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Based on observation, interview, and record review, the governing body failed to carry out its full and complete oversight of the hospital by:.

1. Failing to provide infant security measures that would immediate identify and/or prevent an abduction of any newborn, which resulted in the potential for an infant abduction without being immediately detected in 1 East Unit (Refer to A115 and A144); and

2. Failing to ensure the 1 East Unit had necessary emergency supplies, immediately available, in the event of a cardiac and/or respiratory arrest of a newborn, in accordance to facility policy. This resulted in the potential delay of treatment causing serious harm or death (Refer to A115 and A144).

The cumulative effect of these systemic problems resulted in the failure of the governing body to ensure all patients were provided and received care in a safe setting.

Findings:

On October 20, 2011, at 10 a.m., the GBC and DCQI were interviewed. The GBC discussed how facility operation issues and/or concerns were communicated to the GB. The GBC stated he was informed of the immediate jeopardy issues that the survey team had identified on October 19, 2011. He stated he was not aware of the issues prior to October 19, 2011.

On October 20, 2011, the GB minutes were reviewed. There was no documented evidence that the GB identified any issues related to infant abduction security and the lack of emergency supplies for a newborn that would sustain cardiac and/or respiratory arrest, in the 1 East Unit.

On October 20, 2011, at 10:30 a.m., the DCQI verified there was no documentation in the GB minutes, that there had been any discussion related to the immediate issues identified by the survey team, as the facility had not identified these issues to be a problem.

Based on observation, interview, and record review, the facility failed to ensure patients' rights were protected, by:

1. Failing to provide infant security measures that would immediate identify and/or prevent an abduction of any newborn, which resulted in the potential for an infant abduction without being immediately detected in 1 East Unit (Refer to A144); and

2. Failing to ensure the 1 East Unit had necessary emergency supplies, immediately available, in the event of a cardiac and/or respiratory arrest of a newborn, in accordance to facility policy. This resulted in the potential delay of treatment causing serious harm or death (Refer to A144); and

3. Failing to ensure all patient information was kept protected, which resulted in the potential for unauthorized access of patients' protected health information (Refer to A147).

The cumulative effects of these systemic problems resulted in the failure of the hospital to ensure all patients' rights were protected, and care was provided in a safe setting.

Based on observation, interview, and record review, the facility failed to ensure all newborns located in the 1 East Unit (an area used by the facility as an additional post-partum unit for mothers and newborns after delivery) received care in a safe setting.

1. The facility failed to provide infant security measures that would immediate identify and/or prevent an abduction of any newborn, which resulted in the potential for an infant abduction without being immediately detected in 1 East Unit; and

2. The facility failed to ensure the 1 East Unit had necessary emergency supplies, immediately available, in the event of a cardiac and/or respiratory arrest of a newborn, in accordance to facility policy. This resulted in the potential delay of treatment causing serious harm or death.

Findings:

1. On October 17, 2011, at 10:40 a.m., a tour of the facility's 1 East Unit (which was on the first floor) was conducted. This area was being used as an additional area for post-partum patients. The facility's Womens' Services Unit (licensed post-partum area) was located on the second floor, approximately 600 feet away from 1 East.

On October 18, 2011, the following facility's documents were reviewed:

a. Facility's "Carenet Case Management Report" dated October 17, 2011, at 7:03 a.m., indicated that 1 East Unit had seven postpartum mothers and seven newborns.

b. "Shift Assignment" for Women's Services, dated October 18, 2011, 7 a.m. to 7 p.m. shift, was reviewed and 1 East Unit had a census of (total 13 beds): Thirteen postpartum mothers with their 13 newborns.

On October 18, 2011, at 9:40 a.m., the DCQI was interviewed and stated the facility had been using 1 East for postpartum patients. She stated there had not been any formal request, from the facility to the CDPH, to reassign the beds as perinatal (maternity) beds. She stated the beds, located in 1 East, were classified as Medical-Surgical beds.

On October 18, 2011, at 4:10 p.m., RN 11 (assigned at 1 East) was interviewed regarding the unit's infant security system. She stated the unit (1 East) did not have the "Hugs" system (an electronic system which included a device attached to a newborn to detect infant abduction). The "Hugs" system was the infant security system that is used in the Womens' Services Unit (second floor postpartum area). RN 11 stated the staff in the 1 East unit would not know if a newborn was removed from the unit, unless the parent alerted the staff or the staff witnessed it.

On October 19, 2011, at 9:15 a.m., the 1 East Unit nurses' station was observed with a monitoring screen that showed the two entrances in to the unit. The screen was located to the back of where the unit secretary (US) sat. A concurrent interview with the US was conducted, and she stated that the only way she would know if a newborn was removed from the unit was if the parent or a nurse told her.

On October 19, 2011, at 10:15 a.m., the monitoring screen was observed. During the observation, there was no staff monitoring the screen. On the monitor screen, an individual was observed leaving the unit, leading to the hospital's common hallway, and the individual held the door for another person to enter the unit.

On October 19, 2011, at 9:30 a.m., the DWS was interviewed. She stated that the 1 East unit did not have the "Hugs" system. She stated the facility had been using an off-unit (outside of Women's Services Unit) area for postpartum care since "2007 or 2008." She stated the postpartum unit (second floor Women's Services Unit) had a "Hugs" system.

On October 19, 2011, at 12:20 p.m., Operator 1 (Op 1) was interviewed. She stated PBX (the facility's telephone switchboard) would communicate the location of any infant abduction. She stated the PBX operators would know when the light (pointing to a strobe light) flashes and the "Hugs" system would indicate the location through the overhead speaker. She stated the operators could also be alerted using the "44" line (emergency number). Op 1 and Op 2 stated the "Hugs" system was attached to all newborns in the hospital. Op 1 stated infants were located at the Women's Services Unit and 1 East Unit. Both Op1 and Op 2 stated the "Hugs" system included the 1 East Unit. Op 1 stated the facility conducted abduction drills, but has not had the "Hugs" system indicate an abduction was from the 1 East Unit. Op 1 and Op 2 were not aware that the 1 East Unit did not have the "Hugs" security system.

On October 19, 2011, the facility's policy titled, "Infant/Child Abduction Prevention Plan" last revised March 2011, was reviewed. The policy indicated, "Infant/Child security will be maintained at all times...Unauthorized removal of infants will be prevented through a variety of security measures. Examples of these measures are: the Hugs infant protection system, secured, monitored and alarmed exits, keypad locked entrances, education of parents and staff, and reduced instances of maternal-infant separation..." The policy further indicated, "A Hugs tag will be applied to infant after birth if the infant will be assigned to the Women and Infant's Center. For infants who will be assigned to the Perinatal overflow unit, no tag will be applied..."

