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Based on interview, observation and record review, the hospital's Governing Body failed to:

1. Ensure that insulin was administered to patient 41 as ordered by a physician.and failed to ensure parameters were set for the administration and titration of continuous intravenous propofol drips for Patient 22.

Immediate Jeopardy was called on 1/24/12 at 5 PM in the presence of the survey team and facility administration, due to the facility's failure to ensure that insulin was administered to patient 41 as ordered by a physician and that parameters were set for the administration and titration of the continuous intravenous propofol drip for Patient 22. The combination of these circumstances placed patients in a situation which was likely to cause serious injury or death. (Refer to A-0404)

2. Ensure that resources available to the Infection Control (IC) Program were sufficient to meet the needs of the patients. The facility had four IC nurses reporting to the Director of Hospital Epidemiology. However, the facility has over 800 beds spread out over 4 campuses on the hospital license. The Director of Hospital Epidemiology stated that it was difficult for the Infection Control Personnel to adequately perform all tasks needed to ensure the highest standards of IC practice. She had no knowledge that the glucometer (device to read blood sugar) in the Pre-Operative Care Unit (Pre-op) was not being disinfected per hospital policy. The Medical Director for Quality also stated that he had been looking into the need for more IC personnel. This deficient practice resulted in the possibility of harm to patients by possible breaches in infection control practices. (Refer to A-0749)

3. Ensure that a new policy on the use of a hospital wide code blue sheet was being followed by all departments. The Governing body failed to ensure that residents were adequately supervised in the case of an unstable patient that had a code blue during surgery. The Medical Staff bylaws were not followed in this instance. (Refer to A-0438)

4. Ensure that the anesthesiologist resident and attending physician communicated to the surgeon a change in the patient's condition. This resulted in harm to one patient whose surgery was continued due to the failure of the anesthesia physicians' to communicate well with the surgeon. (Refer to A-0338)

5. Ensure that improper range orders were not being used in patient records. This resulted in the possibility of medication orders being unclear to the nursing staff, resulting in inconsistency in the way certain medications were dosed. (Refer to A-0353)

6. Protect and promote patient rights resulting in failure to ensure the patients' right to confidentiality of their medical records, the right to form an advance directive and the right to be informed of their Medicare rights. (Refer to COP A-115)

7. The hospital failed to ensure that a Registered Nurse (RN) supervised and evaluated pressure ulcers, developed and kept current nursing care plans based upon nursing care needs, performed ongoing nursing assessments, and evaluated responses to interventions. The hospital failed to ensure that registered nurses (RN's) were competent to care for patients in the Neonatal Intensive Care Unit (NICU) and the Pediatric Emergency Unit (PEU).

These systemic problems resulted in nursing services not being administered to patients in a safe manner. (Refer to COP A-0385)

8. The hospital failed to develop, implement and maintain an effective, ongoing, hospital-wide, data driven quality program. (Refer to COP A-0263)

9. The hospital failed to ensure that the pharmaceutical service monitored drug therapy.
The Pharmacists failed to ensure that intravenous (IV) insulin administered to a patient was ordered by a physician, failed to clarify physician's range orders for narcotics prescribed on an "as needed" basis. (Range orders are those orders which call for multiple doses of a given drug over a period of time for specific diagnoses.), failed to maintain accurate records regarding the disposition of controlled substances ordered, and the facility failed to remove Darvocet N-100(Propoxyphene NAP w/APAP 100 mg) medication as a selection for pain from approved pre-printed medication order forms. The facility failed to ensure that medications prescribed to patients were being monitored to assure that medication therapy is appropriate and minimizes the occurence of possible adverse events. (Refer to COP A-0490)

The cumulative effects of these deficient practices are the inability for the hospital to ensure that the Governing Body took responsibility over all services of the hospital. It also increased the likelihood of deviation from hospital policy and the standard of care resulting in an inability for the hospital to provide the highest level of patient care.

Based on interview and record review the facility failed to protect and promote patient rights by failing to:

1. Maintain the confidentiality of 1366 patient records that included a variety of protected health information (PHI) and personal information. A facility employee (Employee 1) took the patients' data to her home. The PHI found included a combination of patient/guarantors' name, date of birth, medical record number, address, telephone number, medical insurance numbers and diagnoses. 103 of the 1366 patient records included social security numbers. This failure had the potential to place patients at risk for identity theft. (Refer to A-146)

2. Ensure compliance with advance directive notice requirements for 1 of 31 sampled patients (Patient 26) in a universe of 574. For Patient 26, the hospital failed to protect the rights of the patient, which resulted in the missed opportunity for Patient 26 to formulate an advance directive to make decisions concerning medical care including the right to accept or refuse medical care. (Refer to A-132)

3. The hospital failed to ensure that 1 of 30 sampled patients (Patient 22) and/or their representative were informed of their rights by failing to ensure that the patient received "An Important Message from Medicare about Your Rights" notice within two days of admission. This failure resulted in Patient 22 not being informed of her rights as a hospital inpatient, discharge rights, and the process to appeal a discharge (Refer to A-117)

The cumulative effect of these systemic failures violated the patients' right to confidentiality of their medical records, the right to form an advance directive and the right to be informed of their Medicare rights.

Based on interview and record review, the hospital failed to ensure that 1 of 31 sampled patients (Patient 22) and/or their representative were informed of their rights by failing to ensure that the patient received "An Important Message from Medicare about Your Rights" notice within two days of admission.

This failure resulted in Patient 22 not being informed of her rights as a hospital inpatient, discharge rights, and the process to appeal a discharge.

Findings:

Record review revealed Patient 22 was a 61 year old female admitted to the facility on 1/5/12 with diagnoses that included chronic right hip and shoulder pain.

Record review revealed, "An Important Message from Medicare about Your Rights" form found in the Patient 22's medical record that was not completed.

The "An Important Message from Medicare about Your Rights" form was a document informing patients of their rights as a hospital inpatient, discharge rights, and the process to appeal a discharge.

There was no documented evidence in Patient 22's medical record indicating that the patient or their representative received the Medicare Rights notice within two days of admission. There was no documented evidence that an in-depth discussion had taken place between the facility and Patient 22 and/or their representative discussing, promoting and protecting Patient 22's rights as a hospitalized patient.

During an interview on 1/24/12 at 10:15 AM, RN 2 confirmed that on 1/17/12 there was documentation in Patient 22's medical record indicating that family was at the bedside for a family meeting that included the patient and two sons. RN 2 confirmed that the "An Important Message from Medicare about Your Rights" form was not signed by the patient or their representative.

During an interview on 1/24/12 at 12:12 PM, when asked if Patient 22 was given the Medicare Rights notice, RN 51 stated that she has not had the chart to see if it has been done or not. RN 51 further stated that Patient 22's family calls everyday.

Based on interview and record review, the facility failed to ensure compliance with advance directive notice requirements for 1 of 31 sampled patients (Patient 26) in a universe of 574. For Patient 26, the hospital failed to protect the rights of the patient, which resulted in the missed opportunity for Patient 26 to formulate an advance directive to make decisions concerning medical care including the right to accept or refuse medical care.

Findings:

A record review, on 1/25/12, at 11 AM, of Patient 26 revealed that the patient was admitted on 1/1/12, with a diagnoses which included, all-terrain vehicle accident (ATV- also known as a quad), ascending aortic tear (a tear in the first portion of the largest artery of the body), multiple rib fractures and facial and skull fractures. The record review also revealed that on admission, 1/1/12, Patient 26 was taken to the operating room to repair the aorta and was also intubated (a tube inserted into the lungs to assist in breathing).

A record review, on 1/25/12, at 11:10 AM, of Patient 26, revealed that an advance directive was not signed by the patient or the responsible party to indicate that the hospital informed them of their rights to formulate an advance directive.

An interview and a concurrent medical record review of Patient 26, was conducted on 1/25/12, at 11:10 AM, with RN 1 (a register nurse). She verified that Patient 26 advance directive form was left blank and unsigned by the patient or the responsible party. Additionally, she stated, "He has a mom that's always here, we could have asked her to sign it. It should have been signed."

A record review on 1/26/12, at 2 PM, of the hospital policy titled, "Patients' Rights Regarding Advance Directives and Acceptance/Refusal of Medical Care, effective December 2009," revealed the following:

1. "...(name of hospital) shall recognize that the patient has the right to:"

1.1 "Make decisions about medical care as defined in Policy P-1, Patients' Rights and Responsibilities."
1.2 "Formulate an advance directive in accordance with federal and state statutes, regulations, and court decisions ..."

2. "...(name of hospital) shall do the following concerning all adult and emancipated minor inpatients:

2. 1 "Maintain written policies and procedures to ensure that every adult ...receiving medical care by or through the organization is provided written information at the time of admission concerning an individual ' s right under state law to make decisions regarding his or her medical care. This includes the right to accept or refuse treatment and the right to formulate advance directives."

3. "The duties of caregivers shall be as follows:

3.5 "Review the advance directive with the patient or his or her agent.
3.6 "Document in a prominent part of the patient's medical record whether or not he or she has executed an advance directive ..."

Based on interview and record review, the facility failed to maintain the confidentiality of 1366 patient records that included a variety of protected health information (PHI) and personal information. A facility employee (Employee 1) took the patients' data to her home. The PHI found included a combination of patient/guarantors' names, date of birth, medical record numbers, address, telephone number, medical insurance numbers and diagnoses. 103 of the 1366 patient records included social security numbers. This failure had the potential to place patients at risk for identity theft.

Findings:

Complaint #CA00294008

On 12/29/11 and subsequent dates, a self-reported event of an employee breach of PHI and personal information was investigated.

In an interview on 1/23/12 at 1:00 PM with the facility compliance officer (PO 1), PO 1 stated that a tote bag was discovered in the emergency department (ED) parking lot and was turned in to the facility security department. The bag had coffee that was still hot and when security staff searched the bag they found patient records and an employee pay stub. PO 1 stated that that was how they knew who the bag belonged to. The records in the tote bag found contained 493 pieces of PHI. The employee was working as a registration clerk in the ED at night (Employee 1). "When I interviewed her, she (Employee 1) stated that she had misplaced her keys and the records inadvertently got into her bag." The PO 1 stated "I didn't believe her story so I called the sheriff's department." The sheriff went to Employee 1's home and the employee turned them away. The sheriff later returned with a search warrant and found 873 patient records in the home. The records were returned to the facility corporate compliance office. The facility then sent out notification letters to all the patients whose records were found. The PO 1 further stated that Employee 1 was placed on administrative leave while an investigation was conducted and then subsequently terminated.

A review on 1/23/12 of Employee 1's file showed that she had received training in protecting patient confidentiality. In her confidentiality statement signed by Employee 1 on 12/9/97, the employee indicated that "I also agree and understand that the unauthorized possession, use, or dissemination of confidential information is considered grounds for discipline, including immediate termination of employment."

In an interview with Employee 2 on 1/23/12 at 3:30 PM, he stated that the PHI a registration clerk handles was put into a blue bin designated for papers to be shredded. Employee 2 further stated that any signed documents are placed in a bin to go to the medical records department for scanning into the computer and he acknowledged that there would be no reason to remove the papers from the facility by a registration clerk.

A review of the facility policy and procedure titled "Privacy and Security of Information Resources Transport of Protected Health Information" with an effective date of 3/2011 showed the following:
1. PHI transported from one campus location to another or to an offsite facility shall be based on department business purposes only.
2. Only designated individuals may transport PHI on or off campus.

The facility failed to prevent unauthorized access to patients' confidential protected health information and personal information.

Based on interview and record review, the hospital failed to develop, implement and maintain an effective, ongoing, hospital-wide, data driven quality program as evidenced by the following:

1. The hospital failed to identify all medication errors. (Refer to A-266).
2. The hospital failed to develop and maintain data-driven quality assessment indicators for the hospital's Department of Anesthesia program when it failed to analyze and track adverse events of patients receiving anesthesia in the hospital. (Refer to A-267).

The hospital failed to develop quality indicators for anesthesia-related adverse events when Patient 29's Anesthesia Physician, during insertion of a lumbar epidural catheter, left fragments of the tip of the catheter inside the patient's back This deficient practice had the potential for affecting patient health outcomes, patient safety, and quality of care resulting in missed opportunities for improvement and changes that would lead to improvement. (Refer to A-267).

3. The hospital failed to ensure that the most frequently occurring medication error indicators were analyzed. The hospital failed to ensure that corrective action was taken regarding these frequently occurring errors to improve patient care outcomes. (Refer to A-276).

The cumulative effects of these systemic problems resulted in the hospital's inability to provide quality health care in a safe environment.

Based on interviews, record reviews and document reviews, the hospital failed to identify all medication errors.

Findings:

Summary medication event reports for 2010 and 2011 were provided by Pharm 1. The reports identified the number of medication errors which occurred by month for each calendar year. The total number of errors reported for 2010 was 996; and for 2011, 918.
Data provided by QA 41 on January 24, 2012 revealed:
1. For 2010, the total number of patient days were 199,998. The number of discharges were 31,189. (Total medication errors reported, identified above, were 996.)
2. For 2011, the total number of patient days were 211,271. The number of discharges were 32,016. (Total medication errors reported, identified above, were 918.)

The Institute of Medicine (IOM is a nationally recognized organization which focuses on medication safety), in a book entitled "Preventing Medication Errors: Quality Chasm Series (2007)" concluded that, "on average, a hospital patient is subject to at least one medication error per day."
Thus, according to the research performed by the IOM, the hospital should be reporting, about 199,998 errors per year in 2010, or about 200 times the number of errors actually reported (199,998/996) and 211,271 in 2011 or about 230 times the number actually reported (211,271/918).

A study entitled "Global Trigger Tool Shows That Adverse Events in Hospitals May be Ten Times Greater Than Previously Measured" was published in Health Affairs (HA) dated April 12, 2011, pages 581 to 589. The study identified that closed medical records for 795 patients from 3 hospitals between, October 1 to 31, 2004, were reviewed using the Institute for Healthcare Improvement's (IHI) Global Trigger Tool. The study found that Safety Indicators and Hospital Voluntary Reporting "fail(ed) to detect more than 90 percent of the adverse events that occur among hospitalized patients." The study also showed:
a) 38% of identified adverse events were medication errors.
b) That each patient was subjected to 5.3 medication errors during his/her hospital stay.
According to the HA study, the hospital should be reporting 165,301 (5.3 x 31,189) errors in 2010 and 169,685 (5.3 x 32,016) errors in 2011. This is 165 times (165,301/996) the number actually reported in 2010 and 185 times (169,685/918) the number reported in 2011.

The Agency for Healthcare Research and Quality (AHRQ) in its annual "Hospital Survey on Patient Safety Culture 2011", identified that 54% of the hospitals, on average, reported no events at their hospitals during the past 12 months. Although the initial numbers appear that more than half of hospitals have no incidents, it's more likely they simply go unreported according to AHRQ. "This is an area for improvement for most hospitals because underreporting of events means potential patient safety problems may not be recognized or identified and therefore may not be addressed," according to AHRQ.

The Office of Inspector General (OIG) prepared an adverse event report in January 2012. The objectives of the report were:
1) To identify how hospitals use incident reports.
2) To determine the extent to which hospital incident reporting systems capture patient harm that occurs within hospitals.
Results of the report:
1) 189 hospitals were surveyed.
2) Nurses most often reported the events through the regular course of care.
3) Hospitals relied upon voluntary incident reports to identify
incidents.
4) 38% of the incidents were medication related. Only 13% of these were captured by the hospitals.
This further confirms that the traditional voluntary incident reporting systems capture only a small percentage of the incidents. Hospitals should consider also using other means to capture all or a majority of these incidents.

It is interesting to note that using the IOM and HA study models, the number of errors that should be reported by the hospital are somewhat similar....about 200,000 for each of the hospital sampled years for IOM versus about 170,000 each year for HA....not 996 and 918 which were actually reported.

This is substantiated by a review of the medical records for patients 41, 42 and 43.
a) The medical record for patient 41, reviewed on January 24, 2012 at 2:40 PM, revealed that between 10:28 PM on January 18th and 7:20 AM on January 20th, while in MICU, 14 doses of IV insulin were administered without a physician's order and were not reported. This was confirmed by Pharm 42 and RN 48. Thus, there were 14 errors which occurred in 2 days for this 1 patient that were not reported.
b) The medical record for patient 43, reviewed on January 25, 2012, revealed: 1) At 11:30 PM on December 3, 2011, Hydromorphone (a narcotic) was ordered as 0.2 - 0.4 mg intravenously every 10 minutes prn. Max 2 mg. The order is incomplete and must be clarified to determine as needed for what. At what patient response shall an RN administer 0.2 mg or 0.4 mg or any dose between 0.2 and 0.4 mg.
2) At 11:41 PM on December 3, 2011, Norco (a narcotic) 10/325 was ordered as 1 to 2 tablets PO (orally) every 4 hours as needed for pain. The order is incomplete and must be clarified to determine what degree of pain requires 1 tablet or 2 tablets. Otherwise the order asks a nurse to read the physician's mind as to when 1 or 2 tablets should be administered.
3) At 2:30 AM on December 4, 2011, Dilaudid (a narcotic) was ordered as 0.5 - 2 mg intravenously every 2 hours as needed for breakthrough pain. Again the order is incomplete and must be clarified to determine at what patient response shall the nurse administer 0.5 mg or 2 mg or in fact any dose between 0.5 mg and 2 mg.
c) The medical record for patient 42 was reviewed on January 25, 2012 and revealed:
1) At 7:20 PM on December 4, 2011, Norco (a narcotic) was ordered as 1 - 2 tabs 5/325 mg every 6 hours prn (as needed for) pain. This order is incomplete and should have been clarified as described in (b)(2) above.
2) At 12:30 AM on December 4, 2011, a Dopamine intravenous drip was ordered as 6 mcg - 8 mcg per Kg per minute. (1 Kg = 2.2 pounds.) The order is incomplete and must be clarified to determine why Dopamine was ordered, what outcome is wanted; what dose is needed for a specific outcome and when is administration of the drug to be stopped. Moreover, this is a dangerous situation as Dopamine is used to treat shock; used after open heart surgery or to treat kidney failure and has a Black Box Warning (BBW) from the FDA. A BBW means that a dose of the drug which is administered in error can cause serious harm or death.
There was no evidence found in patients 42 and 43 records which documented that the doses described in (b) and (c) above were clarified and/or changed and no evidence that they were reported.
Thus, in addition to the unreported 14 errors in 2 days described in (a) above, there were an additional 5 errors over 2 days (described in (b) and (c)) that were not reported.
So, a total of 19 errors for 3 patients in 2 days or about 3 errors per patient per day was discovered that were not reported. Even if only 1 additional error per patient per day was reported, that would add about 200,000 errors per year to the total.
Each of the studies/reports described above and the discovery of the unreported errors reveal the hospital is grossly underreporting medication errors. As a result, the hospital is failing to assess and take corrective action to reduce all the likely occurring medication errors.

