The information below comes from the statement of deficiencies compiled by health inspectors and provided to AHCJ by the Centers for Medicare and Medicaid Services. It does not include the steps the hospital plans to take to fix the problem, known as a plan of correction. For that information, you should contact the hospital, your state health department or CMS. Accessing the document may require you to file a Freedom of Information Request. Information on doing so is available here.

CORONA REGIONAL MEDICAL CENTER 800 SOUTH MAIN STREET CORONA, CA 92882 Jan. 30, 2015
VIOLATION: PATIENT CARE ASSIGMENTS Tag No: A0397
Based on interview and record review, the facility failed to ensure a Registered Nurse (RN 8) had completed her unit based clinical competency. This resulted in RN 8 caring for patients in the Intensive Care Unit (ICU) without documented evidence of clinical competency.

Findings:

On January 29, 2015, the employee file for RN 8 was reviewed. RN 8 was hired on September 22, 2014, to the ICU.

RN 8 attended general hospital orientation on September 22, 2014.

On December 2, 2014, RN 8 was counseled for "attendance and time keeping."

There was no indication in RN 8's file that unit based clinical competencies had been completed and verified.

There was no evidence a 90 day performance appraisal had been completed with RN 8.

During an interview with the Chief Nursing Officer (CNO) on January 30, 2015, she reviewed RN 8's employee file and was unable to find documentation of an ICU clinical competency and a 90 day evaluation of RN 8's performance. The CNO stated RN 8's 90 day evaluation, which had been due on December 22, 2014, had not been done. She stated the unit based clinical competency orientation check list was reviewed at the 90 day evaluation and should be completed at this time.

The facility policy and procedure titled "New Hire Orientations" reviewed November 2014, revealed "... The Department Orientation Form is used to record the items covered during the orientation period. The Competency Form is a record of what the employee knows or has demonstrated and what he will need to learn. Both the Department Orientation Form and the Competency Form shall be returned to Human Resources at the end of the employee's initial 90-days of service along with the probationary period evaluation form and will be placed in the employee's personnel file. ..."

The facility policy and procedure titled "Competency Assessment/Certifications (BLS, ACLS, NRP, PALS, etc.)" reviewed November 14, 2014, revealed "... An evaluation of each employee's/volunteer's competence is conducted within the first five days of employment (for core competencies), within 90 days of employment, and annually thereafter. For clinical staff, this evaluation includes an objective assessment of the individual's performance in delivering patient care service in accordance with patients' needs, patient population served, and culture. ..."
VIOLATION: ADMINISTRATION OF DRUGS Tag No: A0405
Based on interview and record review, the facility failed to ensure, when drug diversion was suspected, a follow-up was done to include a complete investigation, an employee corrective action report was given/shared with the employee, substance abuse testing was done as indicated, and the employee was not allowed to return to work for one employee (Registered Nurse [RN] 1). This resulted in RN 1 returning to work, taking care of critically ill patients, and continuing to divert narcotics while working in the Intensive Care Unit (ICU).

Findings:

On January 22, 2015, the employee file for RN 1 was reviewed with the Senior Human Resources Specialist (SHRS). RN 1 was hired on October 4, 2012.

The "Annual Appraisal 2013 - 2014" signed by RN 1 on October 2, 2014, indicated "... had some lapses in focused attention surrounding the administration of medication. He has been counseled and I'm hopeful to see a marked improvement upon his return to work in the next couple of weeks."

There was no indication of counselings given to RN 1.

RN 1 was on a medical leave from February 4, 2014 to June 2, 2014, and from June 7, 2014 to July 21, 2014.

During a concurrent interview with the SHRS, she reviewed RN 1's employee file and was unable to find documentation of employee corrective action reports/counselings.

During an interview with the Interim Director Critical Care (IDCC), on January 22, 2015, at 12:10 p.m., she stated there were "definitely" counselings in RN 1's file because she had reported to the Director Critical Care (DCC) in late 2013 or early 2014, an incident of unusual behavior and three bags of Fentanyl, 1,000 micrograms per 100 milliliters of fluid (powerful synthetic opiate analgesic/narcotic similar to but more potent than morphine, used to treat severe pain), being removed inappropriately from the automated medication dispensing cabinet (Pyxis) by RN 1. In addition, the IDCC stated there was a "unit employee file" and maybe the counselings were in that file.

On January 22, 2015, at 1:30 p.m., RN 1's "unit employee file" was reviewed with the SHRS.

An "Employee Corrective Action Report" signed by RN 1 on February 3, 2014, indicated three Fentanyl bags were removed by RN 1 under one patient's name and RN 1 stated they should have been removed from the automated medication dispensing cabinet for another patient but the order for Fentanyl for this patient had been discontinued and the second patient was no longer receiving Fentanyl. In addition, RN 1 stated the "Fentanyl bags were not scanned upon administration." The statement of what the employee must do to improve indicated "review orders, verify pt (patient) identification and review policy and procedures."

An "Employee Corrective Action Report" unsigned described the incidents of February 3, 2014, the facility's investigation, and the corrective action of "Termination - Would like to offer diversion program, but the acceptance of the offer will not effect the decision to terminate." The "Counseling Event" was "Planned upon arrival of next scheduled shift, before receiving any report or patient assignment." The "Reason" was "(RN 1) has not to date been able to provide an explanation for this behavior and actions. (RN 1) will be notified of the facility's intent to perform a drug screen and placed on administrative leave until the results are confirmed."

There was no indication the "Employee Corrective Action Report" was shared with/given to RN 1.

During a concurrent interview with the SHRS, she stated she was unaware there were any concerns with RN 1 and the diversion of medications.

RN 1 went on medical leave of absence with an effective date of February 4, 2014.

RN 1 returned to work on July 21, 2014, and "Time Card History" indicated RN 1 worked the following days:

- July 21, 22, 24, 29, and 30, 2014;

- August 1, 2, 3, 6, 7, 8, 11, 12, 13, 15, 17, 20, 22, 24, 25, 27, 28, 30, 31, and attended a paid class on August 18, 2014;

- September 1, 3, 6, 7, 11, 13, 14, 16, 18, 21, 23, 25, and 28, 2014;

- October 2, 4, 5, 7, 9, 11, 12, 16, 18, 19, 21, 23, 25, 26, and 30, 2014;

- November 1, 2, 6, 8, 9, 11, 15, 16, 20, 22, and attended a paid class on November 19, 2014; and

- December 4, 5, 6, 7, 11, 12, 13, 14, 18, 20, 25, 26, 27, 28, 30, and attended paid classes on December 3 and 17, 2014.

Eighty one days in 2014.

There was no indication RN 1 was being "watched" for possible narcotic diversion activity.

During an interview with the Chief Nursing Officer (CNO), on January 22, 2015, at 3:30 p.m., she reviewed the records and was unable to find documentation of drug testing being done on RN 1. The CNO stated drug testing should have been done, the counseling should have been shared with RN 1 when he returned to work after his medical leave of absence, and an action plan should have been implemented.

On December 27 and 28, 2014, the facility experienced a sewage backup which required the services of a commercial plumber. The sewage backup occurred in Perinatal Services (first floor) which was directly below the ICU/ICU staff restroom (second floor) and extended down to Surgical Services on the ground floor. A photograph was taken of the items removed which included a syringe, needles, and multiple needle covers.

On January 11, 2015, the facility experienced another sewage backup affecting the same areas. A photograph was taken of the items removed which included a syringe and blue tourniquet.

The "Time Card History" indicated RN 1 worked January 1, 6, 8, 9, 10, 11, and 15, 2015.

During an interview with the IDCC, on January 22, 2015, at 12 p.m., she stated on January 9, 2015, she had received a report from the ICU Charge Nurse that RN 1 had been in the bathroom frequently, had gone over his "breaktime allotment" time, and the family members of his patients were looking for him on several occasions. The IDCC stated she spoke with RN 1 on January 10, 2015, and RN 1 stated he was going through some personal problems. She stated, RN 1 said he was "okay" to work. The IDCC stated she notified the Director Human Resources and the Chief Nursing Officer via the electronic mail system (Saturday, January 10, 2015). The IDCC stated RN 1 worked January 10 and 11, 2015, and no additional concerns were reported to her.

During an interview with Pharmacy Technician (PT) 1, on January 28, 2015, at 1:30 p.m., she stated on December 20, 2014, she saw in the automated medication dispensing cabinet's, withdrawals that RN 1 had removed a Fentanyl, 1,000 micrograms per 100 milliliters intravenous bag shortly after another nurse for the same patient. PT 1 stated she called RN 1 and he stated the withdrawal from the automated medication dispensing cabinet was an error, and PT 1 stated she then told him to return/waste the Fentanyl medication. PT 1 stated on December 21, 2014, she noted that RN 1 had not returned/wasted the Fentanyl intravenous bag. PT 1 stated she left a completed "Pyxis (automated medication dispensing cabinet) Controlled Drug Discrepancy Form" with a note for the Director Pharmacy (DP).

In addition, PT 1 stated on January 16, 2015, while she was reviewing the "Returns & Wastes" and "Charges & Credits" reports for January 15, 2015, she found three discrepancies of Fentanyl, 1,000 micrograms per 100 milliliters intravenous bags being removed from the automated medication dispensing cabinet by RN 1 but never being given to the patient. PT 1 stated on January 17, 2015, she re-reviewed the reports for January 15, 2015, and found two additional discrepancies of Fentanyl, 1,000 micrograms per 100 milliliters intravenous bags being removed from the automated dispensing cabinet by RN 1 but never being given to the patient. PT 1 stated she then did a review of RN 1's removal of Fentanyl, 1,000 micrograms per 100 milliliters intravenous bags from the automated medication dispensing cabinet for January 2015, and found RN 1 had removed 35 bags of Fentanyl 1,000 micrograms per 100 milliliters intravenous which had not been administered/documented as being administered to a patient. PT 1 stated she then electronically sent this information to the DP because "she wanted her to see this on Monday morning (January 19, 2015)."

During an interview with the DP, on January 29, 2015, at 12:10 p.m., she stated the medication discrepancy with RN 1 and the Fentanyl on February 3, 2014, had not been "caught by pharmacy" and a "Pyxis Controlled Drug Discrepancy Form" had not been completed. The DP stated the pharmacy had provided to nursing RN 1's Fentanyl usage for October 2013, through February 3, 2014.