The facility's failure to provide security measures, which immediately identified an abduction of a newborn, resulted in the potential for an infant abduction without being immediately detected in the 1 East Unit. The survey team called an Immediate Jeopardy on October 19, 2011, at 4:20 p.m., in the presence of the COO, CNO, DNP, DOP, DCQI, DWS, and RN 9.

The survey team accepted the facility's plan of action to resolve the Immediate Jeopardy situation on October 19, 2011, at 6:18 p.m. Observations, interviews, and record reviews, revealed that the facility implemented the following action plan:

"1. A security Guard will be stationed in the 1 East Unit 24/7, to ensure an added layer of security. The Security Guard will be able to visually monitor and secure all three exits in the Unit. There will be security coverage during breaks and meals to ensure continuity of security.
2. The West Entrance is closed down and routing visitors to the North entrance.
3. The immediate 1 East staff will be educated on this additional layer of security and the requirement of security presence at all times. All other 1 East staff will be educated on this new practice on their next scheduled shift. New employees will be informed of this practice during the department orientation.
4. Charge Nurse will notify nursing supervisor in the event that Security is not present for immediate intervention.
5. Security Guards stationed on 1 East have demonstrated training and competency in infant abduction."

The Immediate Jeopardy was removed on October 20, 2011, at 12 p.m.


2. On October 17, 2011, at 10:40 a.m., a tour of the facility's 1 East Unit (which was on the first floor) was conducted. This area was being used as an additional area for post-partum patients. The facility's Womens' Services Unit (licensed post-partum area) was located on the second floor, approximately 600 feet away from 1 East.

On October 18, 2011, the following facility's documents were reviewed:

a. Facility's "Carenet Case Management Report" dated October 17, 2011, at 7:03 a.m., indicated that 1 East Unit had seven postpartum mothers and seven newborns.

b. "Shift Assignment" for Women's Services, dated October 18, 2011, 7 a.m. to 7 p.m. shift, was reviewed and 1 East Unit had a census of (total 13 beds): Thirteen postpartum mothers with their 13 newborns.

On October 18, 2011, at 9:40 a.m., the DCQI was interviewed and stated the facility had been using 1 East for postpartum patients. She stated there had not been any formal request, from the facility to the CDPH, to reassign the beds as perinatal (maternity) beds. She stated the beds, located in 1 East, were classified as Medical-Surgical beds.

On October 19, 2011, at 9:45 a.m., an interview was conducted with the DNP and RT 1. The DNP stated the facility used "Code White" when a neonate (newborn) required respiratory and/or cardiac resuscitation. He stated the "Code White" responders included (at a minimum): a physician, NICU RT, and an NICU RN. The DNP stated the crash cart (cart or container which contained essential supplies to respond for an emergency resuscitation) for NICU was used only in the NICU. For any "Code White" in the OB Unit (Women's Services located at the second floor, adjacent to the NICU; west side of the hospital), the NICU RT would bring the "Code White" box.

A concurrent inspection of the "Code White" box was conducted. In the RT room (located in the NICU), there were two orange-colored boxes. The NICU RT stated the boxes were completed and maintained in the RT room. If there was a "Code White" to be called in the OB Unit, the NICU RT would bring one of the boxes, which contained all essential supplies for cardiac and/or respiratory resuscitation of a neonate (newborn infant).

On October 19, 2011, at 8:50 a.m., observation of the 1 East Unit (located approximately 600 feet away from the hospital's NICU and Women's Services Unit and one floor below) was conducted. The unit had an adult crash cart, pediatric crash cart (Broselow Cart - cart containing emergency supplies for children), and an infant respiratory resuscitation bag (contained respiratory supplies; no emergency medications or respiratory intubation supplies). There was no "Code White" box located in the 1 East Unit.

On October 19, 2011, at 12:30 p.m., the DNP and RT 1 were interviewed. Both DNP and RT 1 stated if a "Code White" was needed at the 1 East Unit, the "Code White" team would respond. The NICU RT would bring one of the "Code White" boxes (located in the NICU) to the 1 East Unit. Both stated there was no "Code White" box located in the 1 East Unit, but the Broselow Cart was available for neonatal resuscitation.

On October 19, 2011, at 2 p.m., the content lists for the "Code White" box (located in NICU), Broselow Cart (located in 1 East), and infant respiratory resuscitation bag (located in 1 East) were reviewed and compared. The 1 East Unit did not have the following supplies:
- Calcium Gluconate 10% 10 ml vial (one of the medications used in the resuscitation of a neonate);
- #3.0 Rusch ETT (specific size of an airway tube used for intubation of a neonate); and
- #3.5 Rusch ETT.

The 1 East Unit Broselow Cart contained Calcium Chloride 10 %, 10 ml vial. The cart did not contain Calcium Gluconate.

On October 19, 2011, Calcium Gluconate and Calcium Chloride were compared using Lexicomp (a widely-used drug reference). According to Lexicomp, Calcium Chloride had three times more elemental calcium than Calcium Gluconate. Lexicomp further indicated, "Administration issues: calcium gluconate may be confused with calcium chloride...Medication Safety Issues: Calcium chloride may be confused with calcium gluconate..."

The facility policy titled, "Neonatal Resuscitation/Code White" revised July 2010, was reviewed. The policy indicated, "...NRP Guidelines will be followed on all infants...A code white should be called for any neonate in the Perinatal Unit that exhibits evidence of distress, RDS, cardiac, seizures, etc..Code White Box: (included) 1 Calcium Gluconate 10 % 10 ml vial, #3.0 Rusch ETT, and #3.5 Rusch ETT"; and "Reference: AAP, ACOG, NRP Guidelines."

The facility's failure, to ensure all essential emergency supplies for a neonatal resuscitation were immediately available in the 1 East Unit, resulted in the potential delay of treatment causing serious harm or death. The survey team called an Immediate Jeopardy on October 19, 2011, at 4:20 p.m., in the presence of the COO, CNO, DNP, DOP, DCQI, DWS, and RN 9.

The survey team accepted the facility's plan of action to resolve the Immediate Jeopardy situation on October 19, 2011, at 6:18 p.m. Observations, interviews, and record reviews, revealed that the facility implemented the following action plan:

"1. The code white response kit will be duplicated and secured on 1 East. This provides a single standard of care for emergency resuscitation needs of all infants across continuum.
2. The immediate 1 East staff will be educated on the contents of the code white response kit demonstrating a single standard of care for infant resuscitation. All other 1 East staff will be educated on this new practice on their next scheduled shift. New employees will be informed of this practice during the department orientation.
3. The integrity and security of this kit will be verified daily by pharmacy personnel during daily rounds and will be logged."

