HospitalInspections.org

Based on observation, interview, a review of selected policies and procedures and a review of professional credentials files and human resource files, the hospital failed to ensure the governing body carried out its full and complete oversight for the hospital as a whole. The cumulative effect of these systemic problems identified during the Life Safety Code (LSC) and Full Health Medicare Validation survey resulted in exhibiting the hospital's inability to ensure the provision of quality health care in a safe environment.

Findings:

The governing body failed to ensure that the medical staff bylaws and appointments of practitioners to the medical staff had been performed in a manner consistent with the medical staff bylaws of the hospital. See A045, A341 and A353.

The governing body failed to ensure the provision of care in a safe environment. See A144 and A724 #4 .

The governing body failed to ensure an effective, data driven QAPI program that addressed high risk, problem prone areas and used the data collected to identify opportunities for improvement. See A263.

The governing body failed to ensure the security and patient safety for the newborn nursery area. See A310.

The governing body failed to ensure a safe environment was maintained for fire safety for patients in the radiology, cardiac catheterization, and emergency departments and the Wound Care Center. See A710.

The governing body failed to ensure the preparation of a complete and accurate medical record. See A274, A450, A457 and A1005.

The governing body failed to ensure compliance with the condition of participation for nursing services. See A385.

The governing body failed to ensure development and implementation of policies and procedure for infection control. See A747.

The governing body failed to ensure safety and compliance with the condition of participation for Emergency Services. See A 1100.

The cumulative effect of these systemic problems resulted in the failure by the hospital to provide quality care in a safe environment.

Based on observation, interview and a review of professional credentials files, the governing body failed to ensure which practitioners were eligible for appointment to the medical staff for six of 11 PA (PAs 1, 2, 6, 8, 10 and 11) credential files reviewed which could potentially effect the quality of medical care the patients received.

Findings:

1. During an on site visit to the hospital and interviews with M56 conducted on 1/14/10 at approximately 1400 hours, the credentials files for 11 physician assistants were reviewed. PA1 applied for medical staff privileges and was appointed to the staff. The privileges for PA1 expired prior to the completion of proctoring for PA1. The medical staff bylaws specify concurrent and retrospective review of medical records and services provided by each PA for 10 cases, prior to appointment to the staff of the hospital.

2. PA2 was appointed to the medical staff of the hospital on 3/10/09. A review of the credentials file for PA2 and interviews with M56 revealed that proctoring was completed on the evening of 1/13/10, during the survey process for the hospital. According to interviews with the medical staff representative and a review of the medical staff bylaws of the hospital, "proctoring shall consist of retrospective and concurrent case reviews."

3. PA6 was appointed to the medical staff of the hospital on 10/19/09. A review of the credentials file for PA6 and interviews with the medical staff representative revealed that proctoring was completed on the evening of 1/13/10, during the survey process for the hospital.

4. PA8 was appointed to the medical staff of the hospital on 4/16/07. A review of the credentials file for PA8 revealed that documentation of proctoring was performed for nine cases on 4/30/08. This did not comply with the medical staff bylaws of the hospital that specify 10 concurrent and retrospective case reviews. When interviewed on 1/14/10 at approximately 1440 hours, PA8 stated that she was unaware of her "responsibility to initiate contact with her proctor when treating a patient."

5. The professional credentials file for PA10 revealed that proctoring was performed for 10 cases on the same date. There was no written documentation that the medical records review was consistent with the medical staff bylaws that require concurrent and retrospective case review.


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6. On 1/11/10 at 1350 hours, an interview was conducted with PA11. PA11 was observed sitting in a room designated as a MSE room. MSE's are patient examinations done to determine if a patient has an emergency medical condition. PA11 stated that she did MSEs for ED patients and ordered tests and treatments.

On 1/12/10, a review of the credential file for PA11 failed to show any written evidence of proctoring.

The governing body failed to ensure that appropriate proctoring of each category of practitioner for appointment to the medical staff had been implemented in accordance with the medical staff bylaws of the hospital. See A341 #6 and A353.

Based on observation, interview and record review the hospital failed to comply with the requirements of CFR 482.55. By failing to ensure:

1. The provision of a valid back up specialty on call schedule. See A1102.

2. The following was implemented in the ED:
a. Not housing patients and equipment in emergency egress corridors and in front of emergency pull stations which subjected the patients to danger from fire. See A710 and A1104 #1.

b. A process was in place to accurately document patients' arrival times in the ED. See A1104 #2.

c. Patient privacy was provided. See A1104 #3.

d. LVN assignments reflected the patients' acuities. See A1104 #4

3. Six of 11 PAs were competent to perform MSEs. See A1112.

The cumulative effect of these systemic problems resulted in the failure by the hospital to provide quality care in a safe environment.

Based on observation, interview and record review, the hospital failed to

1. Ensure the patients' right to receive care in a safe setting in the Emergency and Radiology Departments, Cardiac Catheterization Laboratory, and the newborn nursery of the RSMC campus and the Wound Care Center of the IVMC campus.

The emergency egress corridor for the ED, Radiology Department and Cardiac Catheterization Laboratory was blocked with patients in gurneys, patient care equipment and visitor chairs 80% of the time per staff interview.

The newborn nursery failed o have adequate safeguards in place to prevent infant abduction after removal of a security alarm system approximately one year prior to the survey.

There was not maintenance of the fire emergency equipment, smoke wall barriers, and emergency evacuation procedures in the Wound Care Center. See A144, and A710.

2. Ensure the patients' rights to personal privacy in the ED of the RSMC campus. See A143.

3. The hospital failed to ensure adequate systems in place to ensure the temperature and humidity monitors in the OR were calibrated and tested for accuracy on a regular basis. See A 144.

The cumulative effect of these systemic problems resulted in the failure by the hospital to provide quality care in a safe environment.

Based on observations and interviews, the hospital failed to provide privacy for ED patients at the RSMC campus and patients in the preoperative and PACU area of the IVMC campus which could potentially affect the patients' rights to respect and dignity.

Findings:

1. On 1/11/10 at 1400 hours and 1/12/10 at 0950 hours, the hospital's RSMC campus ED was toured and a lack of patient privacy was observed on both days:

A double doorway served as an exit from the ED into the hallway of the Radiology Department. The long radiology hallway had ED patients on gurneys lining the entire right side of the hallway. A shorter hallway on the left had two patients in gurneys lining the left side which filled the left side to the exit doors. All eight patients, on both days, had screen between each gurney but no screens or curtains in front of them and all eight patients were visible to people (which included hospital staff and visitors), walking down the hall. On 1/11/10 at 1430 hours, one of the unsampled patient was uncovered and had one hand down the front of his pants.

On 4/11/10 at 1430 hours, the surveyor was conducting an interview with Patient 317 in ED Room 3. The room was intended for one patient but there were two patients in the room. A staff members discussion with the other patient was clearly audible at Patient 314's bedside.


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2. On 1/11/10 a confidential patient interview was conducted. The patient stated he had to leave the ED waiting room due to embarrassment about other people in the waiting area seeing his condition. When the patient was taken to the treatment area he was placed in a bed in the hallway. He stated this lacked privacy but then he was transferred to a regular space in the ED. This also lacked privacy because everyone kept coming in to get supplies out of the room. He stated he was in Room 5.

At 1100 hours on 1/11/10 observations of the ED were made. There were patients on gurneys in the hallway. There were privacy curtains between patients but each patient could be viewed by any visitor walking down the hallway. Room 5 of the ED was observed to contain supply carts, casting equipment, and the blanket warmer for the ED patients. A patient was on the gurney in this bay but the privacy curtain had not been pulled to maintain privacy from visitors in the ED.


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3. On 1/12/10 at 1045 hours, the preoperative area at IVMC's campus was toured accompanied by M36. One patient, in Bay #5 was observed in a reclining chair receiving a blood transfusion. In Bay #6, another patient was semi-reclining in a gurney receiving an IV infusion. There was no privacy protection device provided between the two patients. M36 stated the preoperative area was used to prepare patients for procedures and outpatient IV infusions.

4. On 1/12/10 at 1140 hours, the PACU at the IVMC campus was toured with M36. No patient's privacy curtain was present between Bays 7 and 8. M36 stated the unit was designed as an eight bay patient recovery unit. Bay 8 currently was used for storage of the OR C-arms, camera tower, and OR patient positioning devices. Patients being recovered in Bay 7 could be exposed to staff members when they were using the C-arms or supplies from Bay 8.

Based on observation, interviews and a tour of the hospital, the hospital failed to ensure the provision of care in a safe environment which could potentially effect fire safety in the ED and the OR at RSMC campus and the WCC at the IVMC campus. Also, the hospital did not protect infants from being abducted at the RSMC campus.

Findings:

1. Based on observation and staff interview, the hospital failed to ensure that the physical plant, equipment and hospital environment were maintained in such a manner that the safety and well-being of patients was assured. At RSMC, by not maintaining exit access in the emergency department (ED), by penetrations in the smoke barrier wall enclosing the ED suite, and by obstructed access to manual pull stations, the hospital created the potential for lack of safety. This affected 19 patients in the ED and in the Radiology Department corridor outside the ED, visitors, radiology department patients and hospital staff. See A710.

On 1/13/10 at the WCC on the IVMC campus, there were penetrations in the walls, insufficiency of firewalls/firedoors, no alarm system in place and no staff training for patient evacuation. This could potentially result in the inability to stop the spread of fire and evacuate patients in the event of a fire resulting in potential harm or death. See A710.

2. A tour of the surgical suites at RSMC campus was performed on 1/11/10 at approximately 1300 hours. The temperature and humidity for each surgical suite was provided by a hand held device fixed to the wall of the surgical area. This device, or fluke as it was called by representatives from the operating room and plant maintenance, registered the room temperature and humidity. Hospital employees E141 and M46 stated that these devices had been calibrated at the factory. When asked to produce a log to document that these devices had been re-calibrated or re-tested to ensure accuracy, representatives from the facility were unable to do so. Temperature and humidity control in the operating rooms is essential to decrease the risk of fire in this oxygen rich environment.

3. The hospital failed to ensure the provision of safety for its pediatric patients when it failed to ensure that the exit areas adjacent to the newborn nursery had appropriate alarms or security measures to protect from infant abduction. See A724.

Based on observation, interview and record review the hospital failed have an effective QAPI program by failing to ensure:

Data used in the ED to measure performance was accurate and reflected actual practice and data collected for healthcare associated infections was used to identify opportunities for improvement and make changes. - See A267.

QAPI activities were in place for monitoring compliance with hospital P&Ps designed to detect and prevent the spread of MRSA. See A267.

Data collected for hospital associated infections was used to improve performance. See A267, A276.

The executive responsibilities for oversight of QAPI data collection, analysis and use for performance improvement were defined and ongoingly implemented. See A310.

The cumulative effect of these systemic problems resulted in the failure by the hospital to ensure the providsion of quality care in a safe environment.

Based on interviews and record review, the hospital failed to have a process in place to accurately document patients' arrival times in the ED so data collection for QAPI was accurate, implement and use data collected for use in preventing healthcare associated infections, implement a system to monitor compliance with the hospital's P&Ps for detecting and preventing the spread of MRSA and ensure data collection to monitor the timely administration of antibiotics was conguent with P&Ps. This resulted in the potential for the hospital not to recognize problems and correct processes that could improve patient outcomes.

Findings:

1. On 1/12/10, review of the most recent quarter performance improvement dashboards for both the RSMC and IVMC showed areas for measurement included ED turn around times, time to provider, and other measures. When the ED logs for the EDs were reviewed, the arrival time was part of the ED log. However, further investigation showed this was not the time the patient actually arrived at the ED for walk-in patients (that is all patients not arriving by EMS ambulance) but the time the patient was triaged.

According to M49, interviewed on 1/12/10 at 1530 hours, upon arrival to the ED walk-in patients obtained a form from the admissions clerk titled "ED Demographics." The patients were to fill out this form on arrival to the ED. The top of the form had a section for date and time of arrival. A review of 12 sampled ED patients showed no arrival time for five patients (Patients 16, 294, 295, 296, and 318) and an inaccurate time for one patient (Patient 16). See A1104.

On 1/13/10 at 1630 hours, M48 confirmed there was no record that accurately showed total patient time in the EDs.

2. On 1/13/10 at 1215 hours an interview was conducted with M14 and E166. During the interview, M14 and E166 was asked about their process for reducing healthcare associated infections. E166 stated that in July 2009, the hospital had developed subcommittees for "Bundles" (a group of actions that together reduce the risk of developing a healthcare associated infection); but, had not done much with the data collected or analyzed from the four bundles developed.

During the same interview, M14, stated that the two hospital campuses planned on implementing the four bundles in 2010.

3. On 1/11/10 at 1600 hours, the hospital's 4/09, policy and procedure titled, "MRSA - screening and prevention program" (methicillin resistant staphylococcus aureus). On page two direction was given that the following patients must be tested within 24 hours of admission:
Any patient scheduled to undergo an inpatient surgery.
Any patient who has been previously discharged from a general acute care hospital within 30 days prior to the current hospital admission.
Any patient being transferred from a skilled nursing facility.
Any patient admitted to ICU, NICU units (Intensive care unit, neonatal intensive care unit).
Any patient who receives inpatient dialysis or outpatient dialysis treatment.
Any patient who has a prior history of MRSA infection.

On 1/12/10 at 0910 hours, an interview was conducted with E26. E26 was asked to describe the MRSA screening process in accordance with their policy and procedure. E22 stated that neither of the two hospital campuses tracked compliance with their MRSA policy. E22 further stated that the two hospital campuses had no idea what their MRSA policy and procedure compliance was.

4. On 1/15/10 at 1140 hours, AS5 stated that the quality review for antibiotic administration was to assure that antibiotics were administered within 6 hours, however, according to the hospitals policy and procedure entitled, "Intravenous Therapy: Medications given intravenously by a Registered Nurse," antibiotics needed to be administered within two hours of the physician order to prevent or treat an infection. The QAPI program data collection measurement was not in accordance with the standards of care developed by the hospital for the timely administration of antibiotics.

Based on interview, the hospital failed to ensure the data collected for hospital acquired infections was used to identify opportunities for improvement.

Findings:

On 1/13/10 at 1215 hours an interview was conducted with M14 and E166. During the interview, M14 and E166 was asked about their process for reducing healthcare associated infections. E166 stated that in July 2009, the hospital had developed subcommittees for "Bundles" (a group of actions that together reduce the risk of developing a healthcare associated infection); but, had not done much with the data collected or analyzed from the four bundles developed.

During the same interview, M14, stated that the two hospital campuses planned on implementing the four bundles in 2010.

Based on observation, interview and record review, the executive leadership, medical staff and administrative officials failed to ensure QAPI data collection was defined, measured progress toward meeting the goals of the antibiotic administration P&Ps and was accurate, that it ongoingly implemented processes to make improvements in hospital acquired infections, and maintained surveillance and data evaluation of MRSA admissions and hospital acquired infections.

Findings:

1. Interview with Patient 16 on 1/11/10 showed he had come to the Emergency Department at approximately 2115 hours on 3/9/10 and was not seen by a nurse to assess his condition until approximately two hours later. Review of documents used to collect QAPI data about arrival to treatment times (ED Demographics forms) showed they were not always filled out and/or the time entered on the form was the time of triage by a nurse not the actual arrival time.

On 1/12/10, review of the most recent quarter performance improvement dashboards for both the RSMC and IVMC showed areas for measurement included ED turn around times, time to provider, and other measures.

On 1/13/10 at 1630 hours, M48 confirmed there was no record that accurately showed total patient time in the EDs. See A267.

2. On 1/13/10 at 1215 hours an interview was conducted with M14 and E166. During the interview, M14 and E166 was asked about their process for reducing healthcare associated infections. E166 stated that in July 2009, the hospital had developed subcommittees for "Bundles" (a group of actions that together reduce the risk of developing a healthcare associated infection); but, had not done much with the data collected or analyzed from the four bundles developed.

During the same interview, M14, stated that the two hospital campuses planned on implementing the four bundles in 2010. The executive leaership failed to ensure the data collected was acted on to improve the hospital's performance. See A276.

3. On 1/15/10 at 1140 hours, AS5 stated that the quality review for antibiotic administration was to assure that antibiotics were administered within 6 hours, however, according to the hospitals policy and procedure entitled, "Intravenous Therapy: Medications given intravenously by a Registered Nurse," antibiotics needed to be administered within two hours of the physician order to prevent or treat an infection. The QAPI program data collection measurement was not in accordance with the standards of care developed by the hospital for the timely administration of antibiotics. See A500.

4. On 1/12/10 at 0910 hours, an interview was conducted with E26. E26 was asked to describe the MRSA screening process in accordance with their policy and procedure. E22 stated that neither of the two hospital campuses tracked compliance with their MRSA policy. E22 further stated that the two hospital campuses had no idea what their MRSA policy and procedure compliance was. The executive leadership failed to ensure data was collected to monitor this important aspect of care to ensure potential problems were identified and actions taken to improve the hospital's performance. See A267.

Based on interviews, a tour of the facility during an onsite visit to the hospital conducted on 1/12/10 and a review of selected documents and medical staff bylaws, the medical staff failed to be accountable to the governing body for the quality and appropriateness of care provided to its patients.

Findings:

The medical staff failed to ensure the preparation and maintenance of a complete and accurate medical record for anesthesia and emergency department medical records. See A449.

The medical staff failed to ensure the appropriate credentialling of physician assistants providing direct care in the emergency department. See A341.

The cumulative effect of these systemic problems resulted in the failure by the hospital to provide a safe and quality care for patients.

Based on interviews and a review of 11 credentials files for physician assistants (PA) providing services in the emergency department of the hospital, the medical staff failed to follow its own mechanism for proctoring six of 11 applicants (PAs 1, 2, 6, 8, 10 and 11). This resulted in a lack of oversight of mid-level practioners delivering treatment and care to patients within the hospital.

Findings:

During an on site visit to the hospital and interviews with the medical staff representative conducted on 1/14/10 at approximately 1400 hours, the credentials files for 10 physician assistants were reviewed:

1. PA1 applied for medical staff privileges and was appointed to the staff. The privileges for PA1 expired prior to the completion of proctoring for PA1. The medical staff bylaws specify concurrent and retrospective review of medical records and services provided by each PA for 10 cases, prior to appointment to the medical staff of the hospital.

2. PA2 was appointed to the medical staff of the hospital on 3/10/09. A review of the credentials file for PA2 and interviews with the medical staff representative revealed that proctoring was completed on the evening of 1/13/10, during the survey process for the hospital. According to interviews with the medical staff representative and a review of the medical staff bylaws of the hospital, "proctoring shall consist of retrospective and concurrent case review."

3. PA6 was appointed to the medical staff of the hospital on 10/19/09. A review of the credentials file for PA6 and interviews with the medical staff representative revealed that proctoring was completed on the evening of 1/13/10, during the survey process for the hospital.

4. PA8 was appointed to the medical staff of the hospital on 4/16/07. A review of the credentials file for PA8 revealed that documentation of proctoring was performed for nine cases on 4/30/08. This did not comply with the medical staff bylaws of the hospital that specify 10 concurrent and retrospective case reviews. When interviewed on 1/14/10 at approximately 1440 hours, PA8 stated that she was unaware of her "responsibility to initiate contact with her proctor when treating a patient."

