Los Alamitos Hematology/Oncology

Summary Statement of Deficiencies D2121 HEMATOLOGY CFR(s): 493.851(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on surveyor review of the API proficiency testing evaluation report for the third event of 2022 and interview with the laboratory staff on 04/22/2024 at 11:30 AM, the laboratory failed to attain a score of at least 80 percent for monocytes for the 3rd event of 2022. The findings include: 1) The laboratory performed Complete Blood Count (CBC) test using HORIBA ABX Micros 60 Analyzer. The laboratory participated in the American Proficiency Institute (API) proficiency testing program for the CBC test in 2022, 2023 and 2024. The laboratory attained a score of 40 percent for monocytes for the 3rd event of 2022, which was unsatisfactory for the testing event. Therefore, the accuracy of the laboratory's test results cannot be assured and may have potential to harm patients. 2) On 04/22/2024 at 11:30 AM, the laboratory testing personnel confirmed that the laboratory attained a score of 40 percent for monocytes and the laboratory director signed the proficiency testing performance evaluation form. 3) The laboratory's testing declaration form, signed by the laboratory director on 04/19/2024 stated that the laboratory performed approximately 8,000 tests in hematology, annually. D2128 HEMATOLOGY CFR(s): 493.851(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, 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 -- 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 surveyor review of the API proficiency testing evaluation report for the first and third events of 2022 and interview with the laboratory staff on 04/22/2024 at 11: 30 AM, the laboratory failed to take remedial action for the unacceptable results of Monocytes and Leukocytes in the first and third events of 2022, respectively. The findings include: 1) The laboratory performed Complete Blood Count (CBC) test using HORIBA ABX Micros 60 automated analyzer. The laboratory participated in the American Proficiency Institute (API) proficiency testing program for the CBC test in 2022, 2023 and 2024. In 2022, the laboratory had one unacceptable result for monocytes out of 5 samples during the first event and one unacceptable result for leukocytes count out of 5 samples during the third event. The laboratory failed to take remedial action for the unacceptable results for monocytes and leukocytes. Therefore, the accuracy of the laboratory's test results cannot be assured and may have potential to harm patients. 2) On 04/22/2024 at 11:30 AM, the laboratory testing personnel confirmed that the laboratory did not take remedial action for unacceptable hematology results. 3)The laboratory's testing declaration form, signed by the laboratory director on 04/19/2024 stated that the laboratory performed approximately 8,000 tests in hematology, annually. 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 laboratory's personnel competency evaluation policy and documents, and interview with the laboratory staff on 04/22/2024 at 11:30 AM, the laboratory failed to have and follow written policies and procedures to assess employee. The findings include: 1) The laboratory did not have a written policy and procedure to assess employee. The laboratory did not perform competency assessment of any of the 3 testing personnel in 2023 and 2024. The last competency evaluation for the testing personnel were performed on 01/28/2022. Therefore, the competency of the testing personnel cannot be assured and may have potential to harm patients as incompetent personnel might report incorrect results. 2) On 04/22/2024 at 11:30 AM, the laboratory testing personnel confirmed the laboratory did not have policy and procedure for personnel competency training and all three testing personnels did not have a competency evaluation in 2023 and 2024. 3) The laboratory's testing declaration form, signed by the laboratory director on 04/19/2024 stated that the laboratory performed approximately 8,000 tests in hematology, annually. D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process. (b) The -- 2 of 5 -- laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on surveyor review of the Levy-Jennings graphs and interview with the laboratory staff on 04/22/2024 at 11:30 AM, the laboratory failed to monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. The findings include: 1) The laboratory did not monitor over time the accuracy and precision of test performance. From 07/03/2023 to 07/31/2023, there was a shift in the Levy-Jennings graph for platelet counts, MCV and RBC, and from 03/02/2023 to 05/05/2023, there was a shift for RBC, HGB, HCT and the laboratory did not monitor them and failed to take action to correct the problems. Therefore, the accuracy of the laboratory's test result cannot be assured and might have had harmed patient. 2) On 04/22/2024 at 11:30 AM, the laboratory testing personnel confirmed the laboratory did not review the Levy-Jennings graphs to monitor the trend and shift. 3) The laboratory's testing declaration form, signed by the laboratory director on 04/19 /2024 stated that the laboratory performed approximately 8000 tests in hematology, annually. D5779

