The Hospital At Westlake 360

Summary Statement of Deficiencies D0000 Based on a proficiency testing desk review survey performed on July 15, 2025, the laboratory was found to be out of compliance based on the following CONDITION LEVEL DEFICIENCIES: D2016 - 42 C.F.R. 493.803 Condition: Successful participation D6000 - 42 C.F.R. 493.1403 Condition: Laboratory Director, moderate complexity D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on a review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report, 155 Individual Laboratory Profile, and American Proficiency Institute (API) records, the laboratory failed to achieve successful performance in two Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- of three consecutive testing events for 2023 and 2024 and two consecutive testing events in 2025, resulting in non-initial unsuccessful PT performance. Refer to D2096. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) (f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and the American Proficiency Institute (API) testing records for 2023, 2024, and 2025, the laboratory failed to achieve satisfactory performance (80% or greater) for two of three consecutive testing events in 2023 and 2024 and two consecutive events in 2025 for the analyte Creatine Kinase (CK) resulting in non-initial unsuccessful PT performance. The findings included: 1. A review of the CASPER Report 155 listed the following scores for the PT analyte CK, Total: 2023 Event 2: CK, Total - 60 2024 Event 1: CK, Total - 60 2025 Event 1: CK, Total - 60 2025 Event 2: CK, Total - 60 2. A desk review of API proficiency testing records for 2023, 2024, and 2025 confirmed that the laboratory received the following CK, total scores: 2023 Event 2: CK, Total - 60 2024 Event 1: CK, Total - 60 2025 Event 1: CK, Total - 60 2025 Event 2: CK, Total - 60 D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on a desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile, the American Proficiency Institute (API) testing records, the laboratory director failed to ensure successful participation in an HHS approved proficiency testing program for the analyte Creatine Kinase (CK), total for two of three consecutive events from 2023 to 2024 and two consecutive testing events in 2025 resulting in non-initial unsuccessful PT performance. Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) (e)(4)(i) The proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on a desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and the American Proficiency Institute (API) proficiency testing records, the laboratory director failed to ensure -- 2 of 3 -- successful participation in a HHS approved proficiency testing program for the analyte Creatine Kinase (CK), total for two of three consecutive events from 2023 to 2024 and two consecutive testing events in 2025 resulting in non-initial unsuccessful PT performance. Refer to D2096. -- 3 of 3 --

Summary Statement of Deficiencies D0000 The laboratory was surveyed and found to be in compliance with the Conditions of the CLIA regulations found at 42 CFR 493.1 through 493.1780, and recertification is recommended. Standard level deficiencies were cited. D2010 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(2) The laboratory must test samples the same number of times that it routinely tests patient samples. This STANDARD is not met as evidenced by: Based on review of the laboratory's policy and procedures, proficiency test (PT) records, and interview, the laboratory failed to test PT samples the same number of times it routinely tests patients for four out of five events reviewed for 6 out of 30 CBC (Complete Blood Count) and chemistry specimens. Findings follow. A. Review of the laboratory's policy and procedure titled Proficiency Testing Procedure, revised 07/11/2023, under Specific Policies stated, "...This laboratory will test proficiency testing specimens in the same manner as we test patients' specimens. We will use personnel who are authorized by the laboratory director and who routinely test patients' specimens. We will also use methods, and instruments that routinely test patients' specimens. We will test the proficiency specimens integrated into the routine workload using the same number of replicates used for patients' testing...." B. Review of the laboratory's policy and procedure titled Critical Values, revised 03/20/2019, under policy stated, "...Critical values, once they are verified, must be called to the patient care unit responsible for the patient and/or the patient's provider..." Critical Values Chart from the procedure CHEMISTRY Low High Total Bilirubin 15.0 Mg /dL Albumin 0.5 6.0 M/dL Creatinine 3.0 Mg/dL Calcium 6 mg per dL 13.0 mg per dL Carbon Dioxide 10 mEq per L 40.0 mEq per L Chloride 77 121 mEq per L Glucose (Adults) 40 mg per dL 500 Magnesium 1 mg per dL 5.0 mg per dL Phosphorus 1 mg per dL Potassium 3.0 mEq per L 6.0 mEq per L Sodium 120 mEq Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- per L 160.0 mEq per L DRUG LEVELS Acetaminophen 150 mg per dL Salicylate 30 mg per dL C. Review of the American Proficiency Institute (API) Hematology PT testing records for CBCs from the 2nd and 3rd events of 2023, and the 1st event of 2024 showed the PT was distributed to multiple testing personnel and revealed specimens XE-09 was tested in duplicate on 07/17/2023 by testing personnel #2 (as listed on the CMS-209 form); XE-15 was tested on 11/13/2023 and 11/27/2023 by testing personnel #2; and XE-03 was tested twice on 03/08/2024 by testing personnel #4. All three specimens were normal with no indication they should be repeated. Review of the American Proficiency Institute (API) Chemistry Core PT testing records from the 1st and 2nd events of 2024 showed the PT was distributed to multiple testing personnel and revealed specimens CH-01 was tested on 01/12/2024 and repeated on 01/19/2024 by testing personnel #5; CH-04 was tested in positions 4, 5, and 7 on the Vitro on 01/11/2024 and TDM-04 was tested in positions 1 and 2 on the Vitros on 01/11/2024 by testing personnel #4. CH-01 was repeated for Blood Urea