The Immediate Jeopardy was removed on October 20, 2011, at 12 p.m.

Based on observation, interview, and record review, the facility failed to ensure all patient information was kept protected, which resulted in the potential for unauthorized access of the patients' protected health information.

Findings:

1. On October 18, 2011, at 8:57 a.m., a WOW (Work station On Wheels) cart was observed in the common hallway on 3 Sinatra, in front of patient rooms. The WOW cart contained a portable computer, as well as supply drawers. There was no staff near or within eye sight of the cart. The screen to the computer was left on showing the names and room numbers of four patients.

Approximately three minutes later, RN 7 was observed coming out of room 3317. In a concurrent interview with RN 7, she stated the WOW cart was hers. RN 7 stated she left the cart in the hallway because she needed to help a patient. RN 7 also stated, she should have turned the monitor off before leaving the cart unattended.

2. On October 18, 2011, at 9:14 a.m., a WOW (Work station On Wheels) cart was observed in the common hallway on 2 Sinatra, in front of patient rooms. The WOW cart contained a portable computer, as well as supply drawers. There was no staff near or within eye sight of the cart. The screen to the computer was left on showing the name, age, birthdate, medical record number, and account number of one patient. In addition there was a nurses work sheet, face up on the work top area, which contained the name, birthdate, diagnoses, as well as other protected health information, for two patients.

Approximately 7 minutes later RN 8 returned to the cart. In a concurrent interview with RN 8, he stated the cart was his. He stated that normally when he was done using it, he would turn it off and move it to the end of the hallway. RN 8 also stated, he should not have left his paperwork, that contained patient information, on top of the work station.

The facility policy titled, "Patient Confidentiality and Privacy," dated May 2011, was reviewed. The policy indicated the following:
a. "Patients have the right to... Have his/her medical record and other medical documents read only by individuals directly involved with his/her treatment... Expect all communications and other records pertaining to his/her care, including the source of payment or the treatment to be rendered, be treated as confidential."
b. "Information Management Systems (Computer Access) ... Employees must log off their computer workstations when they are not being accessed for an extended period... All electronic records are to be afforded the same level of confidentiality and protection as is given to paper records."
c. "Patient Privacy... Patient medical records or other patient documents will be secured appropriately, so as not to allow unauthorized staff or others to read information."

Based on interview and record review, the hospital failed to ensure that nursing staff developed and kept current, a nursing care plan for 6 of 35 sampled patients (Patients 21, 23, 57, 29, 32, and 33).

1. For Patient 23, the nursing staff failed to update a plan of care for alteration in immune status as it relates to infection, when the patient was assessed with eye drainage.

2. For Patient 21, the nursing staff failed to initiate an impaired skin integrity plan of care after the patient was assessed with a skin tear on admission.

3. For Patients 24, 29, and 32, the nursing staff failed to initiate a skin breakdown plan of care after the patients were identified on Braden Scale Score assessment (summated rating scale made up of six sub scales for predicting the risk of developing a pressure ulcer), to be at low to moderate risk for skin breakdown.

4. For Patient 33, the nursing staff failed to initiate a fall/injury plan of care after the patient was identified on assessment to be at high risk for a fall/injury.

These failures had the potential to result in the lack of, or delay in appropriate care and monitoring of these patients.

Findings:

1. On October 18, 2011, the record for Patient 23 was reviewed. Patient 23 was a preterm newborn admitted to the NICU on October 1, 2011. There was a physician order, dated October 13, 2011, to send a swab of eye drainage for a C&S (a test to determine the type of infection and the best treatment for that particular infection), and to apply Vancomycin (an antibiotic) eye drops to each eye every six hours.

The NICU form titled, "Anticipated Recovery Path," was reviewed. The care plan for "Alteration in immune status related to infection," with a goal of, "Infant will be free of infection after the desired course of antibiotic therapy prescribed by physician," was not updated to include the possible eye infection, and the intervention of antibiotic treatment to the eyes.

On October 18, 2011, at 11:20 a.m., RN 9 was interviewed. RN 9 stated, the nurse should have updated the #14 variance to include the eye culture and the treatment.

The facility policy for "Neonatal Initial Assessment and Reassessment," with a revised/reviewed date of July 2010, was reviewed. The policy indicated, "Interventions will be identified for each variance and initialed with implementation date."

2. On October 18, 2011, the record for Patient 21 was reviewed. Patient 21 was admitted to the facility on October 14, 2011, with a diagnosis of left femur fracture. The admission assessment indicated the patient had a skin tear to her left arm. A care plan for impaired skin integrity for the skin tear was not initiated.

On October 18, 2011, at 9:30 a.m., RN 10 was interviewed. RN 10 stated whichever nurse did the admission assessment was responsible to initiate the care plan and any focus that applied to that patient. In addition, she stated any nurse doing their shift assessment should address the care plan and add to it as needed.

3. a. On October 18, 2011, the record for Patient 24 was reviewed. Patient 24 was admitted to the facility on October 15, 2011, with diagnosis including status post revision of ORIF (a surgical procedure to repair a fracture) left hip.

The nursing admission assessment, dated October 15, 2011, indicated a Braden Scale Score of 15. The facility policy and procedure titled, "Pressure Ulcer Assessment, Prevention, Treatment and Management" reviewed November 2010, indicated, "... Braden Scale completed: Risk Assessment daily (every shift for ICU and high risk). Braden Scale Score 15-18: Minimal risk for breakdown. Braden Scale Score 13-14: Moderate risk for breakdown. Braden Scale Score 12 or less: High risk for breakdown. ... Initiate plan of care for risk category immediately. ..."

Shift assessments, dated October 15 through 18, 2011, indicated the Braden Scale Score ranged from 15 to 18.

The "Interdisciplinary Plan of Care," with a focus of "Low to Moderate Risk: Braden Scale Score 13-18" was not initiated.

On October 18, 2011 at 3:45 p.m., RN 10 was interviewed. RN 10 stated whichever nurse did the admission assessment was responsible to initiate the care plan and any focus that applied to that patient. In addition, she stated any nurse doing their shift assessment should address the care plan and add to it as needed.



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b. On October 17, 2011, the record for Patient 29 was reviewed. Patient 29 was admitted to the facility on October 7, 2011, with diagnoses including an abscess (collection of pus/infection).

The Braden Scale Score on October 9, 2011, at 8:04 p.m., was assessed by the nurse to be 14.

The Braden Scale Score on October 12, 2011, at 8:35 a.m., was assessed by the nurse to be 13.