In addition, the DP stated the pharmacy's investigation of RN 1's Fentanyl usage started on January 16, 2015, and covered July 21, 2014, through January 15, 2015. She stated the pharmacy only looked at RN 1's Fentanyl usage, did not investigate the use of any other narcotics, and verified RN 1 removed the Fentanyl from the automated medication dispensing cabinet and did not administer the medication to a patient.

The facility policy and procedure titled "Employee Substance Abuse" reviewed April 2012, revealed "... The facility reserves its right to perform drug testing of employees under the following conditions: ... When medication is missing or there is a medication error. ..."

The facility policy and procedure titled "Corrective Action Plan" reviewed April 2012, revealed "... There shall be documentation of all actions taken with copies provided to the employee if so requested and the original corrective action submitted to HR (Human Resources) for inclusion in the employee's HR file. ..."
VIOLATION: QUALITY ASSESSMENT AND PERFORMANCE IMPROVEMENT Tag No: A0308
Based on interview and record review, the facility failed to ensure a mechanism was in place for the Governing Body to evaluate the quality of each contracted clinical service to ensure it was provided in a safe and effective manner. This failed practice resulted in the potential for missed opportunities to identify problems and improve the care provided to patients through contracted services.

Findings:

On January 27, 2015, the Governing Body (GB) meeting minutes for 2014 were reviewed. There was no indication clinical services provided to patients through a contract (nursing registry, dialysis, wound care) were discussed and evaluated for quality, safety, or effectiveness.

On January 27, 2015, at 3:25 p.m., an interview was conducted with the Chief Operating Officer (COO). He stated the GB was presented with a review/evaluation of physician based facility contracts. The COO stated the GB was not presented with a review/evaluation of other clinical contracts such as the facility's dialysis contract, registry nursing services contract, or the Wound Care Clinic contract. He stated he was in the process of establishing a process to evaluate/review the facility's contracts which would then be presented to the GB in February 2015.

On January 29, 2015, at 2:45 p.m., an interview was conducted with two GB members.

The members stated they were provided with facility policies and procedures to review and approve, they reviewed the medical staff appointments and reappointments, and they reviewed the quality of medical staff contracts such as the anesthesia services contract and the contract for the Emergency Department physicians.

They stated they were not provided with an opportunity or request to review the quality, safety, or effectiveness of other clinical contracts, such as dialysis, nursing registry services, or wound care. The GB stated they had not received a review of the care provided under a facility contract other than the physician services contracts from the facility.
VIOLATION: EXECUTIVE RESPONSIBILITIES Tag No: A0309
Based on interview and record review, the facility failed to ensure an effective, ongoing program for the identification of diversion was defined, implemented and maintained. This failed practice resulted in Registered Nurse (RN) 1 diverting narcotic medications from the facility for approximately two years.

Findings:

A review of the related documents following the facility's reported narcotic drug diversion involving RN 1, an ICU nurse, revealed the following:

The facility provided All Station Events Pyxis (an automated dispensing cabinet for medications) report was reviewed and it indicated that from January 1, 2015, to January 17, 2015, thirty-five 100-ml bags containing fentanyl 1000 mcg were removed from the Pyxis by RN 1 and not charted on the electronic Medication Administration Record (eMAR).

A review of an additional facility provided report indicated from July 24, 2014, to December 30, 2014, the total amount of fentanyl accessed from Pyxis by RN 1 that was not accounted for totaled mcg which included sixty-one bags of 100-ml containing fentanyl 1000 mcg and ten 2-ml vials of injectable fentanyl 100 mcg.

A review of the facility provided report titled, "Users With CS (controlled substance) Doses Dispensed > 2 SD (standard deviations) All Stations" showed that RN 1 appeared in the following months with the corresponding SD values:

January 2014 - 4.7 SD for fentanyl;
February 2014 - 3 SD for fentanyl;
July 2014 - 3.6 SD for fentanyl;
August 2014 - 2.2 SD for fentanyl;
December 2014 - 4.9 SD for fentanyl; and
January 2015 - 4.2 SD for fentanyl.

A review of the facility provided report for RN 1's Pyxis removal of fentanyl that was not accounted for indicated from December 15, 2012, to February 3, 2014, 233.3 infusion bags of fentanyl 1000 mcg per 100 ml were removed but not documented as administered. This was the time period immediately before RN 1 went on a medical leave and after RN 1 was hired to work at the facility.

Additional reports requested by the surveyor for Pyxis access of all CS by RN 1 between the date of hire and the date he went on a medical leave indicated there were numerous absences of documentation of administration for other potent narcotic pain medications such as injectable hydromorphone (brand name: Dilaudid) which had been accessed from the Pyxis.

A review of the facility's policy and procedure titled, "Controlled Drugs" revised on April 2012, indicated,

"A pharmacist will review a Pyxis generated discrepancy report every morning, upon opening, to verify that all discrepancies have been resolved before the night shift ends their shift.

The Director of Pharmacy or designee will prepare a quarterly report of all controlled drug discrepancies.

The controlled drug discrepancy report will be reviewed by the CNO and/or designee, CEO and the Pharmacy and Therapeutics Committee at the end of each quarter.

The Director of Pharmacy will report to the CNO and CEO and Chairman of the Pharmacy and Therapeutics Committee immediately if it is felt that there is a situation involving abuse or diversion.

Pharmacy will run a Pyxis generated report for all controlled drug charges hospital wide on a daily basis ...

A pharmacist technician will also review this report and reconcile it to a Siemens Pharmacy report listing all patients currently on controlled drugs.

The pharmacy technician will look for controlled drugs that were given earlier than the physician order indicated, dose taken is greater than the dose prescribed with no record of waste, and any unusual pattern of controlled drug removal."

During an interview on January 27, 2015, at 11 a.m., Pharmacy Technician (PT) 2 stated that daily monitoring of Pyxis controlled substance use involved comparing the Returns and Waste reports to Charges and Credit reports from the Pyxis and looking for staff frequently documenting waste of CS, frequent access to CS, and early access to CS. These suspicious activities were then compared to the documentation in the eMAR for appropriateness. PT 2 stated that Pyxis access to injectable CS for continuous infusion would be difficult to audit because the rate of infusion could change.

During an interview on January 28, 2015, at 1:30 p.m., PT 1 stated that she did not look for irregularities with the use of CS infusion bags during her daily audit of Pyxis CS use, expressing the need for guidelines for how to look at fentanyl infusion bags. PT1 stated she trained PT 2.

During an interview on January 27, 2015, at 10 a.m., DP stated resources available for CS monitoring from the Pyxis before upgrade from 3500 to 4000 version were not utilized as it was not made known to her and no training was given to her regarding the capabilities of the newer version. DP also indicated the pharmacy process of CS monitoring was not working and the only way to identify drug diversion was by "tip off."

During an interview on January 27, 2015, at 11:30 a.m., Pharm 1 stated she assisted with researching the incident involving RN 1 and generating reports due to "wonky" documentation, at the request of the HR Director at the time and assumed, RN 1 was terminated at that time. Pharm 1 stated that she was not aware RN 1 came back from medical leave and was still working.

During an interview on January 30, 2015, at 9:30 a.m., DP indicated she still needed to review the reports to determine the loss or diversion of other Pyxis narcotic CS that were not documented by RN 1.

During an interview on January 30, 2015, at 8:15 a.m., DP stated the report, "Users With CS Doses Dispensed > 2 SD," was generated monthly and reviewed for ED only until now as it was determined to be the "high risk" area. The DP stated the report was not generated for the ICU.

During an interview on January 27, 2015, at 3:30 p.m., DP stated that she was not actively involved in the investigations and that the communication between the pharmacy and nursing was broken. DP stated that two CNO's ago the drug diversion related reports were taken much more seriously.

During an interview on January 27, 2015, at 10 a.m., DP stated she did not recall if she was informed of the investigation of RN 1 in February 2014, and did not remember the name of RN 1 at the time, and she should have paid more attention to the names. DP also stated that she did not keep track of resolved and unresolved discrepancies in ED.

A review of the discrepancy forms sent to the DED in 2014, revealed nine discrepancies were returned to the Pharmacy with explanations and 64 discrepancies were still waiting to be resolved or returned with explanation.

During an interview on January 29, 2015, at 11:20 a.m., the DED stated discrepancy forms received by email would be given to the staff directly involved for explanation and the staff was relied on to return the forms. The DED indicated he was the director, the manager, and the educator, and the ED was extremely busy. The DED stated no regular staff was disciplined for discrepancies in 2014, and he did not keep track of resolved and unresolved discrepancies.

During an interview on January 29, 2015, at 11 a.m., DP stated she did not keep a watch list of facility staff with access to Pyxis with potential CS drug diversion.

A review of the Pharmacy performance Improvement indicator titled, "Nursing Pyxis Controlled Substances discrepancies" showed 66.2% of discrepancies were not resolved in fourth quarter of 2013, 40% in first, 34.8% in second, and 58.9% in third quarter of 2014, with the fourth quarter figure pending.

During an interview on January 29, 2015, at 11:30 a.m., DP stated that it was frustrating to see discrepancies were not being resolved in a timely manner and she did not know what else to do other than repeatedly request for the form to be returned to the Pharmacy with a resolution.

According to ASHP Guidelines on the Safe Use of Automated Medication Storage and Distribution Devices, a guideline published by American Society of Health-Systems Pharmacists (ASHP), a nationally recognized pharmacy organization;

"The organization should have a written plan for the monitoring and surveillance of medications accessed through automated systems ...the plan should include ...
Assignment of responsibility for resolving discrepancies, scheduling the resolution of discrepancies, following up on unresolved discrepancies, and taking action if the discrepancy is not resolved on schedule, and a description of the process for investigating trends in discrepancies and assigning responsibility for this.

