Trinity Medical Clinical Laboratory

Summary Statement of Deficiencies D0000 A Recertification survey was performed at Trinity Medical Clinical Laboratory, CLIA ID 19D0710168, on July 14, 2025 through July 17, 2025. Trinity Medical Clinical Laboratory was found not in compliance with the following CONDITION LEVEL DEFICIENCIES: 42 CFR 493.803: CONDITION: Successful participation 42 CFR 493.1441 CONDITION: Laboratories performing high 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 review of proficiency testing records and interview with personnel, the laboratory failed to achieve a score of at least 80% for Bacteriology testing of Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 17 -- anaerobic wound cultures for two consecutive events, resulting in an initial unsuccessful performance. Refer to D2021. D2021 BACTERIOLOGY CFR(s): 493.823(b) (b) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3) The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: Based on review of the laboratory's proficiency testing records and interview with personnel, the laboratory failed to successfully participate in wound culture testing for anaerobes for Bacteriology testing for two (2) consecutive events. Findings: 1. Review of the laboratory's American Proficiency Institute (API) proficiency testing records revealed the laboratory received the following unacceptable scores for Bacteriology testing: 2025 Microbiology 1st Event: Wound Culture-Anaerobic, score 0% 2024 Microbiology 3rd Event: Wound Culture-Anaerobic; score 0% 2. In interview on July 14, 2025 at 4:29 pm, Technical Consultant 2 stated the laboratory does not perform anaerobic testing and the PT results should not have been reported. Technical Consultant 2 confirmed the laboratory received two (2) consecutive unsuccessful PT scores for Wound Culture anaerobic Bacteriology testing. D3025 REQUIREMENTS FOR TRANSFUSION SERVICES CFR(s): 493.1103(d) Investigation of transfusion reactions. The facility must have procedures for preventing transfusion reactions and when necessary, promptly identify, investigate, and report blood and blood product transfusion reactions to the laboratory and, as appropriate, to Federal and State authorities. This STANDARD is not met as evidenced by: Based on review of the nursing administration's transfusion policies, transfusion records, and interview with personnel, the facility failed to follow their established policy for transfusion services for blood products for two (2) of three (3) patients reviewed. Findings: 1. Review of Nursing Administration's "Blood Administration" policy revealed "Vital signs will be obtained just prior to administration of each unit, then q 15 minutes x 4, then q 30 minutes x 2, then hourly thereafter." 2. Review of random selection of patient transfusion records revealed vital signs were not documented per blood administration policy for the following patients: a) July 10, 2025: Patient 10396972: vital signs documented prior to administration, fifteen (15) minutes, thirty (30) minutes, and hourly until end of transfusion b) April 16, 2025: Patient 10388482: vital signs documented prior to administration, fifteen (15) minutes, thirty (30) minutes, and hourly until end of transfusion. 3. In interview on July 17, 2025 at 11:10 am, the ER Nurse Manager stated for transfusions performed in -- 2 of 17 -- the ER they document vital signs, prior to administration, fifteen minutes, thirty minutes and hourly until end of transfusion as listed on the lab forms. The ER Nurse Manager confirmed the blood administration's policy for documentation of vital signs was not followed. 4. In interview on July 17, 2025 at 11:36 am, the Med Surg ICU Manager stated for the identified patient transfused on July 10, 2025, the vital signs were not documented per the Nursing Administration's Blood Administration policy. 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 review of the laboratory's CMS-209 form, personnel records, and interview with personnel, the laboratory failed to ensure competency assessments for personnel serving as Technical Consultants, Technical Supervisors, and General Supervisors were complete for three (3) of four (4) personnel reviewed. Findings: 1. Review of the laboratory's CMS-209 (Laboratory Personnel Report) form revealed the laboratory had three (3) personnel serving as Technical Consultants, three (3) personnel serving as Technical Supervisors, and four (4) personnel serving as General Supervisors. 