HospitalInspections.org

Based on document review and interview, in 4 of 10 grievance files reviewed the hospital did not provide patient or the patient's representative with a written notice of the hospitals resolution of the grievance. Additionally, the hospital policy in this matter did not ensure prompt resolution of patient grievance.


Review of grievance file #1 identified the following information: On 10/31/14 the facility received a complaint from the patient's father on 10/31/14. The complainant alleged that he was not informed of his daughter being placed in isolation and for the reason of the EKG changes. He alleged that the facility allowed the patient to refuse Doppler study, claiming that the patient cannot make that decision because she is cognitively unable to decide. He also alleged that the patient was perky the day before and that the patient's left eye is swollen and red, also that the patient is urinating frequently in large amounts, and they fear she is dehydrated.

It was noted that an acknowledgement letter was sent to the complainant on 11/3/14. It was noted that on 1/6/15, the hospital representative spoke to the complainant and apologized for the experience, and also that the facility called complainant on 1/9/15 and informed him of the response to his allegations regarding abdominal sonograms. The file showed that the grievance was closed on 1/9/15.

As of the day of review on 6/16/15, there was no evidence that the complainant was provided with a written response on the outcome of the investigation.


Review of grievance file #2 identified the following information: On 3/27/15 the facility received a complaint from the patient's wife. The complainant alleges that the staff was having difficulty obtaining pulse oximetry on her husband after trying all fingers. She alleges that they then brought in another machine and different staff members. She alleges that having so many staff members in the room added to her husband's anxiety. Complainant alleges that her husband tried to get out of the bed and stand up because he felt he needed to take a deep breath and that a staff member tried to prevent him from getting up by pushing him back in the bed. The complainant also expressed concerned that staff seemed inexperienced with using equipment. It was noted that the complainant would like a response in writing in regards to the investigation and follow up plan. It was noted that the grievance was closed on 3/27/15. As of the day of review on 6/17/15, there was no evidence that the complainant was provided with a written response on the outcome of the investigation.


The same lack of written responses provided to complainants regarding the outcome of the hospital's investigations was found in Grievance File #s 3 and 4.


The hospital policy and procedure titled "Patient Complaints", last revised/reviewed September 2014, stated the following: "That upon completion of the grievance review, a written response will be sent to the complainant. Grievances will be responded to within 30 business days of receipt of the grievance. If a response is not provided within 30 business days, the patient or patient's representative will be informed of the delay and indicate when a response will be provided".

The hospital is using 30 days as a time frame for responding to grievances. Based on CMS guidelines, using an average, 7 days is an appropriate timeframe for the resolution and provision of a written response.

The hospital's grievance process and lack of timely resolution and written response for patient grievances was discussed with Staff #1 and Staff #2.

Based on record review and interview it was determined that the pharmacy failed to communicate with medical and nursing staff regarding the availability of alternate routes of a non formulary urgent drug prescribed to a patient. This finding was evident in one of ten records reviewed.


Findings include:


Review of the MR#1 on 6/15/15 at approximately 12 PM found that a physician's order for Desmopressin 0.3 mg po (by mouth) every eight hours was not administered to the patient for 3 consecutive doses The missed doses were 10/30/14 10:00 PM dose, 10/31/14 6:00 AM dose and 10/31/14 2:00 PM dose. These missed doses were confirmed by the chief pharmacist.

Further review of the medical record found nursing notes dated 10/31/14 in which the pharmacist reported that the medication is not available in that it is "non-formulary" and that no substitutes are allowed. The nursing notes make reference to the pharmacist on duty as reporting this issue.

On 6/17/15, review of a memorandum dated 11/5/14 from the pharmacy director to the pharmacist, who communicated this inaccurate and incomplete information to physicians and nursing staff, found that the desmopressin medication was in fact in stock in the pharmacy in injectable and intranasal routes at all times during this incident. It was documented on that memorandum that the prescribers should have been advised of this option of the medication availability via alternate routes of administration.

At interview with the pharmacist on 6/16/15, it was reported that she did not communicate the availability of desmopressin in alternate routes of administration to nursing or medical staff.

It was confirmed during interview with the attending physician on 6/16/15 that she (the attending physician) was not informed of the availability in stock of alternate routes of administration of desmopressin. She stated that had she known she would have changed the route on the order in that the patient required this medication.

Review of the formulary on 6/16/15 found that the po form of desmopressin was not found in formulary, but the injectable and intranasal routes are available and in formulary.

Based on review of records, policies and procedures, and other documents and interviews, it was determined that the pharmacy failed to implement a system to obtain urgent non-formulary drugs ordered for patient care in a timely manner. This finding was noted in one of ten applicable medical records reviewed.


Findings include:


Review of MR #1 on 6/15/15 found that the patient was admitted to the Traumatic Brain Injury (TBI) rehabilitation unit on 10/30/14 from another hospital after undergoing brain surgery to remove a tumor. Desmopressin had been administered to the patient post operatively in the sending hospital to prevent hypernatremia, (abnormally high sodium levels), a condition that can cause serious medical complications. The transfer note from the sending facility indicated that the patient was receiving this medication po (by mouth).

