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Based on observation, interview, and record review, the facility's Governing Body (GB) failed to ensure the hospital's operation was conducted in an effective and organized manner by failing:

1. To develop, implement and maintain an effective, ongoing, hospital-wide, data-driven quality assessment and performance improvement (QAPI) program, in which the governing body (GB) ensured that the program reflected the different department/services; and that the program focused on indicators in improving health outcomes and the prevention of medical errors (A263, A266, A267, A274, A286, A287, A297, A310, and A311); and

2. To ensure pharmaceutical services and operations were provided in a safe and effective manner that would meet the patients' needs (A490, A494, A500, and A505).

The cumulative effect of these systemic problems resulted in failure of the governing body to ensure patients were receiving quality care in a safe and effective manner.

Based on interview and record review, the facility failed to follow their policy and procedure in regards to the follow-up response to the patient/responsible party and expected resolution time frame for three of four grievances reviewed. This had the potential to result in the patient/responsible party not knowing what the facility had done to resolve their concerns in a timely manner.

Findings:

On June 20, 2012, at 3 p.m., an interview was conducted with the Director Quality and Risk Management (DQRM), Grievance Coordinator (GC), and Quality Data Analyst (QDA).

The facility "Grievance Log" was reviewed.

Grievance Case 1 was received by the facility on February 29, 2012, via a telephone call from the patient's wife. An "initial letter," dated March 5, 2012, was sent to the patient which revealed the facility would be investigating the patient's/wife's concerns, but there was no indication in the letter as to when the facility would respond back to the patient with their resolution of the investigation. A final letter, dated June 18, 2012, was sent to the patient with the investigation resolution (104 days after the initial letter had been sent to the patient).

The patient/patient's wife was not notified of the status of the investigation for their concerns and the expected resolution time frame when the grievance resolution was not achieved within seven days of the filing of the grievance, in accordance to the facility's policy and procedure.

Grievance Case 2 was received by the facility on April 13, 2012, via a telephone call from the patient. An "initial letter," dated April 13, 2012, was sent to the patient which revealed the facility would be investigating the patient's concerns, but there was no indication in the letter as to when the facility would respond back to the patient with their resolution of the investigation. A final letter, dated June 16, 2012, was sent to the patient with the investigation resolution (63 days after the initial letter had been sent to the patient).

The patient was not notified of the status of the investigation for her concerns and the expected resolution time frame when the grievance resolution was not achieved within seven days of the filing of the grievance, in accordance to the facility's policy and procedure.

Grievance Case 3 was received by the facility on April 12, 2012, via a letter sent by the patient. An "initial letter," dated April 13, 2012, was sent to the patient which revealed the facility would be investigating the patient's concerns, but there was no indication in the letter as to when the facility would respond back to the patient with their resolution of the investigation. A final letter had not been sent (67 days after the initial letter was sent to the patient).

The patient was not notified of the status of the investigation for his concerns and the expected resolution time frame when the grievance resolution was not achieved within seven days of the filing of the grievance, in accordance to the facility's policy and procedure.

During a concurrent interview with the DQRM, GC, and QDA, they stated the facility was in the process of defining their "new" grievance process, and they had started a "Grievance Committee" on March 9, 2012. They stated the "Quality Council and Directors" had been educated on the process within the last 30 days, and their goal was to close a grievance within 30 days of receipt of that grievance. In addition, they stated the facility policy and procedure would be updated once they had their process defined to include the correct address of the California Department of Public Health, Licensing & Certification office for the patient to contact if they wished to make a complaint.

The facility policy and procedure titled "Patient Complaints and Grievances" dated February 1, 2011, revealed "... All grievances received by Patient Relations from a patient or his or her authorized representative shall receive an initial written response within seven (7) days. ... If a resolution cannot be achieved within a seven (7) day period following the filing of a grievance, the patient shall be notified of the status of the issue and the expected resolution time frame. ..."

Based on interview and record review, the facility failed to develop, implement and maintain an effective, ongoing, hospital-wide, data-driven quality assessment and performance improvement (QAPI) program, in which the governing body (GB) ensured that the program reflected the different department/services; and that the program focused on indicators in improving health outcomes and the prevention of medical errors. The facility failed:

1. To establish a program that showed measureable improvement in indicators for which there was evidence that identified, tracked, and reduced medication errors for the purpose of improving patient care A266);

2. To collect data that measured, analyzed, and tracked quality indicators, including adverse patient events, and other aspects of performance that assessed processes of care, hospital services, and operations. In addition, the facility failed to identify and collect data specifically for the services provided such as infection control and prevention, pharmaceutical services, nursing services, and any other patient care areas (A267);

3. To collect data that included patient care data and other department's relevant data (A274);

4. To track medication related events for the purpose of improving patient care (A286);

5. To review and analyze the cause of medication related events for the purpose of improving patient care (A287);

6. To conduct performance improvement projects by failing to collect data that measured, analyzed, and tracked quality indicators of care, hospital services, and operations (297);

7. To ensure an ongoing program for quality improvement was defined, implemented, and maintained (A310); and

8. To ensure an ongoing program for patient safety, including the reduction of medical errors was defined, implemented, and maintained (A311).

The cumulative effect of these systemic problems resulted in the failure for the facility quality assurance, performance improvement program to ensure high quality healthcare and a safe environment for all patients.

Based on interview and document review, the facility failed to establish a program that showed measureable improvement in indicators for which there was evidence that identified, tracked, and reduced medication errors for the purpose of improving patient care.

Findings:

An interview was conducted with DQRM and the DOP to discuss the facility's quality assurance program that tracked, reviewed, and analyzed medication related adverse events on June 21, 2012, starting at 11 a.m. During the interview, both stated that medication errors were vastly underreported and there were not enough reported to conduct analysis for trends at this time.

The DQRM stated that she was told medication errors would be presented and discussed in the Pharmacy and Therapeutics Committee, but she was unable to find documented evidence in the P&T meeting minutes.

Based on interview and record review, the facility failed to collect data that measured, analyzed, and tracked quality indicators, including adverse patient events, and other aspects of performance that assessed processes of care, hospital services, and operations. In addition, the facility failed to identify and collect data specifically for the services provided such as infection control and prevention, pharmaceutical services, nursing services, and any other patient care areas.

These failures had the potential to result in missed opportunities to identify and investigate processes of care, and identify opportunities for performance improvement.

Findings:

On June 20, 2012, the facility's Quality Improvement Council (QIC) minutes and Performance Improvement Committee (PIC) minutes were reviewed. The documents reviewed contained "PI Executive Summary" reports and a variety of other reports. The reports did not contain any hospital department-specific data that measured, analyzed, and tracked opportunities and/or indicators that focused on improving health outcomes.

On June 20, 2012, at 9:10 a.m., the members of the facility's QIC, PIC, and Patient Safety and Reliability Council (PSRC) were interviewed. The DQRM presented the facility's structure for Quality Assessment and Performance Improvement (QAPI). The DQRM also presented a reporting calendar for the facility's quality/patient safety program. The DQRM stated the facility had current ongoing PI projects, but had not aggregated data that measured, tracked, and analyzed the information in order to identify opportunities for improvement. The DQRM stated the facility had projects, but the facility did not have documented evidence of data measurement, tracking, and analysis.

The facility did not have documented evidence of QAPI data related to infection control and prevention.

The DQRM stated the facility's adverse event reporting was being completed by filling out an incident report form and was submitted to the Risk Management department. The DQRM stated the facility recently started a process of monitoring these events, but did not have aggregated data of measurement, tracking, and analysis of any events.

The DQRM stated the facility had started implementing the facility's grievance process and started tracking whether the facility was following the established facility policy. The facility did not currently have aggregated data that measured, tracked, and analyzed these grievances.

Based on interview and record review, the facility failed to collect data that included patient care data and other department's relevant data (Refer to A267).

These failures had the potential to result in missed opportunities to identify and investigate processes of care, and identify opportunities for performance improvement.

Findings:

On June 20, 2012, the facility's Quality Improvement Council (QIC) minutes and Performance Improvement Committee (PIC) minutes were reviewed. The documents reviewed contained "PI Executive Summary" reports and a variety of other reports. The reports did not contain any hospital department-specific data that measured, analyzed, and tracked opportunities and/or indicators that focused on improving health outcomes.

On June 20, 2012, at 9:10 a.m., the members of the facility's QIC, PIC, and Patient Safety and Reliability Council (PSRC) were interviewed. The DQRM presented the facility's structure for Quality Assessment and Performance Improvement (QAPI). The DQRM also presented a reporting calendar for the facility's quality/patient safety program. The DQRM stated the facility had current ongoing PI projects, but had not aggregated data that measured, tracked, and analyzed the information in order to identify opportunities for improvement. The DQRM stated the facility had projects, but the facility did not have documented evidence of data measurement, tracking, and analysis.

The facility did not have documented evidence of QAPI data related to infection control and prevention.

The DQRM stated the facility's adverse event reporting was being completed by filling out an incident report form and was submitted to the Risk Management department. The DQRM stated the facility recently started a process of monitoring these events, but did not have aggregated data of measurement, tracking, and analysis of any events.

The DQRM stated the facility had started implementing the facility's grievance process and started tracking whether the facility was following the established facility policy. The facility did not currently have aggregated data that measured, tracked, and analyzed these grievances.

Based on interview and document review, the facility failed to track medication related events for the purpose of improving patient care.

Findings:

An interview was conducted with DQRM and the DOP to discuss the facility's quality assurance program that tracked, reviewed, and analyzed medication related adverse events on June 21, 2012, starting at 11 a.m. During the interview, both stated that medication errors were vastly underreported and there were not enough reported to conduct analysis for trends at this time.

The DQRM stated that she was told medication errors would be presented and discussed in the Pharmacy and Therapeutics Committee, but she was unable to find documented evidence in the P&T meeting minutes.

Based on interview and document review, the facility failed to review and analyze the cause of medication related adverse events for the purpose of improving patient care.

Findings:

An interview was conducted with DQRM and the DOP to discuss the facility's quality assurance program that tracked, reviewed, and analyzed medication related adverse events on June 21, 2012, starting at 11 a.m. During the interview, both stated that medication errors were vastly underreported and there were not enough reported to conduct analysis for trends at this time.

The DQRM stated that she was told medication errors would be presented and discussed in the Pharmacy and Therapeutics Committee, but she was unable to find documented evidence in the P&T meeting minutes.

Based on interview and record review, the facility failed to conduct performance improvement projects by failing to collect data that measured, analyzed, and tracked quality indicators of care, hospital services, and operations (Refer to A267).

These failures had the potential to result in missed opportunities to identify and investigate processes of care, and identify opportunities for performance improvement.

Findings:

On June 20, 2012, the facility's Quality Improvement Council (QIC) minutes and Performance Improvement Committee (PIC) minutes were reviewed. The documents reviewed contained "PI Executive Summary" reports and a variety of other reports. The reports did not contain any hospital department-specific data that measured, analyzed, and tracked opportunities and/or indicators that focused on improving health outcomes.

