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Based on observation, interview and record review, it was determined the facility failed to administer oral medications according to accepted standards of practice on one (1) of forty two (42) sampled patients. This being patient # 32. Observation of the medication pass on the Joint Replacement Unit on 05/19/11 at 9:15am revealed the registered nurse opened medication packages and removed medication with her bare hands.

The findings include:

A policy/procedure regarding proper administration of oral medications was requested by the surveyor on 05/20/11; however, interview with the Director of Nursing on 05/20/11 at 12:45pm revealed there was not a specific policy regarding the actual procedure.

A medication pass was completed on the Joint Replacement Unit on 05/19/11 at 9:45am . Observation revealed the Registered Nurse to open the package for eight oral medications for one patient (#32) and remove each pill with her fingers, then place the medication into the medication cup.

Interview with the Registered Nurse on 05/19/11 at 9:30am revealed the normal procedure would be to separate the package and drop each pill into the medication cup. The RN stated she should not have picked up the medication with her fingers. Handwashing was not observed prior to the medication pass, nor were gloves placed.

Interview with the Director of Nursing on 05/20/11 at 12:45pm revealed that nurses should not be taking medication out of packages with bare hands and administering the medication.

Interview with the Nursing Educator on 05/20/11 at 1:00pm revealed that although there was not a policy, this should be considered nursing standards of practice, which is taught during orientation, and is part of the annual skills testing. The Educator also stated that any nursing questions would be referred to the Kentucky Board of Nursing Advisory Opinion website, and was used as their standards of practice resources.

Based on observation, review of informed consent forms, and interview with hospital staff, it was determined the facility failed to ensure all informed consent for procedures and treatments were properly executed prior to treatment or procedures on three (3) of forty two (42) sampled patients. These being patients # 41, #16 and #19. Patient # 41 received dialysis without the physician's signed acknowledgeable on the informed consent, Patient # 16 had a cardiac catheterization procedure without the physician's signature indicating he had spoken to the patient prior to the procedure, and Patient #19 had a bronchial lavage procedure that required Proprofol to be given by an anesthesiologist without an informed consent executed.

The findings include:

Review of the operative and other procedures policy and procedure effective March 1, 2011 revealed the facility supports a patient's right to make informed decisions regarding his/her care and that would include the right to accept or refuse treatment based on the doctrine of informed consent. The policy stated the physician/surgeon must provide the patient/surrogate sufficient medical information to enable the patient to decide whether to accept or refuse treatment. "An executed signed informed consent form is obtained by the physician/surgeon for all surgical, major therapeutic and diagnostic procedures, administration of blood and blood products and for the use of moderate sedation and any anesthesia prior to the procedure." Explanation of risks/benefits needs to be discussed with the patient or surrogate prior to administration of sedation and anesthesia. If a patient cannot give consent and does not have a health care surrogate, the consent must be obtained from the nearest designated individual under "Legal Next of Kin". The patient's spouse would be considered after a legal guardian and power of attorney.

1. Observation of a scheduled Bronchial Lavage procedure for Patient #19 on 05/19/11 at 9:40am revealed the patient could not be sedated with routine medications given for this type of procedure. The physician requested the service of an anesthesiologist to administer the drug Proprofol (short acting anesthetic). Once an anesthesiologist was located, he came into the endo room and administrated the drug without informed consent. When asked about the informed consent, the anesthesiologist replied, "it would be considered an emergency situation because the patient was under the influence of sedatives and unable to sign." However, the nurse informed the anesthesiologist and physician that Patient #19's husband was in the waiting area and could sign. The husband was not consulted and the drug was given without his knowledge.

Further review of the above informed consent policy revealed "Emergencies" are broadly interpreted in which immediate treatment is necessary to prevent jeopardy of life, health or limb, disfigurement, or impairment of faculties. The policy state attempts should always be made to obtain consent prior to proceeding with any treatment if medically feasible and no other representative of the patient is available to give consent in time to address the emergency. Patient #19 was not in an emergency situation and the drug Proprofol was not required to treat a life threatening condition.