Nitrogen (BUN), Creatinine, Sodium, Chloride, Carbon Dioxide (CO2), Amylase, Lipase, Calcium, Magnesium, Phosphorus, Total Protein, Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALKP), Creatinine Kinase (CK), Total Bilirubin that did not meet the repeat criteria. CH-04 was repeated for Glucose, BUN, Sodium, Chloride, CO2, Amylase, Lipase, Magnesium, Phosphorus, Total Protein, AST, ALKP, CK, Total Bilirubin that did not meet the repeat criteria. D. Interview with Technical Supervisor on June 27, 2024 at 1400 hours confirmed the findings. D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on a desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile, the laboratory's American Proficiency Institute (API) proficiency testing records, and confirmed in an interview with laboratory personnel, the laboratory failed to achieve successful performance in two of three testing events for the subspecialty Compatibility testing (See D2181). D2181 COMPATIBILITY TESTING CFR(s): 493.863(e) -- 2 of 6 -- Failure to achieve an overall testing event score of satisfactory for two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile, the laboratory's American Proficiency Institute (API) proficiency testing records, and confirmed in an interview with laboratory personnel, the laboratory failed to attain a score of at least 80 percent for the subspecialty of Compatibility Testing in two out of three testing events in 2023 and 2024 for Immunohematology. Findings follow. A. Review of the CASPER Report 155 Individual Laboratory Profile revealed the laboratory received the following unsuccessful performance for Compatibility Testing in the specialty of Immunohematology in two out of three events: 2023 API 2nd event 80% 2024 API 1st event 0% Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. For Compatibility Testing, any score less than 100% is unsatisfactory performance. B. Review of the API PT Performance Evaluation for the 1st, 2nd, and 3rd testing events from 2023 and the 1st testing event from 2024 PT records revealed the laboratory received a score of 80% in the 2nd event of 2023 and 0% for the 1st event of 2024. The laboratory received a score of 80% when the laboratory reported AUT-10 as Compatible, and the Expected result was Incompatible. The laboratory received a score of 0% when they failed to submit the results by the submission due date. C. Interview with the General Supervisor on June 25, 2024 at 1700 hours in the office confirmed the findings. 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 nursing and laboratory policies and procedures, transfusion records, pre-survey paperwork, and interview, the facility failed to follow its policy and procedure for recording vital signs used to identify blood and blood product transfusion reactions for seven (7) out of eight (8) units reviewed. Findings follow. A. Review of the nursing policy and procedure titled "Blood and Blood Product - Adverse Reaction to Transfusion," revised 07/2021, under Procedure stated, "... Patients receiving blood or blood product transfusion shall have vital signs assessed prior to the infusion, fifteen minutes after initiation of the transfusion and every 30 minutes during the transfusion and upon completion of the transfusion..." The policy does not define what constitutes a vital sign. The policy required vital signs every 30 minutes during the transfusion. B. Review of the laboratory's policy and procedure titled Suspected Transfusion Reaction, revised 06/10/2021, under Principle stated, "... Changes in vital signs may be an indication of an acute adverse reaction to a transfusion. Patients receiving blood or blood product transfusion shall have vital signs assessed prior to the infusion, fifteen minutes after initiation of the transfusion and every 30 minutes during the transfusion and upon completion of the -- 3 of 6 -- transfusion..." The policy does not define what constitutes a vital sign. The policy required vital signs every 30 minutes during the transfusion. B. Seven (7) out of eight (8) randomly selected units transfused reviewed were missing vital signs: 1. Medical Record Number (MR#) 880114518 Unit # W221623656777 packed red blood cells Started 10/09/2023 at 0523 Stopped 10/09/2023 at 0820 Vitals taken at: 05:37 (prior), 0600 (15 minute), 0630 (30 minute), 0700 (1 hour), 0800 (2 hours), 0820 (post) Per policy, missing 1 hour 30-minute vital signs 2. Medical Record Number (MR#) 880114518 Unit # W221623617050 packed red blood cells Started 10/09/2023 at 1148 Stopped 10/09/2023 at 1500 Vitals taken at: 1145 (prior), 1203 (15 minute), 1218 (30 minute), 1248 (1 hour), 1348 (2 hours), 1455 (3 hours), 1512 (post) Per policy, missing 1 hour 30-minute vital signs and 2 hour 30 minute vital signs 3. Medical Record Number (MR#) 880042126 Unit # W221623618747 packed red blood cells Started 11/01/2023 at 2316 Stopped 11/02/2023 at 0216 Vitals taken at: 2316 (prior), ? (15 minute), ? (30 minute), 0025 (1 hour), 0151 (2 hours), 0216 (post) Per policy, missing 1 hour 30-minute vital signs 4. Medical Record Number (MR#) 880042126 Unit # W221623952855 packed red blood cells Started 11/02/2023 at 1210 Stopped 11/02/2023 at 1432 Vitals taken at: 1209 (prior), 1225 (15 minute), 1240 (30 minute), 1310 (1 hour), 1410 (2 hours), 1432 (post) Per policy, missing 1 hour 30-minute vital signs 5. Medical Record Number (MR#) 880042126 Unit # W221623657462 packed red blood cells Started 11/02/2023 at 2236 Stopped 11/03 /2023 at 0200 Vitals taken at: 2223 (prior), 2251 (15 minute), 2310 (30 minute), 0010 (1 hour), 0200 (post) Per policy, missing 1 hour 30-minute vital signs and 2 hour vital signs 6. Medical Record Number (MR#) 880123087 Unit # W22162410855 packed red blood cells Started 03/13/2024 at 1735 Stopped 03/13/2024 at 2000 Vitals taken at: 1715 (prior), 1750 (15 minute), 1605[1805?] (30 minute), 1905 (1.5 hour), 2005 (post) Per policy, missing 1 & 2 hour vital signs 7. Medical Record Number (MR#) 880123514 Unit # W221623656777 packed red blood cells Started 06/09/2024 at 1513 Stopped 06/09/2024 at 1900 Vitals taken at: 1512 (prior), 1628 [1528?] (15 minute), 1543 (30 minute), 1615 (1 hour), 1712 (2 hours), 1900 (post) Per policy, missing 1 hour 30-minute vital signs, 2 hour 30 minute vital signs The Transfusion Record form was missing the 1 hour 30-minute vital signs and 2 hour 30 minute and 3 hour 30 minute vital signs. C. Review of the pre-survey paperwork titled Annual Test Volume & Proficiency Testing Programs Worksheet showed approximately 12 units were transfused in 2023. D. Interview with the General Supervisor on June 26, 2024 at 1630 hours in the office confirmed the findings. