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Based on observation, interview, medical record review and document review, the hospital failed to have an effective governing body that assumed full responsibility for the conduct of the hospital as an institution and that ensured the hospital was in compliance with all conditions of participation, as evidenced by:

1. The governing body failed to ensure the facility maintained an effective hospital-wide quality assessment and performance improvement program. (Refers to A-263)

2. The governing body failed to ensure that registered nurse employees of the facility always followed facility policy and procedure and updated care plans to prevent the formation of decubitus ulcers. (Refers to A-385)

3. The governing body did not ensure that the facility maintained a pharmaceutical service that met the needs of each patient and ensured medications were always administered in accordance with state and federal law and standards of professional practice. (Refers to A-490)

4. The governing body failed to ensure that the facility's dietary performance improvement program included a comprehensive evaluation of the full depth and breadth of the dietetic scope of services. The governing body failed to maintain an organized dietetic service that is directed and staffed by adequately qualified personnel who always use safe food handling practices. (Refers to A-618)

5. The governing body failed to ensure that the facility's environments were always sanitary and that infection controls were in place to avoid sources and transmission of infections and communicable diseases. (Refers to A-747)

6. The governing body failed to ensure that surgical services were always provided in accordance with federal and state requirements, and provided in accordance with acceptable standards of practice. This failure allowed a patient (Patient 32), to receive surgical services that were not in accordance with the patient's informed consent. (Refers to A-940)

7. The governing body did not ensure that all staff of on-and off-campus outpatient sites understood and were prepared to implement the facility's policy and procedures for emergency care within the outpatient facilities. (Refers to A -1076)

8. The governing body failed to ensure that the needs of patients seen in the emergency department meet acceptable standards of practice. (Refers to A - 1100)

The cumulative effect of these systemic problems resulted in the hospital's inability to ensure the provision of an effective and responsible governing body.

Based on observation, review of documents, policy and procedures, and clinical records, and interview of staff, the facility failed to maintain an effective, ongoing, hospital-wide, data-driven quality assessment and performance improvement program as evidenced by the following:

1. The hospital failed to ensure that the comprehensive dietary department performance improvement program included an evaluation of the current scope of service, as evidenced by a lack of evaluation to fully evaluate the depth and breadth of dietetic services. (See A 264 and A-618)

2. The facility failed to identify medication errors. (See A 266)

3. The facility failed to set priorities for performance improvement that focus on high risk or problem prone areas as Medication Use Evaluation (MUE) for fentanyl patches (Duragesic) was completed in 2008; however, there was no evidence that the results were used for performance improvement to reduce the risk of harm to patients and ensure that the medication was used appropriately. The facility failed to ensure that look-alike medications were stored in a safe manner. The facility failed to conduct random checks or audits to evaluate use of controlled substance and to detect possible theft, abuse, or misuse. (See A-285).

4. The facility failed to ensure that pharmaceutical services met the need of each patient and was administered in accordance with state and federal land standards of professional practice. Situations of immediate jeopardy situations were identified twice as relates to administration of medications (fentanyl and droperidol) (See A-490)

The cumulative effect of these systemic problems resulted in the Facility's inability to comply with the statutorily mandated Condition of Participation: Quality Assessment Performance Improvement.

Based on interviews, record reviews, and document reviews, the facility failed to ensure that all nursing services are furnished and/or supervised by a licensed registered nurse in the following instances:

1 a. Nursing staff failed to evaluate and document the progression of pressure wounds for a patient. Failure to document treatment progress may result in the delay of identification of ineffective treatments further compromising the clinical condition of patients.

2. The facility failed to ensure comprehensive care planning for one patient as evidenced by documentation of wound improvement without measurable parameters. (Refer to A 396)

3. The facility failed to ensure that medications were administered in accordance with physician order. Drugs and biologicals were not prepared and administered in accordance with Federal laws, and acceptable standards of practice. (Refer to A 404)
4. The facility failed to ensure that all entries were dated and timed in four of 18 records reviewed. (Refer to A 450)
5. The facility failed to ensure that all licensed nurses document all information regarding the patient's condition in the patient's permanent record in three of ten Emergency Department records reviewed. (Refer to A 467)
The cumulative effect of these systemic problems placed patients with decubitus ulcers that were not evaluated and documented under conditions that may delay the identification of ineffective treatments that further compromise the clinical conditions of those patients. The absence of a registered nurse to supervise and evaluate the nursing care of patients in the Sleep Study Clinic failed to ensure the statutorily-mandated compliance with the Condition of Participation: Nursing Services.

Based on food service observations, dietary and administrative staff interview, and dietary and administrative document review, the hospital failed to:

1. Ensure the availability of organized dietetic services that are directed and staffed by adequately qualified personnel (Cross Reference A 620, A 622, A 631, A 701, A 703 and A 749).

2. Provide organized dietetic services as evidenced by findings of unsafe food handling practices and lack of effective monitoring of potentially hazardous foods (Cross Reference A 620 and A 749).

The cumulative effects of these systemic problems resulted in the inability of the hospital's food and nutrition services to direct and staff in such a manner to ensure organized dietetic services and to ensure the nutritional needs of patients were met in accordance with acceptable standards of practice.

