Cgt Global

Summary Statement of Deficiencies D0000 Based on desk review of proficiency testing (PT) for 2025, the laboratory failed to meet the following conditions, resulting in an initial unsuccessful PT participation: D2016 - 42 C.F.R. 493.803 Condition: Successful participation [proficiency testing] D6000 - 42 C.F.R. 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on a desk review of proficiency testing (PT) records from the Certification and Survey Provider Enhanced Reporting (CASPER) 0155 report and College of American Pathologist (CAP) 2025 records, the laboratory failed to successfully 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 -- participate in a proficiency testing program approved by HHS, for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. The laboratory failed to successfully participate in the specialty of Hematology for the analyte of Hematocrit (HCT). Refer to D2130. D2130 HEMATOLOGY CFR(s): 493.851(f) (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 proficiency testing desk review of CASPER 0155 report and CAP Proficiency Testing 2025 records (Events 1, 2 and 3), the laboratory failed to achieve satisfactory performance (80% or better) for the same analyte for three consecutive testing events in the specialty of Hematology for the analyte Hematocrit (HCT). Findings include: 1. Review of the CASPER 0155 report revealed the following results: Hematology 2025-2nd Event the laboratory received an unsatisfactory score of 60% for Hematocrit (HCT). Hematology 2025-3rd Event the laboratory received an unsatisfactory score of 40% for Hematocrit (HCT). 2. A review of the CAP Proficiency Testing records confirmed the laboratory received the above results. 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 a proficiency testing desk review of CASPER 0155 report and College of American Pathologists (CAP) Proficiency Institute 2025 records, the laboratory director failed to provide overall management and direction of the laboratory services. The laboratory director failed to ensure proficiency testing samples were tested as required. 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 a proficiency testing desk review of CASPER 0155 report and CAP 2025 records, the laboratory director failed to ensure proficiency testing samples were tested as required. The laboratory director failed to ensure successful participation in an HHS approved proficiency testing program. Refer to D2130. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A CLIA recertification survey was conducted for the CGT Global laboratory on 10/16 /2025 pursuant to the Clinical Laboratory Improvement Amendments (CLIA) of 1988 and CLIA regulations at 42 CFR 493. D2128 HEMATOLOGY CFR(s): 493.851(e) (e)(1) For any unsatisfactory analyte or test performance or testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unacceptable analyte or testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: . Based on record review of the laboratory's College of American Pathologists (CAP) proficiency testing (PT) scores and interview with the Technical Consultant (TC), the laboratory failed to investigate and perform

Summary Statement of Deficiencies D0000 A CLIA recertification survey was conducted for the CGT Global laboratory on 02/16 /2024 pursuant to the Clinical Laboratory Improvement Amendments (CLIA) of 1988 and CLIA regulations at 42 CFR 493. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (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 record review and interview with the Laboratory Operations Manager (LOM) on 2/16/24, the laboratory failed to perform calibration verifications every six 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 -- months or, as appropriate, as evidenced by the following: The surveyor reviewed the quality control records on 2/16/24 for the calendar years 2022 and 2023. The review revealed that calibration verifications of at least three points were not performed once every six months for four (4) out of four (4) analytes requiring calibration verification on the Sysmex pocHi-100i analyzer. The six-month calibration verifications for erythrocyte count (RBC), hemoglobin, leukocyte count (WBC), and platelets were performed on 1/12/24 and 10/14/22. The calibration verifications were not performed every six months; none performed in 2023. The LOM confirmed in an interview on 2 /16/24 at 2:09 P.M. that calibration verifications had not been performed every six months for four (4) out of four (4) hematology analytes requiring calibration verification. The laboratory performs 5,000 hematology tests annually. D9999 493.51 NOTIFICATION REQUIREMENTS FOR LABORATORIES ISSUED A CERTIFICATE OF COMPLIANCE Laboratories issued a certificate of compliance must meet the following