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SALEM, OR 97301

PATIENT RIGHTS: INFORMED CONSENT

Tag No.: A0131

Based on interview, policy review, review of grievance documentation, and review of 1 of 3 medical records (Record #5) of pediatric patients who received anesthesia services for an outpatient surgical procedure, it was determined the hospital failed to ensure the patient representative's right to be fully informed of the patient's health status, including the outcome and treatments provided during recovery from anesthesia services.

Findings include:

1. Patient record #5 was reviewed: The record reflected the patient was 14-months old and underwent a right thumb irrigation and debridement surgery on 02/08/2012. The physician operative/invasive procedure note signed 02/11/2012 at 0857," reflected the patient received a masked general anesthetic for the procedure. The operative note reflected the patient was awakened from the anesthesia after the procedure and taken to the recovery room in stable condition.

Review of PACU nurse progress notes dated 02/08/2012 at 0821 reflected, "On arrival to [the] PACU [Post Anesthesia Care Unit], [patient] was not breathing, [patient] turning dusky, oxygen saturations decreasing..." The record reflected Physician H, Patient #5's anesthesiologist, was at the bedside and started "bagging" [providing assistance with breathing] the patient. The patient's oxygen level and skin color improved, but he/she was still not breathing spontaneously.

Review of PACU nurse flowsheets dated 02/08/2012 at 0823, reflected the patient's Sp02 (oxygen saturation) was 81%, respiratory rate was 14, respiratory pattern was "Apneic [periods of absence of breathing]," and Physician H was "bagging" the patient.

Review of PACU nurse flowsheets dated 02/08/2012 at 0824, reflected the patent's Sp02 was 50% and respiratory rate was 7.

Review of PACU nurse flowsheets dated 02/08/2012 at 0825, reflected the patient's Sp02 was 94%, respiratory rate was 36, respiratory pattern was "Apneic," and Physician H was "bagging" the patient.

Review of PACU nurse progress notes dated 02/08/2012 at 0830, reflected the patient was breathing spontaneously.

Review of PACU nurse flowsheets dated 02/08/2012 described the patient's level of consciousness as "Asleep from anesthesia," at 0835, 0840, 0845, 0900, 0915, 0920 and 0925.

Review of PACU nurse progress notes dated 02/08/2012 at 0933, reflected the nurse contacted Physician G, the Anesthesiologist in Charge (AIC). Physician G came to the bedside to check on the patient, and ordered Narcan [a medication ordered for oversedation and respiratory depression].

Review of the medication administration record reflected the PACU nurse gave the patient Narcan 40 mcg intravenously on 02/08/2012 at 0937, and Narcan 20 mcg intravenously on 02/08/2012 at 0943.

Review of PACU nurse progress notes dated 02/08/2012 at 0948, reflected the patient was awake and crying.

Review of PACU nurse progress noted dated 02/08/2012 at 1130, reflected the patient was transported to the pediatric unit.

The nurse discharge summary filed 02/08/2012 at 1512, reflected the patient was discharged home 02/08/2012 at 1355.

2. An interview was conducted with Nurse A, the nurse who cared for Patient #5 in the PACU on 06/08/2012 at 1400. The nurse stated that within minutes after Patient #5 arrived to the PACU, he/she was "not as pink" and "wasn't breathing when [Nurse A] listened to [his/her] breath sounds." He/she stated that Physician H started "bagging" Patient #5 and continued to "bag" Patient #5 for 20 minutes before the patient was breathing spontaneously. The nurse further stated the patient received 2 doses of Narcan while he/she was in the PACU, because he/she was not "waking up" as quickly as expected.

3. Review of the hospital policy titled, "The Patient at Salem & West Valley Hospitals," effective 02/2011 identified the following internal requirements: The policy contained a list of patient rights which included, "...the patient and others as requested by the patient are informed of the outcomes of care, treatment or services provided, including unanticipated outcomes."