The compliance with the plan should be monitored through the organization's quality assurance program."
VIOLATION: NURSING SERVICES Tag No: A0385
Based on interview and record review, the facility failed to ensure it provided an organized nursing service to all patients by failing to:

1. Ensure, when drug diversion was suspected, follow-up was done to include a complete investigation, an employee corrective action report was given/shared with the employee, substance abuse testing was done as indicated, and the employee was not allowed to return to work for one employee (Registered Nurse [RN] 1). (Refer to A405);

2. Ensure a physician's order for a "septic workup" was completed for one sampled patient (Patient 14). (Refer to A392);

3. Ensure a physician's order for restraints was documented in the record when the restraints were applied for one sampled patient (Patient 10). (Refer to A392);

4. Ensure a Registered Nurse (RN 8) had completed her unit based clinical competency. (Refer to A397);

5. Ensure the triage policy was updated when they changed from a three level acuity system to a five level emergency severity index (ESI) system. (Refer to A1104); and

6. Ensure Emergency Department (ED) nurses followed their written standardized procedures for providing initial emergency care in the absence of a physician for two of two ED patients presenting with chest pain (Patients 34 and 37). (Refer to A1104).

The cumulative effects of these systemic problems resulted in the failure of the nursing department to ensure care was being provided in a safe and effective manner.
VIOLATION: STAFFING AND DELIVERY OF CARE Tag No: A0392
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on interview and record review, the facility failed:

1. To ensure a physician's order for a "septic workup" was completed for one sampled patient (Patient 14). This had the potential to result in the infant developing Group B streptococcus (GBS - bacterial infection that can be passed from a mother to her infant during a vaginal delivery) without the facility being aware.

2. To ensure a physician's order for restraints was documented in the record when the restraints were applied for one sampled patient (Patient 10). This resulted in no documented order in the record for when restraints were applied.

Findings:

1. On January 28, 2015, the record for Patient 13 was reviewed. Patient 13 was Patient 14's mother.

The record indicated Patient 13's Group B Streptococcus (GBS) status was "unknown" and she was not treated with antibiotics prior to delivering Patient 14, vaginally, on January 28, 2015, at 5:14 a.m.

On January 28 and 29, 2015, the record for Patient 14 was reviewed.

The "Orders" dated January 28, 2015, at 6:52 a.m., indicated "Observe for signs of sepsis. ... If mother is GBS positive or unknown and has not received antibiotic treatment greater than 4 hours prior to delivery, order a septic workup. (cbc [complete blood count] with manual diff[erential] and blood culture [blood tests done to check for/monitor an infection]). Unless a c/s (Cesarean Section - abdominal delivery of an infant) not rupture (bag of waters surrounding the infant in the uterus) prior to delivery."

There was no indication a "cbc with manual diff and blood culture" were done on Patient 14.

During an interview with Registered Nurse (RN) 9, on January 29, 2015, at 9 a.m., she reviewed the record and was unable to find documentation of a "cbc with manual diff and blood culture" being done as indicated by the physician's order. RN 9 stated Patient 13's GBS status remained "unknown."

During an interview with the Director Perinatal Services (DPS), on January 29, 2015, at 9:10 a.m., she stated a "septic workup" for Patient 14 should have been done per facility policy and procedure.

The facility policy and procedure titled "Management of Group B Streptococcus (GBS)" reviewed August 2012, revealed "... Upon delivery of the infant whose mother is GBS positive or GBS unknown, the nursing staff will inform the Pediatrician. If intrapartum antimicrobial prophylaxis was not given at least 4 hours prior to delivery of the infant, order a CBC with manual differential and Blood Culture to be drawn and observe for signs of sepsis. ..."

2. On January 28, 2015, the record for Patient 10 was reviewed. Patient 10 was admitted to the facility on on [DATE], with diagnoses including kidney stones with flank pain and sepsis (potentially life-threatening complication of an infection).

The record indicated Patient 10 had "nonviolent bilateral soft wrist restraints" in place on the following days/times:

- January 21, 2015, at 10 p.m. until January 22, 2015, at 6:59 a.m.

- January 22, 2015, at 7 p.m. until January 24, 2015, at 5:59 p.m.

- January 25, 2015, at 7 a.m. until January 28, 2015, at 9 a.m.

There was no indication in the record the "nonviolent bilateral soft wrist restraints" had been terminated on January 22, 2015, at 7 a.m. until January 22, 2015, at 6:59 p.m., and January 24, 2015, at 6 p.m. until January 25, 2015, at 6:59 a.m.

The "Order Sheet(s)" indicated orders for "Restraint Nonviolent" were entered as follows:

- On January 22, 2015, at 8:57 a.m., with an order entry date and time of January 23, 2015, at 11:15 a.m., by a Registered Nurse (RN).

- On January 22, 2015, at 11 p.m., with an order entry date and time of January 23, 2015, at 11:13 p.m., by a RN.

- On January 23, 2015, at 8:27 p.m., with an order entry date and time of January 24, 2015, at 11:32 p.m., by "SYSTEM."

- On January 24, 2015, at 5:53 p.m., with an order entry date and time of January 27, 2015, at 6:44 p.m., by a RN.

- On January 25, 2015, at 5:29 p.m., with an order entry date and time of January 26, 2015, at 6:01 p.m., by a RN.

- On January 26, 2015, at 5:10 p.m., with an order entry date and time of January 27, 2015, at 6:44 p.m., by a RN.

- On January 27,2015, at 6:22 p.m., with an order entry date and time of January 27, 2015, at 6:22 p.m., by a RN.

There was no indication an order for "nonviolent bilateral soft wrist restraints" had been ordered by the physician on January 21, 22 at 7 p.m., or January 23, 2015.

During an interview with the Interim Director Critical Care (IDCC), on January 28, 2015, at 9:15 a.m., she reviewed the record and was unable to find documentation of "restraint nonviolent" orders for Patient 10 on January 21, 22 at 7 p.m., or January 23, 2015. The IDCC stated there must be an order for restraints if restraints were applied.

During a subsequent interview with the IDCC, on January 28, 2015, at 3 p.m., she stated she had contacted the nurses who cared for Patient 10 on January 21, 22 at 7 p.m., and January 23, 2015. The IDCC stated the nurses had obtained orders from the physicians but "had forgotten to write the orders." In addition, the IDCC stated the "nonviolent bilateral soft wrist restraints" were removed for the entire day shift on January 22, 2015, and the nurse should have documented when they were removed and why.

The facility policy and procedure titled "Restraints and Seclusion" revised October 2014, revealed "... The use of restraints must be in accordance with the order of a physician or licensed independent practitioner (LIP) who is responsible for the care of the patient and is authorized to order restraints by hospital policy and medical staff by-laws. ... Non-violent/Non-self-destructive: Each order for restraint use to ensure the physical safety of the non-violent or non-self-destructive patient is renewed each calendar day. ... Documentation of each episode of restraint/seclusion includes: ... Written orders for use - including each order for continuation ... Time of initiation and termination of restraint/seclusion ..."
VIOLATION: GOVERNING BODY Tag No: A0043
Based on observation, interview, and record review, the facility's Governing Body (GB) failed to ensure the hospital's operation was conducted in an effective, safe, and organized manner by:

1. Failing to ensure the hospital had an effective GB legally responsible for the conduct of the hospital as an institution (Refer to A076 and A084).

2. Failing to ensure nursing services and operations were provided in a safe and effective manner that would meet the patients' needs (Refer to A392, A397, and A405).

3. Failing to ensure pharmaceutical services and operations were provided in a safe and effective manner that would meet the patients' needs and detect the possible diversion of medications (Refer to A494 and A500).

4. Failing to ensure the hospital developed, implemented, and maintained an effective, ongoing, hospital wide, data driven quality assessment and performance improvement program (Refer to A273 and A309).

The cumulative effect of these systemic problems resulted in the failure of the Governing Body to ensure patients were receiving quality care in a safe and effective manner.
VIOLATION: INSTITUTIONAL PLAN AND BUDGET Tag No: A0076
Based on interview and record review, the facility failed to ensure the Governing Body (GB) verified the facility's operating budget was reviewed and updated annually. This resulted in the GB not being aware of the facility's annual operating budget for 2014.

Findings:

On January 27, 2015, the GB meeting minutes for 2014 were reviewed.

There was no indication the G reviewed, updated as necessary, and approved the facility's operating budget.

On January 28, 2015, at 3:45 p.m., an interview was conducted with the Chief Operating Officer (COO). He stated he reviewed the GB meeting minutes for 2014 and he could not see where the annual operating budget for 2014 was presented to the GB. The COO stated the facility's operating budget for 2014 should have been presented to the GB in January/February of 2014.

On January 29, 2015, at 2:45 p.m., an interview was conducted with the GB.

They stated they were provided with facility policies and procedures to review and approve, they reviewed the medical staff appointments and reappointments, and they reviewed the quality of medical staff contracts such as the anesthesia services contract and the contract for the Emergency Department physicians. The GB stated they were provided with a facility five year plan in the past and "roughly what it costs to run the facility."

They stated they did not review and update the facility's operating budget annually.
VIOLATION: CONTRACTED SERVICES Tag No: A0084
Based on interview and record review, the facility failed to ensure a mechanism was in place to evaluate the quality of each contracted service, to ensure each contracted service was provided in a safe manner, and this information was presented to the Governing Body. This resulted in the Governing Body being unaware of the quality of care being provided or not provided by some contracted services.

Findings:

On January 27, 2015, the Governing Body (GB) meeting minutes for 2014 were reviewed. There was documentation indicating Anesthesia physician services, Emergency Department physician services, Radiology physician services, Laboratory physician services, and Hospitalist physician services were evaluated by the medical staff and presented to the GB.

There was no indication other clinical services contracted by the facility were evaluated for safety or for quality of care. There was no documentation to indicate this information was presented to the GB.

On January 27, 2015, at 3:25 p.m., an interview was conducted with the Chief Operating Officer (COO). He stated the GB had only been presented with a review/evaluation of physician based facility contracts. The COO stated the GB had not been presented with a review/evaluation of other clinical contracts such as the facility's dialysis contract, registry nursing services contract, or the Wound Care Clinic contract. He stated he was in the process of establishing a process to evaluate/review the facility's contracts which would then be presented to the GB in February 2015.

On January 29, 2015, at 2:45 p.m., an interview was conducted with the GB.

They stated they were provided with facility policies and procedures to review and approve, they reviewed the medical staff appointments and reappointments, and they reviewed the quality of medical staff contracts such as the anesthesia services contract and the contract for the Emergency Department physicians.

