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333 MERCY AVENUE

MERCED, CA 95340

PATIENT RIGHTS

Tag No.: A0115

Based on staff interview, clinical record and administrative document review, the hospital failed to protect and promote each patient's rights when:

1. Information necessary to make an informed consent was not provided to the parents of two of ten sampled patients (Patient 1 and Patient 9) to make an informed decision about the care provided. (refer to A131)

2. A light source, used by staff, for other than the manufacturer's intended purpose burned Patient 1's (an infant) hand while being treated in the Emergency Department. The parents were not informed the light source was used for other than its intended purpose. (refer to A144)

The cumulative effect of these systemic problems resulted in the hospital's inability to ensure the provision of Patient Rights.

PATIENT RIGHTS: INFORMED CONSENT

Tag No.: A0131

Based on staff interview, clinical record and administrative document review, the hospital failed to protect the right of the patient, or the right of his or her representative, to make informed decisions regarding the patient's care for two of ten sampled patients (Patient 1 and Patient 9). This failure resulted in care being provided without consent and without protecting the right to make an informed decision.

Findings:

1. On 3/27/12, Patient 1 (an infant) was admitted for fever and diarrhea. The treatment for the infant's dehydration (excessive loss of body fluid) included multiple attempts to initiate intravenous access (insert a needle into a vein through the skin). None of the attempts were successful. As a final effort, the ED Nurse Supervisor used a vaginal light (without its speculum cover) as a "vein finder". The use of this light source, used for other than the manufacturer's intended purpose) was not perceived by staff as a risk or explained to Patient 1's parents. The use of this light resulted in second to third degree burns to the palm of Patient 1's left hand, as noted in clinic notes dated 4/1/12 and 4/10/12.

On 6/29/12 at 2:12 p.m., the Chief Nursing Officer (CNO) stated the staff lost awareness of the number of times the IV was attempted. The CNO stated the ED staff never questioned the appropriateness of using the vaginal light without its speculum cover for the purpose of starting an IV.

During an interview on 7/2/12 at 3:25 p.m., the Risk Regulatory Compliance Officer (RRCO) stated staff were unaware of the burn until 3/30/12, when the parent complained to the "Patient Advocate" (Hospital's Complaint Department) that Patient 1 sustained a burn. The RRCO stated the staff did not explain to the parents of Patient 1 that the light got hot.

The clinical record did not indicate the parents of Patient 1 were informed of the risks and benefits and consented to the use of medical equipment (the vaginal light) for other than its intended purpose.

The manufacturer's instructions for the WelchAllyn "KleenSpec Vaginal Specula Illumination System contained the following under Warnings and Cautions: "Warning: Lamp is harmful to skin if touched. Allow lamp to cool for 5 minutes before replacing. Lamp generates heat and should remain off until just prior to and immediately after use. Do not place illuminator onto flammable surface if lamp is illuminated."

2. Clinical record for Patient 9 was reviewed and indicated he had undergone a lumbar puncture (a procedure to obtain spinal fluid by introducing a needle into the spine for diagnostic laboratory studies) on 5/8/12. No documented evidence was provided to indicate this procedure (lumbar puncture) had been explained or that the parents understood and consented for it to be done.

On 7/2/12 at 3:52 p.m., during an interview, the Emergency Room Director (EDD) stated the registrars do consents for treatment. The EDD stated the parents of Patient 1 were Spanish speaking only. The EDD stated the "Conditions of Admission" were in Spanish. The "Conditions of Admission Part 2" were in English and Spanish. The consent to transfer and the patient notification for transfer was in English. The EDD stated, "According to the record these forms should have been in Spanish or by interpreter. I don't see anything about a lumbar puncture. There should have been a consent in Spanish in the record."

PATIENT RIGHTS: CARE IN SAFE SETTING

Tag No.: A0144

Based on staff interview, clinical record and administrative document review, the hospital failed to ensure the right of the patient to receive care in a safe setting for one of 10 patients (Patient 1) when RN 1 used a light source, in a manner not intended for use per the manufacturer's guidelines, to illuminate the veins in Patient 1's (an infant) hand resulting in second to third degree burns to the hand. This failure resulted in Patient 1 receiving care in a setting that was not safe.

Findings:

On 3/27/12 at 11:32 p.m., Patient 1 was admitted to the ED for fever and diarrhea. The treatment for the infant's dehydration (excessive loss of body fluids) included placing an intravenous (IV - tubing placed in the vein through the skin) line. In the process of placing the IV, multiple attempts were made unsuccessfully. As a final effort, the ED Nurse Supervisor used a vaginal light without its attached speculum cover in order to illuminate the veins in the 2 month and 23 day old baby's hand. The use of this light source, (used for other than the manufacturer's intended purpose) was not perceived by staff as a risk. The use of the vaginal light was not explained to Patient 1's parents. The use of this light resulted in second to third degree burns as noted in clinic notes dated 4/2/12.

