HospitalInspections.org

Based on record review and interviews the hospital failed to ensure that practitioners/physicians and staff followed hospital policy for completion of informed consents as evidenced by patient consents that contained: blank sections without required documentation, no provider signatures, no provider/provider group documented, and/or dates and times of signatures not documented for 5 (#1, #2, #3, #4, #5)of 7(#1-#6, #8) records reviewed for properly executed informed consents, of a total sample of 9.
Findings:


Review of a Hospital Patient Care Manual Policy, #600-035, titled Consent, Informed Consent for Medical or Surgical Procedures, provided by S14Qaulity/RM (Quality/Risk Management), as current, revealed the following in part:

I. Purpose:
A. To provide the physician, hospital, dentist, and hospital personnel with a legal document of consent by the patient or his/her representative of any surgical and/or invasive procedure to be performed upon him/her (patient
B. To provide the patient or his/her representative the right to acknowledge, by signature that to his/her understanding and satisfaction, the nature and course of the procedure, the alternatives, complications, and possible associated risks have been explained by the provider...
II. Policy: All patients undergoing a surgical and/or invasive procedure must have a signed consent prior to the procedure.
A. Procedures requiring Informed Consent include:
1. Major or minor surgery, which involves any entry into the body either through an incision or through one of the natural body orifices;
2. All procedures in which anesthesia (general, regional, or local) is used regardless of whether an entry is made or not;
3. Non-surgical procedures involving more than a minimal risk of a change in the patient's body structure ( Lumbar punctures and amniocentesis);
4. Organ or tissue biopsies;
5. Any use of drugs for non-FDA approved uses...
6. All other procedures which the medical staff determines a specific explanation is needed for the procedure;
7. Any doubts as to the necessity of obtaining the patient's consent for a procedure should be resolved in favor of obtaining the consent.
B. The physician performing the procedure will be responsible for obtaining the patient's informed consent as stated in Louisiana Revised Statue 40"1299.40...2. The physician responsible for the treatment or procedure must obtain consent in a timely manner and place the appropriately signed consent form in the patient's medical record prior to the procedure. The physician or his/her designee shall write the nature of the operation or procedure in full without abbreviations...
F. All spaces on the consent form describing the procedure will be completed in words that are understandable to the patient prior to the procedure...
J. No additions, corrections, or alternatives of the informed consent shall be made after the document has been signed.
N. It is the responsibility of both the Health Care Provider and the patient's nurse to ensure that the consent of invasive, diagnostic, and/or surgical procedure is completed (to include all blanks), prior to such procedure as documented on the pro-operative checklist.
III. Procedure: A. Steps of the Procedure: The Registered Nurse (RN) will:
1. Ensure that the informed consent has been completed prior to the performance of the procedure.
2. All blanks on the form must be filled in
3. The consent is signed by the patient/authorizing agent, dated, and timed...
IV. Responsibility: A. Physician, B. NNP (Neonatal Nurse Practitioner) C. Nurse Clinician D. RN E. LPN (Licensed Practical Nurse)...

Patient #1:
Review of the medical record for Patient #1 revealed he was admitted 11/30/14 with diagnoses of Symptomatic Superior Vena Cava Syndrome with a history of multiple complex PTA (Percutaneous Transluminal Angioplasty) and stents., End-stage Renal Disease (ESRD) on hemodialysis, and Dysfunctional right arm hemodialysis graft. Patient #1 underwent an Angiogram of the left and right upper extremity venous system, PTA of the left and right subclavian veins and the right axillary vein on 12/1/14. Further review revealed an informed consent titled Patient Consent to Medical Treatment or Surgical Procedure and Acknowledgment of Receipt of Medical Information. Further review of Patient #1's consent revealed the treatment/procedure was documented (typed) as Peripheral Angiogram/Possible Percutaneous Transluminal Angioplasty-Peripheral Stenting-Atherectomy, Possible Laser, Angioget, Use of Thrombolytics, Anticoagulants and Antiplatelet medications. Further review revealed the following areas contained blank lines: -Description, nature of the treatment/procedure, -Patient's diagnosis, description of the nature of the condition or ailment for which the medical treatment, surgical procedure or other therapy described in Item 2 was indicated and recommended:, -:Additional risks (if any) particular to the patient because of a complicating medical condition:, -Authorizing Physician: The physician (or physician group authorized to administer or perform the medical treatment, surgical procedures or other therapy described in item 2 is: ,and date/time next to the signature of Physician.

In an interview 12/10/14 at 11:55 a.m. S9RN and S14Quality/RM (Risk Management) after reviewing Patient #1's medical record verified that the Informed Consent for his procedure in the Cath Lab (Catherization Lab) was not completely filled out and verified the above noted omissions. S14Quality/RM agreed that the Informed Consent document should not have had any areas left blank.