Based on interview and record review, the hospital's Quality Improvement Organization failed to develop and maintain data-driven quality assessment indicators for the hospital's Department of Anesthesia program when it failed to analyze and track adverse events of patients receiving anesthesia in the hospital for 1 of 31 sampled patients (Patient 29). The hospital failed to develop quality indicators for anesthesia-related adverse events when Patient 29's Anesthesia Physician, during insertion of a lumbar epidural catheter, left fragments of the tip of the catheter inside the patient's back This deficient practice had the potential for affecting patient health outcomes, patient safety, and quality of care resulting in missed opportunities for improvement and changes that would lead to improvement.

Findings:

On 9/2/11, Patient 29, prior to a planned vaginal delivery, underwent a lumbar epidural procedure in which fragments of the epidural catheter was retained inside her epidural space. (The term epidural is often short for epidural analgesia, a form of regional analgesia involving injection of drugs through a catheter placed into the epidural space. The injection can cause both a loss of sensation (anesthesia) and a loss of pain (analgesia) by blocking the transmission of signals through nerves in or near the spinal cord).

On 9/22/11, the medical record of Patient 29 was reviewed. Patient 29 was a gravida 2, para 1 female (gravida=a total number of female pregnancies; para=number of viable infants) who was admitted to the facility on 9/1/11 at 41 weeks for induction of labor for post dates and a planned vaginal delivery of a baby boy. Patient 29 elected to have a lumbar epidural catheter inserted for pain control. The Anesthesia Preoperative Evaluation was completed by the Anesthesia Resident A, on 9/1/11 at 8:05 PM, and Patient 29 was found to have an ASA (American Society of Anesthesiologists) score of 2 (indicating the patient was found to be a low risk for anesthesia)

On 9/22/11, a review of the hospital's Anesthesia Report titled, "PROCEDURE COMMENTS" dated 9/22/11 for Patient 29 was conducted. The entry dated 9/2/11, and timed 4:50 AM, documented the following: "...Needle advanced until loss of resistance at depth of 4.5 centimeters. Catheter threaded to 10 centimeters at needle hub with transient paresthesia to left. Some resistance met at this depth. Catheter retracted to enable recheck of location of resistance. However, as the catheter was pulled from end of Tuohy needle (a needle used to insert the epidural catheter into the epidural space) it was noted that catheter tubing was severed at the 6 centimeter mark. Touhy needle was removed over internal wire and catheter to expose entry site ..."

On 9/22/11, a review and examination of the Lumbar Epidural Catheter Sample Kit along with the manufactures' recommended instruction sheet; similar to the one used on Patient 29 was conducted. The Smiths-Medical Portex Continuous Epidural Catheter Kit documented the following warnings and precautions: "NEVER WITHDRAW THE CATHETER BACK THROUGH THE EPIDURAL NEEDLE AS THIS MAY CAUSE THE CATHETER TO KINK OR SHEAR."

On 9/22/11, at approximately 3:00 PM, during an interview with the Patient Safety & Reliability Director, when asked if the facility had hospital-wide a policy and procedure on "Standards of Lumbar Epidural Catheter Placement", she responded, "No, but the Department of Anesthesia has their own policy and procedure for epidural placement for teaching purposes for anesthesia residents."

On 9/22/11, at approximately 3:05 PM, an interview was conducted with Anesthesia Physician A (a fourth year Anesthesia Resident). When asked what occurred on 9/2/11 while attempting to insert a lumbar epidural catheter into Patient 29's back, she stated, "I was attempting to insert the epidural catheter into the patient's (Patient 29) back prior to delivery. On insertion of the epidural catheter, I met resistance at a certain level and retracted the catheter back. When I retracted the catheter I noticed the tip of the catheter was missing."

When asked if her insertion technique might have been the problem causing the tip of the epidural catheter to be sheared off at the 6 centimeter mark and remained lodged in Patient 29's epidural space, she stated, "Yes, I think so, I should not have pulled out the catheter without pulling out the needle as one."

On 9/22/11, at approximately 3:14 PM, an interview was conducted with Anesthesia Physician B (an Anesthesia Attending Physician). When asked if he thought the retained fragment of the epidural catheter was possibly due to Anesthesia Physician A's insertion technique, he responded, "Yes." When asked further if he thought the retained fragment of the epidural catheter was possibly due to a "device defect", he stated, "I don't think so, but I did call the manufacturer, maker of the epidural catheter, just to make sure."

There was no documented evidence that the hospital-wide Quality Assurance and Performance Department tracked, measured, analyzed or developed quality indicators for anesthesia related adverse events following Patient 29's incident.

There was no documented evidence that the hospital-wide Quality Assurance and Performance Department reviewed Patient 29's anesthesia related adverse event, or its QA system and review process. There was no opportunity for root-cause determination, corrections, or corrective actions for effectiveness monitoring as deemed appropriate. In addition, there was no opportunity for improvement through collection, analysis and reporting of data in order to monitor performance and verify compliance with hospital-wide requirements.

And finally, there was no opportunity for continuous improvement through analysis results, research, best practices and effectiveness monitoring at the Organizational/Hospital level.

On 9/22/11, at approximately 4:20 PM, and on 1/25/12, at approximately 9:45 AM, during an interview with the Patient Safety & Reliability Director, when asked if this anesthesia-related adverse event was reported to the California Department of Public Health and the Hospital-Wide Quality Assurance Performance Improvement Program, she stated, "No, the evaluation of the incident stays at the Department of Anesthesia level and the physicians felt the retained fragment was purposefully retained and therefore not reported."

Based on interviews and document reviews, the hospital failed to ensure that the most frequently occurring medication error indicators were analyzed. The hospital failed to ensure that corrective action was taken regarding these frequently occurring errors to improve patient care outcomes.

Findings:

Summary medication event reports for 2009, 2010 and 2011 were provided by Pharm 1. The reports identified types of medication errors which occurred by month for each calendar year. The most frequently reported errors were "Wrong Dose/Rate/Amount" and doses "Not Given". They remained static and represented 33% of the errors in 2009, 38% in 2010 and 27% in 2011.
"Other" medication errors were also reported and represented an additional 7% in 2010 and 15% in 2012. There were no "other" errors reported in 2009. Thus "Wrong Dose/Rate/Amount, "Not Given" and "Other" errors represented 45% of the errors in 2011 and 42% of the errors in 2012.
During a meeting with Pharm 1, Pharm 2, Pharm 3 and QA 41 starting at 2:00 p.m. on January 25, 2012, Pharm 1 stated that medication errors are reported to the MERP subcommittee (also referred to as the Medication Safety Committee (MSC)). The MSC assesses the errors and submits a report to the Pharmacy and Therapeutics Committee (P&T). The P&T then submits a report to the Medical Executive Committee (MEC).

MSC minutes for 2011 were reviewed on January 24, 2012 starting at 3:45 p.m. There was no evidence in any of the minutes that the MSC analyzed the most frequently occurring medication errors or recommended corrective action to improve patient care. Further, there is no evidence the MSC questioned the increase in "Other" errors or requested an analysis of what those errors were.

The P&T minutes for 2011 were also reviewed at that time. There is no evidence in any of the minutes that the P&T analyzed the most frequently occurring medication errors or took corrective action to improve patient care. Further, there is no evidence the P&T questioned the increase in "Other" errors or requested an analysis of what those errors were.

During the above referenced meeting with Pharm 1, Pharm 2, Pharm 3 and QA 1, they confirmed there was no evidence the MSC or P&T addressed the most frequently occurring error indicators.

Based on interview and record review, the hospital failed to ensure that the Medical Staff Bylaws were followed in the case of 1 of 31 sampled patients (Patient 31) undergoing surgery who had a significant deterioration in medical condition that was not communicated from the consulting physicians (Anesthesia resident and attending) to the patient's primary physician, the surgeon. The Medical Staff bylaws state that a consulting physician must notify the patient's primary physician if there is a change in condition. This resulted in a missed opportunity to stop the surgery promptly, and the patient going into a Code Blue (cardiac or respiratory arrest). The Medical Staff also failed to follow the hospital's policy on the use of range orders. This resulted in the possibility of confusion when the nursing staff tried to follow these orders and give the dose of medication intended by the physician.

Findings:

The hospital failed to ensure that the Medical Staff Bylaws were followed in the case of Patient 31 undergoing surgery who had a significant deterioration in medical condition that was not communicated from the consulting physicians (Anesthesia resident and attending) to the patient's primary physician, the surgeon. See A-0353 ?482.22(c)

The cumulative effect of these deficient practices resulted in the failure of the Medical Staff to ensure that the bylaws were followed and that the highest quality of patient care was provided.

Based on interview and record review, the hospital failed to ensure that the Medical Staff Bylaws were followed in the case of 1 of 31 sampled patients (Patient 31) undergoing surgery who had a significant deterioration in medical condition that was not communicated from the consulting physicians (Anesthesia resident and attending) to the patient's primary physician, the surgeon. The Medical Staff bylaws state that a consulting physician must notify the patient's primary physician if there is a change in condition. This resulted in a missed opportunity to stop the surgery promptly, and the patient going into a Code Blue (cardiac or respiratory arrest).

Findings:

Complaint # CA00283238

The Medical Staff Bylaws were reviewed 1/25/12 at 9:00AM. They stated that the consulting physician is responsible for notifying the attending physician of a change in the patient's condition.

Patient 31's record was reviewed and showed on the Anesthesia Record that there were several times that the blood pressure dropped during surgery. The resident responded by giving IV fluids.

The director of surgery was interviewed on 01/24/12. She stated that the situation in the OR when the patient began to have an unstable blood pressure was at a time that the attending anesthesia physician was in and out of the room. She further stated that there was suboptimal communication between the anesthesia physician and the surgeon. The case was handled by an Anesthesia resident. The resident communicated the instability of the patient to his monitoring physician, the Anesthesia attending but neither reported this information to the surgeon.

A record review on 1/24/12 of Patient 31's medical record showed that the patient went to ICU after surgery and never regained consciousness. The patient was made a do not resusitate by the family on 11/7/10 and life support was withdrawn at 3:00 PM on 11/7/10 and the patient subsequently died.

Based on interviews and record review, the hospital failed to:

1. Ensure that insulin was administered to patient 41 as ordered by a physician. (Refer to A-404)

2. Ensure parameters were set for the administration and titration of continuous intravenous propofol drips for Patient 22. (Refer to A-404)

3. The facility failed to ensure that a Registered Nurse (RN) supervised and evaluated pressure ulcers for 2 of 31 sampled patients (Patients 21 and 26) in a universe of 574. (Refer to A-395)

4. The facility failed to ensure that the nursing staff developed and kept current nursing care plans for 4 (Patients 21,26, 27 and 29) of 31 sampled patients, in a universe of 574, based upon nursing care needs, ongoing nursing assessments, and responses to interventions. These failures had the potential to affect health outcomes and quality of care for Patients 21, 26, 27 and 29).

A. For Patient 21, the hospital failed to ensure that nursing developed a plan of care for the patient who was admitted as a result of low sodium levels and a fever. Additionally, the facility failed to develop a care plan when the patient was found to have a hospital acquired pressure ulcer (a localized injury to the skin and/or underlying tissue usually over a bony prominence, as a result of pressure/shear and/or friction). This failure had the potential to delay assessment and treatment of the hospital acquired pressure ulcer.

B. For Patient 26, the hospital failed to ensure that nursing developed a plan of care for the patient who was identified on 1/9/12 as having an unstageable pressure ulcer, a full thickness tissue loss in which the base of the ulcer is covered by slough (yellow,tan, gray, green or brown) or eschar (tan, brown or black) in the wound bed. Pressure ulcers are staged from Deep Tissue Injury which are purple/maroon and the skin is intact, to Stage IV, the most tissue damage and unstageable (full tissue loss and the wound is covered by slough and or eschar; National Pressure Ulcer Advisory Panel up-date 2/2007).

C. For Patient 29, the hospital failed to ensure that the Post Partum nursing staff had developed a comprehensive, coordinated individualized plan of care addressing specific signs and symptoms of neurological regression to Patient 29's lower extremities as a result of a retained epidural catheter fragment in her back (epidural space).

D. For Patient 27, the hospital failed to ensure that the SICU (surgical intensive care unit) nursing staff developed a plan of care for the patient admitted to the unit with a diagnosis of chronic renal failure who underwent a liver and kidney transplant on 1/24/12 addressing the transplant, care of drains in place after the transplant, and signs and symptoms of a transplant rejection. This failure had the potential to result in substandard care to be delivered as a result of the care plan not being updated, individualized and kept current with the patients identified needs and goals. (Refer to A-396)

5. The hospital failed to ensure that registered nurses (RN's) were competent to care for patients in the Neonatal Intensive Care Unit (NICU) and the Pediatric Emergency Unit (PEU). (Refer to A-397)

The cumulative effect of these systemic problems resulted in nursing services not being administered to patients in a safe manner.

Based on interview and record review, the facility failed to ensure that a Registered Nurse (RN) supervised and evaluated pressure ulcers for 2 of 31 sampled patients (Patients 21 and 26) in a universe of 574.

Pressure Ulcer Definition: A pressure ulcer is a localized injury to the skin and/or underlying tissue usually over a bony prominence, as a result of pressure, or pressure in combination with shear and/or friction, National Pressure Ulcer Advisory Panel (NPUAP), February 2007.


Findings:

1. A record review on 1/24/12, at 10 AM, of Patient 21 revealed that the patient was admitted on 1/20/12, with diagnoses which included cancer of the right base of the tongue, hyponatremia (low sodium levels) and fevers.

A record review on 1/24/12, at 10 AM, of Patient 21, indicated that the patient did not have an initial admission assessment performed by a RN.

An interview was conducted on 1/24/12, at 10 AM, with RN 6, who reviewed the medical record and stated that no initial nursing assessment was done for Patient 21.

An interview and a concurrent record review were conducted on 1/24/12, at 11 AM, of Patient 21's medical record with RN 2. She stated that an admission assessment was not performed on 1/20/12 upon admission but that it was done on 1/23/12. Additionally, she stated that it should have been done on 1/20/12, when the patient was admitted.

A record review on 1/24/12, at 10 AM, of Patient 21's nursing "Pressure Ulcer Review" (a patient skin assessment where nurses document identified abnormal skin conditions, such as pressure ulcers) from 1/20/12 at 12:57 PM to 1/23/12 at 4 AM, indicated that Patient 21 had no identified pressure ulcers. However on 1/23/12, at 7 PM, a nurse documented that a pressure ulcer was identified and staged it at a 2. There were no measurements of the pressure ulcer documented.


A record review on 1/24/12, at 10 AM, of a picture taken of Patient 21's pressure ulcer on the coccyx region, revealed that the picture was taken on 1/23/12, at 1:30 PM.

An interview and a concurrent record review of Patient 21's pressure ulcer documentation were conducted, on 1/24/12, at 2:15 PM, with RN 4. The RN stated that she did a skin assessment of Patient 21 but that she did not turn the patient completely because the pressure ulcer was on the crevice and she could not visualize it entirely. RN 4 stated that she "Only saw" the pressure ulcer on a picture that some else took, on 1/23/12. RN 4 stated that she did not document her assessment but described it as a Stage 2. Additionally, she stated that she did not provide any treatment because it was change of shift and she passed it on to the next shift.

An interview and a concurrent record review of Patient 21's pressure ulcer skin assessment documentation were conducted, on 1/24/12, at 3:10 PM, with RN 5. The RN stated that based on the documentation that was in the medical record, Patient 21 developed a hospital acquired pressure ulcer and she described it as a Stage 3. RN 5 reviewed the picture that nursing took of the pressure ulcer on 1/23/12, as well as the staging that they did when they described it as a Stage 2. RN 5 stated that Patient 21's pressure ulcer was " Definitely, a Stage 3. Nursing tries but they did not completely spread open the area to expose the pressure ulcer. " RN 5 stated that the pressure ulcer was not a Stage 2 and also stated that nursing required more education on staging and documenting of pressure ulcers.

