Labcorp Oklahoma, Inc Cityplex

Summary Statement of Deficiencies D0000 The recertification survey was performed on 09/09,10,11,12/2024. The laboratory was found in compliance with standard-level deficiencies cited. The findings were reviewed with the laboratory manager, lead technologist, director of clinical operations, and the laboratory director during an exit conference performed at the conclusion of the survey. 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 a review of records, nursing policy, and interview with the laboratory manager, the facility failed to ensure written policies were followed for documenting vital signs for five of five units of packed red blood cells; and failed to administer three of five units of packed red blood cells according to policy. Findings include: VITAL SIGNS (1) On 09/11/2024 at 2:30 pm, the laboratory manager stated that blood transfusions were performed by nursing staff; (2) A review of the hospital policy titled, "Blood Product Administration" defined vitals as temperature, blood pressure, pulse and respirations and stated: (a) "Baseline vital signs should be taken within 30 minutes before initiation of transfusion"; (b) "Check vitals for the first 15 minutes after initiation (plus or minus five minutes) of the transfusion and then every hour (plus or minus ten minutes) during the transfusion until transfusion is complete"; (c) "A post vital sign should be documented within 20 minutes of stop time". (3) A review of transfusion records for five units identified the policy had not been followed for five units as follows; (a) Unit #W091024188491 - The unit was started at 08:30 am and vital signs were not taken between 8:45 am and 10:15 am; (b) Unit Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 8 -- #W091024163657 - The unit was started at 10:50 am and vital signs were not taken following the completion of the transfusion; (c) Unit #W091024286815 - The unit was started at 06:00 am and vital signs were not taken at the completion of the unit at 08:30 am; (d) Unit #W091024180672 - The unit was started at 9:25 am and vital signs were not taken before or after the completion of the transfusion; (e) Unit #W091024178186 - The unit was started at 2:45 pm and vital signs were not taken after the conclusion of the transfusion. (4) The records were reviewed with the laboratory manager who stated on 09/11/2024 at 02:30 pm, the vital signs had not been documented according to policy. BLOOD ADMINISTRATION (1) On 09/11 /2024 at 2:30 pm, the laboratory manager stated that blood transfusions were performed by nursing staff; (2) A review of the hospital policy titled, "Blood Product Administration" defined the procedure to administer blood products and stated: (a) "Blood components must be started within 30 minutes of issue from the blood bank and must be completed within four hours"; (3) A review of transfusion records for five units identified the policy had not been followed for three units as follows; (a) Unit #W091024163657 - The unit was issued at 10:12 am and was started at 10:50 am; (b) Unit #W091024180672 - The unit was started at 9:25 am and ended at 1:30 pm; (c) Unit #W091024178186 - The unit was started at 2:45 pm and ended at 7:45 pm. (4) The records were reviewed with the laboratory manager who stated on 09/11 /2024 at 02:30 pm, the blood had not been administered according to policy. D5203 SPECIMEN IDENTIFICATION AND INTEGRITY CFR(s): 493.1232 The laboratory must establish and follow written policies and procedures that ensure positive identification and optimum integrity of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results. This STANDARD is not met as evidenced by: Based on a review of policy, observation, and interview with testing person #3 the laboratory failed to follow the policy for preparing platelet poor plasma (PPP) for coagulation testing to ensure optimum integrity of patient specimens. Findings include: (1) On 09/11/2024 at 11:00 am, testing person #3 stated that platelet poor plasma (PPP) was obtained, for coagulation testing performed on the ACL TOP 300 analyzer, by using the Cardinal 24V centrifuge; (2) A review of the policy "Procedure for Verifying Platelet Poor Plasma Using Sysmex XN-100r" stated that the specimens should be spun at 3500 revolutions per minute (RPM) for ten minutes and the platelet count should be less than 10,000; (3) A review of the Platelet Poor Plasma Worksheet revealed that the centrifuge was last checked on 06/12/2024 at the appropriate speed and time of 3500 RPM for 10 minutes; (4) Observation of the laboratory on 09/11 /2024 revealed that the Cardinal 24V centrifuge speed was set at 3350 RPM's; (5) The findings were reviewed with testing person #3 who stated on 09/11/2024 at 11:00 am, the laboratory could not provide evidence the specimens were centrifuged at the appropriate speed to obtain PPP. 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. -- 2 of 8 -- This STANDARD is not met as evidenced by: Based on a review of records, written policies, and interview with the laboratory manager, the laboratory failed to follow their written policy to assess the competency of the technical consultants, based on the position responsibilities as listed in Subpart M, for two of three persons. Findings include: (1) A review of the laboratory policy titled, "Education and Competency Assessment" required the competency of technical consultants be assessed annually; (2) A review of the Form CMS-209 (Laboratory Personnel Report) and personnel records for competency assessments performed during the review period of January 2023 through the current date identified competencies, based on job responsibilities, had not been performed for two of three persons listed as technical consultants on Form CMS-209; (3) The findings were reviewed with the laboratory manager who stated on 09/10/2024 at 10:15 am, the policy had not been followed. 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, written procedure, observation, and interview with the director of clinical operations, laboratory manager, and lead technologist, the laboratory failed to follow their written procedure for coagulation reagent lot change studies for two of two lot numbers; and failed to follow their written procedure for QC (quality control) lot changes for two of two lot numbers. Findings include: REAGENT LOT CHANGES (1) On 09/11/2024 at 09:45 am, the lead technologist stated PT/INR (Prothrombin Time/International Normalized Ratio) and PTT (Partial Thromboplastin Time) testing were performed using the ACL TOP 300 analyzer; (2) On 09/11/2024 at 01:00 pm, the laboratory manager stated the following reagents were put into use on 03/30/2024: (a) PT Reagent - HemosIL Recombiplastin 2G, lot #N1026877 (b) PTT Reagent - HemosIL SynthasIL, lot #N1036542 (3) A review of the procedure titled, "Annual Reagent Lot Change and Quality Control Lot Changes" identified the following: (a) The section titled, "Annual Lot Conversion - Correlation Between Reagent Lots" under "Normal Specimen Collection" stated, "Collect at a minimum, 20 ideally unfrozen specimens for PT and PTT normal reference range verification over a period of 1-3 days. The following criteria for the normal patients must be documented:" (i) "Age - Includes ages that span the population reflecting patient diversity"; (ii) "Sex - Approximately equal numbers of males and females"; (iii) "Drug History - patients excluded if taking the following drugs: Birth control or estrogen containing products, Coumadin, Heparin, Direct Thrombin Inhibitors, Antibiotics"; (iv) "Conditions - Patients excluded if they are pregnant or have any known immunologic disease". (4) A review of the implementation records for the new PT and PTT reagent lot numbers identified the written procedure had not been followed for the normal specimen collection as follows: (a) Although 20 donors had been tested, there was no documentation of the age, gender, health status and medication history of the donors. (5) The records were reviewed with the laboratory manager and lead technologist. Both stated on 09/11/2024 at 01:55 pm, the laboratory -- 3 of 8 -- had not followed their procedure for the PT and PTT lot change studies. QC LOT CHANGES (1) On 09/11/2024 at 03:00 pm, the director of clinical