On June 20, 2012, at 9:10 a.m., the members of the facility's QIC, PIC, and Patient Safety and Reliability Council (PSRC) were interviewed. The DQRM presented the facility's structure for Quality Assessment and Performance Improvement (QAPI). The DQRM also presented a reporting calendar for the facility's quality/patient safety program. The DQRM stated the facility had currently ongoing PI projects, but had not aggregated data that measured, tracked, and analyzed the information in order to identify opportunities for improvement. The DQRM stated the facility had projects, but the facility did not have documented evidence of data measurement, tracking, and analysis.

The facility did not have documented evidence of QAPI data related to infection control and prevention.

The DQRM stated the facility's adverse event reporting was being completed by filling out an incident report form and was submitted to the Risk Management department. The DQRM stated the facility recently started a process of monitoring these events, but did not have aggregated data of measurement, tracking, and analysis of any events.

Based on interview and record review, the facility's governing body failed to ensure an ongoing program for quality improvement was defined, implemented, and maintained (Refer to A266, A267, A274, A286, A287, and A297).

Findings:

On June 21, 2012, at 11:15 a.m., members of the facility's governing body (GB) were interviewed. The GB members stated they received reports regularly in their board meetings through "Executive Summaries." The GB members stated, in November 2011, the GB identified the reports being presented to them did not "capture data" that provided measurement of performance improvement. The GB stated they had already approved to purchase a new computer system (MIDAS) that would better aggregate data and information that would "streamline" the QAPI process. The GB also stated hiring of the new CEO, CNO, and DQRM were measures taken to ensure the operation of the facility, which included the QAPI process, be acted upon.

The GB stated they currently have not been presented any data that measured, tracked, and analyzed QAPI projects.

Based on interview and record review, the facility's governing body failed to ensure an ongoing program for patient safety, including the reduction of medical errors was defined, implemented, and maintained (Refer to A266, A286, and A287).

Findings:

On June 21, 2012, at 11:15 a.m., members of the facility's governing body (GB) were interviewed. The GB members stated they received reports regularly in their board meetings through "Executive Summaries." The GB members stated, in November 2011, the GB identified the reports being presented to them did not "capture data" that provided measurement of performance improvement. The GB stated they had already approved to purchase a new computer system (MIDAS) that would better aggregate data and information that would "streamline" the QAPI process. The GB also stated hiring of the new CEO, CNO, and DQRM were measures taken to ensure the operation of the facility, which included the QAPI process, be acted upon.

The GB stated they currently have not been presented any data that measured, tracked, and analyzed QAPI projects.

Based on observation, interview, and record review, the facility failed to ensure the physician's order to assess the patient for an expanding hematoma beneath the skin (reflected by bruising caused by an injury with damage to small blood vessels) was implemented for one of 37 sampled patients (Patient 30). This failed practice potentially could lead to confusion with the assessment regarding the status of the hematoma and the ongoing medical treatment indicated.

Findings:

On June 18, 2012, at 9:45 a.m., Patient 30 was observed lying on the hospital bed. The patient was awake and alert as she stated she had a cardiac catheterization (invasive procedure in which a catheter/tube is placed into the femoral vein-in the groin and threaded into the heart to monitor various cardiac functions) performed a few days ago, but has had ongoing bleeding under the skin in her groin area, due to a leaking vein after the procedure was completed.

Patient 30 then removed the bed sheet to reveal a large area of bruising covering both her right and left groin areas. The patient stated she was anxious and afraid that she would become light headed and may have to stay in the facility a week or more before the bleeding beneath her skin stopped.

A review of Patient 30's record was conducted. Patient 30 was admitted to the facility on June 15, 2012, for a scheduled cardiac catheterization. On June 15, 2012, at 4:50 p.m., after the procedure was completed and the patient arrived back to the medical/telemetry unit, the record indicated a, "Small hematoma medial to puncture site, outlined by cath lab RN (Catheterization Laboratory Registered Nurse)."

A review of a physician's order dated June 15, 2012, at 4:23 p.m. indicated, "Apply manual pressure to vascular access site for a minimum of 20 minutes for any bleeding or hematoma, and notify physician if not resolved. Routine assess (assessment) for bleeding or hematoma per unit protocol."

Further record review failed to show a descriptive assessment of the hematoma after June 15, 2012, at 5:35 p.m., or documentation to reflect that the initial physician's order to apply pressure was implemented, and for how long.

A review of the facility policy, "Standards of Care for Acute and Critical Care," (Approval Date March 9, 2011) was conducted. The policy indicated the Registered Nurse caring for acute patients would collect relevant patient health data and a re-assessment would be completed whenever there is a change in the patient's condition, a new diagnosis and after any therapeutic interventions.

An interview was conducted with the Infection Control Preventionist on June 19, 2012, at 9:30 a.m., who stated a nursing assessment of the hematoma should consist of noting the size and color of the hematoma, any outward signs or symptoms of bleeding, or any increased complaints of pain in the area.

Based on observation, interview, and record review, the facility failed to ensure that the nursing service evaluated the care of each patient by failing:

1. To ensure a patient (Patient 2) was identified to have a wound/ulcer on the left lower leg on the initial nursing assessment (a nutritional risk factor; high risk), which would have triggered a Registered Dietitian (RD) consult within 24 hours of admission. This failure resulted in the patient not receiving a nutritional assessment from the RD; and

2. To ensure a Labor & Delivery (L&D) outpatient discharge order was written for one of 37 sampled patients (Patient 9). This had the potential to result in an inappropriate discharge from the facility.

Findings:

1. On June 18, 2012, Patient 2's record was reviewed with the Cath Lab Manager (CLM). Patient 2 was admitted on June 15, 2012, with diagnoses that included, "Wound infection-complicated, blood clots in legs, sickle cell anemia (a serious disorder which affects blood flow in the blood vessels of the limbs and organs and could cause blocked blood flow causing pain, serious infections, and organ damage)..."

The "Adult Patient History (Initial Assessment)" dated June 15, 2012, included a section entitled, "Nutritional Screen." The section was left blank.

On June 18, 2012, at 3:10 p.m., the CLM was not able to find documented evidence that a RD had conducted a consult.

On June 19, 2012, at 10:15 a.m., Patient 2's record was reviewed with RD 1. RD 1 stated the RNs completed the initial "Nutritional Screen," it would automatically trigger a RD consult. She stated the urgency of the consult was determined according to what the RN identified in this section.

The facility policy titled, "Nutritional Screening #769" dated April 15, 2011, was reviewed and indicated, "Patients who are at risk for nutrition problems will be identified within 24 hours of admission by nursing and referred to the RD as outlined in the Policy 5016 - Nutrition Care Process..."

"Nutritional Risk Criteria...Priority/Risk levels for Initial RD Assessments:

- High Risk (RD assessment within 24 hours following the patient's first day of admission);
- Moderate Risk (RD assessment within 48 hours following the patient's first day of admission); and
- Low Risk (RD assessment within 72 hours following the patient's first day of admission)."

RD 1 stated Patient 2 should have been identified as high risk secondary to having wound/ulcers. The patient should have been seen by the RD within 24 hours of being admitted.



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2. On June 19, 2012, the record for Patient 9 was reviewed. Patient 9 presented to the facility on April 15, 2012, at 9:26 p.m., with a full term pregnancy and complaining of uterine contractions.

The "Obstetrical Forms" dated April 15, 2012, revealed Patient 9 was having uterine contractions every five to seven minutes, and her cervix was two centimeters dilated.

The "Clinical Notification" dated April 15, 2012, at 10:05 p.m., revealed the physician was notified of Patient 9's complaint of uterine contractions and vaginal examination results, and the physician responded, discharge the patient home with labor precautions.

Patient 9 was discharged from the facility on April 15, 2012, at 10:56 p.m.

There was no physician's order to discharge the patient from the facility.

During an interview with the Director Perinatal Services (DPS) on June 19, 2012, at 2:50 p.m., she reviewed the record and was unable to find documentation of a physician discharge order for Patient 9 when she was discharged from the facility on April 15, 2012, at 10:56 p.m. The DPS stated a discharge order was not required because the nurse wrote that the physician was notified and the response from the physician was to discharge the patient.

The facility policy and procedure titled "Patient Discharge Process" dated April 15, 2011, revealed "... A physician's order is required for discharge. ..."

Based on observation, interview, and record review, the facility failed to ensure nursing staff developed and implemented care plans for four of 37 sampled patients (Patients 1, 10, 12, and 35).

1. For Patient 35, the facility failed to identify the patient being a high fall risk and implemented a care plan. This failure could lead to a lack of communication between the nursing staff and enhance the patient's risk of falling and sustaining an injury;

2. For Patient 10, there was no individualized plan of care initiated when Patient 10 was identified as being Group B Beta-Streptococcus positive (a germ that can cause an infection which can make the infant sick during the first day of life and sometimes can lead to death), which had the potential to result in a delay of care and treatment;

3. For Patient 12, there was no individualized post-partum (after delivery) plan of care initiated, which had the potential to result in a delay of care and treatment; and

4. For Patient 1, the facility failed to ensure nursing staff developed a plan of care for the patient's shingles (also known as herpes zoster - a painful, blistering skin rash due to the varicella-zoster virus; the virus that causes chickenpox). This failure had the potential to result in lack of providing the patient adequate care. In addition, this failure had the potential to result in staff taking improper isolation precautions.

Findings:

1. A review of Patient 35's record was conducted on June 18, 2012. Patient 35 was admitted to the facility on June 16, 2012, with a chief complaint of headache and dizziness, which the patient described as feeling "off-balance."

The patient's Morse scale (a numerical determination of fall risk) was identified on:
June 17, 2012, at 8 a.m., as 30;
June 17, 2012, at 7 p.m., as 30; and on,
June 18, 2012, at 7 a.m. as 35.

A review of the facility policy, "Falls Risk Program (Approved April 8, 2011)" was conducted. The assignment of a Fall Risk Score was based on risk criteria including the professional nursing assessment of psychological and environmental factors. The policy indicated if a patient was assessed with a score of 25-44 they were identified as being at a moderate risk for falling.

A review of the facility policy, "Standards of Care for Acute and Critical Care," (Approved March 9, 2011), was conducted. Standard Four indicated the RN (registered nurse) caring for acute and critically ill patients developed a plan of care that prescribed interventions to attain expected outcomes. The care plan provided for continuity of care, was initiated within eight hours of admission, re-evaluated each shift, and revised based on the patient's needs.

Further record review failed to show a plan of care related to the patients moderate risk of falling.

An interview was conducted with the Registered Nurse (RN 6) on June 18, 2012, at 11:30 a.m. RN 6 stated if a patient was deemed to be a fall risk a care plan should be initiated.



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2. On June 18, 2012, the record for Patient 10 was reviewed. Patient 10 was admitted to the facility on June 15, 2012, with diagnoses including term pregnancy with spontaneous rupture of membranes (rupture of the amniotic sac surrounding the fetus).

Patient 10's prenatal record revealed she was Group B Beta-Streptococcus positive (a germ that can cause an infection which can make the infant sick during the first day of life and sometimes can lead to death).

