HospitalInspections.org

Based on interview and record review, the hospital failed to implement one of 25 preventive actions it had identified following a medication error. The deficient practice had the potential to limit the hospital's efforts to prevent a similar event in the future.

Findings:

Review of the summary of a root cause analysis dated 10/29/13 indicated a medication error had occurred in 10/13. The summary included an attachment titled "Action Planning from Dec 3rd 2013 meeting". The attachment indicated the hospital would develop an online education module for recovery room and intensive care nurses, which would be posted by 1/6/14 and completed by 2/3/14. Review of photocopies from the online module provided by the hospital indicated it consisted of the title page, but there were no contents.

In an interview on 2/4/14 at 3:45 p.m., Staff C stated the online education module had not been completed yet. Staff D stated it would be another two weeks before it was posted.

Based on observation, interview, and record review, the hospital failed to store irrigation fluids in the main operating room (OR) according to the manufacturer's instructions. The deficient practice had the potential to allow the use of a compromised product.

Findings:

In an observation and interview on 2/3/14 at approximately 2:45 p.m., a blanket warmer in the OR central core contained plastic bottles of 0.9% sodium chloride and sterile water irrigation fluids. The blanket warmer was set to 130 degrees F (Fahrenheit). The labels on the bottles indicated they should be stored at room temperature. Staff D stated he would obtain a letter from the manufacturer indicating whether or not storage contrary to the product label was acceptable.

Review of product information sheets for "Sterile Water for Irrigation, USP" (revised 6/10) and "0.9% Sodium Chloride Irrigation, USP" (revised 5/09) both indicated "Exposure to temperatures above 25 [degrees] C [Centigrade]/77 [degrees] F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period... Do not heat container over 66 [degrees] C (150 [degrees] F)... Store at 20 to 25 [degrees] C (68 to 77 [degrees] F)."

Review of a letter from the manufacturer to the hospital dated 2/4/14 indicated the manufacturer recommended storing the irrigation fluids at room temperature, but for clinical situations that required a higher temperature, the products could be warmed to 104 degrees F for no longer than two weeks, or to temperatures between 104 and 150 degrees F for no more than 24 hours.

In an interview on 2/4/14 at 4:21 p.m., Staff D stated he had previously tried storing the irrigation fluids at 104 degrees, but the surgeons wanted it warmer, so he was storing them at 130 degrees Fahrenheit.

In an observation and interview on 2/5/14 at 10:06 a.m., the irrigation fluids in the blanket warmer were marked with dates ranging from 2/16 to 2/18. Staff D stated those were the dates the fluids would be discarded, and once again stated that the surgeons had insisted the fluids be kept warmer than when he had the blanket warmer set to 104 degrees F.

In an observation on 2/5/14 at 11:20 a.m., a member of the biomedical engineering department checked the temperature of two bottles of irrigation fluid taken from the blanket warmer set at 130 degrees F. The temperature reading of the first bottle was 111 degrees F; the second bottle was 108 degrees F.

Based on interviews and document review, the hospital failed to involve the pharmacy department in the quality improvement process by failing to include a pharmacist in the root cause analysis (RCA, a method of problem solving to identify the root causes of faults or problems) of a significant medication error. The pharmacist, as an expert in the medication delivery, plays an integral role in managing and preventing medication errors.

Findings:

On 11/1/13, the California Department of Public Health received a report from the hospital indicating a potential care management event occurred. The event involved a patient's death associated with a medication error.

On 2/3/14 and 2/4/14, the onsite investigation revealed an intravenous (given directly into the vein) medication Neo-Synephrine (medication to increase blood pressure) was accidentally given to a patient during the recovery stay after an elective surgery, carotid endarterectomy (a surgery to remove plaque build-up in the large artery on the side of the neck to prevent strokes). The medication error contributed to the complications the patient experienced, including high blood pressure, profuse bleeding, requiring tracheostomy (surgical opening through the neck into the trachea), one-hour code (an emergency code where immediate medical attention was required) with cardiopulmonary resuscitation (emergency procedures to revive unresponsive patient), and a return to surgery.

