and staff B in performing their delegated responsibilities is to be performed annually by the laboratory director. 3. Review of the laboratory records showed a new laboratory director was assigned to this laboratory on May 1, 2024. 4. Review of the competency evaluation records showed the previous director had performed competency on staff A and staff B for their delegated responsibilities on March 21, 2024. Further review shoed no evidence the new laboratory director evaluated the competence of staff A and B in performing their assigned technical consultant, technical supervisor and technical consultant responsibilities. 5. Interview with staff A on September 4, 2024, at 12:35 PM confirmed the laboratory did not follow written policies and procedures to assess the competence for personnel designated as technical consultant, technical supervisor and general supervisor. D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on surveyor review of laboratory records and procedures and interview with the technical consultant, the laboratory director did not approve, sign and date two of five new Stago Compact Max coagulation procedures prior to patient use. Findings include: 1. Review of verification of performance specifications on the Stago Compact Max showed the go-live date for the analyzer was September 13, 2023. 2. Review of Stago Compact Max coagulation testing procedures showed the following procedures were approved and signed by the laboratory director in November 2022. Prothrombin Time (PT) Policy and Procedure (System) Activated Partial Thromboplastin Time (aPTT) Policy and Procedure (System) STA-Liatest D-Dimer Policy and Procedure (System) Further review showed additional procedures related to the Stago Compact Max were approved and signed by the laboratory director in December 2023. Quality Control Program for Coagulation Testing (Stago Compact Max) Stago Compact Max Maintenance and Consumable Supply Replacement Procedure 3. Interview with the technical consultant on September 4, 2024, at 3:45 PM confirmed the laboratory director did not approve, sign and date new coagulation procedures prior to patient use. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. -- 2 of 5 -- This STANDARD is not met as evidenced by: Based on review of laboratory records, observation of reagents and interview with the technical consultant, the laboratory used expired reagents to perform gram stains for five of five specimens tested. Findings include: 1. Review of the "Micro Maintenance Log" for June 2024 showed the following: Reagent / Lot / Expiration date Crystal Violet Stain / 3031845 / 8-31-2024 Iodine / 2300388 / 5-31-2024 Decolorizer / 3320105 / 4-30-2025 Safranin Stain / 3297852 / 3-31-2025 2. Review of the "Microbiology Log" showed five American Proficiency Institute (API) proficiency testing (PT) samples were performed on June 6, 12, 19, 21, and 22, 2024. 3. Observation of the microbiology reagents on September 4, 2024, at 12:50 PM showed the following reagents available for use: Reagent / Lot / Expiration date Crystal Violet Stain / 3031845 / 08/31/2024 Iodine / 2300388 / 05/31/2024 Decolorizer / 3320105 / 04/30/2025 Safranin Stain / 3297852 / 03/31/2025 4. Interview with the technical consultant on September 4, 2024, at 12:55 PM confirmed the laboratory used expired reagents to perform gram stain testing. This is a repeat deficiency from October 4-5, 2022. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on surveyor review of laboratory records and interview a general supervisor, staff B, and the chemistry lead, staff C, the laboratory did not perform calibration verification every six months for three of three chemistry analytes on the Siemens Dimension EXL chemistry analyzer. Finding include: 1. Review of Siemens Dimension EXL calibration verification records showed calibration verification was performed on sodium, potassium and chloride on March 19, 2023, November 25, 2023, and June 20, 2024. Further review showed no additional calibration verifications. 2. Review of quality control testing records showed testing was performed between September 19, 2023, when calibration verification was due, and -- 3 of 5 -- November 25, 2023, and May 25, 2024, when calibration verification was due, and June 20, 2024. 