The "Vital Signs" dated June 16, 2012, at 6:06 a.m., revealed Patient 10 had a temperature of 101.0?F (Fahrenheit), and at 7:30 a.m., a temperature of 102.2?F.

The "Medication Administration Record" revealed Patient 10 was given Intravenous (IV) Ampicillin (antibiotic) 2 grams on June 15, 2012, at 8 p.m., and Ampicillin 1 gram on June 16, 2012, at 12:01 a.m., and 4 a.m.

There was no individualized plan of care initiated when Patient 10 was identified as being Group B Beta-Streptococcus positive.

During an interview with RN 11, on June 18, 2012, at 12:10 p.m., she reviewed the record and was unable to find documentation that an individualized care plan for maternal Group B Beta-Streptococcus positive had been initiated for Patient 10. RN 11 stated an individualized care plan should have been initiated when Patient 10 was identified as being positive for Group B Beta-Streptococcus.

3. On June 18, 2012, the record for Patient 12 was reviewed. Patient 12 was admitted to the facility on June 17, 2012, with a diagnosis of term pregnancy in active labor.

Patient 12 had a vaginal delivery of a baby girl on June 17, 2012, at 4:24 p.m.

There was no individualized postpartum (after delivery) plan of care initiated for Patient 12.

During an interview with RN 12, on June 18, 2012, at 2:15 p.m., she reviewed the record and was unable to find documentation that an individualized care plan for postpartum vaginal delivery care. RN 12 stated there had been no care plans initiated since Patient 12 delivered on June 17, 2012, at 4:24 p.m., and a care plan should have been initiated for postpartum vaginal care.




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4. On June 18, 2012, at 10:45 a.m., a tour was conducted of the Medical-Surgical Unit located on the fourth floor. A patient room had a sign that read "Airborne Precaution." The room was a negative pressure room (a room with a ventilation system that generates negative pressure to allow air to flow into the isolation room but not escape from the room, thereby preventing contaminated air from escaping the room).

On June 18, 2012, Patient 1's record was reviewed and indicated the patient was admitted on June 17, 2012. The record indicated the patient had shingles to her chest and left arm.

On June 18, 2012, at 1:20 p.m., Patient 1's record was reviewed with the CLM. The CLM was not able to find a care plan for shingles. The CLM was not able to find documented evidence indicating the type of isolation precautions staff were taking.

The facility policy and procedure titled, "Standards of Care for Acute and Critical Care" dated March 9, 2011, revealed, "...The RN caring for acute and critically ill patients develops a plan of care that prescribes interventions to attain expected outcomes and document in Care Plan Orders section. Plan is individualized to reflect the patient's characteristics and needs..."

Based on interview and record review, the facility failed to ensure the nursing personnel's performance was evaluated and they were determined to be qualified and competent to safely provide patient care, for four of seven Registered Nurses' (RNs') files reviewed (RN 2, 7, 10, and 12) by failing to:

1. Ensure annual required hospital competencies were completed (RNs 10 and 12);

2. Ensure annual unit competencies were completed (RN 10);

3. Ensure an annual evaluation was completed per facility policy and procedure (RN 10); and

4. Ensure initial unit-specific orientation, initial competency assessment, and a 90-day evaluation were completed (RN 7 and 2).

These failures could potentially result in the inability of staff to meet the patient's medical and nursing needs.

Findings:

1a. On June 21, 2012, the employee file for RN 10 was reviewed.

RN 10 was hired on January 25, 2011. RN 10's general hospital orientation, that included corporate compliance and topics required by regulatory bodies, was dated January 25, 2011.

The file did not contain evidence of an annual review (due January 25, 2012), of topics required by the facility and other regulatory bodies.

b. On June 21, 2012, the employee file for RN 12 was reviewed.

RN 12 was hired on February 7, 2011. RN 12's general hospital orientation, that included corporate compliance and topics required by regulatory bodies, was dated February 22, 2011.

The file did not contain evidence of an annual review (due February 22, 2012), of topics required by the facility and other regulatory bodies.

During an interview with the Director Human Resources (DHR), on June 21, 2012, at 2:50 p.m., he reviewed the employee files for RN 10 and RN 12, and was unable to find documentation of the annual review program completion for 2012 for either RN. The DHR stated the annual review program should have been completed by both RNs, and the education department tracked this information.

The facility policy and procedure titled "Employee Orientation, Competency & Staff Development" dated March 9, 2011, revealed "... The Goal of an Annual Review (AR) program is provided an opportunity for all staff to complete education requirements that are necessary to provide quality patient care in a healthcare culture of safety. Many of the topics reviewed are driven by Joint Commission and/or other regulatory bodies. ..."

2a. On June 21, 2012, the employee file for RN 10 was reviewed.

RN 10 was hired on January 25, 2011. RN 10's unit specific orientation, that included unit skills competency, was dated February 22, 2011.

The file did not contain evidence of an annual review of unit specific competency assessment and skills training for 2012.

During an interview with the DHR, on June 21, 2012, at 2:50 p.m., he reviewed the employee file for RN 10 and was unable to find documentation of the annual review of unit specific competency assessment and skills training for 2012. The DHR stated the annual review of unit specific competency assessment and skills training for 2012 should have been completed by RN 10, and the education department tracked this information.

The facility policy and procedure titled "Employee Orientation, Competency & Staff Development" dated March 9, 2011, revealed "... Competency assessment and skills training are coordinated by the Education Department with hospital departments annually. ..."

3. On June 21, 2012, the employee file for RN 10 was reviewed.

RN 10 was hired on January 25, 2011.

The file did not contain evidence of an annual employee performance appraisal until June 18, 2012 (almost six months late).

During an interview with the DHR, on June 21, 2012, at 2:50 p.m., he reviewed the employee file for RN 10 and was unable to find documentation of an annual employee performance appraisal until June 18, 2012. The DHR stated RN 10's annual employee performance appraisal was late because the department director had 45 days to complete the annual review from the date of hire which was January 25th.

The facility policy and procedure titled "Employee Performance Appraisal" dated March 9, 2011, revealed "... All departments are required to appraise all employees prior to the conclusion of the employee's third month of employment, and annually thereafter. (Managers have 45 days to complete the annual review before it is considered as a late review.) ..."




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4 a. On June 21, 2012, RN 7's personnel file was reviewed. RN 7 was hired on December 26, 2010. The personnel file did not contain documented evidence of a 90-day performance evaluation.

On June 21, 2012, at 1:20 p.m., the DHR was interviewed. The DHR stated all employees should have an initial unit-specific orientation, initial competency assessment, and a 90-day evaluation. The DHR was unable to find documented evidence of a 90 day assessment in RN 7's file.



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b. On June 21, 2012, RN 2's personnel file was reviewed. RN 2 was hired on February 13, 2012. The personnel file did not contain documented evidence of initial unit-specific orientation, initial competency assessment, and a 90-day performance evaluation.

On June 21, 2012, at 1:20 p.m., the DHR was interviewed. The DHR stated all employees should have an initial unit-specific orientation, initial competency assessment, and a 90-day evaluation. The DHR was unable to find documented evidence of all three requirements in RN 2's file.

The facility policy and procedure titled, "Employee Orientation, Competency & Staff Development" dated March 9, 2011, revealed,

"Department Specific Orientation...Department orientation programs will also address department policies and procedures...age and population specific knowledge and skills, performance of low volume, high risk, problem-prone tasks..."

"Competency Assessment/Skills Training...Competency assessment and skills training needs are provided based on assessed employee and department needs, job description, department specific requirements...age/population specific knowledge and skills, and peer review activities..."

The facility policy and procedure titled, "Employee Performance Appraisal #28" dated March 9, 2011, was reviewed and indicated, "All departments are required to appraise all employees prior to the conclusion of the employee's third month of employment..."

Based on observation, interview and record review, the facility failed:

1. To ensure two intravenous (IV) orders were not simultaneously active, intravenous Labor & Delivery (L&D) orders were canceled when the patient delivered her infant, and the patient received the IV as ordered following delivery or the post partum order was clarified with the physician if the staff felt the post delivery order was inappropriate for one of 37 sampled patients (Patient 6);

2. To ensure the urinalysis with micro (examination of urine to reveal disease or infection), as ordered by the physician through a telephone order, was obtained and results were available for one of 37 sampled patients (Patient 12);

3. To ensure the blood glucose monitoring, as ordered by the physician through a telephone order, was obtained and results were available for one of 37 sampled patients (Patient 13).

4. To ensure medications were administered as prescribed for two of 37 sampled patients (Patient 24 and 34).

These failures resulted in IV's not being administered as ordered by the physician, medications not being administered as ordered by the physicians, and laboratory tests not being done as ordered by the physician, and had the potential to result in a delay in care and treatment to the patients.

Findings:

1. On June 19, 2012, the record for Patient 6 was reviewed. Patient 6 was admitted to the facility on June 18, 2012, with diagnoses including term pregnancy and delivery.

Patient 6 had a cesarean section (abdominal delivery of an infant) on June 18, 2012, at 8:33 p.m.

The "Orders" dated June 18, 2012, at 5:27 p.m., revealed the physician ordered an intravenous (IV) solution of 1000 milliliters (ml) of Lactated Ringers to run at 125 ml per hour for Patient 6 while she was in labor. The Pharmacist verified the order on June 18, 2012, at 5:53 p.m.

The "Orders" dated June 18, 2012, at 9:12 p.m., revealed the physician ordered an IV solution of 1000 ml of Lactated Ringers with 20 units of Pitocin (a drug that causes the uterus to contract) to run at 125 ml per hour for three days for Patient 6 following her cesarean section delivery. The Pharmacist verified the order on June 18, 2012, at 9:22 p.m.

Two (2) IV orders were in effect for Patient 6 from June 18, 2012, at 9:12 p.m., until June 19, 2012, at 7:39 a.m., when RN 12 canceled the labor orders in the computerized documentation system.

During an observation on June 19, 2012, at 11:15 a.m., Patient 6 was observed lying in bed with an IV of Lactated Ringers running at 125 ml per hour via an infusion pump.

During an interview with RN 12 on June 19, 2012, at 11:10 a.m., she reviewed the record and verified that two IV orders were active for Patient 6 from June 18, 2012, 9:12 p.m., until June 19, 2012, at 7:39 a.m. RN 12 stated neither the physician nor the post partum nurse discontinued the Labor & Delivery (L&D) orders for Patient 6 once she had delivered, and the L&D orders should have been discontinued following the patient's delivery. In addition, RN 12 stated the night shift nurse used the L&D IV orders on June 19, 2012, at 5 a.m., when Patient 6 became nauseated, and she hung a bag of 1000 ml Lactated Ringers to run at 125 ml per hour.

RN 12 stated the physician's post partum cesarean section order for an IV solution of 1000 ml of Lactated Ringers with 20 units of Pitocin to run at 125 ml per hour for three days was not a "standard" order for a cesarean section patient, and the order would need clarification from the physician. In addition, RN 12 stated she had not been aware of the order for an IV of 1000 ml of Lactated Ringers with 20 units of Pitocin to run at 125 ml per hour for three days.

