Hackleburg Medical Clinic

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) (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 Association of Bioanalysts-Medical Laboratory Evaluation (AAB-MLE) Proficiency Testing (PT) records, and an interview with the Practice Manager (PM) and Testing Personnel 1 (TP1), the laboratory failed to ensure attestation statements were signed by the LD (or designee) and the TP (analysts). This was noted for seven of the seven 2023-2025 PT events. The findings include: 1. A review of the AAB-MLE records revealed no evidence of the LD and TP signatures on attestation statements for the following events: A) 2023 Hematology M1-M3 Testing Events B) 2024 Hematology M1-M3 Testing Events C) 2025 Hematology M1 Testing Event 2. During the exit interview on 04-16-2025 at 2:30 PM, the PM and TP1 confirmed the above findings. D2123 HEMATOLOGY CFR(s): 493.851(c) (c) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3) The laboratory participated in the previous two 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 -- proficiency testing events. This STANDARD is not met as evidenced by: Based on review of the American Association of Bioanalysts-Medical Laboratory Evaluation (AAB-MLE) Proficiency Testing (PT) records, and an interview with the Practice Manager (PM) and Testing Personnel 1 (TP1), the laboratory failed to provide documentation of participation in one of the seven 2023-2025 Hematology PT events. The findings include: 1. A review of the AAB-MLE PT records revealed no documentation of the laboratory participating in the 2024 Hematology M-1 Testing Event. 2. During the exit conference interview on 04-16-2025 at 2:30 PM, the PM stated this event occurred when the TP in charge of the laboratory retired. The PM and TP1 could not remember what happened to this PT event. 3. On 4-17-2025 the CLIA State Agency contacted AAB-MLE "Tech Support". In an email dated 4-17- 2025, the MLE representative confirmed the 2024 M-1 PT samples were shipped, however the laboratory did not report any scores for the event. The laboratory should have received scores of 0% due to "failure to participate". 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 Association of Bioanalysts-Medical Laboratory Evaluation (AAB-MLE) Proficiency Testing (PT), and an interview with the Practice Manager (PM) and Testing Personnel 1 (TP1), the laboratory failed to ensure review and evaluation of PT results was performed and documented. This was noted for seven out of the seven 2023-2025 PT events. The findings include: 1. A review of the AAB-MLE PT records revealed no documentation of Hematology PT performance reviews from the Laboratory Director, or designee, for the following surveys: A) 2023 Hematology M1-M3 Testing Events B) 2024 Hematology M1-M3 Testing Events C) 2025 Hematology M1 Testing Event 2. The PM and TP1 confirmed the above findings during the exit conference on 04-16-2025 at 2:30 PM. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) (c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (c)(1) Identity and when significant, titer, strength or concentration. (c)(2) Storage requirements. (c)(3) Preparation and expiration dates. (c)(4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on an observation during the laboratory tour, a review of the Complete Blood Count (CBC) Quality Control (QC) package insert, and an interview with the Practice Manager (PM) and Testing Personnel 1 (TP1), the laboratory failed to write the new expiration dates on QC vials after opening. The surveyor noted three of the three levels of QC currently in use had only the open dates recorded. The findings include: -- 2 of 5 -- 1. During the laboratory tour on 04-16-2025 at approximately 8:48 AM the surveyor observed the three levels of CBC QC in use were labeled with the open date, "4-14- 25", however the testing personnel had not recorded the new expiration date on the vials after opening. 2. A review of the Boule QC package insert revealed the QC materials should not be utilized more than 14 days after opening. 3. During an interview with TP1 on 04-16-2025 at 8:49 AM, TP1 stated TP opens a new set of QC materials every 14 days. D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) (a )Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (a)(1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (a)(2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (a)(2)(i) Using calibration materials appropriate for the test system and, if possible, traceable to a reference method or reference material of known value; and (a) (2)(ii) Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and (a)(3) Whenever calibration verification fails to meet the laboratory's acceptable limits for calibration verification. This STANDARD is not met as evidenced by: Based on a review of the Hematology records, the analyzer operator's manual, and an interview with the Practice Manager (PM) and Testing Personnel 1 (TP1), the laboratory failed to perform calibrations on the Medonic M-Series Hematology analyzer every six months as per manufacturer's instructions. The surveyor noted no documentation for one of two calibrations due in 2024. The findings include: 1. A review of the Hematology calibration records revealed the Medonic M-Series Hematology analyzer was calibrated on on 09-14-2023 and 8-18-2024. There was no documention of the calibration performed on March 2024. 2. A review of the Medonic operator's manual indicated calibration is required at least every six months. 