Memorial Medical Center

Summary Statement of Deficiencies D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on the laboratory's records and staff interview, the laboratory failed to have documentation of performing two of two accuracy assessments in 2024 for one non- regulated analyte, C-reactive protein (CRP). Findings include: 1. A review of the laboratory's records revealed the laboratory performed CRP testing on the Beckman Coulter DxC AU 700 chemistry analyzers. 2. Further review of the laboratory's records revealed the laboratory failed to have documentation of performing two accuracy assessments for the non-regulated analyte CRP in 2024. 3. In an interview on 1/8/25 at 8:40 a.m. in the office, after review of the records, the general supervisor confirmed the above findings. D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) (a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (a)(1) Patient preparation. (a)(2) Specimen collection. (a)(3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (a)(4) Specimen storage and preservation. (a)(5) Conditions for specimen transportation. (a)(6) Specimen processing. (a)(7) Specimen acceptability and rejection. (a)(8) Specimen referral. This STANDARD is not met as evidenced by: Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) (b)(2)(i) Define a function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (b)(2)(ii) Perform and document the function checks, including background or baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks must be within the laboratory's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on a review of the 'Preventive Maintenance and Quality Control Checklist for Centra-W Cell Washer' records from 2024, the laboratory's records, and staff interview, the laboratory failed to ensure the quarterly checks of the Centra-W cell washer's motor speed fell within the acceptable range for two of four times quarterly maintenance was performed in 2024. Findings include: 1. A review of the 'Preventive Maintenance and Quality Control Checklist for Centra-W Cell Washer' records revealed the Centra-W cell washer (serial number: 23923389) required a quarterly check of the motor speed with an acceptable range of 3400 - 3600. 2. Further review of the 'Preventive Maintenance and Quality Control Checklist for Centra-W Cell Washer' records revealed the laboratory performed the quarterly checks on the following dates and the readings were outside of the acceptable range: Date: 10/3/24 Actual reading: 2720 Date: 12/12/24 Actual reading: 2590 3. A review of the laboratory's records revealed the laboratory estimated performing 3,506 immunohematology tests annually. 4. In an interview on 1/8/25 at 10:55 a.m. in the laboratory, after review of the records, the general supervisor confirmed the above findings. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3)-- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on review of the laboratory's calibration verification records from 2023 and 2024, and staff interview, the laboratory failed to have documentation of performing -- 2 of 4 -- calibration verification every six months. The findings included: 1. A review of the laboratory's calibration records from 2023 and 2024 identified studies were preformed at the following times: a) GC1 analytes: Potassium, Chloride, Sodium, Calcium, Glucose, Albumin, Creatinine, Blood Urea Nitrogen, Total Protein, Magnesium, Phosphorus, Cholesterol, Triglycerides, Lactate Perform: 06/2023 and 12/2024 Elapsed time: 18 months b) GC4 analytes: Direct Bilirubin, Total Bilirubin Performed: 08/2023 and 08/2024 Elapsed time: 12 months 2. General supervisor number 1 confirmed the finding in an interview on 01/07/2024 at 1445 hours in the Inpatient Surgery waiting room. D5559 IMMUNOHEMATOLOGY CFR(s): 493.1271(e)(f) (e) Investigation of transfusion reactions. (e)(1) According to its established procedures, the laboratory that performs compatibility testing, or issues blood or blood products, must promptly investigate all transfusion reactions occurring in facilities for which it has investigational responsibility and make recommendations to the medical staff regarding improvements in transfusion procedures. (e)(2) The laboratory must document, as applicable, that all necessary remedial actions are taken to prevent recurrences of transfusion reactions and that all policies and procedures are reviewed to assure they are adequate to ensure the safety of individuals being transfused. (f) Documentation. The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on