The Condition for Food and Dietetic Services was not met.

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

1. Failure to ensure that after each patient, glucometers (machines used to measure a patient's blood sugar), were cleaned and disinfected, to reduce the incidence of cross contamination (Refer to A 749, item 1).

2. Failure to ensure that all health care workers (HCW), were annually screened for evidence of Mycobacterium tuberculosis (Refer to A 749, item 2).

3. Failure to ensure that a practitioner who has the authority, to order the insertion or removal of a central venous catheter (CVC), performed a daily assessment and determined if continued use of the CVC was medically necessary (Refer to A 749, item 3).

4. Failure to ensure that endocavitary (inserted inside body cavities and have high risk of contact with mucous membranes), were cleaned and reprocessed using high level disinfection methods (Refer to A 749, item 4).

5. Failure to ensure that the patient or his or her responsible person, was notified by a physician that laboratory screening for methicillin resistant staphylococcus aureus (MRSA) was positive (Refer to A 749, item 5).

6. Failure to ensure that patients who were readmitted to the hospital within 30 days of discharge from a general acute care hospital, were screened for (MRSA), within 24 hours of admission (Refer to A 749, item 6).

7. Failure to ensure that blood pressure cuffs used in the Cancer Center were cleaned before and/or after each patients use (Refer to A 749, item 8).

8. Failure to ensure that surgical attire was not worn outside the hospital, was laundered in accordance with acceptable standards of practice, including cloth hair coverings, and personal clothing worn underneath surgical attire was completely covered (Refer to A 940, item 2).


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9. Failure to provide safe/effective dietetic services as evidenced by findings of unsafe food handling practices and lack of effective monitoring of potentially hazardous foods and practices that minimized the risk of cross contamination of patient meal trays during meal delivery (Cross Reference A 620 and A 749).

The cumulative effect of these systemic problems resulted in the inability of the hospital's infection control program and food and nutrition services ensure that patients' food were monitored in accordance with acceptable standards of practice.

Based on observation, interview, medical record review, and policy review, the hospital failed to ensure that surgical services were provided in accordance with the informed consent for one patient (Patient 32), and that surgical services were provided in accordance with acceptable standards of practice as evidence by:

* Failure to ensure that the surgical procedures performed on Patient 32 , was in accordance with informed consent signed by the patient. (Refer to A 747, item 1).

* Failure to ensure that clothing worn in surgical suites was laundered and sanitized in accordance with acceptable standards of practice, and that surgical masks were immediately removed and disposed of when exiting the surgical suite (Refer to A 747, item 2).

Findings:

1. The hospital failed to ensure that surgical procedures performed on one patient (Patient 32), were consistent with the informed consent signed by the patients prior to surgery.

On 9/1/10 at 2 pm, Patient 32's medical record was reviewed. Documentation in the medical record showed that the patient was admitted to the hospital for surgery on 10/7/09. Documentation in the medical record disclosed that the patient had signed an informed surgical consent on 10/6/09, for a laparoscopic-assisted vaginal hysterectomy (removal of uterus), and bilateral salpingo-oophorectomy (removal of fallopian tubes and ovaries).

A review of the "Correct Patient/Procedure/Site Verification Form" completed on 10/7/09 at 7:32 am, verified the patient was scheduled for a laparoscopic vaginal hysterectomy with bilateral salpingo oophorectomy. It was noted that registered nurses had completed the site verification form. Additional review of the medical record contained no evidence that the surgeon had participated in verifying the surgical procedure before surgery started.

Documentation in the physician's operative note disclosed that the patient had a laparoscopic-assisted vaginal hysterectomy.

A review of the progress notes written by the surgeon on 10/7/09 at 11 am, disclosed that, "After the surgery I became aware that the ovaries were supposed to be removed and I didn't do it. Discussed with the patient and husband. Will go back to OR for lap (Laparoscopic) BSO (bilateral salpingo-oophorectomy)."

Documentation in the medical record showed that on 10/7/09 at 12:25 pm, the patient had a second surgical procedure, under general anesthesia, to remove her fallopian tubes and ovaries.

On 9/2/10 at 2:45 pm, the hospital's 11/9/09 policy and procedure titled, "Wrong site, wrong procedure and wrong person surgery/invasive procedure prevention" was reviewed. On Page 3, under Item F, direction was given, "Physicians and procedural team member(s) "pause" or take a "Time out" and confirm the correct patient, procedure and operative / invasive procedure site immediately prior to initiation of the procedure, by using active communication and documenting the process on the checklist. Documents used in verifying the procedure site include the consent, history and physical, physician's orders, and applicable imaging studies. The process and checklist include: 1. Correct patient identity. 2. Correct site and side. 3. Agreement on the procedure to be done. 4. Correct patient position. 6. "Time out" documentation is to be completed during the actual performance of the "Time out." ......Under Item H, direction was given that "Verification of the process is completed by use of the Correct Patient/Procedure/Site Verification form and documented by physicians and licensed personnel in the medical record."

