Advanced Care Oncology &

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 surveyor review of the Procedure Manual (PM), and interview with the Testing personnel (TP), the laboratory failed to document calibration on the Sysmex XN-550 analyzer from 4/23/2024 to 9/30/2025. The findings include: 1. The laboratory uses Sysmex BeyondCare Quality Monitor (BCQM). 2. The BCQM verifies calibration of the analyzer via the "Continuous Calibration" report. 3. There was no documented evidence that the "Continous Calibration" report was generated and reviewed after 4/23/24. 4. The TP confirmed on 9/30/2025 at 11:15 am, the laboratory failed to generated and review the Continuous Calibration report. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on surveyor review of the PT records and interview with the Testing Personnel (TP), the laboratory failed to maintain Attestation Statements (AS) for Hematology testing performed with the American Proficiency Institute (API) in the Third event for 2021 and first event for 2022.. The TP #1 listed on CMS form 209 confirmed on 8/18 /22 at 1:45 am that the AS was not maintained. 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 surveyor review of Proficiency Testing (PT) records and interview with the Testing Personnel (TP), the laboratory failed to retain graded results for Hematology Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 7 -- /coagulation PT event 3-2021 and 1-2022 performed with the American Proficiency Institute. The TP confirmed on 8/18/22 at 11:45 am that all PT graded results were not retained. D5024 HEMATOLOGY CFR(s): 493.1215 If the laboratory provides services in the specialty of Hematology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1269, and 493. 1281 through 493.1299. This CONDITION is not met as evidenced by: Based on surveyor review of Manufactures Instructions (MI), Procedure Manual (PM), Quality Control (QC) Records, the lack of Calibration Records (CR) and interview with the Testing Personnel (TP), the laboratory failed to ensure that quality systems for the pre-analytic, and analytic phases of Hematology testing were monitored on the date of survey. 1. The laboratory failed to maintain Attestation Statements. Cross refer 2015 2.. The laboratory failed to maintain Proficiency Testing (PT) records. Cross refer to D3037. 3. The laboratory failed to have all applicable procedures for Hematology Tests. Cross refer D5403 4. The laboratory failed to follow Manufacturer Package insert for control values. Cross refer D5411. 5. The laboratory failed to ensure that all Performance Specifications records were adequate. Cross refer D5421. 6. The laboratory failed to perform Calibration Verification. Cross refer D5439 7. The laboratory failed to verify commercial Quality Control material. Cross refer D5469 8. The laboratory failed to have available

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 office review of the CASPER reports 153 and 155 and Proficiency Testing (PT) provider reports, the laboratory failed to achieve a score of 80% or more for Hematology test performed with the American Proficiency Institute (API). The findings include: 1) The laboratory scored 0% for White Blood Cell Differential (WCBD) for 3-20 event and 72% for 1-21 event with the API. 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 an office review of the proficecny testing provider reports and CASPER reports 153 and 155 and Proficiency Testing (PT), the laboratory failed to achieve a score of 80% or more in two out of three event for for Hematology tests performed with the American Proficiency Institute (API). The findings include: 1) The laboratory scored 0% for White Blood Cell Differential (WCBD) for 3-20 event and 72% for 1- 21 event with the API. 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 an office review of the laboratory's performance in Proficiency Testing (PT) surveys, the Laboratory Director failed to provide appropriate direction to the laboratory personnel to ensure that the PT surveys were performed satisfactorily and compliance with the CLIA regulations are maintained. -- 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 office review of the CASPER reports 153 and 155 and Proficiency Testing (PT) provider reports, the laboratory failed to achieve a score of 80% for Hematology testing. The findings include: 1) The laboratory scored 60% for Platelets for 2-20 event with the American Proficiency Institute (API). 2) The laboratory scored 0% for Platelets 3-20 event with the API. D2123 HEMATOLOGY CFR(s): 493.851(c) 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 participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3) The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: Based on an office review of the CASPER reports 153, 155 and the performance summary form American Proficiency Institute (API) 2020 hematology/coagulation - 3 event. The laboratory failed to participate in the third API aformentioned Proficiency Testing (PT) event of 2020 for Hematology tests. 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 an office review of the CASPER reports 153 and 155 and Proficiency Testing (PT) provider reports, the laboratory failed to achieve a score of 80% for platelets. The finding includes: The laboratory scored 0% in 3-20 and 60% in 2-20 PT events with the American Proficiency Institute. . 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 an office review of the laboratory's performance in Proficiency Testing (PT) surveys, the laboratory director failed to provide appropriate direction to the laboratory personnel to ensure that the PT surveys are performed satisfactorily and compliance with the CLIA regulations are maintained. -- 2 of 2 --