operations and laboratory manager stated the following QC materials used for PT and PTT testing were put into use on 11/23/2023: (a) HemosIL Normal Control 1, lot #N0330178 (b) HemosIL Abnormal Control 3, lot #N0330391 (2) A review of the procedure titled, "Annual Reagent Lot Change and Quality Control Lot Changes" identified the following: (a) The section titled, "Quality Control (QC) Lot Changes" stated: (i) "The minimum number of data points need to establish this site's QC ranges is 30 (30 points for the normal control and 30 points for the abnormal control)"; (ii) "This testing protocol applies to all testing performed on the ACL TOP 300"; (iii) "After new QC means and ranges are calculated, all data points and calculations, after being signed off by the site's Medical Director, should be stored in the appropriate files"; (iv) "The new means and target ranges will be entered into the instrument's QC files when ready to start using the new QC lots". (3) A review of QC records identified the following for PT and PTT testing: (a) No evidence the QC means and ranges had been established for each level of QC materials prior to putting into use; (b) The means and ranges for the new lot numbers were identical to the previous lot numbers that had been in use until 11/22/2023 (Normal control lot #N320752 and Abnormal control lot#N0925651). (4) Interview with the director of clinical operations and laboratory manager confirmed the laboratory had carried over the means and ranges that had been used for the previous lot numbers instead of establishing new means and ranges for the new lot numbers of QC materials. 47979 Based on a review of records, policies and procedures, and interview with the laboratory manager and lead technologist, the laboratory failed to follow their written procedure for performing manual differentials for two of five patient reports. Findings include: (1) On 09/09 /2024 at 02:50 pm, the lead technologist stated CBC (Complete Blood Count) testing was performed on the Sysmex XN-1000 hematology analyzer; (2) A review of the laboratory policy and procedure manual titled" Criteria for Scans and Manual Differentials" stated the following as guidance for when to perform a manual differential or slide review: (a) "Manual Differential are indicated when:" (i) "C. If >2. 0% IG or IMGR or IG PRESENT flag: perform manual diff. If you see >1% Meta, Myelos, or Pros, report the manual differential" (3) A review of five patient records meeting the criteria for a manual differential identified no evidence the laboratory followed their written procedure for two of the five patient records as follows: (a) Patient tested on 06/14/2024 at 04:32 pm with a WBC IP Message of "IG Present" and 3.5% obtained. A slide had been scanned and documented as "Few bands and metas"; (b) Patient tested on 06/15/2024 at 05:51 pm with a WBC IP Message of "IG Present" and 3.6% obtained. A slide had been scanned and documented as "Few immatures seen metas". (4) The findings were reviewed with the laboratory manager who stated on 09/11/2024 at 01:45 pm that the procedure had not been followed as indicated above. 48517 Based on a review of policies and procedures and interview with the laboratory manager, the laboratory failed to have a written procedure that explained the current practices and procedures for issuing blood and blood products. Findings include: BLOOD BANK (1) On 09/11/2024 at 3:30 pm, the laboratory manager stated the laboratory performed blood and blood product transfusions; (2) A review of documentation and interview with the laboratory manager revealed no policy for blood and blood product administration; (3) The findings were reviewed with the laboratory manager, who stated on 09/22/2024 at 3:30 pm, the blood bank did not have a written policy for blood and blood product administration. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) -- 4 of 8 -- 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: (1) Water quality. (2) Temperature. (3) Humidity. (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 lead technologist, the laboratory failed to ensure one of one EPOC test card was being stored as required; and failed to ensure blood collection tubes were stored as required in two of two areas observed in the hospital. Findings include: EPOC TEST CARD STORAGE (1) On 09/10/2024 at 09: 45 am, the lead technologist stated Blood Gas (pH, pCO2, pO2), Sodium, Potassium, Chloride, CO2, BUN (Urea Nitrogen), Creatinine, Ionized Calcium, Hemoglobin, and Hematocrit testing were performed in the ICU (Intensive Care Unit) using the BGEM test card and the EPOC analyzer; (2) Observation of the ICU testing area identified one BGEM card stored in the refrigerator (2-8 degrees Centigrade-C); (3) Review of the manufacturer's storage requirements, as stated on the test card, showed a storage requirement of 15-30 degrees C; (4) The findings were reviewed with the lead technologist who stated on 09/10/2024 at 11:25 am, the test card was not being stored as required by the manufacturer. ICU SUPPLY ROOM (1) Observation of the ICU supply room on 09/10/2024 at 10:15 am identified the following examples of blood collection tubes with the manufacturer's storage requirement, in the room: (a) Ten BD Vacutainer Lithium Heparin tubes, lot #401167; storage requirement of 4-25 degrees C; (b) 13 BD Vacutainer K2 EDTA 7.2 mg tubes, lot #4135162; storage requirement of 4-25 degrees C; (c) 13 BD Vacutainer Buff Na Citrate 3.2% tubes, lot #3352647; storage requirement of 4-25 degrees C. (2) Interview with the lead technologist on 09 /10/2024 at 10:30 am confirmed the temperature of the ICU supply room was not being monitored. NINTH FLOOR STORAGE AREA (1) Observation of the ninth floor storage area on 09/10/2024 at 10:20 am identified the following examples of blood collection tubes with the manufacturer's storage requirement, in the room: (a) 200 BD Vacutainer SST tubes, lot #4130825; storage requirement of 4-25 degrees C; (b) 100 BD Vacutainer K2 EDTA 7.2 mg tubes, lot #4102827; storage requirement of 4-25 degrees C; (c) 200 BD Vacutainer Buff Na Citrate 3.2% tubes, lot #4045029; storage requirement of 4-25 degrees C. (2) Interview with the lead technologist on 09 /10/2024 at 10:30 am confirmed the temperature of the ninth floor storage area was not being monitored. 48517 Based on a review of records, observation, and interview with the laboratory manager, the laboratory failed to ensure 40 of 40 boxes of Liquid Assayed Multiqual quality control materials were stored as required by the manufacturer. Findings include: (1) On 09/10/2024 at 11:00 am observation of the contents of the laboratory freezer #3 identified the following materials: (a) 40 boxes of Liquid Assayed Multiqual quality control material, master lot # 45950; (2) The storage requirement, as stated on the box for the materials was -20 degrees C (Celsius) or colder; (3) Observation of the freezer temperature log from 07/01/2024 through 07 /31/2024 identified the following: (a) The temperatures were warmer than -20 degrees C for two of 31 days reviewed. (4) The findings were reviewed with the laboratory manager who stated on 09/10/2024 at 11:00 am, the freezer temperatures were not within the manufacturer's storage requirements. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) -- 5 of 8 -- 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 observation and interview with the lead technologist, the laboratory failed to ensure testing materials had not exceeded their room expiration date for one of one Troponin I test cartridge observed; and failed to ensure expired blood collection tubes were not available for use in one of two areas observed in the hospital. Findings include: TROPONIN I TEST CARTRIDGE (1) On 09/10/2024 at 09:45 am, the lead technologist stated Troponin I testing was performed in the ICU (Intensive Care Unit) using the cTnI cartridge and the iSTAT 1 analyzer; (2) Observation of the ICU testing area on 09/10/2024 at 11:25 am, identified one cTnI test cartridge (lot #524077A) stored at room temperature, without documentation of when it had been removed from refrigeration; (3) Review of the manufacturer's storage requirements, as stated on the cartridge, showed the following: (a) Stability at 2-8 degrees C (Centigrade) until the expiration date listed on the box; (b) Stability at room temperature (18-30 degrees C) for 14 days. (4) Interview with the lead technologist on 09/10/2024 at 11:25 am, confirmed the cartridge had been placed at room temperature without a method to monitor if it exceeded the manufacturer's room temperature expiration date. EXPIRED BLOOD COLLECTION TUBES (1) Observation of the ninth floor storage area on 09/10/2024 at 11:45 am, identified the following expired supplies that appeared to be available for use: (a) 35 BD Vacutainer Buff. Na Citrate 0.109 M, 3.2% blood collection tubes, lot #3257661 with an expiration date of 06/30/2024. (2) Interview with the lead technologist on 09/10/2024 at 11:50 am confirmed the collection tubes had exceeded their expiration date and were available for use. 47979 Based on a review of manufacturer's instructions, observation, and interview with the lead technologist, the laboratory failed to ensure control materials had not been used beyond the modified expiration date for two of two lot numbers reviewed. Findings include: (1) One 09/09/2024 at 02:50 pm, the lead technologist stated the following: (a) The laboratory performed qualitative serum pregnancy testing using the Cardinal Health hCG Combo Rapid test kit; (b) Quidel positive and negative serum hCG quality control materials were tested monthly according to the IQCP. (2) Observation of the laboratory refrigerator on 09/10/2024 at 09:30 am, identified Quidel serum hCG quality control materials, lot 848A and lot 848B with an opened date of 08/23/2024; (3) A review of the manufacturer's package insert for the QC materials under the heading "Preparation of Controls" stated, "Write the date of reconstitution on the vial label. Controls can be used for two weeks after reconstitution. Store refrigerated."; (4) The findings were discussed with the lead technologist who stated on 09/10/2024 at 09:30 am, the expired positive and negative serum hCG controls were available for use beyond the modified expiration date. 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: -- 6 of 8 -- Based on a review of records, manufacturer's instructions, and interview with the lead technologist and testing person #2, the laboratory failed to ensure the manufacturer's instructions were followed for performing maintenance procedures for the ACL TOP 300 analyzer during the review period of August 2023 through July 2024. Findings include: (1) On 09/11/2024 at 10:00 am, the lead technologist stated PT/INR (Prothrombin Time/International Normalized Ratio), PTT (Partial Thromboplastin Time), and Anti Xa testing were performed using the ACL TOP 300 analyzer; (2) A review of the manufacturer's maintenance log showed the following required maintenance procedure: (a) Every Three Months - Change Bottles (3) A review of maintenance logs from August 2023 through July 2024 identified no documentation the maintenance had been performed between 01/24/2024 and 05/01/2024; (4) The records were reviewed with the lead technologist and testing person #2. Both stated on 09/11/2024 at 10:30 am, the maintenance procedure had not been documented as performed as shown above. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of records and interview with the lead technologist, the laboratory failed to perform QC (quality control) as stated in the IQCP (Individualized Quality Control Plan) for the qualitative serum pregnancy testing for one of nine months reviewed from January 2024 through the current date. Findings include: (1) On 09/09 /2024 at 2:47 pm, the lead technologist stated the following: (a) The laboratory performed qualitative serum pregnancy testing using the Cardinal Health hCG Combo Rapid test kit; (b) Quidel positive and negative serum hCG quality control materials were tested monthly according to the IQCP. (2) A review of QC records from January 2024 through the current date identified no documentation to prove QC had been performed between 07/18/2024 and 09/10/2024; (3) The records were reviewed with the lead technologist who stated on 09/10/2024 at 02:35 pm, QC had not been performed as stated above. D5553 IMMUNOHEMATOLOGY CFR(s): 493.1271(b)(f) (b) Immunohematological testing and distribution of blood and blood products. Blood and blood product testing and distribution must comply with 21 CFR 606.100(b)(12); 606.160(b)(3)(ii) and (b)(3)(v); 610.40; 640.5(a), (b), (c), and (e); and 640.11(b). (f) Documentation. The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: -- 7 of 8 -- Based on a review of records, written policy, and interview with the general supervisor, the laboratory failed to comply with 21 CFR 606.160(b)(3)(v). The laboratory failed to ensure that emergency release of blood forms had been signed by the physician for one of one emergency releases reviewed. Findings include: (1) On 09 /12/2024 at 9:00 am, the general supervisor stated the laboratory maintained units of (PRBC's) packed red blood cells. The units were to be used for patient transfusions; (2) On 09/12/2024 a review of the emergency transfusion tag stated, "I authorize the issuance of blood without Crossmatch as emergency since the life of the patient would be in danger without this blood" and includes a space for physician signature; (3) A review of documentation of emergency issue blood for one patient identified the following for one of one patient records: (a) Unit #W091024267879 was given emergent on 07/09/2024 and the emergency transfusion tag was not signed by the physician. (4) The findings were reviewed with the lab manager on 09/12/2024 at 9:00 am who confirmed that the form had not been signed by the physician. -- 8 of 8 --

Summary Statement of Deficiencies D0000 The recertification survey was performed on 07/26,27,28,29/2022. The laboratory was found in compliance with standard-level deficiencies cited. The findings were reviewed with technical consultant #1, technical consultant #2, and laboratory support at the conclusion of the survey. D2179 COMPATIBILITY TESTING CFR(s): 493.863(d) (1) For any unsatisfactory 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 unsatisfactory 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 technical consultant #1, technical consultant #2, and laboratory support, the laboratory failed to take

Summary Statement of Deficiencies D0000 The recertification survey was performed on 10/26,27,28/2020. The laboratory was found out of compliance with the following CLIA regulation: 493.1409; D6033: Technical Consultant The findings were reviewed with the laboratory director, laboratory manager, director of laboratory operations, laboratory support MLS, and laboratory lead during an exit conference performed at the conclusion of the survey. D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory manager, the laboratory director or designee failed to sign proficiency testing attestation statements for 1 of 13 events. Findings include: (1) On 10/27/2020, surveyor #2 reviewed 2019 and 2020 proficiency testing records and identified the following for 1 of 13 events: (a) First 2019 Chemistry Core Event- The attestation statement had not been signed by the laboratory director or designee. (2) Surveyor #2 reviewed the findings with the laboratory manager who stated on 10/27/2020 at 02:50 pm, the attestation statement had not been signed by the laboratory director or designee as indicated above. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 16 -- D2094 ROUTINE CHEMISTRY CFR(s): 493.841(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 remedial action for unacceptable proficiency testing scores. Findings include: (1) On 10/27/2020, surveyor #2 reviewed 2019 and 2020 proficiency testing records. The following was identified: (a) First 2019 Chemistry Core Event (i) Sodium - The laboratory received a score of 40%. The results for samples CH-01, CH-04, and CH-05 had failed. There was no documentation to prove that remedial action had been taken. (2) Surveyor #2 reviewed the records with the laboratory manager and asked if remedial action had been taken for the failures. The laboratory manager reviewed the records and stated on 10/27/2020 at 02:55 pm there was no evidence that remedial action had been taken. 