Regence Health Network Ross

Summary Statement of Deficiencies D0000 An unannounced onsite investigation was conducted for complaint TX22020331 on July 26, 2023. The laboratory was surveyed and failed to meet the following conditions of the CLIA regulations found at CFR 42 493.1 through 493.1780: 493.801 Condition: Enrollment and testing of samples; 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director. D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based upon review of the Casper report 155 Individual Laboratory Profiles, proficiency testing records, and interview of facility personnel the laboratory failed to avoid inter-laboratory communications of proficiency testing results prior to the final submission date for grading to the proficiency testing agency. (See D2011 and D2013) D2011 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(3) Laboratories that perform tests on proficiency testing samples must not engage in any inter-laboratory communications pertaining to the results of proficiency testing sample 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 -- (s) until after the date by which the laboratory must report proficiency testing results to the program for the testing event in which the samples were sent. Laboratories with multiple testing sites or separate locations must not participate in any communications or discussions across sites/locations concerning proficiency testing sample results until after the date by which the laboratory must report proficiency testing results to the program. This STANDARD is not met as evidenced by: Based upon review of Casper Reports 155 Individual Laboratory Profiles, proficiency testing records, Lab quality assurance policy and interviews of facility personnel found the laboratory failed to avoid communication of proficiency testing results with other laboratories prior to the submission deadline of the American Proficiency Institute (API) proficiency testing agency in one of three Chemistry Core testing events in 2022. The findings included: 1. Review of the Casper report 155 Individual Laboratory Profiles generated on June 12, 2023 in preparation of recertification inspections for CLIA certificates: 45D0506643 at 125 W. Park Ave. Hereford, TX 79045 45D0664603 at 3113 Ross St. Amarillo, TX 79103 45D0506774 at 410 Canyon Street Plainview, TX 79072 Found that the facilities obtained the same unacceptable score of 60% for Human Chorionic Gonadotropin (HCG) in the 2022 Chemistry Core 1st testing event. 2. Review of the API Performance Evaluations for the 2022 Chemistry Core 1st testing event (obtained through API) on June 12, 2023 found each of the three laboratories (45D0506643, 45D0664603 and 45D0506774) failed to submit acceptable results for two of five samples as follows: a. Sample HCG- 02 - the laboratory reported a result of Positive with an expected result of Negative. b. Sample HCG-05 - the laboratory reported a result of Positive with an expected result of Negative. 3. Review of the 2022 Chemistry Core 1st proficiency testing records for 45D0506774 included: a. The original submission forms defined a deadline submission of Wednesday, 2/2/2022 11:59 PM ET and had the following results documented on the bubble sheet by testing personnel: Sample HCG-01 - positive result filled Sample HCG-02 - positive and negative results both filled with an (X) marked through the negative result. Sample HCG-03 - positive result with a (/) marked through the result. Sample HCG-04 - positive result filled Sample HCG-05 - positive and negative results both filled with an (X) marked through the negative result. b. Review of the attestation statement found the testing personnel documented testing completed on 1-13-22 and the Laboratory Director signing on 01/28/2022. c. Review of the 2022 Chemistry Core 1st Event Submitted Result Forms (obtained from API) found the submission time stamp to be January 28, 2022 12:22 PM, with the following results documented: Sample HCG-01 - Positive Sample HCG-02 - Positive Sample HCG-03 - Positive Sample HCG-04 - Positive Sample HCG-05 - Positive 4. Review of the 2022 Chemistry Core 1st event proficiency testing records for 45D0506643 included: a. Original submission forms (reviewed onsite during the recertification inspection conducted June 20, 2023) found a deadline submission of Wednesday, 2/2/2022 11:59 PM ET and had the following results documented on the bubble sheets by testing personnel: Sample HCG-01 - positive result filled Sample HCG-02 - negative result filled Sample HCG-03 - positive result filled Sample HCG- 04 - positive result filled Sample HCG-05 - negative result filled b. A copy of the results submission form bubble sheet included in the proficiency testing records found results entered as follows: Sample HCG-01 - positive result filled Sample HCG-02 - positive and negative