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Based on interview and document review, the governing body failed to ensure that all services performed under contract:

1. Were provided in a safe and effective manner, and
2. Permitted the hospital to comply with all applicable conditions of participation, including those previously cited as deficient.

On 9/30/13 at 10:30 am, the Chief Clinical Officer (CCO) acknowledged that as recently as 8/13, the hospital had been unaware all of its service contracts. He explained that it was on 8/22/13 that he became aware of a previously unknown contract with Compounding Pharmacy A. That contract was for providing compounded medications which were mixed to order. These medications were then administered to patients intrathecally (via a small catheter) to the tissues around their spinal cord.

On 10/2/13 at 1:40 pm, the CCO further explained that, once the contract with Compounding Pharmacy A had been identified, two Performance Indicators (PIs) had been assigned: 1) verification of licensure and accreditation and 2) "all medications are delivered prior to scheduled (medication administration.)" However, those PIs had not been reviewed by a pharmacist and had not been selected to assure the medications were safe for injection. On 9/26/13 at 12:35 pm, an Immediate Jeopardy (IJ) was declared related to the questionable sterility of these compounded medications provided by Compounding Pharmacy A. (Refer to A-490 and A-500 for additional details.)

ON 10/2/13 at 1:40 pm, CCO stated that previously the hospital had not recognized the complexity of managing all of the contracts. CCO recognized that additional work needed to be done, in order that absolutely all contracts service provided under contract were identified. CCO also acknowledged that more review of the PIs was needed to make sure they all were sufficient to ensure that all conditions of participation were covered and safety was assured.

Based on observation, interview, and record review, the facility did not ensure that patient grievances were acted upon in a timely manner for four of 83 sampled inpatients when:

1. A patient informed the night shift registered nurse (RN 86) of a concern about her nursing care related to pain management, which was not reported to the nurse-in-charge nor reported to the next nurse who provided her care. This failure caused a delay in addressing the patient's concerns about her pain management care, and did not follow hospital policy. (Patient 231)

2. Two patients' complaints regarding noise during the night were not responded to, according to hospital policy. (Patients 244 and 245)

3. A request by Patient 212's family to speak to Administration regarding a problem with the patient's care was denied and not reported to Administration.

These failures resulted in patients' complaints and care concerns being unresolved, interfered with Patients 244 and 245 ability to rest/sleep, causing unnecessary anxiety and loss of sleep/needed rest on two nights, and had the potential to negatively impact their ability to recover from their illnesses.

Findings:

1. On 9/24/13 at 9:45 am, during an observation and interview on Nursing Unit 3 Main, Patient 231 stated she had informed the night nurse, RN 86, during the night (9/24/13) about her concerns with her nursing care and pain management. Patient 231 stated that on 9/20/13, a nurse had refused to give her medication when she was in pain. She stated that when she thought about how she felt, she became upset. She did not know why the nurse did not give her pain medication when she had asked for it. She stated that no one "has discussed anything" with her, and that she does not know what "happened" with her complaint.

Patient 231's record was reviewed on 9/24/13. Patient 231 was admitted to the hospital on 9/19/13, with a diagnosis of gastroenteritis - bacterial (diarrhea) infection, was alert and able to make her needs known. The record indicated that Patient 231 had a history of falls, and that she was currently recovering from a fall at home from which she sustained a left arm fracture that required a fixator (metal pins in the bone to stabilize the fracture).

The physician ordered intravenous (IV) pain medication Dilaudid (a very potent narcotic) every four hours for severe pain, on 9/19/13. On 9/20/13, Patient 231 developed low blood pressure (BP), and the nurse had to inform her that due to her low BP, she had to wait for medication. The nurse contacted the physician and obtained additional orders. The record did not contain any documentation that Patient 231 had expressed any concerns to the nurse on 9/23 to 9/24/13.

On 9/24/13 at 10:12 am, Nurse Manager (NM) 19 stated that when a patient expresses a concern or grievance to a nurse, that the nurse is to follow the chain-of-command, and immediately report to the nurse-in-charge, and to report to the next nurse that will provide that patient's care. The unit manager is informed by the charge nurse about all concerns or complaints.

On 9/24/13 between 10:15 and 10:20 am, NM 19, NM 35, and RN 87 (who was assigned to care for Patient 231) stated that they were not aware and had not been informed that Patient 231 had expressed a concern about the care she had received on 9/20/13 to nursing staff.

A hospital policy, dated 6/11, titled, "Patient Concerns, Complaints, and Grievances and/or Service Recovery - Hospitalwide" read, "The employee who initially receives a concern, complaint or grievance should resolve any problems within his/her authority immediately by using a script or your own ... words, then notify their Department Director or the House Supervisor if unable to resolve immediately... The employee who receives a concern, complaint, or grievance is responsible for notifying the appropriate Department Director. If it is after hours or the concern needs to be channeled up the chain of command, fill out the Patient Concern Hand-Off Form... Inform the patient of the process ..."

On 9/26/13 at 2 pm, NM 19 explained that the nursing staff had expressed concerns that Patient 231 was overmedicated which was causing her to have a low blood pressure and therefore were unable to provide further pain medication as requested. NM 19 stated that she did confirm with RN 86 that Patient 231 had expressed a concern about her care and no one had followed up on Patient 231's concerns according to hospital policy.


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2. a. Patient 244 was admitted to the hospital's Intensive Care Unit (ICU, for patients with the most severe and or life threatening illnesses) on 9/19/13, with diagnoses that included acute anemia (lack of red blood cells that carry oxygen to the organs) and needed blood transfused. Patient 244 was later transferred to Room 215 Bed A, 2 West Unit (a lower level of care).

During the initial tour of the hospital, on 9/23/13 at 2:20 pm, Patient 244 was observed in Room 215 Bed A. Patient 244 was interviewed and stated that it was loud at night. Patient 244 was observed to be very pale and breathing rapidly. Patient 244 stated that it had been loud last night (9/22/13) and that there had been a party the night of 9/20/13 and that it got "real loud" that night as well. Patient 244 further stated that it was, "Not fair to the people who are really sick." Patient 244 reported that she asked them (staff) to keep the noise down and confirmed that it interfered with her sleep. Patient 244 further reported that when she complained, the nurse told her that, "Nothing was going on." Patient 244 stated that although staff closed the door to the room, someone always reopened it. Patient 244 further stated that she was overtired and anxious, and now was "Afraid to stay here."

On 9/24/13, Patient 244's Physician Progress Report, dated 9/21/13, read, "...She couldn't sleep last night, she said, due to a lot of noise during the night...." The report described her as alert with no signs of neurological (brain) impairment.

Patient 244's Physician Progress Report, dated 9/23/13, read, "...She is more anxious. She said she could not sleep at night. She is complaining of feeling weak, tired..."

2b. Patient 245 was admitted to the hospital's ICU on 9/18/13, with diagnoses that included kidney injury possibly secondary to sepsis (bacteria in the blood). She was later transferred to Room 215 Bed B, 2 West Unit (a lower level of care).

During the initial tour of the hospital, on 9/23/13 at 2:22 pm, Patient 245 was observed in Room 215 Bed B. Patient 245 was interviewed and stated that it was loud at night; especially three nights ago on the evening of 9/20/13. Patient 245 stated that at 10 pm, there was a lot of laughing and yelling. Patient 245 further stated she heard a male nurse jokingly saying, "I'm falling, help me!" Patient 245 recalled that staff were yelling from one end of the hall, where there was a nurses station near their room, towards the middle of the hall, where the main nurses station was located.

On 9/23/13 at 2:30 pm, Patient 245's family member stated that he had complained to the charge nurse on the evening of 9/20/13 but that the charge nurse just, "shrugged it off." Patient 245's family member further stated that he asked the staff to close the door but they kept leaving it open. Patient 245's family member stated that it was sad they do not respect the patients; that staff will say something but then walk out and do it again.

On 9/23/13 at 2:32 pm, Patient 245 stated that on the evening of 9/20/13, it was a nurse's birthday and that the noise occurred for 30 to 45 minutes at a time several times throughout the night. Patient 245 stated that the noise interrupted her sleep on both nights (9/20 and 9/22/13).

On 9/26/13 at 9:20 am, Nurse Manager (NM) 32 was interviewed and stated she had been told there had been a patient complaint about the noise on the unit. NM 32 stated that on the evening of 9/20/13, the family member of Patient 245 had asked to stay over, due to the noise.

On 9/26/13 at 3:40 pm, the hospital's policy, titled, "Patient Concerns, Complaints, Grievances and/or Service Recovery," dated 6/22/11, was reviewed with NM 1. The policy defined, "Concern: Concern is not a complaint but an issue that is not meeting the expectation of the patient or patient representative." Procedure B showed the employee that received the complaint was responsible for notifying the appropriate Department Director or Administrative House Supervisor if unable to resolve the complaint.

NM 1 concurrently confirmed she had not received report of Patient 244 and Patient 245's complaints regarding excessive noise and that the hospital had not followed their policy for complaint resolution.



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3. A review of Patient 212's record disclosed that he was a 93 year old admitted to the facility on 8/16/13 with diagnoses that included chest pain, high blood pressure, and diabetes.

During an interview on 9/19/13 at 2 pm, Patient 212's Family Member stated that Patient 212's discharge was delayed due to a delay in getting a nuclear stress test read. His request to speak to Administration was denied and he was told that they already knew about the problem.

During an interview on 10/2/13 at 2 pm, the Director of Quality Management (DQM) confirmed that there was a delay in the discharge of Patient 212. DQM explained that this was because there was a delay in the cardiologist reading the EKG portion of the stress test. DQM confirmed that the family's request to speak to Administration was not conveyed to Administration.

Based on observation, interview, and record review, the hospital did not ensure that patient's rights were maintained for three of 83 sampled inpatients when:

1. Patient 236 was not informed of her newborn infant's (Patient 237) health status, diagnosis, and prognosis by the physician for three days.

This failure caused a patient's representative to be worried and upset, uninformed, and unable to participate in the health care decisions of her baby.

2. The facility failed to ensure that one of 83 sampled inpatients' responsible party was given necessary information regarding the initiation of an anti-psychotic medication.

This failure had the potential to result in an overall decline in the condition of the patient. (Patient 212)

Findings:

1. On 9/24/13 at 10:50 am, a tour of the mother-baby unit at the Fremont Hospital campus was conducted. Patient 236 was observed in her room with a visitor. Patient 236 stated that her baby (Patient 237), had been in the neonatal intensive care unit (NICU), since his birth, on 9/21/13. She stated that Medical Staff Member (MSM) 75, a pediatrician, saw her briefly on 9/21/13, and that he had not been in to see her since birth to give her an update or progress report about her baby, over two and one-half days ago.

Patient 236 stated that she was aware that MSM 75 or another MD had been in to see her baby, but did not come and see her. She stated that the nurses could not tell her any details about her baby, and that she felt "left out of the loop" regarding her baby's care, and that she was worried about his condition and diagnosis.

On 9/24/13 at 11 am, Nurse Manager (NM) 34 was immediately informed of the above situation. She stated that it was "not the standard of care for the mother or responsible party not to be informed of an infant's medical status, and that the expectation was for the physician to see the mother each time they see the infant, and provide medical information."

On 9/24/13, Patient 237's record was reviewed. Patient 237 was delivered on 09/21/13 at 4:04 pm, and was admitted to the NICU under the care of MSM 75 with a diagnosis that included fluid in the lungs. The record indicated that Patient 237 was seen by a physician daily since birth on 9/21/13, and was last seen on 9/24/13 at 8 am.

On 9/24/13 at 12:25 pm, NM 34 stated that she had called MSM 75, and confirmed that he had not seen Patient 236 since 9/21/13. MSM 75 had stated he "forgot" to see Patient 236 that he planned to see her today to provide her with updated information about her baby, Patient 237. NM 34 stated that she has filled out an incident occurrence, and stated that it was "inexcusable" that the mother of an infant that was in the NICU had not been seen by the pediatrician, and given a progress report.

