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Based on review of records and interview, the facility failed to ensure the medical record contained properly executed informed consent forms in 5 (Patient #s 14, 17, 18, 22, and 23) of 10 patient blood transfusion records reviewed.

On 12-5-2016 blood transfusion records were reviewed for 10 patients (Patient #s 14, 17, 18, 19, 20, 21, 22, 23, 24 and 25). Five of the consents (Patient #s 14, 17, 18, 22, and 23) did not contain the physician's signature date and time in the designated blocks of the facility's form.

Review of records by Staff #3 was completed. Per Staff #3, no physician documentation was found in the physician progress notes stating that informed consent information was provided by the physician to the patient.



Review of the policy titled "LAB - Issuing of Blood and Blood Components" was completed. The policy states:

"Purpose:

To outline the procedure for issuing blood and blood products for transfusion.

...

4. The technician and nurse will carefully check the following:

...
f. Blood consent form is dated and has both patient and witness signature in place."



The policy did not address ensuring the physician had signed the consent, certifying that the physician provided the elements for an informed consent by the patient. The policy did not address the physician documenting the same in a physician progress note prior to the transfusion as an alternative to the physician signature on the consent.

An interview was conducted with Staff #10. Staff #10 stated that he was involved with the development of blood transfusion policies. Staff #10 stated that per professional guidelines, the nurse, as the transfusionist, was qualified to provide the necessary information for informed consent and sign the consent.

Review of the professional guidelines, AABB (American Association of Blood Banks) Technical Manual revealed the following under Recipient Consent:

"The AABB Standards for Blood Banks and Transfusion Services states, 'The blood bank or transfusion service medical director shall participate in the development of policies, processes, and procedures regarding recipient consent for transfusion.' Recipient informed consent should address indications for; risks, benefits, and possible side effects of; and alternatives to transfusions of allogeneic blood components ..."

Review of the professional guidelines, AABB (American Association of Blood Banks) Technical Manual revealed the following under Patient Education and History:

"The transfusionist should educate the patient about reporting any symptoms that may be indicative of reaction and how long the transfusion will take. The patient's questions should be answered before the transfusion is started."

The guidelines did not mention anything about the transfusionist being the person to provide information to the patient for the patient to be able to make informed consent.

Staff #10 confirmed that the indications for; risks, benefits, and possible side effects of; and alternatives to transfusions of allogeneic blood components could vary greatly by patient and disease process. Staff #10 confirmed that this would require medical education and knowledge of the patient and disease process that the transfusionist would not possess.


The Medical Staff Rules and Regulations were reviewed. The language in section 4.4 Informed Consent was specific to surgeons and surgery. The language did not address non-surgeons providing informed consent for medical procedures such as blood administration and anesthesia.

The Rules and Regulations section 4.4 Informed Consent was as follows:

"A written, informed and signed surgical consent shall be obtained and placed on the patient's chart prior to all operative procedures, invasive diagnostic procedures, and other high risk treatments (as provided by hospital policy and/or state law) except in those situations wherein the patient's life is in jeopardy and suitable signatures cannot be obtained due to the condition of the patient. The consent form shall be signed by the patient, or any person to whom the patient has properly delegated representative authority, only after the risks and benefits of the procedure, alternative treatment methods, current health status of the patient, plan of care, and other information necessary to make a fully informed consent has be explained to the patient by the responsible physician. After informed consent has been obtained by the surgeon, the nurse may witness the patient's signature on the consent form. In those emergencies involving a minor or unconscious patient in which consent for surgery cannot be immediately obtained from parents, guardian or next of kin, the circumstances should be fully explained on the patient's medical record. A consultation in such instances is desirable before the emergency operative procedure is undertaken, if time permits. If it is known in advance that two (2) or more specific procedures are to be carried out at the same time, said procedures may be described and consented to on the same form. Each consent form shall include the name of the hospital where the procedure is to take place; the name of the specific procedure for which consent is being given; the name of the responsible practitioner who is performing the procedure; a statement that the procedure, including anticipated benefits, material risks, and alternative therapies, was explained to the patient or the patient's legal representative; and the signature of the patient or the patient's legal representative. The form must also comply with the requirements of applicable state law.