A record review conducted on 1/25/12, at 3 PM, of a facility policy titled, "Interdisciplinary Assessment and Reassessment of Patients: Overview of Discipline-Specific Criteria and Procedures, effective 05/2009, "instructed RNs that "Initial Assessment Time Frame" was to be completed "Upon admission and documented according to unit specific protocols." The "Reassessment Time Frame" was "A minimum of each shift for inpatients ...changes in condition, diagnosis, treatment plan, and patient response to care." The policy also informed nurses and directed them to document in the "Nursing Section/(name of facility) Power Chart in Admission History/Assessment, Shift Assessment, Patient Care Flow Sheet/Progress Note, Nurse's Notes."

A record review was conducted on 1/25/12, at 3 PM, of a protocol that the facility stated they utilized, titled "Mosby's Nursing Skills Pressure Ulcer Treatment Quicksheet, Copyright 2006-2012, Elsivier Inc." The protocol informed nurses to "...Reassess area (pressure ulcer) at least every shift ...Stage wound as per National Pressure Ulcer Advisory Panel guidelines...Measure and photograph ulcers or wounds, on first identification of ulcer or wound ...Measure longest length by widest width of ulcer ...Ensure documentation of: 1. All ulcer, wound, dressing observations/assessment ...3. All needs, problem list, patient goals and interventions in the care plan." The protocol defined the pressure ulcers as 5 stages: Stage 1 was intact skin, Stage 2 was a partial-thickness wound, Stages 3 and 4 were full thickness wounds and the fifth was unstageable/eschar (tan, brown or black) however it did not define the pressure ulcer at that stage.

A record review on 1/30/12, at 2 PM, of "The National Pressure Ulcer Advisory Panel" definition and staging of pressure ulcers was reviewed and the following was revealed:

1. In February 2007 the NPUAP redefined the definition and the stages of pressure ulcers. It included the original 4 stages (Stages 1 to 4) and added 2 stages, which were deep tissue injury and unstageable pressure ulcers.

2. The staging system provided a name to the amount of anatomical tissue loss because the original definitions were confusing to many clinicians and lead to inaccurate staging of ulcers.

3. The staging of the pressure ulcers were as followed:
Suspected Deep Tissue Injury: Purple or maroon localized area of discolored intact skin or blood-filled blister due to damage of underlying soft tissue from pressure and/or shear. It may be preceded by tissue that is painful, firm, mushy, boggy, warmer or cooler as compared to the surrounding tissue. The wound may further progress and become covered by thin eschar. Progression may be rapid exposing additional layers of tissue even with optimal treatment.Stage I: Intact skin with non-blanchable redness of a localized area usually found over a bony area. Dark pigmented skin may not have visible blanching; its color may differ from the surrounding area. It may be painful, firm, soft, warmer or cooler, compared to adjacent tissue.
Stage II: Partial thickness loss of the dermis which presented as a shallow open ulcer with a red pink wound bed and without slough (yellow, tan, gray, green or brown). It may also present as an intact or open/ruptured fluid filled blister and presented as a shiny or dry shallow ulcer without slough or bruising. Bruising indicated suspected deep tissue injury.Stage III: Full thickness tissue loss and the subcutaneous fat may be visible but bone, tendons or muscles are not exposed. Slough may be present but does not obscure the depth of the tissue loss. It may also include undermining and tunneling. Stage IV: Full thickness tissue loss with exposed bone, tendon or muscle is visible or palpable. Slough or eschar may be present on some parts of the wound and often includes undermining and tunneling.Unstageable:Full thickness tissue loss and the base of the ulcer is covered by slough and/or eschar in the wound.


2. A record review, on 1/25/12, at 11 AM, of Patient 26 revealed that the patient was admitted on 1/1/12, with diagnoses which included, all-terrain vehicle accident (ATV- also known as a quad), ascending aortic tear (a tear in the first portion of the largest artery of the body), multiple rib fractures and facial and skull fractures. The record review revealed that on admission, 1/1/12, Patient 26 was taken to the operating room to repair the aorta and was also intubated (a tube inserted into the lungs to assist in breathing).

A record review, on 1/25/12, at 11 AM, of Patient 26 nursing "Pressure Ulcer Review," from Patient 26's day of admission on 1/1/12 (at 1 PM) thru 1/9/12 (at 5:30 PM), indicated that Patient 26 had no pressure ulcers.

A record review, on 1/25/12, at 11 AM, of Patient 26 nursing "Pressure Ulcer Review" conducted on 1/9/12, at 7 PM, indicated that nursing identified an "Unstageable" pressure ulcer on Patient 26's buttocks however no measurements were obtained. The documentation also indicated that a picture of the pressure ulcer was obtained on 1/9/12 however no pictures dated 1/9/12 were found in the medical record.

A record review, on 1/25/12, at 11 AM, of Patient 26's nursing assessment performed by a WOCN (a nurse consultant who specializes in the identification and treatment of wounds including pressure ulcers), documented that on 1/10/12, at 9:58 AM, that Patient 26 had a
"Deep Tissue Injury" on the buttocks that was 7 centimeters by 2 centimeters and had no drainage. A picture of the pressure ulcer was obtained by the WOCN and dated 1/10/12.

A record review, on 1/25/12, at 11 AM, of Patient 26 nursing "Pressure Ulcer Review" performed by nursing from 1/10/12 at 11 AM to 1/16/11 at 3 PM documented the following inconsistencies:

1. All the "Pressure Ulcer Reviews" performed by the nursing staff documented no measurements of the pressure ulcer.
2. Some nurses documented that the pressure ulcer was closed and did not have any drainage. Other nurses documented that the pressure ulcer was open and had drainage while others documented nothing other than a "Deep Tissue Injury."
3. On 1/11/12, from 7 AM to 6 PM, the "Pressure Ulcer Review" under the section titled "Abnormal Skin/Wound," (the section where the nurses can document any skin abnormalities), was left blank.
4. On 1/16/12, at 4 PM, a nurse documented "Length 2 centimeters, width 10 centimeters and depth 0.2 centimeters," nothing else was documented to describe an assessment of the skin.
5. On 1/16/12, at 6:30 PM, indicated that the pressure ulcer on Patient 26's buttocks progressed to a Stage 2 pressure ulcer. No measurements were documented.

An interview and a concurrent record review of Patient 26's medical record, on 1/25/12, at 11:30 AM, with RN 1 were conducted. RN 1 was asked about the inconsistencies in the skin assessment and pressure ulcer descriptions. RN 1 stated, "We need help with that (staging of pressure ulcers). The nurses have problems identifying the pressure ulcers. We need more education. We used to have a sign that had pictures to help us identify the pressure ulcers. We used it for guidance but they told us that it had to be taken down." Additionally, RN 1 stated that the facility does not have policies on pressure ulcers and that they used "Mosby's protocol" to guide them.

An interview was conducted on 1/25/12, at 2:30 PM, with RN 2 (a RN educator), to discuss the inconsistencies with the nursing assessments of Patient 26's pressure ulcers. She stated that she agreed that there were inconsistencies and that more education needed to be provided to the nurses. RN 2 confirmed that the facility had no policies regarding pressure ulcers and that they utilized "Mosby's protocol" to guide them.

A record review was conducted on 1/25/12, at 3 PM, of a protocol that the facility stated they utilized, titled "Mosby's Nursing Skills Pressure Ulcer Treatment Quicksheet, Copyright 2006-2012, Elsivier Inc." The protocol informed nurses to "...Reassess area (pressure ulcer) at least every shift ...Stage wound as per National Pressure Ulcer Advisory Panel guidelines...Measure and photograph ulcers or wounds, on first identification of ulcer or wound ...Measure longest length by widest width of ulcer ...Ensure documentation of: 1. All ulcer, wound, dressing observations/assessment ...3. All needs, problem list, patient goals and interventions in the care plan." The protocol defined the pressure ulcers as 5 stages: Stage 1 was intact skin, Stage 2 was a partial-thickness wound, Stages 3 and 4 were full thickness wounds and the fifth was unstageable/eschar (tan, brown or black) however it did not define the pressure ulcer at that stage.


A record review on 1/30/12, at 2 PM, of "The National Pressure Ulcer Advisory Panel" definition and staging of pressure ulcers was reviewed and the following was revealed:

1. In February 2007 the NPUAP redefined the definition and the stages of pressure ulcers. It included the original 4 stages (Stages 1 to 4) and added 2 stages, which were deep tissue injury and unstageable pressure ulcers.

2. The staging system provided a name to the amount of anatomical tissue loss because the original definitions were confusing to many clinicians and lead to inaccurate staging of ulcers.

3. The staging of the pressure ulcers were as followed:
Suspected Deep Tissue Injury: Purple or maroon localized area of discolored intact skin or blood-filled blister due to damage of underlying soft tissue from pressure and/or shear. It may be preceded by tissue that is painful, firm, mushy, boggy, warmer or cooler as compared to the surrounding tissue. The wound may further progress and become covered by thin eschar. Progression may be rapid exposing additional layers of tissue even with optimal treatment.Stage I: Intact skin with non-blanchable redness of a localized area usually found over a bony area. Dark pigmented skin may not have visible blanching; its color may differ from the surrounding area. It may be painful, firm, soft, warmer or cooler, compared to adjacent tissue.
Stage II: Partial thickness loss of the dermis which presented as a shallow open ulcer with a red pink wound bed and without slough (yellow, tan, gray, green or brown). It may also present as an intact or open/ruptured fluid filled blister and presented as a shiny or dry shallow ulcer without slough or bruising. Bruising indicated suspected deep tissue injury.Stage III: Full thickness tissue loss and the subcutaneous fat may be visible but bone, tendons or muscles are not exposed. Slough may be present but does not obscure the depth of the tissue loss. It may also include undermining and tunneling. Stage IV: Full thickness tissue loss with exposed bone, tendon or muscle is visible or palpable. Slough or eschar may be present on some parts of the wound and often includes undermining and tunneling.Unstageable:Full thickness tissue loss and the base of the ulcer is covered by slough and/or eschar in the wound.

Based on interview and record review, the facility failed to ensure that the nursing staff developed and kept current nursing care plans for 4 (Patients 21,26, 27 and 29) of 31 sampled patients, in a universe of 574, based upon nursing care needs, ongoing nursing assessments, and responses to interventions. These failures had the potential to affect health outcomes and quality of care for Patients 21, 26, 27 and 29).

1. For Patient 21, the hospital failed to ensure that nursing developed a plan of care for the patient who was admitted as a result of low sodium levels and a fever. Additionally, the facility failed to develop a care plan when the patient was found to have a hospital acquired pressure ulcer (a localized injury to the skin and/or underlying tissue usually over a bony prominence, as a result of pressure/shear and/or friction). This failure had the potential to delay assessment and treatment of the hospital acquired pressure ulcer.

2. For Patient 26, the hospital failed to ensure that nursing developed a plan of care for the patient who was identified on 1/9/12 as having an unstageable pressure ulcer, a full thickness tissue loss in which the base of the ulcer is covered by slough (yellow,tan, gray, green or brown) or eschar (tan, brown or black) in the wound bed. Pressure ulcers are staged from Deep Tissue Injury which are purple/maroon and the skin is intact, to Stage IV, the most tissue damage and unstageable (full tissue loss and the wound is covered by slough and or eschar; National Pressure Ulcer Advisory Panel up-date 2/2007).

3. For Patient 29, the hospital failed to ensure that the Post Partum nursing staff had developed a comprehensive, coordinated individualized plan of care addressing specific signs and symptoms of neurological regression to Patient 29's lower extremities as a result of a retained epidural catheter fragment in her back (epidural space).

4. For Patient 27, the hospital failed to ensure that the SICU (surgical intensive care unit) nursing staff developed a plan of care for the patient admitted to the unit with a diagnosis of chronic renal failure who underwent a liver and kidney transplant on 1/24/12 addressing the transplant, care of drains in place after the transplant, and signs and symptoms of a transplant rejection. This failure had the potential to result in substandard care to be delivered as a result of the care plan not being updated, individualized and kept current with the patients identified needs and goals.

Findings:

1. A record review on 1/24/12, at 10 AM, of Patient 21 revealed that the patient was admitted on 1/20/12, with diagnoses which included cancer of the right base of the tongue, hyponatremia (low sodium) and fevers. On admission, Patient 21 had a PEG tube (Percutaneous Endoscopic Gastrostomy tube - is also called a feeding tube and if not cared for properly could result in an infection).

A record review on 1/24/12, at 10 AM, of a physician's transfer note, dated 1/23/12, at 7:10 PM, revealed that Patient 21 was scheduled for a tongue biopsy on 1/20/12 however prior to the procedure, the patient developed a fever and hyponatremia which resulted in the patient's hospital admission.

A record review on 1/24/12, at 10 AM, of Patient 21's nursing "Pressure Ulcer Review" (a patient skin assessment which nurses perform to identify abnormal skin conditions, such as pressure ulcers) from 1/20/12 at 12:57 PM to 1/23/12 at 4 AM, indicated that Patient 21 had no identified pressure ulcers.

A record review on 1/24/12, at 10 AM, of Patient 21's "Wound Care Team" assessment revealed that the WOCN (a nurse consultant who specializes in the identification and treatment of wounds including pressure ulcers), identified a Stage 3 pressure ulcer on Patient 21's coccyx (buttocks region) that was 2.5 centimeters by 1 centimeters and 0.5 centimeters deep.

A record review on 1/24/12, at 10 AM, of Patient 21's care plans revealed that the patient's plan of care did not reflect Patient 21's health care needs for the fevers, the hyponatremia and the PEG tube. Additionally, there was no care plan to reflect that Patient 21 had a Stage 3 pressure ulcer on the coccyx.

An interview and a concurrent record review of Patient 21's care plans, on 1/24/12, at 11 AM, were conducted with RN 2. RN 2 stated that there were no care plans in the medical record to address Patient 21's fever and there was no care plan for the hyponatremia.

An interview and a concurrent record review of Patient 21's care plans, on 1/24/12, at 2:15 PM, were conducted with RN 4, who stated that there were no care plans developed for the patient's fevers, hyponatremia, and for the PEG tube. RN 4 also stated that the care plan in Patient 21's medical record did not reflect the patient's current needs and that Patient 21 was admitted with a PEG tube and should have had a care plan developed. Additionally, RN 4 stated that there was no care plan to indicate that Patient 21 had a Stage 3 pressure ulcer on the coccyx.

A record review, on 1/25/12, at 3 PM, of the facility policy titled, "Patient Care Process and Documentation (Inpatient) - effective 08/2009," documented the following:

"...B. Plan of Care/Treatment Plan- 1. A plan of care for each patient shall be initiated by a registered nurse immediately after completing the admission assessment, in coordination with the medical plan of care. 2. All other disciplines involved in the patient's care shall document on the plan of care immediately following their assessments. Care plan updates shall be documented by all disciplines, as appropriate, following reassessments ..."

A record review, on 1/25/12, at 3 PM, of educational material provided to the staff by the facility on 5/13/11, titled "...Pressure Ulcer Documentation Change to Documentation," indicated that staff received the following information regarding pressure ulcer documentation: "Include the date of initiation when documenting interventions. This addition will facilitate the evaluation of the effectiveness of the intervention ...Updating the Care Plan as to the location of the wound and interventions helps communicate to other staff what is being done for the patient ...Update the Needs/Problem List and Patient Goals ..."

A record review conducted on 1/25/12, at 3 PM, of a protocol that the facility utilizes, titled "Mosby's Nursing Skills Pressure Ulcer Treatment, Copyright 2006-2012, Elsivier Inc." informed nurses to "Ensure documentation of: 1. All ulcer, wound, dressing observations/assessment ...3. All needs, problem list, patient goals and interventions in the care plan."

2. A record review, on 1/25/12, at 11 AM, of Patient 26 revealed that the patient was admitted on 1/1/12, with diagnoses which included, all-terrain vehicle accident (ATV- also known as a quad), ascending aortic tear (a tear in the first portion of the largest artery of the body), multiple rib fractures and facial and skull fractures. The record review revealed that on admission, 1/1/12, Patient 26 was taken to the operating room to repair the aorta and was also intubated (a tube inserted into the lungs to assist in breathing).

A record review, on 1/25/12, at 11 AM, of Patient 26 nursing "Pressure Ulcer Review," from Patient 26 day of admission on 1/1/12 (at 1 PM) thru 1/9/12 (at 5:30 PM), indicated that Patient 26 had no pressure ulcers.

A record review, on 1/25/12, at 11 AM, of Patient 26 nursing "Pressure Ulcer Review" conducted on 1/9/12, at 7 PM, indicated that nursing identified an "Unstageable" pressure ulcer on Patient 26's buttocks.

A record review, on 1/25/12, at 11 AM, of Patient 26 nursing assessment performed by a WOCN, documented that on 1/10/12, at 9:58 AM, that Patient 26 had a "Deep Tissue Injury" on the buttocks that was 7 centimeters by 2 centimeters.

A record review, on 1/25/12, at 11 AM, of Patient 26 nursing "Pressure Ulcer Review" performed by nursing on 1/16/12, at 6:30 PM, indicated that the pressure ulcer on Patient 26's buttocks progressed to a Stage 2 pressure ulcer.

A record review, on 1/25/12, at 11:30 AM, of Patient 26's care plans, from 1/1/12 to 1/17/12 revealed no care plan to address the pressure ulcer, even after it had been identified as an "Unstageable" pressure ulcer by nursing on 1/9/12. There was no care plan for the "Deep Tissue Injury" that was identified by the WOCN on 1/10/12. Additionally, there was no care plan to address Patient 26's progression of the Stage 2 pressure ulcer that nursing identified on 1/16/12.

