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Based on interviews and document review, the General Acute Care Hospital failed to ensure accurate and appropriate written policies and procedures were in place for the appraisal and referral of emergencies (e.g. Malignant Hyperthermia (MH); a rare inherited genetic disorder of the skeletal muscles triggered in susceptible individuals in most instances by inhalation anesthetic agents and/or succinycholine, resulting in hypermetabolism, skeletal muscle damage, hyperthermia (extreme elevated body temperature) and death, if untreated) at the Outpatient Surgery Center (OPSC), an off campus department without emergency services.

Findings:

On 2/24/15 at the OPSC, the Interim Outpatient Surgery Director/OR Nurse Educator (ORED) provided the Department with the facility's policy and procedure titled, "Malignant Hyperthermia". The policy was last approved by the Governing Body on 12/6/12. A review of the policy revealed elements that were not consistent with the requirements for the OPSC including: a. The "Facility Alert" process read, "Dial *8 and notify operator to page overhead: "Malignant Hyperthermia Alert" and location of the patient in the event of a MH emergency anywhere in the facility...The MH cart will be immediately retrieved and brought to the patient by the [Administrative Nursing Supervisor] if the occurrence happens outside of the [Emergency Department, Operating Room, Outpatient Services or Family Birth Center.]" b. An example of the "Malignant Hyperthermia Cart Check List" was attached to the policy. The check list included a column to document (verify) the presence of "3 Bags 1000 NS in Freg (sic)", intravenous saline solution, in the OPSC's Omnicell (a brand of automatic medication dispensing cabinet) refrigerator. The check list observed on the MH cart in OPSC did not include this column. and; c. The policy references were outdated: "Malignant Hyperthermia Association of United States (MHAUS) Emergency Therapy for Malignant Hyperthermia Protocol, 2011 (current 2016) [and] Association of Operating Room Nurses (AORN) Malignant Hyperthermia Guidelines 2006 (current 2015)".

In a concurrent interview with ORED, she acknowledged the facility 2012 MH policy and procedure was the current policy used at the Main Hospital and the OPSC.

On 2/25/16 at the Main Hospital, the Director of Business Development provided the Department with the same 2012 policy for MH. She stated it was reviewed by the "Board" today, 2/25/16, and no revisions were made. In a concurrent review of the MH policy, it was noted that the attached "Malignant Hyperthermia Cart Check List" was not updated to include verification of normal saline in the Omnicell refrigerator. Other attachments that were reviewed in the same MH policy, previously given to the Department in the OPSC, were missing as well.

On the morning of 2/26/16, the Quality Senior Director (QD) acknowledged the MH policy did not include all aspects of care specific to OPSC and recognized the discrepancies between the two policies.

In an interview with the Vice President of Medical Affairs (VPMA) on the morning of 2/26/16, he acknowledged after review, neither the Medical Staff Bylaws nor the Rules and Regulations referred to the responsibility of the Governing Body to assure written policies and procedures were in effect for the OPSC with respect to emergencies such as Malignant Hyperthermia.

Based on observations, interviews and record review, the General Acute Care Hospital (GACH) failed to ensure the safety of patients and the quality of care given when:

1. The Pharmacy Department failed to define an action plan to assess the severity of a problem with the storage and distribution of high risk medications following an investigation of an adverse event in which a mislabeled cardiac medication was administered to a patient in labor and; (Refer to A-0500)

2. Surgical Services failed to define an action plan to assess the severity of a problem with the management of a malignant hyperthermia (a rare inherited genetic disorder of the skeletal muscles triggered in susceptible individuals in most instances by inhalation anesthetic agents and/or succinycholine, resulting in a fast rise in body temperature (hyperthermia) and severe muscle contractions, muscle damage, and death, if untreated), crisis following an investigation of an adverse event in which staff were not appropriately trained or equipment readily available in an emergency in the outpatient setting (Refer to A-951).

The cumulative effect of these systemic failures resulted in the inability of the hospital to comply with the statutorily mandated Condition of Participation Quality Assurance Performance Improvement Services.

Based on observation, staff interview and document review, the facility failed to identify opportunities for improvement and change or focus on high risk, high volume, or problem prone areas affecting health outcomes, patient safety and quality of care when:

1. The facility did not change the training policy for pharmacy staff to ensure staff were trained and competent before working independently; and

2. The facility did not change the automated dispensing cabinet restocking policy in order to ensure patient safety, even after an identified restocking error occurred in August of 2015. This error in restocking contributed to the administration of a medication (norepinephrine) for blood pressure instead of a medication for uterine contractions (oxytocin) during labor and delivery. This medication error resulted in harm to Patient 1; and,

3. There was no evidence of any audits, observations, or double-checking to ensure that medications were labeled correctly. Lack of quality assurance resulted in a mislabeled intravenous medication, dobutamine (a heart medication) being stored in a crash cart (cart containing emergency medications and supplies); dobutamine was labeled as lidocaine (a medication for irregular heart beat); and

4. Considering the system failure that resulted in the August 2015 medication error, the facility did not change their Medication Error Prevention policy to include tighter measures to prevent future medication errors from occurring; and

5. The facility did not ensure that accurate or appropriate written policies and procedures were in place for the appraisal and referral of emergencies (e.g. Malignant Hyperthermia (MH); a rare inherited genetic disorder of the skeletal muscles triggered in susceptible individuals in most instances by inhalation anesthetic agents and/or succinycholine, resulting in hypermetabolism, skeletal muscle damage, hyperthermia and death, if untreated) at the Outpatient Surgery Center (OPSC). Facility staff in the OPSC, the Family Birth Center and the Emergency Department could not demonstrate sufficient staff proficiency and/or timely access to supplies to initiate the time-critical management of a patient with MH.

Findings:

1. During a concurrent interview on 11/2/15 at 11:15 a.m., the Family Birth Center Director (FBD) and a facility pharmacist (Pharm 2) explained that on 8/18/15 at approximately 6 a.m., an intravenous bag (supposedly oxytocin) was pulled from the Automated Dispensing Cabinet (ADC); however, norepinephrine was removed instead. Intravenous bags of norepinephrine had been placed in the same drawer of the ADC as oxytocin. This contributed to the administration of the wrong medication to Patient 1.

The restocking error was related to the incomplete orientation and insufficient training of pharmacy technicians and allowing volunteers to work in the pharmacy.

On 2/26/16 at 11 a.m., during a meeting with members of the Quality Assurance and Process Improvement Committee, Pharm 2 stated they had changed the checklist for training and specified that a pharmacist would train new technicians. However, a review of the 10/22/15 Staff Competency policy showed, in general terms, that the pharmacist or technician would complete a new employee department orientation within 90 days. The policy did not specify required elements that technicians would have to complete before the training was considered completed or the technician considered competent to work independently. For example, the policy did not define any acceptable criteria for the documentation of preceptorships or staff proficiencies. The policy did not require the completion of new hire orientation prior to technicians working independently.

2. On 2/23/16, a review of the facility policy for restocking medications in the ADC, titled, "Omnicell Automated Dispensing System", approved 1/12/16, showed under the heading of Restocking Medications that, "All medications require barcode scanning upon filling Omnicell."

The policy did not have specific procedures detailing what specific steps technicians must take when restocking the ADC. In addition, the policy lacked safety steps to ensure barcode technology was used correctly to ensure accurate restocking of medications.

The concern of not scanning all medications stocked in the ADC was discussed with the Corporate Director of Quality Services (DRQ) and Corporate Pharmacist 5 (CPharm 5). Their concern was that scanning each medication was a lengthy process and would take a technician too long to complete the restocking task.

According to the Institute of Safe Medication Practice (ISMP), "Guidance on the Interdisciplinary Safe Use of Automated Dispensing Cabinets, core process #7 Recommended Processes for the Delivery of Medications to the ADC included:
- Ideally, use bar-code scanning to identify the correct drawer and pocket/container and to scan the drug being delivered to promote accurate placement in the designated ADC location...
- Process/restock one individual medication and strength at a time...
-Take steps to differentiate look-and sound-alike medications within the ADC .... Other options may be to separate these medications or make the bins more distinctive..."

There was no documented evidence that the facility was monitoring the accuracy of what was being placed in the ADCs, or if there was any periodic audits to ensure accuracy of medication delivery, especially high risk medications.

3. On 2/24/16 at approximately 1 p.m., during inspection of the Radiology Department, the emergency crash carts were inspected. In one of the medication drawers, there was a pre-mixed IV bag with the manufacturer's label identifying the contents as dobutmine (medication used in acute but potentially reversible heart failure to improve the heart's pumping capacity). The bag had a bright orange sticker with lidocaine (a medication used to treat life threatening abnormal heart rhythms) printed on the top of it. The sticker was about 4 x 5 inches and had a table format listing doses and the matching rates for lidocaine infusion. The Radiology Department Manager (RM) confirmed the observation.

In August 2015, the facility had an incident related to the mislabeling of high alert medications resulting in the administration of the wrong medication (norepinephrine) instead of intravenous oxytocin. Patient 1, who was in labor, received intravenous norepinephrine. According to the Institute of Safe Medication Practice (ISMP) norepinephrine is a high alert medication. High alert medications are "drugs that bear a heightened risk of causing significant patient harm when they are used in error. Although mistakes may or may not be more common with these drugs, the consequences of an error are clearly more devastating to patients."

The medication error in August 2015 was a result of both pharmacy and nursing staff depending on the auxiliary bright label placed on the bags and failing to check the manufacturer's label for accurate identification of medications.

On 2/24/16, similar to the incident in August 2015, a bag of a high alert intravenous medication, dobutamine was labeled with an auxiliary bright orange sticker that read "lidocaine" with lidocaine doses and infusion rates.

The facility had a multisystem failure that lead to a medication administration error in August of 2015. However, there was no evidence that the system was fixed six months after the incident. The potential risk for further medication administration errors remained as a mislabeled high risk medication was found on 2/14/16.

4. On 8/18/15 at 6 a.m., two nurses (RN 5, RN 6) observed at Patient 1's bedside, scanned the medication to be administered to Patient 1, but instead of a confirmation screen a warning appeared on the computer system linked to the scanning device. The nurses thought the reason for the warning was regarding the expiration date of the medication. They repeated the process again.

The Family Birth Director (FBD) provided the Department a copy of the visual ALERT (or similar alert) that appeared on 8/18/15, at the time when the nurses were trying to start oxytocin on Patient 1. The alert showed, "The scanned medication, norEPINEPHrine (Levophed) [another name for norEPINEPHrine] 4 mg. was not within the Medication Task List."

The two nurses at the bedside (RN 5, RN 6), after confirming the medication had not expired, scanned the armband of the patient and the medication to be administered; the same warning alert appeared on the screen. The nurses ignored the warning that appeared a second time, manually added the medication "oxytocin" onto the Medication Administration Record (MAR) and started the infusion at 5:59 a.m., on 8/18/15. The manual entry into the MAR bypassed the scanning technology and used a short cut commonly termed (override). The manual entry allowed the nurses in this case to administer Norepinephrine instead of the intended medication oxytocin.

On 11/2/15 at 2 p.m., a list of the manual override entries into the MARs was requested. On 2/23/16 at approximately 9 a.m., the list of the manual override entries into the MAR was requested again. On 2/24/16 at 8 a.m., the Quality Senior Director (QD) stated that they were still working on the manual override reports. On 2/26/16 at 8:45 a.m., RN 4 stated that the override reports are generated daily during weekdays and weekly on Mondays. These reports are then given to the Chief Nursing Executive (CNE) for evaluation. The daily manual override report for 2/25/16 was concurrently reviewed with RN 4. The report had the percent of patients and medication scanned per nursing area; the percent of scanning ranged from 50 to a 100 percent. There were some areas where patients were scanned only 50% of the time. Similarly there were medications, in some areas of the hospital, that were scanned only 57%.