On 9/24/13, the perinatal hospital admission packet was reviewed. A handout titled, "Speak out!" read, "Participate, talk with your physician about your child's care as you have a right to know!" Another brochure, from the CA Department of Health Services, titled, "Your Right to Make Decisions About Medical Treatment" read ...your doctor must tell you about your medical condition..."

A document, dated 2012, titled, "Patient Rights," read, "You have the right to receive information about your health status, diagnosis, prognosis, course of treatment, prospects for recovery and outcomes of care in terms you understand. You have the right to effective communication and to participate in the development and implementation of your plan of care."



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2. A review of Patient 212's record disclosed that he was a 93 year old admitted to the facility on 8/16/13 with diagnoses that included chest pain, high blood pressure, and diabetes. Admitting orders from his physician included Risperdal (an anti-psychotic medication used for patients who are not in touch with reality) 0.5 milligrams at bedtime. This was a new medication that Patient 212 had not taken prior to his admission. This medication has a boxed warning (also called a "black box" warning) which is the most serious warning required by the FDA to be placed in the product labeling (also called the package insert) for a medication. Boxed warnings document potential problems that can lead to serious injury or death. Lexicomp's Geriatric Dosage Handbook, 12th edition read as follows: "Elderly patients with dementia-related behavioral disorders treated with atypical antipsychotics are at an increase risk of cerebrovascular adverse events and death compared to placebo."

The Medication Administration Record (MAR) contained "Black Box warning" next to Risperdal. The nurses signed the MAR each time the medication was given.

A review of the plan of care in the record contained a section for education of medication to include purpose and side effects. This had not been completed for Risperdal. There was also no care plan that included this medication.

During an interview on 9/19/13 at 2 pm, Patient 212's Family Member stated that he and Patient 212's daughter were not told about changes in Patient 212's medication including the Risperdal.

During an interview on 10/2/13 at 2 pm, the Director of Quality Management (DQM) confirmed that there was no education given by the nurses and no nursing care plan that related to the use of Risperdal.

A document, dated 2012, titled, Patient Rights, read, "You have the right to receive information about your health status, diagnosis, prognosis, course of treatment, prospects for recovery and outcomes of care in terms you can understand. You have the right to effective communication and to participate in the development and implementation of your plan of care."

Based on interview and record review, the hospital failed to ensure that one of five sampled patients who were in restraints had a current care plan that addressed the restraints (Patient 224).

This failure had the potential for staff not to adequately assess and plan for the potential risks involved with using restraints, and could result in patient's anxiety, entrapment, and other physical harm.

Findings:

On 9/26/13, a record review of five patients who were in restraints within the past 24-hours was conducted.

Patient 224 was admitted to the facility on 9/22/13, with diagnoses that included respiratory failure requiring mechanical ventilation (a machine that delivers oxygen via a endotracheal tube (ET) directly into the patient's lungs). Patient 224 had soft wrist restraints (foam straps around both wrists that are tied to the bed frame) ordered by the physician to prevent her from accidentally removing this tube from her mouth.

Patient 224's record contained a document titled, "Plan of Care and Problem List," initiated on 9/22/13. It was noted that Page 8 and 9 of this Plan of Care that specifically addresses restraints had not been initiated and was blank. Patient 224's care plan did not address the patient's risk for potential restraint use, the goal for the patient to remain restraint free, and alternatives to restraints.

During a concurrent interview and record review with Nurse Manager (NM) 27 on 9/26/13 at 8:45 am, NM 27 confirmed that the section of Patient 224's Plan of Care that addresses restraints had not been initiated and that it should have been per hospital policy.

A review of the hospital policy, titled, "Restraints, Hospital-wide," dated 1/13, showed the policy required, "Plan of Care: Restraint use must be in accordance with a written modification to the patient's plan of care. Plan of care will reflect assessment, intervention and evaluation. Plan of care will also identify the patient's risk for potential restraint use, goal for the patient to remain restraint free and alternatives to restraint."

Based on staff interview and document review, the hospital failed to ensure that processes of care and operations, including several previously cited as deficient practices, were measured, analyzed, and tracked as quality indicators to demonstrate implementation of corrective actions and sustaining safe care practices. Documented evidence was lacking to show the following care processes were effectively evaluated when continued evidence of regulatory violations were identified:

1. Adequacy of nursing care plans and care provided to patients, in accordance with physicians orders and accepted standards of practice. Refer to A 385.

2. Adequacy of sterile instrument processing, compliance with isolation hand washing procedures, sterile compounding environment, cleanliness of ice machines. aseptic technique for contrast media, proper use of single use/dose products, surgical attire, and sanitary patient care environment. Refer to A 490, A 620, and A 747.

3. Adequacy of intrathecal products provided by an outside vendor. Refer to A 490.

4. Accuracy and timeliness of medical record entries. Refer to A 438 and 457.

5. The preparation, distribution, storage and usage of medications and other pharmaceuticals. Refer to A 490.

6. Timeliness of patient complaint/grievance response. Refer to A 118.

7. Emergency Services are performed according to hospital policy and accepted standards of practice. Refer to A 1100.

8. Failure to measure quality indicators for all hospital services and operations.

These failures resulted in continued care practices that jeopardized patient outcomes and safety.

Findings:

A. In an interview on 10/2/13 at 10:25 am with the Chief Quality Officer (CQO) and the Director of Quality Management (DQM), the quality program documentation was reviewed. The following practices were not measured as part of the quality program:

- Accuracy of patient weight measurements. Refer to A 396.

- Physicians orders were followed by nursing staff for oxygen administration, patient weights, and medications. Refer to A 396.

- Timeliness of patient complaint/grievance response. Refer to A 118.

- Cleanliness of ice machines. Refer to A 620.

- Expired supplies are not used for assessing pharmacy compounding product sterility; Refer to A 490 and 500.

- Medication stored at correct temperature. Refer to A 490 and 491.

- The distribution, usage and disposition of controlled substances stored in Acudose stations in the Feather River Surgical Center. Refer to A 490 and 494.

- Emergency Services are performed according to hospital policy and accepted standards of practice. Refer to A 1100 and 1112.

During the above interview, the CQO confirmed that not all processes of care and hospital services and operations were represented in the quality program, and that was identified in their next steps in building their quality program.

B. In an interview on 10/2/13 at 10:25 am, CQO stated that a Quality Improvement Organization (QIO 1) was hired to perform a "gap analysis" (the difference between current performance and expected performance) in June 2013.

The gap analysis by QIO1 was presented in a report to the hospital Special Quality Oversight Sub-Committee of the Board of Directors on 7/2/13 and contained the following observations:

1. Not all departments have department specific PI (performance improvement) indicators especially non-clinical departments.
2. Some metrics (indicators) have analysis, discussion and actions taken, however, not every applicable metric has analysis or documentation of actions taken to improve.
3. Non-compliance with surgical attire was noted.
4. Inconsistent pain reassessment.
5. Inconsistent documentation of discharge medication teaching.

The hospital Board of Directors meeting, dated 8/29/13, included a report by CQO on Regulatory/Condition of Participation compliance which primarily focused on progress made since the last survey. The report did not indicate analysis of why compliance had not been achieved or actions that were being taken to improve performance in areas of current ongoing deficient practices such as infection control, environmental cleanliness, medication storage, and monitoring of pregnant emergency room patients.

When asked how the information from the gap analysis was incorporated into the quality program, CQO acknowledged that not all items identified in the, "gap" analysis were added to the quality program.

Based on interview and record review, the hospital failed to evaluate non-compliance with regulatory quality indicators and make changes that would lead to sustainable improvement as evidenced by the following quality indicators for previously cited deficient practices that were identified as ongoing deficient practices:

- Inadequate discharge instructions. Refer to A 1112, item 1.
- Patient reassessments and vital signs are not performed, according to hospital policy. Refer to A 1112, item 2.
- Pregnant emergency room patients are not monitored, according to policy. Refer to A 1112, item 3.
- The emergency room patient's presenting complaint was not addressed in the provider's medical screening examination. Refer to A 1112.
- Staff not observing isolation precautions. Refer to A 749, item 8.
- Staff not knowledgeable of the appropriate precautions for Clostridium difficile (an antibiotic resistant microorganism). Refer to A 749, item 8.
- Patient care supplies were on the floor. Refer to A 749, item 11.
- Environment and equipment were not clean and sanitary. Refer to A 749, items 9 and 10.
- Medications are not stored securely or according to policy. Refer to A 502, items 1-3.
- Aseptic (sterile) technique was not used for parenteral (go into the circulatory system) fluids and medications. Refer to A 405, item 4.
- Medications were not properly labeled. Refer to A 405, item 5.
- Controlled substances were not dispensed, used, and disposed of, consistent with hospital policy. Refer to A 494.
- Physicians were not notified of medications that are not given. Refer to A 405, item 6.
- Scheduled medication doses were not given within 60 minutes before or after the time they are due. Refer to A 405, item 1.
- Medical record entries were not timed and dated. Refer to A 454.
- Verbal orders were not authenticated within 48 hours. Refer to A 457, items 1-7.
- Restraints were not part of the patient's care plan. Refer to A 166.

In an interview on 10/2/13 at 10:25 am with the Chief Quality Officer (CQO) and the Director of Quality Management (DQM), the quality program documentation was reviewed. CQO acknowledged that they had been monitoring over 400 indicators and have started asking "why" indicators are in the "red" (defined by the organization as less than 100% compliance). CQO acknowledged that more needed to be done to evaluate the effectiveness of their actions. CQO stated the systems problems have been addressed on these indicators and the hospital was now focused on individual compliance. CQO further stated that the hospital has to rely on a large number of outside contractors, such as traveling nurses and interim department managers, to fill vacancies and there is a disconnect in how these staff understand patient safety and quality assessment and performance improvement. When asked what training is provided to staff, CQO identified that more training was required and that they have identified that they need to redesign the orientation process to ensure compliance of all staff serving patients. CQO further elaborated that the Board (governing body) is getting "oodles" of data that is overwhelming them because it is so much more than they received in the past. CQO was encouraged because indicator trend lines were upward (positive) but acknowledged that "We are not there yet (fully compliant)."

Based on staff interview and document review, the hospital's governing body, medical staff, and administrative officials failed to ensure that the QAPI program was effective in achieving full regulatory compliance and correction of all previously identified regulatory deficiencies and related opportunities for improvement. The QAPI program is not comprehensive to address all areas of care and services, unable to effectively evaluate non-compliance, design action plans to improve performance, and ensure sustained compliance with regulatory statutes and professionally accepted standards of practice. This failure resulted in an incomplete and ineffective QAPI program that does not ensure patient safety. Refer to A-315.

Findings:

1. Review of administrative documents, demonstrated that in 6/12 the hospital's regulatory compliance was evaluated by an outside Quality Improvement Organization (QIO1) and received a lengthy Gap Analysis Report, which identified a number of specific opportunities (identified gaps in current and expected performance) to improve regulatory compliance for six regulatory Conditions of Participation, Governing Body, QAPI, Surgical Services, Nursing Services, EMTALA and Pharmacy Services. The following opportunities for improvement that had been recorded in the Gap Analysis Report include:

a. EMTALA: "Current medical staff bylaws, rules and regulations or any other document do not specify specific categories of non-physicians who can perform the MSE (medial screening exam), nor has this been approved by the Governing Body." On 10/26/13, review of the medical staff bylaws, rules and regulations and the minutes of the Medical Executive Committee (MEC) and the Governing Body, showed that no corrective action had been taken.

b. EMTALA: "Review of Emergency Department (ED) Physician Assistants (PA) and Nurse Practitioner's (NP) credentials files do not demonstrate granted privileges to perform medical screening exams." On 9/26/13 at 2:00 p.m. and 10/3/13 at 1:30 p.m., the credential files of five Allied Health Practitioners (AHP, 4 PA and 1 NP) that worked in the ED were reviewed (PA 41, PA 42, PA 43, PA 44 & NP 45). During those reviews, each of the files were noted to contain a form titled, "Medical Screen Exam" listed on their "Clinical Privileges - Emergency Medicine" and each had been properly signed before the 6/13 review by the QIO1. However, none of the five files contained any privileges relevant to care of an obstetrical patient and none documented any education, training or Professional Proficiency Evaluations relevant to obstetrical care.

c. EMTALA: "A current list of those individuals allowed to perform MSE is not up to date with staff member names."

