Oncology Hematology Care Of Connecticut

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 record review and staff interview, the laboratory failed to follow its established procedure manual in the specialty of Hematology. Findings include: 1. Record review on 5/10/22 of the laboratory's procedure manual for calibration verification revealed Hematology analyzer calibrations are to be performed twice annually. 2. Record review on 5/10/22 of the Medonics M series hematology analyzer calibration log revealed the lack of documentation of semiannual calibration for the second half of the year 2020. 3. Staff interview with the technical consultant and the laboratory director on 5/10/22 at 1245 PM confirmed the above findings. 4. The laboratory performs 42,000 hematology tests annually. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) 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 -- The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

Summary Statement of Deficiencies D0000 A proficiency testing desk review of the Oncology & Hematology Care of Connecticut LLC Laboratory was conducted pursuant to 42CFR Part 493 of the Clinical Laboratory Improvement Amendments (CLIA) of 1988. 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 record review of proficiency testing (PT) data report (Report 155) and graded results from Medical Laboratory Evaluation (MLE), the laboratory failed to achieve successful participation in PT for the regulated analyte of cell identification or 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 -- white blood cell differential (cell id/wbc diff) in the specialty of hematology. The laboratory received unsatisfactory scores for events 1 and 3 of 2021. Refer to D2127, D2128, D2130. D2127 HEMATOLOGY CFR(s): 493.851(d) Failure to return proficiency testing results to the proficiency testing program within the time frame specified by the program is unsatisfactory performance and results in a score of 0 for the testing event. This STANDARD is not met as evidenced by: Based on record review and phone interview with the technical consultant (TC), the laboratory failed to submit proficiency testing (PT) results on time during event 3 of 2021 for the specialty of hematology. Findings include: 1) Record review on 12/23/21 of the CMS CASPER PT report, 155D, revealed a score of 0 for analyte 765, cell identification or white blood cell differential (cell id/wbc diff), for event 3, 2021. 2) Record review on 12/23/21 of the Medical Laboratory Evaluation (MLE) instructions accompanying event 3 (ME3) revealed results had to be returned by the deadline 10/1 /21. 3) Record review on 12/23/21 of 'Boule (DCS) Medonic M series' instrument print out for MLE-ME3 revealed specimens HD11-HD15 were run on 9/28/21. 4) Phone interview on 12/20/21 at 11:20 AM with the TC revealed specimen results were not submitted to MLE. 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, 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 and phone interviews, the laboratory failed to undertake appropriate action necessary to correct unsatisfactory performance during proficiency testing (PT) for the analyte of cell identification or white blood cell differential (cell id /wbc diff) for events 1 and 3 of 2021 in the specialty of hematology. Findings include: 1) Record review on 12/23/21 of the CMS CASPER PT report, 155D, revealed the following: a. Event 1 2021: score 66 for the analyte 765 cell id/wbc diff. b. Event 3 2021: score 0 for analytes 765 Cell Id/WBC Diff, 775 RBC, 785 HCT (Non-waived), 795 HGB ( Non-waived), 805 WBC, and 815 Platelets 2) Record review on 12/23/21 of the "Proficiency Testing Evaluation 2021 MLE-ME1" revealed the following: a. Samples HD1-HD5 had unacceptable results for granulocyte/neut (percent). b. The analyte cell id/wbc diff received an overall score of 66% resulting in unsatisfactory performance for the analyte. c. No

