Quest Diagnostics Austin Rrl

Summary Statement of Deficiencies D0000 The laboratory was surveyed and found to be in compliance with the Conditions of the CLIA regulations found at 42 CFR 493.1 through 493.1780, and recertification is recommended. Standard level deficiencies were cited. 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 laboratory's policies and procedures, test directory, interview, observation, requisition slips, test reports, and pre-survey paperwork, the laboratory failed to monitor and document transport and received temperatures for eight out of eight samples observed on 09/17/2024 and 09/18/2024. Findings follow. A. The laboratory's policies and procedures 1. Total Bilirubin (T Bili) & Direct Bilirubin (D Bili Neo) Review of the laboratory's policy and procedure titled Neonatal Direct Bilirubin on the Beckman Coulter AU Series, approved 07/05/2024; Total Bilirubin on the Beckman Coulter AU Series, approved 07/05/2024: Under 3. Specimen Requirements at 3.2 Specimen Type & Handling stated for Stability and Storage Requirements: Analyte Stability & Storage Requirements a. T Bili Room Temperature: Serum: 3 days b. D Bili Neo Room Temperature: Serum: 24 hours 2. Comprehensive Metabolic Panel (CMP) Review of the laboratory's policies and procedures titled Alkaline Phosphatase (ALP) on the Beckman Coulter AU Series, approved 07/03/2024; Alanine Aminotransferase (ALT) on the Beckman Coulter AU Series, approved 07/16/2024; Total Bilirubin (T Bili) on the Beckman Coulter AU 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 -- Series, approved 07/05/2024; Electrolytes (Na, K, Cl) on the Beckman Coulter AU Series, approved 07/03/2024: Under 3. Specimen Requirements at 3.2 Specimen Type & Handling stated for Stability and Storage Requirements: Analyte Stability & Storage Requirements a. ALP Room Temperature: Serum: 3 days b. ALT Room Temperature: Serum: 3 days c. T Bili Room Temperature: Serum: 3 days d. Na Room Temperature: Serum: 3 days e. K Room Temperature: Serum: 3 days f. Cl Room Temperature: Serum: 3 days 3. Estradiol, Leutinizing Hormone (LH), Progesterone Review of the laboratory's policies and procedures titled Estradiol by Siemens Centaur, approved 07/03/2024; LH by Siemens Centaur, approved 07/05/2024; Progesterone by Siemens Centaur, approved 07/05/2024: Under 3. Specimen Requirements at 3.2 Specimen Type & Handling stated for Stability and Storage Requirements: Analyte Stability & Storage Requirements a. Estradiol Room Temperature: 20 hours b. LH Room Temperature: 8 hours c. Progesterone Room Temperature: 8 hours The policies and procedures did not define what room temperature was in Celsius/Fahrenheit. B. Review of the laboratory's policy and procedure titled Logistics On-Route SOP, prepared 01/31/2022, defines Ambient temperature as "the temperature between 18 - 25 degrees Celsius". C. Review of the on-line Quest Test Directory for the following tests for Transport Temperature and Specimen Stability stated: Analyte/Transport Temperature/Specimen Stability 1. Bilirubin, Total and Direct, Neonatal/Room Temperature/Room Temperature: 24 hours 2. CMP/Room Temperature/Room Temperature: 72 hours 3. Estradiol/Room Temperature/Room Temperature: 7 days 4. LH/Room Temperature/Room Temperature: 7 days 5. Progesterone/Room Temperature/Room Temperature: 72 hours The test directory did not define what room temperature was in Celsius /Fahrenheit. The test directory exceeded the Specimen and Handling requirements of the policies and procedures for the Endocrinology testing. D. Interview with testing personnel #1 (as listed on the CMS Form 209) on 09/17/2024 at 1310 hours in the laboratory stated they don't take temperatures of the samples received, that they feel the samples to determine if they are acceptable. E. Surveyor observed couriers dropping off specimens and had no thermometer or ice packs in a thinly insulated bag. The following samples and requisition slips were dropped off: Observation Accession # Test 1. 09/17/2024@1256 DL 687719P T Bili 2. 09/17/2024@1256 DL 687736 P T Bili, D Bili Neo 3. 09/17/2024@1440 DL 687985 P T Bili, D Bili Neo 4. 09/18 /2024@1027 DL 709003 P T Bili, D Bili Neo 5. 09/18/2024@1030 DL 708852 P Estradiol, LH, Progesterone 6. 09/18/2024@1118 DL 709105 P T Bili, D Bili Neo 7. 