2. Review of the laboratory's personnel records revealed the laboratory utilized forms that included columns for description of responsibilities, assessment method, and director's review for the performance of annual competency assessments for Technical Consultants, Technical Supervisors, and General Supervisors. The form stated "A checkmark or initials in the Director Review column indicates the associate fulfills the required responsibility." 3. Further review of the laboratory's competency assessment forms for the Technical Consultants, Technical Supervisors, and General Supervisors revealed the following were not complete: a) Technical Consultant 1, who also serves as a Technical Supervisor and General Supervisor: 2024 Technical Consultant Competency, the Laboratory Director did not include a check mark or initials in the "Director Review" column indicating competency. The Laboratory Director signed the form on February 25, 2024. 2025 Technical Consultant competency, the Laboratory Director did not include a check mark or initials in the "Director Review" column indicating competency. The Laboratory Director signed the form on February 26, 2025. 2025 General Supervisor Competency, the the Laboratory Director did not include a check mark or initials in the "Director Review" column indicating competency. The Laboratory Director signed the form on February 21, 2025. b) General Supervisor 4: 2025 Microbiology General Supervisor competency, the Laboratory Director did not include a check mark or initials in the "Director Review" column indicating competency. The Laboratory Director signed the form on January 8, 2025. c) Technical Consultant 2, who also serves as a Technical Supervisor and General Supervisor: 2025 Technical Consultant competency, the Laboratory Director did not include a check mark or initials in the "Director Review" column indicating competency. The Laboratory Director signed the form on January 8, 2025. 2025 General Supervisor Competency, the Laboratory Director did not include a check mark or initials in the "Director Review" column indicating competency. The Laboratory Director signed the form on February 21, 2025 4. In interview on July 15, 2025 at 10:44 am, Technical Consultant 1 confirmed the identified competency assessments for personnel serving as Technical Consultants, Technical Supervisors, and General Supervisors were not complete. -- 3 of 17 -- D5213 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(1) (b) The laboratory must verify the accuracy of the following: (b)(1) Any analyte or subspecialty without analytes listed in subpart I of this part that is not evaluated or scored by a CMS-approved proficiency testing program. This STANDARD is not met as evidenced by: Based on review of the laboratory's policy, proficiency testing records, and interview with personnel, the laboratory failed to evaluate non graded proficiency testing (PT) scores. Findings: 1. Review of the laboratory's "Proficiency testing policy" revealed the laboratory did not include detailed written instructions related to evaluation of educational and not graded proficiency testing scores. 2. Review of the laboratory's American Proficiency Institute (API) proficiency testing records revealed the laboratory did not evaluate the following non graded PT scores: 2025 1st event Microbiology-Bacteriology: Educational Culture ID, Educational Susceptibility, MIC Value A, MIC Value B 2025 1st event Hematology/Coagulation: Not graded Nucleated RBC's 2024 3rd event Hematology/Coagulation: Educational Blood cell identification, lymphocyte, metamyelocyte, monocytes, myelocyte, neutrophil, NRBC, platelet estimates, RBC morphology for differentials 2024 3rd event Microbiology-Bacteriology: Educational Culture ID, Educational Susceptibility, ESBL, MIC Value 2024 2nd event Microbiology-Bacteriology: Educational Culture ID, Educational Susceptibility, MIC Value 2024 2nd event Hematology/Coagulation: Educational Blood cell identification, lymphocyte, metamyelocyte, monocytes, myelocyte, neutrophil, NRBC, platelet estimates, RBC morphology for differentials 2024 1st event Hematology/Coagulation: Educational Blood cell identification, lymphocyte, metamyelocyte, monocytes, myelocyte, neutrophil, NRBC, platelet estimates, RBC morphology for differentials 2024 1st event Microbiology- Bacteriology: Educational Culture ID, Educational Susceptibility, MIC Value (BL), MIC Value (Sf), and MIC Value (UR) 3. Review of the laboratory's PT evaluation forms for the identified events revealed the laboratory stated the results for ungraded and educational are reviewed; however, the acceptability of the results were not included. 