5. The professional credentials file for PA10 revealed that proctoring was performed for 10 cases on the same date. There was no written documentation that the medical records review was consistent with the medical staff bylaws that require concurrent and retrospective case review.




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6. On 1/11/10 at 1350 hours, an interview was conducted with PA11. PA11 was observed sitting in a room designated as a MSE room. MSE's are patient examinations done to determine if a patient has an emergency medical condition. PA11 stated that she did did MSEs for ED patients and ordered tests and treatments.

On 1/13/10, a review of the credential file for PA11 failed to show any written evidence of proctoring for MSEs.

Based on interviews and a review of 19 professional credentials files of the medical staff, the medical staff failed to enforce its own bylaws. This resulted in a lack of oversight of mid-level practioners delivering treatment and care to patients in the ED.

Findings:

A review of 19 professional credentials files revealed that the medical staff failed to comply with its own medical staff bylaws for the proctoring of 6 of 19 applicants to the medical staff of the hospital. When reviewed, the professional credentials files for six physician assistants revealed that the proctoring in concurrent and retrospective chart review, had not been completed. See A341.

Based on observation, interview, and record review, the hospital failed to ensure the organized delivery of nursing services by failing to:

1. Assess and/or re-evaluate patients regarding pain and their response to intervention on an ongoing basis per hospital policy. See A395 #1 and #4.

2. Implement policies and procedures for two of two patients sampled for fall prevention. See A395 #2 and #3.

3. Intervene for a patient with with low blood pressure. See A395 #6.

4. Develop and keep current nursing care plans. See A396.

5. Show documentation of how the ED LVN assignments were related to patient acuity. See A397.

6. Carry out physician orders to administer two medications to lower blood pressure. See A404 #1.

7. Administer Dilaudid according to written policies and procedures. See A404 #2.

8. Carry out the 24 hour check of a patient's MAR for accuracy. See A404 #3.

9. Check a patient's blood pressure prior to administration of a medication that lowered blood pressure. See A404 #3.

10. Administer the first dose of intravenous antibiotics to patients within two hours of the order according to the hospital's P&P. See A405.

The cumulative effect of these systemic problems resulted in the failure by the hospital to provide quality care in a safe environment.

Based on observation, interview and record review, the hospital failed to assess and/or re-evaluate four of 86 sampled patients (Patients 2, 16, 66 and 169) regarding pain and their response to intervention on an ongoing basis per hospital policy and a hypertensive (high blood pressure) patient with low blood pressure (Patient 66). The hospital failed to ensure policies and procedures were implemented for two of two patients sampled for fall prevention (Patients 32 and 320). The failures resulted in ineffective relief and management of acute pain and possible patients' injuries secondary to fall and low blood pressure. Additionally, one RN was unable to correctly use a cardiac defibrillator/pacemaker which could potentially result in a delayed response in an emergency.

Findings:

1. At 1015 hours on 1/11/10 Patient 16 was interviewed. He was observed to have a nasogastric tube for drainage of stomach contents. Patient 16 stated he was waiting to have emergency surgery on his abdomen. The patient and family stated he had come to the ED at approximately 2115 hours on 1/9/10 with severe abdominal pain. The patient stated it had taken two hours before he saw a nurse in the ED to evaluate the severity of his condition. During the long wait in the ED before seeing a nurse, the patient had to step outside because he was embarrassed to be seen doubled over in pain. When he did see a nurse, the family member stated the patient stated his pain was 13 on a scale of 1 to 10 with 10 being the worst pain. Review of the patient's record on 1/13/10 revealed the "ER Demographics" form did not document a time that the patient arrived at the ED. There was a hand written note on this form that said the patient was called at 2240 hours and there was no answer. The ED record revealed a nurse first saw Patient 16 at 2308 hours and he complained of a "10" pain. Interview with Patient 16 at 1600 hours on 1/12/10 revealed the surgeon had found an intestinal blockage approximately the size of a small cantaloupe.

2. On 1/12/10 at 1505 hours the door to Patient 32's room was observed closed. There was a sticker on the room number of the door identifying the patient was a high risk for falls. D1 stated the patient's door could be closed if the patient requested. Review of the policy and procedure titled Patient Fall Prevention Program identified that the patient identified to be at risk for falls would have a yellow arm band and door sign applied during the admission process. At 1600 hours on 1/12/10 Patient 32 was interviewed. She was observed not to have a yellow arm band on. She stated she was dizzy sometimes and therefore was at risk of falling. She stated she had been in the hospital for one week and had never had a yellow arm band.

3. At 1540 hours on 1/12/10 Patient 320 was observed ambulating in the hallway with the assistance of staff. He was using a walker and had a gait belt around his waist. He was observed to enter a room that had a sign identifying him at a risk for falls. Review of the Patient 320's medical record revealed an admission date of 1/11/10. As of 1550 hours on 1/12/10 there was no documented evidence of nursing education given to the patient about how to prevent falls while in the hospital. After talking with the patient's RN, this was confirmed by D1 who stated the RN had not done the patient education as described in the Patient Fall Prevention Program policy and procedure.


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4. On 1/15/10 at 1300 hours, review of the hospital's P&P on Pain Management (revised on 2/09) stated, "Monitor efficacy of pain treatment and patient satisfaction. Any adverse reaction or uncontrolled pain should be reported to the physician as quickly as possible. Pain interventions that are deemed ineffective will be addressed and alternative measures will be taken and documented on the Interdisciplinary Plan of Care."

In the pain management P&P entitled "Special Considerations," it was stated on #7 that, "Patients who are in a special procedure, or in another department who need narcotic pain medication must be monitored for 30 minutes post narcotic administration by an RN. Monitoring includes assessment for pain control, and repeat vital signs to include O2 saturation."

At RSMC medical-surgical floor, east side, on 1/14/10 at 0930 hours, the medication pass to three patients was observed with M54. E18 told Patient 2 that the patient's medications had not been delivered by the pharmacy. Patient 2 nodded in acknowledgement but with painful facial grimaces. E18 was ready to leave Patient 2's bedside without assessing the patient's pain until M54 indicated to turn off the lights because it looked like the patient was having pain. Only then did E18 ask Patient 2 about pain. Patient 2 complained of abdominal pain which was rated at 8/10, with 10 as the most painful on a scale of 1-10.

E18 verified the physician's order for Dilaudid 2 mg to be given intravenously as necessary for pain. The pain medication was administered by pushing Dilaudid 2mg intravenously into the patient's IV access within 40 seconds, based on the second hand of the patient's wall clock. The patient's facial grimaces were noted to relax. E18 left the patient's room and charted the medication in the MAR as given.

Per review of the nursing care plan for Patient #2 on 1/14/10 at 1000 hours, regarding the nursing problem of alteration in comfort (pain), the goal was to achieve a pain level of 2/10.

Review of the nurses' notes and MAR on 1/15/10 at 1030 hours revealed that, on 1/14/10, Patient 2 continued to receive Dilaudid 2 mg intravenously every two hours from 1000 hours to 2045 hours. The abdominal pain was continuously rated by the patient as 8/10 pain level at 1000 and 1200 hours subsiding to only 6/10, an hour after the Dilaudid was pushed intravenously. The pain rating went up twice to pain level of 9/10 at 1400 hours and 1600 hours, however, record review failed to reveal any evidence that the physician was informed for other alternative pain relieving measures. Further record review revealed that the pain level and medication response was not consistently re-assessed/re-evaluated after narcotic administration per the written plan of nursing care. There was no evidence that repeat vital signs were taken 30 minutes after medication administration per hospital policy and/or whether the patient was monitored for respiratory depression per MAR instruction.

On 1/15/10 at 1300 hours, M54 and M55 acknowledged that the physician was not informed the pain medication was not working as stated in the hospital policy. Both stated that the 30-minute vital signs were being monitored only in special procedures and not on a medical-surgical floor despite the patient receiving narcotic pain medication.


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5. Review of the RSMC "Structure Standards-Med/Surg/Tele" showed that vital signs are to be taken every four hours and could be monitored more frequently if necessary.

On 1/11/10 at 0915 hours, Patient 66's medical record was reviewed. The patient was admitted to the RSMC campus Telemetry Unit on 1/9/10. The patient had multiple diagnoses including a history of hypertension (high blood pressure). The initial B/P reading was taken at 0130 hours and was recorded as 82/45 (below normal) with the patient complaining of weakness. There was no documentation the physician was notified of the low blood pressure. The next blood pressure was not taken until 0400 and was 107/55. When the low B/P reading was reviewed with M50, an RN, she stated she would have taken another blood pressure sooner - within 15 minutes. Further review of Patient 66's medical record showed the patient had another episode of low blood pressure in the 80s on 1/10/10 and the rapid response team was called.

6. On 1/13/10 at 1150 hours, E162, was asked to demonstrate a defibrillator/pacemaker machine equipment check. E162 was unable to perform the check because she could not locate where the pacer/defibrillator cable was connected to the machine. According to M51, the charge nurse in the ICU checked the machine on a daily basis.

Based on observation, record review and staff interview, the nursing staff failed to develop and keep current nursing care plans on one of three patients (Patient 2) observed for medication pass. This failure contributed to ineffective pain management.

Findings:

On 1/15/10 at 1300 hours at RSMC, review of the hospital policy on Pain Management (revised on 2/09) stated that, "Monitor efficacy of pain treatment and patient satisfaction. Any adverse reaction or uncontrolled pain should be reported to the physician as quickly as possible. Pain interventions that are deemed ineffective will be addressed and alternative measures will be taken and documented on the Interdisciplinary Plan of Care."

On 1/14/10 at 0930 hours, medication pass for three patients by E18 was observed with M54. Patient 2 received Dilaudid 2 mg intravenously pushed (IVP) in 40 seconds for abdominal pain rated at 8/10, with 10 as the most painful on a scale of 1-10. The pain level was reduced to 6/10 after 1000 hours. Per review of the nursing care plan on alteration of comfort (pain) dated 1/12/10, the goal was to achieve a pain level of 2/10.

On 1/15/10 at 1000 hours, review of the patient care flow sheet and MAR dated 1/14/10 revealed that Patient 2 continuously received Dilaudid 2 mg intravenously every two hours from 0800 till 2045 hours. The lowest pain level documented in response to the pain medication was 6/10, however, the care plan was not revised to note the efficacy of the pain intervention and to suggest other pain relief alternative measures. In addition, the written intervention in the plan of care to reassess the patient's response to pain medication 30 minutes after the pain medication was administered was not evident. The patient's vital signs continued to be taken routinely every 4 hours without monitoring respiratory depression per MAR instruction.

On 1/15/10 at 1300 hours, M54 and M55 acknowledged that the physician was not informed for alternative pain measures. Both made no comment regarding updating the care plan to keep it's interventions current on an ongoing basis.

Based on interview and record review, the hospital failed to have show documentation of how the ED LVN's assignments were related to patient acuity. This had the potential for LVN's to be assigned to patients who require a higher level of care which could effect the quality of the patient care.

Findings:

Review of the hospital's ED policy Structure Standards: Emergency Department (revised 10/09), showed assignments would consider patient needs and in another section of the Standards, LVNs receive direction from the Staff Nurse, Charge Nurse and other nurse managers. Additionally, the Structure Standards showed that patient assignments would consider patient needs, staff credentialing and certifications.

On 1/11/10 at 1355, M49 stated RSMC's ED had three LVNs on staff. At 1500 hours, on 1/11/10 M49 was asked about the ED patient acuity system. According to M49, the ED used a five level triage system that ranged from Level One as the most acutely ill and Level 5 as the least acute patient.

On 1/12/10, review of the Five Level Triage P & P failed to show how the acuity would be used for assignments by staff licensure/qualifications. Further review of the ED policy Structure Standards: Emergency Department failed to show any specific direction of how LVN assignments would be made.

Based on observation, interview and record review, the hospital failed to carry out physician orders to administer two antihypertensive medications (medications to lower blood pressure) to Patient 304 who had a history of high blood pressure and congestive heart failure. The failure could result in patient injury. In addition, one of three patients (Patient 2), observed for medication pass, received Dilaudid 2 mg intravenously pushed (IVP) within 40 seconds instead of the written standards of practice of administering Dilaudid 2 mg IVP at a rate of over 2-3 minutes. The failure could result in respiratory depression and low blood pressure. The hospital also failed to carry out the 24 hour check of Patient 256's MAR for accuracy of a Ramipril order by failing to note the lack of a hold parameter on the 1/13/10 MAR as ordered by the physician. As a result, the nurse did not check or even consider the patient's blood pressure before administering the Ramipril to Patient 256 on 1/14/10. Potentially, Patient 256 could have received this blood pressure medication when her systolic blood pressure, as determined by the physician, was too low for her to receive this medication.

Findings:

1. At RSMC, on 1/13/10 at 1629 hours, review of Patient 304's medical record revealed an order to administer Lasix and Aldactone (blood pressure medications) today at 1230 hours. The dose of Lasix was 40 milligrams by intravenous route (in the vein) and Aldactone 12.5 milligrams by mouth. During an interview with E58 who stated she decided to hold these two medications because Patient 304's blood pressure was 98/61 mmHg. (The mmHg is millimeters of mercury-the units used to measure blood pressure). When asked if there was a physician order to hold these medications based on blood pressure parameters, E58 stated there wasn't. She stated she holds blood pressure medications if the systolic blood pressure (top number) is below 100 mmHg and may hold the medications if the systolic blood pressure is between 100 - 110 mmHg. E58 held two blood pressure medications and made this decision on her own and not in accordance with the orders of the physician or hospital policies.


21262


2. On 1/14/10 at 0930 hours, E18 was observed for medication pass to three patients on the medical-surgical floor, east side.

Patient 2 complained of abdominal pain rated at 8/10, 10 being the most painful on a scale of 1-10. E18 verified the physician's order for Dilaudid 2 mg to be given intravenously as necessary for pain.

The pain medication was administered by pushing Dilaudid 2mg intravenously to the patient's IV access within 40 seconds, based on the second hand of the patient's wall clock. The patient's facial grimace was noted to relax. E18 left the patient's room and charted the medication in the MAR as given.

On 1/14/10 at 1300 hours, the Risk Manager provided the requested hospital's Guidelines of Intravenous Medications. It revealed that Hydromorphone (Dilaudid) 1-4 mg (undiluted) could be given in Critical Care Units, PACU, Medical-Surgical Telemetry Unit, and at Women's Center. However, Dilaudid should be intravenously pushed at a rate of over 2-3 minutes.

Further record review of the MAR and nursing care plan revealed instructions to monitor for respiratory depression and reassess response to pain medication after 30 minutes. However, neither one was evident except the vital signs routinely taken every four hours.


15338


3. On 1/14/10 at 0913 hours at the IVMC, E105 passed medications including a Ramipril 5 mg tablet (used to treat high blood pressure) to Patient 256. A review of Patient 256's medical record at 0946 hours on 1/14/10 indicated a physician had written an order on 1/12/10 to hold the Ramipril for systolic (top number) blood pressure less than 110 mmHg. E105 had not measured Patient 256's blood pressure before she administered the Ramipril. During an interview of E105 at this time, she stated she was not aware Ramipril was to be held for a systolic blood pressure of less than 110 mm of Hg. She did point out that this information did not appear on Patient 256's MAR (used by nurses to accurately medicate their patients and to document the date and time a dose of medication was administered) and that the Patient 256's systolic blood pressure had been measured at 168 mm of Hg that morning at 0830 hours but she stated she did not take that information into account when medicating the patient.

A review of the 1/14/10 MAR at 0955 hours indicated that the hold parameters were not printed on the Ramipril entry on this document, which nursing staff depend on to accurately medicate their patients. During an interview of M32 on 1/14/10 at 1019 hours, he stated that the MARs were printed on the nursing units at 2300 hours daily using data from the pharmacy computerized patient medication profiles. He stated that the pharmacist who entered the order should have entered the hold parameters which would then have printed out on the MAR. He stated that if nurses detected an error on an MAR, they were to correct the error by hand on the MAR and fax a copy of the corrected MAR to the pharmacy so that the pharmacy staff could correct the error in the computerized patient medication profile.

On 1/14/10 at 1029 hours during an interview of M30, he stated that there was a 12 hour and a 24 hour check of the accuracy of the MARs by nursing staff. He stated that the 24 hour check would have been done after midnight by the night shift (after midnight on 1/13/10 for this order). He stated the nurse should have hand written in the correction on the 1/13/10 MAR. He stated the nurse missed the error in the pharmacy order entry.

Based on interview and record review, the hospital failed to administer the first dose of intravenous antibiotics to three of three patients on both campuses within two hours of the order (Patients 1, 257, and 304). According to the hospitals policy and procedure entitled, "Intravenous Therapy: Medications given intravenously by a Registered Nurse,"antibiotics need to be administered within two hours of the physician order to prevent or treat an infection." Not administering the medication within this two hour time slot and leaving the infection untreated, may lead to an elevated fever and spread of the infection.

Findings:

At RSMC on 1/14/10 at 1140 hours, during an interview, E157 stated the time to initiate intravenous antibiotics when a bed was available in the ED was one to two hours but usually one hour. At 1145, during an interview E16 stated that sometimes the emergency department was crowded and could take as long as four hours to initiate intravenous antibiotics but usually it only takes one to two hours and often one hour.

1. At RSMC, on 1/14/10 at 1524 hours, review of Patient 1's medical record revealed that he was admitted to the hospital with a severe ankle wound. Fortaz 1 gram (antibiotic medication) was ordered intravenously every 8 hours on 1/8/10 at 1540 hours. The dose was not given until 0600 hours on 1/9/10 (over 14 hours after the medication was ordered). E59, who was unable to find any earlier dose of Fortaz documented in the chart as administered replied, "I can't explain it."

2. At IVMC, on 1/15 /10 at 1530 hours, review of Patient 257's clinical record revealed he was admitted to the hospital with the diagnosis of pneumonia. Rocephin 1 gram (antibiotic medication) was ordered intravenously one time on 1/2/10 at 0950 hours. Review of the Pyxis withdrawal report shows the medication was removed at 1004 hours but was never documented as administered. E161 stated the medication should have been given after the blood cultures were drawn.

3. At RSMC, on 1/15/10 at 0900 hours, review of Patient 304's medical record revealed he was admitted on 1/11/10 with shortness of breath and an exacerbation of congestive heart failure. Levaquin 500 milligrams (antibiotic medication) was ordered intravenously every 24 hours on 1/11/10 at 1050 hours. The dose was not given until 2130 hours on 1/11/10 (over 10 ? hours after the medication was ordered). M49 was asked if she could explain why the dose was not administered even though it was located on the nursing unit in their Pyxis Medstation which makes the medication readily available. M49 stated the patient was transferred from the ED to the Medical-Surgical floor at 1600 hours. She had no explanation as to why the medication as not given until 2130 hours.

