Mercy Hospital Love County

Summary Statement of Deficiencies D0000 The recertification survey was performed on 10/28,29,30/2025. The laboratory was found in compliance with standard-level deficiencies cited. The laboratory had not been operational from 04/27/2024 through 09/01/2025 due the hospital being destroyed by a tornado on 04/27/2024. A temporary Emergency Department and Laboratory were built in the parking lot until a new hospital could be built, and the laboratory began patient testing in the temporary facility on 09/02/2025. Two new analyzers had been purchased while some of the analyzers were salvageable and reinstated for patient testing. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) (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: Based on a review of records, written policies and procedures, observation, and interview with the laboratory manager, the laboratory failed to follow the written policy to ensure that emergency release of blood forms had been signed by the physician for one of one emergency releases reviewed; and failed to follow the written policy for centrifuging urine specimens for microscopic sediment examinations. Findings include: EMERGENCY RELEASE (1) On 10/28/2025 at 10:00 am, the laboratory manager stated the laboratory maintained units of (PRBC's) packed red blood cells in the Helmer refrigerator. The units were to be used for emergency transfusions; (2) A review of the policy titled, "MHLC LAB Emergency Release of Uncrossmatched Blood" stated, "The caregiver will complete an Emergency Transfusion Release Form for the physician's signature. Form should be returned to the lab once signed." (3) A review of documentation of an emergency release 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 -- identified the following for one of one patient record: (a) One unit of O negative packed red blood cells had been released to a patient on 09/10/2025 at 11:02 am. The "Emergency Transfusion Release Form" appeared to be signed by a mid-level provider and not a physician. (4) The documentation was reviewed with the laboratory manager who stated on 10/28/2025 at 02:10 pm, the emergency release had not been signed by a physician. URINE CENTRIFUGE (1) On 10/28/2025 at 11:05 am, the laboratory manager stated microscopic urine sediment examinations were performed in the laboratory and the specimens were processed at a speed of 1500 rpm (revolutions per minute) for five minutes using the Unico centrifuge; (2) Observation of the laboratory on 10/28/2025 at 11:14 am, identified the centrifuge digital display showed it was currently set at 1800 rpm for five minutes; (3) A review of the procedure titled, "MHLC LAB Microscopic Urinalysis" stated, "Place the KOVA tube in a balanced centrifuge and centrifuge at 1500 rpm for five minutes." (4) Interview with the laboratory manager on 10/29/2025 at 11:50 am confirmed the laboratory was not following their procedure for processing urine specimens. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) (b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (b)(1) Water quality. (b)(2) Temperature. (b)(3) Humidity. (b)(4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on observation and interview with the laboratory manager, the laboratory failed to ensure five of five Vacutainer brand tubes were stored as required by the manufacturer. Findings include: (1) Observation of the laboratory refrigerator and interview with the laboratory manager on 10/28/2025 at 10:40 am, identified the following: (a) Five Vacutainer K2, EDTA tubes, lot # 5169892, storage temperature of 4-25 degrees Celsius. (2) Interview with the laboratory manager on 10/28/2025 at 10:40 am confirmed the tubes were being stored below the manufacturer's stated temperature requirements. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) (c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (c)(1) Identity and when significant, titer, strength or concentration. (c)(2) Storage requirements. (c)(3) Preparation and expiration dates. (c)(4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on observation and interview with the laboratory manager and testing person #2, the laboratory failed to label three of three containers with the identity, expiration date, and lot number of the contents. Findings include: (1) On 10/28/2025 at 09:45 -- 2 of 5 -- am, the laboratory manager and testing person #2 stated the laboratory stained peripheral blood smears to perform manual differential testing; (2) Observation of the laboratory on 10/28/2025 at 09:46 am identified three unlabeled Coplin jars, appearing to contain materials used to stain peripheral blood smears; (3) The findings were reviewed with the laboratory manager and testing person #2 who on 10/28/2025 at 09:59 am stated the Coplin jars contained staining materials had not been labeled with the identity, expiration date, and lot numbers. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) (b) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (b)(1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (b)(1)(i) (A) Accuracy. (b)(1)(i)(B) Precision. (b)(1)(i)(C) Reportable range of test results for the test system. (b)(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 records and interview with the laboratory manager, the laboratory failed to utilize the demonstrated reportable range for one of five test systems reinstated for patient testing. Findings include: (1) On 10/28/2025 at 09:30 am, the laboratory manager stated the laboratory reinstated using the Quidel Triage analyzer to perform patient D-dimer testing on 09/02/2025; (2) A review of the performance specification records identified the laboratory had demonstrated a reportable range of 216-3980 ng/ml; (3) Interview with the laboratory manager on 10 /28/2025 at 02:55 pm confirmed the laboratory was using the manufacturer's reportable range of 100-5000 ng/ml instead of the reportable range that had been demonstrated by the laboratory. 