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Based on medical record review and staff interview, it was determined that three of 23 records did not contain an admission consent to treat each patient. This failure did not ensure the patients and/or patients' representatives were properly informed of their rights.

The findings were:

Medical record review completed on 10/14/2010 revealed that sample patient medical records #21, #22 & #23 did not contain admission consents.
Sample record #21 was a patient admitted emergently for respiratory failure on 5/13/2010 and discharged on 5/25. Sample record #22 was a patient admitted on 7/15/2010 for altered mental status and discharged on 7/19. Sample record #23 was a patient admitted on 7/23/2010 for generalized weakness and discharged on 7/30.

In an interview with the facility's Director of Accreditation on 10/14/2010 at approximately 12:30 p.m., s/he stated she did not believe the facility necessarily got a new consent when the patient's were transferred in from the facility's Skilled Nursing Facility or Rehab Facility. However, medical record review revealed that each transfer back to Rehab or the Skilled Nursing Facility had an admission consent. In further correspondence with the Director of Accreditation on 10/18/10 via email, s/he stated that the Medical Records Department informed him/her that they don't always get a new set of admission consents when a person goes downhill and that they use the prior consent to treat, but get any further informed consents pertinent to the care.

In summary, three of 23 sample medical records did not contain evidence that the patients or patients' representatives were given the information needed in order to make "informed" decisions regarding their care upon admission to the facility.

Based on medical record review, staff interview, and review of the facility's policies/procedures, it was determined that the facility failed to obtain a new LIP or physician's order for each episode of restraint and failed to ensure restraints were not used as a standing order or protocol. This failure did not maintain compliance with this regulation and created the potential for a negative patient outcome.

The findings were:

Medical record review on 10/14/10 revealed one of 23 medical records in which a patient only had one signed physician order for restraints, although the patient was restrained on and off for several days. The patient, sample #21, was admitted on 5/13/10 for line sepsis and respiratory failure and was discharged on 5/25/10. On 5/15/10, a physician ordered and signed "Ventilator Management Standing Orders" wherein s/he checked the order "Restrain per ventilator protocol (patient must be evaluated and order checked by MD)." Thereafter, according to nursing documentation on the "ICU Critical Care 24 Hour Flowsheet," the patient was restrained on 5/15/10 from 3:00 p.m. until 5/16/10 at 6:00 a.m. The patient was then restrained again on 5/16/10 at 11:00 p.m. until 5/17/10 at 7:00 a.m. The patient was restrained again on 5/17/10 from 7:00 p.m. until 5/18/10 at 7:00 a.m. On 5/18/10, the restraints were initiated again at 11:00 p.m. and then removed on 5/19/10 at 4:00 a.m. On 5/19/10 at 4:00 a.m., the patient's restraints were reapplied and then removed at 9:00 a.m.

The facility's "Critical Care Restraint Protocol" was reviewed on 10/14/10. The policy stated the following, in pertinent part:
"Critical Care Protocols: Ventilator Protocol and Line/Tube Safety Protocol Critical Care Units provide care to a wide variety of patients and with complex diagnosis... At times it may become necessary to initiate protective procedures. These procedures are considered when alternative and less restrictive measures are ineffective in changing the behaviors that may lead to patient injury and possible negative outcomes.
To initiate these protective measures the following 2 medical staff approved protocols were developed for critical care area.
I. Ventilator Protocol: describes when restraints may be applied in the critical care setting when a patient has an endotracheal tube, and mechanically ventilated and when following medical staff approved criteria...
II. Line/ Tube Safety Protocol: describes when restraints are applied to patients in the critical care setting with patients with Swan Ganz lines, central lines, chest tubes, intra-aortic balloon, pacemaker lines or other invasive lines when following approved medical staff criteria...
III. Critical Care Criteria for Initiating Either Protocol:
The following medical staff approved criteria must be met before the initiation of restraint (s):
A. The patient demonstrates a fluctuating or lack of decision making capacity...
B. This lack of decision making ability can manifest itself in any of the following ways and may result in grabbing, pulling or tugging of invasive tubes(s) and/or lines...
IV. Critical Care Restraint Protocol Procedure:
The critical care nursing personnel will follow the appropriate steps in implementing the restraint protocol.
A. A qualified registered nurse will assess the patient and makes a decision that the restraint criteria has been met.
B. The nurse will initiate the restraint(s) as indicated after obtaining a one time physician order to initiate the restraint or the appropriate critical care clinical protocol...
F. If, upon reassessment by the registered nurse, it is determined that the patient no longer meets the critical care restraint protocol criteria the restraints(s) will be discontinued. Subsequently if the patient demonstrates the same behavior (and the associated risks related to tube or line removal) restraints may be re-initiated following the established protocol.
G. The nurse will discuss the patient's behavior and the application of restraint(s) (per protocol) to the physician(s).
H. The physician will evaluate the patient daily to assess need for continuation of the episode of restraint under the protocol."

