Christus Spohn Hospital Kleberg Lab

Summary Statement of Deficiencies D0000 The laboratory was found out of compliance with the CLIA regulations. The conditions not met were: D5026 - 42 C.F.R. 493.1217 Condition: Immunohematology D5400 - 42 C.F.R. 493.1250 Condition: Analytic systems D6000 - 42 C.F.R. 493.1403 Condition: Laboratory Director: Moderate Complexity Noted deficiencies and plans of correction were discussed with the laboratory representative at the exit conference. The facility representatives were given an opportunity to provide evidence of compliance with noted deficiencies and no such evidence was provided prior to survey exit. 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 a surveyor observation, review of laboratory policy, proficiency testing records, and confirmed in an interview, the laboratory failed to test proficiency testing samples the same number of times that it routinely tests patient samples for 3 of 3 proficiency test (PT) events reviewed in 2022 for i-STAT blood gas testing. The findings included: 1. In a tour of the laboratory on 4/4/2023 at 09:30 hours, the surveyor noted the following i-STAT used in blood gas analysis: Serial: 337410 TP 11 stated that the i-STAT in use (serial: 337410) was previously the secondary analyzer and that the primary analyzer (serial: 351409) was out of service. 2. Review of the laboratory policy titled "Arterial Blood Gas Manual: Quality Assurance", section "Proficiency Testing" had the following statement: "All survey materials will be tested, when possible, in exactly the same manner as patient samples and as part of the regular workflow." 3. Review of the laboratory PT records, and instrument printouts, for 2022, had the following PT specimens performed on the primary and secondary i-STAT analyzer. AQI-A 2022 Critical Care Blood Gas, iSTAT - CAP Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 26 -- Sample: AQI-A 1 Performed on 02MAR2022 at 16:55, serial: 351409 Performed on 02MAR2022 at 16:55, serial: 337410 Sample: AQI-A 2 Performed on 02MAR2022 at 17:04, serial: 351409 Performed on 02MAR2022 at 17:04, serial: 337410 Sample: AQI-A 3 Performed on 02MAR2022 at 17:10, serial: 351409 Performed on 02MAR2022 at 17:10, serial: 337410 Sample: AQI-A 4 Performed on 02MAR2022 at 17:14, serial: 351409 Performed on 02MAR2022 at 17:15, serial: 337410 Sample: AQI-A 5 Performed on 02MAR2022 at 17:20, serial: 351409 Performed on 02MAR2022 at 17:20, serial: 337410 AQI-B 2022 Critical Care Blood Gas, iSTAT - CAP Sample: AQI-B 6 Performed on 09JUL2022 at 00:42, serial: 351409 Performed on 09JUL2022 at 00:42, serial: 337410 Sample: AQI-B 7 Performed on 09JUL2022 at 00:47, serial: 351409 Performed on 09JUL2022 at 00:47, serial: 337410 Sample: AQI- B 8 Performed on 09JUL2022 at 00:52, serial: 351409 Performed on 09JUL2022 at 00:52, serial: 337410 Sample: AQI-B 9 Performed on 09JUL2022 at 00:57, serial: 351409 Performed on 09JUL2022 at 00:57, serial: 337410 Sample: AQI-B 10 Performed on 09JUL2022 at 01:02, serial: 351409 Performed on 09JUL2022 at 01:02, serial: 337410 AQI-C 2022 Critical Care Blood Gas, iSTAT - CAP Sample: AQI-C 11 Performed on 03NOV2022 at 19:33, serial: 351409 Performed on 03NOV2022 at 19:33, serial: 337410 Sample: AQI-C 12 Performed on 03NOV2022 at 19:38, serial: 351409 Performed on 03NOV2022 at 19:38, serial: 337410 Sample: AQI-C 13 Performed on 03NOV2022 at 19:43, serial: 351409 Performed on 03NOV2022 at 19: 43, serial: 337410 Sample: AQI-C 14 Performed on 03NOV2022 at 19:49, serial: 351409 Performed on 03NOV2022 at 19:49, serial: 337410 Sample: AQI-C 15 Performed on 03NOV2022 at 19:54, serial: 351409 Performed on 03NOV2022 at 19: 54, serial: 337410 Surveyor queried on 4/4/2022 at 12:30 if patients were tested on each analyzer in routine testing, TP 11 stated patients were only tested on one analyzer without routine repeat testing. 