The scanning from one nursing area (third floor) was evaluated further; this review showed about 94% for scanning medications and patients. The detailed report for that area showed individual staff and the number of scans each performed during that day for patients and medications. For one of the staff, there was a total of fourteen scans: three were for patients and eleven were for medications. RN 4 said that every medication must be associated with a patient; a patient can receive more than one medication. However, for every medication there has to be a patient scan. In this case, the report showed 11 medications but only three patient scans; eight patients were not scanned. RN 4 added, to find out what truly happened, you need to check the patient record to see if the medications were administered or not.

There was no follow up from any staff to explain how the information was being used and no evidence was presented to demonstrate that the information was analyzed to identify weak processes and areas for improvement.

The policy titled, "Medication Error Prevention (High-risk Medications)", approved 12/4/14, was reviewed. The policy included: "Systems will be implemented to reduce the risk of medicating errors from high-risk medications or in high-risk patient population."

There was no evidence that the hospital policy was updated or modified to tighten processes or add other safety measures to prevent a similar occurrence to the medication error that occurred in August of 2015.

5. Observations were made of the off-campus Outpatient Surgery Department on 2/24/16 at 8:15 a.m. with the Interim Outpatient Surgery Director/Nurse Educator (ORED). A MH cart was observed in an alcove outside the surgical suites. A numbered plastic lock, used to secure and show if the cart had been opened, was not present. In a concurrent interview, the ORED acknowledged since the cart was "unsealed" without the plastic lock, she could not determine whether the MH cart had been checked by central supply and/or pharmacy and therefore ready for use. The February 2016 MH Cart Check List did not include a column to document (verify) the presence, quantity or location of chilled normal saline in the OPSC department.

The Quality Senior Director (QD) was interviewed on 2/26/18 at 10:30 a.m. She acknowledged the facility did not have a written policy or procedure for the restocking and redeployment of the MH cart. The QD stated that a plastic lock should be in place on the outside of the MH cart or, alternatively, a log book with documentation to show when anything was added, removed or changed by central supply or pharmacy.

On 2/24/16 at 9:17 a.m., the ORED unlocked the door to a medication room where an Omnicell (brand name of an automated dispensing cabinet) was located. When asked who had access to this room, ORED stated the "nurses" and no one else. The representative asked to see where the ice was located. The ORED escorted the representative from the Department to the coffee cart in the foyer of the building. An ice machine (containing ice) was behind the cart. When the contracted coffee vendor (CV) was asked about the ice, she stated she "makes" very little. The ORED was asked if the OPSC had an alternative source of ice. A small ice machine for beverages was observed in the clean utility room.

A review of the last OPSC Malignant Hyperthermia Drill Report dated 7/22/15 revealed that several members of the MH team, particularly the ancillary staff, did not respond to the overhead page nor were they present at the patient's bedside. Post drill recommendations included: "1. Go over team roles in MH codes, 2. Staff be aware that cool NS (normal saline) is available in refrigerator in med room and 3. Teach the staff about MH and MH codes.

A review of the individual in-service and competency files for outpatient surgery RNs 2, RN 8 and RN 9 was completed. The last MH in-service(s) found in their files was from 2013.

In a later interview with ORED on 2/24/16 at 9:30 a.m., she acknowledged the OPSC staff were not provided an in-service about MH recently.

During a tour of the FBC on 2/23/16 at 11 a.m. with Certified Nurse Anesthetist 1 (CRNA 1) and the Family Birth Center Manager (FBM), an observation was made of the Malignant Hyperthermia cart in the hall outside the surgical suite. The February 2016 MH Cart Check List did not include a column to document (verify) the presence, quantity or location of chilled normal saline in the department. CRNA 1 was observed attempting to unlock the cart with a key from her key ring labeled for the MH cart. CRNA 1 wasn't able to unlock the cart with the key. "They must have changed out the lock", she said. Additionally, CRNA 1 did not know the four digit code required to open the cart.

In a concurrent observation and interview with the FBM on 2/23/16 at 11:20 a.m. in the FBC, a request was made to see the Omnicell. A door identified as "Restricted Area" and "2270 Report Room" was opened by the FBM with a key card and she entered the room. Upon opening the refrigerator to the Omnicell, 3 separate 1 liter bags of intravenous normal saline were observed. The FBM acknowledged she was not aware the normal saline was in the Omnicell.

On 2/24/16 at 9:45 a.m., the Family Birth Center Director (FBD) was interviewed. She acknowledged the refrigerator with the normal saline had been removed from the anesthesia supply room earlier this week. The FBD stated, however, there would be no expectation for the CRNAs or physicians to know about the relocation of the normal saline. The FBD acknowledged anesthesiologists or CRNAs take the lead role during a MH crisis in the surgical suite. She concluded saying there was no expectation the CRNAs or anestheologists would know how to access or have the ability to access a MH cart.

On 2/25/16 at 12:40 p.m., observations were made of the Emergency Department. In the medication room, RN 3 was asked to remove a 1 liter bag of cold intravenous normal saline from the Omnicell. After entering her password into the key pad display of the Omnicell, RN 3 made numerous selections from the display, the list of medications, in an attempt to find and remove the normal saline. After several tries, RN 3 found it and tapped the display to select a 1 liter bag of intravenous normal saline and unlock the Omnicell refrigerator. RN 3 was unable to unlock the refrigerator because she could not "override" the selection for normal saline.

At 12:50 p.m., RN 3 was asked to show representatives from the Department the location of the Malignant Hyperthermia cart in the ED. RN 3 was observed asking the Emergency Department Clinical Coordinator/Charge Nurse (EDCC) where the MH cart was located. RN 3 located the cart after she walked down two separate hallways in the ED. The February 2016 MH Cart Check List did not include a column to document (verify) the presence, quantity or location of chilled normal saline in the ED department.

A review of the in-service and competency files for ED RNs 3, 10 and 11 was completed concurrently with the ED Educator (EDED) on 2/26/16 at 9:10 a.m. None of the three files contained documented evidence the RNs were provided MH in-services in 2015. The nurses' level of competence and/or proficiency in the management of a patient with MH was not assessed, as evident by the lack of documentation in their files.

Based on observations, interviews and record and facility policy review, the hospital failed to provide nursing services in accordance with acceptable standards of practice and state and federal regulations for the preparation and administration of medications to ensure the safety of patients and the quality of care given when:

1. Policies and procedures for the verification of a high risk medication were not followed and a patient (Patient 1) was given the wrong medication which resulted in severe cardiomyopathy (damage to the heart muscle) and required a transfer to a higher level of care and; (Refer to Tag A-0405)

2. Physician's orders for the rate of administration of morphine to Patient 21 were not followed which resulted in severe respiratory distress, intubation, (the placement of a flexible plastic tube into the windpipe to maintain an open airway), and required a transfer to the critical care unit, and; (Refer to Tag A-0405)

3. Policies and procedures for the labeling and storage of medications were not followed when a syringe of medication (fentanyl, a narcotic) was unlabeled and unattended at the bedside of Patient 5, and; (Refer to Tag A-0405)

4. Licensed nurses (RN 1 and RN 2) failed to utilize resources for preventing needle stick injuries when re-capping needles at the bedside of Random Patient A and Patient 5 on 2/23/16 and 2/24/16 respectively, and; (Refer to Tag A-0405)


5. Patient 5 was not informed of the medications being given, including the name, dose, risks, benefits and side effects. (Refer to Tag A-0405)

These failures (described in detail in Tag A-0405) resulted in the potential for increased medication errors and adverse outcomes for all patients. The cumulative effect of these systemic failures resulted in the inability of the hospital to comply with the statutorily mandated Condition of Participation for Nursing Services.

Based on observations, staff interviews, document and record review, the General Acute Care Hospital (GACH) failed to ensure that medications were prepared and administered according to state and federal regulations, acceptable standards of practice and nursing medication administration policies and procedures for 4 of 32 (1, 5, 21, Random Patient (RP) A) sampled patients when:

1. Three licensed nurses (RN 5, 6, 7) failed to follow established policies to verify the identity of a high risk medication and therefore administered norepinephrine (a medication used to increase blood pressure during cardiopulmonary arrest) instead of oxytocin (a medication given to enhance uterine contractions) to Patient 1 in labor and post delivery on 8/18/15, and

2. A licensed nurse (RN 14) failed to follow the physician's orders for the rate of administration of morphine to Patient 21 on 2/22/16 which resulted in severe respiratory distress, intubation (the placement of a flexible plastic tube into the windpipe to maintain an open airway) and a transfer to the critical care unit and;

3. A licensed nurse (RN 2) left a syringe of medication (fentanyl, a narcotic) unlabeled and unattended at the bedside of Patient 5 on 2/24/16 and;

4. Licensed nurses (RN 1 and RN 2) failed to utilize resources for preventing needle stick injuries when re-capping needles at the bedside of RP A and Patient 5 on 2/23/16 and 2/24/16 respectively, and;

5. A licensed nurse (RN 2) failed to inform Patient 5 on 2/24/16 about medications prior to administration, including the name, dose, risks, benefits and side effects.

The failure to follow established policies and procedures for medication management resulted in two serious medication errors which caused serious disability and loss of function to two of 32 patients (Patients 1 and 21). In addition, the failure to follow acceptable standards of practice for medication preparation and administration resulted in the potential for additional medication errors and complications.

Findings:

1. The following findings were a result of the state investigation of an adverse event conducted from 11/2/15 to 2/26/16.

During a concurrent interview on 11/2/15 at 11:15 a.m., the Family Birth Director (FBD) and a facility pharmacist (Pharm 2) stated that oxytocin was designated as a High Risk medication that required, by policy, verification by two registered nurses prior to administration. An electronic device (Barcode scanner) is used to scan the armband to confirm the patient's identification; then the same device is used to scan the medication.

The FBD explained that on 8/18/15 at 5:59 a.m., one of the two nurses at the bedside (RN 5 with RN 6 as the verifier) scanned the armband for Patient 1 then scanned the medication. FBD stated that when the nurse scanned the medication bag (supposedly oxytocin) that was pulled from the Omnicell, instead of a confirmation screen, a warning appeared on the computer system linked to the scanning device. The nurses thought the reason for the error/warning was regarding the expiration date. They repeated the process again. Again, the same error alert appeared on the screen.

The two nurses, at the bedside (RN 5, RN 6), after confirming the medication had not expired, ignored the warning that appeared a second time and resumed the action of administration of the medication, which was not oxytocin, as prescribed, but norepinephrine which had been placed by the Pharmacy Technicians in the wrong assigned area in the Omnicell. RN 5 and RN 6 then manually added the medication "oxytocin" onto the Medication Administration Record (MAR) and started the infusion at 5:59 a.m., on 8/18/15. The actual medication being administered was Norepinephrine 4 milligram (mg) intravenous drip.

The FBD provided, to the surveyors, a copy of the visual ALERT (or similar alert) that appeared at the time the oxytocin was initiated: "The scanned medication, norEPINEPHrine (Levophed) 4 mg. was not within the Medication Task List"

The bag that the nurses removed from Omnicell for administration to Patient 1 was norepinephrine, but had a hot (bright/neon) pink sticker that read oxytocin 15 units affixed to a clear outer bag. The oxytocin hot pink sticker was designated to be placed by pharmacy staff on oxytocin bags to alert nursing staff that oxytocin was a high-risk medication, which requires nurses to double check at initiation of each new bag.

Review of Medication Management policy, dated 12/4/2014, showed the following instructions under medication administration: "The Patients EMAR (electronic MAR) must always be within view for visual verification of the seven rights of the medication administration." The same policy identified the seven rights for medication administration as the Right Patient, Right Medication, Right Dose, Right Route, Right Time, Right Documentation, and Right Reason.

On 11/2/15 at 11:15 a.m., during interview, the FBD explained that for high-risk medications, such as oxytocin, two nurses were required to mark and verify the intravenous line from the bag to the patient with a brightly colored alert sticker for easy identification. The FBD further stated that at the change of shift, a two-nurse verification process should take place for every intravenous medication being infused. The process included tracking (holding between fingers) each of the lines from the bag (to identify the drug) to the pump (to verify the rate) / to the site of infusion (to visually inspect the infusion site). The FBD stated that this (bedside double check) process was not done, on 8/18/15, between RN 5 (night shift) and RN 7 (day shift) during the change of shift report, between 7-7:30 a.m. In addition, the FBD acknowledged the two nurse verification process should have occurred when a new bag was initiated.