a review of the facility's policies, the laboratory's policies, patient transfusion records, and staff interview, the laboratory failed to have documentation of reviewing and investigating suspected transfusion reactions (per the facility's defined criteria) for six of twenty patient's transfusions reviewed from July 2023 to December 2024. Findings include: 1. A review of the facility's policy titled 'Blood Product Transfusion' revealed the following: "Review possible transfusion reaction symptoms: - Blood pressure changes either hypertension or hypotension: - Hypotension: defined as drop in systolic blood pressure of greater than or equal to 30 mmHg - Hypertension: defined as systolic or diastolic increase by at least 30 mmHg during the transfusion. When a transfusion reaction is suspected the nurse must: - Stop the transfusion - Keep the IV open with 0.9 percent normal saline - Report the reaction to both the laboratory and attending physician immediately." 2. A review of the laboratory's policy titled 'Investigation of Possible Transfusion Reactions' revealed the following: "Irrespective of the reason, all transfusion reactions should be investigated to attempt to determine the cause. This requires a re-check of every aspect of the transfusion including clerical records as well as the serological procedures." 3. A review of patient transfusion records from July 2023 to December 2024 identified the following six transfusions where the patients' vital signs met the criteria for a suspected transfusion reaction, however the transfusions were not stopped and the transfusion reactions were not reviewed and investigated by the laboratory: a) Patient ID: 1571158 Transfusion date: 7/25/23 Blood pressure at 15 minutes: 110/55 Blood pressure at 30 minutes: 149/65 (increase in systolic blood pressure of 39 mmHg) Blood pressure at 60 minutes: 145/67 Blood pressure at 90 minutes: 87/59 (decrease in systolic blood pressure of 58 mmHg) b) Patient ID: 1571616 Transfusion date: 7/27/23 Blood pressure at 15 minutes: 94/55 Blood pressure at 45 minutes: 131/69 (increase in systolic blood pressure of 37 mmHg) c) Patient ID: 1591327 Transfusion date: 1/25/24 Baseline blood pressure: 117/58 Blood -- 3 of 4 -- pressure at 2 hours: 152/75 (increase in systolic blood pressure of 35 mmHg) d) Patient ID: 1594083 Transfusion date: 2/20/24 Baseline blood pressure: 110/58 Blood pressure at 3 hours: 149/52 (increase in systolic blood pressure of 39 mmHg) e) Patient ID: 1605749 Transfusion date: 6/5/24 Blood pressure at 60 minutes: 182/52 Blood pressure at 90 minutes: 109/71 (decrease in systolic blood pressure of 73 mmHg) f) Patient ID: 1627914 Transfusion date: 12.27/24 Baseline blood pressure: 136/70 Blood pressure at 90 minutes: 167/52 (increase in systolic blood pressure of 31 mmHg) 4. In an interview on 1/8/25 at 10:55 a.m. in the laboratory, after review of the records, the general supervisor confirmed the above findings. D6126 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(8)(vi) (b)(8)(vi) Assessment of problem-solving skills; and This STANDARD is not met as evidenced by: Based on a review of the laboratory's submitted CMS 209 form, the laboratory's competency assessment documents, and staff interview, the technical supervisor failed to document the assessment of problem-solving skills for two of eleven testing personnel performing high complexity testing in 2024. Findings include: 1. A review of the laboratory's submitted CMS 209 form revealed the laboratory identified 11 testing personnel performing high complexity testing in the specialty of Immunohematology in 2024. 2. A review of the laboratory's Competency Assessment documents revealed that the technical supervisor failed to document the assessment of problem-solving skills for the following testing personnel: - Testing person #10 competency assessment performed April 2024 - Testing person #11 competency assessment performed October 2024 3. In an interview on 1/7/25 at 11:00 a.m. in the inpatient surgery waiting room, after review of the records, the general supervisor confirmed the above findings. -- 4 of 4 --

Summary Statement of Deficiencies D0000 Noted deficiencies and plans of correction were discussed with the laboratory representative(s) at the exit conference. The facility representative(s) were given an opportunity to provide evidence of compliance with the noted deficiencies, and no such evidence was provided prior to survey exit. The facility was found in compliance with applicable CLIA Conditions, and recertification is recommended. Note: The CMS-2567 (Statement of Deficiencies) is an official, legal document. All information must remain unchanged except for entering the

