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Tag No.: A0450
Based on interview and record review, the facility failed to ensure that 2 of 7 sampled patients (Patients 1 & 3) in a universe of 62, medical record entries were legible, complete, dated and timed by the physicians responsible for the entries. This failure resulted in the potential for errors in transcription and the potential to affect the safety and quality of care that the patients received.
1. For Patient 1, an informed consent (a legal process that ensures that a patient and/or the patient's legal responsible party is aware of the risks and benefits of a given medical treatment/procedure) for a central line placement (an intravenous [IV - within the blood vessel] line that is inserted into a large vein typically in the neck or near the heart for therapeutic or diagnostic purposes) was illegible, not timed and not dated.
2. For Patient 3 an order for insulin (a medication used for diabetic patients, which helps control blood sugar levels) was incomplete, not dated and not timed.
Findings:
1.) A record review of Patient 1 was conducted on June 18, 2013, at 2:35 PM and revealed that the patient was admitted on June 16, 2013, with diagnoses which included septic shock (a serious condition that occurs when an overwhelming infection leads to a life-threatening low blood pressure) and dehydration (the excessive loss of water from the body or from an organ due to illness or fluid deprivation).
A record review of Patient 1's physician informed consent for a central line placement, which was inserted on June 16, 2013, contained an illegible physician signature and was neither dated nor timed.
An interview with the Intensive Care Unit (ICU) Charge Nurse was conducted on June 18, 2013, at 2:35 PM. After she reviewed the informed consent, she stated that the physician's signature was not legible and did not contain a date nor a time when the physician signed the document.
A record review of the hospital "General Rules & Regulations of The Medical Staff, revised on 12/6/11" was reviewed on June 19, 2013 at 3:50 PM. The rules and regulations indicated the following, "MEDICAL RECORDS All medical record entries shall be dated, timed and authenticated...Diagnostic and Therapeutic Orders: ...The physicians' orders must be written clearly, legibly and completed, transcribed accurately, dated and timed. Orders which are illegible or improperly written, shall not be carried out until rewritten or clarified by the nurse ..."
2.) A record review of Patient 3 and a concurrent interview were conducted on June 18, 2013 at approximately 3:45 PM with an ICU Registered Nurse (RN 1). The record review indicated that Patient 3 was admitted on June 8, 2013 with a diagnosis which included septic shock.
A record review of Patient 3 and a concurrent interview were conducted on June 18, 2013, at approximately 3:45 PM with RN 1. The record review revealed an incomplete "Administration of Insulin Per Sliding Scale Orders For Adults" (a document of a physician order for insulin administration). The order indicated to administer a "Low Dose Regimen" and did not include a physician's signature and was neither dated nor signed. RN 1 stated that Patient 3 was on a low dose insulin regimen but the order had not been completed or signed by the physician. RN 1 also stated that they placed a "Sign Here" sticker on the order to remind the physician to complete it but the physician had not signed the document.
A record review of the hospital "General Rules & Regulations of The Medical Staff, revised on 12/6/11" was reviewed on June 19, 2013 at 3:50 PM. The rules and regulations indicated the following, "MEDICAL RECORDS All medical record entries shall be dated, timed and authenticated ...Diagnostic and Therapeutic Orders:...The physicians' orders must be written clearly, legibly and completed, transcribed accurately, dated and timed. Orders which are illegible or improperly written, shall not be carried out until rewritten or clarified by the nurse ..."
Tag No.: A0955
28020
Based on interview and record review, the hospital failed to ensure that a comprehensive informed consent (a legal process that ensures that a patient and/or the patient's legal responsible party is aware of the risks and benefits of a given medical treatment and/or procedure) was completed per the hospital's "Medical Staff Bylaws Rules & Regulations" and accepted standard of care for 1 of 7 sampled patients (Patient 2) in a universe of 62. This practice had the potential to increase the risk of a patient not receiving pertinent information, prior to having medical procedure, decreasing the patient's ability to make an informed decision regarding said procedure.
Findings:
A record review of Patient 2, conducted on June 18, 2013, at 3:05 PM, indicated that the patient was admitted on June 16, 2013 with septic shock (a serious condition that occurs when an overwhelming infection leads to a life-threatening low blood pressure) and had a central line (an intravenous [IV - within the blood vessel] line that is inserted into a large vein typically in the neck or near the heart for therapeutic or diagnostic purposes).