The "Interdisciplinary Plan of Care" with a form date of November 2010, and dated October 8, 2011 through October 17, 2011, indicated, "Focus - Low to Moderate Risk: Braden Scale Score 13-16, and High Risk: Braden Scale Score 12 or lower." All of the boxes were blank for "Date Initiated, Focus, Expected Outcomes, Interventions, and Date Resolved."

During an interview with Clinical Manager (CM) 6, on October 17, 2011, at 2:45 p.m., she reviewed the record and was unable to find documentation of a "Low to Moderate Risk: Braden Scale Score 13-16" plan of care for Patient 29. CM 6 stated there should have been a plan of care initiated for "Low to Moderate Risk: Braden Scale Score 13-16" on October 9, 2011, when Patient 29 was assessed to have a Braden Scale Score of 14.

c. On October 18, 2011, the record for Patient 32 was reviewed. Patient 32 was admitted to the facility on October 17, 2011, with diagnoses including breast cancer.

The Braden Scale Score on October 17, 2011, at 4 p.m., was assessed by the nurse to be 18.

The "Interdisciplinary Plan of Care" with a form date of February 2011, and dated October 17, 2011 through October 19, 2011, indicated, "Focus - Low to Moderate Risk: Braden Scale Score 13-18, and High Risk: Braden Scale Score 12 or lower." All of the boxes were blank for "Date Initiated, Focus, Expected Outcomes, Interventions, and Date Resolved."

The facility policy and procedure titled, "Pressure Ulcer Assessment, Prevention, Treatment and Management" reviewed November 2010, indicated, "... Braden Scale completed: Risk Assessment daily (every shift for ICU and high risk). Braden Scale Score 15-18: Minimal risk for breakdown. Braden Scale Score 13-14: Moderate risk for breakdown. Braden Scale Score 12 or less: High risk for breakdown. ... Initiate plan of care for risk category immediately. ..."

During an interview with the Clinical Director 6, on October 18, 2011, at 11:15 a.m., she reviewed the record and was unable to find documentation of a "Low to Moderate Risk: Braden Scale Score 13-18" plan of care for Patient 32. The Clinical Director 6 stated there should have been a plan of care initiated for "Low to Moderate Risk: Braden Scale Score 13-18" on October 17, 2011, when Patient 32 was assessed to have a Braden Scale Score of 18. In addition, the Clinical Director 6 stated the nursing staff were "tuned into the fall risk care plans but not the Braden care plans."

4. On October 19, 2011, the record for Patient 33 was reviewed. Patient 33 was admitted to the facility on October 16, 2011, with diagnoses including right femur fracture.

The Morse Fall Risk Score (rapid and simple method of assessing a patient's likelihood of falling) on October 17, 2011, at 2 a.m., was assessed by the nurse to be 60.

The Morse Fall Risk Score on October 17, 2011, at 8 a.m., and 5 p.m., were assessed by the nurse to be 35.

The "Interdisciplinary Plan of Care" dated October 16, 2011 through October 19, 2011, indicated, "Focus - Fall/Injury Ultra High Risk Related to: Fall during current hospitalization; Fall/Injury High Risk Related to: Morse Fall Scale of ______ (45 & above); and Fall/Injury Low Risk Related to: Morse Fall Scale of ______ (25 - 44)." All of the boxes were blank for "Date Initiated, Focus, Expected Outcomes, Interventions, and Date Resolved."

During an interview with the ICU Manager, on October 18, 2011, at 3:10 p.m., she reviewed the record and was unable to find documentation of a "Fall/Injury High Risk Related to: Morse Fall Scale of _______ (45 & above)" plan of care. The ICU Manager stated the care plan for fall risk should have been initiated at the time of admission when Patient 33's Morse Fall Risk Score was 60.

The facility policy and procedure titled, "Fall Prevention Program and Post Fall Care" revised February 2011, indicated, "... Patients are risk stratified into no risk, low risk or high risk category based on the initial score from the Morse Fall Risk Assessment Tool. ... Patients are re-assessed for a fall risk every shift... If it is determined the patient is a low or high risk for falls, a fall prevention plan of care is initiated as a primary problem. ..."

Based on interview and record review, the facility failed to ensure medications were prepared and administered in accordance with the orders of the practitioner and/or the accepted standards of practice for two patients of 35 sampled patients (Patients 16 and 2).


Findings:

1. The electronic medical record of Patient 16, an NICU patient, was reviewed on October 20, 2011, at 11 a.m., with RPH 1. It was noted that there was a physician order for two antibiotics, ampicillin 35 mg IV every 8 hours and gentamicin 1.6 mg IV every 24 hours.

It was also noted that the order was scanned to pharmacy at 4 p.m., processed by the Pharmacy at 4:28 p.m., and was documented as administered by the administering nurses at different times, ampicillin given at 6:10 p.m., and gentamicin given at 8 p.m., with both assigned an administration time scheduled for 5 p.m.

During a concurrent interview, RPH 1 was not able to explain why one medication was given three hours after the scheduled administration time and could not determine whether the late administration was due to delay by Pharmacy or Nursing.

During an interview on October 20, 2011, at 11:30 a.m., the Director of NICU agreed that administering an antibiotic 3 hours later than scheduled time should not have happened as the bacteria growth was exponential and antibiotics should have been administered right away. He was unable to explain the delay in administration of one antibiotic and not the other.

The facility's policy and procedure titled, "Timing of Medication Administration for Patient Under 14 YO (years old)" was reviewed:

"Purpose:
To ensure the prompt and consistent administration of medication to patients less than 14 years old...
All medication orders for NICU and other patients less than 14 years shall be filled as STAT or NOW orders."



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2. On October 19, 2011, Patient 1 (Patient 2's mother) and Patient 2's records were reviewed. Patient 1 gave birth to Patient 2 on May 11, 2011, at 6:43 a.m.

Patient 2's "Physician Order" dated May 11, 2011, included, "Give Hepatitis B vaccine 0.5 ml (milliliter) one time within 1 hour of delivery." There was no order for Tdap (a type of vaccine used for mothers) vaccine.

The "Progress Notes-Physician" dated May 11, 2011, indicated, "As noted this baby...given...(Boostrix [Tdap vaccine]) by nurse who intended to give baby Hepatitis B vaccine..."

The "Discharge Summary" dated May 12, 2011, indicated, "...It was brought to my attention that the infant had been inadvertently given DTaP (actually Tdap) vaccine or adult Boostrix vaccine instead of hepatitis B vaccine through a nursing error. The situation was reviewed, it was discussed with several infectious disease specialists and also the drug manufacturer (name of manufacturer)...There is no experience with the use of the vaccine at this age in a newborn. Therefore, possible adverse effects are not known..."

