Manhattan Medical Group, Llc

Summary Statement of Deficiencies 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 performed; This STANDARD is not met as evidenced by: Based on the review of the CMS 209, 2023 training records, test report records, and interview with Testing Personnel (TP) #1, the technical consultant failed to ensure one of five testing personnel received adequate training prior to performing patient testing. Findings: 1. Review of the CMS 209 personnel form revealed two new TP since last survey on 8/22/22. 2. Request was made for the training documentation on the new TP. No documentation of training was provided on TP #5 at the time of survey. 3. Test report records revealed 73 non-waived test results on seven patients were reported from 2/16/23 to 8/7/23. 4. Interview with TP #1 on 4/11/24 at 3:30 p.m. confirmed, the technical consultant failed to ensure one of five testing personnel received adequate training prior to performing patient testing. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

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: Based on the review of proficiency testing (PT) records, the laboratory failed to successfully participate in PT from American Proficiency Institute (API) under the specialties: 1. Routine Chemistry for the regulated analytes: pCO2 Blood Gas. See D2096. 2. Hematology for the regulated analytes overall score derived from: Prothrombin time, Hematocrit (HCT) and Hemoglobin (HGB). See D2130. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) 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 -- Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a desk review of PT scores from the provider API under Routine Chemistry for the regulated analyte pCO2 and phone interview revealed the following: 1 .Second Event Chemistry 2021 revealed a score of 60% for pCO2. 2. Third Event Chemistry 2021 revealed a score of 0% for pCO2 3. Phone interview with the lab manager on 11 /4/21 at 2:00 p.m. confirmed, the laboratory failed to achieve an acceptable score of 80% or higher for two of three consecutive testing events on the regulated analyte pCO2. 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. This STANDARD is not met as evidenced by: Based on a desk review of PT scores from the provider API under the specialty Hematology for the regulated analytes of hematocrit (HCT), hemoglobin (HGB) and prothrombin time, and phone interview revealed the following: 1. Second Event Hematology 2021 revealed an overall score of 66% derived from 100% HCT, 100% HGB and 0% prothrombin time. 2. Third Event Hematology 2021 revealed an overall score of 0% derived from 0% HCT and 0% HGB. 3. Phone interview with the lab manager on 11/4/21 at 2:00 p.m. confirmed, the laboratory failed to achieve an acceptable score of 80% or higher for two of three consecutive testing events on the specialty Hematology. -- 2 of 2 --