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Tag No.: A0466
Based on interview, record review and policy review, the facility failed to address a patient's written request (Patient #1) to fully explain and answer questions concerning a radiological procedure and failed to ensure a patient's (Patient #29) consent forms were signed in accordance with facility policy.
Findings included
Patient #1
Patient #1 was admitted on 11/4/11, with diagnoses including syncope, altered mental status, ear pain, hypertension, chronic back pain and seizure disorder.
On 11/10/11, Patient #1 was scheduled for an MRI (Magnetic Resonance Imaging).
A line on the bottom of the consent for MRI documented, "...The nature and risk of this examination...have been explained to me..."
Patient #1 documented on the line of the MRI consent form, "...Have not explained to patient and family dated 11/10/11 at 11:37 AM..."
The MRI consent form documented:
I understand this information. Patient #1 checked the box indicating, "no"
I have questions. Patient #1 checked the box indicating, "yes"
I would like to discuss this with a physician. Patient #1 checked the box indicating, "yes"
On 12/19/12 at 2:45 PM, The Director of Imaging indicated normally the nurse on the floor where the patient received care or the physician would explain to the patient if he/she had any questions.
The Director of Imaging indicated he did not know who spoke to Patient #1.
The line that documented, "...Signature of Witness..." was blank and not dated.
The consent for MRI contained no documentation Patient #1's questions were answered.
The Policy and Procedure titled Informed Consent (revised July 2010) documented:
"...III Policy
B. It is the physician's responsibility to convey the necessary information as to the nature of the treatment, the risk, possible complications, together with alternate forms of treatment in a language which the person can understand, thus allowing the patient or surrogate decision maker to give informed consent..."
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Patient #29
On 11/21/11, Patient #29 was admitted with diagnoses of altered mental status, respiratory distress, congestive heart failure, pulmonary edema, chronic obstructive pulmonary disease, pleural effusion, aortic dissection, coronary artery disease, hypertension, anemia, and benign prostatic hypertrophy.
On 11/20/11 at 11:53 PM, Employee #8 signed Patient #29's Patient Rights And Responsibilities Addendum, Consent To Treatment And Conditions Of Admission, Consent To Hospital Procedures, and Assignment Of Benefits due to Patient #29's altered level of consciousness.
According to the facility's policy, Informed Consent, #RI-303 last reviewed July 2010, "...5. e. If an emergency situation occurs and the condition is: 1) Life threatening to the patient; and 2) The patient is unable to give informed consent; and 3) A legally responsible person is unavailable to give oral or written consent then the following must take place: a) Attending physician or designee must document the urgency of the situation; and b) A second physician must verify and document the urgency of the situation; and c) Attempts to reach a legally responsible person must be documented..."
On 11/21/11 at 8:00 PM, a nurse documented Patient #29 as alert and oriented to person, place, and time. Patient #29's medical record lacked documented evidence of further attempts to obtain consent. The aforementioned documents remained unsigned throughout the hospital stay.
Tag No.: A0467
Based on interview, clinical record review, and policy review, the facility did not ensure the clinical record for 2 of 30 sampled patients was maintained in accordance with facility policy (Patient #7 and #29).
Findings included
The facility's "Health Information Management Department Guidelines & Procedures Manual", dated 2/09, indicated "patient medical records are timely, meaningful, authentic and legible...".
The policy titled "EMTALA (Emergency Medical Treatment and Active Labor Act) Transfer Policy, dated 8/2010, stated in part, "... the transferring hospital must, within its capability, provide treatment to minimize the risks to the health of the individual or unborn child..."
Patient #7
Patient #7 was admitted to the facility on 09/24/2012, with diagnoses including syncope and fracture of the maxillary sinus.
Patient #7's clinical record was reviewed on 12/20/2012. Patient #7 was admitted to the facility on 09/24/2012, after a fall at home when she sustained facial injuries. The facility admitted her through the emergency room. A CT (Computerized Tomography) of her face revealed a depressed fracture of the anterior right maxillary sinus with a 5 millimeter depression of the fracture fragment. There was moderate fluid in the right maxillary sinus and marked soft tissue swelling to the right cheek. The orthopaedic surgeon on call did not perform maxillary surgery. The decision was reasonably made to transport the patient to another acute facility for appropriate treatment.
Patient #7's clinical record included the document, dated 09/24/2012, and titled "Patient Transfer Documentation - Physician". The listed diagnosis was "syncope, (right) maxillary sinus (fracture)". There was no listed "condition of patient", "reason for transfer", "risks that can reasonably be anticipated by the transfer may include...", "benefits that can reasonably be expected from such transfer may include...". These sections were all left blank. The form was signed by the patient's Power of Attorney and the physician.
On 12/20/2012 at 9:52 AM, the Director of Compliance and Risk Management stated the physician should have filled out the document.
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Patient #29
On 11/21/11, Patient #29 was admitted with diagnoses of altered mental status, respiratory distress, congestive heart failure, pulmonary edema, chronic obstructive pulmonary disease, pleural effusion, aortic dissection, coronary artery disease, hypertension, anemia, and benign prostatic hypertrophy.
On 12/20/12, a medical record review revealed two intravenous contrast forms dated 11/25/11 and 11/28/11. The accompanying patient signature/witness signature forms for each date failed to include the procedure performed.
On 11/23/11 at 4:27 AM, a pathology report indicated a specimen collection time for pleural fluid for cytology.
On 11/23/11 at 9:40 PM, Patient #29 signed a surgical consent for an ultrasound-guided thoracentesis of the left chest.
On 11/24/11 at 10:46 AM and 10:50 AM respectively, a radiology report and a pre and post procedure form indicated an ultrasound-guided thoracentesis was performed.
On 11/24/11 at 10:57 AM, the pathology report indicated the lab received the pleural fluid for cytology specimen.
On 1/9/13 at 11:00 AM, the System Director of Regulatory Compliance and Accreditation indicated the facility's clinical lab director said the aforementioned specimen collection time for the pleural fluid was misentered since the procedure was not performed until 11/24/11.