Summary Statement of Deficiencies D0000 The laboratory was surveyed and found to be in compliance with the conditions of participation found in the CLIA regulations at 42 CFR 493 and recertification is recommended. 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: A. Based on review of manufacturer's instructions, review of patient results, and confirmed in interview of facility personnel, the laboratory failed to follow the manufacturer's instructions to ensure plasma samples for lactic acid were separated from the cells within 15 minutes of collection. The findings included: 1. Review of the manufacturer's instructions for Lactic Acid under, "Specimen Collection and Preparation" (Instructions For Use BAOSR6X93 10, January 2019), it stated, " ...Keep the sample on ice and separate plasma from cells within 15 minutes of collection ..." 2. Review of 20 patient final reports from May 2021 found the following 4 samples were tested when the laboratory failed to provide documentation of separating plasma from cells within 15 minutes of collection: Order #72864 Date: 05-21-2021 Collection Time: 2015 Receive Time: 2040 (elapsed time past 15 minutes was 10 minutes) Order #73445 Date: 05-23-2021 Collection Time: 2024 Receive Time: 2049 (elapsed time past 15 minutes was 10 minutes) Order #73474 Date: 05-24-2021 Collection Time: 0005 Receive Time: 0032 (elapsed time past 15 minutes was 12 minutes) Order #75601 Date: 05-27-2021 Collection Time: 0033 Receive Time: 0059 (elapsed time past 15 minutes was 11 minutes) 3. The laboratory was asked to provide documentation of ensuring the plasma samples were separated from the cells within 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 -- 15 minutes of collection. No documentation was provided. 4. Interview with the technical consultant on July 20, 2021 at 14:00 hours in the laboratory confirmed the findings. She revealed that times may not have been entered correctly. This confirmed the findings. B. Based on review of manufacturer's instructions, review of patient results, and confirmed in interview of facility personnel, the laboratory failed to follow the manufacturer's instructions to ensure that results provide only a preliminary analytical test result. The findings included: 1. Based on review of the manufacturer's instructions for Emit II Plus Cannabinoid Assay (August 2010, 9N052.2D_B) stated under the Intended Use section, " ...The Emit II Plus Cannabinoid Assay provides only a preliminary analytical result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Other chemical confirmation methods are available ..." 2. Based on review of the manufacturer's instructions for Emit II Plus Opiate Assay (September 2010, 9B052.6D_D) stated under the Intended Use section, " ...The Emit II Plus Opiate Assay provides only a preliminary analytical result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Other chemical confirmation methods are available ..." 3. A random review of patient results from July 2021 revealed the following patient urine drug screens were resulted as positive or negative, and not as a preliminary positive: Order # 301 Date: 07-07-2021 Cannabinoid Result: Positive Order #6785 Date: 07-19-2021 Cannabinoid: Positive 4. The patient report did not indicate that the results would be sent out for confirmation. Nor, did the patient report state the results were preliminary positive. 5. Interview with the technical consultant on July 20, 2021 at 13:15 hours in the laboratory confirmed the findings. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on a review of the laboratory's verification studies, a review of patient test records, and staff interview, it was revealed the laboratory failed to have documentation of verifying its normal range for the analytes run on the GEM 4000 chemistry analyzer. The findings included: 1. A review of the laboratory's verification records for the GEM 4000 chemistry analyzer revealed the laboratory performed studies in January 2020 for the following analytes: pH PO2 PCO2 HCO3 Hemoglobin CO2 2. A review of the laboratory's patient test records revealed the laboratory identified three patient normal ranges for Arterial Blood Gases: Adult Arterial Blood Gas: Analyte Normal Range Unit pH 7.35 - 7.45 none PO2 83 - 108 mmHg PCO2 35 - 48 mmHg HCO3 21 - 28 mmol/L Hemoglobin 12 - 15 g/dL CO2 22 - 32 mmol/L Adult Venous Blood Gas: Analyte Normal Range Unit pH 7.32 - 7.43 L PO2 35 - 42 mmHg PCO2 41 - 51 mmHg HCO3 22 - 29 mmol/L Hemoglobin 14 - 18 g/dL CO2 22 - 32 mmol/L Cord Blood Gas Venous: Analyte Normal Range Unit pH 7.25 - 7.45 none PO2 17 - 41 mmHg PCO2 27 - 49 mmHg 3. The laboratory was asked to -- 2 of 3 -- provide documentation of verifying the normal ranges to ensure they were reflective of their population. No documentation was provided. 