3. Interview with staff B and staff C on September 5, 2024, at 12:35 PM confirmed the laboratory did not perform calibration verification every six months on the Siemens Dimension EXL chemistry analyzer. This is a repeat deficiency from October 4-5, 2022. D5807 TEST REPORT CFR(s): 493.1291(d) Pertinent "reference intervals" or "normal" values, as determined by the laboratory performing the tests, must be available to the authorized person who ordered the tests and, if applicable, the individual responsible for using the test results. This STANDARD is not met as evidenced by: Based on survey review of a patient's chemistry test report and laboratory procedures and interview with the technical consultant, the reference ranges shown on the patient report were not the same as the approved reference ranges for twelve of fourteen chemistry analytes reviewed. Findings include: 1. Review of the reference range of a chemistry test report from September 5, 2024, in the electronic medical record (EMR) for patient 1 (an adult female) showed the following expected ranges: Analyte / Reference range Sodium / 133-144 Milliequivalents/Liter (mEq/L) Potassium / 3.5- 8.0 mEq/L Chloride / 95-107 mEq/L Carbon Dioxide / 21-32 mEq/L Blood Urea Nitrogen (BUN) / 8-24 milligrams/deciliter (mg/dL) Creatinine / 0.50-1.2 mg/dL Glucose / 70-100 mg/dL Calcium / 8.6-10.4 mg/dL Aspartate aminotransferase (AST) / 11-41 International units/Liter (IU/L) Alanine transaminase (ALT) / 9-40 IU/L Alkaline Phosphatase / 35-121 IU/L Total Bilirubin / 0.2-1.2 mg/dL Albumin / 3.5-5.2 grams/deciliter (g/dL) Total Protein / 6.2-8.5 g/dL 2. Review of the "Dimension EXL- Specifications" which listed references ranges showed the approved reference ranges for an adult female are: Analyte /Reference range Sodium / 136-145 Milliequivalents /Liter (mEq/L) Potassium / 3.5-5.0 mEq/L Chloride / 98-107 mEq/L Carbon Dioxide / 21-32 mEq/L Blood Urea Nitrogen (BUN) / 7-18 milligrams/deciliter (mg/dL) Creatinine / 0.51-1.17 mg/dL Glucose / 70-99 mg/dL Calcium / 8.5-10.1 mg/dL Aspartate aminotransferase (AST) / 15-37 International units/Liter (IU/L) Alanine transaminase (ALT) / 12-59 IU/L Alkaline Phosphatase / 46-116 IU/L Total Bilirubin / 0.0-1.0 mg/dL Albumin / 3.4-5.0 grams/deciliter (g/dL) Total Protein / 6.4-8.2 g/dL Further review showed the sodium, chloride, BUN, creatinine, glucose, AST, ALT, alkaline phosphatase, total bilirubin, albumin and total protein reference ranges in the procedure did not match the patient's test report. 3. Interview with the technical consultant on September 5, 2024, at 1:35 PM confirmed the reference ranges for twelve analytes in the procedure were not the same as the test report. D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (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. This STANDARD is not met as evidenced by: Based on competency assessment records and interview with the technical consultant, the technical consultant did not document competency assessment for nine of nine -- 4 of 5 -- testing personnel responsible for urine microscopy and wet prep testing in the laboratory in 2023. Findings include: 1. Review of competency assessments for the laboratory showed no documentation of competency assessment for urine microscopy testing in the laboratory for 2023. 2. Interview with the technical consultant on September 4, 2024, at 10: 15 AM, confirmed the technical consultant did not document competency assessment for testing personnel performing urine microscopy and wet prep testing in 2023. -- 5 of 5 --

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 surveyor review of laboratory records and interview with a general supervisor, the laboratory's evaluation of the alarm system on the refrigerator used to store red blood cell products did not ensure the maintenance of acceptable refrigerator storage temperatures in 2021 and 2022. Findings include: 1. Review of the 'Laboratory Blood Bank Activation Temps' worksheets from March 7, 2021 through September 17, 2022 showed the high temperature set point for the alarm is 7.0 degrees Celsius (C). The records show the alarm triggered at 6.7 - 6.9 C. 2. Interview with a general supervisor (staff A) on October 5, 2022 at 1:00 PM confirmed the 7.0 degree C high alarm set temperature for the refrigerator would not ensure blood products are kept at appropriate storage temperatures (1 - 6 degrees C) to prevent deterioration. 