The hospital conducted the RCA for this medication error on 11/4/13.

On 2/3/14 at 3:40 p.m., during an interview with an assistant director of pharmacy (Pharmacist A), he said a pharmacist was not included in the said RCA. When asked if the pharmacy department had been involved in the improvement processes to prevent the recurrence of the medication error since the date of the event, Pharmacist A said, "Not that I am aware of."

On 2/4/14, a review of the RCA revealed there was no pharmacist participation.

On 2/4/14 at 2:15 p.m., the director of quality management confirmed a pharmacist was not invited to the RCA. She said the pharmacy director was "informed. "

The pharmacy director, who was on medical leave during the survey, was not available for interview. However, during a telephone interview on 11/19/13 at 12:20 p.m. (this was during the licensing investigation of the medication error), the pharmacy director said she was not aware of the above-mentioned medication error until she talked to the director of risk management earlier that day (11/19/13). She agreed although a pharmacy staff was not involved in the medication error, the pharmacy department should have been invited to the RCA to help identify underlying causes and to be part of the medication management process to prevent recurrence of the medication error.

In the current publication entitled "The Pharmacist's Role In Quality Improvement" of the American Society of Health-System Pharmacists (a national professional organization representing pharmacist practices in various settings), it indicated: "In all healthcare systems, continuous monitoring of medical care processes, including medication management, is critical to the identification and prevention of errors. Most healthcare systems have committees or teams that are charged with identifying and preventing errors, and a pharmacist is, or should be, a core member of the team. In particular, the input and participation of a pharmacist in creating and maintaining the medication management process are essential. Pharmacist leadership and involvement in the medication management process are key to improving safety and efficiency throughout the patient's stay."

Based on observation and interview, the hospital failed to ensure outdated medications were removed from patient care areas. This failure had the potential for patients to be given expired medications.

Findings:

1. During a visit to the operating room (OR) with Pharmacist A on 2/4/14 at 11 a.m., it was noted one of two diltiazem injectable vials (to treat high blood pressure or chest pain) in the OR medication refrigerator had expired on 1/31/14. Pharmacist A confirmed the medication expired.



26674

2. In an observation and interview on 2/3/14 at 2:38 p.m., operating room 4 contained a bottle of isoflurane (an inhaled anesthetic). The label indicated the contents of the bottle had expired on 12/31/12. Staff D stated the anesthesia department had not disposed of the expired medication.

Based on observation, interview, and record review, the hospital failed to adhere to its own policies and standards of practice requiring surgical attire in semi-restricted areas (clean parts of operating room [OR] suites with limited access and where surgical attire is usually required) and in ORs where cesarean sections were performed, failed to adhere to standards of practice requiring signs at entries to semi-restricted areas, and failed to adhere to standards of practice that corrugated cardboard shipping boxes should not enter semi-restricted areas. The deficient practices had the potential to contribute to surgical site infections.

Findings:

1. In an observation and interview on 2/3/14 at 2:15 p.m., Staff D approached double doors with signs indicating surgical attire was required and scrub sinks visible beyond the doors. Staff D offered the surveyor a blue gown and stated the surveyor could put the gown over his street clothes to tour the outer corridor of the OR, but that the surveyor would need to wear scrubs to enter individual ORs or the central core. The gown was of insufficient length to completely cover the legs of the surveyor's pants. Staff D stated the hospital did not have coveralls for OR visitors. In an interview on 2/3/14 at 2:26 p.m., Staff D stated the hospital did not follow a national guideline regarding surgical attire.

In an observation and interview on 2/4/14 at 10:04 a.m., Staff E offered the surveyor a blue gown and stated the surveyor could put the gown over his street clothes to tour the OR in the family birth center where cesarean sections were performed. The gown was of insufficient length to completely cover the legs of the surveyor's pants. Staff E stated the hospital did not have coveralls for OR visitors, who usually wore a yellow paper gown over their street clothes. Staff F showed the surveyor a "father kit" containing a yellow gown, hat, and mask. Staff F stated fathers would wear the yellow gown over their street clothes to go in the OR if their child was being delivered by cesarean section. Staff E stated she was not aware of a different guideline regarding surgical attire.