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 record review and staff interview, the laboratory failed to have a policy in place to assess the competency of all laboratory personnel. Findings include: 1. Review of the laboratory personnel competency records on 9/10/19 revealed the following: a. The laboratory did not have policy in place to assess the competency of the technical consultant (TC) and clinical consultant. b. Competency documentation for the above laboratory personnel was not available. 2. Staff interview with the TC on 9/10/19 at 10:10 AM confirmed the laboratory did not have a policy in place to assess the competency of the above laboratory personnel and they were not assessed. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: 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 -- Based on observation, record review and staff interview, the laboratory failed to ensure proper storage of reagents, patient samples and quality control (QC) materials in the specialty of hematology. Findings include: 1. Record review on 9/10/19 of the laboratory's temperature log for the specimen refrigerator and freezer revealed: a. Refrigerator temperature was documented as 6 degree Celsius (C)in 2018 and through out 2019 to-date. b. Freezer temperature was documented as -15 degree C in 2018 and through out 2019 to-date. 2. Surveyor observation on 9/10/19 at 11:45 AM revealed: a. A thermometer (Cooper SN#54546-4) kept in the refrigerator was due for calibration on 12/23/16. It was observed that the temperature was showing as 13C for the above thermometer. b. A second thermometer intended to measure refrigerator temperature was kept in the freezer. c. Another thermometer (Cooper MSN#54546-1) kept in the freezer was due for calibration on 12/23/16. d. The laboratory is storing reagents, patient samples and QC materials in the refrigerator. 3. Current calibration documentation for the above Cooper thermometers were functioning properly was not available. 4. Record review of the QC package insert on 9/10/19 revealed it needs to be to stored at 2-8 degrees C. 5. Staff interview with the technical consultant on 9/10 /19 at 12:30 PM confirmed the above findings. 6. The laboratory performs 2,000 complete blood count tests annually. 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: Based on surveyor observation and staff interview, the laboratory failed to document centrifuge function checks every 6 months to ensure platelet poor plasma (PPP) is obtained. Findings include: 1. Record review on 9/10/19 of the laboratory's procedure manual titled 'Platelet poor plasma check' revealed "PPP procedure must be performed semi-annually and recorded in the QC report for review by the director". 2. Record review on 9/10/19 of the centrifuge maintenance records reveled: a. The above procedure is not followed and documentation for semi-annual PPP is not available. b. The laboratory failed to provide documentation of yearly centrifuge taching for 2017 and 2018. 3. Staff interview with the technical consultant (TC) on 9/10/19 at 11:20 AM, confirmed the above findings. The TC further stated coagulation specimens are sent to an outside reference laboratory. 4. This is a repeat deficiency. 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 -- 2 of 4 -- 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 staff interview, the laboratory failed to perform calibration of the hematology analyzer in the required frequency. Findings include: 1. Calibration record review on 9/10/19 revealed the following: a. Medonic M hematology analyzer: SN# 20806 was calibrated on 10/4/18. b. Records of semi- annual calibration was not available since 10/4/18. 2. Record review on 9/10/19 of the procedure manual titled "Medonic M Calibration" revealed 'In order to verify the accuracy of CBC results produced by the hematology instrument, a calibration must be performed semi-annually'. 3. Staff interview with the technical consultant (TC) on 9 /10/19 at 11:30 AM confirmed the six month calibrations were not performed in a timely manner as stated in the procedure. TC further stated he/she was under the impression semiannual calibration was performed along with preventive maintenance. 4. This is a repeat deficiency and the laboratory performs 2,000 CBC tests annually. D5481 CONTROL PROCEDURES CFR(s): 493.1256(f)(g) (f) Results of control materials must meet the laboratory's and, as applicable, the manufacturer's test system criteria for acceptability before reporting patient test results. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to follow the laboratory policy for acceptable quality control (QC) prior to reporting patient test results in the specialty of hematology. Findings include: 1. Record review on 9/10/19 of the laboratory procedure titled 'Daily Quality Control and Action Limits, Hematology' revealed "three levels of assayed whole blood controls are run on each day of operation, on the analyzer (Medonic M). Should the result of any parameter of any control exceed the acceptable limits, that parameter is considered out of control and the control(s) need to be repeated and within acceptable limits before patient results may be released". 2. Record review of the March 25, 2019 'daily QC log' on 9 /10/19 revealed the laboratory director reviewed and signed off the background counts and the low, normal and high controls. 3. Record review of the Medonic March 2019 'Quality Control Summary Report' on 9/10/19 revealed asterisks next to low and high QC results on March 25, 2019. 4. Record review of the March 25, 2019 Medonic instrument quality control (QC) printouts on 9/10/19 revealed the following: a. Low QC: Lot # 2181121 run indicates an error code 'EC'. b. High QC: Lot # 2181123 run indicates an error code 'EC'. 5. Record review of the Medonic operators manual on 9 /10/19 revealed the error code 'EC' means expired controls. Documentation for