Based on interview and record review, the hospital failed to administer the first dose of intravenous antibiotics to three of three patients on both campuses (Patients 1, 257, and 304) within two hours of the order. According to the hospital's policy and procedure entitled, "Intravenous Therapy: Medications given intravenously by a Registered Nurse," antibiotics need to be administered within 2 hours of the physician order to prevent or treat an infection. By not administering the medication within this 2 hour time slot and leaving the infection untreated, may lead to an elevated fever and spread of the infection. Additionally, at IVMC, the hospital failed to follow its own P&P regarding labeling intravenous medications. This had the potential for the prolong utilization of intravenous medications beyond their effectiveness and continuing the practice of not labeling intravenous medications that could expand hospital wide.

Findings:

1. At RSMC on 1/14/10 at 1140 hours, during an interview, E157 stated the time to initiate intravenous antibiotics when a bed was available in the ED (Emergency Department) is 1 - 2 hours but usually 1 hour. At 1145, during an interview E156 stated that sometimes the emergency department was crowded and could take as long as four hours to initiate intravenous antibiotics but usually it only takes 1 - 2 hours and often 1 hour.

a. At RSMC, on 1/14/10 at 1524 hours, review of Patient 1's medical record revealed that he was admitted to the hospital with a severe ankle wound. Fortaz 1 gram (antibiotic medication) was ordered intravenously every 8 hours on 1/8/10 at 1540 hours. The dose was not given until 0600 hours on 1/9/10 (over 14 hours after the medication was ordered). E59, who was unable to find any earlier dose of Fortaz documented in the chart as administered replied, "I can't explain it."

b. At IVMC, on 1/15 /10 at 1530 hours, review of Patient 257's clinical record revealed he was admitted to the hospital with the diagnosis of pneumonia. Rocephin 1 gram (antibiotic medication) was ordered intravenously one time on 1/2/10 at 0950 hours. Review of the Pyxis withdrawal report shows the medication was removed at 1004 hours but was never documented as administered. E15 stated the medication should have been given after the blood cultures were drawn.

c. At RSMC, on 1/15/10 at 0900 hours, review of Patient 304's medical record revealed he was admitted on 1/11/10 with shortness of breath and an exacerbation of congestive heart failure. Levoquin 500 milligrams (antibiotic medication) was ordered intravenously every 24 hours on 1/11/10 at 1050 hours. The dose was not given until 2130 hours on 1/11/10 (over 10 ? hours after the medication was ordered). M49 was asked if she could explain why the dose was not administered even though it was located on the nursing unit in their Pyxis Medstation (medication cabinet that stores medications that are frequently needed on the nursing unit) which makes the medication readily available. M49 stated the patient was transferred from the Emergency Department to the Medical-Surgical floor at 1600 hours. She had no explanation as to why the medication as not given until 2130 hours.


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2. Review of the hospital P&P for the IVMC and RSMC campuses entitled IV Certification and Administration For Licensed Nurses, revision date 11/07, showed that all peripheral IVs would be labeled with the date and initials of the nurse initiating the IV. Further review of the policy also showed that all IV solutions would be changed every 48 hours, if they did not contain additives. IV solutions containing additives would be changed every 24 hours, if prepared by appropriate hospital staff. Manufactured pre-mixed IV solutions would be changed equal to or less than every 48 hours.

On 1/12/10 at 1000 hours, during a tour of the 2 West medical/surgical unit at the IVMC campus with M29, it was found that IV medication bags in rooms 251, 253, 259, and 252 did not have labels to show the date, time, and signature to show when the IV medication bags were hung. When M29 was asked why some IV medication bags were labeled with date, time, and signature and others were not, she was not able to answer and deferred the question to E32. E32 stated that IV bags were usually labeled when hung.

On 1/12/10 at 1100 hours, during a tour of the 2 Central medical/surgical unit at the IVMC campus with E30, IV bags were found unlabeled in rooms 235 and 221.

On 1/12/10 at 1200 hours, during a tour of the 2 East medical/surgical unit at the IVMC campus with M30, IV bags in rooms 205, 206, 207, and 208 were not labeled. When M30 was asked about the unlabeled IV bags, he stated that he was not sure what the usual practice was and believed the nurses usually documented in the MAR the time and date of when IV medications were hung. M30 added that he would find out what the practice was.

On 1/12/10 at 1245 hours, during an interview with E6, she stated that the normal practice was to document on the MAR of when IV's were hung.

Based on medical record review and staff interview, the hospital failed to ensure that medical records were accurately written due to blank spaces being left in transcribed reports, and that all entries were authenticated in nine of 19 records reviewed (Patients 33, 272, 273, 275, 276, 277, 278, 279, and 283.) This led to the potential for clinical information to be missing for care of the patients and the inability to determine the authenticity of a physician's order.

Findings:

On 1/13/10 and 1/14/10, open and closed record review revealed the following deficiencies.

1. Transcribed history and physical examination, code blue note, operative and discharge summary reports contained spaces within the content of the report (to indicate the transcriptionist could not understand information that was dictated). Subsequent interview on 1/14/10 beginning at 0930 with M4 revealed that physicians are requested to fill in the spaces before signing the report. These records were considered "complete," even though information was missing (Patients 272, 273, 275, 276, and 278).

2. Admission Data Base forms lacked a space for signature by the nurse who
documented on the form. Per interview on 1/14/10 beginning at 0930 hours with M4, this form had been recently revised; however, the signature line had not been included (Patients 33, 273, 277, and 279).

3. The Emergency Department Physician Record contained a space to document the time the patient was seen. This information was not completed in the records of Patients 272, 273, 277, 279, 283 and 276. In addition, there was no date documented on the form in the records of Patients 272 and 277. These omissions were verified by M4 on 1/14/10 beginning at 0930 hours.

Based on a review of six open and closed anesthesia records, the hospital failed to provide accurate documentation to describe the response of each patient to medications and interventions being provided for two of six patient anesthesia records reviewed (Patients 253 and 277). The hospital also failed to ensure that four of 12 emergency department records reviewed (Patients 306, 314, 315 and 316) provided accurate documentation to describe the response of each patient to medications and interventions being provided. These findings led to inaccurate medical records and could potentially affect continuity of care for the patients.

Findings:

1. During a tour of the operating room areas of IVMC conducted on 1/12/10, the anesthesia record for Patient 253 was reviewed. This demonstrated that the post-anesthesia record for Patient 253 had been pre-filled out, signed and dated prior to the time that the procedure and anesthesia had been completed for Patient 253.

2. Patient 277 came to the hospital for a surgical procedure that was performed on 12/25/09. The record for Patient 277 revealed that the post-operative anesthesia evaluation had been signed and filled out prior to the completion of the operative procedure by the attending anesthesiologist.

3. Patient 314 came to the ED at RSMC on 1/11/10. A review of the closed medical record for Patient 314 revealed no documentation of the disposition or condition of Patient 314 at the time of discharge from the ED. The "ED Physician record" contained entry boxes at the bottom of the form that read "Disposition": "Home, 24 hr obs (observation), Admit, Transfer, Expired." These boxes were unchecked. Below this, a series of entries read: "Condition: Good, Stable, Guarded, Critical." Each of these boxes was left unchecked. The hospital failed to ensure that the medical record was complete and reflected the disposition and status for Patient 314 at the time of discharge.

4. Patient 315 came to the ED on 1/11/10. A review of the closed medical record for Patient 315 revealed no documentation of the disposition or condition of Patient 315 at the time of discharge from the ED. The "ED Physician record" contained entry boxes at the bottom of the form that read "Disposition: Home, 24 hr obs (observation), Admit, Transfer, Expired." These boxes were unchecked. Below this, a series of entries read: "Condition:" Good, Stable, Guarded, Critical." Each of these boxes was left unchecked. The hospital failed to ensure that the medical record was complete and reflected the disposition and status for Patient 315 at the time of discharge.

5. Patient 316 came to the ED on 1/12/10. A review of the closed medical record for Patient 316 revealed no documentation of the disposition or condition of Patient 316 at the time of discharge from the emergency department. The "ED Physician record" contained entry boxes at the bottom of the form that read "Disposition: Home, 24 obs (observation), Admit, Transfer, Expired." These boxes were unchecked. Below this, a series of entries read: "Condition:" Good, Stable, Guarded, Critical." Each of these boxes was left unchecked. The hospital failed to ensure that the medical record was complete and reflected the disposition and status for Patient 316 at the time of discharge.

6. Patient 306 came to the ED on 1/13/10. A review of the closed medical record for Patient 306 revealed no documentation of the disposition or condition of Patient 306 at the time of discharge from the ED. The "ED Physician record" contained entry boxes at the bottom of the form that read "Disposition": "Home, 24 obs (observation), Admit, Transfer, Expired." These boxes were unchecked. Below this, a series of entries read: "Condition:" Good, Stable, Guarded, Critical." Each of these boxes was left unchecked. The hospital failed to ensure that the medical record was complete and reflected the disposition and status for Patient 306 at the time of discharge.

Based on closed record review and staff interview, the hospital failed to ensure that all medical record entries were complete, dated, timed and authenticated within 12 of 21 charts reviewed (Patients 33, 272, 273, 275, 276, 277, 278, 279, 283, 286, 319, and 51). This failure resulted in incomplete/inaccurate medical records for health team member usage and could potentially effect the continuity of care for the patient.

Findings:

On 1/13/10 and 1/14/10, open and closed medical record review revealed the following deficiencies:

1. Transcribed history and physical examination, code blue note, operative and discharge summary reports contained spaces within the content of the report (to indicate the transcriptionist could not understand information that was dictated). Subsequent interview on 1/14/10 beginning at 0930 hours with M4, revealed that physicians were requested to fill in the spaces before signing the report. These records were considered "complete" even though information was missing (Patients 272, 273, 275, 276, and 278).

2. Admission Data Base forms lacked a space for signature by the nurse who documented on the form. Per interview on 1/14/10 beginning at 0930 with M4, this form had been recently revised; however, the signature line had not been included (Patients 33, 273, 277, 279).

3. The Emergency Department Physician Record contained a space to document the time the patient was seen. This information was not completed in the records of Patients 272, 273, 277, 279, 283, and 286. In addition, there was no date documented on the form in the records of Patients 272 and 277. These omissions were verified by Administrative Staff M4 on 1/14/10 beginning at 0930.

4. Review of IVMC and RSMC's P&P entitled Physician's Orders, revision date 4/09, showed that physicians' orders for medications were to be dated, timed, and authenticated by the ordering physician, and that orders would be noted with the date, time, signature and title by the appropriate RN/LVN.

a. On 1/11/10 at 1000 hours, review of Patient 319's medical record showed a physician's order, dated 1/7/10, with no physician's signature and was not noted by the RN/LVN taking care of the patient with a date, time, and printed name. The order did not show the practitioner who initiated the order nor who among the staff RN/LVNs noted the order.

b. On 1/11/10 at 1000 hours, review of Patient 51's medical record showed a designated place for noting telephoned orders, and for physician signatures. Five sets of physicians' orders, dated 1/5/10, showed the physician had signed in the place for telephone orders. Two of the five sets of physicians' orders were not noted by a RN/LVN.

Based on medical record and document review, the hospital failed to ensure that all verbal/telephone orders were authenticated within 48 hours in three of 21 records reviewed (Patients 1, 51 and 319 ) This failure had the potential to result in orders not being accurately carried out, if misunderstood.

Findings:

The policy Admin #061/Nur #P3, last revised 4/09, was reviewed on 1/13/10. Section 10 stated: "Verbal/Telephone orders for medications and/or blood products are to be authenticated within 48 hours by the physician giving the order or the physician covering for the ordering physician." Per interview with M4 on the morning of 1/14/10, it was explained that the hospital's practice was to require that all types of verbal/telephone orders be authenticated within 48 hours, not just those for medications and/or blood products, as stated in the policy. This was not implented as follows:

1. On 1/11/10 at 1000 hours, review of Patient 51's medical records showed no physician's signature for telephone orders dated 1/4/10 and 1/6/10. The physician orders were not authenticated within 48 hours.

2. On 1/11/10 at 1000 hours, review of Patient 1's, medical record showed no physician's signature for a telephone order dated 1/7/10. The physician orders were not authenticated within 48 hours.

3. On 1/11/09 at 1000 hours, review of Patient 319's medical record showed no physician's signature for four pages of telephone orders, dated 1/5/10, and two sets of telephone orders, dated 1/7/10. The physician orders were not authenticated within 48 hours.

Based on staff interview and document review, the hospital failed to ensure recommendations made regarding patient assessments were acknowledged by the physician for two of eight patients sampled for nutritional review (Patients 233 and 134) which resulted in nutritional recommendations not being implemented with the potential for delayed wound healing for Patient 233 and continued nutritional decline for Patient 134.

Findings:

1. Patient 233 was admitted 11/19/09 with sepsis (systemic infection), tube feeding, respiratory failure, Diabetes Mellitus, and a Stage 2 pressure ulcer.

On 1/13/10 at 1445 hours the patient's medical record was reviewed. The nutrition follow-up dated 11/26/09 was reviewed. The assessment identified Patient 233 at high nutrition risk with depressed albumin at 2.3 mg/dl (11/22), and a Stage 2 peri-rectal (near the rectum) pressure ulcer. The registered dietitian (RD) recommended MVI (multivitamin), vitamin C, Zinc, and FeS04 (iron sulfate supplement).

The nutrition follow-up notes dated 12/4/09, 12/8/09, 12/11/09, and 12/15/09 continued to identify Patient 233 at high nutrition risk and recommended MVI, Vitamin C, Zinc, and FeSo4 to help with wound healing. Review of physician progress notes showed no acknowledgement of the 11/26/09, 12/4/09, 12/8/09, or 12/11/09 RD recommendations for MVI, Vitamin C, Zinc, and FeSo4 for wound healing.

The nutrition follow-ups dated 12/24/09 and 12/29/09, stated high nutrition risk and history of depleted visceral protein and no new albumin laboratory results. The RD recommended an order for prealbumin (used to assess nutrition status).

The nutrition follow-up dated 1/9/10 identified Patient 233 with high nutrition risk and depressed albumin of 2.0 mg/dl (severe visceral protein depletion). The RD recommendation was to order prealbumin. Review of the physician progress reports showed no acknowledgement for the RD recommendations on 12/24/09, 12/29/09, and 1/9/10 for prealbumin.

An interview on 1/13/10 at 1300 hours with E23 and E24 stated there was no system for the physician to acknowledge the RD recommendations. In an additional interview on 1/13/10 at 1300 hours E28, a staff RD, stated "we just keep writing recommendation and sometimes talk to the physician," but there was no system for the physician to acknowledge the RD's recommendations.

2. Patient 134 was admitted 12/2/09 with abdominal pain and severe nausea. The patient's medical record was was reviewed 1/13/10 at 1100 hours. A nutritional follow-up, dated 1/1/10, stated high nutritional risk secondary to moderate depletion of visceral protein with the albumin 2.7 mg/dl. Patient 134's meal intake was poor at less that 25 percent. The RD recommended Megace (appetite stimulus medication) to increase appetite. The nutritional follow-up dated 1/4/10 stated Patient 134 was at high nutritional risk and recommended Megace.

During an interview on 1/13/10 at 1115 hours, E25 stated the nursing staff was not aware of the RD's recommendations and there was no system for the physician to acknowledge the RD's recommendations. Review of the nursing notes and the physician progress noted with staff E25 showed there was no documentation by the physician for the RD recommendations for Megace made on 1/1/10 and 1/4/10.

Based on observation, interview, and medical record, document, and policy and procedure review, the hospital failed to ensure that pharmaceutical services carried out its full and complete oversight that met the needs of the patients in the hospital.

Findings:

1. Pharmaceutical services failed to develop and implement a policy and procedure to ensure the safe use of fentanyl patches that would ensure minimal risk of clinically significant hypoventilation (a state where a reduced amount of air enters the lungs) with concomitant risk of death as stipulated by the hospital policy and procedure regarding medications with Black Box Warnings. See A500, #7.

2. Pharmaceutical services failed to ensure pharmacists who regulate medications by approved hospital protocols were competent in all protocols and not just some. See A500, #1.

3. Pharmaceutical services failed to ensure that first doses of antibiotics were administered within 2 hours of the order according the their policy and procedure entitled, "Intravenous Therapy: Medications given intravenously by a Registered Nurse" to prevent the spread of infection. See A500, #6.

4. Pharmaceutical services failed to ensure that their approved "Insulin Drip Protocol" was clear from ambiguities and didn't require interpretation by the nursing staff, and failed to ensure correct doses of insulin were charted as administered. See A500, #5.

5. Pharmaceutical services failed to ensure that drugs administered to patients in the hospital were ordered by a physician and the order was documented in the patient's medical record.
See A500, #3.

6. Pharmaceutical services failed to ensure that intravenous chemotherapeutic medications (used to treat cancer and have significant side effects) were compounded in a cabinet designed for that purpose, failed to ensure that the deactivating agent to decontaminate the cabinet was used in sufficient quantities, and pharmacy staff was evaluated for competency to compound medications and decontaminate the cabinet. See A500, #8-11.

7. Pharmaceutical services failed to ensure that medications stored in the emergency medication crash carts were stored in sufficient quantities as stipulated by the hospital's policy and procedure. See A500, #19.

8. Pharmaceutical services failed to ensure that expired medications, wound dressings, intravenous normal saline solution, outdated scrub sponges, and unusable medications in the intubation trays and IV solutions in the surgery warmers and mislabeled Dilaudid were not available for patient use. The hospital failed to follow it's policy and procedure regarding labeling intravenous medications to determine the expiration date. See A505 #1-12.

9. Pharmaceutical services failed to ensure that pharmacists checked the Rapid Intubation Drug Box before the box was delivered to the floor for patient use. See A500 #2.

10. Pharmaceutical services failed to ensure routine maintenance was performed on the main pharmacy's medication refrigerators according to the hospital's policy and procedure. See A0500 #4.

11. Pharmaceutical services failed to ensure that two of two MH (Malignant Hyperthermia) carts, one each at the RSMC and IVMC campuses, were stocked according the standards of practice and the hospital's treatment guidelines for MH. See A500, #12.

12. Pharmaceutical services failed to ensure that the policy and procedure regarding MH carts had a current content list which matched the contents for two of two MH carts, one each at RSMC and IVMC. See A500, #13.

13. Pharmaceutical services failed to ensure that written policies and procedures were developed that established the contents of Adult and Pediatric Crash Carts. See A500, #14.

14. Pharmaceutical services failed to develop written policies and procedures establishing the contents for and the procedures for use of Intubation Kits maintained on the RSMC and IVMC campuses. See A500, #15.

15. Pharmaceutical services failed to ensure that the solutions in the RSMC Surgery Department Warmer, were stored at a temperature stipulated by the hospital policy and procedure and failed to ensure that four of five of these solutions were stored at temperatures recommended by the manufacturer. See A500, #16.

16. Pharmaceutical services failed to ensure that solutions in the warmers in the RSMS and IVMC Surgery Departments were inspected by pharmacists as required by state regulation. See A500, #17.

17. Pharmaceutical services failed to ensure that opened foil packages of Xopenex were dated once opened as per the pharmacy standard of practice so that the more rapid expiration date of the product that went into effect once the foil pouch was opened could be tracked. See A500, #18.