4. In an interview on 4/4/2022 at 12:35, in the respiratory department, TP 11 confirmed that patients were not routinely tested on each i-STAT analyzer and that the PT should not have been tested as such. This 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 the laboratory and facility blood product transfusion policies, facility blood transfusion forms, a random review of patient transfusion records (01/01 /2023-01/15/2023 and 08/01/2023-08/15/2023), and confirmed in staff interview, it was revealed the facility failed to ensure transfusion reaction policies promptly identified, investigated, and documented transfusion reactions for 6 of 25 patients that received blood products. Findings Included: 1. Review of facility policy, "Blood Transfusion Administration Procedure" (Revised 05/2022) revealed the following: "13. To initiate, maintain and discontinue the transfusion of unit of blood products:.. b. Document pre-transfusion vital signs. ..g. The RN should remain with or be in a position to closely observe the patient for at least the first 15 minutes of infusion. Signs and symptoms of a fatal transfusion reaction usually occur within this time period. h. The RN or LVN will periodically observe and assess patient for symptoms of transfusion reactions. i. Additional vital signs should be documented as follows: i. -- 2 of 26 -- Just prior to initiating the infusion. ii. Within fifteen (15) minutes after transfusion has started. iii. Every 30 to 60 minutes or more frequently as indicated by patient's condition. iv. At the end of the transfusion. v. One-hour post-transfusion. ..o. Signs and symptoms as described in the next section may occur several hours to several days post transfusion and should be reported to the Transfusion Service for investigation. 14. Transfusion Reaction a. Complications to a transfusion may include the following: i. Urticaria ii. Chills iii. Temperature 2 degrees over baseline iv. Headache v. Nausea vi. Pain vii. Shortness of breath 2. Review of the laboratory policy, "Transfusion Reaction Investigation" (Version 5; Effective 11/05/18) revealed the following: "Procedure: ..8. Review clinical signs and symptoms pre- and post- transfusion. See guidelines to classification of transfusion reaction." 3. During an interview with the regional blood bank supervisor on 04/04/2023 at 1426 hours in the laboratory, the supervisor was asked to provide the guidelines for transfusion reaction classification. The following facility guidelines were provided: "Transfusion Reaction Report Complete information below when a transfusion complication occurs. Type of complication: Urticaria; Chills; Fever; Headache; Shortness of breath; Cyanosis; Nausea; Back Pain; Pain at infusion site; Increased pulse rate; Decreased blood pressure; Significant increase in systolic BP (greater that 40 mm/Hg)" The facility, laboratory policies and facility guidelines failed to define criteria for respiration rate to indicate a transfusion reaction. The facility, laboratory policies and facility guidelines failed to define criteria for pulse rate changes. The laboratory policy and facility guidelines failed to define criteria for an increase in temperature to indicate a transfusion reaction. The facility policy failed to define criteria for systolic blood pressure changes. 4. A random review of blood product administration patient records (01/01/2023-01/15/2023 and 08/01/2023-08/15/2023), revealed the following 6 of 25 patients in which the facility did not follow its own policy to ensure transfusion reactions were promptly identified, investigated, and documented for all blood products: a. Patient 0103:BB00041R Unit Number: W230821720320; Red Blood Cells Transfusion Begin Date/Time: 01/05/2022/0835 Transfusion End Date/Time: 01 /05/2022/1002 Time: 1002 hours Transfusion comment: Time: 1002 hours: PATIENT TRANSPORTED TO EMERGENCY ROOM. PATIENT WAS EXPERIENCING SOB. The patient experienced shortness of breath following the start of a transfusion and was transported to the emergency room. Per facility policy, indicated a possible transfusion reaction. No documentation of a transfusion reaction investigation was provided. b. Patient 0106:BB00045S Unit Number: W230821164034; Red Blood Cells Transfusion Begin Date/Time: 01/06/2022/1620 Transfusion End Date/Time: 01 /06/2022/1832 Pre-Transfusion Vitals documented at 1617: Temperature: 98.0; Blood Pressure: 125/58; Pulse/HR 85; Respiratory rate: 18 Vitals documentation at 1832: Temperature: 98.0; Blood Pressure: 173/74; Pulse/HR 83; Respiratory rate: 18 The patient had a blood