On 9/2/10 at 3 pm, an interview was conducted with the Manager of Risk Management. She was asked to explain the hospital process for verifying that patients had the correct surgical procedure performed. The Manager of Risk Management stated that the hospital's process was to verify the physician's order, confirming the surgical procedure with the patient, verifying the procedure listed on the informed consent, with the procedure scheduled. When asked if she was aware that surgical procedure performed on Patient 32, was inconsistent with the signed informed consent, she stated that she was aware of the event. The Manager of Risk Management stated that because Patient 32, eventually had the correct surgical procedure, the hospital did not consider that Patient 32 had the wrong surgical procedure.

On 9/2/10 at 3:30 pm an Immediate Jeopardy was declared due the hospital's failure to ensure that the correct surgical procedure was performed on the correct patient. Hospital Administrative staff present when the Immediate Jeopardy was declared were: The Chief Executive Officer, Director of Quality Resources, Vice President of Ancillary Services, Vice president of Patient Care Services, Vice President of Finance, and the Director and Assistant Director of Surgical Services.

On On 9/7/10 at 4:30 pm, the Immediate Jeopardy for failure to ensure all performed surgical procedures were consistent with the patients' informed consent was abated. Based on the submitted Plan of Action, and documents reviewed during monitoring visits on 9/3/10, 9/4/10, 9/5/10, and 9/6/10, the hospital demonstrated their ability to ensure patients had the correct surgical procedure.

2. On 8/30/10 at 5:20 pm, a male dressed in blue surgical attire was observed in the physician parking lot changing a flat tire on a white sport's utility vehicle.

On 8/31/10 at 7:30 am, the hospital's 2/07 policy and procedure titled, "Dress and personal appearance" was reviewed. At the bottom of Page 1, under section titled, "Home laundered scrubs/hair covers," direction was given that, "Personal scrubs may be worn in OR/PACU and home-laundered by surgical services employees with the exception of scrubs that are contaminated with blood or other potentially infectious material. 1. Personal scrubs (tops, pants and hair covers) must be laundered between each use, i.e., not re-worn the following day...."

On 9/1/10 at 2 pm, the Director of Surgical Services was interviewed. The Director of Surgical Services was asked if the hospital allowed wearing home-laundered surgical scrubs in the semi and restricted areas in surgery. The Director of Surgical Services stated that the hospital allowed surgery staff to wear home-laundered scrubs in surgery, sterile processing and cental supply areas.

On 9/7/10 at 9:45 am, a tour was conducted of the surgical services area. During the tour, MSM T was observed walking down a semirestricted hallway in the surgical services area. It was noted that MSM T was wearing a dark colored tee shirt under his surgical scrubs, and that 2-3 inches of his tee shirt sleeves, was exposed below the sleeves of his scrub top.

During the tour, it was also noted that four out of approximately 20 members of the surgical staff were wearing cloth hair coverings. Surgical staff were also observed leaving surgical suites with their surgical masks pulled down under their chin or hanging from one ear.

On 9/7/10 at 11:30 am, a tour was conducted of the central supply area (area where supplies and equipment are sterilized and stored). During the tour, a female working in the decontamination and reprocessing area was observed wearing red surgical scrubs.

During a concurrent interview, the Central Supply Lead stated that staff working in central supply were to change into hospital provided surgical scrubs each day. When asked if the red surgical scrubs were hospital provided, the Central Supply Lead replied, "No. They were personal scrubs."

On 9/7/10 at 1 pm, the 2010, AORN, "Perioperative standards and recommended practices" was reviewed. On page 67, under Recommendation I, the recommendation was that, "All individuals who enter the semirestricted and restricted areas of the surgical suite should wear freshly laundered surgical attire intended for use only within the surgical suite." On Page 68, under Item 11, direction was given that, "Other garments should be contained completely, within or covered by the surgical attire. Clothing that cannot be covered by the surgical attire should not be worn."

On Page 69, under, Recommendation II, AORN recommended that "Personnel should cover head.....when in the semirestricted and restricted areas of the surgical suite." Under Item 3, AORN recommended that, "Single-use head gear should be removed and discarded in a designated receptacle as soon as possible after daily use. Reusable hats or hoods should be laundered in a commercial laundry after each use." Under Recommendation III, AORN recommended that, "All individuals entering restricted areas of the OR suite should wear a mask ..." Under Item 2, the direction was that, " Masks should be removed carefully.....and should be discarded immediately. Masks should not be saved by hanging them around the neck or tucking them into a pocket for future use..."

The cumulative effect of these systemic problems placed all patients at risk of having surgical procedures that were not consistent with their signed informed consents, and failure to ensure that surgical attire was in accordance with national standards of practice, placed all surgical at risk of developing post operative infections.