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

Based on observation, interview, medical record, document review, and policy and procedure review, the hospital:

* Failed to ensure four of four staff pharmacists (E55, E111, E113 and E114) that regulate medications based on approved hospital medication protocols were competent in all six protocols which require expertise in medication dosing, laboratory ordering, and monitoring for medication adverse events.
* Failed to ensure that a pharmacist checked all medications in the Rapid Intubation Drug Box before the box(es) were delivered to the floor for patient use. Twoof three boxes were missing documentation that this was done.
* Failed to ensure that medications were ordered by a physician before they they were administered to Patient 304.
* Failed to ensure that routine maintenance of two of two medication refrigerators located in the main pharmacy were performed according to the hospital's approved policy and procedure. The failure could lead to inaccurate temperature ranges which could compromise drug stability and sterility.
* Failed to ensure that the hospital approved Insulin Drip Protocol was clear of ambiguities and didn't require interpretation and clarification by two of two nurses (E56 and E57), and the protocol was followed and the correct dose of insulin was administered to Patient 70.
* Failed to administer the first dose of intravenous antibiotics to 3 of 3 patients (Patients 1, 257, and 304) within two hours of the order. According to the hospital's policy and procedure entitled, "Intravenous Therapy: Medications given intravenously by a Registered Nurse," antibiotics need to be administered within 2 hours of the physician order to prevent or treat an infection. Not administering the medication within this 2 hour time slot and leaving the infection untreated, may lead to an elevated fever and spread of the infection.
* Failed to develop and implement a policy and procedure to ensure the use of fentanyl patches that would ensure minimal risk of clinically significant hypoventilation with concomitant risk of death as stipulated by the hospital policy and procedure regarding medications with black box warnings.
* Failed to ensure that IV chemotherapeutic medications (used to treat cancer and which have significant side effects including mutagenic side effects) were compounded in a cabinet designed for that purpose when in fact such a cabinet had been purchased; failed to ensure that a process was developed to decontaminate and inactivate all chemotherapeutic agents compounded in this cabinet before it was used to compound regular IV solutions (Rituximab was not inactivated by the decontaminating agent used by the hospital); failed to ensure that the deactivating agent was used in sufficient quantity to decontaminate the cabinet, and failed to develop pharmacist driven policies and procedures that mirrored the current working conditions in the pharmacy, that pharmacy staff was evaluated annually as per the policy and procedure, and that competencies had been developed to evaluate the ability of the pharmacy technicians to compound chemotherapeutic agents and decontaminate the cabinet.
* Failed to ensure that two of two MH Carts, one each at the RSMC and IVMC Campuses, were stocked according the standards of practice and the hospital's treatment guidelines for MH.
* Failed to ensure that the policy and procedure regarding MH Carts had a current content list which matched the contents of two of two MH Carts, one each at RSMC and IVMC.
* Failed to ensure that written policies and procedures were developed that established the contents of Adult and Pediatric Crash Carts.
* Failed to develop written policies and procedures establishing the contents for and the procedures for use of Intubation Kits maintained on the RSMC and IVMC Campuses.
* Failed to ensure that five of five solutions inspected in the RSMC Surgery Department Warmer were stored at a temperature stipulated by the hospital policy and procedure and failed to ensure that four of five of these same solutions were stored at recommended temperatures as documented by the manufacturer.
* Failed to ensure that solutions in the warmers in the RSMS and IVMC Surgery Departments were inspected by pharmacists as required by state regulation.
* Failed to ensure that opened foil packages of Xopenex were dated once opened as per the pharmacy standard of practice so that the more rapid expiration date of the product that went into effect once the foil pouch was opened could be tracked.
* Failed to ensure epinephrine was available on an emergency cart.

These failures could potentially result in medication errors, unusauble medications being used, delay in treatment and poor patient outcomes.

Findings:

1. At RSMC, on 1/11/10 at 1124 hours, the DOP stated, "Pharmacists provide clinical services including aminoglycosides, vancomycin (antibiotic medications), total parenteral nutrition (provides a patient with all the fluid and essential nutrients they need when they are unable to feed themselves by mouth), heparin and coumadin (blood thinning medications to prevent blood clots), and renal dosing (dosing medications when kidney function changes)." These services were provided by the pharmacists following protocols that were approved by hospital committees. According to the protocols for these medications, the pharmacist, "Using clinical experience will assist the medical staff in the safe and effective use of aminoglycosides and vancomycin." The protocols approve the pharmacist to order doses, order appropriate laboratory tests, and order blood levels tests of the medications and adjust doses based on these levels.

The American College of Clinical Pharmacy (ACCP), a well known national standard of practice states clinical pharmacists, "Must have a defined list of competencies against which they can measure performance. Describe abilities necessary to practice as a clinical pharmacist and to perform a self-assessment and thereby determine what areas need to be strengthened. Changes and advances in medicine will require periodic reevaluation and modification of therapeutic knowledge areas."

On 1/11/10 at 1131 hours, review of E55's competency chart revealed no specific competencies for aminoglycosides and vancomycin. Successful competencies in these areas would qualify the pharmacists as being adequately trained and qualified to perform these services. On 1/11/10 at 1140 hours, according to M44, "There were no pharmacist competencies for aminoglycosides and vancomycin but there were competencies for the other clinical services provided."

On 1/14/10 at 1220 hours, review of competencies for E111, 113 and 114 revealed missing competencies for aminoglycosides and vancomycin. There were other competencies in these employee charts; however, none contained questions pertaining to aminoglycosides or vancomycin.

2. At IVMC, on 1/12/10, review of the, "Emergency Department Rapid Intubation Kit Order Sheet" revealed that some kits were checked and initialed by a pharmacist before dispensing to the ED and others were not (two kits were not). On 1/12/10 at 1142, during an interview M32 stated all kits should be checked, dated and initialed by a pharmacist according to hospital policy.

3. At RSMC, on 1/13/10 at 1629 hours, review of Patient 304's medical record revealed an order written for Protonix 40 milligrams (medication to treat stomach pain) on 1/12/10. Protonix was discontinued and changed to Prilosec 40 milligrams without a physician's order. Prilosec was administered on 1/13/10 and charted on the Medication Administration Record (MAR) as administered at 1215 hours. When M32 was asked if he could locate an order in the chart for Prilosec, he stated he couldn't. The hospital approved an "Automatic Therapeutic Substitution" protocol which was last revised in 8/03. This protocol allowed for the automatic substitution of Prilosec for Protonix but not Protonix for Prilosec. According to the protocol there would be an order in the chart making this change. There was no order per protocol or by Patient 304's physician to execute this change.

4. At RSMC, on 1/14/10 at 1415 hours, M30 stated that the refrigerators in the hospital that contain vaccines and other medications were not routinely maintained. "All we do is a visual inspection. There was nothing written by us. This is located in the Plant Operations policy and procedure."

On 1/14/10 at 1435 hours, M46 stated that he had not needed to inspect medication refrigerators because he had not been called. Routine maintenance was performed visually and he had no documentation when this was last done.

On review of the policy and procedure entitled, "Routine Maintenance of POM Equipment" last revised in 11/09, on page 6 under Maintenance of Refrigeration Units, "All patient refrigeration units shall be given a preventive maintenance check at least annually using the following guidelines,"
a.Clean condenser coils and compressor area.
b.Check for loose screws and nut.
c.Check operation of condenser and evaporator fans for noise or other signs of malfunction.
d. Check evaporator drain for proper drainage.
e. All discrepancies shall be entered on work orders.

5. a. At RSMC, on 1/12/10 at 1000 hours, review of Patient 70's medical record revealed an order for insulin intravenous infusion per hospital approved protocol. On 1/11/10 at 0700 hours, the insulin infusion was increased from algorithm 2 to algorithm 3. According to the "ICU-PCU DKA Insulin Drip Protocol," there is an order that states, "Move up to the next higher algorithm if the BS (blood sugar) does not decrease by 60 mg/dl (milligrams/deciliter) x 2 hours." When asked how to interpret this statement, E56 stated she would have to clarify the statement with a physician because it was incomplete and didn't provide a clear understanding of what to do. When asked the same question, E57 stated she would move up to the next algorithm which was a higher dose. When E57 was asked if the blood sugar was in goal range but did not decrease 60 mg/dl after 2 hours would she increase to the next algorithm which would put the patient in jeopardy of experiencing a low blood sugar reaction? Her reply was no and she stated, "This statement was unclear and I would need to clarify the order." According to the two nurses interviewed, clarification was needed to accurately interpret, and evaluate orders of this protocol.

The "ICU-PCU DKA Insulin Drip Protocol was approved by the Pharmacy and Therapeutics Committee in 5/2007. This protocol had been in use for over 2 ? years and E56 and 57 were unable to interpret part of the protocol that if instituted as directed, could lead to severe hypoglycemic (very low blood sugars) effects including seizure, coma, and death.

b. At RSMC, on 1/12/10 at 1023 hours, review of Patient 70's medical record revealed a dose of insulin administered on 1/12/10 at 0300 hours. This dose was based on the protocol entitled, "ICU-PCU DKA Insulin Drip Protocol" which called for blood sugar levels to be drawn hourly. The dose of insulin at 0300 hours was charted as 5 units administered however no blood sugar was documented as being drawn at that time. Without a documented blood sugar at 0300 hours, the dose of 5 units of insulin did not follow the protocol as ordered. The blood sugar at 0400 hours, increased from 148 mg/dl at 0200 hours to 170 mg/dl at 0400 hours which was above the desired goal.

6. At RSMC on 1/14/10 at 1140 hours, during an interview, M49 stated the time to initiate intravenous antibiotics when a bed was available in the ED (Emergency Department) was one to two hours but usually one hour. At 1145 hours during an interview, E156 stated that sometimes the ED was crowded and it could take as long as four hours to initiate intravenous antibiotics, but usually it only takes one to two hours, and often one hour.

a. At RSMC, on 1/14/10 at 1524 hours, review of Patient 1's medical record revealed that he was admitted to the hospital with a severe ankle wound. Fortaz 1 gram (antibiotic medication) was ordered intravenously every 8 hours on 1/8/10 at 1540 hours. The dose was not given until 0600 hours on 1/9/10 (over 14 hours after the medication was ordered). M59, who was unable to find any earlier dose of Fortaz documented in the chart as administered replied, "I can't explain it."

b. At RSMC, on 1/15/10 at 0900 hours, review of Patient 304's medical record revealed he was admitted on 1/11/10 with shortness of breath and an exacerbation of congestive heart failure. Levaquin 500 milligrams (antibiotic medication) was ordered intravenously every 24 hours on 1/11/10 at 1050 hours. The dose was not given until 2130 hours on 1/11/10 (over 10 ? hours after the medication was ordered). M49 was asked if she could explain why the dose of antibiotic was not administered even though it was readily available on the nursing unit in their Pyxis Medstation (medication cabinet that stores medications that are frequently needed on the nursing unit). M49 stated the patient was transferred from the ED to the Medical-Surgical floor at 1600 hours. She had no explanation as to why the medication was not given until 2130 hours.

c. At RSMC at 1530 hours, review of Patient 257's medical record revealed he was admitted to the hospital with the diagnosis of pneumonia. Rocephin 1 gram (antibiotic medication) was ordered intravenously one time on 1/2/10 at 0950 hours. Review of the Pyxis withdrawal report showed the medication was removed at 1004 hours but was never documented as administered. E15 stated the medication should have been given after blood cultures were drawn.

On 1/15/10 at 1140 hours, AS5 stated that the quality review for antibiotic administration was to assure that antibiotics were administered within 6 hours, however, according to the hospitals policy and procedure entitled, "Intravenous Therapy: Medications given intravenously by a Registered Nurse," antibiotics needed to be administered within two hours of the physician order to prevent or treat an infection.


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7. On 1/14/10 at 1221 hours, a review of Patient 257's closed medical record indicated that she was admitted to the IVMC on 12/14/09 at 0630 hours with intractable neck and left arm pain and underwent surgery.

On 12/16/09 at 0930 hours, a physician ordered a 12.5 mcg/hr fentanyl patch for Patient 257 and the MAR (medication administration record) documented that the patch was applied to the patient at 1200 hours on the same day.

Fentanyl patch, also known as fentanyl transdermal system, contains fentanyl, a potent synthetic opiate medication used to treat pain. This medication has a black box warning (BBW) which is the most serious warning required by the Food and Drug Administration to be placed in the product labeling (package insert) for a medication. Boxed warnings document potential problems that can lead to serious injury or death. The boxed warning for the fentanyl patch documents that it has an associated risk of fatal overdose due to respiratory depression. It is indicated for the management of persistent moderate to severe chronic pain that requires continuous around-the-clock opioid (narcotic pain relievers derived from or having the pain relieving action of opium) administration for an extended period of time and that cannot be managed by other pain medications, and that use of the patch is contraindicated in the treatment of postoperative pain. The boxed warning also documents that it should only be used in patients who are opioid-tolerant which is defined in the boxed warning as those patients who have taken at least 60 mg of oral morphine, 30 mg of oral oxycodone, or 8 mg of oral hydromorphone (opiate medications used to treat pain) or an equal dose of another opiate medication daily for a week or longer, and that use of this patch to treat patients who are not opioid-tolerant is contraindicated because serious or life-threatening respiratory depression can occur.

There was no documented evidence that Patient 257 received (during her hospital stay) enough narcotics to be considered opiate tolerant and to indicate appropriate use of the fentanyl patch. Additionally, there was no documented evidence that Patient 257 received any narcotics before her admission to the hospital. Review of the "INPATIENT HOME MEDICATION LIST" (a list of the patient's home medications) for Patient 257 revealed that she did not take opioid based pain relieving medications at home.

Despite the boxed warning, Patient 257 received fentanyl patch to control post surgical pain. The patient who had not received around the clock opioid pain relieving medications at doses specified in the product labeling for at least a week.

On 1/14/10 at 1417 hours, during an interview of M32, he stated that the pharmacists were alerted by the pharmacy computer system that fentanyl patches had a BBW and gave them a brief description of the BBW issues. He said that the pharmacist was supposed to determine if a patient was opioid tolerant before dispensing the medication. Discussions with the physician were supposed to be documented in the pharmacy computer system. He produced a copy of a pharmacist note for Patient 257's computerized medication profile that read: "ordered by pain management, dose equivalent."

On 1/14/10 at 1456 hours during an interview of E109, he identified the medication profile note for Patient 257 as his. He stated that "ordered by pain management," meant that a pain specialist ordered the fentanyl patch. He stated that "dose equivalent" meant he had calculated the dose equivalence for a day. He stated that he used a chart (entitled Fentanyl patch dosing based on current narcotic analgesic therapy) that was posted on the wall to determine that Patient 257 had received enough morphine over a 24 hour period to receive at least a 25 mcg/hr fentanyl patch. During the interview, E109 did not say that a pharmacist would need to determine regular use of morphine at stipulated doses over a seven day period to meet the product labeling requirements for use of this patch and he did not mention that use of this patch to treat post-operative pain was a contraindication to the use of this medication.

On 1/15/10 at 1108 hours a review of the policy and procedure entitled Fentanyl Transdermal Patches, Orders for, indicated the following:

? "Orders for Transdermal Fentanyl Patches (TPF) will be reviewed by a pharmacist for appropriate patient selection and dose. Orders not conforming to the guidelines herein shall be referred back to the prescriber."

? "...this product not suitable for post-operative pain management."

The policy was not clear that one would have to take the stipulated daily doses for seven days to be considered opiate tolerant, and did not mention the contraindications to the use of this medication for post-operative pain. The policy provided no guidance to pharmacy staff as to what they should do if there was pharmacist/physician disagreement as to whether the use of this medication was contraindicated in a given patient.

On 1/15/10 at 1148 hours during an interview of M32, he stated that fentanyl patches were not indicated for the management of post-operative pain or for use non-opioid tolerant patients. He stated that the phrase "Orders for Transdermal Fentanyl Patches (TPF) will be reviewed by a pharmacist for appropriate patient selection and dose" found in the hospital fentanyl patch policy meant that the pharmacist was to check to see if the patient was opiate tolerant. He stated that this policy made no mention of the seven day requirement used to determine opioid tolerance (as stipulated in the product labeling). He stated that E106 did not have proper guidance from this policy.

8. On 1/11/10 at 0915 hours, during an interview of M10, he stated that there was only one cabinet in the pharmacy at RSMC and it was used to compound IV chemotherapeutic medications and standard IVs. He stated they had a chemotherapeutic order about once a week and after the chemotherapeutic medication had been compounded it was cleaned out. He stated they used an American Society of Health System Pharmacists recommended product to clean out this cabinet. During a visit to the pharmacy at 1059 hours on 1/11/10, the cabinet proved to be a closed cabinet with an antechamber into which IV medications and solutions could be placed and the outer door closed. Then the operator could stick his arms into a sleeve and glove assembly, which was built into the front wall of the cabinet, and remove the products from the antechamber, via an inner door, into the main body of the cabinet where the compounding took place.

On 1/13/10 at 1633 hours a review of the manual that came with the cabinet indicated the model number of the cabinet was: Microsphere 6X2 and that it was manufactured by IsoTech Design.

On 1/14/10 at 0738 hours during a telephone interview of DSM1 from IsoTech, he stated that the Microsphere cabinet was not designed for compounding IV chemotherapeutic medications and a hospital should not use it for that purpose. He stated that the company is very clear about this when they sell it to an end user. He said it was designed to compound sterile products. He stated that they made a cabinet called Chemosphere that was intended to be used for compounding IV chemotherapeutic products. He stated that the Microsphere cabinet was a positive pressure cabinet while the Chemosphere cabinet was a negative pressure cabinet.

On 1/14/10 at 1655 hours review of an undated letter to M10 documented that IsoTech Design had "congratulated" M10 on his purchase of a Chemosphere cabinet. This letter was produced by M44 at 1655 hours on 1/14/10.

9. On 1/11/10 at 0915 hours, during an interview of M10, he stated that there was only one cabinet in the pharmacy at RSMC and it was used to compound IV chemotherapeutic medications and standard IVs. He stated they used an American Society of Health System Pharmacists recommended product to clean out this cabinet. At 1058 hour on this date, inspection of the pharmacy indicated they had a product called Surface Safe that staff stated was used to clean the cabinet after IV chemotherapeutic agents were compounded in the cabinet.

On 1/14/10 at 1636 hours during an interview of M44, he stated that he had E111 compare the chemotherapeutic medications that had been ordered by the pharmacy to compound in the Microsphere cabinet to the medications listed on the Surface Safe product labeling and she found that one of the medications used by the hospital, rituximab, was not listed on the Surface Safe product labeling. He stated that he called the company that made Surface Safe and they could not tell him if it inactivated Rituximab.

A review, at this time of a list of chemotherapeutic medications that had been ordered by the hospital from 1/1/09 through 1/1/10 indicated that a 100 mg and a 500 mg vial of rituximab had been ordered on 11/13/09 and again on 12/10/09. He stated that the Microsphere cabinet had been installed at the end of October 2009. He stated that chemotherapeutic medications were only prepared when a physician had written an order for the medication. He said the orders were written in advance so the pharmacy would have time to order the drug. Therefore, these rituximab vials were ordered and used to compound IV chemotherapeutic solutions in the pharmacy and no evidence was provided that the pharmacy staff had an agent that could deactivate this medication in the Microsphere cabinet before it was used to make standard IVs.

