Cancer And Hematology Centers, The

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: A. Based on record review and interview with the Office Manager and Testing Personnel #2 and #7, the laboratory failed to ensure written competency policies established contained all the requirements from subpart M for 8 (Testing Personnel #1 - #8) of 8 Testing Personnel reviewed in 2022 and 2023. Findings include: 1. Record review of the testing personnel competency evaluation records on 1/11/2024 at 9:25 am, revealed for 8 of 8 testing personnel a lack of documentation for the assessment of problem-solving skills. 2. When queried, the Office Manager and Testing Personnel #2 and #7 were not aware of that skill to be evaluated. 3. An interview on 1/11/2024 at 12:45 pm, the Office Manager and Testing Personnel #2 and #7 confirmed the above findings. B. Based on record review and interview with the Office Manager and Testing Personnel #2 and #7, the laboratory failed to establish and implement policies and procedures to assess the competency of personnel serving the roles of Clinical Consultant, Technical Consultant, and Testing Personnel job responsibilities for 23 (April 2022 to January 2024) of 23 months reviewed. Findings include: 1. A review of the laboratory's personnel records revealed a lack of documentation for the competency assessments for the CC, TC, and TP job responsibilities. 2. A review of the laboratory's policy and procedure for assessing competency revealed a lack of job responsibilities for the CC, TC, and TP. 3. An interview on 1/118/24 at 12:45 pm, the Office Manager and Testing Personnel #2 and #7 confirmed the laboratory had not established or implemented a policy or procedure for assessing competency for job responsibilities for the roles listed above. 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 -- D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: . Based on record review and interview with the Office Manager, the laboratory failed to include the patient's scanned final complete blood cell count (CBC) report into the electronic medical records (EMR) for 1 (#5) of 9 patient charts audited. Findings include: 1. Record review revealed for 1 of 9 patient charts audited, the final CBC report for patient #5 tested on 5/25/2023 was not scanned into the patient's EMR file. 2. An interview on 1/11/2024 at 12:45 pm, the Office Manager confirmed the final CBC report for patient #5 was not scanned into the EMR system. 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 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 record review and interview, the laboratory failed to meet the requirements for the specialty in Hematology as specified in 493.1230 through 493.1256, 493.1269, and 493.1281 through 493.1299. Findings include: 1. The laboratory failed to perform calibration for hematology testing on the Beckman Coulter DxH 520 analyzer at least every 6 months. Refer to D5439. 2. The laboratory failed to manually enter the complete blood cell (CBC) count parameters into the electronic medical record (EMR). Refer to D5801. D5431 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(2) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document function checks as defined by the manufacturer and with at least the frequency specified by the manufacturer. Function checks must be within the manufacturer's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: A. Based on observation, lack of documentation, and interview with Testing Personnel #1 (TP1), the laboratory failed to perform and document the traceable thermometer calibration checks as required by the manufacturer before the expiration for 1 (traceable thermometer) of 2 thermometers in use in the laboratory. Findings Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- include: 1. During a tour of the laboratory on 4/28/2022 at 9:57 am, the surveyor observed a traceable thermometer in the Frigidaire refrigerator in use past the expiration date of 11/23/2000. 2. A lack of documentation upon review of the laboratory records revealed the thermometer was not calibrated and/or replaced by the expiration of 11/23/2000. 3. When queried on 4/28/2022 at 9:57 am, TP1 was unaware that an expiration date was present on the thermometer. 