Ut Erlanger Women's Oncology

Summary Statement of Deficiencies D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) (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 American Proficiency Institute (API) proficiency testing (PT) records and staff interviews, the laboratory failed to retain the signed attestation statement for 2 years (1 of 15 events reviewed for 2024, 2025, and 2026). The findings include: 1. A review of the laboratory's API PT records on the survey date (07 /10/2026) revealed that the signed attestation statement for the Chemistry Core 2025 Event 1 was not retained. 2. An interview with the laboratory liaison on 07/10/2026 at 3:00 p.m. confirmed the survey findings. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on a review of the Centers for Medicare and Medicaid Services (CMS) Laboratory Personnel Report (Form CMS-209), laboratory procedure, personnel records, and staff interviews, the laboratory failed to follow the established procedure for annual competency assessment for 1 of 4 testing personnel (TP) in 2025. The findings include: 1. A review of the Form CMS-209 completed for the survey on 07/10 /2026 revealed that the laboratory director served as the technical consultant, and four 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 -- testing personnel performed moderately complex patient testing. 2. A review of the laboratory procedure titled "Competency Evaluation" (POL.024A) revealed, "For Non- Waived Testing, use of all 6 elements must be assessed annually by the technical consultant or the Laboratory Director". 3. A review of the laboratory's personnel records revealed no documentation of an annual competency assessment for TP 2 in 2025. 4. An interview with the laboratory liaison on 07/10/2026 at 3:00 p.m. confirmed the survey findings. 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 observation of the laboratory, a review of the laboratory's American Proficiency Institute (API) proficiency testing (PT) records, and staff interview, the laboratory failed to evaluate 6 non-graded scores for the Bilirubin, total (BILI, total) analyte for 3 of 6 events reviewed for 2025 and 2026. The findings include: 1. Observation of the laboratory on 07/10/2026 at 8:35 a.m. revealed the Beckman Coulter AU480 (serial number 2022120197) instrument used for chemistry patient testing, which included BILI, total analyte. 2. A review of the laboratory's API PT records revealed the following non-graded scores for the BILI, total analyte: 2025 Chemistry-Core 2nd Event: Samples CH-07, CH-09, CH-10 2025 Chemistry-Core 3rd Event: Samples CH-12, CH-15 2026 Chemistry-Core 1st Event: Sample CH-05 Documentation of the evaluation of the non-graded scores was not available on the date of the survey (07/10/2026). 3. An interview with the laboratory liaison on 07/10 /2026 at 3:00 p.m. confirmed the survey findings. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on observation of the laboratory, a review of the Centers for Medicare and Medicaid (CMS) Clinical Laboratory Improvement Amendments (CLIA) Application for Certification (Form CMS-116), lack of records, and staff interviews, the laboratory failed to verify the accuracy of the urine total protein analyte in 2025, with approximately 87 patients reported. The findings include: 1. Observation of the laboratory on 07/10/2026 at 8:35 a.m. revealed the Beckman Coulter AU480 (serial number 2022120197) instrument used for chemistry patient testing, including the urine total protein analyte. 2. A review of the Form CMS-116 completed for the survey date (07/10/26) revealed that the laboratory listed urine total protein as a test performed. 3. The laboratory did not have records for the verification of accuracy studies for the urine total protein analyte for 2025. 4. An interview with the laboratory liaison on 07/10/26 at 3:00 p.m. confirmed the survey findings. An electronic interview with the laboratory liaison on 07/13/2026 at 1:03 p.m. confirmed the laboratory performed 87 patient tests for urine total protein in 2025. -- 2 of 5 -- D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) (b) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (b)(1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (b)(1)(i) (A) Accuracy. (b)(1)(i)(B) Precision. (b)(1)(i)(C) Reportable range of test results for the test system. (b)(1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on laboratory observation, a review of instrument validation records, a lack of