On October 19, 2011, at 11:20 a.m., RN 4 was interviewed. She stated she was the nurse who administered the wrong medication. She stated she got the medication from the refrigerator located near the Labor and Delivery area. She got the syringe of what she thought was the Hepatitis B vaccine. She stated the facility previously had both the Hepatitis B vaccine and the Tdap vaccine in a syringe form, both with the same color. She stated she thought what she had removed from the refrigerator was Hepatitis B vaccine. RN 4 scanned the medication using the facility's electronic system for medication administration, had to override the system, and entered she was administering the Hepatitis B vaccine to Patient 2. After she had administered the medication to the patient, she read the label on the syringe and realized she had the wrong medication (Tdap instead of Hepatitis B vaccine).

The facility policy titled, "Medication Administration" last revised October 2008, was reviewed. The policy indicated, "To Provide guidelines for the safe and accurate administration of medications..." The policy further indicated, "...All medications...will be administered in a safe manner following 'The Five Rights.' Prior to administration the licensed personnel will do the following: Check to be sure that the right medication is being dispensed. The label on the drug will be checked against the patient's electronic medication administration record or order..."

Based on interview and record review, the facility failed to ensure the physician responsible for obtaining the informed consent for the caesarean section (a surgical procedure made through the abdomen to deliver one or more babies), documented the discussion in the medical record for one of 35 patients (Patient 10). This resulted in an incomplete medical record and had the potential to result in patients to receive surgery or procedure without receiving necessary information to make an informed decision.

Findings:

On October 19, 2011, Patient 10's record was reviewed. The patient was admitted on October 19, 2011, at 6:03 a.m., for a scheduled C-Section. Patient 10's newborn was born on October 19, 2011, at 8:18 a.m.

The "Consent to Surgery/Special Procedures/Anesthesia" form was reviewed. The document indicated Patient 10 signed the form to indicate the patient had given the consent for the procedure. The form had a section, "Physician Certification" that certified the physician had discussed the procedure with the patient or legal representative, including the risks and benefits of the procedure, and any other information about the procedure or surgery. The section did not have the date, time, and signature of the physician.

The "Obstetrical Pre-Delivery Assessment" dated October 19, 2011, was reviewed. The form had a section which indicated, "Informed Consent with Risks, Benefits and Alternatives have been explained." This section was not marked or filled-out.

On October 19, 2011, at 11 a.m., Patient 10's record was reviewed with RN 12. RN 12 stated she was the circulating nurse for Patient 10's C-Section. She stated she heard Physician 1 (who performed the procedure) talk to the patient prior to the procedure explaining the risks and benefits of the procedure. RN 12 stated Physician 1 should have signed the "Consent to Surgery" or filled-out the "Obstetrical Pre-Delivery Assessment" to indicate the discussion with the patient.

The facility policy titled, "Informed Consent" revised May 2009, was reviewed. The policy indicated, "Informed Consent...Documenting Informed Consent...The physician is responsible for obtaining the informed consent and for documenting this discussion on the record..."

Based on observation, interview, and document review the facility failed to control and distribute medications in accordance with accepted standards of practice consistent with state regulations by failing to:

1. Inform the Pharmacy of the malfunctioning medication refrigerator and have the pharmacy responsible for the transfer of the medications in L&D medication refrigerator to the OB OR 1 medication refrigerator.

2. Prepare all medications used by critical patients in NICU in ready to administer, unit-dosed form and not have available as floor stock injectable medications for nursing staff to measure and calculate the dose which potentially increases the chance of medication errors.

3. Store refrigerated medications in the OB OR 1 in an orderly manner to prevent crowding.

4. Use the IV hood in the NICU satellite pharmacy in accordance with the policy and procedure and accepted standard of practice.

5. Develop an updated policy and procedure that addressed the locations of the Malignant Hyperthermia (MH) Cart and the content of the cart.

6. Maintain content list of emergency medication supply kits/boxes on the outside.

7. Ensure the "Infant Respiratory Resuscitation Bag" contained the supplies on the inventory list as indicated, and the supplies in the bag were not expired. This had the potential to result in the supplies not being available in an emergency.

Findings:

1. The facility's L&D and Post-Partum area were toured on October 17, 2011, starting at 10 a.m., and it was observed the L&D medication refrigerator was not being used and no medications were inside.

During concurrent interview, RN 1 stated all medications from the L&D medication refrigerator was moved to the medication refrigerator located in OB OR 1 because the seal was not working properly and the right temperature range could not be maintained.

During an interview on October 18, 2011, at 12 p.m., RN 2 stated that on October 14, 2011 during the shift change at 7 p.m., the Plant-Op (Operations) was notified of the improper sealing of the L&D medication refrigerator which the Plant-Op staff could not immediately fix. RN 2 stated that she had been relieved of her shift duties at the time and was not able to recount what happened after that.

During an interview on October 18, 2011, at 11:30 a.m., PT 1 stated that she was not aware of the problem with the L&D refrigerator until she came back to work on October 17, 2011, and noticed all medications were removed and she was told medications delivered from the Pharmacy needed to go to the medication refrigerator located in OB OR 1. PT 1 did not know who moved the medications from L&D refrigerator to the OB OR 1 refrigerator.

During an interview on October 18, 2011, at 11:45 a.m., the Operations Manager from the Pharmacy (OM 1) stated that the clinical manager of L&D and a pharmacy technician working that Friday evening could have been involved with transferring the medications, but could not confirm exactly which pharmacy staff was notified of the refrigeration malfunction and which pharmacy staff transferred the medications.

During an interview on October 17, 2011, at 4 p.m., the DOP stated that he did not know about the L&D medication refrigerator not being used and that the medications were now moved to the refrigerator in OB OR 1 until this morning. The DOP stated that he did not know who moved the medications and acknowledged that the medications stored in a crowded condition would not be able to maintain proper temperature.

In a separate interview on October 19, 2011, at 12:30 p.m., the DOP stated that the Pharmacy was not notified of the medication refrigerator malfunction and that medications were moved to the medication refrigerator in OB OR 1 by the nursing staff without the knowledge of the Pharmacy. The DOP stated that the medications should not have been moved by the nursing staff and should have been properly handled by the Pharmacy.