Review of the hospital's main OR policy "OPERATING ROOM ATTIRE" (reviewed 2013) indicated, "All persons entering the restricted area of the Surgery Department beyond the double doors of the department shall wear clean operating room attire (scrub uniforms) provided by the hospital. Review of the facility's policy "TRAFFIC PATTERNS IN THE MAIN OPERATING ROOM" (approved 7/13) indicated the outer OR corridor was considered a semi-restricted area and that scrub attire was required. The policy indicated the central core and the ORs themselves were restricted areas where scrub attire was also required. The hospital policies provided to the surveyors did not address surgical attire in the family birth center.

Review of the Association of periOperative Registered Nurses (AORN) Recommended Practices for Traffic Patterns in the Perioperative Practice Setting (effective 1/1/06) indicated they were intended as guidelines adaptable to practice settings including traditional ORs as well as labor and delivery units with OR suites. The guidelines stated, "The semirestricted area includes the peripheral support areas of the surgical suite. It has storage areas for clean and sterile supplies, work areas for storage and processing of instruments, scrub sink areas, and corridors leading to the restricted areas of the surgical suite. Traffic in this area is limited to authorized personnel and patients. Personnel are required to wear surgical attire and cover all head and facial hair. The restricted area includes ORs, procedure rooms, and the clean core area. Surgical attire and hair coverings are required. Masks are required where open sterile supplies or scrubbed persons are located. All persons entering the restricted area should follow the AORN."

Recommended practices for surgical attire. "Persons entering the semirestricted or restricted areas of the surgical suite for a brief time for a specific purpose (eg, law enforcement officers, parents, biomedical engineers) should cover all head and facial hair and may don either freshly laundered surgical attire or a single-use coverall suit (eg, jumpsuit) designed to totally cover outside apparel."

2. In an observation and interview on 2/4/14 at 11:26 a.m., a stairwell from an outside parking lot opened through an unlocked door to the corridor adjacent to Endoscopy Room 1 in the outpatient surgery center. The portion of the corridor with the stairwell opening was beyond signs in the surgery center stating that surgical attire was required, but the door from the stairwell did not have similar signs. Staff H confirmed the stairwell provided a passageway from the parking lot to the semi-restricted area, and did not have signs indicating that surgical attire was required. She stated the door from the stairwell into the corridor was locked after hours, but not during the day.

Review of the AORN Recommended Practices for Traffic Patterns in the Perioperative Practice Setting (effective 1/1/06) indicated, "Signs should clearly indicate the appropriate environmental controls and surgical attire required."

3. In an observation and interview on 2/3/14 at 2:27 p.m., hospital staff moved a gurney piled with corrugated cardboard boxes out of the double doors from the main OR semi-restricted area. Staff D stated the boxes were in the area to offload supplies.

Review of the AORN Recommended Practices for Traffic Patterns in the Perioperative Practice Setting (effective 1/1/06) indicated, "Supplies and equipment should be removed from external shipping containers and web-edged or corrugated cardboard boxes in the unrestricted area before transfer into the surgical suite. External shipping containers and web-edged cardboard boxes may collect dust, debris, and insects during shipment and may carry contaminants into the surgical suite."

Based on interview and record review, the hospital failed to ensure 5 of 25 sampled patients (Patients 21 through 25) had a documented physical examination as part of the pre-anesthesia assessment, as required by hospital policies and anesthesia standards of practice. The hospital also failed to ensure the pre-anesthesia assessment was legible for 1 of 25 sampled patients (Patient 25). The deficient practices eliminated accountability that each patient had been properly assessed to determine the appropriate anesthesia care.

Findings:

1. Review of the hospital's "Medical Staff Policy: Pre-anesthetic Assessment" (effective 2013) indicated, "The patient is reevaluated immediately before anesthesia induction. Pre-anesthetic assessment to include:... Focused physical examination as appropriate to the patient."