Based on observation, staff and administrative interviews, and facility document review, the facility failed to ensure the Out-Patient Services' emergency treatment of patients and/or any individual presenting to the on-or off-campus facilities were conducted in accordance with acceptable standards of practice in the following instances:

1. The off-campus facility's staff did not understand the facility policy and procedure for integrating the emergency situation and treatment with the main hospital's Emergency Department (ED) and the follow-up procedure for documentation of a presented emergency to their facility, after transfer and/or discharge was not verbalized by any staff. (Refer to A 1077, Item 1-a, b, c, d, and e)

2. The on-campus facility did not know that the facility's policy and procedure for emergency treatment of patients and/or individuals presenting to their facility for emergency assistance were to integrated with the main hospital's ED by calling the ED first. (Refer to A 1077, item 2)

On 9/1/10 at 4:35 pm, an Immediate Jeopardy was declared due to the hospital's failure to ensure the treatment of on- and off-campus out-patient emergencies were coordinated and integrated with the main hospital emergency department and that all staff in the out-patient facilities understood the facility's policies and procedures for initiating, reporting, and documenting patient emergencies within their facilities. Hospital Administrative staff present when the Immediate Jeopardy was declared were: The Chief Executive Officer, Director of Quality Resources, Vice President of Ancillary Services, Vice President of Patient Care Services, and the Vice President of Finance.

Based on the submitted Plan of Action, documents reviewed during monitoring visits on 9/3/10, 9/7/10, and 9/8/10, and on-site revisits and interviews with staff on 9/7/10 and 9/8/10, the hospital demonstrated their ability to ensure patients and individuals presenting to all the out-patient facilities with medical emergencies would receive integrated/coordinated care with the main hospital's Emergency Department.

On 9/8/10 at 10 am, the Immediate Jeopardy was abated for failure to ensure the treatment of on and off-campus out-patient emergencies were coordinated and integrated with the main hospital emergency department and that staff were instructed and understood the policies and procedures for patients and/or individuals presenting with emergencies within their facilities

3. The Sleep Study Clinic failed to have a registered nurse available to supervise and evaluate the nursing care of each patient before or during patient testing. (Refer to A 1079)

The cumulative effect of these systemic problems placed all out-patients at risk of incomplete and/or inadequate emergency treatment by staff available if care was not integrated with expertise of ED staff, increased the risk of inaccurate or incomplete information given to ED personnel by ambulance personnel if the emergency situation was not relayed to the main hospital ED, failed to ensure proper professional staff were available to supervise and evaluate patients within the outpatient sleep clinic, and failed to ensure statutorily-mandated compliance with the Condition of Participation: Outpatient Services.

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

*Failure to perform a Medical Screening Exam (MSE) for Patient 46 whose length of stay in the ED exceeded five hours and for Patient 42 whose length of stay in the ED exceeded three hours. (See A1112)
*Failure to perform a triage exam for Patients 41 and 45, both of whom had a length of stay that exceeded one and one half hours, and for Patient 47 whose length of stay was almost one hour. Patient 41 returned to the ED the following day and was admitted to the facility.(See A1112)
*Failure to document all patient assessment information as part of the permanent medical record for three of ten patients. (Patients 42, 45 and 46) (See 467)
*Use of preemptive test guidelines (allows nurses to implement certain physicians orders prior to a MSE being completed) had not been approved by the Governing Body. (See 1104)

Findings:

1a. On 9/2/10, a review of Patient 46's record disclosed that the patient presented to the ED with a complaint of chest pain on 6/16/10 at 11:41 am and was discharged at 5:35 pm. Following a triage assessment (short assessment performed by licensed staff to determine the order MSEs will occur) Patient 46 was assigned a Level 3 urgent (condition that may progress into an acute threat to life, limb, or bodily function without intervention) status and placed in a bed. Lab tests, a chest x-ray, and EKG were done in accordance with the preemptive test guidelines. The last entry by a licensed nurse was timed at 2:51 pm. There were no further entries between 2:51 pm and the time Patient 46 was noted to be Left Without Being Seen (LWBS) at 5:35 pm. The length of stay was recorded as five hours and 35 minutes. Patient 46 did not receive a MSE.

A facility policy titled, "Compliance with Emergency Medical Treatment and Active Labor (EMTALA)" dated 1/12/09, read as follows: "An MSE must be offered to any individual who comes to the ED for examination and treatment of a medical condition. The MSE must be provided within the capabilities of the Dedicated ED. . ." The policy read as follows: "Refusal of MSE - if a patient leaves the hospital before receiving an MSE, either with or without notice (elopement) to staff of his/her departure, staff should document the circumstances and reasons (if known) for the patient's departure and the time of departure

During an interview on 9/1/10 at 3 pm, Administrative Staff R (Admin R) stated that the facility had one physician and one physician's assistant, who worked daily from 10 am to 10 pm, to perform MSEs.

During an interview on 9/2/10 at 1:20 pm, Admin R confirmed that a MSE had not been completed and a discharge note had not been written by the nurse for Patient 46. Admin R was asked to obtain additional information if possible. During a subsequent interview on 9/8/10 at 8:30 am, Admin R stated she had acquired no explanation or further information.

1b. A review of Patient 42's record on 8/31/10, disclosed that she presented to the ED with a complaint of an allergic reaction on 6/1/10 at 8:18 pm and was discharged at 11:31 pm. Following a triage assessment, Patient 42 was assigned a Level 3 urgent status and placed in a bed. Lab tests and a chest x-ray were done and an IV (intravenous line) was started. The last entry by a licensed nurse was timed at 10 pm. There were no further entries between 10 pm and the time Patient 42 was noted to be LWBS at 11:31 pm. The length of stay was recorded as three hours and 12 minutes. Patient 42 did not receive a MSE.