4. In interview on July 14, 2025 at 4:29 pm, Technical Consultant 2 stated for non graded PT results the data summaries are reviewed. Technical Consultant 2 stated she does not maintain the data summaries with the PT records. Technical Consultant 2 confirmed she did not include the acceptability of the non graded and educational results. D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) (a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (a)(1) Patient preparation. (a)(2) Specimen collection. (a)(3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (a)(4) Specimen storage and preservation. (a)(5) Conditions for specimen transportation. (a)(6) Specimen processing. (a)(7) Specimen acceptability and rejection. (a)(8) Specimen referral. This STANDARD is not met as evidenced by: Based on observation by surveyor, review of the manufacturer's package insert, laboratory's patient test logs, and interview with personnel, the laboratory failed to -- 4 of 17 -- ensure patient samples for Lactic Acid testing were centrifuged within fifteen (15) minutes of collection per the manufacturer's instructions for thirty eight (38) of one hundred forty nine (149) reviewed. Findings: 1. Observation by surveyor during the laboratory tour on July 14, 2025 at 1:37 pm revealed the laboratory utilizes the Beckman Coulter AU 700 and Beckman Coulter AU 480 analyzers for Lactic Acid patient testing. 2. Review of the Beckman Coulter package insert for Lactic Acid under "Specimen Collection and Preparation" revealed the following: "Keep the sample on ice and separate plasma from cells within 15 minutes of collection." 3. Review of the laboratory's "Lactate Daily Log" revealed the laboratory documents the collection date/time and the centrifugation date/time. 4. Review of the laboratory's patient test logs for Lactic Acid testing from April 2025 to May 2025 revealed the following thirty eight (38) of one hundred forty nine (149) patients were not centrifuged within fifteen (15) minutes of collection per manufacturer's instructions: a) Acct #10387085: collected April 3, 2025 at 10:39 am and centrifuged at 10:59 am (exceeds the manufacturer's instructions by four (4) minutes) b) Acct # 10388000: collected April 11, 2025 at 14:23 and centrifuged at 14:40 (exceeds the manufacturer's instructions by two (2) minutes) c) Acct # 10388173: collected April 14, 2025 at 16: 45 and centrifuged at 17:04 (exceeds the manufacturer's instructions by four (4) minutes) d) Acct # 10388235: collected April 14, 2025 at 18:36 and centrifuged at 18: 55 (exceeds the manufacturer's instructions by four (4) minutes) e) Acct # 10388180: collected April 14, 2025 at 14:00 and centrifuged at 14:18 (exceeds the manufacturer's instructions by three (3) minutes) f) Acct # 10388203: collected April 14, 2025 at 15: 50 and centrifuged at 16:10 (exceeds the manufacturer's instructions by five (5) minutes) g) Acct # 10388323: collected April 15, 2025 at 12:50 pm and centrifuged at 13:16 (exceeds the manufacturer's instructions by eleven (11) minutes) h) Acct # 10388334: collected April 15, 2025 at 18:36 and centrifuged at 14:25 (exceeds the manufacturer's instructions by eleven (11) minutes) i) Acct # 10388879: collected April 21, 2025 at 15:19 and centrifuged at 15:39 (exceeds the manufacturer's instructions by five (5) minutes) j) Acct # 10388900: collected April 21, 2025 at 15:08 and centrifuged at 15:39 (exceeds the manufacturer's instructions by sixteen (16) minutes) k) Acct # 10388808: collected April 21, 2025 at 10:17 am and centrifuged at 10:39 am (exceeds the manufacturer's instructions by seven (7) minutes) l) Acct # 10388872: collected April 21, 2025 at 13:22 and centrifuged at 13:42 (exceeds the manufacturer's instructions by five (5) minutes) m) Acct # 10389174: collected April 23, 2025 at 22:25 and centrifuged at 22:42 (exceeds the manufacturer's instructions by two (2) minutes) n) Acct # 10389183: collected April 23, 2025 at 23:00 and centrifuged at 23:17 (exceeds the manufacturer's instructions by two (2) minutes) o) Acct # 10389165: collected April 23, 2025 at 18:50 and centrifuged at 19:06 (exceeds the manufacturer's instructions by one (1) minute) p) Acct # 10389168: collected April 23, 2025 at 18:47 and centrifuged at 19:06 (exceeds the manufacturer's instructions by four (4) minutes) q) Acct # 10389166: collected April 23, 2025 at 19: 34 and centrifuged at 19:50 (exceeds the manufacturer's instructions by one (1) minute) r) Acct # 10389171: collected April 23, 2025 at 20:12 and centrifuged at 20: 30 (exceeds the manufacturer's instructions by three (3) minutes) s) Acct # 10389547: collected April 28, 2025 at 11:16 am and centrifuged at 11:33 am (exceeds the manufacturer's instructions by two (2) minutes) t) Acct # 10389540: collected April 28, 2025 at 12:08 pm and centrifuged at 12:25 pm (exceeds the manufacturer's instructions by two (2) minutes) u) Acct # 10390350: collected May 5, 2025 at 11:23 am and centrifuged at 11:40 am (exceeds the manufacturer's instructions by two (2) minutes) v) Acct # 10390186: collected May 2, 2025 at 13:17 and centrifuged at 13: 36 (exceeds the manufacturer's instructions by four (4) minutes) w) Acct # 10390384: collected May 5, 2025 at 14:47 and centrifuged at 15:03 (exceeds the manufacturer's instructions by one (1) minute) x) Acct # 10390390: collected May 5, 2025 at 15:28 -- 5 of 17 -- and centrifuged at 15:45 (exceeds the manufacturer's instructions by two (2) minutes) y) Acct # 10390419: collected May 5, 2025 at 17:32 and centrifuged at 17:48 (exceeds the manufacturer's instructions by one (1) minute) z) Acct # 10390689: collected May 7, 2025 at 18:53 and centrifuged at 19:10 (exceeds the manufacturer's instructions by two (2) minutes) aa) Acct # 10390715: collected May 8, 2025 at 08:19 am and centrifuged at 08:35 am (exceeds the manufacturer's instructions by one (1) minute) bb) Acct # 10390734: collected May 8, 2025 at 11:20 am and centrifuged at 11:38 am (exceeds the manufacturer's instructions by three (3) minutes) cc) Acct # 10390826: collected May 8, 2025 at 19:40 and centrifuged at 19:56 (exceeds the manufacturer's instructions by one (1) minute) dd) Acct # 10390901: collected May 9, 2025 at 16:47 and centrifuged at 17:05 (exceeds the manufacturer's instructions by three (3) minutes) ee) Acct # 10391129: collected May 12, 2025 at 18:24 and centrifuged at 18:44 (exceeds the manufacturer's instructions by five (5) minutes) ff) Acct # 10391278: collected May 13, 2025 at 17:55 and centrifuged at 18:15 (exceeds the manufacturer's instructions by five (5) minutes) gg) Acct # 10391862: collected May 4, 2025 at 13:42 and centrifuged at 14:00 (exceeds the manufacturer's instructions by three (3) minutes) hh) Acct # 10392151: collected May 21, 2025 at 18: 56 and centrifuged at 19:13 (exceeds the manufacturer's instructions by two (2) minutes) ii) Acct # 10392397: collected May 23, 2025 at 18:00 and centrifuged at 18: 16 (exceeds the manufacturer's instructions by one (1) minutes) jj) Acct # 10392401: collected May 23, 2025 at 19:40 and centrifuged at 19:57 (exceeds the manufacturer's instructions by two (2) minutes) kk) Acct # 10392705: collected May 28, 2025 at 09: 35 am and centrifuged at 10:09 am (exceeds the manufacturer's instructions by nineteen (19) minutes) ll) Acct # 10392718: collected May 28, 2025 at 10:43 am and centrifuged at 11:04 am (exceeds the manufacturer's instructions by six (6) minutes) 5. In interview on July 16, 2025 at 2:43 pm, the Technical Consultant confirmed the laboratory did not follow the manufacturer's instructions for Lactic Acid sample collection and handling. D5317 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(d) (d) If the laboratory accepts a referral specimen, written instructions must be available to the laboratory's clients and must include, as appropriate, the information specified in paragraphs (a)(1) through (a)(7) of this section. This STANDARD is not met as evidenced by: Based on review of the laboratory's client service manual, test menu, and interview with personnel, the laboratory failed to ensure that current written instructions for providers to maintain integrity of samples were established. Findings: 1. Review of the laboratory's test menu and client service manual for providers revealed the laboratory failed to include written instructions for the following Chemistry analytes: amylase, alanine aminotransferase (ALT). 2. In interview on July 16, 2025 at 11:05 am, the Technical Consultant confirmed the identified analytes were not included in the client service manual. D5393 PREANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1249(b)(c) (b) The preanalytic systems assessment must include a review of the effectiveness of