3. PM and TP1 confirmed the above findings during the exit conference on 04-16-2025 at 2: 30 PM. D6017 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(ii) (e)(4)(ii) Ensure that results are returned within the timeframes established by the proficiency testing program; This STANDARD is not met as evidenced by: Based on a review of the American Association of Bioanalysts-Medical Laboratory Evaluation (AAB-MLE) Proficiency Testing (PT) records, a lack of documentation, and an interview with the Practice Manager (PM) and Testing Personnel 1 (TP1), the surveyor determined the Laboratory Director failed to ensure the staff returned the proficiency testing results to AAB-MLE by the submission deadline, to ensure grading by the provider for the 2024 Hematology M1 testing event. This affected one of seven testing events, reviewed by the surveyor in 2023-2025. The findings include: 1. A review of the AAB-MLE PT records revealed a lack of documentation for the -- 3 of 5 -- 2024 Hematology M1 testing event. 2. During the exit conference interview on 04-16- 2025 at 2:30 PM, the PM stated this event occurred when the TP in charge of the laboratory retired. The PM and TP1 could not remember what happened to this PT event. 3. CLIA State Agency contacted AAB-MLE tech support on 04-17-2025. The AAB-MLE representative sent an email confirming 2024 Hematology M1 testing event samples were sent to the laboratory, but no results were submitted. The laboratory should have received scores of 0% due to "failure to participate". D6033 TECHNICAL CONSULTANT-MODERATE COMPLEXITY 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 reviews of Proficiency Testing (PT) records, Medonic M-Series Hematology analyzer records, personnel records, and interviews with the Practice Manager (PM) and Testing Personnel 1 (TP1), the surveyor determined the Technical Consultant (also the Laboratory Director) failed to provide technical and scientific oversight and direction from the date of the previous survey, 09-29-2022 to the date of the current survey, 04-16-2025. The findings include: 1. Refer to D6036. D6036 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413 The technical consultant is responsible for the technical and scientific oversight of the laboratory. The technical consultant is not required to be onsite at all times testing is performed; however, he or she must be available to the laboratory on an as needed basis to provide consultation, as specified in paragraph (a) of this section. This STANDARD is not met as evidenced by: Based on reviews of Proficiency Testing (PT) records, Medonic M-Series Hematology analyzer calibration records, personnel records, and interviews with the Practice Manager (PM) and Testing Personnel 1(TP1), the surveyor determined the Technical Consultant (also the Laboratory Director) failed to provide technical and scientific oversight and direction from the date of the previous survey, 09-29-2022 to the date of the current survey, 04-16-2025. The findings include: 1. A review of laboratory records revealed a lack of technical and scientific oversight and direction contributed to the following deficiencies: A) Failure to ensure PT attestation statements were signed; PT events were performed and submitted for the provider to grade; and all PT performance evaluations obtained were reviewed and documented. (Refer to D2009, D2123, D5211) B) Failure to ensure manufacturer's calibration requirement was performed and documented semi-annually on the Medonic M-Series Hematology analyzer. (Refer to D5437) C) Failure to ensure annual competencies were performed and documented for all TP performing moderate complexity testing. (Refer to D6054) 2. During the exit summation on 04-16-2025 at 2:30 PM, the lack of technical and scientific oversight and direction was discussed and confirmed by the PM and TP1. D6046 TECHNICAL CONSULTANT RESPONSIBILITIES -- 4 of 5 -- CFR(s): 493.1413(b)(8) (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. The procedures for evaluation of the competency of the staff must include, but are not limited to-- This STANDARD is not met as evidenced by: Based on a review of the Testing Personnel (TP) records and an interview with the Practice Manager (PM) and Testing Personnel 1 (TP1), the Technical Consultant (TC) (also the Laboratory Director) failed to ensure competency assessments for TP performing moderate complexity testing included all six CLIA minimal regulatory requirements. The surveyor noted six of the six requirements were missing from the annual competencies. The findings include: 1. A review of the 2023-2024 TP records revealed TP competency assessments for Hematology specialty had no documentation for the six CLIA minimal regulatory requirements. The surveyor noted the missing six requirements were as follows: (1) Direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing, and testing. (2) Monitoring the recording and reporting of test results. (3) Review of intermediate test results of worksheets, quality control records, proficiency testing results, and preventive maintenance results. (4) Direct observation of performance of instrument maintenance and function checks. (5) Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples. (6) Assessment of problem-solving skills. 