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 and interview with the laboratory manager, the laboratory failed to have a written technical supervisor and general supervisor competency policy based on the job responsibilities as listed in Subpart M. Findings include: (1) On 10/26/2020, surveyor #2 reviewed personnel records for competency assessments performed during 2019 and 2020. There was no evidence competencies had been performed for the technical supervisor and general supervisor based on their job responsibilities; (2) Surveyor #2 asked the laboratory manager if a written policy to evaluate the technical supervisor and general supervisor, based on job responsibilities, was available and if competencies had been performed during the review period. The laboratory manager stated to surveyor #2 on 10/28/2020 at 04:30 pm, a policy to evaluate the technical supervisor and general supervisor based on job responsibilities had not been written; and competencies had not been performed. 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. -- 2 of 16 -- 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 2 of 13 events. Findings include: FAILURES (1) On 10/27/2020, surveyor #2 reviewed 2019 and 2020 proficiency testing records and identified the following failures: (a) First 2019 Chemistry Core Event (i) CO2 - The laboratory failed the results for 3 of 5 samples (CH-01, CH-03, CH-05); (ii) Total Protein - The laboratory failed the results for 1 of 5 samples (CH-02) (b) Second 2020 Chemistry Core Event (i) TCO2 - The laboratory failed the results for 1 of 5 samples (IB-09) (2) The records were then reviewed further by the surveyor. There was no evidence

Summary Statement of Deficiencies D0000 The survey was performed 06/26/18 through 06/28/18. The laboratory was found out of compliance with the following CLIA regulations: 493.1215: D5024: Condition: Hematology 493.1250: D5400: Condition: Analytic Systems 493.1407: D6000: Condition: Laboratory Director, Moderate Complexity The findings were reviewed with the technical consultant and the patient services director at the conclusion of the survey. D5024 HEMATOLOGY CFR(s): 493.1215 If the laboratory provides services in the specialty of Hematology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1269, and 493. 1281 through 493.1299. This CONDITION is not met as evidenced by: Based on a review of records, manufacturer's instructions, and interview with the technical consultant, the patient services director, testing person #1, and testing person #2, the laboratory failed to ensure the requirements were met for the specialty of Hematology. Findings include: (1) The laboratory failed to follow the manufacturer's instructions for testing performed. Refer to D5411; (2) The laboratory failed to demonstrate the performance specifications for a new test system. Refer to D5421; (3) The laboratory failed to follow the manufacturer's specifications for control materials. Refer to D5479. 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 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 14 -- 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 a review of records, manufacturer's instructions, policies and procedures, and interview with the technical consultant, the patient services director, testing person #1, and testing person #2, the laboratory failed to monitor and evaluate the overall quality of analytic systems. Findings include: (1) The laboratory failed to ensure the laboratory's policies and procedures were followed. Refer to D5401; (2) The laboratory failed to follow the manufacturer's instructions for the testing performed. Refer to D5411; (3) The laboratory failed to demonstrate the performance specifications for a new test method. Refer to D5421; (4) The laboratory failed to perform the manufacturers' required maintenance procedures. Refer to D5429; (5) The laboratory failed to have quality control procedures that monitored the accuracy and precision of the analytic process. Refer to D5441; (6) The laboratory failed to document the reactivity of the H&E stain quality control slide each day of patient testing. Refer to D5473; (7) The laboratory failed to follow the manufacturer's specifications for control materials. Refer to D5479; (8) The laboratory failed to ensure permanent testing records were maintained. Refer to D5787; (9) The laboratory failed to have an effective ongoing mechanism for performing analytic quality assessment. Refer to D5791. NOTE: D5400 was cited on the initial certification survey performed 06/14/16-06/16/16. 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, policies and procedures, and interview with the technical consultant and the patient services director, the laboratory failed to follow its policy and procedure for storage of blood components. Findings include: (1) On the second day of the survey, the surveyor reviewed the "Testing Component Storage Equipment Alarms" policy and procedure for the blood bank refrigerator, which stated the following: (a) High alarm activation: (i) After the low alarm activation check is performed, "Remove the sensor and adjust the temperature of the water back to about 4 degrees C;" (ii) "Allow the thermometer to equilibrate to the temperature of the water;" (iii) "Place the sensor into the cup or beaker. With continuous stirring, slowly add room temperature water to create a slow rise in temperature of about 0.5 degrees C per minute" (iv) "The alarm should sound at 5.5 degrees C;" (v) "Evaluate acceptability of results." (2) The surveyor then reviewed the quarterly refrigerator alarm check records from 01/01/17 through 06/27/18. The records indicated 3 of the 4 quarterly refrigerator high alarm checks performed during the review period were unacceptable, as follows: (a) 02/28/17: The high temperature check activated the alarm at 6.0 degrees C (b) 08/28/17: The high temperature check activated the alarm at 6.0 degrees C (c) 11/30/17: The high temperature check activated the alarm at 6.0 degrees C (3) The surveyor reviewed the findings with the technical consultant and -- 2 of 14 -- the patient services director, who stated to the surveyor the laboratory failed to follow its policy for the acceptable limits of the high alarm checks, as listed above. NOTE: D5401 was cited on the initial certification survey performed 06/14/16-06/16/16. 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 technical consultant, the patient services director, and testing person #1, the laboratory failed to follow the manufacturer's instructions for the testing performed. Findings include: (1) On the first day of the survey, the technical consultant stated to the surveyor the laboratory discontinued using the Stago Satellite coagulation analyzer and replaced it with the ACL TOP 300 analyzer on 11/10/17 to perform PT/INR (Protime/International Normalized Ratio), PTT (Partial Thromboplastin Time), D- dimer, Fibrinogen, and Anti-Xa testing on 11/10/17; (2) The surveyor reviewed the laboratory's implementation records and identified the laboratory's reference intervals (i.e. normal patient ranges) were established using 45 patients, instead of the 120 patients as required by the manufacturer for a full reference interval study when a new instrument and/or methodology is put into use for patient testing; (3) The surveyor asked the technical consultant and the patient services director if the laboratory had conducted a full reference interval study using 120 patients for the testing performed on the new analyzer. The technical consultant and the patient services director stated to the surveyor, the laboratory did not perform a full reference study for the testing performed on the new analyzer; (4) The surveyor then asked the technical consultant and the patient services director for the manufacturer's implementation instructions. The technical consultant and the patient services director explained there were no instructions available. (During the survey, testing person #1 contacted the manufacturer for instructions, but the documentation had not been received by the laboratory prior to the conclusion of the survey); (5) After the survey (06/29/18), the surveyor reviewed the surveyor's copy of the manufacturer's instructions. It included the following instructions: (a) "Establishing a Normal Reference