2. On 9/26/13, the Governing Body (GB) meeting minutes were reviewed and it was noted that on 7/2/13, the GB Special Quality Sub-Committee reviewed the Gap Analysis Report provided to the hospital by QIO1. The 7/2/13 minutes do not document specific action taken to correct the various identified gaps. During further review of the GB minutes, no action items were found where the GB made a clear statement of their expectation for safety and/or quality.

3. On 9/25/13 at 9:45 a.m. during a group interview with the Chairman of the GB, the Chairman of the GB Special Quality Sub-Committee, and the Chief Executive Officer (CEO), the Chairman of the GB stated that since the new Chief Quality Officer (CQO) had started one year ago, the hospital had made some improvement; that the now the GB Special Quality Sub-Committee was meeting regularly with the CQO. He said, "we've done a pretty good job ... we're getting there, I think." Then the Quality Sub-Committee Chairman spoke and said that "We have room to grow ... clear to us (we're) making progress." Since the CQO had arrived they were "making progress" but that they "still have some difficulty (with) understanding exactly how well the hospital is doing" on correcting previous regulation deficiencies. "We take it (the "2567-report" [statement of deficiencies] and the "Plan of Correction") very seriously"..., he indicated that the GB knew the hospital was not yet fully compliant, had not yet achieved all of their goals in the Plan of Correction, but were satisfied that they were making progress. They had "hired a company (QIO1) to do a mock survey ... did well ... 89% (percent) compliance."

4. On 10/3/13 at 11:40 a.m. during an interview with the Chief Quality Officer (CQO), the 13 page "Organizational Regulatory Compliance Dashboard, Month of August 2013" (August Compliance Dashboard) was concurrently reviewed. He explained that the August Compliance Dashboard was the first ever constructed; that it was in response to the findings of the Gap Analysis Report provided by QIO-1 in June; and that it contained data collected for the departments' performances during July. He explained that the compliance targeted had been set at 100% for each of the Compliance Tracers (CT) because the federal regulations required nothing less than full compliance for each tracer that had been chosen. When asked, he said that there was a September Compliance Dashboard with data from August, and that he would provide a copy. The August Compliance Dashboard had 28 "departments" listed. However, 6 departments listed no data. For the 22 departments with data, the "Overall Compliance by Category" was 95.3%. The CQO acknowledged that the hospital had gotten a late start in analyzing regulatory compliance, especially regarding EMTALA regulations. The hospital had known of their EMTALA deficiencies since it was called to their attention during surveys in September 2012, November 2012 and February 2013. The CQO acknowledged that not all of the compliance data had been adequately collected; and that the hospital had much to do before they could achieve full compliance for all of the regulatory requirements. CQO stated that although they knew they had not yet achieved full substantial compliance for all of the previously cited deficient Conditions of Participation, they did have data to show improvement and would eventually achieve compliance.

Further review of the August Compliance Dashboard showed it contains 18 tracers under the heading "EMTALA (Monthly)", with data only for 10 of the 18 tracers. Results are less than 100 % for 5 of those 10 tracers; they are 91.0%, 40.0%, 63.3%, 90.0% and 96.4% respectively. Under the heading of "Credentialing" there are 5 tracers, each without any data. There was no evidence provided to show that additional training or other adjustments had been made to improve the hospital's monthly EMTALA regulation compliance. A September Compliance Dashboard was not provided for review.

Based on staff interview and document review, the Medical Staff failed to adhere to their Medical Staff Rules and failed to be accountable to the governing body for the quality and safety of services provided to pregnant women.

1. The medical staff permitted Anesthesiologist to provide epidural anesthesia to laboring pregnant women without the benefit of an available anesthesiologist in the event of an anesthesia related medical emergency. Refer to A347.

2. The medical staff permitted Physician Assistant's (PA) and Nurse Practitioner's (NP) to initiate Medical Screening Exams of pregnant women in the Emergency Department, without ensuring that during the credentialing process there had been clear evidence that the practitioners had been trained in obstetrical care and had undergone professional proficiency evaluation to demonstrate that they were competent to provide such care. Refer to A309, finding 1.

These failures put patients at risk for substandard care and adverse events. The cumulative effect of these systemic problems resulted in the inability of the hospital to comply with the statutorily-mandated Condition of Participation for Medical Staff.

Based on staff interview and document review, the Medical Staff failed to enforce their anesthesia department rules, and in so doing, failed to be accountable to the governing body for the quality and safety of anesthesia care provided to perinatal patients receiving epidural anesthesia (also known as neuraxial anesthesia, is a type of regional anesthesia that involves continuous injection of anesthetic medication, via pump initially placed by an anesthesiologist, into the fatty tissue that surround the nerve roots as they exit the spine) during their labor. Record review showed that 80 or more expectant mothers, per month, received epidural anesthesia in the perinatal unit without an anesthesiologist in attendance or immediately available to intervene in the event of an anesthesia related medical emergency.

Findings:

On 9/26/13 at 10:40 am, an Immediate Jeopardy (IJ) situation was declared regarding epidural anesthesia provided to laboring maternity patients on the Perinatal Unit at the Fremont campus, without the availability of an ACLS (Advanced Cardiovascular Life Support) certified anesthesia provider to provide emergent rescue in the event of an epidural anesthesia emergency situation.

During interviews (9/24/13 at 3:40 PM with Physician F, on the Perinatal Unit and 9/25/13 at 5:20 PM with Chief of Medical Staff, Vice Chief of Anesthesia, Physicians F and Chief of Quality, in the Administrative Offices) and record review (9/25/13 at 8:30 AM on the Perinatal Unit,) the hospital's practice of permitting anesthesiologists to leave the facility after initiating epidural anesthesia for maternal patients who were in active labor was confirmed. [See A-1000 for full details related to these interviews and the documents reviewed.]

Review of the Department of Anesthesia Rules and Regulations, approved 11/11, shows that the rules called for: "Practices employed in the delivery of anesthetic care shall be consistent with good anesthetic care." And, "There will be appropriate monitoring of vital signs during anesthesia, ASA (American Society of Anesthesiologists) standards for monitoring shall be considered minimal standards." The ASA standard for "Neuraxial (Epidural) Anesthesia in Obstetrics", [Further details at A-1000] states: "A physician with appropriate (anesthesia) privileges should remain readily available during the neuraxial (epidural) anesthetic to manage anesthetic complication until the patient's post-anesthesia condition is satisfactory and stable." Also, "There should be a policy to assure the availability in the facility of a physician to manage complications and to provide cardiopulmonary resuscitation (CPR) for patients receiving post-anesthesia care."

During the 9/25/13 interview at 5:20 pm with the Chief of Staff 2, the Vice Chief of Anesthesia, Anesthesiologist (Physician F), and CQO, it was acknowledged that the hospital did not have specific policies that required an anesthesiologist to be immediately available for emergency care of perinatal patients while they received epidural anesthesia during labor.

Based on interview and record review, the hospital failed to ensure admission orders were dated and signed for one of 83 insampled patients. This had the potential for inaccurate treatment and medication error.

Findings:

Patient 247 was admitted to the hospital on 9/23/13, directly from his primary care provider's office, with diagnoses that included right chest cellulitis (skin infection).

On 9/24/13, Patient 247's record was reviewed and included his admission physician orders and there was no date or time documenting when the orders were written.

On 9/24/13 at 3:05 pm, Registered Nurse 76 confirmed the admitting physician orders should have been timed and dated.

Based on observation, interview and record review, the hospital failed to ensure that the pharmacy was administered in accordance with accepted professional principles as evidenced by:

1. Failure to ensure that compounding equipment was maintained clean to facilitate effective disinfection of the compounding environment. Brown and black substances, white sticky substances, cracked side panels and a broken side panel were observed in the 2 laminar flow hoods where drug for intravenous use were prepared. Surface sampling of the laminar flow hood and the compounding environment was not performed on a periodic basis in accordance with accepted standards of practice. No surface sampling had been performed to ensure a suitable microbially controlled environment for sterile compounding.

2. Beyond-use dates for compounded sterile preparations for intravenous use were not assigned in accordance with the hospital sterile compounding policy and procedure, and current accepted professional standards of practice. Compounded sterile products prepared in batches were assigned beyond-use dates of 14 days, inconsistent with the hospital policy and USP <797> guidelines to ensure sterility and safety of the compounded sterile preparations (CSPs).

USP <797> is chapter 797 "Pharmaceutical Compounding - Sterile Preparations," in the USP National Formulary, an accepted professional standards of practice on sterile compounding.

3. Expired testing kits were used to conduct media fill tests to assess aseptic manipulative skills of staff. In addition, specimens were not incubated in accordance with manufacturer's instructions for 14 days before confirming negative result. Test kits were read at Day 13 before the end of the incubation period.

Media fill test is a test used to qualify aseptic technique of compounding personnel or processes and to ensure that the processes used are able to produce sterile product without microbial contamination.

4. The hospital failed to control and evaluate all medication products used in the hospital according to professionally accepted standards when pharmacy monthly inspections did not include storage of large volume intravenous fluids. This failure had the potential of exposing patients to ineffective or unusable medications.

5. The hospital failed to store drugs in accordance with manufacturer's directions when Lorazepam injections were stored at room temperature, and not in the refrigerator, in accordance with the manufacturer guidelines. This failure had the potential of exposing patients to ineffective or contaminated drugs.

On 10/1/13 at 11:43 am, an Immediate Jeopardy (IJ) situation was declared pertaining to the failure of the hospital to maintain the cleanliness of compounding equipment to ensure effective disinfection of the compounding environment with failure to administer environmental surveillance in accordance with accepted standards of practice to ensure a suitable microbially controlled environment for sterile compounding. The CEO, CIO, COO, CQO, CNO, and DQM were notified of the IJ situation on 10/1/13 at 3:54 pm. On 10/2/13 at 3:23 pm, the CEO, COO, CFO, CNO, CIO, CQO and DQM were notified that the IJ was abated after an immediate corrective action plan was accepted by the Department.

Findings:

1. During a tour of the IV Room (an environmental controlled room for the preparation of sterile medications) with Pharmacy Technician 3 (Pharm Tech 3) at approximately 2:15 p.m. on 9/23/13, two laminar flow hoods were observed in the IV Room, one on the right side against the wall and another one on the left side against the wall. For the laminar flow hood on the left side, brown and black substances were observed accumulating on the bottom of the right side plexiglass panel between the plexiglass and the bottom metal strip of the hood. Dark brown substance was also observed under the HEPA filter (High Efficiency Particulate Air Filter) of the hood where the back panel met the working counter of the hood. Patches of white sticky substances were observed on the inside of both plexiglass panels facing the compounding counter. For the laminar flow hood on the right side, multiple cracks were observed on both plexiglass side panels and the top panel. The right side plexiglass panel was broken with an exposed uneven edge. Pharm Tech 3 stated that the hood on the left side was the main hood used to prepare IV (intravenous, into the vein) medications for patients in the hospital including the Fremont Campus. Pharm Tech 3 also stated that the hood on the right side had not been used regularly. Pharm Tech 3 stated that she believed the brown and black substances were from spillage of medications during compounding. Pharm Tech 3 added that she removed a sample of the brown and black substance and asked the laboratory of the hospital to examine under a microscope about 2 months ago and she was told by the laboratory that no fungus was identified. When asked by the surveyor if the brown and black substances were cultured and incubated to evaluate for bacterial or other microbial growth, Pharm Tech 3 answered, "No."

A review of the certification test reports of the IV Room, dated 1/30/13 and 7/29/13, showed that the surfaces of the laminar flow hoods and the IV Room were not sampled to evaluate for the control of the compounding environment.

During a telephone interview at 3:30 p.m. on 9/27/13, Technician A identified himself as the technician who performed the certification test of the IV Room at Rideout Memorial Hospital on 7/29/13. Technician A stated that he noticed the brown and black substances around the hood on the left side and the cracked and broken plexiglass panels of the hood on the right side during his visit on 7/29/13. Technician A also stated that the brown and black substances were not cultured for evaluation of microbial growth. Technician A further stated that he recommended to the hospital to have the cracked and broken plexiglass panels replaced and to have the plexiglass panels of the hood on the left side taken out for thorough cleaning. Technician A confirmed that no surface sampling was performed during his certification visits because surface sampling was not one of the requested services.

