HospitalInspections.org

Based on clinical record review, staff interview, and facility policy/procedure review, it was determined the facility staff failed to ensure informed consent was obtained from the patient as per facility policy for seven (7) of ten (10) patient medical records reviewed.

The findings include:

On 12/13/2021 and 12/14/2021, the surveyors reviewed the medical records for ten (10) patients.

A review of the records for Patient's #1, #2, #3, and #4 contained no documentation of the facility's "Authorization for Healthcare Services" consent form in the record.

A review of the "Authorization for Healthcare Services" for Patient #8 contained evidence of no printed name, signature, or date from the patient or person authorized to sign for that patient.

A review of the "Authorization for Healthcare Services" for Patient #9 contained evidence that "Verble [sic] Consent" was obtained with an illegible reason documented and the date. The form did not contain the appropriate verbal consent documentation as per the facility's policy on telephone consents.

A review of the "Authorization for Healthcare Services" for Patient #10 contained evidence that "Verbal Consent" was obtained with the reason "Unable to sign" documented and the date and two initials. The form did not contain the appropriate verbal consent documentation as per the facility's policy on telephone consents.

During an interview on 12/14/2021, Staff Member (SM) # 1 stated that general consent for treatment forms or the "Authorization for Healthcare Services" form should be completed as per facility policy for every patient and be scanned in to every patient's medical record. SM #1 stated that as per the facility's "Informed Consent" policy the definition of "Verbal Consent" states "Consent either in person, when the patient cannot physically sign, or over the telephone" and that the policy's section on "Telephone Consents" should be followed for documenting verbal consent.

A review of the facility's policy titled, "Informed Consent," states in part:
...Policy
...B. All patients or their personal representative must provide authorization for medical treatment on the form titled "Authorization for Healthcare Services". Specifics on the completion of the form can be found in Section 3.
...2. Documentation of Informed Consent in Special Circumstances
2.1. Telephone Consents
2.1.1. Obtaining informed consent by telephone is only permissible when the following conditions exist:
1. The patient cannot consent for themselves (e.g. minor, incapacitated, incompetent) and; the person who is legally authorized to consent on behalf of the patient is not reasonably available to be present.
2.1.2. The procedure for obtaining a telephone consent is as follows:
1. The responsible Attending Physician or their designee (an individual who is knowledgeable about the procedure-See section 8.2 telephones the individual legally authorized to consent for the patient, describes the necessary treatment/procedure and includes the elements of informed consent.
2. A registered nurse, Nurse Practitioner, Physician Assistant, Radiology Assistant, or another physician must witness the hone call by listening to the conversation.
3. The responsible attending physician or their designee documents in a progress note that consent was obtained by telephone.
4. The consent form should be completed as usual and include:
Designate "Telephone Consent" on the form where patient representative would sign.
Document the signature with date and time, name and title of the second person who listened to the call.
Document the signature of the attending physician or designee who obtained the informed consent with date and time;
Record the date and time of the conversation;
Record the name and relationship to the patient of the person who was contacted...
2.2. Incapacitated Patients. If a patient is deemed incapacitated, consent must be obtained as follows:
1. In a non-emergent but urgent situation, where medical treatment is deemed necessary, but no personal representative is reasonably available, consent may be obtained by contacting a Special Justice who will evaluate the situation and determine if judicial consent is appropriate.
2.3. Emergency Situations
1. In an emergency situation, the attending physician or his/her designee and at least one other physician must document in the medical record the existence of an emergency with supporting clinical data.
2. Contact a Social Worker from the Care Coordination Department to assist the physician in locating the next of kin or a personal representative. Emergency care or treatment is not delayed while the Social Worker attempts to find the patient's next of kin or personal representative.
...3. Procedure for Obtaining Authorization for General Medical Treatment
3.1. At the time of admission/registration or as soon as possible, the Patient Access Services personnel, or other personnel responsible for registering patients, will obtain the patient or personal representative's signature on the Conditions for Health Care Services form.
3.2. This form includes the authorization for medical treatment. Include the Authorization for Health Care Services form in the patient's electronic medical record (scanned documents) it covers such procedures as, but not limited to, IV fluids, injections, phlebotomies, insertion of naso-gastric tubes, arterial blood gases and deemed consent for HIV testing...