Patient # 2:
Review of the medical record of Patient #2, currently admitted to hospital 12/07/14, revealed she was admitted 12/7/14 with diagnoses of Vomiting, Diarrhea, and Elevated Potassium (K). Further review of an Arterial Line Procedural Note revealed she had an Arterial Line Inserted 12/9/14 at 10:50 a.m. for hemodynamic monitoring due to a diagnosis of Respiratory Failure. Review of an Informed Consent document for the Insertion of an Arterial Line revealed it was signed by the patient's daughter with a date/time of 12/9//14 at 10:30 (a.m.) Further review of the Informed consent revealed the following areas were left blank: -purpose of the procedure, -patient's diagnosis, description of the nature of the condition or ailment for which the medical treatment, surgical procedure or other therapy described was indicated and recommended, -additional risks particular to the patient because of a complicating medical condition, - reasonable therapeutic alternatives and risks associated therewith, risks of no treatment, -authorized physician: The physician (or physician group) authorized to administer or perform the medical treatment, surgical procedures or other therapy described in item 2, - signature of the physician, time/date , - time/date of witness signature on the material risks list page.

Patient #3
Review of the medical record for Patient #3, currently admitted to the hospital, revealed, in part the following:
Patient #3 was admitted 11/29/14, following a MVA (motor vehicle accident), with diagnoses that included multiple fractured ribs, clavicle and scapular fracture, a left pleural effusion, and possible Pneumothorax. During his admission Patient #3 developed aspiration pneumonia, ARDS (Acute Respiratory Distress Syndrome), SVT (Sinus Ventricular Tachycardia) requiring Cardioversion, and Acute Rental Failure requiring Hemodialysis.
A Consent for Hemodialysis was noted to have the following areas blank: Purpose (of treatment/procedure), patient's condition or diagnosis for which the hemodialysis was indicated and recommended, additional risks (if any) particular to the patient because of a complicating medical condition, reasonable therapeutic alternatives and risks associated and risks of no treatment, the name of the authorized physician or group, the signature of the physician, and date and time of physician signature.

In an interview 12/10/14 at 2:00 p.m. S12ICU reviewed the informed consents for Patients
#2 and #3, verified the blank areas as noted, and confirmed the consents were not completed as they should have been.

Patient #4
Review of the medical record for Patient #4 revealed she was admitted to the hospital 11/25/14 for management of ESRD (End Stage Renal Disease) which included the placement of a Tunneled Dialysis Catheter and the initiation of Hemodialysis. On admission Patient #4 complained of chest pain. She was placed on the CVICU (Cardiovascular Intensive Care Unit) Further review revealed an informed consent for placement for a Tunneled Dialysis Catheter which had blanks in the following areas: Purpose of the treatment/procedure, patient's condition/diagnosis for which the surgical procedure was indicated and recommended, material risks of treatment procedures, additional risks (if any) particular to the patient because of a complicating medical condition, reasonable therapeutic alternatives and risks associated therewith, and risks of no treatment. The consent was signed by the patient 12/1/14 and by the physician 12/2/14.

In an interview 12/10/14 S14Quality/RM and S11Education verified the above findings, after review, of Patient #4's medical record. S14Quality/RM and S11Education indicated that all blanks in a patient's consent should be completed, whether answered as indicated, noted as "not applicable", or "none".

Patient #5
Review of the medical record for Patient #5, a current patient in CVICU , was admitted 12/9/14 for Cardiac Catherization and Aortic Valve replacement. His diagnoses included Critical aortic stenosis, Diabetes Mellitus- Type 2, Chronic atrial fibrillation, acute on chronic systolic congestive heart failure, and Chronic obstructive lung disease. Further review revealed 2 informed consents that were not completely filled out, signed by the physician, the patient, and an RN witness. An informed consent for a Cardiac Catherization signed and dated by Patient #5's representative and and RN witness 12/8/14 at 9:30 a.m. revealed blanks in the areas of "purpose (of treatment/procedure), patient's diagnosis/description of the nature of the condition for which the treatment, surgical procedure, or other treatment was indicated and recommended, any additional risks particular to the patient because of a complicating medical condition, reasonable therapeutic alternatives and risks associate therewith, risks of no treatment. Review of an Informed consent for Coronary Intervention (Stents and Atherectomy)/Directional Coronary Arthrectomy (DCA), Transluminal Extraction Catheter Arthrectomy (TEC) and Rotational Atherectomy, also signed 12/8/14 at 9:30 a.m. by the patient's representative and RN witness revealed the same areas as the Cardiac Catherization consent were left blank. Further review revealed the physician signed both consents 12/8/14.

In an interview 12/10/14 at 2:30 p.m. S16DirCVServices (Director of Cardiovascular Services) and S14Quality/RM verified the incomplete consents in Patient #5's medical record as noted above. S16DirCVServices agreed that the consents should have been completely filled out before the patient or his representative signed them.