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26502




26500


Based on interview, record and document review, the hospital failed to ensure that Critical Care Intravenous (IV- within the vein) titratable (a process of determining the concentration of a medication required to bring about a desired clinical result) medications were administered in a safe manner by Registered Nurses (RN) as follows:

1. RN 2 increased the intravenous Nitroprusside (a medication used to reduce high blood pressure) drip to achieve a desired clinical result without a physician's order that specified the titration parameters for 1 of 7 sampled patients (Patient 4). This failure had the potential to result in an adverse effects, such as hypotension (low blood pressure) and palpitations (irregular heart beats), experienced by Patient 4 and all patients that received IV titratable medications in the hospital.

2. The Neonatal Intensive Care Unit (NICU) RNs did not receive unit specific critical care IV medication competencies. This failure had the potential for all patients that received Dopamine (a positive inotropic agent [a medication that increase the strength of heart muscle contractions] used to treat hypotension, low cardiac output and poor perfusion of vital organs) in the NICU to not receive the appropriate, therapeutic dosages which may contribute to a decline in their overall health status.

Findings:

1. On June 18, 2013, a review of Patient 4's medical record was conducted with Registered Nurse (RN) 3. Patient 4 presented to the Emergency Department (ED) on April 30, 2013 with the chief complaint of high blood pressure.

A review of the Physicians Orders (PO), dated April 30, 2013 at 12:05 PM, was conducted. The PO included the following:

a. Nitroprusside drip
b. 0.2 micrograms (mcg)/kilogram (kg)/minute (min)
c. Titrate to systolic blood pressure 160 milliliters of mercury (mmHg)
d. Maximum dose 10 mcg/kg/min

The PO did not include the titration parameters to achieve the desired clinical result.
On June 18, 2013 at 3:05 PM, RN 3 confirmed that the PO did not include titration parameters. She stated that the PO should have included titration parameters. RN 3 also confirmed that the PO for the Nitroprusside drip titration parameters was not clarified by the ordering physician.

A review of the ED nursing documentation, dated April 30, 2013 at 12:35 PM, was conducted. The documentation showed that RN 2 started the Nitroprusside drip at 0.2 mcg/kg/min to attain blood pressure (B/P) of 160 mmHg with max dose of 10 mcg/kg/min.

A review of the ED nursing documentation, dated April 30, 2013 at 1:30 PM was conducted. The documentation showed that RN 2 increased the Nitroprusside drip to 0.4 mcg/kg/min.

A review of the ED nursing documentation, dated April 30, 2013 at 2 PM was conducted. The documentation showed, "titrating Nipride (Nitroprusside) for B/P." The patient's B/P was 190/131 mmHg at 2 PM.

A review of the ED nursing documentation, dated April 30, 2013 at 4 PM was conducted. The documentation showed that the patient's B/P was 158/124 mmHg via the left arm and 155/114 mmHg via the right arm.

On June 18, 2013 at 3:30 PM, an interview and record review was conducted with the Cardiac Catheterization Laboratory Manager (CCLM) that was covering for the ED Director. The CCLM stated that the titration parameters should have been clarified with the ordering physician.

On June 19, 2013 at 10:38 AM, an interview was conducted with the ED Director (EDD). The EDD reviewed the incomplete PO for the Nitroprusside drip and the nursing documentation that showed the RN had increased the drip without specific parameters. The EDD confirmed that the PO did not include the specific titration parameters. The EDD stated that the RN should have clarified the order with the ordering physician. He stated that RN should not have increased the Nitroprusside drip from 0.2 mcg/kg/min to 0.4 mcg/kg/min without specific titration parameters from the ordering physician.

On June 20, 2013 at 9:25 AM, an interview and record review was conducted with RN 2, the nurse who had implemented the incomplete PO for Patient 4. When asked if he received an in-service education regarding the administering of critical care IV titratable drips, he replied, "yes." RN 2 was able to state the elements that the PO required. RN 2 reviewed the PO for the Nitroprusside drip and confirmed that it did not include specific titration parameters. He stated that PO should have included the titration parameters. RN 2 stated that he should have clarified with the physician who had ordered the Nitroprusside drip, prior to increasing the medication from 0.2 mcg/kg/min to 0.4 mcg/kg/min.

A review of the Memorandum regarding notification to the RNs, guiding them that they cannot titrate a medication without a specific physicians order, dated March 28, 2013, was conducted. The memo indicated that the order must specify the initial or bolus (a large amount of a medication given for the purpose of rapidly achieving the needed therapeutic concentration in the bloodstream) dose, the specific titration amount, parameters for titration, the maximum dose and stop rate. If the order did not have these parameters, the RN was to contact the physician. The pharmacist may assist with this order. The RNs were required to sign a sign-in log to ensure that they had received the education and understood their responsibilities.

A review of the Acknowledgement sign-in log was conducted and it showed that on March 31, 2013, RN 2 signed the log acknowledging that he understood that medications could not be titrated without specific orders.

2. A review of the NICU Acknowledgement sign-in log, dated from March 28, 2013 through April 1, 2013 was conducted. It noted that the NICU RNs had received the policies on critical care IV medication titration and understood their responsibilities.

On June 19, 2013 at 1:06 PM, an interview with the NICU Clinical
Supervisor/Educator was conducted. She stated that NICU RNs signatures on the Acknowledgement log indicated that the RNs understood the components of a complete physician's orders for IV titratable medications. The NICU Clinical Supervisor/Educator stated that the only titratable medication that NICU RNs administered was IV Dopamine. When asked to review the NICU RNs competencies related IV Dopamine administration, the Clinical Supervisor/Educator stated that the NICU RNs did not receive unit specific competencies related to Dopamine administration. She stated that she did not develop a system, such as a post test, to ensure that the RNs were competent to safely administer the unit specific critical care IV medication as the plan of correction indicated.

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 ..."

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..."