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of the IQCP (Individualized QC plan), quality control (QC) records, patient testing records, query, and interview, the laboratory failed to perform external QC every 14 days on the iSTAT used to test blood gases for pH, partial Carbon -- 4 of 6 -- Dioxide (PCO2), and partial Oxygen (PO2) for five (5) out of eight (8) patients tested over a 6-month period. Findings follow. A. Review of the IQCP plan stated, "iStat Blood gases test system qualifies for an Option 1 external control versus internal control study over a 14-day period. The Laboratory has documentation of the successful performance of the control study for a 14-day period. The IQCP control procedure for iStat Blood Gases testing using the G3+ cartridge will include: Documentation of system QC device results every 8 hours. 1. perform and document 2 levels of external controls with each new lot, each shipment, and twice each month for the current lot in use. New testing personnel should also run QC to verify their ability to perform the testing. 2. Perform 2 levels of liquid controls and system QC device whenever results are questioned by the practitioner. If the laboratory fails to perform the IQCP control process correctly, or an external control fails after 1 repeat, or proficiency testing fails, the laboratory must successfully repeat the 14-day study of external and internal controls..." B. Review of QC records from 06/30/2023 - 09/31 /2023 and 02/01/2024 - 04/30/2024 revealed external QC was performed: 1. 06/30 /2023 2. 07/12/2023 3. 08/03/2023 4. 09/01/2023 5. 02/02/2024 6. 03/01/2024 7. 04/01 /2024 C. Review of patient testing records showed patient testing was performed on 1. 08/19/2023 185289 2. 08/24/2023 185383 3. 09/18/2023 185253 4. 03/30/2024 188176 5. 04/17/2024 187762 D. Review of the test count query showed approximately 25 blood gases were performed in 2023. E. Interview with Technical Consultant on June 26, 2024 at 1130 hours confirmed the findings. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on review of the laboratory's policy and procedure, proficiency test (PT) records, and interview, the laboratory director failed to ensure PT samples were tested the same number of times it routinely tests patients for four out of five events reviewed (refer to D2010). 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 a desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile, the laboratory's American Proficiency Institute (API) proficiency testing records, and confirmed in an interview with laboratory personnel, the Laboratory Director failed to provide overall management and direction of the laboratory (refer to D6089). -- 5 of 6 -- 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 a desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile, the laboratory's American Proficiency Institute (API) proficiency testing records, and confirmed in an interview with laboratory personnel, the laboratory director failed to ensure successful participation in an HHS approved proficiency testing program for the subspecialty of Compatibility Testing for two out of three testing events in 2023 and 2024 (refer to D2181). -- 6 of 6 --

Summary Statement of Deficiencies D0000 The laboratory was surveyed and found to be in compliance with the Conditions of the CLIA regulations found at 42 CFR 493.1 through 493.1780, and recertification is recommended. Standard level deficiencies were cited. D2010 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(2) The laboratory must test samples the same number of times that it routinely tests patient samples. This STANDARD is not met as evidenced by: Based on review of the laboratory's policy and procedures, proficiency test (PT) records, and interview, the laboratory failed to test PT samples the same number of times it routinely tests patients for four out of five events reviewed for 6 out of 30 CBC (Complete Blood Count) and chemistry specimens. Findings follow. A. Review of the laboratory's policy and procedure titled Proficiency Testing Procedure, revised 07/11/2023, under Specific Policies stated, "...This laboratory will test proficiency testing specimens in the same manner as we test patients' specimens. We will use personnel who are authorized by the laboratory director and who routinely test patients' specimens. We will also use methods, and instruments that routinely test patients' specimens. We will test the proficiency specimens integrated into the routine workload using the same number of replicates used for patients' testing...." B. Review of the laboratory's policy and procedure titled Critical Values, revised 03/20/2019, under policy stated, "...Critical values, once they are verified, must be called to the patient care unit responsible for the patient and/or the patient's provider..." Critical Values Chart from the procedure CHEMISTRY Low High Total Bilirubin 15.0 Mg /dL Albumin 0.5 6.0 M/dL Creatinine 3.0 Mg/dL Calcium 6 mg per dL 13.0 mg per dL Carbon Dioxide 10 mEq per L 40.0 mEq per L Chloride 77 121 mEq per L Glucose (Adults) 40 mg per dL 500 Magnesium 1 mg per dL 5.0 mg per dL Phosphorus 1 mg per dL Potassium 3.0 mEq per L 6.0 mEq per L Sodium 120 mEq Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- per L 160.0 mEq per L DRUG LEVELS Acetaminophen 150 mg per dL Salicylate 30 mg per dL C. Review of the American Proficiency Institute (API) Hematology PT testing records for CBCs from the 2nd and 3rd events of 2023, and the 1st event of 2024 showed the PT was distributed to multiple testing