10. On 1/11/10 at 0915 hours, during an interview of M10, he stated that there was only one cabinet in the pharmacy at RSMC and it was used to compound IV chemotherapeutic medications and standard IVs. He stated they used an American Society of Health System Pharmacists recommended product to clean out this cabinet. At 1058 hours on 1/11/10, inspection of the pharmacy indicated they had a product called Surface Safe that staff stated was used to clean the cabinet after IV chemotherapeutic agents were compounded in the cabinet.

On 1/13/10 at 1535 hours a review of the product labeling removed from a box of Surface Safe indicated the following:
* The inactivating agent (sodium hypochlorite) in a soap solution was contained in "towelette Number 1" and an agent used to neutralize the inactivating agent (sodium thiosulfate) was contained in "towelette Number 2."
* The product was supplied in cartons containing 15 boxes each with each box containing a Number 1 and Number 2 towelette.
* It documented that "...preliminary studies suggest that there is no universal inactivating substance for the different classes of cancer chemotherapeutic drugs."
* The towelettes were to be applied in numerical order and contained enough solution to treat two square feet of surface area.

On 1/13/10 at 1602 hours during an interview of M44, he stated pharmacy staff used the procedure in the Surface Safe product labeling to decontaminate the cabinet.

On 1/13/10 at 1604 hours during an interview of E108 she stated the cabinet contained 12 square feet of surface area and she used six pairs of towelettes to decontaminate the interior of the cabinet including the antechamber. She said that on average, the hospital admitted one patient/week that was using a chemotherapeutic medication, but the course of treatment could range from one to seven days with the average being three days. She stated that sometimes they would go a week without making an IV chemotherapeutic medication and then could have a run where an IV chemotherapeutic medication was made for five or six days straight.

On 1/13/10 at 1652 hours during an interview of E112, he stated he did not know the square footage of the cabinet but he used six pairs of towelettes to decontaminate the interior of the cabinet.

On 1/14/10 at 1721 hours a re-inspection of the Microsphere cabinet in the RSMC pharmacy indicated that it contained 10 plastic bins containing hypodermic needles, syringes, and alcohol wipes used to compound IV solutions including IV chemotherapeutic agents. During an interview of E108, she said that pharmacy staff did not decontaminate these bins or supplies after compounding an IV chemotherapeutic medication.

On 1/19/10 at 1324 hours during a telephone interview of M44 he stated that the Microsphere cabinet contained 79.5 square feet of interior surface space, including the floor and walls, (but not the ceiling) of the antechamber and the main cabinet including the sleeves and gloves in the main working area of the cabinet. He stated his staff had told him that they used six pairs of towelettes to decontaminate the cabinet. Based on the manufacturer's specification in the product labeling, he stated this would be enough to decontaminate only 15 percent of the interior of the Microsphere cabinet.

11. On 1/13/10 at 1739 hours a review of the policy and procedure entitled Preparation of Antineoplastics indicated the following:
* The pharmacy would establish and maintain policies and procedures for the preparation and transport of chemotherapeutic medications.
* The purpose of the policy was: "To ensure a safe and optimal process for the ...preparing, dispensing, transporting ...chemotherapy."
* Personnel involved in the handling of chemotherapeutic medications would undergo an orientation program, testing, and certification which would be documented in the employee's educational record.
* Part of this orientation training would include a review of this policy, a review of an educational video tape entitled: Safe Handling of Chemotherapy and Hazardous Drugs and "...supervision by trained personnel." It did not specify who these trained personnel were or how they were qualified to provide this supervision.
* All chemotherapeutic agents would be prepared in a Class II vertical-flow biologic safety cabinet (the Microsphere is an ISO Class 4 cabinet as per Iso Tech Design specifications provided by DSM1 on 1/14/10 at 0815 hours via an e-mail).
* It did not provide any description of the deactivating product, Surface Safe, or a procedure on how to use it.

On 1/14/10 at 1632 hours during an interview of M44, he stated that he did not think there was pharmacist-directed training of the pharmacy technicians with regard to decontamination of the Microsphere cabinet. He stated there was no hands-on demonstration of competency. He stated that he could not locate the chemotherapy training video. He stated that the Pharmacy Techs took a competency exam regarding the compounding of sterile products but it was not specific to chemotherapeutic medications. He produced a list showing documentation that 13 pharmacy staff had watched the "Chemo Preparation Video." Each name had a date after it and the range was from 11/26/06 through 11/27/07.

On 1/15/10 at 1142 hours during an interview of M44, he stated that he did not have chemotherapy specific competencies for his Pharmacy Technician staff and he still could not locate the training video.

No evidence was provided that the hospital developed pharmacist driven policies and procedures that mirrored the current working conditions in the pharmacy, that pharmacy staff was evaluated annually as per the policy and procedure, and that competency criteria had been developed to evaluate the ability of the Pharmacy Technicians to compound chemotherapeutic agents and decontaminate the cabinet.

12. Malignant Hyperthermia (MH) is a life threatening emergency associated with the use of succinylcholine (used to relax muscles during surgery) and anesthetic gases used during surgery. It is characterized by a rapid rise in body temperature that can be life threatening, and can result in irregular heart beats. The Malignant Hyperthermia Association of the United States (MHAUS), a nationally recognized organization regarding the treatment of MH has published recommended list of medications to be contained in an MH emergency kit. It recommends that the cart contain lidocaine (used to treat dangerous irregular heart rhythms) and calcium chloride (used to counteract the effect of high potassium levels on the heart that can potentially occur during a case of MH).

a. On 1/11/10 at 1517 hours an inspection of the MH Cart in the RSMC PACU indicated that it contained two 20 ml vials of lidocaine 2% labeled by the manufacturer as indicated for local nerve blocks. Lidocaine is available in pre-loaded syringes indicated for use in the treatment of dangerous irregular heart rhythms. The cart did not contain any calcium chloride.

During an interview of M44 at 1517 hours on 1/11/10, he could give no reason why calcium chloride had been excluded from the supply. The next day, 1/12/10, at 0957 hours he stated that there was no reason to exclude calcium chloride from the supply and stated he felt it should be added to the MH medication supply.

On 1/12/10 at 0936 hours a review of the policy and procedure entitled Malignant Hyperthermia (issued 4/97 and last revised 10/09) indicated that it listed the use of calcium chloride to treat life threatening high potassium levels.

b. On 1/12/10 at 1442 hours an inspection of the MH Cart in the IVMC PACU indicated it contained two 20 ml vials of lidocaine 2% labeled by the manufacturer for use as a local nerve block.

On 1/19/10 at 1324 hours during a telephone interview of M44 he stated that lidocaine was put on the MH Cart to treat heart arrhythmias (irregular heart rhythms). He stated that the 20 ml vial observed in the MH Carts on the RSMC and IVMC MH Carts was the wrong product and that 5 ml pre-filled syringes of lidocaine should have been placed in these emergency supplies. He stated that he felt that this was due to a typographical error on the content list for the lidocaine listing.

13. On 1/12/10 at 0936 hours a review of the policy and procedure entitled Malignant Hyperthermia (issued 4/97 and last revised 10/09) indicated that the content list contained in the policy did not match the content list contained in the medication tray in the MH Carts on both the RSMC and the IVMC MH Carts. Inspection of both of these supplies on 1/11/10 at 1517 hours at RSMC and on 1/12/10 at 1442 hours at IVMC indicated that the medication tray contents on both of these carts matched the content list found inside these trays and that both content lists were identical to each other. The policy content list documented the supply contained six v

Based on observation, interview, and document and policy and procedure review, the hospital failed to ensure that expired medications to treat infection, asthma and paralyze muscles in people undergoing operations, wound dressings, intravenous normal saline solution, outdated scrub sponges, mislabeled medications and unusable medications in the intubation trays stored outside recommended storage temperatures and IV solutions in the surgery warmers dated with marker pens were not available for patient use. The hospital failed to date IV bags after the outer covering was removed per the hospital P&P. The hospital failed to follow it's P&P regarding labeling intravenous medications which had the potential to prolong utilization of these medications beyond their effectiveness. These failures could potentially result in medications with altered potency and contamination.
Findings:

1. At RSMC, on 1/11/10 at 1100 hours, during a tour of the main pharmacy, an intravenous (IV) antibiotic medication was found in the IV room refrigerator. The medication was Gentamicin 600 milligrams in 250 milliliters of Normal Saline and found to have expired on 1/10/10. The medication was in the refrigerator and available to be dispensed to Patient #1. The DOP (Director of Pharmacy) removed the medication and said it had expired.


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2. On 1/12/10 at 1417 hours, while inspecting the IVMC Pharmacy, inspection of a bin containing Xopenex (for use in inhalation nebulizer machines in order to open restricted airways) indicated that one foil pouch containing seven unit dose pillows was open and two more pillows were stored openly in the bin outside of the foil pouch in which the manufacturer packaged them. A label on the carton that held the foil pouches documented that these vials were to be used within two weeks if stored in an open foil pouch and within one week if stored outside of the foil pouch.

During a concurrent interview E109 stated that the foil pouches were to be dated when opened (so the more rapid expiration could be tracked). He stated that the pillows outside the foil pack should have been discarded. There was no date on the foil pack.

During an interview of M32 at this time he stated that the foil pouches of Xopenex were to be dated by staff when opened. He stated he did not know how long these pillows had been stored in the open pouch or outside the pouch and that there was no way to determine this. He then discarded the nine pillows.

3. On 1/11/10 at 1443 hours during an inspection of the RSMC Surgery Department, expired sponges were found in an open box labeled to contain 30 Scrub Care Sponges. The expiration dates on the sponges were 9/2007 (two years and three months prior to the survey). During an interview of M22 at this time she stated the sponges were over a "backup" sink but they potentially could be used. These sponges would be used by physicians and nurses to scrub before surgery.

4. On 1/12/10 at 1442 hours at IVMC an inspection of the MH cart in the PACU indicated the first posted expiration date posted outside the MH Cart was 4/1/10 and the information so posted documented that the medications to expire were furosemide (used to increase urine flow) and heparin (a blood thinner). Inspection of the cart indicated the heparin vials were labeled by the manufacturer as expiring 9/2010. The expiration date for the heparin posted outside the cart was not accurate.

5. On 1/12/10 at 1442 hours at IVMC an inspection of the MH cart in the PACU revealed seven of nine inaccurate expiration dates on the internal content list of medications stored in tray in this cart:

a. The expiration date documented on the content list for furosemide (used to increase urine flow) was 2/1/11. Inspection of the medication tray indicated the manufacturer's expiration date on all four of the vials was 4/1/10.

b. The expiration date documented on the content list for amiodarone (used to treat dangerous irregular heart rhythms) was 8/2010. Inspection revealed the manufacturer's expiration date on all three vials was 2/2011

c. The expiration date documented on the content list for dextrose 50 percent injection was 9/2010. Inspection of the medication tray showed the manufacturer's expiration date for both pre-filled syringes was 10/2011.

d. The expiration date documented on the content list for heparin (a blood thinner) was 4/2010. Inspection of the medication tray showed the manufacturer's expiration date on all three vials was 9/2010.

e. The expiration date documented on the content list for lidocaine 2% was 2/1/11. Inspection of the medication tray indicated a manufacturer's expiration date for both vials was 9/1/10.

f. The expiration date documented on the content list for mannitol 20% IV solution was 1/1/11. Inspection of the medication tray indicated a manufacturer's expiration date on both IV bags was 6/1/10.

g. The expiration date documented on the content list for the IV bags of sterile water for injection (used to reconstitute the dantrolene used to treat MH) was 2/2012. Inspection of the medication tray indicated a manufacturer's expiration date on both IV bags was 4/2011.

The content list serves as a label for the medications in the medication tray and the inaccurate expiration dates mislabeled the medications in this tray.

6. On 1/13/10 at 1026 hours during an interview of E111, she stated that an intubation tray containing medications for rapid intubation (insertion of a tube into the throat to facilitate breathing) was maintained in the E.D. She stated there was an ICU Intubation tray that was identical to the ED tray except midazolam (a sedative used to produce loss of memory of unpleasant procedures) was not included in the ICU tray.

A review of content lists for the RSMC Intubation Tray stored in the ED and the RSMC ICU Intubation tray indicated that both contained atropine (used to treat slowly beating hearts), lidocaine (used to treat dangerous irregular heart rhythms), pancuronium, succinylcholine, and vecuronium (these last three are muscle relaxants used to facilitate insertion of the breathing tube), etomidate (use to induce anesthesia) and, in the ED tray, midazolam.

A review of the content list for the IVMC Emergency Department Rapid Intubation tray provided by M32 at 1059 hours on 1/13/10 indicated that it contained atropine, lidocaine, succinylcholine, vecuronium, etomidate, and midazolam.

An inspection of the RSMC ED refrigerator indicated these intubation trays were stored in the refrigerator. Lexi-Comp Online ( a drug resource website) documents that injectable atropine, lidocaine, vecuronium, and etomidate should be stored at room temperature.

During an interview of M10 at 1059 hours on 1/13/10, he stated he had not obtained any information from the manufacturers or from professional literature that supported the storage of these medications under refrigeration. During an interview of M32 at this time he stated that they stored the intubation kits at room temperature, not under refrigeration, at IVMC.

7. On 1/11/10 at 1419 hours an inspection of the single warmer in the RSMC Surgery Department indicated it contained 1000 ml IV bags of NS and lactated ringers solutions made by the same manufacturedr. Staff had written dates on these bags with marker pens. During an interview of M22 at this time she stated that these were expiration dates.

On 1/12/10 at 1558 hours an inspection of one of two warmers in the IVMC Surgery Department located in the sub-sterile room between OR 1 and OR 2 indicated it contained 1000 ml IV bags of NS and lactated ringers solutions manufactured by the same company. Staff had written expiration dates on these bags with marker pens.

The manufacturer had documented in a letter dated 3/30/06 to CDPH that: "We cannot recommend the procedure (of writing on these containers with a marking pen). We cannot conclusively say that the ink that is used in the marking pens will not leach into the solution since there are no standards for the pen industry as to the type of ink that is used. The use of time tapes for recoding data is recommended."


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8. An inspection of the difficult intubation tray in the surgical suite on 1/11/10, revealed four vials of expired Anectine, a powerful paralytic drug, used for intubation.



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9. At IVMC on 1/12/10 at 1600 hours, the outpatient service for the Wound Care Center was toured. In the treatment room, the following expired supply items were found:
* a three pack of Restore 4 inches x 4 inches wound dressing (Silver Sulfate Triacet 3.22 gm/sq) with an expiration date of 4/2009.
* One package of Puracol Plus Collagen Dressing with an expiration date of 4/2009.

A concurrent interview with the Director of Wound Care Services disclosed that the Certified Hyperbaric Technicians (CHT) inspected all of the medications and biomedical products monthly. E21 monitored the CHT's inspection. The last inspection was performed in late December. E21 was unable to provide documented evidence to show the monthly inspections.


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10. The hospitals' policy and procedure related to large volume IV fluids showed that if the IV bag's outer protective cover was removed and the IV was not used immediately, the bag was to be dated and discarded after 30 days.

On 1/13/10 at 1100 hours, the ICU supply cart at IVMC was inspected. There were two 1000 ml bags of normal saline without a protective cover. There was no date identifying when the bags had been removed from the protective cover. During a concurrent interview with M51, she stated if the bags were opened and not used they were to be dated and discarded after 30 days.


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11. Review of the hospital P&P for the IVMC and RSMC campuses entitled IV Certification and Administration For Licensed Nurses, revision date 11/07, showed that all peripheral IVs would be labeled with the date and initials of the nurse initiating the IV. Further review of the policy also showed that all IV solutions would be changed every 48 hours, if they did not contain additives. IV solutions containing additives would be changed every 24 hours, if prepared by appropriate hospital staff. Manufactured pre-mixed IV solutions would be changed no less often than every 48 hours.

On 1/12/10 at 1000 hours, during a tour of the 2 West medical/surgical unit at the IVMC campus with M29, it was found that IV medication bags in rooms 251, 253, 259, and 252 did not have labels to show the date, time and signature of the staff who hung the IV bags. When M29 was asked why some IV medication bags were labeled with date, time, and signature of person who hung the IV and others were not, she was not able to answer and deferred the question to E32. E32 stated that IV bags were usually labeled when hung.

On 1/12/10 at 1100 hours, during a tour of the 2 Central medical/surgical unit at the IVMC campus with E30, IV bags were found unlabeled in rooms 235 and 22.

On 1/12/10 at 1200 hours, during a tour of the 2 East medical/surgical unit at the IVMC campus with M30, IV bags in rooms 205, 206, 207, and 208 were not labeled. When M30 was asked about the unlabeled IV bags, he stated that he was not sure what the usual practice was and believed the nurses usually documented in the MAR the time and date of when IV solutions were hung. M30 added that he would find out what the practice was.

On 1/12/10 at 1245 hours, during an interview with E6, she stated that the normal practice was to document on the MAR when IVs were hung. This was not in accordance with the P&P.

Based on observation, staff interview, and inspection of the building, it was determined that the facility failed to ensure the hospital was protected from fire, that all building construction and fire protection systems were maintained and tested, as required to provide facilities for diagnosis and treatment and for special hospital services appropriate to the needs of the community. The cumulative effect of these systemic problems identified during the Life Safety Code (LSC) and Health Full Medicare Validation survey resulted in the hospital's inability to ensure the provision of quality health care in a safe environment. The condition of participation for Physical Environment was Not Met.

The CEO was notified immediate jeopardy was identified on 1/12/10, at 1825 hours. The immediate jeopardy was due to the obstruction of the only emergency egress corridors for the ED, Radiology Department, Cardiac Catheterization Laboratory and a special procedures (cystoscopy) room and obstructed fire alarm manual pull stations in the emergency department and radiology department at Rancho Springs Medical Center, creating an increased risk for failure to protect patients, staff and visitors and an increased risk to evacuate patients through the corridors in the event of a fire or other emergency. (See K38, K52 and K72 of the Life Safety Code survey document).

After implementation of an acceptable plan of correction, the CEO was notified the immediate jeopardy was abated on 1/19/2010, at 1530 hours.

Findings:

The hospital failed to ensure the hospital is protected from fire, and that all building construction, fire protection systems and egress/exit corridors are maintained as required. The results of the survey and interviews are cross referenced to the CMS 2567 representing the K tags for the Life Safety Code. (See A701 and A710 in the Health Survey and K11, K12, K25, K29, K38, K50, K51, K52, K72 and K142 of the LSC survey document).

1. The hospital failed to maintain the integrity of the occupancy separation walls, as evidenced by unsealed penetrations in one wall in the Wound Care Center. (See K11 of the LSC survey document).

2. The hospital failed to maintain the integrity of the building construction, as evidenced by the failure to seal penetrations in the walls and ceilings. Penetrations in the walls in the Wound Care Center hyperbaric room would allow the spread of smoke or fire in a oxygen enriched environment.
(See K12 and K142 of the LSC survey document).