An interview and a concurrent record review of Patient 26's care plans, on 1/25/12, at 11:30 AM, with RN 1 (a Registered Nurse) were conducted. RN 1 verified that Patient 26 had no care plan developed to address the "Unstageable" pressure ulcer. RN 1 also stated that a care plan should have been developed to address the "Deep Tissue Injury" pressure ulcer that was identified by the WOCN on 1/10/12 of Patient 26's buttocks. RN 1 also verified that there was no care plan developed to address the progression of Patient 26's pressure ulcer when it was identified by nursing to be a Stage 2 and to reflect Patient 26's change in condition.

An interview was conducted on 1/24/12, at 11:45 PM with RN 3 (a WOCN). She stated that the WOCN's do not update patient care plans. Additionally, she stated that after the WOCN's perform their assessments, they report it to the registered nurse, who is supposed to update the care plan for the patient.

A record review, on 1/25/12, at 3 PM, of the facility policy titled, "Patient Care Process and Documentation (Inpatient) - effective 08/2009," documented the following:

"...B. Plan of Care/Treatment Plan- 1. A plan of care for each patient shall be initiated by a registered nurse immediately after completing the admission assessment, in coordination with the medical plan of care. 2. All other disciplines involved in the patient's care shall document on the plan of care immediately following their assessments. Care plan updates shall be documented by all disciplines, as appropriate, following reassessments ..."

A record review, on 1/25/12, at 3 PM, of educational material provided to the staff by the facility on 5/13/11, titled "...Pressure Ulcer Documentation Change to Documentation," indicated that staff received the following information regarding pressure ulcer documentation: "Include the date of initiation when documenting interventions. This addition will facilitate the evaluation of the effectiveness of the intervention ...Updating the Care Plan as to the location of the wound and interventions helps communicate to other staff what is being done for the patient ...Update the Needs/Problem List and Patient Goals ..."




25882

4. Record review revealed that Patient 27 was a 59 year old male admitted to the facility on 1/16/12 with a diagnosis of chronic renal failure.

Record review of the Immediate Post-Op (post operative: occurring after surgery) Orders to ICU (Intensive Care Unit) - Liver/Kidney, dated 1/24/12 at 5 PM revealed admission orders to the surgical intensive care unit (SICU) by the Transplant Service. The admitting diagnosis was status post (occurring after) liver/kidney transplantation.

Further review of this same order sheet revealed the following orders:
4. "... Keep all doors closed at all times. Masks for visitors only.
7. "NGT (NGT: a tube insert through the nose and into the stomach) to low continuous suction. Notify Transplant Attending if NGT drainage becomes coffee ground (vomiting of dark brown material that resembles coffee grounds) or bloody. JP drains to bulb suction. Notify Transplant Attending if JP output becomes bloody. Strip drains every 1 hour/empty every 8 hours only."

Record review of Patient 27's care plan, in the Needs/Problem List (Barriers to Discharge, page 2 of 11) revealed the following 7 Needs/Problems identified with corresponding patient goals:

"1. Mechanical Vent (ventilator: a machine which mechanically assists patients in the exchange of oxygen and carbon dioxide; sometimes referred to as artificial respiration).
2. Pain: controlled pain within pain goal.
3. Fluid Volume excess: Strict intake and output measurement.
4. Impaired Skin Integrity: Maintain or improve skin integrity.
5. ALOC (altered level of consciousness): Improved mental status.
6. IV access lines: Remove IV's, no signs and symptoms of infection.
7. Pulmonary Insufficiency (incomplete closure of the pulmonary valve in the heart, allowing blood to return from the pulmonary artery into the right ventricle of the heart): Cough and deep breath every two hours."

A record review of the Interdisciplinary Care Plan-Adult (Page 2 of 11) for Patient 27, was conducted on 1/25/12 and showed no mutually set goals, there were no dates/initials or status updates on the identified needs/problems to determine if there was regression, minimal progress, if the goal was met or if there was no progress. This section was noted to be blank.

Record review of Patient 27's care plan revealed that the plan of care did not reflect Patient 27's health care needs as it related to the liver/kidney transplantation occurring on 1/24/12.

There was no documented evidence in the care plan that indicated Patient 27 had a nasogastric tube connected to low continuous suction that needed to be monitored for coffee ground or bloody drainage and notification to the Transplant Attending if observed.

There was no documented evidence on the care plan indicating that the Transplant Attending physician was to be notified if the JP drain (Jackson-Pratt, JP drain, or bulb drain, is a surgical drainage device used to pull excess fluid from the body by constant suction.) became bloody or to empty the drains every 8 hours.

There was no documented evidence on the care plan indicating that the doors were to be closed at all times requiring visitors to wear masks.

Record review of the facility's policy titled, "Patient Care Process and Documentation (Inpatient), dated 8/2009 revealed the following:

" ...B. Plan of Care/Treatment Plan- 1. A plan of care for each patient shall be initiated by a registered nurse immediately after completing the admission assessment, in coordination with the medical plan of care. 2. All other disciplines involved in the patient's care shall document on the plan of care immediately following their assessments. Care plan updates shall be documented by all disciplines, as appropriate, following reassessments ... "

During an interview on 1/25/12 at 10:40 AM, RN confirmed that the care plan for Patient 27 was not individualized for the patient and did not reflect the liver/kidney transplantation that the patient underwent on 1/24/12 and the patients care needs.



26502

3. A record review, on 9/22/11, at approximately 3:45 PM, of Patient 29's medical record revealed that Patient 29 was a gravida 2, para 1 female (gravida-total number of pregnancies; para-total number of viable infants) who was admitted to the facility on 9/1/11 at 41 weeks for induction of labor for post dates; and had elected to have a lumbar epidural catheter inserted for pain control.

Patient 29, prior to a planned vaginal delivery, underwent a lumbar epidural procedure in which fragments of the epidural catheter was retained inside her epidural space. (The term epidural is often short for epidural analgesia, a form of regional analgesia involving injection of drugs through a placed epidural catheter, into the epidural space. The injection can cause both a loss of sensation and a loss of pain (analgesia) by blocking the transmission of signals through nerves in or near the spinal cord). This adverse event had the potential to result in affecting the health and safety of Patient 29.

On 9/22/11, at approximately 3:55 PM, an interview was conducted with Anesthesia Physician A (a fourth year Anesthesia Resident). When asked what occurred on 9/2/11 while attempting to insert a lumbar epidural catheter into Patient 29's back, she stated, "I was attempting to insert the epidural catheter into the patient's (Patient 29) back prior to delivery. On insertion of the epidural catheter, I met resistance at a certain level and retracted the catheter back. When I retracted the catheter I noticed the tip of the catheter was missing."

On 9/8/11, a review of Patient 29's MRI (Magnetic Resonant Imaging-a specialized x-ray machine) results dated 9/5/11 documented that "a thin radiopaque catheter in the posterior epidural space just right of midline at L1-2 disk. The catheter courses laterally to the left of the neuroformainal epidural space and then inferiorly to the L-3 level, where it appears curve around the terminate in the posterior epidural space near midline."

On 9/22/11, a review of Patient 29's Neurosurgery Consult report dated 9/3/11, and timed at 3:31 PM, revealed that fragments of the epidural catheter was present in the epidural space and lodged at the level of L-1 or L-2 area (anatomical location of the lumbar spine). Further documentation indicated that the Neurosurgery Consultant discussed with Patient 29 the possibility of surgery to extract the fragment lodged in the patient's epidural space and explained the risks and benefits of having or not having surgery. Patient 29 declined surgery at that time. Documentation also indicated that Patient 29 would be at risk for an "abscess" in approximately 3 months after delivery. In addition, the Neurosurgery consultant recommended possible surgery if the following conditions existed:
a. Patient regresses to have weakness.
b. Patient experiences changes in sensation.
c. Patient experiences urinary incontinence.
d. Patient experiences bowel incontinence.

On 9/16/11, a review of Patient 29's Interdisciplinary Care Plan for Postpartum care, dated 9/2/11, documented the following problems/needs that were addressed and needed to be monitored:
a. Learning needs related to self care.
b. Abnormal bleeding.
c. Infections.
d. Pain related to vaginal delivery.
e. Safety, fall prevention.

There was no documented evidence that a comprehensive, coordinated individualized Interdisciplinary Care Plan was developed to address Patient 29's retained epidural catheter in her epidural space while on the Post Partum Unit.

There was no indication that the postpartum nursing staff incorporated in the Interdisciplinary Care Plan the neurosurgeon's recommendation to observe and report to the physician any neurological changes Patient 29 might experience such as regression in weakness to her lower extremities, any lower extremity sensation changes or any signs and symptoms of urinary and bowel incontinence.

On 9/22/11, a review of the facility's policy and procedure titled, "PATIENT CARE PROCESS AND DOCUMENTATION: PLAN OF CARE/TREATMENT PLAN" dated 8/2009, stipulated, "A plan of care for each patient shall be initiated by a Registered Nurse immediately after completing the admission assessment, in coordination with the medical plan of care. All other disciplines involved in the patient's care shall document on the plan of care immediately following their assessment. Care plan updates will be documented by all disciplines. In all cases, there shall be collaboration among all pertinent disciplines to ensure consistency in the treatment planning process."

On 9/16/11, a review of the facility's policy and procedure titled, "DISCHARGE PLANNING/CONTINUITY OF PATIENT CARE ", dated 12/10, stipulated in section (3): "...The case manager, in conjunction with the clinical nurse, shall be responsible for assessing the patient prior to or upon admission, planning for continuing care based on the patient's individual needs..."

On 9/16/12, at approximately 11:30 AM, the Director of the Post Partum Unit confirmed the finding that the nursing staff did not develop a care plan addressing Patient 29's retained epidural catheter in her epidural space while on the Post Partum Unit after delivery of her infant on 9/2/11.

Based on observations and interviews, the hospital failed to ensure that registered nurses (RN's) were competent to care for patients in the Neonatal Intensive Care Unit (NICU) and the Pediatric Emergency Unit (PEU).

Findings:

The NICU was visited on January 23, 2012 at approximately 1:00 p.m. RN 1 was asked to calculate a dose for an infant. RN 1 was given the infant's weight in pounds (lb) and dose in milligrams (mg) per kilogram (kg). RN 1 was not able to calculate the dose.
RN 2 was then asked to do the same. RN 2 was given the infant's weight in lb and dose in mg per kg. RN 2 was not able to calculate the dose.
Both instances were confirmed by RN 5.

The PEU was visited on January 24, 2012 starting at 8:45 a.m. RN 3 was asked to calculate and withdraw a dose of Epinephrine (a drug used in allergic emergencies). RN 3 was not able to properly withdraw the very small dose of Epinephrine.
RN 4 was then asked to do the same. RN 4 was also unable to properly withdraw the very small dose of Epinephrine.
Both instances were confirmed by RN 6.

Epinephrine for emergency use is only available in a 10 ml abboject syringe. An Abboject syringe is a ready-to-use syringe which is packaged by the manufacturer. Because this syringe contains a much larger volume (10 ml) than required for a pediatric dose, it is necessary to withdraw the very small volume into a small syringe first. Trying to administer a fraction of the volume - less than 1 ml - from this 10 ml syringe directly to the pediatric patient would likely result in an overdose.
RN 3 and RN 4 were not able to correctly and safely withdraw the less than 1 ml dose from the abboject syringe. This could result in a delay of treatment in an emergency or the administration of an incorrect dose.

Based on interviews and record review, the hospital failed to:

1. Ensure that insulin was administered to patient 41 as ordered by a physician.

2. Ensure parameters were set for the administration and titration of continuous intravenous propofol drips for Patient 22.

Findings:

During a tour of the hospital, the medical intensive care unit (MICU) was visited starting at 1:45 p.m. on January 23, 1012. Pharm 44 and Pharm 45 were interviewed at that time. While discussing the administration of intravenous (IV) insulin, Pharm 44 and 45 stated that registered nurses (RN's) usually adjusted the doses of insulin and further said they were not permitted to write in a patient's medical record. Pharm 44 also stated he is a Clinical Pharmacist Specialist and is assigned to the MICU to provide assistance to physicians and RN's regarding drug therapy. During the same time RN 47 confirmed that RN's usually adjusted the doses of IV insulin and MD 41 stated that RN's have their own guidelines to adjust IV insulin. During an interview with MD 42 at 2:15 p.m. on January 24, 2012, she stated RN's can adjust IV insulin as patients respond differently to insulin therapy. During the same time, however, RN 48 stated that RN's do not have their own insulin guidelines and adjust insulin IV doses based upon physician orders. Thus, there seemed to be a difference in understanding as to how insulin IV therapy is to be administered to a patient.

Patient 41 medical record was reviewed on January 24, 2012 starting at 2:40 p.m. Patient 41 was admitted to the emergency department (ED) at 7:18 p.m. on January 18, 2012. He was diagnosed with Diabetic-Keto-Acidosis (DKA) at 8:30 p.m. This is a very serious condition which can cause a coma (unconsciousness) or death and is characterized by an extremely high blood sugar (BS).
1) At 8:30 p.m. Patient 41 BS was reported as 538. (A normal BS value is approximately 100.) 6 units of IV insulin per hour was ordered at that time.
2) At 8:53 p.m. the BS was greater than 500.
3) At 10:28 p.m. on January 18, 2012 Patient 41 was transferred to the medical intensive care unit (MICU). 6 units of IV insulin per hour was again ordered.
4) At 11:58 p.m. the BS was 424.
5) Between 10:28 p.m. on January 18th and 7:20 a.m. on January 20th, while in MICU, Patient 41 medical record revealed 14 changes in the dose of IV insulin from a high of 8 units per hour to stopping the insulin therapy at 6:18 p.m. on January 19th for 2 hours. (IV insulin was again started by an RN at 8:27 p.m. on January 19th.)
A continuing review of Patient 41 medical record revealed while there were numerous orders for other drugs between 10:28 p.m. on January 18 and 7:20 a.m. on January 20, there was no evidence of a physician's order to change any IV insulin dose nor any evidence a pharmacist had monitored the therapy.
At 2:45 p.m. on January 24, 2012, Pharm 42 and RN 48 confirmed there were no physician orders changing the dose of IV insulin between 10:28 p.m. on January 18th and 7:20 a.m. on January 20th and no evidence a pharmacist had intervened to ensure that a physician was ordering the changes in IV insulin doses.

Thus: 1. There is a discrepancy between nurses and physicians as to how I.V. insulin is to be administered.
2. Nurses independently determined the doses of IV insulin which were administered to patient 41 without a physician's order.
3. Pharmacists are unable to write in a patient's medical record and there is no evidence a pharmacist monitored the IV insulin therapy for patient 41.



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2. Record review revealed Patient 22 was a 61 year old female admitted to the facility on 1/5/12 with diagnoses that included chronic right hip and shoulder pain.

Record review of the Physician Orders, dated 1/8/12 at 4:50 PM revealed the following order: "Propofol 1000 mg (milligrams) /100 ml (milliliters) premix bottle. Start at 5 mcg (micrograms) /min x 1 (one time). Titrate to MAP 65".

Propofol is a strong intravenous (within the vein) sedative-hypnotic agent (brand name Diprivan) used in the induction and maintenance of anesthesia or sedation. (FDA: Food and Drug Administration, 2012).

Record review of the Telephone Orders Only sheet, dated 1/8/12 at 6:30 PM and signed by the physician on 1/12/12 (4 days later), revealed the following orders: "Clarification order. Titrate up propofol drip to SBP 90(systolic blood pressure) and MAP 65 (mean arterial pressure: a term used to describe an average blood pressure in an individual). ..."

Record review of the Physician Orders, dated 1/13/12 at 3 PM revealed the following order: "2) Propofol 1000 mg/100 ml premix bottle. Start at 10 mcg/kg (kilogram)/minute, titrate (incremental increase in drug dosage to provide optimal therapeutic effect) to limit burst suppression (to reduce brain activity) to less than 2 burst suppressions per screen on continuous EEG (electroencephalogram: a test used to detect abnormalities; it measures and records the electrical activity of the brain using electrodes attached to the head and hooked by wires to a computer) monitoring.

During an interview on 1/24/12 at 10:55 AM, RN 2 (MICU Educator) stated that the facility had no protocol on propofol which would stipulate guidelines on its usage. RN 2 stated that some physicians like to be notified when the propofol drip is titrated above 25 mcg, however there are some physicians that do not require notification. RN 2 further stated that the nurses used to titrate the propofol drip to the ramsey scale (a scale is used to assess the level of sedation of a patient) and that they now titrate to the RASS goal.

The Richmond Agitation and Sedation Scale consists of a scale ranging from +4 to -5. A score of 0 is equated with a patient who is alert and calm. On one end of the RASS score, +4 represents a very combative, violent patient who is considered dangerous to the staff. On the other extreme, -5 represents a patient who is unarousable, with no response to voice or physical stimulation.

During an interview on 1/24/12 at 12:12 PM, when asked what the maximum propofol dose was on the MICU (medical intensive care unit), RN 50 stated it was 20 mcg.

During an interview on 1/24/12 at 2:55 PM, when asked what burst suppression was, RN 51 who was the team leader of the unit, stated that if a patient is status epilepticus (a life-threatening condition in which the brain is in a state of persistent seizure), neurology (the study of the nervous system) will order propofol or versed (a prescription drug that can be used as a sedative) to suppress seizures. RN 51 further stated that the parameter (limits, guidelines) for the propofol was the burst suppression and stated that there was usually no parameter. When asked what the maximum propofol dose was on the unit, RN 51 stated it was 60 mcg/kg/min.

Record review of the Initial 24 Hour Post Cardiac Arrest Coma Intensive Care Unit Physician Orders, dated 1/5/12 at 6:23 PM revealed the following orders on page 2 of this order sheet:

"Sedatives: Titrate to Modified Ramsey Sedation Scale". Box number 3 was checked which read, "responds to command only".

