Regence Health Network, Inc

Summary Statement of Deficiencies D0000 An unannounced onsite investigation was conducted for complaint TX22020953 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 5 -- (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 event 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: 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 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 5. Review of the 2022 Chemistry Core 1st proficiency testing records for 45D0664603 included: a. The original submission -- 2 of 5 -- 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 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 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. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on review of calibration records and interview, the laboratory failed to retain all calibration records on the Horiba ABX Micros 60 for Complete Blood Counts (CBCs) for one of two calibrations performed from 01/01/2022 - 05/09/2023. Findings follow. A. Attempted review of the calibration performed on 05/04/2023 showed no records for review. B. Interview with the Regional Director of Operations on May 10. 2023 at 1415 hours in the office acknowledged the printer on the Horiba was not working and confirmed it was no longer printing calibration reports. 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). Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- This STANDARD is not met as evidenced by: Based on review of proficiency testing records and interview, the laboratory failed to verify the accuracy of analytes not graded by the proficiency testing agency for one of one exception reviewed. Findings follow. A. Review of the laboratory's American Proficiency Institute's (API) Microscopy/Urine Sediment proficiency testing reports from the 1st event of 2023, and the 1st, 2nd, and 3rd events from 2022 showed the laboratory failed to evaluate the results for Vaginal Wet Preparation for one of one exception reviewed. In the 2nd event of 2022, the proficiency testing agency failed to grade 1 of 1 specimen for Vaginal Wet Preparation. Review of the results on the 2022 2nd Event Comparative Evaluation found that VA-02 was "Not Graded" with Exception Code 2 (No Consensus). B. Interview of Testing personnel #1, as listed on the CMS Form 209, on May 10, 2023 at 1150 hours in the office acknowledged he thought the specimen was not up to par and did not self-grade. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: I. Based on review of a textbook procedure, the laboratory's policy and procedure, query, and interview, the laboratory failed to follow textbook procedure for performing Wet Preps used for the identification of yeast when they failed to examine a drop of the vaginal secretions with 10% KOH (potassium hydroxide) for 85 of 85 patients tested from 01/01/2023 - 05/09/2023. Findings follow. A. Review of the laboratory's textbook procedure from Clinical Methods: The History, Physical, and Laboratory Examinations, 3rd Edition, 1990, Chapter 179, Tests on Vaginal Discharge, under Technique stated, "Place the sample in 1 ml of saline and agitate to mix. Take a drop of this mixture and place it on a slide... cover with a cover slip.... The slide may be warmed briefly (to increase motility of trichomonas) and should be looked at promptly. A careful search of several fields should be made at both medium and high power for trichomonas, clue cells, and yeast. Trichomonas are motile flagellated organisms about the size of a white blood cell (WBC). They are best recognized by their characteristic twisting motion. Clue cells are vaginal epithelial cells with adherent coccobacilli. Yeast may be seen as budding or hyphal forms, and may be seen best with the addition of potassium hydroxide. Lastly, the presence or absence of a large number of leukocytes should be noted. A few may be normal, but more than 10 per high-power field is abnormal. An additional [drop] should be ... placed on a slide. Add a drop of 10% potassium hydroxide (KOH) and cover with a cover slip... The slide should then be examined carefully for the presence of budding yeast or hyphae." B. Review of the laboratory's policy and procedure titled Wet Prep/ Hanging Drop, reviewed 10/06/2022, stated, "Procedure for Wet Mounts ...The provider performs the collection of vaginal secretions. The swab is collected form the vaginal walls, or any area that appears to be inflamed. The swab is placed in a tube containing sterile physiologic saline. The tube should be thoroughly mixed. Preparation of the slide: 1. Place a clean microscope slide on a flat, level surface. Use the tip of a dripping swab to transfer a drop of the saline suspension to the surface of the slide. 2. Immediately lay a cover slip over the material. 