When asked about the policy which defined the shift report and additional processes for verification, the FBD stated there was no policy to reflect this standard, but added that it is a "standard of practice". However, a review of a 2015 document titled "Medication Safety High Alert Medication Competency Validation for Nurses" included the following requirements.
"Understand the requirements of the independent double check required for all High Alert Medications:
a. Independent verification of the order, drug and dose prior to administration.
b. Documentation of the independent double check by 2 licensed personnel.
c. Identified when independent double check is required (ex. new bag, rate changes, shift change, etc.)".

Review of the "Oxytocin Management, Intrapartum" policy approved on 10/17/13, showed that the requirements for double check of the medication were clearly stated and underlined: "Oxytocin is a high alert medication which requires 2 RN signatures upon initiation of every new bag."

The FBD also added at shift change, a report was to be given to the oncoming nurse by the outgoing nurse, to go over and address what the patient was receiving. She acknowledged if the shift change check were performed that day, then the error could have been identified sooner. Consequently, the large amount of Norepinephrine (when the rate of oxytocin was increased to 999 ml/hr) that was infused after delivery and led to the development of headaches and shortness of breath necessitating the transfer to the Intensive Care Unit (ICU) could have been prevented.

On 11/2/15 at approximately 11:30 a.m., Pharm 2 produced the bag of Norepinephrine, the one that was infused, and sequestered by the pharmacy. The bag had a manufacturer label which identified the medication as Norepinephrine 4 mg, but did not have a patient specific label attached to it, which should have included the patient's name, name of medication, dose, date or time noted on the bag. Pharm 2 acknowledged labeling in accordance with facility's policy was not done.

A GACH policy titled Medication Management, dated 12/4/14, was reviewed. The purpose of the policy was "to provide guidelines for the safe prescribing, ordering, transcribing, administration and storage of medications". The following was noted:

Page 6: "Label IV [intravenous] medications removed from the Omnicell (without a pharmacy label) with the patient's name, name of the medication, dose, date and time."

Page 6: "Label the distal (end) of the IV tubing with the name of the medication. Label the tubing after it has been attached to the medication."

Page 9: "Document Administration: 10. Followed the policy on Medication Error Prevention (High-risk Medications). "High Alert " medications that are required by policy to have a co-signature include: e. Oxytocin (upon initiation and whenever a new bag is hung)."

A GACH policy titled Oxytocin Management, Intrapartum, dated 10/17/13, page 2, stipulated, "6. Oxytocin is a high alert medication which requires 2 RN signatures upon initiation of every new bag."



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2. On 2/24/16 at approximately 11 a.m., the medical record for Patient 21 was concurrently reviewed with facility registered nurse 14 (RN 14). Review of the record showed that Patient 21, an 80 year old, was brought to the emergency department (ED), on 2/22/16, after a fall at home. Patient 21 had a history of high blood pressure and diabetes and, according to the initial ED nurse's notes dated 2/22/16, he was not complaining of pain when he arrived at the ED.

At approximately 10 a.m., Patient 21 was ordered morphine, (an opioid/narcotic/strong pain medication), to be given by intravenous injection (IV push). The dose was 2-6 milligrams (mg), with specific instructions to give 2 milligrams for the first dose only and every 15 minutes thereafter as needed up to the dose prescribed using a pain rating scale. The order further indicated to administer 2 mg for a pain rating between 1-3; 4 mg for a pain rating between 4-6; and 6 mg for a pain rating between 7-10. The pain rating scale used in the facility was 0-10 with 0 being no pain and 10 being the maximum or worst pain. According to the history and physical and medication reconciliation portion of the report, Patient 21 was not receiving any opioid type medications (morphine or morphine like) for pain prior to admission.

Morphine is a strong pain medication that has a boxed warning which is the most serious warning required by the Food and Drug Administration to be placed in the product labeling for a medication. Boxed warnings document potential problems which can lead to serious injury or death. One of the concerns listed in the boxed warning for morphine was respiratory (breathing) depression (serious, life threatening, or fatal respiratory depression may occur) with specific products; however, morphine is strongly associated with sedation and respiratory depression as side effects.

According to drug information from Lexi.com (an on-line drug information resource), "All morphine sulfate formulations are capable of causing respiratory depression; risk increased in elderly patients, debilitated patients,...Monitor for respiratory depression especially during initiation and titration (change of the dose)." In addition there are geriatric (older patient) considerations for prescribing and administering morphine. "The elderly may be particularly susceptible to the central nervous system (CNS) depressant...effects of opioids (such as sedation, confusion, and decreased level of consciousness, and coma)."

According to the medication administration record, Patient 21 was administered 4 milligrams of morphine for a pain intensity of 5, on 2/22/16 at 10:01 a.m. There was no documented evidence that the first dose of 2 mg of morphine was given as ordered by the physician.

Concurrent review of the record with RN 4, showed ED physician notes, dated 2/22/16 at 11:10 a.m., "Patient was given morphine at 1000. He later became unresponsive and stopped breathing and needed to be intubated." Intubation is insertion of a tube into the airways to help protect the airway and facilitate breathing. Additional physician notes, dated 2/22/16 at 1:11 p.m., included that Patient 21 had acute (sudden/serious) respiratory failure with suspected decrease in respiratory rate which was exacerbated (to make something that is already bad even worse) by a "moderately large dose iv morphine."

The recommended morphine dose by IV is 2.5 to 5 mg every three to four hours; that dose is recommended for opioid naive patients (patients that have not used morphine or morphine like medications). General recommended doses are usually for healthy young adult males. The dose recommendation also included instructions to give a small dose and monitor patients. According to Lexi.com, "Administration of 2 to 3 mg every 5 minutes until pain relief or if associated sedation, oxygen saturation (amount of oxygen in the blood) <95%, or serious adverse event occurs may be appropriate..." Additionally, for geriatric patients, it is recommended to "Use with caution; may require reduced dosage in the elderly and debilitated patients."

Patient 21, an opioid naive 80 years old, was administered 4 mg of morphine inconsistent with the physician order. Patient 21 was not monitored every 15 minutes after the first dose as the order specified.

In an attempt to reverse the side effects associated with the "moderately large" morphine dose, Patient 21 was administered 1 mg of Narcan on 2/22/16 at 11:16 a.m. Narcan, also known as naloxone, is used to reverse the effect related to excessive use of opiates/opioid medications such as morphine. Narcan is categorized as an opiate antagonist (a substance that interferes with or inhibits the physiological action of another). Hence, naloxone and similar medications are termed antidotes, reversal or rescue agents.

Nurse's notes indicated that Narcan was unsuccessful in waking the patient up. Additional Nurses Notes indicated that Patient 21 was intubated at 11:12 a.m. and later admitted to the Intensive Care Unit.



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3. During an observation of the Post Anesthesia Care Unit (PACU) in the Outpatient Surgery Center (OPSC) on 2/24/16 at 8:50 a.m., Patient 5 was observed recovering from an umbilical hernia repair. Patient 5 was reclined on a gurney with his head elevated. He was awake and alert. A peripheral intravenous (IV) line was observed attached to a catheter in his left hand.

At 8:53 a.m., RN 2, assigned to Patient 5, was observed drawing up the entire contents of a 2 milliliter (ml) vial of medication with a needle and syringe. The label on the vial read: "Fentanyl 100 mcg/2 ml." RN 2 administered a portion of the fentanyl intravenously. RN 2 recapped the needle that remained attached to the syringe, and left the syringe with the remaining fentanyl on the work station next to the patient's bedside. RN 2 did not label the syringe of fentanyl. Shortly after, RN 2 walked away from Patient 5's bedside leaving the syringe of fentanyl unattended. RN 2 requested that RN 9 keep an eye on her patient while she retrieved something. RN 9 was located 2 "bays" from Patient 5, attending to a patient with an oral airway, who just arrived to the PACU from surgery.

A review of a 2014 facility policy titled "Medication Management", confirmed the following: "All medications are labeled when transferred from the original packaging into another container..." and "Never leave medications at the bedside".

4. During an observation on 2/23/16 at 10:30 a.m., Random Patient A (RP A) arrived to the Inpatient PACU after a right total knee replacement. A bag of intravenous fluid was infusing via tubing and a peripheral IV catheter in her left arm. RN 1 was observed drawing up the entire content of medication from a 2 ml glass vial using a needle and syringe. After withdrawing the syringe and needle from the rubber stopper of the vial, RN 1 recapped the needle. She then walked to the other side of RP A's gurney, removed the capped needle from the syringe, and instilled the medication via a needless port in the tubing.

During an observation in the PACU of the OPSC on 2/24/16 at 8:53 a.m., RN 2 was observed drawing up the entire content of medication from a 2 ml glass vial using a needle and syringe. RN 2 withdrew the syringe and needle from the rubber stopper of the vial. RN 2 recapped the needle using both hands. RN 2 proceeded to remove the capped needle from the syringe and administered the medication intravenously to Patient 5.

In a concurrent observation and interview on 2/25/16 at 1:45 p.m., in the Inpatient Preoperative Area, RN 12 was asked if the facility had or used a needleless system for the withdrawal of medications or other solutions from vials/bags. RN 12 was unable to produce a needleless access device or a needle with safety features. RN 12 handed the representative of the Department a needle in a package labeled, "Blunt Fill Needle".

On 2/25/16 at 1:50 p.m. RN 13 was interviewed. RN 13 provided the sample "Blunt Fill Needle" when asked what she used to withdraw medications from vials. RN 13 was unable to produce a needleless access device or needle with safety features. Upon removing the plastic wrap and plastic cap from the "Blunt Fill Needle", it was observed to be sharp enough to pierce skin.

The Infection Control Manager (ICM) was interviewed on 2/26/16 at 10 a.m. The ICM stated that recapping of needles (regardless of type) was unacceptable nursing practice and should never happen. She also explained the "scoop" one-handed method was unacceptable as well. The ICM was not aware of any needleless access device at the facility that was used as an alternative to drawing up medication with a needle.

In a later observation and interview with the ICM on 2/26/16 around 1 p.m., the ICM brought an example of a "BD SafetyGlide Needle" available to facility staff. The ICM demonstrated how after using the SafetyGlide needle, the nurse could engage a hard plastic sleeve to cover the needle, rendering it useless and safe to discard.

According to a 5/28/15 facility policy and procedure titled, "Bloodborne Pathogens Exposure Control Plan", "Engineering controls are used to minimize or eliminate occupational exposures to bloodborne pathogens. These controls will include, but not limited to, sharps with engineered safety, such as needleless systems, needle devices, and non-needle sharps...A needleless system will be used for the withdrawal of body fluids, the administration of fluids and medications and any other procedures involving the potential for an exposure incident for which a needleless system is available as an alternative to the use of a needle device. When a needle or sharp is required, engineered sharps injury protection will be used..."

5. During an observation of the PACU at the Outpatient Surgery Center (OPSC) on 2/24/16 at 8:50 a.m., Patient 5 was observed recovering from an umbilical hernia repair. Patient 5 was reclined on a gurney with his head elevated. He was awake and alert. A peripheral intravenous line was observed attached to a catheter in his left hand.

At 8:53 a.m., RN 2 was observed drawing up medication from a small vial using a needle and syringe. She administered a portion of the contents of the syringe intravenously to Patient 5. The label on the vial read: "Fentanyl 100 mcg/2 ml." Prior to the administration of the fentanyl, RN 2 did not communicate the name of the drug, dose, potential side effects, risks or benefits. At 9 a.m., Patient 5 asked, "What did you give me in my IV?"

With further observation, RN 2 administered the remaining fentanyl in the syringe to Patient 5 at 9:12 a.m. No education or information about Fentanyl was provided to Patient 5 prior to administration.

A review of the 2/24/16 Medication Administration record indicated Patient 5 received 50 mcg of intravenous fentanyl at 8:53 a.m. by RN 2. A second dose of fentanyl 50 mcg was given by RN 2 at 9:14 a.m. RN 2 charted, "Education on medication purpose/side effect" at 8:45 a.m. and 9:14 a.m. in the nursing notes, although this was not observed.