They stated they were not provided with a quality of care review of other facility contracts such as the facility's dialysis contract, registry nursing services, and the Wound Care Clinic. The GB stated they had not received a review of the care provided under a facility contract other than the physician services contracts from the facility.
VIOLATION: QAPI Tag No: A0263
Based on interview and record review, the facility failed to:

1. Ensure data was collected, measured, analyzed, and tracked to monitor the effectiveness and safety of services and quality of care provided by nursing staff in the Emergency Department (ED), resulting in missed opportunities to identify processes for improvement, and the potential for unsafe practices to go unnoticed and unchanged in the ED (A273);

2. Ensure a mechanism was in place for the Governing Body to evaluate the quality of each contracted clinical service to ensure it was provided in a safe and effective manner, resulting in the potential for missed opportunities to identify problems and improve the care provided to patients through contracted services (A308); and,

3. Ensure an effective, ongoing program for the identification of diversion was defined, implemented and maintained, resulting in Registered Nurse (RN) 1 diverting narcotic medications from the facility for approximately two years (A309).

The cumulative effect of these systemic problems resulted in the facility's failure to ensure patients were receiving quality care in a safe and effective manner.
VIOLATION: PROGRAM SCOPE, PROGRAM DATA Tag No: A0273
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on interview and record review, the facility failed to ensure data was collected, measured, analyzed, and tracked to monitor the effectiveness and safety of services and quality of care provided by nursing staff in the Emergency Department (ED). This failed practice resulted in missed opportunities to identify processes for improvement, and the potential for unsafe practices to go unnoticed and unchanged in the ED.

Findings:

The facility Performance Improvement (PI) Plan was reviewed on January 28, 2015. According to the plan:

a. The objective was to provide safe, quality clinical services, and demonstrate superior patient outcomes;

b. The scope included measurement and evaluation of processes related to patient safety and medication safety;

c. Departmental PI would include identification of processes or outcome oriented, high volume, high risk, or problem prone aspects of care, treatment, or services, and the development of measures that were objective, clinically valid, evidence-based, and measurable for use in the evaluation of care, treatment, and services provided;

d. Criteria used to identify and prioritize quality initiatives included issues that promoted patient safety;

e. Priorities for the ED service line included throughput times and improvement of operations; and

f. Sources of data for PI included administrative data (billing/computer systems), survey data (patient satisfaction surveys), clinical data (electronic medical records), occurrence reports (electronic reporting system), and reference databases (comparing with state and national standards and benchmarks). Sources of data did not include observation of procedures, processes, or interactions.

The PI projects for the ED service line were chosen as throughput times and improving operations.

1. The Broselow system for pediatric resuscitation is a color coded system that uses a child's body length to determine their weight in kilograms (kg), the correct medication doses to be used, and the appropriate sized supplies to use when resuscitation is necessary. The tape is accurate and effective for pediatric patients weighing three kg to 36 kg (6 - 80 pounds). One end of the (Broselow) tape is placed even with the top of the child's head, and the other end is extended down the side of the body until it reaches the heels. The color on the tape where it is level with the heels is that child's color zone. Within the color zone are the child's weight in kg, supply sizes for that child, medications and dosages to be used for medical emergencies, and defibrillation (shocking the heart) doses to treat dangerous or fatal heart rhythms.

The Broselow cart has multicolored drawers. The top drawer is for medications, and each subsequent drawer correlates with a color zone on the Broselow tape. Each colored drawer contains supplies appropriate for use in a child who falls in the corresponding zone on the Broselow tape. When a child is in need of treatment for a medical emergency, or resuscitation, the child is measured and his/her color zone is determined. Medications are given according to the recommended doses in their color zone. Defibrillations are performed using the recommended doses found in their color zone. Their color zone drawer on the cart is opened, and the supplies from that drawer are the appropriate size and/or length, and are safe for use on that child. The Broselow system is based on recommendations from the American Heart Association (AHA) for the performance of Pediatric Advanced Life Support (PALS).

During a tour of the Emergency Department (ED) on January 28, 2015, at 9:35 a.m., accompanied by the Director of Emergency Department (DED) and the Director of Quality/Patient Safety (DQ), the pediatric crash cart was observed behind the patient curtain in Bed 1. The DED stated the facility used the Broselow system for pediatric resuscitation.

The contents of the cart were reviewed with Emergency Department Registered Nurse (EDRN) 1 (a preceptor in the ED). The RN stated they used the Broselow system for pediatric resuscitation, and they had laminated cards for each color zone that they used for their reference. He stated the laminated cards were exact replicas of each color zone of the Broselow tape, but they were larger and laminated for easier use. Multiple cards were observed on top of the cart. The RN attempted to locate the purple card to demonstrate use of the system. The purple card was located after seven minutes of searching.

The top (medication) drawer had a label on the outside that read, "6 kg to 36 kg." EDRN 1 was not able to explain what he would do within the ED if he needed medications for a patient that weighed three to five kg (six to 11 pounds). He stated the pharmacist came to the codes, and he would ask them for help.

After the medication drawer was opened, using the reference cards that matched the Broselow tape and the list of medications in the medication drawer (dated 7/2013), the following was noted:

a. The Broselow tape indicated atropine (used to increase the heart rate when it is beating too slowly) 0.1 milligrams (mg) per milliliter (ml) should be available for intravenous (IV) or intraosseous (IO) (into the bone marrow) use. The tape further indicated if the atropine needed to be given into the endotracheal tube (ETT) (a tube inserted into the mouth, past the vocal chords, and into the trachea to assist in breathing), the available dilution should be 0.4 mg/ml (medications given into the ETT go straight into the lungs. A more concentrated form of atropine allows the larger required dose to be given while minimizing the amount of fluid injected into the lungs).

The medication drawer did not contain atropine 0.4 mg/ml;

b. The Broselow tape indicated epinephrine 1:10,000 (increases blood flow to the coronary arteries during resuscitation) should be available for IV or IO use. The tape further indicated if the epinephrine needed to be given into the ETT, the available dilution should be 1:1,000.

The medication drawer did not contain epinephrine 1:1,000;

c. The Broselow tape indicated magnesium (for treatment of fast heart rates) should be available for IV or IO use.

The medication drawer did not contain magnesium;

d. The Broselow tape indicated sodium bicarbonate (to help maintain a balanced pH in the blood) 4.2% should be available for use in infants weighing five kg or less.

The medication drawer did not have sodium bicarbonate 4.2%; and

e. The Broselow tape indicated 25% dextrose should be available for use in infants weighing five kg or less.

The medication drawer did not have 25% dextrose.

EDRN 1 stated he would ask the pharmacist for assistance if he needed the medications that were not available in the cart.

During an interview with the Director of Pharmacy (DP) on January 29, 2015, at 8:20 a.m., the DP stated she did not know why the medications in the pediatric crash cart did not match the medications recommended for use in the Broselow system. The DP stated the medication list was approved by the Pharmacy and Therapeutics (P&T) Committee and the Medical Executive Committee (MEC). The DP was not able to determine when the medication list was last discussed, or if the discussion included a conscious, purposeful deviation from the recommended medications.

The 2014 Skills Day agenda was reviewed on January 29, 2014. (Skills day is done on an annual basis, and used as a means to educate, re-educate, and verify competency on the skills and knowledge required of staff who work at the facility). The skills day agenda included a mock code blue (adult resuscitation) - code white (pediatric resuscitation) station, attended by 632 staff members. The team members expected to respond included the house supervisor, an intensive care unit (ICU) nurse (ICU nurses do not care for pediatric patients), the primary nurse, and a respiratory therapist. There was no indication a pharmacist was expected to respond as a member of the code team. 24 behaviors were listed that were expected to be observed, including properly calling the code, performing CPR correctly, obtaining the crash cart, using oxygen and suction equipment, establishing an IV, identifying rhythms, defibrillating, team leading, and documentation. There was no information related to expectation, observation, or education regarding use of the Broselow system for pediatric resuscitation or medication dosing and administration for pediatric patients.

During a tour of the ED on January 29, 2015, at 11:10 a.m., accompanied by the DQ, the DED, and Pharmacist (Pharm) 2, the pediatric crash cart was observed in the same location it was in the previous day. The medication drawer was unlocked, the medication tray was unsealed, and the medication list was missing from the medication tray.

The DED moved the cart to the clean utility room so an ED nurse could demonstrate how it was used. While waiting for a nurse to arrive, Pharm 2 opened the bottom drawer of the cart and revealed a drug tray for use on infants who weighed five kg or less. During an interview, Pharm 2 was not able to explain why EDRN 1 had no knowledge of the tray the previous day. Pharm 2 stated he had done inservices for the staff on the contents of the cart.

At 11:15 a.m., EDRN 2 demonstrated how the pediatric crash cart was used. The demonstration was observed by the DQ and Pharm 2. She stated there were two different references for medication dosages, the Broselow tape/cards, or a manual (a three ring binder) specific to the facility that had one page for each weight and listed all of the medications and their dosages for that sized infant or child. EDRN 2 stated she preferred to use the manual. Four kg was selected as the weight of the child for the demonstration, so EDRN 2 opened the manual to the page displaying the information for four kg.

When she was asked what medication tray she would use, she pointed to the one in the top drawer (labeled for use on six kg to 36 kg). She looked and was unable to locate any other medications. She was not able to explain why the medication tray was labeled for six kg to 36 kg, but said that was the drug tray they always used for a pediatric resuscitation.

EDRN 2 was asked to demonstrate how she would give dextrose. She located the dextrose dosage on the paper, and stated it said to give 2 grams (g), or eight ml, of 25% dextrose. She was not able to locate 25% dextrose in the medication tray. Dextrose 50% was in the tray, but the RN was not able to calculate the amount of medication (in ml) she would give.

EDRN 2 was asked to demonstrate how she would give atropine down the ETT. She located the atropine dosage on the paper, and stated it said to give 0.1 mg, or 1 ml, of atropine 0.1 mg/ml. She stated she would draw up 1 ml of the medication and give it down the ETT. The dosage section of the paper had two asterisks next to the ETT route. The asterisks in the, "tips," section directed the staff to give two to 10 times the dose down the ETT. The RN stated she did not see that comment, and after it was pointed out to her, she stated she would give 0.4 mg of the medication that was provided. She was not able to determine how many ml of the medication she would draw up to put down the ETT. The Broselow tape reference card indicated the ETT dose for a four kg child was 0.2 mg, or 0.5 ml, of atropine 0.4 mg/ml. EDRN 2 was asked to demonstrate how she would give that amount down the ETT. She looked through the medications in the tray, and stated she could not find any atropine 0.4 mg/ml.