2. The PM and TP1 confirmed the above findings during the exit conference on 04-16-2025 at 2:30 PM. D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) (b)(9) Thereafter, evaluations must be performed at least annually This STANDARD is not met as evidenced by: Based on a review of personnel evaluation records and an interview with the Practice Manager (PM) and Testing Personnel 1 (TP1), Technical Consultant (TC) (also the Laboratory Director) failed to assess and document the annual competency of individuals responsible for moderate complexity testing. This was noted for two out of two Testing Personnel's annual competencies from 2023-2024. The findings include: 1. A review of personnel records revealed the TC failed to perform and document the 2023 and 2024 annual competency assessments for two Testing Personnel listed on the CMS 209 (Laboratory Personnel Report-CLIA). 2. A further review of the personnel records revealed TP annual performance evaluations were performed by personnel not listed on the CMS 209 (Laboratory Personnel Report-CLIA). 3. During the exit conference on 04-16-2025 at 2:30 PM, the PM and TP1 confirmed the above findings. -- 5 of 5 --

Summary Statement of Deficiencies D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on a review of the Medonic M Series Hematology records, and an interview with Testing Personnel #1, the laboratory failed to ensure daily maintenance was performed and documented from the date of the previous survey (4/28/2021) to the date of the current survey (9/29/2022). The findings include: 1. A review of the Medonic M Series records revealed the laboratory documented the 2021 and 2022 monthly and six-month maintenance on "Maintenance and Calibration Schedule" forms. There was no documentation of daily maintenance. 2. A review of the Maintenance section in the Medonic M Series Users Manual revealed instructions for daily maintenance which included cleaning the Open Tube and Pre-dilute probes with an alcohol wipe; in addition the laboratory should remove any blood or salt crystals from around the probes, rinse cup, and cap piercer. 3. During an interview with Testing Personnel #1 on 9/29/2022 at 3:05 PM, the surveyor reviewed the "Daily Quality Control and Maintenance" log available in the Medonic M Series Users Manual. There was also space available for recording the lot numbers of Clot Prevention and Cleaning kits used for the monthly and six-month maintenance. The surveyor explained the laboratory should document the lot numbers in case there is a reagent problem or a recall. Testing Personnel #1 stated she never knew about this daily maintenance sheet. . D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) 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 -- (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 a review of the Medonic M Series Hematology Quality Control (QC) records, and interviews with Testing Personnel (TP) #1 and #3, the laboratory failed to ensure data from each day of QC was included on Levy Jennings (L-J) charts or the Interlaboratory Quality Assurance Program (IQAP) reports to track for shifts and trends over time. The laboratory failed to include 43 days of QC data from August 2021 through August 2022. The findings include: 1. A review of the Medonic M Series Hematology QC records revealed the laboratory printed cumulative monthly reports with the daily QC data, and the L-J charts attached. However, the surveyor noted five months with a total of 43 days of missing QC results, as follows: A) 8/2--8 /11/2021 B) 1/28--2/7/2022 C) 3/1--3/9/2022 D) 5/2--5/16/2022 E) 8/1--8/12/2022 The surveyor confirmed QC was performed on the above date by reviewing the daily instrument printouts. 2. A further review of the CDS (Clinical Diagnostic Solution) IQAP data revealed QC from the above dates was not included in the laboratory's monthly reports. 3. During an interview on 9/29/2022 at 2:45 PM, the surveyor asked TP #1 and #3 about the the process for printing the cumulative monthly QC, and submitting the data to CDS for inclusion in the IQAP statistics. TP #1 explained she had noticed whenever she implemented a new lot number of QC in the middle of the month, then only the data for the current lot number would print at the end of the month. As an example, the only data available for August 2022 was the 8/15--8/31 /2022 QC. TP #3 also confirmed this was the only data available to submit to the CDS IQAP website. 4. As the interview continued on 9/29/2022 at 3:05 PM, the surveyor explained it was possible data from the old lot number of QC was deleted whenever a new lot number was implemented. However, the laboratory should confer with the Medonic Tech Support and implement a mechanism to ensure all the QC data was documented and included in the I-J charts and the IQAP evaluation. . D5481 CONTROL PROCEDURES CFR(s): 493.1256(f)(g) (f) Results of control materials must meet the laboratory's and, as applicable, the manufacturer's test system criteria for acceptability before reporting patient test results. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of Medonic M Series Hematology Quality Control (QC), reviews of patient test logs and charts, and an interview with Testing Personnel #1, the laboratory failed to ensure QC performed in the MC (Microcontainer) mode was within acceptable ranges before patient CBC's (Complete Blood Counts) were run. The surveyor noted two to three levels of QC were unacceptable on nine days of -- 2 of 4 -- patient testing in June and July 2022. The findings include: 1. A review of Medonic M Series records revealed testing personnel ran three levels of QC in the CP/OT (Cap Piercing/Open Tube) mode and the MC mode each day of patient testing. Only the individual instrument printouts displayed the mode in which a QC or patient specimen was performed. 