The 2014 facility policy and procedure titled "Medication Management" was reviewed. The following instructions were identified: "Provide education to the patient/family prior to administration of the first dose of each medication including the name of the medication, the purpose of the medication, potential side effects, the expected outcome and any warnings..."

Based on observations, interviews and record review, the hospital failed to provide pharmaceutical services in accordance with acceptable standards of practice and state and federal regulations for the provision and distribution of medications to ensure the safety of patients and the quality of care given when:

1. The absence of sufficient training and lack of detailed and specific policy and procedures for stocking of medications caused the incident where a medication used to increase blood pressure (norepinephrine) and another to induce labor (oxytocin) were mixed up because they look similar in size and labeling (look alike). The medications were stored next to one another in the pharmacy, so the wrong medication (norepinephrine) was selected and delivered to labor and delivery. Norepinephrine bags had a hot pink sticker for oxytocin affixed to it by pharmacy staff. These bags were placed in the storage bins used for oxytocin in the labor and delivery automated medication dispensing cabinet. A Norepinephrine bag labeled as oxytocin was obtained by nurses and infused in full to a patient in labor. Patient 1, who received Norepinephrine instead of oxytocin, developed cardiomyopathy, a heart condition that can lead to heart failure and possible death. (See A-0405 and A-0500)

2. A mislabeled medication bag was identified in the emergency medication supplies in Radiology. An intravenous bag of dobutamine (medication used to to improve the heart pumping capacity) was found to have a bright orange sticker labeled lidocaine (used to treat abnormal heart rhythms). Due to the absence of a system to ensure accurate distribution and labeling of medications six months after a similar medication error (related to mislabeling and placing a norepinephrine bag in the storage compartment designated for oxytocin in labor and delivery), a situation of Immediate Jeopardy (IJ) was identified.

Because of the above failures which potentially put patients at risk for serious medication errors an IJ was called, so that the facility could put in place immediate remedies to ensure patient safety.

On 2/24/16 at , at 4:20 p.m., hospital management staff Chief Operating Officer,(COO), Chief Nurse Executive, (CNE), Quality Director (QD), Pharmacist, (Pharm 2), and Vice President of Medical Affairs (VPMA)), were informed of the IJ situation related to a system failure that involved risky practices for storage and mislabeling of medications. Such failure resulted in a medication error for Patient 1 in August 2015. In addition, the potential for medication errors was still in place when a mislabeled intravenous medication used in emergencies was found in the emergency medication supply in the Radiology area on 2/24/16 at 1:00 p.m.

On 2/24/16 at approximately 5 p.m., hospital management staff presented a plan of corrective action to commence immediately to ensure safe administration of medications. The actions to be taken were summarized as follows:

Facility administrative staff will check all intravenous medications being infused to ensure that they are correct; will check all emergency medication carts to ensure that no mislabeled medications were still available; pharmacy staff will ensure all medications in the pharmacy have accurate and correct labels; Pharmacy staff will specifically ensure that dobutamine and lidocaine IV bags in the automated dispensing cabinets (ADC) are accurately labeled; and that pharmacy staff will also check all medications in the ADC for accurate labeling. Other actions included training staff and future plans for evaluating and changing policies as applicable.

On 2/25/16 at approximate 9 a.m., the facility provided evidence of the corrective actions they had completed and evidence of staff training.

On 2/25/16 at 1:45 p.m., after the survey team validated, by observations and interviews, that the immediate action plan was implemented, hospital administrative staff (COO, CNE, VPMA, etc...) were informed that the IJ was abated.

3. There was no specific policy to address storage of refrigerated medications. The refrigerated medications were kept at a temperature that was inconsistent with the standard of practice as stated in state regulations. (See A-500)

4. The facility policy for recalled devices was not implemented when three recalls for devices were not evaluated or acted on timely or appropriately; therefore allowing potentially ineffective devices to be available for use. ( See A- 0500)


5. Expired or mislabeled medications were not removed from storage areas and were available for use. (Refer to Tag A-0505)

6. Manufacturer's specifications were not followed for duration of use and stop orders. (Refer to Tag A-0507)

7. An adverse drug reaction was not reported immediately. (Refer to Tag A-0508)

These failures (described in detail in Tag A-500, A-505, A-507, and A-508) resulted in the potential for increased medication errors and adverse outcomes for all patients. The cumulative effect of these systemic failures resulted in the inability of the hospital to comply with the statutorily mandated Condition of Participation for Pharmaceutical Services.

Based on observations, staff interviews and records and policies review, the facility failed to ensure that policies for safe and effective use of medications were developed and/or implemented as follows:
1. Medications for intravenous (IV) infusion, one to induce labor (oxytocin) and the other used to increase blood pressure (norepinephrine), were similar in size and appearance and were stored next to one another in the pharmacy. The wrong IV bags (norepinephrine) were selected and placed into the automated dispensing cabinet (ADC) in labor and delivery as they had a hot (neon/bright) pink oxytocin alert sticker affixed to it by pharmacy staff. The wrong IV bag (Norepinephrine with an oxytocin sticker) was obtained by nurses and infused in full to a patient in labor.

2. The facility's policy for restocking medication in the ADC was not modified or updated to ensure accurate distribution and restocking of medications.

3. There was no system in place to ensure accurate distribution and labeling of medications. Approximately six months after the medication error (oxytocin and norepinephrine mix up) related to mislabeling and inaccurate stocking of medication, a mislabeled medication IV bag was identified in the emergency medication supplies in the Radiology area. An IV bag bearing a manufacturer's label of dobutamine (medication used to improve the heart pumping capacity) was found with a bright orange sticker for lidocaine (a numbing agent used to treat abnormal heart rhythms).

4. The facility had a nonspecific policy for training pharmacy technicians. The policy did not specify the duration required for training, the tasks to be completed during the training, or specific competency measures to be attained before a technician could work independently.

5. There was no specific policy addressing storage of refrigerated medications and at what temperature these medications should be kept. The facility's medication temperature storage range was inconsistent with the State's temperature storage regulation.

6. The facility policy for recalled devices was not implemented when three recalls for devices were not evaluated or acted on timely or appropriately.

7. There were no specific policies or procedures for preparing oral hazardous medications to ensure the safety of staff, patients or visitors to the pharmacy as hazardous medications were prepared in the main pharmacy without protective equipment consistent with standards of practice.

Findings:

1. During a concurrent interview on 11/2/15 at 11:15 a.m., the Family Birth Center Director (FBD) and facility pharmacist (Pharm 1) stated that oxytocin was designated as a high risk medication and was stored in the medication automated dispensing cabinet (ADC). It was explained that the wrong medication, norepinephrine (used to increase blood pressure in very ill patients), was administered to Patient 1 instead of the prescribed medication, oxytocin, which is used to stimulate/augment uterine contraction for delivery. Norepinephrine was placed in the bin where oxytocin was supposed to be stored in the ADC.

During an interview on 11/2/15 at 1 p.m., with FBD and Pharm 1, Pharm 1 stated when pharmacy technicians pull medications from pharmacy stock for delivery, a pharmacist double-checks the selected medications to ensure the selection was consistent with the list indicating what was to be restocked in a specific area of the hospital.

Pharm 1 added that all high risk medications (any medications that have a heightened risk of causing significant patient harm when used in error), including oxytocin, would be delivered to the ADCs by two pharmacy technicians who would verify accurate medications were being placed in their designated place in the ADC. Pharm 1 acknowledged that on the day of the error, an undetermined number of 250 cc (cubic centimeters - a unit of volume) IV bags, containing 4 mg (milligram - a unit of weight) of norepinephrine were inadvertently placed by two pharmacy technicians in the space specified for oxytocin in the ADC. Pharm 1 stated the two pharmacy technicians were required to verify the medication, the alert label (name of drug on a hot pink sticker), and the storage area to ensure safe and secure medication storage.

Continuing the interview with the FBD and Pharm 1 revealed that approximately 9 a.m., on 8/18/15, a 250 cc bag of norepinephrine that had a hot pick oxytocin alert sticker had been found in another labor and delivery room. The nurse who found the bag, (RN 5) informed the Clinical Coordinator (CC 1). CC1 told RN 5 to call the Pharmacy. Pharm 1 stated that she was the one who took the call from RN 5. Pharm 1 instructed the pharmacy technicians to check the Omnicell (brand name of ADC) units in labor and delivery and to retrieve any additional bags of norepinephrine. Pharm 1 did not ask staff to check for any IV bags that were currently being infused. Pharm 1 said norepinephrine would never be stocked in labor and delivery as it is a high risk cardiac medication.

As a result of the above incident, Pharm 1 stated that the facility changed the procedure for delivering medications; the procedure now required double verification by two technicians when placing medications in the ADC.

On 11/2/15, at approximately 3 p.m., Techs 11 and 12 were observed delivering and stocking high risk medications. Tech 11 selected a high risk (norepinephrine) medication from the fill list and pulled two bags of norepinephrine to restock into the ADC in the Intensive Care Unit (ICU). At the ADC, Tech 11 signed on, pointed to the light indicator on the cabinet illustrating where the medications were to be placed, opened the door, and stated that she had to verify the count and check the expiration date of what was already in the cabinet. Tech 11 then instructed Tech 12, who was having a side conversation with other people in the medication room, to enter the data into the ADC. Tech 11 completed the process by checking the expiration dates of the two bags to be added, verifying the name of the medication and the presence of the high alert pink sticker on them. Tech 11 told Tech 12 to key-in the amount added. Tech 12 was not in close proximity and had not observed what Tech 11 was doing in order to see and verify any of the tasks performed by Tech 11.

Tech 12 was asked about her role in the restocking process; she stated that she was supposed to co-sign. She pointed to the ADC and said, "I am supposed to co-sign, and I provided my fingerprint."

Review of the facility policy titled "Dispensing Medications from Omnicell," approved 6/26/2014, showed no specific instructions on what the technicians restocking the machine were supposed to do. It only included the following: "Inventory levels will be checked daily."

norepinephrine and oxytocin were the same size (250 cc bags) and had similar labeling (black and white lettering labels); this is defined as look alike medications. Look alike medications are associated with increased risk for being confused for another medication (mix up). These medications were not recognized by the facility for the increased risk of mix up. They were stored next to one another in the pharmacy; coupled with not implementing policies and procedures for stocking medications, lead to obtaining the wrong medication and infusing the bag in full to Patient 1. As a result, Patient 1 developed cardiomyopathy (heart failure).

2. On 2/23/16 at approximately 2 p.m., accompanied with Pharm 1, Tech 15 was observed restocking the ADC with four different medications. Tech 15 used a scanner to identify the medication that was to be added to existing stock. Tech 15 started with one liter bags of IV fluids containing potassium chloride. Potassium chloride is a supplement that is given as replacement when low potassium blood levels are detected. Potassium chloride has serious symptoms associated with high and low levels. Low levels of potassium can cause muscle weakness and irregular heartbeat and high level can also cause irregular heartbeat.

Tech 15 scanned one bag, but added 12 bags to the ADC without scanning any of the additional bags. Tech 15 also scanned one sealed tray that contained ten individual doses of potassium chloride oral liquid, but placed two trays, 20 individual doses, in the ADC. Not scanning each unit before placing it in the ADC has an inherent risk for errors by putting a wrong medication (tray, bag, or dose) in the wrong bin by assuming the remaining un-scanned doses of medications were the same as what was scanned.

On 2/24/16, the facility policy for restocking medications in the ADC, titled "Omnicell Automated Dispensing System," approved 1/12/16, was reviewed. Under the heading "Restocking Medications," the policy included: "All medications requires barcode scanning upon filling Omnicell."

The policy did not have specific procedures detailing what specific steps technicians have to take when they are restocking the ADC. In addition, the policy lacked safety steps to ensure barcode technology is used correctly for accurate stocking of medications.