4. A interview on 4 /28/2022 at 9:57 am, TP1 confirmed the traceable thermometer was not calibrated and /or replaced by the 11/23/2000. B. . Based on record review and interview with Testing Personnel #1 (TP1), the laboratory failed to perform and document Beckman Coulter DxH 520 hematology analyzer monthly maintenance as required by the manufacturer for 9 of 18 months reviewed. Findings include: 1. A record review of the "DxH 520 Instrument Maintenance Checklist" log revealed a lack of documentation of the monthly maintenance for the following months: a. November and December 2020 b. February - May and October 2021 c. February and March 2022 2. An interview on 4/28/2022 at 1:30 pm, TP1 confirmed the monthly maintenance had not been performed and documented. 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 Testing Personnel #1 (TP1), the laboratory failed to perform calibration for hematology testing on the Beckman Coulter DxH 520 analyzer at least every 6 months for 1 (2021) of 2 years in use. Findings include: 1. A review of the laboratory's calibration documents for the Beckman Coulter DxH 520 hematology analyzer revealed a lack of documentation for the calibrations due in 2021 as follow: Due dates a. 4/2021 b. 12/2021 2. An interview on 4/28/2022 at 11:53 am, TP1 confirmed the laboratory did not perform calibrations at least every 6 months. D5785

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 observation, record review, and interview with Testing Personnel (TP) #1, TP2, and the Office Manager (OM), the laboratory failed to establish written procedures to perform testing on the new Beckman Coulter DxH 520 hematology instrument for 14 (11/4/2020 to 11/18/2020) of 14 days of operation. Findings include: 1. An observation made by the surveyor on 11/18/2020 at 9:18 am during a tour of the laboratory revealed a Beckman Coulter DxH 520 hematology instrument in the laboratory. 2. A review of the laboratory's procedures revealed a lack of procedures to perform the hematology testing for 14 (11/4/2020 to 11/18/2020) of 14 days of operation for the Beckman Coulter DxH 520 instrument. 3. An interview on 11 /18/2020 at approximately 4:00 pm with TP1, TP2, and the OM confirmed the laboratory did not establish procedures to perform hematology testing on the new instrument prior to putting into use. 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) 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 -- (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 record review and interview with Testing Personnel (TP) #1, TP2, and the Office Manager (OM), the laboratory failed to perform the hematology calibration procedures as stated in the operator's manual for 2 ( 10/4/2019 and 10/16/2020) of 5 calibrations reviewed. Findings include: 1. A review of the operator's manual for the Beckman Coulter AcT diff 2 calibration procedure revealed the laboratory is to perform a reproducibility and carryover test prior to performing the calibration. 2. A record review of the calibration documents for 2 of 5 calibrations performed revealed a lack of documentation for the reproducibility and carryover testing as follows: a. 10 /4/2019 b. 10/16/2020 3. On 11/18/2020 at 11:27 am when requested, TP1 was not able to provide the surveyor with the documentation to show the reproducibility and carryover processes were completed prior to the calibration of the hematology instrument. 4. During the interview on 11/4/2020 at 11:27 am, TP1 confirmed the documentation of the reproducibility and carryover were not available. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: . Based on record review and interview with Testing Personnel (TP) #1, TP2, and the Office Manager (OM), the laboratory failed to ensure control procedures were followed according to laboratory-established requirements for 31 testing days out of 2 years reviewed. Findings include: 1. A review of the laboratory's established "Quality Control " procedure revealed in a section titled "QC procedure using COULTER 4C PLUS Cell Control" step 12 states "Do not report patient test results until control values are acceptable." 2. A review of the laboratory's quality control records for the Beckman Coulter AcT Diff 2 hematology analyzer revealed for 31 days of 2 years reviewed the following days had only two of the three levels of controls within acceptable ranges: a. low control out of range 1. 1/10/2019 - 13 patients run 2. 2/14 /2019 - 10 patients run 3. 5/7/2019 - 9 patients run 4. 