Heritage Medical Associates, Pc

Summary Statement of Deficiencies D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3)-- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on observation of the laboratory, a review of the laboratory's procedures, calibration records, lack of records, and staff interviews, the laboratory failed to perform calibration verification every six months for the hemoglobin A1c analyte in 2024, 2025, and 2026. The findings include: 1. Observation of the laboratory on 08/10 /2026 at 10:00 a.m. revealed the Bio-Rad D-100 instrument (Serial # DT5L107114) used to perform hemoglobin A1c patient testing. 2. A review of the laboratory's procedure titled "Hemoglobin A1c (Bio-Rad D-100)" revealed the following: Section "Preparation of Reagents": The laboratory used a two-point calibrator pack and two levels of Diabetes Control. Section "Quality Control": The laboratory used Levels 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 -- One and Two of the Diabetes Control each day of patient testing. Section "Calibration": The laboratory performed calibrations with each new analytical cartridge. 3. A review of the laboratory's hemoglobin A1c calibration report performed on 07/13/2026 revealed a two-point calibration. 4. No documentation of calibration verification studies with three or more points was available on the date of the survey (08/10/2026) for 2024, 2025, or 2026. 5. An interview with technical consultants one and two on 08/10/2026 at 3:00 p.m. confirmed the survey findings. D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) (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. This STANDARD is not met as evidenced by: Based on laboratory observation, a review of the manufacturer's quality control (QC) package inserts, a review of the laboratory's QC records, and staff interviews, the laboratory failed to verify QC ranges when the ranges listed on the manufacturer's QC package inserts for randomly reviewed analytes did not match the hematology analyzer's monthly QC reports for 2 of 2 randomly reviewed lot numbers of QC in 2026. The findings include: 1. Observation of the laboratory on 08/10/2026 at 9:30 a. m. revealed two Sysmex XN2000 (Serial #'s 14341/41481) instruments used for complete blood count with automated differential (CBC w/Diff) and reticulocyte (Retic) patient testing. 2. A review of the manufacturer's QC package inserts labeled "XN Check Hematology Controls for Sysmex XN-L Analyzers" and the laboratory's printed instrument QC chart records revealed that the instrument QC ranges differed from the manufacturer's package insert for randomly selected analytes as follows: Lot 6139 Expiration Date: 08/09/2026 (06/01/2026-06/30/2026) Level 1- 61391101 RBC (10^6/uL) Package insert: 2.18-2.41 Laboratory (Nickname XN-2000-1-R): 2.17-2.43 HCT (%) Package insert: 14.8-17.0 Laboratory (Nickname XN-2000-1-R): 15.0-17.2 HGB (g/dL) Package insert: 5.2-5.7 Laboratory (Nickname XN-2000-1-R): 5.1-5.7 PLT (10^3/uL) Package insert: 58-107 Laboratory (Nickname XN-2000-1-R): 51-103 Laboratory (Nickname XN-2000-1-L): 51-103 WBC (10^3/uL) Package insert: 2.86- 3.72 Laboratory (Nickname XN-2000-1-R): 2.70-3.36 Laboratory (Nickname XN- 2000-1-L): 2.69-3.35 Retic (%) Package insert: 5.32-9.05 Laboratory (Nickname XN- 2000-1-R): 4.79-6.75 Level 2 (61391102) RBC (10^6/uL) Package insert: 4.07-4.40 Laboratory (Nickname XN-2000-1-R): 4.00-4.42 HCT (%) Package insert: 31.4-35.4 Laboratory (Nickname XN-2000-1-R): 31.4-35.8 HGB (g/dL) Package insert: 11.2- 12.2 Laboratory (Nickname XN-2000-1-R): 11.0-12.0 PLT (10^3/uL) Package insert: 206-273 Laboratory (Nickname XN-2000-1-R): 198-258 Laboratory (Nickname XN- 2000-1-L): 199-259 WBC (10^3/uL) Package insert: 6.91-8.44 Laboratory (Nickname XN-2000-1-R): 6.30-7.44 Laboratory (Nickname XN-2000-1-L): 6.30-7.44 Retic (%) Package insert: 2.22-3.78 Laboratory (Nickname XN-2000-1-R): 1.98-2.88 Level 3 (61391103) RBC (10^6/uL) Package insert: 4.81-5.21 Laboratory (Nickname XN- 2000-1-R): 4.72-5.20 HGB (g/dL) Package insert: 14.8-16.1 Laboratory (Nickname -- 2 of 3 -- XN-2000-1-R): 14.6-15.8 PLT (10^3/uL) Package insert: 476-594 Laboratory (Nickname XN-2000-1-R): 459-565 Laboratory (Nickname XN-2000-1-L): 462-568 WBC (10^3/uL) Package insert: 16.83-19.75 Laboratory (Nickname XN-2000-1-R): 15.28-17.52 Laboratory (Nickname XN-2000-1-L): 15.27-17.51 Retic (%) Package insert: 0.96-1.95 Laboratory (Nickname XN-2000-1-R): 0.85-1.65 Lot 6083 Expiration Date: 06/14/2026 (06/01/2026-06/12/2026) Level 1 (60831101) RBC (10^6 /uL) Package insert: 2.15-2.37 Laboratory (Nickname XN-2000-1-R): 2.12-2.38 HCT (%) Package insert: 15.1-17.4 Laboratory (Nickname XN-2000-1-R): 15.2-17.4 HGB (g/dL) Package insert: 5.2-5.8 Laboratory (Nickname XN-2000-1-R): 5.1-5.7 PLT (10^3/uL) Package insert: 53-119 Laboratory (Nickname XN-2000-1-R): 53-109 WBC (10^3/uL) Package insert: 2.66-3.25 Laboratory (Nickname XN-2000-1-R): 2.61-3.25 Retic (%) Package insert: 4.83-7.10 Laboratory (Nickname XN-2000-1-R): 4.98-7.00 Level 2 (60831102) RBC (10^6/uL) Package insert: 4.02-4.36 Laboratory (Nickname XN-2000-1-R): 3.95-4.37 HCT (%) Package insert: 31.4-35.4 Laboratory (Nickname XN-2000-1-R): 31.5-35.9 HGB (g/dL) Package insert: 11.0-11.9 Laboratory (Nickname XN-2000-1-R): 10.8-11.8 PLT (10^3/uL) Package insert: 200- 276 Laboratory (Nickname XN-2000-1-R): 197-259 WBC (10^3/uL) Package insert: 6.51-7.49 Laboratory (Nickname XN-2000-1-R): 6.33-7.47 Retic (%) Package insert: 1.94-2.97 Laboratory (Nickname XN-2000-1-R): 1.95-2.83 Level 3 (60831103) RBC (10^6/uL) Package insert: 4.83-5.23 Laboratory (Nickname XN-2000-1-R): 4.74-5.24 HCT (%) Package insert: 41.1-46.3 Laboratory (Nickname XN-2000-1-R): 41.2-46.6 HGB (g/dL) Package insert: 14.8-16.1 Laboratory (Nickname XN-2000-1-R): 14.6- 15.8 PLT (10^3/uL) Package insert: 471-612 Laboratory (Nickname XN-2000-1-R): 467-575 WBC (10^3/uL) Package insert: 15.79-17.81 Laboratory (Nickname XN- 2000-1-R): 15.50-17.76 Retic (%) Package insert: 0.78-1.70 Laboratory (Nickname XN-2000-1-R): 0.78-1.52 3. An interview with technical consultants (TC) one and two on 08/10/2026 at 3:00 p.m. confirmed the survey findings. Word Key: # = number RBC = Red Blood Cell HCT = Hematocrit HGB = Hemoglobin PLT = Platelet WBC = White Blood Cell 10^6/uL = million/microliter % = percent g/dL = grams/deciliter 10^3/uL = thousand/microliter D6023 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(6) (e)(6) Ensure the establishment and maintenance of acceptable levels of analytical performance for each test system; This STANDARD is not met as evidenced by: Based on a review of the hematology quality control (QC) records for June 2026 and an interview with technical consultant (TC) one and two, the laboratory director failed to ensure the establishment and maintenance of acceptable levels of performance for QC testing on the hematology instruments used to perform complete blood count with automated differential (CBC w/Diff) and reticulocyte (Retic) patient testing in 2026. The findings include: 1. A review of the hematology QC records from the hematology instruments revealed QC ranges on the monthly QC printouts for RBC, HCT, HGB, PLT, WBC, and Retic for June 2026 (lots 6139 and 6083) were disparate from those stated in the manufacturer's QC package insert. No documentation was available to show how the laboratory established the QC ranges in use or how staff evaluated daily QC runs for acceptability. 2. An interview with TC one and two on 08/10/2026 at 3:00 p.m. confirmed the survey findings. -- 3 of 3 --