During an interview at 11:40 a.m. on 9/30/13, Pharm 3 stated that the hood on the right side had not been used for 6 months. The hospital Infection Control Practitioner 1 (ICP1) responded that the hood needed to be maintained clean and disinfected whether or not it was being used in order to maintain the overall environment of the IV Room suitable for sterile compounding. ICP 1 indicated that surfaces needed to be cleaned before they could be effectively disinfected. ICP 1 also indicated that the brown and black substances and white sticky patches needed to be removed before the surfaces could be effectively disinfected.

According to the Guideline for Disinfection and Sterilization in Healthcare Facilities published in 2008 by the Healthcare Infection Control Practices Advisory Committee (HICPAC), disinfection describes a process that eliminates many or all pathogenic microorganisms, except bacterial spores, on inanimate objects. Factors that affect the efficacy of both disinfection and sterilization include prior cleaning of the object; organic and inorganic load present; type and level of microbial contamination. Cleaning is the removal of visible soil (e.g., organic and inorganic material) from objects and surfaces and normally is accomplished manually or mechanically using water with detergents or enzymatic products. Thorough cleaning is essential before high-level disinfection and sterilization because inorganic and organic materials that remain on the surfaces of instruments interfere with the effectiveness of these processes.

During an interview at 12:05 p.m. on 9/30/13, Pharm Tech 5 confirmed that the hospital did not do any surface sampling to evaluate the overall control of the compounding environment. Pharm Tech 5 stated that she thought surface sampling was included in the semiannual certification visit by Technician A.

A review of the hospital policy and procedure "Sterile /Compounding Quality Assurance Procedures -Pharmacy," last reviewed and approved on 4/18/13, showed that surface sampling was not included as part of the environmental surveillance procedures.

A review of the hospital pharmacy batch compounding log showed that over 800 doses of intravenous medications were prepared in the IV Room by the pharmacy staff from 7/29/13 to 9/30/13.

On 10/1/13 at 11:43 am, an Immediate Jeopardy (IJ) situation was declared pertaining to the failure of the hospital to maintain the cleanliness of compounding equipment to ensure effective disinfection of the compounding environment with failure to administer environmental surveillance in accordance with accepted standards of practice to ensure a suitable microbially controlled environment for sterile compounding. The CEO, CIO, COO, CQO, CNO, and DQM were notified of the IJ situation on 10/1/13 at 3:54 pm.

According to USP <797> for Pharmaceutical Compounding - Sterile Preparations, surface sampling is an important component of the maintenance of the suitable microbially controlled environment for compounding CSPs, especially since transfer of microbial contamination from improperly disinfected work surfaces via inadvertent touch contact by compounding personnel can be a potential source of contamination into CSPs. It is useful for evaluating facility and work surface cleaning and disinfecting procedures and employee competency in work practices such as disinfection of component/vial surface cleaning. Surface sampling shall be performed in all ISO classified areas on a periodic basis. The value of viable microbial monitoring of surfaces of components and compounding environment are realized when the data are used to identify and correct an unacceptable work practice. Sampling data shall be collected and reviewed on a routine basis as a means of evaluating the overall control of the compounding environment.

USP <797> refers to chapter 797 "Pharmaceutical Compounding - Sterile Preparations," in the USP National Formulary. It is the first set of enforceable sterile compounding standards issued by the United States Pharmacopeia (USP). USP 797 describes the guidelines, procedures and compliance requirements for compounding sterile preparations and sets the standards that apply to all settings in which sterile preparations are compounded.

On 10/2/13 at 3:23 pm, the CEO, COO, CFO, CNO, CIO, CQO and DQM were notified that the IJ was abated after an immediate corrective action plan was accepted by the Department.

2. During a tour of the hospital pharmacy at 2:05 p.m. on 9/23/13, compounded sterile preparations in the refrigerator were observed to be assigned expiration dates of 14 days. The products identified included oxytocin ( a medication for labor induction), hydromorphone (an opiate for pain control) for PCA (patient controlled analgesia) use.

During an interview at 2:05 p.m. on 9/23/13, Pharm Tech 6 stated that compounded sterile preparations prepared by the pharmacy in batches were to be assigned BUD (beyond-use dates, similar to expiration dates) of 2 days if stored at room temperature or 14 days if stored refrigerated.

A review of the batch compounding record of the hospital pharmacy showed that over 800 doses of the following products were compounded in batches since 7/29/13 and all doses were assigned expiration dates of 14 days with no storage condition specified in the record:

Hydromorphone (an opioid pain medication) in normal saline for Patient controlled Anesthesia (PCA) 20mg/100ml;

Fentanyl (an opioid pain medication) for epidural (into the space around the dura mater of the spinal cord) use in Labor and Delivery Department;

Morphine (an opioid pain medication) in normal saline for PCA use 100mg/100ml;

Fentanyl preservative free 1000mcg (micrograms) drips.

A review of the hospital policy and procedure, "Standard Operating Procedures for Sterile Compounding-Pharmacy," last approved in 1/2010, indicated under "Assigning Beyond Use Dating" that in the absence of sterility testing, storage periods and beyond-use dating for all CSPs shall not exceed the following:

For USP <797> Low Risk Level compounding - 48 hours at room temperature, 14 days at refrigerated temperature and 45 days at frozen state.

For USP <797> Medium Risk Level compounding - 30 hours at room temperature, 9 days at refrigerated temperature and 45 days at frozen state.

According to USP <797>, beyond-use date is the date and time after which a compounded sterile preparation shall not be stored or transported. The date is determined from the date or time the preparation is compounded. The above batch products involving multiple individual doses of sterile products combined or pooled to prepare a CSP that will be administered either to multiple patients or to one patient on multiple occasions are considered medium risk level CSPs. Beyond-use dates assigned to medium risk CSPs, in the absence of passing a sterility test, cannot exceed 30 hours at controlled room temperature, 9 days at cold temperature and for 45 days in solid frozen state between -25 degree and -10 degree.

During an interview at 10:05 a.m. on 9/25/13, the hospital Chief Clinical Officer, the hospital Director of Pharmacy (DOP), Pharmacist 3 (Pharm 3) and Pharmacy Technician 7 (Pharm Tech 7) were unable to state the reason for the BUD assignment on CSPs inconsistent with the hospital policy and procedure and USP <797> and they were not able to provide references to support the BUD assignment of 14 days on CSPs prepared in batches. Pharm 3, presented a document titled " Batching Guide " which indicated that fentanyl epidural, morphine PCA, hydromorphone PCA, fentanyl drips should be assigned BUD of 48 hours for storage at room temperature and 14 days for storage under refrigeration. Pharm 3 added that the batching guide was prepared by the former pharmacy clinical coordinator and had been followed by all pharmacy staff when preparing CSPs in batches. Pharm 3 was not able to provide reference to support the BUD assignment practice.

The beyond use dates (BUD) or expiration dates assigned to batch CSPs prepared by the pharmacy were not in accordance with the hospital sterile compounding policy and procedure and USP <797>, an accepted professional standards of practice, to ensure the sterility of the products and patient safety. The personnel involved in the interviews, 2 pharmacy technicians, a pharmacist, the Director of Pharmacy, the Chief Clinical Officer, were all unable to identify the inconsistency in the BUD assignments to CSPs prepared in the pharmacy and were unable provide reference to support the BUD assignment practice which deviated from the hospital policy and procedure as well as current accepted standards of practice.

3. A review of the hospital medium-risk level media-fill challenge record for 2013 showed that 3 of the 42 tests were conducted using expired test kits as follow:

Pharm 5: Media fill test performed on 5/15/2013 using test kit expired on 3/22/2013. The result was read on 5/28/13 (incubated for 13 days)

Pharm Tech 3: Media fill test performed on 7/15/13 using test kit expired on 3/22/13. The result was read on 7/28/13 (incubated for 13 days)

Pharm Tech 4: Media fill test performed on 7/1/13 using test kit expired on 3/22/13. The result was read on 7/14/13 (incubated for 13 days)

The manufacturer of the testing kit indicated on the instructions that specimens should be incubated for 14 days to confirm negative growth.

During an interview at 12:00 p.m. on 9/30/13, Pharmacy Technician 5 (Pharm Tech 5) stated that she was responsible for administering the media fill tests to pharmacy staff. Pharm Tech 5 stated that she was not sure the reason for expired test kits being used for testing and said she would use the lot number of the kit to verify the expiration date with the manufacturer. Pharm Tech 5 also acknowledged that expired testing kits were not suitable for conducting aseptic skill assessment. No additional information was provided by the hospital to support that the test kits were not expired at the time of the tests.

According to USP <797> for Pharmaceutical Compounding - Sterile Preparations, Media-filled vials are, generally incubated at 20° to 25° or at 30° to 35° for a minimum of 14 days. USP <797> refers to chapter 797 "Pharmaceutical Compounding - Sterile Preparations," in the USP National Formulary. It is the first set of enforceable sterile compounding standards issued by the United States Pharmacopeia (USP). USP 797 describes the guidelines, procedures and compliance requirements for compounding sterile preparations and sets the standards that apply to all settings in which sterile preparations are compounded.


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4. On 9/24/13 at 10:40 a.m. during a tour accompanied by registered pharmacist Pharm 3 and pharmacy technician Pharm Tech 2, an unlocked closet in a patient and visitor accessible hallway was observed on nursing unit 3West.
Inspection of the closet revealed an automated dispensing cabinet (ADC) for storing large volume parenteral solutions (LVP's administered via IV route, through the vein for hydration, nutrition or electrolyte replenishment).
Further inspection of the ADC revealed a 1000 milliliter (ml) LVP containing 20 Meq (milliequivalents) Potassium Chloride/ 5% Dextrose and 0.45% Sodium Chloride was observed stored without an overwrap or beyond use date and was available for use.
In a concurrent interview Pharm Tech 2 stated that pharmacy inspections only included medications stocked by pharmacy and as LVP's were stocked by the hospitals central supply department, they were not included in the monthly inspections.
On 9/24/13 at 12 p.m. inspection of intensive care unit ADC's that stored LVP's revealed the following without an overwrap or a beyond use date:
-5% Dextrose in Lactated Ringers injection, one 1000 ml bag.
-0.3% Potassium chloride/5% Dextrose/0.45% Sodium Chloride, one 1000 ml bags.
-0.15% Potassium chloride/5% Dextrose/0.2% Sodium Chloride, one 1000 ml bag.
-0.15% Potassium chloride in 0.9% Sodium Chloride, two 1000 ml bags.
-20 Meq Potassium chloride in 0.45% Sodium Chloride, one 1000 ml bag.
In a concurrent interview Pharm 3 acknowledged that the LVP's without overwraps should not be available for use.
Review of facility policy "Medication storage of stock" dated 6/21/13 indicated "Medications will not be removed from their containers/protective wrapping until it is time to dispense/administer the medications. "
During an interview on 9/25/13 at 11:20 a.m. director of pharmacy, DOP stated that the ADC's storing LVP's were managed by central supply and pharmacy had limited access to those ADC's. DOP acknowledged that the LVP's were medications and should be included in the pharmacy monthly inspections.
Review of facility policy "Drug Storage Inspections" dated 5/10 indicated "The department of Pharmaceutical Services is responsible for the proper security and storage and dispensing of all drugs within the pharmacy and throughout the facility. "
The Institute for Safe Medication Practices ISMP describes how the protective overwrap serves an important purpose "to control the amount of water vapor that escapes from an IV solution. Once IV bags are removed from their overwraps and exposed to room air, the rate of evaporation increases. Over time, the drug's concentration will increase because the amount of drug in the bag stays the same while amount of fluid decreases.
High levels of potassium in the body can cause muscle weakness/paralysis and cardiac conduction abnormalities (heart block, ventricular arrhythmias) per Lexi-comp (nationally recognized drug data base).

