|Survey Date: 5/24/2010|
Regulation Title: MD RESP-MED DIR QUAL/ACCOUNTABLE TO GOV BODY
Regulation Description: The dialysis facility must have a medical director who meets the qualifications of §494.140(a) to be responsible for the delivery of patient care and outcomes in the facility. The medical director is accountable to the governing body for the quality of medical care provided to patients.
Based on a review of facility documents, it was determined the facility failed to ensure the Medical Director was involved in the resolution of quality issues identified in the quality improvement program.
The findings were:
A review of the facility's internal documents was conducted on 5/20/10.
On 4/5/10, sample patient #1 was being dialyzed. It was realized by the reuse technician that the dialyzer belonging to sample patient #2 was used on sample patient #1. This was determined after sample patient #1 had completed dialysis and had left the facility. Sample patient #2 was determined to have a history of MRSA (Methicillin-resistant Staphylococcus aureus) infection and was not currently receiving hemodialysis in the facility.
Two corrective action forms dated 4/5/10 for the patient care technicians involved in setting up the dialysis machine for the patient with the wrong patient's dialyzer on 4/5/10 were reviewed.
Minutes from the Quality Improvement & Facility Management Meeting (QIFMM) dated 5/4/10 were reviewed. There was a mention of the wrong patient dialyzer being used in a section titled "Adverse Occurrence Reporting". A plan of action was identified in that section, and stated "Teammate (TM) in-service held 4/29/10 to review that TM will not sign off dialyzer until patient is in their chair as well as having patient read/read to them their dialyzer."
A facility document titled "Teammate in-service April 29, 2010" was reviewed. The document contains a topic regarding dialyzers being checked by teammates as well as a sign-in sheet with all the staff of the facility listed. It states, "Dialyzers MUST be verified by 2 teammates (PCT/RN) for the correct name, and type immediately before being started on dialysis. Do NOT sign off dialyzer until patient is sitting in the chair. Make sure you show the patient their dialyzer, reading the name to them."
The facility's policies were reviewed on 5/20/10. The policies regarding the verification of re-use dialyzers were not revised after the incident on 4/5/10.
On 5/21/10 a revised policy titled "Prescription Verification and Safety Checks" was received by the surveyors. The policy was approved by the medical director and governing body after revision. The policy was revised by adding to the section titled "Prescription Verification". The addition states, in pertinent parts, "After verification is complete by two teammates, teammates will initial the dialyzer label located on the patient dialyzer."
In summary, after the facility had identified that an error took place in which a dialyzer from one patient was used on another patient, the facility's Medical Director did not make any changes to the facility's policies or procedures. There was no evidence that the Medical Director was involved in the efforts to prevent an error similar to the one identified from occurring again.
Facility Plan of Correction:
The Medical Director is accountable to the GB and will ensure the security of medical records, be involved in the quality improvement process in evaluation and prevention of medical errors, and ensure teammates adhere to policies and procedures. 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. The Clinical Services Specialist (CSS) will have pre QAPI and QIFMM meetings with the FA’s X 6 months to ensure all plans of correction are documented correctly. Clinical Services Specialist (CSS) to attend QAPI meetings X 6 months to ensure Medical Director Participation. Administrative Assistant (AA) will attend QAPI meetings to record the meeting and POC’s developed by the IDT during the meetings. FA and Medical Director are responsible for ongoing compliance with POC.