Regional Cancer Care Associates

Summary Statement of Deficiencies 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 surveyor review of the Competency Assessment (CA) records, Procedure Manual (PM) and interview with the Laboratory Manager (LM), the laboratory failed to follow its policies for assessing the competency of Testing Personnel (TP) from 1/1 /24 to 9/30/25. The findings include: 1. There was no documented evidence CA was performed on TP # 1 as listed on the CMS 209 form in calendar year 2024. 2. The LM confirmed on 9/30/25 at 11:30 am, the laboratory failed to follow its policies for assessing the competency of TP in calendar year 2024. 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 Laboratory Manager (LM), the laboratory failed to review all unsatisfactory scores and document

Summary Statement of Deficiencies 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 surveyor review of the Procedure Manual (PM), Instrument Correlation Records (ICR) and interview with the Testing Personnel (TP), the laboratory failed to define the relationship between Hematology test results performed on the Two Horiba ABX Micros analyzers from 2/9/23 to 3/13/24. The finding includes: 1. The "Hematology Instrument Correlation Procedure" states "review the data by the established correlation criteria in relation to the target values and approve or disapprove the correlation." 2. The procedure failed to have written criteria for acceptable differences in test values or state what the established correlation criteria was for the Horiba ABX Micros analyzer. 3. The TP # 1 as listed on the CMS form 209, confirmed on 3/13/24 at 11:00 AM that the laboratory failed to have written criteria for acceptable differences in test values for correlation studies performed on the two Horiba ABX Micros 60 analyzers. B) Based on surveyor review of the Procedure Manual (PM), ICR and interview with the Testing Personnel (TP), the laboratory failed to review instrument correlation data performed on the Two Horiba ABX Micros analyzers from 2/9/23 to 3/13/24. The finding includes: 1. There was no documented evidence the ICR test values performed on 2/9/23, 10/17/23, and 2/27/24 were reviewed and if the ICR were approved or disapproved. 2. The above mentioned ICR were not signed by the Laboratory Director or designee. 3. The TP # 1 as listed 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 -- on the CMS form 209, confirmed on 3/13/24 at 11:10 AM that the laboratory failed to have documented evidence of review for ICR performed on the two Horiba ABX Micros 60 analyzers. -- 2 of 2 --

Summary Statement of Deficiencies 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: a) Based on surveyor review of the Procedure Manual (PM), and interview with the Practice Administrator (PA), the laboratory failed to to have a procedure written for correlation studies for Complete Blood Counts (CBC) performed on the ABX Micros 60 analyzers from Jun 2020 to the date of survey. The PA confirmed on 1/31/23 at 11: 30 am that the laboratory did not have the aforementioned procedure. b) Based on surveyor review of the Procedure Manual (PM), and interview with the Practice Administrator (PA), the laboratory failed to to follow their procedure for "Quality Assurance" for Complete Blood Counts (CBC) performed on the ABX Micros 60 analyzers from Jun 2020 to the date of survey. The findings include: 1) The PM stated "Monthly Quality Control (QC) is reviewed by lab director using Level Jennings Monthly Print". 2) There was no documented evidence that the aforementioned procedure was performed. 3) The PA confirmed on 1/31/23 at 11:30 am that the laboratory did not follow the above mentioned procedure. 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 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 must document all test result comparison activities. This STANDARD is not met as evidenced by: Based on surveyor review of the Laboratory Records and interview with the Practice Administrator (PA), the laboratory failed to perform and document correlation studies for Complete Blood Counts (CBC) performed on the ABX Micros 60 analyzers twice per year from June 2020 to the date of the survey. The PA confirmed on 1/31/23 at 12: 20 pm that the laboratory did not do correlation studies. D6013 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(ii) 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)(3) Ensure that-- (e)(3)(ii) Verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method; This STANDARD is not met as evidenced by: Based on the lack of Performance Specification (PS) records and interview with the Practice Administrator (PA), the Laboratory Director (LD) failed to ensure that PS procedures performed for Hematology tests performed on the ABX Micros 60 analyzers Micros 1 and Micros 2 were adequate from June 2020 to the date of survey. The findings include: 1. There was no evidence that linearity was performed on both analyzers. 2. There was no evidence that a Reference Range was verified on both analyzers 3. There was no evidence that precision and accuracy were performed on on both analyzers 4. The PA confirmed on 1/31/23 at 12:15 pm that PS records were not adequate. 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: Based on surveyor review of the Quality Control (QC) records, Procedure Manual (PM) and interview with the Practice Administrator (PA), the Laboratory Director (LD) failed to ensure that the QC program was maintained for laboratory services provided from June 2020 to the date of the survey. The findings include: 1. There was no documented evidence that the QC program defined in the PM was followed. Cross refer D5401 2. The PA confirmed on 1/31/23 at 11:30 am the LD did not ensure the QC plan was maintained. . -- 2 of 2 --

Summary Statement of Deficiencies 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 surveyor review of the Competency Assessment (CA) records and interview with the Testing Personnel (TP), the laboratory failed to perform a CA on six out of six TP from May 2018 to the date of survey. The TP # 1 listed on CMS form 209 confirmed on 8/20/19 at 12:20 pm that CA was not performed on TP. 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 Testing Personnel (TP), the laboratory failed to follow the Quality Control (QC) Guidance procedure for Hematology tests performed on the ABX Micros 60 in the calendar year 2018. The finding includes: 1. The PM stated to verify new QC before use. 2. There was no documented evidence QC verification was performed from: a. 3/5 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 -- /18 to 6/25/18 b. 6/25/18 to 11/5/18 3. Old QC expired 12/5/18 but the new QC lot was verified 12/31/18. 4. The TP #1 listed on CMS form 209 confirmed on 8/20/19 at 1:30 pm that the laboratory did not follow the PM. 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 delegate competency evaluation to a qualified person for the performance of Complete Blood Count analysis from 8/22/17 to the date of the survey. The TP # 1 confirmed on 8/20/19 at 1: 00 pm that LD did not delegate the evaluation of competency to a qualified person. 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: Based on surveyor review of Personnel Files (PF) and interview with the Testing Personnel (TP), the Laboratory Director failed to have education and training documented for all Testing Personnel from 8/22/17 to the date of the survey. The findings include: 1. A review of PF revealed: a. Two out of six TP did not have diplomas. b. Three of four new TP did not have training records. 2. The TP #1 listed on CMS form 209 confirmed on 8/20/19 at 12:40 pm that all education and training records were not available. -- 2 of 2 --