After Hours Clinic Sumiton

Summary Statement of Deficiencies 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 direct observation during the laboratory tour, a review of the Complete Blood Count (CBC) Quality Control (QC) package insert, and an interview with Testing Personnel 1 (TP1), the laboratory failed to write the new expiration dates on the QC vials after opening. The surveyor noted three of the three levels of QC currently in use had no open expiration dates recorded. The findings include: 1. During the laboratory tour on 09-16-2025 at approximately 9:18 AM the surveyor observed TP had not recorded the new expiration date on the CBC QC vials after opening. 2. A review of the Boule QC package insert revealed the manufacturer's open vial stability of 14 days. 3. During an interview on 09-16-2025 at 9:26 AM, TP1 stated TP utilized a new set of Hematology QC every 10-11 days, however they had failed to record the new open expiration date on the vials. 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) 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 -- (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 reviews of the Medonic M-Series Hematology calibration records, the Medonic M-Series Procedure Manuals, and an interview with Testing Personnel 1 (TP1), the laboratory failed to perform calibration at least every six months, as required by the manufacturer. There was no record of one of two calibrations due in 2024. The findings include: 1. A review of the Hematology calibration records revealed the Medonic M-Series had no evidence of calibration the second half of 2024. 2. A review of the Medonic M- Series manual and the Quick Reference Guide revealed instructions specifying calibrations should be performed every six months. 3. The TP1 confirmed the above findings during the exit conference on 09-16-2025 at 3: 07 PM. D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) (b)(9) 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 (TP1), the TC failed to assess and document the 2024 semi-annual competency for two of the seven Testing Personnel (TP) responsible for moderate complexity testing. The findings include: 1. A review of personnel records for TP listed on the CMS-209 Form (Laboratory Personnel Report) revealed the TC failed to perform and document the semi-annual 2024 competency assessments for TP2 and TP4 in 2024. 2. A further review of personnel records revealed the following: A) Training for TP2 was performed on 07-15-2023 with annual competency evaluations on 07-01-2024 and 07-01-2025. There was no evidence of a semi-annual evaluation performed by the TC during the first year of patient testing. B) Training for TP4 was performed on 07-15-2023 with annual competency evaluations on 07-15-2024 and 07- 01-2025. There was no evidence of a semi-annual evaluation performed by the TC during the first year of patient testing. 2. During the exit conference on 09-16-2025 at 3:07 PM, TP1 confirmed the above findings. 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 Testing Personnel 1 (TP1), the TC failed to assess and document the 2025 annual competency -- 2 of 3 -- for one of the seven Testing Personnel (TP) responsible for moderate complexity testing. The findings include: 1. A review of personnel records for TP listed on the CMS-209 Form (Laboratory Personnel Report) revealed the TC failed to perform and document the annual competency assessment for TP7 in April 2025. 2. During the exit conference on 09-16-2025 at 3:07 PM, TP1 confirmed the above findings. -- 3 of 3 --

Summary Statement of Deficiencies D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years. This STANDARD is not met as evidenced by: Based on a review of the API (American Proficiency Institute) proficiency testing (PT) records and an interview with Testing Personnel (TP) #1, the laboratory failed to retain the instrument printouts for one of six 2021 - 2023 API surveys reviewed. The findings include: 1. A review of the API PT records revealed the laboratory failed to retain the CBC (Complete Blood Count) instrument prints for API 2022 Event #2. 2. During an interview on 9/05/2023 at 2:00 PM, the above noted findings were reviewed and confirmed with Testing Personnel #1. TP #1 explained she was on emergency leave mid-2022, and the survey was performed by a previous employee "who just didn't care". . D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(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 general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on reviews of proficiency testing (PT) records and an interview with Testing Personnel (TP) #1, the surveyor determined the laboratory failed to implement procedures to ensure proficiency testing failures were effectively investigated, with

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on a review of CMS (Centers for Medicare and Medicaid Services) CASPER reports and API (American Proficiency Institute) proficiency testing evaluations, the laboratory failed to successfully participate in White Blood Cell Differential testing for two of three consecutive testing events, Event #2, 2022 and Event #1, 2023. These failures result in an initial unsuccessful proficiency testing participation. The findings include: Refer to D2130. D2130 HEMATOLOGY CFR(s): 493.851(f) 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 -- Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a review of CMS (Centers for Medicare and Medicaid Services) CASPER reports and API (American Proficiency Institute) proficiency testing evaluations, the laboratory failed to satisfactorily perform in White Blood Cell (WBC) Differential testing for two of three consecutive testing events, Event #2. 2022 and Event #1, 2023. The findings include: 1. A review of the CASPER reports revealed the laboratory scored the following: a) Event #2, 2022 WBC Differential 60 % b) Event #1, 2023 WBC Differential 67 % 2. The API proficiency testing evaluations confirmed the above noted scores. -- 2 of 2 --

Summary Statement of Deficiencies D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (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 (2)(ii) Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and (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 calibratioin records for the Medonic Hematology analyzer, a lack of documentation of calibrations since December of 2017, a review of the manufacturer's recommendations, and an interview with the Laboratory Manager [also Testing Personnel (TP) #1], the surveyor determined the laboratory failed to perform and document instrument calibrations, at least every six months as required by the policy. This affected instument calibrations in 2018 -2019 July. The findings include: 1. A review of the calibration records for the Medonic, since the last survey in March of 2017, revealed the instrument was calibrated on 8/07/2017 by the manufacturer representative during service and again on 12/21/2017. The laboratory failed to provide any documentation the instument was calibrated since 12/21/2017. 2. A review of the Medonic M-series User's Manual, signed by the Laboratory Director, 4 /13/2017, revealed in Section 7: Calibration: It is recommended to calibrated the instrument every six months. 3. In an interview on 7/16/2019 at 12:10 PM, TP #1 (Laboratory Manager) stated the laboratory's policy was to calibrate the instrument at least every six months. TP #1 reviewed the manuals (2017 - 2019) and boxes for 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 2 -- missing calibration reports. None were found beyond the calibration performed in December of 2017. 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 the personnel records, a lack of documentation, and an interview with the Laboratory Manager [also Testing Personnel (TP) #1], the surveyor determined the Technical Consultant failed to assess the competency of TP #4, semiannually during the first year of employment as testing personnel of moderate complexity testing. This affected one of four testing personnel. The findings include: 1. A review of the personnel records on 7/16/2019, revealed TP #4 was initially trained on 9/21/2016. TP #1 was not listed on the personnel report from the previous survey, dated 3/24/2017. Although the file included competency assessments, dated 7 /11/18 and 9/05/17 (annual assessments), there was no documentation the employee's competency had been assessed semiannually the first year of employment (between 9 /2016 - 9/2017). 2. During an interview on 7/16/2019 at 11:05 AM, the surveyor inquired of the Laboratory Manager if a semiannual competency assessment had been performed on TP #4. The Laboratory Manager stated the assessment may be at another location, since the personnel also worked at a sister location. The surveyor requested the assessment be faxed to the office of the State Agency by Friday, July 19 at noon. 3. A "Laboratory Personnel Training Checklist" and a "Laboratory Personnel Evaluation" was faxed to the State Agency and received on 7/29/2019. The checklist and evaluation were dated 1/10/2019. No semiannual competency assessment for TP #4 was provided. -- 2 of 2 --