Afterhours Clinic Inc

Summary Statement of Deficiencies 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 calibration records, Medonic user manual, and an interview with Testing Personnel #1, the Laboratory failed to perform calibrations on the Medonic Hematology analyzer every six months as per manufacturer's requirements. This was noted for one of two possible calibrations reviewed in 2023 through 2024. The findings include: 1. A review of the Hematology calibration records revealed the Medonic was calibrated 7/19/2023 and then ten months later on 5 /1/2024. There was no evidence of documentation to review for the first half of 2024. 2. A further review of the Medonic user manual page 59 revealed, "Section 7: Calibration... It is recommended to calibrate the instrument every 6 months." 3. During an interview on 7/22/2025, at 11:56 AM, Testing Personnel #1 confirmed the calibration due in January 2024 was not performed. D5481 CONTROL PROCEDURES CFR(s): 493.1256(f)(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 2 -- (f) Results of control materials must meet the laboratorys and, as applicable, the manufacturers 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 the 2024 Hematology Quality Control (QC) records for the Medonic Hematology analyzer, the patient results log, and an interview with Testing Personnel #1, the laboratory failed to ensure at least two levels of QC were run and acceptable, prior to analyzing patient specimens and reporting the results. This was noted for 1 day out of 31 days reviewed in May 2024. The findings include: 1. A review of the QC records for the Medonic Hematology analyzer revealed on 5/19 /2024 both Low and High levels of QC records were not acceptable. 2. A review of the cumulative patient log printed from the instrument revealed 70 patient CBCs (Complete Blood Count) were performed on 5/19/2024. 3. During an interview on 7 /22/2025 at 11:39 AM, Testing Personnel #1 confirmed QC was out for both Low and High control on 5/19/2024. -- 2 of 2 --

Summary Statement of Deficiencies D3041 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(6) Test reports. Retain or be able to retrieve a copy of the original report (including final, preliminary, and corrected reports) at least 2 years after the date of reporting. (i) In addition, retain immunohematology reports as specified in 21 CFR 606.160(d) (ii) and pathology test reports for at least 10 years after the date of reporting. This STANDARD is not met as evidenced by: Based on a review of Medonic M Series Hematology records, and an interview with Testing Personnel #1, the laboratory failed to retain the instrument printouts for patient CBC's (Complete Blood Counts) since the previous survey on 7/20/2021. The surveyor noted five days in 2022-2023 when Quality Controls (QC) run in the CP/OT (Cap Piercer/ Open Tube) mode were outside acceptable limits, however there were no instrument printouts retained to prove no patient CBC's were run in the CP/OT mode on these five days. The findings include: 1. A review of Medonic M Series Hematology records revealed three days in 2022 and two days in 2023 when QC run in the CP/OT mode was unacceptable. [Refer to D5481.] 2. A review of patient records revealed the laboratory had not saved the instrument printouts which specified the mode in which the CBC specimens were run. 3. During an interview on 5/25/2023 at 1:55 PM, the surveyor confirmed the laboratory had saved an electronic copy of the CBC printout in the patient's Electronic Medical Record until 2021. However, when the Medonic was interfaced, the lab stopped scanning the printout. The laboratory had no other mechanism to document the mode in which patient CBC's were run on days when QC was outside acceptable parameters. . D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an 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 -- 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 a review of the API (American Proficiency Institute) Hematology proficiency testing (PT) records, and interviews with Testing Personnel #1, the surveyor determined the laboratory failed to perform effective Quality Assurance (QA) reviews of the PT results to ensure the causes of unsuccessful PT performance (any scores less that 100 percent) were determined, and implement corrective measures to prevent recurrence. The laboratory further failed to implement QA reviews to ensure all required documentation for each survey was complete. This was noted on four out of five 2021-2022 PT surveys. The findings include: 1. A review of API PT records revealed the following: A) 2021 Hematology Event #3: i) Scores: Red Blood Cell (RBC), Hemoglobin and MPV (Mean Platelet Volume) each with a score of 80%, resulting in a score of 93% for this event. ii) Lab's