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: Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 11 -- Based on surveyor review of blood administration procedures and transfusion records and interview with a general supervisor, the facility did not promptly identify a potential transfusion reaction and did not notify the Food and Drug Administration (FDA) of a fatality that occured during a transfusion when signs were present of a potential transfusion reaction. Findings include: 1. The policy, 'Guidelines for Blood Administration and Monitoring', revision date November 2018, included a 'Signs and Symptoms to Watch For' section that listed indicators of a potential transfusion reaction; the list includes tachycardia. The policy outlined immediate actions to take when signs and symptoms indicate a potential transfusion reaction. The first action listed is "Stop the transfusion". 2. Review of a 'Blood Transfusion / Blood Bank Products' form showed patient 1 received a unit of blood on January 5, 2022. The record showed the time started was 1400 (2:00 PM). Personnel documented the time the transfusion was stopped as 1515 (3:15 PM), and 'Reaction to Transfusion (No)' is marked 'No'. 3. Review of the vital signs record for patient 1 on January 5, 2022 showed the patient's heart rate was 84 at 2:00 PM, 100 at 2:24 PM, 170 at 2:49 PM and 162 at 2:59 PM. There is no indication the transfusion was immediately stopped when the heart rate increased to 170 at 2:49 PM. 4. The laboratory provided no evidence of an evaluation of the tachycardia that occured during the transfusion or notification to the FDA of a potential transfusion related fatility. 5. Email communication with a general supervisor (staff A) on October 13, 2022 at 11:28 AM included the following statement, "there was no indication of death related to the transfusion" and on October 17, 2022 at 9:15 AM, "There are no indications of a transfusion reaction or any issues with the blood." Additional documentation provided by staff A showed no evaluation of the tachycardia that occurred during the transfusion to determine whether a transfusion reaction occurred. D5026 IMMUNOHEMATOLOGY CFR(s): 493.1217 If the laboratory provides services in the specialty of Immunohematology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493. 1271, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on surveyor review of procedures and interview with laboratory personnel, the laboratory has not met the requirements specified in 493.1230 through 493.1256, 493. 1271, and 493.1281 through 493.1299 for immunohematology. Findings include: 1. The laboratory did not have a procedure for evaluating and resolving decrepancies between ABO forward and reverse typing results. See D5401. 2. The laboratory did not ensure nursing staff evaluated recipient vital signs to identify a potential transfusion reaction. See D5559. 3. The laboratory did not ensure the relationship between ABO forward and reverse types were in agreement before reporting a patient ABO blood type and transfusing blood products. See D5777. The deficiencies identified in this condition level citation resulted in a finding of immediate jeopardy at the time of the on-site survey. The immediate jeopardy determination has since been removed. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks -- 2 of 11 -- may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on surveyor review of laboratory procedures and interview with a general supervisor, the laboratory did not have a procedure that identified the steps testing personnel take when testing shows a discrepant result between ABO forward (red cell) and reverse (serum or plasma) typing. Additionally, the ABO test procedure did not show the expected forward and reverse results for common blood types. Findings include: 1. Review of laboratory procedures showed no evidence of a procedure for resolving discrepant ABO test results. The Ascension 'ABO/Rh Patient Typing - Gel' procedure, 'Interpretation' section stated, "ABO serum and ABO red cells grouping should always agree. Discrepancies between forward and reverse grouping should be resolved." The interpretation section defined negative and positive results; the procedure did not identify the expected forward and reverse types for common ABO blood types. 2. Interview with a general supervisor (staff A) on October 4, 2022 at 3: 40 PM confirmed the laboratory did not have a procedure for resolving ABO blood typing discrepancies. 