Bernalillo Health Care Corp

Summary Statement of Deficiencies D0000 An onsite recertification survey conducted at Bernalillo Health Care Corp dba Albq Ambulance on January 16, 2024, found the laboratory to be out of compliance with the CLIA regulations found at 42 CFR, Part 493 Laboratory Requirements, with the following condition not met: D6063 - 42 C.F.R. 493.1421 Condition: testing personnel moderate complexity testing D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on review of Albuquerque Ambulance i-STAT procedure, patient test list, and interview the laboratory failed to monitor and document room temperature for the mobile units, and in house storage of i- STAT instruments and cartridges for 2023. Findings included: 1. Review of Albuquerque Ambulance i-STAT procedure lists the following storage conditions. 1. i-STAT: operating temperature, 16 - 30 Celsius (C) 2. i-STAT Cartridges: Stored for limited time at room temperature, 18 - 30 C 2. A patient test list from November 2023 through December 2023 was requested which showed the following patients were tested on the following dates. 1. Patient 1: 12/25 /2023 2. Patient 2: 12/25/2023 3. Patient 3: 12/15/2023 4. Patient 4: 12/15/2023 5. Patient 5: 11/30/2023 Confirming patients were being tested, and the instruments and cartridges needed to be stored in proper room temperature conditions. 3. The laboratory was asked to provide documentation that room temperature was being 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 -- documented on the mobile units and in house storage for 2023. None was provided. 4. Interview on 1/16/2023 at 12:12 pm with technical consultant #3 stated, i-Stat cartridges are removed from refrigerated storage and placed in a kit with the i-Stat instrument. The kit is then stored at room temperature on the mobile unit, then transferred to room temperature in house storage when not in use. This confirmed the findings. D6063 LABORATORY TESTING PERSONNEL CFR(s): 493.1421 The laboratory must have a sufficient number of individuals who meet the qualification requirements of 493.1423, to perform the functions specified in 493. 1425 for the volume and complexity of tests performed. This CONDITION is not met as evidenced by: Based on review of CMS 209 form and interview the laboratory failed to provide education records for 1 of 10 testing personnel. Refer to D6065 D6065 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(b)(1)(2)(3)(4)(i) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located or have earned a doctoral, master's, or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution; or (b)(2) Have earned an associate degree in a chemical, physical or biological science or medical laboratory technology from an accredited institution; or (b)(3) Be a high school graduate or equivalent and have successfully completed an official military medical laboratory procedures course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); or (b)(4)(i) Have earned a high school diploma or equivalent; and This STANDARD is not met as evidenced by: Based on review of CMS 209 form and interview the laboratory failed to provide education records for 1 of 10 testing personnel (testing person #5). Finding included: 1. Review of CMS 209 form showed testing person #5 (TP#5) listed to perform moderate complexity testing. 2. The laboratory was asked to provide documentation of TP#5 education. None was provided. 3. Interview on 1/16/2024 at 1:21 pm with technical consultant #1 confirmed the findings. -- 2 of 2 --

Summary Statement of Deficiencies D0000 The following standard deficiences were cited as the results of a recertification survey on 09/06/2022. 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. 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 the review of patient test records/reports for the i-STAT test system, review of laboratory i-STAT policy/procedure, and interviews with Point of Care (POC) staff, the laboratory failed to ensure their patient test reports included all required information for 2 of 2 patients tested on 07/02/2022 and on 01/16/2022. Findings included: 1. Review of two patient test reports (Sample ID# 202201059511 for Chem 8+, analyzed on 07/02/22 and Sample ID# 202201004891 for CG4+, analyzed on 01 /16/22) revealed the following: A. The laboratory patient reports failed to positively identify the patients with a name and an identification number, or a unique patient identifier and identification number. B. The laboratory patient reports failed to identify name, and address, or the specific location where the testing was performed. The laboratory patient reports had the name of the laboratory as "TriCore Reference Lab" printed on top of the reports and the address of the testing laboratory was not on 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 -- the report. 2. Review of the Laboratory policy titled "PHS Albuquerque Ambulance i- STAT Procedure", Reference number-POCT-SOP-0086, Section labeled "Documentation", page 9, stated the following; "2. In the Zoll Charting Program .... a. Select Source i. Arterial ii. Capillary iii. Venous" The laboratory failed to follow the written policy to ensure the source was included on their patient reports. The two patient reports failed to identify the source of the specimen needed by the laboratory to accurately perform testing and report results. 3. During an interview on 09/06/22 at 09:00 am with POC Staff members, it was confirmed that the i-STAT testing for Chem 8+ and CG4+ is performed only on 2 of 82 CCT (Critical Care Transport) ambulances and not at TriCore Reference Lab. -- 2 of 2 --