5/16/2019 - 17 patients run 5. 5 /21/2019 - 7 patients run 6. 5/23/2019 - 10 patients run 7. 6/5/2019 - 14 patients run 8. 6/11/2019 - 10 patients run 9. 6/26/2019 - 11 patients run 10. 1/15/2020 - 5 patients run 11. 2/21/2020 - 1 patient run 12. 3/31/2020 - 9 patients run 13. 4/16/2020 - 11 patients run 14. 7/13/2020 - 15 patients run 15. 7/14/2020 - 10 patients run 16. 8/12 /2020 - 10 patients run 17. 8/17/2020 - 11 patients run 18. 9/2/2020 - 8 patients run b. normal control out of range 1. 1/24/2019 - 6 patients run 2. 1/30/2019 - 7 patients run -- 2 of 4 -- 3. 1/31/2019 - 13 patients run 4. 6/7/2019 - 1 patient run 5. 9/23/2019 - 10 patients run 6. 10/8/2019 - 11 patients run 7. 12/18/2019 - 8 patients run 8. 1/2/2020 - 17 patients run 9. 1/27/2020 - 12 patients run 10. 3/23/2020 - 20 patients run c. high control out of range 1. 8/13/2019 - 7 patients run 2. 11/18/2019 - 15 patients run 3. 3/10/2020 - 7 patients run 3. An interview on 11/18/2020 at approximately 4:00 pm with TP1, TP2 and the OM confirmed all three levels of controls are required to be in range before reporting patient results. D5807 TEST REPORT CFR(s): 493.1291(d) Pertinent "reference intervals" or "normal" values, as determined by the laboratory performing the tests, must be available to the authorized person who ordered the tests and, if applicable, the individual responsible for using the test results. This STANDARD is not met as evidenced by: . Based on record review and interview with Testing Personnel (TP) #1, TP2, and the Office Manager (OM), the laboratory failed to provide reference intervals on test reports for 8 (#8 - #15) of 15 patient charts audited. Findings include; 1. On 11/18 /2020 at approximately 9:15 am, the OM stated that the facility started working with another healthcare entity in 1/1/2020. 2. A record review of patient charts chosen from the daily logs and patient complete blood cell count (CBC) test results entered into the electronic medical record (EMR) system showed for 8 of the 15 charts audited, the test reports did not have a reference range listed on the final report as follows: a. Patient #8 - no Mean Platelet Volume (MPV) b. Patient #9 - no MPV c. Patient #10 - no Red Blood Cell Count (RBC), Hemoglobin (Hgb), and MPV d. Patient #11 - no MPV e. Patient #12 - no RBC, Hgb, and MPV f. Patient #13 - no RBC, Hgb, and MPV g. Patient #14 - no RBC, Hgb, and MPV h. Patient #15 - no RBC, Hgb, and MPV 3. During an interview on 11/18/2020 at approximately 4:00 pm, TP1, TP2, and the OM confirmed the final CBC report in the EMR since the joining with the new healthcare entity did not contain all the analyte reference ranges. D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (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. This STANDARD is not met as evidenced by: . Based on record review and interview with Testing Personnel (TP) #1, TP2, and the Office Manager (OM), the Technical Consultant (TC) failed to evaluate the competency of testing personnel performing the hematology testing for 8 (TP1, TP2, TP3, TP4, TP5, TP6, TP7, and TP8) of 8 testing personnel listed on the CMS-209 form. Findings include: 1. A record review of testing personnel competency assessments revealed testing personnel competencies were assessed by a "reviewer" TP1 and a TP no longer listed on the CMS-209 for the following: a. TP1 assessed by employee no longer listed on the CMS-209 with an assessment date of 2/27/2019. b. TP2 assessed by TP1, assessment dates of 3/16/2020 and 9/10/2020. c. TP3 assessed by TP1, assessment dates of 2/28/2019 and 4/6/2020. d. TP4 assessed by TP1, assessment dates of 2/27/2019 and 5/9/2020. e. TP5 assessed by TP1, assessment -- 3 of 4 -- dates of 2/28/2020 and 8/19/2020. f. TP6 assessed by TP1, assessment dates of 5/14 /2019 and 5/7/2020. g. TP7 assessed by TP1, assessment dates of 8/16/2019, 3/20 /2020, and 5/7/2020. h. TP8 assessed by TP1, assessment dates of 2/27/2019 and 5/8 /2020. 2. A record review revealed the laboratory did not have a policy and procedure to show the technical consultant/supervisor is responsible for assessing the competency of the testing personnel. 3. An interview on 11/18/2020 at approximately 4:00 pm, TP1, TP2, and the OM confirmed TP1 and an employee no longer listed on the CMS-209 assessing the TP competencies was not qualified as a TC and not listed on the CMS-209 form as a TC. -- 4 of 4 --