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 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 surveyor review of the federal Certification and Survey Provider Enhanced Reports (CASPER) and American Proficiency Institute (API) proficiency testing (PT) records and interview with the technical consultant, the laboratory failed to attain satisfactory performance in PT for the Compatibility Testing subspecialty in the Immunohematology specialty for event two in 2020. Findings include: 1. Review of PT records in the federal CASPER reporting system showed the laboratory had unsatisfactory performance for Compatibility Testing subspecialty on event two in 2020. A score of 100% is required for satisfactory performance for compatibility testing. a. Event 2020-2: 80% 2. Review of API PT evaluation report confirmed the unsatisfactory performance for compatibility Testing subspecialty in the Immunohematology specialty for event two in 2020. 3. Interview with the technical consultant on February 15, 2021 at 10:30 AM, confirmed the laboratory did not attain satisfactory performance in PT for the Compatibility Testing subspecialty in the Immunohematology specialty for event two in 2020. This is a repeat deficiency from June 9, 2005. 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 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 -- 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 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 surveyor review of the federal Certification and Survey Provider Enhanced Reports (CASPER) Proficiency Testing (PT) and American Proficiency Institute (API) Proficiency Testing (PT) records, the laboratory failed to successfully participate in PT for the White Blood Cell (WBC) Differential (Diff) analyte in the Specialty of Hematology for events 2019-3 and 2020-1. See D2130. D2130 HEMATOLOGY CFR(s): 493.851(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 in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on surveyor review of the federal Certification and Survey Provider Enhanced Reports (CASPER) Proficiency Testing (PT) and American Proficiency Institute (API) PT records, the laboratory failed to achieve satisfactory performance in PT for the White Blood Cell (WBC) Differential (Diff) analyte in the Specialty of Hematology for events 2019-3 and 2020-1. Findings include: 1. Review of PT records in the federal CASPER reporting system shows that the laboratory failed two consecutive PT events for the WBC Diff analyte in the Specialty of Hematology: Event 2019-3, score 64% and Event 2020-1, score 40%. 2. Surveyor review of the API PT evaluation reports on September 8, 2020 confirmed the failed PT scores for the WBC Differential analyte. This results in a failure to achieve an overall testing event score of satisfactory performance for two consecutive testing events which is unsuccessful PT performance. -- 2 of 2 --

Summary Statement of Deficiencies D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on surveyor review of proficiency testing (PT) records and interview with the general supervisor, the laboratory has not evaluated proficiency testing event 2017-3 for antibody detection, ABO/RH, D(RHO), and compatibility testing that received 0% scores by the PT provider. Findings include: 1. Review of immunohematology PT records for event 2017-3 shows that the laboratory received 0% scores for antibody detection, ABO/RH, D(RHO), and compatibility testing due to a computer issue when submitting the PT results to the PT provider. There is no evidence that the laboratory evaluated the results from the PT provider's participant summary results to verify the accuracy of their responses. 2. Interview with the general supervisor on October 17, 2018 at 10:45 AM confirmed the accuracy of the results were not verified by the laboratory for the zero scores from the PT provider. This is a repeat deficiency previously cited on July 2, 2008. 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 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 -- 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 surveyor review of Blood Agar Plate (BAP), Chocolate agar (CHOC), and MacConkey agar (MAC) media records and interview with the technical consultant, the laboratory does not check each batch of BAP, CHOC, and MAC media for its ability to support growth, inhibit specified organisms or document the physical characteristics of each lot of media. Findings include: 1. Review of BAP and MAC media records show no evidence the laboratory documents the media's growth characteristics or condition for each lot of media. Review of CHOC media records show no evidence the laboratory documents the condition for each lot of media. 2. Interview with the technical consultant on October 18, 2018 at 9 AM confirmed the laboratory does not document the media's growth characteristics or condition for each lot of BAP and MAC media and the media condition for each lot of CHOC media. -- 2 of 2 --