4. n interview with the laboratory manager on July 20, 2021 at 15:30 hours in the laboratory revealed the laboratory did not verify the patient normal ranges. The ranges from the previous analyzer were carried over but not verified. Key: PO2 - partial pressure oxygen PCO2 - partial pressure carbon dioxide HCO3 - bicarbonate CO2 - carbon dioxide mmHg - millimeters Mercury g/dL - grams per deciliter mmol/L - millimoles per liter L - liters 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 review of quality control logs, review of patient final reports, and confirmed in interview with facility personnel, the laboratory failed to provide documentation of performing a positive and negative control each day of patient testing for acid fast bacilli (AFB) smears. The findings included: 1. Review of acid fast stain quality control logs for February 2020 found a positive and negative quality control was documented on February 27, 2020 and February 28, 2020. 2. Review of patient final reports for acid fast found the following 1 of 3 patient results was performed when the laboratory failed to have documentation of performing a positive and negative quality control: Order #42050 Date: 02-29-2020 Direct Acid Fast Stain Result: No AFB seen 3. An interview with the technical consultant on July 21, 2021 at 13:30 hours confirmed the findings. -- 3 of 3 --

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the CMS (Center for Medicare Services) national database and verified with the proficiency testing company, American Proficiency Institute (API). The facility was found to be out of compliance with the conditions of participation of the CLIA program. The following CONDITION LEVEL DEFICIENCIES were found to be out of compliance: 493.803 successful participation in a proficiency testing program 493.1403 laboratories performing moderate complexity testing; laboratory director D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: 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 -- Based on a desk review of proficiency testing records, it was determined that the laboratory has not successfully participated in a proficiency testing program approved by HHS, for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. The laboratory did not successfully participate in the specialty of chemistry for the analyte Albumin (refer to D2096). D2087 ROUTINE CHEMISTRY CFR(s): 493.841(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on a proficiency testing desk review of CMS form 155 and American Proficiency Institute API records found that the laboratory failed to attain a score of at least 80% for the following chemistry analyte Albumin. Findings: 1. API 2020 - 2nd event the laboratory received an unsatisfactory score of 0% for Albumin. 2. API 2020 - 3rd event the laboratory received an unsatisfactory score of 0% for Albumin. 3. API 2020 - 1st event the laboratory received an unsatisfactory score of 60% for pH Blood Gas. 4. API 2020 - 1st event the laboratory received an unsatisfactory score of 40% for PO2 Blood Gas. 5. API 2020 - 1st event the laboratory received an unsatisfactory score of 60% for PCO2 Blood Gas. 6. API 2019 - 2nd event the laboratory received an unsatisfactory score of 60% for Theophylline. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a desk review of American Proficiency Institutes (API) proficiency testing records, it was determined that laboratory failed to achieve satisfactory performance (80% or greater) for the same analyte in two out of three consecutive testing events. The laboratory failed to achieve satisfactory performance in the specialty of chemistry for the analyte Sodium. Two out of three unsatisfactory scores results in unsuccessful PT performance. Findings: 1. API 2020 - 2nd event the laboratory received an unsatisfactory score of 0% for Albumin. 2. API 2020 - 3rd event the laboratory received an unsatisfactory score of 0% for Albumin. 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 desk review of laboratory proficiency testing it was revealed that the -- 2 of 3 -- laboratory director failed to provide overall management and direction of the laboratory services. Findings: 1. Review of the laboratory proficiency testing results revealed the laboratory director failed to ensure that the laboratory participated successfully (refer to D6016). D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on a desk review of proficiency testing results it was revealed that the laboratory director failed to ensure the overall quality of the laboratory services provided. The laboratory director failed to ensure successful participation in a HHS approved proficiency testing program (refer to D2096). -- 3 of 3 --

