Victory Medical Center

Summary Statement of Deficiencies D0000 The laboratory was surveyed and failed to meet the following conditions of the CLIA regulations found at CFR 42 493.1 through 493.1780: 493.1240 Condition: Preanalytic systems; 493.1250 Condition: Analytic systems; 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director; 493.1409 Condition: Laboratories performing moderate complexity testing; technical consultant; D3007 FACILITIES CFR(s): 493.1101(b) The laboratory must have appropriate and sufficient equipment, instruments, reagents, materials, and supplies for the type and volume of testing it performs. This STANDARD is not met as evidenced by: Based on observation and interview, the laboratory failed to ensure there was a working interface between the Laboratory Information System (LIS) and Electronic Medical Records (EMR). Findings follow. On November 12, 2020 at 0900 hours surveyor observed testing personnel #1 manually scanning patient test results into the EMR. Interview with testing personnel #1 on the CMS form 209 on November 12, 2020 at 0915 hours in the laboratory acknowledged she manually scans test reports into the EMR because the interface between the LIS and EMR was not working and has not worked for months. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 22 -- This STANDARD is not met as evidenced by: I. Based on review of data logs, user manual, and interview, the laboratory failed to retain all testing records for at least 2 years on the Act Diff II Hematology analyzer 1 1 /2 out of 3 months reviewed. Findings follow. A. Random review of the Act Diff II Hematology analyzer (used until June 16, 2019) data logs for a three-month period from Oct 1, 2018 - Dec 29, 2018 showed missing data logs from Oct 1, 2018 - Nov 17, 2018. B. Review of the Beckman Coulter Act Diff II Operator's Guide, PN4237495BC March 2017, under 4.1 Printing Stored Sample Results stated, "the instrument automatically saves up to 250 patient results (numerical only, excluding histograms)." C. Interview with testing personnel (TP) #1 on the CMS form 209 on November 11, 2020 at 0930 hours in the laboratory acknowledged the LIS does not capture all runs from the Beckman Coulter, the original [patient or QC] runs were not retained, and the instrument was not set to print each sample run. Data logs on the Act Diff II were printed every 30-60 days, but some data would drop off and was no longer available to print. II. Based on review of quality control (QC) testing records, and interview, the laboratory failed to retain all testing records on the Siemens Advia 500 Hematology analyzer for 2 of 2 months reviewed. Findings follow. A. Random review of QC records printed from the LIS for the Siemens Advia 560 Hematology analyzer (resumed on June 26, 2019) from Feb 2020 and Oct 2020 showed all passing QC runs with each day of testing, but there were no repeated runs in situations when QC failed. B. Interview with TP #1 on November 11, 2020 at 1000 hours acknowledged the LIS only retained one QC value for each day per level, and she did not retain instrument print-outs. Failed runs of QC and original patient runs were not retained on the LIS because the LIS overrides the results when they repeated the sample. The laboratory had switched to the Siemens Advia 560 and plans to make backups of the files but has not started that yet. This is a repeat deficiency from survey conducted on 06/17/2018. KEY: LIS = Laboratory Information System D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on review of the laboratory's policy and procedure, proficiency testing (PT) records and interview, the laboratory failed to verify the accuracy of results for each analyte and specialty assigned a proficiency testing score of 100% when the laboratory failed to test specimens and submit to the PT agency for Hematology and Chemistry test systems in 2 out of 6 events reviewed. Findings follow. A. Review of the American Academy of Family Physicians (AAFP) PT records from the 2nd (B) and 3rd (C) events of 2019 showed the laboratory failed to test specimens and submit to the PT agency for Hematology. 