09/18/2024@1328 DL 709738 P T Bili, D Bili Neo 8. 09/18/2024@1448 DL 709857 P CMP * Exception: #5 was transported in a insulated bag with an ice pack in a lower separated compartment. F. Interview with the Laboratory Director on 09/18/2024 at 1330 hours in the laboratory confirmed the laboratory had no means to monitor transport and received specimen temperatures. G. Review of the test reports for the above samples showed testing was completed and reported. H. Review of the presurvey paperwork titled Annual Test Volume & Proficiency Programs Worksheet showed an estimated annual test volume of 43,193 in chemistry, and 2,634 in endocrinology. D5423 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(2) Each laboratory that modifies an FDA-cleared or approved test system, or introduces a test system not subject to FDA clearance or approval (including methods developed in-house and standardized methods such as text book procedures), or uses a test system in which performance specifications are not provided by the manufacturer must, before reporting patient test results, establish for each test system the -- 2 of 4 -- performance specifications for the following performance characteristics, as applicable: (2)(i) Accuracy. (2)(ii) Precision. (2)(iii) Analytical sensitivity. (2)(iv) Analytical specificity to include interfering substances. (2)(v) Reportable range of test results for the test system. (2)(vi) Reference intervals (normal values). (2)(vii) Any other performance characteristic required for test performance. This STANDARD is not met as evidenced by: I. Based on review of the laboratory's policies and procedures, stability studies, interview, and pre-survey paperwork, the laboratory failed to challenge the upper limit of their study on a fresh sample performed on the Beckman Coulter AU 480 for 16 of 16 of its chemistries. Findings follow. A. Review of the laboratory's policies and procedures titled Alkaline Phosphatase (ALP) on the Beckman Coulter AU Series, approved 07/03/2024; Alanine Aminotransferase (ALT) on the Beckman Coulter AU Series, approved 07/16/2024; Neonatal Direct Bilirubin (D Bili Neo) on the Beckman Coulter AU Series, approved 07/05/2024; Total Bilirubin (T Bili) on the Beckman Coulter AU Series, approved 07/05/2024; Cholesterol (Chol) on the Beckman Coulter AU Series, approved 07/03/2024; Creatine Kinase (CK) on the Beckman Coulter AU Series, approved 07/03/2024; Creatinine (Crea) on the Beckman Coulter AU Series, approved 07/03/2024; Gamma Glutamyltransferase (GGT) on the Beckman Coulter AU Series, approved 07/05/2024; Electrolytes (Na, K, Cl) on the Beckman Coulter AU Series, approved 07/03/2024; Direct Low Density Lipoprotein (DLDL) on the Beckman Coulter AU Series, approved 07/03/2024; Lipase on the Beckman Coulter AU Series, approved 07/05/2024; Magnesium (Mg) on the Beckman Coulter AU Series, approved 07/05/2024; Triglycerides (Trig) on the Beckman Coulter AU Series, approved 07/05/2024; Uric Acid (UA) on the Beckman Coulter AU Series, approved 07/05/2024: Under 3. Specimen Requirements at 3.2 Specimen Type & Handling stated for Stability and Storage Requirements: Analyte Stability & Storage Requirements 1. ALP Room Temperature: Serum: 3 days 2. ALT Room Temperature: Serum: 3 days 3. D Bili Neo Room Temperature: Serum: 24 hours 4. T Bili Room Temperature: Serum: 3 days 5. Chol Room Temperature: Serum: 7 days 6. CK Room Temperature: Serum: 3 days 7. Crea Room Temperature: Serum: 3 days 8. GGT Room Temperature: Serum: 7 days 9. Na Room Temperature: Serum: 3 days 10. K Room Temperature: Serum: 3 days 11. Cl Room Temperature: Serum: 3 days 12. DLDL Room Temperature: Serum: 3 days 13. Lipase Room Temperature: Serum: 7 days 14. Mg Room Temperature: Serum: 7 days 15. Trig Room Temperature: Serum: 3 days 16. UA Room Temperature: Serum: 3 days The policies and procedures did not define what room temperature was in Celsius/Fahrenheit. B. Review of the stability studies for the chemistries performed on the Beckman Coulter AU 480, 06/13/2023 - 11/30/2023, did not state the temperatures the samples were exposed to in the study, nor did they challenge the upper range of 25 degrees Celsius at a controlled temperature. In addition, the first sample (0) was not tested on a fresh sample, but a sample