Summary Statement of Deficiencies 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 review of the laboratory's policies, personnel records, and staff interview, the laboratory failed to establish and follow written policies and procedures to assess employee competency. The findings included: 1. The laboratory failed to have written policies and procedures on performing competency in a moderate complexity laboratory. 2. Based on review of personnel records the following employees' competency assessments were being performed by the general supervisor: Testing Person 2 Testing Person 3 Testing Person 4 Testing Person 11 Testing Person 20 3. An interview with the technical consultant on November 1, 2018 at 10:30 hours in the laboratory confirmed the findings. She confirmed the laboratory did not have a policy for competency assessments and agreed some of the assessments were being done by the general supervisor for moderate complexity testing. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: A. Based on review of patient test records from 2017 and 2018, and staff interview, it was revealed the laboratory failed to have documentation of performing twice annual Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 7 -- accuracy assessments for multiple analytes in 2017. The findings were: 1. A review of patient test records from 2017 revealed the laboratory performed the following testing in 2017: Bleeding Time Legionella pneumophilia Urinary Antigen Streptococcus pneumoniae Urinary Antigen Fetal Stain 2. The laboratory was asked to provide documentation of being enrolled in proficiency testing or of performing twice annual accuracy assessment for each of the missing analytes in 2017. No documentation was provided. 3. An interview with the technical consultant on October 30, 2018 at 12:00 hours in the laboratory confirmed the findings. B. Based on review of proficiency testing records from 2017 and confirmed in interview of facility personnel, the laboratory failed to perform twice annual accuracy for body fluid analysis in 2017. The findings were: 1. Review of the laboratory's proficiency testing records from WSLH for 2017 revealed the laboratory received the following scores: Body Fluid Analysis (RBC) 2017 Event 1 Score: 66% Body Fluid Analysis (RBC) 2017 Event 2 Score 33% 2. Because the laboratory failed to achieve an 80% or higher twice annually in 2017, the laboratory did not perform twice annual accuracy. 3. An interview with the technical consultant on October 30, 2018 at 12:00 hours in the laboratory confirmed the findings. Key: RBC - red blood cell 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 the CLIA Form 116, surveyor observations, review of manufacturer's instructions, review of patient results, and confirmed in interview of facility personnel, the laboratory failed to follow the manufacturer's instructions to ensure tubes are maintained in a vertical position at all times. The findings were: 1. Review of the laboratory's submitted Form CMS 116 signed by the laboratory director on October 30, 2018 revealed the laboratory's Chemistry-14 Panel and Lipid Panel consists of the following analytes: CHEM-14 LIPID PROFILE Sodium Cholesterol Potassium High Density Lipoprotein Chloride Triglycerides Carbon Dioxide Low Density Lipoprotein Calcium Glucose Albumin Alkaline Phosphatase Alkaline Aminotransferase Aspartate Aminotransferase BUN Creatinine Total Bilirubin Total Protein 2. Surveyor observation in the laboratory on October 30, 2018 and November 1, 2018 revealed patient samples brought in by courier service. The two times samples arrived, they were brought in a cooler with an ice pack. Each of the specimens was in an individual biohazard bag and laying down in the cooler. 3. Review of the manufacturer's instructions for the Beckman Coulter reagent "Glucose" (Chemistry Information Sheet A18496 AG, July 2011) under, "Specimen" stated, "1. Tubes of blood are to be kept closed at all times and in a vertical position ..." 