47979 Based on a review of records and interview with the laboratory manager, the laboratory failed to demonstrate the reportable range and failed to ensure the performance specification data had been evaluated prior to reinstating the Diesse Mini-Cube test system; and failed to utilize the demonstrated reportable ranges for two of six analytes reviewed on the new Sysmex XN-450 test system. Findings include: I. DEISSE MINI-CUBE ESR (1) On 10/28/2025 at 09:55 am, the laboratory manager stated the laboratory reinstated using the Diesse Mini- Cube analyzer to perform ESR (Erythrocyte Sedimentation Rate) testing on 09/04 /2025; (2) A review of the performance specification records for the new test system identified the following: (a) No evidence the reportable ranges for the analyte ESR had been demonstrated; (b) No evidence the performance specification data had been signed and dated as approved by the laboratory director prior to putting into use for patient testing. (3) Interview with the laboratory manager on 10/28/2025 at 01:25 pm confirmed there was no documentation to substantiate the reportable ranges had been demonstrated and the data had been signed and dated as approved by the laboratory director prior to beginning patient testing. II. SYSMEX XN-450 (1) On 10/28/2025 at 10:00 am, the laboratory manager stated the laboratory began performing CBC (Complete Blood Count) testing using the Sysmex XN-450 analyzer on 09/02/2025; (2) On 10/29/2025, a review of the performance specification records identified the laboratory had demonstrated the following reportable ranges: (a) Hemoglobin: 0.0 - 24.1 g/dL (b) Hematocrit: 0.0 - 68.7% (3) Interview with the laboratory manager on 10 /29/2025 at 11:00 am confirmed the laboratory was using the following manufacturer's reportable ranges: (a) Hemoglobin: 0.1 - 26.0 g/dL (b) Hematocrit: 0.0 -- 3 of 5 -- - 74.5 % 48517 Based on a review of records and interview with the point of care manager, the laboratory failed to utilize the demonstrated reportable ranges for one of five test systems reinstated for patient testing. Findings include: (1) On 10/28/2025 at 10:15 am, the laboratory manager stated the laboratory reinstated using the iSTAT 1 analyzer (serial #(21)399461 and the CG4+ cartridge to perform Blood Gas (pH, pCO2, pO2) testing on 09/02/2025: (2) On 10/29/2025, a review of the performance specifications records identified the laboratory had demonstrated the following reportable ranges: (a) pCO2 - 16.4-84.0 (b) pO2 - 55-409 (3) Interview with the laboratory manager on 10/09/2025 at 01:30 pm confirmed the laboratory was using the following manufacturer's reportable ranges instead of the reportable ranges that had been demonstrated by the laboratory: (a) pCO2 - 5-130 (b) pO2 - 15-530 D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(g) (d)(3)(ii) Each qualitative procedure, include a negative and positive control material; This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory manager, the laboratory failed to perform a negative and positive control material 27 of 40 days of patient urine drug screen testing reviewed from 09/02/2025 through the current date. Findings include: (1) On 10/28/2025 at 09:50 am, the laboratory manager stated the following: (a) The laboratory reinstated using the Med Tox Scan to perform patient Urine Drug Screen testing on 09/02/2025; (b) Negative and Positive QC (Quality Control) materials were performed weekly; (c) An IQCP (Individualized Quality Control Plan) had not been developed for the test system. (2) On 10/29/2025, a review of QC and patient testing records for testing performed from 09/02/2025 through the current date identified negative and positive QC materials had not been performed each day of patient testing for 27 of 40 days. The specific days were (a) 09/03, 04,05,10,12,16,17,18,19,21,23,24,25,26,30/2025 (b) 10/01, 02,03,05,07,08,09,10,14,22,23,24/2025 (3) The records were reviewed with the laboratory manager who stated on 10/29/2025 at 03:15 pm, negative and positive QC materials had not been performed each day of patient testing; D5545 HEMATOLOGY CFR(s): 493.1269(b)(d) (b) For all nonmanual coagulation test systems, the laboratory must include two levels of control material each 8 hours of operation and each time a reagent is changed. This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory manager, the laboratory failed to perform two levels of quality control materials each eight hours of D-dimer testing for one of 30 days of patient testing reviewed from 09/02/2025 through the current date. Findings include: (1) On 10/28/2025 at 09:30 am, the laboratory manager stated the following: (a) The laboratory reinstated using the Quidel Triage analyzer to perform patient D-dimer testing on 09/02/2025; (b) Two levels of QC (Quality Control) materials were performed each eight hours of patient testing. (2) A review of QC and patient records for 30 days of testing performed from 09/02/2025 through the current date identified two levels of QC materials had not been performed each eight hours of patient testing as follows: (a) Two levels of QC -- 4 of 5 -- testing had been performed on 09/23/2025 at 11:12 am (b) A patient test had been performed on 09/23/2025 at 09:33 pm (3) The records were reviewed with the laboratory manager who stated on 10/29/2025 at 01:25 pm two levels of QC materials had not been performed each eight hours of patient testing. D5805 TEST REPORT CFR(s): 493.1291(c) (c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on a review of records, manufacturer package insert, and interview with the laboratory manager, the laboratory failed to ensure test reports for Troponin I testing included information required for interpretation for one of one patient report. Findings include: (1) On 10/28/2025 at 09:30 am, the laboratory manager stated the laboratory reinstated using the Quidel Triage analyzer to perform patient D-dimer testing on 09 /02/2025; (2) A review of the manufacturer's instructions contained in the D-dimer assay package insert for the test system on page 2 under "Warnings and Precautions" stated, "The Quidel Triage D-dimer test should not be used as absolute evidence for PE or DVT. As with all in vitro diagnostic tests, the test results should be interpreted by the physician in conjunction with clinical findings and other test results"; (3) A review of one patient report with D-dimer test results reported on 10/27/2025 at 09:24 am identified the report did not include the manufacturer's statement; (4) The findings were discussed with the laboratory manager who stated on 10/28/2025 at 02:58 pm, the patient reports did not include the statement. -- 5 of 5 --

Summary Statement of Deficiencies D0000 The recertification survey was performed on 10/26,27,28/2022. The laboratory was found in compliance with standard-level deficiencies cited. The findings were reviewed with the administrator, chief of staff, laboratory director, laboratory manager, technical consultant #3, and general supervisor #2 during an exit conference performed at the conclusion of the survey. D2128 HEMATOLOGY CFR(s): 493.851(e) (1) For any unsatisfactory analyte or test performance or testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unacceptable analyte or testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory manager, the laboratory failed to take