pressure increase of 48 mmHg from vitals documented at 1617 hours. Per facility guidelines, an increase in blood pressure by 40 mmHg indicated a possible transfusion reaction. No documentation of a transfusion reaction investigation was provided. c. Patient 0109:BB00045S Unit Number: W230821369206; Red Blood Cells Transfusion Begin Date/Time: 01/11/2022/0054 Transfusion End Date/Time: 01/11/2022/0311 Pre-Transfusion Vitals documented at 0139: Temperature: 98.7; Blood Pressure: 107/52; Pulse/HR 88; Respiratory rate: 12 Vitals documentation at 0310: Temperature: 98.7; Blood Pressure: 159/72; Pulse/HR 100; Respiratory rate: 20 The patient had a blood pressure increase of 52 mmHg from vitals documented at 0310 hours. Per facility guidelines, an increase in blood pressure by 40 mmHg indicated a possible transfusion reaction. No documentation of a transfusion reaction investigation was provided. d. Patient 0808:BB00045S Unit Number: W230822453272; Red Blood Cells Transfusion Begin Date/Time: 08/08 /2022/1141 Transfusion End Date/Time: 08/08/2022/1515 Pre-Transfusion Vitals -- 3 of 26 -- documented at 1145: Temperature: 97.8; Blood Pressure: 94/64; Pulse/HR 112; Respiratory rate: 24 Vitals documentation at 1500: Temperature: 98.1; Blood Pressure: 136/76; Pulse/HR 94; Respiratory rate: 21 The patient had a blood pressure increase of 42 mmHg from vitals documented at 1500 hours. Per facility guidelines, an increase in blood pressure by 40 mmHg indicated a possible transfusion reaction. No documentation of a transfusion reaction investigation was provided. e. Patient 0810:BB00087R Unit Number: W230822682435; Red Blood Cells Transfusion Begin Date/Time: 08/10/2022/2250 Transfusion End Date/Time: 08/11/2022/0042 Pre- Transfusion Vitals documented at 2342: Temperature: 99.1; Blood Pressure: 115/58; Pulse/HR 87; Respiratory rate: 20 Vitals documentation at 0042: Temperature: 99.8; Blood Pressure: 158/67; Pulse/HR 87; Respiratory rate: 18 The patient had a blood pressure increase of 43 mmHg from vitals documented at 1500 hours. Per facility guidelines, an increase in blood pressure by 40 mmHg indicated a possible transfusion reaction. No documentation of a transfusion reaction investigation was provided. f. Patient 0815:BB00029R Unit Number: W230822682658; Red Blood Cells Transfusion Begin Date/Time: 08/15/2022/1128 Transfusion End Date/Time: 08/15 /2022/1351 Pre-Transfusion Vitals documented at 1213: Temperature: 98.2; Blood Pressure: 105/57; Pulse/HR 78; Respiratory rate: 16 Vitals documentation at 1451 (1 hour post vitals): Temperature: 98.4; Blood Pressure: 152/52; Pulse/HR 86; Respiratory rate: 16 The patient had a blood pressure increase of 47 mmHg from vitals documented at 1451 hours. Per facility guidelines, an increase in blood pressure by 40 mmHg indicated a possible transfusion reaction. No documentation of a transfusion reaction investigation was provided. 5. During an interview with the blood bank regional lead technologist on 04/05/2023 at 1324 hours in the conference room, the lead technologist confirmed the facility failed to ensure transfusion reaction policies promptly identified, investigated, and documented transfusion reactions for 6 of 25 patients that received blood products. Word Key RN: Registered Nurse LVN: Licensed Vocational Nurse HR: Heart Rate mm/Hg: millimeters of mercury SOB: Shortness of breath D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on surveyor observation, review of laboratory policy, review of laboratory records, and confirmed in interview, the laboratory failed to retain documentation of test records for the Avoximeter (AVOX) 4000 used in co-oximetry testing for 2021 and 2022. The findings included: 1. In a tour of the laboratory on 4/4/2023 at 09:30 hours, the surveyor noted the following instrument used in Co-Oximetry testing: AVOX 4000: SN 50207 2. Review of the laboratory policy titled "Arterial Blood Gas Manual, Analyzing the Blood Gas Sample" section 2. "Analyzing Co-Oximetry Specimens on the AVOX 4000:" stated the following: "q. Place results printed from AVOX printer in door pocket in ABG Lab for review by the Cardiopulmonary Manager or Clinical Specialist." 