An interview was conducted with the Intensive Care Unit (ICU) Charge Nurse on June 18, 2013, at 3:30 PM. She stated that Patient 2's physician documented in the progress notes that he inserted a central line but that there was no documented evidence that the physician provided an informed consent from the patient.
A record review was conducted on June 18, 2013, at 3:10 PM, of the hospital policy titled, "Consent and Informed Consent, revised on 7/09." The policy indicated the following, "...Informed Consent: 1. The patient shall be given, by his/her physician, as much information about any proposed treatment of procedure as he/she may need in order to give an informed decision or to refuse this course of treatment. Except in emergencies, this information shall include the following: a. Nature of the procedure or treatment. b. The expected benefits, risks involved in this treatment, and the risks of refusing to undergo the recommended procedure. c. The alternative course of treatment and the associated risks. d. The name(s) of the individual(s) who will perform the procedure or treatment ..."
A record review of the hospital "General Rules & Regulations of The Medical Staff, revised on 12/6/11" was reviewed on June 19, 2013 at 3:50 PM. The rules and regulations indicated the following, "INFORMED CONSENTS the medical staff abides by the hospital policies and procedures regarding consents guided by the CONSENT MANUAL prepared for the California Hospital Association, modified as necessary to reflect changes in legislation, regulations, and judicial decisions affecting delivery of health care in this institution. To ensure a patient's right to be informed about the proposed care and treatment when he/she seeks medical care in this hospital, the medical records shall contain evidence of the patient's informed consent for any procedure or treatment for which it is appropriate...Informed consent is the responsibility of the attending physician. There shall be appropriate documentation in the medical record of such informed consent prior to any special diagnostic procedure or surgery..."
Tag No.: A0955
28020
Based on interview and record review, the hospital failed to ensure that a comprehensive informed consent (a legal process that ensures that a patient and/or the patient's legal responsible party is aware of the risks and benefits of a given medical treatment and/or procedure) was completed per the hospital's "Medical Staff Bylaws Rules & Regulations" and accepted standard of care for 1 of 7 sampled patients (Patient 2) in a universe of 62. This practice had the potential to increase the risk of a patient not receiving pertinent information, prior to having medical procedure, decreasing the patient's ability to make an informed decision regarding said procedure.
Findings:
A record review of Patient 2, conducted on June 18, 2013, at 3:05 PM, indicated that the patient was admitted on June 16, 2013 with septic shock (a serious condition that occurs when an overwhelming infection leads to a life-threatening low blood pressure) and had a central line (an intravenous [IV - within the blood vessel] line that is inserted into a large vein typically in the neck or near the heart for therapeutic or diagnostic purposes).
An interview was conducted with the Intensive Care Unit (ICU) Charge Nurse on June 18, 2013, at 3:30 PM. She stated that Patient 2's physician documented in the progress notes that he inserted a central line but that there was no documented evidence that the physician provided an informed consent from the patient.
A record review was conducted on June 18, 2013, at 3:10 PM, of the hospital policy titled, "Consent and Informed Consent, revised on 7/09." The policy indicated the following, "...Informed Consent: 1. The patient shall be given, by his/her physician, as much information about any proposed treatment of procedure as he/she may need in order to give an informed decision or to refuse this course of treatment. Except in emergencies, this information shall include the following: a. Nature of the procedure or treatment. b. The expected benefits, risks involved in this treatment, and the risks of refusing to undergo the recommended procedure. c. The alternative course of treatment and the associated risks. d. The name(s) of the individual(s) who will perform the procedure or treatment ..."
A record review of the hospital "General Rules & Regulations of The Medical Staff, revised on 12/6/11" was reviewed on June 19, 2013 at 3:50 PM. The rules and regulations indicated the following, "INFORMED CONSENTS the medical staff abides by the hospital policies and procedures regarding consents guided by the CONSENT MANUAL prepared for the California Hospital Association, modified as necessary to reflect changes in legislation, regulations, and judicial decisions affecting delivery of health care in this institution. To ensure a patient's right to be informed about the proposed care and treatment when he/she seeks medical care in this hospital, the medical records shall contain evidence of the patient's informed consent for any procedure or treatment for which it is appropriate...Informed consent is the responsibility of the attending physician. There shall be appropriate documentation in the medical record of such informed consent prior to any special diagnostic procedure or surgery..."