Summary Statement of Deficiencies D0000 The recertification survey was performed on 01/25,26,27/2021 The findings were reviewed with laboratory director, laboratory manager, technical consultant #3, general supervisor #5, chief of staff, quality director nurse manager, and the hospital administrator during an exit conference performed at the conclusion of the survey. The laboratory was found out of compliance with the following CLIA regulations: 493.1447; D6108: Technical Supervisor D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on a review of records, written policy, and interview with the laboratory manager, the laboratory failed to have a written technical consultant and general supervisor competency policy based on the position responsibilities as listed in Subpart M. Findings include: (1) On 01/25/2021 the surveyor reviewed the competency assessment policy. It did not include guidance for assessing the competency of the technical consultant and general supervisor; (2) The surveyor then reviewed personnel records for competency assessments performed during 2019 and 2020. There was no evidence of competencies performed for the technical consultant #2, technical consultant #3, general supervisor #1, general supervisor #2, general supervisor #3, general supervisor #4, and general supervisor #5 based on their job responsibilities; (3) The surveyor asked the laboratory manager if a written policy to evaluate the technical consultant and general supervisor based on job responsibilities was available. The laboratory manager stated on 01/25/2021 at 01:25 pm a policy had not been written and the above competencies had not been performed. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 15 -- D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory manager, the laboratory failed to review and evaluate proficiency testing results for two of 28 events. Findings include: (1) On 01/25/2021, the surveyor reviewed 2019 and 2020 proficiency testing records. The following biases were identified (biases were identified using the SDI (Standard Deviation Index) values assigned by the proficiency program): (a) Third Chemistry Core Event (i) Total Cholesterol - 5 of 5 results exhibited a negative bias (aa) Sample CH-11 - SDI of -2.3 (bb) Sample CH-12 - SDI of -2.3 (cc) Sample CH-13 - SDI of -2.7 (dd) Sample CH-14 - SDI of -2.2 (ee) Sample CH-15 - SDI of -2.5 (ii) BNP - 3 of 5 results exhibited a negative bias (aa) Sample CH-12 - SDI of -3.0 (bb) Sample CH-13 - SDI of -2.1 (cc) Sample CH-15 - SDI of -2.4 (iii) Albumin - 3 of 5 results exhibited a negative bias (aa) Sample CH-11 - SDI of -2.8 (bb) Sample CH-12 - SDI of -2.2 (cc) Sample CH-14 - SDI of -2.3 (b) First 2020 Chemistry Core Event (i) Total Cholesterol - 3 of 5 results exhibited a negative bias (aa) Sample CH-02 - SDI of -2.6 (bb) Sample CH-04 - SDI of -2.5 (cc) Sample CH-05 - SDI of -2.0 (ii) Troponin - 3 of 5 results exhibited a positive bias (aa) Sample CM-01 - SDI of 2.6 (bb) Sample CM-03 - SDI of 2.7 (cc) Sample CM-04 - SDI of 2.2 (2) The surveyor could not locate evidence in the records proving the biases had been identified and addressed; (3) The records were reviewed with the laboratory manager. The laboratory manager stated on 01/25/2021 at 06:00 pm the biases had not been addressed. 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: Based on a review of records, manufacturer's instructions, and interview with the laboratory manager, the laboratory failed to follow the manufacturer's instructions for test timing for a blood gas cartridge for one of four test reports. Findings include: (1) On 01/25/2021 at 11:25 am, the laboratory manager stated to the surveyor: (a) The laboratory performed pH, pCO2,and pO2 using the CG4+ cartridge with the Abbott iSTAT 1 Analyzer; (2) On 01/27/2021, the surveyor reviewed the manufacturer's instructions under the section titled, "Mixing and Test Timing (time from collection to cartridge fill) for Chemistry and Blood Gas Cartridge". For test timing, the instructions stated, "Samples for pH, PCO2, PO2, TCO3 and ionized calcium should be tested within 10 minutes."; (3) On 01/27/2021, the surveyor reviewed patient testing records on 1/26/2020, 11/10/2020, 12/02/2020, 12/17/2020, and 12/18/2020 and identified the following for one of four patient test reports: (a) Patient Report -- 2 of 15 -- #20LC-300G0001- The specimen collection date and time was on 10/26/2020 and the result time was on 10/26/2020 at 10:46 am (18 minutes later). (4) The surveyor reviewed the findings with the laboratory manager. The laboratory manager stated on 01/27/2021 at 02:26 pm, the laboratory could not prove the specimen was collected and tested within 10 minutes as required by the manufacturer. 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: Based on a review of records and interview with the laboratory manager, the laboratory failed to follow manual differential procedures for one of 18 patient reports. Findings include: (1) On 01/25/2021 at 11:30 am, the laboratory manager stated to the surveyor CBC (Complete Blood Count) testing was performed on the Sysmex 1000i analyzer; (2) On 01/27/2021, the surveyor reviewed the laboratory's written procedure titled, "HEMATOLOGY CRITERIA FOR MANUAL DIFFERENTIAL" under the section titled, "General Description" stated: (a) "8. When MCHC is > 36 (look for Spherocytes) also look for lipemia or icteric plasma and consider Cold Agglutinens as a possibility.". (3) On 01/27/2021, the surveyor reviewed patient records on 12/03/2020, 12/05/2020, and 12/06/2020 and identified the following: (a) Patient E1504057622 - Tested on 12/03/2020 at 12:47 pm with a MCHC (Mean Corpuscular Hemoglobin Concentration) result of 36.5 g/dL. (4) The surveyor reviewed the record with the laboratory manager and asked if the laboratory had followed their written procedure for MCHC results greater than 36 g/dL. The laboratory manager stated on 01/27/2021 at 10:05 am, the procedure had not been followed as indicated above. D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on a review of records, manufacturer's instructions, and interview with the laboratory manager, the laboratory failed to follow the manufacturer's instructions for verifying morphology flags for four of 18 patient reports. Findings include: (1) On 01 /25/2021 at 11:30 am, the laboratory manager stated to the surveyor CBC (Complete Blood Count) testing was performed on the Sysmex 1000i analyzer; (2) 01/27/2021, the surveyor reviewed the manufacturer's instructions for verifying morphology flags obtained on the analyzer. The following were examples of flags, with the corresponding instructions: (a) Anemia - "Verify RBC morphology on slide" (b) Blasts? - "Perform manual differential" (c) WBC ABN Scattergram - "Perform manual differential" (3) The surveyor randomly reviewed 18 patient records which -- 3 of 15 -- contained morphology flags from CBC testing performed on 12/03/2020, 12/05/2020, and 12/06/2020. For four of the records, there was no evidence the laboratory followed the manufacturer's instructions for verifying the flags. The findings for the four records were: (a) Testing was performed on 12/05/2020 at 02:57 am, with an WBC Abn Scattergram flag obtained; (b) Testing was performed on 12/05/2020 at 08: 44 pm, with an Anemia flag obtained; (c) Testing was performed on 12/06/2020 at 12: 19 am, with an Anemia flag obtained; (c) Testing was performed on 12/06/2020 at 08: 09 am, with a Blasts? flag obtained. (4) The surveyor reviewed the records with the laboratory manager, who stated on 01/27/2020 at 03:41 pm that the flags obtained for the above four patients had not been verified. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory manager, the laboratory failed to ensure control materials were not used beyond the manufacturer's open vial stability for one of one lot number for Erythrocyte Sedimentation Rate; and failed to ensure control materials were not used beyond the manufacturer's expiration date for two of two days. Findings include: ERYTHROCYTE SEDIMENTATION RATE QUALITY CONTROL (1) On 01/25/2021 at 11:00 am, the laboratory manager stated the following to the surveyor: (a) The laboratory performed ESR (erythrocyte sedimentation rate) was performed using the Mini-Cube analyzer; (b) Two levels of ESR-Chex Plus quality control materials were performed each day of patient testing. (2) On 01/26/2021, the surveyor reviewed the manufacturer's information sheet for the control materials. Under the section, "Open-vial stability" the manufacturer stated once opened the controls were stable for "7 days"; (3) The survey reviewed quality control records for one lot number of quality control materials used from 01/03/2021 through the second day of the survey (01/26/2021). It was identified controls had been used beyond the manufacturer's open vial stability date for one of one lot number reviewed as follows: (a) Level 1 (L1) - Lot# 611 had an open date of 01/03/2021 (written on the bottle and observed by the surveyor on 01 /25/2021 at 11:10 am); (1) The quality control material was available for use beyond the manufacturer's open vial stability of 01/10/2021; (b) Level 2 (L2) - Lot# 611 had an open date 01/03/2021 (written on the bottle and observed by the surveyor at 11:10 am); (1) The quality control material was available for use beyond the manufacturer's open vial stability of 01/10/2021. (4) The surveyor reviewed the records with the laboratory manager. The laboratory manager stated on 01/25/2021 at 04:10 pm, the quality control materials were available for use beyond the manufacturer's stability date. BLOOD BANK QUALITY CONTROL (1) On 01/25/2021 at 10:10 am, the laboratory manager stated to the surveyor Crossmatch testing was performed in the laboratory which included ABO Typing using the tube method; (2) On 01/26/2021, the surveyor reviewed quality control for testing performed from 08/14/2019 through 09/07/2019 and identified expired Confidence (Cell 1, Cell 2, Antibody used to validate blood bank procedures) had been used two of three days of quality control testing reviewed. The quality control had been performed on 09/03/2019 and 09/07 /2019 using the expired following reagents: (a) Confidence lot# CNF-160, expiration date 08/27/2019. (3) The surveyor reviewed the records with the laboratory manager -- 4 of 15 -- who stated on 01/26/2021 at 04:15 pm the blood bank reagents had been changed but not documented on the Blood Bank MTS QC Records. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on a review of records, manufacturer's instructions, and interview with the laboratory manager, the laboratory failed to follow the manufacturer's instructions for performing weekly maintenance procedures on the hematology analyzer for two and seven months; and failed to follow manufacturer's instructions for performing weekly maintenance procedures on the MTS Dispenser for 10 of 22 months. Findings include: SYSMEX 1000i (1) On 01/25/2021 at 11:30 am, the laboratory manager stated to the surveyor CBC (Complete Blood Count) testing was performed on the Sysmex XS 1000i analyzer; (2) On 01/26/2021, the surveyor reviewed the manufacturer's maintenance requirements as stated on the manufacturer's maintenance log. The weekly requirement was as follows: (a) Power Down IPU (3) On 01/26/2020, the surveyor reviewed maintenance records from April 2020 through October 2020. The weekly maintenance had not been documented as performed between: (a) 04/22/2020 and 05/07/2020 (b) 10/07/2020 and 10/21/2020 (4) The surveyor reviewed the findings with the laboratory manager. The laboratory manager stated on 01/26/2021 at 04:00 pm the weekly maintenance had not been documented as performed as identified above. MTS DISPENSER (1) On 01/25/20201 at 11:45 am, the laboratory manager stated to the surveyor the laboratory preformed blood bank testing using the Ortho MTS gel system; (2) On 01/26/2020, the surveyor reviewed the manufacture's maintenance requirements as stated on the manufacturer's maintenance log. The weekly requirements were a follows: (a) Clean with 70% isopropyl Alcohol and rinse with deionized or distilled water (3) On 01/26/2021, the surveyor reviewed maintenance records from January 2019 through October 2020. The weekly documented had not been documented as performed between: (a) 02/15/2019 - 03/16 /2019 (b) 03/16/2019 - 04/19/2019 (c) 08/11/2019 - 08/14/2019 (d) 08/14/2019 - 09/26 /2019 (e) 02/14/2020 - 03/13/2020 (f) 05/13/2020 - 05/26/2020 (g) 09/22/2020 - 10/16 /2020 (4) The surveyor reviewed the findings with the laboratory manager. The laboratory manager stated on 01/26/2021 at 04:10 pm the weekly maintenance had not been documented as performed as identified above. D5555 IMMUNOHEMATOLOGY CFR(s): 493.1271(c)(f) (c) Blood and blood products storage. Blood and Blood products must be stored under appropriate conditions that include an adequate temperature alarm system that is regularly inspected. (c)(1) An audible alarm system must monitor proper blood and blood product storage temperature over a 24-hour period. (c)(2) Inspections of the alarm system must be documented. (f) Documentation. The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: -- 5 of 15 -- Based on a review of records and interview with the laboratory manager, the laboratory failed to ensure units of blood were stored under appropriate conditions for five of 13 refrigerator temperature charts. Findings include: (1) On 01/25/2021 at 10: 10 am, the laboratory manager stated the following to the surveyor: (a) The laboratory stored units of packed red blood cells in the blood bank refrigerator; (b) The above units were to be used for patient transfusions. (2) On 01/25/2021 at 10:15 am, the surveyor observed the thermograph temperature recorder for the blood bank refrigerator. It had a recorder connected to it for continuously recording the temperature on thermograph charts (Note: units of packed cells must be stored at 1-6 degrees (C) Centigrade). Each chart monitored the temperature for a 7 day period; (3) On 01/26/2021, the surveyor reviewed 13 refrigerator charts from 08/23/2020 through 11/25/2020. The review showed that five of 13 charts had not been changed by the 7th day of usage as follows: (a) Chart #3 - The chart was put into use on 09/05/2020 and removed on 09/13/2020 (9 days); (b) Chart #6 - The chart was put into use on 09/26 /2020 and removed on 10/04/2020 (9 days); (c) Chart #7 - The chart was put into use on 10/04/2020 and removed on 10/17/2020 (13 days); (d) Chart #8 - The chart was put into use on 10/17/2020 and removed on 10/25/2020 (8 days); (e) Chart #11 - The chart was put into use on 11/07/2020 and removed on 11/15/2020 (9 days); (4) The surveyor reviewed the charts with the laboratory manager who stated on 01/26/2021 at 03:00 pm, the charts had not been changed by the 7th day as stated above. D5559 IMMUNOHEMATOLOGY CFR(s): 493.1271(e)(f) (e) Investigation of transfusion reactions. (e)(1) According to its established procedures, the laboratory that performs compatibility testing, or issues blood or blood products, must promptly investigate all transfusion reactions occurring in facilities for which it has investigational responsibility and make recommendations to the medical staff regarding improvements in transfusion procedures. (e)(2) The laboratory must document, as applicable, that all necessary remedial actions are taken to prevent recurrences of transfusion reactions and that all policies and procedures are reviewed to assure they are adequate to ensure the safety of individuals being transfused. (f) Documentation. The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on a review of written policies and interview with laboratory manager, the laboratory failed to ensure that written policies provided safety for individuals being transfused for two of seven units of packed red blood cells. Findings include: (1) On 05/12/2021 at 10:05 am, technical consultant #2 stated to the surveyor the laboratory performed Crossmatch Testing, which consisted of ABO/Rh, Antibody Screen, and Compatibility testing (performed between the patient and red blood cell donor unit(s)) using the tube method; (2) The surveyor reviewed the hospital policy regarding transfusion reactions. The policy titled, "BLOOD PRODUCT ADMINISTRATION" under the section titled, "DOCUMENTATION", stated: (a) "8. Vital signs are to be recorded prior to starting the blood product, every five minutes for the first fifteen minutes, every thirty minutes times one, and then hourly until the infusion is complete." (3) The surveyor then reviewed records for seven units of PRBCs (Packed Red Blood Cells) that had been transfused on 11/18/2019, 10/28/2020, 12/22/2020, 04 /14/2021, and 04/26/2021 for five patients, and identified the following: (a) Every five minutes for the first fifteen minutes after the transfusion started (i) Patient # V00000883835 - Transfused with 1 unit PRBCs (unit # W091020455662) on 12/22 -- 6 of 15 -- /2020. The transfusion started at 09:05 pm and the first vital was documented at 10:50 pm (1 hour 45 minutes later). (b) Vitals signs every 30 minutes after the first 15 minutes of the transfusion (i) Patient #J00000623009 - Transfused with 1 unit PRBCs (unit #W091020388888) on 10/28/2020. The transfusion started at 07:25 pm and vitals were document at 07:30 pm, 07:35 pm and 08:05 pm (25 minutes later); (4) The surveyor reviewed the findings with technical consultant #2 and general supervisor #3, both stated on 05/13/2021 at 04:00 pm the written policy and procedure for blood administration had not been followed as indicated above. 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 review of records and interview with the laboratory manager, the laboratory director failed to attest that, at the time of testing, proficiency testing samples were tested in the same manner as patient specimens as required under Subpart H for five of 28 events. Findings include: (1) On 01/25/2021, the surveyor reviewed 2019 and 2020 proficiency testing events. For five of 28 events, the attestation statements had been signed approximately one to four months after the samples had been tested (not within a timeframe for the director to attest that, at the time of testing, the proficiency samples had been tested as required) as follows: (a) First 2019 Chemistry Core Event - The sample testing had been completed on 02/04 /2019, and the attestation statement had not been signed by the laboratory director /designee until 06/20/2019; (b) Second 2019 Microbiology Event - The sample testing had been completed on 07/08/2019, and the attestation statement had not been signed by the laboratory director/designee until 08/20/2019; (c) Third 2019 Microbiology Event - The sample testing had been completed on 10/22/2019, and the attestation statement had not been signed by the laboratory director/designee until 12/17/2019; (d) Second 2020 Chemistry Core Event - The sample testing had been completed on 06/09/2020, and the attestation statement had not been signed by the laboratory director/designee until 7/14/2020; (e) Second 2020 Hematology/Coagulation Event - The sample testing had been completed on 07/22/2020, and the attestation statement had not been signed by the laboratory director/designee until 10/20/2020. (2) The surveyor reviewed the findings with the laboratory manager who stated on 01/25 /20201 at 04:45 pm the attestations had been signed approximately one to four months after the proficiency samples had been tested. The surveyor explained that attestation statements must be signed within a timeframe to definitively attest to the fact that proficiency samples were tested in the same manner as patient specimens. D6108 LABORATORY TECHNICAL SUPERVISOR CFR(s): 493.1447 The laboratory must have a technical supervisor who meets the qualification requirements of 493.1449 of this subpart and provides technical supervision in accordance with 493.1451 of this subpart. -- 7 of 15 -- This CONDITION is not met as evidenced by: Based on a review of records and interview with laboratory manager, the technical supervisor failed to provide technical supervision in accordance with 493.1447 of this subpart. Findings include: (1) The technical supervisor failed to ensure the individual who performed the duties and responsibilities of the technical supervisor met the educational qualifications. Refer to D6111. D6111 TECHNICAL SUPERVISOR QUALIFICATIONS CFR(s): 493.1449 (a) The technical supervisor must possess a current license issued by the State in which the laboratory is located, if such licensing is required; and (b) The laboratory may perform anatomic and clinical laboratory procedures and tests in all specialties and subspecialties of services except histocompatibility and clinical cytogenetics services provided the individual functioning as the technical supervisor-- (b)(1) Is a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (b)(2) Is certified in both anatomic and clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or Possesses qualifications that are equivalent to those required for such certification. (c) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the subspecialty of bacteriology, the individual functioning as the technical supervisor must-- (c)(1)(i) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (c)(1)(ii) Be certified in clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (c)(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and (c)(2)(ii) Have at least one year of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of bacteriology; or (c)(3)(i) Have