3. Surveyor queried as to annual patient test volume for the AVOX 4000 and TP 11 stated, on 4/4/2023 at 11:05 hours, that they estimated five patients were done annually. Surveyor queried for the testing records for 2021 and 2022. TP 11 stated that the records would be hard to pull from the laboratory information system (LIS), but that they would attempt retrieval. At the time of the -- 4 of 26 -- inspection exit on 4/6/2023 at 13:40, the records had not been produced. This confirmed the findings. D5026 IMMUNOHEMATOLOGY CFR(s): 493.1217 If the laboratory provides services in the specialty of Immunohematology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493. 1271, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on review of the Immunohematology records, patient records, and interviews the laboratory failed to meet applicable requirements in the specialty of Immunohematology (refer to D5555 and D5559). 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: I. Based on review of the laboratory's policies, submitted Centers for Medicare and Medicaid Services (CMS) 209 form, personnel records, and staff interview, it was revealed the laboratory failed to have documentation of a policy to assess competency, based on the position responsibilities, for 2 of 2 Technical Consultants (TC-1 and TC-2) performing moderate complexity oversight. Findings Included: 1. Review of laboratory policy, "Employee Competency Evaluation" (Version 4; Effective: 10/05/2018" revealed the following: "The laboratory has defined the following job descriptions: Medical director, Laboratory Manager, Lead Technologist, Medical Technologist, Medical Laboratory Technician, Medical Technologist Student, Phlebotomist, Lab Aide. New employees competence is monitored for the first three months and evaluated thereafter. All employees performance is assessed annually in their job specific performance evaluation." 2. Review of the Centers for Medicare and Medicaid (CMS -209) form submitted at the time of survey, 04/04 /2023, revealed 2 technical consultants (TC-1 and TC-2) for moderate complexity testing. 3. Review of personnel records revealed no documented competency assessment for the duties performed as a technical consultant in 2021 and 2022. 4. On 04/04/2023 at 1148 hours in the conference room, the laboratory was asked to provide a documentation policy of when and how a competency assessment was to be performed on the technical consultant. No documentation was provided. This confirmed the above findings. II. Based on review of the laboratory's policies, submitted Centers for Medicare and Medicaid Services (CMS) 209 form, personnel records, and staff interview, it was revealed the laboratory failed to have documentation of a policy to assess competency, based on the position responsibilities, for 2 of 2 General Supervisors (GS-1 and GS-2) performing high complexity oversight. Findings Included: 1. Review of laboratory policy, "Employee Competency Evaluation" (Version 4; Effective: 10/05/2018" revealed the following: "The laboratory has defined the following job descriptions: Medical director, Laboratory Manager, Lead Technologist, Medical Technologist, Medical Laboratory -- 5 of 26 -- Technician, Medical Technologist Student, Phlebotomist, Lab Aide. New employees competence is monitored for the first three months and evaluated thereafter. All employees performance is assessed annually in their job specific performance evaluation." 2. Review of the Centers for Medicare and Medicaid (CMS -209) form submitted at the time of survey, 04/04/2023, revealed 2 general supervisors (GS-1 and GS-2) for high complexity testing. 3. Review of personnel records revealed no documented competency assessment for the duties performed as a general supervisor in 2021 and 2022. 4. On 04/04/2023 at 1148 hours in the conference room, the laboratory was asked to provide a documentation policy of when and how a competency assessment was to be performed on the general supervisors. No documentation was provided. This confirmed the above findings. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on review of the laboratory's test menu, review of the laboratory's records and staff interview, it was revealed the laboratory failed to have documentation of performing twice annual accuracy assessments for 13 of 13 analytes tested on the MEDTOXscan analyzer in 2021 and 2022. The finding included: 1. A review of the laboratory's test menu revealed the following 13 analytes were tested on the MEDTOXscan analyzer in 2021 and 2022: Tetrahydrocanabinol Phencyclidine Cocaine Methamphetamine Opiates Amphetamine Benzodiazepine Barbiturates Tricyclic antidepressants Methadone Oxycodone Propoxyphene Buprenorphrine 2. A review of the laboratory's College of American Pathologists' and American Proficiency Institute's proficiency testing records from 2021 and 2022 revealed the laboratory failed to include analytes tested on the MEDTOXscan analyzer as part of the proficiency testing. 3. The laboratory was asked to provide documentation of performing twice annual accuracy assessments in 2021 and 2022 for the identified analytes. No documentation was provided. 4. An interview with general supervisor number 2 (as listed on Form CMS 209) on 04/05/2023 at 1240 hours in the laboratory - after her review of the records- confirmed the findings. D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: I. Based on review of manufacturer's instructions for the Architect STAT Troponin-I assay, review of the manufacturer's instructions Architect Alkaline Phosphatase assay, review of the manufacturer's instructions for the Architect Glucose assay, review of the manufacturer's instructions for the Architect ICT (Na, K, Cl) assay, review of -- 6 of 26 -- patient test records, and staff interview, it was revealed the laboratory failed to have a mechanism in place to ensure samples received by the laboratory were kept at a temperature that maintained sample stability. The findings included: 1. A review of the manufacturer's instructions for the Architect STAT Troponin-I assay (G1-0467 /R11, B2K4Y0) under the section titled "Specimen Storage" revealed: Room Temperature 8 hours 2 - 8C less than 72 hours 2. A review of the manufacturer's instructions for the Architect Alkaline Phosphatase assay (307217/R01, B7DVF0) under the section titled "Specimen Storage" revealed: 20 - 25C 7 days 3. A review of the manufacturer's instructions for the Architect Glucose assay (G95983RO2, B3L8C0) under the section titled "Specimen Storage" revealed: 20 - 25C 2 days 4. A review of the manufacturer's instructions for the Architect ICT (Na, K, Cl) assay (306954/R04, B2P3X0) under the section titled "Specimen Storage" revealed: Sodium 20 - 25C 2 weeks Potassium 20 - 25C 1 week Chloride 20 - 25C 7 days 4. A sampling of patient samples received from outside the facility from December 2022 to April 2023 identified the following specimens for which the laboratory did not have a mechanism in place to ensure the samples were received at a temperature that maintained sample stability: a) Date: 12/09/2022 Acct Number: AQ0001404972 Tests: Sodium Potassium Chloride Glucose No documentation sample was kept at 20 - 25C during transport. b) Date: 02/17/2023 Acct Number: AQ0001411497 Tests: Sodium Potassium Chloride Glucose Alkaline Phosphatase No documentation sample was kept at 20 - 25C during transport. c) Date: 01/20/2023 Acct Number: AQ0001408870 Test: Troponin Time from collection to receipt: 12 hours 15 minutes No documentation of temperature the sample was received at to ensure it was received at 2 - 8C. d) Date: 02/01/2023 Acct Number: AQ0001409931 Test: Troponin Time from collection to receipt: 10 hours 36 minutes No documentation of temperature the sample was received at to ensure it was received at 2 - 8C. e) Date; 04/04/2023 Acct Number: AQ0001415875 Test: Troponin Time from collection to receipt: 10 hours 14 minutes No documentation of temperature the sample was received at to ensure it was received at 2 - 8. f) Date: 04/05/2023 Acct Number: AQ0001413450 Test: Troponin Time from collection to receipt: 11 hours 16 minutes No documentation of temperature the sample was received at to ensure it was received at 2 - 8. 5. The laboratory was asked to provide documentation of monitoring the temperature of samples received in the laboratory. No documentation was provided. 