Summary:
Summary Statement of Deficiencies D0000 The Certified Dermatology Tech and Histology Manager were at the entrance conference conducted 08/31/2018. The survey process was discussed. An opportunity for questions and comments was given. Exit conference was held with the Certified Dermatology Tech and Histology Manager on 08/31/2018. The laboratory was found to be in substantial compliance for the specialties/subspecialties for which it was surveyed. The standard level deficiency cited was discussed. The process for submitting the corrections was explained. CMS form 2567 will be emailed from the Texas Department of State Health Services, Health Facility Compliance Arlington Group. D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years. This STANDARD is not met as evidenced by: Based on review of American Proficiency Institute (API) Proficiency Testing (PT) records and confirmed in interview, the laboratory failed to retain result forms for Potassium Hydroxide (KOH) test for 2 of 3 testing events in 2017 (2017-2, 2017-3) and 1 of 1 testing event in 2018 (2018-1). Findings included: 1. Review of the API PT records for 2017 and 2018 revealed the laboratory did not retain the result forms submitted to the PT company for the following events and samples tested: 2017-2: PT samples KOH-3 and KOH-4 (attestation signed 09/06/17) 2017-3: PT samples KOH-5 and KOH-6 (attestation signed 10/06/17) 2018-1: PT samples KOH-1 and KOH-2 (results reviewed and signed 02/27/18) 2. During an interview on 08/31/2018 at 9:30 am, the Certified Dermatology Tech confirmed the above findings. The laboratory was unable to provide the result forms for the above events. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) 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 -- 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: Based on review of laboratory's policies, potassium hydroxide (KOH) records and confirmed in interview, the laboratory failed to follow their own written policy for ensuring the laboratory director signed KOH records for 2017 (01/2017 through 05 /2017). Findings included: 1. Review of "KOH QUALITY CONTROL" records for 2017 stated, "Split specimen; one from each doctor. Document doctor's results. Lab Director to read one of the split specimens and will document results in Control Specimen Results." Review of "KOH QUALITY CONTROL; Accuracy and Reliability of Test Method" 2017 records stated, "One KOH procedure will be split into two specimens. The provider performing the KOH procedure will collect the specimen on two slides then read one slide and document the results below. The Lab Director's designee will read the second side and document the results below under Control. This procedure will be performed two times a year." 2. Review of "KOH QUALITY CONTROL" records for 2017 included the following 6 patient specimens for KOH test: Patient #3174238; read by a provider on 01/11/17 and Testing Person -7 read the slide 01/13/17. Patient #3000165; read by a provider on 01/30/17 and Testing Person -7 read the slide 01/31/17. Patient #3062682; read by a provider on 02/08/17 and Testing Person -7 read the slide 02/10/17. Patient #3177740; read by a provider on 04/06/17 and Testing Person -7 read the slide 04/07/17. Patient #3160935; read by a provider on 04/27/17 and Testing Person -7 read the slide 04/28/17. Patient #3178047; read by a provider on 05/04/17 and Testing Person -7 read the slide 05/05 /17. The split specimens were not read by the laboratory director. The form included a section for the "Lab Director Signature" but was signed and dated by TP-7 on 02/12 /18. The laboratory director had not delegated these duties to TP-7 in writing. 3. Review of "KOH QUALITY CONTROL; Accuracy and Reliability of Test Method" 2017 records included two specimens for accuracy and reliability in 01/2017, as follows: Patient #3174238; read by a provider on 01/11/17 and Testing Person -7 read the slide 01/13/17. Patient #3000165; read by a provider on 01/30/17 and Testing Person -7 read the slide 01/31/17. The procedure performed twice a year did not include the laboratory director's signature for reading the slides. The form included a section for the "Lab Director or Designee Signature" and was signed and dated by TP- 7 on 01/31/17. The laboratory director had not delegated these duties to TP-7 in writing. The laboratory failed to ensure they followed their own written policies for the above KOH procedures. 4. During an interview on 08/31/2018 at 9:46 am, the Certified Dermatology Tech and Histology Manager confirmed the above findings. The laboratory was unable to provide delegated duties for TP-7 by the laboratory director. 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 -- 2 of 6 -- 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)