The facility policy and procedure titled "Guidelines for Ordering, Dispensing & Administration" dated March 17, 2011, revealed "... Medication orders will be discontinued or suspended (and reviewed to continue) when a patient goes to OR, is upgraded or downgraded to another level of care, is transferred to another Medical-Surgical Service. ... The licensed care provider (e.g. nurse, respiratory therapist, etc) must ensure the 'five rights' before administration of any medication; i.e., right patient, right drug, ..."

2. On June 18, 2012, the record for Patient 12 was reviewed. Patient 12 was admitted to the facility on June 17, 2012, with diagnoses of term pregnancy in active labor.

The "Orders" dated June 17, 2012, at 3:10 p.m. and 3:28 p.m., revealed a urinalysis with microscopic examination was ordered via a telephone order from the physician to RN 10.

The "Orders" for a urinalysis with microscopic examination were electronically verified and signed by the physician on June 17, 2012, at 4:48 p.m.

The urinalysis with microscopic examination was never obtained and there were no results available.

During an interview with RN 10 on June 18, 2012, at 2 p.m., she stated the urinalysis with microscopic examination was never obtained even though it had been ordered. RN 10 stated the order for a urinalysis with microscopic examination was a "check box telephone order" from the physician and the "check box" should never have been checked. In addition, RN 10 stated telephone orders were obtained "per protocol" through the computer system and she could not see if the physician had electronically verified the order.

3. On June 18, 2012, the record for Patient 13 was reviewed. Patient 13 was born on June 17, 2012, at 4:24 p.m., by a spontaneous vaginal delivery.

The "Orders" dated June 17, 2012, at 4:49 p.m., revealed "Blood Glucose Monitoring POC - At birth, at 30 minutes of life, then q (every) 1 hour x (times) 4, then before feedings not to exceed 3 hours in between feedings for the remained(r) of the first 24 hours of life. Test on adequately warmed heel, follow protocol for correction of blood glucose < (less than) 40 mg (milligrams)/dL (deciliter) on infants less than 4 hours of age and < 45 mg/dL on infants greater than 4 hours of age" was ordered via a telephone order from the physician to a nurse.

The "Orders" for blood glucose monitoring had not been electronically verified and signed by the physician as of June 21, 2012, at 12:55 p.m.

The "Blood Glucose Monitoring" was never done and there were no results available.

During an interview with RN 12 on June 18, 2012, at 2:25 p.m., she reviewed the record and was unable to find documentation of blood glucose monitoring, with results, as ordered by the physician. RN 12 stated she did not know why blood glucose monitoring was ordered for Patient 13, and it could have been an ordering error.

During an interview with the Director Perinatal Services on June 18, 2012, at 2:05 p.m., she stated she could not see if and when a physician verified a telephone/verbal order, and there was a way through the computerized documentation system to do the "read back and verification" of physician's telephone and verbal orders.

The facility policy and procedure titled "Guidelines for Ordering, Dispensing & Administration" dated March 17, 2011, revealed "... The TO/VO (telephone order/verbal order) order must be attributed to the ordering physician, be documented by the caregiver taking it in (computerized documentation system) and indicated RBV or "read back and verified. All verbal and telephone medication orders must be authenticated within 48 hours by the ordering physician or covering physician/designee. ..."

During an interview with the Director Quality and Risk Management (DQRM) on June 19, 2012, at 12:15 p.m., she stated the computerized documentation system did not have the capability of indicating the "read back and verification" of physicians' telephone and verbal orders as indicated by the facility's policy and procedure. The DQRM stated she did not know how the nurses' were "reading back and verifying" physicians' orders.




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4 a. During a tour of the Intensive Care Unit (ICU) on June 20, 2012, at 11:30 a.m., Patient 24 was observed. The patient was breathing with ventilator support and appeared non responsive.

A review of the patient's record indicated Patient 24 was admitted to the facility on June 18, 2012, with diagnoses of intestinal bleeding and kidney failure. The patient also had a history of glaucoma (an increase in the pressure of the eye which can result in blindness).

On June 18, 2012, at 3:27 p.m., Alphagan P, 0.1% eye solution (to treat glaucoma) to be instilled in both eyes twice daily was ordered for Patient 24. Further record review failed to show that the Alphagan P was given to Patient 24, since it was ordered, nor was the order clarified to indicate how many drops of solution should be instilled in each eye.

A review of the facility policy, "Guidelines for Ordering, Dispensing & Administration (Approval Date: March 17, 2011)," was conducted. The policy indicated, "The following elements must be properly attributed in any medication order including...dose..."

An interview was conducted with the Registered Nurse (RN 9) on June 20, 2012, at 11:50 a.m. RN 9 stated the Alphagan P had not been given as the computer note indicated the order had been "refused" by the pharmacy.

An interview was conducted with Pharmacist 5 on June 20, 2012, at noon. Pharmacist 5 stated the medication was not brought to the ICU (refused) because the pharmacists were waiting on the family to bring in the medication. However, the medication should have been delivered to the unit and administered because of the potential that the pressure in the patient's eyes may increase without the medication.

b. A review of Patient 34's record was conducted on June 18, 2012, at 11:30 a.m. with the Registered Nurse (RN 5). Patient 34 was admitted to the facility on June 15, 2012, with a diagnosis of lung cancer.

A review of the patient's medications indicated a Normal Saline Flush 5 milliliters, was to be administered intravenously every 8 hours. The last time the Normal Saline Flush was administered was indicated as June 17, 2012, at 9:58 p.m.

A review of the facility policy, "Guidelines for Ordering, Dispensing & Administration (Approved March 17, 2011)," indicated routine scheduled medication which is to be administered every 8 hours will be administered at 6 a.m., 2 p.m. and at 10 p.m.

A concurrent interview was conducted with RN 5, who stated the nurse had not administered the Normal Saline Flush, it was due at 6 a.m. and should have been given a half hour before or after the time the medication was due.

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

1. Ensure that accountability procedures were in place and implemented to control the use of all controlled substances (CSs), and to readily identify loss or diversion of all controlled substances in such a manner as to minimize the time frame between the actual loss or diversion to the time of detection and determination of the extent of loss or diversion (A494);

2. Provide oversight of controlled and non-controlled medication use in the Emergency Department (ED) by not reviewing and monitoring staff access of medications via override without physician order being entered in to the facility's Computerized Physician Order Entry (CPOE) system (A500);

3. Identify possible duplication of medication therapy involving large volume intravenous fluids (IVFs) with or without pitocin during pharmacist review (A500);

4. Monitor and review a high risk medication for appropriateness in accordance with the facility's policy and procedure (A500);

5. Use insulin vials patient specific in accordance with the facility's policy and procedure in the ED and control dispensing and use of insulin vials brought back from the nursing units and kept in the pharmacy medication refrigerators (A500);

6. Ensure identified refrigerated medications that were stored outside the acceptable temperature range were promptly reported to the Director of Pharmacy (DOP) and responded to in order to prevent unsafe use of the refrigerated medications (A500);

7. Ensure Surgery/Post Anesthesia Care Unit (PACU) staff were knowledgeable of the location of an insulin vial, one of the medications that make up the Malignant Hyperthermia (MH) crash cart to provide immediate treatment during life-threatening emergencies (A500); and

8. Ensure unusable medications were not available for use and failed to dispose of patient's medications brought into the hospital from home that were not returned at the time of discharge in a timely manner according to the facility's policy and procedure (A505).

The cumulative effect of these systemic problems resulted in the facility being unable to provide safe and effective pharmaceutical services.

Based on observation, interview, and document review, the facility failed to ensure that accountability procedures were in place and implemented to control the use of all controlled substances (CSs), and to readily identify loss or diversion of all CSs in such a manner as to minimize the time frame between the actual loss or diversion to the time of detection and determination of the extent of loss or diversion.

Findings:

During an interview on June 20, 2012, at 9 a.m., the Director of Pharmacy (DOP) stated that the Emergency Department (ED) staff removed the medications from the Cerner Rx Station (ADC, an automated medication dispensing device) before entering the medication order in Cerner Computerized Physician Order Entry (CPOE) and stated that these two medications removed on June 18, 2012, did not have the corresponding physician orders entered in the Cerner CPOE.

The DOP also explained that ED emergency/urgent medications entered in CPOE and removed from the ADC would be viewable in the pharmacy computer system immediately and would be able to be verified within minutes. However, the pharmacist would not be able to verify the orders without the corresponding CPOE medication order and electronic Medication Administration Record (eMAR).

The DOP confirmed those medications were not verified by the pharmacist and would not be verified unless there was a corresponding CPOE order entry for them.

The DOP stated all medications in ED ADC could be removed by way of override and he acknowledged the need to turn off the override function in ED, given the capability for ED staff to access any medication (by entering as one of Auto Verification order in CPOE).

Furthermore, the DOP stated controlled substance overrides were not reviewed daily as indicated in the facility's policy and procedure.

The DOP also stated that prior to May 16, 2012, the facility was not able to generate Diversion Reports from the Cerner System in order to review high user (staff) activities dealing with controlled substance access from the ADC and that the reports were not reviewed at all.

Review of the facility's policy and procedure titled, "Automated Dispensing Cabinet Procedures (Rx Station)" indicated the following:

"Pharmacy will review override lists daily to check for overrides without corresponding orders. Such issues will be referred to the Nurse manager/Director of the area for resolution/investigation.

Reports
Profile Override: This report is used to verify that all medications that were obtained from the RxStation during the day via "override" were correct per the physicians order entered into the Cerner Millennium. This report is generated and used by Pharmacy staff. It should be generated just prior the end of a shift.

Diversion Reports
The Cerner automated cabinets Drug Diversion Reports (CDDR) are compiled in the Cerner automated cabinets Controlled Substances System. They analyze all users and compile the average number of controlled substance accesses for users for a particular unit. Further, the standard deviation is calculated for this sample. Standard deviation is a measure of the variability of a sample. Assuming the distribution of user cabinet entries fits a normal distribution, the standard deviation will show how much of an outlier a user maybe vs. their peers re: accesses. For example, one standard deviation (SD) above or below the mean means that 68 percent of the users will be within that variation around the mean. Two SD will mean that more than 95 percent of users in any sample will be within the mean (and 5 percent of the sample will be outlier's), three SD means that a user is in the 0.5 percent of users above the mean. Thus 2 or more SD will show that a particular user is a significant outlier above or below the mean. The CDDR identifies these users...

Nurse/Clinical Area Manager Follow-up: Follow-up to the reports is done by looking deeper at the activity of the outlier's...
The follow up is reported back to pharmacy listing user names over 2-3 SD and what actions have been taken to review the situation..."