Review of the facility's "PROFESSIONAL ANESTHESIA SERVICES AGREEMENT" dated 7/1/13 indicated, "A Medical Group Physician, before the delivery of anesthesia care, is responsible for... performing a focused examination of the patient... Recording an assessment... on the patient's chart in accordance with professional, accreditation and regulatory standards."

Review of the American Society of Anesthesiologists "BASIC STANDARDS FOR PREANESTHESIA CARE" (affirmed 10/20/10) indicated, "The anesthesiologist, before the delivery of anesthesia care, is responsible for... performing a focused examination of the patient to... Assess those aspects of the patient's physical condition that might affect decisions regarding perioperative risk and management... Documenting in the chart that the above has been performed."

Review of the American Society of Anesthesiologists "STATEMENT ON DOCUMENTATION OF ANESTHESIA CARE" (amended 10/16/13) indicated, "The record should include documentation of... Appropriate physical examination, including vital signs and documentation of airway assessment."

Review of the medical records for Patients 21 through 25 indicated the "PRE AND POST ANESTHESIA NOTE INFORMED CONSENT FOR ANESTHESIA" had a section labeled "PRE-ANESTHESIA ASSESSMENT to be completed by anesthesiologist". The entries in this section did not record vital signs, airway assessment, or the results of a physical examination for Patients 21 or 23 through 25. For Patient 22, the pre-anesthesia assessment indicated the patient was intubated (had a breathing tube in place), but did not record vital signs or other aspects of a physical examination.

Review of the "ANESTHESIA RECORD" for Patients 21 through 25 indicated each included the patient's vital signs just prior to induction of anesthesia as well as a series of check boxes under the heading "Pre-induction checks" which had check marks next to "OR [operating room] Evaluation of patient", "Pre-anesthesia induction assessment completed", and "I have reevaluated the patient immediately before induction and find that the patient is still fit for the planned anesthetic and procedure." No notations were present indicating that the anesthesiologist had performed a physical examination of the patient prior to induction or what were the findings of that examination. For Patients 21 and 23 through 25, no notations were present documenting an airway assessment prior to induction of anesthesia.

In an interview on 2/5/14 at 2:08 p.m., Staff A confirmed there was no other documentation of a pre-op examination by an anesthesiologist in Patient 21's record. In an interview on 2/5/14 at 2:29 p.m., Staff A and Staff B both confirmed there was no physical examination by an anesthesiologist documented in Patient 22's record. In an interview on 2/5/14 at 2:38 p.m., Staff B stated she did not see a pre-operative physical exam by an anesthesiologist for Patient 23. In an interview on 2/5/14 at 3:11 p.m., Staff A and Staff B confirmed there was no physical examination by an anesthesiologist in Patient 25's record.

2. Review of the hospital's 2014 Medical Staff Rules and Regulations indicated, "All entries in the medical record must be legible."

Review of Patient 25's pre-anesthesia assessment dated 12/19/13 indicated the names of six of the seven medications listed were not legible and the plan for anesthesia was not legible. In an interview on 2/5/14 at 3:11 p.m., Staff A and Staff B both stated they could not read the medications or the plan.

Based on interview and record review, the facility failed to ensure the intraoperative anesthesia record was legible for two of 25 sampled patients (Patients 22 and 25). The deficient practice rendered the records unusable for ascertaining what medications were administered by the anesthesiologist.

Findings:

Review of the hospital's 2014 Medical Staff Rules and Regulations indicated, "All entries in the medical record must be legible."

Review of Patient 22's anesthesia record dated 12/30/13 indicated the name of the last medication on page 2 was not legible. In an interview on 2/5/14 at 2:29 p.m., Staff A and Staff B both stated they could not tell what was the name of the medication.

Review of Patient 25's anesthesia record dated 12/18/13 indicated the first three lines of handwritten medications were not legible. In an interview on 2/5/14 at 3:10 p.m., Staff A and Staff B both stated the anesthesia record was illegible.