Summary:
Summary Statement of Deficiencies 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 testing personnel competency records, no written competency records could be produced for staff performing potassium hydroxide (KOH) preparations. Findings include: 1. Upon review of the CMS 116 form for renewal, it was noted that the facility had logged twenty three (23) KOH preps performed on page four (4) of the document. 2. When asked for the required written documentation of bi-annual verification for staff performing KOH preps, none could be provided during survey 07/15/2020. 3. During a phone converstaion with the Laboratory Director on 07/15/2020 at approximately 12:00 pm, he confirmed that the laboratory had failed to perform bi-annual verification for staff performing KOH preps. 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: Based upon review of the procedure manual for Histopathology tissues and slides for this laboratory, there was no written procedure for the process of sending out "Slow Mohs" specimens. Findings include: 1. Upon review of the procedure manual, it was 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 -- noted that a written procedure for the process of specimens sent for Slow Mohs tissues collected on site was lacking. 2. Upon interview with the back office manager during survey 07/15/2020 at approximately 1230 pm, she confirmed no written procedure could be produced. 3. No procedure on what to do after the results / diagnosis for the Slow Mohs specimens were received could be produced as well. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on physical inspection of reagent and discussion with staff, the potassium hydroxide (KOH) used to perform KOH mounts was out dated. Findings include: 1. The KOH solution provided to me during survey outdated 09/09/2010. -- 2 of 2 --