Interval:" (i) "Reference intervals should be established whenever there is a change in instrumentation and/or methodology, lot number of reagent, sample collection procedures, and at least once a year;" (ii) "Be performed for all tests performed on the analyzer;" (iii) "The number of samples can vary depending on whether the laboratory is establishing a new platform/methodology, or new analyte." (b) "Specimen Collection and Preparation:" (i) "The number of samples used can vary depending on whether the laboratory is establishing a full reference interval (120 normal donors) or attempting to verify a range established elsewhere (different laboratory, literature source, etc.) (20 normal donors)." (6) The surveyor then contacted the technical consultant and the patient services director via email and explained the laboratory failed to follow the manufacturer's instructions which stated a full 120 reference interval study must be performed on a new testing platform/methodology for all the analytes tested with the ACL Top 300 analyzer. The technical consultant and the patient services director agreed the laboratory failed to follow the manufacturer's instructions for establishing reference intervals for the testing performed on the ACL -- 3 of 14 -- Top 300 analyzer; (7) Examples of patient testing performed when the laboratory failed to follow the manufacturer's requirements for establishing reference intervals follow: (a) PT/INR and PTT: (i) Patient #31: Testing performed on 11/14/17 (ii) Patient #34: Testing performed on 12/05/17 (iii) Patient #35: Testing performed on 12 /07/17 (iv) Patient #36: Testing performed on 01/03/18 (v) Patient #37: Testing performed on 01/31/18 (vi) Patient #38: Testing performed on 02/05/18 (vii) Patient #39: Testing performed on 02/06/18 (viii) Patient #40: Testing performed on 03/02/18 (ix) Patient #41: Testing performed on 03/09/18 (x) Patient #42: Testing performed on 04/03/18 (xi) Patient #43: Testing performed on 04/05/18 (xii) Patient #44: Testing performed on 05/02/18 (xiii) Patient #45: Testing performed on 05/04/18 (xiv) Patient #46: Testing performed 05/17/18 (xv) Patient #47: Testing performed on 06/04/18 (xvi) Patient #48: Testing performed 06/18/18 (b) PT/INR:Patient #33: Testing performed on 11/21/17 (c) PTT:Patient #32: Testing performed on 11/14/17 (d) D- dimer: (i) Patient #49: Testing performed on 11/30/17 (ii) Patient #34: Testing performed on 12/05/17 (iii) Patient #50: Testing performed on 12/14/17 (iv) Patient #51: Testing performed on 01/08/18 (v) Patient #39: Testing performed on 02/06/18 (vi) Patient #52: Testing performed on 03/02/18 (vii) Patient #53: Testing performed on 03/08/18 (viii) Patient #54: Testing performed on 04/04/18 (ix) Patient #55: Testing performed on 04/12/18 (x) Patient #46: Testing performed 05/17/18 (e) Fibrinogen: (i) Patient #56: Testing performed on 11/29/17 (ii) Patient #34: Testing performed on 12/05/17 (iii) Patient #46: Testing performed on 05/17/18 (f) Anti-Xa: (i) Patient #57: Testing performed on 01/15/18 (ii) Patient #58: Testing performed on 01/16/18 NOTE: D5411 was cited on the initial certification survey performed 06/14 /16-06/16/16. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on a review of records and interview with the technical consultant, the patient services director, and testing person #2, the laboratory failed to demonstrate the performance specifications for a new test system. Findings include: (1) On the first day of the survey, the technical consultant and the patient services director stated to the surveyor the laboratory used the Hemachron Signature Elite analyzer (serial #13390) and ACT-LR cuvettes into use to perform ACT (Activated Clotting Time) testing on 06/12/17; (2) On the third day of the survey, the surveyor reviewed the validation records for the Hemochron Signature Elite analyzer but could not locate documentation which showed the performance specifications (i.e. accuracy, precision, and reportable range) had been demonstrated on the Hemachron Signature Elite analyzer; (3) The surveyor then reviewed test records and identified the analyzer had been used to perform patient testing beginning on 06/12/17 through the third day of the survey; (4) The surveyor asked the technical consultant and the patient services director for documentation to prove the performance specifications had been demonstrated on the analyzer before it was used for patient testing; (5) The technical -- 4 of 14 -- consultant, the patient services director, and testing person #2 could not locate the validation records prior to the conclusion of the survey. The technical consultant and patient services director stated to the surveyor documentation that showed laboratory demonstrated the performance specifications for the analyzer, could not be located; (6) Examples of patient ACT testing performed when the laboratory failed to demonstrate the accuracy, precision, and reportable range for the Hemachron Signature Elite analyzer prior to performing patient testing, include the following: (a) Patient #1: Testing performed on 06/13/17 (b) Patient #2: Testing performed on 06/19 /17 (c) Patient #3: Testing performed on 06/29/17 (d) Patient #4: Testing performed on 07/05/17 (e) Patient #5: Testing performed on 07/19/17 (f) Patient #6: Testing performed on 07/31/17 (g) Patient #7: Testing performed on 08/01/17 (h) Patient #8: Testing performed on 08/08/17 (i) Patient #9: Testing performed on 08/30/17 (j) Patient #10: Testing performed on 09/12/17 (k) Patient #11: Testing performed on 09 /22/17 (l) Patient #12: Testing performed on 10/04/17 (m) Patient #13: Testing performed on 10/27/17 (n) Patient #14: Testing performed on 11/02/17 (o) Patient #15: Testing performed on 11/27/17 (p) Patient #16: Testing performed on 12/15/17 (q) Patient #17: Testing performed on 12/28/17 (r) Patient #18: Testing performed on 01/02/18 (s) Patient #19: Testing performed on 01/16/18 (t) Patient #20: Testing performed on 01/30/18 (u) Patient #21: Testing performed on 02/07/18 (v) Patient #22: Testing performed on 02/28/18 (w)Patient #23: Testing performed on 03/07/18 (x) Patient #24: Testing performed on 03/19/18 (y) Patient #25: Testing performed on 03/29/18 (z) Patient #26: Testing performed on 04/18/18 (aa) Patient #27: Testing performed on 04/30/18 (bb) Patient #28: Testing performed on 05/07/18 (cc) Patient #29: Testing performed on 05/30/18 (dd) Patient #30: Testing performed on 05/16/18 NOTE: D5421 was cited on the initial certification survey performed 06/14/16-06/16 /16. 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 technical consultant and the patient services director, the laboratory failed to perform the manufacturers' required maintenance procedures. Findings include: BECKMAN COULTER AU480 CHEMISTRY ANALYZER (1) On the first day of the survey, the technical consultant and the patient services director stated to the surveyor the laboratory performed Chemistry testing (i.e., Albumin, Amylase, Glucose, Potassium, Sodium, Direct Bilirubin, etc.) using the Beckman Coulter AU480 chemistry analyzer, put into use in January 2017; (2) On the second day of the survey, the surveyor reviewed records from 01/01/17 through the second day of the survey. The surveyor identified the manufacturer's required monthly maintenance procedures, as recorded on the AU480 Maintenance Schedule log, were as follows: (a) Clean sample and reagent probe wash wells (b) Clean the mix bar wash wells (c) Clean the wash nozzle unit and check the tube mounting joints (d) Clean the deionized water tank (e) Clean the deionized water and sample probe filters (3) From the review, the surveyor identified the required monthly maintenance procedures had not been documented as performed in 1 of the 18 months reviewed: September 2017; (4) The surveyor reviewed the findings with the technical consultant and the laboratory services -- 5 of 14 -- director who stated to the surveyor there was no documentation which showed the laboratory performed the manufacturer's required monthly maintenance procedures, as listed above. AP LEICA CM 1850UV CRYOSTAT (1) On the first day of the survey, the technical consultant and the patient services director stated to the surveyor the laboratory performed microscopic interpretations of slides made from