3. The hospital failed to maintain hazardous areas with 1 hour rated construction and failed to ensure hazardous areas are separated from other spaces by smoke resisting partitions and self closing doors.
(See K29 of the LSC survey document).

4. The hospital failed to ensure that exit access corridors were maintained free of obstructions to allow the evacuation of patients in the event of a fire. (See K38 of the LSC survey document).

5. The hospital failed to maintain the integrity of the smoke barrier walls, as evidenced by the failure to seal penetrations in the smoke barrier walls in the emergency department and radiology department. (See K25 of the LSC survey document).

6. The hospital failed to ensure fire drills are held at least quarterly on each shift and staff are familiar with fire procedures. (See K50 of the LSC survey document).

19.7.1.2 - Fire drills in health care occupancies shall include the transmission of a fire alarm signal and simulation of emergency fire conditions. Drills shall be conducted quarterly on each shift to familiarize facility personnel (nurses, interns, maintenance engineers, and administrative staff) with the signals and emergency action required under varied conditions.

7. The hospital failed to maintain the integrity of the fire alarm system devices in the Wound Care Center, in accordance with NFPA 99, Chapter 19, NFPA 101 and NFPA 72. (See K51 of the LSC survey document).

8. The hospital failed to ensure maintenance of the fire alarm manual pull station devices. The devices are required to be readily available and unobstructed. This was evidenced by two manual fire alarm pull stations that were obstructed by hospital beds and equipment. (See K52 of the LSC survey document).

9. The hospital failed to maintain the egress path in exit corridors free of all furnishings that obstruct access to or egress from exits. This was evidenced by a heat pump, a computer on wheels (COW), chairs, tables, vitals machines, hospital beds, patient transport gurneys and other equipment that were placed in the exit corridors in patient treatment areas of the hospital (See K72 of the LSC survey document).

10. The hospital failed to maintain the integrity of the hyperbaric facility in accordance with NFPA 99, Chapter 19 and NFPA 101. This was evidenced by failing to maintain the building construction and the occupancy separation walls, by failing to ensure fire alarm notification, by failing to provide smoke detection devices in required areas, by failing to conduct fire evacuation drills, and by failing to maintain the integrity of the electrical wiring and connections. (See K142 of the LSC survey document).

Based on observation and staff interview, the hospital failed to ensure that the physical plant, equipment and hospital environment was maintained in such a manner that the safety and well-being of patients were assured. By not maintaining exit access in the emergency department (ED), by unsealed penetrations in the occupancy separation walls in the Wound Care Center, and by obstructed access to manual pull stations, the facility created the potential for lack of safety. This affected 19 patients in the ED and in the radiology department corridor outside the ED, visitors in the ED, radiology department patients, Wound Care Center patients and hospital staff. This could result in the inability to evacuate patients in the event of a fire resulting in potential harm or death.

Findings:

The hospital failed to ensure the hospital is protected from fire, and that all building construction, fire protection systems and egress corridors are maintained as required. The results of the survey and interviews are cross referenced to the CMS 2567 representing the K tags for the Life Safety Code. (See A710 of this document and K11, K12, K38, K52, and K72 of the LSC survey document).

1. The hospital failed to maintain the integrity of the occupancy separation walls, as evidenced by penetrations in one wall in the Wound Care Center. This could result in the spread of smoke and fire.

2. The hospital failed to maintain the integrity of the building construction, as evidenced by the failure to seal penetrations in the walls and ceilings. Penetrations in the walls in the Wound Care Center hyperbaric room would allow the spread of smoke or fire in a oxygen enriched environment.
(See K12 and K142 of the LSC survey document).

3. The hospital failed to maintain the integrity of the smoke barrier walls, as evidenced by the failure to seal penetrations in the walls in the emergency department and radiology department. (See K25 of the LSC survey document).

4. The hospital failed to ensure that exit access corridors were maintained free of obstructions to allow the evacuation of patients in the event of a fire. (See K38 of the LSC survey document).

5. The hospital failed to ensure maintenance of the fire alarm manual pull station devices. The devices are required to be readily accessible and unobstructed. This was evidenced by two manual fire alarm pull stations that were obstructed. (See K52 of the LSC survey document).

6. The hospital failed to maintain the exit corridors free of all furnishings that obstruct access to or egress from exits. This was evidenced by a heat pump, a computer on wheels (COW), chairs, tables, vitals machines, hospital beds, hospital gurneys and other equipment that were placed in the exit corridors in patient treatment areas of the hospital (See K72 of the LSC survey document).

Based on observation, facility staff interviews, and building and fire alarm system inspections, the hospital did not meet the provisions of the 2000 edition of the Life Safety Code 101 of the National Fire Protection Association. The facility failed to maintain the integrity of the building structure, failed to protect hazardous areas with self-closing doors, failed to ensure exit access was maintained, ensure staff were trained on fire protection procedures, maintained clear corridors, maintained the integrity of the fire alarm system and protected hyperbaric areas in accordance with NFPA 99. These failures affected the entire hospital, and could result in a failure of the fire protection system, an increased risk of fire, an increased risk of delay in evacuation in the event of a fire, or the spread of smoke and fire.

Findings:

During the facility tour, building inspection and interviews, from 1/11/10 to 1/15/10, the hospital was found not in compliance with the 2000 edition of the Life Safety Code 101 of the National Fire Protection Association. The results of the survey and interviews are cross referenced to the CMS 2567 representing the K tags for the Life Safety Code. The deficiencies written after survey of the emergency department and Wound Care Center, were as follows: K11, K12, K29, K38, K50, K51, K52, K72 and K142.

Rancho Springs Medical Center Campus:

1. At 1045 hours on 1/11/10, eight patients on gurneys/beds were observed in the hallways of the ED. The eight ED patient curtained areas (bays) were also full. Concurrently, M13 and E154 stated the patients in the corridors were waiting for an inpatient bed. The eight patients in the corridors had portable vital signs and cardiac monitoring machines at their bedsides. In addition, visitors were observed sitting in chairs next to the patient's gurneys. This made walking down the corridors difficult to maneuver without tripping on pieces of equipment and/or chairs. (See K38 and K72 of the LSC survey document).

2. On 1/11/10 at 1400 hours and 1/12/10 at 0950 hours, the hospital's Rancho Springs campus ED was toured and the following was observed on both days:

There was a double doorway that served as an exit from the ED into the hallway of the Radiology Department. The long radiology hallway had ED patients on gurneys lining the entire right side of the hallway all the way to the exit. A shorter hallway on the left had two patients in gurneys lining the left side which filled the left side to the exit doors. The short Radiology hallway had the numbers 11 and 12 over each respective patient gurney and each patient gurney lining the long hallway had a number on the wall over each gurney; these were numbered 13 through 18. Between each gurney there was a portable screen. In addition to the gurneys blocking egress from the hallway, there were visitors on chairs and portable equipment, for example an EKG machine, and patients being transported down the hallway during which time the hallway was completely blocked.

As noted above, the ED patient gurneys were in the Radiology hallway. Between gurneys 13 and 14 was a doorway to the CAT scan room, between gurneys 14 and 15 there was a doorway into an X-ray room, between gurneys 15 and 16 there was a control room and at the end to the hallway there was a fluoroscopy room. Additionally, across from Gurney 15 there was a special procedure room. The patient activity in and out these rooms added to the crowding of the hallways.

3. On 1/11/10 at 1540 hours, M48 stated there were ED patients down the Radiology hallway 80% of the time.

4. On 1/12/10 at 1000 hours, a patient in a bed was being wheeled from the Radiology Department down the short hallway to the Medical/Surgical department. In order for the patient in the bed to get through the hallway, two visitors at the side of the Gurney #12 stood up, removed themselves and their chairs out into a hallway. As the bed passed by gurney the hallway was completely blocked.

5. A tour of the hospital was conducted during the week of 1/11/10 through 1/14/2010. On 1/12/10 it was observed that patients were being relocated from the emergency department (ED) into the hallway, extending toward ultrasound and the cardiac catheterization laboratory. These patient gurneys were noted to obscure and block access to the fire alarm pull stations. Red lines placed on the floor of the hallway, to identify the pull stations, were obscured. Interviews with nursing staff, including E15 and E16, revealed that the ED nurses were unable to identify the location of the fire alarm pull stations. (See K52 of the LSC survey document).

6. During a tour of the Wound Care Center on 1/13/10, 1/14/10 and 1/15/10, the facility was observed and records for fire drills and fire sprinkler testing were requested.
a. There were penetrations in the occupancy separation wall, in the Wound Care Center.
b. There were penetrations in the walls in the Wound Care Center hyperbaric room that would allow the spread of smoke or fire in a oxygen enriched environment.
c. There were no manual pull stations located in the Wound Care Center building.
d. There were no annunciation devices installed at the Wound Care Center to notify patients and staff in the event of a fire. There was no audible alarm activation during testing of the fire sprinkler system.
e. There were no records for fire drills during four of four quarters and no records for fire sprinkler quarterly testing for three of four quarters.
(See K11, K12, K50, K51 and K142 of the LSC survey document).


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7. A tour of the hospital was conducted during the week of 1/11/10 through 1/15/10. On 1/12/10 it was observed that patients were being relocated from the emergency department (ED) into the hallway, extending toward the ultrasound room and the cardiac catherterization laboratory. The patient gurneys were noted to obscure and block access to the fire alarm pull stations. The red lines placed on the floor of the hallway, to identify the pull stations, were obscured. Interviews with the nursing staff, including E15 and E16, revealed that the ED nurses were unable to identify the location of the fire alarm pull stations.


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8. On 1/11/10 at 1400 hours and 1/12/10 at 0950 hours, the hospital's RSMC campus ED was toured and the following was observed on both days:

There was a double doorway that served as an exit from the ED into the hallway of the Radiology Department. The long radiology hallway had six ED patients on gurneys lining the entire right side of the hallway to the exit doors. A shorter hallway on the left side had two ED patients in gurneys which filled half of the hallway to the exit doors. The gurneys along the hallway were identified by their respective numbers written on the wall from 11-18. Between each gurney was a portable screen. In addition to the gurneys blocking egress from the hallway, there were visitors on chairs and portable equipment, e.g., an EKG machine. These gurneys and medical equipment, aside from the visitors, were noted to block the way of patients being transported down the hallway.

Moreover, the patient activity of going in and out of Radiology rooms added burden to the already crowded traffic of the Radiology hallway. It was noted that between gurneys 13 and 14 was a doorway to the CAT scan room while between gurneys 14 and 15 there was a doorway into an X-ray room. There was a control room between gurneys 15 and 16 and at the end to the hallway, there were the fluoroscopy room and the cardiac catheterization laboratory. Additionally, across from Gurney 15 there was a special procedure room.

On 1/11/10 at 1540 hours, M48 stated there were ED patients down the Radiology hallway 80% of the time.

On 1/12/10 at 1000 hours, a patient in a bed was noted being wheeled from the Radiology Department down the short hallway to the Medical/Surgical department. In order for the patient in the bed to get through the hallway, two visitors at the side of the Gurney #12 stood up, removed themselves and their chairs out into another hallway. As the bed passed by the gurney, the hallway was observed almost completely blocked.

Based on interviews, and observations, the hospital failed to ensure an acceptable level of patient safety by the removal of infant safety alarms from the newborn nursery. The hospital failed to ensure the performance of routine maintenance on two of two medication refrigerators located in the main pharmacy which could lead to inaccurate temperature ranges compromisng drug stability and sterility. In the ICU at RSMC campus, a pacemaker had an expired battery, while the other two pacemakers and a neurological tester in the ICU at IVMC did not have current Biomedical stickers which could potentially result in equipment failure on both campuses. In addition, the anesthesia machine in the L&D suite was found without an Ambu bag and a glucometer (medical equipment to check blood sugar level) in the Post Partum unit was found dirty with blood stains. This resulted in the potential for a delay in providing life sustaining treatment, the spread of infection, an unsafe environment for neonates and unusable medications.

Findings:

1. A tour of the hospital, conducted on 1/11/10 through 1/15/10. During the onsite tour of 1/11/10 at approximately 1300 hours, and on 1/14/10, hospital staff M46 revealed that infant safety alarms had been removed from the hallway directly outside the newborn nursery. When interviewed on 1/14/10, at approximately 1100 hours, M46, AS3,and E42 revealed that the hallway alarm directly outside the nursery entrance/exit had been removed approximately one year earlier for installation in the new hospital building. During the tour of the labor and delivery areas, including the newborn nursery, no security alarms had been provided to secure the two exit doors, directly adjacent to the newborn nursery and no mechanism was in place to provide security in the hallway in the direction of the emergency department, to secure the area to prevent infant abduction.


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2. At RSMC, on 1/14/10 at 1415 hours, M30 stated that the refrigerators in the hospital that contain vaccines and other medications were not given routine maintenance. "All we do is a visual inspection. There is nothing written by us." M30 stated, this was the way it was documented in the Plant Operation's P&P.

On 1/14/10 at 1435 hours, M46 stated that he had not needed to inspect medication refrigerators because he had not been called. Routine maintenance was performed visually. When asked if he had documentation when this visual maintenance was done, he stated no.

On review of the policy and procedure entitled, "Routine Maintenance of POM Equipment" last revised in 11/09, on page 6 under Maintenance of Refrigeration Units, "All patient refrigeration units shall be given a preventive maintenance and check at least annually using the following guidelines:

1. Clean condenser coils and compressor areas.
2. Check for loose screws and nuts.
3. Check operation of condenser and evaporator fans for noise or other signs of malfunction.
4. Check evaporator drain for proper drainage.
5. All discrepancies shall be entered on work orders."


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3. a. On 1/11/10 at 1000 hours, an inspection of the ICU at RSMC showed the battery in the internal pacemaker was expired. This was acknowledged by M50 who was present.

b. On 1/13/10 at 1130 hours, an inspection of the ICU supply room at IVMC showed one internal pacemaker with the serial number PFGO21434P with no Biomedical sticker and another internal pacemaker with the serial number PEP021015P with a Biomedical sticker dated 10/08. Additionally, there was a handheld device labeled as a Stratavarius Serial #10374 (a neurological testing unit) that had no Biomedical sticker. The batteries in this unit were undated.

During an interview with M33 on 11/13/10 at 1140 hours, he stated he was unaware of the Stratavarius unit. He stated the recent Biomedical checks for the pacemaker units were on a handheld device which he was unable to access during the interview.

On 1/14/10 a record for each of the pacemakers titled "Masterplan i Desk" was provided to the surveyor which showed the two pacemakers with the following comments for both pacemakers "01/14/2010CVH-Facility had PMs scheduled annually for this device. Should be semi-annual. Change made this date."


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4. During a tour of the Labor and Delivery Room across from the Nursery at RSMC, conducted on 1/11/10 at 1000 hours with E45 and M54, the anesthesia machine inspected was without an Ambu bag, a necessary equipment needed for resuscitation and to support patients' respiratory depression. E45 had to step out of the room to provide the necessary equipment.

5. During a tour of the Post Partum unit at RSMC conducted on 1/11/10 at 1100 hours with E45 and M54, a glucometer was found dirty with blood stains.

E45 demonstrated how the quality control was done but admitted to not being sure if there was a hospital P&P regarding glucometer cleaning and maintenance.

Based on observation, interview, and document review, the hospital failed to provide a sanitary environment to avoid sources and transmission of infections and communicable diseases as evidenced by:

1. Failure to develop and implement a policy and procedures that ensured all healthcare workers were screened for tuberculosis (See A749, #1).

2. Failure to implement hospital policy and procedures ensuring surgical attire was implemented in all areas where surgical procedures were performed (See A749, #2).

3. Failure to implement hospital policy and procedures for the use of Cidex OPA, ensuring that individuals who used the high level disinfectant had training on the safe use, appropriate disposal, and that the high level disinfectant was used in a well ventilated environment (See A749, #3).

4. Failure to implement hospital policy and procedures for standard based precautions (See A749, #4).

5. Failure to develop and implement a policy and procedure that ensured single patient use items were not used for multiple patients (See A749, #5).

6. Failure to develop and implement a policy and procedure that ensured that the inside of hyperbaric chambers were routinely disinfected (See A749, #6).

7. Failure to ensure implementation of the P&P for labelling and changing intravenous solutions. (See A749 #7).

8. Failure to ensure the correct use of PPE. (See 749 #8 and #10)

9. Failure to develop and implement a policy and procedure that ensured potentially hazardous foods were thoroughly cleaned reducing the risk of cross contamination (See A749, #9).

10. Failure to implement hospital policy on dish and silverware cleaning and sanitizing procedures to prevent cross contamination (See A749, #11).

The cumulative effect of these systemic problems resulted in the failure by the hospital to provide quality care in a sanitary environment.

Based on observation, interview, and document review, the infection control officer failed to develop and implement policies and procedures governing control of infections and communicable diseases. This resulted in incorrectly cleaned sterile instruments, contamination of water systems, staff exposure to noxious chemicals, equipment used that could not be properly cleaned, prolonged use of IV solutions and medications and incorrect isolation, food sanitation and PPE procedures and the potiental for tuberculosis and infectious disease exposure, surgical infections and food borne illness.

Findings:

1. On 1/14/10 at 1225 hours, an interview was conducted with the M56. M56 was asked for a list of active medical staff members and mid-level practitioners (PAs), and the dates they had been screened for tuberculosis (TB).

During a concurrent interview, M56 stated that the hospital only screened employees for TB. M56 also stated that members of the medical staff and mid-level practitioners were not employees and the hospital did not require them to be screened for TB.

M56 was asked for an approximate number of active medical staff members and mid-level practitioners at the hospital. M56 stated between the two hospital campuses there were about 290 active medical staff members and 20 mid-level practitioners. M56 was asked if she was aware that in 2005, the CDC (Centers for Disease Control and Prevention) recommended that physicians and mid-level practitioners be included in the hospital's TB screening plan. M56 stated she was not aware the CDC had recommended that physicians and mid-level practitioners should be included in the hospital's TB screening program.

On 1/14/10 at 1300 hours, the 4/03 hospital's policy and procedure titled, "Employee physical: TB annual screening" was reviewed. On page one, under the policy section, item "C" direction was given that, "All employees and volunteers with a negative or doubtful skin test will have a tuberculin PPD skin test done annually."

On 1/14/10 at 1330 hours, the CDC's 2005, Guidelines for Preventing the Transmission of Mycobacterium Tuberculous in Health-Care Settings was reviewed. On page three of the document the CDC recommends that healthcare workers (HCW), "Refers to all paid and unpaid persons working in a health care settings who have the potential for exposure to M. tuberculous through air space shared with persons with infectious TB disease. Part time, temporary, contract, and full-time HCWs should be included in TB screening programs. All HCWs who have duties that involve face to face contact with patients suspected or confirmed TB disease (including transport staff) should be included in a TB screening program...." A review of CDC's list of HCWs who should be included in TB screening programs included, "Physicians (assistant, attending, fellow, resident, or intern), including anesthesiologists, pathologists, psychiatrists, psychologists..."