Based on interviews, medical record review, and document review, it was determined the facility failed to ensure medication administration and documentation as per facility policy for one (1) of one (1) patient with a nasogastric tube.

The findings include:

A review of the medical record for Patient #8 contained evidence that Patient #8 had an nasogastric (NG - tube that carries food and medicine to the stomach through the nose) tube, was intubated, and could not take medications by mouth (PO), but had an order for PO medications. The documentation contained evidence that medications were documented as given to the patient PO when the patient had a NG tube and was unable to take medications by mouth.

The documentation contained evidence that:
"Rifaximin 550 mg PO" was administered at 11:19 p.m on 10/26/2021, at 9:23 a.m. on 10/27/21, and at 9:03 a.m. on 11/3/2021.
"Folic Acid 1 mg PO" was documented as given at 9:23 a.m. on 10/27/2021.
"Sodium Zirconium 10 g PO" was documented as given at 8:45 a.m. on 11/3/2021.
"Thiamine 100 mg PO" was documented as given at 9:03 a.m.

The documentation contained evidence of the following medication orders:
Folic acid 1 mg, Tab, PO/NG, daily, Give first dose: NOW, Start 10/27/21 11:07 [a.m.]
Thiamine 100 mg, Tab, PO/NG, daily, Give first dose: NOW, Start: 10/27/21 11:06 [a.m.]
Sodium zirconium cyclosilicate (Lokelma) 10 g, (Maintenance dose), Powder-Oral, PO, ac breakfast, Give first dose: NOW, Start: 11/01/21 11:47 [a.m.]
Rifaximin 550 mg, Tab, PO, every 12 hours, Medical Prophylaxis, Other (Specify), na, Give first dose: Routine, Start: 10/22/21 10:00 [a.m.].

During an interview on 12/14/2021 at 11:30 a.m., Staff Member (SM) #23 stated that the medication order to administer medications by nasogastric tube (NG) should say that best practice is "PO/NG".

During an interview on 12/14/21 at 11:35 a.m., SM #14 stated nurses can assume that they can give PO medications through the NG tube and that it is common practice to give PO medications by NG tube and not orally. SM #14 stated that medications are not given via NG tube without confirming placement of the tube prior to use.

During an interview on 12/14/21 at 2:00 p.m., SM #18 stated that the expectation would be that the order would be written to give the medication NG/PO if medications are to be given through the NG tube.

During an interview on 12/14/21 at 2:00 p.m., SM #17 stated that the nurse should ask the provider to change the medication order to NG/PO when the patient has an NG tube.

A review of the facility's policy titled, "Lippencott Procedures - Oral Drug Administration," states in part:
...Verify that you're administering the medication at the proper time, in the prescribed dose, and by the correct route to reduce the risk of medication errors
...If necessary, contact the practitioner for an order to change the administration route
...Documentation
Document the medication strength, dose, administration route, and date and time of administration.

A review of the facility's policy titled, "Lippencott Procedures - Nasogastric tube drug instillation," states in part:
...Make sure that the medication is being administered at the proper time, in the prescribed dose, and by the correct route.

A review of the facility's policy titled, "Lippencott Procedures - Safe Medication Administration Practices, General," states in part:
...Verifying the medication order
...Verify that the other essential elements of the medication order are present, including the patient's name, age, and weight (in kilograms); the date and time that the practitioner wrote the order; the name of the drug to be administered; the dosage of the drug; the route of administration of the drug; the frequency of administration of the drug; dose calculation requirements (when applicable); the exact strength or concentration of the drug (when applicable); and the signature of the person writing the information.
...Document administration of all medications in the patient's MAR [medication administration record] or EMAR [electronic medication administration record]. Documentation must include the medication strength, dose, route of administration, and date and time of administration. The record should also include any access site for the medication, administration devices you used, and the rate of administration.