"Propofol 1000 mg/100 mL D5W (an IV [intravenous] solution containing dextrose) IV. Start at 10 mcg/kg/min (minute) to a maximum dose of 50 mcg/kg/min".

Record review of a form titled, Telephone Orders Only, dated 1/18/12 at 11:50 AM by an RN and signed by the physician on 1/23/12 at 11:10 AM, revealed the following order, "Ativan 1 mg IV Q (every) 5 min PRN (as needed) seizure. May give 3 doses. If pt (patient) cont (continue) to seize (have seizures) after 3 doses start Propofol 1000mg/100 ml IV, start at 5 mcg/kg/min. Titrate to no seizure".

Record review of the facility's Micromedex 2.0 drug summary for Propofol, modified 12/20/11 revealed the following details: Sedation for a mechanically ventilated patient, Intensive care unit; 5 mcg/kg/min. IV infusion for 5 min then titrate in 5 to 10 mcg/kg/min increments to achieve desired level of sedation; allow minimum of 5 min between dose adjustments; usual maintenance rates 5 to 50 mcg/kg/min or higher.

The combination of these circumstances place patients in a situation which is likely to cause serious injury or death. Thus, an immediate jeopardy was called in a meeting with hospital administration at 5:00 PM on January 24, 2012.

The hospital's plan of correction (POC) established specific doses of IV insulin and propofol based upon specific patient parameters and required a physician to start the therapy. The POC included education for all nurses, pharmacists and physicians regarding the new IV insulin and propofol administration guidelines.

While the POC was accepted at 7:30 PM on January 24, 2012 verification of education of hospital staff was confirmed on the following day. The immediate jeopardy was abated at 4:30 PM on January 25, 2012 with hospital administration.

Based on interview and record review, the hospital failed to ensure that the medical records for 2 out of 3 patients (Patients 3 and 4) who underwent a code blue during surgery were accurately written, and completed. This resulted in difficulty in following the sequence of events in the OR, specifically the details of the code blue.

Findings:

1. The medical record for Patient 3 was reviewed on 1/23/12 at 9:30 AM. This is a patient that underwent open heart surgery. The patient underwent a code blue during the procedure. The code blue sheet stated, "documentation on periop record." The code sheet was otherwise blank. The record of the code on the perioperative record was not organized in a similar way to the code blue sheet and was difficult to follow. The medications given during the code were documented. It did not contain necessary information such as who performed CPR and when did CPR start.

2. The medical record for Patient 4 was reviewed on 1/23/12 at 9:35 AM. Patient 4 also had a code blue during surgery, with a minimum of data entered on the code blue sheet, and the majority of the data entered onto the anesthesia record. The Director of Surgical Services stated that the hospital-wide code blue sheet was not used in the Cardiac Surgery OR. However, the facility could not provide a policy that stated that certain patient care units would follow the policy for the code blue form and that other patient care units would follow another procedure.

The Operating Room (OR) suites were toured with the Director of Surgery on 1/23/12 at 10:35 AM. The Director was questioned about Code Blue (emergency measures when the heart is not pumping blood through the tissues adequately, or the blood is depleted of oxygen due to a respiratory problem) in the OR's. She stated the OR's do not use the hospital wide Code Blue flow sheet and the code teams from the hospital do not come into the OR's. The anesthesiologist runs the code with the assistance of a respiratory therapist, nurses, and resident physicians. The code blue flow sheet is available on top of the code blue cart but this is not used in the OR's. The Director was asked about providing a policy for Code Blues that would include which units used the Code Blue Sheet and which departments used alternative methods of documentation. This was unable to be provided.

Based on interview and record review, the hospital failed to ensure that the medical records for 2 out of 3 patients (Patients 3 and 4) who underwent a code blue during surgery after September 18, 2012 and one patient (Patient 22) who underwent a code blue in the emergency department (ED) were accurately written, and completed. This resulted in difficulty in following the sequence of events in the OR and ED, specifically the details of the code blue.

Findings:

1. The medical record for Patient 3 was reviewed on 1/23/12 at 9:30 AM. This is a patient that underwent open heart surgery. The patient underwent a code blue during the procedure. The code blue sheet stated, "documentation on periop record." The code sheet was otherwise blank. The record of the code on the perioperative record was not organized in a similar way to the code blue sheet and was difficult to follow. The medications given during the code were documented. It did not contain necessary information such as who performed CPR and when did CPR start.

2. The medical record for Patient 4 was reviewed on 1/23/12 at 9:35 AM. Patient 4 also had a code blue during surgery, with a minimum of data entered on the code blue sheet, and the majority of the data entered onto the anesthesia record. The Director of Surgical Services stated that the hospital-wide code blue sheet was not used in the Cardiac Surgery OR. However, the facility could not provide a policy that stated that certain patient care units would follow the policy for the code blue form and that other patient care units would follow another procedure.

The Operating Room (OR) suites were toured with the Director of Surgery on 1/23/12 at 10:35 AM. The Director was questioned about Code Blue (emergency measures when the heart is not pumping blood through the tissues adequately, or the blood is depleted of oxygen due to a respiratory problem) in the OR's. She stated the OR's do not use the hospital wide Code Blue flow sheet and the code teams from the hospital do not come into the OR's. The anesthesiologist runs the code with the assistance of a respiratory therapist, nurses, and resident physicians. The code blue flow sheet is available on top of the code blue cart but this is not used in the OR's. The Director was asked about providing a policy for Code Blues that would include which units used the Code Blue Sheet and which departments used alternative methods of documentation. This was unable to be provided.



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3. Record review revealed Patient 22 was a 61 year old female admitted to the facility on 1/5/12 with diagnoses that included chronic right hip and shoulder pain.

Record review of the MICU (medical intensive care unit) H&P (history and physical), dated 1/5/12 at 8:35 PM revealed the following documentation in the PMH (past medical history) section: "While in the ED (emergency department), patient coded for 45 minutes with no shock administered. Patient likely had PEA (pulseless electrical activity is a rhythm that occurs when there is electrical activity in the heart but no pulse; a clinical condition characterized by unresponsiveness and lack of a palpable pulse) after coughing up coffee ground emesis (vomiting of dark brown material that resembles coffee grounds) which may be a sign of internal bleeding). Patient was intubated and resuscitated and then transferred over to MICU".

Record review of the CPR (cardiopulmonary resuscitation) Record for Patient 22, pages 1 of 2 and pages 2 of 2 were noted to be lacking a date for which the code blue occurred.

The following observations were noted during review of pages 1 and 2 of the CPR Record:

Date: blank, Time Arrest Noted: blank, Witnessed: Y/N (yes/no): blank, Age: blank, Weight: blank, family notified: blank, Time of first assisted ventilation: blank, Intubation time: blank, Size: blank, By Whom: blank, Verified by: blank. Signatures were noted of the RN that recorded the code blue and the physician. There was no documentation indicating the date of the signatures. The times of the signatures were noted to be documented. On the CPR Record, the medication given during the code were listed but there were no clear orders for the medications.

Record review of this same CPR Record for Patient 22 that was without a date and found in Patient 22's medical record, revealed a detachable portion titled, "Code Blue Evaluation" with a printed note indicating that the evaluation was for QI purposes only and was not to be inserted in the patient chart. There was also a pre printed note to please detach this page and send immediately to Nurse Manager or Department Head. This detachable portion of the CPR Record was noted to be blank on sides 1 and 2.

Further review of the Code Blue Evaluation form revealed the following information to be obtained during a code and forwarded for review:
1. Date/time of code, location,
2. Describe anything that needs to be reviewed during this code,
3. Were there any pre-code issues that need to be reviewed,
4. Was Narcan or Romazicon used,
5. Was the Attending MD notified of the patient coding,
6. Review metrics-if time is over goal you must comment why or what occurred,
Arrest outcome: expired, survived, transported to; name of person completing form.

On side 2 of the Code Blue Evaluation Form, there was a place to attach a rhythm strip (an EKG which records the electrical activity of the heart). There was no rhythm strip attached to the form. There was a portion on the form for Nurse Managers and department heads to give a description of actions/follow-up, and a section for the code blue committee for follow up recommendations. These sections were also noted to be blank.

During an interview on 1/24/12 at 11:18 AM, RN 2 (MICU Educator) confirmed that the CPR Record for Patient 22 was incomplete and lacked a date. RN 2 also confirmed that the detachable Code Blue Evaluation portion of the CPR Record (for QI [quality improvement] purposes) was not completed and was still attached to the CPR Record which was in Patient 22's medical record. RN 2 further stated that the Code Blue Evaluation portion of the CPR Record was normally given to her and that she goes over it with the unit manager and uses it to debrief.

During an interview on 1/26/12 at 8:05 AM, QA 41 stated she was not aware of the code blue involving Patient 22 in the ED and stated that they cannot be everywhere. QA 41 stated that shift assessments by the charge nurse or team leader would be another way to track code blues that occur in addition to having the Code Blue Evaluation form that detaches from the Code Blue Record for forwarding to unit managers, department heads, and the code blue committee for analysis and feedback of the code.

Based on interview and record review, the hospital failed to ensure that the medical records for 2 out of 3 patients (Patients 3 and 4) who underwent a code blue during surgery and 1 patient (Patient 22) who underwent a code blue in the emergency department (ED) contained complete and authenticated patient orders as well as accurate reports of treatment rendered including complications. This resulted in difficulty in following the sequence of events in the OR and ED, specifically the details of the code blue.

Findings:

1. The medical record for patient 3 was reviewed on 1/23/12 at 9:30 AM. This is a patient that underwent open heart surgery in the Cardiac Surgery Operating Room (OR). The patient underwent a code blue during the procedure. The code blue sheet stated "documentation on periop record." The code sheet was otherwise blank. The record of the code on the perioperative record was not organized in a similar way to the code blue sheet and was difficult to follow. On the perioperative records, the medications given during the code were documented but there were no clear orders for the medications. It did not contain necessary information such as who performed CPR and when did CPR start.

2. The medical record for Patient 4 was reviewed on 1/23/12 at 9:35 AM. Patient 4 also had a code blue during surgery, with a minimum of data entered on the code blue sheet, and the majority of the data entered onto the anesthesia record. The Director of Surgical Services stated that the hospital-wide code blue sheet was not used in the Cardiac Surgery OR. However, the facility could not provide a policy that stated that certain patient care units would follow the policy for the code blue form and that other patient care units would follow another procedure. On the anesthesia record, the medications given during the code were listed but there were no clear orders for the medications. The Director of Surgical Services stated that the hospital-wide code blue sheet was not used in the Cardiac Surgery OR. However, the facility could provide no policy that stated that certain patient care units would follow the policy for the code blue form and that other patient care units would follow another procedure.

The Operating Room (OR) suites were toured with the Director of Surgery on 1/23/12 at 10:35 AM. The Director was questioned about Code Blue (emergency measures when the heart is not pumping blood through the tissues adequately, or the blood is depleted of oxygen due to a respiratory problem) in the OR's. She stated the OR's do not use the hospital wide Code Blue flow sheet and the code teams from the hospital do not come into the OR's. The anesthesiologist runs the code with the assistance of a respiratory therapist, nurses, and resident physicians. The code blue flow sheet is available on top of the code blue cart but this is not used in the OR's. The Director was asked about providing a policy for Code Blues that would include which units used the Code Blue Sheet and which departments used alternative methods of documentation. This was unable to be provided.



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3. Record review revealed Patient 22 was a 61 year old female admitted to the facility on 1/5/12 with diagnoses that included chronic right hip and shoulder pain.

Record review of the MICU (medical intensive care unit) H&P (history and physical), dated 1/5/12 at 8:35 PM revealed the following documentation in the PMH (past medical history) section: "While in the ED (emergency department), patient coded for 45 minutes with no shock administered. Patient likely had PEA (pulseless electrical activity is a rhythm that occurs when there is electrical activity in the heart but no pulse; a clinical condition characterized by unresponsiveness and lack of a palpable pulse) after coughing up coffee ground emesis (vomiting of dark brown material that resembles coffee grounds) which may be a sign of internal bleeding). Patient was intubated and resuscitated and then transferred over to MICU.

Record review of the CPR (cardiopulmonary resuscitation) Record for Patient 22, pages 1 of 2 and pages 2 of 2 were noted to be lacking a date for which the code blue occurred.

The following observations were noted during review of pages 1 and 2 of the CPR Record:

Date: blank, Time Arrest Noted: blank, Witnessed: Y/N (yes/no): blank, Age: blank, Weight: blank, family notified: blank, Time of first assisted ventilation: blank, Intubation time: blank, Size: blank, By Whom: blank, Verified by: blank. Signatures were noted of the RN that recorded the code blue and the physician. There was no documentation indicating the date of the signatures. The times of the signatures were noted to be documented. On the CPR Record, the medication given during the code were listed but there were no clear orders for the medications.

Record review of this same CPR Record for Patient 22 that was without a date and found in Patient 22's medical record, revealed a detachable portion titled, "Code Blue Evaluation" with a printed note indicating that the evaluation was for QI purposes only and was not to be inserted in the patient chart. There was also a pre printed note to please detach this page and send immediately to Nurse Manager or Department Head. This detachable portion of the CPR Record was noted to be blank on sides 1 and 2.

Further review of the Code Blue Evaluation form revealed the following information to be obtained during a code and forwarded for review:
1. Date/time of code, location,
2. Describe anything that needs to be reviewed during this code,
3. Were there any pre-code issues that need to be reviewed,
4. Was Narcan or Romazicon used,
5. Was the Attending MD notified of the patient coding,
6. Review metrics-if time is over goal you must comment why or what occurred,
Arrest outcome: expired, survived, transported to; name of person completing form.

On side 2 of the Code Blue Evaluation Form, there was a place to attach a rhythm strip (an EKG which records the electrical activity of the heart). There was no rhythm strip attached to the form. There was a portion on the form for Nurse Managers and department heads to give a description of actions/follow-up, and a section for the code blue committee for follow up recommendations. These sections were also noted to be blank.

During an interview on 1/24/12 at 11:18 AM, RN 2 (MICU Educator) confirmed that the CPR Record for Patient 22 was incomplete and lacked a date. RN 2 also confirmed that the detachable Code Blue Evaluation portion of the CPR Record (for QI [quality improvement] purposes) was not completed and was still attached to the CPR Record which was in Patient 22's medical record. RN 2 further stated that the Code Blue Evaluation portion of the CPR Record was normally given to her and that she goes over it with the unit manager and uses it to debrief.

During an interview on 1/26/12 at 8:05 AM, QA 41 stated she was not aware of the code blue involving Patient 22 in the ED and stated that they cannot be everywhere. QA 41 stated that shift assessments by the charge nurse or team leader would be another way to track code blues that occur in addition to having the Code Blue Evaluation form that detaches from the Code Blue Record for forwarding to unit managers, department heads, and the code blue committee for analysis and feedback of the code.

Based on interviews and record reviews, the hospital failed to ensure that the pharmaceutical service monitored drug therapy.

1. Pharmacists failed to ensure that intravenous (IV) insulin administered to patient 41 was ordered by a physician.

2. Pharmacists failed to clarify physician's range orders for narcotics prescribed on an "as needed" basis. (Range orders are those orders which call for multiple doses of a given drug over a period of time for specific diagnoses.)

3. Pharmacists failed to clarify a physician's range order for Dopamine. (Dopamine is used to treat shock; for heart attacks; used after open heart surgery or to treat kidney failure and has a Black Box Warning (BBW) from the FDA. A BBW means that a dose of the drug which is administered in error can cause serious harm or death.)

4. Pharmacists failed to maintain accurate records regarding the disposition of controlled substances ordered for Patient 22, by failing to track two Controlled Drug Records for Parenteral Infusion (CDRPI) per facility policy. This failure had the potential for loss or diversion to occur. (Refer to A-491)

5. The facility failed to ensure accountability and maintenance of accurate records regarding the disposition of controlled substances ordered for 1 of 30 sampled patients, (Patient 22), by failing to track two Controlled Drug Records for Parenteral Infusion (CDRPI) per facility policy. This failure had the potential for loss or diversion to occur. (A-494)

6. The facility failed to remove Darvocet N-100(Propoxyphene NAP w/APAP 100 mg) medication as a selection for pain from approved pre-printed medication order forms. The facility failed to ensure that medications prescribed to patients were being monitored to assure that medication therapy is appropriate and minimizes the occurence of possible adverse events for 1 of 31 sampled patients (Patient 29). The facility failed to recognize that the medication Norco, prescribed to a patient after delivery for pain relief, had a possible medication related adverse effect on her breastfed newborn. This deficienct finding resulted in Patient 29's newborn infant being transported to the hospital emergently for respiratory complications. (A-500)

The cumulative effect of these systemic problems resulted in the hospital's inability to ensure the provision of pharmaceutical services in a safe environment.

Based on interviews and record reviews, the hospital failed to ensure that a pharmacist monitored drug therapy.

1. Pharmacists failed to ensure that intravenous (IV) insulin administered to patient 41 was ordered by a physician.

2. Pharmacists failed to clarify physician's range orders for narcotics prescribed on an "as needed" basis. (Range orders are those orders which call for multiple doses of a given drug over a period of time for specific diagnoses.)

3. Pharmacists failed to clarify a physician's range order for Dopamine. (Dopamine is used to treat shock; for heart attacks; used after open heart surgery or to treat kidney failure and has a Black Box Warning (BBW) from the FDA. A BBW means that a dose of the drug which is administered in error can cause serious harm or death.)

4. Pharmacists failed to maintain accurate records regarding the disposition of controlled substances ordered for Patient 22, by failing to track two Controlled Drug Records for Parenteral Infusion (CDRPI) per facility policy. This failure had the potential for loss or diversion to occur.

