Regional Cancer Care Associates

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: Based on surveyor review of the Procedure Manual (PM), and interview with the Testing Personnel (TP), the laboratory failed to have a procedures for a method compression between the two Horiba analyzers for Hematology testing from April 2023 to the date of survey. The TP confirmed on 7/24/24 at 12:30 pm that the laboratory failed to have the above mentioned procedure. D5479 CONTROL PROCEDURES CFR(s): 493.1256(e)(5)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (5) Follow the manufacturer's specifications for using reagents, media, and supplies and be responsible for results. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on surveyors observation of Quality Control (QC) material in use and interview with the Testing Personnel (TP), the laboratory failed to follow Manufacturers Specifications (MS) for controls from 6/1/22 to the date of survey. The finding includes: 1. Controls in use did not have correct expiration dates documented as per MS. 2. The TP confirmed on 7/24/24 at 11:20 am that MS were not followed. 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 -- 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 Laboratory Records and interview with the Testing Personnel (TP), the laboratory failed to perform and document correlation studies for Complete Blood Counts (CBC) performed on the Horiba analyzers twice per year from April 2023 to the date of the survey. The TP confirmed on 7/24/24 at 11:20 am 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 surveyor review of the Performance Specification (PS) records and interview with the Testing Personnel (TP), the Laboratory Director (LD) failed to ensure that PS procedures performed on Horiba analyzer were adequate from April 2023 to the date of survey. The findings include: 1. The LD did not review and sign the PS results. 2. There was no source for the patient Reference Range. 3. The TP confirmed on 7/24/24 at 10:35 am that PS records were not adequate. -- 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% or more for Hematology tests performed with the American Proficiency Institute (API). The finding includes: 1) The laboratory scored 60% for Blood Cell Identification in events 2nd event - 2022 and 1st event - 2023 with 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 surveyor review of Proficiency Testing (PT) and interview with the Testing Personnel (TP), the laboratory failed to achieve a score of 80% or more in two out of three events for for Hematology tests performed with the American Proficiency Institute (API). The findings include: 1) The laboratory scored 60% for Blood Cell Identification in events 2nd event - 2022 and 1st event - 2023 with 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 are performed satisfactorily and compliance with the CLIA regulations are maintained. -- 2 of 2 --