3. The slide is ready for direct examination under a microscope. Microscopic examination of the slide: 1. The -- 2 of 5 -- slide should be thoroughly examined (a minimum of ten fields) for motile trophozoites of Trichomonas, budding yeast, yeast cells, pseudohyphae of yeast, and clue cells which are sloughed epithelial cells, many of which are completely covered by tiny, rods and coccobacilli." The laboratory's current procedure may inhibit testing personnel from identifying budding yeast and pseudohyphae. C. Review of the query of Wet Mounts performed from 01/01/2023 - 05/09/2023 showed 85 Wet Preps were performed. D. Interview with testing personnel #1, as listed on the CMS Form 209, on May 10, 2023 at 1500 hours in the office confirmed the laboratory does not perform the Wet Mount with KOH. II. Based on review of a textbook procedure, the laboratory's policy and procedure, query, and interview, the laboratory failed to follow textbook procedure for performing Wet Preps used for the identification of trichomonas, clue cells, and yeast when they failed to place the vaginal swab into 1 ml of saline for 85 of 85 patients tested from 01/01/2023 - 05/09/2023. Findings follow. A. Review of the laboratory's textbook procedure from Clinical Methods: The History, Physical, and Laboratory Examinations, 3rd Edition, 1990, Chapter 179, Tests on Vaginal Discharge, under Technique stated, "Place the sample in 1 ml of saline and agitate to mix. Take a drop of this mixture and place it on a slide... cover with a cover slip.... The slide may be warmed briefly (to increase motility of trichomonas) and should be looked at promptly. A careful search of several fields should be made at both medium and high power for trichomonas, clue cells, and yeast. Trichomonas are motile flagellated organisms about the size of a white blood cell (WBC). They are best recognized by their characteristic twisting motion. Clue cells are vaginal epithelial cells with adherent coccobacilli. Yeast may be seen as budding or hyphal forms, and may be seen best with the addition of potassium hydroxide. Lastly, the presence or absence of a large number of leukocytes should be noted. A few may be normal, but more than 10 per high-power field is abnormal. An additional [drop] should be ... placed on a slide. Add a drop of 10% potassium hydroxide (KOH) and cover with a cover slip... The slide should then be examined carefully for the presence of budding yeast or hyphae." B. Review of the laboratory's policy and procedure titled, Wet Prep/ Hanging Drop, reviewed 10/06/2022, stated, "Procedure for Wet Mounts ...The provider performs the collection of vaginal secretions. The swab is collected form the vaginal walls, or any area that appears to be inflamed. The swab is placed in a tube containing sterile physiologic saline. The tube should be thoroughly mixed." The laboratory's current procedure does not specify the amount of saline in the tube. C. Review of the query of Wet Mounts performed from 01/01/2023 - 05/09/2023 showed 85 Wet Preps were performed. D. Interview with testing personnel #1, as listed on the CMS Form 209, on May 10, 2023 at 1515 hours in the office acknowledged it depends on how much saline they send to us, and confirmed the amount is not specified. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on review of manufacturer's instructions, observation, and interview, the laboratory failed to label their Complete Blood Count (CBC) reagents with the open -- 3 of 5 -- date and open expiration date using the Horiba ABX Micros 60 analyzer for three of three reagents reviewed. Findings follow. A. Manufacturer's Instructions: 1. Review of the package insert for the ABX Minidil LMG, 04/26/2022, under Storage and Stability stated, "Open Stability: 6 months maximum at 18-25 degrees Celsius after opening and within the expiration limit." 2. Review of the package insert for the ABX Alphalyse, 02/23/2022, under Storage and Stability stated, "Open Stability: 3 months maximum at 18-25 degrees Celsius after opening and within the expiration limit." 3. Review of the package insert for the ABX Miniclean, 04/27/2022, under Storage and Stability stated, "Open Stability: 3 months maximum at 18-25 degrees Celsius after opening and within the expiration limit." B. During a tour of the laboratory on May 10, 2023 at 1205 hours, the surveyor observed the reagents on the Horiba AB Micros 60 did not have open dates or open expirations noted on them: 1. ABX Minidil LMG, Lot 220503F1, (closed date) expiration 11/03/2023 2. ABX Alphalyse, Lot 22071853, (closed date) expiration 07/18/2023 3. ABX Miniclean, Lot 220727T1, (closed date ) expiration 07/27/2023. C. Interview with testing personnel #1, as listed on the CMS Form 209, on May 10, 2023 at 1205 hours in the laboratory confirmed the findings. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on review of the patient test report, and interview, the laboratory failed to provide the reference range for clue cells, trichomonas, and yeast on three of three Wet Prep reports reviewed. Findings follow. A. Review of three of three Wet Prep patient test reports showed no reference range for clue cells, trichomonas, and yeast on the test report as listed by collection date and MRN: Collection Date MRN 1. 03/02 /2023 214397 2. 02/14/2023 342186 3. 01/09/2023 177113 B. Interview with the Regional Director of Operations on May 10. 2023 at 1545 hours in the office confirmed there were no reference ranges for clue cells, trichomonas, and yeast. KEY: MRN: Medical Record Number D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on review of the Laboratory Technical Consulting Agreement, competency evaluations and interview, the technical consultant failed to evaluate the competency of all testing personnel performing Complete Blood Counts (CBCs), wet mounts, and -- 4 of 5 -- serum hCG (human chorionic gonadotropin) for 5 of 5 testing personnel. Findings follow. A. Review of the Laboratory Technical Consulting Agreement, reviewed on 11 /10/2021, stated under Duties and Responsibilities, "Consults with RHN's Lab Director to evaluate the required competencies of testing personnel." B. Review of competency evaluations for testing personnel #1-5, as listed on the CMS Form 209, showed it was unclear to determine who performed the competency evaluations. C. Interview with testing personnel #1 on May 10, 2023 at 1100 hours in the office confirmed he performed all competency evaluations [testing personnel #2-5], and the Lab Director performed the competency evaluation for himself. -- 5 of 5 --