On 6/28/12, at 3:10 p.m., during an interview in the Administration Conference Room, Registered Nurse (RN) 1 (the RN Supervisor in the ED on the night of 3/27/12) stated he used the vaginal light on Patient 1. RN 1 stated, "It never occurred to anyone that the practice [use of the light] was unsafe or painful."

On 6/29/12 at 9:10 a.m., during a telephone interview, the registered nurse (RN 2) assigned to care for Patient 1 on 3/27/12 stated, "The Vag [vaginal] light gets very hot, very quickly... I was not aware that an injury was occurring."

On 6/29/12 at 2:12 p.m., the Chief Nursing Officer (CNO) stated the staff lost awareness of the number of times the IV was attempted. The CNO stated the ED staff never questioned the appropriateness of using the vaginal light without its speculum.

The manufacturer's instructions for the WelchAllyn "KleenSpec Vaginal Specula Illumination System contained the following under Warnings and Cautions: "Warning: Lamp is harmful to skin if touched. Allow lamp to cool for 5 minutes before replacing. Lamp generates heat and should remain off until just prior to and immediately after use. Do not place illuminator onto flammable surface if lamp is illuminated."

NURSING CARE PLAN

Tag No.: A0396

Based on staff interview, clinical record and administrative document review, the hospital failed to ensure nursing staff developed, updated, and kept current the nursing care plans for eight of ten sampled patients (Patients 1, 2, 3, 6, 7, 8, 9, and 10). These failures prevented the hospital from providing adequate health care for each patient.

Findings:

On 6/28/12 at 4:05 p.m., during an interview, Registered Nurse (RN) 1 stated he was a RN supervisor for the Emergency Department (ED). RN 1 stated the ED electronic record (ED ER) had no section titled Care Plan. RN 1 stated the area of the electronic ED record titled Nursing Diagnosis was the area intended for care planning. This section of the ED ER had a list of diagnoses or problems that automatically popped up on all ED ER . RN 1 validated that no care plan was documented in this section for Patient 1.

Patients 1, 2, 3, 6, 7, 8, 9, and 10 clinical records indicated no evidence of care plans were documented.

During an interview on 7/2/12 at 3:25 p.m., the Risk Regulatory Compliance Officer (RRCO) reviewed the clinical records for Patients 1, 2, 3, 6, 7, 8, 9, and 10. The RRCO confirmed the records had problems (diagnoses) identified and but the records were without further evidence of care planning.

During an interview on 7/2/12 at 4:30 p.m., the ED Director (EDD) was given an opportunity to review the medical records for Patients 1, 2, 3, 6, 7, 8, 9, and 10. The EDD confirmed the clinical records had problems identified and the clinical records had no further evidence of care planning.

Review of the ED Policy and Procedure titled, "Standards of Practice," dated 1/12 indicated, "...The Standards of Practice for the Emergency Department (ED) at [name of the facility] are based on evidence based practices from the American Nurses Association and the Emergency Nurses Association. The nursing process focuses on assessment... solution development for best patient outcomes, and evaluation of outcome criteria... D. Standard IV - Is the development of the nursing care plan..."

ACCEPTING VERBAL ORDERS FOR DRUGS

Tag No.: A0408

Based on staff interview, clinical record and administrative document review, the hospital failed to follow their policy and procedure for documenting verbal orders for one of ten sampled patients (Patient 1) when a physician's verbal order was given, but not documented in the clinical record for Patient 1. The verbal order was for the insertion of a urinary catheter - a tube inserted through the urethra (opening to urinate) into the bladder to drain urine. This failure placed Patient 1 at risk of receiving care that was not ordered by a physician.

Findings:

Review of Patient 1's clinical record for the Emergency Department (ED) visit on 3/28/12 was conducted. The record contained documentation which RN 2 indicated, "Attempt to cath baby without success... baby appears to be dehydrated unable to obtain urine."

On 6/29/12 at 8:40 a.m., during a telephone interview RN 2 stated, "I received the physician's verbal order for Patient 1 to get a catheter. Verbal orders are supposed to be written down. That didn't happen [for Patient 1]."

The hospital's policy and procedure titled, "Physician (Licensed Independent Practitioner) Orders," dated 12/10 indicated, "...All telephone or verbal orders will be recorded on the Physician Order Form..."