Findings:

1. During a tour of the hospital, the medical intensive care unit (MICU) was visited starting at 1:45 p.m. on January 23, 1012. Pharm 44 and Pharm 45 were interviewed at that time. While discussing the administration of IV insulin, Pharm 44 and 45 stated that registered nurses (RN's) usually adjusted the doses of IV insulin and further said they were not permitted to write in a patient's medical record. Pharm 44 also stated he is a Clinical Pharmacist Specialist and is assigned to the MICU to assist RN's and physicians regarding drug therapy. During the same time RN 7 confirmed that RN's usually adjusted the doses of IV insulin and MD 41 stated that RN's have their own guidelines to adjust IV insulin. During an interview with MD 42 at 2:15 p.m. on January 24, 2012, she stated RN's can adjust IV insulin as patients respond differently to insulin therapy. During the same time, however, RN 8 stated that RN's do not have their own insulin guidelines and adjust insulin IV doses based upon physician orders. Thus, there seemed to be a difference in understanding as to how insulin IV therapy is to be administered to a patient.
The American Society for Health-Systems Pharmacists (ASHP) is an internationally recognized organization which establishes standards of practice for pharmacists in hospitals. "ASHP Statement on Pharmacist's Responsibility for Distribution and Control of Drug Products" reads: "The fundamental purpose of pharmaceutical services in any setting is to ensure the safe and appropriate use of drug products and drug-related devices. Fulfillment of this responsibility is enhanced through the pharmacist's involvement in all aspects of the use of drugs." ASHP's Standard III, "Optimizing Medication Therapy" reads: "An important aspect of pharmaceutical care is optimizing medication use. This must include processes designed to ensure the safe and effective use of medications and increase the probability of desired patient outcomes."

Patient 41 medical record was reviewed on January 24, 2012 starting at 2:40 p.m. Patient 41 was admitted to the emergency department (ED) at 7:18 p.m. on January 18, 2012. He was diagnosed with Diabetic-Keto-Acidosis (DKA) at 8:30 p.m. This is a very serious condition which can cause a coma (unconsciousness) or death and is characterized by an extremely high blood sugar (BS).
a) At 8:30 p.m. patient 41 BS was reported as 538. (A normal BS value is approximately 100.) 6 units of IV insulin per hour was ordered at that time.
b) At 8:53 p.m. the BS was greater than 500.
c) At 10:28 p.m. on January 18, 2012 patient 41 was transferred to the medical intensive care unit (MICU). 6 units of IV insulin per hour was again ordered.
d) At 11:58 p.m. the BS was 424.
e) Between 10:28 p.m. on January 18th and 7:20 a.m. on January 20th, while in the MICU, Patient 41 medical record revealed 14 changes in the dose of IV insulin from a high of 8 units per hour to stopping the insulin therapy at 6:18 p.m. on January 19th for 2 hours. (IV insulin was again started by an RN at 8:27 p.m. on January 19th.)
A continuing review of Patient 41 medical record revealed while there were numerous orders for other drugs between 10:28 p.m. on January 18 and 7:20 a.m. on January 20, there was no evidence of a physician's order to change any IV insulin dose. The review also revealed there was no evidence a pharmacist had intervened to ensure that a physician was ordering the changes in IV insulin doses.
At 2:45 p.m. on January 24, 2012, Pharm 42 and RN 48 confirmed there were no physician orders changing the dose of IV insulin and no pharmacist intervention documented between 10:28 p.m. on January 18th and 7:20 a.m. on January 20th.
In summary:
A. There is a discrepancy between nurses and physicians as to how IV insulin is to be administered.
B. Nurses decided the doses of IV insulin which were administered to patient 41 without a physician's order.
C. Pharmacists are unable to write in a patient's medical record and there is no evidence a pharmacist monitored the IV insulin therapy for patient 41. This was again confirmed by Pharm 44 on January 25, 2012 at approximately 9:00 a.m.

Pharmacists did not monitor the IV insulin drug therapy for patient 41, to ensure that insulin was administered safely as ordered by a physician and, therefore, did not comply with principles of professional practice. This created an unsafe patient care environment.

2. While reviewing 2 patient medical records (patients 42 and 43) on January 25, 2012, the following incomplete range orders were found:

a) For patient 43:
1) at 11:30 p.m. on December 3, 2011, Hydromorphone (a narcotic) was ordered as 0.2 - 0.4mg intravenously every 10 minutes prn (as needed). Max 2mg. The order is incomplete and must be clarified to determine when the medication is needed for specific symptoms exhibited by the patient. Also the order must be clarified as to what patient response shall this medication be held after an initial administration and what response shall an RN continue to administer 0.2mg or 0.4mg or any dose between 0.2 and 0.4mg of the medication.
2) at 11:41 p.m. on December 3, 2011, Norco (a narcotic) 10/325 was ordered as 1 to 2 tablets PO (orally) every 4 hours as needed for pain. The order is incomplete and must be clarified to determine what degree of pain requires 1 tablet or 2 tablets of Norco. Otherwise the order asks a nurse to use her judgment when 1 or 2 tablets of the medication should be administered to the patient.
3) at 2:30 a.m. on December 4, 2011, Dilaudid (a narcotic) was ordered as 0.5 - 2mg intravenously every 2 hours as needed for breakthrough pain. Again the order is incomplete and must be clarified to determine what patient exhibited symptom and/or resultant response to the administered medication shall an RN administer 0.5mg or 2mg or any dose between 0.5 and 2mg.

b) For patient 42, at 7:20 p.m. on December 4, 2011, Norco (a narcotic) was ordered as 1 - 2 tabs 5/325mg every 6 hours prn pain. This order should have been clarified as described in (a)(2) above.

3. For patient 42, at 12:30 a.m. on December 4, 2011, Dopamine intravenous drip was ordered as 6mcg - 8mcg per Kg per minute (1Kg = 2.2 pounds). The order must be clarified to determine why Dopamine was ordered. What outcome is wanted; what dose is needed for a specific outcome and when is administration of the drug to be stopped. As described in (3) above, this drug has a BBW and must be administered very carefully.

At the very least a nurse must clarify an unclear dose before administering any drug. However, pharmacy provides 24 hour service every day (as identified by Pharm 3 during a meeting on January 23, 2012 which started at 9:00 a.m.). ASHP professional standards, described above, requires a pharmacist to ensure the safety and effectiveness of drug therapy. A pharmacist should have clarified the physician's order to make certain the drug was administered as intended or that the dose was appropriate. There is no evidence in patient 42 or 43 medical record that a pharmacist clarified the orders creating an unsafe patient care environment.



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4. Controlled Drug Record For Parenteral Infusion (CDRPI): To keep tracking dispensing, delivery and administration of controlled substances in order to assure patient safety and comply with regulatory requirements for prevention or potential diversion of controlled substances.

Record review revealed the following two CDRPI filed in the medical record for Patient 22:

1. CDRPI No. 361984, dated 1/5/12, received and signed by RN 49 in the ED (emergency department). Drug: Fentanyl 5000 mcg (micrograms). Unit Instructions noted on the form to place sheet (CDRPI) in MAR (medication administration record) folder after signing for delivery. Also there was a note to return the completed sheet to pharmacy ASAP after:
a. a completed administration,
b. a wasted dose,
c. an unused dose to be returned to pharmacy.

Review of the CDRPI revealed that the start date of the continuous infusion was 1/5/12 at 5:58 PM by RN 49. The section of the sheet where the stop date and time can be documented was noted to be blank. Volume infused was circled and the amount 250 cc (cubic centimeters) was documented. There was also the following documentation noted on the sheet, "late entry 1/25/12....med infused on 1/5/12.

2. CDRPI No. 361983, dated 1/5/12, received and signed by RN 49 in the ED (emergency department). Drug: Lorazepam 100 mg (milligrams). Unit Instructions noted on the form to place sheet (CDRPI) in MAR (medication administration record) folder after signing for delivery. Also there was a note to return the completed sheet to pharmacy ASAP after:
a. a completed administration,
b. a wasted dose,
c. an unused dose to be returned to pharmacy.

Review of the CDRPI revealed that the start date of the continuous infusion was 1/5/12 at 6 PM by RN 49. The section of the sheet where the stop date and time, volume infused/wasted and RN signature can be documented was noted to be blank.

During an interview on 1/24/12 at 10:48 AM, RN 2 (MICU Educator) confirmed the two CDRPI's (361983 and 361984) were filed in the medical record for Patient 22 and stated that normally the CDRPI's go back to the pharmacy. RN 2 further stated that sometimes the CDRPI's are left in the chart if the medication is still infusing. When RN 2 was shown the two CDRPI's one lacking an infusion stop date and time and the other lacking a stop date, time, and the amount infused or wasted, RN 2 stated, "I don't know".

During an interview on 1/24/12 at 11:15 AM, regarding CDRPI No. 361984 (fentanyl drip), RN 2 stated that 183.3 ml was infused out of the 250 ml bag (leaves approximately 66.7 ml). Regarding CDRPI No. 361983 (Ativan drip), RN 2 stated that she was only to provide evidence that the Ativan drip was started on 1/5/12 and was unable to determine the amount that was infused.

During an interview on 1/25/12 at 2:10 PM regarding CDRPI No. 361983, RN 2 stated there were no titrations (incremental increase in drug dosage to provide optimal therapeutic effect) of Ativan, a controlled substance, after the infusion started. RN 2 stated the Ativan drip was started in the emergency department and that the patient was transferred to Unit 9100, MICU (medical intensive care unit). RN 2 further stated that she spoke with the nurse that received the patient in the MICU and the nurse stated the CDRPI was not with the medical record upon Patient 22 arriving on the unit. RN 2 stated that the receiving nurse wasted the Ativan and informed the pharmacy she did not have a copy of the CDRPI.

Additionally, during this same interview, RN 2 stated that the nurse signed another CDRPI with the pharmacy. When asked who was the RN that witnessed the waste of the medication, RN 2 stated that the receiving nurse did not indicate who the nurse was that witnessed the waste of the medication and indicated that the facility was trying to locate a copy of the CDRPI that was re-issued by pharmacy as a result of the lost CDRPI.

Record review of the facility's Pharmacy Services algorithm (a set of steps for solving a particular problem), dated January 2012 for processing the CDRPI revealed the following steps to take in the event the bottom copy of the CDRPI is not returned to the pharmacy within 48 hours:

A 48 hour delinquency note is sent with a copy of the middle sheet by the Utility Tech. If the completed sheet is not returned to the pharmacy within the next 24 hours, a second delinquency notice is sent to unit by the Utility Tech. If the completed bottom sheet is not returned within 24 hours, sheets are given to Pharmacy Directors for follow-up with Nursing Directors.

During an interview on 1/25/12 at 4 PM, Pharm 41 stated that normally the original portion of the CDRPI stays in the pharmacy, pharmacy personnel delivers the controlled medication to the appropriate unit, it is then signed by the RN who receives the medication. Pharm 41 stated that the CDRPI stays with the product (medication) and that two signatures by nurses are needed if the medication was wasted. Pharm 41 further stated that the CDRPI should have been returned from the unit within 48 hours and that a letter was sent out to the unit.

During an interview on 1/26/12 at 12:04 PM regarding CDRPI No. 361984, RN 48 (MICU: Medical Intensive Care Unit Manager) stated that the Fentanyl drip was started in the Emergency Department. She stated that there was approximately 30 cc (cubic centimeters) lost from the IV tubing and that the bag of Fentanyl was totally empty. RN 48 stated that the RN (Registered Nurse) that wasted (a controlled substance that was not used and requires witnessing by a second licensed nurse) the Fentanyl could not find the CDRPI and called the pharmacy. RN 48 further stated that the bag of Ativan was primed (to expel the air from the IV tubing with the medication to be infused) but decided not to infuse (to put into) the medication into the patient.

Record review of the facility's Controlled Drug Management policy and procedure dated 8/2011 revealed the following:

"7. Parenteral (administered intravenously or by injection) Infusions for Controlled Drugs....7.2 The directions on the CDRPI sheet shall be followed...7.4 If the CDRPI sheet is missing or lost, notify the pharmacy for directions".

"10. Missing controlled substances shall be reported to the department manager/administrative supervisor, who shall then report that information to Pharmacy administration. Pharmacy administration shall report missing controlled substances to the CEO (Chief Engineering Officer)".

"11. Discrepancies shall be resolved daily. Controlled substance loss forms shall be completed for any unaccounted for controlled substances".

During an interview on 1/26/12 at 8:05 AM, QA 41 confirmed that there was a problem with nursing and pharmacy and stated that the CDRPI sheet was not staying with the patient as they transferred between units.

Based on interview and record review, the facility failed to ensure accountability and maintenance of accurate records regarding the disposition of controlled substances ordered for 1 of 30 sampled patients, (Patient 22), by failing to track two Controlled Drug Records for Parenteral Infusion (CDRPI) per facility policy. This failure had the potential for loss or diversion to occur.

Findings:

Controlled Drug Record For Parenteral Infusion (CDRPI): To keep tracking dispensing, delivery and administration of controlled substances in order to assure patient safety and comply with regulatory requirements for prevention or potential diversion of controlled substances.

Record review revealed the following two CDRPI filed in the medical record for Patient 22:

1. CDRPI No. 361984, dated 1/5/12, received and signed by RN 49 in the ED (emergency department). Drug: Fentanyl 5000 mcg (micrograms). Unit Instructions noted on the form to place sheet (CDRPI) in MAR (medication administration record) folder after signing for delivery. Also there was a note to return the completed sheet to pharmacy ASAP after:
a. a completed administration,
b. a wasted dose,
c. an unused dose to be returned to pharmacy.

Review of the CDRPI revealed that the start date of the continuous infusion was 1/5/12 at 5:58 PM by RN 49. The section of the sheet where the stop date and time can be documented was noted to be blank. Volume infused was circled and the amount 250 cc (cubic centimeters) was documented. There was also the following documentation noted on the sheet, "late entry 1/25/12....med infused on 1/5/12.

2. CDRPI No. 361983, dated 1/5/12, received and signed by RN 49 in the ED (emergency department). Drug: Lorazepam 100 mg (milligrams). Unit Instructions noted on the form to place sheet (CDRPI) in MAR (medication administration record) folder after signing for delivery. Also there was a note to return the completed sheet to pharmacy ASAP after:
a. a completed administration,
b. a wasted dose,
c. an unused dose to be returned to pharmacy.

Review of the CDRPI revealed that the start date of the continuous infusion was 1/5/12 at 6 PM by RN 49. The section of the sheet where the stop date and time, volume infused/wasted and RN signature can be documented was noted to be blank.

During an interview on 1/24/12 at 10:48 AM, RN 2 (MICU Educator) confirmed the two CDRPI's (361983 and 361984) were filed in the medical record for Patient 22 and stated that normally the CDRPI's go back to the pharmacy. RN 2 further stated that sometimes the CDRPI's are left in the chart if the medication is still infusing. When RN 2 was shown the two CDRPI's one lacking an infusion stop date and time and the other lacking a stop date, time, and the amount infused or wasted, RN 2 stated, "I don't know".

During an interview on 1/24/12 at 11:15 AM, regarding CDRPI No. 361984 (fentanyl drip), RN 2 stated that 183.3 ml was infused out of the 250 ml bag (leaves approximately 66.7 ml). Regarding CDRPI No. 361983 (Ativan drip), RN 2 stated that she was only to provide evidence that the Ativan drip was started on 1/5/12 and was unable to determine the amount that was infused.

During an interview on 1/25/12 at 2:10 PM regarding CDRPI No. 361983, RN 2 stated there were no titrations (incremental increase in drug dosage to provide optimal therapeutic effect) of Ativan, a controlled substance, after the infusion started. RN 2 stated the Ativan drip was started in the emergency department and that the patient was transferred to Unit 9100, MICU (medical intensive care unit). RN 2 further stated that she spoke with the nurse that received the patient in the MICU and the nurse stated the CDRPI was not with the medical record upon Patient 22 arriving on the unit. RN 2 stated that the receiving nurse wasted the Ativan and informed the pharmacy she did not have a copy of the CDRPI.

Additionally, during this same interview, RN 2 stated that the nurse signed another CDRPI with the pharmacy. When asked who was the RN that witnessed the waste of the medication, RN 2 stated that the receiving nurse did not indicate who the nurse was that witnessed the waste of the medication and indicated that the facility was trying to locate a copy of the CDRPI that was re-issued by pharmacy as a result of the lost CDRPI.

Record review of the facility's Pharmacy Services algorithm (a set of steps for solving a particular problem), dated January 2012 for processing the CDRPI revealed the following steps to take in the event the bottom copy of the CDRPI is not returned to the pharmacy within 48 hours:

A 48 hour delinquency note is sent with a copy of the middle sheet by the Utility Tech. If the completed sheet is not returned to the pharmacy within the next 24 hours, a second delinquency notice is sent to unit by the Utility Tech. If the completed bottom sheet is not returned within 24 hours, sheets are given to Pharmacy Directors for follow-up with Nursing Directors.

During an interview on 1/25/12 at 4 PM, Pharm 41 stated that normally the original portion of the CDRPI stays in the pharmacy, pharmacy personnel delivers the controlled medication to the appropriate unit, it is then signed by the RN who receives the medication. Pharm 41 stated that the CDRPI stays with the product (medication) and that two signatures by nurses are needed if the medication was wasted. Pharm 41 further stated that the CDRPI should have been returned from the unit within 48 hours and that a letter was sent out to the unit.