Summary Statement of Deficiencies D6123 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(8)(iii) The procedures for evaluation of the competency of the staff must include, but are not limited to review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records. This STANDARD is not met as evidenced by: A follow-up survey was performed at Trinity Medical Clinical Laboratory, CLIA ID #19D0710168, on March 13, 2024 through March 14, 2024. Based on review of the laboratory's CMS-209 (Laboratory Personnel Report) form and personnel records as well as interview with laboratory personnel, the Technical Supervisor failed to ensure semiannual competency assessments for two (2) of four (4) laboratory testing personnel included review of Vitek quality control records. Findings: 1. Review of the laboratory's CMS-209 (Laboratory Personnel Report) form revealed the Laboratory Director also served as the Technical Supervisor. 2. Review of personnel records revealed semiannual competency assessments documented for the following personnel, but the laboratory did not have raw data to support review of quality control on the Vitek analyzer: - Testing Personnel 3 - Testing Personnel 5 3. In interview on March 13, 2024, General Supervisor 2 confirmed the laboratory did not have the raw data to support review of Vitek quality control records for the semiannual competency of the personnel identified above. ________________________________ A Recertification survey was performed at Trinity Medical Center Laboratory, CLIA # 19D0710168, on October 23, 2023 through October 27, 2023. D6124 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(8)(iv) The procedures for evaluation of the competency of the staff must include, but are not 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 -- limited to direct observation of performance of instrument maintenance and function checks. This STANDARD is not met as evidenced by: A follow-up survey was performed at Trinity Medical Clinical Laboratory, CLIA ID #19D0710168, on March 13, 2024 through March 14, 2024. Based on review of the laboratory's CMS-209 (Laboratory Personnel Report) form and personnel records as well as interview with personnel, the Technical Supervisor failed to ensure semiannual competency assessments for testing personnel included direct observation of performance of Vitek instrument maintenance and function checks for four (4) of four (4) testing personnel reviewed. Findings: 1. Review of the laboratory's CMS-209 (Laboratory Personnel Report) form revealed the Laboratory Director also served as the Technical Supervisor. 2. Review of personnel records revealed semiannual competency assessments documented for the following personnel, but direct observation of Vitek maintenance was not documented: - Testing Personnel 2 - Testing Personnel 3 - Testing Personnel 5 - Testing Personnel 7 3. In interview on March 13, 2024, General Supervisor 2 confirmed the laboratory did not document direct observation of Vitek maintenance for the semiannual competency of the personnel identified above. ________________________________ A Recertification survey was performed at Trinity Medical Center Laboratory, CLIA # 19D0710168, on October 23, 2023 through October 27, 2023. D6125 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(8)(v) The procedures for evaluation of the competency of the staff must include, but are not limited to assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples. This STANDARD is not met as evidenced by: A follow-up survey was performed at Trinity Medical Clinical Laboratory, CLIA ID #19D0710168, on March 13, 2024 through March 14, 2024. Based on review of personnel records and the laboratory's CMS 209 form as well as interview with personnel, the Technical Supervisor failed to ensure four (4) of five (5) testing personnel were assessed semiannually through testing previously analyzed specimens, internal blind samples, or external proficiency samples for microbiology. Findings: 1. Review of the laboratory's CMS-209 (Laboratory Personnel Report) form revealed the Laboratory Director also served as the Technical Supervisor. 