an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution; and (c)(3)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of bacteriology; or (c)(4)(i) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (c)(4)(ii) Have at least 2 years of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of bacteriology; or (c)(5)(i) Have earned a bachelor's degree in a chemical, physical, or biological science or medical technology from an accredited institution; and (c)(5)(ii) Have at least 4 years of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of bacteriology. (d) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the subspecialty of mycobacteriology, the individual functioning as the technical supervisor must-- (d)(1)(i) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (d)(1)(ii) Be certified in clinical pathology by the -- 8 of 15 -- American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (d) (2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor or podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and (d)(2)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of mycobacteriology; or (d)(3)(i) Have an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution; and (d)(3)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of mycobacteriology; or (d)(4)(i) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (d)(4)(ii) Have at least 2 years of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of mycobacteriology; or (d)(5)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (d)(5)(ii) Have at least 4 years of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of mycobacteriology. (e) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the subspecialty of mycology, the individual functioning as the technical supervisor must-- (e)(1)(i) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (e)(1)(ii) Be certified in clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (e) (2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and (e)(2)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of mycology; or (e)(3)(i) Have an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution; and (e)(3)(ii) Have at least 1 year of laboratory training or experience, or both in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of mycology; or (e)(4) (i) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (e)(4)(ii) Have at least 2 years of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of mycology; or (e)(5)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (e)(5)(ii) Have at least 4 years of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of mycology. (f) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the subspecialty of parasitology, the individual functioning as the technical supervisor must-- (f)(1)(i) Be a doctor of medicine or a doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (f)(1)(ii) Be certified in -- 9 of 15 -- clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (f)(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and (f)(2)(ii) Have at least one year of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of parasitology; (f)(3)(i) Have an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution; and (f)(3)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of parasitology; or (f)(4)(i) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (f)(4)(ii) Have at least 2 years of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of parasitology; or (f)(5)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (f)(5)(ii) Have at least 4 years of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of parasitology. (g) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the subspecialty of virology, the individual functioning as the technical supervisor must-- (g)(1)(i) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (g)(1)(ii) Be certified in clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (g) (2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and (g)(2)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of virology; or (g)(3)(i) Have an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution; and (g)(3)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of virology; or (g)(4)(i) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (g)(4)(ii) Have at least 2 years of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of virology; or (g)(5)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (g)(5)(ii) Have at least 4 years of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of virology. (h) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the specialty of diagnostic immunology, the individual functioning as the technical supervisor must- (h)(1)(i) Be a doctor of medicine or a doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (h)(1)(ii) Be certified in -- 10 of 15 -- clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (h)(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and (h)(2)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing for the specialty of diagnostic immunology; or (h)(3)(i) Have an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution; and (h)(3)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of diagnostic immunology; or (h)(4)(i) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (h)(4)(ii) Have at least 2 years of laboratory training or experience, or both, in high complexity testing for the specialty of diagnostic immunology; or (h)(5)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (h)(5)(ii) Have at least 4 years of laboratory training or experience, or both, in high complexity testing for the specialty of diagnostic immunology. (i) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the specialty of chemistry, the individual functioning as the technical supervisor must-- (i)(1)(i) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (i)(1)(ii) Be certified in clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (i)(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and (i)(2)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing for the specialty of chemistry; or (i)(3)(i) Have an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution; and (i)(3)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of chemistry; or (i) (4)(i) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (i)(4)(ii) Have at least 2 years of laboratory training or experience, or both, in high complexity testing for the specialty of chemistry; or (i)(5)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (i)(5)(ii) Have at least 4 years of laboratory training or experience, or both, in high complexity testing for the specialty of chemistry. (j) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the specialty of hematology, the individual functioning as the technical supervisor must-- (j)(1)(i) Be a doctor of medicine or a doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (j)(1)(ii) Be certified in clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (j)(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and (j)(2)(ii) Have at least one year of laboratory training or experience, or both, in high complexity testing for the specialty of hematology (for example, physicians certified either in hematology or hematology and medical oncology by the American Board of Internal Medicine); or (j) (3)(i) Have an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution; and (j)(3)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the -- 11 of 15 -- specialty of hematology; or (j)(4)(i) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (j)(4)(ii) Have at least 2 years of laboratory training or experience, or both, in high complexity testing for the specialty of hematology; or (j) (5)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (j)(5)(ii) Have at least 4 years of laboratory training or experience, or both, in high complexity testing for the specialty of hematology. (k)(1) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the subspecialty of cytology, the individual functioning as the technical supervisor must-- (k)(1)(i) Be a doctor of medicine or a doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (k)(1)(ii) Meet one of the following requirements-- (k)(1)(ii)(A) Be certified in anatomic pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (k)(1)(ii) (B) Be certified by the American Society of Cytology to practice cytopathology or possess qualifications that are equivalent to those required for such certification; (l) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the subspecialty of histopathology, the individual functioning as the technical supervisor must-- (l)(1) Meet one of the following requirements: (l)(1)(i)(A) Be a doctor of medicine or a doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (l)(1)(i)(B) Be certified in anatomic pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; (l)(1)(ii) An individual qualified under 493.1449(b) or paragraph (l)(1) of this section may delegate to an individual who is a resident in a training program leading to certification specified in paragraph (b) or (l)(1)(i)(B) of this section, the responsibility for examination and interpretation of histopathology specimens. (l)(2) For tests in dermatopathology, meet one of the following requirements: (l)(2)(i)(A) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located and-- (l) (2)(i)(B) Meet one of the following requirements: (l)(2)(i)(B)(1) Be certified in anatomic pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (l)(2)(i)(B)(2) Be certified in dermatopathology by the American Board of Dermatology and the American Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (l)(2)(i)(B) (3) Be certified in dermatology by the American Board of Dermatology or possess qualifications that are equivalent to those required for such certification; or (l)(2)(ii) An individual qualified under 493.1449(b) or paragraph (l)(2)(i) of this section may delegate to an individual who is a resident in a training program leading to certification specified in paragraphs (b) or (l)(2)(i)(B) of this section, the responsibility for examination and interpretation of dermatopathology specimens. (l) (3) For tests in ophthalmic pathology, meet one of the following requirements: (l)(3)(i) (A) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located and-- (l)(3)(i)(B) Must meet one of the following requirements: (l)(3)(i)(B)(1) Be certified in anatomic pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (l)(3)(i)(B)(2) Be certified by the American Board of Ophthalmology or possess qualifications that are equivalent to those required for such certification and have successfully completed at least 1 year of formal post-residency fellowship training in ophthalmic pathology; or (l)(3)(ii) An individual qualified under 493.1449(b) or -- 12 of 15 -- paragraph (1)(3)(i) of this section may delegate to an individual who is a resident in a training program leading to certification specified in paragraphs (b) or (1)(3)(i)(B) of this section, the responsibility for examination and interpretation of ophthalmic specimens; or (m) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the subspecialty of oral pathology, the individual functioning as the technical supervisor must meet one of the following requirements: (m)(1)(i) Be a doctor of medicine or a doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located and-- (m)(1)(ii) Be certified in anatomic pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (m)(2) Be certified in oral pathology by the American Board of Oral Pathology or possess qualifications for such certification; or (m)(3) An individual qualified under 493.1449(b) or paragraph (m)(1) or (2) of this section may delegate to an individual who is a resident in a training program leading to certification specified in paragraphs (b) or (m)(1) or (2) of this section, the responsibility for examination and interpretation of oral pathology specimens. (n) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the specialty of radiobioassay, the individual functioning as the technical supervisor must-- (n)(1)(i) Be a doctor of medicine or a doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (n)(1)(ii) Be certified in clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (n)(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and (n)(2)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing for the specialty of radiobioassay; or (n)(3)(i) Have an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution; and (n)(3)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of radiobioassay; or (n)(4)(i) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (n)(4)(ii) Have at least 2 years of laboratory training or experience, or both, in high complexity testing for the specialty of radiobioassay; or (n)(5)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (n)(5)(ii) Have at least 4 years of laboratory training or experience, or both, in high complexity testing for the specialty of radiobioassay. (o) If the laboratory performs tests in the specialty of histocompatibility, the individual functioning as the technical supervisor must either-- (o)(1)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and (o)(1)(ii) Have training or experience that meets one of the following requirements: (o)(1)(ii)(A) Have 4 years of laboratory training or experience, or both, within the specialty of histocompatibility; or (o)(1)(ii)(B)(1) Have 2 years of laboratory training or experience, or both, in the specialty of general immunology; and (o)(1)(ii)(B)(2) Have 2 years of laboratory training or experience, or both, in the specialty of histocompatibility; or (o)(2)(i) Have an earned doctoral degree in a biological or clinical laboratory science from an accredited institution; and (o)(2)(ii) Have training or experience that meets one of the following requirements: (o) (2)(ii)(A) Have 4 years of laboratory training or experience, or both, within the specialty of histocompatibility; or (o)(2)(ii)(B)(1) Have 2 years of laboratory training or experience, or both, in the specialty of general immunology; and (o)(2)(ii)(B)(2) Have 2 years of laboratory training or experience, or both, in the specialty of -- 13 of 15 -- histocompatibility. (p) If the laboratory performs tests in the specialty of clinical cytogenetics, the individual functioning as the technical supervisor must-- (p)(1)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and (p)(1)(ii) Have 4 years of training or experience, or both, i