2. Observation of the dialysis unit on 05/20/11 at approximately 9:00am revealed Patient #41 was already receiving hemodialysis. Observation at 9:05am revealed a nurse from the unit Patient #41 was transferred from entered the dialysis unit and signed the informed consent as a witness. However, review of the informed consent revealed the physician had not signed the consent indicating the physician had counseled the patient regarding the planned procedure.

Interview with the contract dialysis nurse during the time of the above observation revealed informed consent should be signed by the patient and physician upon the first hemodialysis treatment. She stated it was not uncommon for the physicians to sign the informed consent form while the patient was already receiving dialysis.

3. Observation on 05/19/11 at 11:10am of a cardiac catheterization for Patient #16 revealed the physician had already inserted the catheter through the right groin and was injecting dye through the heart arteries. Review of the clinical record revealed the patient had signed the informed consent on 05/19/11 at 9:15am. However, the physician had not signed as completed. After the procedure was completed, the physician took the clinical record and signed the informed consent.

Interview with the unit manager on 05/20/11 at 12:15pm revealed the physician would usually review the procedure with the patient and sign the informed consent prior to the procedure. However, she acknowledged, this physician failed to complete the informed consent until after the procedure was completed. She stated nurses try to remind the physicians to sign the consent form, however, it is not their responsibility to ensure the physicians complete the forms.

Interview with the facility's Quality Manager on 05/20/11 at 12:35pm and Director of Privacy Officer at 12:50pm revealed the facility had identified there was a problem with physicians not completing informed consent forms in January 2011. The facility tracked this problem and identified there was a major problem in regard to physicians completing the informed consent forms. Review of the data from September 2010 to April 2011 revealed physician compliance was from 32.5% to 54.1%. The same tracking data revealed 96.6% of patient completion and 100% of witness (nurses) compliance. This data was present to the Medical Record committee with three (3) surgeons are a member. The findings and committee minutes was forward to the medical executive committee to be forward to all medical staff. They stated this information will be forward to the department of surgery for help with action plans. However, this has not occurred to date.

Based on observations and staff interviews, it was determined the facility failed to have an effective system in place to ensure food and milk, that was available for patient use, was stored properly.

The findings include:

1. Observations during a tour of the Intensive Care Unit, conducted on 05/19/11 at 4:00 PM, revealed a small freezer with ice cream stored in it. The freezer had a thick layer of ice in it and the ice cream cartons were covered in frost.

An interview on 05/19/11 at 4:15 PM, with the Registered Nurse Clinical Supervisor, revealed the ice cream was in the freezer for the patients. She stated the freezer needed to be defrosted. There was a defective seal on the freezer causing it to freeze over. She had sent a work order on 05/18/11 but the freezer had not been repaired.

2. Observations during a tour of the general medical floor, conducted on 05/20/11 at 10:20 AM, revealed a refrigerator in the kitchen, with one-half gallon of milk that expired on 05/16/11 and two small cartons of milk that expired on 05/18/11.

An interview on 05/20/11 at 10:25 AM, with the Charge Nurse, revealed the milk in the kitchen was available for patients' use. The Charge Nurse stated that each day a staff member was assigned to check the food and milk in the refrigerator and dispose of all expired items.

Based on interview and record review it was determined the facility failed to ensure all informed consent for surgery were properly executed prior to the surgery for three (3) of forty two (42) sampled patients. these being patients # 30, #1, and #42. Patient # 30 had a cesarean without the physician's signature to indicate risks/benefits, and explanation of the surgery to be performed. Patient #1 had direct microlaryng with injection of radiesse in right vocal cord under general anesthesia. The patient had not signed or dated the informed consent form for the general anesthesia. Patient #42 had a laproscopic splenectomy, permacath placement on 05/16/11; however, review of the informed consent form revealed as of 05/20/11, the physician had not signed that information was given to the patient prior to the surgery.