2. Review of personnel records revealed the following: - Blind sample correlation: Must include urine, blood, and upper respiratory. 3. Further review of personnel records revealed the following personnel did not have documentation of blind samples for gram stains and cultures of the specimen types required by the laboratory: - Testing Personnel 1 - gram stain (testing personnel only performs gram stains) - Testing Personnel 3 - urine, blood, and respiratory cultures including gram stain - Testing Personnel 5 - urine, blood, and respiratory cultures including gram stain - Testing Personnel 7 - blood and respiratory cultures including gram stain 4. In interview on March 13, 2024 at 11:20 a.m., General Supervisor 2 confirmed the laboratory did not have documentation of blind samples performed as identified above. ________________________________ A Recertification survey was performed at Trinity Medical Center Laboratory, CLIA # 19D0710168, on October 23, 2023 through October 27, 2023. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A Recertification survey was performed at Trinity Medical Center Laboratory, CLIA # 19D0710168, on October 23, 2023 through October 27, 2023. Trinity Medical Center Laboratory was found not in compliance with the following CONDITION LEVEL DEFICIENCIES: 42 CFR 493.1201: CONDITION: Bacteriology 42 CFR 493.1441: CONDITION: Laboratories Performing High Complexity Testing; Laboratory Director 42 CFR 493.1447: CONDITION: Laboratories Performing High Complexity Testing; Technical Supervisor 42 CFR 493.1459: CONDITION: Laboratories Performing High Complexity Testing; General Supervisor D5002 BACTERIOLOGY CFR(s): 493.1201 If the laboratory provides services in the subspecialty of Bacteriology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1261, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on observation by surveyor, review of laboratory policy and bacteriology records, as well as interview with personnel, the laboratory failed to ensure quality laboratory services for the subspecialty of Bacteriology. Findings: 1. The laboratory failed to follow their policy for reporting urine culture colony count for three (3) of eight (8) patient test records reviewed. Refer to D5401 I. 2. The laboratory failed to perform gram stain quality control daily as required by the laboratory for six (6) of eight (8) days reviewed. Refer to D5401 II. 3. The laboratory failed to maintain complete policies and procedures for Microbiology. Refer to D5403. 4. The laboratory failed to have complete performance verification studies for the Vitek 2 analyzer. Refer to D5421 I. 5. The laboratory failed to have complete performance verification studies for the BacT/Alert 3D analyzer. Refer to D5421 II. 6. The laboratory failed to verify performance specifications for microbiology media. Refer to D5421 III. 7. The laboratory failed to verify the organism colony count was included on the patient final Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 21 -- report for positive urine cultures. Refer to D5421 IV. 8. The laboratory failed to have a complete Individualized Quality Control Plan (IQCP) to support the reduction in frequency of quality control (QC) for Microbiology susceptibility testing on the Vitek 2 analyzer. Refer to D5445. 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 review of laboratory policy, CMS Laboratory Personnel Report (CMS-209), personnel records and interview with personnel, the laboratory failed to ensure written policies and procedures to assess competency for the General Supervisor were complete. Findings: 1. In interview on October 25, 2023 at 9:00 am, General Supervisor 2 stated that she wanted to update the CMS-209 form to include testing personnel 3 as General Supervisor for the specialty of Bacteriology. 2. Review of the laboratory's policy and procedure manual revealed the laboratory did not include a policy to assess the competency for the General Supervisor position and the frequency at which the competency is performed. 3. Review of the Laboratory Personnel Report (CMS-209) form revealed the laboratory identified Personnel 3 serves as General Supervisor. 4. Review of the personnel records for Personnel 3 in 2023 revealed that a competency assessment was not performed for the General Supervisory position. 