Summary:
Summary Statement of Deficiencies D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on procedure manual review, lack of documentation, and confirmation by the director, the current laboratory director failed to sign and date the manual as approved. The laboratory performed potassium hydroxide (KOH) and scabies presence or absence as the only non waived tests. The laboratory performed approximately 125 KOH tests per year and a rare scabies skin scraping examination. Findings include: 1. Procedure manual review failed to include the new director's signature and date of approval. 2. In an interview conducted on 04/10/2019 at approximately 11:00 A.M., the office manager and director confirmed the director had not signed the procedure manual since the change of director occurred in 2018. D5891 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess and, when indicated, correct problems identified in the postanalytic systems specified in 493.1291. This STANDARD is not met as evidenced by: Based on patient test log book review, patient chart record review, and interview with the director and office manager, the laboratory failed to establish and follow a procedure for an ongoing mechanism to monitor, assess and when indicated, correct problems identified in the post analytic (test report) system for 2 of 13 patient 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 -- Potassium Hydroxide (KOH) tests reviewed. The laboratory performed approximately 125 KOH tests per year. Findings include: 1. Patient KOH test log book review included KOH tests were performed for patient date of birth (DOB) 04/28/1950 tested on 03/20/2018 and patient DOB 06/22/1951 tested on 04/09/2019. 2. Patient chart records reviewed failed to include the KOH tests results for patients (date of birth) 04 /28/1950 and 06/22/1951. 3. In an interview with the office manager and director on 04/11/2019 at approximately 12:20 P.M., the office manager confirmed the chart records for patients DOB 04/28/1950 and 06/22/1951 did not include KOH results in the charts reviewed. The director and office manager stated the laboratory did not have a written quality assessment plan that included a procedure for monitoring that patient test reports were reliably entered into the patient's test records. -- 2 of 2 --