1. Review of the 2019 B and 2019 C Proficiency Testing Evaluation form for White Blood Cell Count, Lymphocyte percent (%), Monocyte %, Monocyte/Mixed %, Granulocyte %, Red Blood Cell Count, Hemoglobin, Hematocrit, MCV (Mean Corpuscular Volume) and Platelet Count showed "Not Graded - Changed Instrument Method." Further review showed the laboratory was given a false score of a 100%. 2. Review of the AAFP 2019 B event -- 2 of 22 -- paperwork showed the samples were received on May 17, 2019 and the submission deadline was June 26, 2019. 3. Review of patient testing records showed the Act Diff II hematology analyzer was suspended on June 16, 2019, and the Advia 560 Hematology analyzer had resumed patient testing on June 26, 2019 for White Blood Cell Count, Lymphocyte (%), Monocyte %, Granulocyte %, Eosinophil %, Basophil %, Red Blood Cell Count, Hemoglobin, Hematocrit, MCV (Mean Corpuscular Volume) and Platelet Count. 4. From July 2019 to April 2020, 6137 Complete Blood Counts had been performed on the Advia 560. 5. Interview with testing personnel (TP) #1 on the CMS form 209 on November 11, 2020 at 1300 hours in the laboratory acknowledged the testing platform and test menu had changed and the previous Laboratory Director had not updated the information with AAFP before he left. B. Review of the American Academy of Family Physicians (AAFP) PT records from the 2nd (B) and 3rd (C) events of 2019 showed the laboratory failed to test specimens and submit to the PT agency for Chemistry. 1. Review of the 2019 B & C Proficiency Testing Evaluation form for Sodium, Potassium, Chloride, CO2 (Bicarbonate), Calcium, Creatinine, Glucose, Urea Nitrogen, Albumin, Alkaline Phosphatase, ALT (Alanine Transferase), AST (Aspartate Aminotransferase), Total Bilirubin, Total Protein, Total Cholesterol, Cholesterol HDL (High Density Lipoprotein), Triglycerides, Direct Bilirubin, Iron, Urine Microalbumin showed "Not Graded - Changed Instrument Method." Further review showed the laboratory was given a false score of a 100%. 2. Review of the AAFP 2019 B event paperwork showed the samples were received on May 17, 2019. Review of the AAFP 2019 C event paperwork showed the samples were received on Oct 9, 2019. 3. Review of patient testing records showed the Beckman Coulter AU480 chemistry analyzer began patient testing on May 1, 2019 for Sodium, Potassium, Chloride, CO2, Calcium, Creatinine, Glucose, Urea Nitrogen, Albumin, Alkaline Phosphatase, ALT, AST, Total Bilirubin, Total Protein, Total Cholesterol, Cholesterol HDL (High Density Lipoprotein), Triglycerides, Amylase, Direct Bilirubin, Magnesium, and Iron. 4. 5204 patients were tested for Sodium in 2019. 5. Interview with testing personnel (TP) #1 on the CMS form 209 on November 11, 2020 at 1300 hours in the laboratory acknowledged the testing platform and test menu had changed and the previous Laboratory Director had not updated the information with AAFP before he left. TP #1 explained, for example the laboratory didn't get urine specimens for urine testing. TP #1 did not have access to update the platform with AAFP, and the testing menus were completely different. TP #1 confirmed PT samples were not tested. D5300 PREANALYTIC SYSTEMS CFR(s): 493.1240 Each laboratory that performs nonwaived testing must meet the applicable preanalytic system(s) requirements in 493.1241 and 493.1242, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the preanalytic systems and correct identified problems as specified in 493. 1249 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on review of manufacturer's instructions for use, laboratory policies and procedures, verification studies, patient test records and interview with facility personnel, the laboratory failed to meet the requirements for pre analytic systems when testing patient blood specimens using the Siemens Advia 560 hematology analyzer and the Beckman Coulter AU 480 Chemistry analyzer. The laboratory failed -- 3 of 22 -- to follow the manufacturer's instructions for testing blood specimens for Complete Blood Count (CBC) within 7 hours of collection using the Siemens Advia 560 hematology analyzer. The Laboratory failed to follow the manufacturer's instructions for testing blood specimens for bicarbonate (CO2) within 24 hours of collection using the Beckman Coulter AU 480. (see D5311) 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 review of manufacturer's instructions for use, laboratory policies and procedures, patient requisitions, patient test reports, patient testing volume, and interview, the laboratory failed to follow the manufacturer's instructions when testing blood specimens for Bicarbonate (CO2) within 24 hours of collection using the Beckman Coulter AU480 chemistry analyzer. Findings follow. 