During an interview and concurrent record review on 8/31/10 at 2:20 pm, Licensed Nurse (LN) Y stated that the nurse caring for the patient should have documented what time she discontinued the IV and what time the patient left. LN Y stated that the nurse should have documented if the patient got up and walked out or if the nurse went to the bedside and found the bed empty.

During an interview on 9/1/10 at 2:45 pm, LN CC stated that she did not recall Patient 42 but said it was her usual practice to chart when she discontinued an IV and when the patient left. LN CC stated that the "LWBS" written on the bottom of the page was not in her handwriting, and she thought that maybe a clerk saw Patient 42 when she left, wrote LWBS and took the patient out of the computer as being discharged.

Admin R was present during the interview with LN CC and stated that she also did not know who took Patient 42 out of the computer. Admin R stated that the physician on duty at the time Patient 42 presented to the ED was unavailable for interview.

2a. A review of Patient 41's record on 8/31/10, disclosed that she presented to the ED with a complaint of abdominal pain on 8/20/10 at 8:02 pm and was discharged at 9:51 pm. No triage assessment was done. LWBS was written in the recordt. Length of stay was recorded as one hour and 49 minutes. Patient 41 returned to the ED less than 17 hours later, was admitted, and remained hospitalized for three days.

A policy titled, "Triage" dated 5/11/09, read as follows: "The triage nurse will complete a triage assessment within 30 minutes of the patient's arrival unless otherwise indicated."

During an interview on 9/1/10 at 3 pm, Admin R acknowledged that the facility policy required triage assessments to be completed within 30 minutes, and this had not been done for Patient 41.

2b. A review of Patient 45's record on 9/2/10, disclosed that he was a six year old who presented to the ED with complaints of vomiting, diarrhea, and fever on 7/11/10 at 4:11 pm and was discharged at 6 pm. No triage assessment was done. LWBS was written in the chart. Length of stay was recorded as one hour and 49 minutes.

During an interview on 9/2/10 at 1:20 pm, Admin R stated that she would have expected a temperature to be taken by the nurse. She had no explanation for why the temperature had not been taken or why a triage assessment had not been performed within 30 minutes.

2c. A review of Patient 47's record on 9/2/10, disclosed that she presented to the ED with a complaint of a headache on 8/7/10 at 12:37 pm. Patient 47 was called for a triage assessment at 1:30 pm, at which time "not in lobby" was written. This was 53 minutes after Patient 47 presented to the ED.

During an interview on 9/2/10 at 1:20 pm, Admin R confirmed that triage should have been done within 30 minutes in accordance with their policy.

3a. A review of Patient 46's record on 9/2/10, disclosed that he presented to the ED with a complaint of chest pain on 6/16/10 at 11:41 am and was discharged at 5:35 pm. The last entry by a licensed nurse was timed at 2:51 pm. There were no further entries between 2:51 pm and the time Patient 46 was noted to be LWBS at 5:35 pm.

An ED charge ticket was provided by Admin R with the following charted by the nurse: "pt LWBS from ER 4 unaware of pt's departure, pt had been free from discomfort during ER visit."

During an interview on 9/2/10 at 5:05 pm, Administrative Staff C (Admin C) confirmed that the ED charge ticket was not part of the patient's permanent record.

3b. A review of Patient 45's record on 9/2/10, disclosed that he was a six year old who presented to the ED with complaints of vomiting, diarrhea, and fever on 7/11/10 at 4:11 pm and was discharged at 6 pm. No triage assessment was done. LWBS was written in the chart. Length of stay was recorded as one hour and 49 minutes.

An ED charge ticket was provided by Admin R with the following entry: "LWBS before triage, pt's parent didn't want to wait to be seen."

During an interview on 9/2/10 at 5:05 pm, Admin C confirmed that the ED charge ticket was not part of the patient's permanent record.

4. A review of the facility's policy titled, "Triage" dated 5/11/09, read as follows: "Triage nurse will order testing as outlined in the Preemptive Test guidelines (approved by ED medical staff) if there will be a delay in rooming a patient, and/or if MSE will not be initiated within 20 minutes or arrival/being placed in treatment room."

Admin R provided a copy of the facility's "Preemptive Test Guidelines" with a date at the bottom of the page of 2/10.

During an interview and concurrent policy review on 9/8/10 at 11:30 am, Administrative Staff G (Admin G) stated that the mention of the guidelines followed by "approved by ED medical staff" meant that the ED physicians' medical group only had approved the guidelines. Admin G stated that the guidelines were not approved by the Emergency Services Committee until 5/26/10, and the guidelines then went to the Policy Committee. The guidelines had not yet been approved by the Governing Body Committee.

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 interview and document review, the governing body (GB) had not developed a system to ensure that all services delivered under contract were done in a safe and effective manner that would deliver services that permitted the hospital to comply with all applicable conditions of participation.

Findings:

The hospital did not have a consolidated and complete list of all services performed under contract. Available lists of contracts did not contain a full description of the nature and scope of contracted services. (Refer to A0085)

The GB and hospital administration had not yet developed a comprehensive system of quality review designed to address the safety and effectiveness of each contracted service. (Refer to A0084)

Based on interview and document review, the govering body (GB) had not ensured that all services performed under contract were provided in a safe and effective manner.