documentation, a review of the laboratory procedure manual, instrument report, and staff interviews, the laboratory failed to evaluate the normal reference ranges for the Thyroid Stimulating Hormone (TSH), Cancer Antigen 125 (CA-125), Carcinoembryonic Antigen (CEA), Free Thyroxine (FreeT4), and Beta-human chorionic gonadotropin (bHCG) analytes for the Access2 instrument used for patient testing since April 2026. The findings include: 1. Observation of the laboratory on 07 /10/2026 at 8:35 a.m. revealed the Access2 instrument (serial number 574055) used for patient testing for TSH, CA-125, CEA, FreeT4, and bHCG analytes. During the observation, the testing person 1 stated that patient testing began in April 2026. 2. A review of the laboratory's instrument validation records for the Access2 instrument revealed no documented normal reference range studies for any of the analytes. 3. A review of the laboratory's procedure titled "Operation of the Beckman Coulter Access 2 Immunoassay System," approved by the laboratory director for use on 04/09/2026 in section "VIII. Reporting Results," revealed the following normal ranges: TSH-0.340- 5.600 uIU/mL CA-125 0-35 U/mL CEA-0.1-5.0 ng/mL FreeT4- 0.54-1.24 ng/dL bHCG-0.0-5.0 mIU/mL 4. A review of the Access2 "Continuous Sample Report" instrument report printed for patients reported on 06/23/2026 revealed the following: Patient 03340385: Ca-125 Patient 03807967: TSH, FreeT4 Patient 03574503: TSH, Ca-125 Patient 01396080: TSH, Ca-125, and FreeT4 5. An interview with the laboratory liaison on 07/10/2026 at 3:00 p.m. and a subsequent phone interview on 07 /13/2026 at 11:57 a.m. confirmed the survey findings. Word Key: uIU/ml- micro- International Units per milliliter U/mL- units per milliliter ng/mL- nanograms per milliliter ng/dL- nanograms per deciliter mIU/mL- milli-international units per milliliter 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 -- 3 of 5 -- 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 Centers for Medicare and Medicaid (CMS) Clinical Laboratory Improvement Amendments (CLIA) Application for Certification (Form CMS-116), manufacturer's user guide, instructions for use, package inserts, lack of records, and staff interviews, the laboratory failed to perform calibration verification at least every six months for analytes with less than three calibrators that spanned the reportable range for analytes performed (8 of 8 reviewed) on the Beckman Coulter AU480 chemistry instrument in 2024, 2025, and 2026. The findings include: 1. Observation of the laboratory on 07/10/2026 at 8:35 a.m. revealed the Beckman Coulter AU480 instrument (serial number 2022120197) used for chemistry patient testing. 2. A review of the Form CMS-116 completed for the survey (07/10/2026) revealed an estimated annual test volume for the chemistry specialty as 77,316. 3. A review of the manufacturer's User's Guide in Chapter 8, section 8.12.2, "ISE CALIBRATION," revealed that the ISE module for Sodium (Na), Potassium (K), and Chloride (Cl) analytes required calibration every 24 hours using a high standard and a low standard. 4. A random review of the manufacturer's analyte instructions for use revealed the following: Albumin, Glucose, and Magnesium calibration was performed with the Chemistry Calibrator (CAT#DR0070). Alkaline Phosphatase and Aspartate Transferase (AST) calibration was performed with the System Calibrator (CAT#66300X). 5. A review of the manufacturer's package inserts revealed the following: Chemistry Calibrator (CAT#DR0070), lot# 6101K41 /6102K41, included two-point calibrators for Albumin, Glucose, and Magnesium. System Calibrator (Cat#66300X) lot# 1126, included one-point calibrators for Alkaline Phosphatase and AST. 6. No documentation of calibration verification studies with three or more points was available for any of the analytes performed on the Beckman Coulter AU480 instrument for 2024, 2025, or 2026. 