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 surveyor review of the Competency Assessment (CA) records and interview with the Technical Supervisor (TS), the laboratory failed to perform a CA on TS for the calendar year 2017. The TS confirmed on 4/25/18 at 1:05 pm that the CA was not performed. 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 surveyor review of the laboratory work records and interview with the Technical Supervisor (TS), the laboratory failed to follow Laboratory Information System (LIS) verification procedure from 11/10/16 to the date of survey. The finding includes: 1. There was no documentation to substantiate that the laboratory verified electronically transferred data from analyzer to LIS on annual basis. 2. The TS stated on 4/25/18 at 1:00 pm that LIS verification procedure was not followed. D6107 LABORATORY DIRECTOR RESPONSIBILITIES 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 -- CFR(s): 493.1445(e)(15) The laboratory director must specify, in writing, the responsibilities and duties of each consultant and each supervisor, as well as each person engaged in the performance of the preanalytic, analytic, and postanalytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or result reporting and whether supervisory or director review is required prior to reporting patient test results. This STANDARD is not met as evidenced by: Based on surveyor review of the Personnel Files and interview with the Technical Supervisor (TS), the Laboratory Director failed to specify in writing the list of job responsibilites for TS from 11/10/16 to the date of survey. The TS confirmed on 4/25 /18 at 1:30 pm that documented job duties and resposibilites was not on site. -- 2 of 2 --