Summary Statement of Deficiencies D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) 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 surveyor review of the Quality Control (QC) records and interview with the Office Manager (OM), the laboratory failed to retain all QC records for tests performed on the Horiba ABX Pentra 60C+ from January 2020 to the date of survey. The finding includes: 1. All Hematology QC that was repeated due to a failed QC run were not retained. 2. The OM confirmed on 6/1/2022 at 11:00 am that the all QC records were not retained. 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 Office Manager (OM), the laboratory failed to review and evaluate results when they received an unacceptable score in Hematology tests performed with the American Proficiency Institute (API) for the second and third event in the calendar year 2021. The findings include: 1. The laboratory received an "unacceptable" Grade for Blood Cell Identification sample BCI-15 event 3, 2021 2. The laboratory received an "Not Graded 2" Grade for Blood Cell Identification sample BCI-07 event 2, 2021 3. There was no documented evidence that the laboratory investigated the failures. 4. 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 -- The OM confirmed on 6/1/2022 at 10:45 am that the laboratory did not review and document an evaluation of unacceptable PT results. 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 Operators Manual (OM) and interview with the Office Manager (OM), the laboratory failed to follow their procedure for "Error Flags" from 1/10/22 to the date of survey. The finding include: 1. OM page 113 "6. Results Interpretation", "6.1 General Alarms" "6.1.1. Parameter Reject" states as follows: a) "6.1.1. Parameter Reject, A Parameter reject is show by "*" and indicates that the result is not coherent. The sample has to be checked. A rejected result cannot be validated." b) Sample ID 508734, 151393,149936, White Blood Cell Count (WBC) were flagged with an "*" on 5/25/2022 and were not checked and rerun . c) Sample ID 309534, 119295, WBC were flagged with an "*" on 5/31/2022 and were not checked and rerun . 2. OM page 114 "6. Results Interpretation", "6.1 General Alarms", "6.1.2 Suspicion" states as follows: a) "LMNE Suspicion", "Condition: "!" on WBC", "Action: The result is presumed erroneous, it must be checked with a rerun sample or with a reference method if the second result is still alarmed." b) Sample ID 102972, 108148, 264660, 510529 were flagged with an "!" on 5/25/2022 and were not checked and rerun. c) Sample ID 99042, 103075, 118979, 510529, were flagged with an "!" on 5/27/2022 and were not checked and rerun. d) Sample ID 509101, 480693, 102344, 97417, 506537, 510529, were flagged with an "!" on 5/31/2022 and were not checked and rerun. 3. The OM confirmed on 6/1/2022 at 11:21 am the policy "6. Results Interpretation" were not being followed. D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (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 (2)(ii) Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and (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 Calibration (C) records, User Manual (UM) and interview with the Office Manager (OM), the laboratory failed to perform, document and meet acceptable limits for all Calibration results and procedures at least once every six months for Hematology Tests performed on the Horiba Pentra 60c+ analyzer -- 2 of 4 -- in the calendar year 2021. The findings include: 1. A review of C records revealed that the laboratory failed to perform and document "repeatability" a) The UM states in the "Preparation for Calibration" procedure to "perform a repeatability study by running one normal patient sample ten times mixing well before each run. Ensure repeatability is acceptable by making certain the variation coefficients are displayed in black font" 2. The laboratory last performed C 9/2/2021, but there was no documented evidence CV was performed after that date. 3. C failed meet acceptable limits for White Blood Cell (WBC), Red Blood Cell (RBC), Hemoglobin (HGB), and Platelets (PLT) on 7/17/2020. 4. C Failed to meet acceptable limits for WBC, RBC, and PLT on 1/29/2021 5. The OM confirmed on 6/1/2022 at 11:32 am that the laboratory failed to perform, document and meet acceptable limits for C once every six months. D5783

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: Based on surveyor review of the Procedure Manual (PM), Patient work records and interview with the Office Manager (OM), the laboratory failed to follow their PM policy for "Act Diff #2 Flags and Codes" for Hematology tests ran on the Beckman Coulter AcT diff 2 from 11/21/17 to the date of survey. The finding includes: 1) The PM stated "X flag indicates that one of the multiple Alert criteria was not met. 1. Thoroughly mix and rerun the sample. 2. If the flag does not repeat report result. 3. If flag repeats, clean the aperture as instructed in zapping the aperture. 4. if after cleaning, problem persists contact your Beckman Coulter Representative". a) A review of 10 Patients work records revealed that 10 out of 10 patients results with "X" flag were not rerun. 2) The OM confirmed on 11/12/19at 11:05 am the above mentioned procedures was not followed. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. 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 -- This STANDARD is not met as evidenced by: Based on surveyor observation of the Quality Control (QC) material in use and interview with the Office Manager (OM) the laboratory failed to label the control material used in Hematology testing with an open and new expiration date after opening at the time of survey. The finding includes: 1) There was no open and expiration date written on the QC material. 2) The OM confirmed on 11/12/19 at 10: 10 am controls were not labeled. 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 surveyor review of Calibration Verification (CV) records and interview with the Office Manager (OM), the laboratory failed to perform and document CV procedures at least once every six months for Hematology Testing on the Beckman Coulter AcT diff 2 analyzer in the calendar year 2019. The finding includes: 1. The laboratory performed CV 10/5/18 and 10/2/19. 2. There was no documented evidence that CV was performed every six months. 3. The OM confirmed on 11/13/19 at 11:30 pm CV was not performed every six months. -- 2 of 2 --