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 upon discussion with the Technical Consultant (TC) for Point of Care Testing (POCT), review of the Kaiser Permanente Northwest (KPNW) Procedure for performing Potassium Hydroxide (KOH) Examinations, the laboratory failed to follow written policy for assessing Providers performing KOH wet mounts on patients. Finding include: 1. In a three page Standard Operating Procedure (SOP) policy authored by the TC, titled "KOH Preparation, PPMP", approved 4/20/2017, the third page contains dialog pertaining to assessing competency of Providers performing PPMP yearly. After review of initial training records and subsequent competency assessments since the date of hire for the three (3) new providers hired in Dermatology since the last survey, it was found that this SOP was not followed. 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 upon discussion with the Technical Consultant (TC) for Point of Care Testing (POCT) and review of records, the laboratory failed to ensure Providers performing Potassium Hydroxide wet mounts (KOH) had the required initial training and 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 -- biannual competency required under CFR 493.1236 "Standard: Evaluation of proficiency testing performance". Findings include: 1. There have been three (3) Providers hired into the Dermatology area under this CLIA since the last survey. Provider one (#1) was hired 8/29/2016. There are no records of initial training or six (6) and twelve (12) month competency assessment of this Provider performing KOH examinations. Records show this Provider has reported out results of KOH mounts on five (5) patients between 9/30/16 and 9/11/17. 2. Provider two (#2) was hired 9/16/16. There is no record of initial training, or six (6) and twelve (12) month competency assessment of this Provider performing KOH examinations. Records show this Provider has reported out results of KOH mounts on eight (8) patients between 9/28 /16 and 12/20/17. 3. Provider three (#3) was hired 7/31/2017. There is no record of initial training competency assessment of this Provider performing KOH examinations. Records show this Provider has reported out results of KOH mounts on twenty (20) patients between 8/17/17 and 1/31/2018. Nineteen (19) of the twenty (20) patient specimen KOH exams performed by this Provider were performed prior to the six (6) month competency for KOH (completed by Provider 1/25/2018). -- 2 of 2 --