Summary Statement of Deficiencies D0000 During an initial certification survey completed on 11/26/19 for 42 CFR part 493 Laboratory Requirements, the facility was found out of compliance with the following conditions: 42 CFR Part 493.801 Proficiency Testing Enrollment 42 CFR Part 493.1403 Laboratory Director, moderate complexity 42 CFR Part 493.1413 Technical Consultant An on-site initial survey was scheduled for 10/02/19. During interview on 10/02/19 09:05 am, the Laboratory Director stated the laboratory had just completed the validation studies and had not started testing patients. Based on this information, the laboratory's initial survey was postponed until 11/26/19. Definitions: B-type natriuretic peptide (BNP) measurements can be used as an aid in the diagnosis and assessment of the severity of congestive heart failure. Cardiac Troponin I measurements are used in the diagnosis and treatment of myocardial infarction and as an aid in the risk stratification of patients with acute coronary syndromes with respect to their relative risk of mortality. Coefficient of Variation is defined as the ratio of the standard deviation to the mean (or its absolute value). The CV is widely used in analytical chemistry to express the precision and repeatability of an assay. The standard deviation (SD) is a measure of the amount of variation or dispersion of a set of values. 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. 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 -- This CONDITION is not met as evidenced by: Based on review of proficiency testing records, emails, and interviews with laboratory staff, the laboratory failed to enroll in proficiency testing for Blood gases (ph and PCO2 or Carbon Dioxide). Findings are: A. During interview on 10/02/19 09:05 am, the Laboratory Director stated the laboratory had just completed the validation studies and had not started testing patients. She also stated that the laboratory had not enrolled in Proficiency Testing. B. During interview on 11/26/19 at 01:30 pm, TC (Technical Consultant) #2 stated the laboratory had submitted the enrollment for API (American Proficiency Institute) and a P.O. (Purchase Order) but did not have enrollment confirmation from the company. C. Review of available proficiency documents on 11 /26/19 confirmed the only document available was the enrollment form. D. Review of an email dated 11/27/19 at 09:16 am from API revealed no account with their company using the address or CLIA number. E. Review of an email dated 11/27/19 at 12:16 pm from TC #3 confirmed the laboratory had not enrolled in Proficiency Testing. 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 the review of FDA (Food & Drug Administration) approval letter, manufacturer instructions and validation studies, the laboratory failed to ensure the BNP precision studies met the manufacturer's requirements for accuracy. Findings are: A. Review of the manufacturer's instructions indicated an overall precision or CV of 11.1 % for Level 1 control and 9.8% for Level 3 control. B. Review of FDA 510(k) approval letter K053597 dated 07/21/2006 also indicated an overall precision or CV of 11.1 % for Level 1 control and 9.8% for Level 3 control. C. Review of the laboratory's validation statistics revealed 1 of the 2 i-Stat analyzers (SN 407092) failed to meet the CV requirement provided by the manufacturer. The CV for SN 4070992 was 12.0%. D. Review of the "Point of Care New Instrument Studies-BNP" signed by the Laboratory Director on 09/30/19 revealed the laboratory failed to use the correct CV target. 1. The document indicated under comments "CV within 10% for all but Level 1 BNP QC on iStat SN 407092 per validation protocol. CV was 12.0% which is within Manufacturer target CV of 20.0%" 2. There was no documentation indicating the laboratory would repeat the study. 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. -- 2 of 7 -- This STANDARD is not met as evidenced by: Based on the review of the IQCP (Individualized Quality Control Plan), validation plans, quality control data, emails and interview with TC #2, the laboratory failed to perform studies to support the laboratory's quality control plan for BNP, Troponin, Lactate, and Blood Gases. Findings are: A. During interview on 11/26/19 at 01:14 pm, TC (Technical Consultant) #2 stated external or liquid quality control materials were tested monthly. B. Review of the laboratory's IQCP revealed no documentation of quality control studies that supported a monthly quality control plan including a review of internal controls. 