1. Review of the Beckman Coulter AU Instructions for Use for Bicarbonate (CO2), BAOSR5X37 11 (rev June 2020), under Specimen Storage and Stability stated, "Once separated from cells, Bicarbonate in serum and plasma is stable for 24 hours when stored at 20 - 25C and protected from exposure to air." 2. Review of the laboratory's written policy and procedure titled Bicarbonate (CO2) (reviewed by the Laboratory Director on 10/06 /2019), under Specimen Storage and Stability stated, "Once separated from cells, Bicarbonate in serum and plasma is stable for 24 hours when stored at 20 - 25C and protected from exposure to air." And under "Additional handling conditions as designated by this laboratory" stated, "Samples collected at offsite locations will be collected and placed in the Refrigerator." 3. Surveyor observed the receipt of 62 requisitions for patient testing on 11/12/2020 at 0930 in the laboratory. Of those 62 requisitions, 31 patient reports were provided at the time of the survey. Of the 31 patient reports, 17 requested Comprehensive Metabolic Panels that included CO2 testing. 4. Review of 17 of 17 paired requisition forms and patient reports for CO2 tested on November 12, 2020 found the laboratory tested patient specimens that were greater than 24 hours old as listed below by Patient ID: a. 173171: collected 11/11 /2020 at 1139 hours and tested on 11/12/2020 at 1824 hours (30 hours and 45 minutes later); b. 292730: collected 11/11/2020 at 1233 hours and tested on 11/12/2020 at 1733 hours (29 hours and 00 minutes later); c. 265959: collected 11/11/2020 at 1222 hours and tested on 11/12/2020 at 1729 hours (29 hours and 07 minutes later); d. 295881: collected 11/11/2020 at 1033 hours and tested on 11/12/2020 at 1742 hours (31 hours and 5 minutes later); e. 195885: collected 11/11/2020 at 1035 hours and tested on 11/12/2020 at 1818 hours (31 hours and 43 minutes later); f. 242283: collected 11/11/2020 at 0812 hours and tested on 11/12/2020 at 1836 hours (34 hours and 24 minutes later); g. 237804: collected 11/11/2020 at 0848 hours and tested on 11 /12/2020 at 1815 hours (33 hours and 27 minutes later); h. 193697: collected 11/10 /2020 at 1457 hours and tested on 11/12/2020 at 1854 hours (51 hours and 57 minutes later); i. 237042: collected 11/10/2020 at 1600 hours and tested on 11/12/2020 at 0851 hours (50 hours and 51 minutes later); j. 261530: collected 11/10/2020 at 0814 hours and tested on 11/12/2020 at 1827 hours (58 hours and 13 minutes later); k. 293525: -- 4 of 22 -- collected 11/11/2020 at 0849 hours and tested on 11/12/2020 at 1806 hours (33 hours and 17 minutes later); l. 272251: collected 11/11/2020 at 1029 hours and tested on 11 /12/2020 at 1830 hours (32 hours and 1 minute later); m. 146218: collected 11/11 /2020 at 1344 hours and tested on 11/12/2020 at 1754 hours (28 hours and 10 minutes later); n. 147274: collected 11/11/2020 at 1301 hours and tested on 11/12/2020 at 1720 hours (28 hours and 19 minutes later); o. 147912: collected 11/11/2020 at 1321 hours and tested on 11/12/2020 at 1809 hours (28 hours and 48 minutes later); p. 295635: collected 11/11/2020 at 1245 hours and tested on 11/12/2020 at 1748 hours (29 hours and 3 minutes later); q. 286945: collected 11/11/2020 at 1345 hours and tested on 11/12/2020 at 1841 hours (28 hours and 56 minutes later). 5. Review of the CMS form 116 showed an annual test volume of 6000 for CO2. 