conditions: (a) Notify HHS or its designee within 30 days of any change in-- (1) Ownership; (2) Name; (3) Location; (4) Director; or (5) Technical supervisor (laboratories performing high complexity only). (b) Notify HHS no later than 6 months after performing any test or examination within a specialty or subspecialty area that is not included on the laboratory's certificate of compliance, so that compliance with requirements can be determined. (c) Notify HHS no later than 6 months after any deletions or changes in test methodologies for any test or examination included in a specialty or subspecialty, or both, for which the laboratory has been issued a certificate of compliance. Based on record review and interview, the laboratory failed to notify HHS or its designee within 30 days of a change in name and a change in location as evidenced by the following: A CMS-116 indicating a change in name effective July 1, 2023 and a change in location effective October 3, 2022 was received at the State Agency on February 9, 2024. The State Agency was not notified within 30 days of change in name and location. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An initial CLIA certification survey was conducted for the StemExpress laboratory pursuant to the Clinical Laboratory Improvement Amendments (CLIA) of 1988 and CLIA regulations at 42 CFR 493. 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 surveyor review of Hematology test records, lack of proficiency testing records, and staff interview, the laboratory failed to enroll in an approved proficiency testing program for Hematology. Findings include: 1. Record review conducted on 04 /29/21 of testing records revealed that the laboratory began Hematology testing March 2019. 2. Staff interview conducted on 04/29/21 at 11:00 AM with the Technical Consultant 2 confirmed that the laboratory started Hematology testing during March 2019 and did not enroll in an approved proficiency testing program for 2019, 2020, and 2021. 3. The laboratory's estimated Completed Blood Count (CBC) annual test volume is 1,000. . D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) 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 -- Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: . Based on record review and interview on 4/29/21, the laboratory failed to retain quality control (QC) records for at least 2 years as evidenced by the following: 1. Surveyors reviewed Hematology QC records for calendar years 2019, 2020, and 2021 on 4/29/21. The review revealed that the laboratory did not retain QC result records since the laboratory started testing on 3/4/2019 until 4/16/21. 2. Technical Consultant 1 confirmed in an interview on 4/29/21 at 11:30 AM that the laboratory documented whether QC was run and within range but did not retain the QC results until 4/16/21. 3. The laboratory's estimated Completed Blood Count (CBC) annual test volume is 1,000. 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 record review and interview on 4/29/21, the laboratory failed to follow policies and procedures in place for all tests, assays, and examinations performed by the laboratory as evidenced by the following: 1. The surveyors reviewed the pocH- 100i Hematology Analyzer procedure manual on 4/29/21. Section 5.1 Quality Control (QC) Procedures states, "Remove all 3 vials of the control material from the refrigerator and equilibrate to room temperature (18 - 30 degrees C) for 15 minutes before mixing." 2. The surveyors requested to review room temperature records of the laboratory space where QC material is equilibrated. Technical Consultant (TC) 1 and TC 2 stated that room temperature is not checked or documented in the laboratory. 3. TC 1 and TC 2 confirmed in an interview on 4/29/21 at 1:30 PM that the laboratory failed to follow their procedure manual ensuring that QC material is equilibrated within acceptable room temperature requirements. . D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: . Based on procedure manual review and interview on 4/29/21, the laboratory director (LD) failed to approve, sign, and date laboratory procedures as evidenced by the following: 1. Surveyors reviewed the laboratory's procedure manuals on 4/29/21. The review revealed that the LD did not approve, sign, and date all laboratory policies and -- 2 of 4 -- procedures before use. 2. The Operations Director confirmed in an interview on 4/29 /21 at 1:00 PM that the LD did not approve, sign, and date all laboratory policies and procedures before use. . 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 documentation and interview with the Technical Consultant (TCs), the laboratory failed to verify the performance specifications of the Sysmex Poch-100i Hematology Analyzer prior to reporting patient test results. Findings include: 1. Record review conducted on 04/29/21 of patient testing records revealed that the laboratory began Hematology testing using the Sysmex Poch-100i Hematology Analyzer on March 2019. 