Aggie Health And Wellness / Nmsu

Summary Statement of Deficiencies D0000 An onsite recertification survey conducted on May 15, 2024, at Aggie Health and Wellness / NMSU found the laboratory to be in compliance with the CLIA regulations found at 42 CFR, Part 493 Laboratory Requirements, with standard deficiencies cited. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

Summary Statement of Deficiencies D0000 Based upon the onsite recertification survey conducted on 12/09/2022, this facility was found NOT to be in compliance with the CLIA regulations found at 42 CFR for the specialties/subspecialties in which it was surveyed. 42 CFR Part 493.1441 Condition: Laboratories performing high complexity testing; laboratory director 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 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: Based on direct observation, review of the manufacturer's instructions, patient test records and logs, CMS (Centers for Medicare & Medicaid Services) form 116, Annual Test Volume Spreadsheet and interview with the laboratory director, the laboratory failed to establish performance specifications studies for the modified, non-FDA cleared, LW Scientific refractometer prior to testing and resulting 43 of 48 patient samples from July 20, 2022 to November 15, 2022. Findings included: 1. During a tour of the laboratory on 12/09/2022 at 10:00am, a new ATC refractometer, by LW Scientific, serial # 2114020014 was observed on the counter of the laboratory. 2. The manufacturer's package insert for the ATC refractometer from LW Scientific stated, "For veterinary and educational use only." The laboratory failed to perform 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 -- performance specification studies to include accuracy, precision, analytical sensitivity, reportable range and reference intervals for the modified test system which was used to test human samples. 3. Review of patient test records and test logs revealed a total of 48 patients had a urine specific gravity verified by the ATC refractometer. Of the 48 patient specific gravities verified by the ATC refractometer, 43 specific gravities were reported. The 43 patients reported from the ATC refractometer: Date of test Medical Record # SG result 7/20/2022 121467 1.005 7/27/2022 99044 1.022 8/02 /2022 119920 1.012 8/05/2022 102825 1.022 8/09/2022 117974 1.026 8/09/2022 120414 1.018 8/11/2022 119417 1.026 8/16/2022 92309 1.030 8/23/2022 125825 1.016 8/24/2022 125834 1.012 8/24/2022 116609 1.020 8/26/2022 125837 1.016 8/30 /2022 116696 1.028 9/01/2022 125961 1.018 9/02/2022 115637 1.009 9/07/2022 125990 1.026 9/08/2022 125500 1.024 9/13/2022 126014 1.020 9/13/2022 125526 1.022 9/14/2022 126048 1.008 9/14/2022 120969 1.020 9/16/2022 125360 1.018 9/26 /2022 119653 1.015 9/26/2022 122861 1.030 9/26/2022 126234 1.010 9/30/2022 126249 1.025 10/07/2022 124244 1.012 10/07/2022 102527 1.008 10/07/2022 125968 1.030 10/12/2022 125976 1.018 10/18/2022 126379 1.018 10/18/2022 126390 1.014 10/20/2022 126414 1.020 10/20/2022 124138 1.024 10/24/2022 126439 1.018 10/31 /2022 126390 1.026 11/02/2022 126557 1.014 11/08/2022 124134 1.030 11/08/2022 119328 1.020 11/09/20222 126534 1.023 11/11/2022 126629 1.020 11/15/2022 126686 1.030 11/15/2022 124244 1.010 4. Review of the CMS (Centers for Medicare & Medicaid Services) form 116, and the Annual Test Volume Spreadsheet confirmed that that the facility was performing specific gravities using a manual refractometer and reported an annual test volume of 252 for 2021. 5. During an interview on 12/09 /2022 at 10:30 am, the laboratory director stated that he only uses the manual refractometer to confirm weak urines when performing urine HCG (Human Chorionic Gonadotropin) pregnancy tests and he confirmed the findings. 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 laboratory policy, Urinalysis Patient/QC log, and staff interview, the laboratory failed to establish the number and frequency of performing quality controls to ensure accuracy and precision and to detect immediate errors for the ATC refractometer from LW Scientific, prior to reporting 43 specific gravities from July 21,2022 to Dec 12, 2022. Findings included: 1. Review of the laboratory policy /procedure titled "Urinalysis Procedures Urine Specific Gravity, Procedure #; UA. 0001.00.03", dated June 1, 2013, and reviewed by laboratory director on 10-07-22 revealed; Under section 6.3 labeled Control Frequency: "Analyze Distilled water, 5% NaCl solution, and Level 1 and 2 Dipper controls daily or when a new lot is opened." Under section 10.0 labeled Procedural Notes: "Refractometer Specific Gravity will be -- 2 of 4 -- used in place of Urine Dipstick specific gravity. If Refractometer is broken or if unavailable the Urine dipstick method can be substituted." The laboratory failed to update the Urine Specific Gravity procedure to include the implementation of a new refractometer and to follow the written protocol in regard to the frequency of performing quality control (QC). 2. Review of the Urinalysis Patient/QC log from July 21, 2022 to Dec 12, 2022 shows that quality control was performed once a week. 3. During interview on 12/09/2023 at 8:30 am, the Laboratory Director stated that the refractometer was placed in use in July 2022 and that quality control was performed once a week on Mondays using water (H2O) as a blank and 5% saline. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on the review of personnel credentials, CMS (Centers for Medicare & Medicaid Services) Laboratory Personnel Report form 209, facility and laboratory policies, patient urine/HCG logs, patient final reports, manufacturer's instructions for use, the Laboratory Director failed to provide overall direction and management of the laboratory. Findings included: The laboratory director failed to ensure that the facility employed a director who meets the qualifications requirements to manage and direct a laboratory performing high complexity testing. Refer to D6078 D6078 LABORATORY DIRECTOR QUALIFICATIONS CFR(s): 493.1443 The laboratory director must be qualified to manage and direct the laboratory personnel and performance of high complexity tests and must be eligible to be an operator of a laboratory within the requirements of subpart R. (a) The laboratory director must possess a current license as a laboratory director issued by the State in which the laboratory is located, if such licensing is required; and (b) The laboratory director 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) Be a doctor of medicine, a 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)(i) Have at least one year of laboratory training during medical residency (for example, physicians certified either in hematology or hematology and medical oncology by the American Board of Internal Medicine); or (b)(2)(ii) Have at least 2 years of experience directing or supervising high complexity testing; or (b)(3) Hold an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution and-- (b)(3)(i) Be certified and continue to be certified by a board approved by HHS; or (b)(3)(ii) Before February 24, 2003, must have served or be serving as director of a laboratory performing high complexity testing and must have at least-- (b)(3)(ii)(A) Two years of laboratory training or experience, or both; and (b)(3)(ii)(B) Two years of laboratory experience directing or supervising high complexity testing. (b)(4) Be serving as a laboratory -- 3 of 4 -- director and must have previously qualified or could have qualified as a laboratory director under regulations at 42 CFR 493.1415, published March 14, 1990 at 55 FR 9538, on or before February 28, 1992; or (b)(5) On or before February 28, 1992, be qualified under State law to direct a laboratory in the State in which the laboratory is located; or (b)(6) For the subspecialty of oral pathology, be certified by the American Board of Oral Pathology, American Board of Pathology, the American Osteopathic Board of Pathology, or possess qualifications that are equivalent to those required for certification. This STANDARD is not met as evidenced by: Based on the review of personnel records (college transcripts) and the CMS (Centers for Medicare & Medicaid Services) Laboratory Personnel Report form 209, list of non- waived testing performed at the laboratory, the Laboratory failed to ensure he met the qualification requirements to manage and direct a laboratory performing high complexity testing. Findings included: 1. Review of personnel credentials (college transcripts) revealed the Laboratory Director had a Bachelor of Science degree and did not meet the qualification requirements to function as the laboratory director of a high complexity laboratory. 2. Review of the CMS (Centers for Medicare & Medicaid Services) Laboratory Personnel Report form 209 revealed one laboratory director who also functions as a testing person. 3. Review of the "non-waived" testing systems performed at the laboratory revealed that the laboratory modified the manufacturer's instructions for a non-FDA cleared, LW Scientific refractometer, making it a high complexity test system. -- 4 of 4 --

Summary Statement of Deficiencies D0000 The following deficiency was cited as the result of a recertification survey on 08/19 /2020 for 42 CFR part 493 Laboratory Requirements. D5801 TEST REPORT CFR(s): 493.1291(a) The laboratory must have an adequate manual or electronic system(s) in place to ensure test results and other patient-specific data are accurately and reliably sent from the point of data entry (whether interfaced or entered manually) to final report destination, in a timely manner. This includes the following: (a)(1) Results reported from calculated data. (a)(2) Results and patient-specific data electronically reported to network or interfaced systems. (a)(3) Manually transcribed or electronically transmitted results and patient-specific information reported directly or upon receipt from outside referral laboratories, satellite or point-of-care testing locations. This STANDARD is not met as evidenced by: Based on the review of patient test reports, instrument printouts and interview with the Laboratory Director, the laboratory failed to ensure the automated WBC (White Blood Cell) differential (classification of cells) results from the hematology automated cell counter (Abbott Emerald) were reported accurately on the final patient test report. The laboratory reported performing 135 automated WBC differentials per year. Findings are: A. Review of the instrument printouts from the Abbott Emerald Hematology analyzer revealed the analyzer reported a 3-part WBC differential; Lymphocytes, Granulocytes (including basophils, eosinophils and monocytes) and MID (a measure of rare cells and a number of precursor white cells). B. Review of patient test results printed from the Laboratory Information System revealed the laboratory reported a 5- part WBC differential, not a 3-part WBC differential as reported from the Abbott Emerald. Patient #1, tested 08/14/2020 at 02:12 pm 1. Automated WBC differential from Abbott Emerald Analyzer printout Granulocytes percentage = 68.0 (this value includes all neutrophils, basophils, eosinophils and monocytes not just neutrophils) 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 -- MID percentage = 6.5 (this value includes less frequently occurring and rare cells correlating to monocytes, eosinophils, basophils, blasts and other precursor white cells that fall in a particular size range, not monocytes as reported by the laboratory. 2. Reported values 08/14/2020 at 01/39 pm (sic) from the Laboratory Information System Neutrophils = 68% Monocytes = 6% 3. During interview on 08/18/2020 at 11: 20 am, the Laboratory Director stated there was no written policy for reporting the automated 3 - part WBC differential as a 5 - part WBC differential. -- 2 of 2 --