personnel and revealed specimens XE-09 was tested in duplicate on 07/17/2023 by testing personnel #2 (as listed on the CMS-209 form); XE-15 was tested on 11/13/2023 and 11/27/2023 by testing personnel #2; and XE-03 was tested twice on 03/08/2024 by testing personnel #4. All three specimens were normal with no indication they should be repeated. Review of the American Proficiency Institute (API) Chemistry Core PT testing records from the 1st and 2nd events of 2024 showed the PT was distributed to multiple testing personnel and revealed specimens CH-01 was tested on 01/12/2024 and repeated on 01/19/2024 by testing personnel #5; CH-04 was tested in positions 4, 5, and 7 on the Vitro on 01/11/2024 and TDM-04 was tested in positions 1 and 2 on the Vitros on 01/11/2024 by testing personnel #4. CH-01 was repeated for Blood Urea Nitrogen (BUN), Creatinine, Sodium, Chloride, Carbon Dioxide (CO2), Amylase, Lipase, Calcium, Magnesium, Phosphorus, Total Protein, Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALKP), Creatinine Kinase (CK), Total Bilirubin that did not meet the repeat criteria. CH-04 was repeated for Glucose, BUN, Sodium, Chloride, CO2, Amylase, Lipase, Magnesium, Phosphorus, Total Protein, AST, ALKP, CK, Total Bilirubin that did not meet the repeat criteria. D. Interview with Technical Supervisor on June 27, 2024 at 1400 hours confirmed the findings. D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on a desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile, the laboratory's American Proficiency Institute (API) proficiency testing records, and confirmed in an interview with laboratory personnel, the laboratory failed to achieve successful performance in two of three testing events for the subspecialty Compatibility testing (See D2181). D2181 COMPATIBILITY TESTING CFR(s): 493.863(e) -- 2 of 6 -- Failure to achieve an overall testing event score of satisfactory for two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile, the laboratory's American Proficiency Institute (API) proficiency testing records, and confirmed in an interview with laboratory personnel, the laboratory failed to attain a score of at least 80 percent for the subspecialty of Compatibility Testing in two out of three testing events in 2023 and 2024 for Immunohematology. Findings follow. A. Review of the CASPER Report 155 Individual Laboratory Profile revealed the laboratory received the following unsuccessful performance for Compatibility Testing in the specialty of Immunohematology in two out of three events: 2023 API 2nd event 80% 2024 API 1st event 0% Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. For Compatibility Testing, any score less than 100% is unsatisfactory performance. B. Review of the API PT Performance Evaluation for the 1st, 2nd, and 3rd testing events from 2023 and the 1st testing event from 2024 PT records revealed the laboratory received a score of 80% in the 2nd event of 2023 and 0% for the 1st event of 2024. The laboratory received a score of 80% when the laboratory reported AUT-10 as Compatible, and the Expected result was Incompatible. The laboratory received a score of 0% when they failed to submit the results by the submission due date. C. Interview with the General Supervisor on June 25, 2024 at 1700 hours in the office confirmed the findings. 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 nursing and laboratory policies and procedures, transfusion records, pre-survey paperwork, and interview, the facility failed to follow its policy and procedure for recording vital signs used to identify blood and blood product transfusion reactions for seven (7) out of eight (8) units reviewed. Findings follow. A. Review of the nursing policy and procedure titled "Blood and Blood Product - Adverse Reaction to Transfusion," revised 07/2021, under Procedure stated, "... Patients receiving blood or blood product transfusion shall have vital signs assessed prior to the infusion, fifteen minutes after initiation of the transfusion and every 30 minutes during the transfusion and upon completion of the transfusion..." The policy does not define what constitutes a vital sign. The policy required vital signs every 30 minutes during the transfusion. B. Review of the laboratory's policy and procedure titled Suspected Transfusion Reaction, revised 06/10/2021, under Principle stated, "... Changes in vital signs may be an indication of an acute adverse reaction to a transfusion. Patients receiving blood or blood product transfusion shall have vital signs assessed prior to the infusion, fifteen minutes after initiation of the transfusion and every 30 minutes during the transfusion and upon completion of the -- 3 of 6 -- transfusion..." The policy does not define what constitutes a vital sign. The policy required vital signs every 30 minutes during the transfusion. B. Seven (7) out of eight (8) randomly selected units transfused reviewed were missing vital signs: 1. Medical Record Number (MR#) 880114518 Unit # W221623656777 packed red blood cells Started 10/09/2023 at 0523 Stopped 10/09/2023 at 0820 Vitals taken at: 05:37 (prior), 0600 (15 minute), 0630 (30 minute), 0700 (1 hour), 0800 (2 hours), 0820 (post) Per policy, missing 1 hour 30-minute vital signs 2. Medical Record Number (MR#) 880114518 Unit # W221623617050 packed red blood cells Started 10/09/2023 at 1148 Stopped 10/09/2023 at 1500 Vitals taken at: 1145 (prior), 1203 (15 minute), 1218 (30 minute), 1248 (1 hour), 1348 (2 hours), 1455 (3 hours), 1512 (post) Per policy, missing 1 hour 30-minute vital signs and 2 hour 30 minute vital signs 3. Medical Record Number (MR#) 880042126 Unit # W221623618747 packed red blood cells Started 11/01/2023 at 2316 Stopped 11/02/2023 at 0216 Vitals taken at: 2316 (prior), ? (15 minute), ? (30 minute), 0025 (1 hour), 0151 (2 hours), 0216 (post) Per policy, missing 1 hour 30-minute vital signs 4. Medical Record Number (MR#) 880042126 Unit # W221623952855 packed red blood cells Started 11/02/2023 at 1210 Stopped 11/02/2023 at 1432 Vitals taken at: 1209 (prior), 1225 (15 minute), 1240 (30 minute), 1310 (1 hour), 1410 (2 hours), 1432 (post) Per policy, missing 1 hour 30-minute vital signs 5. Medical Record Number (MR#) 880042126 Unit # W221623657462 packed red blood cells Started 11/02/2023 at 2236 Stopped 11/03 /2023 at 0200 Vitals taken at: 2223 (prior), 2251 (15 minute), 2310 (30 minute), 0010 (1 hour), 0200 (post) Per policy, missing 1 hour 30-minute vital signs and 2 hour vital signs 6. Medical Record Number (MR#) 880123087 Unit # W22162410855 packed red blood cells Started 03/13/2024 at 1735 Stopped 03/13/2024 at 2000 Vitals taken at: 1715 (prior), 1750 (15 minute), 1605[1805?] (30 minute), 1905 (1.5 hour), 2005 (post) Per policy, missing 1 & 2 hour vital signs 7. Medical Record Number (MR#) 880123514 Unit # W221623656777 packed red blood cells Started 06/09/2024 at 1513 Stopped 06/09/2024 at 1900 Vitals taken at: 1512 (prior), 1628 [1528?] (15 minute), 1543 (30 minute), 1615 (1 hour), 1712 (2 hours), 1900 (post) Per policy, missing 1 hour 30-minute vital signs, 2 hour 30 minute vital signs The Transfusion Record form was missing the 1 hour 30-minute vital signs and 2 hour 30 minute and 3 hour 30 minute vital signs. C. Review of the pre-survey paperwork titled Annual Test Volume & Proficiency Testing Programs Worksheet showed approximately 12 units were transfused in 2023. D. Interview with the General Supervisor on June 26, 2024 at 1630 hours in the office confirmed the findings. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of the IQCP (Individualized QC plan), quality control (QC) records, patient testing records, query, and interview, the laboratory failed to perform external QC every 14 days on the iSTAT used to test blood gases for pH, partial Carbon -- 4 of 6 -- Dioxide (PCO2), and partial Oxygen (PO2) for five (5) out of eight (8) patients tested over a 6-month period. Findings follow. A. Review of the IQCP plan stated, "iStat Blood gases test system qualifies for an Option 1 external control versus internal control study over a 14-day period. The Laboratory has documentation of the successful performance of the control study for a 14-day period. The IQCP control procedure for iStat Blood Gases testing using the G3+ cartridge will include: Documentation of system QC device results every 8 hours. 1. perform and document 2 levels of external controls with each new lot, each shipment, and twice each month for the current lot in use. New testing personnel should also run QC to verify their ability to perform the testing. 2. Perform 2 levels of liquid controls and system QC device whenever results are questioned by the practitioner. If the laboratory fails to perform the IQCP control process correctly, or an external control fails after 1 repeat, or proficiency testing fails, the laboratory must successfully repeat the 14-day study of external and internal controls..." B. Review of QC records from 06/30/2023 - 09/31 /2023 and 02/01/2024 - 04/30/2024 revealed external QC was performed: 1. 06/30 /2023 2. 07/12/2023 3. 08/03/2023 4. 09/01/2023 5. 02/02/2024 6. 03/01/2024 7. 04/01 /2024 C. Review of patient testing records showed patient testing was performed on 1. 08/19/2023 185289 2. 08/24/2023 185383 3. 09/18/2023 185253 4. 03/30/2024 188176 5. 04/17/2024 187762 D. Review of the test count query showed approximately 25 blood gases were performed in 2023. E. Interview with Technical Consultant on June 26, 2024 at 1130 hours confirmed the findings. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on review of the laboratory's policy and procedure, proficiency test (PT) records, and interview, the laboratory director failed to ensure PT samples were tested the same number of times it routinely tests patients for four out of five events reviewed (refer to D2010). 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 a desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile, the laboratory's American Proficiency Institute (API) proficiency testing records, and confirmed in an interview with laboratory personnel, the Laboratory Director failed to provide overall management and direction of the laboratory (refer to D6089). -- 5 of 6 -- 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 a desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile, the laboratory's American Proficiency Institute (API) proficiency testing records, and confirmed in an interview with laboratory personnel, the laboratory director failed to ensure successful participation in an HHS approved proficiency testing program for the subspecialty of Compatibility Testing for two out of three testing events in 2023 and 2024 (refer to D2181). -- 6 of 6 --

Summary Statement of Deficiencies D0000 Based on a proficiency testing desk review survey performed on March 5, 2024 the laboratory was found to be out of compliance based on the following CONDITION LEVEL DEFICIENCIES: D2016 - 42 C.F.R. 493.803 Condition: Successful participation D6000 - 42 C.F.R. 493.1403 Condition: Laboratory Director, moderate complexity D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on a review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and American Proficiency Institute (API) records, the laboratory failed to achieve successful performance for Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- two of three consecutive testing events for 2023 and 2024, resulting in unsuccessful performance. Refer to D2096. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and the American Proficiency Institute (API) testing records for 2023 and 2024, the laboratory failed to achieve an overall testing event score of satisfactory performance (80% or greater) for two of three consecutive testing events for the analyte Creatine Kinase (CK). Two out of three overall testing event scores of unsatisfactory performance results in unsuccessful PT performance. The findings included: 1. A review of the CASPER Report 155 listed the following scores for the PT analyte CK, Total: Year Event: Analyte - Score 2023 Event 2: CK, Total - 60 2024 Event 1: CK, Total - 60 2. A desk review of API proficiency testing records for 2023 and 2024 confirmed that the laboratory received a CK, Total score of 60% for the 2nd Event of 2023 and the 1st Event of 2024. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on a desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile, the American Proficiency Institute (API) testing records, the laboratory director failed to ensure successful participation in an HHS approved proficiency testing program for the analyte Creatine Kinase (CK), total for two of three consecutive events from 2023 to 2024. Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on a desk review of the Certification and Survey Provider Enhanced Reporting -- 2 of 3 -- (CASPER) Report 155 Individual Laboratory Profile and the American Proficiency Institute (API) proficiency testing records, the laboratory director failed to ensure successful participation in a HHS approved proficiency testing program for the analyte Creatine Kinase (CK), total, for two of three consecutive events from 2023 to 2024. Refer to D2096. -- 3 of 3 --

Summary Statement of Deficiencies D0000 The facility was found to be in compliance with applicable Conditions of Participation in the CLIA program, and recertification is recommended. D5391 PREANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1249(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the preanalytic systems specified at 493.1241 through 493.1242. This STANDARD is not met as evidenced by: Based on review of the manufacturer's instructions, laboratory's policies and procedures, TAT (Turn Around Time) reports, interview, and LIS (Laboratory Information System) query, the laboratory failed to have a mechanism to monitor whether samples for Lactic Acid performed on the Vitros 350 were spun within 15 minutes of collection for four of 24 samples tested in March 2022. Findings follow. A. Review of the Vitros Instructions for Use, version 11.0 Pub No C-212EN, (also used as the laboratory's policy and procedure) under Specimen Collection Preparation and Storage at Plasma under Specimen Collection and Preparation at Special Precautions stated, "Centrifuge specimens and remove the plasma from the cellular material within 15 minutes of collection." B. Review of the TAT report for March 2022 showed 3 specimens in the 20-24 minute range: Patient ID# Order Date & Time Collection Date & Time Received Date & Time 177841 03/04/2022 20:56 03/04/2022 22:53 03/04/2022 23:15 178043 03/20/2022 8:27 03/20/2022 8:20 03/20/2022 8:40 178152 03/29/2022 4:00 03/29/2022 9:00 03/29/2022 9:20 Review of the TAT report for March 2022 showed 1 specimen in the 30-34 minute range: Patient ID# Order Date & Time Collection Date & Time Received Date & Time 178164 03/28/2022 15: 49 03/28/2022 15:50 03/28/2022 16:22 C. Interview with the Technical Consultant, as listed on the CMS form 209, on May 12, 2022 at 1130 hours in the office explained it was difficult to determine whether the spin within 15 minutes of collection was being Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- met because most of these examples were from patients collected in the ER, and the tubes would have been brought to the lab for processing, sometimes before the physician orders testing. D. LIS Query showed an annual test volume of 274 in 2021. 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 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 facility and laboratory's blood/blood product transfusion policies and procedures, interview, and transfusion records, the facility failed to have defined criteria to identify transfusion reactions following the administration of blood and blood products. Findings follow. 1. Review of the facility's policy and procedure titled Blood and Blood Product- Adverse Reaction to Transfusion, effective 09/02 /2005, under PROCEDURE stated, "Changes in vital signs may be an indication of an acute adverse reaction to a transfusion. Patients receiving blood or blood product transfusion shall have vital signs assessed prior to the infusion, fifteen minutes after initiation of the transfusion and every 30 minutes during the transfusion and upon completion of the transfusion. Vital signs and patient assessment should also be initiated any time there is a suspected reaction to the transfusion. Acute reactions may include allergic, febrile non-hemolytic, septic reactions, circulatory overload and hemolytic reactions. Listed below are signs and symptoms that may be associated with an acute transfusion reaction and can aid in their recognition. Fever with or without chills, defined as 2 degrees F (Fahrenheit) increase in body temperature associated with the transfusion. Shaking chills with or without fever Pain at transfusion site, in chest of flanks. Blood pressure changes, usually acute, either hypertension or hypotension Respiratory distress, including dyspnea, tachypnea, or hypoxemia. Skin changes, including flushing, itching, urticaria, or localized or generalized edema. Nausea with or without vomiting. Circulatory shock in combination with fever, severe chills, hypotension and high-output cardiac failure. 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 -- Circulatory collapse without fever and chills may be the most prominent finding in anaphylaxis." The procedure did not have defined criteria for the change in blood pressure, pulse, or respiratory rate. 2. Review of the laboratory's policy and procedure titled Suspected Transfusion Reaction, revised 01/24/2019, stated, "all personnel involved in ordering and administering transfusions must be able to recognize transfusion reactions, so that if one should occur, the transfusion can be stopped, and