6. Interview of testing personnel #1 on the CMS form 209 on November 11, 2020 at 1350 hours confirmed that she would pick up specimens from the three clinics each morning and bring them to the laboratory for testing. The specimens picked up each morning were collected the previous day and stored in the refrigerator until she picked them up. 28428 Based on review of manufacturer's instructions for use, laboratory policies and procedures, patient test records and interview with facility personnel, the laboratory failed to follow the manufacturer's instructions for testing blood specimens for Complete Blood Counts (CBC) using the Siemens Advia 560 hematology analyzer. The findings included: 1. Review of the Advia 560 Analyzer Operator's Manual (Rev. A 2015-06) found on page 50 under the heading Sample Collection and Handling: "Analyze blood samples within 7 hours of collection." 2. Review of the laboratory's written policy titled CBC Advia 560 (effective date 07/01/2019) found on page 2 under the heading SPECIMEN STORAGE AND STABILITY "5. Stored Specimen Stability: a. If stored at 4-8 degrees C within 6 hours of collection, EDTA blood samples with normal results may be analyzed up to 72 hours without significant loss of differential stability. b. Sample stability at room temperature is 8 hours. Samples stored at room temperature may exhibit an increase in MCV after 24 hours. This may be minimized by refrigeration." 3. Review of patient test records found the laboratory had tested 6137 patient specimens for CBC between June 1, 2019 and November 10, 2020. Review of 30 patient reports tested on November 12, 2020 found the laboratory tested 30 of 30 patient specimens that were greater than 7 hours old. Accession 28424- collected 11/11/2020 at 12:33 PM and tested 29 hours 39 and minutes later on 11/12 /2020 at 6:12 PM. Accession 28428- collected 11/11/2020 at 11:39 AM and tested 30 hours and 34 minutes later on 11/12/2020 at 6:13 PM Accession 28431 - collected 11 /11/2020 at 12:22 PM and tested 29 hours and 52 minutes later on 11/12/2020 at 6:14 PM. Accession 28434- collected 11/11/2020 at 10:35 AM and tested 31 hours and 40 minutes later on 11/12/2020 at 6:15 PM Accession 28438 - collected 11/11/2020 at 10: 33 AM and tested 31 hours and 43 minutes later on 11/12/2020 at 6:16 PM. Accession 28442- collected 11/11/2020 at 09:52 AM and tested 32 hours and 25 minutes later on 11/12/2020 at 6:17 PM. Accession 28446 - collected 11/11/2020 at 08:07 AM and tested 8 hours and 42 minutes later on 11/12/2020 at 6:18 PM Accession 28448 - collected 11/11/2020 at 08:02 AM and tested 34 hours and 17 minute later on 11/12 /2020 at 6:19 PM. Accession 28450 - collected 11/11/2020 at 09:05 AM and tested 33 hours and 15 minutes later on 11/12/2020 at 6:20 PM Accession 28453 - collected 11 /11/2020 at 08:48 AM and tested 33 hours and 33 minutes later on 11/12/2020 at 6:21 PM Accession 28455- collected 11/11/2020 at 08:44 AM and tested 33 hours and 38 minutes later on 11/12/2020 at 6:22 PM Accession 28458 - collected and tested 23 hours and 45 minutes later on 11/12/2020 at 6:23 PM. Accession 28463 - collected 11 /10/2020 at 4:00 PM and tested 50 hours and 25 minutes later on 11/12/2020 at 6:25 PM Accession 28461 - collected 11/10/2020 at 2:57 PM and tested 51 hours and 27 minutes later on 11/12/2020 at 6:24 PM Accession 28458 - collected 11/10/2020 at 2: 25 PM and tested 51 hours and 59 minutes later on 11/12/2020 at 6:24 PM Accession -- 5 of 22 -- 28467 - collected 11/10/2020 at 8:14 AM and tested 58 hours and 12 minutes later on 11/12/2020 at 6:26 PM Accession 28470 - collected 11/11/2020 at 8:49 AM and tested 33 hours and 38 minutes later on 11/12/2020 at 6:27 PM Accession 28472 - collected 11/11/2020 at 09:50 AM and tested 32 hours and 38 minutes later on 11/12 /2020 at 6:28 PM Accession 28476 - collected 11/11/2020 at 10:29 AM and tested 32 hours later on 11/12/2020 at 6:29 PM Accession 28482 - collected 11/11/2020 at 7:57 AM and tested 34 hours and 33 minutes later on 11/12/2020 at 6:30 PM Accession 28484 - collected 11/11/2020 at 2:42 PM and tested 27 hours and 49 minutes later on 11/12/2020 at 6:31 PM Accession 28489 - collected 11/11/2020 at 1:44 PM and tested 28 hours and 48 minutes later on 11/12/2020 at 6:32 PM Accession 28492 - collected 11/11/2020 at 12:56 PM and tested 29 hours and 37 minutes later on 11/12/2020 at 6: 33 PM Accession 28495 - collected 11/11/2020 at 1:01 PM and tested 29 hours and 33 minutes later on 