EDRN 2 was asked to demonstrate how she would give epinephrine (the first line resuscitation drug) down the ETT. She located the epinephrine dosage on the paper, and stated it said to give 0.04 mg, or 0.4 ml, of epinephrine 1:10,000. She stated she would draw up 0.4 ml of the medication and give it down the ETT. The dosage on the reference paper indicated it was the IV or IO dose. There was no information regarding an ETT dose on the paper. The RN stated she did not notice the dose was for IV or IO use only. The Broselow tape reference card indicated the ETT dose for a four kg child was 0.4 mg, or 0.4 ml, of epinephrine 1:1,000 (10 times the IV or IO dose). EDRN 2 was asked to demonstrate how she would give that amount down the ETT. She looked through the medications in the tray, and stated she could not find any epinephrine 1:1,000. If an infant or child received a dose of epinephrine 1:10,000 when 1:1,000 was indicated, they would receive 1/10th of the dose they needed.

At the end of the demonstration, Pharm 2 stated he would restock the medication tray and lock the cart so it could be put back where it came from.

During a tour of the ED on January 29, 2015, at 1:30 p.m., accompanied by the DED, the pediatric crash cart was observed in it's assigned location (against the wall in Bed 1) with red locks on the drawers. The DED stated the pharmacy was responsible for locking the medication drawers, indicating they were ready for use.

The code white/medical emergency practice drills were reviewed on January 29, 2015. Section 5.6 of the document that read, "Demonstrates use of Broselow tape and Medication sheet," was lined out on every sheet. There was no evidence the drills included use of, or practice with, the Broselow system, including use of the tape as a resource along with obtaining correct medications and verbalization of appropriate dosages.

Review of facility documents and committee meeting minutes on January 28 and 29, 2015, indicated code white outcomes were reported to the critical care committee, but there was no evidence of any discussion regarding improvements that were needed in the actual performance of the team.

2. During a tour of the ED on January 28, 2015, at 8:30 a.m., Emergency Department Registered Nurse (EDRN) 3 described the triage and initial treatment process, using Standardized Procedures, that allowed nurses to provide immediate care in the absence of a physician. She stated there were certain chief complaints that the nurses could begin treatment on without a physician present in order to expedite the care of the patient and prevent delays in care.

According to the RN, if a patient presented to the ED for chest pain, the nurse could perform a 12 lead EKG, start an intravenous (IV) line, draw blood and send it to the lab, put the patient on oxygen, order a chest x-ray, and give aspirin and nitroglycerin to try to alleviate the pain. She stated they would notify the physician when they had a patient with chest pain, and the physician would usually be at the bedside by the time they completed the initial interventions.

a. The record for Patient 34 was reviewed on January 30, 2015. Patient 34, a [AGE] year old male, presented on January 26, 2015, at 7:13 a.m., with a complaint of chest pain and a history of cardiac problems.

The record indicated Patient 34 was triaged and initial vital signs were taken at 7:18 a.m. The record further indicated labs were drawn at 8:13 a.m. (55 minutes after arrival), nitroglycerin was given (NTG - given to relieve chest pain by dilating the vessels that provide oxygenated blood to the heart. NTG also dilates all of the other vessels throughout the body, often times resulting in a significant decrease in blood pressure as a result of lack of volume to fill the dilated vessels, and the potential for an unplanned drop in oxygenated blood being sent to the heart. This lack of volume is rapidly treated with IV fluids, thus an IV should be in place prior to giving NTG), an EKG was done at 8:18 a.m. (one hour after arrival), and a chest x-ray (CXR) was done at 8:27 a.m. (one hour and nine minutes after arrival). There was no evidence an IV was started in the ED. There was no evidence the patient was placed on oxygen while in the ED.

b. The record for Patient 37 was reviewed on January 30, 2015. Patient 37, a [AGE] year old female, presented on January 26, 2015, at 6:01 p.m., with a complaint of chest pain, 9 on a 1-10 scale, radiating to the left arm (indicating it may be cardiac in nature). Vital signs taken at 6:02 p.m., indicated her blood pressure (BP) was elevated at 163/108 (normal 120/80).

The ED record indicated an EKG was done at 6:11 p.m., and no further treatment was initiated. No labs were drawn, no CXR was ordered or done, no oxygen was applied, and no IV was started. According to the record, the patient was not placed in a bed or seen by a provider, and no treatment was started until after 9 p.m. (three hours after arriving to the ED).

The facility policy titled, "Standardized Procedure: emergency room ," was reviewed on January 30, 2015. According to the policy, it detailed the specific functions and treatments the ED RN could perform for certain clinical conditions until care was assumed by an ED provider. The policy indicated for chest pain in a patient with known cardiac disease, the nurse could initiate oxygen, do an EKG, insert an IV line, draw blood and order lab tests, and order a CXR.

During an interview with the Director Emergency Department (DED) on January 30, 2015, at 1:50 p.m., the director stated he reviewed the records for Patients 34 and 37. He stated the nurses did not follow the standardized procedure for either patient, and they should have. According to the DED, Patient 34 should not have received NTG without having an IV line in place because, "you never know how they will respond, and you might need that line." The DED stated Patient 37 had, "classic" cardiac symptoms and increased BP, and the nurses should have followed the standardized procedure and started a cardiac workup.

The DED stated there was no quality review process in place to determine whether the standardized procedures were being utilized and correctly followed by the nurses when patients met the criteria for using them.

3. The facility policy titled, "Triage," was reviewed on January 30, 2015. The policy indicated patients would be prioritized into one of three categories by the triage nurse: 1 - Emergent; 2 - Urgent; or, 3 - Non-Urgent. Non-urgent complaints included conditions such as cough and cold, sprains and strains, and suture removals and wound checks.

Record reviews conducted on January 30, 2015, indicated the following:

a. Patient 34, a [AGE] year old male, presented on January 26, 2015, with a complaint of chest pain that was possibly cardiac in nature. The record indicated the triage nurse assigned him a level three (non-urgent);

b. Patient 35, a 7 year old male, presented on January 26, 2015, with complaints of abdominal pain and fever. The record indicated the triage nurse assigned him a level three (non-urgent);

c. Patient 36, a 5 year old male, presented on January 26, 2015, with a complaint of fever. The record indicated the triage nurse assigned him a level four (not an option according to the policy);

d. Patient 37, a [AGE] year old female, presented on January 26, 2015, with complaints of chest pain and high blood pressure. The record indicated the triage nurse assigned her a level three (non-urgent).

During an interview with the DED on January 30, 2014, at 1:50 p.m., the DED stated the assigned triage levels were not done according to the most recently approved policy. He stated they currently used the five level Emergency Severity Index (ESI) to triage and prioritize patients, but the most recently approved policy did not reflect the five level ESI. He stated the triage policy was reviewed in May 2014, and they realized it was not consistent with their current practice, so it had to be revised. He stated they were in the process of revising the policy. The DED stated the nurses did not have a facility approved ESI level policy to use as a resource if they had questions regarding the triage process. He stated they would have to, "rely on each other."

The DED stated the triage system changed, "about a year ago," going from three acuity levels to five acuity levels. The director stated there was no observation, no record review, and no data collection of any kind done then, or currently, to ensure the changes were understood by the nursing staff, and were effective in determining the order and priority in which patients should be seen to ensure timeliness and quality of services.
VIOLATION: PHARMACEUTICAL SERVICES Tag No: A0490
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on observation, interview, and record review, the facility failed to provide pharmaceutical services that met the needs of the patients, by failing to:

1. Ensure a safe and effective pediatric resuscitation system was in place, including immediate availability of medications recommended by nationally recognized organizations, consistent reference materials for staff to use, and staff education and training on pediatric crash cart contents and use (Refer to A500).

2. Ensure that accountability procedures were in place and implemented to control the use of all controlled substances(CS) and to readily identify loss or diversion of all CS in such a manner as to minimize the time frame between the actual loss or diversion to the time of detection and determination of the extent of loss or diversion. This failure resulted in an ICU nurse, RN 1 diverting without accountability for approximately two years placing the nurse and the patients he cared for at a risk for potential harm (Refer to A494).

3. Ensure pharmacists that participate in pediatric and adult cardiopulmonary emergencies were deemed to be competent by either BLS and ACLS certification or annual competency in accordance with the facility's policy and procedure (Refer to A500).

4. Ensure adequate amount of injectable sterile water was available to mix the vials of the medication necessary for immediate treatment of life-threatening [DIAGNOSES REDACTED] (Refer to A500).

5. Ensure patients' medications were secure and locked in the medication cart to prevent access by unauthorized personnel at all times (Refer to A500).

The cumulative effect of these systemic problems resulted in the failure of the facility to provide quality pharmaceutical services and ensure the provision of quality healthcare in a safe environment that met the needs of the patients.
VIOLATION: PHARMACY DRUG RECORDS Tag No: A0494
Based on interview and document review, the facility failed to ensure that accountability procedures were in place and implemented to control the use of all controlled substances (CS) and to readily identify loss or diversion of all CS in such a manner as to minimize the time frame between the actual loss or diversion to the time of detection and determination of the extent of loss or diversion. This failure resulted in an Intensive Care Unit (ICU) Registered Nurse (RN 1) diverting without accountability for approximately two years placing the nurse and the patients he cared for at a risk for potential harm.

Findings:

Review of the related documents following the facility's reported narcotic drug diversion involving RN 1, an ICU nurse, revealed the following:

The facility provided All Station Events Pyxis (an automated dispensing cabinet for medications) report was reviewed and it indicated that from January 1, 2015, to January 17, 2015, thirty-five 100-ml bags containing fentanyl 1000 mcg were removed from the Pyxis by RN 1 and not charted on the electronic Medication Administration Record (eMAR).

Review of an additional facility provided report indicated from July 24, 2014, to December 30, 2014, the total amount of fentanyl accessed from Pyxis by RN 1 that was not accounted for totaled mcg which included sixty-one bags of 100-ml containing fentanyl 1000 mcg and ten 2-ml vials of injectable fentanyl 100 mcg.