During an interview on 1/26/12 at 12:04 PM regarding CDRPI No. 361984, RN 48 (MICU: Medical Intensive Care Unit Manager) stated that the Fentanyl drip was started in the Emergency Department. She stated that there was approximately 30 cc (cubic centimeters) lost from the IV tubing and that the bag of Fentanyl was totally empty. RN 48 stated that the RN (Registered Nurse) that wasted (a controlled substance that was not used and requires witnessing by a second licensed nurse) the Fentanyl could not find the CDRPI and called the pharmacy. RN 48 further stated that the bag of Ativan was primed (to expel the air from the IV tubing with the medication to be infused) but decided not to infuse (to put into) the medication into the patient.

Record review of the facility's Controlled Drug Management policy and procedure dated 8/2011 revealed the following:

"7. Parenteral (administered intravenously or by injection) Infusions for Controlled Drugs....7.2 The directions on the CDRPI sheet shall be followed...7.4 If the CDRPI sheet is missing or lost, notify the pharmacy for directions".

"10. Missing controlled substances shall be reported to the department manager/administrative supervisor, who shall then report that information to Pharmacy administration. Pharmacy administration shall report missing controlled substances to the CEO (Chief Engineering Officer)".

"11. Discrepancies shall be resolved daily. Controlled substance loss forms shall be completed for any unaccounted for controlled substances".

During an interview on 1/26/12 at 8:05 AM, QA 41 confirmed that there was a problem with nursing and pharmacy and stated that the CDRPI sheet was not staying with the patient as they transferred between units.

Based on record review and interview the facility failed to remove Darvocet N-100(Propoxyphene NAP w/APAP 100 mg) medication as a selection for pain from approved pre-printed medication order forms. The facility failed to ensure that medications prescribed to patients were being monitored to assure that medication therapy is appropriate and minimizes the occurrence of possible adverse events for 1 of 31 sampled patients (Patient 29). The facility failed to recognize that the medication Norco, prescribed to a patient after delivery for pain relief, had possible medication related adverse effect on her lactating newborn. This deficient finding resulted in Patient 29's newborn infant being transported to the hospital emergently for respiratory complications.

Findings:

1. Pre-printed medication order forms are approved via the medical staff for use by the facility, and on an annual basis, or when changes are needed.

On 1/ 24 /12 at approximately 3 PM, the following pre-printed medication orders titled " Post Partum Cesarean Delivery Physician Orders, Outpatient Adult Doxil (Dexorubicin Hydrochloride Liposome) Order, Outpatient Adult Paclitaxel Order, Outpatient Adult Rituxan (Rituximab) Order, Carboplatin Order Ambulatory Infusion Center Outpatient Adult, Outpatient Adult Cisplatin (Platinol) order, Outpatient Adult Weekly Taxol (Paclitaxel) Order, Outpatient Adult Topotecan Cisplatin Order, and Outpatient Adult Paclitaxel Carboplatin Order " were reviewed. The review revealed orders for Darvocet N 100 ( (acetaminophen 650 mg & propoxyphene napsylate 100 mg), a medication formerly used for pain.

The medication order sets listed Darvocet N 100 (acetaminophen 650 mg & propoxyphene napsylate 100 mg) 1 tab. By mouth every 4 hours as needed for pain as an option for prescription order communication.

Following a review of the drug Darvocet? in November 2010, the FDA (Food and Drug Administration) and the manufacturer of Darvocet? (Propoxyphene and acetaminophen) and Darvon? withdrew both products from the U.S market. Manufacturers of the generic version were asked to do the same.

The decision was the result of a recent safety study which demonstrated an increased risk of potentially serious and fatal cardiac rhythm abnormalities with propoxyphene. Prescribers were advised to no longer prescribe propoxyphene-containing products.

In a concurrent interview on 1/25/2012 at approximately 11 AM, with Pharm 42, a pharmacy director, he reported that drugs recalled from the U.S. market should be promptly removed from any prescription order communication.




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2. On 9/22/11, the medical record of Patient 29 was reviewed. Patient 29 was a gravida 2, para 1 female who was admitted to the facility on 9/1/11 at 41 weeks for induction of labor for post dates and a planned vaginal delivery of a baby boy; and had elected to have a lumbar epidural catheter inserted for pain control.

On 9/22/11, a review of Patient 29's Discharge Instructions dated 9/5/11 was conducted. The Discharge Instructions sheet documented the following:
a. DISPOSITION: Home
b. MEDICATIONS: Norco, Motrin, Iron Sulfate, Colace.
c. FOLLOWUP: Follow up with MD in 6 weeks.
d. ACTIVITY: Patient is to undergo pelvic rest for a period of 6 weeks. Do not drive for 2 weeks or while taking narcotics.
e. PRECAUTIONS GIVEN TO THE PATIENT: The patient to call MD or return to the ER for temperature elevation greater than 100.4 degrees, uncontrolled pain, intractable nausea or vomiting, inability to void, heavy vaginal bleeding greater than a period.

On 9/22/11, a review of Patient 29's Physicians' Order sheet dated 9/5/11 was conducted. The physicians' order sheet documented that an order for Norco 10/325 milligrams, i-ii tablets to be taken by mouth, every 6 hours for pain as necessary, was ordered at 6:25 PM.

There was no documented evidence in Patient 29's medical record or from other facility sources that precautionary educational information was given to the mother regarding taking the medication Norco for pain relief, and its possible adverse effect on the breastfed infant.

On 9/22/11, a review of the facility's policy and procedure titled, "PATIENT EDUCATION" dated 5/2011, stipulated, "The facility shall offer healthcare education to patients for safe and effective use of medication for specific condition/disease of the patient. Documentation shall include all disciplines, done on approved patient education forms and discharge instructions and reflect assessment, plan, implementation and patient response."

On 9/22/11, a review of the facility's Emergency Room Record, dated 9/7/11 was conducted. The Emergency Room Record, dated 9/7/11, timed at 2: 56 PM, documented that Patient A's baby boy was brought in by paramedic ambulance for chief complaints of lethargy and slow breathing after breastfeeding. Documentation indicated that the patient had taken Norco earlier that morning. IMPRESSION AND DIFFERENTIAL DIAGNOSIS: Bradypnea, due to transmission of Norco via breastfeeding.

On 9/22/11, a review of the facility's Emergency Room's Discharge Instructions sheet, dated 9/7/11 was conducted. The discharge instruction sheet, dated 9/7/11 and timed at 3:21 PM, documented, "...Your baby (Patient 29's baby) was seen for concern of slow breathing after breastfeeding. This is most likely due to the maternal use of Norco while breastfeeding. We recommend that you use formula only while still taking Norco for pain control..."

According to Mosby's Nursing Drug Reference, 22nd Edition, dated 2009, page 545 stated, "Norco is a controlled substance scheduled III medication. It binds to opiate receptors in CNS to reduce Pain. Precautions include: Pregnancy, breastfeeding, respiratory depression, weakness and nausea and vomiting. FDA pregnancy category C. It is not known whether Norco is harmful to an unknown baby, but it could cause breathing problems in a newborn. Acetaminophen and hydrocodone can pass into breast milk and may harm a nursing baby."

The American Society for Health-Systems Pharmacists (ASHP) is an internationally recognized organization which establishes standards of practice for pharmacists in hospitals. "ASHP Statement on Pharmacist's Responsibility for Distribution and Control of Drug Products" reads: "The fundamental purpose of pharmaceutical services in any setting is to ensure the safe and appropriate use of drug products and drug-related devices. Fulfillment of this responsibility is enhanced through the pharmacist's involvement in all aspects of the use of drugs."

ASHP's Standard III, "Optimizing Medication Therapy" reads: "An important aspect of pharmaceutical care is optimizing medication use. This must include processes designed to ensure the safe and effective use of medications and increase the probability of desired patient outcomes."

On 9/22/11, at approximately 9:15 AM, during an interview with the Attending Physician of Obstetrics and Gynecology, she stated, "I'm aware of what occurred with my patient's baby (Patient 29's baby) and I'm not aware that Norco could have caused this problem, usually not a lot of this drug is transmitted via breast milk, but it could have in this case."

Based on observation, interview and document review, the glucometer in Pre-op was not properly disinfected between patient uses. During the tour of Pre-op, an observation/interview was made with the nurse manager for Pre-op and the Director of Surgical Services. The nurse manager demonstrated how the nursing staff cleans the whole outside of the device with soapy water between patients. They only use a disinfection wipe (CaviWipes) when there is visible blood or dirt. In an interview, the hospital epidemiologist stated that soap and water would not be considered disinfection or the instrument as required by policy. This resulted in the potential for blood borne (infectious agents found in the blood of infected persons) to be spread to patients via the glucometer.

Findings:

1. The Pre-op area was toured on 1/24/12. The charge nurse demonstrated how the glucometer was wiped over the entire outside surface. She stated that she used soap and water between patients but would use a disinfectant if there was visible blood or dirt. The Nurse Manager for Pre-op confirmed that soap and water was used unless there was visible contamination in which case the device was cleaned with Caviwipes disinfectant wipes. Current recommendations and standard of practice is to use an antiseptic agent to clean the entire outside surface of multi-patient use glucometers to minimize contamination with blood borne agents that can be deposited on the surface of the device when the strip containing blood is pulled out of the device, causing an aerosol of a small amount of blood. The device can contain small amounts of blood that cannot be seen and have been shown to transmit disease.

2. A policy titled, "Blood Glucose by Roche Accu-Chek Inform Meter" was reviewed. The policy states in section 6.3 that "It is important to keep your system clean and disinfected." The device must be wiped with a pre-moistened towel with one of the following: soapy water, 70% isopropyl alcohol, ammonium chloride or 11:10 bleach. The policy does not describe which solution should be used for which situations. The Hospital Epidemiologist stated that soap and water use would not be considered disinfection and that the policy is meant to direct the staff to properly disinfect the device.

Based on observation, interview and document review, the infection control officer failed to ensure that the policy on the disinfection of the glucometer in Pre-op was followed. This resulted in the potential for blood borne (infectious agents found in the blood of infected persons) to be spread to patients via the glucometer.

Findings:

1. The pre-op was toured on 1/24/12. The charge nurse demonstrated how the glucometer was wiped over the entire outside surface. She stated that she used soap and water between patients but would use a disinfectant if there was visible blood or dirt. The Nurse Manager for Pre-op confirmed that soap and water was used unless there was visible contamination in which case the device was cleaned with Caviwipes disinfectant wipes. Current recommendations and standard of practice is to use an antiseptic agent to clean the entire outside surface of multi-patient use glucometers to minimize contamination with blood borne agents that can be deposited on the surface of the device when the strip containing blood is pulled out of the device, causing an aerosol of a small amount of blood.

2. A policy entitled "Blood Glucose by Roche Accu-Chek Inform Meter" states in section 6.3 that "It is important to keep your system clean and disinfected." The device must be wiped with a pre-moistened towel with one of the following: soapy water, 70% isopropyl alcohol, ammonium chloride or 11:10 bleach. The policy does not describe which solution should be used for which situations. The Hospital Epidemiologist stated that soap and water use would not be considered disinfection.

3. The Director of Hospital Epidemiology was interviewed 1/25/12 at 1:50 PM. She stated that CaviWipes should be used in as two-step process. First the surfaces in the OR, the glucometer and other areas requiring disinfection are wiped down with Caviwipes to remove visible contamination. As many Caviwipes as are needed to remove any visible matter should be used. They should be wiped down with Caviwipes a second time to ensure disinfection. The Director of Hospital Epidemiology (1/25/12 1:50 PM) also stated that the problem with the glucometer disinfection was not picked up by infection control (IC) personnel. She stated that she has four nurses to cover the over 800 beds at four different campuses and that more were needed to adequately monitor for deviations from the policy and procedures (P&Ps) and to address all issues in all units.

4. A policy entitled CaviWipes are replacing Steris was reviewed on 1/15/12 at 11:05 AM. It describes the two steps for the cleaning or all room surfaces.
a. -preclean using as many wipes as needed
b. -disinfection. Keep the surface visibly wet for three minutes.

5. The Medical Director for Quality also stated that he had been looking into the need for more IC personnel. Because of the number of hospital beds, the number of separate campuses, and the complexity of the medical services offered, he had been considering requesting additional personnel for Infection Control.

Based on observation, interview and document review, the infection control personnel failed to monitor the policy and procedure regarding the cleaning and disinfection of the glucometer in Pre-op. The policy states in section 6.3 that " It is important to keep your system clean and disinfected. " The device must be wiped with a pre-moistened towel with one of the following: soapy water, 70% isopropyl alcohol, ammonium chloride or 11:10 bleach. The policy does not describe which solution should be used for which situations. The Hospital Epidemiologist stated that soap and water use would not be considered disinfection. She considered the practice of cleaning the glucometer with only soap and water as a failure to follow IC policy. This resulted in the potential for transmission of blood borne infectious agents to be transmitted to patients and staff.

Findings:

1. The Preoperative area (Pre-op) was toured on 1/24/12. The charge nurse demonstrated how the glucometer was wiped over the entire outside surface. She stated that she used soap and water between patients but would use a disinfectant if there was visible blood or dirt. The Nurse Manager for Pre-op confirmed that soap and water was used unless there was visible contamination in which case the device was cleaned with Caviwipes disinfectant wipes. Current recommendations and standard of practice is to use an antiseptic agent to clean the entire outside surface of multi-patient use glucometers to minimize contamination with blood borne agents that can be deposited on the surface of the device when the strip containing blood is pulled out of the device, causing an aerosol of a small amount of blood.

2. A policy titled, "Blood Glucose by Roche Accu-Chek Inform Meter" policy states in section 6.3 that "It is important to keep your system clean and disinfected." The device must be wiped with a pre-moistened towel with one of the following: soapy water, 70% isopropyl alcohol, ammonium chloride or 11:10 bleach. The policy does not describe which solution should be used for which situations. The Hospital Epidemiologist stated that soap and water use would not be considered disinfection.

3. The Director of Hospital Epidemiology was interviewed 1/25/12 at 1:50 PM. She stated that CaviWipes should be used in as two-step process. First the surfaces in the OR, the glucometer and other areas requiring disinfection are wiped down with Caviwipes to remove visible contamination. They should be wiped down with Caviwipes a second time to ensure disinfection. The Director of Hospital Epidemiology (1/25/12 1:50 PM) also stated that the problem with the glucometer disinfection was not picked up by infection control (IC) personnel. She stated that she has four nurses to cover the over 800 beds at four different campuses and that more were needed.

Based on interview and record review, the facility failed to ensure that a comprehensive, coordinated and individualized discharge plan was developed to meet the specific needs for 1 of 31 sampled patients (Patient 29). The hospital failed to address in Patient 29's discharge instruction form, possible adverse signs and symptoms of neurological regression; due to fragments of a retained epidural catheter in Patient 29's back. In addition, the Hospital failed to ensure that Patient 29 was instructed on the possible adverse side effects of taking the medication Norco for pain relief and its effect on her infant after breast feeding. This deficient practice had the potential to affect the health and safety of Patient 29 and her infant after being discharged resulting in possible rehospitalization for reasons that could have been prevented.

Findings:

On 9/16/11, a medical record review of Patient 29 was conducted. Patient 29 was a gravida 2, para 1 female (gravida-a total number of female pregnancies; para-number of viable infants) who was admitted to the facility on 9/1/11 at 41 weeks for induction of labor for post dates for a planned vaginal delivery of a baby boy; and had elected to have a lumbar epidural catheter inserted for pain control.

On 9/2/11, prior to a planned vaginal delivery, Patient 29 underwent a lumbar epidural procedure in which fragments of the epidural catheter was retained inside her epidural space. (The term epidural is often short for epidural analgesia, a form of regional analgesia involving injection of drugs through a placed epidural catheter, into the epidural space. The injection can cause both a loss of sensation and a loss of pain (analgesia) by blocking the transmission of signals through nerves in or near the spinal cord).

On 9/22/11, a review of the hospital's Anesthesia Report titled, "PROCEDURE COMMENTS" dated 9/22/11 for Patient 29 was conducted. The entry dated 9/2/11, and timed 4:50 AM, documented the following: " ...Needle advanced until loss of resistance at depth of 4.5 centimeters. Catheter threaded to 10 centimeters at needle hub with transient paresthesia to left. Some resistance met at this depth. Catheter retracted to enable recheck of location of resistance. However, as the catheter was pulled from end of Tuohy needle (a needle used to insert the epidural catheter into the epidural space) it was noted that catheter tubing was severed at the 6 centimeter mark. Touhy needle was removed over internal wire and catheter to expose entry site ... "

On 9/16/11, a review of Patient 29's Neurosurgery Consult report, dated 9/3/11 and timed at 3:31 PM, revealed that fragments of the epidural catheter, confirmed by CT imaging, was present in the epidural space and lodged at the level of L-1 or L-2 area (anatomical location of the lumbar spine). Further documentation indicated that the Neurosurgery Consultant discussed with Patient 29 the possibility of surgery to extract the fragment lodged in Patient 29's epidural space with explanation of the risks and benefits of having or not having the surgery. Patient 29 declined surgery at that time. Documentation also indicated that Patient 29 would be at risk for an "abscess" in approximately 3 months after delivery. In addition, the Neurosurgery consultant recommended possible surgery if the following conditions existed:
a. Patient regresses to have weakness.
b. Patient experiences changes in sensation.
c. Patient experiences urinary incontinence.
d. Patient experiences bowel incontinence.

