Birmingham Heart Clinic

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on a review of the American Proficiency Institute (API) Proficiency Testing (PT) records and an interview with the Director of Diagnostics (DOD), the Laboratory Director failed to sign the PT attestation statements for the specialties in Hematology and Chemistry. This was noted for three of six events reviewed in 2023. The findings include: 1. A review of the API PT records revealed no signature by the Laboratory Director (or designee) on attestation statements for the following surveys: a) 2023 Hematology 1st Event. b) 2023 Chemistry 1st Event. c) 2023 Chemistry 2nd Event. 2. During an interview on 8/8/24, at 10:22 AM, the DOD confirmed the above findings. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on a review of the American Proficiency Institute (API) Proficiency Testing (PT) records and an interview with the Director of Diagnostics (DOD), the laboratory failed to ensure documentation of PT review pages for specialties in Hematology and Chemistry. This was noted for five of nine events reviewed from 2023 through 2024. The findings include: 1. A review of the API PT records revealed no documentation 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 -- of a review from the Laboratory Director, or designee, for the following surveys: a) 2023 Hematology 3rd Event. b) 2023 Chemistry 3rd Event. c) 2024 Hematology 1st Event. d) 2024 Chemistry 1st Event. e) 2024 Chemistry 2nd Event. 2. During an interview on 8/8/2024, at 10:22 AM, the DOD confirmed the above findings. 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 the Abbott iSTAT Chemistry-8 cartridge QC (Quality Control) documentation, the iSTAT Value Assignment Sheet (VAS) documentation, and an interview with the Director of Diagnostics, the laboratory failed to ensure Chem-8 reference intervals were updated with each new lot number. This is was noted from the previous survey on 10/4/2022 to current survey of 8/8/24. The findings include: 1. A review of the Chem-8 cartridge QC revealed QC was performed monthly as per the procedure, however the laboratory failed to update reference ranges with every lot change since the previous survey of 10/4/22. There was no evidence of documentation of verification for acceptable QC. 2. A further review of the VAS revealed, "Use Value Assignment Sheets to locate the correct target values and ranges for your i- STAT test cartridge controls." 3. During the exit interview on 8/8/24 at 1:00 PM, the DOD confirmed she was unaware of downloading the VAS and updating the ranges with every new lot. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(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-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on the laboratory tour, a review of the IQCP (Individualized Quality Control Plan), and an interview with the DOD (Director of Diagnostics), the surveyor determined the laboratory failed to establish an IQCP, which included the three required parts: Risk Assessment (to include five components); Quality Control Plan; and Quality Assessment. This affected one of two tests performed by the laboratory. The findings include: 1. During the initial tour of the laboratory, the DOD identified two tests performed by the laboratory staff, the ACT and Chem-8 cartridges which are -- 2 of 3 -- performed on the Abbott I-Stat. 2. A review of the IQCP revealed the ACT test only. There was no evidence of a documented IQCP for the Chem-8 cartridge. An IQCP must address the potential failures and errors identified in the entire testing process: preanalytic, analytic and postanalytic phases of testing. 3. During an interview on 8/8 /24 at 11:55 AM, the DOD confirmed there was no IQCP for the Chem-8 cartridge. D5477 CONTROL PROCEDURES CFR(s): 493.1256(e)(4)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (4) Before, or concurrent with the initial use-- (e)(4)(i) Check each batch of media for sterility if sterility is required for testing; (e)(4)(ii) Check each batch of media for its ability to support growth and, as appropriate, select or inhibit specific organisms or produce a biochemical response; and (e)(4)(iii) Document the physical characteristics of the media when compromised and report any deterioration in the media to the manufacturer. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of the iSTAT Chemistry-8 QC (Quality Control) log, the Chem-8 patient log, and an interview with the DOD (Director of Diagnostics), the laboratory failed to document QC lot numbers and expiration dates for each lot number prior to use for patient testing. This was noted for 51 days of 16 months reviewed in 2023 through 2024. The findings include: 1. A review of the Chem-8 QC log revealed no documentation of QC from when the last lot expired to when the new lot was put into use for the following: a) Lot# H23005A was put into use 5/4/23 and expired 7/7/23; 51 days later, b) Lot# H23094A was put into use 8/28/23 and expired 10/1/23. 2. A review of the patient log revealed 17 patient Chem-8 tests were performed on the 51 days of no QC documentation. 3. During an interview on 8/8/24 at 12:31 PM, the DOD confirmed QC documentation was missed. 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 laboratory tour, a review of the IQCP (Individualized Quality Control Plan), and an interview with the DOD (Director of Diagnostics), the surveyor determined the laboratory failed to establish an IQCP, which included the three required parts: Risk Assessment (to include five components); Quality Control Plan; and Quality Assessment. This affected one of two tests performed by the laboratory. The findings include: 1. Refer to D5445. . -- 3 of 3 --