results both filled with an (X) marked through the negative result. Sample HCG-03 - positive result filled Sample HCG-04 - positive result filled Sample HCG-05 - positive and negative results both filled with an (X) marked through the negative result. c. Review of the attestation statement found the testing -- 2 of 7 -- personnel documented testing completed on 1/25/2022 and the Laboratory Director signing on 02/16/2022. d. Review of the Submitted Result Forms for the 2022 Chemistry Core 1st Event Submitted (obtained from API) found the submission time stamp to be January 28, 2022 12:25 PM, with the following results: Sample HCG-01 - Positive Sample HCG-02 - Positive Sample HCG-03 - Positive Sample HCG-04 - Positive Sample HCG-05 - Positive 5. Review of the 2022 Chemistry Core 1st proficiency testing records for 45D0664603 included: a. The original submission forms defined a deadline submission of Wednesday, 2/2/2022 11:59 PM ET and had the following results documented on the bubble sheet by testing personnel: Sample HCG-01 - positive result filled Sample HCG-02 - positive result filled Sample HCG- 03 - positive result filled Sample HCG-04 - positive result filled Sample HCG-05 - positive result filled b. Review of the attestation statement found the testing personnel documented testing completed on 1-13-22 and the Laboratory Director signing on 01 /28/2022. c. Review of the 2022 Chemistry Core 1st Event Submitted Result Forms (obtained from API) found the submission time stamp to be January 28, 2022 12:26 PM, with the following results documented: Sample HCG-01 - Positive Sample HCG- 02 - Positive Sample HCG-03 - Positive Sample HCG-04 - Positive Sample HCG-05 - Positive 6. Review of a forwarded email sent by testing person one (from 45D0506643) on 07/26/2023 at 2:40 PM included the following: "From: [Testing Person one name], Sent: Tuesday, January 25, 2022 10:07 AM; To: [Lab Coordinator name and email address]; Subject: API's" with a PDF attachment titled "SHereford M22012511190." The attachment "SHereford M22012511190" included "2022 Chemistry Core 1st Event Attestation Statement" with two testing personnel's signatures attesting to testing the Serum HCG PT on 01/25/2022 and original submission forms (bubble sheets) with Serum HCG Proficiency results filled as: Sample HCG-01 - Positive Sample HCG-02 - Negative Sample HCG-03 - Positive Sample HCG-04 - Positive Sample HCG-05 - Negative The original result forms bubble sheets did not include markings through results. These forms were filled by the testing personnel and submitted to the lab coordinator (who was the lab coordinator for all three laboratories) for entering and reporting to the PT company. The coordinator then entered 45D0664603 HCG PT results for 45D0506643. 7. Review of the Lab Quality Assurance Policy (approved by the Lab director on 10/27/2021) found on page 4: "3.2 Proficiency testing (PT) a. Verify PT is performed in accordance with CLIA guidelines. b. Ensure PT is performed in the same manner as patient testing. c. Ensure a review of graded results is conducted and documented. Verify unsuccessful or unsatisfactory PT events are investigated and

Summary Statement of Deficiencies D2098 ENDOCRINOLOGY CFR(s): 493.843(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: Review of proficiency testing records and interview of facility personnel found the laboratory failed to attain satisfactory performance for serum HCG in one of five Chemistry Core proficiency testing events between 2021 and 2023 (three testing events per year). The findings included: 1. Review of the American Proficiency Institute (API) proficiency testing records for kit 42030 found the laboratory submitted unacceptable responses for two of five proficiency specimens in the 2022 Chemistry Core 1st Event as follows: Sample HCG-02 - was reported as positive with an expected result of negative. Sample HCG-05 - was reported as positive with an expected result of negative. Review of the attestation statement found specimens 01 and 02 were tested by testing person 7, and specimens 03, 04,and 05 were tested by testing person 1 on the CMS Report 209 Laboratory Personnel report. Review of the original submission forms found results documented for each of the five specimens as follows: HCG-01 Positive HCG-02 Negative HCG-03 Positive HCG-04 Positive HCG-05 Negative 3. During interview of the lab coordinator conducted June 22, 2023 at 9:33 AM, he confirmed that he entered all proficiency results tested at each of the three locations for which he was responsible. D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(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-- Establish or verify the criteria for acceptability of all control materials. (i) When 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 -- control materials providing quantitative results are used, statistical parameters (for example, mean and standard deviation) for each batch and lot number of control materials must be defined and available. (ii) The laboratory may use the stated value of a commercially assayed control material provided the stated value is for the methodology and instrumentation employed by the laboratory and is verified by the laboratory. (iii) Statistical parameters for unassayed control materials must be established over time by the laboratory through concurrent testing of control materials having previously determined statistical parameters. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based upon review of manufacturer instructions, quality control records and interview of the Lab Coordinator, the laboratory failed to verify Hematology quality control material met the manufacturer's acceptable limits prior to putting it into use for three of three lots or Minotrol-16 used in 2022 and 2023. The findings included: 1. Review of the Horiba Minotrol 16 instructions for use found under the heading Performance characteristics: "Assay values on a new lot of control should be confirmed before it is put into routine use. Test the new lot when the instrument is in good working order and quality control results on the previous lot are acceptable. The laboratory recovered mean should be within the assay range." 2. Review of quality control records found no documentation of the verification of each new lot of quality control material before putting it into use for the following lots: MX 433 in use 12/20/2021 MX 438 in use 10/20/2022 MX 441 in use 04/25/2023 3. During interview of the lab coordinator conducted June 22, 2023 at 11:29 PM, he confirmed that the laboratory did not verify each new lot of Hematology quality control material met the manufacturer's specifications prior to putting it into use as the sole source of quality control. -- 2 of 2 --

Summary Statement of Deficiencies D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) Laboratories eligible for a certificate of waiver must-- (1) Follow manufacturers' instructions for performing the test; and (2) Meet the requirements in subpart B, Certificate of Waiver, of this part. This STANDARD is not met as evidenced by: Review of manufacturer's instructions, patient final reports, personnel records and interview of facility personnel found the laboratory failed to follow the manufacturer's instructions when using the Sofia SARS Antigen FIA test kits for testing patients as defined by the manufacturer under the Emergency Use Authorization (EUA). The findings included: 1. "All operators using your product must be appropriately trained in performing and interpreting the results of your product, use appropriate personal protective equipment when handling this kit, and use your product in accordance with authorized labeling." 2. Review of personnel records found no documentation of training for seven of seven testing personnel. 3. Interview of Testing person one on the CMS Laboratory Personnel Report conducted September 23, 2021 at 09:37AM confirmed the laboratory failed to document training for seven of seven testing personnel. 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: 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 -- Based on review of the laboratory's CBC QC records from 11/1/2020 to 9/22/21 and confirmed in an interview found that the laboratory failed to retain 6 of 7 QC lots of Horiba Minotrol-16 Hematology Reference Control assay sheets for a minimum of 2 years. The findings were: 1. Review of the laboratory QC records found the laboratory failed to retain assay sheets for 6 of 7 quality control lots used between 11/1/20 and 9 /22/21. MX430 Exp: 2021-09-05 MX429 Exp: 2021-07-05 MX428 Exp: 2021-05-05 MX427 Exp: 2021-03-05 MX426 Exp: 2021-01-05 MX425 Exp: 2020-11-05 2. An interview with the lab coordinator on 9/23/21 at 9:35 am in the conference room confirmed the laboratory discarded the assay sheets for previous CBC QC lots when a new CBC QC lot put in use. Key: CBC=Complete Blood Count QC=Quality Control D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on review of the laboratory's verification records, the laboratory's policy, and confirmed in an interview found the laboratory failed to have Horiba Micros 60 policy approved, signed and dated by the current LD for one of one Horiba ABX Micros 60 hematology analyzer, before use. The findings were: 1. Review of the laboratory's verificaiton records revealed the current CBC instrument, Horiba ABX Micros 60 hematology analyzer (SN# 904CS98707) was put in use in March, 2020. 2. Review of the laboratory's policy revealed the policy titled "Horiba Micros 60" had no documentation of being approved, signed and dated by the current LD for Horiba ABX Micros 60 hematology analyzer. 