On 10/30/14 at 6:11 PM, the physician ordered Desmopressin 0.3 milligrams (mg.), PO (by mouth), to be administered every 8 hours. Review of the medication administration record, dated 10/30/14 indicated -10/31/14 found desmopressin 0.3 mg po Q8H was not administered on 10/30/14 at 2200 (10 PM) and on 10/31/14 at 0600 (6 AM). Next to these entries, staff recorded "not available". A third date and time, 10/31/14 at 1400 (2 PM) was recorded, but no entry was made to document whether or not this medication was administered at 2 PM. Further review found written Doctor's orders noted on 10/31/14 at 5:10 PM to "hold 2 PM desmopressin" and another order written on 10/31/14 at 9 PM to "hold desmopressin until available" . At these times there was no po Desmopressin available and could not be "held". On 10/31/14 on the order sheet in right lower corner is a section under "Please renew order" it is written "Desmopression-Not available in Pharmacy."

On 10/31/14 at 2355 hours (11:55 PM) a Critical Test Notification was sent from the lab with a Sodium (Na) result of 161 (Range 132-145). The Critical Test Read back confirmation was by the RN accepting this report and the covering MD receiving this notice on 11/1/14 at 0005 hrs. (12:05 AM).

On 11/1/14 at 12:15 AM a 0.3 mg PO order for desmopressin was written to give an additional dose STAT (as soon as possible). The patient received desmopressin 0.3 mg PO at 0020 (12:20 AM) on 11/1/14. On 10/31 at 2000 hours, 3 doses of desmopressin 0.3 mg tabs were sent from a sister hospital that is part of the corporate network.

During review of document titled "Nonformulary drug request", dated 10/31/14 at 1300 (1 PM), the physician documented need for desmopressin 0.3mg PO Q 8 H. The section in this form labeled "procedure" indicates the completed request form is sent to the pharmacy, and "because it may be necessary to obtain the non-formulary drug from outside the hospital, there may be at least a 24-hour delay in receipt of the drug. The patient may use their own medication once identified by pharmacy and until the medication can be ordered." Handwritten notes on this form indicated that the medication was borrowed from another hospital at 9:30 PM, but this entry was not dated.

As a result of delayed and missed medication, the patient did not receive 3 consecutive ordered doses of Desmopressin (DDAVP). This resulted in the patient's sodium level to rise from 140 to 160, ( Range 132-145 ) which required the patient to be transferred to the Telemetry unit for further management on 11/1/14 (following the physician's order written at 10:20 AM).

Further review of the "medication analysis - corrective action form" dated 11/1/14, found the pharmacy informed the RN the medication was not in the formulary and there was no substitute for Desmopressin.

At interview on 6/16/15 at approximately 2 PM with the supervising attending physician that had managed the patient's case, she stated that she was advised by the pharmacist that there was no Desmopressin in the pharmacy. The supervising attending physician stated that the pharmacist did not advise her that there was desmopressin in the pharmacy that could be administered intranasally and subcutaneously.

At interview with the pharmacist on 6/16/15 at approximately 2:30 PM, she stated that there was no desmopressin PO (by mouth) available. She indicated that she was aware that desmopressin was in storage, but she did not notify the physician that alternative Desmopressin injectable and intranasal routes were in stock in the pharmacy at the time of the order entry. The pharmacist completed a non formulary drug form.

The pharmacist stated that she did not notify the pharmacist on the next shift to follow-up. She also stated she did not communicate to the supervising pharmacist that she did not dispense the medication and placed the form (Not in Formulary Form) under other files. The pharmacy closes at 11 PM and reopens at 7 AM. Therefore, no action would be taken when the pharmacy is closed unless the pharmacist contacts the on call night pharmacist. This did not occur.

Review of employee memo dated 11/5/14 found that when the pharmacist is presented with a non formulary drug, the pharmacist must contact the prescriber and suggest alternative treatment options if one exists.

The hospital's policy for obtaining non-formulary medications in effect in October 2014 at the time this event occurred was not made available to the surveyors during the survey. However, the hospital provided a form titled "Patients Own Medications", approved July 2014 with revisions dating back to February 2005, that references the formulary system. It has references to Non Formulary Forms to be submitted for possible substitutes and states that formulary equivalents will be obtained in a timely manner. At interview with the Chief Pharmacist on 6/17/15 it was stated that this version of the policy has imbedded in it the Non Formulary Policy.

The hospital provided revised Non-Formulary Policies and Procedures on 6/15/15 titled: "Non-formulary Medications", in effect on January 2015.

This follow up Non-formulary Medications policy, dated January 2015, does not describe how to obtain non formulary medications from other facilities nor does it describe actions to be taken to prioritize urgent and high-alert non formulary drugs ordered for patient care. The policy lacks turnaround time for provision of urgent high alert non formulary drugs. The prescriber fills out the form. The top of the form has wording under the section "procedure" which states there may be at least a 24 hour delay in receipt of the drug and references that patients may use their own medications with the notification of the pharmacy.

On June 15, 2015 the facility provided the surveyors another revised Non-formulary Medications policy, which indicated that it was reviewed and revised in June 2015. This revised procedure indicated that the pharmacy staff will contact other health system facilities to borrow medications until the pharmacy's next scheduled delivery, and that the system courier will be contacted for transportation of the medication between facilities. However, this policy lacks a system to prioritize urgent and high-alert non formulary drugs and does not include turnaround time frames for provision of urgent non formulary drugs. The policy states that the pharmacist needs to fill out a non-formulary medication form, and indicates that there may be a delay in obtaining the medication(s).