5. In interview on October 25, 2023 at 9:00 am, General Supervisor 2 stated that Personnel 3 recently stepped in to the supervisory position with the addition of the specialty of Bacteriology. General Supervisor 2 confirmed the laboratory did not have a competency assessment policy or perform assessment for the Personnel 3 for the General Supervisor position. 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 may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: I. Based on review of the laboratory's procedure manual and patient test records as well as interview with laboratory personnel, the laboratory failed to follow their policy for reporting urine culture colony count for three (3) of eight (8) patient test records reviewed. Findings: 1. Review of the laboratory's "Urine Culture Procedure" revealed ">24 hours: Report positive pathogens as X amount in K CFU/ml." 2. Review of patient test records revealed laboratory testing personnel did not document the positive urine culture colony count on the "Micro Flow Sheet" or in the Laboratory Information system (LIS) for the following specimens: - September 17, 2023 - Specimen number 75140 - September 29, 2023 - Specimen number 80567 3. In interview on October 25, 2023 at 3:45 pm, the Laboratory Manager confirmed that testing personnel did not document the colony count for the specimens identified -- 2 of 21 -- above. II. Based on observation, review of patient test records and quality control records, as well as interview with personnel, the laboratory failed to perform gram stain quality control daily as required by the laboratory for six (6) of eight (8) days reviewed. Findings: 1. Observation by surveyors during the laboratory tour on October 23, 2023 at 1:39 p.m. revealed "When to QC" signage in the microbiology department which stated "Gram Stain - Each Day of Use." 2. Further observation by surveyors during the laboratory tour revealed a "Gram Slide" box with hand written instructions stating "QC Gran Stain - Each day of use *Record in yellow binder." 3. In interview on October 23, 2023 at 1:50 p.m., General Supervisor 1 stated gram stain quality control is performed each day of patient testing. 4. Review of patient test records revealed the laboratory did not document gram stain quality control on the "Gram Stain QC Log" on the following days with positive blood culture bottles: - August 13, 2023 - Patient 10325831 - August 15, 2023 - Patient 10325828 - August 19, 2023 - Patient 10326616 - August 22, 2023 - Patient 10326797 - September 13, 2023 - Patient 1032859 - September 17, 2023 - Patient 1032949 5. In interview on October 24, 2023 at 4:20 p.m., General Supervisor 1 confirmed gram stain quality control was not documented on the quality control log on the date identified above. 39352 III. Based on review of the laboratory's policy and procedures, blood bank quality control logsheet and interview with personnel, the laboratory failed to establish complete policies for blood bank. Findings: 1. Review of the blood bank policy manual revealed the laboratory did not have written policies that included the following: a) Blood Bank: written instructions for performance of freezer alarm check quarterly b) Blood Bank: written instructions for documenting the expiration dates for saline 2. In interview on October 25, 2023 at 3:12 pm, General Supervisor 2 stated that an aliquot is poured from the blood bank saline bottle and that the aliquot is utilized for one month (30 days). General Supervisor 1 further stated that personnel documents the monthly expiration date on the aliquot bottle and on the quality control logsheet. 3. Review of the laboratory's blood bank quality control logsheets revealed the laboratory did not document the saline expiration date as per the verbal policy for the following days: a) September 8, 2023 - Lot 2316512 Expiration 12/06/2024 (last documentation of monthly saline expiration on September 1, 2023) b) September 11, 2023 - Lot 2316512 Expiration 12/06/2024 (last documentation of monthly saline expiration on September 1, 2023) c) September 13, 2023 - Lot 2316512 Expiration 12 /06/2024 (last documentation of monthly saline expiration on September 1, 2023) d) September 14, 2023 - Lot 2316512 Expiration 12/06/2024 (last documentation of monthly saline expiration on September 1, 2023) e) September 18, 2023 - Lot 2316512 Expiration 12/06/2024 (last documentation of monthly saline expiration on September 1, 2023) f) September 19, 2023 - Lot 2316512 Expiration 12/06/2024 (last documentation of monthly saline expiration on September 1, 2023) 4. In interview on October 25, 2023 at 3:12 pm, General Supervisor 2 confirmed that laboratory personnel did not document the saline expiration date as required by policy for the above identified dates. 