Findings:

During an interview on 8/31/10 at 3:30 pm, the Medical Staff Coordinator (Admin G) provided information about the GB's actions related to services performed under contract. She provided two different lists of contracts (refer to A0085 for details) and spoke about the GB's overview of the quality and safety of the services provided by contractors on each lists.

The Admin G managed one of these lists, the one that contained information about Clinical Services preformed under contract. For this list, the Medical Executive Committee (MEC) had primary responsibility for the quality of these services. The Admin G provided minutes and data (dashboard spreadsheets) showing that the MEC was doing ongoing periodic review of contracted clinical services, and that the Chief of Staff regularly reported the results to the GB.

The second list of contracts contained those services that were not provided by physicians or groups of physicians that were members of the medical staff. For this list, the Admin G had less information and the information she could gather was less readily available. As a result, much of the information gathered was provided over an extended time in brief conversions.

On 9/2/10 at 3:45 pm brief concluding interview, related to contracts, was conducted with both the MSC and the Director of Quality Resources (Admin A). At that time, the two administrative staff members acknowledged that not all contracted services were reviewed for quality and safety. There was a periodic review of many contracts that were in the computer system to make sure contracts were up to date but not one that focused on safety or quality.

Based on document review and interview, the hospital failed to maintain a list of all contracted services that included the scope and nature of the services provided.

Findings:

On 8/30/10 the hospital's list of "all contracts and agreements" was requested. By 8/31/10, the hospital administrative staff had provided an extensive list of organizations with which the hospital had written contracts. This 13-page spreadsheet document contained three columns, titled "organization name," "effective date" and "expiration date." This list did not contain any information about the scope or nature of the listed contractors. Many of the organization names were repeated several times, sometimes with the same dates and other times with different dates. The list did not appear to contain any healthcare providers; noticeably missing were any names of physicians or physician groups. Additional information was requested.

During an interview with the Medical Staff Coordinator (Admin G) on 8/31/10 at 3:30 pm, she stated that the hospital had several lists of contracts which were managed by several different administrative staff members. She provided two lists:

1. One was the same list provided earlier with an additional column titled, "ContractType." On this list the "contract types" were very short phases that contained some information about the nature of the contract, such as, "wholesale agreement," "full service program" or "pharmacy network agreement."

2. The second list contained three columns titled, "Contract #," "Payment" and "Phys." This was a list of physicians, physician groups or other primary care providers. The contracts on this list were referred to by the hospital as Clinical Services Contracts. The payment column contained very short phrases such as, "Cardio Tests," " EKG Tests" or "Clinic Visits."
Each of these lists contained limited information about the nature of the agreements, but do not provide information concerning the scope of the agreements.

On 8/31/10 at 4:00 p.m. the initial interview with the Admin G concerning contracts concluded with an acknowledgement that the two lists did not contain all of the hospital's service agreements. However, multiple other short conversation concerning contracts ensued that further expanded the survey team's understanding of the GB's actions related to contracts. On 9/2/10 at 3:45 pm, these brief interviews (conversation) was with both the Admin G and the Director of Quality Resources (Admin A), when they both acknowledged that:

1.The hospital had not yet provided a list of all the contracts, some of which were managed by the master organization that oversaw the GB.

2.The hospital had not maintained a master list of all contracts that contained both the nature of the agreements, as well as the scope of services provided under that contract.

Based on medical record review and staff interview, the facility failed to ensure that staff offered patients information about their right to formulate an advance directive in 2 of 6 inpatient records reviewed.

Findings:

Records 52 and 56 were reviewed on 9/1/10 and 9/2/10. The records contained a form, Advance Directive Inquiry Form, that documented if the patient had an advance directive. If the patient did not, there were two additional questions to be asked about if the patient wished a form and additional information, and if so, to whom the information was given. In both these records, the answers to the additional questions were left blank.

On the afternoon of 9/2/10, an interview with Admin Staff A revealed that neither the admitting staff nor the nursing staff had offered the additional information on advance directives to these patients.

Based on observation, record review, and staff interview, the facility failed to ensure that restraint orders were not written for as needed bases. Patient 22 had orders for restraints on two different dates, signed by the physician and the nurse. Both orders did not specify the type of restrains that were going to be used.
Findings
On 9/1/10, at 9:25 am, Patient 24 was observed receiving morning medications. Patient 24 did not have any restraints at that time. Review of the clinical record, at approximately 11 am, revealed orders for physical restraints, which were written and signed with no indication of what type of restraints to be applied.
On 8/30/10Patient 24, a 93-year-old male ,was admitted for unstable angina (chest pain). The preprinted restraint order, signed on 8/31/10, had the indication that the patient "Repeatedly interferes with medical devices, tubes, and dressings." However, the type of restraints to be used was not checked. Similarly, the order written on 9/1/10 had the indication for using restraints without the specific type of restraints. There was no documented rational or clinical justification for writing restraint orders to be used on as needed bases for Patient 24.

