Medipath Llc

Summary Statement of Deficiencies D0000 A recertification survey conducted on 08/03-05/2021 found that the MEDIPATH LLC clinical laboratory was not in compliance with 42 CFR Part 493, Requirements for Laboratories. Cited the following Condition: -D 2000- Enrollment and Testing of Samples D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on lack of records and interview with laboratory director (LD), the laboratory failed to enroll in a Proficiency Testing (PT) program approved by the Department of Health and Human Services (HHS) and Centers for Medicare and Medicaid Services (CMS) for bacterial Vaginosis (BV), human papilloma virus (HPV), Chlamydia trachomatis/Neisseria Gonorrhea (CT)NG), Vaginitis Candida (CV), trichomonas vaginalis, herpes simplex 1 and 2. Findings include: -Review of test menu included in the 116- form revealed that the laboratory is currently performing detection test for: human papilloma virus, Chlamydia trachomatis/Neisseria Gonorrhea (CT/NG), Vaginitis Candida, trichomonas vaginalis, herpes simplex 1 and 2 using molecular technology methods. -The laboratory started patient testing since October 2020 for the methods of reference. In this period the laboratory had the following test volume for each test: a) BV= 624 b) CT/NG=1177 c) HPV=1 d) CV=554 e) Trichomonas=250 - 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 -- Review of College of Americans Pathologists (CAP) records revealed that the Laboratory failed to enroll in proficiency testing for the tests listed above. During an interview on 08/03/2021 at 11:30 AM, the LD confirmed that the facility failed to enroll in PT for 2021 for the tests of reference. 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) 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 recertification survey conducted on 10/09/2019 found that the Medipath Llc clinical laboratory is not in compliance with 42 CFR Part 493, Requirements for Laboratories. 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 interview with laboratory director (LD), the laboratory failed to perform the semi-annual competency assessment for 1 out of 3 testing personnel (TP) (TP # A, TP # B and TP # C); during 1 out of 2 years reviewed. Findings include: Review of staff files revealed that TP # A had initial evaluation on 10/31/2018 in that position. There was no 6 months assessment documented for this TP During an interview on 10/09/2019 at 11:00 AM, with the LD, she confirmed that there was no documentation of the semi-annual competency assessment for the TP # A for the period of reference. D5601 HISTOPATHOLOGY CFR(s): 493.1273(a)(f) (a) As specified in 493.1256(e)(3), fluorescent and immunohistochemical stains must be checked for positive and negative reactivity each time of use. For all other differential or special stains, a control slide of known reactivity must be stained with each patient slide or group of patient slides. Reactions of the control slide with each special stain must be documented. (f) The laboratory must document all control procedures performed, as specified in this section. 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 record review and interview with laboratory director (LD), the laboratory failed to have negative control slides for recording the negative reactivity for each immunohistochemical (IHC) stains for the 6 out of 6 patients reports reviewed. The findings include: Only the microscopic examination of the slides is performed at the laboratory. A review of the following patients IHC slides and reports, revealed that the laboratory failed to have a negative control for IHC stains used: -MPS2019- 007740, immunohistochemical stain for biomarker p16. - MPS2019-007617, immunohistochemical stain for biomarker p16 - MPS2019-007811, immunohistochemical stain for biomarker p16 - VM19-15285, immunohistochemical stain for CD138 -VM19-14560, immunohistochemical stain for biomarker p16 - VM19-15451, immunohistochemical stain for PIN4 and J PIN4 During an Interview on 10/09/2019 at 12.30 pm, the LD confirmed the laboratory did not have negative controls for the IHC stained slide cases of the above-reference. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on patient reports review and interview with laboratory director (LD), the laboratory failed to list the correct address for the laboratory in final patient reports for 3 out of 3 patients reports reviewed. Findings include: A review of the following final patient reports MPS2019-007759, VM19-13610, MPS29019-006775, revealed that the reports had incorrect laboratory address listed. During an interview on 10/09/19 at 11:00 a.m., the laboratory director confirmed that the final report did not include the correct laboratory address. -- 2 of 2 --