Summary Statement of Deficiencies D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on surveyor observations and interview with facility personnel, the laboratory failed to label 2 of 2 large containers in the frozen section work room with storage requirements, preparation dates, and expiration dates on June 19th, 2018. The findings included: 1. At 11:21 hours on 6/19/218, the surveyor observed two (2) large, clear containers on top of the cryostat in the frozen section work room: a) Container 1 was labeled with a sticker that stated "10% Formalin: CAUTION CONTAINS FORMALDEHYDE, Toxic by inhalation and if swallowed irritating to the eyes, respiratory systems, and skin. May cause sensitization by inhalation or skin contact. Risk of serious damage to eyes. Potential cancer hazard. Repeated or prolonged exposure increased the risk." Container 1 was not labeled with the preparation date of the aliquot, the expiration date of the contents, or the storage requirements. b) Container 2 was labeled with a sticker that stated "10% Formalin: CAUTION CONTAINS FORMALDEHYDE, Toxic by inhalation and if swallowed irritating to the eyes, respiratory systems, and skin. May cause sensitization by inhalation or skin contact. Risk of serious damage to eyes. Potential cancer hazard. Repeated or prolonged exposure increased the risk." There was a biohazard sticker on the top of the container and the words "fornylacelyl-alcohol" written on the lid and the body of the container. The container had the date 4/12/2017 on the side, but it was not clear if it was a preparation date or expiration date. No storage requirements or concentration were found on the container. 2. In an interview at 11:23 hours on 6/19/2018, the Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- Laboratory Manager confirmed the two (2 of 2) aliquots were missing required information. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on a review of the Vitros 350 verification studies, laboratory policy, assay instructions for use, patient records, and interview with facility personnel, the laboratory failed to verify 14 of 19 manufacturer reference ranges were appropriate for the laboratory's patient population. The findings included: 1. Based on review of the Vitros 350 chemistry analyzer (Serial number 27005075) verification study performed in March and April of 2017, the laboratory performed a reference range verification on the following 19 assays: Glucose Blood Urea Nitrogen (BUN) Creatinine Sodium (Na) Potassium (K) Chloride (Cl) Carbon Dioxide (CO2) Calcium (Ca) Total Protein (TP) Albumin (ALB) Aspartate Aminotransferase (AST) Alanine Transaminase (ALT) Alkaline Phosphatase (ALP) Total Bilirubin Amylase Lipase Magnesium Phosphorus Creatinine Kinase (CK) 2. Based on review of the laboratory policy "Reference Range Verification", adopted May 10, 2005, under section III: Reference Range Verification Frequency, the procedures state the following: "Verification of the reference range is requirement prior to reporting of patient results. An initial random sampling using representative samples will usually provide sufficient data to verify the manufacturer's reference range." Under the section V. Procedure: "1. When initiating a new procedure, unless the population to which it will be applied is known to be atypical or unusual, the manufacturer's established range is used as the referend range until the Reference Range Verification procedure is completed. A record must be kept of all patient results reported out prior to completion of the verification procedure." 3. Based on review of the Vitros 350 instructions for use, the manufacturer reference ranges differed from the laboratory's reference ranges as follows: Assay: Albumin Vitros manufacturer reference range: 3.5- 5.0 g/dL Reference range verified by the laboratory: 2.9 - 5.0 g/dL Assay: Alanine Transaminase (ALT) Vitros manufacturer reference range -Males: 21 - 72 U /L Vitros manufacturer reference range - Females: 9 - 52 U/L Vitros manufacturer reference range - Adults: 13 - 69 U/L Reference range verified by the laboratory: 11 -66 U/L Assay: Blood Urea Nitrogen (BUN) Vitros manufacturer reference range - Males: 9 - 20 mg/dL Vitros manufacturer reference range - Females: 7 -17 mg/dL Reference range verified by the laboratory: 8 -25 mg/dL Assay: Calcium Vitros manufacturer reference range: 8.4 -10.2 mg/dL Reference range verified by the laboratory: 8.5 - 10.5 mg/dL Assay: Carbon Dioxide (CO2) Vitros manufacturer reference range: 22 - 30 mmol/L Reference range verified by the laboratory: 18 - 30 mmol/L Assay: Creatinine Kinase (CK) Vitros manufacturer reference range -Males: 55 -170 U/L Vitros manufacturer reference range - Females: 30 - 135 U/L Reference range verified by the laboratory: 37 - 289 U/L Assay: Creatinine (Crea) Vitros manufacturer reference range -Males: 0.66 - 1.25 mg/dL Vitros manufacturer -- 2 of 5 -- reference range - Females: 0.52 -1.04 mg/dL Reference range verified by the laboratory: 0.6 - 1.3 mg/dL Assay: Magnesium Vitros manufacturer reference range: 1.6 - 2.3 mg/dL Reference range verified by the laboratory: 1.3 - 2.3 mg/dL Assay: Sodium (Na) Vitros manufacturer reference range: 137 - 145 mmol/L Reference range verified by the laboratory: 133 -146 mmol/L Assay: Glucose Vitros manufacturer reference range: 74- 106 mg/dL Reference range verified by the laboratory: 65 - 100 mg/dL Assay: Potassium Vitros manufacturer reference range: 3.5 -5.1 (serum) mmol /L Plasma may be 0.1 - 0.7 mmol/L lower than serum range Reference range verified by the laboratory: 3.5 - 5.3 mmol/L Assay: Chloride Vitros manufacturer reference range: 98 -107 mmol/L Reference range verified by the laboratory: 97 - 110 mmol/L Assay: Total Protein Vitros manufacturer reference range: 6.3 - 8.2 g/dL Reference range verified by the laboratory: 6.0 - 8.4 g/dL Assay: Total Bilirubin Vitros manufacturer reference range: 0.2 - 1.3 mg/dL Reference range verified by the laboratory: 0.1 -1.3 mg/dL 4. Based on a random review of patient final reports, the reference ranges of unknown origin that were verified by the laboratory were used on the final patient reports. Examples: Patient: 0144027 Verified on 6/19/2018 Glucose value: 105 Reference range on final patient report: 65 -100 mg/dL Vitros 350 manufacturer reference range: 74 - 106 Patient: 0144035 - Female Verified on 6/18 /2018 Creatinine value: 0.8 mg/dL Reference range on final patient report: 0.6 - 1.3 mg /dL Vitros manufacturer reference range - Females: 0.52 -1.04 mg/dL 5. In an interview at 12:21 hours on 6/20/2018 in the office, the Laboratory Manager stated the origin of the discrepant reference ranges was not known and had been in place prior to her date of hire. Key: g/dL -grams per deciliter U/L - units per liter mmol/L - millimols/Liter D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of the laboratory's Individualized Quality Control Plan (IQCP) procedure and interview with facility personnel, the laboratory failed to identify the frequency and potential impact for each potential source of error identified in the laboratory's Risk Assessment (RA) for the Alere hCG Combo Cassette. The findings included: 1. Based on review of Food and Drug Administration (FDA) decision summary K993065, the analyte hCG is moderate complexity on the Alere hCG Combo Cassette when the specimen source is serum. 