Summary Statement of Deficiencies D5431 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(2) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document function checks as defined by the manufacturer and with at least the frequency specified by the manufacturer. Function checks must be within the manufacturer's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on a review of the ISTAT internal Electronic Simulator records, a review of the ISTAT procedure manual, and an interview with the Director of Diagnostics (DOD), the Laboratory failed to ensure the internal Electronic Simulator check met the manufacturer's acceptable criteria before patient testing began. This was noted for one day of nine months reviewed in 2022. The findings include: 1. A review of the ISTAT records revealed the internal Electronic Simulator check failed on May 18, 2022. Three patient Hematology Activating Clotting Time (ACT) tests were run on this date. 2. A review of the ISTAT Procedure Manual on page 15 revealed, "...if FAIL is displayed... rerun the cartridge..... or repeat the procedure with a different external Electronic Simulator." There was no documentation the laboratory had repeated the external Electronic Simulator check as per procedure. 3. During an interview on October 4, 2022, at 11:00 AM, the Director of Diagnostics confirmed, "failed internal Electronic Simulator's need to be repeated." Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies 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: Based on a review of the American Proficiency Institute (API) proficiency testing records and an interview with the Laboratory Director (also the Technical Consultant) and an office manager, the surveyor determined two testing personnel performed proficiency testing on the same specimens (IAC05 and IAC06) for Event #3, 2019 [Activated Clotting Time (ACT)]. This affected one of six proficiency testing events, reviewed by the surveyor. The findings include: 1. A review of the attestation statements for Event #3, 2019 for ACT testing revealed two testing personnel signed for the testing of the same two specimens (IAC05 and IAC06). 2. During an interview on 12/02/2020 at 10:57 AM, the office manager stated sometimes the testing personnel run the same samples to double-check. When the surveyor asked if patients were run in the same manner, the office manager stated patient specimens were not run twice to verify. The Laboratory Director was present for this interview. D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing 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 -- samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on a review of the American Proficiency Institute (API) proficiency testing records and an interview with the Laboratory Director (also the Technical Consultant), the surveyor determined the laboratory failed to ensure an attestation statement was completed and retained for Event #1, 2020 [Activated Clotting Time (ACT) testing]. This affected one of six proficiency testing events, reviewed by the surveyor. The findings include: 1. A review of the proficiency testing records revealed no attestation statement for Event #1, 2020. 2. During an interview on 12/02/2020 at 11:10 AM, the office manager was asked about the missing attestation statement for Event #1, 2020. The office manager reviewed the proficiency testing records and confirmed the above noted findings. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on a review of American Proficiency Institute (API) proficiency testing records and an interview with the Laboratory Director (LD), who also serves as the Technical Consultant, the surveyor determined the laboratory failed: a) To implement and document

Summary Statement of Deficiencies 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 an observation of reagent cartridges, a review of the policy and procedure manual, including temperature records/logs, and an interview with the Laboratory Director (also the Technical Consultant), the surveyor determined the laboratory failed to monitor the room temperature of the storage area of the ACT (Activated Clotting Time) cartridges, tested on the Abbott I-stat. The cartridges were required to be at room temperature, prior to testing; and may only be held at room temperature for a limited time, after removing them from the refrigerator. The findings include: 1. Upon the initial tour of the laboratory with the Laboratory Director, the surveyor observed a partial box of ACT cartridges in the drawer of the testing area. "Use by" dates were observed handwritten on the cartridge packages. At this time, the Laboratory Director, stated once the cartridges are removed from the refrigerator, the "use by" dates must be noted on the cartridges, as the shelf life is lessened when not refrigerated. 