Summary:
Summary Statement of Deficiencies D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(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 general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on record review and an interview with Practice Manager (PM), the laboratory failed to establish and follow written policies and procedures and document all assessment activities of an ongoing mechanism to monitor, assess, and correct problems identified in the general laboratory systems. Findings Include: 1. Review of the laboratory's "Policy and Procedures" manuals provided on the second meeting for the inspection at the Ohio Department of Health, found no mention of general laboratory quality assessment. 2. The Surveyor requested the laboratory's quality assessment policy and procedure to include the general laboratory systems and 2016, 2017 and 2018 general laboratory systems quality assessment documentation from the PM. The PM confirmed the laboratory did not have any quality assessment policy and procedure established, and did not document any quality assessment activities, and was unable to provide the requested documentation on the date of the second meeting. The interview occurred on 03/15/2018 at 11:15 AM. D5391 PREANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1249(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 preanalytic systems specified at 493.1241 through 493.1242. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- This STANDARD is not met as evidenced by: Based on record review and an interview with Practice Manager (PM), the laboratory failed to establish and follow written policies and procedures and document all assessment activities of the ongoing mechanism to monitor, assess, and correct problems identified in the preanalytic systems. Findings Include: 1. Review of the laboratory's "Policy and Procedures" manuals provided on the second meeting for the inspection at the Ohio Department of Health, found no mention of general laboratory preanalytic quality assessment. 2. The Surveyor requested the laboratory's preanalytic quality assessment policy and procedure to include the general laboratory systems and 2016, 2017 and 2018 preanalytic general laboratory systems quality assessment documentation from the PM. The PM confirmed the laboratory did not have any preanalytic quality assessment policy and procedure established, and did not document any preanalytic quality assessment activities, and was unable to provide the requested documentation on the date of the second meeting. The interview occurred on 03/15/2018 at 11:15 AM. 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 record review and an interview with Practice Manager (PM), the laboratory failed to establish and follow written policies and procedures and document all assessment activities of the ongoing mechanism to monitor, assess, and correct problems identified in the postanalytic systems. Findings Include: 1. Review of the laboratory's "Policy and Procedures" manuals provided on the second meeting for the inspection at the Ohio Department of Health, found no mention of general laboratory post analytic quality assessment. 2. The Surveyor requested the laboratory's post analytic quality assessment policy and procedure to include the general laboratory systems and 2016, 2017 and 2018 post analytic general laboratory systems quality assessment documentation from the PM. The PM confirmed the laboratory did not have any post analytic quality assessment policy and procedure established, and did not document any post analytic quality assessment activities, and was unable to provide the requested documentation on the date of the second meeting. The interview occurred on 03/15/2018 at 11:15 AM. D6091 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(iii) The laboratory director must ensure all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require