received by courier, where temperatures were also not monitored. C. Interview with testing personnel #1 (as listed on the CMS Form 209) on 09/17/2024 at 1310 hours in the laboratory stated the samples were tested in the laboratory at room temperature and the first sample (0) was tested after the courier brought it into the laboratory. He confirmed the baseline sample (0) was tested after exposure to transport temperatures versus using a fresh sample, and the age of the sample was not monitored. D. Review of the presurvey paperwork titled Annual Test Volume & Proficiency Programs Worksheet showed an estimated annual test volume of 43,193 in chemistry. II. Based on review of the manufacturer's instructions, the laboratory's policy and procedure, stability study, patient reports, presurvey paperwork, and interview, the laboratory failed to ensure an extended specimen stability study was -- 3 of 4 -- performed for the Complete Blood Count (CBC) on the Sysmex XN-450 for four out of 14 patient samples reviewed. Findings follow. A. Review of the Sysmex XN-450 Basic Operation manual, 06/2017, at 4.3 Preparing Samples, for Handling Whole Blood stated, "The sample should be analyzed within 4 hours after collection. If it is not possible to analyze the sample within 4 hours, store it in a refrigerator at 2 to 8 degrees Celsius until it can be analyzed..." The manufacturer did not define the stability of the CBC beyond 4 hours after collection. B. Review of the Sysmex XN- 450 General Information manual, at Chapter 5 Instrument Specifications stated, "Long term stability is determined by comparing the results of the initial analysis (within 2 hours of collection) to results from samples stored at controlled room and refrigerated temperature for 48 hours..." C. Review of the laboratory's policy and procedure titled Sysmex XNL- Series Operation for CBC, reviewed by previous laboratory director 05 /14/2020, under 3.2 Specimen Type & Stability at Stability and Storage Requirements for High Complexity Sites stated, "High Complexity Room Temperature: 48 hours/ High Complexity Refrigerated: 48 hours". D. The laboratory's specimen stability study was requested on September 18, 2024 at 1355 hours but not provided. E. Random review of patient reports to the STAT Tracking Management Report Summary Detail Report revealed 4 out of 14 exceeded the manufacturer's stability of 4 hours as listed by Accession No, date and time of collection, date and time released, and elapsed time: Accession # Test Collection date and time Released date and time Elapsed Time 1. DL504449M CBC 04/23/2024@0932 04/23/2024@1350 4 hours 18 minutes 2. DL504462M CBC 04/23/2024@0943 04/23/2024@1359 4 hours 16 minutes 3. DZ756240K CBC 06/24/2024@0806 06/24/2024@1213 4 hours 7 minutes 4. DZ039599L CBC 07/16/2024@0728 07/16/2024@1956 12 hours, 28 minutes F. Review of the presurvey paperwork titled Annual Test Volume & Proficiency Programs Worksheet showed an estimated annual test volume of 23,362 for Hematology. G. Interview with technical consultant #1 (as listed on the CMS form 209) on September 18, 2024 at 1355 hours confirmed a stability study to establish the extended specimen stability of the CBC was not performed. -- 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 was found to be in compliance with applicable Conditions of Participation in the CLIA program, and recertification is recommended. 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 validation records, manufacturer's instructions, laboratory's policy and procedure, observation, requisition slips, courier records, interview, and pre-survey paperwork, the laboratory failed to spin the neonatal total bilirubin and neonatal direct bilirubin using the Advanced Bilirubin Stat-Analyzer Photometer by Advanced Instruments within approximately 30 minutes to one hour after collection for five out of five specimens reviewed. Findings follow. A. Review of the validation showed the Advanced Bilirubin Stat-Analyzer Photometer was validated on 5/12 /2021. B. Review of the Advanced Instruments technical reference titled INSTRUCTION- In-Vitro Diagnostic of Neonatal Bilirubin Using the Advanced BR2 Bilirubin Stat-Analyzer, CL00357 Rev 0, under VII. SAMPLE REQUIREMENTS for Serum at Collection/Preparation stated, "Allow the