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Based on observation, interview and document review the facility failed to establish a process that provided and insured patients were given an oportunity to provide informed consent upon admission to the facility for 1 (labor and Delivery) of 5 (Nursing, Outpatient Surgery, Medical Surgical, and Emergency) departments reviewed.

This deficient practice had the likelihood to effect all patients of the hospital.

Findings included:


On the morning of 4/4/2017 an interview with the Director of the Health Information's Management Department confirmed the Labor and Delivery department of women's services had been identified as not consistently providing an oportunity for informed consent to women admitted to the unit. Over the month of March 2017, 17 patients who were treated in the L&D unit failed to receive informed consent upon admission.

On the morning of 4/4/2017, in the conference room an interview with staff #2, the Emergency Department (ED) Director confirmed all patient's (Pt/pt) who came through the ED for direct admission to the Labor and Delivery (L&D) unit were given oportunity to provide informed consent for admission and treatment signed in the ED, prior to transfer to the L&D unit.


On the morning of 4/4/2017 an interview with L&D staff Registered Nurse (RN) #6 indicated, "They (the nurses) did not do the admission paper work and admission consent. They called an admission clerk who would come to the unit and complete the consent and admission process with the patient".


On the morning of 4/4/2017 in the office of the Admission Coordinator, an interview with the Director, staff #3 confirmed "no admission staff went to the Labor and Delivery unit to complete patient admission information or provide oportunity for informed consent". She further explained that all pt's, who were pre-admitted by a physician's order, would be completely registered by the admission department prior to their arrival to the L&D unit. All information obtained during that process was scanned into the electronic medical record system. However, any patient who might walk into the hospital (after hours or by-pass the ED) could walk directly to the L&D unit. They could be admitted with a telephone order from their physician, without being pre-admitted or the admissions department being aware of it.


On the morning of 4/4/2017, in the L&D unit, interview with staff RN #5 revealed the process for admission and consent for a newly admitted patient to the Labor and Delivery unit. Staff #5 accessed the computer data base and printed a consent to admit and treat with patient #12's name printed on the form. The form was not signed by the patient. Staff #5 then explained she printed the form to show they had access to the form.

Staff #5 confirmed the L&D unit used a paper medical record. When asked to review patient #12's medical record there was no consent to admit or treat found in the paper medical record. Staff #5 was asked, "Wouldn't completion of the consent to admit and treat be the responsibility of the admitting nurse"? Staff #5 replied "Well, I suppose". She then recalled that pt #12 had been pre-registered and they would have already obtained the consent. However, staff #5 could not verify that an informed consent had been obtained for pt #12.

On 4/4/2017 in the late morning an interview with the Admission Coordinator, staff #3, indicated the nurses had received admission packets from their unit supervisor. Staff #3 indicated the L&D unit supervisor had inserviced her staff on the use of the admission packets. The L&D unit supervisor, staff #4 was working nights to fill in for a vacancy and was not present for interview.

On 4/4/2017 in the afternoon, an interview with staff #9, the Quality Manager, confirmed she had not received any education from the L&D unit supervisor on the use of admission packets for her staff or department. She could not confirm education had in fact occurred.


On 4/5/2017 in the conference room the policies for the facility revealed there was no policy found that included "Informed Consent" upon admission as a part of the required chart content.


On the afternoon of 4/4/2017 in the conference room a review of the Medical Record Quality data indicated on2/21/2017 and again on 3/28/2017 "Informed consent obtained: Consent for procedure-not informed consent" the facility was aware through it's Quality program that for 60 days the L&D Department was not consistently obtaining informed consent upon admission.

Based on document review the governing body, medical staff and administrative officials failed to ensure an effective Quality Program. The administrative officials:

A. did not provide quality oversite and monitoring of blood product being administered to patients.
B. allowed an unapproved policy (Medication Administration Guidelines) to be implemented facility wide.

A. A follow up survey for a previous survey conducted on 01/31/2017 revealed the emergency room director will monitor 100% of blood transfusions in that department and the medical-surgical director will monitor 100% of the blood transfusion in that department.
A review of the document titled Quality and Patient Safety Council dated March 23, 2017 revealed no evidence of the monitoring of blood transfusions or discussion of the plan to monitor blood transfusions.

B. Review of the facility policy titled "Medication Administration Guidelines" revealed a revision date of 03/2017.

A review of the document titled Medical Executive Committee Minutes and dated March 22. 2017 revealed no evidence the policy titled Medication Administration Guidelines was approved.
An interview on 4/5/2017 with staff #9, 10, and staff #11confimed the policy titled "Medication Administration Guidelines" with the revision date of 3/2017 had been implemented through out the facility.

An interview on 4/5/2017 with staff #9 revealed the policy had not been to Medical Staff for approval. Staff #9 confirmed the policy required Medical Staff approval before it could be implemented.