6. An interview with general supervisor number 1 (as listed on Form CMS 209) on 04/04/2023 at 1600 hours in her office revealed the laboratory did not monitor the temperature of samples received from other facilities. This confirmed the findings. Key Na - sodium K - potassium Cl - chloride 44278 II. Based on direct observation, review of laboratory policy, random review of patient fibrinogen results (11/2022-12/2022) and staff interview, it was revealed that the laboratory failed to follow their own written policy for fibrinogen specimen acceptability for 2 of 12 patient reviewed in 11/2022 and 12 /2022. Findings Included: 1. During a tour of the laboratory on 04/05/2023 at 1535 hours, the inspector observed 1 ACL Top 350 Coagulation Analyzer processing patient specimens. (SN:19081560) 2. Review of laboratory policy, "ACL TOPS Q.F. A FIBRINOGEN" (Version 1.0; Effective: 01/16/2020) revealed the following: "D. Stored Specimen Stability: 1. Plasma may be analyzed up to 4 hours, if stored at room temperature. 2. If testing is not completed within 4 hours or if shipment is required, the plasma may be stored frozen at less than or equal to -18 Celsius or below for up to 4 weeks if frozen within 4 hours of blood collection." 3. Review of patient fibrinogen reports revealed 2 of 12 patients that were tested beyond the 4 hour stability: a. Patient 1114:CG00148S Ordered: Fibrinogen Collected Date/Time: 11/14/2022/0610 Received Date/Time: 11/14/2022/1211 Elapsed time: 6 hours and 1 minute b. Patient 1114:CG00148S Ordered: Fibrinogen Collected Date/Time: 12/11/2022/0727 Received Date/Time: 12/11/2022/1319 Elapsed time: 5 hours and 52 minutes 4. -- 7 of 26 -- During an interview with the hematology regional lead technologist on 04/06/2023 at 0930 hours in the conference room, the supervisor was asked to provide documentation of the above specimens being frozen after the 4 hour stability, before being analyzed. No documentation was provided. This confirmed the laboratory failed to follow their own written policy for fibrinogen specimen acceptability for 2 of 12 patient reviewed in 11/2022 and 12/2022. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on review of the laboratory's policies, review of laboratory records, review of manufacturer's instructions and staff interview, it was revealed the laboratory failed to meet analytical system requirements. The findings include: 1. The laboratory failed to follow its policy for performing sampling mode comparisons (refer to D5401 I). 2. The laboratory failed to follow its own policy for hematoxylin and eosin (H&E) staining for frozen section processing (refer to D5401 II). 3. The laboratory failed to define, in policy, the intended reactivity for Hematoxylin and Eosin (H&E) staining to ensure predictable staining characteristics of quality control slides for 173 of 173 patients tested in 2021 and 2022 (refer to D5403). 4. The laboratory failed to follow the manufacturer's instructions to ensure samples did not contain platelets (refer to D5411 I). 5. The laboratory failed to follow the manufacturer's instructions to ensure urine samples were within a pH value of 3 - 11 prior to testing (refer to D5411 II). 6. The laboratory failed to follow manufacturer's instructions for establishing the reference interval (patient normal range) for PT reagent (RecombiPlastin) upon installation for 2 of 2 ACL Top Family Series coagulation analyzers in 2019 (refer to D5411 III). 7. The laboratory failed to follow the manufactures instructions for the processing of urine for urine sediment examination for 17 of 17 random patients reviewed in November 2022 (refer to D5411 IV). 8. The laboratory failed to have documentation of performing required studies for 2 of 2 modified FDA-approved assays (refer to D5423). 9. The laboratory failed to have documentation of performing daily maintenance on 3 of 61 days (refer to D5429). 10. The laboratory failed to have a mechanism in place to monitor QC for accuracy and precision over time for the Avoximeter (AVOX) 4000 used in co-oximetry testing for 12 of 12 months (refer to D5441). 11. The laboratory failed to perform two levels of quality control each day of patient testing for 2 out of 59 days for HIV testing (refer to D5447). 