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the national database. 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 proficiency testing scores, the laboratory failed to successfully participate in a proficiency testing program for the subspecialty of Hematology. Findings include: (1) The laboratory failed to achieve satisfactory performance in two of three testing events for the analyte Cell ID/WBC (White Blood Cell) Differentials. Refer to D2128 and D2130. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- D2128 HEMATOLOGY CFR(s): 493.851(e) (1) For any unsatisfactory analyte or test performance or testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unacceptable analyte or testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Based on a desk review of proficiency testing scores, the laboratory failed to achieve successful performance for the analyte Cell ID/WBC (White Blood Cell) Differential. Findings include: (1) The laboratory failed to achieve satisfactory performance on the Second event in 2019 and the First event in 2020. Refer to D2130. NOTE: The only acceptable

Summary Statement of Deficiencies D0000 The recertification survey was performed 09/10/18-09/13/18. The laboratory was found to be in compliance with standard-level deficiencies cited. The findings were reviewed with the laboratory director and health system vice president via conference call; and with the hospital administrator, laboratory manager, testing person #1, and the director of regional laboratory services at the conclusion of the survey. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on a review of records, manufacturer's instructions, and interview with the laboratory manager, and the director of regional laboratory services, the laboratory failed to perform maintenance procedures as required by the manufacturers of the analyzers used for patient testing. Findings include: COAGULATION ANALYZER (1) On the first day of the survey, the laboratory manager stated to the surveyor, the laboratory performed patient coagulation testing - PT/INR (Prothrombin Time /International Normalized Ratio) and PTT (Partial Thromboplastin Time) testing using the Stago Satellite analyzer; (2) The surveyor identified the following weekly maintenance procedures required by the manufacturer, as documented on the manufacturer's maintenance log: (a) Decontaminate needle and washing well (b) Clean shields (c) Clean carousels (d) Clean sample and product compartments (e) Clean rail (f) Clean rail glass (g) Clean rail, sample and product covers, needle passage (h) Clean optical sensor (i) Clean cover and monitor (j) Decontaminate stir bars (3) The surveyor then reviewed the maintenance logs from 10 months (February, March, May, July, August, and December 2017; and February, April, May, and August 2018) and identified during 3 of the 10 months reviewed, the weekly Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- maintenance had not been documented as performed: (a) Between 02/15/17 and 03/04 /17 (b) Between 05/04/17 and 05/15/17 (4) The findings were reviewed with the laboratory manager and the director of regional laboratory services, who stated to the surveyor, the weekly maintenance had not been documented as performed, as listed above. HEMATOLOGY ANALYZER (1) On the first day of the survey, the laboratory manager stated to the surveyor, the laboratory performed CBC (Complete Blood Count) testing using the Sysmex XS-1000i analyzer; (2) On the second day of the survey, the surveyor identified the manufacturer's required weekly maintenance procedure as documented on the manufacturer's maintenance log, which was "power down the IPU (Internal Processor Unit);" (3) The surveyor then reviewed the maintenance records from 20 months (January 2017 through December 2017, and January 2018 through August 2018) and identified during 6 of the 20 months reviewed, the weekly maintenance had not been documented as performed: (a) Between 03/24/17 and 04/06/17 (b) Between 03/24/18 and 04/02/18 (c) Between 04/23 /18 and 05/04/18 (d) Between 05/22/18 and 06/07/18 (4) The surveyor reviewed the findings with the laboratory manager and the director of regional laboratory services, who stated to the surveyor the weekly maintenance had not been documented as performed, as listed above. D5431 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(2) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document function checks as defined by the manufacturer and with at least the frequency specified by the manufacturer. Function checks must be within the manufacturer's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on a review of records, manufacturer's instructions, and interview with the laboratory manager and the director of regional laboratory services, the laboratory failed to ensure function checks were within the manufacturer's acceptable limits before patient testing was conducted. Findings include: (1) On the first day of the survey, the laboratory manger stated to the surveyor the laboratory performed Chemistry (i.e., Albumin, Carbon Dioxide, Glucose, CK (Creatinine Kinase), Lactic Acid, Lipase, Total Protein, etc.), Toxicology (Acetaminophen, Alcohol, and Digoxin), and Endocrinology (i.e. Free Thyroxine and Prostate Specific Antigen) testing using the Siemens Dimension Expand analyzer; (2) On the second day of the survey, the surveyor reviewed the manufacturer's instructions for performing function checks on the analyzer. The manufacturer required the daily recording of the cuvette temperature. In addition, the manufacturer's acceptable cuvette temperature range was 36.8 to 37.2 degrees Centigrade; (3) The surveyor then reviewed the cuvette temperature records from February, March, April, and November 2017; and January, February, March, April, and August 2018) and identified the temperature was warmer than the manufacturer's acceptable limit on 40 of the 274 days reviewed, as follows: (a) 2017: 21 of 122 days (i) February: 7 of 28 temperatures: Days 1,2, 3,5,6,9,15 (ii) March: 8 of 31 temperatures: Days 12,17 ,20,21,22,26,28,30 (iii) April: 6 of 30 temperatures: Days 5,8,18, 21,22,27 (b) 2018: 19 of 152 days: (i) January: 9 of 31 temperatures: Days 22,23, 25,26,27,28,29,30,31 (ii) February: 8 of 28 temperatures: Days 2,4, 7,9,12,14,21,22 (iii) March: 2 of 31 temperatures: Days 2,7 (4) The surveyor reviewed the records with the laboratory manager, who stated the temperatures had not been maintained as defined by the manufacturer. -- 2 of 2 --