Review of the facility provided report titled, "Users With CS Doses Dispensed > 2 SD (Station) All Stations" showed that RN 1 appeared in the following months with the corresponding SD values:

4.7 SD for fentanyl access in January 2014.
3 SD for fentanyl access in February 2014.
3.6 SD in July 2014.
2.2 SD in August 2014.
4.9 SD in December 2014
4.2 SD in January 2015

Review of the facility provided report for RN 1's Pyxis access to fentanyl that were not accounted for from December 15, 2012 to February 3, 2014 equated to a total of 233.3 infusion bags of fentanyl 1000 mcg per 100 ml not documented as administered. This was the time period immediately before RN 1 went on a medical leave and after RN 1 was hired to work at the facility.

Additional reports requested by the surveyor for Pyxis access of all CS by RN 1 between the date of hire and the date he went on a medical leave indicated there were numerous absences of documentation of administration for other potent narcotic pain medications such as injectable hydromorphone (brand name: Dilaudid) which had been accessed from the Pyxis.

Review of the facility's policy and procedure titled, "Controlled Drugs" revised on April 2012, indicated,

"A pharmacist will review a Pyxis generated discrepancy report every morning, upon opening, to verify that all discrepancies have been resolved before the night shift ends their shift.

The Director of Pharmacy or designee will prepare a quarterly report of all controlled drug discrepancies.

The controlled drug discrepancy report will be reviewed by the CNO and/or designee, CEO and the Pharmacy and Therapeutics Committee at the end of each quarter.

The Director of Pharmacy will report to the CNO and CEO and Chairman of the Pharmacy and Therapeutics Committee immediately if it is felt that there is a situation involving abuse or diversion.

Pharmacy will run a Pyxis generated report for all controlled drug charges hospital wide on a daily basis ...

A pharmacist technician will also review this report and reconcile it to a Siemens Pharmacy report listing all patients currently on controlled drugs.

The pharmacy technician will look for controlled drugs that were given earlier than the physician order indicated, dose taken is greater than the dose prescribed with no record of waste, and any unusual pattern of controlled drug removal."

During an interview on January 27, 2015, at 11 a.m., Pharmacy Technician (PT) 2 stated that daily monitoring of Pyxis controlled substance use involved comparing the Returns and Waste reports to Charges and Credit reports from the Pyxis and looking for staff frequently documenting waste of CS, frequent access to CS, and early access to CS. These suspicious activities were then compared to the documentation in the electronic Medication Administration Record (eMAR) for appropriateness. PT 2 stated that Pyxis access to injectable CS for continuous infusion would be difficult to audit because the rate of infusion could change.

During an interview on January 28, 2015, at 1:30 p.m., PT 1 stated that she did not look for irregularities with the use of CS infusion bags during her daily audit of Pyxis CS use expressing the need for guidelines for how to look at fentanyl infusion bags and that she trained PT 2.

During an interview on January 27, 2015, at 10 a.m., DP stated that resources available for CS monitoring from the Pyxis before upgrade from 3500 to 4000 version were not utilized as it was not made known to her and no training was given to her of the capabilities of the newer version. DP also indicated that the pharmacy process of CS monitoring was not working and the only way to identify drug diversion was by "tip off."

During an interview on January 27, 2015, at 11:30 a.m., Pharm 1 stated that she assisted with researching the incident involving RN 1 and generating reports due to "wonky" documentation at the request of the HR Director at the time and assumed RN 1 was terminated at that time. Pharm 1 stated that she was not aware that RN 1 came back from medical leave and was still working.

During an interview on January 30, 2015, at 9:30 a.m., DP indicated that she still needed to review the reports to determine the loss or diversion of other Pyxis narcotic CS that were not documented by RN 1.

During an interview on January 30, 2015, at 8:15 a.m., DP stated that the report, Users With CS Doses Dispensed > 2 SD, was generated monthly and reviewed for ED only until now as it was determined to be the "high risk" area but not for ICU.

During an interview on January 27, 2015, at 3:30 p.m., DP stated that she was not actively involved in the investigations and that the communication between the pharmacy and nursing was broken. DP stated that two CNO's ago the drug diversion related reports were taken much more seriously.

During an interview on January 27, 2015, at 10 a.m., DP stated that she did not recall if she was informed of the investigation of RN 1 in February 2014, and did not remember the name of RN 1 at the time and that she should have paid more attention to the names. DP also stated that she did not keep track of resolved and unresolved discrepancies in ED.

Review of the discrepancy forms sent to the DED in 2014, revealed that 9 discrepancies were returned to the Pharmacy with explanations and 64 discrepancies were still waiting to be resolved or returned with explanation.

During an interview on January 29, 2015, at 11:20 a.m., the DED stated that discrepancy forms received by email would be given to the staff directly involved for explanation and relied on the staff to return the forms. The DED indicated that he was the director, the manager, and the educator and that the ED was extremely busy. The DED stated that no regular staff was disciplined for discrepancies in 2014, and he did not keep track of resolved and unresolved discrepancies.

During an interview on January 29, 2015, at 11 a.m., DP stated that she did not keep a watch list of facility staff with access to Pyxis with potential CS drug diversion.

Review of the Pharmacy performance Improvement indicator titled, "Nursing Pyxis Controlled Substances discrepancies" showed 66.2% of discrepancies were not resolved in fourth quarter of 2013, 40% in first, 34.8% in second, and 58.9% in third quarter of 2014, with the fourth quarter figure pending.

During an interview on January 29, 2015, at 11:30 a.m., DP stated that it was frustrating to see that the discrepancies were not being resolved in a timely manner and that she did not know what else to do other than repeatedly request for the form to be returned to the Pharmacy with a resolution.

According to ASHP Guidelines on the Safe Use of Automated Medication Storage and Distribution Devices, a guideline published by American Society of Health-Systems Pharmacists (ASHP), a nationally recognized pharmacy organization;

"The organization should have a written plan for the monitoring and surveillance of medications accessed through automated systems ...the plan should include ...
Assignment of responsibility for resolving discrepancies, scheduling the resolution of discrepancies, following up on unresolved discrepancies, and taking action if the discrepancy is not resolved on schedule, and a description of the process for investigating trends in discrepancies and assigning responsibility for this.

The compliance with the plan should be monitored through the organization's quality assurance program."
VIOLATION: DELIVERY OF DRUGS Tag No: A0500
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on observation, interview and document review, the facility failed to control and distribute medications in a safe manner to protect the patients by failing to ensure:

1. A safe and effective pediatric resuscitation system was in place, including immediate availability of medications recommended by nationally recognized organizations, consistent reference materials for staff to use, and staff education and training on pediatric crash cart contents and use;

2. Pharmacists that participated in pediatric and adult cardiopulmonary emergencies were deemed to be competent by either BLS and ACLS certification or annual competency in accordance with the facility's policy and procedure;

3. Adequate amount of injectable sterile water was available to mix the vials of the medication necessary for immediate treatment of life-threatening [DIAGNOSES REDACTED]; and

4. Patients' medications were secure and locked in the medication cart to prevent access by unauthorized personnel at all times.

Findings:

1. The Broselow system for pediatric resuscitation is a color coded tape system that uses a child's body length to determine their weight in kilograms (kg), the correct medication doses to be used, and the appropriate sized supplies to use when resuscitation is necessary.

The tape is accurate and effective for pediatric patients weighing three kg to 36 kg (6 - 80 pounds). One end of the (Broselow) tape is placed even with the top of the child's head, and the other end is extended down the side of the body until it reaches the heels. The color on the tape where it is level with the heels is that child's color zone. Within the color zone are the child's weight in kg, supply sizes for that child, medications and dosages to be used for medical emergencies, and defibrillation (shocking the heart) doses to treat dangerous or fatal heart rhythms.

The Broselow cart has multicolored drawers. The top drawer is for medications, and each subsequent drawer correlates with a color zone on the Broselow tape. Each colored drawer contains supplies appropriate for use in a child who falls in the corresponding zone on the Broselow tape. When a child is in need of treatment for a medical emergency, or resuscitation, the child is measured and his/her color zone is determined.

Medications are given according to the recommended doses in their color zone. Defibrillations are performed using the recommended doses found in their color zone. Their color zone drawer on the cart is opened, and the supplies from that drawer are the appropriate size and/or length, and are safe for use on that child. The Broselow system is based on recommendations from the American Heart Association (AHA) for the performance of Pediatric Advanced Life Support (PALS).

During a tour of the Emergency Department (ED) on January 28, 2015, at 9:35 a.m., accompanied by the Director of the Emergency Department (DED) and the Director of Quality and Patient Safety (DQ), the pediatric crash cart was observed behind the patient curtain in Bed 1. The DED stated the facility used the Broselow system for pediatric resuscitation.

The contents of the cart were reviewed with Emergency Department Registered Nurse (EDRN) 1 (a preceptor in the ED). The RN stated they used the Broselow system for pediatric resuscitation, and they had laminated cards for each color zone that they used for their reference. He stated the laminated cards were exact replicas of each color zone of the Broselow tape, but they were larger and laminated for easier use. Multiple cards were observed on top of the cart. The RN attempted to locate the purple card to demonstrate use of the system. The purple card was located after seven minutes of searching.

The top (medication) drawer had a label on the outside that read, "6 kg to 36 kg." EDRN 1 was not able to explain what he would do within the ED if he needed medications for a patient that weighed three to five kg (six to 11 pounds). He stated the pharmacist came to the codes, and he would ask them for help.

After the medication drawer was opened, using the reference cards that matched the Broselow tape and the list of medications in the medication drawer (dated 7/2013), the following was noted:

a. The Broselow tape indicated atropine (used to increase the heart rate when it is beating too slowly) 0.1 milligrams (mg) per milliliter (ml) should be available for intravenous (IV) or intraosseous (IO) (into the bone marrow) use. The tape further indicated if the atropine needed to be given into the endotracheal tube (ETT) (a tube inserted into the mouth, past the vocal chords, and into the trachea to assist in breathing), the available dilution should be 0.4 mg/ml (medications given into the ETT go straight into the lungs. A more concentrated form of atropine allows the larger required dose to be given while minimizing the amount of fluid injected into the lungs).