5. On 9/24/13 at 10 a.m. inspection of an ADC on nursing unit 3West, revealed injections of Lorazepam (used for agitation or seizures) 2 milligram/ milliliter stored in a drawer at room temperature.
The Lorazepam injections had a label indicating a use by date of 12/20/13. In a concurrent interview Pharm 3 stated that the date on the labels indicated the injections were good for 90 days out of the refrigerator.
The manufacturer of the Lorazepam injections indicated on the package insert "Keep in a refrigerator 2° to 8°C (36° to 46°F)," (C-Celsius and F-Fahrenheit: temperature scales).
In an interview on 9/25/13 at 10:50 a.m. DOP stated that the manufacturer of the Lorazepam injections could not provide literature to support the storage of 90 days at room temperature.
Review of an email communication document provided by the facility from the manufacturer of Lorazepam injections indicated "We only have the package insert at the moment and I believe there is no information provided for the product's stability outside the refrigerator."

Based on observation, interview and record review, the hospital failed to ensure that medications were securely stored and only accessible by authorized personnel evidenced by:

Chemotherapeutic agents for intravenous use were not secured and were accessible to patients and visitors in the cancer center of the hospital.

Large volume intravenous fluids were observed in an unlocked cabinet in a patient/visitor hallway.

Medications were left at a patient's beside, without a physician's order. (Patient 243).

These failures had the potential of exposing patients or visitors to adverse effects of medications.

Findings:

1. During a tour of the pharmacy located in the cancer center of the hospital with the hospital Chief Clinical Officer (CCO) and Director of Pharmacy (DOP) at 9:10 a.m. on 9/25/13, three bags of chemotherapeutic agents prepared for patients were found on the counter of the pharmacy accessible from the outside of the pharmacy. The access to the counter was unrestricted with barriers limiting access.

During an interview at 9:15 a.m. on 9/25/13, the Pharmacist in charge (Pharm 4) stated that prepared chemotherapeutic agents were placed on the counter to provide easy access to nursing staff. Pharm 4 acknowledged that there was no barrier restricting non-authorized personnel such as patients and visitors from approaching the counter and accessing the chemotherapeutic agents.

A review of the hospital's policy and procedure on high risk medications showed that chemotherapeutic agents are identified as high alert medications. High alert medications were defined by the hospital as agents that posed a high risk of patient harm if not ordered, dispensed, administered, monitored and/or stored safely.


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2. On 9/24/13 at 10:40 a.m., during a tour accompanied by registered pharmacist (Pharm 3) and pharmacy technician (Pharm Tech 2), an unlocked closet in a patient and visitor accessible hallway was observed on nursing unit 3West.

Inspection of the closet revealed an automated dispensing cabinet (ADC) for storing large volume parenteral solutions (LVP's- administered through the vein for hydration, nutrition or electrolyte replenishment).

The ADC was in a dark closet and the light was not working. Pharm Tech 2 acknowledged in a concurrent interview that the light was not working. Review of facility policy "Drug storage inspections," dated 5/10, indicated, "Medication storage areas must have adequate space, lighting and ventilation."

The ADC was observed to be unlocked. In a concurrent interview Pharm 3 acknowledged that the ADC should have been locked. Review of facility policy "Security of Medications," dated 3/25/11, indicated, "All drugs not in a secure area will be stored in lockable containers or areas."


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3. Patient 243 was admitted to the hospital on 9/22/13, with diagnoses that included right lower extremity (leg) cellulitis (skin infection).

During an initial tour of the hospital on 9/23/13 at 9:20 am, with Nurse Manager (NM) 1, Patient 243 was observed in his isolation room (private room for patients with multi drug resistant organisms to minimize cross contamination between patients) while Registered Nurse (RN) 84 was performing care. There was an Lantus insulin pen (prescribed medication to treat diabetes stored in multi dose injector) observed on the window sill and an albuterol inhaler (prescribed rescue inhaler for asthma) was observed on Patient 243's bedside table.

Upon our exit from the room, the Lantus insulin pen and albuterol inhaler were left in the room. When RN 84 was asked why she left the medications in the room, she stated that she leaves them in the room because it is an isolation room. NM 1 was asked if it was the hospital's policy to leave medications at the bedside in isolation room. NM 1 stated that it was not the hospital's policy to leave medications in isolation rooms and that the physician had to write an order to keep the medications at the bedside. NM 1 confirmed the hospital had not obtained an order to keep Patient 243's medications at the bedside.

On 9/23/13 at 11:45 am, Patient 243's family member was observed at the bedside and stated that Patient 243 had kept his inhaler on his bedside table because he needed and used it for his asthma.

The hospital's Medication Administration - Hospitalwide policy, dated 9/24/12, showed that "Medication may be given only upon the specific order of the physician." Under the section titled, "Medications Left At Patient's Bedside:...included Bronchial inhalants...There must be a physician's order for medications to be left at the patient's bedside...The medication and dose must be recorded by the nurse on the MAR (medication administration record) when it is taken by the patient."

On 10/1/13 at 9:15 am, Chief Nursing Officer (CNO) stated that medications should go home or to the pharmacy and that the hospital had not followed their policy for medications left at the bedside. She confirmed that medications were not to be left at the bedside without a physician's order. CNO confirmed that it was not the hospital's policy to leave medications at the bedside in isolation rooms.

Based on interview and record review, the hospital failed to ensure that anesthesia services provided were consistent with recognized standards for anesthesia care when anesthesia services were not staffed in such a manner as to ensure the health and safety of patients receiving laboring epidural anesthesia (continuous injection of an anesthetic agent via pump, initially placed by an Anesthesiologist into the epidural space-above the outer covering of the spinal cord-for pain relief in laboring women) and an anesthesia provider was not immediately available for all patients with a laboring epidural in place, at the Labor & Delivery (L&D) Unit, Fremont Hospital campus.

This failure had the potential to result in 80-100 patients per month being without immediate coverage (immediate presence in an emergency) by an anesthesia provider of patients with laboring epidurals, and an ACLS (Advanced Cardiopulmonary Life Support) trained provider present, to lend assistance in an emergency medical situation, which could result in adverse clinical outcomes, including maternal and fetal death.

On September 26, 2013 at 10:40 am, Immediate Jeopardy (IJ) was declared regarding the lack of immediate coverage (immediate presence in an emergency) by an anesthesia provider of patients with laboring epidural anesthesia, at the the Fremont Hospital campus, L&D Unit. This practice increased the risk for adverse clinical outcomes, including maternal and fetal death, for all of the facility patients with a laboring epidural anesthesia infusion. The Chief Executive Officer (CEO), Chief Operating Officer (COO), Chief Financial Officer (CFO), Chief Nursing Officer (CNO), Chief Information Officer (CIO), Chief Quality Officer (CQO) and the Director of Quality Management (DQM) were notified of the IJ situation at 2:40 pm on 9/26/13. After an acceptable immediate corrective action plan was received and approved, the IJ was abated on 9/26/13 at 5:09 pm with CQO and COO.

Findings:

During an interview on the L&D Unit at the Fremont Hospital campus, on September 24, 2013, just minutes before the beginning of the noon scheduled cesarean section, Anesthesiologist (Physician F) indicated that the anesthesia providers perform about 100 or more epidurals per month. When Physician F was questioned further about how their anesthesia staff has time to provide and monitor 100 continuous epidural infusions each month, Physician F replied that the anesthesia provider went home after placing the epidural, if they lived within 20 minutes of the hospital.

A review of the American Society of Anesthesiologists (ASA) Statement on Regional Anesthesia, Committee of Origin: Anesthesia Care Team (Approved by the ASA House of Delegates on October 12, 1983, and last amended on October 17, 2012) indicated, "Therefore, the successful performance of regional anesthesia requires medical as well as technical expertise. The medical component generally comprises the element of medical direction and includes: a. Pre-anesthetic evaluation of the patient. b. Development and prescription of the anesthetic plan. c. Ensuring that the regional anesthetic is performed in an appropriate physical environment where appropriate medications (including lipid emulsion-a rescue agent used in case of an overdose of anesthetic that can cause the heart to stop) and equipment are immediately available. d. Personal participation in the technical aspects of the regional anesthetic when appropriate. e. Following the course of the anesthetic. f. Remaining physically available for the immediate diagnosis and treatment of emergencies. g. Providing indicated post-anesthesia care."

During a review of the Guidelines for Neuraxial Anesthesia in Obstetrics, Committee of Origin: Obstetrical Anesthesia (Approved by the American Society of Anesthesiologists (ASA) House of Delegates on October 12, 1988, and last amended on October 20, 2010) indicated, "Guideline VIII. "A physician with appropriate privileges should remain readily available during the Neuraxial anesthetic to manage anesthetic complications until the patient's postanesthesia condition is satisfactory and stable." Also, "Guideline X. There should be a policy to assure the availability in the facility of a physician to manage complications and to provide cardiopulmonary resuscitation (CPR) for patients receiving postanesthesia care."

A review of the Department of Anesthesia Rules and Regulations, approved November 2011, indicated, "Practices employed in the delivery of anesthetic care shall be consistent with good anesthetic care." Also, "There will be appropriate monitoring of vital signs during anesthesia, ASA (American Society of Anesthesiologists) standards for monitoring shall be considered minimum standards." "The purpose of the Anesthesia Department shall be to provide anesthesia services and maintain a high standard of care. This shall include not only the administration of anesthetics, but also consultation for various other related care such as ...cardiopulmonary resuscitation (CPR)."

Review of the facility Medical Staff Bylaws, dated 1/2013, under "Responsibilities" indicated, "To provide continuous, timely, and high quality care to all patients for whom the Member has responsibility, while meeting the professional standards of the Medical Staff of this Hospital."

During an interview with the Perinatal Director of Labor & Delivery (PDLD) on September 24, 2013, at 3:40 pm, she was asked about the practice by the anesthesiologists to leave the Fremont Hospital campus after placing an epidural in a laboring patient. The PDLD confirmed that this practice did take place and that the L&D nurses monitored the mother and fetus after the anesthesiologist went home. The PDLD added that the anesthesiologist was available by phone. When asked if there was a physician in the house (at Fremont Hospital campus) at all times (like in the main hospital emergency department), PDLD replied, "No." "There is no physician in house at all times." When asked who comes to help L&D nurses if the patient suddenly has problems such as respiratory arrest (patient stops breathing) or cardiac arrest (patient's heart stops beating), she replied that it depended on who was at the Fremont Hospital campus. If an anesthesiologist is there, the L&D nurse would call the anesthesiologist for help with the mother and fetus. However, if the anesthesiologist is not in the building, and an Obstetrician (OB physician) was there, the L&D nurse would call the OB for help with CPR (cardiopulmonary resuscitation). If neither were there, the L&D nurse would call the Rapid Response Nurse (RRN) for help with CPR. The RRN is trained in ACLS (Advanced Cardiopulmonary Life Support). When asked if the RRN was present at the Fremont campus 24 hours a day, seven days a week, the PDLD stated that the RRN is present "most of the time." However, PDLD added that the RRN is an ICU (Intensive Care Unit) nurse and can be called away to the main Rideout Hospital campus if they need an ICU nurse. The PDLD indicated that there have been times when the RRN was not at the Fremont campus.

During a group interview on September 24, 2013, at 5:20 pm, the Chief of Staff 2, the Vice Chief of Anesthesia, Anesthesiologist (Physician F), and CQO met to discuss the lack of anesthesia provider oversight of continuous epidural infusions in laboring patients (at Fremont). Anesthesiologist Physician F stated that he feels it (physical onsite presence of the anesthesiologist at Fremont Hospital) depends on the location of the patient. If the patient is in the O.R. (Operating Room), then he feels an anesthesia provider should be there. However, if the patient has a labor epidural (and is on L&D Unit), he feels he doesn't need to be there. When asked about the average number of epidurals placed in labor & delivery patients in one month, Physician F stated that the Fremont campus has 180-200 deliveries per month, and that 50% of those patients have a laboring epidural. He further stated, "the Labor & Delivery nurses can act as our eyes, ears & hands" (in the anesthesiologist's absence). The hospital did not have specific policies that required an anesthesiologist to be immediately available for emergency care of perinatal patients while they received epidural anesthesia during labor.