4. Review of the manufacturer's instructions for the Beckman Coulter reagent "Cholesterol" (Chemistry Information Sheet A18476 AH, May 2011) under, "Specimen" stated, "1. Tubes of blood are to be kept closed at all times and in a vertical position ..." 5. Review of the manufacturer's instructions for the Beckman Coulter reagent "LDLD" (Chemistry Information Sheet A18513 AK, December 2010) under, "Specimen" stated, "1. Tubes of blood are to be kept closed at all times and in a vertical position ..." 6. Review of -- 2 of 7 -- the manufacturer's instructions for the Beckman Coulter reagent "Triglycerides" (Chemistry Information Sheet A18554 AG, September 2012) under, "Specimen" stated, "1. Tubes of blood are to be kept closed at all times and in a vertical position ..." 7. Review of the manufacturer's instructions for the Beckman Coulter reagent "BUN" (Chemistry Information Sheet A18467 AF, August 2010) under, "Specimen" stated, "1. Tubes of blood are to be kept closed at all times and in a vertical position ..." 8. Review of the manufacturer's instructions for the Beckman Coulter reagent "Creatinine" (Chemistry Information Sheet A44573 AG, September2012) under, "Specimen" stated, "1. Tubes of blood are to be kept closed at all times and in a vertical position ..." 9. Review of the manufacturer's instructions for the Beckman Coulter reagent "Alanine Aminotransferase (ALT)" (Chemistry Information Sheet A18452 AG, September 2012) under, "Specimen" stated, "1. Tubes of blood are to be kept closed at all times and in a vertical position ..." 10. Review of the manufacturer's instructions for the Beckman Coulter reagent "Aspartate Aminotransferase AST)" (Chemistry Information Sheet A18460 AH, September 2012) under, "Specimen" stated, "1. Tubes of blood are to be kept closed at all times and in a vertical position ..." 11. Review of the manufacturer's instructions for the Beckman Coulter reagent "Alkaline Phosphatase (ALP)" (Chemistry Information Sheet A18450 AG, August 2010) under, "Specimen" stated, "1. Tubes of blood are to be kept closed at all times and in a vertical position ..." 12. Review of the manufacturer's instructions for the Beckman Coulter reagent "Total Protein (TP)" (Chemistry Information Sheet A20656 AH, June 2012) under, "Specimen" stated, "1. Tubes of blood are to be kept closed at all times and in a vertical position ..." 13. Review of the manufacturer's instructions for the Beckman Coulter reagent "Total Bilirubin" (Chemistry Information Sheet A18553 AH, September 2012) under, "Specimen" stated, "1. Tubes of blood are to be kept closed at all times and in a vertical position ..." 14. Review of the manufacturer's instructions for the Beckman Coulter reagent "Potassium (K)" (Chemistry Information Sheet A18509 AF, August 2010) under, "Specimen" stated, "1. Tubes of blood are to be kept closed at all times and in a vertical position ..." 15. Review of the manufacturer's instructions for the Beckman Coulter reagent "Sodium (Na)" (Chemistry Information Sheet A18529 AF, August 2010) under, "Specimen" stated, "1. Tubes of blood are to be kept closed at all times and in a vertical position ..." 16. Review of the manufacturer's instructions for the Beckman Coulter reagent "Chloride (Cl)" (Chemistry Information Sheet A18480 AF, August 2010) under, "Specimen" stated, "1. Tubes of blood are to be kept closed at all times and in a vertical position ..." 17. Review of the manufacturer's instructions for the Beckman Coulter reagent "Carbon Dioxide (CO2)" (Chemistry Information Sheet A18481 AG) under, "Specimen" stated, "1. Tubes of blood are to be kept closed at all times and in a vertical position ..." 18. Review of the manufacturer's instructions for the Beckman Coulter reagent "High Density Lipoprotein (HDL) Cholesterol" (Chemistry Information Sheet B48208AB EN, 1/15) under, "Specimen" stated, "1. Tubes of blood are to be kept closed at all times and in a vertical position ..." 