Summary Statement of Deficiencies D0000 During a recertification survey completed on 05/24/2018 for 42 CFR part 493 Laboratory Requirements, the facility was found out of compliance with the following condition: 42 CFR Part 4931403 Laboratory Director, moderate complexity D5503 BACTERIOLOGY CFR(s): 493.1261(a)(2) (a) The laboratory must check the following for positive and negative reactivity using control organisms: (a)(2) Each week of use for gram stains. This STANDARD is not met as evidenced by: Based on the review of patient test records, application records, quality control records and interview with the laboratory director, the laboratory failed to perform and document quality control for gram stains each week of use August - December 2017 for 29 (P1-P29) of 29 (P1-P29) patients reviewed. This failed practice could result in the laboratory's failure to identify staining failures related to poor technique or deterioration of the stains. Findings are: A. During interview on 5/24/18 at 11:06 am, the laboratory director stated that there was no quality control performed for gram stains prior to January 2018. He further stated that there were no quality control slides available when he started working for the laboratory in August 2017. The laboratory director identified the problem and started performing quality control in January 2018. B. Review of the 2018 gram stain quality control records confirmed that the laboratory starting performing quality control on 01/03/18. C. Review of the laboratory's "Laboratory Productions" reports for State Fiscal Year 2018 (July 2017- April 2018) revealed that the laboratory performed at total of 131 gram stains July 2017-December 2017. Review of the August and September patient logs confirmed testing for 19 patients (P1-P19) in August 2017 and 10 patients (P20-P29) in December 2017. D. In September 2016, the laboratory submitted an application on 09 /14/16 to change from a high complexity laboratory (bacterial identification tuning a manual culture method) to a moderate complexity laboratory and to change the 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 -- laboratory director. Review of the application revealed no reference to the continued performance of gram stains in the laboratory. The application was signed by the previous laboratory director on 09/13/16. E. In August 2017, the laboratory submitted an application to change the laboratory director. Review of the application revealed no reference to the continued performance of gram stains in the laboratory. The application was signed by the current laboratory director on 08/01/17. 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 the review of patient test records, application records, quality control records, proficiency records from the Centers for Medicare & Medicaid (CMS) database and the proficiency agency, and interview with the laboratory director, the laboratory director failed to provide overall management and direction of the laboratory. Findings are: A. The laboratory director failed to ensure the laboratory was enrolled in proficiency testing for gram stains for the years 2016-2017. See D6015 B. The laboratory director failed to ensure a quality control plan was established and followed for gram stain quality control. See D6020 D6015 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4) 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) Ensure that the laboratory is enrolled in an HHS approved proficiency testing program for the testing performed. This STANDARD is not met as evidenced by: Based on the review of patient test records, application records, proficiency records from the Centers for Medicare & Medicaid (CMS) database and the proficiency agency, and interview with the laboratory director, the laboratory director failed to ensure the laboratory was enrolled in proficiency testing for gram stains for the years 2016-2017. Findings are: A. On 5/24/18 at 11:06 am, the laboratory director stated that the laboratory was not enrolled in proficiency testing for gram stains when he started working in the laboratory in August 2017. He also stated that he had identified the problem and enrolled for 2018. B. Review of the 2016-2017 proficiency test scores from the CMS confirmed that no results for bacteriology were reported to CMS for the 3rd event of 2016 and all three events of 2017. C. Review of the 2016-2018 proficiency test records from the College of American Pathologists (CAP) confirmed the laboratory had not enrolled or participated in proficiency testing for gram stains since the first event of 2016. D. Review of the laboratory's "Laboratory Productions" reports for State Fiscal Year 2018 (July 2017-April 2018) revealed that the laboratory performed at total of 131 gram stains July 2017-December 2017. Review of the August and September patient logs confirmed testing for 19 patients (P1-P19) in -- 2 of 3 -- August 2017 and 10 patients (P20-P29) in December 2017. E. In September 2016, the laboratory submitted an application on 09/14/16 to change from a high complexity laboratory (bacterial identification tuning a manual culture method) to a moderate complexity laboratory and to change the laboratory director. Review of the application revealed no reference to the continued performance of gram stains in the laboratory. The application was signed by the previous laboratory director on 09/13/16. F. In August 2017, the laboratory submitted an application to change the laboratory director. Review of the application revealed no reference to the continued performance of gram stains in the laboratory. The application was signed by the current laboratory director on 08/01/17. D6020 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 director must-- (e)(5) Ensure that the quality control program is established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on the review of patient test records (P1-P29), application records, quality control records and interview with the laboratory director, the laboratory director failed to ensure a quality control plan was established and followed for gram stain quality control. Findings are: The laboratory failed to perform and document quality control for gram stains each week of use August - December 2017 for 29 (P1-P29) of 29 (P1-P29) patients reviewed. See D5503 -- 3 of 3 --