On 9/22/11, a review of Patient 29's Discharge Instructions dated 9/5/11 was conducted. The Discharge Instructions sheet documented the following:
a. DISPOSITION: Home
b. MEDICATIONS: Norco, Motrin, Iron Sulfate, Colace.
c. FOLLOWUP: Follow up with MD in 6 weeks.
d. ACTIVITY: Patient is to undergo pelvic rest for a period of 6 weeks. Do not drive for 2 weeks or while taking narcotics.
e. PRECAUTIONS GIVEN TO THE PATIENT: The patient to call MD or return to the ER for temperature elevation greater than 100.4 degrees, uncontrolled pain, intractable nausea or vomiting, inability to void, heavy vaginal bleeding greater than a period.

On 9/22/11, a review of Patient 29's Physicians' Order sheet dated 9/5/11 was conducted. The physicians' order sheet documented that an order for Norco 10/325 milligrams, i-ii tablets, taken by mouth, every 6 hours for pain when necessary, was ordered at 6:25 PM.

There was no documented evidence in Patient 29's Discharge Summary Instruction sheet, dated 9/5/11, that addressed Patient 29's retained epidural fragment in her epidural space, along with specific instructions to be aware for signs and symptoms of neurological deterioration. Neurological deterioration would include signs and symptoms such as increase lower extremity weakness, changes in sensation to the lower extremities and bowel and bladder incontinence. Such changes should also be reported to the physician.

There was no documented evidence in Patient 29's Discharge Summary Instruction sheet, dated 9/5/11, that addressed precautionary educational information was given to the patient when taking the medication Norco for pain relief, and its possible adverse effect on the lactating infant.

According to Mosby's Nursing Drug Reference, 22nd Edition, dated 2009, page 545 stated, "Norco is a controlled substance scheduled III medication. It binds to opiate receptors in CNS to reduce Pain. Precautions include: Pregnancy, breastfeeding, respiratory depression, weakness and nausea and vomiting." The FDA lists Norco as pregnancy category 'C' class medication. It is not known whether Norco is harmful to an unknown baby, but it could cause breathing problems in a newborn. Acetaminophen and hydrocodone can pass into breast milk and may harm a nursing baby.

On 9/22/11, a review of the facility's policy and procedure titled, "DISCHARGE PLANNING/CONTINUITY OF PATIENT CARE" dated 12/2010, stipulated, "Identified needs of the patient shall determine which clinical discipline will be involved in discharge planning. The prescriber or pharmacist shall discuss with the patient use and storage of medications, the importance of compliance, harmful effects of medications and its substantial risk."

On 9/22/11, a review of the facility's Emergency Room Record, dated 9/7/11 was conducted. The Emergency Room Record, dated 9/7/11, timed at 2: 56 PM, documented that Patient 29's infant was brought in by paramedic ambulance for chief complaints of lethargy and slow breathing after breastfeeding. Further documentation indicated that the infant's mother had taken Norco earlier that morning. IMPRESSION AND DIFFERENTIAL DIAGNOSIS: Bradypnea (slow rate of breathing) was due to transmission of Norco via breastfeeding.

On 9/22/11, a review of the facility's Emergency Room's Discharge Instructions sheet, dated 9/7/11 was conducted. The discharge instruction sheet, dated 9/7/11 and timed at 3:21 PM, documented, "Your baby (Patient 29's baby) was seen for concern of slow breathing after breastfeeding. This is most likely due to the maternal use of Norco while breastfeeding. We recommend that you use formula only while still taking Norco for pain control."

On 9/22/11, at approximately 10:45 AM, the Director of the Post Partum Department confirmed the finding that Patient 29's discharge instruction sheet did not contain educational information regarding the patient's retained fragment in the epidural space with possible neurological changes, and reporting such changes to the physician, along with precautionary information when taking Norco when lactating.

Based on interview and record review, the facility failed to ensure that an individualized discharge planning evaluation was developed and was discussed with Patient 29 in order to meet her specific needs for 1 of 31 sampled patients (Patient 29). The hospital failed to address in Patient 29's medical record that an discharge evaluation plan was performed addressing possible adverse signs and symptoms of neurological regression; due to fragments of a retained epidural catheter in Patient 29's back. In addition, the Hospital failed to ensure that a discharge evaluation was performed instructing Patient 29 on the possible adverse side effects of taking the medication Norco for pain relief and its effect on her infant after breast feeding. These deficient practices had the potential to affect the health and safety of Patient 29 and her infant after being discharged resulting in possible rehospitalization for reasons that could have been prevented.

Findings:

On 9/16/11, a medical record review of Patient 29 was conducted. Patient 29 was a gravida 2, para 1 female (gravida=a total number of female pregnancies; para=number of viable infants) who was admitted to the facility on 9/1/11 at 41 weeks for induction of labor for post dates for a planned vaginal delivery of a baby boy; and had elected to have a lumbar epidural catheter inserted for pain control.

On 9/2/11, prior to a planned vaginal delivery, Patient 29 underwent a lumbar epidural procedure in which fragments of the epidural catheter was retained inside her epidural space. (The term epidural is often short for epidural analgesia, a form of regional analgesia involving injection of drugs through a placed epidural catheter, into the epidural space. The injection can cause both a loss of sensation and a loss of pain (analgesia) by blocking the transmission of signals through nerves in or near the spinal cord).

On 9/16/11, a review of Patient 29's Neurosurgery Consult report, dated 9/3/11 and timed at 3:31 PM revealed that fragments of the epidural catheter, confirmed by CT imaging, was present in the epidural space and lodged at the level of L-1 or L-2 area (anatomical location of the lumbar spine). Further documentation indicated that the Neurosurgery Consultant discussed with Patient 29 the possibility of surgery to extract the fragment lodged in Patient 29's epidural space with explanation of the risks and benefits of having or not having the surgery. Patient 29 declined surgery at that time. Documentation also indicated that Patient 29 would be at risk for an "abscess" in approximately 3 months after delivery. In addition, the Neurosurgery consultant recommended possible surgery if the following conditions existed:
a. Patient regresses to have weakness.
b. Patient experiences changes in sensation.
c. Patient experiences urinary incontinence.
d. Patient experiences bowel incontinence.

On 9/22/11, a review of Patient 29's Discharge Instructions dated 9/5/11 was conducted. The Discharge Instructions sheet documented the following:
a. DISPOSITION: Home
b. MEDICATIONS: Norco, Motrin, Iron Sulfate, Colace.
c. FOLLOWUP: Follow up with MD in 6 weeks.
d. ACTIVITY: Patient is to undergo pelvic rest for a period of 6 weeks. Do not drive for 2 weeks or while taking narcotics.
e. PRECAUTIONS GIVEN TO THE PATIENT: The patient to call MD or return to the ER for temperature elevation greater than 100.4 degrees, uncontrolled pain, intractable nausea or vomiting, inability to void, heavy vaginal bleeding greater than a period.

On 9/22/11, a review of Patient 29's Physicians' Order sheet dated 9/4/11 was conducted. The physicians' order sheet documented that an order for Norco 10/325 milligrams, i-ii tablets taken by mouth every 6 hours for pain as necessary, was ordered at 6:25 PM.

There was no documented evidence in Patient 29's medical record or from other facility sources, prior to Patient 29's discharge from the Post Partum Unit, on 9/4/11, that a discharge planning evaluation was developed involving the Interdisciplinary Discharge Team and Patient 29's neurosurgeon pertaining to retained fragments in her epidural space and the possibility of experiencing neurological changes. There was no documented evidence in the medical record that a discharge planning evaluation was developed by the facility's pharmacist, Patient 29's physician or primary nurse provider evaluating the possible adverse effect of Patient 29 taking Norco, for pain relief, and its possible adverse affect on her lactating newborn.

There was no documented evidence in Patient 29's Discharge Summary Instruction sheet, dated 9/4/11, that addressed Patient 29's retained epidural fragment in her back, with specific instructions for her to be aware of signs and symptoms of neurological deterioration, such as increase lower extremity weakness, changes in sensation to the lower extremities and bowel and bladder incontinence; and to report those changes to her physician.

There was no documented evidence in Patient 29's Discharge Summary Instruction sheet, dated 9/4/11, that addressed precautionary educational information that was given to the patient regarding her taking the medication Norco for pain relief, and its possible adverse affect on the breast fed infant.

On 9/22/11, at approximately 10:45 AM, the Director of the Post Partum Department confirmed the finding that Patient 29's medical record did not contain a discharge planning evaluation between the Interdisciplinary Discharge Team and Patient 29's neurosurgeon pertaining to retained fragment in her epidural space and the possibility of experiencing neurological changes or an evaluation was developed by the pharmacist or prescribing physician or primary nurse provider evaluating the possible adverse effect of Patient 29 taking Norco and its possible effect on her breast fed infant.

Based on interview and record review, the facility failed to ensure that all reportable, defined adverse healthcare events, after detection, were reported to the California Department of Public Health in a timely manner. The facility failed to report an adverse event when Patient 29's anesthesia physician (a fourth year Anesthesia Resident), prior to a planned vaginal delivery on 9/2/11, attempted to insert a lumbar epidural catheter and later found fragments of the tip of the epidural catheter missing. The missing tip of the epidural catheter was later confirmed to be lodged inside Patient 29's epidural space. This finding had the potential to negatively affect the health and well being of Patient 29 before and after delivery of her baby.

Findings:

Complaint #CA00283210

On 9/2/11, prior to a planned vaginal delivery, Patient 29 underwent a lumbar epidural procedure in which fragments of the epidural catheter was retained inside her epidural space. (The term epidural is often short for epidural analgesia, a form of regional analgesia involving injection of drugs through a placed epidural catheter, into the epidural space. The injection can cause both a loss of sensation and a loss of pain (analgesia) by blocking the transmission of signals through nerves in or near the spinal cord). This deficient finding had the potential to result in affecting the health and safety of Patient 29.

On 9/22/11, the medical record of Patient 29 was reviewed. Patient 29 was a gravida 2, para 1 female (gravida-a total number of female pregnancies; para-number of viable infants) who was admitted to the facility on 9/1/11 at 41 weeks for induction of labor for post dates and a planned vaginal delivery of a baby boy; and had elected to have a lumbar epidural catheter inserted for pain control. The Anesthesia Preoperative Evaluation was completed by the Anesthesia Resident A, on 9/1/11 at 8:05 PM, and Patient 29 was found to have an ASA (American Society of Anesthesiologists) score of 2 (indicating the patient was found to be a low risk for anesthesia)

On 9/22/11, a review of the hospital's Anesthesia Report titled, "PROCEDURE COMMENTS" dated 9/22/11 for Patient 29 was conducted. The entry dated 9/2/11, and timed 4:50 AM, documented the following: " ...Needle advanced until loss of resistance at depth of 4.5 centimeters. Catheter threaded to 10 centimeters at needle hub with transient paresthesia to left. Some resistance met at this depth. Catheter retracted to enable recheck of location of resistance. However, as the catheter was pulled from end of Tuohy needle (a needle used to insert the epidural catheter into the epidural space) it was noted that catheter tubing was severed at the 6 centimeter mark. Touhy needle was removed over internal wire and catheter to expose entry site ... "

On 9/22/11, a review and examination of the Lumbar Epidural Catheter Sample Kit along with the manufactures' recommended instruction sheet; similar to the one used on Patient A was conducted. The Smiths-Medical Portex Continuous Epidural Catheter Kit documented the following warnings and precautions: "NEVER WITHDRAW THE CATHETER BACK THROUGH THE EPIDURAL NEEDLE AS THIS MAY CAUSE THE CATHETER TO KINK OR SHEAR."

On 9/22/11, at approximately 3:00 PM, during an interview with the Patient Safety & Reliability Director, when asked if the facility had hospital-wide a policy and procedure on "Standards of Lumbar Epidural Catheter Placement " , she responded, "No, but the Department of Anesthesia has their own policy and procedure for epidural placement for teaching purposes for anesthesia residents."

On 9/22/11, at approximately 3:05 PM, an interview was conducted with Anesthesia Physician A (a fourth year Anesthesia Resident). When asked what occurred on 9/2/11 while attempting to insert a lumbar epidural catheter into Patient 29's back, she stated, "I was attempting to insert the epidural catheter into the patient's (Patient 29) back prior to delivery. On insertion of the epidural catheter, I met resistance at a certain level and retracted the catheter back. When I retracted the catheter I noticed the tip of the catheter was missing."

When asked if her insertion technique might have been the problem causing the tip of the epidural catheter to be sheared off at the 6 centimeter mark and remained lodged in Patient A's epidural space, she stated, "Yes, I think so, I should not have pulled out the catheter without pulling out the needle as one."

On 9/22/11, at approximately 3:14 PM, an interview was conducted with Anesthesia Physician B (Anesthesia Attending Physician). When asked if he thought the retained fragment of the epidural catheter was possibly due to Anesthesia Physician A's insertion technique, he responded, "Yes." When asked further if he thought the retained fragment of the epidural catheter was possibly due to a "device defect" , he stated, "I don't think so, but I did call the manufacturer, maker of the epidural catheter, just to make sure."

On 9/22/11, at approximately 4:15 PM, during an interview with the Patient Safety & Reliability Director, when asked if this anesthesia-related adverse event was reported to the Californian Department of Public Health, she responded, "No." She further stated the physicians felt this was not a reportable event because they (facility) chose to purposefully retain the epidural fragment in Patient 29's epidural space at that time due to the high risk of surgery outweighing the benefits of removal of the retained fragments.

On 1/25/12, a review of the Department's master log of all documented adverse events in San Bernardino County, reported from 9/1/11 through 1/25/12, from all General Acute Care Hospitals (GACHs), all Acute Psychiatric Hospitals (APH) and all Special Hospitals (SH) was conducted. There was no documented evidence that the facility notified (reported) to the Department the adverse event involving Patient 29 that occurred on 9/2/11.

On 9/8/11, a review of Patient 29's MRI results dated 9/5/11 documented that "a thin radiopaque catheter in the posterior epidural space just right of midline at L1-2 disk. The catheter courses laterally to the left of the neuroforamainal epidural space and then inferiorly to the L3 level, where it appears curve around the terminate in the posterior epidural space near midline."

Further documentation indicated that the Neurosurgery Consultant discussed with Patient 29 the possibility of surgery to extract the fragment lodged in Patient 29's epidural space and had explained the risks and benefits of having or not having the surgery. Patient 29 declined surgery at that time. Documentation also indicated that Patient A would be at risk for an "abscess" in approximately 3 months after delivery. In addition, the Neurosurgery consultant recommended possible surgery if the following conditions existed:
a. Patient regresses to have weakness.
b. Patient experiences changes in sensation.
c. Patient experiences urinary incontinence.
d. Patient experiences bowel incontinence.

On 9/16/11, a review of Patient A's Interdisciplinary Care Plan for Postpartum care, dated 9/2/11, documented the following patient problems/needs that were addressed:
a. Learning needs related to self care.
b. Abnormal bleeding.
c. Infections.
d. Pain related to vaginal delivery.
e. Safety, fall prevention.

There was no documented evidence that a comprehensive, coordinated individualized Interdisciplinary Care Plan was developed to address Patient 29's retained epidural catheter in her epidural space (back) while on the Post Partum Unit. There was no indication that the postpartum nursing staff incorporated in the Interdisciplinary Care Plan the neurosurgeon's recommendation to observe and report to the physician any neurological changes Patient 29 might experience, such as regression in weakness and sensation to her lower extremities or any signs of urinary and bowel incontinence.

On 9/22/11, a review of the facility's policy and procedure titled, "PATIENT CARE PROCESS AND DOCUMENTATION: PLAN OF CARE/TREATMENT PLAN" dated 8/2009 stipulated, "A plan of care for each patient shall be initiated by a Registered Nurse immediately after completing the admission assessment, in coordination with the medical plan of care. All other disciplines involved in the patient's care shall document on the plan of care immediately following their assessment. Care plan updates will be documented by all disciplines. In all cases, there shall be collaboration among all pertinent disciplines to ensure consistency in the treatment planning process."

On 9/16/11, a review of the facility's policy and procedure titled, "DISCHARGE PLANNING/CONTINUITY OF PATIENT CARE " dated 12/10, stipulated in section (3): "...The case manager, in conjunction with the clinical nurse, shall be responsible for assessing the patient prior to or upon admission, planning for continuing care based on the patient's individual needs..."

On 1/25/12, at approximately 9:45 AM, during an interview with the Executive Director of Patient Safety & Reliability Director, when asked if this anesthesia-related adverse was reported to the Public Health Department and to the Hospital-Wide Quality Assurance and Performance Improvement Department, she stated, "No, the evaluation of the incident stays at the Department of Anesthesia level and the physicians felt that the retained fragment was purposefully retained and therefore deemed not reportable to the California Department of Public Health."

On 9/22/11, a review of the hospital's policy and procedure titled, "REPORTABLE EVENTS " dated 3/2011 stipulated, " ...According to the California Health and Safety Code, Section 1279.1, a specified list of events are reportable to the State Department of Public Health. The list includes 28 enumerated occurrences that should never occur at a health care facility. If an event on the list occurs, it shall be reported to the California Department of Public Health (CDPH) within five (5) days of its discovery, unless the event is an ongoing urgent or emergent threat to the welfare, safety, or health of patients, personnel, or visitors, in which case the event shall be reported to CDPH within 24 hours of its discovery..."
Therefore, the facility failed to ensure that all reportable, defined adverse healthcare events, after detection, were reported to the California Department of Public Health in a timely manner. The facility specifically failed to report an adverse event when Patient 29's anesthesia physician (a fourth year Anesthesia Resident), prior to a planned vaginal delivery on 9/2/11, attempted to insert a lumbar epidural catheter and later found fragments of the tip of the epidural catheter missing. There was no documented evidence that the adverse event was reported to the California Department of Public Health by the facility within the regulatory time frame.