19. The following patient samples were tested when the manufacturer's instructions were not followed to maintain tubes in a vertical position (samples identified during the 2 of 2 direct observations). Sample ID: 12122 Date: 10/30/2018 Sodium: 137 mmol/L Potassium: 3.8 mmol/L Chloride: 98 mmol/L Carbon Dioxide: 30 mmol/L Calcium: 9.3 mg/dL Glucose: 108 mg/dL Albumin: 4.2 g/dL Alkaline Phosphatase: 63 IU/L Alanine Aminotransferase: 28 IU/L Aspartate Aminotransferase: 22 IU/L BUN: 16 mg/dL Creatinine: 0.87 mg/dL Total Bilirubin: 0.9 mg/dL Total Protein: 7.2 g/dL Cholesterol: 107 mg/dL HDL: 31 mg/dL Triglycerides: 110 m/dL LDL: 54 mg/dL Sample ID: 12230 Date: 10/30/2018 Sodium: 140 mmol/L Potassium: 3.6 mmol/L Chloride: 102 mmol/L Carbon Dioxide: 27 mmol/L Calcium: 9.2 mg/dL Glucose: 180 mg/dL Albumin: 3.8 g/dL Alkaline Phosphatase: 55 IU/L Alanine Aminotransferase: -- 3 of 7 -- 16 IU/L Aspartate Aminotransferase: 18 IU/L BUN: 24 mg/dL Creatinine: 1.74 mg /dL Total Bilirubin: 1.0 mg/dL Total Protein: g/dL Sample ID: 12888 Date: 11/01 /2018 Sodium: 140 mmol/L Potassium: 3.6 mmol/L Chloride: 104 mmol/L Carbon Dioxide: 23 mmol/L Calcium: 8.7 mg/dL Glucose: 155 mg/dL Albumin: 3.5 g/dL Alkaline Phosphatase: 34 IU/L Alanine Aminotransferase: 16 IU/L Aspartate Aminotransferase: 22 IU/L BUN: 52 mg/dL Creatinine: 0.80 mg/dL Total Bilirubin: 1.0 mg/dL Total Protein: 6.3 g/dL Sample ID: 12881 Date: 11/01/2018 Sodium: 140 mmol/L Potassium: 4.7 mmol/L Chloride: 100 mmol/L Carbon Dioxide: 30 mmol/L Calcium: 9.4 mg/dL Glucose: 92 mg/dL Albumin: 4.3 g/dL Alkaline Phosphatase: 55 IU/L Alanine Aminotransferase: 33 IU/L Aspartate Aminotransferase: 30 IU/L BUN: 18 mg/dL Creatinine: 0.88 mg/dL Total Bilirubin: 0.3 mg/dL Total Protein: 8.1 g/dL Sample ID: 12818 Date: 11/01/2018 Sodium: 140 mmol/L Potassium: 4.6 mmol/L Chloride: 102 mmol/L Carbon Dioxide: 29 mmol/L Calcium: 9.1 mg/dL Glucose: 115 mg/dL Albumin: 3.8 g/dL Alkaline Phosphatase: 75 IU/L Alanine Aminotransferase: 12 IU/L Aspartate Aminotransferase: 19 IU/L BUN: 16 mg/dL Creatinine: 0.73 mg /dL Total Bilirubin: 0.7 mg/dL Total Protein: 7.2 g/dL Sample ID: 12876 Date: 11/01 /2018 Sodium: 142 mmol/L Potassium: 4.3 mmol/L Chloride: 107 mmol/L Carbon Dioxide: 25 mmol/L Calcium: 9.4 mg/dL Glucose: 95 mg/dL Albumin: 3.9 g/dL Alkaline Phosphatase: 51 IU/L Alanine Aminotransferase: 11 IU/L Aspartate Aminotransferase: 21 IU/L BUN: 40 mg/dL Creatinine: 1.62 mg/dL Total Bilirubin: 0.6 mg/dL Total Protein: 6.9 g/dL 20. An interview with the Technical Consultant on November 1, 2018 at 09:15 hours in the laboratory confirmed the findings. Key: CLIA - Clinical Laboratory Improvement Amendments Mmol/L - millimols per liter Mg/dL - milligrams per deciliter g/dL - grams per deciliter IU/L - international units per liter 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: Review of verification studies found that the laboratory failed to ensure that each system introduced had been validated to ensure it met the manufacturer's specifications prior to testing patients. The findings were: 1. Validation studies for the Solana Trichomonas performed in May 2018 was incomplete. Missing documentation was as follows: a. Final review by laboratory director 2. The laboratory was asked to provide documentation of the missing verification records. No documentation was provided. 3. Interview with the technical consultant on 10/31/2018 at 10:21 hours in the laboratory confirmed the findings. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- -- 4 of 7 -- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of the laboratory Individualized Quality Control Plan (IQCP), review of quality control records, review of patient records, and confirmed in interview of facility personnel, the laboratory failed to follow its IQCP for Group B Streptococcus testing on the Illumigene. The findings were: 1. Review of the laboratory's IQCP for Group B Streptococcus testing on the Illumigene approved by the laboratory director on May 14, 2018, stated, "2. External positive and negative controls are ran with each new lot, shipment, and every thirty days." 2. Review of quality control records for Group B Streptococcus testing on the Illumigene from October, November, and December 2017 revealed external quality control was performed as follows: October 3, 2017 November 12, 2017 (40 days later) 3. Review of patient results from October, November, and December 2017 revealed the following patient specimen was performed when quality control had not been performed: Account: 1356675 Date: November 10, 2017 4. An interview with the technical consultant on October 31, 2018 at 11:20 hours in the laboratory confirmed the findings. She stated that she had been working on identifying these types issues through QA (quality assurance) but had not had a chance to go back that far. D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(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-- At least once a day patient specimens are assayed or examined perform the following for-- Each qualitative procedure, include a negative and positive control material; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: A) Based on review of the CLIA and FDA database, review of laboratory policy, review of manufacturer's instructions, review of quality control records, review of patient records, and confirmed in interview of facility personnel, the laboratory failed to perform an external positive and negative quality control each day of patient testing for Legionella pneumophilia urinary antigen. 