2. A review of the individual instrument QC printouts from June and July 2022 revealed nine days when two to three levels of QC run in the MC mode were unacceptable and 51 patient CBC's were performed (according to the patient test logs), as follows: A) 6/23/2021--Ten patient CBC's B) 7/02/2021--Four patient CBC's C) 7/09/2021--One patient CBC D) 7/12/2021--Ten patient CBC's E) 7/14/2021-- Eight patient CBC's F) 7/15/2021--Six patient CBC's G) 7/16/2021--Two patient CBC's H) 7/23/2021--One patient CBC I) 7/26/2021-Nine patient CBC's 3. A review of the laboratory processes for test reporting revealed the facility utilized the instrument printout as the patient report, and included these in each patient's paper chart. The facility was unable to pull 51 patient charts on the day of the survey to determine how many patient CBC's were performed in the MC mode. 4. During an interview on 9/29/2021 at approximately 2:00 PM, the surveyor asked Testing Personnel #1 for an estimate of what percentage of patient CBC's were performed in the MC mode; Testing Personnel estimated 50-60%. The surveyor then asked for a sampling and requested the charts of patients with CBC's on 7/14/2022 when three levels of QC were outside acceptable ranges. The interview continued at 2:30 PM when the surveyor and Testing Personnel reviewed patient charts. On 7/14/2022 eight patient CBC's were performed; five were run in the MC mode, and three were performed in the CP mode. The surveyor explained the laboratory must implement a mechanism to ensure no patient CBC's are run in the OT/CP or MC modes when the QC performed in that sampling mode is unacceptable. . D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on a review of Quality Assurance (QA) and Medonic M Series Hematology records, and an interview with Testing Personnel #1, the laboratory failed to follow the QA procedure to ensure quality control (QC) results were within acceptable limits each day of patient testing. The laboratory further failed to implement QA reviews to ensure daily maintenance was performed and documented, and monthly cumulative QC included data for the entire month. This was noted from the date of the previous survey (4/28/2021) to August 2022. The findings include: 1. A review of the monthly QA checklist revealed, "All Quality Control / Calibrations were performed and were within acceptable limits before patient test results were reported". The laboratory had answered "Y" [Yes] to this QA indicator every month from April 2021 through August 2022. However, the surveyor noted nine days in June and July 2021 when QC was unacceptable, and 51 patient CBC's (Complete Blood Counts) were performed. (Refer to D5481.) The surveyor further noted the laboratory had failed to investigate the cause of QC failures and implement

Summary Statement of Deficiencies D0000 The surveyor determined this laboratory is in substantial compliance with the requirements of the Clinical Laboratory Improvement Amendments of 1988 (CLIA'88). D3000 FACILITY ADMINISTRATION CFR(s): 493.1100 Each laboratory that performs nonwaived testing must meet the applicable requirements under 493.1101 through 493.1105, unless HHS approves a procedure that provides equivalent quality testing as specified in Appendix C of the State Operations Manual (CMS Pub. 7). (a) Reporting of SARS-CoV-2 test results During the Public Health Emergency, as defined in 400.200 of this chapter, each laboratory that performs a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (hereinafter referred to as a "SARS-CoV-2 test") must report SARS-CoV-2 test results to the Secretary in such form and manner, and at such timing and frequency, as the Secretary may prescribe. This CONDITION is not met as evidenced by: Based on record review and interview, the laboratory failed to report SARS-CoV-2 (Severe Acute Respiratory Syndrome Coronovirus 2) test results for negative Coronovirus Disease 2019 (COVID-19) performed on the Sofia2 Flu + SARS Antigen FIA from January 25, 2021 to April 28, 2021. The laboratory failed to report negative results for SARS-CoV-2 for the COVID-19 antigen test results to the Alabama Department of Public Health and positive results were reported to the Report Card for Alabama Department of Public Health (which is not the mechanism to use to report a patient that has a reportable disease). Findings include: 1. A review of SARS-CoV-2 test results revealed patients were tested for SARS-CoV-2 using the Sofia2 Flu + SARS Antigen FIA, starting January 25, 2021 through April 28, 2021. A total of 37 test were performed (3 Positives and 34 Negatives) during this time period. 2. During an interview on April 28, 2021 at 09:55 AM, Testing Personnel #2 stated positive 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 -- results were reported to the Novel Coronavirus (COVID-19) Report Card to the Alabama Department of Public Health. The Report Card has the following statement "If you are a Laboratorian, reporting on behalf of a laboratory, blood bank, or plasma center, the REPORT Card is not the mechanism you should use to report a patient that has a reportable disease or health condition." Testing Personnel #2 confirmed the laboratory had reported only positives (to the Report Card) but none of the negative SARS-CoV-2 patient test results were reported to the Alabama Department of Public Health. -- 2 of 2 --