11/12/2020 at 6:34 PM Accession 28500 - collected 11/11/2020 at 4:23 PM and tested 26 hours and 12 minutes later on 11/12/2020 at 6:35 PM Accession 28505 - collected 11/11/2020 at 12:45 PM and tested 29 hours and 51 minutes later on 11/12/2020 at 6:36 PM Accession 28507 - collected 11/11/2020 at 1: 21 PM and tested 29 hours and 16 minutes later on 11/12/2020 at 6:37 PM Accession 28510 - collected 11/11/2020 at 1:45 PM and tested 28 hours and 53 minutes later on 11/12/2020 at 6:38 PM Accession 28513 - collected 11/11/2020 at 09:45 AM and tested 32 hours and 55 minutes later on 11/12/2020 at 6:40 PM Accession 28517 - collected 11/11/2020 at 08:21 AM and tested 34 hours and 3 minutes later on 11/12 /2020 at 6:24 PM Accession 28519 - collected 11/11/2020 at 09:12 AM and tested 33 hours and 30 minutes later on 11/12/2020 at 6:42 PM 5. Interview of Testing Person one on the CMS report 209 Laboratory Personnel Report conducted on November 11, 2020 at 1:50 PM confirmed that she would pick up specimens from the three clinics each morning, and transport them to the laboratory for testing. The specimens picked up each morning were collected the previous day, and stored in the refrigerator until she picked them up. She would transport the specimens to the laboratory for testing. She would spend her morning accessioning the specimens, and would typically test them in the afternoon. Analytes included in the CBC : White Blood Cell (WBC) Red Blood Cell (RBC) Hemoglobin (Hgb) Hematocrit (Hct) Mean Corpuscular Volume (MCV) Mean Corpuscular Hemoglobin (MCH) Mean Corpuscular Hemoglobin Concentration (MCHC) D5391 PREANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1249(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the preanalytic systems specified at 493.1241 through 493.1242. This STANDARD is not met as evidenced by: Based on review of the laboratory policies and procedures and interview of facility personnel found the laboratory failed to have a written policy to monitor, assess and correct problems in the pre-analytic laboratory systems. The laboratory failed to follow the manufacturer's storage and handling instructions for CBC and CO2 blood specimens as defined by the manufacturer. (See D5311) D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic -- 6 of 22 -- systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on review of observations, manufacturer's instructions for use and assay sheet, review of temperature records laboratory policies and procedures, patient testing records, verification of performance specifications, quality control (QC) records, and interview of facility personnel, the laboratory failed to monitor and evaluate the overall quality of the analytic systems and correct problems in testing performed in Chemistry and Hematology. Findings follow. 1. The laboratory failed to store Bio- Rad Quality control materials in a non-frost-free freezer as directed by the manufacturer (refer to D5411). 2. The laboratory failed to verify the manufactuerer's reference ranges and failed to establish alternative storage and stability criteria for Bicarbonate (CO2) specimens stored at refrigerated temperatures greater than 24 hours when tested on the Beckman Coulter AU480 chemistry analyzer (refer to D5421). 3. The laboratory failed to define the acceptable limits of QC as required by the manufacturer, and of their own policy on the Beckman Coulter AU480 chemistry analyzer for 22 out of 24 analytes reviewed (refer to D5469). 4. The laboratory failed to ensure QC results met the laboratory's criteria for acceptability before reporting patient test results for testing performed on the Beckman Coulter AU480 chemistry analyzer (refer to D5481). 5. The laboratory failed to document all