2. On 1/12/10 at 1100 hours, the RSMC Cardiac Catherization Laboratory was toured. Prior to entering, M57 was asked at what point would the surveyor be required to change into surgical attire. M57 replied that surgical attire was not required before entering the Cardiac Catherization Lab. During the tour, M57 was asked if permanent cardiac pacemakers were implanted in the Cardiac Catherization Lab. M57 replied yes, permanent pacemakers were implanted.

During a concurrent interview M57 was asked for clarification on allowing street clothes in a surgical suite. M57 stated that surgical scrubs were not needed in the Cath Lab, because every morning housekeeping cleaned the Cardiac Catherization Lab. During the interview, M57 was asked about the location and process for performing a surgical scrub. M57 stated that the surgical scrub was performed at the sink located in procedure room (approximately two feet from the procedure table). When asked if the sterile instruments and supplies were open when the physician scrubbed, M 57 stated, "Yes, most of the time."

On 1/12/10 at 1600 hours, the hospital's 7/09 policy and procedure titled, "Surgical attire" was reviewed. On Page 1, under the definition section, the policy directed, "The restricted area - requires wearing of masks and head coverings in addition to the scrub attire of the semi-restricted area and consists of the operating room during surgical procedures. This includes operating and procedure rooms, the clean core, and scrub sink areas. Surgical attire and hair covering are required...."

3. On 1/12/10 at 1230 hours, a tour of the wound care center of the IVMC campus was conducted. During the tour two uncovered square pink plastic basins were observed sitting on a counter in the soiled utility room. It was noted that one basin (in front), contained a clear solution (labeled Cidex OPA) and the other basin (in back) a blue solution (labeled Ultizyme). During the tour E22 was asked to explain the process she used to clean and sanitize, (including the solutions), the instruments used for wound debridement (process used to remove dead tissue). E22 stated the two solutions were mixed every day. When asked to explain the process for preparing the solutions for use, E22 stated the Cidex OPA was mixed 1 part Cidex OPA with about 4 parts of water, and the Ultizyme was used full strength. E22 stated that after rinsing the used instruments with water, they were placed in the Cidex OPA solution for 10 minutes and rinsed again with water. E22 stated that the instruments were then placed in the Ultizyme for 10 minutes. E22 stated that after 10 minutes, the instruments were removed from the Ultizyme, rinsed again, dried, and then wrapped in peel pouches for sterilization. E22 stated that the wrapped instruments were then sent to central supply for sterilization.

E22 was asked to describe the process used to discard the Cidex OPA and Ultizyme. E22 stated that the two solutions were discarded down the sink drain. When asked if anything was added to either solution before being discarded, E22 replied, "I just pour them down the sink drain." When asked how long she had worked in the wound center, E22 stated that she had worked in the wound center for two and a half years. When asked who had trained her on the process used to clean and sanitize the instruments, E22 stated she was trained by the previous manager of the wound center.

On 1/12/10 at 1600 hours, the hospital's 11/10/09 policy and procedure titled, "High level disinfection with Cidex OPA" was reviewed. On page one, under additional information, item 6, the direction was, "Only the following approved locations are allowed to high-level disinfect equipment:

Rancho Springs - SPD (sterile processing department), and Imaging.
Inland Valley / Outpatient Imaging Center - Cardiology Department and Radiology - Ultra sound probes.

On page 2, under additional information, staff were directed to use Cidex OPA in a well ventilated area and in closed containers with tight fitting lids. If adequate ventilation was not provided by the existing air conditioning system, use local exhaust hoods, or in ductless fume hoods/ portable ventilation devices, which contain filter media, which absorb ortho-Phthalaldehyde from the air.

On page 4, under directions for discarding solution, staff was directed to pour one container of Kem-Safe neutralizing powder into one gallon container of Cidex OPA, stir solution, reaction is complete in five minutes, and a color change will occur, the neutralized solution is safe for disposal via hopper.

On 1/13/10 at 0800 hours a request was made to review the air exchange reports for the wound center, and the manufacturers' recommendations for both the Cidex OPA and Ultizyme.

During an interview on 1/13/10 at 0830 hours, M14 stated that the hospital conducted environment of care (EOC), rounds twice a year, and the EOC staff was not aware that Cidex OPA was used in the wound center. M14 also stated that the hospital had no documentation showing that the air exchanges had been monitored in the wound care center's soiled utility room.

On 1/13/10 at 1000 hours, the 2009, Association of periOperative Registered Nurses (AORN), Standards and Recommended Practices was reviewed. On page 421, Under the section titled, "Recommended HVAC (Heating, Ventilation and Air Conditioning), Settings" disclosed that AIA (American Institute of Architects) recommended that soiled decontamination rooms have a minimum of 10 air exchanges per hour, and that the air should not be recirculated.

On 1/13/10 at 1100 hours, the manufacturer recommendations for Cidex OPA and were provided, reviewed, and disclosed:

a. The manufacturer of Cidex OPA labeled the solution as "A high level disinfectant for reprocessing heat sensitive reusable semi-critical medical devices, for which sterilization is not feasible, and when used according to the directions for use." Under directions for use the manufacturer directed that the solution did not require activation before use, and that the solution was to be used, as provided for a period up to 14 days (with use of test strips before each use). The manufacturer also directed that 25 grams of glycine (free base) should be used to neutralize one gallon of Cidex OPA (minimum recommended neutralization time is one hour), before discarding residual solution into a drain.

b. The manufacturer of Ultizyme labeled the solution as a multi-enzyme detergent, and directed that one ounce of product was to be added to one gallon of water. The manufacturer also directed that after removal, the instruments were to dry before proceeding to the disinfection process.

4. On 1/11/10 at 1000 hours, a tour was conducted of the medical surgical unit of the RSMC campus. During the tour E26 was asked to explain the process used to identify inpatients in transmission based infection control precautions. E26 stated that nursing staff entered those specific patients into the computer system, and each morning she printed the patient list. E26 stated that she then made rounds to ensure that the appropriate transmission based precautions had been implemented, and were appropriate for each patient.

During the tour, on 1/11/10 at 1030 hours, a sign posted outside Patient 13's room showed that the patient was in "Protective precautions." A review of the patient census printed on 1/11/10 at 0812 hours, documented that Patient 13 was in, "Protective precautions."

A review of E26's "Isolation log" dated 1/11/10 and printed at 1011 hours, showed that Patient 13 was not included in the list of patients in transmission based precautions.

On 1/11/10 at 1040 hours, Patient 13's medical record was reviewed. Documentation showed that the patient was admitted on 1/8/10, with diagnoses that included bone marrow suppression.

A review of the physicians' orders disclosed an order written 1/10/10, directing that the patient was, "Okay to walk in hall with mask ad lib." A review of the nursing flow sheets showed, beginning on 1/9/10, nursing documented that the patient was in, "Neutropenic precautions."

During a concurrent interview, E26 was asked how nursing staff would know what protective precautions meant. E26 stated that nursing staff would just know.

On 1/11/10 at 1130 hours, the hospital's 5/09 policy and procedure titled, "Isolation precautions" was reviewed. On page one of the policy, under the purpose section, the policy directed that, "reverse (or protective) isolation - there is no CDC category for reverse (protective) isolation. Strict adherence to standard precautions is all that is necessary..."

5. On 1/12/10 at 1450 hours, a tour of the IVMC intensive care unit (ICU) was conducted. During the tour, a request was made to inspect the pressure infusers used at the hospital. M13, escorted the surveyor to the equipment storage room. The surveyor was shown two pressure infusers manufactured by different companies. Stamped on the outside of the first pressure infusor was, "Recommended for single patient use." The plastic package covering the second pressure infusor documented, "Disposable pressure infusor."

During a concurrent interview, M13 stated that she was not aware that the pressure infusors were recommended for single patient use. M13 was also asked to clarify with the manufacturer what "Disposable pressure infusor" stamped on the outside of the second pressure infusor's package meant.

On 1/13/10 at 0800 hours, the hospital provided documentation from the manufacturer of the second pressure infusor showing the pressure infusor was a single patient use item.

6. On 1/12/10 at 1344 hours, a tour was conducted of the wound care center including the room where the two hyperbaric chambers were located.

During a concurrent interview, E21 was asked to explain the process used to clean the hyperbaric chambers. E21 stated that the inside of the two hyperbaric chambers were cleaned once a week. When asked to identify the cleaning solution E21 stated that staff used soap and water to clean the inside of the hyperbaric chamber. E21 also stated that he followed the manufacturer recommendations listed in the user manual.

On 1/12/10 at 1600 hours, the manufacturer's user guide was reviewed. The manufacturer's guide directed that the outside of the hyperbaric chamber was to be wiped down with a lint free cloth using a mild non-abrasive soap. The manufacturer recommended that the inside of the acrylic hyperbaric chamber be cleaned and disinfected in accordance with approved medical staff policies using one of the 10 approved products. The manufacturer's user guide did not specify how frequent the inside of the hyperbaric chamber should be cleaned.

On 1/12/10 at 1630 hours the wound care center's policy and procedure was reviewed. The wound care center's policy and procedure contained no additional information directing wound care staff on how frequently the inside of the acrylic hyperbaric chamber should be cleaned.



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7. Review of the hospital P&P for the IVMC and RSMC campuses entitled IV Certification and Administration For Licensed Nurses, revision date 11/07, showed that all peripheral IVs would be labeled with the date and initials of the nurse initiating the IV. Further review of the policy also showed that all IV solutions would be changed every 48 hours, if they did not contain additives. IV solutions containing additives would be changed every 24 hours, if prepared by appropriate hospital staff. Manufactured pre-mixed IV solutions would be changed equal to or less than every 48 hours.

On 1/12/10 at 1000 hours, during a tour of the 2 West medical/surgical unit at the IVMC campus with M29, it was found that IV medication bags in rooms 251, 253, 259, and 252 did not have labels to show the date, time, and signature to show when the IV medication bags were hung. When M29 was asked why some IV medication bags were labeled with date, time, and signature of person hanging the IV and others were not, she was not able to answer and deferred the question to E32. E32 stated that IV bags were usually labeled when hung.

On 1/12/10 at 1100 hours, during a tour of the 2 Central medical/surgical unit at the IVMC campus with E30, IV bags were found unlabeled in rooms 235 and 221.

On 1/12/10 at 1200 hours, during a tour of the 2 East medical/surgical unit at the IVMC campus with M30, IV bags in rooms 205, 206, 207, and 208 were not labeled. When M30 was asked about the unlabeled IV bags, he stated that he was not sure what the usual practice was and believed the nurses usually documented in the MAR the time and date of when IV bags were hung. M30 added that he would find out what the practice was.

On 1/12/10 at 1245 hours, during an interview with E6, she stated that the normal practice was to document on the MAR of when IV's were hung. This was not in accordance with hopsital P&Ps.



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8. Review of the P&P titled "Personal Protective Equipment" (PPE) showed gloves should be removed first before removing the cover gown used for isolation precautions.

On 1/11/10 at 1012 hours, at the RSMC's ICU, M50 was observed removing PPE in a contact isolation patient's room. M50 untied and removed the protective gown with the soiled gloves on.



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9. On 1/11/10 at 0900 hours on the RSMC campus, E14 was observed with one cantaloupe in a bowl of water in a food preparation sink. E14 stated that she rinsed the cantaloupe in running water and then peeled the melon for service to patients.

Interview with E31, responsible for the Food and Dietetic Department, stated there was no policy that specified the thorough cleaning of cantaloupe or leaving produce in standing water. The FDA Food Code dated 2005 identifies cantaloupe as a potentially hazardous food that requires thorough cleaning of the rough and netted exterior to prevent the potential of food borne illness. The Food Code specifies ready to-eat fruits not be in standing water where cross contamination can occur.

On 1/12/10 at 0950 hours two infection control staff were interviewed. M14 stated he was responsible for the hospital wide infection control program.

M14 and E26 stated the infection control monitoring was part of the environmental rounds and emphasis was on cleanliness of the environment, concentration of solutions, cleaning schedules, and equipment temperatures when reviewing the kitchens.

M14 stated that he was not familiar with the food safety procedures like HACCP (hazard analysis and critical control point) program developed in the FDA Food Code. He stated that he had not reviewed the policies with the dietary management staff for food safety practices to prevent cross contamination and food borne illness. M14 stated he had not reviewed the practices of ensuring the cantaloupe were in compliance with the FDA Food Code standards for thorough cleaning.

10. On 1/14/10 at 1200 hours at the IVMC campus kitchen, E52 was observed putting clean disposable plastic gloves in her apron pocket and then washing hands. E52 then put on the contaminated disposable gloves from her apron pocket. E52 stated that she got the gloves and put them in her pocket before washing her hands to save time. E31 acknowledged the dietary staff should put on disposable gloves after washing hands and not put them in the apron pockets.

11. On 1/13/10 at 1030 hours at the IVMC campus kitchen, E102 was observed using a cloth to wipe the sanitized patient trays at the end of the dishwashing cycle. E102 stated the trays were wet on the back and she used the cloth daily to dry the remaining moisture.

Review of the policy titled Dishes and Silverware: Cleaning and Sanitizing Procedures on 1/13/10 at 1600 hours showed "Air-dry all utensils."

E31 acknowledged the trays were to be air-dried and not dried with a cloth to prevent cross contamination.

Based on observation, interview, and medical record review, the IVMC and RSMC campus, both failed to ensure four of 11 patients reviewed for discharge planning (Patients 42, 123, 169, and 319) were assessed early during hospitalization for discharge planning needs. This had the potential to increase the chances for the patients to suffer from further illness or injury after being discharged to home.

Findings:

1. On 1/12/10 at 1100 hours, during an interview with Patient 123, she stated that she was being discharged to home today and requested to speak to a CM and had not spoken to one as of yet. She stated that she lived alone and needed help so she would not cause injury to her arm anymore.

On 1/12/10 at 1530 hours, during an observation and follow-up interview with Patient 123 and interview with E162, Patient 123 was able to ambulate without assistive devices, but was not able to stand fully erected. The upper portion of the patient's body was bent foreword when she walked, which increased the patient's susceptibility for falls. Patient 123 stated that she was limited in doing some things, such as not being able to drive because of current episodes of pain in her arm. The patient also stated the physician wanted her to get unspecified subsequent services, but she did not have money to pay for those services. The patient had a cast that extended from the middle of her left forearm to her hand. She also stated that she only needed temporary help. E165 stated that a SW (social worker) came by between 1200 and 1500 hours and spoke with the patient.

On 1/13/10 at 1120 hours, during an interview and medical record review with E29, she stated that each hospital was assigned four to six CM and that on Saturdays there was a CM (case manager) on duty from 0700 hours to 1700 hours. After 1700 hours the House Supervisor would be notified if there were any case management needs identified. On Sunday there was usually a CM on call, who would be notified by the House Supervisor in the event that CM needs were identified. She also stated that discharge planning was usually done within the next business day. When Patient 123's discharge planning record was presented to E29, she stated that discharge planning done for Patient 123 on the day the patient was being discharged was not the usual practice.

Review of the hospitals' P&P entitled, Case Management: Discharge Planning-Screening and Assessment, revision date 11/09, showed that patients were initially screened for discharge planning each morning by Case Management. In addition, it showed that CMs would identify final plans/disposition of the patient, and document patient and family agreement to discharge plans.

Review of Patient 123's medical record showed the patient had been admitted on 1/10/10. The History and Physical Examination showed the patient was alert and oriented, suffered a left wrist fracture, and the patient lived alone. Review of the discharge planning record, showed the Initial Discharge Planning Screening was not done until 1/11/10. The Needs Assessment portion of the discharge planning record was not done until 1/12/10, which was the day of the patient being discharged from the hospital. SW discharge assistance was ordered by the physician on 1/12/10. Further review of the record also showed discharge instructions, dated 1/12/10, that showed the box for driving restrictions was not checked, and the community resource information and additional home care instruction portions of the document were left blank. There was no documentation to show that a CM or SW had spoken to the patient in regards to discharge planning.

Review of the CM schedule for the month of January 2010 showed that there was a CM on-call on 1/10/10 (Sunday), and that seven CMs and one SW were on duty on 1/11/10.

2. On 1/12/10 at 1220 hours, Patient 169 and family were interviewed regarding his discharge plan. Patient 169 stated he was readmitted to the hospital on 1/3/10 for a complication that developed after his last surgical procedure. The patient and family had not received any information regarding a discharge plan at the time of this interview. The family did not recall that there was any discharge planning explained to them for the prior admission. No discharge instructions had been provided for either admission. See A395.

3. On 1/11/10 at 0900 hours, during interview with Patient 42 and the patient's family member, they stated that they were never approached by a SW or CM regarding discharge planning. The patient was due to be discharged that day. During that time, the patient was osbserved sitting at the bedside with a walker placed in front of her.

On 1/11/10 at 1000 hours, review of Patient 42's medical record with E34 showed the patient was admitted on 1/9/10 (Saturday). Review of the Admission Data Base, dated 1/9/10, showed the patient was identified for discharge planning needs and a referral was made to the case management department on the day of admission. No discharge planning record was found at the time of the medical record review. E34 concurred the referral to case management was done, but the discharge planning was not.

On 1/11/10 at 1200 hours, the surveyor was given Patient 42's discharge planning document. The document showed the initial discharge screening and needs assessment was done on 1/11/10, on the day of the patient being discharged to home.

4. Review of Patient 319's medical record showed the patient was admitted on 12/30/09 for a hip fracture. Further review of the medical record showed documentation of the discharge planning initial screening and needs assessment was not done until 1/5/10.

Review of the CM's schedule for the month of December 2009 and January 2010 showed that CMs were on duty from 12/30/09 to 1/4/10. The discharge planning P&P had not been followed for Patient 319.

Based on observation, interview, medical and hospital record review, IVMC failed to ensure one of 11 patients sampled for discharge planning (Patient 123) request for discharge planning services was fulfilled. This had the potential for the patient to not receive an appropriate or no discharge planning evaluation prior to being discharged home, thereby; increasing the chances of post hospital services and care to not be provided. See A800 #1, #2, and #3.

Based on observation, interview, and medical record review, IVMC hospital failed to ensure discharge planning addressed post hospital needs for three of 11 sampled patients (Patients 123, 169 and 184) reviewed for discharge planning. This had the potental for patients to not have access for post hospital services to maintain continuity of care to prevent further injury or illness.

