Andalusia Family Practice

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 Wisconsin State Laboratory of Hygiene (WSLH) Proficiency Testing (PT) records and an interview with Testing Personnel 1 (TP1), the surveyor determined the Laboratory Director (or Designee) failed to sign the Attestation statements for six out of the six survey events. The findings include: 1. A review of the 2023-2024 WSLH PT records revealed the TP examining the PT samples had signed the Attestation statements but were not signed by the Laboratory Director (or Designee) for the following PT events: A) 2023 Hematology Events #1, #2, and #3 B) 2024 Hematology Events #1, #2, and #3 2. A further review of the WSLH PT Handbook under General Information, Ten Steps to Successful Proficiency Testing, page 5, revealed the following instructions: 7. Resulting PT samples: "Have the attestation statement signed by the testing personnel and the laboratory director." 3. TP1 confirmed the above findings during the exit conference on 03-27-2025 at 12:30 PM. 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: 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 -- Based on a review of the Wisconsin State Laboratory of Hygiene (WSLH) Proficiency Testing (PT) records and an interview with the Testing Personnel 1 (TP1), the laboratory failed to ensure review and evaluation of PT performance results for the Hematology specialty. This was noted for six out of the six events reviewed from 2023 through 2024. The findings include: 1. A review of the 2023-2024 WSLH PT records revealed no documentation of the Hematology PT results review from the Laboratory Director, or designee, for the following surveys. A) 2023 Hematology Events #1, #2, and #3 B) 2024 Hematology Events #1, #2, and #3 2. A further review of the WSLH PT Handbook under General Information, Ten Steps to Successful Proficiency Testing, page 5, revealed the following instructions: 9. When your report comes back: Review the entire report (evaluation, event notes...) 3. TP1 confirmed the above findings during the exit conference on 03-27-2025 at 12:30 PM. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) (d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on direct observation and an interview with the Testing Personnel 1 (TP1), the surveyor determined the laboratory utilized expired EDM3 Solutions HealthLink Potassium Hydroxide (KOH) 10 percent reagent for the Provider Performed Microscopy (PPM). The expired date was noted on the reagent bottle to the current date of the survey on 03-27-2025. The surveyor noted the reagent had been expired since before the previous survey on 2-8-2023. The findings include: 1. During the laboratory tour with TP1 at approximately 8:30 AM, the surveyor observed KOH reagent, Lot 0310 with Expiration date of 11-05-2022. No open date was written on the bottle. 2. A further review revealed the laboratory did not have any unexpired KOH solution on site. TP1 stated the volume for the KOH patient testing was so low during the past years, the laboratory had not ordered any new reagent. 3. An interview with TP1 revealed 20 KOH preps on patients had been performed since the previous survey on 2-8-2023. No patient log was available for review at the time of the survey. 4. TP1 confirmed the above findings during the exit conference on 03-27-2025 at 12: 30 PM. D5431 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(2) (a)(2) Function checks as defined by the manufacturer and with at least the frequency specified by the manufacturer. Function checks must be within the manufacturers established limits before patient testing is conducted. (b) Equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer. The laboratory must do the following: This STANDARD is not met as evidenced by: Based on review of maintenance records and an interview with Testing Personnel 1 (TP1), the laboratory failed to perform and document maintenance on the microscope the Laboratory Director (LD) utilized for Provider Performed Microscopy (PPM). The -- 2 of 3 -- surveyor noted there was no documentation of microscope maintenance from the date of the previous survey on 2-8-2023 to the date of the current survey on 3-27-2025. The findings include: 1. A review of maintenance records revealed no documentation of microscope maintenance from 2023 to 2025. 2. During the interview with TP1 on 03-27-2025 at 11:37 AM, she stated the LD performed the microscope maintenance and function checks whenever needed, however the LD had not recorded them. 3. TP1 confirmed the above findings during the exit conference on 03-27-2025 at 12:30 PM. -- 3 of 3 --

Summary Statement of Deficiencies D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on a review of personnel evaluation records and an interview with Testing Personnel #1, the Technical Consultant failed to evaluate the performance of personnel at least semiannually during the first year of performing Complete Blood Counts (CBC's) on the Beckman Coulter DxH 520. This was noted for one of two Testing Personnel listed on the Laboratory Personnel Report (CMS-209). The findings include: 1. A review of personnel evaluation records revealed an initial training on the Beckman Coulter DxH 520 Hematology Analyzer for Testing Personnel #2 on 4/29 /2021. An annual competency for Testing Personnel #2 was completed on 1/2/2023, nearly two years later. 2. During an interview on 02/8/2023 at 10:00 AM, Testing Personnel #1 confirmed the above findings. D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least annually, after the first year. This STANDARD is not met as evidenced by: Based on a review of personnel evaluation records and an interview with Testing Personnel #1, the Technical Consultant failed to evaluate the performance of 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 -- personnel annually for the Beckman Coulter DxH 520 Hematology Analyzer. This was noted for one of two Testing Personnel listed on the Laboratory Personnel Report (CMS-209). The findings include: 1. A review of personnel evaluation records revealed an initial training on the Beckman Coulter DxH 520 Hematology Analyzer for Testing Personnel #2 on 4/29/2021 and an annual competency on 1/2/2023. No evidence of an annual competency performed in 2022 was found. 2. During an interview on 02/8/2023 at 10:00 AM, Testing Personnel #1 confirmed the above findings. -- 2 of 2 --