2. Review of the Risk Assessment portion of the IQCP for the Alere hCG Combo Cassette, signed by the laboratory director on 12/01/2016, included potential sources of error and mitigation strategies. The Risk Assessment DID NOT include the frequency with which the laboratory defined potential sources of error had occurred or were likely to occur. As a potential risk, the laboratory identified "Are specimens properly collected and are rejected specimens correctly documented? The laboratory failed to identify the frequency of improperly collected specimens for the Alere hCG Combo Cassette -- 3 of 5 -- serum testing. 3. The Risk Assessment DID NOT include an assessment of the potential impact on patient results for each laboratory defined potential source of error. The lab defined "Do all testing personnel have documented training in all aspects of the test method?" as a potential risk of error. The laboratory did not define the potential impact on patient testing when testing personnel have not been trained in all aspects of the test method. 4. In an interview at 14:13 hours on 06/20/2018 in the office, the Laboratory Manager stated that the laboratory monitored potential sources of error through quality assurance activities but had not defined the frequency and impact of each source of error as part of the IQCP risk assessment. Key: hCG -Human chorionic gonadotropin D5465 CONTROL PROCEDURES CFR(s): 493.1256(d)(8)(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-- Test control materials in the same manner as patient specimens. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of AimTab Ketone Tablet instructions for use, laboratory quality control records, patient records, and interview with facility personnel, the laboratory failed to use a control material of a similar matrix to serum 4 of 4 days patients were tested between January 25, 2018 and June 11, 2018. The findings included: 1. Based on review of the AimTab Ketone Tablet instructions for use (Lot: 71093, Expiration: 1 /31/2019), under QUALITY CONTROL: "Performance can be confirmed by suing commercially available positive and negative control materials. Contact Germaine Laboratories at 210-692-4192 for a list of acceptable control materials." 2. Based on a review of quality control and patient testing records from January 25, 2018 and June 11, 2018, serum ketone testing was performed on four (4) patient samples on four (4) days: Date: 1/25/2018 Patient: 0140158 Results: Negative Date: 03/21/2018 Patient: 0141691 Results: Small Date: 03/25/2018 Patient: 0141757 Results: Negative Date: 06 /11/2018 Patient: 0143729 Results: Negative Quality control was documented as being acceptable on all four (4) dates: 1/25/2018, 3/21/2018, 3/25/2018, and 6/11 /2018. 3. In an interview at 13:45 hours on 6/19/2018, when asked what control materials were used on the dates listed above, the Laboratory Manager stated the lab used Kova-Trol Human Urinalysis Controls. When asked if the laboratory had a control material with a similar matrix to serum, the Lab Manager stated the lab did not have a serum quality control material and had always used urine matrix controls to assess the performance of serum AimTab ketone tab performance. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on review of the laboratory's quality managment policy, quality assessment -- 4 of 5 -- records, quality control records, laboratory policies and procedures, patient records, and interview with facility personnel, the laboratory failed to establish and follow quality assessment policies and procedures to identify, monitor, assess, and correct problems in analytic sytems between April 2017 and June 20, 2018. The findings included: 1. The laboratory's quality assessment procedures failed to detect that the laboratory failed to label 2 of 2 large containers in the frozen section work room with storage requirements, preparation dates, and expiration dates on June 19th, 2018. Refer to D5415. 2 The laboratory's quality assessment procedures failed to detect that the laboratory failed to verify 14 of 19 manufacturer reference ranges were appropriate for the laboratory's patient population. Refer to D5421. 3 The laboratory's quality assessment procedures failed to detect that the laboratory failed to identify the frequency and potential impact for each potential source of error identified in the laboratory's Risk Assessment (RA) for the Alere hCG Combo Cassette. Refer to D5445. 4. The laboratory's quality assessment procedures failed to detect that the laboratory failed to use a control material of a similar matrix to serum 4 of 4 days patients were tested between January 25, 2018 and June 11, 2018. Refer to D5465. D6021 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(5) Ensure that quality assessment programs are established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on review of the laboratory's quality assessment records, Vitros 350 chemistry analyzer assay instructions for use, analyzer verification records, quality control records, patient test records, and staff interview, the laboratory director failed to ensure that the quality assessment program was maintained to assure the quality of laboratory services. The findings included: 1. The laboratory director failed to ensure policies and procedures were established and followed to detect problems in analytic laboratory systems. Refer to D5791. -- 5 of 5 --