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 -- 3 of 21 -- 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 D0000 A Recertification survey was performed on January 18, 2022 through January 21, 2022 at Trinity Medical Clinical Laboratory, CLIA ID # 19D0710168. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. D5317 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(d) If the laboratory accepts a referral specimen, written instructions must be available to the laboratory's clients and must include, as appropriate, the information specified in paragraphs (a)(1) through (a)(7) of this section. This STANDARD is not met as evidenced by: Based on review of the laboratory's client service manual, manufacturer package inserts and interview with laboratory personnel, the laboratory failed to establish current written instructions for providers to maintain the integrity of samples. Findings: 1. Review of the laboratory's "Client Service Manual" which includes written instructions for sample requirements revealed the laboratory did not include the following (not an all inclusive list) requirements: a) Lactic Acid specimen handling requirements that reflect the manufacturer's instructions b) Ammonia specimen handling requirements that reflect the manufacturer's instructions c) CO2 specimen handling requirements that reflect the manufacturer's instructions d) Calcium specimen handling requirements that reflect the manufacturer's instructions e) Alkaline Phosphatase specimen handling requirements that reflect the manufacturer's instructions f) Albumin specimen handling requirements that reflect the manufacturer's instructions g) ISE (Sodium, Potassium, Chloride) specimen handling requirements that reflect the manufacturer's instructions 2. In interview on January 19, 2022 at 3:45 pm, Personnel 6 stated the laboratory is updating the client service manual. Personnel 6 confirmed the laboratory's client service manual did not include the identified specimen requirements. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 12 -- 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 D0000 A PT Desk Review was performed on June 22, 2020. Riverland Medical Center, CLIA ID # 19D0710168, was found not in compliance with the following CONDITION LEVEL DEFICIENCIES: 42 CFR 493.803 CONDITION: Successful Participation 42 CFR 493.1441 CONDITION: Laboratories performing high 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 review of proficiency testing (PT) results from the CASPER 155D report, the laboratory failed to successfully participate in proficiency testing for Hematology. Refer to D2130. 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 -- D2130 HEMATOLOGY CFR(s): 493.851(f) 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 review of proficiency testing results from the CMS-155D, the laboratory failed to achieve a score of at least 80% for Hematology analytes in two consecutive events, resulting in initial unsuccessful performance. Findings: 1. Review of proficiency testing records and the CMS 155D Report revealed the laboratory received a score of 60% for the following analytes resulting in initial unsuccessful performance: a. 2019 Event 2: Score of 60% for Cell ID or WBC Diff b. 2019 Event 3: Score of 60% for Cell ID or WBC Diff 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 record review and interview with personnel, the Laboratory Director failed to provide overall management and direction. Refer to D6089. D6089 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(i) The laboratory director must ensure the proficiency testing samples are tested as required under subpart H of this part. This STANDARD is not met as evidenced by: Based on record review and interview with laboratory personnel, the laboratory director failed to ensure that proficiency testing samples are satisfactory as required. Findings: 1. The laboratory failed to obtain a satisfactory overall score for Proficiency Testing events for Cell ID or WBC Diff. Refer to D2130. -- 2 of 2 --