The medication drawer did not contain atropine 0.4 mg/ml;

b. The Broselow tape indicated epinephrine 1:10,000 (increases blood flow to the coronary arteries during resuscitation) should be available for IV or IO use. The tape further indicated if the epinephrine needed to be given into the ETT, the available dilution should be 1:1,000.

The medication drawer did not contain epinephrine 1:1,000;

c. The Broselow tape indicated magnesium (for treatment of fast heart rates) should be available for IV or IO use.

The medication drawer did not contain magnesium;

d. The Broselow tape indicated sodium bicarbonate (to help maintain a balanced pH in the blood) 4.2% should be available for use in infants weighing five kg or less.

The medication drawer did not have sodium bicarbonate 4.2%; and

e. The Broselow tape indicated 25% dextrose should be available for use in infants weighing five kg or less.

The medication drawer did not have 25% dextrose.

EDRN 1 stated he would ask the pharmacist for assistance if he needed the medications that were not available in the cart.

During an interview with the Director of Pharmacy (DP) on January 29, 2015, at 8:20 a.m., the DP stated she did not know why the medications in the pediatric crash cart did not match the medications recommended for use in the Broselow system. The DP stated the medication list was approved by the Pharmacy and Therapeutics (P&T) Committee and the Medical Executive Committee (MEC). The DP was not able to determine when the medication list was last discussed, or if the discussion included a conscious, purposeful deviation from the recommended medications.

The 2014 Skills Day agenda was reviewed on January 29, 2014. (Skills day is done on an annual basis, and used as a means to educate, re-educate, and verify competency on the skills and knowledge required of staff who work at the facility). The skills day agenda included a mock code blue (adult resuscitation) - code white (pediatric resuscitation) station, attended by 632 staff members. The team members expected to respond included the house supervisor, an intensive care unit (ICU) nurse (ICU nurses do not care for pediatric patients), the primary nurse, and a respiratory therapist. There was no indication a pharmacist was expected to respond as a member of the code team. 24 behaviors were listed that were expected to be observed, including properly calling the code, performing CPR correctly, obtaining the crash cart, using oxygen and suction equipment, establishing an IV, identifying rhythms, defibrillating, team leading, and documentation. There was no information related to expectation, observation, or education regarding use of the Broselow system for pediatric resuscitation or medication dosing and administration for pediatric patients.

During a tour of the ED on January 29, 2015, at 11:10 a.m., accompanied by the DQ, the DED, and Pharmacist (Pharm) 2, the pediatric crash cart was observed in the same location it was in the previous day. The medication drawer was unlocked, the medication tray was unsealed, and the medication list was missing from the medication tray.

The DED moved the cart to the clean utility room so an ED nurse could demonstrate how it was used. While waiting for a nurse to arrive, Pharm 2 opened the bottom drawer of the cart and revealed a drug tray for use on infants who weighed five kg or less. During an interview, Pharm 2 was not able to explain why EDRN 1 had no knowledge of the tray the previous day. Pharm 2 stated he had done inservices for the staff on the contents of the cart.

At 11:15 a.m., EDRN 2 demonstrated how the pediatric crash cart was used. The demonstration was observed by the DQ and Pharm 2. She stated there were two different references for medication dosages, the Broselow tape/cards, or a manual (a three ring binder) specific to the facility that had one page for each weight and listed all of the medications and their dosages for that sized infant or child. EDRN 2 stated she preferred to use the manual. Four kg was selected as the weight of the child for the demonstration, so EDRN 2 opened the manual to the page displaying the information for four kg.

When she was asked what medication tray she would use, she pointed to the one in the top drawer (labeled for use on six kg to 36 kg). She looked and was unable to locate any other medications. She was not able to explain why the medication tray was labeled for six kg to 36 kg, but said that was the drug tray they always used for a pediatric resuscitation.

EDRN 2 was asked to demonstrate how she would give dextrose. She located the dextrose dosage on the paper, and stated it said to give 2 grams (g), or eight ml, of 25% dextrose. She was not able to locate 25% dextrose in the medication tray. Dextrose 50% was in the tray, but the RN was not able to calculate the amount of medication (in ml) she would give.

EDRN 2 was asked to demonstrate how she would give atropine down the ETT. She located the atropine dosage on the paper, and stated it said to give 0.1 mg, or 1 ml, of atropine 0.1 mg/ml. She stated she would draw up 1 ml of the medication and give it down the ETT. The dosage section of the paper had two asterisks next to the ETT route. The asterisks in the, "tips," section directed the staff to give two to 10 times the dose down the ETT. The RN stated she did not see that comment, and after it was pointed out to her, she stated she would give 0.4 mg of the medication that was provided. She was not able to determine how many ml of the medication she would draw up to put down the ETT. The Broselow tape reference card indicated the ETT dose for a four kg child was 0.2 mg, or 0.5 ml, of atropine 0.4 mg/ml. EDRN 2 was asked to demonstrate how she would give that amount down the ETT. She looked through the medications in the tray, and stated she could not find any atropine 0.4 mg/ml.

EDRN 2 was asked to demonstrate how she would give epinephrine (the first line resuscitation drug) down the ETT. She located the epinephrine dosage on the paper, and stated it said to give 0.04 mg, or 0.4 ml, of epinephrine 1:10,000. She stated she would draw up 0.4 ml of the medication and give it down the ETT. The dosage on the reference paper indicated it was the IV or IO dose. There was no information regarding an ETT dose on the paper. The RN stated she did not notice the dose was for IV or IO use only. The Broselow tape reference card indicated the ETT dose for a four kg child was 0.4 mg, or 0.4 ml, of epinephrine 1:1,000 (10 times the IV or IO dose). EDRN 2 was asked to demonstrate how she would give that amount down the ETT. She looked through the medications in the tray, and stated she could not find any epinephrine 1:1,000. If an infant or child received a dose of epinephrine 1:10,000 when 1:1,000 was indicated, they would receive 1/10th of the dose they needed.

At the end of the demonstration, Pharm 2 stated he would restock the medication tray and lock the cart so it could be put back where it came from.

During a tour of the ED on January 29, 2015, at 1:30 p.m., accompanied by the DED, the pediatric crash cart was observed in it's assigned location (against the wall in Bed 1) with red locks on the drawers. The DED stated the pharmacy was responsible for locking the medication drawers, indicating they were ready for use.

The Chief Executive Officer (CEO), Chief Operating Officer (COO), and Chief Nursing Officer (CNO) were notified that Immediate Jeopardy was identified on January 29, 2015, at 2:30 p.m.

The Immediate Jeopardy was identified due to the facility's failure to ensure a safe and effective pediatric resuscitation system was in place, including immediate availability of medications recommended by nationally recognized organizations, consistent reference materials for staff to use, and staff education and training on pediatric crash cart contents and use.

An acceptable plan of correction was received that included the following:

a. Revision of the medication trays to included all medications, strengths, and dosages for pediatric patients weighing 36 kg and below, in accordance with the Broselow system;

b. Revision of reference materials to match the Broselow system;

c. Revision of current policy to reflect the new contents of the medication tray;

d. Placement of a sign at the head of the bed for every patient in the Pediatric Unit with Broselow guidelines for resuscitation for that size child;

e. Education for all pharmacy, nursing, and physician staff regarding the revision of the pediatric crash carts; and,

f. Conducting code white (pediatric resuscitation) drills on all shifts, and in all areas of the hospital that treat pediatric patients.

Following verification of implementation of the plan, the CNO and COO were notified the Immediate Jeopardy was abated on January 30, 2015, at 11:20 a.m.




2. During an interview on January 29, 2015, at 10 a.m., DP stated that all pharmacists were required to attend the codes (code blue and white) and were BLS (Basic Life Support) and ACLS (Advanced Cardiovascular Life Support) certified. DP stated that pharmacists were also required to complete a written competency, and she acknowledged that some of the pharmacists were not up to date on the competency, and BLS and ACLS certification.

Review of the facility provided staff list and the BLS and ACLS certification of pharmacists revealed that seven out of 20 pharmacists did not have the BLS and ACLS certification and the written competencies for all pharmacists were not done annually.

During an interview on January 29, 2015, at 11:45 a.m., Pharm 1 stated that pharmacists were told to be BLS and ACLS certified to be ready for 2014 per policy and that no prep training was provided to pharmacists in 2014.

Review of the facility's policy and procedure, "Attendance and Responsibilities of Pharmacists at Code Blue/White" indicated,

"Code Blue: Cardiopulmonary resuscitation (CPR) will be initiated and the code team activated immediately, when a patient exhibits the signs and symptoms of [DIAGNOSES REDACTED]
Code White: Provide immediate and effective emergency response in the event of cardiopulmonary/respiratory arrest with pediatric patients ...

All pharmacists assigned to attend Code Blue or Code White duties must show annual written competency. Pharmacists are required to complete basic cardiopulmonary resuscitation (CPR) and advanced cardiopulmonary resuscitation (ACLS) prep/training or certification."

3. During inspection of the medication storage in Labor and Delivery (L&D) Unit on January 28, 2015, at 11:15 a.m., it was observed that in the facility's [DIAGNOSES REDACTED] (MH) Cart, there were only two 1000-ml bags of injectable sterile water kept inside.

During a concurrent interview, DP agreed that there needed to be at least 2160 ml of sterile water to mix all thirty-six vials of Dantrolene available in the cart.

Dantrolene is the only FDA-approved drug used in the treatment of MH.

Review of the facility's policy and procedure titled, "[DIAGNOSES REDACTED]" indicated,

"[DIAGNOSES REDACTED] is a life-threatening pharmacogenetic disorder triggered by the administration of commonly used volatile or inhaled general anesthetics ..., the depolarizing muscle relaxant succinylcholine, or both ...

Dantrolene sodium IV - 36 vials
Sterile water for injection USP 1000 ml x2 (without a bacteriostatic agent) to reconstitute Dantrolene - 2000 ml. Each vial should be reconstituted with 60 ml of sterile water, and the vial shaken until the solution is clear."

4. During inspection of the medication room in Medical/Surgical Unit on January 28, 2015, at 8:40 a.m., it was observed an MMI Medication Cart containing patients' medication trays remained unlocked and was able to be opened without using the numbered keypad.

During a concurrent interview, RN 10 stated that the keypad needed to be used to enter the code to manually lock the medication cart before leaving the cart.