surgical tissue specimens. The tissue specimens were frozen and sectioned using the AP Leica CM 1800UV cryostat. The tissue was placed on slides, fixed, stained with H&E (Hematoxylin and Eosin), dried, coverslipped, and examined microscopically for diagnosis; (2) On the third day of the survey, the surveyor reviewed the manufacturer's instructions for performing the daily maintenance procedure on the cryostat, which were, "Clean the instrument every day;" (3) The surveyor then reviewed the cryostat maintenance log from 01/01/17 through 06/28/18 and identified the daily maintenance had not been documented as performed on 4 of the 31 days of patient testing reviewed during the review period: (a) 01/27/17 (b) 09/29/17 (c) 10/14 /17 (d) 12/05/17 (4) The surveyor reviewed the maintenance records with the technical consultant and the patient services director, who stated to the surveyor the daily maintenance had not been documented as performed on the 4 days of patient testing, as listed above. NOTE: D5429 was cited on the initial certification survey performed 06/14/16-06/16/16. D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of records and interview with the technical consultant and the patient services director, the laboratory failed to have quality control procedures that monitored over time the accuracy and precision of the analytic process for Chemistry testing. Findings include: (1) On the first day of the survey, the technical consultant and the patient services director stated to the surveyor the laboratory put the Beckman Coulter AU480 analyzer into use in January 2017 to perform chemistry testing (e.g., Albumin, Amylase, Glucose, Potassium, Sodium, Direct Bilirubin, etc.) and the laboratory analyzed two levels (Level 1 and Level 3) of Bio-Rad Liquid Assayed Multiqual control materials each day of patient testing to monitor the accuracy of the testing; (2) On the third day of the survey, the surveyor requested QC (quality control) records from 5 months (May and September 2017; and February, March, and May 2018). For 3 of the 5 months reviewed (September 2017, and February and March 2018), the records did not include Levey-Jennings graphs, peer review, etc. The surveyor asked the technical consultant and the patient services director for the Levey- Jennings graphs or peer review data for the months listed above. The technical consultant explained that the graphs had not been printed each month and the laboratory did not have peer data, but the QC results had been reviewed each day for -- 6 of 14 -- acceptability; (3) The surveyor asked the technical consultant and the patient services director if the laboratory had another method that would monitor over time the accuracy and precision of test performance that might be influenced by changes in the test system performance and environmental conditions, and variances in operator performance. The technical consultant and the patient services director stated to the surveyor the laboratory did not use another method to monitor over time the accuracy and precision of test performance. NOTE: D5441 was cited on the initial certification survey performed 06/14/16-06/16/16. D5473 CONTROL PROCEDURES CFR(s): 493.1256(e)(2)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (2) Each day of use (unless otherwise specified in this subpart), test staining materials for intended reactivity to ensure predictable staining characteristics. Control materials for both positive and negative reactivity must be included, as appropriate. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of records and interview with the technical consultant and the patient services director, the laboratory failed to document the reactivity of the H&E stain quality control slide each day of patient testing. Findings include: (1) On the first day, of the survey, the technical consultant and the patient services director stated to the surveyor the laboratory performed microscopic interpretations of slides made from surgical tissue specimens. The tissue specimens were frozen and sectioned using the AP Leica CM 1800UV cryostat. The tissue was placed on slides, fixed, stained with H&E (Hematoxylin and Eosin), dried, coverslipped, and examined microscopically for diagnosis; (2) On the third day of the survey, the surveyor asked the technical consultant and the patient services director to explain the laboratory's QC (quality control) procedure for the staining. The technical consultant and the patient services director explained the acceptability of the staining was noted on the patient testing log by the pathologist examining the patient slides; (3) The surveyor reviewed the patient testing logs from 01/01/17 through 06/28/18 and identified on 1 day of the 31 days of patient testing reviewed, a question mark was noted for the reactivity of the H&E stain QC, instead of whether the stain was acceptable or unacceptable (Patient #59- Testing performed on 10/09/17); (4) The surveyor reviewed the findings with the technical consultant and the patient services director who stated to the surveyor, the laboratory failed to document the reactivity of the QC slide for the 1 day of patient testing listed above. D5479 CONTROL PROCEDURES CFR(s): 493.1256(e)(5)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (5) Follow the manufacturer's specifications for using reagents, media, and supplies and be responsible for results. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of records, manufacturer's instructions, and interview with the technical consultant and the patient services director, the laboratory failed to follow -- 7 of 14 -- the manufacturer's specifications for control materials. Findings include: (1) On the first day of the survey, the technical consultant and the patient services director stated to the surveyor, the laboratory performed ACT (Activated Clotting Time) testing using the Hemochron Signature Elite analyzer and ACT-LR cuvettes. In addition, 2 levels (Normal and Abnormal) of directCHECK Whole Blood control materials were tested each 8 hours of patient testing; (2) On the third days of the survey, the surveyor reviewed the manufacturer's specifications (package insert) for the quality control materials. It stated the following, "Accriva recommends that each institution establish its own expected range of response based on the +/- standard deviations of at least 20 repeated test results. The local mean values established should fall within the manufacturer's acceptable performance range. Studies show that intra-laboratory variation in test results should produce a coefficient of variation of approximately 14% or less for coagulation control tests."; (3) The surveyor then reviewed QC (Quality Control) records from 06/12/17 through the third day of the survey. For 12 of the 12 months reviewed, there was no evidence the laboratory established their own expected range of response as required in the manufacturer's specifications; (4) The surveyor reviewed the findings with the technical consultant and the patient services director. The technical consultant and the patient services director stated to the surveyor, the laboratory failed to follow the manufacturer's specifications for establishing its own expected range of response for the QC materials; (5) Lot numbers of QC materials used when the laboratory failed to follow the manufacturer's specifications, follow: (a) Normal Control: 3 of 3 lot numbers: (i) Lot #C7DNL011: (aa) Used from 06/12/17-09/29/17 and (bb) Used from 02/06/18-02/09/18 (ii) Lot #F7DNL018: Used from 09/29/17- 02/06/18 (iii) Lot #J7DN027: Used from 02/12/18 through the third day of the survey (b) Abnormal Control: 3 of 3 lot numbers (i) Lot #C7DLA012: Used from 06/12/17- 08/11/17 (ii) Lot #C7DLA015: Used from 08/11 /17- 10/27/17 (iii) Lot #G7DLA025: Used from 10/27/17 through the third day of the survey (6) The following are examples of patient ACT testing performed when the laboratory failed to follow the manufacturer's specifications for the quality control materials: (a) Patient #1: Testing performed on 06/12/17 (b) Patient #2: Testing performed on 06/13/17 (c) Patient #3: Testing performed on 06/14/17 (d) Patient #4: Testing performed on 06/19/17 (e) Patient #5: Testing performed on 06/29/17 (f) Patient #6: Testing