Med-Ped Healthcare Llc

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 review of the federal proficiency testing data report and review of the comparative evaluation summery from American Proficiency Institute (API) proficiency testing (PT) program, the laboratory failed to successfully participate in the API PT program for hematology testing, in which the laboratory is certified under CLIA. (Refer to D2127 and D2130) D2127 HEMATOLOGY CFR(s): 493.851(d) 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 -- 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 review of the federal proficiency testing data report and review of the comparative evaluation summery from American Proficiency Institute (API) proficiency testing (PT) program, the laboratory failed to successfully participate in the API PT program for hematology testing, the following analyte was noted as failed in the 2020 2nd event. Findings: American Proficiency Institute 2020 2nd event Hematology 0% 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 review of the federal proficiency testing data report and review of the comparative evaluation summery from American Proficiency Institute (API) proficiency testing (PT) program, the laboratory failed to successfully participate in the API PT program for hematology testing, the following analyte was noted as failed in the 2020 2nd event and the 2019 3rd event. Findings: 1. American Proficiency Institute 2020 2nd event hematology Cell Identification or White Blood Cell Differential 0% 2. American Proficiency Institute 2019 3rd event hematology Cell Identification or White Blood Cell Differential 0% D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on review of the federal proficiency testing data report and review of the comparative evaluation summery from American Proficiency Institute (API) proficiency testing (PT) program, the laboratory director failed to ensure the laboratory successfully participated in the API PT program for hematology testing, in which the laboratory is certified under CLIA. (Refer to D2127 and 2130) D6019 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iv) 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)(iv) Ensure that an approved

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 review of proficiency testing (PT) records and interview with the technical consultant (TC), the laboratory did not perform a review of all PT results. Findings: 1. The laboratory did not perform an evaluation of the 2018 3rd event Hematology. 2. The PT results were not reviewed and signed by the laboratory director nor the TC. 3. The TC stated that it is his responsibility to evaluate PT results and confirmed that the 2018 3rd event Hematology results was not reviewed. D5301 TEST REQUEST CFR(s): 493.1241(a) The laboratory must have a written or electronic request for patient testing from an authorized person. This STANDARD is not met as evidenced by: Based on review of patient records, interview with the testing person (TP), and the technical consultant (TC), the laboratory did not have a written nor a electronic test request to perform hematology testing. Findings: 1. The laboratory performs hematology testing and began testing in September 2018. 2. The laboratory did not have written nor electronic physician orders to perform a patient test. 3. The testing person stated they are able to electronically order patient test requests but they have not performed since they began testing in September of last year. 4. The TC confirmed that physicians orders for patient testing was not performed. 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 -- D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: Based review of the written procedure manual, interview with the testing person (TP) and the technical consultant (TC), the laboratory did not have written procedures for labeling hematology specimens. Findings: 1. The laboratory did not have written procedures for labeling hematology specimens once collected for testing. 2. The testing person stated that she hand writes the patient name on the tube. 3. The TP stated they are able to print out a label with patient name, date of birth, date of collection, and unique identifier for the patient samples once the test is ordered but she was not told to do that. 4. The TC confirmed that a written procedure for labeling patient samples for hematology testing was not available. D5787 TEST RECORDS CFR(s): 493.1283(a) The laboratory must maintain an information or record system that includes the following: (a)(1) The positive identification of the specimen. (a)(2) The date and time of specimen receipt into the laboratory. (a)(3) The condition and disposition of specimens that do not meet the laboratory's criteria for specimen acceptability. (a)(4) The records and dates of all specimen testing, including the identity of the personnel who performed the test(s). This STANDARD is not met as evidenced by: Based on review of the written procedure manual, interview with the testing person (TP) and the technical consultant (TC), the laboratory did not have procedures for identifying the TP performing hematology testing. Findings: 1. The laboratory did not have written procedures for testing personnel to follow when identifying the person who drew the patient samples for testing and the name of the testing person who performed the test. 2. The TC confirmed that written procedures for identifying the person who drew and ran hematology samples was not available. -- 2 of 2 --