Based on medical record review, staff, licensed staff and administrative interviews, and administrative document review the hospital failed to ensure that:
* Nursing staff effectively evaluated and documented the progression of pressure wounds for one patient (Patient 4). Failure to document treatment progress may result in the delay of identification of ineffective treatments further compromising the clinical condition of patients and
*A registered nurse was in attendance for initial and continuous assessments of patients in the sleep clinic during clinic hours.

Findings:

1. Patient 4 was admitted with diagnoses including failure to thrive with marasmus (a form of protein-calorie malnutrition). Medical record review was conducted on 9/7/10 beginning at 10 am. It was noted that Patient 4 as admitted with Stage 2 and Stage 3 pressure sores. A comprehensive skin assessment completed by nursing on 9/3/10 revealed that the patient had an unstagable pressure ulcer on the coccyx that measured 1cm x 6 cm. It was also noted that nursing staff documented two other unstagable pressure ulcers on the right big toe and between the 4th and 5th toe on the right foot. It was also noted there were no other documentations regarding the progression/treatment related to the identified wounds.

In an interview on 9/7/10 at 10 am, LN X was asked to describe the wounds. She stated that she was taking care of the patient on 9/7/10 and stated the wounds were improving. The surveyor asked LN X to describe the physician ordered treatment. She stated that the physician ordered calmoseptine lotion to be applied twice each day. The surveyor also asked her to describe the practice within the hospital for wound documentation. She stated that the policy was to measure wounds each shift and document the result in the nursing flow sheet. She also stated that she would not have classified the wounds on the toe as pressure ulcers, rather would have described them as other types of wound. She also stated that the wound between the 4th and 5th toe was likely due to a fungal infection. LN X acknowledged that she should have re-measured the wounds and taken additional pictures.

Concurrent review of undated hospital policy titled, "Skin Assessment" guided staff that the licensed nurse was to document a skin assessment every shift in the assessment charting. The policy also noted that photographs should be taken on admission and throughout the treatment and during the discharge process.

Based on medical record review, nursing staff interview and hospital document review, the facility failed to ensure comprehensive care planning for one patient as evidenced by documentation of wound improvement without measurable parameters. (Patient 4)

Findings:

Patient 4 was admitted with diagnoses including failure to thrive with marasmus (a form of protein-calorie malnutrition). Medical record review was conducted on 9/7/10 beginning at 10 am. It was noted that Patient 4 was admitted with Stage 2 and Stage 3 pressure sores. A comprehensive skin assessment completed by nursing on 9/3/10 revealed that the patient had an unstagable pressure ulcer on the coccyx that measured 1cm x 6 cm. It was also noted that nursing staff documented two other unstagable pressure ulcers on the right big toe and between the 4th and 5th toe on the right foot. It was also noted there were no other documentations regarding the progression/treatment related to the identified wounds.

In an interview on 9/7/10 at 10 am, LN X she was asked to describe the plan for wound treatment. She stated that she was taking care of the patient on 9/7/10 and stated the wounds were improving. The surveyor asked LN X to describe the physician ordered treatment. She stated that the physician ordered calmoseptine lotion to be applied twice each day. LN X also stated that she was currently floating the heels of the patient. The surveyor also asked her to describe the practice within the hospital for wound documentation. She stated that the policy was to measure wounds each shift and document the result in the nursing flow sheet.

Review of the care plan titled, "Pressure Ulcer Care-Nursing" initiated on 9/4/10 noted the desired outcome to be "reduction in wound dimensions." It was also noted that on 9/6 and 9/7/10 nursing staff documented that the reduction in the wound was achieved; despite the absence of any additional documentation of skin assessment since 9/4/10 at the time of admission.

In a concurrent interview, Administrative Nurse W acknowledged that the accuracy of the care plan would be difficult to assess without documentation of measurable progress. It was also noted that the care plan did not include documentation to float the patient's heels or other measures to prevent development of additional pressure sores.

Based on medical record review and staff interview, the facility failed to ensure that all entries were dated and timed in four of 18 records reviewed. (Patients 43, 44, 51, and 52) As a result, it was difficult to determine if the Medical Screening Exam for Patient 43 and 44 had been completed in a timely manner.

Findings:

1. Record 51 was reviewed on the morning of 9/1/10. The pre-anesthesia note was dated, but not timed when written by the physician.

2. Record 52 was reviewed on the afternoon of 9/1/10. The endoscopic procedure orders were neither dated nor timed when written by the physician. These findings were confirmed by Admin BB at the time the records were reviewed.


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3. Emergency Department records for Patients 43 and 44 were reviewed on 8/31/10. The physician's handwritten Medical Screening Exam (MSE) notes were not timed. As a result, it was difficult to determine if the MSE had been completed in a timely manner.

During an interview and concurrent record review on 8/31/10 at 2:30 pm, Licensed Nurse (LN) Y confirmed that no time was written by the MSE notes for Patients 43 and 44. LN Y was unable to locate any other documentation elsewhere in the record that showed what time the MSE was done by the physician.