performed on 07/05/17 (g) Patient #7: Testing performed 07/07/17 (h) Patient #8: Testing performed on 07/19/17 (i) Patient #9: Testing performed on 07 /31/17 (j) Patient #10: Testing performed on 08/01/17 (k) Patient #11: Testing performed on 08/08/17 (l) Patient #12: Testing performed on 08/30/17 (m) Patient #13: Testing performed on 09/12/17 (n) Patient #14: Testing performed on 09/22/17 (o) Patient #15: Testing performed on 10/04/17 (p) Patient #16: Testing performed on 10/27/17 (q) Patient #17: Testing performed on 11/02/17 (r) Patient #18: Testing performed on 11/27/17 (s) Patient #19: Testing performed on 12/15/17 (t) Patient #20: Testing performed on 12/28/17 (u) Patient #21: Testing performed on 01/02/18 (v) Patient #22: Testing performed on 01/02/18 (w) Patient #23: Testing performed on 01 /16/18 (x) Patient #24: Testing performed on 01/30/18 (y) Patient #25: Testing performed on 02/07/18 (z) Patient #26: Testing performed on 02/28/18 (aa) Patient #27: Testing performed on 03/07/18 (bb) Patient #28: Testing performed on 03/19/18 (cc) Patient #29: Testing performed on 03/29/18 (dd) Patient #30: Testing performed on 04/18/18 (ee) Patient #31: Testing performed on 04/30/18 (ff) Patient #32: Testing performed on 05/07/18 (gg) Patient #33: Testing performed on 05/16/18 (hh) Patient #34: Testing performed on 05/30/18 NOTE: D5479 was cited on the initial certification survey performed 06/16/16-06/18/16. D5787 TEST RECORDS CFR(s): 493.1283(a) -- 8 of 14 -- The laboratory must maintain an information or record system that includes the following: (a)(1) The positive identification of the specimen. (a)(2) The date and time of specimen receipt into the laboratory. (a)(3) The condition and disposition of specimens that do not meet the laboratory's criteria for specimen acceptability. (a)(4) The records and dates of all specimen testing, including the identity of the personnel who performed the test(s). This STANDARD is not met as evidenced by: Based on a review of records and interview with the technical consultant and the patient services director, the laboratory failed to ensure permanent testing records were maintained. Findings include: (1) On the first day of the survey, the technical consultant and the patient services director stated to the surveyor the laboratory performed microscopic interpretations of slides made from surgical tissue specimens. The tissue specimens were frozen and sectioned using the AP Leica CM 1800UV cryostat. The tissue was placed on slides, fixed, stained with H&E (Hematoxylin and Eosin), dried, coverslipped, and examined microscopically for diagnosis; (2) On the third day of the survey, the surveyor reviewed records for the testing from 01/01/17 through 06/28/18. The surveyor identified from the review, records which had been documented in pencil: (a) Cryostat temperatures: (i) October 2017: Days 17,18 (ii) November 2017: Days, 2,3,4,5,6,7,8,14, 15,16,17,23 (iii) January 2018: Days 8,9,10,11,12,15,23 (iv) April 2018: Days 2,4,5,6,9,10 (v) May 2018: Days 15,25 (b) Patient testing records: (i) Patient #60: Testing performed on 10/04/17 (ii) Patient #61: Testing performed on 10/09/17 (iii) Patient #62: Testing performed on 10/12/17 (iv) Patient #63: Testing performed on 10/24/17 (v) Patient #64: Testing performed on 10 /24/17 (vi) Patient #65: Testing performed on 11/30/17 (vii) Patient #66: Testing performed on 01/11/18 (viii) Patient #67: Testing performed on 01/18/18 (ix) Patient #68: Testing performed on 02/03/18 (x) Patient #69: Testing performed on 02/08/18 (xi) Patient #70: Testing performed on 02/13/18 (xii) Patient #71: Testing performed on 06/19/18 (xiii) Patient #72: Testing performed on 06/28/18 (xiv) Patient #73: Testing performed on 06/28/18 (3) The surveyor reviewed the findings with the technical consultant and the patient services director and explained use of pencil does not ensure permanence of documentation. The technical consultant and the patient services director stated to the surveyor, the laboratory failed to maintain permanent laboratory records when documentation was recorded in pencil. NOTE: The Interpretive Guidelines at 493.1283(a) states, "Laboratory records should not be documented in pencil and the use of whiteout is not acceptable for making corrections." D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on a review of records, manufacturer's instructions, and interview with the technical consultant, the patient services director, testing person #1, and testing person #2, the laboratory failed to have an ongoing mechanism for performing effective -- 9 of 14 -- analytic quality assessment. Findings include: (1) It was determined the laboratory did not have an effective mechanism for performing analytic quality assessment due to the following issues identified during the survey: (a) The laboratory failed to follow its policy and procedure for storage of blood components. Refer to D5401; (b) The laboratory failed to follow the manufacturer's instructions for the testing performed. Refer to D5411; (c) The laboratory failed to demonstrate the performance specifications for a new test system. D5421; (d) The laboratory failed to follow the manufacturer's instructions for performing maintenance procedures. Refer to D5429; (e) The laboratory failed to have control procedures that monitored the accuracy and precision of the analytic process. Refer to D5441; (f) The laboratory failed to follow the manufacturer's specifications for control materials. Refer to D5479. NOTE: D5791 was cited on the initial certification survey performed 06/16/16-06/18/16. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on a review of records, manufacturer's instructions, policies and procedures, and interview with the technical consultant, the patient services director, and testing person #1, the laboratory director failed to provide overall management and direction for moderate complexity testing. Finding include: (1) The laboratory director failed to ensure verification procedures were adequate to determine the accuracy, precision, and other pertinent performance characteristics of a new test method. Refer to D6013; (2) The laboratory director failed to ensure test methods were performed as required by the manufacturer to ensure accurate and reliable results were reported. Refer to D6014; (3) The laboratory director failed to ensure a quality control program was maintained to ensure the quality of laboratory services. Refer to D6020; (4) The laboratory director failed to ensure a quality assessment program had been established and maintained. Refer to D6021. NOTE: D6000 was cited on the initial certification survey performed 06/14/16-06/16/16. D6013 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(ii) 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)(3) Ensure that-- (e)(3)(ii) Verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method; This STANDARD is not met as evidenced by: Based on a review of records, interview with the technical consultant, the patient services director, and testing person #1, the laboratory director failed to ensure that verification procedures used were adequate to determine performance characterisitics. Findings follow: (1) The laboratory director failed to ensure verification procedures -- 10 of 14 -- were adequate to determine the accuracy, precision, and other pertinent performance characteristics of a new test method. Refer to D5421. NOTE: D6013 was cited on the initial certification survey performed 06/14/16-06/16/16. D6014 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(iii) 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)(3) Ensure that-- (e)(3)(iii) Laboratory personnel are performing the test methods as required for accurate and reliable results. This STANDARD is not met as evidenced by: Based on a review of records, manufacturer's instructions, and interview with the technical consultant, and the patient services director, the laboratory director failed to ensure test methods were performed as required by the manufacturer to ensure accurate and reliable results were reported. Findings include: (1) The laboratory director failed to ensure the manufacturer's instructions were followed for the testing performed. Refer to D5411; (2) The laboratory director failed to