Summary Statement of Deficiencies D0000 An initial CLIA inspection was performed on June 7, 2018. The laboratory was found to be in compliance with all Conditions for Participation in the CLIA regulations at 42 CFR 493. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on review of Beckman Coulter hematology analyzer documentation and interview with facility personnel, the laboratory failed to retain all analytic records from the verification study signed on April 14, 2018. The findings included: 1. Based on a review of the verification studies for the Beckman Coulter AcT 2 Diff hematology analyzer, the laboratory performed a correlation study with another laboratory to assess the accuracy of the instrumentation. From the verification summary: "In this study the laboratory will be validating Analytic Accuracy. This will be done by proving agreement between test result and "true" result. This will be completed utilizing two methods. The first method is Comparison of results between new method and "reference' method. A patient sampling will be tested, and the results achieved in our laboratory will be compared to the results obtained by the current reference testing laboratory." Based on review of the correlation study, the laboratory had evaluated the data, but had not retained the analytic records from performing the testing on the Beckman Coulter AcT 2 Diff hematology analyzer. 2. In an interview at 10:15 hours on 6/7/2018 in the laboratory, Testing Person 1 stated the laboratory was unaware of the requirement to maintain the verification study analytic records and had likely shredded them. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- 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 review of Beckman Coulter hematology analyzer verification study documentation, the analyzer reference manual, and interview with facility personnel, the laboratory failed to verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population in verification study signed on April 14, 2018. The findings included: 1. Based on a review of the verification studies for the Beckman Coulter AcT 2 Diff hematology analyzer, approved on April 14, 2018 by the laboratory director: "The reportable range and reference ranges will be gathered from the package inserts and used until it is determined the patient population demands the setting of our own acceptable range." 2. Based on review of the Beckman Coulter AcT 2 Diff reference manual (PN 4237515BA (August 2010)), on page 4-10, the manufacturer provides the following ranges: "A normal range study was conducted to assess the Reference Ranges for the AcT diff 2 analyzer. Whole-blood samples were collected from 50 donors (equal numbers of males and females). The selection of donors was consistent with guidelines stated in NCCLS, C28-A. See Table 4.12." From Table 4.12 Normal Population Study Value: White blood cell count (WBC) Reference/Normal Values: 3.38 - 8.68 x 1000 cells per microliter Value: Red blood cell count (RBC) Reference /Normal Values: 3.75 -5.25 x 1,000,000 cells per microliter Value: Hemoglobin (Hgb) Reference/Normal Values: 11.69 - 15.82 grams per deciliter Value: Hematocrit Reference/Normal Value: 34.69 - 45.88 percent/ratio Value: Platelet count Reference /Normal Value: 116.10 - 329.27 x 1000/ microliter 3. Based on random review of patient results (Accession: 3876), the laboratory was using the following reference /normal values: Value: White blood cell count (WBC) Reference/Normal Values: 3.5 - 10.5 x 1000 cells per microliter Value: Red blood cell count (RBC) Reference /Normal Values: 4.32 - 5.72 x 1,000,000 cells per microliter Value: Hemoglobin (Hgb) Reference/Normal Values: 13.8 -17.2 grams per deciliter Value: Hematocrit Reference/Normal Value: 38.8 - 50.0 percent/ratio Value: Platelet count Reference /Normal Value: 150 -450 x 1000/ microliter 4.. In an interview at 10:55 hours on 6/7 /2018 in the laboratory, the Laboratory Director stated the laboratory's reference ranges had been set up in the laboratory information system prior to the verification study and the exact source of the reference ranges was not known at the time of the survey. 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 -- 2 of 3 -- 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 review of Beckman Coulter hematology analyzer verification study documentation, the analyzer reference manual, and interview with facility personnel, the laboratory director failed to ensure the laboratory verified that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population in verification study signed on April 14, 2018. Refer to D5421. -- 3 of 3 --