Based on observation, interview, and record review, the facility failed to control drugs and biologicals for the provision of pharmaceutical services in order to meet the needs of the patients by failing to:

1. Provide oversight of controlled and non-controlled medication use in the Emergency Department (ED) by not reviewing and monitoring staff access of medications via override without physician's orders being entered in the facility's Computerized Physician Order Entry (CPOE) system;

2. Identify possible duplication of medication therapy involving large volume intravenous fluids (IVFs) with or without pitocin during pharmacist review;

3. Monitor and review a high risk medication for appropriateness in accordance with the facility's policy and procedure;

4. Use insulin vials which were patient specific in accordance with the facility's policy and procedure in the ED and control dispensing and use of insulin vials brought back from the nursing units and kept in the pharmacy medication refrigerators;

5. Ensure identified refrigerated medications that were stored outside the acceptable temperature range were promptly reported to the Director of Pharmacy (DOP) and responded to prevent unsafe use of the refrigerated medications;

6. Ensure Surgery/Post Anesthesia Care Unit (PACU) staff were knowledgeable of the location of an insulin vial, one of the medications that made up the Malignant Hyperthermia (MH) crash cart in order to provide immediate treatment during life-threatening emergencies;

7. Ensure multiple intravenous (IV) bags were labeled according to the facility's practices for three of 37 sampled patients (Patients 34, 36, and 37) and one unsampled patient (Patient 38);

8. Ensure the contents of the ICU (Intensive Care Unit) Crash Carts were not expired and the ICU intubation boxes had a content supply list posted on the outside of the box; and

9. Ensure three of three neonatal (newborn infant) crash carts did not contain expired supplies.

These failures could potentially result in errors with medication management and the overall provision of medical care and treatment.

Findings:

1. During an interview on June 18, 2012, at 9:30 a.m., the DOP stated that the pharmacist verified all ED medication orders with the use of "Auto Verification x1 orders." The DOP explained that ED medication orders that was not considered emergent or urgent medications for immediate access and administration to the patients, would be entered in the facility's Cerner System's CPOE for pharmacist verification prior to removal of medication from Cerner Rx Station (Automated Dispensing Cabinet also known as ADC, an automated medication dispensing device).

The DOP further explained emergency and urgent need medications in ED could be accessed and removed from the ADC without the pharmacist verification if during the order entry in CPOE medications were selected from the list of the Auto Verification x1 list of medications. This type of access would be reviewed by the pharmacist as they appeared in the pharmacy computer system.

Review of Auto Verification x1 indicated there were 281 different medications that could be removed by the ED nurse staff without prior pharmacist verification.

The DOP stated, in addition to the CPOE "Auto Verification x1" process, the ED staff could access and remove medications without the pharmacist verification by utilizing the override feature of the ADC.

On June 20, 2012, review of Patient 18's ED record from the pharmacy computer system indicated on June 18, 2012, at approximately 8 p.m., ED staff accessed one dose of hydromorphone (controlled substance used for pain) 2 mg/ml injectable vial and one dose of ondansetron (medication used for nausea/vomiting) 4 mg/2 ml injectable vial by way of performing override (Override is a common feature of the ADC that allows privileged staff to access and remove medications from the ADC without the pharmacist verifying the medication order and granting the access).

During an interview on June 20, 2012, at 9 a.m., the DOP stated that the ED staff removed the medications from the ADC before entering the medication order in Cerner CPOE and stated that these two medications removed on June 18, 2012 did not have the corresponding physician orders entered in the Cerner CPOE.

The DOP also explained that ED emergency/urgent medications entered in CPOE and removed from the ADC would be viewable in the pharmacy computer system immediately and be able to be verified within minutes but the pharmacist would not be able to verify the orders without the corresponding CPOE medication order and electronic Medication Administration Record (eMAR).

The DOP confirmed that those medications were not verified by the pharmacist and would not be verified unless there was a corresponding CPOE order entry for them.

The DOP stated that all medications in ED ADC could be removed by way of override and acknowledged the need to turn off the override function in ED given the capability for ED staff to access any medications by entering as one of Auto Verification order in CPOE.

Furthermore, the DOP stated that controlled substance overrides were not reviewed daily as indicated per facility's policy and procedure.

Review of the facility's policy and procedure titled, "Guidelines for Ordering, Dispensing & Administration" indicated,

"Telephone/verbal medication orders may be received and written by licensed nurses ...Use of verbal orders for medications are acceptable only in instances of clinical emergencies where the prescribers' writing of the order will delay or compromise care. The TO/VO (telephone order/verbal order) order must be attributed to the ordering physician, be documented by the caregiver taking it in Cerner Millennium *(CM) and indicate RBV or "read back and verified".
All verbal and telephone medication orders must be authenticated within 48 hours by the ordering physician or covering physician/designee."

American Society of Health-System Pharmacists (ASHP), a nationally recognized pharmacist organization in its publication titled, "ASHP Guidelines on the Safe Use of Automated Dispensing Devices" indicated,

"Subsequent order-based retrieval of the same medication should cause the user to be reminded that an override supply of medication was recently dispensed for the patient. Provision should be made for the retrospective review and reconciliation by a pharmacist of orders that were initiated without a pharmacist's review and approval. Override data (e.g., name of medication, quantity, location of the automated device, any associated adverse drug events) should be routinely reviewed to help evaluate and manage those medications approved for override access. Override data evaluation can aid an organization in improving the outcomes of automated dispensing device use by decreasing medication errors and potential adverse drug events and should be considered part of the routine management process for automated dispensing devices."

2. Review of Patient 6's electronic medication record on June 18, 2012, indicated there was a physician's order for large volume injectable Lactated Ringer solution (IV electrolyte solution) to be infused into vein at 125 ml/hr on June 18, 2012, at 5:27 p.m. as a part of a "power plan" pre L&D (Labor and Delivery) order set.

On June 18, 2012, at 8:12 p.m., there was a physician's order for the same patient for 1000 ml bag of Lactated Ringer solution with oxytocin 20 units added in to be infused IV at 125 ml/hr as a part of the power plan for post-partum order set.

Review of the eMAR (electronic Medication Administration Record) indicated that Lactated Ringer without oxytocin was being infused at 125 ml/hr after Lactated Ringer with oxytocin was ordered.

During an interview on June 20, 2012, at 10 a.m., the DOP explained that the Cerner System did not identify those two drugs to be a possible duplicate therapy and that when the new power plan was activated the previous power plan should have been turned off which did not happen in this case. The DOP acknowledged that the physician did not discontinue the previous power plan, the verifying nurse did not catch the mistake, and the pharmacist failed to identify possible inappropriate therapy. As a result, the patient received a medication not intended to be administered.

The facility's "Job Description for Inpatient Clinical Pharmacist" was reviewed and it indicated the pharmacist to:

"Review physician orders for completeness, accuracy and incompatibilities using patient clinical information ...evaluate the appropriateness ...and efficacy/safety of drug orders for each patient."

Also reviewed was the facility's policy and procedure titled, "Guidelines for Ordering, Dispensing & Administration" which indicated,

"Incomplete, illegible, or unclear/ambiguous orders or those for which there is a professional concern shall be clarified with the prescriber prior to dispensing or administration by the appropriate professionals ...

A pharmacist must review all orders prior to administration ...pharmacists will use professional judgment and use evidence based literature/electronic drug info systems to assess appropriateness of Drug (per indications), dose, route, frequency and any FDA contraindications to use."

3. During an interview on June 20, 2012, dosing various medications under committee approved protocols. The DOP stated that the Pharmacy could monitor and adjust the dose of Coumadin (blood thinner). However, the DOP stated the Pharmacy did not monitor Heparin (a blood thinner administered by infusion into vein).

The DOP stated that there were dosing and laboratory monitoring protocols for nurses to use but the Pharmacy did not do any concurrent or retrospective review to monitor for appropriate use.

According to Institute for Safe Medication Practices (ISMP - a nationally recognized organization), heparin is one of the medications included in the list of High-Alert Medications. ISMP defines high-alert medications as "drugs that bear a heightened risk of causing significant patient harm when they are used in error. Although mistakes may or may not be more common with these drugs, the consequences of an error are clearly more devastating to patients."

According to The Joint Commission's National Patient Safety Goal for 2012, it addresses the importance of monitoring blood thinners such as heparin emphasizing the fact that they "are more likely than others to cause harm due to complex dosing, insufficient monitoring ..."

According to the facility's policy and procedure titled, "High Alert Medications" defined high alert medications to have "the highest risk of causing injury when misused."

Review of the facility's policy and procedure titled, "Guidelines for Ordering, Dispensing & Administration" indicated,

"C. Medication Monitoring:
1. The effects of medication on patients will be monitored to assure clinical efficacy and minimize the occurrence of adverse events.
3. Monitoring includes:
a) Gathering patient's reports and perceptions about efficacy and side effects.
b) Referring to clinical information: i.e., vital signs, laboratory results, progress notes and any other objective or subjective clinical data...
4. Pharmacists will determine patients at risk for adverse drug events (due to medications with a narrow therapeutic window, high potential for toxicity, etc) and monitor as needed.
5. Medications that have specific, mandatory monitoring include:
b) Heparin (PTT - partial thromboplastin time; measures the length of blood clotting time)."

4. During inspection of the Pharmacy's IV Room on June 18, 2012, at 10 a.m., it was noted that in the medication refrigerator, there was a vial of Humulin R (insulin to treat diabetes) with an attached patient label, with the patient name removed, and an expiration date of June 16, 2012.

On June 18, 2012, at 1:20 p.m., in the Pharmacy main medication refrigerator, one open vial of Humulin 70/30 Insulin and one open vial of Lantus Insulin without any label with the open date of 6/1 and 6/2, respectively were observed.

During an interview on June 18, 2012 at 1:20 p.m., Pharmacy Technician (PT) 500 stated that all insulin vials were delivered to the nursing unit with patient specific labeling and once they were no longer needed on the unit they were brought back to the pharmacy and kept in the medication refrigerator.

During a concurrent interview, Pharmacist 500 stated that sometimes insulin doses were prepared in syringes in the pharmacy and delivered to the ED patients because Humulin 70/30 and Lantus were not available in the Cerner Rx Station (ADC, an automated medication dispensing device).

During a concurrent interview, the DOP stated that the used insulin vial, returned to the pharmacy from the nursing units, should not have been kept in the IV Room medication refrigerator and promptly discarded.

The DOP also agreed with Pharmacist 500 that some insulin doses were prepared in the pharmacy and delivered to ED.

However, the DOP was not able to provide evidence that there were insulin orders from ED since those vials were labeled as opened on 6/1 and 6/2 during which time the Pharmacy had not prepared any doses of Humulin 70/30 and Lantus doses for ED patients.

The DOP also agreed that there were no labels to know indicating whether those vials were returns from the nursing units or not. He also stated that each insulin vial should not be used for multiple patients.

The facility's policy and procedure titled, "Medications, Control, Storage of" indicated,

"MDV (Multidose Vial) will be used on, and dedicated to, a single patient rather than used on consecutive patients unless emergent or practical considerations apply ...
All departments shall discard its unusable drugs in pharmaceutical waste bins. Under no circumstances shall they be returned to active pharmacy or patient stock."