Based on observation and interview, the facility failed to ensure the emergency crash carts (a cart that contains emergency supplies to rapidly treat a patient experiencing an unexpected emergency medical event) were maintained with current supplies and medication in 3 of 4 departments. Crash carts in the Labor and Delivery, Neonatal, Medical Surgical unit, and Orthopedic unit were opened and expired supplies and medication were observed. This deficient practice placed all patients at risk for harm.

During a tour of the Labor and Delivery unit, Neonatal unit, Medical Surgical unit, and Orthopedic unit on 12/05/2016 from 3:00 PM to 4:00 PM the following expired supplies and medications were observed:

Findings:

Labor and Delivery Crash Cart:

Multiple Lumen CVC- Kit expired 10/2016

Percutaneous Sheath Introducer Kit 7-7.5 French expired 11/2016

The crash cart had just been checked and signed off by Staff #11 (Registered Nurse) that works the night shift on 12/04/2016. Twelve (12) hours prior to the surveyor checking the crash cart.

Neonatal Unit Crash Cart:

Insyte Autoguard Catheter size 24 X 2 expired 11/2016

Dextrose 10% 500 cc intravenous bag of fluid X 1 expired 11/2016

Multiple Lumen CVC- Kit expired 10/2015

Percutaneous Sheath Introducer Kit 7-7.5 French expired 05/2015

The crash cart had just been checked and signed off by Staff #12 (Registered Nurse) that works the night shift on 12/04/2016. Twelve (12) hours prior to the surveyor checking the crash cart.

Orthopedic Crash Cart:

Insyte Autoguard Catheter size 24 X 4 expired 06/2015

Insyte Autoguard Catheter size 24 X 5 expired 11/2016

Insyte Autoguard Catheter size 20 X 3 expired 11/2015

Insyte Autoguard Catheter size 18 X 5 expired 07/2015

Insyte Autoguard Catheter size 16 X 4 expired 05/2015

Insyte Autoguard Catheter size 14 X 5 expired 07/2016

Lactated Ringers 1000 cc X 1 expired 08/2016

Dextrose 5% Lactated Ringers 1000 cc X 1 expired 07/2015

Dextrose 5% in Water 500 cc X 2 expired 06/2016

Dextrose 5% in Water 250 cc X 2 expired 08/2016

Normal Saline 1000 cc X 1 expired 08/2015

Normal Saline 1000 cc X 1 expired 06/2016

Normal Saline 1000 cc X 1 expired 09/2016

Normal Saline 500 cc X 2 expired 05/2016

Normal Saline 250 cc X 2 expired 06/2015

Normal Saline 250 cc X 1 expired 07/2015

Gloves Size 6 ½ X 2 expired 12/2015

Gloves Size 7 X 1 expired 10/2015

Gloves Size 7 X 1 expired 10/2016

Gloves Size 7 ½ X 3 expired 09/2015

Gloves Size 8 X 2 expired 11/2015

Gloves Size 8 X 1 expired 04/2016

Normal Saline flushes 10 cc X 5 expired 11/2016

Dressing Change Chloraprep X 1 expired 02/01/2016


Broselow Hinkle Pediatric Emergency System Cart: (located in the Orthopedic Unit)

Pink/Red pediatric bag of supplies had expiration dates of 03/2016 and 07/2016

Blue pediatric bag of supplies had expiration date of 03/2016

Purple pediatric bag of supplies had expiration date of 03/2016

Green pediatric bag of supplies had expiration date of 03/2016

Intravenous Start Kit X 3 05/2016

Intravenous Start Kit X 1 10/2016

Extension set X 1 expired 12/1/216

Insyte Autoguard Catheter size 24 X 1 expired 09/2016

Insyte Autoguard Catheter size 24 X 2 expired 11/2016

Insyte Autoguard Catheter size 22 X 5 expired 11/2016

Insyte Autoguard Catheter size 20 X 1 expired 10/2016

Insyte Autoguard Catheter size 20 X 2 expired 11/2016

Insyte Autoguard Catheter size 18 X 1 expired 09/2016

Insyte Autoguard Catheter size 18 X 1 expired 10/2016

The crash cart had just been checked and signed off by Staff #13 (Registered Nurse) on the morning of 12/05/2016. The surveyor checked the crash cart that afternoon of 12/05/2016.


An interview with Staff #3 on 12/05/2016 at 4:00 PM confirmed the above findings of the expired supplies and medication found in the crash carts in the Labor and Delivery unit, Neonatal unit, and the Orthopedic unit.