Summary:
Summary Statement of Deficiencies D0000 An announced recertification survey was conducted 03/31/2023. The laboratory was found out of compliance with the following conditions: 493.1487 Laboratories performing high complexity testing; Testing Personnel D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on review of Centers for Medicare and Medicaid Services (CMS)-116 form, laboratory records, and confirmed in interview, the laboratory failed to verify the accuracy of non-regulated potassium hydroxide (KOH) preparations at least twice annually for 1 of 1 testing events in 2021 and 2 of 2 testing events in 2022. The findings include: 1. Review of the CMS-116 form submitted at survey by the laboratory revealed the laboratory performed KOH preparations. 2. Review of the laboratory's proficiency testing records for 2021 and 2022 revealed the laboratory failed to verify the accuracy of KOH preparations at least twice annually for 1 of 1 testing events in 2021 and 2 of 2 events in 2022. The surveyor requested documentation of twice annual accuracy assessments for KOH preparations for 2021 and 2022. None were provided. 3. During an interview on 03/31/2023 at 11:20 a.m., Testing Person 3 confirmed the above findings. 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 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- 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 on review of laboratory policy, patient test records, and confirmed in interview, the laboratory failed to ensure patient histopathology (Mohs) slides were labeled with at least 2 unique patient identifiers for 35 of 35 slides from January 2023 (random sampling). The findings include: 1. Review of the laboratory policy titled "Permanent Paraffin Sectioning Technique" revealed: "Principle: A tissue specimen is placed in fixative as soon as possible after biopsy. The tissue is processed through a series of graded alcohols, xylene, and paraffin. Finally, the specimen is embedded in a paraffin block; thin sections are cut, mounted on slides, and then prepared for staining ... Procedure ... 4. Once the block has solidified, it is placed in the object holder of the microtome and properly oriented. Sections of 4-6 microns are cut, floated on a warm water bath, and picked up on glass slides labeled with patient information. 5. Slides are incubated for 30 minutes in the slide dryer at 70 degrees. Slides are then removed from the drying oven and allowed to cool to room temperature. 6. Slides are then stained and coverslipped [sic] ..." The laboratory policy did not include labeling instructions to reliably identify patients using unique patient identifiers to distinguish between specimens. Refer to D5403. 2. A random review of patient slides from January 2023 revealed 35 slides labeled with the only a patient last name, medical record number (MRN), date of service, site, and sections. The laboratory failed to ensure patient histopathology (Mohs) slides were labeled with at least 2 unique patient identifiers. 3. During an interview on 03/31/2023 at 12:09 p.m., Testing Person 2 and Testing Person 3 confirmed the above findings. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: I. Based on review of the Centers for Medicare and Medicaid (CMS)- 116 form, laboratory policies, and confirmed in interview, the laboratory failed to have a written procedure available to testing personnel for performing potassium hydroxide (KOH) preparations. The findings include: 1. Review of the CMS-116 form submitted at survey revealed the laboratory performed KOH preparations. 2. Review of the laboratory policy and procedure manual revealed no standard operating procedure (SOP) for KOH preparations. The surveyor requested documentation of a written procedure for KOH preparations. None was provided. 3. During an interview on 03/31 /2023 at 11:32 a.m., Testing Person 3 confirmed the above findings. II. Based on review of laboratory records, laboratory policies, and confirmed in interview, the laboratory failed to have a written procedure available to testing personnel for performing immunohistochemical (IHC) stains. The findings include: 1. Review of laboratory records submitted at survey revealed the laboratory performed IHC stains on the Leica Bond Max automatic staining system. 2. Review of the laboratory policy and procedure manual revealed no standard operating procedure (SOP) for performing -- 2 of 6 -- IHC stains. 3. During an interview with Testing Person 3 on 03/31/2023 at 11:11 a.m., the surveyor requested documentation of a written procedure for IHC stains with staining characteristics defined. None was provided. During another interview with Testing Person 3 on 03/31/2023 at 12:09 p.m., the surveyor requested documentation of a written procedure for IHC stains with staining characteristics defined. None was provided. The laboratory was unable to provide a SOP with staining characteristics defined for IHC stains. This confirmed the above findings. 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)