The findings include:

Review of the operative and other procedures policy and procedure effective March 1, 2011 revealed the facility supports a patient's right to make informed decisions regarding his/her care and that would include the right to accept or refuse treatment based on the doctrine of informed consent. The policy stated the physician/surgeon must provide the patient/surrogate sufficient medical information to enable the patient to decide whether to accept or refuse treatment. "An executed signed informed consent form is obtained by the physician/surgeon for all surgical, major therapeutic and diagnostic procedures, administration of blood and blood products and for the use of moderate sedation and any anesthesia prior to the procedure." Explanation of risks/benefits needs to be discussed with the patient or surrogate prior to administration of sedation and anesthesia. Such procedures include all surgical procedures, endoscopies, hemodialysis, and anesthesia interventions.

1. Observation of the PACU on 05/18/11 at approximately 2:00pm revealed Patient #1 was admitted to the unit after surgery (radiesse right true vocal cord) at 14:01. Review of the clinical record revealed the informed consent was executed on 05/18/11 at 11:50am. However, the consent for anesthesia services was signed by the anesthesia provider at 12:40pm but the patient had not signed giving consent for the general anesthesia.

Interview with the PACU manager at the time of the observation on 05/18/11 revealed the anesthesiologist probably spoke with the patient prior to surgery but failed to get the patient to sign at that time. However, there was no documented evidence that occurred.

2. Review of Patient # 30's clinical record on 05/19/11 revealed the patient had a repeat cesarean section on 05/19/11 with a delivery time of 6:24am. Review of the informed consent revealed the physician had not signed the consent form.

Interview with the unit manager at the time of the review on 05/19/11 revealed the physician had forgotten to sign.

3. Observation of Patient # 42 on 05/2011 at approximately 9:30am in the dialysis unit revealed the patient was to receive hemodialysis. Review of the clinical record revealed the Patient had laprascopic splenectomy surgery on 05/16/11. Review of the informed consent form revealed the physician had not signed the form to indicate the physician had counseled the patient regarding that planned procedure.

Interview with the facility's Quality Manager on 05/20/11 at 12:35pm and Director of Privacy Officer at 12:50pm revealed the facility had identified there was a problem with physicians not completing informed consent forms in January 2011. The facility tracked this problem and identified there was a major problem in regard to physicians completing the informed consent forms. Review of the data from September 2010 to April 2011 revealed physician compliance was from 32.5% to 54.1%. The same tracking data revealed 96.6% of patient completion and 100% of witness (nurses) compliance. This data was present to the Medical Record committee with three (3) surgeons are a member. The findings and committee minutes was forward to the medical executive committee to be forward to all medical staff. They stated this information will be forward to the department of surgery for help with action plans. However, this has not occurred to date. The Director indicated there had been a problem with the physicians' compliance in regard to informed consent before. She stated when she spoke with specific physicians, they indicated that information was provided to the patient in their office; however, there was no document evidence in the medical record that the patient received those services from the physician.

Based on observation, interview and record review, it was determined the facility failed to administer oral medications according to accepted standards of practice on one (1) of forty two (42) sampled patients. This being patient # 32. Observation of the medication pass on the Joint Replacement Unit on 05/19/11 at 9:15am revealed the registered nurse opened medication packages and removed medication with her bare hands.

The findings include:

A policy/procedure regarding proper administration of oral medications was requested by the surveyor on 05/20/11; however, interview with the Director of Nursing on 05/20/11 at 12:45pm revealed there was not a specific policy regarding the actual procedure.

A medication pass was completed on the Joint Replacement Unit on 05/19/11 at 9:45am . Observation revealed the Registered Nurse to open the package for eight oral medications for one patient (#32) and remove each pill with her fingers, then place the medication into the medication cup.

Interview with the Registered Nurse on 05/19/11 at 9:30am revealed the normal procedure would be to separate the package and drop each pill into the medication cup. The RN stated she should not have picked up the medication with her fingers. Handwashing was not observed prior to the medication pass, nor were gloves placed.

Interview with the Director of Nursing on 05/20/11 at 12:45pm revealed that nurses should not be taking medication out of packages with bare hands and administering the medication.

Interview with the Nursing Educator on 05/20/11 at 1:00pm revealed that although there was not a policy, this should be considered nursing standards of practice, which is taught during orientation, and is part of the annual skills testing. The Educator also stated that any nursing questions would be referred to the Kentucky Board of Nursing Advisory Opinion website, and was used as their standards of practice resources.