The concern of not scanning all medications that are stocked into the ADC was discussed with the facility management staff. The Corporate Director of Quality Services (DRQ) and a corporate pharmacist (C Pharm 5) stated that scanning each unit before stocking would be a lengthy process and would take the technician more time to complete the restocking task.

The Guidance on the Interdisciplinary Safe Use of Automated Dispensing Cabinets by the Institute of Safe Medication Practice (ISMP), Core Process #7 defines safe ADC restocking processes and has recommended the following processes for the delivery of medications to the ADCs:
"- Ideally, use bar-code scanning to identify the correct drawer and pocket/container and to scan the drug being delivered to promote accurate placement in the designated ADC location. ...
- Process/restock one individual medication and strength at a time...
-Take steps to differentiate look- and sound -alike medications within the ADC. ... Other options may be to separate these medications or make the bins more distinctive..."

3. On 2/24/16, at approximately 1 p.m., during an inspection of the Radiology Department, the emergency crash carts were inspected. In one of the medication drawers, there was an IV bag with the manufacturer label identifying the contents as dobutamine. However, this bag also had a bright orange sticker attached to it with lidocaine printed on the top of the label. The label, which was about 4 x 5 inches, had a table format listing the doses and the matching rates of infusion for lidocaine. The Radiology Department Manager (RM) confirmed the observation.

In August of 2015, the facility had an incident related to mislabeling of high alert medications which resulted in administering the wrong medication (norepinephrine) instead of oxytocin to Patient 1, who was in active labor. High alert medications are defined by ISMP as "drugs that bear a heightened risk of causing significant patient harm when they are used in error. Although mistakes may or may not be more common with these drugs, the consequences of an error are clearly more devastating to patients."

In the August 2015 incident that involved a patient receiving the wrong IV medication, it was determined that the pharmacy and nursing staff identified the medication by depending on the bright color auxiliary sticker rather than the manufacturer original identification label. That resulted in administration of norepinephrine rather than the ordered oxytocin.

On 2/24/16, an incident similar to the August 2015 incident involving a mislabeled IV bag occurred. In the 2/24/16 incident, a high alert/high risk medication (dobutamine) was labeled with a bright orange sticker. The sticker had the infusion rate for lidocaine, a high risk medication. Dobutamine and lidocaine are both high risk medications and are frequently used in life saving measures. Both medications were in the emergency supplies in Radiology and they would be used in highly stressful situations that would likely delay or prevent medication error recognition.

In August 2015, the facility had a system failure that included pharmacy and nursing. The failure lead to Patient 1 receiving the wrong medication and suffering harm. Six months after this incident, the same system that permitted the wrong medication to be given, still existed. A situation of immediate jeopardy was discussed and declared on 2/24/16 at 4:20 p.m. because of the following: 1) the mislabeling of high risk medications continued to exist even after the August 2015 incident, 2) the facility was aware of the situation and chose not to or were unable to correct the problem, and 3) the potential for a patient to receive an incorrectly labeled medication, which could lead to serious complications and death, was present.

On 2/24/16 at 4:25 p.m., the hospital administration was informed of the immediate jeopardy situation and that an immediate action plan, to ensure patient safety, was required.

4. On 11/2/15 at 11:15 a.m., during an interview, Pharm 1 stated that one of the technicians (Tech 14), who had refilled the medications into the Omnicell on the day of the oxytocin incident, was in training and had not completed the pharmacy orientation or training requirements prior to assuming an independent assignment.

On 11/12 /15 at approximately 10 a.m., during an interview, Tech 13 stated that Tech 14, who filled the oxytocin on the day of the incident was newly hired and had not completed the new hire orientation. Tech 13 was working on her own and training Tech 14, even though Tech 13 had only worked for three nights with another technician for her training. Tech 13 stated she accompanied Tech 14 to the obstetrical service the morning of 8/18/15 and stocked the Omnicell with the medications from the Pharmacy. Tech 13 stated the IV medications were all in one bag and neither she nor Tech 14 verified the identity of each individual bag of intravenous medication. Tech 13 stated that prior to this incident, two pharmacy technicians delivered medications to the ADCs and a second verification was not performed for any of the medications, including those designated as high risk.

On 11/2/15, at approximately 11 a.m., during a concurrent interview with FBD and Pharm 1, they confirmed that there was no policy addressing training requirements or verifying the accuracy of a trainee's work.

A review of the "Department Specific Orientation Checklist Pharmacy Department" for Tech 13 and 14 revealed that the checklists for both technicians were not completed. The checklist was a 5 page document containing specific areas and tasks for training and columns for instructions given and competency demonstrated.

The checklist for Tech 13, who was hired in May 2015, was not completed and did not have the preceptor's name. The checklist had instructions and competency demonstrations completed mainly on one day, 5/27/15; there were a few items (about 10 out of approximately 80) signed off on 5/21/15. Some sections of the form were left completely blank.

Similarly, the checklist for Tech 14, who was hired on 8/3/15, had instructions and competency demonstrations mainly completed on one day, 8/10/15 as very few items were completed on 8/6/15. Some sections of the form were left completely blank.

The checklist included different sections such as specific life safety training, hazardous material, emergency preparedness, department standards, pharmacy process and procedures, and personnel procedures. These sections included specific elements and competency tests as the evaluation mechanism for competency. One of the sub-elements instructed the employee to read "all the policies in the IV (intravenous) binder titled, "Compounding Sterile Preparation related P&P." All the above items had initials and 8/10/15 date, which indicated that they were completed on that day for Technician 14. Evaluating the list of items that needed to be completed, which included written instructions and required completing competency demonstration by observation or by testing, it was impossible for such a list of items to be completed in one day.

On 11/12/15 at 2:10 p.m., Pharm 2 and Pharm 3, stated during interview that the period of orientation for a Pharmacy Technician should be "two weeks." Pharm 2 and Pharm 3 acknowledged the orientation checklist should be completed before a Pharmacy Technician can work independently.

On 11/12/15 at 10 a.m., Tech 13 explained that a volunteer was helping the technician handling medications. According to Tech 13, the volunteer had applied the hot pink alert sticker, labeled oxytocin, to the IV bags.

In an interview on 11/12/15 at 10:30 a.m., Pharm 2 and Pharm 3 acknowledged a volunteer had been working in the Pharmacy. Pharm 2 and 3 revealed there was no job or role description for a volunteer in the Pharmacy and that the volunteer in question had not had orientation, training or evaluation of the work performed. Pharm 2 and 3 stated they were not aware the volunteer had been working directly with pharmacy medications or stock. Pharm 2 and 3 acknowledged a volunteer should not have been allowed to handle or restock medications. Pharm 2 stated the volunteer had been relieved of duties in the pharmacy immediately after the incident.

4.a. On 2/26/16 at 11 a.m., during a meeting with members of the Quality Assurance and Process Improvement Committee, Pharm 2 stated that they had changed the checklist for training and specified that a pharmacist will train new technicians. When asked about the changes, they presented a facility policy titled, "Staff Competency" with a revised date of 10/22/15. A review of the policy showed, in general terms, that the pharmacist or technician will complete a new employee department orientation within 90 days. The policy did not have any specific elements to be completed before the training is considered completed or the technicians is considered competent. For example, the policy did not have any specific items regarding the content or the duration of a technician's training. There were no details about the preceptorship or the criteria for training documentation or staff proficiencies. The policy did not include any language requiring completion of new hire orientation prior to allowing a technician to work independently.

5. On 2/22/16 at 9:40 a.m., during an inspection of the pharmacy, the medication refrigerators and freezers were observed with Pharm 3. When asked about the system the facility used to monitor the temperature, Pharm 3 stated that engineering monitors all refrigerators in the facility remotely.

On 2/22/16 at 3:15 p.m., the engineering area, where the facility's refrigerators are monitored, was visited. The system the facility was using to monitor temperatures was Temp Trak. The person monitoring the refrigerators, Temp Trak Monitor 1 (TTM1), confirmed all refrigerator temperatures are monitored 24 hours a day.

A print out for the pharmacy refrigerator, from 2/8/16 through 2/22/16, showed that the minimum range for the temperature of the pharmacy medication refrigerator was 34 degrees Fahrenheit (F) and the maximum range was 45 degrees F. TTM1 confirmed these limits and stated it was not his department that sets the limits for refrigerators. TTM1 explained that the temperature limits are determined by the requesting department (pharmacy, dietary... etc.).

Refrigerated medications shall be kept between 36 to 46 degrees Fahrenheit, as outlined by California Code of Regulation, Title 22, chapter 5, section 70263 (q)(6).

On 2/25/16 at 11:45 a.m., a follow up visit to the refrigerator monitoring area was made to check the temperature range for the medication refrigerator on the third floor. Two staff were present, TTM 2, and TTM 3. TTM 3 provided a printout displaying the temperature range for that refrigerator; the temperature was between 36-46 degrees F. Even though the temperature was within the limits mandated by the California Code of Regulation, Title 22, chapter 5, section 70263 (q)(6)6-46 F), the minimum range had not been changed; it was still set at 34 degrees F, which is below the acceptable range.

The policy for addressing refrigerated medication storage was requested, and a Temp Trak Refrigerator, Freezer, and Fluid Warmers Monitoring - Facility Service ENG. 7015, was presented. Review of the policy showed that it was approved on 12/4/14. The policy listed eight items requiring manual monitoring in case of Temp Trak downtime. These included:
a. Medication Refrigerators
b. Food Refrigerators
c. Organ Refrigerators
d. Blanket Warmers
e. Negative Pressure Rooms
f. Reagent Storage
g. Product Incubators
h. Temperature and Humidity of identified spaces.

However, there was no evidence of any specific temperatures or temperature ranges for medication refrigerators, medication freezers, or medication rooms. On the afternoon of 2/25/16, during an interview, Pharm 3 confirmed there was no pharmacy policy related to the monitoring of refrigerated medications.

6. On 02/22/16 at 3:40 p.m., during an evaluation of the process for handling recalled medications, Tech 12 said that the Director of Plant Safety (DOPS) was responsible for device recalls. Recalls are defined by the Food and Drug Administration (FDA) as "actions taken by a firm to remove a product from the market. Recalls may be conducted on a firm's own initiative, by FDA request, or by FDA order under statutory authority."

Two recalls were evaluated with DOPS and none of them had evidence of appropriate or timely follow up. The first recall was for JADAK barcode scanners, dated 1/20/16. Looking into the actions taken for this recall showed, "No Action-Not Viewed" entered on 1/21/16 at 7:02 p.m. That comment was entered by three different staff that the recall was assigned to, (two staff from Surgical Services and one from Biomedical Engineering). There was an additional entry, 02/16/16 at 9:53 a.m., indicating that action was reassigned. Further evaluations of the reassigned entry showed that on the same day, 02/16/16 at 9:53 a.m., the recall was reassigned to someone else.

There was no evidence that this recall was evaluated until 02/22/16 at 6:55 p.m., when the DOPS viewed the recall during the survey after having been asked about the process. On 2/23/16, at 12:48 p.m., there was a note indicating that this recall would be addressed by the Clinical Engineering Department and "Will be schedule with our March PMs (preventative maintenance)."

Similarly, the second recall was for Aortic Balloon Catheter dated 02/15/16. This device is a long, thin tube with a balloon on the end of it; it is inserted into the aorta, the body's largest blood vessel that takes blood to the rest of the body, to dilate (enlarge) the artery and makes blood movement better. The actions taken on this recall were as followed: 10 were "No Action-Not Viewed." The "No Action-Not Viewed" actions were from staff assigned this recall in surgical services, quality management, ICU, and imaging services. There were five not applicable responses without additional documentation explaining why it was not applicable to the facility. There was one entry that indicated the recall was viewed on 02/22/16 at 6:42 p.m., when the DOPS viewed the recall during the survey.

On 2/25/16 a third recall was evaluated. The recall was for Alaris Large Volume Pump, used for infusion of IV medications. The device was recalled because of potential over or under infusion of fluids to the patient. This was a Class I recall. Recalls are classified as I, II or III. Class I is defined by the FDA as "a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death." The recall dated, 6/3/15, was received by the facility on 6/11/15. Review of the actions taken for this recall showed documentation that "Not Applicable" was checked seven times on the facility's computerized program for recalls on 6/12/15, 6/16/15 and 7/31/15. The "Not Applicable" responses came from staff in surgical services, pharmacy, ICU, and nursing areas without any explanation for the reason it was not applicable to this facility.