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 the Centers for Medicare and Medicaid Services CASPER reports and American Proficiency Institute Proficiency Testing (PT) Evaluations, the laboratory failed to successfully participate in PT for the White Blood Cell (WBC) Differential for two consecutive events, Event #1 and #2, 2022. 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 the Centers for Medicare and Medicaid Services CASPER reports and American Proficiency Institute (API) Proficiency Testing (PT) Evaluations, the laboratory failed to satisfactorily perform in PT for the White Blood Cell (WBC) Differential for two consecutive events, Event #1 and #2, 2022. These failures resulted in an initial unsuccessful PT participation. The findings include: 1. A review of the CASPER reports revealed the following PT scores: Event #1, 2022 WBC Differential 0 % (zero percent) Event #2, 2022 WBC Differential 73 % 2. A review of the API PT evaluations confirmed the above noted scores. -- 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 API (American Proficiency Institute) proficiency testing (PT) records, and an interview with Testing Personnel #1, the surveyor determined the laboratory failed to ensure proficiency testing samples were rotated between all personnel who performed patient testing. Testing Personnel #1 performed five out of seven events and Testing Personnel #4 performed two out of seven events from 2019 - 2021 (a total of seven Testing Personnel performed patient testing in the Laboratory). The findings include: 1. A review of API attestation statements revealed the following: a) Testing Personnel #1 performed 2019 Hematology 2nd Event, 2019 Hematology 3rd Event, 2020 Hematology 1st Event, 2020 Hematology 2nd Event, and 2020 Hematology 3rd Event. b) Testing Personnel #4 performed 2020 Hematology 2nd Event and 2021 Hematology 1st Event. 2. During an interview on 07 /20/2021 at 11:00 AM, Testing Personnel #1 confirmed the proficiency testing was not rotated among all personnel that performed patient testing. D2128 HEMATOLOGY CFR(s): 493.851(e) (1) For any unsatisfactory analyte or test performance or testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unacceptable analyte or testing event score, remedial action must be taken and documented, and the documentation must be 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 -- maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Based on a review of Proficiency Testing records and an interview with Testing Personnel #1, the laboratory failed to document

Summary Statement of Deficiencies D3041 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(6) Test reports. Retain or be able to retrieve a copy of the original report (including final, preliminary, and corrected reports) at least 2 years after the date of reporting. (i) In addition, retain immunohematology reports as specified in 21 CFR 606.160(d) (ii) and pathology test reports for at least 10 years after the date of reporting. This STANDARD is not met as evidenced by: Based on a review of the laboratory test menu, the post-analytical laboratory procedures, a review of quality control and patient results reports, and an interview with Testing Personnel (TP) #1, the surveyor determined the laboratory failed to implement a mechanism to ensure instrument printouts which specified the mode in which the patient CBC (Complete Blood Count) was run, were retained for at least two years. The findings include: 1. On 12/19/2018 at approximately 8:45 AM, during the entrance tour of the laboratory, the surveyor reviewed the moderate-complexity testing procedures. TP #1 included on the test menu CBC's performed on the Medonic M Series Hematology analyzer, and stated the instrument was not interfaced with the Medisys Electronic Medical Record (EMR) system. 2. A review of the Medonic M Series Hematology analyzer procedures revealed patients CBC's (Complete Blood Counts) may be tested in the MC (Microtainer) mode or the OT/CP (Open Tube/Cap Piercing) mode. The procedures required performance of quality controls (QC) in both modes with at least two levels within acceptable ranges in each mode before patient testing began. A review of the QC results and cumulative results log revealed four days of patient testing when QC was outside acceptable ranges in one mode. (Refer to D5481.) 3. On 12/19/2018 at 2:53 PM, the surveyor reviewed the above noted findings with TP #1 who confirmed the cumulative patient log did not specify whether the patient testing was performed in the MC or OT/CP mode; only the instrument printout documented this information. When the surveyor asked for instrument printouts from patient CBC's performed on the days when QC was out of range, TP #1 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- explained the laboratory used the instrument printout to manually enter each patient's CBC results in the EMR. After the physician's review of the results, the printout was then shredded; TP #1 confirmed the laboratory had not retained the CBC printouts for a two-year period as required by CLIA, and there was no other mechanism to determine the mode in which the patient CBC was performed. . 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 reviews of the Medonic M Series Hematology analyzer procedures, Hematology quality control (QC) records, patient results, Quality Assurance (QA) records, and an interview with Testing Personnel (TP) #1, the surveyor determined the laboratory failed to ensure at least two levels of Hematology QC were within acceptable limits in both performance modes prior to analyzing patient specimens and reporting the results on four days in 2017-2018. The findings include: 1. A review of the Medonic M Series Hematology analyzer procedures revealed patients CBC's (Complete Blood Counts) may be tested in the MC (Microtainer) mode or the OT/CP (Open Tube/Cap Piercing) mode. The procedures required performance of quality controls in both modes with at least two levels within acceptable ranges in each mode before testing patients. 2. A review of the Hematology cumulative QC report revealed the following days when the laboratory had no documentation of at least two levels of QC within acceptable ranges in one mode of testing: A) 02/02/2017: MC Mode-Two levels of QC out of acceptable ranges [