Review of a second hospital policy titled, "Disclosure of Adverse Events Guidelines," effective 10/2009 identified the following internal requirements: "These guidelines are provided to facilitate patient/healthcare provider communications that respect the rights and needs of the patient...Unanticipated Outcome - the outcome of any treatment or procedure that differs significantly from the expected outcome although not necessarily an adverse outcome or related to medical error...Disclosure Communications - the process, (not event), of open communication and information-sharing when an Unanticipated Outcome or Adverse Event occurs, the purpose of which is to inform the patient and provide support, respect his/her rights in the clinical decision-making process. Salem Health is committed to achieving a culture of patient safety, through open and effective communication between healthcare providers and their patients, including rapid disclosure of Unanticipated Outcomes...This communication recognizes that patients are entitled to information about themselves and their medical conditions/illnesses..."

4. An interview was conducted with Nurse B, the PACU Assistant Nurse Manager on 06/08/2012 at 1400. During the interview, Nurse B reviewed the definition of an "Unanticipated Outcome," contained within the policy titled, "Disclosure of Adverse Events Guidelines," above and stated that Patient #5's recovery in the PACU met the definition of an unanticipated outcome because the patient had to remain at the hospital longer than expected in order to monitor his/her recovery from the anesthesia. He/she also stated the patient needed more interventions than usual.

Nurse B described the process in which family members of PACU patients were provided information about a patient's recovery. He/she said the charge nurse made hourly rounds of patients in the PACU and and took notes on their recovery status. A note was then written on a dry erase board which was given to the PACU receptionist for the purpose of providing a "quick update" to family members in the PACU waiting area. He/she stated that Patient #5's family was informed by the receptionist via the dry erase board that Patient #5 was "very sleepy," but they were not given specific information about Patient #5's recovery from anesthesia or treatments provided. Nurse B stated, "Communication with the family [of Patient #5] should have been better."

5. Review of hospital grievance documentation regarding Patient #5, included a letter dated 03/19/2012, addressed to Patient #5's [family member] from Physician F, the Chief of Anesthesia. Review of the letter reflected, "...after taking your child to the recovery room there wasn't a respiratory complication, but instead a very brief period when [Patient #5] needed breathing assistance. [Physician H] had given some pain medication at the end of surgery that likely caused this sedation...Since [Patient #5] was sleepy longer than normal, [he/she] received Narcan, a drug that reverses pain medicine effects. Because of this [he/she] then needed additional observation in the recovery room and Pediatrics ward...If possible, I always try to speak with parents after I've taken care of small children, but this didn't happen in your case."

Further review of the grievance documentation included a letter dated 04/18/2012, addressed to Patient #5's [family members], from Nurse B. Review of the letter reflected, "It is difficult to predict how each individual reacts to anesthesia. Some wake up very quickly. Some remain very sleepy for an extended period of time, as was the case with your [child] [Patient #5]...Some of our anesthesiologist's [sic] speak to [family members] after their child's procedure. However, this is not policy and was not done in your [child's] case...the nurses consulted with our 'AIC' for the day...regarding your [child's] continued sedation. This would have been the appropriate time for the PACU nurse or anesthesiologist to give you an update, and this did not happen..."

PRE-ANESTHESIA EVALUATION

Tag No.: A1003

A. Based on interview, review of medical staff rules and regulations and policy review, it was determined the hospital failed to fully develop and implement its anesthesia policies to ensure a pre-anesthesia evaluation was completed and documented within 48 hours prior to surgery or a procedure that required anesthesia as required.

Findings include:

1. An interview was conducted with the Accreditation Administrator on 06/11/2012 at 1250. He/she acknowledged that current hospital policies were not fully developed to include a requirement ensuring that a pre-anesthesia evaluation was completed and documented within 48 hours prior to surgery for each patient.

2. Review of the hospital's medical staff rules and regulations identified they lacked a procedure to ensure that a pre-anesthesia evaluation was completed and documented by an individual qualified to administer anesthesia within 48 hours prior to surgery for each patient.

3. Review of the policy titled, "Anesthesia - Safety Practices," effective 04/2010, and the corresponding "Attachment B," revised 05/2008, identified they lacked a procedure to ensure that a pre-anesthesia evaluation was performed within 48 hours prior to surgery for each patient as required.