1. Review of the BNP quality control reports indicated test dates of 08/01/19 - 08/12/19, a 12-day period. 2. Review of the Lactate/Blood Gas quality control reports indicated test dates of 08/09/19 - 08/10/19, a 2-day period. 3. Review of the Troponin quality control reports indicated test dates of 07/18/19 - 08/02 /19, a 15-day period. 4. Review of the laboratory's validation plan indicated TC #2 would run 2 levels (level 1 and level 3) 10 times each for all analytes over a 2-day period. C. Review of emails from TC #2 and TC #1 dated 11/26/19 provided no additional documentation of quality control studies. 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 review of proficiency testing records, personnel records, IQCP (Individualized Quality Control Plan), quality control data, emails and interviews with laboratory staff, 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 Blood gases. See D6015 B. The Laboratory Director failed to ensure all quality control studies were completed to support the laboratory's quality control plan for BNP, Troponin, Lactate, and Blood Gases. See D6020 C. The Laboratory Director failed to ensure the responsibilities of Technical Consultant were performed by qualified staff. See D6028 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 review of proficiency testing records, emails, and interviews with laboratory staff, the Laboratory Director failed to ensure the laboratory was enrolled in proficiency testing for Blood Gases (ph and PCO2 or Carbon Dioxide). Findings are: -- 3 of 7 -- A. During interview on 10/02/19 09:05 am, the Laboratory Director stated the laboratory had just completed the validation studies and had not started testing patients. She also stated that the laboratory had not enrolled in Proficiency Testing. B. During interview on 11/26/19 at 01:30 pm, TC (Technical Consultant) #2 stated the laboratory had submitted the enrollment for API (American Proficiency Institute) and a P.O. (Purchase Order) but did not have enrollment confirmation from the company. C. Review of available proficiency documents on 11/26/19 confirmed the only document available was the enrollment form. D. Review of an email dated 11/27/19 at 09:16 am from API revealed no account with their company using the address or CLIA number. E. Review of an email dated 11/27/19 at 12:16 pm from TC #3 confirmed the laboratory had not enrolled in Proficiency Testing. 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 the IQCP (Individualized Quality Control Plan), quality control data, emails and interview with TC #2, the Laboratory Director failed to ensure all quality control studies were completed to support the laboratory's quality control plan for BNP, Troponin, Lactate, and Blood Gases. Findings are: A. During interview on 11/26/19 at 01:14 pm, TC (Technical Consultant) #2 stated external or liquid quality control materials were tested monthly. B. Review of the laboratory's IQCP revealed no documentation of quality control studies that supported a monthly quality control plan including a review of internal controls. 1. Review of the BNP quality control reports indicated test dates of 08/01/19 - 08/12/19, a 12-day period. 2. Review of the Lactate/Blood Gas quality control reports indicated test dates of 08/09 /19 - 08/10/19, a 2-day period. 3. Review of the Troponin quality control reports indicated test dates of 07/18/19 - 08/02/19, a 15-day period. C. Review of emails from TC #2 and TC #1 dated 11/26/19 provided no additional documentation of quality control studies. D6028 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(10) 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)(10) Employ a sufficient number of laboratory personnel with the appropriate education and either experience or training to provide appropriate consultation, properly supervise and accurately perform tests and report test results in accordance with the personnel responsibilities described in this subpart; This STANDARD is not met as evidenced by: -- 4 of 7 -- Based on the review of personnel records and interview with the Laboratory Supervisor, the Laboratory Director failed to ensure the responsibilities of Technical Consultant were performed by qualified staff. Findings are: A. Review of personnel files revealed 4 (TP #1, TP #2, TP #6 and TP #9) of 18 (TP #1-18) testing personnel were trained by TP #8 and TP #10. B. Review of the personnel files for TP #8 and TP #10 revealed no documentation of technical consultant qualifications to perform tasks such as training. C. During interview on 11/26/19 at 03:18 pm, the Laboratory Supervisor stated both TP #8 and TP #10 were "Superusers" and permitted to train staff in Emergency Medical procedures. He confirmed there was no "delegation of authority" from the Laboratory Director for laboratory testing. 