3. An interview with the lab coordinator on 9/23 /21 at 9:23 am in the breakroom confirmed the above findings. Key: LD=Laboratory Director CBC=Complete Blood Count 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 the laboratory's verification records, the laboratory's procedures, CMS 116 application, and confirmed in an interview revealed the laboratory failed to verify four of four required performance specifications, accuracy, precision, reportable ranges, and reference range, on Horiba ABX Micro 60 hematology analyzer. The findings were: 1. Review of the laboratory's verification records for Horiba ABX Micros 60 (SN# 904CS98707) revealed the laboratory did not verify four performance specifications. Accuracy Precision Linearity (Reportable Range) Normal Range (Reference Range) 2. Review of CMS 116 application signed by the CEO on 9/13/21 revealed the CBC annual volume was 45,726. 3. An interview with -- 2 of 7 -- the lab coordinator on 9/23/21 at 9:23 am in the conference room confirmed the above performance specifications were not verified. Key: CMS=Center of Medicare and Medicaid Service CEO=Chief executive officer CBC=Complete Blood Count D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of the manufacturer's user manual, the laboratory's policy, and confirmed in an interview found the laboratory failed to establish CBC QC acceptability criteria for three of three QC materials on Horiba ABX Micros 60 Hematology Analyzer. The findings were: 1. Review of Horiba ABX Micros 60 Hematology Analyzer User Manual (Ref: RAB 043MUS) revealed under 2. Daily Quality Control & Calibration verification, "Before analyzing any patient blood samples, it is recommended that that Operator performs Quality Control analysis on 3 levels of Control Blood Material, (Low, Normal, and High), to verify that the ABX Micros 60 is performing within the specified ranges of the Quality control material." 2. Review of the laboratory's policy titled "Horiba Micros 60" revealed under Quality Control, "Analyze three levels of control material (low, normal, & high) per day of testing according to regulatory standards of performance." 3. Further review of the laboratory's policy titled "Horiba Micros 60" revealed no documentation of CBC QC acceptability criteria for Horiba ABX Micros 60 Hematology Analyzer (SN#904CS98707). 4. An interview with the lab coordinator on 9/23/21 at 11:00 am in the conference room confirmed the above findings. Key: CBC=Complete Blood Count QC=Quality Control RHN=Regence Health Network D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(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 quantitative procedure, include two control materials of different concentrations; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of manufacturer's CBC QC acceptable ranges, CBC QC records from 2020-2021, patient records, and confirmed in an interview found the laboratory failed to have two of three levels of QC testing materials to meet manufacturer's acceptable ranges for one of three analytes reviewed (RBC) before patient testing for 1 of 10 -- 3 of 7 -- days reviewed. The findings were: 1. Review of RBC QC on Lot#424 Exp: 2020-09- 05 for Level Low, Normal, and High on 8/13/20 revealed the manufacturer's acceptable ranges were: L: 2.21-2.51 N: 4.38-4.74 H: 5.45-5.85 2. Review of RBC QC on Lot#424 Exp: 2020-09-05 for each level (L, N, H) on 8/13/20 revealed two of three RBC QCs did not meet the manufacturer's acceptable ranges between 7:47 am to 12:44 pm when the low control met the manufacturer's acceptable range at 12:45 pm. Low at 0747 am 2.18 (RBC range for Low: 2.21-2.51) at 1241 pm 2.19 (RBC range for Low: 2.21-2.51) High at 0751 am 5.38 (RBC range for High: 5.45-5.85) at 1243 pm 5.40 (RBC range for High: 5.45-5.85) at 1248 pm 5.40 (RBC range for High: 5.45- 5.85) 3. Review of patient records revealed the laboratory tested 19 patients between 7: 47am to 12:44 pm before two QCs met the manufacturer's acceptable ranges. 8/13/20 at 08:54 am Patient#: 161505 8/13/20 at 09:36 am Patient#: 223006 8/13/20 at 10:08 am Patient#: 189758 8/13/20 at 10:09 am Patient#: 170636 8/13/20 at 10:38 am Patient#: 106524 8/13/20 at 10:46 am Patient#: 223172 8/13/20 at 10:48 am Patient#: 130679 8/13/20 at 10:59 am Patient#: 113576 8/13/20 at 11:02 am Patient#: 323811 8 /13/20 at 11:19 am Patient#: 337502 8/13/20 at 11:23 am Patient#: 261689 8/13/20 at 11:25 am Patient#: 189169 8/13/20 at 11:35 am Patient#: 219596 8/13/20 at 11:44 am Patient#: 343263 8/13/20 at 11:51 am Patient#: 128472 8/13/20 at 12:01 pm Patient#: 237250 8/13/20 at 12:21 pm Patient#: 117459 8/13/20 at 12:25 pm Patient#: 357595 8 /13/20 at 12:35 pm Patient#: 352421 4. An interview with the lab coordinator on 9/23 /21 at 11:40 am in the conference room confirmed the above findings. Key: CBC=Complete Blood Count QC=Quality Control RBC=Red Blood Cell L=Low N=Normal H=High D5783