Findings:

1. On 1/12/10 at 1220 hours, Patient 169 was observed with a double lumen PICC line in the left upper forearm with a continuous IV fluid infusing. The patient and family were interviewed regarding his discharge plan. Patient 169 stated he was readmitted to the hospital on 1/3/10 for a complication that developed after his last surgical procedure. The patient and family had not received any information regarding a discharge plan at the time of this interview. The family recalled from a previous admission that Patient 169 had emergency surgery that resulted in an extensive procedure due to complications. The family did not recall that there was any discharge planning explained to them for that admission. The family stated that at that time, there was one conversation with a physical therapist about stairs in the home. No other discharge instructions had been provided for either admission.

a. On 1/14/10, review of Patient 169's medical record showed an Admission form, dated 12/28/09, that Patient 169 was admitted on 12/28/09, A note on this section instructed that if any risk factors were identified, to initiate a referral to Case Management (CM). A referral to CM was made on 12/29/09. Further review of the medical record showed E51 did a discharge planning assessment on 12/29/09. The only risk factor identified was for no insurance. The rest of the sections on the form were left blank. There was no further assessment of discharge needs by E51.

b. Further review of the patient's medical record showed Patient 169 was readmitted on 1/3/10 for pain and vomiting. On 1/14/10, a review of the Admission Data Base used for the patient's readmission showed the section for determining if a CM referral was needed was not completed. The patient had been identified on the section for not having medical insurance, which was considered a risk factor. Once a risk factor was identifed on section of the document, the case management department was to be contacted to conduct a more indept discharge planning evaluation. Review of the Discharge Planning Extended Screen Data, completed by E159, also identified Patients 169's readmission as a risk factor.

On 1/14/10 at 1400 hours, during an interview, E158 stated she readmitted Patient 169 on 1/3/10. E158 stated the admitting nurse should have initiated the discharge care plan on admission. E158 reviewed the patient's record and stated the discharge care plan had not been initiated. A concurrent interview with M30, disclosed Patient 169 had insurance. The Admission Data Base that identified Patient 169 of not having medical insurance was incorrect while the appropriate risk factor, the patient's readmission, was left blank.

2. On 1/12/10 at 1100 hours, Patient 123 expressed that she would be needing assistance once discharged from the hospital. She was to be discharged on 1/12/10. There was no documentation in her medical record that addressed post hospital needs. See A800 #1.

3. On 1/12/09, review of Patient 184's medical record showed the patient had been admitted 1/9/10 for chest pain. The discharge planning intitial screening was done on 1/11/10, however; the needs assessment and therefore an evaulation of post hospital needs were not addressed.

On 1/13/10 at 1120 hours, during an interview with E29, she stated that discharge planning was usually done within the next business day.

Based on observation, interview, and medical record review, IVMC hospital failed to ensure discharge planning addressed post hospital needs for three of 11 sampled patients (Patients 123, 169 and 184). This had the potential for patients to be not cared for once discharged back into previous environment prior to hospitalization.

Findings:

The hospital failed to ensure the discharge planning evaluation for Patients 123, 169 and 184 determined their capacity for self care and/or the need for assistance. See A808.

Based on interview and medical record and hospital record review for IVMC and RSMC, both campus failed to ensure discharge planning was timely implemented for four of 11 sampled patients. (Patients 42, 123, 319, and 184) This had the potential for patients to not receive appropriate post hospital guidance or assistance prior to being discharge.

See A800 and A808.

Based on interview and record review, the hospital failed to ensure three of 11 patients (Patients 123, 184 and 169) sampled for discharge planning was evaluated for post hospital needs. The lack of discharge planning evaluation could subject patients who are discharged to further injury or illness.

Findings:

1. On 1/12/10 at 1220 hours, Patient 169 was observed with a double lumen PICC line in the left upper forearm with a continuous IV fluid infusing. The patient and family were interviewed regarding his discharge plan. Patient 169 stated he was readmitted to the hospital on 1/3/10 for a complication that developed after his last surgical procedure. The family recalled from the previous admission that Patient 169 had emergency surgery that resulted in an extensive procedure due to complications. The family did not recall if there had been any discharge planning explained to them during the previous admission. The family stated that at that time, there was one conversation with a physical therapist about stairs in the home. No discharge instructions had been provided for the previous admission. The patient and family had not received any information regarding discharge planning since being readmitted on 1/3/10.

1a. On 1/14/10, review of Patient 169's medical record showed an Admission form, dated 12/28/09, that Patient 169 was admitted on 12/28/09, A note on this section instructed that if any risk factors were identified, to initiate a referral to Case Management (CM). A referral to CM was made on 12/29/09. Further review of the medical record showed E51 did a discharge planning assessment on 12/29/09. The only risk factor identified was for no insurance. The rest of the sections on the form were left blank. There was no further assessment of discharge needs by E51.

1b. Further review of the patient's medical record showed Patient 169 was readmitted on 1/3/10 for pain and vomiting. On 1/14/10, a review of the Admission Data Base used for the patient's readmission showed the section for determining if a CM referral was needed was not completed. The patient had been identified on the section for not having medical insurance, which was considered a risk factor. Once a risk factor was identifed on a section of the document, the case management department was to be contacted to conduct a more indepth discharge planning evaluation. Review of the Discharge Planning Extended Screen Data, completed by E159, also identified Patients 169's readmission as a risk factor.

On 1/14/10 at 1400 hours, during an interview, E158 stated she readmitted Patient 169 on 1/3/10. E158 stated the admitting nurse should have initiated the discharge care plan on admission. E158 reviewed the patient's record and stated the discharge care plan had not been initiated.


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2. The hospital failed to show within Patient 123's medical record a discharge plan evaluation and record of discussion with the patient regarding discharge needs. See A800 #1.

3. The hospital failed to show within Patient 184's medical record a discharge plan evaluation and record of discussion with the patient regarding discharge needs.See A808 #2.

Based on observation, interview, and medical record review, IVMC failed to ensure one of 11 patients sampled for discharge planning (Patient 123) received consultation for meeting post discharge needs. This had the potential for the patient to be discharged without any information to assist in meeting discharge needs.

Findings:

The hospital failed to provide discharge consultation when requested by Patient 123. See A800 #1.

Based on observation and interview, the hospital failed to ensure surgical equipment was safe for patient use. The failure could potentially cause serious patient injury, unnecessary delay of surgery, and prolonged anesthesia.

Findings:

1. At RSMC, on 1/11/10 at 1135 hours, the surgical service area was toured. In Operating Room #3, an OR table was observed placed in its lowest position. The metal cover of the base of the OR table was not completely attached to the telescoping mechanism used to raise the OR table. When E159 elevated the OR table up to its highest position, the metal cover attached to the base snapped off. Each portion of the telescoping mechanism malfunctioned and the inside contents, such as electrical cords and machine parts, were exposed. A concurrent interview with E159 revealed OR staff put an anti-embolic pump under the OR table during surgery. The staff lowered the OR table without removing the pump and the table was blocked from moving to the lowest position. M22 stated that she would notify biomedical engineering for immediate repairs.

2. A tour of the surgical suites at RSMC campus was performed on 1/11/10 at approximately 1300 hours. The temperature and humidity for each surgical suite was provided by a hand held device fixed to the wall of the surgical area. This device, or fluke as it was called by representatives from the operating room and plant maintenance, registered the room temperature and humidity. Hospital employees E141 and M46 stated that these devices had been calibrated at the factory. When asked if these devices had been re-calibrated or re-tested to ensure accuracy, representatives from the facility were unable to produce documented evidence. A review of the "Masterplan Medical Equipment Maintenance Priority Table" and "Masterplan - Medical Equipment Management Program: PM Procedures," revision date 3/08 failed to reveal evidence the flukes were included in the preventitive maintenance program. The 2008 edition of Perioperative Standards and Recommended Practices by the Association of periOperative Registered Nurses states at V.b.2 and V.c that humidity and temperature of the perioperative environment should be monitored and recorded daily using a log format or documentation provided by the HVAC system.

Based on a review of six anesthesia open and closed medical records, the hospital failed to provide documentation that was accurate and specific to the type of anesthesia services being provided for five of six records reviewed (Patients 87, 97, 98, 300, and 310). This resulted in information specific to recovery from the type of anesthesia being utilized during the surgical procedure to not be available for clinical care of the patient.

Findings:

1. Patient 97 came to the hospital on 1/11/10 for an urgent caesarean section (c-section). The surgical procedure was completed at 0130 hours using spinal anesthesia. The post-anesthesia record was labeled as "Post-Labor Epidural Evaluation" when Patient 97 had the procedure performed under spinal anesthesia. The record for "Post-Labor Epidural Evaluation" was dated, timed and signed by MD E133; however, there was no documentation that the assessment for "movement and sensation in the lower extremities" had been evaluated.

2. Patient 98 came to the hospital on 1/10/10 for a primary c-section that was completed at 1100 hours using spinal anesthesia. The post-anesthesia record was labeled as "Post-Labor Epidural Evaluation" when Patient 98 had the procedure performed under spinal anesthesia.

3. Patient 300 came to the hospital for a repeat C-section that was performed on 1/12/10. The medical record for Patient 300 revealed that the post-anesthesia record was labeled as "Post-Labor Epidural Evaluation" when Patient 300 had the procedure performed under spinal anesthesia.

4. Patient 87 came to the hospital for surgical services that was performed on 1/10/10. The medical record for Patient 87 revealed that the post-anesthesia record was labeled as "Post-Labor Epidural Evaluation" when Patient 87 had the procedure performed under spinal anesthesia.

5. Patient 310 came to the hospital for surgical services provided on 1/10/10. The medical record for Patient 310 revealed that the post-anesthesia record was labeled as "Post-Labor Epidural Evaluation" when Patient 310 had the procedure performed under spinal anesthesia.

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


1. The provision of a valid back up specialty on call schedule - See A1102.

2. ED policies were implemented by:
a. Housing patients and equipment in emergency egress corridors and in front of emergency pull stations which subjected the patients to danger from fire. See A1104 #1 and the LSC survey.

b. A process was in place to accurately document patients' arrival times in the ED. See A1104 #2.

c. Patient privacy was provided. See A1104 #3.

d. LVN assignments reflected the patients' acuities. See A1104, #4.

3. Six of 11 PAs were competent to perform MSEs. See A1112.

The cumulative effect of these systemic problems resulted in the failure by the hospital to provide quality care in a safe environment.

Based on interviews and a tour of the RSMC emergency department conducted on 1/13/10 at approximately 1400 hours, the qualified member of the medical staff failed to ensure the provision of a valid back-up physician specialty on-call schedule. This led to the possibility of the medical staff to not provide consultation services, when required, to meet the needs of its patients.

Findings:

During the on-site tour of the emergency department, a daily on call back-up physician by specialty schedule was requested. M49 produced a schedule that failed to list the name of the physician responsible for the hospitalist back-up on-call for patients requiring hospitalization. M49 stated that the hospitalist was located by computer website for the hospital intranet. However, M49 agreed that she would have difficulty contacting the physician responsible for the call in the event of computer malfunction.

Based on observation, interview and record review, the hospital failed to ensure ED policies were implemented by 1. Housing patients and equipment in emergency egress corridors and in front of emergency pull stations which subjected the patients to danger from fire for 8 ED patients and all patients in Radiology and the special procedures room; 2. Failing to have a process in place to accurately document patients arrival times in the ED which resulted in a delay in service for one of 12 sampled ED patients (Patient 16) and inaccurate/incomplete data for five of 12 sampled patients ED patients (Patients 16, 294, 295, 296, and 318); 3. Failing to provide for patient privacy. 4. Failing to have clear assignments by acuities for three of three LVNs which could potentially have an effect on the quality of the patient care (E10, E163, and E164).

Findings:

1. Review of the hospital's ED policy "Structure Standards: Emergency Department" showed the hospital had a commitment to a safe environment of care.

On 1/11/10 at 1400 hours and 1/12/10 at 0950 hours, the hospital's RSMC campus ED was toured and the following was observed on both days:

Egress from the Radiology hallway was blocked with eight ED gurneys with patients, equipment and visitors preventing safe exiting from the hallway. See A710.

2. Review of the hospital's ED policy "Structure Standards: Emergency Department" showed the hospital had as an objective to treat patients in a timely manner. On 1/11/10, at 1400 hours, the "Emergency Department Patient Log" at RSMC was reviewed. The log had the name of the patient, the patient's arrival time, discharge date and disposition. According to M13, who was interviewed concurrently this represented the patients arrival to the ED. Further review of patient records showed the arrival time on the ED log was the triage time and not the actual time the patient arrived to the ED.

According to M49, interviewed on 1/12/10 at 1530 hours, upon arrival to the ED non-ambulance patients obtained a form from the admissions clerk titled "ED Demographics." The patient was to fill out this form on arrival to the ED. The top of the form had a section for date and time of arrival.

Five of the 12 patient charts reviewed for MSE showed the following:

a. At 1015 hours on 1/11/10, Patient 16 was interviewed. He was observed to have a nasogastric tube for drainage of stomach contents. Patient 16 stated he was waiting to have emergency surgery on his abdomen. The patient and family stated he had come to the ED at approximately 2115 hours on 1/9/10 with severe abdominal pain. The patient stated it had taken two hours before he saw a nurse in the ED to evaluate the severity of his condition. During the long wait in the ED before seeing a nurse, the patient had to step outside because he was embarrassed to be seen doubled over in pain. When he did see a nurse, the family member stated the patient stated his pain was 13 on a scale of 1 to 10 with 10 being the worst pain. Review of the patient's record on 1/13/10 revealed the "ER Demographics" form did not document a time that the patient arrived at the ED. There was a hand written note on this form that said the patient was called at 2240 hours and there was no answer. The ED record revealed a nurse first saw Patient 16 at 2308 hours and he complained of a "10" pain. Interview with Patient 16 at 1600 hours on 1/12/10 revealed the surgeon had found an intestinal blockage approximately the size of a small cantaloupe.

b. Review of the ED log for 1/11/10, showed Patient 295 arrived at 1126 hours, the triage record showed the patient as triaged at 0959 hours. The ED Demographic form sections date and time of arrival were left blank.

c. Review of the ED log for 1/12/09 showed Patient 296's arrival and triage times as 0959 hours. The ED Demographic form sections date and time of arrival were left blank.

d. Review of the ED log for 1/12/09 showed Patient 294's arrival and triage times as 1053 hours. The ED Demographic form sections date and time of arrival were left blank.

e. On 1/14/10 at 0930 hours, review of Patient 318's medical record at the IVMC campus showed a patient triage time of 1340 hours on 1/11/10. The ED Demographic form sections date and time of arrival showed the patient arrived to the hospital on 1/11/10 at 1435. When questioned about the discrepancy M13 stated sometimes the patients put down the wrong times.

On 1/13/10 at 1630 hours, M48 confirmed the ED log did not contain the arrival patient's arrival time and there was no ongoing record that accurately showed the total time a patient was in the ED.

3. On 1/11/10 at 1400 hours and 1/12/10 at 0950 hours, the hospital's RSMC campus ED was toured and the lack of patient privacy was observed on both days:

A double doorway served as an exit from the ED into the hallway of the Radiology Department. The long radiology hallway had ED patients on gurneys lining the entire right side of the hallway. A shorter hallway on the left had two patients in gurneys lining the left side which filled the left side to the exit doors. All eight patients, on both days, had no screen or curtain in front of them and all eight patients were visible to people (which included hospital staff and visitors), walking down the hall. On 1/11/10 at 1430 hours, one of the unsampled patients was uncovered and had one hand down the front of his pants.

On 4/11/10 at 1430 hours, the surveyor was conducting an interview with Patient 317 in ED Room 3. The room was intended for one patient but there were two patients in the room. A staff members discussion with the other patient was clearly audible at Patient 314's bedside.

4. Review of the hospital's ED policy Structure Standards: Emergency Department, showed assignments would consider patient needs and in another section of the Standards, LVNs receive direction from the Staff Nurse, Charge Nurse and other nurse managers. Additionally, the Structure Standards showed that patient assignments would consider patient needs and staff credentialing and certifications.

On 1/11/10 at 1355 hours M49 stated the RSMC campus ED had three LVNs on staff. At 1500 hours, on 1/11/10 M 49 was asked about the ED patient acuity system. According to M49, the ED used a five level triage system that ranged from Level 1 as the most acutely ill to Level 5 as the least acute patient.

On 1/12/10, review of the Five Level Triage P & P failed to show how the acuity would be used for assignments by staff licensure/qualifications. Further review of the ED policy Structure Standards: Emergency Department failed to show any specific direction of how LVN assignments would be made.

Based on observation, interview and record review, the hospital failed to ensure six of 11 PAs (PAs 1, 2, 6, 8, 10, and 11) were competent to perform MSEs which could potentially result in misdiagnoses and inappropriate treatments.

Findings:

1. PA1 applied for medical staff privileges and was appointed to the staff. The privileges for PA1 expired prior to the completion of proctoring for PA1. The medical staff bylaws specify concurrent and retrospective review of medical records and services provided by each PA for 10 cases, prior to appointment to the staff of the hospital.

2. PA2 was appointed to the medical staff of the hospital 3/10/09. A review of the credentials file for PA2 and interviews with M56 revealed that proctoring was completed on the evening of 1/13/10, during the survey process for the hospital. According to interviews with M56 and a review of the medical staff bylaws of the hospital, "proctoring shall consist of retrospective and concurrent case review."

3. PA6 was appointed to the medical staff of the hospital on 10/19/09. A review of the credentials file for PA6 and interviews with M56 revealed that proctoring was completed on the evening of 1/13/10, during the survey process for the hospital.

4. PA8 was appointed to the medical staff of the hospital on 4/16/07. A review of the credentials file for PA8 revealed that documentation of proctoring was performed for 9 cases on 4/30/08. This did not comply with the medical staff bylaws of the hospital that specify 10 concurrent and retrospective case reviews. When interviewed on 1/14/10 at approximately 1440 hours, PA 8 stated that she was unaware of her "responsibility to initiate contact with her proctor when treating a patient."

5. The professional credentials file for PA10 revealed that proctoring was performed for 10 cases on the same date. There was no written documentation that the medical records review was consistent with the medical staff bylaws that require concurrent and retrospective case review.

6. On 1/11/10 at 1350 hours, an interview was conducted with PA 11. PA 11 was sitting in a room designated as a MSE room. MSEs are patient examinations done to determine if a patient has an emergency medical condition. PA 11 stated that she did MSEs for ED patients and ordered tests and treatments.

On 1/12/10, a review of the credential file for PA 11 failed to show any written evidence of proctoring as required by the Medical Staff bylaws prior to appointment by the medical staff.

Based on interview and document review, the hospital failed to ensure the Respiratory Care Service's policy and procedures addressed staff competency for emergency intubation procedures which could potentially result in patient injury.

Findings:

On 1/12/10, review of the policy and procedure "Endotracheal Intubation" showed that appropriate personnel "skilled in intubation" should be assembled but did not define what constituted skilled in intubation. Also, the P&P showed that RCPs intubated infants, children, and adults.

On 1/12/10 at 1610 hours, during an interview E116 stated the RCPs competencies for the past year included neonatal intubation but did not include competencies for children and adults. E116 also added that RCPs intubated about 5 neonates a month. E116 stated the RCPs rarely intubated adults or children; usually the ED physician or an anesthesiologist intubated these patients.

On 1/13/10 at 1015 hours during interview, M53 stated that usually the ED physicians responded and performed emergency intubations in the hospital. M53 went on to confirm M52's statement that RCPs rarely intubated infants and adults but went on to add that the intubation policy allowed them to intubate in the event the ED physician was unavailable. When asked what competencies were in place for adult and pediatric intubation, M53 stated the RCPs had to have PALS (Pediatric Advanced Life Support) and ACLS (Advanced Cardiac Life Support). PALS and ACLS are courses offered through the American Heart Association but does not ensure continued competency.