Verley Gordon Md Pa

Summary Statement of Deficiencies D0000 The laboratory was found NOT to be in compliance with the CLIA regulations found at 42 CFR 493 CLIA requirements for laboratories as a result of an announced recertification survey completed on March 10, 2026. The condition not met was: D6063 - 42 C.F.R. 493.1421 Condition: Laboratories performing moderate complexity testing; testing personnel; D5213 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(1) (b) The laboratory must verify the accuracy of the following: (b)(1) Any analyte or subspecialty without analytes listed in subpart I of this part that is not evaluated or scored by a CMS-approved proficiency testing program. This STANDARD is not met as evidenced by: Based on review of the laboratory's American Proficiency Institute's proficiency testing records from 2025 and staff interview, the laboratory failed to have documentation of evaluating 2 of 2 results reported by the proficiency testing agency as 'ungraded'. The findings included: 1. A review of the laboratory's American Proficiency Institute's proficiency testing records from 2025 (events 1, 2 and 3) determined the proficiency agency returned two results marked as "ungraded". They were: a) Event 2 2025 Sample: HEM-09 Analyte: Hematocrit b) Event 2 2025 Sample: HEM-09 Analyte: Red Cell Count 2. The laboratory did not have documentation of evaluating the ungraded results. 3. The laboratory director confirmed the findings in an interview conducted on 03/10/2026 at 1230 hours in exam room 3. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) (d) Reagents, solutions, culture media, control materials, calibration materials, and 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 -- 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 review of the manufacturer's instructions for the CDS 3PD Hematology Controls, review of the laboratory's quality control records from September 2025 to March 2026, review of patient test records from September 2025 to March 2026, and staff interview, the laboratory failed to ensure controls materials were not used for 6 of 7 control changes. The findings included: 1. The manufacturer's instructions for the CDS 3PD Hematology Control (PN 202448C R06.05.18) stated: "Open Vial Stability: 14 days" 2. A review of the laboratory's quality control logs from September 2025 to March 2026 identified the laboratory changed controls on the following dates: Lot: 32508 opened: 9/11/2025 Lot: 32508 opened: 10/9/2025 elapsed time: 28 days Lot: 32508 opened: 11/4/2025 elapsed time: 25 days Lot: 32508 opened: 12/1/2025 elapsed time: 26 days Lot: 32511 opened: 12/18/2025 elapsed time: 17 days Lot: 32511 opened: 1/20/2026 elapsed time: 32 days Lot: 32511 opened: 2/16/2026 elapsed time: 26 days Lot: 32511 opened: 3/02/2026 elapsed time: 14 days 3. A review of patient test records identified the following patients tested on days when expired control materials were used: a) 9/16/2025 to 10/8/2025 45 patients tested (see patient alias list) b) 10/24/2025 to 11/3/2025 27 patients tested (see patient alias list) c) 11/19/2025 to 11/30/2026 22 patients tested (see patient alias list) d) 12/16/2026 to 12/17/2026 8 patients tested (see patient alias list) e) 01/02/2026 to 01/19/2026 47 patients tested (see patient alias list) f) 02/04/2026 to 02/15/2026 39 patients tested (see patient alias list) 4. The laboratory director confirmed the findings after his review of the records in an interview conducted on 03/10/2026 at 1230 hours in exam room 3. 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 from 2024 and 2025, and staff interview, it was revealed that the laboratory adjusted calibration factors without documentation of performing a calibration. The findings included: 1 . The facility performed a calibration of the Coulter AcT diff 2 hematology analyzer on 10/31/2024. This calibration record showed calibration factors of: WBC (white blood cell count): 1.061 RBC (red blood cell count): 1.139 HGB (hemoglobin): 1.134 MCV (mean Corpuscular hemoglobin): 0.9247 PLT (platelets count): 1.166 MPV (mean platelet volume): 1.059 2. The facility performed the next calibration on 03/27/2025. The pre- -- 2 of 5 -- calibration records indicated the following calibration factors were in use prior to calibration: WBC: 1.061 RBC: 1.147 HGB: 1.137 MCV: 0.9247 PLT: 1.166 MPV: 1.059 There was no documentation to show where the RBC and HGB calibration factors were derived and when they were changed. There was no documentation of a calibration from 10/31/2024 to 03/27/2025. Calibration factors in use as a results of the calibration performed on 03/27/2025 were: WBC: 1.061 RBC: 1.147 HGB: 1.113 MCV: 0.9247 PLT: 1.166 MPV: 1.059 3. The facility performed the next calibration on 07/17/2025. The pre-calibration records indicated the following calibration factors were in use prior to calibration: WBC: 1.061 RBC: 1.147 HGB: 1.105 MCV: 0.9247 PLT: 1.166 MPV: 1.059 There was no documentation to show where the HGB calibration factor was derived and when it was changed. There was no documentation of a calibration being performed between 3/27/2025 to 07/17/2025. Calibration factors in use as a results of the calibration performed on 07/17/2025 were: WBC: 1.061 RBC: 1.147 HGB: 1.105 MCV: 0.9247 PLT: 1.166 MPV: 1.059 4. The facility performed the next calibration on 11/14/2025. The pre-calibration records indicated the following calibration factors were in use prior to calibration: WBC: 1.061 RBC: 1.147 HGB: 1.108 MCV: 0.9247 PLT: 1.166 MPV: 1.059 There was no documentation to show where the HGB calibration factor was derived and when it was changed. There was no documentation of a calibration from 07/17/2025 to 11/14 /2025. 5. The laboratory director confirmed the findings in an interview conducted on 03/10/2026 at 1230 hours in exam room 3. D5785