Summary Statement of Deficiencies D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on surveyor review of the Proficiency Testing (PT) records and interview with the Testing Personnel (TP), the laboratory failed to evaluate results when they received an unacceptable score in Hematology tests performed on the Sysmex XS 1000i series analyzer with the American Proficiency Institute (API) in the 3-2018 and 2-2019 events. The findings include: 1. The laboratory received an "Unacceptable" result for % Lymphocyte on samples XE-15 in 3-2018 and XE10 in 2-2019. 2. There was no documented evidence that the laboratory investigated the failures. 3. The TP #1 listed on CMS form 209 confirmed on 9/27/19 at 1:10 pm that the laboratory did not perform and document an evaluation of unacceptable PT results. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

Summary Statement of Deficiencies D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on review of Proficiency Testing (PT) records and interview with the Testing Personnel (TP), the laboratory failed to enroll in an approved PT program for Complete Blood Count test from July 2017 to the date of survey. The TP # 1 listed on CMS form 209 confirmed on 4/3/18 at 10:45 am the laboratory was not enrolled in PT testing. 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 surveyor review of the Procedure Manual and interview with the Testing 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 -- Personnel ( TP), the laboratory failed to establish a written procedure for enrollment, performance and evaluation of Proficiency Testing (PT) from July 2017 to the date of survey. The TP # 1 listed on CMS form 209 confirmed on 4/3/18 at 11:00 am that a PT procedure was not established. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on surveyor review of the Procedure Manual (PM) and interview with the Tesing Personnel (TP), the laboratory failed to follow "Reagent Verification" procedure from July 2017 to the date of survey. The finding includes: 1. The PM stated that new lot of Cellpack and Stromatolyse-WH must be verified against old reagent lot but there was no documented evidence that it was performed. 2. The TP # 1 listed on CMS form 209 confirmed on 4/3/18 at 10:45 am that PM was not followed. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (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 lack of Performance Specifications (PS) records and interview with the Testing Personnel (TP), the laboratory failed to verify PS for Complete Blood Count tests performed on the Sysmex XS 1000i analyzer from July 2017 to the date of survey. The TP #1 listed on CMS form 209 confirmed on 4/3/18 at 11:15 am that the PS were not performed. 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 surveyor review of the Laboratory Records and interview with the Testing Personnel (TP), the Laboratory Director (LD) failed to provide overall management -- 2 of 5 -- and direction to the laboratory. The findings include: 1. The LD failed to ensure that competency assessmet was performed accurately. Cross refer to D 6004. 2. The LD failed to eusure that the laboratory enrolled for proficiency testing correctly. Cross refer to D 6015. 3. The LD failed to eusure that Quality Control programs were maintained. Cross refer to D 6020. 4. The LD failed to establish that Quality Assessment programs were established and maintained. Cross refer to D 6021. 5. The LD failed to ensure that prior to testing patients' samples all testing personnel had the appropriate training. Cross refer to D 6029. D6004 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(a)(b) 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. (a) The laboratory director, if qualified, may perform the duties of the technical consultant, clinical consultant, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications of 493.1409, 493.1415, and 493.1421, respectively. (b) If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed. This STANDARD is not met as evidenced by: Based on surveyor review of the Personnel Records (PR) and interview with the Testing Personnel (TP), the Laboratory Director (LD) failed to ensure the competency of Testing Personnel (TP) in the performance of Complete Blood Count analysis was performed and documented correctly in 2017. The findings include: 1. Review of PR indicated that the evaluation for Competency Assessment (CA) of two out of three TP did not include all six criteria as stated at 493.1413 (b) (8) (i) (ii) (iii) (iv) (v) (vi). 2. The designated TP # 1 listed on CMS form 209 confirmed the lack of all required criteria in evaluating the CA for TP. 3. The LD did not ensure that the evaluation of CA performed by the assigned TP # 1was not qualified to perform CA. 4. The TP # 1 confirmed on 4/3/18 at 11:30 am that LD did not ensure the competency was performed and documented accurately. D6015 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4) 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) Ensure that the laboratory is enrolled in an HHS approved proficiency testing program for the testing performed. This STANDARD is not met as evidenced by: Based on surveyor review of Proficiency Testing (PT) and interview with the Testing Personnel (TP), the Laboratory Director (LD) failed to ensure the laboratory was enrolled in an appropriate module with approved PT program from July 2017 to the date of the survey. The findings include: 1. The LD did not ensure that the laboratory had enrolled in a correct module with American Proficiency Institute. 