Summary:
Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on a personnel record review and an interview with the laboratory director, the laboratory director who is the technical supervisor failed to perform competency assessments on the testing personnel performing potassium hydroxide (KOH) examinations since the last survey on September 21, 2016. Findings: 1. A personnel record review revealed the laboratory director failed to assess the competency for 1 out of 1 testing personnel listed on the CMS-209 Personnel Report who perform KOH examinations from the skin since the last survey. 2. An interview with the laboratory director on August 1, 2018 at 1:20 PM confirmed assessments have not been performed for the physician assistant. 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 record review and an interview with the laboratory director, the laboratory director failed to document the accuracy of histopathology microscopic examinations at least twice annually since the last survey on September 21, 2106. Findings: 1. A document review revealed the laboratory failed to document the accuracy of 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 -- histopathology microscopic examinations performed from MOHS procedures and frozen biopsy sections at least twice annually since the last survey. 2. An interview with the laboratory director on August 1, 2018 at 1:40 PM, confirmed the laboratory failed to document the microscopic examinations at least twice a year. 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. (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 record review and an interview with the laboratory technician, the laboratory failed to document the temperature of the Cryostat used in MOHS procedures and frozen section biopsy procedures for the dates reviewed between January through July 2018. Findings: 1. A record review of the laboratory daily temperature log sheets revealed the temperature for the Cryostat was not documented. 2. An interview with the laboratory technician on August 1, 2018 at 1:55 PM, confirmed the laboratory technician did not write a temperature but instead would write a check mark on the day it was observed. -- 2 of 2 --