Summary Statement of Deficiencies D0000 The laboratory was surveyed and failed to meet the following conditions of the CLIA regulations found at CFR 42 493.1 through 493.1780: 493. 1409 Condition: Laboratories Performing Moderate Complexity Testing; Technical Consultant D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Review of the CMS 209 Laboratory Personnel Report, proficiency testing records and interview of facility personnel found the laboratory failed to ensure all testing personnel participated in five of five proficiency testing events for Hematology in 2020 and 2021. The findings included: 1. Review of the CMS report 209 Laboratory Personnel report found the laboratory designated three testing personnel performing non-waived testing. 2. Review of American Proficiency Institute (API) proficiency testing records for 2020 and 2021 found Five of five events tested by testing person one on the CMS Report 209 Laboratory Personnel Report. 3. Interview of the Lab Coordinator conducted October 20, 2021 at 1:58 PM confirmed that testing person one was the only person that participated in the proficiency testing events. D6021 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory 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 -- director must-- (e)(5) Ensure that quality assessment programs are established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Observations, review of policies and procedures, manufacturers instructions, quality control records, patient test records, and interview of facility personnel found the laboratory director failed to establish and maintain a quality assessment program to assure the quality of laboratory services. D6033 TECHNICAL CONSULTANT-MODERATE COMPEXITY CFR(s): 493.1409 The laboratory must have a technical consultant who meets the qualification requirements of 493.1411 of this subpart and provides technical oversight in accordance with 493.1413 of this subpart. This CONDITION is not met as evidenced by: Review of the CMS Report 209 Laboratory Personnel Report, personnel records and interview of facility personnel found the laboratory failed to have a technical consultant to provide oversight of laboratory services that met the minimum education requirements. ( see D 6035) D6035 TECHNICAL CONSULTANT QUALIFICATIONS CFR(s): 493.1411 (a) The technical consultant must be qualified and must possess a current license issued by the State in which the laboratory is located, if such licensing is required. (b) The technical consultant must-- (b)(1)(i) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (b)(1)(ii) Be certified in anatomic or clinical pathology, or both, by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (b)(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and (b)(2)(ii) Have at least one year of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible (for example, physicians certified either in hematology or hematology and medical oncology by the American Board of Internal Medicine are qualified to serve as the technical consultant in hematology); or (b)(3)(i) Hold an earned doctoral or master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (b)(3)(ii) Have at least one year of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible; or (b)(4)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (b)(4)(ii) Have at least 2 years of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible. Note: The technical consultant requirements for "laboratory training or experience, or both" in each specialty or subspecialty may be acquired concurrently in more than one of the specialties or subspecialties of service, -- 2 of 3 -- excluding waived tests. For example, an individual who has a bachelor's degree in biology and additionally has documentation of 2 years of work experience performing tests of moderate complexity in all specialties and subspecialties of service, would be qualified as a technical consultant in a laboratory performing moderate complexity testing in all specialties and subspecialties of service. This STANDARD is not met as evidenced by: Review of the CMS Report 209 Laboratory Personnel Report, personnel records and interview of facility personnel found the laboratory failed to have a technical consultant to provide oversight that met the minimum education requirements. The findings included: 1. Review of the CMS Report 209 Laboratory Personnel Report found one Technical Consultant identified. 2. Review of the Technical Consultant credentials provided for review found he had earned the following degrees: Associate in Applied Science for Medical Laboratory Technology Bachelor of Business Administration Master of Business Administration Management 3. Interview of the director of the Lab Coordinator conducted October 20, 2021 at 1:38 PM confirmed the individual identified as the Technical Consultant of the laboratory had not earned at least a bachelor degree in a chemical, physical or biological science or medical technology. -- 3 of 3 --