Summary:
Summary Statement of Deficiencies D0000 An announced validation survey was conducted on November 30, 2018. An entrance conference was held with the Laboratory Director and the primary testing person to explain the purpose and process of the survey. Based on the onsite survey conducted on 11/30/2018, this facility was found not in compliance with the CLIA regulations found at 42 CFR: 493.1250 Analytic Systems 493.1441 Laboratory Director High Complexity 493.1487 Testing Personnel, High Complexity An exit conference was held with the primary testing person. The survey findings were discussed; 2567 report to be sent to Dallas Regional CMS (Centers for Medicare and Medicaid Services) office. NOTE: Laboratories issued a certificate of accreditation must: (a) Notify HHS and the approved accreditation organization program within 30 days of any changes in- (1) Ownership; (2) Name; (3) Location; or (4) Director The laboratory did not notify CLIA of a change in location within 30 days of its changes. The CLIA 116 database and the CLIA certificate posted in the laboratory still listed the facility's address at 5112 North 10th Street, McAllen, Texas 78504. 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 a review of laboratory quality assessment records and an interview with facility personnel, it was revealed that the laboratory failed to perform twice annual accuracy for 3 of 3 tests it performs in 2016 and 2017. The findings were: 1. A review of the laboratory's test menu revealed the laboratory performs the following high complexity testing procedures: a. Grossing b. H & E staining (Hematoxylin and Eosin) c. Mohs histopathology reporting 2. A review of the laboratory's quality assurance records revealed the laboratory performed one accuracy assessment for each test it performs (Grossing, H & E, and Mohs histopathology reporting) in 2016 during Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 12 -- the American College of Osteopathic Dermatology annual examination. The records did not contain documentation of a complete second assessment in 2016. 3. A review of the laboratory's quality assurance records revealed the laboratory performed one accuracy assessment for each test it performs (Grossing, H & E, and Mohs histopathology reporting) in 2017 during the American College of Osteopathic Dermatology annual examination. The records did not contain documentation of a complete second assessment in 2017. 4. During an interview with the laboratory director on November 30, 2018 at 11:40 hours in the office, the above findings were confirmed. He revealed that he attends annual testing and participates in peer review. When asked for documentation of the second accuracy assessments for 2016 and 2017 that were done by peer review along with their evaluation, he stated that they are, "Not formally documented" and that the, "Cases had already been refiled." 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 on surveyor observation, review of laboratory policy, and confirmed in interview of facility personnel, the laboratory's "Mohs Surgery" policy failed to include specimen processing instructions for labeling of slides. The findings were: 1. Surveyor observation of 5 randomly reviewed Mohs cases from 2017 and 2018 revealed the slides for each case were labeled with a handwritten specimen identification number. 2. Review of the laboratory's procedure, "Histopathology - Mohs Surgery" reviewed and approved by the laboratory director on January 3, 2016 under, "Test Procedure" it stated, "...Sections are mounted on glass slides. These may be coated with Poly-L-Lysine, egg albumin, or other substances to help ensure that the tissue adheres to the slides." 3. The policy did not include instructions on how to label slides and what patient identifying information to include on the slides. 4. Interview with the laboratory director on November 30, 2018 at 11:15 hours in the office confirmed the findings. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on review of laboratory policy, review of manufacturer's instructions, review of quality control records, review of patient records, review of environmental records, -- 2 of 12 -- and confirmed in interview of facility personnel, the laboratory failed to monitor and evaluate the overall quality of its analytic systems as evidenced by: 1. The laboratory failed to define an acceptable humidity range for the laboratory. (refer to D5413) 2. The laboratory failed to ensure that expired items were not available for use. (refer to D5417) 3. The laboratory failed to to include a control slide of known reactivity with each group of patients slides to document the quality of hematoxylin and eosin (H&E) stains. (refer to D5601) 4. The laboratory failed to document