On September 25, 2013, at 8:30 am, a review of the L&D Log (at Fremont) confirmed the average of 160-200 deliveries per month and that half of the patient's (50%) had epidural anesthesia for the delivery. During a concurrent interview with the PDLD, she confirmed the estimation of 100 epidurals performed per month. When she was questioned further regarding the immediate availability of an anesthesia provider when needed, she indicated that there have been at least four incidents in 2013 when the anesthesia provider did not arrive on L&D Unit in a timely fashion (delays of 30 minutes to 2 1/2 hours).

A concurrent record review of the four delayed anesthesia responses documented by the facility in 2013 included the following incidents:
1) On 6/15/13, Anesthesiologist G was called twelve times by L&D nursing staff, within a 1 1/2 hour timeframe, to come in for an unscheduled Caesarian Section (C-Section-surgical removal of baby) for a female laboring patient who had a previous history of CS. The operating crew and the patient had to wait 1 1/2 hours for the anesthesiologist to arrive.
2) On 2/20/13, Anesthesiologist F was notified at 7:08 am of plans for a C-Section to be performed at 7:30 am for a female pregnant patient who was 34-weeks pregnant and bleeding with placenta previa. Anesthesiologist F did not arrive until 8 am (52 minutes later). The situation was described as an emergency situation, and by facility policy, required a 30 minute response from the time the decision was made to operate to the operation incision time.
3) On 5/26/13, two laboring patients were in need of epidural anesthesia care. Anesthesiologist G was first paged by nursing staff at 5:55 am, paged again at 7:13 am, and paged again at 7:43 am. Anesthesiologist G did not arrive to the hospital until 7:57 am, two hours after first being paged by nursing staff.
4) On 6/28/13, Anesthesiologist G was paged by nursing staff "multiple times" for a laboring patient who was waiting for epidural anesthesia pain relief for 2 1/2 hours, due to Anesthesiologist G's failure to respond.

On September 26, 2013 at 10:40 am, IJ was declared regarding the lack of immediate coverage (immediate presence in an emergency) by an anesthesia provider of patients with laboring epidural anesthesia, at the the Fremont Hospital campus, L&D Unit. This practice increased the risk for adverse clinical outcomes, including maternal and fetal death, for all of the facility patients with a laboring epidural anesthesia infusion. The CEO, COO, CFO, CNO, CIO, CQO, and the DQM were notified of the Immediate Jeopardy situation at 2:40 pm on 9/26/13.

On September 26, 2013 at 5:00 pm, the facility presented the following immediate corrective action plan to remove the IJ: A policy entitled, "Policy Defining Availability of Anesthesiologists Infusing Epidurals for Obstetric Patients-Anesthesia Services. Policy: 1. The anesthesia provider must remain physically present at Fremont Medical Center campus after placing epidural catheters in obstetric patients while those epidural catheters are infusing and the anesthesia provider must be immediately available to respond to the needs of the patient."

On September 26, 2013 at 5:09 pm, the IJ was abated, based on the implementation of the above immediate corrective action plan, with CQO and COO.

Based on interview and record review, the facility failed to ensure that the needs of patients seen in the Emergency Department (ED) met acceptable standards of practice as evidenced by:

1. Failure to provide adequate discharge instructions for one of 65 sampled ED patients. Refer to A 1112, item 1.

2. Failure to perform patient reassessments and vital signs for one of 65 sampled ED patients. Refer to A 1112, item 2.

3. Failure to provide fetal monitoring for one of 65 sampled ED patients. Refer to A 1112, item 3.

4. Failure to perform an adequate and timely evaluation of a potential heart attack for one of 65 sampled ED patients. Refer to A 1112, item 4.

Thes failures resulted in the potential for increased adverse outcomes when emergency conditions are not promptly recognized and treated. The cumulative effect of these systemic problems resulted in the facility's inability to comply with the statutorily mandated Condition of Participation: Emergency Services.

Based on observation, interview, and record review, the facility did not ensure that patient grievances were acted upon in a timely manner for four of 83 sampled inpatients when:

1. A patient informed the night shift registered nurse (RN 86) of a concern about her nursing care related to pain management, which was not reported to the nurse-in-charge nor reported to the next nurse who provided her care. This failure caused a delay in addressing the patient's concerns about her pain management care, and did not follow hospital policy. (Patient 231)

2. Two patients' complaints regarding noise during the night were not responded to, according to hospital policy. (Patients 244 and 245)

3. A request by Patient 212's family to speak to Administration regarding a problem with the patient's care was denied and not reported to Administration.

These failures resulted in patients' complaints and care concerns being unresolved, interfered with Patients 244 and 245 ability to rest/sleep, causing unnecessary anxiety and loss of sleep/needed rest on two nights, and had the potential to negatively impact their ability to recover from their illnesses.

Findings:

1. On 9/24/13 at 9:45 am, during an observation and interview on Nursing Unit 3 Main, Patient 231 stated she had informed the night nurse, RN 86, during the night (9/24/13) about her concerns with her nursing care and pain management. Patient 231 stated that on 9/20/13, a nurse had refused to give her medication when she was in pain. She stated that when she thought about how she felt, she became upset. She did not know why the nurse did not give her pain medication when she had asked for it. She stated that no one "has discussed anything" with her, and that she does not know what "happened" with her complaint.

Patient 231's record was reviewed on 9/24/13. Patient 231 was admitted to the hospital on 9/19/13, with a diagnosis of gastroenteritis - bacterial (diarrhea) infection, was alert and able to make her needs known. The record indicated that Patient 231 had a history of falls, and that she was currently recovering from a fall at home from which she sustained a left arm fracture that required a fixator (metal pins in the bone to stabilize the fracture).

The physician ordered intravenous (IV) pain medication Dilaudid (a very potent narcotic) every four hours for severe pain, on 9/19/13. On 9/20/13, Patient 231 developed low blood pressure (BP), and the nurse had to inform her that due to her low BP, she had to wait for medication. The nurse contacted the physician and obtained additional orders. The record did not contain any documentation that Patient 231 had expressed any concerns to the nurse on 9/23 to 9/24/13.

On 9/24/13 at 10:12 am, Nurse Manager (NM) 19 stated that when a patient expresses a concern or grievance to a nurse, that the nurse is to follow the chain-of-command, and immediately report to the nurse-in-charge, and to report to the next nurse that will provide that patient's care. The unit manager is informed by the charge nurse about all concerns or complaints.

On 9/24/13 between 10:15 and 10:20 am, NM 19, NM 35, and RN 87 (who was assigned to care for Patient 231) stated that they were not aware and had not been informed that Patient 231 had expressed a concern about the care she had received on 9/20/13 to nursing staff.

A hospital policy, dated 6/11, titled, "Patient Concerns, Complaints, and Grievances and/or Service Recovery - Hospitalwide" read, "The employee who initially receives a concern, complaint or grievance should resolve any problems within his/her authority immediately by using a script or your own ... words, then notify their Department Director or the House Supervisor if unable to resolve immediately... The employee who receives a concern, complaint, or grievance is responsible for notifying the appropriate Department Director. If it is after hours or the concern needs to be channeled up the chain of command, fill out the Patient Concern Hand-Off Form... Inform the patient of the process ..."

On 9/26/13 at 2 pm, NM 19 explained that the nursing staff had expressed concerns that Patient 231 was overmedicated which was causing her to have a low blood pressure and therefore were unable to provide further pain medication as requested. NM 19 stated that she did confirm with RN 86 that Patient 231 had expressed a concern about her care and no one had followed up on Patient 231's concerns according to hospital policy.


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2. a. Patient 244 was admitted to the hospital's Intensive Care Unit (ICU, for patients with the most severe and or life threatening illnesses) on 9/19/13, with diagnoses that included acute anemia (lack of red blood cells that carry oxygen to the organs) and needed blood transfused. Patient 244 was later transferred to Room 215 Bed A, 2 West Unit (a lower level of care).

During the initial tour of the hospital, on 9/23/13 at 2:20 pm, Patient 244 was observed in Room 215 Bed A. Patient 244 was interviewed and stated that it was loud at night. Patient 244 was observed to be very pale and breathing rapidly. Patient 244 stated that it had been loud last night (9/22/13) and that there had been a party the night of 9/20/13 and that it got "real loud" that night as well. Patient 244 further stated that it was, "Not fair to the people who are really sick." Patient 244 reported that she asked them (staff) to keep the noise down and confirmed that it interfered with her sleep. Patient 244 further reported that when she complained, the nurse told her that, "Nothing was going on." Patient 244 stated that although staff closed the door to the room, someone always reopened it. Patient 244 further stated that she was overtired and anxious, and now was "Afraid to stay here."

On 9/24/13, Patient 244's Physician Progress Report, dated 9/21/13, read, "...She couldn't sleep last night, she said, due to a lot of noise during the night...." The report described her as alert with no signs of neurological (brain) impairment.

Patient 244's Physician Progress Report, dated 9/23/13, read, "...She is more anxious. She said she could not sleep at night. She is complaining of feeling weak, tired..."

2b. Patient 245 was admitted to the hospital's ICU on 9/18/13, with diagnoses that included kidney injury possibly secondary to sepsis (bacteria in the blood). She was later transferred to Room 215 Bed B, 2 West Unit (a lower level of care).

During the initial tour of the hospital, on 9/23/13 at 2:22 pm, Patient 245 was observed in Room 215 Bed B. Patient 245 was interviewed and stated that it was loud at night; especially three nights ago on the evening of 9/20/13. Patient 245 stated that at 10 pm, there was a lot of laughing and yelling. Patient 245 further stated she heard a male nurse jokingly saying, "I'm falling, help me!" Patient 245 recalled that staff were yelling from one end of the hall, where there was a nurses station near their room, towards the middle of the hall, where the main nurses station was located.

On 9/23/13 at 2:30 pm, Patient 245's family member stated that he had complained to the charge nurse on the evening of 9/20/13 but that the charge nurse just, "shrugged it off." Patient 245's family member further stated that he asked the staff to close the door but they kept leaving it open. Patient 245's family member stated that it was sad they do not respect the patients; that staff will say something but then walk out and do it again.

On 9/23/13 at 2:32 pm, Patient 245 stated that on the evening of 9/20/13, it was a nurse's birthday and that the noise occurred for 30 to 45 minutes at a time several times throughout the night. Patient 245 stated that the noise interrupted her sleep on both nights (9/20 and 9/22/13).

On 9/26/13 at 9:20 am, Nurse Manager (NM) 32 was interviewed and stated she had been told there had been a patient complaint about the noise on the unit. NM 32 stated that on the evening of 9/20/13, the family member of Patient 245 had asked to stay over, due to the noise.

On 9/26/13 at 3:40 pm, the hospital's policy, titled, "Patient Concerns, Complaints, Griev

Based on observation, interview, and record review, the hospital did not ensure that patient's rights were maintained for three of 83 sampled inpatients when:

1. Patient 236 was not informed of her newborn infant's (Patient 237) health status, diagnosis, and prognosis by the physician for three days.

This failure caused a patient's representative to be worried and upset, uninformed, and unable to participate in the health care decisions of her baby.

2. The facility failed to ensure that one of 83 sampled inpatients' responsible party was given necessary information regarding the initiation of an anti-psychotic medication.

This failure had the potential to result in an overall decline in the condition of the patient. (Patient 212)

Findings:

1. On 9/24/13 at 10:50 am, a tour of the mother-baby unit at the Fremont Hospital campus was conducted. Patient 236 was observed in her room with a visitor. Patient 236 stated that her baby (Patient 237), had been in the neonatal intensive care unit (NICU), since his birth, on 9/21/13. She stated that Medical Staff Member (MSM) 75, a pediatrician, saw her briefly on 9/21/13, and that he had not been in to see her since birth to give her an update or progress report about her baby, over two and one-half days ago.

Patient 236 stated that she was aware that MSM 75 or another MD had been in to see her baby, but did not come and see her. She stated that the nurses could not tell her any details about her baby, and that she felt "left out of the loop" regarding her baby's care, and that she was worried about his condition and diagnosis.