7. An interview with the laboratory liaison on 07/10/2026 at 3:00 p.m. confirmed the survey findings. D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. The procedures for evaluation of the competency of the staff must include, but are not limited to-- This STANDARD is not met as evidenced by: Based on observation of the laboratory, a review of the Centers for Medicare and Medicaid Services (CMS) Laboratory Personnel Report (Form CMS-209), laboratory personnel records, and staff interviews, the technical consultant failed to evaluate testing personnel competency assessments for 4 of 4 testing personnel (TP) in 2025 and 2026 that performed complete blood count with differential (CBC), chemistry, endocrinology, and immunology patient testing on the DxH520, Au480, and Access2 instruments. The findings include: 1. Observation of the laboratory on 07/10/2026 at 8: 35 a.m. revealed the following instruments: DxH520 (serial number 8379956) was -- 4 of 5 -- used for CBC patient testing. Au480 (serial number 2022120197) was used for chemistry patient testing. Access2 (serial number 574055) was used for patient testing in chemistry, endocrinology, and immunology. 2. A review of the Form CMS-209 completed for the survey on 07/10/2026 revealed that the laboratory director served as the technical consultant, and four testing personnel performed moderately complex patient testing. 3. A review of the laboratory personnel competency assessment records revealed that the laboratory director/technical consultant indicated on Form CMS-209 was not the evaluator for the following: TP 1- Semiannual competency assessment was initialed by TP 3 as the assessor/evaluator/trainer. Competency Assessment Log 6-month dated 03/20/2026 for the DxH520 and Au480. Au480 Competency Checklist dated 03/20/2026 and was signed by the laboratory director /technical consultant on 03/23/2026. CBC Annual Competency Worksheet dated 03/20 /2026 and was signed by the laboratory director/technical consultant on 03/23/2026. TP 2- Annual competency assessment was initialed by TP 1 as the evaluator. Au480 Chemistry Annual Competency Worksheet dated 04/09/2026 and was signed by the laboratory director/technical consultant on 04/15/2026. CBC Annual Competency Worksheet dated 04/09/2026, and was signed by the laboratory director/technical consultant on 04/15/2026. TP 3- Semiannual competency assessment was initialed by TP 1 as the assessor. Competency Assessment Log dated 03/20/2026 for the DxH520, Au480, and Access2 instruments. Assessor initials were TP 1. TP 4: Initial Competency Assessment was initialed by TP 1 as the assessor/evaluator/trainer. Competency Assessment Log dated 06/24/2026 for the DxH520, Au480, and Access2. Au480 Competency Checklist dated 06/24/2026 and was signed by the laboratory director/technical consultant on 06/26/2026. 4. An interview with the laboratory liaison on 07/10/2026 at 3:00 pm confirmed the survey findings. -- 5 of 5 --

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 laboratory observation, a review of the Centers for Medicare & Medicaid Services Laboratory Personnel Report (CLIA) (FORM CMS-209), personnel records, American Proficiency Institute (API) proficiency testing (PT) records, and staff interviews, the laboratory failed to ensure that one of two testing personnel (TP) who performed hematology and chemistry patient testing also participated in proficiency testing in 2023 and 2024. The findings include: 1. Observation on 10/09/2024 at 8:30 a.m. revealed the laboratory used a Beckman Coulter DxH 520 hematology analyzer (ID: BG100552) and a Beckman Coulter AU 480 (ID: 2022120197) chemistry analyzer for patient testing. 2. A review of the FORM CMS-209 revealed two persons (TP1 and TP2) who perform moderately complex patient testing. 3. A review of the laboratory's personnel records revealed that TP1 and TP2 perform hematology and chemistry patient testing. 4. A review of the laboratory's 2023 and 2024 API PT attestation statements revealed that TP2 did not participate in any PT events (0 of 9 reviewed). 5. An interview with TP1 and the physician's office laboratory (POL) coordinator on 10/09/2024 at 3:30 p.m. confirmed that TP2 performed patient testing and did not participate in any PT events in 2023 and 2024. 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 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 -- 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 laboratory observation, a review of the manufacturer instructions for use (IFU), a review of the laboratory's policies, environmental monitoring records, and staff interviews, the laboratory failed to define appropriate freezer temperature ranges and monitor freezer conditions, leading to the improper storage of quality control (QC) material used in chemistry testing for 18 of 18 months reviewed in 2023 and 2024. The findings include: 1. An observation on 10/09/2024 at 8:30 a.m. revealed that the laboratory used a Beckman Coulter AU 480 (ID: 2022120197) chemistry analyzer for patient testing. Two levels of Biorad Liquid Assayed Multiqual QC material (lot: 4596) were used to verify the test system's performance. The laboratory stored the QC material in a Frigidaire freezer (SN: BA02821407). 