Summary:
Summary Statement of Deficiencies D0000 A recertification survey was conducted on September 10, 2020. Alliant Dermatology PA clinical laboratory was not in compliance with 42 CFR 493, requirements for clinical laboratories. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to retain Quality Control (QC) records for the histopathology laboratory for 1 (May 2019) out of 21 months (January 2019 to September 2020). Findings: Review of the laboratory's records showed that the "Daily H/E Slide Quality Control" log sheet for May 2019 was missing. According to the Clinical Laboratory Improvement Amendments (CLIA) Application for Certification signed and dated by the Laboratory Director on 9/10/20, the laboratory had an estimated annual test volume of 45,000 histopathology tests per year. During an interview on 9/10/20 at 1:51 PM, the Laboratory Consultant stated he was unable to locate the missing log. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. 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 -- (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on observation, record review and interview, the laboratory failed to record the temperature for 1 out of 2 Leica CM1850 Cryostats from 9/10/18 to 9/10/20. Findings: During a tour of the laboratory on 9/10/2020 at 11:00 AM, both Leica 1850 Cryostats were turned on. Review of the laboratory's "Temperature / Humidity / Microscope / AC / H&E" log showed there was only one column with one temperature recorded for the two cryostats. According to the Clinical Laboratory Improvement Amendments (CLIA) Application for Certification signed and dated by the Laboratory Director on 9/10/20, the laboratory had an estimated annual test volume of 45,000 histopathology tests per year. During an interview on 9/10/20 at 12: 45 PM, the Mohs Assistant stated they used one cryostat for freezing the tissue and the other cryostat for cutting the tissue. During an interview on 9/10/20 at 12:47 PM, the Laboratory Consultant stated they were not recording the temperature of both cryostats. 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. This STANDARD is not met as evidenced by: Based on record review, observation, and interview, the laboratory failed to have negative control slides for recording the negative reactivity for 2 (#1, 2) out of 8 (#1 - 8) histopathology patients. Findings: The laboratory evaluated the following Immunohistochemical (IHC) stained slides: BerEp4 (Epithelial Antigen IHC stain), CD8 (Cluster of Differentiation 8 T cell Lymphocytic IHC stain), CD10 (Cluster of Differentiation 10 Cell Surface Enzyme IHC stain), CD20 (Cluster of Differentiation 20 B cell Lymphocytic IHC stain), CD31 (Cluster of Differentiation 31 platelet endothelial cell adhesion molecule-1 IHC stain), CD34 (Cluster of Differentiation 34 progenitor cells IHC stain), CD68 (Cluster of Differentiation 68 transmembrane glycoprotein), CK7 (Cytokeratin 7 glandular and transitional epithelial IHC stain), CK20 (Cytokeratin 20 IHC stain), Desmin (Smooth Muscle Tumor IHC stain), EMA (Epithelial Membrane Antigen IHC stain), Factor XIIIa (Factor XIIIa protein IHC stain), MART-1 (Melanocytic Marker IHC stain), MITF (Microphthalamia Transcription Factor IHC stain), Pan-Keratin (MCK- muscle creatine kinase antibody IHC stain), and Sox-10 (melanoma marker IHC stain). Review of the final pathology reports showed that patients #1 and #2 had Mart-1 and MITF IHC stains reported on their final pathology report. Observation of the slides for patient #1 and #2 showed that each patient had a Mart-1 and a MITF IHC stained slide, and no negative control slides specific for Mart-1 and MITF IHC stains. During an interview on 9/10/20 at 2: 49 PM, Histotech B stated they did not have a negative control slide specific for each IHC stain. -- 2 of 3 -- D5781