The policy for Environment of Care Programs and Plans, approved, 01/08/2015, was obtained and reviewed. Page 9 of the policy indicated: "Individuals from designated department resolve the alerts." Page 28 of the policy, under the heading "Medical Equipment Management Plan," indicated the facility would "Identify and respond appropriately to equipment hazard and recall notices in a timely manner."

There was no documented evidence that the policy for recall devices was implemented.

7. On 2/22/16 at approximately 10 a.m., during a tour of the pharmacy, Tech 16 was interviewed about repackaging medications. When asked, Tech 16 confirmed that hazardous medications are repackaged in the pharmacy. According to the American Society of Healthsystem Pharmacist (ASHP) Guidelines for Handling Hazardous Drugs, 2006, "The federal hazard communication standard (HCS) defines a hazardous chemical as any chemical that is a physical or health hazard. A health hazard is defined as a chemical for which there is statistically significant evidence, based on at least one study conducted in accordance with established scientific principles, that acute or chronic health effects may occur in exposed employees." Tech 16 explained that he wears gloves when he repackages any of these oral agents; he clarified that they are not packaged in any of the machines, but they are done manually (by hand). The medications are repackaged on the counter top in a room where the two repackaging machines are placed. The room has other supplies and two pharmacy computers that are used by other techs and pharmacist on a regular basis.

On 2/22/16 at approximately 4 p.m., it was confirmed that at least three different hazardous drugs were repackaged. Letozol (a medication for breast cancer), biacaluamind (medication for prostate cancer), and mercaptopurine (medication for leukemia, which is a cancer of the body's blood-forming tissues) were presented as examples of medications repackaged. All of these medications are classified as antineoplastic (anticancer) agents that are listed on the 2014, National Institute for Occupational Safety and Health (NIOSH) List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings. Many of the side effects associated with antineoplastic agents occur because treatment destroys the body's normal cells in addition to cancerous cells. These agents also affect rapidly dividing normal cells and are likely to suppress the bone marrow, suppress growth, impair healing, cause sterility, cause hair loss, and other side effects.

Drugs in Table 1 on the NIOSH list, "meet one or more of the NIOSH criteria for a hazardous drug. These drugs represent an occupational hazard to health care workers and should always be handled with use of recommended engineering controls and personal protective equipment (PPE), regardless of their formulation (IV [intravenous], SC [subcutaneous], topical, tablet, or capsule)."

According to ASHP "Hazardous drugs should be compounded in a controlled area where access is limited to authorized personnel trained in handling requirements. Due to the hazardous nature of these preparations, a contained environment where air pressure is negative to the surrounding areas or that is protected by an airlock or anteroom is preferred."

ASHP guidelines addressed: "Preparation and handling of noninjectable hazardous drug dosage forms. Although noninjectable dosage forms of hazardous drugs contain varying proportions of drug to non-drug (non-hazardous) components, there is the potential for personnel exposure to and environmental contamination with the hazardous components if hazardous drugs are handled (e.g., packaged) by pharmacy staff...Tablet trituration (crushing and mixing with other powder) has been shown to cause fine dust formation and local environmental contamination. Procedures for the preparation and the use of equipment (e.g., Class I BSCs (biological safety cabinet) or bench-top hoods with HEPA filters) must be developed to avoid the release of aerosolized powder or liquid into the environment during manipulation of hazardous drugs."

The policy for Cytotoxic (toxic to cells) Drugs and Mutagenic (chemical agent that changes the genetic material, usually DNA, of an organism and increases the frequency of mutations) Biological Agents, approved 2/26/2015, was reviewed. The policy included specific details on preparation of injectable cytotoxic preparations. The policy specified the following: "Work with Hazardous drugs must be carried out in the vertical hood (or glove box) on a disposable, plastic-backed paper liner, which should be changed after each preparation is complete. When the vertical hood (or glove box) is not functional, all the procedures described should still be followed."

The facility's policy did not include any directions or specific information for preparation of hazardous drugs in an open area in the pharmacy.

Based on observation, staff interview, document review and facility Policy and Procedure review, the facility failed to ensure that:

1. Intravenous (IV) solutions used to mix antibiotics had not expired after removal from the protective outer wrap;
2. Medication had not been mislabeled by pharmacy;
3. Several expired IV solutions were found in the Endoscopy Department (Endo); and when
4. Expired or mislabeled medications were not removed from an emergency cart of rescue medications in the Radiology Department (RD) and available for Patient use.
Expired medications were found in emergency medication carts and in different nursing units.

These failures had the potential for Patients to receive expired or wrong medications and be at risk for treatment failure.

Findings:

1. During pharmacy inspection with the facility Pharmacist 3 (Pharm 3), on 2/22/16 at approximately 10 a.m., it was observed that IV solutions used to mix antibiotics were removed from the protective outer wrap. Once removed from the protective outer wrap, the IV solutions are considered stored under modified storage conditions and are usable for a shorter period of time than the manufacturer's given expiration date.
According to the manufacturer's directions for use, the outer wrap of the IV solution container should not be removed until the product is needed for use as the outer wrap protects the container from damage and prevents evaporation of the contents. Pharm 3 stated that the duration of use for the unwrapped bags was 30 days.
The facility had IV solutions made by Baxter. The manufacture specified that small IVs (50 and 100 milliliter (ml) bags) are usable for 15 days after removal from the protective outer wrap, and larger IV bags (between 100 ml and 1000 ml) are usable for 30 days after removal from the protective outer wrap.
The facility did not have a system in place to ensure that these IV solution bags were not used beyond that time frame recommended by the manufacturer. On 2/26/16, at approximately 10 a.m., The Chief Nurse Executive (CNE) stated the facility did not have a policy addressing this issue;
2. During a concurrent interview and observation with the Radiology Manager (RM) in the RD on 2/24/16 at 1:30 p.m., of the emergency drug cart, Dobutamine (medication used to strengthen heart contractions) had been mislabeled as Lidocaine (medication to decrease irritability of the heart muscle) by placement of a bright orange sticker on the Dobutamine manufacturer's package by pharmacy. RM confirmed Dobutamine had been mislabeled as Lidocaine;
2a. During an observation on 2/25/16 at 10 a.m., in the RD, the following IV fluid had expired: 100 ml Dextrose injectable had expired 1/16;
3. During an observation on 2/24/16 at 10:30 a.m. in the Endoscopy Department, the following IV fluids had expired 11/15: Two (2) 100 ml Dextrose and Saline; One (1) 1000 ml Dextrose and Saline; One (1) 500 ml Dextrose. A five (5) ml vial of saline had expired 11/14; and
4. During an observation in the Intensive Care Unit (ICU) on 2/22/16, at 11:30 a.m., the following medication had expired:
4a. A five (5) ml tube which contained 100 mg lidocaine jelly expired 9/13; and
4b. Humalog insulin in a patient's current medication cassette had expired 2/21/16.
In an interview with the Pharmacy Director (PD) on 2/22/16, at 11:35 a.m., the PD acknowledged the lidocaine jelly and insulin had in fact expired and was available for patient use in the ICU.

Review of facility Policy and Procedure titled, "Medication Control and Storage Inspection", dated 1/2015, indicated the following:
A. "Procedure;...C. ...6. Outdated floor stock and IV's are to be returned to pharmacy for crediting or for destruction";
B. "C. ...10. Medications that are easy to confuse drugs (i.e. Sound-alike Look-alike drugs), or reagents are segregated whenever possible and warning labels affixed to them."

Based on interview and document review the facility failed to ensure that the duration for use of medications was not limited in accordance with the manufacturer's specification. The facility policy for automatic stop orders did not reflect the manufacturers guidelines for use of ketorolac, an anti-inflammatory medication, to limit its use to five days.
This failure put patients at risk of receiving medications inconsistent with manufacturer's specification and putting patients at risk of bleeding associated with prolonged use of ketorolac.

Findings:

On 2/22/16 at approximately 10 a.m., the policy for stop order was requested. Review of the facility's policy Automatic Stop Orders showed the following, " Injectable ketorolac has an automatic stop date of five days." A concurrent review of the package insert for ketorolac with Pharmacist 1 (Pharm 1), under indication and usage, showed the following:

"Combined use of ketorolac...injection and tablets is not to exceed 5 days of use because of the potential of increasing the frequency and the severity of adverse reactions..."

Ketorolac has a boxed warning, which is the most serious warning required by the Food and Drug Administration, to be placed in the product labeling for a medication. Boxed warnings document potential problems that can lead to serious injury or death. The boxed warning for ketorolac limits its use to five days because prolonged use or increased dosage will result in increasing the risks of developing severe adverse events summarized as follows: Bleeding, Cardiovascular thrombotic events, including MI (myocardial infarction - heart attack) and stroke (bleeding into the heart and brain tissue), and gastrointestinal (digestive system) irritation, inflammation, ulceration, bleeding, and perforation.

Based on staff interview and review of medical record, policies and related documents, the facility failed to ensure that adverse drug reactions were reported immediately as appropriate through their reporting system for one out of three patients (Patient 21). Patient 21 was given morphine (a strong pain medication) and developed breathing problems and became unresponsive; the facility had to insert a tube into his airway to facilitate breathing. Respiratory depression and sedation are the most common side effects associated with morphine and morphine like products. There was no documented evidence that the adverse drug reaction, possibly related to morphine use, was reported.

This failure prevents the hospital from tracking and analyzing adverse drug reactions, evaluating the adverse reactions for being potentially caused by medication errors, and taking action to prevent future recurrences. Such failure put patients at risk for harm related to medication treatments and associated side effects.

Findings:

On 2/24/16 at approximately 11 a.m., the medical record for Patient 21 was concurrently reviewed with facility registered nurse 4 (RN 4). Review of the record showed that Patient 21, an 80 year old, was brought to the emergency department (ED) on 2/22/16 after a fall at home. Patient 21 had a history of high blood pressure and diabetes. According to the ED notes, dated 2/22/16, Patient 21 was not complaining of pain.


At approximately 10 a.m., Patient 21 was ordered morphine, a strong pain medication. According to the history and physical and medication reconciliation, Patient 21 was not receiving any opiate type medications (similar to morphine) for pain at home before coming to the ED. The order was for morphine to be given by intravenous injections (IV push). The dose was 2-6 milligrams (mg - a measure of weight) with specific instructions for the first dose given to be 2 milligrams. Every 15 minutes thereafter, morphine could be given as needed up to the dose prescribed from using the numeric pain scale. The order further clarified that for a pain scale of 1-3, the dose was 2 mg; for a pain scale of 4-6, the dose is 4 mg, and for a pain scale of 7-10, the dose is 6 mg. The pain scale used in the facility was a 0-10 pain scale, with 0 being no pain and 10 being the worst possible pain.

Morphine (an opiate) is a strong pain medication that has a boxed warning, which is the most serious warning required by the Food and Drug Administration to be placed in the product labeling for a medication. Boxed warnings document potential problems that can lead to serious injury or death. One of the concerns listed in the boxed warning was respiratory depression (serious, life threatening, or fatal respiratory (breathing) depression may occur); morphine is strongly associated with sedation and respiratory depression as side effects. According to drug information (Lexi.com) "All morphine sulfate formulations are capable of causing respiratory depression; risk increased in elderly patients, debilitated patients,...Monitor for respiratory depression especially during initiation and titration (adjustment of the dose)." In addition, there are geriatric (older patient) considerations when prescribing and administering morphine. "The elderly may be particularly susceptible to the central nervous system (CNS) depressant ... effects of opioids (such as sedation, confusion, and a decrease level of consciousness, and coma)."

According to the medication administration record, Patient 21 was administered 4 milligrams of morphine for a pain intensity of 5, on 2/22/16 at 10:01. There was no documented evidence that the first dose was given in increments of 2 mg every 15 minutes.

