Bellin Health Brillion

CLIA Laboratory Citation Details

2
Total Citations
5
Total Deficiencyies
3
Unique D-Tags
CMS Certification Number 52D0978594
Address 235 East Ryan Street, Brillion, WI, 54110
City Brillion
State WI
Zip Code54110
Phone920 756-2055
Lab DirectorCHRISTOPHER SIPPLE

Citation History (2 surveys)

Survey - November 8, 2022

Survey Type: Standard

Survey Event ID: 0EGO11

Deficiency Tags: D6072

Summary:

Summary Statement of Deficiencies D6072 TESTING PERSONNEL RESPONSIBILITIES CFR(s): 493.1425(b)(3) Each individual performing moderate complexity testing must adhere to the laboratory's quality control policies, document all quality control activities, instrument and procedural calibrations and maintenance performed. This STANDARD is not met as evidenced by: Based on surveyor review of laboratory procedures and records and interview with the technical consultants, testing personnel did not follow quality control procedures when sodium controls required

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Survey - October 29, 2018

Survey Type: Standard

Survey Event ID: ZHSK11

Deficiency Tags: D6053 D6054 D6053 D6054

Summary:

Summary Statement of Deficiencies D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on surveyor review of competency evaluation records and interview with the technical consultant, the technical consultant did not document the semi-annual evaluation of competency of one of one new testing personnel during the first year the individual performed testing. Findings include: 1. Review of competency evaluation records for staff A showed no semiannual evaluation of competency during the first year of testing. Initial competency was documented in July 2017 and annual competency was documented in October 2018. 2. Interview with the technical consultant on October 29, 2018 at 10:30 AM confirmed the semi-annual competency evaluation was not documented for staff A. D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least annually, after the first year. This STANDARD is not met as evidenced by: Based on surveyor review of competency evaluation records and interview with the technical consultant, the technical consultant did not document annual competency evaluation of one of two testing personnel in 2017. Findings include: 1. Review 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 -- competency evaluation records shows no annual evaluation of competency of staff B in 2017. 2. Interview with the technical consultant on October 29, 2018 at 10:30 AM confirmed annual competency evaluation was not documented for staff B in 2017. -- 2 of 2 --

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