ensure the manufacturer's maintenance procedures were performed as required. Refer to D5429; (3) The laboratory director failed to ensure the manufacturer's specifications were followed for control materials. Refer to D5479. NOTE: D6014 was cited on the initial certification survey performed 06/14/16-06/16/16. D6020 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(5) Ensure that the quality control program is established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on a review of records, manufacturer's instructions, and interview with the technical consultant, and the patient services director, the laboratory director failed to ensure a quality control program was maintained to ensure the quality of laboratory services. Findings include: (1) The laboratory director failed to ensure control procedures monitored over time the accuracy and precision of the analytic process for Chemistry testing. Refer to D5441. NOTE: D6020 was cited on the initial certification survey performed 06/14/16-06/16/16. D6021 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently -- 11 of 14 -- and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(5) Ensure that quality assessment programs are established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on a review of records, manufacturer's instructions, and interview with the technical consultant, the patient services director, testing person #1, and testing person #2, the laboratory director failed to ensure a quality assessment program had been established and maintained. Findings include: (1) The laboratory director failed to ensure there was an effective, ongoing mechanism for performing effective analytic quality assessment. Refer to D5791. NOTE: D6021 was cited on the initial certification survey performed 06/14/16-06/16/16. D6040 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(2) The technical consultant is responsible for-- (b)(2) Verification of the test procedures performed and the establishment of the laboratory's test performance characteristics, including the precision and accuracy of each test and test system. This STANDARD is not met as evidenced by: Based on a review of records and interview with the technical consultant, patient services director, and testing person #2, the technical consultant failed to ensure verification procedures were adequate to determine the performance characteristics. Findings include: (1) The technical consultant failed to ensure the laboratory demonstrated the performance specifications for a new test method. Refer to D5421. D6042 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(4) (b) The technical consultant is responsible for-- (b)(4) Establishing a quality control program appropriate for the testing performed and establishing the parameters for acceptable levels of analytic performance and ensuring that these levels are maintained throughout the entire testing process from the initial receipt of the specimen, through sample analysis and reporting of test results; This STANDARD is not met as evidenced by: Based on a review of records, manufacturer's instructions, and interview with the technical consultant, and the patient services director, the technical consultant failed to ensure the establishment and maintenance of acceptable levels of analytic performance. Findings include: (1) The technical consultant failed to ensure control procedures monitored the accuracy and precision of the testing process over time. Refer to D5441. D6070 TESTING PERSONNEL RESPONSIBILITIES CFR(s): 493.1425(b)(1) Each individual performing moderate complexity testing must follow the laboratory's procedures for specimen handling and processing, test analyses, reporting and maintaining records of patient test results. -- 12 of 14 -- This STANDARD is not met as evidenced by: Based on a review of patient test reports and interview with the technical consultant and the patient services director, testing personnel failed to follow the laboratory's procedure for test analysis. Findings include: (1) On the first day of the survey, the technical consultant and the patient services director stated to the surveyor the laboratory performed manual WBC (White Blood Cell) differentials on patient CBC's (Complete Blood Counts) which met specific criteria (i.e., flagged values, WBC counts below 2.0, etc.); (2) The technical consultant and the patient services director stated to the surveyor the laboratory performed a manual WBC differential microscopically on a stained peripheral blood smear. A total of 100 WBC's were counted and differentiated as Segmented Neutrophils (Segs), Bands, Lymphocytes (Lymphs), Monocytes (Monos), Eosinophils (Eos), Basophils (Basos), and Atypical Lymphocytes (Atyp Lymphs. The manual WBC differential results were reported along with the automated total WBC count obtained by the analyzer; (3) On the third day of the survey, the surveyor reviewed 58 patient reports, which contained flags chosen at random from 2 months (May 2017 and May 2018). The surveyor identified on 1 of the 58 reports, the moderate complexity manual WBC differential did not equal 100 cells, as follows: (a) Patient #74: Testing performed on 05/07/18-Total number of WBC's reported for the manual differential: 99 (i) Segs: 19 (ii) Lymphs: 79 (iii) Monos: 1 (4) The surveyor reviewed the findings with the technical consultant and the patient services director who verified the manual WBC differential listed above should have totaled 100 WBC's. The technical consultant and the patient services director stated to the surveyor, the laboratory failed to ensure testing personnel followed the laboratory's policy and procedure to report a total of 100 WBC's for the manual differential and failed to ensure testing personnel reported tests results accurately and reliably. D6175 TESTING PERSONNEL RESPONSIBILITIES CFR(s): 493.1495(b)(1) Each individual performing high complexity testing must follow the laboratory's procedures for specimen handling and processing, test analyses, reporting and maintaining records of patient test results. This STANDARD is not met as evidenced by: Based on a review of records, and interview with the technical consultant and the patient services director, the laboratory failed to ensure testing personnel followed the policy for performing test analyses. Findings include: (1) On the first day of the survey, the technical consultant and the patient services director stated to the surveyor the laboratory performed manual WBC (White Blood Cell) differentials on patient CBC's (Complete Blood Counts) which met specific criteria (i.e., flagged values, WBC counts below 2.0, etc.); (2) The technical consultant and the patient services director explained the manual WBC differentials were performed microscopically on a stained peripheral blood smear. It was the laboratory's policy to count a total of 100 WBC's and differentiate the WBC's as Segmented Neutrophils (Segs), Bands, Lymphocytes (Lymphs), Monocytes (Monos), Eosinophils (Eos), Basophils (Basos), Atypical Lymphocytes (Atyp Lymphs), and immature WBC forms, if present (i.e., Blasts, Metamyelocyte, etc.). The manual WBC differential was reported along with the automated total WBC count obtained by the analyzer; (3) On the third day of the survey, the surveyor reviewed 58 patient reports which obtained flags chosen at -- 13 of 14 -- random from 2 months (May 2017 and May 2018). The surveyor identified 1 high complexity manual WBC differential performed, did not equal 100 WBC's, as follows: (a) Patient #75: Testing performed on 05/03/18-Total number of WBC's reported for the manual differential: 101 (i) Segs: 77 (ii) Bands: 1 (iii) Lymphs: 18 (iv) Monos: 2 (v) Eos: 1 (vi) Metamyelocyte: 1 (vii) Myelocyte: 1 (4) The surveyor reviewed the findings with the technical consultant and the patient services director who verified the high complexity manual WBC differential listed above should have totaled 100 WBC's. The technical consultant and the patient services director stated to the surveyor, the laboratory failed to ensure testing personnel followed the laboratory's policy and procedure to report a total of 100 WBC's for the manual differential and failed to ensure testing personnel reported tests results accurately and reliably. -- 14 of 14 --