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5/25/2010 Survey Tag 0634 Detail for:
Tuesday, May 26, 2020 12:27 AM

Survey Date: 5/25/2010

Regulation Number:0634


Regulation Description: The program must include, but not be limited to, the following: (vi) Medical injuries and medical errors identification.

Surveyor Findings:

Based on review of facility documents and staff interviews, it was determined that the facility failed to implement process changes to ensure that an individual patient's dialyzer would not be used on another patient.

The findings were:

A review of the facility's internal documents was conducted on 5/19/10.

On 2/24/10, sample patient #2 was being dialyzed. It was realized approximately 1 1/2 hours into the treatment, that s/he was being dialyzed with sample patient #1's dialyzer. Sample patient #1 was determined to have active Hepatitis C.

A corrective action form, dated 3/2/10, for the patient care technician involved in setting up the dialysis machine for the patient with the wrong patient's dialyzer on 2/24/10 was reviewed.

Minutes from the Quality Improvement & Facility Management Meeting (QIFMM) dated 3/2/10 were reviewed. The only mention of the wrong patient dialyzer being used was in a section titled "Adverse Occurrence Reporting". No plan is identified in that section, nor is a priority level selected where available to do so. In the additional review items/notes page, is written, "Home room lesson to be held re: Dialyzer identity, Team mate meeting re policy 1-03-01, 1-03-02, 1-03-04A".

An agenda of the Team Meeting, dated 3/18/10, was reviewed. The agenda contained an Agenda topic of Dialyzer Verification that was scheduled for five minutes of the meeting. The minutes from the meeting state, in pertinent part: " ...The reuse dialyzer needs to be visually verified by 2 teammates and documented ...Failure to not verifying dialyzer and patient match is VERY SERIOUS and result in patient injury ..."

The facility's policies were reviewed on 5/19/10. The policies referred to in the QIFMM minutes were not revised after the incident on 2/24/10.

An interview with the facility administrator was conducted on 5/18/10 at approximately 12:45 p.m. S/he stated that the incident was reviewed in the QIFMM meeting and was determined to be a employee education issue, rather than a system's issue. S/he stated that there was no change in the facilities policies and procedures in response to the error and in regards to any additional checks or oversight. S/he stated that the facility began to write the last name of the patient in bigger writing on each dialyzer in black permanent marker to aid in patient identification and matching of correct dialyzers.

Another interview with the facility administrator was conducted on 5/25/10 at approximately 8:00 AM. S/he stated that the staff have been writing their initials on the patients dialyzer as an additional measure to ensure the 2-person check is completed in accordance with the facility's policies and procedures. The nurse has been checking to ensure the two employee's initials are present on the dialyzer.

Facility Plan of Correction:

The Governing Body will ensure the facility maintains an effective, data driven,
quality assessment and performance
improvement program (QIFMM) that
includes a review of medical errors
identification. Adverse occurrences will
be reviewed in QIFMM meeting with
action plans developed and implemented
as needed. Policy changes will be made if
indicated. After internal review of cited
incidents a plan of action was put in place
that required that the teammate not sign off
dialyzer until the patient is in their chair.
Policy # 01-03-02 “Prescription
Verification and Safety Checks” was
revised to include written verification on
the dialyzer while the patient is present, by
2 teammates. A governing body meeting
which included the Medical Director was
held on 05/20/2010 approving the new
policy. Documentation of this meeting is
on file in the facility. All teammates were
in-serviced on this policy on 05/21/2010
and 05/22/2010. The Charge Nurse/
Clinical Coordinator is observing the
PCT's for compliance with verification
while the patient is in the chair. In
addition, audits will be conducted on
100% of reuse dialyzers X 1 month
followed by auditing of 50% of reuse
dialyzers X 1 month, to ensure
compliance. The dialyzer audits were
implemented on 06/08/2010. These audits
are being conducted by the reuse
technician and given to the FA for review
daily. Results of audits will be reported in
QIFMM and addressed as necessary. FA is
responsible for ongoing compliance with


Colorado Department of Public Health and Environment
Health Facilities and Emergency Medical Services Division
4300 Cherry Creek Drive South
Denver CO 80246-1530
Email us or phone 303.692.2800 main

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