blood to clot at room temperature (approximately 30-60 minutes) and separate the serum from cells by centrifugation as soon as possible after clot formation." C. Review of the laboratory's policy and procedure titled Neonatal Bilirubin by Bilirubinometer, 11/2012, under 3. SPECIMEN 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 -- REQUIREMENTS for 3.1 Patient Preparation at Specimen Collection and/or Timing stated, "Collect using standard phlebotomy techniques for neonates. Separate from clot as soon as possible after visible clot formation, usually 30 minutes after collection." And, under 3. SPECIMEN REQUIREMENTS for 3.2 Specimen Type & Handling at Timing Considerations stated, "Sample collected in serum separator tube must be allowed to clot for at least 30 minutes, but no longer than 1 hour." D. Surveyor observed neonatal bilirubin and direct bilirubin samples received in the laboratory unspun: 1. At 1115 hours on 07/20/2022, surveyor observed sample, requisition # 311423083, from account #10764290 was in the drop-off tray in the laboratory. Review of the requisition slip showed it was collected at 9:37 AM. Review of the Route Detail Sheet STAT Calls form showed the Call Received Time as 9:56 AM, and the Pick Up Time was 10:59 AM, Delivery Time was 11:07 hours (elapsed time thus far was 1 hour 38 minutes). 2. At 1211 hours on 7/20/2022, surveyor observed sample, requisition # 38942869, from account #4902575, was dropped off in the laboratory. Review of the requestion slip showed it was collected at 10:48 AM. review of the Route Detail Sheet STAT Calls form showed the Call Received Time as 10:49 AM, and the Pick Up Time was 11:27 AM, Delivery Time was 12:06 hours. At 1211 hours surveyor observed testing personnel #2, as listed on the CMS form 209, centrifuge the sample (elapsed time was 1 hour 23 minutes). 3. At 1336 hours on 7/20 /2022, surveyor observed sample, requisition # 0115582, from account #56924, was in the drop-off tray in the laboratory. Review of the requestion slip showed it was collected at 10:18 AM. review of the Route Detail Sheet STAT Calls form showed the Call Received Time as 11:20 AM, and the Pick Up Time was 12:38 PM, Delivery Time was 13:17 hours. At 1405 hours surveyor observed testing personnel #2 centrifuge the sample (elapsed time was 3 hours 47 minutes). 4. At 1336 hours on 7/20 /2022, surveyor observed sample, requisition # 0008471, from account #61179, was dropped off in the laboratory. Review of the requestion slip showed it was collected at 11:18 AM. review of the Route Detail Sheet STAT Calls form showed the Call Received Time as 11:53 AM, and the Pick Up Time was 12:34 PM, Delivery Time was 13:36 hours. At 1405 hours surveyor observed testing personnel #2 centrifuge the sample (elapsed time was 2 hours 47 minutes). 5. At 1336 hours on 7/20/2022, surveyor observed sample, requisition # 0023525, from account #61178, was dropped off in the laboratory. Review of the requestion slip showed it was collected at 10:57 AM. review of the Route Detail Sheet STAT Calls form showed the Call Received Time as 12:22 PM, and the Pick Up Time was 1:11 PM, Delivery Time was 13:36 hours. At 1405 hours surveyor observed testing personnel #2 centrifuge the sample (elapsed time was 3 hours 8 minutes). E. Interview with testing personnel #1, as listed on the CMS form 209, on July 20, 2022 at 1115 hours acknowledged the lab receives samples from outpatient clients that may or may not be spun and was unaware of the processing time for neonatal bilirubins and looked it up in the SOP for the surveyor. F. Review of the Annual Test Volume & Proficiency Testing Programs Worksheet showed an annual testing volume of 2,010 for the Bilirubinometer. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (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 -- 2 of 3 -- 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 validation records, calibration verification records and interview, the laboratory failed to perform calibration verifications on Progesterone, Estradiol, Total Human Chorionic Gonadotropin (THCG) every 6 months on the Siemens Centaur CP for one of two events reviewed from March 2021 - July 2022. Findings follow. A. Review of validation records for the Centaur CP showed the validation was completed 3/22/2021. B. Review of the calibration verification records for Progesterone, Estradiol, and THCG performed on the Centaur CP analyzer showed calibration verifications were performed on 3/23/2022 (elapsed time was 12 months). C. Surveyor requested on July 20, 2022 at 1015 hours additional calibration verification records. Interview with testing personnel #1, as listed on the CMS form 209, on July 20, 2022 at 1040 hours in the laboratory verified one of two calibration verifications were not performed. D6007 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(1) 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)(1) Ensure that testing systems developed and used for each of the tests performed in the laboratory provide quality laboratory services for all aspects of test performance, which includes the preanalytic, analytic, and postanalytic phases of testing; This STANDARD is not met as evidenced by: Based on review of the validation records, manufacturer's instructions, laboratory's policy and procedure, observation, requisition slips, courier records, interview, and pre-survey paperwork, the Laboratory Director failed to ensure the laboratory spun neonatal total bilirubin and neonatal direct bilirubin using the Advanced Bilirubin Stat- Analyzer Photometer by Advanced Instruments within approximately 30 minutes to one hour after collection for five out of five specimens reviewed (see D5311). -- 3 of 3 --

Summary Statement of Deficiencies D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years. This STANDARD is not met as evidenced by: Review of 2019 College of American Pathologists (CAP) proficiency testing records and interview of facility personnel found that the laboratory failed to retain records for one of three proficiency testing events in Hematology testing for at least two years. The findings included: 1. Review of the College of American Pathologists (CAP) 2019 proficiency testing records for Hematology found that the laboratory failed to retain results for the FH13-C 2019 Hematology Auto Differentials, FH13 testing event. The laboratory failed to retain the original test records, attestation statements, and instrument test records for this event. 2. Proficiency testing records were requested but not provided. 3. Interview of testing person two on the CMS report 209 Laboratory Personnel Report conducted on February 2, 2021 at 2:25 PM confirmed that proficiency testing records for this event were not retained. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on review of the College of American Pathologists (CAP) proficiency testing records from 2019 and staff interview, the laboratory failed to review and evaluate proficiency testing results for one of three hematology testing events. The findings included: 1. Review of CAP proficiency testing records from 2019 (3 testing events Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- annually) found no documentation of review for the FH13-C 2019 Hematology Auto Differentials, FH13 testing event. 2. Interview of testing person two on the CMS report 209 Laboratory Personnel Report conducted on February 2, 2021 at 2:25 PM confirmed that proficiency testing records for this event were not retained. 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 proficiency testing records, patient test records, and interview, the laboratory failed to participate in proficiency testing for quantitative serum Human Chorionic Gonadotropin (hCG) tested on the Dade Dimension Xpand for 1 of 6 events reviewed and received a false score of 100%. Findings follow. Review of the College of American Pathologists Survey Result Form from the first event of 2020, C-A General Chemistry, showed the laboratory did not participate in the testing event and submitted exception code 11 (unable to analyze) on 3/26/2020. Documentation showed proficiency samples were received on 3/10/2020, and due on 4/07/2020. Review of patient testing records from 3/10/2020 - 4/07/2020 showed 67 patients were reported. Interview with Technical Consultant #1, listed on the CMS form 209, on February 2, 2021 at 1455 in the laboratory confirmed the laboratory did not participate in the event for hCG on the Dimension and received a false score of 100% and continued to test patients at that time. -- 2 of 2 --