2. Medication pass observation was conducted with RN 3 on October 18, 2011, at 2:35 p.m., in NICU. RN 3 was observed to be reconstituting a powdered 500 mg vial of injectable ampicillin (an antibiotic) with 5 ml of 0.9 percent normal saline, a diluent. She was then observed to draw from the reconstituted ampicillin vial a dose of 185 mg using a sterile 3-ml syringe. It was observed the syringe contained 1.8 ml as evidenced by the base of the plunger lined up at the graduated line indicating 1.8 ml.

During an interview on October 18, 2011, at 4:30 p.m., RN 3 stated that the facility policy and procedure was followed with the assistance of the Pharmacy in regards to the volume of normal saline to use to reconstitute the ampicillin vial. RN 3 stated that she always added 5 ml of normal saline to the 500 mg vial of ampicillin in order to make 100 mg/ml concentration of ampicillin.

Review of the facility's policy and procedure titled, "Reconstitution of Ampicillin in the NICU" did not indicate how much of the normal saline to use for reconstitution.

During the same interview, RN 3 was not sure if she had given the exact amount of 1.85 ml using 3-ml syringe for 185 mg ampicillin dose. RN 3 also stated that nursing staff in NICU would prepare the injectable dose for the NICU patients from the Pharmacy prepared multi-dose injectable vials as the Unit Floor Stock items and that one of the medications was gentamicin (an antibiotic routinely monitored by the Pharmacy due to possible ear and kidney damage).

On October 19, 2011, at 9:20 a.m., NICU medication room was inspected and it was observed in the medication refrigerator following injectable multi-dose vials that the Pharmacy prepared as Floor Stock medications for this unit for patient use:

Three vials of Vancomycin 5 mg/ml;
One 30 ml vial of heparin 15 units/0.15 ml;
One vial of metoclopramide 1mg/ml;
Three vials of cefotaxime 100 mg/ml;
One vial of famotidine 1mg/ml.

During an interview on October 19, 2011, at 9:30 a.m., RPH 4 stated that reconstituting the ampicillin vial with 5 ml normal saline would yield 5.2 ml due to the powder volume and agreed it would not give exactly 100 mg/ml concentration of ampicillin.

During the same interview, RPH 4 stated the multi-dose injectable vials were prepared by the main pharmacy and that nursing staff were allowed to draw up the correct dose for the NICU patients. RPH 4 stated that due to staffing, some of the injectable medications were made available by the Pharmacy in a multi-dose form and that there was a satellite pharmacy on the same floor that was not utilized due to staffing issues. RPH 4 further stated that ideally all medications needed to be unit-dosed (term to indicate all correct doses prepared by the Pharmacy for NICU patient use individually) and not be allowed for the nurses to prepare the dose from the multi-dose vials to reduce the potential for medication error.

During an interview on October 19, 2011, at 12:30 p.m., the DOP acknowledged that he was aware that unit-dosing of all NICU medications was needed and stated that it would definitely improve the process of eliminating dosing error for critical patients in NICU by having a satellite Pharmacy staffed with a pharmacist. The DOP stated currently the satellite pharmacy on that floor was not staffed with a pharmacist most of the times and not used to its full potential.

A nationally recognized pharmacy organization, American Society of Health-system Pharmacists (ASHP) published the following guidelines relating to preventing medication errors and pharmaceutical care in pediatric patients:

"ASHP Guidelines on Preventing Medication Errors in Hospitals

Except in emergency situations, all sterile and nonsterile drug products should be dispensed from the pharmacy department for individual patients. The storage of nonemergency floor stock medications on the nursing units or in patient-care areas should be minimized."

"ASHP Guidelines for Providing Pediatric Pharmaceutical Services in Organized Health Care Systems

Unit Dose System.
The pediatric unit dose system must meet the original intent of these systems, which is to minimize
errors and provide drugs to the patient care areas in ready to administer form. Multi-dose containers and stock medications should be avoided. An extemporaneous preparation service should facilitate the preparation and packaging of medications according to sound compounding principles."

3. During tour of the L&D and Post-Partum, on October 17, 2011, at 11 a.m., it was observed in the OB OR 1 a medication refrigerator (similar to one found in a dormitory room) were filled with medications not specifically designated and without physical partitions. There were different medications that were lined in rows, as well as stacked vertically up to four different medications.

During concurrent interview, RN 1 stated all medications from the L&D medication refrigerator were moved to the medication refrigerator located in OB OR 1 on Friday October 14, 2011, because the seal was not working properly and the right temperature range could not be maintained.

During concurrent interview, RPH 1 acknowledged that the medications were stored in a crowded way.

During an interview on October 17, 2011, at 4 p.m., the DOP stated that he did not know about the L&D medication refrigerator not being used and that the medications were now moved to the refrigerator in OB OR 1 until this morning. The DOP stated that he did not know who moved the medications and acknowledged that the medications stored in a crowded condition would not be able to maintain proper temperature.

The facility's policy and procedure titled, "Storage of Pharmaceuticals" was reviewed which indicated the medications would be stored properly in the following manner:

"Drugs shall be stored neatly and orderly in well lighted RX Station cabinets (or ADC's) shelves, drawers or carts of sufficient size to prevent crowding."

4. During inspection of the facility's NICU Satellite Pharmacy on October 17, 2011, at 11:45 a.m., it was observed that the IV (intravenous) Hood in which oral and injectable medications were compounded for patient use was turned off.

During an interview on October 17, 2011, at 11:45 a.m., RPH 1 stated that the IV hood would be turned on for use in situations that required medications that needed to be prepared for immediate use and that the IV Hood was cleaned just after turning on the IV Hood and before compounding IV injectable medications.

During an interview on October 17, 2011, at 12 p.m., RPH 2 stated that the IV Hood was only turned on when there were injectable medications that needed to be prepared for administration right away. RPH 2 also stated the IV Hood needed the warm up period of 20 minutes. RPH 2 further stated that the IV Hood cleaning was not performed if the IV Hood was not turned on.

During the same interview, RPH 2 acknowledged that waiting upwards of 20 minutes for the IV Hood to warm up and prepare the type of medications that needed to be made in NICU Satellite Pharmacy IV Hood would be too long.

During an interview on October 18, 2011, at 10:30 a.m., RPH 3 stated that she had worked a shift in the NICU Satellite Pharmacy about two weeks ago and had to make an emergency injectable medication containing Calcium that was needed right away. RPH 3 also stated that the IV Hood would be turned off after the shift.

Review of the NICU Satellite IV Hood Cleaning Log indicated that for the month of September 2011, the IV Hood was turned on and cleaned only once, 18 days in August, 21 days in July, and 7 days in October 2011. It was also noted that there was one signature for each day the IV Hood was turned on regardless of whether it was in use or not.