On 9/24/13 at 11 am, Nurse Manager (NM) 34 was immediately informed of the above situation. She stated that it was "not the standard of care for the mother or responsible party not to be informed of an infant's medical status, and that the expectation was for the physician to see the mother each time they see the infant, and provide medical information."

On 9/24/13, Patient 237's record was reviewed. Patient 237 was delivered on 09/21/13 at 4:04 pm, and was admitted to the NICU under the care of MSM 75 with a diagnosis that included fluid in the lungs. The record indicated that Patient 237 was seen by a physician daily since birth on 9/21/13, and was last seen on 9/24/13 at 8 am.

On 9/24/13 at 12:25 pm, NM 34 stated that she had called MSM 75, and confirmed that he had not seen Patient 236 since 9/21/13. MSM 75 had stated he "forgot" to see Patient 236 that he planned to see her today to provide her with updated information about her baby, Patient 237. NM 34 stated that she has filled out an incident occurrence, and stated that it was "inexcusable" that the mother of an infant that was in the NICU had not been seen by the pediatrician, and given a progress report.

On 9/24/13, the perinatal hospital admission packet was reviewed. A handout titled, "Speak out!" read, "Participate, talk with your physician about your child's care as you have a right to know!" Another brochure, from the CA Department of Health Services, titled, "Your Right to Make Decisions About Medical Treatment" read ...your doctor must tell you about your medical condition..."

A document, dated 2012, titled, "Patient Rights," read, "You have the right to receive information about your health status, diagnosis, prognosis, course of treatment, prospects for recovery and outcomes of care in terms you understand. You have the right to effective communication and to participate in the development and implementation of your plan of care."



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2. A review of Patient 212's record disclosed that he was a 93 year old admitted to the facility on 8/16/13 with diagnoses that included chest pain, high blood pressure, and diabetes. Admitting orders from his physician included Risperdal (an anti-psychotic medication used for patients who are not in touch with reality) 0.5 milligrams at bedtime. This was a new medication that Patient 212 had not taken prior to his admission. This medication has a boxed warning (also called a "black box" warning) which is the most serious warning required by the FDA to be placed in the product labeling (also called the package insert) for a medication. Boxed warnings document potential problems that can lead to serious injury or death. Lexicomp's Geriatric Dosage Handbook, 12th edition read as follows: "Elderly patients with dementia-related behavioral disorders treated with atypical antipsychotics are at an increase risk of cerebrovascular adverse events and death compared to placebo."

The Medication Administration Record (MAR) contained "Black Box warning" next to Risperdal. The nurses signed the MAR each time the medication was given.

A review of the plan of care in the record contained a section for education of medication to include purpose and side effects. This had not been completed for Risperdal. There was also no care plan that included this medication.

During an interview on 9/19/13 at 2 pm, Patient 212's Family Member stated that he and Patient 212's daughter were not told about changes in Patient 212's medication including the Risperdal.

During an interview on 10/2/13 at 2 pm, the Director of Quality Management (DQM) confirmed that there was no education given by the nurses and no nursing care plan that related to the use of Risperdal.

A document, dated 2012, titled, Patient Rights, read, "You have the right to receive information about your health status, diagnosis, prognosis, course of treatment, prospects for recovery and outcomes of care in terms you can understand. You have the right to effective communication and to participate in the development and implementation of your plan of care."

Based on staff interview and document review, the hospital failed to ensure that processes of care and operations, including several previously cited as deficient practices, were measured, analyzed, and tracked as quality indicators to demonstrate implementation of corrective actions and sustaining safe care practices. Documented evidence was lacking to show the following care processes were effectively evaluated when continued evidence of regulatory violations were identified:

1. Adequacy of nursing care plans and care provided to patients, in accordance with physicians orders and accepted standards of practice. Refer to A 385.

2. Adequacy of sterile instrument processing, compliance with isolation hand washing procedures, sterile compounding environment, cleanliness of ice machines. aseptic technique for contrast media, proper use of single use/dose products, surgical attire, and sanitary patient care environment. Refer to A 490, A 620, and A 747.

3. Adequacy of intrathecal products provided by an outside vendor. Refer to A 490.

4. Accuracy and timeliness of medical record entries. Refer to A 438 and 457.

5. The preparation, distribution, storage and usage of medications and other pharmaceuticals. Refer to A 490.

6. Timeliness of patient complaint/grievance response. Refer to A 118.

7. Emergency Services are performed according to hospital policy and accepted standards of practice. Refer to A 1100.

8. Failure to measure quality indicators for all hospital services and operations.

These failures resulted in continued care practices that jeopardized patient outcomes and safety.

Findings:

A. In an interview on 10/2/13 at 10:25 am with the Chief Quality Officer (CQO) and the Director of Quality Management (DQM), the quality program documentation was reviewed. The following practices were not measured as part of the quality program:

- Accuracy of patient weight measurements. Refer to A 396.

- Physicians orders were followed by nursing staff for oxygen administration, patient weights, and medications. Refer to A 396.

- Timeliness of patient complaint/grievance response. Refer to A 118.

- Cleanliness of ice machines. Refer to A 620.

- Expired supplies are not used for assessing pharmacy compounding product sterility; Refer to A 490 and 500.

- Medication stored at correct temperature. Refer to A 490 and 491.

- The distribution, usage and disposition of controlled substances stored in Acudose stations in the Feather River Surgical Center. Refer to A 490 and 494.

- Emergency Services are performed according to hospital policy and accepted standards of practice. Refer to A 1100 and 1112.

During the above interview, the CQO confirmed that not all processes of care and hospital services and operations were represented in the quality program, and that was identified in their next steps in building their quality program.

B. In an interview on 10/2/13 at 10:25 am, CQO stated that a Quality Improvement Organization (QIO 1) was hired to perform a "gap analysis" (the difference between current performance and expected performance) in June 2013.

The gap analysis by QIO1 was presented in a report to the hospital Special Quality Oversight Sub-Committee of the Board of Directors on 7/2/13 and contained the following observations:

1. Not all departments have department specific PI (performance improvement) indicators especially non-clinical departments.
2. Some metrics (indicators) have analysis, discussion and actions taken, however, not every applicable metric has analysis or documentation of actions taken to improve.
3. Non-compliance with surgical attire was noted.
4. Inconsistent pain reassessment.
5. Inconsistent documentation of discharge medication teaching.

The hospital Board of Directors meeting, dated 8/29/13, included a report by CQO on Regulatory/Condition of Participation compliance which primarily focused on progress made since the last survey. The report did not indicate analysis of why compliance had not been achieved or actions that were being taken to improve performance in areas of current ongoing deficient practices such as infection control, environmental cleanliness, medication storage, and monitoring of pregnant emergency room patients.

When asked how the information from the gap analysis was incorporated into the quality program, CQO acknowledged that not all items identified in the, "gap" analysis were added to the quality program.

Based on observation, interview and record review, the hospital failed to ensure that the pharmacy was administered in accordance with accepted professional principles as evidenced by:

1. Failure to ensure that compounding equipment was maintained clean to facilitate effective disinfection of the compounding environment. Brown and black substances, white sticky substances, cracked side panels and a broken side panel were observed in the 2 laminar flow hoods where drug for intravenous use were prepared. Surface sampling of the laminar flow hood and the compounding environment was not performed on a periodic basis in accordance with accepted standards of practice. No surface sampling had been performed to ensure a suitable microbially controlled environment for sterile compounding.

2. Beyond-use dates for compounded sterile preparations for intravenous use were not assigned in accordance with the hospital sterile compounding policy and procedure, and current accepted professional standards of practice. Compounded sterile products prepared in batches were assigned beyond-use dates of 14 days, inconsistent with the hospital policy and USP <797> guidelines to ensure sterility and safety of the compounded sterile preparations (CSPs).

USP <797> is chapter 797 "Pharmaceutical Compounding - Sterile Preparations," in the USP National Formulary, an accepted professional standards of practice on sterile compounding.

3. Expired testing kits were used to conduct media fill tests to assess aseptic manipulative skills of staff. In addition, specimens were not incubated in accordance with manufacturer's instructions for 14 days before confirming negative result. Test kits were read at Day 13 before the end of the incubation period.

Media fill test is a test used to qualify aseptic technique of compounding personnel or processes and to ensure that the processes used are able to produce sterile product without microbial contamination.

4. The hospital failed to control and evaluate all medication products used in the hospital according to professionally accepted standards when pharmacy monthly inspections did not include storage of large volume intravenous fluids. This failure had the potential of exposing patients to ineffective or unusable medications.

5. The hospital failed to store drugs in accordance with manufacturer's directions when Lorazepam injections were stored at room temperature, and not in the refrigerator, in accordance with the manufacturer guidelines. This failure had the potential of exposing patients to ineffective or contaminated drugs.

On 10/1/13 at 11:43 am, an Immediate Jeopardy (IJ) situation was declared pertaining to the failure of the hospital to maintain the cleanliness of compounding equipment to ensure effective disinfection of the compounding environment with failure to administer environmental surveillance in accordance with accepted standards of practice to ensure a suitable microbially controlled environment for sterile compounding. The CEO, CIO, COO, CQO, CNO, and DQM were notified of the IJ situation on 10/1/13 at 3:54 pm. On 10/2/13 at 3:23 pm, the CEO, COO, CFO, CNO, CIO, CQO and DQM were notified that the IJ was abated after an immediate corrective action plan was accepted by the Department.

Findings:

1. During a tour of the IV Room (an environmental controlled room for the preparation of sterile medications) with Pharmacy Technician 3 (Pharm Tech 3) at approximately 2:15 p.m. on 9/23/13, two laminar flow hoods were observed in the IV Room, one on the right side against the wall and another one on the left side against the wall. For the laminar flow hood on the left side, brown and black substances were observed accumulating on the bottom of the right side plexiglass panel between the plexiglass and the bottom metal strip of the hood. Dark brown substance was also observed under the HEPA filter (High Efficiency Particulate Air Filter) of the hood where the back panel met the working counter of the hood. Patches of white sticky substances were observed on the inside of both plexiglass panels facing the compounding counter. For the laminar flow hood on the right side, multiple cracks were observed on both plexiglass side panels and the top panel. The right side plexiglass panel was broken with an exposed uneven edge. Pharm Tech 3 stated that the hood on the left side was the main hood used to prepare IV (intravenous, into the vein) medications for patients in the hospital including the Fremont Campus. Pharm Tech 3 also stated that the hood on the right side had not been used regularly. Pharm Tech 3 stated that she believed the brown and black substances were from spillage of medications during compounding. Pharm Tech 3 added that she removed a sample of the brown and black substance and asked the laboratory of the hospital to examine under a microscope about 2 months ago and she was told by the laboratory that no fungus was identified. When asked by the surveyor if the brown and black substances were cultured and incubated to evaluate for bacterial or other microbial growth, Pharm Tech 3 answered, "No."

A review of the certification test reports of the IV Room, dated 1/30/13 and 7/29/13, showed that the surfaces of the laminar flow hoods and the IV Room were not sampled to evaluate for the control of the compounding environment.

During a telephone interview at 3:30 p.m. on 9/27/13, Technician A identified himself as the technician who performed the certification test of the IV Room at Rideout Memorial Hospital on 7/29/13. Technician A stated that he noticed the brown and black substances around the hood on the left side and the cracked and broken plexiglass panels of the hood on the right side during his visit on 7/29/13. Technician A also stated that the brown and black substances were not cultured for evaluation of microbial growth. Technician A further stated that he recommended to the hospital to have the cracked and broken plexiglass panels replaced and to have the plexiglass panels of the hood on the left side taken out for thorough cleaning. Technician A confirmed that no surface sampling was performed during his certification visits because surface sampling was not one of the requested services.

During an interview at 11:40 a.m. on 9/30/13, Pharm 3 stated that the hood on the right side had not been used for 6 months. The hospital Infection Control Practitioner 1 (ICP1) responded that the hood needed to be maintained clean and disinfected whether or not it was being used in order to maintain the overall environment of the IV Room suitable for sterile compounding. ICP 1 indicated that surfaces needed to be cleaned before they could be effectively disinfected. ICP 1 also indicated that the brown and black substances and white sticky patches needed to be removed before the surfaces could be effectively disinfected.