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: Based on the review of FDA (Food & Drug Administration) approval letter, manufacturer instructions, validation studies, proficiency testing records, emails, IQCP (Individualized Quality Control Plan), personnel records, quality control data, and interviews with laboratory staff, the Technical Consultant failed to provide technical oversight of the laboratory. Findings are; A. The Technical Consultant failed to ensure the laboratory was enrolled in proficiency testing for Blood gases. See D6041 B. The Technical Consultant failed to ensure all studies were completed and met manufacturer's specifications. See D6040 C. The Technical Consultant failed to establish a quality control plan for all tests performed on the i-Stat analyzer. See D6042 D. The Technical Consultant failed to train 4 (TP #1, TP #2, TP #6 and TP #9) of 18 (TP #1-18) testing personnel. See D6045 D6040 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(2) The technical consultant is responsible for-- (b)(2) Verification of the test procedures performed and the establishment of the laboratory's test performance characteristics, including the precision and accuracy of each test and test system. This STANDARD is not met as evidenced by: Based on the review of FDA (Food & Drug Administration) approval letter, manufacturer instructions and validation studies, the Technical Consultant failed to ensure all studies were completed and met manufacturer's specifications. Findings are: The laboratory failed to ensure the BNP precision studies met the manufacturer's requirements for accuracy. See D5421 D6041 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(3) (b) The technical consultant is responsible for-- (b)(3) Enrollment and participation in an HHS approved proficiency testing program commensurate with the services offered; -- 5 of 7 -- This STANDARD is not met as evidenced by: Based on review of proficiency testing records, emails, and interviews with laboratory staff, the Technical Consultant failed to ensure the laboratory was enrolled in proficiency testing for Blood gases (ph and PCO2 or Carbon Dioxide). Findings are: A. During interview on 10/02/19 09:05 am, the Laboratory Director stated the laboratory had just completed the validation studies and had not started testing patients. She also stated that the laboratory had not enrolled in Proficiency Testing. B. During interview on 11/26/19 at 01:30 pm, TC (Technical Consultant) #2 stated the laboratory had submitted the enrollment for API (American Proficiency Institute) and a P.O. (Purchase Order) but did not have enrollment confirmation from the company. C. Review of available proficiency documents on 11/26/19 confirmed the only document available was the enrollment form. D. Review of an email dated 11/27/19 at 09:16 am from API revealed no account with their company using the address or CLIA number. E. Review of an email dated 11/27/19 at 12:16 pm from TC #3 confirmed the laboratory had not enrolled in Proficiency Testing. D6042 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(4) (b) The technical consultant is responsible for-- (b)(4) Establishing a quality control program appropriate for the testing performed and establishing the parameters for acceptable levels of analytic performance and ensuring that these levels are maintained throughout the entire testing process from the initial receipt of the specimen, through sample analysis and reporting of test results; This STANDARD is not met as evidenced by: Based on the review of the IQCP (Individualized Quality Control Plan), quality control data, emails and interview with TC #2, the Technical Consultant failed to establish a quality control plan for all tests performed on the i-Stat analyzer. Findings are: A. The laboratory failed to perform studies to support the laboratory's quality control plan for BNP, Troponin, Lactate, and Blood Gases. See D5447 B. Review of emails from TC #2 dated 11/26/19 revealed no additional documenation. D6045 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(7) (b) The technical consultant is responsible for-- (b)(7) Identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed; This STANDARD is not met as evidenced by: Based on the review of personnel records and interview with the Laboratory Supervisor, the Technical Consultant failed to train 4 (TP #1, TP #2, TP #6 and TP #9) of 18 (TP #1-18) testing personnel. Findings are: A. Review of personnel files revealed 4 (TP #1, TP #2, TP #6 and TP #9) of 18 (TP #1-18) testing personnel were trained by TP #8 and TP #10. B. Review of the personnel files for TP #8 and TP #10 revealed no documentation of technical consultant qualifications to perform tasks such as training. C. During interview on 11/26/19 at 03:18 pm, the Laboratory Supervisor -- 6 of 7 -- stated that both TP #8 and TP #10 were "Superusers" and permitted to train staff in Emergency Medical procedures. He confirmed there was no "delegation of authority" from the Laboratory Director for laboratory testing. -- 7 of 7 --