2. A review of the Biorad Liquid Assayed Multiqual IFUs revealed that the storage requirements are "-20 C to -70C." 3. A review of the laboratory's "Temperature Checking and Recording" policy (POL.063) revealed the following statements: - "It is recognized that some materials are only stable within certain prescribed temperature ranges and that some reagents are greatly influenced by small changes in temperature. For these reasons, it is necessary to verify that the correct temperatures are being maintained in all refrigerators and freezers used in the laboratory, as well as the ambient temperature of the laboratory itself." - "the temperatures of all refrigerators and freezers which contain either samples or reagents, and of the room itself, are to be recorded on a permanent record each day the office is open." 4. A review of the monthly "Laboratory Temperature Check Sheets" from April 2023 to October 2024 revealed the following: - The laboratory's stated acceptable freezer temperature range is "-15 to -25C." - The laboratory did not document freezer temps from April 2023 to September 2024. - The laboratory documented freezer temperatures warmer than -20C for all testing days in October 2024 (7 of 7). 5. An interview with TP1 and the POL coordinator on 10/09/2024 at 3:30 p.m. confirmed that the laboratory did not define freezer temperature ranges consistent with the manufacturer's instructions or verify that the correct temperatures were maintained, leading to the improper storage of QC materials in 2023 and 2024. Key: C = degrees celcius 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. (g) The laboratory must document all control procedures performed. -- 2 of 4 -- This STANDARD is not met as evidenced by: Based on laboratory observation, a review of laboratory policies, lack of documentation, and staff interviews, the laboratory failed to monitor chemistry testing quality control (QC) performance over time (18 of 18 months) in 2023 and 2024. The findings include: 1. An observation on 10/09/2024 at 8:30 a.m. revealed that the laboratory used a Beckman Coulter AU 480 (ID: 2022120197) chemistry analyzer for patient testing. Two levels of Biorad Liquid Assayed Multiqual QC material (lot: 4596) were used to verify the test system's performance. 2. A review of the laboratory's "Quality Control Procedure" (POL.9247) revealed the following statements: - "On a monthly basis Levy-Jennings charts for all QC will be printed including the statistical calculations such as SD and CV." - "QC is evaluated for trends. If a trend is noted, an investigation should begin and/or technical support should be contacted." - "Results will be reviewed by the Lab Designee and the Laboratory Director and

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 review of the Centers for Medicare and Medicaid Casper Report 155 (CMS 155) and the laboratory's 2022 and 2023 American Proficiency Institute (API) proficiency testing (PT) evaluation reports, the laboratory failed to maintain satisfactory participation for two out of three proficiency testing events for the White Blood Cell Differential (CELL-ID), Erythrocyte Count (RBC), Hematocrit (HCT), Hemoglobin (HGB), Leukocyte Count (WBC), and Platelet Count (PLT) analytes (Refer to D2130) and the Hematology specialty (Refer to D2131) resulting in initial unsuccessful PT performance. 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 -- D2130 HEMATOLOGY CFR(s): 493.851(f) 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 desk review of the CMS 155 and the laboratory's API PT evaluation reports, the laboratory failed to maintain satisfactory performance for two of three test events for the White Blood Cell Differential (CELL-ID), Erythrocyte Count (RBC), Hematocrit (HCT), Hemoglobin (HGB), Leukocyte Count (WBC), and Platelet Count (PLT) analytes. The findings include: 1. Review of the CMS 155 report revealed the following unsatisfactory scores: -2022 Event 3: 0% for CELL-ID, RBC, HCT, HGB, WBC, PLT -2023 Event 1: 0% for CELL-ID, RBC, HCT, HGB, WBC, PLT 2. Review of the laboratory's 2022 and 2023 API Hematology/ Coagulation PT evaluation reports revealed the following unsatisfactory scores: -2022 Event 3: 0% for CELL-ID, RBC, HCT, HGB, WBC, PLT -2023 Event 1: 0% for CELL-ID, RBC, HCT, HGB, WBC, PLT D2131 