2. PT must be -- 3 of 5 -- enrolled for each CLIA number. 3. The TP # 1 listed on CMS form 209 confirmed on 4/3/18 at 10:00 am the laboratory was not enrolled in correct module. D6020 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) 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)(5) Ensure that the quality control program is established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: a) Based on surveyor review of the Quality Control records and interview with the Testing Personnel (TP), the Laboratory Director (LD) failed to maintain a Quality Control Program (QCP) that verified the Quality Control (QC) materials performance prior to initial use for the Complete Blood Count analysis in the Sysmex XS 1000i analyzer from July 2017 to the date of survey. The findings include: 1. The laboratory had no QC lots verification records of five out of five lots used so far. 2. The TP # 1 listed on CMS form 209 confirmed on 4/3/18 at 11:00 am that QC material was no not verified. b) Based on surveyor review of the QC records, Manufacture Package Insert (MPI), QC material, and interview with the Testing Personnel (TP), the LD failed to ensure that laboratory was following QCP for Complete Blood Count tests performed on the Sysmex XS 1000i analyzer in Octber 2017 and February 2018. The findings include: 1. The laboratory used expired QC material for Complete Blood Count tests performed on the Sysmex XS 1000i analyzer in Octber 2017 and February 2018. 2. The laboratory used expired QC lot # 72130804, 805 and 806 on 10/24/17, 10/25/17 and 10/26/17 when QC expired on 10/22/17. 3. The laboratory used expired QC lot # 73250804, 805 and 806 on 2/13/18 when QC expired on 2/10/18. 4. Approximately 60 patient specimens were run on each day. 5. The TP #1 listed on CMS form 209 confirmed on 4/3/18 at 11:45 am that the laboratory used expired QC material. c) Based on the surveyor review of the QC records and interview with the TP, the LD failed to ensure that the laboratory rotated control material testing among all TP who perform Complete Blood Count test from July 2017 to the date of survey. The finding includes: 1. The QC was performed by one out of three TP on each day of patient testing. 2. The TP #1 listed on the CMS form 209 confirmed on 8/18/15 at 10:35 AM that only one out of three TP performed QC testing. D6021 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) 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)(5) Ensure that quality assessment programs are established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on review of the Procedure Manual (PM), the Manufacturer Package Inserts -- 4 of 5 -- (MPI) and interview with the Testing Personnel (TP) , the Laboratory Director (LD) failed to ensure that the establishment and maintenance of Quality Assessment programs(QAP) in all phases ( pre-analytical, analytical, post-analytical) of Complete Blood Count testing in the Sysmex XS 1000i analyzer from July 2017 to the date of survey. The findings include: 1. Review of laboratory records revealed that the laboratory had no written Quality Assessment program. 2. Although the MPI instruction stated that quality control material must be stored in the refrigerator at 2-8 degress Centigrade (C), the laboratory stored at 10 degrees C on the day of survey. The same temperature was observed at 9:30 and 11:30 am. 3. The laboratory did not monitor and document refrigerator temperature where quality control material were stored from July 2017. 4. There was no established procedure to evaluate, periodically, the reliability and accuracy of electronic data transmission from Sysmex XS 1000i analyzer to the electronic medical records. 5. The LD failed to establish a procedure for verifying new QC material used on Sysmex XS 1000i analyzer from July 2017. 6. The TP # 1 listed on CMS form 209 confirmed on 4/3/18 at 11:45 am that the QAP was not establised and maintained. D6029 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(11) 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)(11) Ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: a) Based on review of Personnel Files (PF) and interview with the Testing Personnel (TP), the Laboratory Director (LD) failed to ensure that the training records were documented for three of three TP for Complete Blood Count tests from July 2017 to the date of survey. The TP # 1 listed on the CMS form 209 confirmed on 4/3/18 that LD did not ensure that training records were in PF. b) Based on review of PF and interview with the TP, the LD failed to ensure that the TP # 1 was not qualified to perform the competency assessment of testing personnel. The finding includes: 1. Personnel records indicated the TP # 1 had a high school diploma and she confirmed it. c) Based on review of PF and interview with the TP, the LD failed to ensure that all TP had their job duties and responsibilities doumented. The TP # 1 confirmed on 4/3 /18 at 11:45 am that the LD did not establish job duties and responsibilities for TP. -- 5 of 5 --