An interview with an Educator/Director of Intensive Care was conducted on 10/13/10 at approximately 2:45 p.m. S/he stated the following about the ICU Restraint Protocol: "When a patient is in ICU and for prevention of lines/extubation, we have the physician write one order for the restraint and then if the patient is never taken out of the restraints, we don't need a new order."

In summary, a physician or other LIP order must be present for each episode of restraint and sample patient #21 was un-restrained and re-restrained several times without a new physician order. A protocol cannot serve as a substitute for obtaining a physician or LIP order prior to initiating each episode of restraint. The use of restraint is a last resort when less restrictive measures have been determined ineffective to ensure the safety of the patient.

Based on review of the facility's policies/procedures and medical records, along with staff interview, it was determined that the facility failed to ensure that a patient's reported allergies were treated as such and transferred to the Medication Administration Record (MAR) for appropriate use by the patient's nurses administering medications. This failure did not maintain proper supervision and evaluation of nursing care and created the potential for a negative patient outcome.

The findings were:

Review of 23 sample medical records revealed that one patient (sample #16) did not have any of the medications that were on the patient's "History & Physical" (H&P), Pre-Operative Orders, or nursing "Beginning to End Admission Assessment" listed on the patient's "Medication Administration Record." The patient was admitted for surgery on 5/26/10 and discharged on 5/30/10. The MARs for each day of the patient's hospital stay stated "NO KNOWN DRUG ALLERGY" in the "DIAGNOSIS ALLERGIES" section. However, the "Beginning to End Admission Assessment," completed five days prior to admission, stated that the patient had 13 allergies. The patient's "Pre-Op Orders," also completed five days prior to admission, stated that the patient had six allergies. The dictated H&P on the patient's chart stated that the patient had 13 different allergies.

An interview with the Director of Pharmacy was conducted on 10/13/10 at approximately 10:50 a.m. S/he stated that a number of people may record the patient's allergies in the computer system. The allergies are recorded as text and "in order to appear on the MAR they must be coded by the Pharmacist. In this case, the pharmacist made the judgement call that they are most likely not truly allergies." The Director of Pharmacy stated that it would be likely to assume they are adverse drug reactions and stated that they should have been recorded as such. The precaution of labeling a medication as an adverse drug reaction (ADR) is that if the drug is later ordered, a pop-up will notify that drug is an ADR.

The facility's policies/procedures were reviewed on 10/13/10.
The policy titled, "Adverse Drug Reaction Definition and Reporting" stated the following, in pertinent part:
"POLICY An adverse drug reaction (ADR) is any response to a drug that is noxious and unintended and occurs in does for prophylaxis, diagnosis, or therapy.
A system exists at (the facility) to monitor patients for ADRs..."
The policy titled, "Medication Allergies, Height and Weight" stated the following, in pertinent part:
"POLICY Patient height, weight and medication allergies will be reported to the Pharmacy.
PROCEDURE 1. The RN signing the Admission Assessment is responsible for obtaining information regarding patient medication allergies, height and weight..."

In summary, regardless of if the patient's reported allergies were true allergies or ADRs, they were not clearly identified on the patient's MARs throughout the entire hospitalization in order to provide effective monitoring. The patient's allergies were listed as such in the physician's H&P as well as the nursing pre-op documentation, however, the pharmacist did not do further investigation on these allergies and instead deemed the patient had no allergies. Nursing staff did not monitor the care of each patient by not identifying the need for follow-up with pharmacy in regards to this patient's allergies.