1. The laboratory did not perform an IQCP (Individualized Quality Control Plan) for Legionella pneumophilia urinary antigen. The laboratory must perform an external positive and negative quality control test each day of patient testing. 2. Review of the CLIA and FDA database revealed the BinaxNOW Legionella pneumophilia urinary antigen kit is a moderate complexity test kit. 3. Review of the laboratory's policy, "Alere BinaxNOW Legionella urinary Antigen Card Laboratory Procedure" reviewed and approved by the laboratory director on February 22, 2018 stated, " ...Alere kits contain Positive and Negative Control swabs. These swabs will monitor the entire assay. Test these swabs with each new shipment received. Other controls may be tested in order to conform with: local, state and/or federal regulations, accrediting groups and/or, your lab's standard Quality Control procedures." 4. Review of the manufacturer's instructions for the BinaxNOW -- 5 of 7 -- Legionella pneumophilia urinary antigen kit (IN8520050 Rev. 9, 2017/02) under "Quality Control" stated, "Alere BinaxNOW Legionella kits contain Positive and Negative control Swabs. These swabs will monitor the entire assay. Test these swabs with each new shipment received. Other controls may be tested in order to conform with: local state, and/or federal regulations, accrediting groups, and/or, your lab's standard Quality Control procedures." 5. Review of quality control records in conjunction with patient results from January 1, 2018 to October 30, 2018 revealed the following patients were tested when an external positive and negative quality control had not been performed: Account Number: 1381870 Date: 07-31-2018 6. An interview with the technical consultant on October 31, 2018 at 15:00 hours in the laboratory confirmed the findings. B) Based on review of the CLIA and FDA database, review of manufacturer's instructions, review of quality control records, review of patient records, and confirmed in interview of facility personnel, the laboratory failed to perform an external positive and negative quality control each day of patient testing for Streptococcus pneumoniae urinary antigen. 1. The laboratory did not perform an IQCP (Individualized Quality Control Plan) for Streptococcus pneumoniae urinary antigen. The laboratory must perform an external positive and negative quality control test each day of patient testing. 2. Review of the CLIA and FDA database revealed the BinaxNOW Streptococcus pneumoniae urinary antigen kit is a moderate complexity test kit. 3. Review of the laboratory's policy, "Alere BinaxNOW Legionella urinary Antigen Card Laboratory Procedure" reviewed and approved by the laboratory director on February 22, 2018 stated, " ...Alere kits contain Positive and Negative Control swabs. These swabs will monitor the entire assay. Test these swabs with each new shipment received. Other controls may be tested in order to conform with: local, state and/or federal regulations, accrediting groups and/or, your lab's standard Quality Control procedures." 4. Review of the manufacturer's instructions for the BinaxNOW Streptococcus pneumoniae urinary antigen kit (IN710050 Rev. 10, 2018/07) under "Quality Control" stated, "Alere BinaxNOW Legionella kits contain Positive and Negative control Swabs. These swabs will monitor the entire assay. Test these swabs with each new shipment received. Other controls may be tested in order to conform with: local state, and/or federal regulations, accrediting groups, and/or, your lab's standard Quality Control procedures." 5. Review of quality control records in conjunction with patient results from January 1, 2018 to October 30, 2018 revealed the following patients were tested when an external positive and negative quality control had not been performed: Account Number: 1370411 Date: 04-02-2018 Account Number: 1370851 Date: 04-06-2018 Account Number: 1381870 Date: 07-31-2018 6. An interview with the technical consultant on October 31, 2018 at 15:00 hours in the laboratory confirmed the findings. D5781