Summary Statement of Deficiencies D0000 Based on a proficiency testing desk review survey performed on April 28, 2025, the laboratory was found to be out of compliance based on the following CONDITION LEVEL DEFICIENCIES: D2016 - 42 C.F.R. 493.803 Condition: Successful participation D6000 - 42 C.F.R. 493.1403 Condition: Laboratory Director, moderate complexity 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 review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and American Proficiency Institute's proficiency reports, the laboratory failed to achieve satisfactory 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 -- performance in two of three testing events for the analyte of red blood cell, resulting in an initial unsuccessful performance. Refer to D2131. D2131 HEMATOLOGY CFR(s): 493.851(g) (g) Failure to achieve an overall testing event score of satisfactory performance for two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and American Proficiency Institute's proficiency reports, the laboratory failed to achieve satisfactory performance for two of three events in 2024 and 2025 for the analyte of red blood cell. The findings included: 1. Based on review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile report, the laboratory received the following unsatisfactory performances for red blood cell in two of three events: 2024 API 2nd event 60% 2025 API 1st event 0% 2. Based on review of the American Proficiency Institute's proficiency reports, the laboratory received the following unsatisfactory performances for red blood cell in two of three events: 2024 API 2nd event 60% 2025 API 1st event 0% D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and American Proficiency Institute's proficiency reports, the laboratory director failed to provide overall management and direction of the laboratory services. Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) (e)(4)(i) The proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and American Proficiency Institute's proficiency reports, the laboratory director failed to ensure successful participation in a HHS approved proficiency testing program for the analyte of red blood cell for two of three events in 2024 and 2025, resulting in an initial unsuccessful performance. Refer to D2131. -- 2 of 2 --

Summary Statement of Deficiencies D0000 Noted deficiencies and plans of correction were discussed with the laboratory representative at the entrance and exit conferences. The facility representative was given an opportunity to provide evidence of compliance with the noted deficiencies, and no such evidence was provided prior to survey exit. The facility was found to be in compliance with applicable Conditions of Participation in the CLIA program, and recertification is recommended. Note: The CMS-2567 (Statement of Deficiencies) is an official, legal document. All information must remain unchanged except for entering the

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 review of the laboratory's submitted Form CMS 209, review of the laboratory's American Proficiency Institute's proficiency testing records from 2016 and 2017, and confirmed in staff interview, it was revealed the laboratory failed to have documentation of rotating proficiency testing among all testing personnel. The findings were: 1. A review of the laboratory's submitted Form CMS 209 revealed the laboratory identified 3 testing personnel. 2. A review of the laboratory's American Proficiency Institute's proficiency testing records from 2016 (events 1,2, and 3) and 2017 (events 1, 2, and 3) revealed testing personnel #2 as listed on Form CMS 209 performed proficiency testing for each of the 3 events in 2017. 3. The laboratory was asked to provide documentation of the other three testing personnel participating in proficiency testing. No documentation was provided. 4. An interview with testing personnel #1 and #2 on 01/24/2018 at 1530 hours at the nurse's station confirmed the findings. Key: CMS - Centers for Medicare and Medicaid Services 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. 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 -- (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 direct observation, review of the manufacturer's instructions for the AcT diff 2 hematology analyzer, review of the laboratory's environmental records, and confirmed in interview of facility personnel, the laboratory failed to define an acceptable temperature range for the laboratory. The findings were: 1. Direct observation made in the laboratory during the initial tour of the laboratory on 01/24 /2018 at 1410 hours revealed that the laboratory had an environmental log posted on the refrigerator. The log revealed that the laboratory defined the room temperature as 60 degrees Fahrenheit to 83 degrees Fahrenheit. 2. Review of the manufacturer's instructions for the AcT diff 2 hematology analyzer (PN 4237495A) under, "Cell Controls" revealed the operating temperature for the analyzer is, "20 to 25 degrees Celsius" or 68 to 77 degrees Fahrenheit. 3. The laboratory was asked to provide documentation of defining an acceptable room temperature range according to the manufacturer's instructions. No documentation was provided. 4. An interview with testing personnel #2 on 01/24/2018 at 1700 hours at the nurse's station confirmed the findings. D5793 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(b)(c) (b) The analytic systems quality assessment must include a review of the effectiveness of