Concurrent review of the medical record with RN 4 showed that on 2/22/16 at 11:09 a.m., an order to give Patient 21 a STAT (immediately) 1 mg of Narcan, for opiate reversal, was administered on 2/22/16 at 11:16. Narcan, also known as naloxone, is used to reverse the effect related to excessive use of opiates/opioid medications such as morphine. Hence, naloxone and similar medications are termed antidotes, reversal or rescue agents.

Continued review of the record with RN 4 showed documentation in nurses notes that Narcan was unsuccessful in waking the patient up; Patient 21 was intubated at 11:12 a.m. and later admitted to the Intensive Care Unit. The ED Physician Notes, dated 2/22/16 at 11:10 a.m. included: "Patient was given morphine at 1000. He later became unresponsive and stopped breathing and needed to be intubated." Additional physician notes, dated 2/22/16 at 1:11 p.m., included that Patient 21 had acute respiratory failure with suspected decrease in respiratory rate exacerbated by "moderately large dose iv morphine."

On 2/26/16 at approximately 12 noon, the Quality Senior Director(QD) confirmed that this incident was not reported through the facility's adverse drug reaction (ADR) system.

The Facility's policy, Adverse Drug Reaction Monitoring and Reporting, approved 6/26/14, was reviewed. It defined ADR as: "Any Adverse reaction or event to medication that requires intervention and /or monitoring..." It was clarified that adverse drug events will be identified by drugs that could be used to treat ADR's. The policy also indicated that all ADRs with severity of three or more will be reported to Risk Management. A level 3 severity is defined in the policy as follows: "Medication held, discontinued, or changed, and/or antidote or additional treatment needed, and/or resulted in admission to the hospital."

Patient 21 was administered morphine, developed respiratory depression, and became unconscious. Narcan (an antidote) was ordered and administered; the patient was then intubated (additional treatment needed) and later admitted to an intensive care setting; however, there was no evidence that the incident (potentially related to a high morphine dose) was reported as an ADR as of 2/26/16 at approximately 1 p.m.

Based on observations, staff interviews, medical record reviews, and facility policy and procedure (P&P) reviews, the General Acute Care Hospital failed to maintain high standards of medical practice when:
1. Operating Room (OR) standards for surgical attire were not adhered to when:
1a. An Anesthesiologist 1 (A1) and a Surgical Tech (ST) did not wear surgical attire that covered their arms in the restricted area of the OR suite, and:
1b. A Post Anesthesia Care Unit Registered Nurse 1 (PACU RN 1) was wearing artificial nails while caring for patients after surgery.
2. Appropriate cleaning and disinfecting of the OR suite between surgical cases was not completed according to facility infection control standards and manufacturer's guidelines, and;
3. Facility staff in the Family Birth Center (FBC), Outpatient Surgery Center (OPSC), and Emergency Department (ED) could not demonstrate sufficient staff proficiency to initiate the time-critical management of a patient with Malignant Hyperthermia (MH, a rare inherited genetic disorder of the skeletal muscles triggered in susceptible individuals in most instances by inhalation anesthetic agents and/or succinycholine, resulting in hypermetabolism, skeletal muscle damage, hyperthermia and death, if untreated) or timely access to supplies.

These failures had the potential for an increased risk of infection and the inability of staff to locate life-saving supplies in the event of a Malignant Hyperthermia crisis.

Findings:

1a. During an observation on 2/23/16 at 7:40 a.m., Tracer Patient Number 26 was transferred to an OR table by four (4) staff members. Two (2) of the staff members, a Surgical Tech (ST) and Anesthesiologist 1 (A1), were observed with bare arms.

In an interview with the Interim Surgery Director (SD) on 2/23/16, at 6 a.m., the SD stated the hospital followed the Association of Peri-Operative Registered Nurses (AORN) standards for perioperative standards and acknowledged A1 and ST were not dressed in the appropriate surgical attire.

The 2015 Edition of AORN perioperative standards for surgical attire indicated:
A. "Purpose:...Reducing the patient's exposure to microorganisms that are shed from the skin and hair of perioperative personnel may reduce the patient's risk for surgical site infection (SSI). Patient safety is the primary consideration for perioperative personnel..."; and
B. "Arms are covered with a long-sleeved jacket, the jacket is snapped closed and closely fitted to the body in the restricted area".

1b. During a concurrent observation and interview on 2/23/16, at 9:20 a.m., PACU RN 1 was observed wearing artificial fingernails while providing nursing care to a post operative surgical patient. PACU RN 1 stated she had been wearing artificial nails in the PACU for 5 years, and was allowed to wear artificial nails in the PACU.

On 2/23/16 at 10:30 a.m. the Infectious Disease Specialist (MD 1) acknowledged artificial nails were not appropriate for the PACU. In reference to PACU RN 1 and her artificial nails, he stated, "I don't know why this has happened."

In an interview with the Human Resources Manager (HRM) on 2/24/16 at 3 p.m., the HRM stated, "Someone should have closed the loop with [PACU RN 1] back in 2011." HRM further acknowledged PACU RN 1 should not have been working in patient care areas with artificial nails.

The 2015 Edition of AORN perioperative standards regarding artificial nails, indicated the following:
A. "I.a.3. ...The variety and amount of potentially pathogenic bacteria cultured from fingertips of health care personnel wearing artificial nails was greater than for those with natural nails, both before and after handwashing..."

Review of facility policy and procedure titled, "Perioperative Dress Code" dated 5/28/15, indicated the following:
A. "Policy:...8. Fingernails need to be kept short, clean, natural, and healthy. a. Artificial nails are not permissible."



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2. On 2/23/16 at 8:30 a.m. in the Surgery Department (Main OR), an observation was made of Room "OR 2" being cleaned between surgery cases (after Patient 19's laparoscopic gall bladder removal). One of the Environmental Services employees (EVS 1), was observed mopping the floor. The room was noted to smell of bleach. In a concurrent interview, EVS 1 did not know the concentration of the cleaning solution he was using to mop the floor. EVS 1 stated that the cleaning solution was prepared before he started his shift at 9 a.m. EVS 1 explained the solution used on the floors was also used to clean all of the surfaces and equipment in the OR (separate buckets but the same solution).

In a concurrent observation and interview with EVS 2 (not wearing shoe covers in OR 2) on 2/23/16 at 8:50 a.m., she stated she made the bleach solution used in OR 2. EVS 2 did not know the concentration of the bleach solution nor the required concentration for cleaning the operating room. When asked to see where the bleach solution was prepared, EVS 2 escorted the representatives of the Department to an EVS closet in the Main OR. On the far wall of the closet were two disinfectant cleaning solution dispensers. The dispenser on the left was labeled "Oxyvir",which is a type of disinfectant. The dispenser on the right contained bleach, EVS 2 explained, but was not in service at this time. EVS 2 explained the dispensers delivered the correct amount and concentration of disinfectant solution, so there was no need to dilute either solution with water. Since the bleach dispenser was out of service, EVS 2 was asked what alternative bleach solution was used and how did she ensure it was the correct concentration before use. EVS 2 pointed out the "stock" gallon bleach bottles in a container on the floor of the closet, and stated she used an indicator strip to measure the bleach concentration after dilution with water. When asked to see the strips, EVS 2 could not find them, and admitted she did not use an indicator strip this morning in the preparation of the bleach solution. EVS 2 acknowledged that documentation of past test strip results existed, but could not locate this either. EVS 2 explained she determined the bleach solution was at the correct concentration based on its clarity and smell. EVS 2 admitted she "feels bleach works better than Oxyvir".

The EVS Manager (EVSM) was interviewed on 2/25/16 at 10 a.m. EVSM stated that Oxyvir should be used to clean the operating rooms. He stated bleach was used if a patient had known Clostridium difficile (C. diff; a type of bacteria). EVSM stated that both dispensers were relatively new and had been in working order. He confirmed that a color-coded indicator was used to ensure the required bleach concentration, but no documentation existed.

During an interview with the Quality Senior Director (QD) on 2/26/16 at 8:50 a.m., she stated there was no reason to use bleach in OR 2 after Patient 19's surgery on 2/23/16 at 7:30 a.m. The QD stated Patient 19 was not known to have C. diff.

The facility's copy of the Product Specification Sheet for 1 gallon bottles of "Activate 5.25% Institutional Bleach Hospital Disinfectant" (the product used in OR 2) was reviewed. Under the section "Directions for Use", the document read: "It is a violation of Federal law to use this product inconsistent with its labeling...Use 1 part Activate 5.25% Institutional Bleach to 9 parts water to achieve a 1:10 dilution (~5000 parts per million available chorine). This can be prepared by diluting 14 oz (1 3/4 cup) Activate 5.25% Institutional Bleach per gallon of water...This product degrades with age; test active level of diluted product periodically with high level chlorine test strips."

According to a 2013 facility policy and procedure titled "EVS: Cleaning the Surgical Suite/Perioperative Setting", in the preparation of a disinfectant, ''follow the manufacture's instruction to ensure: amount, dilution, contact time, personal protective equipment, safe use and disposal..." For C. diff, "thoroughly clean and disinfect all surfaces with 1:10 dilution 0.5% sodium hypochlorite (bleach)..."

The Infection Control Manager (ICM) was interviewed on 2/25/16 at 2:30 p.m. The ICM stated the EVS staff should know which disinfectant to use and how to prepare it via the dispensers. Her expectation was that all EVS staff were competent to perform their jobs in accordance with departmental in-services and facility standards.

3a. Family Birth Center
During an interview with the Surgery Director (SD) on 2/23/16 at 10:30 a.m., she stated that one of the Certified Nurse Anesthetist (CRNA 1) was concerned chilled 1 liter bags of intravenous normal saline (0.9 % saline solution) were unavailable in the Family Birth Center (FBC), used in the event of a Malignant Hyperthermia (MH) reaction to anesthesia.

In response to this information, CRNA 1 and SD were interviewed in the FBC on 2/23/16 at 10:30 a.m. CRNA 1 explained that a small refrigerator, containing 1 liter bags of intravenous normal saline had been located in the anesthesia supply room between the two surgical suites in the FBC. She said the refrigerator was no longer there and understood cold intravenous saline had been removed from the FBC, including the "Omnicell" (a brand of automated dispensing cabinet). The SD said that cold normal saline for intravenous infusion must "be readily available" in any area anesthetizing gas or medications were used, in the event of a MH reaction.

During a tour of the FBC on 2/23/16 at 11 a.m. with CRNA 1 and the Family Birth Center Manager (FBM), it was noted that the anesthesia supply room did not contain a refrigerator for 1 liter bags of intravenous saline. An observation was made of the Malignant Hyperthermia cart in the hall outside the surgical suite. The current MH check list on the top of the cart did not include a column to document (verify) the presence, quantity or location of chilled normal saline in the department. CRNA 1 was observed attempting to unlock the cart with a key from her key ring labeled for the MH cart. CRNA 1 unable to unlock the cart with the key. "They must have changed out the lock", she said. Additionally, CRNA 1 did not know the four digit code required to open the cart until she was directed by the FBM that the code was posted on the back of the cart.

In a concurrent observation and interview with the FBM on 2/23/16 at 11:20 a.m. in the FBC, she stated at the time, she was not in agreement with removal of the chilled normal saline from the FBC. A request was made to see the Omnicell. A door identified as "Restricted Area" and "2270 Report Room" was opened by the FBM with a key card and she entered the room. The FBM opened a second door with her key card and entered a small room with an Omnicell. When asked who had access to these rooms, the FBM stated the nurses, pharmacy and the CRNAs. A password was required to access the saline from the Omnicell. Upon opening the refrigerator to the Omnicell, 3 separate 1 liter bags of intravenous normal saline were observed. The FBM acknowledged she was not aware the normal saline was in the Omnicell.

On 2/24/16 at 9:45 a.m., the Family Birth Center Director (FBD) was interviewed. She acknowledged the refrigerator with the normal saline had been removed from the anesthesia supply room earlier this week. The FBD stated, however, there would be no expectation for the CRNAs or physicians to know about the relocation of the normal saline. The FBD acknowledged anesthesiologists or CRNAs take the lead role during a MH crisis in the surgical suite. She concluded saying there was no expectation the CRNAs or anesthesiologists would know how to access or have the ability to access a MH cart.