2. The policy and procedure manual revealed the cartridge shelf life (ACT)/processing temperature: The cartridges, kept at 2 -8 degrees Celsius, should be brought to room temperature (let stand for 5 minutes at room temperature). 3. In an interview at 10:55 AM, the Laboratory Director confirmed the room temperature had not been monitored and documented. 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 -- D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(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-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on the laboratory's test menu, a review of quality control policies and records, an electronic version of an IQCP (Individualized Quality Control Plan), a lack of documented policies and procedures for Quality Assessment, and an interview with the Laboratory Director (also the Technical Consultant), the surveyor determined the laboratory failed to establish a complete IQCP, which included the three required parts: Risk Assessment (to include five components); Quality Control Plan; and Quality Assessment. This affected one of one test, performed by the laboratory. The findings include: 1. During the initial tour of the laboratory, the Laboratory Director identified the only test performed by the laboratory staff as the ACT, which was run on the Abbott I-Stat. 2. A review of the policy and procedure manual revealed a log with ACT cartridge lot numbers/expiration dates, external quality control (levels #1 and #2) lot numbers and expiration dates, and an internal electronic simulator. During an interview at this time, 10:16 AM, the Laboratory Director stated the quality control had been run for several days (16 days) to establish an IQCP. According to the Laboratory Director, the electronic simulator, an internal system check, was run each day of testing, as well as 2 external quality control levels. A section of the policy and procedure manual, labeled QC (Quality Control), signed by the Laboratory Director, revealed the external quality control was tested with every shipment of supplies, which was usually received once per week. The plan was not inclusive of all quality control to be tested, to include the type, number and frequency, as well as, acceptable criteria. 3. At 10:49 AM, a review of the "IQCP" via electronic means, revealed the laboratory did not provide documentation of risk mitigation associated with the five necessary elements, to ensure the risk associated with each element was mitigated across the entire testing process, pre-analytic, analytic and post-analytic processes. The instructions for risk mitigation was to refer to the Abbott manual, which was greater than 500 pages. At this time, the Laboratory Director also failed to show how the data, accumulated as described above, was included or considered with the development of the IQCP. 4. The policy and procedure manual did not include a Quality Assessment program or plan. 5. A review of the quality control records revealed the external controls and internal control (electronic simulator) had been tested for several days between 6/04 and 6/28/18, 7/09; 8/01 and 9/02. This record did not reflect once per week quality control testing of the external quality controls. 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 -- 2 of 3 -- 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 laboratory's test menu, a review of quality control policies and records, an electronic version of an IQCP (Individualized Quality Control Plan), and an interview with the Laboratory Director (also the Technical Consultant), the surveyor determined the Laboratory Director failed to ensure an IQCP was established to include the three required parts: Risk Assessment (to include five components); Quality Control Plan; and Quality Assessment. This affected one test, ACT (Activated Clotting Time) of one test, performed by the laboratory. The findings include: 1. Refer to D5445. 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 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: Based on the laboratory's test menu, a review of quality control policies and records, an electronic version of an IQCP (Individualized Quality Control Plan), a lack of documented policies and procedures for Quality Assessment, and an interview with the Laboratory Director (also the Technical Consultant), the surveyor determined the Laboratory Director failed to ensure an acceptable and complete IQCP was established and implemented, which included the three required parts: Risk Assessment (to include five components); Quality Control Plan; and Quality Assessment. This affected one test, ACT (Activated Clotting Time) of one test, performed by the laboratory. The findings include: 1. Refer to D5445. Patricia Watson, BS, MT (ASCP) Licensure and Certification Supervisor -- 3 of 3 --