Bhmg Ocean Hematology And Oncology

Summary Statement of Deficiencies D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on surveyor review of the Proficiency Testing (PT) records and interview with the Testing Personnel (TP), the laboratory failed to review and evaluate PT results obtained from Medical Laboratory Evaluation (MLE) for Hematology with Auto Differential events performed in 2019. The finding includes: 1. There was no evidence of evaluation documentated. The "CMS Performance Summary" was not signed and dated for MLE-M3 in 2019 2. The TP # 2 as listed on CMS form 209 confirmed on 7 /15/21 at 9:45 am that the laboratory did not review and evaluate all PT results. 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 Testing Personnel (TP), the laboratory failed to review and evaluate results when they received an unacceptable score in Hematology tests performed with the Medical Laboratory Evaluation (MLE) Proficiency Testing for the first event in the calendar year 2019. The findings include: 1. The laboratory received an unacceptable score for Platelet Count sample HD-1 (* Result Unacceptable) 2. The laboratory received an unacceptable score for Hematocrit sample HD-1 (* Result Unacceptable) 3 There was no documented evidence that the laboratory investigated the failures. 4. The TP # 2 as 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 -- listed on CMS form 209 confirmed on 7/15/21 at 9:30 am that the laboratory did not review and document an evaluation of unacceptable PT results. Note: This is a repeat deficiency from survey performed on 4/10/18 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 surveyor review of the Procedure Manual (PM) and interview with the Testing Personnel (TP), the laboratory failed to follow the procedure to verify new Quality Control (QC) material before use from January 2020 to the date of the survey. The TP # 2 listed on CMS form 209 confirmed on 7/15/21 at 10:00 am the laboratory did not follow the procedure to verify new QC lots. 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 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 Proficiency Testing (PT) records and interview with the Testing Personnel (TP), the laboratory failed to attain at least 80% or more for Hematology test performed on the Abbott Cell Dyn Emerald analyzer with the American Association of Bioanalysts. The finding includes: 1. The laboratory received an unacceptable grade in the MLE-M2 2016 event for sample HD-6 through 10 for Red Blood Cell Count and received an CMS analyte score of 0%. 2. The laboratory received an unacceptable grade in the MLE-M2 2016 event for sample HD- 6-7 and HD-9-10 for Hematocrit and received a CMS analyte score of 20%. 3. The TP #1 confirmed on 4/10/18 at 10:55 am that the laboratory failed to achieve at least 80% for Hematology testing. 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. 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 -- This STANDARD is not met as evidenced by: Based on surveyor review of the Proficiency Testing (PT) records and interview with the Testing Personnel (TP), the laboratory failed to undertake appropriate training and employ technical assistance necessary to correct problems associated with PT failures performed with the American Association of Bioanalysts (AAB). The findings include: 1. There was no remedial action taken and documented for unacceptable grade in the MLE-M2 2016 event for sample HD-6 through 10 for Red Blood Cell Count and received an CMS analyte score of 0%. (Refer to D 2121). 2. There was no remedial action taken and documented for unacceptable grade in the MLE-M2 2016 event for sample HD-6-7 and HD-9-10 for Hematocrit and received a CMS analyte score of 20%. (Refer to D 2121). 3. The TP #1 confirmed on 4/10/18 at 10:55 am that