Review of the NICU Satellite IV Hood Cleaning Log also indicated that there was not an identifiable initial that indicated that the IV Hood was turned on and cleaned by RPH 3 during the month of October 2011.

Review of the facility's policy and procedure titled, "Compounding of Sterile Products (CSP)" described the proper use and maintenance of the IV Hoods used in the facility:

"Proper Use and Maintenance of the LAFHs (Laminar Air Flow Hoods) and Class II BSC (Biological Safety Cabinet)...

All hoods shall remain "on" except for filter changes and other required maintenance. If a hood is turned off, at least a 30-minute warm-up plus a thorough cleaning should be done to prepare the hood for use...

The hoods shall be cleaned at the following times:
i. At the beginning of each shift
ii. Before any work in the hood is begun
iii. Anytime work in the hood is concluded
iV. After placing non-sterile objects into the hood, other than for the compounding of admixtures
v. After any spillage...

Cleaning of the hood shall be documented on the hood cleaning record form..."

The facility practice indicated that the 30 minute warm-up period for the IV Hood was not observed, the IV Hood was not cleaned after the work was concluded, and the IV Hood did not remain on at all times.

5a. During the tour of the facility's Labor and Delivery (L&D) Unit on October 17, 2011, starting at 11:30 a.m., it was observed that in OB (Obstetrics) OR (Operating Room) 1 there was a two-sided cart with drawers containing anesthesia medications and supplies on one side and MH Cart (a cart that stored medications and supplies that are needed to treat an emergency life-threatening condition of patients predisposed to reacting to the use of certain muscle relaxant and volatile anesthetic agents) medications and supplies on the other side. Both sides of the cart could be accessed simultaneously by way of entering the code on the numbered pad.

Upon inspection of the MH side of the cart, it was noted that there were 19 vials of Dantrolene (drug used to treat MH) 20 mg injectable vials in powdered form.

Review of the facility's policy and procedure titled, "Malignant Hyperthermia" indicated the following amount of dantrolene would be situated in the MH Carts:

Dantrolene (Dantrium) 20 mg vials: 24 vials in OR (referring to Adult Surgery Department), 12 vials in OB.

During an interview on October 17, 2011, at 12 p.m., RN 1 acknowledged that there were more than the number of dantrolene vials specified on the content list.

b. During the tour of the ED (Emergency Department) Central Medication Room on October 17, 2011, at 3:45 p.m., it was observed there was a black box labeled "Malignant Hyperthermia Box" which contained twelve vials of dantrolene and other medications with the content list that did not match the actual content of the MH Box located in the ED.

It was also observed that the MH Box was locked with a key which was stored separately in different location accessible by the nursing staff.

During concurrent interview, the Director of ED acknowledged that the content of the MH Cart did not match the list which was located inside the box and the box was secured with a key.

During an interview on October 19, 2011, at 12:30 p.m., the DOP acknowledged that breakable seal was not present and stated that the ED MH cart was not included in the current policy and procedure. The current system in place would not meet the California Code of Regulation (CCR)Title 22 requirements which indicated,

"70263(f)(2) The emergency drug supply shall be stored in a clearly marked portable container which is sealed by the pharmacist in such a manner that a seal must be broken to gain access to the drugs..."

6a. During the tour of the ED (Emergency Department) Central Medication Room on October 17, 2011, at 3:45 p.m., it was observed there was a black box labeled "Malignant Hyperthermia Box" which contained twelve vials of dantrolene and other medications with the content list found inside the box that did not match the actual content of the MH Box located in the ED.

During concurrent interview, RPH 1 agreed that the content list should have been placed outside.

b. During tour of the facilities NICU, on October 19, 2011, at 10 a.m., it was observed there were two NICU Code White Boxes that contained emergency medications and supplies without content list attached on the outside the box.

During concurrent interview, RPH 1 agreed that the content list should have been placed outside.

According to the CCR, Section 70263(f)(2),

"...The contents of the container shall be listed on the outside cover and..."



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7. On October 19, 2011, at 8:50 a.m., a tour was conducted on "1 East/Maternity" with Quality Services Staff.

Located on top of the Broselow Pediatric Crash Cart was a black bag which was locked with a blue pull away lock number 266890. The inventory list in a side pocket of the bag indicated "Infant Respiratory Resuscitation Bag."

The "Infant Respiratory Resuscitation Bag" inventory list indicated the quantity of the equipment
present, equipment present, and the expiration date. The following was listed:
a. Specimen tubes for CBG (capillary blood gas), expiration September 2011.
b. Purple Caps for CBG, quantity 20.
c. Mixing Magnate for CBG, "pending NICU to order."

The "Broselow Pediatric Crash Cart Monitor Log" dated May 31, 2011, indicated the pull away lock number was 7672789.

The "Broselow Pediatric Crash Cart Monitor Log" dated June 1, 2011, indicated the pull away lock number was 266890. The pull away lock was not removed from June 1, 2011, through October 18, 2011.

On October 19, 2011, at 8:55 a.m., the "Infant Respiratory Resuscitation Bag" was opened with Quality Services Staff 1.
a. The Specimen tubes for CBG had expired September 2011.
b. There were 4 purple caps for CBG (instead of 20).
c. There was no Mixing Magnate for CBG in the bag.

During a concurrent interview with Quality Services Staff 1, she stated the specimen tubes were expired, the bag was missing 16 purple caps for CBG, and the mixing magnate was not in the bag.

On October 19, 2011, at 9 a.m., an interview was conducted with RN 6. She stated the black bag on top of the Broselow Pediatric Crash Cart contained supplies needed by respiratory therapy in case of an infant emergency, and the bag was checked daily for the intactness of the lock, and based on the inventory list, for expiration dates of products. RN 6 stated the daily check of the black bag was recorded on the "Broselow Pediatric Crash Cart Monitor Log." In addition, RN 6 stated she did not see that the specimen tubes for CBG were expired, and she did not know when or if the NICU had ordered the mixing magnate. RN 6 stated the nursing staff did not look inside the black bag, that was done by respiratory therapy.

Based on observation, interview and record review, the facility failed to secure medications which had the potential to result in the unauthorized access by individuals to medications.

Findings:

1. On October 17, 2011, at 10 a.m., a tour of Intensive Care Unit (ICU) "POD 2" was conducted with the Administrative Resident.

A cabinet inside the unit, with a keypad type of lock, was opened by pulling the cabinet door handle. The keypad lock was not used. Inside the cabinet were bins with room numbers and some of the bins contained intravenous medications with the name of a patient.

The cabinet had an 8 1/2 by 11 inch piece of paper on the cabinet door that indicated "Policy This Cabinet Must Be Kept Locked."

