Redmed Of Crosstown

Summary Statement of Deficiencies 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 the laboratory policies, proficiency testing (PT) records, and staff interview the laboratory failed to follow their policies for unacceptable results on the Medical Laboratory Evaluation (MLE) PT 2022 event one (one of one event with unacceptable results for 2021, 2022, and 2023). The findings inlcude: 1. Review of the laboratory policies related to PT titled "Proficiency Testing" and "PROTOCOL FOR SUCCESSFUL PERFORMANCE OF PROFICIENCY TESTING" revealed that any score less than 100% the samples should be reran and results evaluated by the technical consultant (TC). 2. Review of the laboratory's MLE PT records revealed 2022 Event one sample HD-3 had unacceptable results for the white blood count (WBC), red blood count (RBC), hemoglobin (Hgb), hematocrit (Hct), and platelet count (PLT) analytes. Documentation of unacceptable result review was not available. 3. Interview on 05/11/2023 at 1:00 p.m. with the technical consultant confirmed the laboratory did not follow their own policy for unacceptable results for the MLE PT event one in 2022. D6045 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(7) (b) The technical consultant is responsible for-- (b)(7) Identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services 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 -- performed; This STANDARD is not met as evidenced by: Based on review of laboratory records, personnel training records, and staff interview, the technical consultant failed to review training documents for four of seven testing personnel (TP) for the new Sysmex XP300 complete blood count (CBC) instrument for patient testing in July 2022. The findings include: 1. Review of laboratory records for the Sysmex XP300 (serial C4846) CBC instrument revealed the laboratory began using the instrument July 2022. 2. Review of the laboratory personnel training records for the Sysmex XP300 CBC instrument revealed the following training documents lacking the signature of the technical consultant: TP one training dated 07/15/2022. TP two training dated 07/14/2022. TP three training dated 07/14/2022. TP four training dated 07/15/2022. 3. Interview on 05/11/2023 at 1:00 p.m. with the technical consultant confirmed the former technical consultant failed to review the training for TP one, two, three, and four for the new Sysmex XP300 CBC instrument for patient testing in July 2022. D6055 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing whenever test methodology or instrumentation changes. The individual's performance must be reevaluated to include the use of the new test methodology or instrumentation prior to reporting patient test results. This STANDARD is not met as evidenced by: Based on review of laboratory records, personnel records, and staff interview, the technical consultant failed to evaluate the competency for four of seven testing personnel (TP) for the use of the new Sysmex XP300 complete blood count (CBC) instrument prior to patient testing in 2022. The findings include: 1. Review of laboratory records for the Sysmex XP300 (serial C4846) CBC instrument revealed the laboratory began using the instrument for patient testing in July 2022. 2. Review of laboratory personnel records revealed no documentation of competency assessment evaluation for TP 1, TP 2, TP 3, and TP 6 (four of seven TP) prior to CBC patient testing with the Sysmex XP300 in 2022. 3. Interview on 05/11/2023 at 1:00 p.m. with the technical consultant confirmed the former technical consultant failed to assess competency for TP one, two, three, and six for the new Sysmex XP300 CBC instrument prior to patient testing in July 2022. -- 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: The laboratory failed to maintain satisfactory proficiency testing (PT) performance for the red blood cell (RBC) analyte for 2018 events two and three resulting in the first unsuccessful occurrence for the RBC analyte. (See D2130) D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. 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 a desk review of the Centers for Medicare and Medicaid Services Casper Report 155 (CMS 155), and the laboratory's 2018 events two and three proficiency testing (PT) reports, the laboratory failed to maintain satisfactory performance for the red blood cell (RBC) analyte for two consecutive events resulting in the first unsuccessful occurrence. The findings incude: 1. Review of the CMS 155 report revealed the following unsatisfactory scores for the RBC analyte: 2018 event two = 60%, 2018 event three = 60%. 2. Review of the laboratory's 2018 event two PT report revealed sample numbers HD-8 and HD-10 had unacceptable grades for RBC, resulting in a score of 60%. 3. Review of the laboratory's 2018 event three PT report revealed sample numbers HD-11 and HD-13 had unacceptable grades for RBC, resulting in a score of 60%, and the first unsuccessful PT occurrence for the RBC analyte. -- 2 of 2 --