According to "APIC Position Paper: Safe Injection, Infusion and Medication Vial Practices in Healthcare" published by APIC (Association for Professionals in Infection Control and Epidemiology),

"Always follow the manufacturer's instructions for storage and use.
? Use single-use or single-dose vials whenever possible...
? If a multi-dose vial must be used, it should be used for a single patient whenever possible. The risk of transmission posed by inappropriate handling of multi-dose vials has been clearly demonstrated and mandates a practice of one vial per one patient whenever possible. Infection transmission risk is reduced when multi-dose vials are dedicated to a single patient...
? Dispose of opened multi-dose medication vials 28 days after opening, unless specified otherwise by the manufacturer, or sooner if sterility is questioned or compromised."

5. Review of the facility's Medication Refrigerator Daily Temperature Monitor for the nursing unit located on the 5th floor for June of 2012, was reviewed and the following was noted under the comment section:

"6/12/12. Refrig. (Refrigerator) Door left open. Temp. was 60 degrees."

During an interview on June 21, 2012, at 3:40 p.m., PT 501 stated that during medication delivery to the nursing unit medication room on the 5th floor she noticed the refrigerator door open and the temperature was out of range so she noted it on the temperature log and closed the refrigerator door. PT 501 stated the finding was not relayed to the DOP or a pharmacist.

During a concurrent interview, the DOP stated he was not made aware of the medication refrigerator temperature being out of range and that he could not ensure medications stocked in the 5th floor medication refrigerator were safe for patient use.

Review of the facility's policy and procedure titled, "Medication, Control, Storage of" indicated,

"The Director of Pharmacy (or designee) will assure that drugs are stored according to provisions of the USP/NF and/or specifications of the manufacturer under the proper conditions of sanitation, temperature, light, moisture, ventilation, organization, segregation, safety, and security."

Review of the facility's policy and procedure titled, "Medication Refrigeration" indicated,

"Medications that require refrigeration are properly stored and secured...Refrigerator temperature range: 2 ?C (36 ?F) to 8 ?C (46 ?F)."
Review of the medications that were in the medication refrigerator on the 5th floor at the time the temperature was out of range indicated there were Pneumococcal Vaccines, injectable vials of diltiazem (blood pressure medication), and injectable vials of famotidine (stomach acid reducer).

According to Centers for Disease Control and Prevention (CDC) Vaccine Storage and Handling Guide, "Vaccine exposed to temperatures outside the recommended range - either too warm or too cold - requires immediate corrective action!"

6. During a tour of the facility's Surgery Department and Post Anesthesia Care Unit (PACU) on June 18, 2012, at 2 p.m., the Malignant Hyperthermia (MH) Cart was inspected. According to the medication content list, a vial of Regular Insulin (used to control high blood sugar level) would be located in the medication refrigerator located in the Surgery Department (SD).

Review of the MH Cart Drugs indicated the following:

"Regular Insulin 100 units/ml #1 Keep in OR refrigerator"

During the same observation, it was noted that RN 3 had to access the Cerner Rx Station for medications located in the medication refrigerator in the SD. It was also observed that there was no option given by the Cerner system to choose Regular Insulin.

During a concurrent interview, RN 3 stated that the Regular Insulin could not be selected in order to open the refrigerator and that the Regular Insulin was not in the SD medication refrigerator.

During the same observation, it was also noted that RN 4 had the identical problem and was not able to open the medication refrigerator.

During a concurrent interview, RN 4 stated that the medication refrigerator could not be opened because Regular Insulin was not stocked and that the facility had Regular Insulin in the medication refrigerator located in PACU.

During a concurrent interview, the DOP indicated that Regular Insulin was in the SD medication refrigerator, but due to the absence of being able to select Regular Insulin from the Cerner Rx Station, staff were having problem opening the medication refrigerator.

It was observed that the staff were trying to open the medication refrigerator to access Regular Insulin for approximately 5 minutes.

Review of the facility's policy and procedure titled, "Emergency/Urgent Use Drug Supplies-Kits" indicated,

"All personnel who might utilize emergency medication carts should be familiar with the contents and how to use the medications and supplies."



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7a. A tour and observation of the Third floor Medical/Telemetry Unit was conducted with the Registered Nurse (RN 6) on June 18, 2012, at 10 a.m.

An observation of Patient 34 was conducted on June 18, 2012, at 10:05 a.m. Patient 34 was lying on the hospital bed. An IV (intravenous infusion) of Levofloxacin (antibiotic) 1 Gram was infusing into the patient. The IV bag was not labeled with the date or the time the IV was hung.

An observation of Patient 36 was conducted on June 18, 2012, at 10:15 a.m. Patient 36 had an IV of Ceftriaxone (antibiotic) 1 Gram which was infusing into the patient. The IV bag was not labeled with the date or the time the IV was hung.

An observation of Patient 37 was conducted on June 18, 2012, at 10:30 a.m. Patient 37 was lying on the hospital bed. An IV of Sodium Chloride was infusing into the patient. The IV bag was not labeled with the date or the time the IV was hung.

An interview was conducted with RN 6 on June 18, 2012, at 11 a.m. RN 6 stated when an IV medication was hung, the RN had to indicate the date and time on the IV bag and also write their initials on the IV bag.

b. On June 18, 2012, at 9:40 a.m., during a tour of the Medical-Surgical Unit, located on the fifth floor, a patient (Patient 38), had intravenous fluids (IVFs) hung at the bedside. The IVFs was D5 1/2 NS (Dextrose 5% 1/2 normal saline) with 20 milliequivalent Potassium Chloride infusing at 125 milliliter per hour. The IVF bag did not have any other label indicating the patient's name, date, and time the bag was hung.

In a concurrent interview with Registered Nurse (RN) 1, she stated the bag should be labeled with the patient's name and the date and time the IVF bag was hung.

8. A tour and observation of the ICU was conducted with RN 8 on June 20, 2012, at 10 a.m. A locked intubation box was observed next to the nursing station. Further observation failed to show a document which listed the contents in the box.

During a concurrent interview conducted with RN 8 she stated the contents of the box were to be listed and posted on the outside of the intubation box but the list of the supplies in the box were missing.

As the tour of the ICU progressed, Crash Carts #1 and # 17 (carts containing medication and supplies indicated for use in the event of a cardiac arrest) were observed. The supply contents list on the top of Crash Cart # 1 indicated the first expired item which was not specifically identified expired on March, 2012. The supply contents list on the top of Crash Cart # 17 indicated the first expired item which was not specifically identified expired on April, 2012.

A review of the facility policy titled, "Maintenance and Quality Control of Crash Cart," (Approval Date: April 15, 2011), indicated the purpose of the policy was, "To assure efficient and specialized emergency crash cart equipment, drugs and supplies is consistently and systematically available for respiratory and cardiac arrest...Intubation boxes to contain list of supplies with earliest expiration date listed on outside of kit."

An interview was conducted with the Anesthesiology Technician (AT) on June 20, 2012, at 11 a.m., who stated it was the responsibility of the AT to check the crash cart supplies monthly and remove and replace outdated items.

During an interview with RN 8 on June 20, 2012, at 11:15 a.m., she stated she will have to open the Crash Carts in order to determine what is expired and dispose of those items.



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9. On June 18, 2012, at 9:30 a.m., a tour of the Perinatal Services unit was conducted with the Director Perinatal Services (DPS) and RN 10.

The neonatal crash cart (emergency cart with supplies used for rescusitation),located in the "Exam Room" contained:
a. Two yellow top collection tubes with an expiration date of May 2012.

The neonatal crash cart located in the "Postpartum area" contained:
a. Two green top collection tubes with an expiration date of February 2012;
b. Two purple top collection tubes, one with an expiration date of April 2012, and one with an expiration date of May 2012; and
c. Two yellow top collection tubes with an expiration date of May 2012.

The neonatal crash cart located in the "Newborn Nursery" contained:
a. Two green top collection tubes with an expiration date of February 2012;
b. Two purple top collection tubes with an expiration date of February 2012; and
c. Two yellow top collection tubes with an expiration date of May 2012.

During a concurrent interview with RN 10, she stated it was the nurses' responsibility to check the neonatal crash cart but she had never checked to see if there were expired supplies.

During a concurrent interview with the DPS, she stated the collection tubes on the neonatal crash carts were expired, the neonatal crash carts were not on an "exchange system" and it was the nurses' responsibility to check for expired supplies on the neonatal crash carts.

The facility policy and procedure titled "Maintenance and Quality Control of Crash Cart" dated April 15, 2011, revealed "To assure efficient and specialized emergency crash cart equipment, drugs and supplies is consistently and systematically available for respiratory and cardiac arrest. ..."

The facility policy and procedure titled "Materials Management Safety" dated March 9, 2011, revealed "... Expired supplies must be removed from stock immediately and disposed of in the manner set forth by Materials Management/Administration. ..."

Based on observation, interview, and document review, the facility failed to:

1. Ensure unusable medications were not available for use and failed to dispose patient's medications brought into the hospital from home that were not returned at the time of discharge in a timely manner according to the facility's policy and procedure; and

2. Ensure single use containers of Betadine and Hibiclens solutions were not opened, partially used, and left in a cabinet for future patient use in the Labor, Delivery, and Recovery rooms (LDRs).

Findings:

1a. During a tour of the Pharmacy on June 18, 2012, at 10 a.m., it was noted in the IV (intravenous) Room there was a vial of Penicillin G (an antibiotic) 5 million units connected to an IV Piggyback container via "addEASE Connector" with the expiration date of May 31, 2012.

Also noted was a vial of Humulin R (insulin used to treat diabetes) in the IV Room medication refrigerator with the expiration date of June 16, 2012.

During a concurrent interview, the DOP acknowledged the vials were expired and should have been thrown away.

b. During a tour of the Emergency Department (ED) on June 18, 2012, at 1:50 p.m., it was noted in the Medication Room, there was a 30-ml single dose vial of Bupivacaine 5 mg/ml preservative free with the opened date of June 15.

During a concurrent interview, the DOP acknowledged that the vial should have been thrown away.

Review of the facility's policy and procedure titled, "Medications, Control, Storage of" indicated,

"Unusable drugs shall not be distributed or administered. Pharmacy, Nursing, and other personnel who discover unusable drugs and shall discard them in the pharmaceutical waste bins or hazardous pharmaceutical waste, whichever applies. Unusable drugs are:
Expired (outdated) ..."

c. During inspection of the Pharmacy on June 18, 2012, at 10 a.m., it was observed that there were numerous bags in one of the drawers containing patients' medications that were brought to the hospital kept in the room in which automated controlled substance safe was located.

Review of the document called, "Patient's Own Medication Log" indicated patients' own medications were not consistently destroyed within 30 days after patients were discharged or deceased.

For instance, Patient 19, who was discharged had home medications that were checked in and kept in the pharmacy since November 8, 2012, and still remained in the Controlled Substance Safe in the Pharmacy.

During a concurrent interview, the DOP acknowledged that there were too many patients' medications bags that were not destroyed within 30 days.