HEMATOLOGY CFR(s): 493.851(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 a desk review of the CMS 155 and the laboratory's API PT evaluation reports, laboratory failed to achieve satisfactory performance for the overall specialty of Hematology in two of three PT events in 2022 and 2023. The findings include: 1. Review of the CMS 155 report revealed the following unsatisfactory Hematology PT event scores: -2022 Event 3: 0% -2023 Event 1: 0% 2. Review of the laboratory's 2022 and 2023 API Hematology/ Coagulation PT evaluation reports revealed the following unsatisfactory Hematology event scores: -2022 Event 3: 0% -2023 Event 1: 0% -- 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: Based on an off-site desk review of the laboratory's Centers for Medicare and Medicaid Services Casper Report 155 (CMS 155) and the laboratory's American Proficiency Institute (API) Proficiency Testing (PT) evaluation reports, the laboratory failed to maintain satisfactory performance for two consecutive PT events for the Sodium (NA) analyte, resulting in the first unsuccessful PT occurrence for the Sodium analyte. (Refer to D2096) D2096 ROUTINE CHEMISTRY CFR(s): 493.841(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 or test in 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 an off-site desk review of the laboratory's Centers for Medicare and Medicaid Services Casper Report 155 (CMS 155) and the laboratory's American Proficiency Institute (API) Proficiency Testing (PT) evaluation reports, the laboratory failed to maintain satisfactory performance for two consecutive PT events for the Sodium (NA) analyte, resulting in the first unsuccessful PT occurrence for the Sodium analyte. The findings include: 1. Review of the report CMS 155 revealed the following scores for the Sodium (NA) analyte: 2022 event three = 60% 2023 event one = 0% 2. Review of the laboratory's API PT evaluation reports revealed the following: Sodium scored as 60% for 2022 event three and 0% for 2023 event one, resulting in the first unsuccessful PT occurrence for the Sodium (NA) analyte. -- 2 of 2 --

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(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 review and request of the laboratory's American Proficiency Institute (API) proficiency testing (PT) records and interview with the office manager and lead testing person, it was determined the testing personnel and/or the laboratory director failed to sign the attestation sheets for 11 of 12 PT events for 2021 and 2022. The findings include: 1. Request of the laboratory's PT records revealed the following: -No attestation pages available for the following: Hematology/Coagulation 2021 event one and two and 2022 event one Chemistry 2021 event one, two and three and 2022 event one -Attestation pages not signed by the testing personnel and/or laboratory director for the following: Hematology/Coagulation 2022 event two and three Chemistry 2022 event two and three 2. Interview with the office manager and lead testing person on 12.15.2022 at 1pm confirmed the above findings. D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(iii) Ensure that all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require

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 two events for the analyte ALT (Alanine Transaminase), resulting in the first unsuccessful proficiency testing (PT) occurrence for ALT (Refer to D2096). ==================================== D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in two 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 -- consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: ===================================== Based on a desk review of the CMS CASPER Report 0155D and the Laboratory's 2019 and 2020 Proficiency Testing (PT) Program Performance Summary, determined the Laboratory failed to maintain satisfactory performance in two consecutive events for the ALT (Alanine Transaminase) analyte, event three of 2019 and event one of 2020, resulting in the first unsuccessful occurrence. The findings include: 1. A review of the CMS CASPER Report 0155D for Proficiency Testing revealed the ALT scores as 60% for event three of 2019 and event one of 2020. 2. A review of the 2019 PT Program Performance Summary for ALT revealed an unsatisfactory score of 60% for event three of 2019 and event one of 2020, resulting in the first unsuccessful occurrence for the ALT analyte. ===================================== -- 2 of 2 --