During a concurrent interview, DP acknowledged that the medication cart was not locked.

Review of the facility's policy and procedure titled, "Secure Medication Storage and Access to Medications" indicated,

"Licensed nurses and pharmacy personnel will be the only personnel having access to the medication carts. All drugs storage areas and medication carts must be locked when authorized person is not in attendance. The medication cart will be locked at all times that a nurse is not in attendance."
VIOLATION: INFECTION CONTROL OFFICER RESPONSIBILITIES Tag No: A0749
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on interview and record review, the facility failed to ensure the system for controlling sources of infection in accordance with internal policies and procedures, and nationally recognized infection control practices and guidelines, was followed when contracted dialysis nurses failed to obtain the Hepatitis B status for one patient (Patient 4) undergoing dialysis treatments. These failed practices resulted in the potential for transmission of Hepatitis B from one patient to another.

Findings:

Hepatitis B is an infectious inflammatory disease of the liver caused by the hepatitis B virus (HBV).

According to The Centers for Disease Control (CDC), chronic hemodialysis patients are at high risk for infection because the process of hemodialysis requires vascular access for prolonged periods. In an environment where multiple patients receive dialysis concurrently, repeated opportunities exist for person-to-person transmission of infectious diseases, directly or indirectly via contaminated devices, equipment and supplies, environmental surfaces, or hands of personnel. Preventing the transmission of HBV depends on timely detection of patients converting from HBV- (HbsAG-negative) to HBV + (HbsAG-positive), and rapid implementation of isolation procedures before cross-contamination occurred.

The record for Patient 4 was reviewed on January 28, 2015. Patient 4, a [AGE] year old male, was admitted to the facility on on [DATE], with diagnoses that included end stage renal (kidney) disease requiring long term hemodialysis (removing excess fluid and waste from the blood stream using an artificial kidney machine). The record indicated Patient 4 had been receiving dialysis treatments at an outpatient dialysis center on a regular basis.

The Dialysis Flowsheet dated January 25, 2015, indicated Patient 4 completed a dialysis treatment at 2 a.m. The flowsheet indicated Patient 4 had an, "unknown," HbsAG status, indicating the facility staff and dialysis nurses did not know whether or not he had HBV.

A second Dialysis Flowsheet dated January 25, 2015, indicated Patient 4 completed an additional dialysis treatment at 5 p.m. The flowsheet section containing information on Patient 4's HbsAG status was left blank, indicating the facility staff and dialysis nurses did not know whether or not he had HBV.

The Dialysis Flowsheet dated January 27, 2015, indicated Patient 4 completed a dialysis treatment at 11:15 p.m. The flowsheet indicated Patient 4 had an, "unknown," HbsAG status, indicating the facility staff and dialysis nurses did not know whether or not he had HBV. The flowsheet indicated the HbsAG test was drawn and sent to the lab on January 28, 2015 (4 days after admission to the facility, and after his third dialysis treatment).

The contracted dialysis service policy titled, "Hepatitis B Surface Antigen Positive Patients," was reviewed on January 30, 2015. The notes section of the policy indicated it was intended to protect all patients, dialysis staff, and hospital staff until the patient's hepatitis status was known, and that it was to be followed at all times. According to the policy, when a patient with an unknown Hepatitis status was receiving dialysis treatments, the staff would wear full protective gear, and the internal parts of the machines would be cleaned with bleach after each use.

The contracted dialysis service policy titled, "Hepatitis Surveillance and Infection Control Measures," was reviewed on January 30, 2015. The purpose of the policy was to minimize the spread of hepatitis infections in the dialysis setting. According to the policy, when a patient required dialysis treatment in the hospital, the Hepatitis B status should be ascertained at the time of the first treatment either by a written report from their dialysis facility, or by performing a Hepatitis blood test.

During an interview with Hemodialysis Registered Nurse (HDRN) 1 on January 28, 2015, at 10:25 a.m., the RN stated when a patient with an unknown Hepatitis status received a dialysis treatment, the machine needed to be, "bleached."

During an interview with HDRN 3 on January 29, 2015, at 9 a.m., the RN stated if there was not a known Hepatitis status on a patient, he would first call the dialysis center the patient belonged to and attempt get the information. He stated if the information was not available, he would categorize the patient as an unknown status, then contact the patient's physician and obtain an order for a Hepatitis panel. He stated they should do the Hepatitis panel as soon as possible.

Patient 4 was in the facility for four days, and underwent three dialysis treatments before his Hepatitis panel was drawn. During this time, the machines used on him underwent a different cleaning process than usual. Failure to obtain his Hepatitis status in a timely manner resulted in the potential for spread of hepatitis to other dialysis patients if the machines were not properly cleaned, and he was found to be HBV positive.
VIOLATION: EMERGENCY SERVICES POLICIES Tag No: A1104
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on interview and record review, the facility failed to ensure:

1. The triage policy was updated when they changed from a three level acuity system to a five level emergency severity index (ESI) system, resulting in lack of a reference for the triage nurse assigning an ESI level and determining the priority in which a patient would be seen, and the potential for a delay in necessary emergency care, harm, and death; and

2. Emergency Department (ED) nurses followed their written standardized procedures for providing initial emergency care in the absence of a physician for two of two ED patients presenting with chest pain (Patients 34 and 37), resulting in the potential for delay in care, harm, or death.

Findings:

1. The facility policy titled, "Triage," was reviewed on January 30, 2015. The policy indicated patients would be prioritized into one of three categories by the triage nurse: 1 - Emergent; 2 - Urgent; or, 3 - Non-Urgent. Non-urgent complaints included conditions such as cough and cold, sprains and strains, and suture removals and wound checks.

Record reviews conducted on January 30, 2015, indicated the following:

a. Patient 34, a [AGE] year old male, presented on January 26, 2015, with a complaint of chest pain that was possibly cardiac in nature. The record indicated the triage nurse assigned him a level three (non-urgent);

b. Patient 35, a 7 year old male, presented on January 26, 2015, with complaints of abdominal pain and fever. The record indicated the triage nurse assigned him a level three (non-urgent);

c. Patient 36, a 5 year old male, presented on January 26, 2015, with a complaint of fever. The record indicated the triage nurse assigned him a level four (not an option according to the policy); and

d. Patient 37, a [AGE] year old female, presented on January 26, 2015, with complaints of chest pain and high blood pressure. The record indicated the triage nurse assigned her a level three (non-urgent).

During an interview with the Emergency Department Director (DED) on January 30, 2014, at 1:50 p.m., the DED stated the assigned triage levels were not done according to the most recently approved policy. He stated they currently used the five level ESI to triage and prioritize patients, but the most recently approved policy did not reflect that. He stated the triage policy was reviewed in May, 2014, and they realized it was not consistent with their current practice, so it had to be revised. He stated they were in the process of revising the policy. The DED stated the nurses did not have a facility approved ESI level policy to use as a resource if they had questions regarding the triage process. He stated they would have to, "rely on each other."

2. During a tour of the ED on January 28, 2015, at 8:30 a.m., Emergency Department Registered Nurse (EDRN) 3 described the triage and initial treatment process, using Standardized Procedures, that allowed nurses to provide immediate care in the absence of a physician. She stated there were certain chief complaints that the nurses could begin treatment on without a physician present in order to expedite the care of the patient and prevent delays in care.

According to the RN, if a patient presented to the ED for chest pain, the nurse could perform a 12 lead EKG, start an intravenous (IV) line, draw blood and send it to the lab, put the patient on oxygen, order a chest x-ray, and give aspirin and nitroglycerin to try to alleviate the pain. She stated they would notify the physician when they had a patient with chest pain, and the physician would usually be at the bedside by the time they completed the initial interventions.

a. The record for Patient 34 was reviewed on January 30, 2015. Patient 34, a [AGE] year old male, presented on January 26, 2015, at 7:13 a.m., with a complaint of chest pain and a history of cardiac problems.

The record indicated Patient 34 was triaged and initial vital signs were taken at 7:18 a.m. The record further indicated labs were drawn at 8:13 a.m. (55 minutes after arrival), nitroglycerin was given (NTG - given to relieve chest pain by dilating the vessels that provide oxygenated blood to the heart. NTG also dilates all of the other vessels throughout the body, often times resulting in a significant decrease in blood pressure as a result of lack of volume to fill the dilated vessels, and the potential for an unplanned drop in oxygenated blood being sent to the heart. This lack of volume is rapidly treated with IV fluids, thus an IV should be in place prior to giving NTG), an EKG was done at 8:18 a.m. (one hour after arrival), and a chest x-ray (CXR) was done at 8:27 a.m. (one hour and nine minutes after arrival). There was no evidence an IV was started in the ED. There was no evidence the patient was placed on oxygen while in the ED.

b. The record for Patient 37 was reviewed on January 30, 2015. Patient 37, a [AGE] year old female, presented on January 26, 2015, at 6:01 p.m., with a complaint of chest pain, 9 on a 1-10 scale, radiating to the left arm (indicating it may be cardiac in nature). Vital signs taken at 6:02 p.m., indicated her blood pressure (BP) was elevated at 163/108 (normal 120/80).

The ED record indicated an EKG was done at 6:11 p.m., and no further treatment was initiated. No labs were drawn, no CXR was ordered or done, no oxygen was applied, and no IV was started. According to the record, the patient was not placed in a bed or seen by a provider, and no treatment was started until after 9 p.m. (three hours after arriving to the ED).

The facility policy titled, "Standardized Procedure: emergency room ," was reviewed on January 30, 2015. According to the policy, it detailed the specific functions and treatments the ED RN could perform for certain clinical conditions until care was assumed by an ED provider. The policy indicated for chest pain in a patient with known cardiac disease, the nurse could initiate oxygen, do an EKG, insert an IV line, draw blood and order lab tests, and order a CXR.

During an interview with the DED on January 30, 2015, at 1:50 p.m., the director stated he reviewed the records for Patients 34 and 37. He stated the nurses did not follow the standardized procedure for either patient, and they should have. According to the director, Patient 34 should not have received NTG without having an IV line in place because, "you never know how they will respond, and you might need that line." The director stated Patient 37 had, "classic," cardiac symptoms and increased BP, and the nurses should have followed the standardized procedure and started a cardiac workup.