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 2018 - 2021 AAFP (American Academy of Family Physicians) proficiency testing (PT) records, personnel records, and an interview with the Technical Consultant, the surveyor determined the laboratory failed to ensure proficiency testing samples were rotated between all personnel who performed moderate complexity Hematology testing on patients. This was noted on eight of eight survey events reviewed. The findings include: 1. A review of AAFP attestation statements revealed the Technical Consultant had performed all the testing on the eight surveys performed from 10/15/2018 through 3/4/2021 (the most current survey). None of the PT testing had been performed by Testing Personnel (TP) #1 or #2. 2. A review of the personnel files of testing personnel listed on the Form CMS-209 (Laboratory Personnel Report) revealed TP #1 and #2 were full time, and had been qualified to perform moderate complexity Hematology testing since the previous survey (on 7/24/2018). TP #3 was a new employee. 3. During an interview on 5/4 /2021 at 1:20 PM, the Technical Consultant confirmed she had performed all the Hematology proficiency testing because she was the primary testing personnel until she leaves the laboratory at 11:00 AM, then the "nurses" (TP #1, #2 and #3) performed the patient CBC's (Complete Blood Counts). The surveyor then explained all testing personnel listed on the CMS-Form 209 must periodically participate in the performance of proficiency testing. . D6040 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(2) 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 -- 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 reviews of the installation and validation records for the Beckman Coulter DxH-520 Hematology analyzer, and interviews with Testing Personnel #1 and the Technical Consultant, the surveyor determined the Technical Consultant failed to document review and approval of the validation before patient testing began. This affected one of one Hematology analyzers. The findings include: 1. During the entrance tour on 5/4/2021 at approximately 10:40 AM Testing Personnel #1 stated the laboratory had one new analyzer, the Beckman Coulter DxH-520 Hematology analyzer, installed in January 2020, with patient CBC (Complete Blood Count) testing beginning on 1/21/2020. 2. A review of the January 2020 validation records for the Beckman Coulter DxH-520 revealed no documentation of the Technical Consultant's review and approval (as indicated by a signature and date). 3. During an interview on 5 /4/2021 at 3:10 PM, the Technical Consultant confirmed the above noted findings. . 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 a review of personnel files, and an interview with the Technical Consultant, the laboratory failed to ensure educational documentation was available for two of three Testing Personnel (TP) performing and reporting CBC's (Complete Blood Counts) on patient samples. The findings include: 1. A review of the personnel files of testing personnel listed on the Form CMS-209 (Laboratory Personnel Report) revealed TP #1 had been employed since the previous survey on 7/24/2018, performing and reporting CBC's (Complete Blood Counts) on patient samples when the Technical Consultant was not working, however there were no educational documents on file. 2. A review of the file for TP #3 revealed she was a new employee, with training in progress as of 4/22/2021, performing patient testing with supervision, however the laboratory had failed to request her educational documentation until the day of the survey. 3. During an interview on 5/4/2021 at 12:20 PM, the Technical Consultant confirmed the above noted findings. . D6066 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(b)(4)(ii) -- 2 of 3 -- Have documentation of training appropriate for the testing performed prior to analyzing patient specimens. This STANDARD is not met as evidenced by: Based on a review of personnel files, the installation records for the Beckman Coulter DxH-520 Hematology analyzer, and an interview with the Technical Consultant, the laboratory failed to document Testing Personnel training occurred before testing and reporting CBC's (Complete Blood Counts) on patient samples. The findings include: 1. A review of the personnel files of Testing Personnel (TP) listed on the Form CMS- 209 (Laboratory Personnel Report) revealed TP #1 and #2 had been employed since the previous survey on 7/24/2018, and had been trained to perform moderate CBC testing on the Beckman Coulter DxH-520 on 4/29/2021. TP #3 was a new employee, and her training was in progress. 2. A review of the Beckman Coulter DxH-520 records revealed the analyzer was installed in January 2020, with patient CBC (Complete Blood Count) testing beginning on 1/21/2020. 3. During an interview on 5 /4/2021 at 12:20 PM, the surveyor asked the Technical Consultant when training on the Beckman Coulter (B/C) DxH-520 occurred. The Technical Consultant (TC) explained she was trained by the B/C Technician during the installation. Afterward, the TC trained TP #1 and #2, and they began performing patient CBC's when the TC was off, however the TC had failed to document the testing personnel training. Then before the CLIA inspection, TP #1 realized the training documentation would be required; TP #1 and #2 signed the training record on 4/29/2021. SURVEYOR ID# 32558 Licensure and Certification Surveyor -- 3 of 3 --