Review of the facility's policy and procedure titled, "Patients Own Medication Handling" indicated,

"Medications left more than 30 days after patient's discharge are assumed to be abandoned property and may be destroyed. Destruction must be accomplished by the pharmacist. Destruction of controlled substances will be documented with 2 pharmacists witnessing the destruction and documented per DEA regulations."

d. During a tour of the Pharmacy on June 18, 2012, at 10:20 a.m., it was noted that Pharmacy kept expired and unusable controlled substances (CS) on the bottom drawer in the automated safe containing controlled substances. It was observed that the expired CS were piled in such a way there was no clear separation of expired CS and non-expired CS on the bottom drawer.

During a concurrent interview, the DOP acknowledged that there were too many expired and unusable CS stored on the bottom shelf right next to the controlled substances that were not expired.



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2. On June 18, 2012, at 9:20 a.m., a tour of Perinatal Services was conducted with the Director Surgical Services (DSS) and RN 10, and the following observations were made:

a. The supply cupboard in LDR 3 contained an opened, partially used, 4 ounce bottle of Hibiclens solution available for patient care use.

b. The supply cupboard in LDR 4 contained opened, partially used bottles of solution, one 4 ounce bottle of Hibiclens solution and one 8 ounce bottle of Betadine solution which were available for patient care use.

During a concurrent interview with the DSS and RN 10, they stated the bottles of solution were opened and partially used. In addition, the DSS stated the bottles of Hibiclens and Betadine solutions were single use items and should have been discarded once opened.

Based on observation, interview, and document review, the facility's Food Service Department failed to provide effective daily management of the dietary service by failing to ensure expired food items were not available for patient consumption, in accordance the with the facility policy. These failures had the potential to result in patients consuming the expired food items, which may subsequently cause gastrointestinal (GI) disease.

Findings:

1. On June 18, 2012, at 9:25 a.m., a tour of the medical-surgical (MS) unit, located on the fifth floor, was conducted. The food refrigerator on the west side was inspected. The refrigerator contained five cartons of 4-ounce milk with an expiration date of June 17, 2012, and a meat sandwich labeled, "Use by June 17, 2012."

The food refrigerator log dated June 2012, was reviewed. The log indicated the refrigerator temperature was not checked on June 2, 3, 7, 8, 9, 10, 13, 14, and 17 (nine of 17 days).

In a concurrent interview with RN 1 (charge nurse), she stated the refrigerator contents was checked daily for expired items. RN 1 also stated the refrigerator temperature readings should be checked daily and documented on the temperature log.

The facility's document titled, "Food Refrigerator/Freezer log" stipulated the refrigerator and freezer temperature readings needed to be checked daily. The facility did not have a current policy indicating how often the refrigerator/freezer temperature readings should be checked.

2. On June 18, 2012, at 10:50 a.m., a tour of the medical-surgical (MS) unit, located on the fourth floor, was conducted. The food refrigerator was inspected and contained two cartons of 4-ounce milk with an expiration date of June 17, 2012.


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3. On June 18, 2012, at 10:15 a.m., a tour of Perinatal Services was conducted with RN 10, and the following observations were made:

The "nutrition refrigerator" in the post partum area contained:
- Four containers of mandarin orange gelatin with an expiration date of May 12, 2012;
- Three containers of orange gel with an expiration date of May 31, 2012; and
- Three, 4 fluid ounce containers, of fat free skim milk with an expiration date of June 17, 2012.

During a concurrent interview with RN 10, she stated the mandarin orange gelatin, orange gel, and milk were expired. In addition, RN 10 stated it was the nurses' responsibility to check the refrigerator for expired items when they checked and recorded the refrigerator temperature.




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4. A tour of the east third floor nourishment area was conducted with the Infection Control Preventionist on June 18, 2012, at 2 p.m. Four, 4 ounce cartons of whole milk were observed to have an expiration date of June 17, 2012.

The facility policy and procedure titled, "Dating Perishable Foods" dated April 15, 2011, revealed, "...All perishable foods stored in the refrigerators will be dated with a discard date. ... Foods not consumed on or before this date will be discarded..."

Based on observation, interview, and record review, the facility failed to ensure facilities, supplies, and equipment were maintained in an acceptable level of safety by failing:

1. To ensure the facility policy and procedure for temperature and humidity control and documentation in specified areas was followed, which had the potential to result in unacceptable temperature and relative humidity ranges, subsequently resulting in bacterial growth;

2. To ensure laboratory collection tubes and other procedure supplies were not expired and available for patient use, which had the potential to result in inaccurate laboratory results;

3. To ensure invasive procedure supplies Swan Ganz Catheters (equipment used for medical diagnostic purposes) were not expired and available for patient use.

These failures could negatively impact the medical care and safety of all patients.

Findings:

1. On June 18, 2012, at 10 a.m., a tour of the Newborn Nursery was conducted with RN 10.

The "(Facility Name) Temperature/Humidity Log" undated, revealed "... Acceptable Temperature Range 68? to 73? Humidity Range 30% to 60% [Action Required if Out of This Range (Round to the nearest whole #)] ..."

The Newborn Nursery "Temperature/Humidity Log" for Isolation Room 1, dated June 2012, revealed on:

- June 3, 2012, the temperature was 75.2?F;
- June 4, 2012, the temperature was 74.8?F;
- June 5, 2012, the temperature and humidity were not recorded;
- June 6, 2012, the temperature was 74.2?F;
- June 7, 8, and 9, 2012, the temperature was 75?F;
- June 10, 2012, the temperature and humidity were not recorded;
- June 11, 12, 13, 14, and 15, 2012, the temperature was 75?F;
- June 16, 2012, the temperature and humidity were not recorded;
- June 17, 2012, the temperature was 74?F; and
- June 18, 2012, the temperature was 75?F.

The Newborn Nursery "Temperature/Humidity Log" for Isolation Room 1, dated May 2012, revealed the temperature was above 73?F for 21 out of 31 days.

The Newborn Nursery "Temperature/Humidity Log" for Isolation Room 2, dated May 2012, revealed the temperature was above 73?F for 22 out of 31 days, and the temperature was not recorded for 2 out of 31 days.

No actions were taken when the temperature was out of range.

During a concurrent interview with RN 10, she stated the temperature and humidity in the Newborn Nursery Isolation Rooms were checked daily and if the temperature and humidity were out of the acceptable range, facilities would be called to assess and correct the out of range temperature and/or humidity. RN 10 stated facilities should of been notified every day the temperature was out of range so it could have been corrected.

On June 20, 2012, at 10:45 a.m., an interview was conducted with the Director Facilities (DF). The DF stated he would expect a telephone call from the specific unit/area if the temperature was out of range. In addition, the DF stated facilities did not receive a telephone call because the temperature in the Newborn Nursery remained out of range for several days.

On June 19, 2012, at 9 a.m., a tour of Surgical Services was conducted with the Director Surgical Services (DSS).

The "(Facility Name) Temperature/Humidity Log" undated, revealed "... Acceptable Temperature Rang
< (less than) 75? Humidity Range < 70% [Action Required if Out of This Range (Round to the nearest whole #)] ..."

The Operating Room (OR) Cesarean Section "Temperature/Humidity Log" for Room 1 and Room 2, dated June 2012, revealed the temperature and humidify readings for June 3, 9, 10, 16, and 17, 2012, were not recorded.

The "Temperature/Humidity Log" being used for ORs 1 and 2, indicated "... Acceptable Temperature Range < (less than) 75? Humidity Range < 70% [Action Required if Out of This Range (Round to the nearest whole #)] ..."

During a concurrent interview with the DSS, she stated the form used by the staff was incorrect and the temperature range should be 68?F to 73?F with the humidity range of 30% to 60%. In addition, the DSS stated the temperature and humidity should be recorded daily in the cesarean section rooms because a cesarean section could be done at anytime.

The DSS stated the "(Facility Name) Temperature/Humidity Log" undated, used for Cesarean Section Rooms 1 & 2; OR 1; and OR 3 was the incorrect log, and should be the log which stated "... Acceptable Temperature Range 68? to 73? Humidity Range 30% to 60% [Action Required if Out of This Range (Round to the nearest whole #)] ..."

The facility policy and procedure titled "Temperature/Humidity Monitoring" dated April 15, 2011, revealed "... The temperature and humidity readings shall be checked and recorded daily in the perioperative spaces, and Newborn Nursery including the operating rooms, cardiac cath labs and the sterile processing/decontamination areas. ... Temperature Range: 68?F (Fahrenheit) - 73?F and Humidity Range: 35% (percent) - 60% ..."

2a. On June 18, 2012, at 9:20 a.m., a tour of Perinatal Services was conducted with RN 10, and the following observations were made:

The supply cabinet in LDR 3 contained three blue top collection tubes with an expiration date of March 2012.

The supply cabinet in LDR 4 contained two blue top collection tubes, one with an expiration date of December 2011, and one with an expiration date of March 2012.

During a concurrent interview with RN 10, she stated the blue top collection tubes were expired. In addition, RN 10 stated the Obstetrical Technicians were responsible for checking the LDRs for outdated supplies, and the collection tubes should have been discarded because they were expired.

On June 18, 2012, at 3 p.m., a tour of the Post Anesthesia Care Unit (PACU) was conducted with the Director Surgical Services (DSS), and the following observations were made:

The supply cabinet in the PACU contained five white top collection tubes with an expiration date of May 2012.

During a concurrent interview with the DSS, she stated the white top collection tubes were expired, and the collection tubes should have been discarded.



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b. An observation of the Emergency Department was conducted with the Registered Nurse (RN 7) on June 19, 2012, at 11 a.m. The pediatric intravenous cart was observed to contain 20 blue top vacuette glass tubes used to contain blood drawn for laboratory tests.

A concurrent interview was conducted with RN 6 who stated the expiration date on the glass tubes was May 2012, and the tubes would be disposed of.



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c. On June 18, 2012, at 10:15 a.m., during a tour of the Medical-Surgical Unit, located on the fifth floor, the medication room was inspected. In one of the drawers, there were ten (10) white-top laboratory blood test tubes available for patient use. The tubes had expired on April 2012.

In a concurrent interview with Registered Nurse (RN) 1, the RN stated that licensed nurses also did blood draws and could obtain laboratory blood test tubes from this location.

3. An observation of the Intensive Care Unit was conducted with RN 8 on June 20, 2012, at 10:30 a.m. Located in the storage room were three Swan Ganz Catheters with expiration dates of May, 2012. A concurrent interview was conducted with RN 8, who stated the supply company was to check, rotate, and dispose of all expired items.

The facility policy and procedure titled, "Materials Management Safety" dated March 9, 2011, revealed, "...Expired supplies must be removed from stock immediately and disposed of in the manner set forth by Materials Management/Administration..."