Summary Statement of Deficiencies D2121 HEMATOLOGY CFR(s): 493.851(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on review of the laboratory's API (American Proficiency Institute) proficiency testing result reports in 2019, 2020 and the Q1 2021 PT records, and interview with the laboratory testing personnel (TP), it was determined that the laboratory failed to attain a score of at least 80 percent of acceptable responses for each analyte in the CBC (complete blood cell count) testing was unsatisfactory analyte performance for the testing event. The findings included: a. The laboratory used Horiba Petra 60+C (Horiba) hematology instrument to perform CBC and report the following parameters: WBC, WBC with 5-part automated cell differential, RBC, Hemoglobin (Hgb), Hematocrit (Hct) and Platelet count (Plt). b. The laboratory enrolled its proficiency testing with API PT provider, to ensure the accuracy, reliability, and timely of the CBC testing, c. The laboratory attained scores of 0% for all the parameters identified in item (a) above in the 3rd 2019 the 3rd 2020 API PT events which were unsatisfactory analyte performance for the testing events. d. The laboratory performed in approximately 400 patient samples monthly. e. The laboratory TP affirmed (5/17 /21 @ 11:35 am) that the laboratory attained 0% for all the CBC parameters in both the 3rd 2019 and the 3rd 2020 API PT events which were unsatisfactory analyte performance for the testing events. 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 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 -- activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on review of the final patient test result reports from the End-user (destination point of the patient test result report), lack of instrument printouts, and interview with the laboratory testing personnel (TP), it was determined that the laboratory failed to retain patient test records for at least 2 years, including instrument printouts, transcribed data, and failed to ensure that the original and the transcribed/transmitted copy were retained or retrievable. The findings included: a. The laboratory used Horiba Pentra 60+C (Horiba) to perform complete blood cell count (CBC) testing and reported WBC, WBC with 5 parts automated cell differentials, RBC, Hemoglobin (Hgb), Hematocrit (Hct), and Platelet count (Plt). b. Beginning in January 2021, the laboratory used an interface computer system, CureMD, to transmit the patient test results directly from Horiba to the End-user, where the in-house providers can review and monitor the patient test results directly online. c. At the time of the survey (5/17 /21 @ 11:55 AM) the laboratory TP was not able to retrieve instrument printout of the patient test results performed previously. d. The TP affirmed that the instrument was not able to retrieve previous patient test results after the Horiba IT personnel completed the interface installation. 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 review of lack of the records for laboratory's validation/verification of the newly installed computer interface system, CureMD, and interview with the laboratory testing personnel (TP), it was determined that the laboratory failed to perform and document the validation/verification of the new computer interface system to demonstrate that it can obtain performance specifications as the manufacturer claimed, and document all the activities to ensure the accuracy, reliability, and timely of the testing process from the point of data entry (whether interfaced or entered manually) to the final report destination/End-user. The findings included: a. The laboratory used Horiba Petra 60+C (Horiba) to perform CBC (complete blood cell count). b. The laboratory failed to show the documents that the newly installed interface computer system could demonstrate that it can obtain performance specifications as the manufacturer claimed, and failed to document all the activities to ensure the accuracy, reliability, and timely of the testing process from the point of data entry (whether interfaced or entered manually) to the final report destination/End-user. D5801 TEST REPORT CFR(s): 493.1291(a) -- 2 of 4 -- The laboratory must have an adequate manual or electronic system(s) in place to ensure test results and other patient-specific data are accurately and reliably sent from the point of data entry (whether interfaced or entered manually) to final report destination, in a timely manner. This includes the following: (a)(1) Results reported from calculated data. (a)(2) Results and patient-specific data electronically reported to network or interfaced systems. (a)(3) Manually transcribed or electronically transmitted results and patient-specific information reported directly or upon receipt from outside referral laboratories, satellite or point-of-care testing locations. This STANDARD is not met as evidenced by: Based on review of the laboratory's patient test result reports, the report format, and interview with the laboratory testing personnel (TP), it was determined that the laboratory failed to have an adequate procedure or electronic system(s) in place to ensure test results and other patient-specific data were accurately and reliably sent from the point of data entry (whether interfaced or entered manually) to final report destination, in a timely manner or correcting the laboratory director's name. The findings included: a. The laboratory use Horiba Petra 60+C(Horiba) hematology analyzer to perform CBC (complete blood cell count). b. At the time of survey (5/17 /21 @ 12:15 PM), the laboratory pulled 6 patient's testing result reports between March and April 2021. c. The survey requested the laboratory to provide the instrument printouts to verify the accuracy of the patient test results. d. The laboratory failed to provide the patient's instrument printout (see D-5421) e. The patient test result reports showed incorrect laboratory director's name f. The laboratory TP acknowledged that the instrument could not print out the previous copies after the newly interface computer system been implemented in January 2021. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) 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)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on review of the laboratory's API (American Proficiency Institute) proficiency testing result reports in 2019, 2020 and the Q1 2021 PT records, and interview with the laboratory testing personnel (TP), it was determined that the laboratory director failed to ensure that the proficiency testing samples were tested as required. The findings included: a. The laboratory director failed to ensure the proficiency testing samples were tested as required. b. The laboratory used Horiba Petra 60+C hematology instrument to perform CBC and report the following parameters: WBC, WBC with 5-part automated cell differential, RBC, Hemoglobin (Hgb), Hematocrit (Hct) and Platelet count (Plt). c. The laboratory enrolled its proficiency testing with API PT provider to ensure the accuracy, reliability, and timely of the CBC testing, d. The laboratory failed to attain a score of 80% for any of the parameters identified in item (a) above in both of the 3rd 2019 the 3rd 2020 API PT events which were unsatisfactory analyte performance for the testing events, see D-2121. -- 3 of 4 -- D6023 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(6) 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)(6) Ensure the establishment and maintenance of acceptable levels of analytical performance for each test system; This STANDARD is not met as evidenced by: Based on review of lack of the records of instrument print-out patient test result reports, lack of the documents of validation/evaluation activities of the Horiba Petra 60+C (Horiba) hematology analyzer with an interface computer system, CureMD, and review of the laboratory's API (American Proficiency Institute) proficiency testing result reports in 2019, 2020 and the Q1 2021 PT records, and interview with the laboratory testing personnel (TP), it was determined that the laboratory director failed to assure the establishment and maintenance of acceptable levels of analytical performance for each test system the laboratory performed, and to assure good quality laboratory operation, and to ensure the accuracy, reliability, and timely of the patient test result reports from the point of data entry (whether interface or enter manually) to final report destination. The findings included: a. The laboratory director failed to maintain the acceptable levels of analytical performance for each test system the laboratory performed and failed to assure the good quality laboratory operation. b. The laboratory used Horiba to perform CBC and report the following parameters: WBC, WBC with 5-part automated cell differential, RBC, Hemoglobin (Hgb), Hematocrit (Hct) and Platelet count (Plt). c. Horiba IT engineer installed an interface computer system, CureMD, with Horiba analyzer, and implemented in January 2021, so that the End-user be able to review and monitor the patient's test results, see D- 5421 and D-5801. d. The laboratory failed to retain the patient test result's instrument printouts for at least two years, see D-3031 -- 4 of 4 --

Summary Statement of Deficiencies D5200 GENERAL LABORATORY SYSTEMS CFR(s): 493.1230 Each laboratory that performs nonwaived testing must meet the applicable general laboratory systems requirements in 493.1231 through 493.1236, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the general laboratory systems and correct identified problems specified in 493.1239 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on the severity of the deficiencies cited herein, the Condition for General Laboratory Systems was not met. The laboratory failed to follow the written laboratory policy and procedure to assess employee competency (See D6030, D6054); failed to at least twice annually (D6053). The laboratory failed to 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 (See D5291). 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 review of (10) random patient sampling from 01/25/2017 to 06/07/2018, 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 -- review quality control documents, absence of laboratory policies and procedures and an interview with the laboratory personnel, it was determined that the laboratory failed to 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. a. On 01/09/2019 (survey date) no documentation could be retrieve to show that the laboratory had a written policy for an ongoing mechanism to monitor, assess and, when indicated, correct problems identified. This correction process involves identification and resolution of the problem, and development of policies that will prevent recurrence. Policies for preventing problems that have been identified must be written as well as communicated to the laboratory personnel and other staff, clients, etc., as appropriate (D6030). b. The testing person confirmed on 01 /09/2019 12:00 that the laboratory did in have a written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the general laboratory systems. C. The annual testing declaration 01/09 /2019 estimated 40,000 hematology tests resulted and reported. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on the severity of the deficiencies cited herein, the Condition: Laboratories Performing Moderate Complexity Testing: Laboratory director was not met. The laboratory director of moderate complexity testing failed to ensure quality testing was monitored and evaluated for the overall quality of the analytical systems and to correctly identify problems for testing performed. (See D5791, D5891) D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (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 analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on the ABX pentra 60 ct hematology analyzer quality control (QC) record review, ten (10) random patient sampling from 01/25/2017 to 06/07/2018 and a testing personnel interview, the laboratory failed to have written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in 493.1251 through 493.1283. The findings included: a. On 01/09/2018 (survey date), it was found that the laboratory had no written quality control (QC) policies and procedures. From 01/03 /2017 through 02/16/2018 the laboratory performed three (3) levels of hematology controls daily (in-use) and when quality controls failed they were repeated numerous -- 2 of 5 -- times with no