During a concurrent interview with RN 5, she stated the cabinet contained intravenous piggy back medications for patients in ICU "POD 2" and Trauma ICU. RN 5 stated the cabinet should have been closed and locked, and she did not know why the cabinet was open.

2. On October 17, 2011, at 11:05 a.m., a tour of Cardiac Intensive Care Unit (CICU) was conducted with the Director of Critical Care (DCC) and the ICU Manager.

At 11:20 a.m., a drawer to the patient cassette medication cart, located in the hallway across from room number 3104, was pulled open. The access code to open the locked patient cassettes was not needed to open the drawer. The drawer contained patient medications.

During a concurrent interview the DCC stated a nurse had just accessed medications from the cart and had walked away from the cart to administer the medications she had removed from the cart to a patient.

On October 17, 2011, at 11:25 a.m., an interview was conducted with RN 5. She stated the locked patient cassette medication cart had an auto lock feature. RN 5 stated she did not know if the cart could be manually locked, she was just aware of the self lock.

The DCC demonstrated to RN 5 how to manually lock the patient cassettes medication cart.

On October 17, 2011, at 11:25 a.m., the locked patient cassettes medication cart was unlocked by the ICU Manager. The time the cart was opened until the time the cart self locked was one minute and 45 seconds.




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3. On October 18, 2011, at 8:57 a.m., a WOW (Work station On Wheels) cart was observed in the common hallway on 3 Sinatra, in front of patient rooms. The WOW cart contained a portable computer, as well as supply drawers. There was no staff near or within eye sight of the cart. One of the drawers was left partially opened, and contained Cymbalta 30 mg (an anti-depressant) and Antivert 12.5 mg (used for management of nausea and vomiting, and dizziness associated with motion sickness).

Approximately three minutes later, RN 7 was observed coming out of room 3317. In a concurrent interview with RN 7, she stated the WOW cart was hers. RN 7 stated she left the cart in the hallway because she needed to help a patient. RN 7 also stated, she should have removed the medications from the cart or made sure the cart drawers were locked before she left the cart unattended.

The facility policy and procedure titled, "Medication Administration," revised January 2011, indicated, "All medications are to be stored in suitable secure locations, which may include: Automated dispensing Cabinets (ADCs), locked patient cassettes, or secured cabinets/drawers... Medication carts are to be locked at all times when not being accessed by licensed personnel..."



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4. During tour of the OB OR 1, on October 17, 2011, at 11 a.m., it was observed in the top drawer of the cart labeled "Anesthesia OB Cart 4" there were four 1-ml injectable vials of epinephrine (drug used for cardiac arrest, anaphylaxis, and other conditions) 1mg/ml and one 2-ml injectable vial of famotidine (acid reducer). It was also observed the cart was not lockable.

During a concurrent interview, RN 1 stated that the cart should not contain any medications.

During an interview on October 17, 2011, at 4 p.m., the DOP stated that all medications on the patient care areas needed to be secured and locked and that those medications did not belong in the Anesthesia OB Cart 4.

Based on observation, interview, and record review, the facility failed to ensure expired intravenous fluids in a warming cabinet, opened single use bottles of antiseptic solution, expired "Remover Lotion," an undated opened vial of medication, and an unsealed/unlabeled inhaler, were not available for patient use. This had the potential to result in expired or contaminated solutions/medications being utilized for patient care.

Findings:

1. On October 18, 2011, at 8:45 a.m., a tour of the Pre-operative area was conducted with the Director of Surgical Services and Surgical Program Manager.

During the inspection of the fluid and blanket warming cabinet the following was observed in the upper cabinet:
a. One bag of 1,000 ml (milliliters) intravenous Lactated Ringers solution, undated.
b. Two bags of 1,000 ml intravenous Lactated Ringers solution, dated October 4, 2011.
c. Multiple bags of 1,000 ml intravenous Lactated Ringers solution, dated October 17, 2011.

During a concurrent interview with the Director of Surgical Services, she stated the staff were probably dating the bags with the date they placed the bag in the warmer not post dating the bags of intravenous fluid by 14 days. In addition, the Director of Surgical Services stated the staff were probably not aware the facility policy had changed in regards to dating of fluids placed in warming cabinets.

The facility policy and procedure titled, "Fluid Warming" revised February 10, 2011, indicated, "... Solutions of volumes 150 ml or greater will be stored in their own wraps until use, and can remain in the warmer for up to 14 days... All solutions for injection will be post dated 14 days from the day placed in the warmer. ..."

2. On October 18, 2011, at 8:55 a.m., a tour of the Surgical Services area was conducted with the Director of Surgical Services and Surgical Program Manager.

During the inspection of Operating Room (OR) 1 the following was observed to be on the surgical prep cart:
a. One bottle of Antiseptic 4% Chlorhexidine Gluconate Solution 8 fluid ounces. The bottle was opened, approximately 1.5 ounces of the solution was missing from the bottle, there was no date on the bottle as to when it had been opened, and there was no expiration date on the bottle.
b. One bottle of Antiseptic 7.5% Providone Iodine Cleansing Solution 4 fluid ounces. The bottle was opened, approximately 1.5 ounces of the solution was missing from the bottle, and there was no date on the bottle as to when the solution had been opened.
c. One bottle of Remover Lotion with an expiration date of July 2010.

During an interview with the Surgical Program Manager on October 19, 2011, at 11:15 a.m., she stated the antiseptic bottles were designed as single use bottles and should have been discarded once opened. In addition, she stated the Remover Lotion should have been discarded when it expired.

3. On October 18, 2011, at 9:40 a.m., a tour of the Post Anesthesia Care Unit (PACU) was conducted with the Director of Surgical Services.

During the inspection of the PACU patient cassette medication cart the following was observed in a drawer:
a. An undated opened vial of Labetalol Hydrochloride (medication used to treat high blood pressure) Injection.
b. An unsealed, unlabeled Ventolin inhaler (medication used to treat spasms of the bronchus).

During a concurrent interview with the PACU Clinical Manager, she stated the vial of Labetalol Hydrochloride should have been dated when it was opened, and multidose vials of medications were good for 30 days. In addition, the PACU Clinical Manager stated the Ventolin inhaler was not typically kept in the patient cassette medication cart, but an anesthesiologist must have given it to the PACU staff so they just put the inhaler in the cart.

The facility policy and procedure titled, "Multi-Dose Vial Expirations" revised February 2011, indicated, "... On every multi-dose vial or bag, note the date, time, and your own initials when first
entering/accessing a multi-dose vial or bag. ... Follow manufacturer's expiration periods strictly, whenever specified, however beyond use dating may not exceed 28 days. ..."