According to the Guideline for Disinfection and Sterilization in Healthcare Facilities published in 2008 by the Healthcare Infection Control Practices Advisory Committee (HICPAC), disinfection describes a process that eliminates many or all pathogenic microorganisms, except bacterial spores, on inanimate objects. Factors that affect the efficacy of both disinfection and sterilization include prior cleaning of the object; organic and inorganic load present; type and level of microbial contamination. Cleaning is the removal of visible soil (e.g., organic and inorganic material) from objects and surfaces and normally is accomplished manually or mechanically using water with detergents or enzymatic products. Thorough cleaning is essential before high-level disinfection and sterilization because inorganic and organic materials that remain on the surfaces of instruments interfere with the effectiveness of these processes.

During an interview at 12:05 p.m. on 9/30/13, Pharm Tech 5 confirmed that the hospital did not do any surface sampling to evaluate the overall control of the compounding environment. Pharm Tech 5 stated that she thought surface sampling was included in the semiannual certification visit by Technician A.

A review of the hospital policy

Based on observation, interview and record review, the hospital failed to ensure that medications were securely stored and only accessible by authorized personnel evidenced by:

Chemotherapeutic agents for intravenous use were not secured and were accessible to patients and visitors in the cancer center of the hospital.

Large volume intravenous fluids were observed in an unlocked cabinet in a patient/visitor hallway.

Medications were left at a patient's beside, without a physician's order. (Patient 243).

These failures had the potential of exposing patients or visitors to adverse effects of medications.

Findings:

1. During a tour of the pharmacy located in the cancer center of the hospital with the hospital Chief Clinical Officer (CCO) and Director of Pharmacy (DOP) at 9:10 a.m. on 9/25/13, three bags of chemotherapeutic agents prepared for patients were found on the counter of the pharmacy accessible from the outside of the pharmacy. The access to the counter was unrestricted with barriers limiting access.

During an interview at 9:15 a.m. on 9/25/13, the Pharmacist in charge (Pharm 4) stated that prepared chemotherapeutic agents were placed on the counter to provide easy access to nursing staff. Pharm 4 acknowledged that there was no barrier restricting non-authorized personnel such as patients and visitors from approaching the counter and accessing the chemotherapeutic agents.

A review of the hospital's policy and procedure on high risk medications showed that chemotherapeutic agents are identified as high alert medications. High alert medications were defined by the hospital as agents that posed a high risk of patient harm if not ordered, dispensed, administered, monitored and/or stored safely.


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2. On 9/24/13 at 10:40 a.m., during a tour accompanied by registered pharmacist (Pharm 3) and pharmacy technician (Pharm Tech 2), an unlocked closet in a patient and visitor accessible hallway was observed on nursing unit 3West.

Inspection of the closet revealed an automated dispensing cabinet (ADC) for storing large volume parenteral solutions (LVP's- administered through the vein for hydration, nutrition or electrolyte replenishment).

The ADC was in a dark closet and the light was not working. Pharm Tech 2 acknowledged in a concurrent interview that the light was not working. Review of facility policy "Drug storage inspections," dated 5/10, indicated, "Medication storage areas must have adequate space, lighting and ventilation."

The ADC was observed to be unlocked. In a concurrent interview Pharm 3 acknowledged that the ADC should have been locked. Review of facility policy "Security of Medications," dated 3/25/11, indicated, "All drugs not in a secure area will be stored in lockable containers or areas."


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3. Patient 243 was admitted to the hospital on 9/22/13, with diagnoses that included right lower extremity (leg) cellulitis (skin infection).

During an initial tour of the hospital on 9/23/13 at 9:20 am, with Nurse Manager (NM) 1, Patient 243 was observed in his isolation room (private room for patients with multi drug resistant organisms to minimize cross contamination between patients) while Registered Nurse (RN) 84 was performing care. There was an Lantus insulin pen (prescribed medication to treat diabetes stored in multi dose injector) observed on the window sill and an albuterol inhaler (prescribed rescue inhaler for asthma) was observed on Patient 243's bedside table.

Upon our exit from the room, the Lantus insulin pen and albuterol inhaler were left in the room. When RN 84 was asked why she left the medications in the room, she stated that she leaves them in the room because it is an isolation room. NM 1 was asked if it was the hospital's policy to leave medications at the bedside in isolation room. NM 1 stated that it was not the hospital's policy to leave medications in isolation rooms and that the physician had to write an order to keep the medications at the bedside. NM 1 confirmed the hospital had not obtained an order to keep Patient 243's medications at the bedside.

On 9/23/13 at 11:45 am, Patient 243's family member was observed at the bedside and stated that Patient 243 had kept his inhaler on his bedside table because he needed and used it for his asthma.

The hospital's Medication Administration - Hospitalwide policy, dated 9/24/12, showed that "Medication may be given only upon the specific order of the physician." Under the section titled, "Medications Left At Patient's Bedside:...included Bronchial inhalants...There must be a physician's order for medications to be left at the patient's bedside...The medication and dose must be recorded by the nurse on the MAR (medication administration record) when it is taken by the patient."

On 10/1/13 at 9:15 am, Chief Nursing Officer (CNO) stated that medications should go home or to the pharmacy and that the hospital had not followed their policy for medications left at the bedside. She confirmed that medications were not to be left at the bedside without a physician's order. CNO confirmed that it was not the hospital's policy to leave medications at the bedside in isolation rooms.

Based on interview and record review, the hospital failed to ensure that anesthesia services provided were consistent with recognized standards for anesthesia care when anesthesia services were not staffed in such a manner as to ensure the health and safety of patients receiving laboring epidural anesthesia (continuous injection of an anesthetic agent via pump, initially placed by an Anesthesiologist into the epidural space-above the outer covering of the spinal cord-for pain relief in laboring women) and an anesthesia provider was not immediately available for all patients with a laboring epidural in place, at the Labor & Delivery (L&D) Unit, Fremont Hospital campus.

This failure had the potential to result in 80-100 patients per month being without immediate coverage (immediate presence in an emergency) by an anesthesia provider of patients with laboring epidurals, and an ACLS (Advanced Cardiopulmonary Life Support) trained provider present, to lend assistance in an emergency medical situation, which could result in adverse clinical outcomes, including maternal and fetal death.

On September 26, 2013 at 10:40 am, Immediate Jeopardy (IJ) was declared regarding the lack of immediate coverage (immediate presence in an emergency) by an anesthesia provider of patients with laboring epidural anesthesia, at the the Fremont Hospital campus, L&D Unit. This practice increased the risk for adverse clinical outcomes, including maternal and fetal death, for all of the facility patients with a laboring epidural anesthesia infusion. The Chief Executive Officer (CEO), Chief Operating Officer (COO), Chief Financial Officer (CFO), Chief Nursing Officer (CNO), Chief Information Officer (CIO), Chief Quality Officer (CQO) and the Director of Quality Management (DQM) were notified of the IJ situation at 2:40 pm on 9/26/13. After an acceptable immediate corrective action plan was received and approved, the IJ was abated on 9/26/13 at 5:09 pm with CQO and COO.

Findings:

During an interview on the L&D Unit at the Fremont Hospital campus, on September 24, 2013, just minutes before the beginning of the noon scheduled cesarean section, Anesthesiologist (Physician F) indicated that the anesthesia providers perform about 100 or more epidurals per month. When Physician F was questioned further about how their anesthesia staff has time to provide and monitor 100 continuous epidural infusions each month, Physician F replied that the anesthesia provider went home after placing the epidural, if they lived within 20 minutes of the hospital.

A review of the American Society of Anesthesiologists (ASA) Statement on Regional Anesthesia, Committee of Origin: Anesthesia Care Team (Approved by the ASA House of Delegates on October 12, 1983, and last amended on October 17, 2012) indicated, "Therefore, the successful performance of regional anesthesia requires medical as well as technical expertise. The medical component generally comprises the element of medical direction and includes: a. Pre-anesthetic evaluation of the patient. b. Development and prescription of the anesthetic plan. c. Ensuring that the regional anesthetic is performed in an appropriate physical environment where appropriate medications (including lipid emulsion-a rescue agent used in case of an overdose of anesthetic that can cause the heart to stop) and equipment are immediately available. d. Personal participation in the technical aspects of the regional anesthetic when appropriate. e. Following the course of the anesthetic. f. Remaining physically available for the immediate diagnosis and treatment of emergencies. g. Providing indicated post-anesthesia care."

During a review of the Guidelines for Neuraxial Anesthesia in Obstetrics, Committee of Origin: Obstetrical Anesthesia (Approved by the American Society of Anesthesiologists (ASA) House of Delegates on October 12, 1988, and last amended on October 20, 2010) indicated, "Guideline VIII. "A physician with appropriate privileges should remain readily available during the Neuraxial anesthetic to manage anesthetic complications until the patient's postanesthesia condition is satisfactory and stable." Also, "Guideline X. There should be a policy to assure the availability in the facility of a physician to manage complications and to provide cardiopulmonary resuscitation (CPR) for patients receiving postanesthesia care."

A review of the Department of Anesthesia Rules and Regulations, approved November 2011, indicated, "Practices employed in the delivery of anesthetic care shall be consistent with good anesthetic care." Also, "There will be appropriate monitoring of vital signs during anesthesia, ASA (American Society of Anesthesiologists) standards for monitoring shall be considered minimum standards." "The purpose of the Anesthesia Department shall be to provide anesthesia services and maintain a high standard of care. This shall include not only the administration of anesthetics, but also consultation for various other related care such as ...cardiopulmonary resuscitation (CPR)."

Review of the facility Medical Staff Bylaws, dated 1/2013, under "Responsibilities" indicated, "To provide continuous, timely, and high quality care to all patients for whom the Member has responsibility, while meeting the professional standards of the Medical Staff of this Hospital."

During an interview with the Perinatal Director of Labor & Delivery (PDLD) on September 24, 2013, at 3:40 pm, she was asked about the practice by the anesthesiologists to leave the Fremont Hospital campus after placing an epidural in a laboring patient. The PDLD confirmed that this practice did take place and that the L&D nurses monitored the mother and fetus after the anesthesiologist went home. The PDLD added that the anesthesiologist was available by phone. When asked if there was a physician in the house (at Fremont Hospital campus) at all times (like in the main hospital emergency department), PDLD replied, "No." "There is no physician in house at all times." When asked who comes to help L&D nurses if the patient suddenly has problems such as respiratory arrest (patient stops breathing) or cardiac arrest (patient's heart stops beating), she replied that it depended on who was at the Fremont Hospital campus. If an anesthesiologist is there, the L&D nurse would call the anesthesiologist for help with the mother and fetus. However, if the anesthesiologist is not in the building, and an Obstetrician (OB physician) was there, the L&D nurse would call the OB for help with CPR (cardiopulmonary resuscitation). If neither were there, the L&D nurse would call the Rapid Response Nurse (RRN) for help with CPR. The RRN is trained in ACLS (Advanced Cardiopulmonary Life Support). When asked if the RRN was present at the Fremont campus 24 hours a day, seven days a week, the PDLD stated that the RRN is present "most of the time." However, PDLD added that the RRN is an ICU (Intensive Care Unit) nurse and can be called away to the main Rideout Hospital campus if they need an ICU nurse. The PDLD indicated that there have been times when the RRN was not at the Fremont campus.

During a group interview on September 24, 2013, at 5:20 pm, the Chief of Staff 2, the Vice Chief of Anesthesia, Anesthesiologist (Physician F), and CQO met to discuss the lack of anesthesia provider oversight of continuous epidural infusions in laboring patients (at Fremont). Anesthesiologist Physician F stated that he feels it (physical onsite presence of the anesthesiologist at Fremont Hospital) depends on the location of the patient. If the patient is in the O.R. (Operating Room), then he feels an anesthesia provider should be there. However, if the patient has a labor epidural (and is on L&D Unit), he feels he doesn't need to be there. When asked about the average number of epidurals placed in labor & delivery patients in one month, Physician F stated that the Fremont campus has 180-200 deliveries per month, and that 50% of those patients have a laboring epidural. He further stated, "the Labor & Delivery nurses can act as our eyes, ears & hands" (in the anesthesiologist's absence). The hospita