3b. Outpatient Surgery Center
Observations were made of the off campus Outpatient Surgery Department on 2/24/16 at 8:15 a.m. with the Interim Outpatient Surgery Director/Nurse Educator (ORED). A MH cart was observed in an alcove outside the surgical suites. The current February MH check list on the top of the cart did not include a column to document (verify) the presence, quantity or location of chilled normal saline in the department. The ORED acknowledged she created a "new" MH cart check list last year to include the cold normal saline. A numbered plastic lock, a measure to secure the cart, was not present/observed. In a concurrent interview, the ORED acknowledged since the cart was "unsealed" without the plastic lock, she could not determine whether the MH cart had been checked by central supply and/or pharmacy and therefore ready for use. Lastly, yellow sticky notes, easily removable, with expiration dates, were attached to each drawer of the cart.

The Quality Senior Director (QD) was interviewed on 2/26/18 at 10:30 a.m. She acknowledged the facility did not have a written policy or procedure for the restocking and redeployment of the MH cart. The QD stated that a plastic lock should be in place on the outside of the MH cart or, alternatively, a log book with documentation to show when anything was added, removed or changed by central supply or pharmacy.

On 2/24/16 at 9:17 a.m., the ORED unlocked the door to a medication room with an Omnicell. Using a password, the ORED unlocked the Omnicell refrigerator containing three 1 liter bags of chilled normal saline. When asked who had access to this room, ORED stated the "nurses" and no one else. The representative asked to see where the ice was located. The ORED escorted the representative from the Department to the coffee cart in the foyer of the building. An ice machine (containing ice) was behind the cart. When the contracted coffee vendor (CV) was asked about the ice, she stated she "makes" very little. The ORED was asked if the OPSC had an alternative source of ice. A small ice machine for beverages was observed in the clean utility room.

At 9:23 a.m., when asked how staff in OPSC were alerted to an MH crisis, the ORED stated that because the department was so small staff would yell out into the hall from the ORs. "I don't like to call overhead because its loud," she said. The ORED stated 911 would be dialed as well.

A review of the last OPSC Malignant Hyperthermia Drill Report dated 7/22/15 revealed that several members of the MH team, particularly the ancillary staff, did not respond to the overhead page nor were they present at the patient's bedside. Post drill recommendations included: "1. Go over team roles in MH codes, 2. Staff be aware that cool NS (normal saline) is available in refrigerator in med room and 3. Teach the staff about MH and MH codes.

A review of the individual in-service and competency files for outpatient surgery RNs, two, RN 8 and RN 9 was completed 2/26/16. The 2015 MH in-service(s) specific to OPSC were not found.

In a later interview with ORED on 2/24/16 at 9:30 a.m., she acknowledged the OPSC staff were not provided an in-service about MH since the Department's last visit in October of 2015.

3c. Emergency Department
On 2/25/16 at 12:40 p.m., observations were made of the Emergency Department. In the medication room, RN 3 was asked to remove a 1 liter bag of cold intravenous normal saline from the Omnicell. After entering her password into the key pad display of the Omnicell, RN 3 made numerous selections from the display, a list of medications, in an attempt to find and remove the normal saline. After several tries, RN 3 found it and tapped the display to select a 1 liter bag of intravenous normal saline and unlock the Omnicell refrigerator. RN 3 was unable to unlock the refrigerator because she could not "override" the selection for normal saline. When asked what she needed in order to override the Omnicell, RN 3 stated she would either need a physician's order or call pharmacy.

At 12:50 p.m., RN 3 was asked to show representatives from the Department the location of the Malignant Hyperthermia cart in the ED. RN 3 was observed asking the Emergency Department Clinical Coordinator/Charge Nurse (EDCC) where the MH cart was located. The EDCC directed RN 3 down one of halls in the ED but RN 3 could not locate the cart. After searching a while longer, RN 3 found the MH cart. The February 2016 MH Cart Check List did not include a column to document (verify) the presence, quantity or location of chilled normal saline in the ED department.

A review of the in-service and competency files for ED RNs 3, 10 and 11 was completed concurrently with the ED Educator (EDED) on 2/26/16 at 9:10 a.m.. None of the three files contained documented evidence the RNs were provided MH in-services in 2015. The nurses' level of competence and/or proficiency in the management of a patient with MH was not assessed, as evident by the lack of documentation in their files.

The facility 2012 policy and procedure titled "Malignant Hyperthermia" read: "The key to successful treatment is the timely administration of Dantrolene Sodium." The policy described the importance of staff anticipating the potential need for patient cooling before and during the emergency management of MH. An undated document (reference unknown) titled "Emergency Therapy for Malignant Hyperthermia" was attachment to the MH policy. In the document, the following was noted: during "the acute phase of treatment...infuse cold saline intravenously." A revised "Malignant Hyperthermia Care Check List" was also attached. The checklist was revised to include documented verification of the availability, quantity and location of chilled 1 liter bags of intravenous normal saline in each department.

According to the 2016 Malignant Hyperthermia Association of the United States (MHAUS) website, www.mhaus.org, "Treatment is predicated upon preparation for a rare event. Every anesthetic must be associated with a plan for treatment of unanticipated MH. With the plan in place, treatment can be prompt and lifesaving. Prompt recognition of the signs of MH is essential to an optimal outcome. Preparedness is essential to prevent death from MH. All locations where general anesthesia is administered should contain: A means to continuously monitor end-tidal carbon dioxide levels, blood
oxygen saturation and core body temperature; A means to actively cool a patient; e.g., a hypothermia blanket(s) (over and under the patient) and a refrigerator containing cold isotonic saline for IV infusion and for gastric, peritoneal or rectal irrigation, as appropriate. Ice is much more effective at cooling, though core cooling using iced saline intravenously may be effective (0.5°C. /liter in a 70 kg adult). The volume of IV saline that should be rapidly infused limits maximum effect."

Based on staff interview, medical record and document review, the General Acute Care Hospital (GACH) failed to ensure that six of 32 patients (4, 5, 7, 11, 15, 25) had an appropriate history and physical assessment (H&P) within 30 days before the date of surgery.

This failure had the potential for adverse surgical outcomes due to the failure to identify risk factors prior to surgery.

Findings:

A concurrent interview and document review was conducted with the Vice President of Medical Affairs (VPMA) at 12 p.m. on 2/25/16. Patients 4 and 5's medical records were reviewed.

1. Patient 4 had an outpatient surgery on 2/23/16. On the form titled "History and Physical" dated 2/23/16, in the section of "Preoperative Diagnosis/Present Illness", there was no documentation of the patient's present illness. In the section of Physical Examination, it had "WNL [within normal limits]" beside "Lungs, Cardiac, Abdomen".

2. Patient 5 had an outpatient surgery on 2/24/16 for an "umbilical hernia" (a condition where abdominal contents protrude through the abdominal wall via the skin at the umbilicus). On the form titled "History and Physical" dated 2/24/16, in the section of "Preoperative Diagnosis/Present Illness", there was no documentation of the patient's present illness. In the section of Physical Examination, it had "WNL" besides "Lungs", and no checks beside the items of "cardiac and abdomen".

The VPMA acknowledged there was no evidence of a cardiac or abdominal examination for Patient 5. In addition, the VPMA acknowledged the use of "WNL" and stated a computerized form was used by the physicians to document the systems assessments. During the survey, the corresponding normal physical parameters for "WNL" were not provided by the GACH.

In review of the GACH's "Rules and Regulations" approved 03/14, in the section of "XV. Medical Records", it was noted that for outpatient surgical procedures, the physician had a choice of full or abbreviated H & P's, or an interval H & P if full or abbreviated H&P was performed more than 30 days prior to the procedure. The rules and regulations also stated that for inpatient surgical procedures, a full H&P must be performed within twenty-fours of the procedure, or there must be an interval H&P if a full H&P was performed less than thirty days prior to procedure, and that an abbreviated H&P was not permissible. The rules and regulations also indicated the definition of a "Full H&P" as containing "A chief complaint, details of the present illness, past medical and surgical history (including allergies, medications, and relevant lab/EKG [heart rhythm exam]/CXR[chest x-ray], review of systems ...a physical examination inventoried by body systems to include at a minimum the following: HEENT [head ear eyes nose throat], Cardio-respiratory, Abdomen, Genitourinary ...A statement on the conclusions or impressions drawn from the history and physical examination ..." The Rules and Regulations defined abbreviated H&P as containing the following data: "a chief complaint, details of present illness, review of systems ..., a relevant physical examination of those body systems pertinent to the operative or invasive procedure performed, but including at a minimum an appropriate assessment of the patient's cardio-respiratory status ...a statement on the conclusions or impressions drawn from the history and physical examination ..."

Further medical record reviews demonstrated the following:

3. Patient 7 had an outpatient surgery on 8/26/13 related to bile duct stones. On the form titled "History and Physical" dated 8/26/13, in the section of "Preoperative Diagnosis/Present Illness", there was no documentation of the present illness, except "Hx [history] of stones". In the section of "significant past-medical/family/social history/ros [review of systems]", there was no documentation of past medical history, although the record reflected that Patient 7 had hypertension (high blood pressure) as past medical history. In the section of Physical Examination, it had "WNL" besides "Lungs, Cardiac, Abdomen". The line beside the item "impression" was blank.

4. Patient 11 had an outpatient procedure on 2/24/16 pertaining to an ear infection. On the form titled "History and Physical" dated 2/24/16, in the section of Physical Examination, "WNL" was documented for "Lungs, Cardiac, Abdomen". There was an office note dated 2/2/16 in the record, which was not a full H&P.

5. Patient 15 had an outpatient eye procedure on 2/24/16. On the form titled "History and Physical" dated 2/24/16, in the section of Physical Examination, there was no evidence of physical assessment of the heart and lungs.

6. Patient 25 was admitted on 2/18/16 for an inpatient hip surgery. On the form titled "History and Physical" dated 2/18/16, in the section of "Preoperative Diagnosis/Present Illness", there was no documentation of the patient's present illness. In the section of Physical Examination, it had "WNL" beside "Lungs, Cardiac, Abdomen, Back/Extremities/Neurologic". Beside the item of "impression", there was some illegible writing. The surveyor was informed that the abbreviated H&P was the only H&P in the record.

Review of the GACH's "Rules and Regulations" approved 03/14, in the section of "XV. Medical Records", under "D. Contents", indicated that "it is the responsibility of the Medical Staff to assure that a medical history and appropriate physical examination (H&P) is performed on patients being admitted for inpatient care, as well as prior to operative and complex invasive procedures in either an inpatient, skilled nursing facility or outpatient setting."

Based on staff interview, medical record review and facility Policy and Procedure review, the facility failed to ensure Patient 29 had signed an Informed Consent (IC) form prior to a central venous line (large bore catheter inserted into a large vein) insertion procedure.

This failure may have led to Patient 29 making an uninformed healthcare related decision.

Findings:

Patient 29 was admitted 2/19/16 and required a central venous line. There was no documented evidence an IC form had been signed by Patient 29 prior to the insertion of a central venous line placed in the Intensive Care Unit (ICU).

Review of Patient 29's medical record titled, "Procedure Report", dated 2/19/16 at 8:23 p.m., indicated the following:
1. "Procedure: Central venous line insertion"; and
2. "Consent: Consent was obtained from the patient prior to procedure after risks and benefits were addressed".

Review of facility Policy and Procedure titled, "Informed Consent and Verification of Consent", dated 4/30/15, indicated the following:
1. "Procedure: The following procedures have been identified by the medical staff as "complex" in nature and therefore require a signed consent form: ...Central Lines"; and
2. "Procedure: 1. The hospital shall use the form "Consent to Surgery or Special Procedure" to document that informed consent has been given by the patient, unless a special consent form is required by law".

In an interview with the Quality Senior Director (QD) on 2/25/16, at 11:30 a.m., the QD acknowledged there was no signed IC form for the surgical procedure: central venous line insertion.