B. Based on interview, review of medical records for 2 of 5 patients (Record #s 1 and 2) who underwent a surgical procedure with general anesthesia, review of medical staff rules and regulations, and policy review, it was determined the hospital failed to ensure documentation that pre-anesthesia evaluations were timed in accordance with its own policy.

1. Review of the hospital policy titled, "Anesthesia - Safety Practices," effective 04/2010, and Attachment B, revised 05/2008 identified an internal documentation requirement that pre-anesthesia evaluations be dated, timed and signed.

2. Patient record #1: Review of the record reflected the patient underwent a left breast implant removal surgery on 02/01/2012. The physician operative/invasive procedure note authenticated 02/17/2012 at 0455, reflected the patient received general endotracheal anesthesia for the procedure. The record contained a pre-anesthesia note dated 02/01/2012, which included a pre-anesthesia evaluation. However, review of the record identified it lacked documentation of the time the evaluation was conducted in accordance with hospital policy.

3. Patient record #2: Review of the record reflected the patient underwent a laparoscopic appendectomy surgery on 02/28/2012. The anesthesiologist intraoperative anesthesia record dated 02/28/2012, reflected the patient received general anesthesia for the procedure. The record contained a pre-anesthesia note dated 02/28/2012, which included a pre-anesthesia evaluation. However review of the record identified it lacked documentation of the time the evaluation was conducted in accordance with hospital policy.

4. These findings were reviewed with the Accreditation Administrator on 06/11/2012 at approximately 1200. He/she revealed that the hospital had conducted an internal audit which identified a lack of documentation for timing of pre-anesthesia examinations.

POST-ANESTHESIA EVALUATION

Tag No.: A1005

A. Based on interview, review of medical staff rules and regulations and policy review, it was determined the hospital failed to fully develop and implement its anesthesia policies to ensure a post-anesthesia evaluation was completed and documented by an individual qualified to administer anesthesia no later than 48 hours after the surgery as required.

Findings include:

1. Review of the policy titled, "Anesthesia - Safety Practices," effective 04/2010 and the corresponding "Attachment B," revised 05/2008 identified they lacked a procedure to ensure that a post-anesthesia evaluation was performed and documented by an individual qualified to administer anesthesia no later than 48 hours after surgery as required.

2. Review of the hospital's medical staff rules and regulations identified they lacked a procedure to ensure that a post-anesthesia evaluation was performed and documented by an individual qualified to administer anesthesia no later than 48 hours after surgery as required.

3. An interview was conducted with the Accreditation Administrator on 06/11/2012 at 1250. He/she acknowledged that current hospital policies did not include a requirement ensuring that a post-anesthesia evaluation was performed by an individual qualified to administer anesthesia no later than 48 hours after surgery as required. He/she revealed that the hospital had conducted an internal audit which identified a lack of documentation for completion, dating and timing of post-anesthesia evaluations within 48 hours.


B. Based on review of medical records for 2 of 5 patients (Record #s 2 and 5) who underwent an outpatient surgical procedure with anesthesia services, and policy review, it was determined the hospital failed to ensure documentation that post-anesthesia evaluations were written, dated and timed in accordance with its own policy.

Findings include:

1. Review of the policy titled, "Anesthesia - Safety Practices," effective 04/2010, "Attachment B," revised 05/2008 identified the following internal post-anesthesia documentation requirements: "...an appropriate note should be written, dated and signed."

2. Patient record #2: Review of the record reflected the patient underwent a laparoscopic appendectomy surgery on 02/28/2012. The anesthesia record dated 02/28/2012 reflected the patient received general anesthesia for the procedure. Review of the record identified it lacked documentation that a post-anesthesia evaluation had been written, dated and timed in accordance with hospital policy, and within 48 hours as required.

This was reviewed with the Accreditation Administrator during an interview on 06/11/2012 at 1200. He/she reviewed Patient record #2 and acknowledged it lacked documentation of a post-anesthesia evaluation.

3. Patient record #5: Review of the record reflected the patient underwent a right thumb abscess irrigation and debridement surgery on 02/08/2012. The anesthesia record dated "2/8," reflected the patient received general anesthesia for the procedure. Review of the record identified it lacked documentation that a post-anesthesia evaluation had been written, dated and timed in accordance with hospital policy, and within 48 hours as required.