2. Record review conducted on 04/29/21 revealed no documentation indicating that the laboratory verified the performance of the performance specifications of the Sysmex Poch-100i Hematology Analyzer prior to reporting patient test results. 3. Staff interview with TC2 on 04/29/21 at 11:30 am confirmed that the laboratory did not verify the performance specifications of the Sysmex Poch-100i Hematology Analyzer prior to reporting patient test results. D6033 TECHNICAL CONSULTANT-MODERATE COMPEXITY CFR(s): 493.1409 The laboratory must have a technical consultant who meets the qualification requirements of 493.1411 of this subpart and provides technical oversight in accordance with 493.1413 of this subpart. This CONDITION is not met as evidenced by: . This Condition is not met as evidenced by: Based on record review and staff interview, the Technical Consultants (TCs) failed to provide technical oversight in accordance with 493.1413. The TCs failed to verify the performance specifications of the Sysmex Poch-100i Hematology Analyzer prior to reporting patient test results (refer to D6040); failed to enroll in an approved proficiency testing (PT) program for 2019, 2020, and 2021 (refer to D6041); and failed to establish a quality control (QC) program appropriate for Hematology Complete Blood Counts (refer to D6042). . D6040 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(2) The technical consultant is responsible for-- (b)(2) Verification of the test procedures performed and the establishment of the laboratory's test performance characteristics, including the precision and accuracy of each test and test system. -- 3 of 4 -- This STANDARD is not met as evidenced by: . Based on lack of documentation and interview with the Technical Consultants (TCs) on 4/29/21, the TCs failed to fulfill the responsibility for verification of the laboratory's test performance characteristics as evidenced by the following: 1. Surveyors requested to review validation records for the Sysmex Poch-100i Hematology Analyzer on 4/29/21. The review revealed no documentation indicating that the laboratory verified the performance specifications of the Hematology Analyzer prior to reporting patient test results starting on 3/4/19. 2. TC confirmed in an interview on 04/29/21 at 11:30AM that the TC did not verify the performance specifications of the Sysmex Poch-100i Hematology Analyzer prior to reporting patient test results. 3. Refer to D5421. D6041 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(3) (b) The technical consultant is responsible for-- (b)(3) Enrollment and participation in an HHS approved proficiency testing program commensurate with the services offered; This STANDARD is not met as evidenced by: . Based on lack of documentation and interview with the Technical Consultants (TCs) on 4/29/21, the TCs failed to enroll and participate in an HHS approved proficiency testing (PT) program commensurate with the services offered as evidenced by the following: 1. The laboratory began Hematology patient testing on 3/4/2019. 2. The surveyors requested to review Hematology PT documentation from calendar years 2019, 2020, and 2021 on 4/29/21. The review revealed that that lab did not enroll in PT. 3. TC 2 confirmed in an interview on 4/29/21 at 11:00 AM that the TCs failed to enroll in an approved PT program for 2019, 2020, and 2021. 4. The laboratory's estimated Completed Blood Count (CBC) annual test volume is 1,000. 5. Refer to D2000. . D6042 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(4) (b) The technical consultant is responsible for-- (b)(4) Establishing a quality control program appropriate for the testing performed and establishing the parameters for acceptable levels of analytic performance and ensuring that these levels are maintained throughout the entire testing process from the initial receipt of the specimen, through sample analysis and reporting of test results; This STANDARD is not met as evidenced by: . Based on quality control (QC) record review and interview on 4/29/21, the Technical Consultants (TCs) failed to establish a QC program appropriate for Hematology testing as evidences by the following: 1. Surveyors reviewed QC records from calendar years 2019, 2020, and 2021. The review revealed that the TCs did not retain QC result records from 3/4/19 to 4/16/21 and did not monitor QC results for shifts and trends. 2. TC 1 confirmed in an interview on 4/29/21 at 11:30 AM that the TCs did not establish a QC program appropriate for Hematology Complete Blood Counts. -- 4 of 4 --