Summary Statement of Deficiencies 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. (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 observation of the laboratory, review of analyzer instructions-for-use (IFU), review of environmental records, and staff interviews, the laboratory failed to monitor ambient humidity in the areas where staff utilized Hematology, Chemistry, and Urinalysis instruments to conduct patient testing in 2022, 2023, and 2024. The findings include: 1. Observation of the laboratory on 04/17/24 at 8:15 a.m. revealed the following test systems in use for patient testing: - A Sysmex XN-2000 hematology test system (ID: 227007) - A Roche Cobas-8000 chemistry test system (ID: 21E5-10 and 2117-06) - Siemens Cliniteck Novus (ID: S001547) and Sysmex UN-2000 (ID: 227678) urinalysis test systems. 2. A review of the manufacturer's IFUs revealed the following: - The Sysmex XN-2000 IFU states an "operating environment (relative humidity)" range of "20 to 85%." - The Roche Cobas-8000 IFU states, "The following environmental conditions must be fulfilled during operation," with an ambient humidity range of "30-85% (non-condensing)." - The Siemens Cliniteck Novus IFU states, "The ambient operating humidity range is 20 to 80% relative humidity." - The Sysmex UN-2000 IFU states an "operation environment relative humidity" range of "30 to 85% (no-condensation)." 3. A review of the laboratory's 2022, 2023, and 2024 environmental records revealed no documentation of ambient humidity. 4. In an interview on 04/17/24 at 1:30 p.m., the lab manager and supervisor confirmed 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 -- laboratory did not monitor ambient humidity in the area where personnel used analyzers to perform hematology, chemistry, and urinalysis patient testing in 2022, 2023, and 2024. D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. (c) The laboratory must document all test result comparison activities. This STANDARD is not met as evidenced by: Based on observation of the laboratory, lack of documentation, and staff interviews, the laboratory failed to compare results between the automated and the manual methods used for White Blood Cell (WBC) differential and urine sediment evaluation twice per year (4 of 4 events) in 2022 and 2023. The findings include: 1. Observation of the laboratory on 04/17/24 at 8:15 a.m. revealed the following: - A Sysmex XN- 2000 hematology test system (ID: 227007) performing WBC automated differentials. - A microscope (ID: 700636) in the hematology section for performing WBC manual differentials. - A Sysmex UN-2000 urinalysis test system (ID: 227678) performing automated urine sediment evaluations. - A microscope (ID: 20110100) in the urinalysis section for performing manual urine sediment evaluations. 2. No comparison studies were documented to evaluate the results obtained between the automated and manual methods for WBC differentials and urine sediment evaluations from 2022 and 2023. 3. In an interview on 04/17/24 at 1:30 p.m., the lab manager and supervisor confirmed the laboratory did not compare the automated and manual methods for WBC differentials and urine sediment evaluations. -- 2 of 2 --

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: The laboratory failed to maintain satisfactory participation in two out of three proficiency testing (PT) events for Phenytoin, resulting the 1st unsucessful PT performance in 2021. . D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is 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 -- unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of the Centers for Medicare and Medicaid Services Casper report 155D (CMS 155) and American Proficiency Institute (API) evaluation reports, the laboratory failed to acheieve satisfactory performance for Phenytoin analyty in two out of three testing events, resulting in the 1sth unsucessful PT performance in 2021. The findings include: 1. Review of the CMS 155D revealed the following scores: Event 2-2021 Phenytoin 60% Event 3-2021 Phenytoin 60% 2. Review of the laboratory's API evaluation report revealed the following scores: Event 2-2021 Phenytoin 60% Event 3-2021 Phenytoin 60% -- 2 of 2 --