12. The laboratory failed to have documentation of performing quality control testing each day of patient testing for 57 of 64 test days on the MEDTOXscan analyzer (refer to D5449). 13. The laboratory failed to test quality control materials as required for body fluid cell counts (refer to D5543). 14. The laboratory failed to have documentation of two instrument comparisons being performed in 2021 and 2022 between the Architect Plus ci4000 analyzer and the MEDTOXscan analyzer (refer to D5775). 15. The laboratory failed to accurately document the date of specimen receipt into the laboratory for 4 of 20 patients (refer to D5787). -- 8 of 26 -- 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 policies and procedures and interview of testing personnel, the laboratory failed to perform result comparisons between the two modes (open and closed) at least once every six months on the Sysmex hematology analyzers as defined in their own policy. The findings included: 1. Review of policy H01 Hematology Quality Assurance (effective 02/99) found on page 6 under the heading Result Comparison:"At least once every six months a comparison between the two modes (open and closed) will be run on the Sysmex XN2000 A and B." 2. The laboratory tested 19,608 patient specimens for Complete Blood Counts using the Sysmex XN Hematology analyzers in 2022. 3. During interview of General Supervisor 1 on the CMS Report 209 Laboratory Personnel Report conducted April 5, 2023 at 11:55 she confirmed that the laboratory did not perform comparison of results between the open and closed modes on the Sysmex Hematology analyzers at least once every 6 months as written in their own procedure. 45469 II. Based on surveyor observation, review of laboratory policy, patient test records, and confirmed in interview, the laboratory failed to follow its own policy for hematoxylin and eosin (H&E) staining for frozen section processing for 173 of 173 patients tested in 2021 and 2022: The findings included: 1. In a tour of the pathology room on 4/5/2023 at 16:10, the surveyor noted the following staining protocol posted above the sink: Solution - Time 1. Frozen Fix - 5-10 seconds 2. H2O - 5 seconds 3. Cryo-Hematoxylin - 1 minute 4. H2O - 10 Seconds 5. Cryo-Acid Alcohol - 1 seconds 6. H2O - 5 seconds 7. Cryo-Bluing Solution - 2 seconds 8. H20 - 10 seconds 9. Cryo-Eosin - 10 seconds 10. Ethanol - 10 seconds 11. Ethanol - 10 seconds 12. Clear Rite3 - 10 seconds 13. Clear Rite3 - 10 seconds 14. Coverslip & Cover Seal or similar mounting medium 2. Review of the laboratory policy titled "Pathology Manual: Frozen Sections", section III "Staining the slides" had the following instruction: "A. Flood the slide with fixative for 5 - 10 seconds. 1. Rinse the slide with deionized water. B. Stain the slide with acidified Hematoxylin for approximately 1 minute. 1. Rinse off the excess stain in deionized water. C. Stain the slide with Cryo-Acid Alcohol rinse on the slide for a 1 seconds 1. Briefly rinse the slide with deionized water. D. Stain the slide with Cryo-Bluing Solution rinse on the slide for a 2 seconds 1. Briefly rinse the slide with deionized water E. Stain the slide with Cryo-Eosin rinse on the slide for a 10 seconds 1. Rinse off the excess stain with Ethanol. 2. Rinse off the excess stain with Clear-Rite. 3. Cover slip with Parmount and a glass cover slip." 3. Review of laboratory specimen logs had the following 173 patient frozen sections stained with H&E: 2021 - 62 patients: A random sampling of 10 are as follows: Date: Specimen # 01/4/2021: 21KS- 1 2/19/2021: 21KS-113 3/18/2021: 21KS-182 05/6/2021: 21KS-295 5/11/2021: 21KS- 306 7/7/2021: 21KS-452 8/6/2021: 21KS-524 9/30/2021: 21KS-629 11/11/2021: 21KS-708 12/23/2021: 21KS - 820 2022 - 111 patients: A random sampling of 10 are as follows: 1/13/2022: 22KS-18 1/24/2022: 22KS-35 2/17/2022: 22KS-90 3/14/2022: 22KS-152 4/14/2022: 22KS-213 5/5/2022: 22KS-263 6/6/2022: 22KS-347 9/22/2022: 22KS-628 10/4/2022: 22KS-669 11/2/2022: 22KS-732 4. In an interview on 4/6/2023 -- 9 of 26 -- at 09:58, in the pathology room, the laboratory director confirmed that the H&E staining protocol in the policy was not the one the laboratory followed when staining frozen tissue samples. This confirmed the findings. 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)