Based on observation, interview, and record review, the facility failed to implement the policy and procedure for infection control and prevention by failing to:

1. Ensure Environmental Services (EVS) Staff 1 was familiar with the clostridium difficile microorganism (C. Diff; a strong organism that affects the gastrointestinal system), which required additional precautions with sanitation of the environment surrounding the patient. In addition, the EVS staff's personnel file did not contain documented evidence of an initial department-specific competency assessment related to C. Diff;

2. Ensure the Ultrasound Technician (UST) practiced proper isolation precautions while in Patient 2's room (contact isolation for MRSA [Methicillin-Resistant Staphylococcus Aureus; a bacteria resistant to strong antibiotics]), by failing to use personal protective equipment (PPE). In addition, the UST failed to observe hand hygiene protocol upon leaving the patient's room. Furthermore, the facility failed to ensure the UST was knowledgeable of the appropriate precautions for patients identified as requiring contact isolation. In addition, the UST's personnel file did not contain documented evidence that an annual competency assessment was completed that included infection control and prevention.

3. Ensure prevention of potential contamination from reuse of multi-dose insulin on multiple patients by storing used and open vials of insulin in the Pharmacy medication refrigerators.

These failures had the potential to spread infection of microorganisms, highly resistant to strong antibiotics, to other patients, staff, and visitors.

Findings:

1. On June 18, 2012, at 10:30 a.m., EVS Staff 1 was observed with the housekeeping cart.

A concurrent interview was conducted with EVS Staff 1. She stated she had transferred to the EVS Department approximately three weeks ago. She stated she was assigned to clean patient rooms. EVS Staff 1 stated when she observed a room with a precaution sign, she would ask a licensed nurse what type of organism the patient had that indicated the type of precaution staff would have to observe.

EVS Staff 1 stated she used "456 (quaternary-based chemical disinfecting agent)" to disinfectant the patient room's environment such as side rails, bedside table, and walls. EVS Staff 1 was not familiar with the C. Diff organism and the disinfecting chemical agent that was used to disinfect patient(s) identified with C. Diff.

On June 18, 2012, at 10:40 a.m., during an interview with RN 1, she stated patients positive for C. Diff were placed in "Contact Isolation." RN 1 stated "Contact Isolation" for C. Diff was different compared with other microorganisms requiring "Contact Isolation." RN 1 stated, for patients testing positive with C. Diff, staff should not be using alcohol-based hand rub agents. RN 1 stated the facility did not use specific signage identifying patients' positive with C. Diff.

On June 18, 2012, at 10:42 a.m., the EVS Director (EVSD) was interviewed. He stated all EVS staff were trained on the different kinds of disinfecting chemical agents. EVSD stated the facility used "Dispatch (bleach-based chemical disinfecting agent)" specifically to disinfect rooms of patients positive for C. Diff. EVSD stated "456" was used for all other patient rooms.

On June 21, 2012, at 1:20 p.m., the Director of Human Resources (DHR) was interviewed and stated all employees should have an initial department-specific competency check-off.

On June 21, 2012, EVS Staff 1's personnel file was reviewed. EVS Staff 1 transferred to EVS from the Dietary Department on May 27, 2012. The personnel file did not contain documented evidence of training that included the differences in approach in disinfecting the environment of patient's with C. Diff.

2. On June 18, 2012, at 2:15 p.m., an Ultrasound Technician (UST) was observed with an ultrasound machine in Room 525. Outside the room, a sign was posted which indicated, "Contact Isolation...Use gown...gloves..." The UST was observed sitting on the patient's bed, having a conversation with the patient. The UST was not wearing any PPE (gloves and/or gown). The UST was also observed using the facility's "Ascom (internal hand-held portable phone system)." After approximately 10 minutes, the UST wheeled the ultrasound equipment out of the patient's room. The UST did not perform any hand hygiene (washing of hands or using alcohol-based hand rub).

On June 18, 2012, at 2:25 p.m., the UST was interviewed. The UST stated the patient in Room 525 was positive with MRSA. The UST stated she donned the gown and gloves when she performed the test on the patient. The UST stated after she completed the ultrasound test, she removed all her PPE and washed her hands. The UST further stated after the test, she continued to stay in the patient's room and conversed with the patient. The UST was not aware that she needed to keep the PPE on while in the patient's room. The UST stated she did not do any hand hygiene prior to exiting the patient's room.

In a concurrent interview with the Cardiac Catheter Laboratory Manager (CLM), she stated the UST should wear the PPE while in the patient's room and remove them only when ready to leave the patient's room. Prior to exiting the patient's room, the UST should have performed hand hygiene.

On June 21, 2012, at 1:20 p.m., the DHR was interviewed and stated all employees should have an annual department-specific competency check-off list.

On June 21, 2012, at 2 p.m., the ICP (Infection Control Preventionist) was interviewed and stated annual competency assessment included infection control and prevention training.

On June 21, 2012, the UST's personnel file was reviewed. The employee was hired on February 28, 2011. The UST's personnel file did not contain documented evidence that an annual competency was completed for 2012, which included infection control and prevention.

On June 18, 2012, Patient 2's (patient in Room 525) record was reviewed and indicated the patient was admitted to the facility on June 15, 2012, with diagnoses that included, "History of MRSA."

The facility policy titled, "Standard and Transmission Based Precautions #131" dated December 16, 2010, was reviewed. The policy indicated,

"Contact Precautions: This isolation is for patients known or suspected to be infected or colonized with epidemiologically important organisms that can be transmitted by direct contact with the patient (hand or skin-to-skin contact) or indirect contact with environmental surfaces or patient care items in the patient's environment. Organisms isolated in Contact Precautions include: multi-drug resistant bacteria (MRSA, VRE, Acinetobacter), clostridium difficile..."

"Hand Hygiene: During patient care, change gloves after having contact with infective material that may contain high concentrations of microorganisms...Remove gloves inside the room, and immediately decontaminate hands."

"Personal Protective Equipment: Wear gown every time you enter the patient's room. You must wear a gown and gloves whether they are colonized or infected..."

"Removal of PPE: PPE must be removed in such a manner as to avoid touching the outside of the mask, goggles, gown and gloves, because they may be contaminated with infectious secretions from the patient...Do not touch surfaces in the patient's room before leaving...Decontaminate hands by washing or using alcohol based hand hygiene..."

The Centers for Disease Control and Prevention (CDC)'s "Morbidity and Mortality Weekly Report (MMWR)...Vital Signs: Preventing Clostridium difficile Infections (CDI)" released March 9, 2012, was reviewed and stipulated:

"Principal recommendations to prevent CDI included improving antibiotic use, early and reliable detection of CDI, isolation of symptomatic patients, and reducing the C. difficile contamination of health-care environmental surfaces..."

"...C. difficile frequently is transmitted between patients via hands of health-care personnel transiently contaminated after contact with symptomatic patients or their surrounding environment. Glove use, with strict adherence to changing between patient contacts, is the best proven method for preventing hand contamination with C. difficile from symptomatic patients. Health-care environmental services have a key role in reducing contamination that can directly transmit to patients or contaminate the hands of health-care personnel. Because C. difficile spores resist killing by usual hospital disinfectants, an Environmental Protection Agency-registered disinfectant with a C. difficile sporicidal label claim should be used to augment thorough physical cleaning..."

The facility policy and procedure titled, "Employee Orientation, Competency & Staff Development" dated March 9, 2011, revealed,

"Competency Assessment/Skills Training: Competency assessment and skills training needs are provided based on assessed employee and department needs, job description, department specific requirements...infection control issues..."

"Competency assessment and skills training are coordinated by the Education Department with hospital departments annually..."




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3. During inspection of the Pharmacy's IV Room on June 18, 2012, at 10 a.m., it was noted that in the medication refrigerator, there was a vial of Humulin R (insulin to treat diabetes) with an attached patient label, with the patient name removed, and an expiration date of June 16, 2012.

On June 18, 2012, at 1:20 p.m., in the Pharmacy main medication refrigerator, one open vial of Humulin 70/30 Insulin and one open vial of Lantus Insulin without any label with the open date of 6/1 and 6/2, respectively were observed.

During an interview on June 18, 2012 at 1:20 p.m., Pharmacy Technician (PT) 500 stated that all insulin vials were delivered to the nursing unit with patient specific labeling and once they were no longer needed on the unit they were brought back to the pharmacy and kept in the medication refrigerator.

During a concurrent interview, Pharmacist 500 stated that sometimes insulin doses were prepared in syringes in the pharmacy and delivered to the ED patients because Humulin 70/30 and Lantus were not available in the Cerner Rx Station (ADC, an automated medication dispensing device).

During a concurrent interview, the DOP stated that the used insulin vial, returned to the pharmacy from the nursing units, should not have been kept in the IV Room medication refrigerator and promptly discarded.

The DOP also agreed with Pharmacist 500 that some insulin doses were prepared in the pharmacy and delivered to ED.

However, the DOP was not able to provide evidence that there were insulin orders from ED since those vials were labeled as opened on 6/1 and 6/2 during which time the Pharmacy had not prepared any doses of Humulin 70/30 and Lantus doses for ED patients.

The DOP also agreed that there were no labels indicating whether those vials were returns from the nursing units or not. He also stated that each insulin vial should not be used for multiple patients.

The facility's policy and procedure titled, "Medications, Control, Storage of" indicated,

"MDV (Multidose Vial) will be used on, and dedicated to, a single patient rather than used on consecutive patients unless emergent or practical considerations apply ...
All departments shall discard its unusable drugs in pharmaceutical waste bins. Under no circumstances shall they be returned to active pharmacy or patient stock."

According to "APIC Position Paper: Safe Injection, Infusion and Medication Vial Practices in Healthcare" published by APIC (Association for Professionals in Infection Control and Epidemiology),

"Always follow the manufacturer's instructions for storage and use.
? Use single-use or single-dose vials whenever possible...
? If a multi-dose vial must be used, it should be used for a single patient whenever possible. The risk of transmission posed by inappropriate handling of multi-dose vials has been clearly demonstrated and mandates a practice of one vial per one patient whenever possible. Infection transmission risk is reduced when multi-dose vials are dedicated to a single patient...
? Dispose of opened multi-dose medication vials 28 days after opening, unless specified otherwise by the manufacturer, or sooner if sterility is questioned or compromised."

Based on observation, interview and record review, the facility failed to develop a system for identifying and controlling infections and communicable diseases of patients by failing to ensure a clean area stayed clean when dirty speculums used in the Labor & Delivery (L&D) "Triage Room" were placed in a container on the triage counter where "clean" supplies and paper items were maintained and stored.

Findings:

On June 18, 2012, at 2:25 p.m., an observation was made in the Perinatal Service "Triage Room," with RN 10 and the Director Surgical Services.

Located on the counter was a red "Transpak" container which contained two dirty/used speculums (instrument used to do a vaginal exam). The cabinets above and below the counter, and the counter surface, contained clean supplies to be used as needed for patients.

During a concurrent interview with RN 10, she stated after being used, the instruments were sprayed with an "Opti Pro Gel Instrument Pre-cleaner," and the Obstetrical Technicians would take the dirty instruments to sterile processing once a shift to be cleaned.

On June 20, 2012, at 1:50 p.m., an interview was conducted with the Infection Control Preventionist(ICP). She stated the location of the "Transpak" container of dirty instruments in the Perinatal Services "Triage Room" was in a designated clean area. The ICP stated an assessment of the location was done and the container would be moved to a dirty utility room.