Based on interview and record review, the facility failed to ensure that all licensed nurses document all information regarding the patient's condition in the patient's permanent record in three of ten Emergency Department (ED) records reviewed. As a result, Patient 42, 45 and 46's condition during their stay in the ED and/or when they left the ED could not be determined. (Patients 42, 45, and 46)

Findings:

1. A review of Patient 42's record on 8/31/10, disclosed that she presented to the ED with a complaint of an allergic reaction on 6/1/10 at 8:18 pm and was discharged at 11:31 pm. An IV (intravenous line) was started. The last entry by a licensed nurse was timed at 10 pm. There were no further entries between 10 pm and the time Patient 42 was noted to be "Left Without Being Seen (LWBS)" at 11:31 pm.

The facility policy titled, "Compliance with Emergency Medical Treatment and Active Labor (EMTALA)", dated 1/12/09, read as follows: "Refusal of MSE - if a patient leaves the hospital before receiving an MSE, either with or without notice (elopement) to staff of his/her departure, staff should document the circumstances and reasons (if known) for the patient's departure and the time of departure."

During an interview and concurrent record review on 8/31/10 at 2:20 pm, Licensed Nurse (LN) Y stated that the nurse who cared for the patient should have documented what time she discontinued the IV and what time the patient left. LN Y stated that the nurse should also have documented if the patient got up and walked out or if the nurse went to the bedside and found the bed empty.

During an interview on 9/1/10 at 2:45 pm, LN CC stated that she did not recall Patient 42, but said it was her usual practice to chart when she discontinued an IV and when the patient left. LN CC stated that the "LWBS" written on the bottom of the page was not in her handwriting. She thought that maybe a clerk saw Patient 42 when she left, wrote LWBS and took the patient's information out of the computer as being discharged.

Administrative Stafff (Admin) R was present during the interview with LN CC and stated that she also did not know who took Patient 42's information out of the computer.

2. A review of Patient 46's record on 9/2/10, disclosed that he presented to the ED with a complaint of chest pain on 6/16/10 at 11:41 am and was discharged at 5:35 pm. The last entry by a licensed nurse was timed at 2:51 pm. There were no further entries between 2:51 pm and the time Patient 46 was noted to be LWBS at 5:35 pm.

The facility's policy titled, "Basic Assessment/Treatment in Emergency Department," dated 10/1/07, addressed on-going assessment as follows: "Patient's status should be noted at least every 60 minutes."

The facility policy titled, "Compliance with Emergency Medical Treatment and Active Labor (EMTALA)", dated 1/12/09, read as follows: "Refusal of MSE - if a patient leaves the hospital before receiving an MSE, either with or without notice (elopement) to staff of his/her departure, staff should document the circumstances and reasons (if known) for the patient's departure and the time of departure."

An ED charge ticket was provided by Admin R with the following charted by the nurse: "Pt LWBS from ER 4; Unaware of pt's departure, Pt had been free from discomfort during ER visit."

During an interview on 9/2/10 at 5:05 pm, Administrative Staff C (Admin C) confirmed that the ED charge ticket was not part of the patient's permanent record.

During an interview on 9/2/10 at 1:20 pm, Admin R confirmed that a discharge note had not been written by the nurse for Patient 46. Admin R was asked to obtain additional information if possible. During a subsequent interview on 9/8/10 at 8:30 am, Admin R stated she had no explanation or further information.

3. A review of Patient 45's record on 9/2/10, disclosed that he presented to the ED with complaints of vomiting, diarrhea, and fever on 7/11/10 at 4:11 pm and was discharged at 6 pm. LWBS was the only other entry written in Patient 45's record.

The facility policy titled, "Compliance with Emergency Medical Treatment and Active Labor (EMTALA)", dated 1/12/09, read as follows: "Refusal of MSE - if a patient leaves the hospital before receiving an MSE, either with or without notice (elopement) to staff of his/her departure, staff should document the circumstances and reasons (if known) for the patient's departure and the time of departure."

An ED charge ticket was provided by Admin R with the following entry: "LWBS before triage: Pt's parent didn't want to wait to be seen."

During an interview on 9/2/10 at 5:05 pm, Admin C confirmed that the ED charge ticket was not part of the patient's permanent record.

Based on observation, records and policies review, and staff interview, the facility failed to ensure that pharmaceutical services met the needs of patients as policies and procedures to provide safe and effective use of drugs were not developed or implemented as evidence by the following:
1. Current and accurate records of controlled substances were not kept. (Refer to A 0494)

2. Medications were not controlled, distributed, and administered to provide patient safety resulting in two situations of immediate jeopardy for fentanyl and droperidol use. (Refer to A 0500)

Because of the facility's failure to have a system in place to protect patients from receiving medications that put them at risk for respiratory depression or fatal arrhythmia by using fentanyl patches or droperidol in a manner inconsistence with directions stipulated by the Food and Drug Administration in the boxed warning, Immediate Jeopardy (IJ) was called twice to ensure immediate remedies of these situations
The IJ for fentanyl patch use was called on 9/1/2010 at 5:45 pm. Hospital management staff presented a plan of corrective action and the IJ was abated on 9/7/2010 at 4:25 p.m.
The IJ for droperidol was called on 9/7/201 at 3:30 pm. Hospital management staff presented a plan of corrective action and the IJ was abated on 9/8/2010 at 5:30 pm.
3. Drugs and biological were not locked when appropriate to prevent unauthorized access. (Refer to A 0502)

The cumulative effect of these systemic problems resulted in the hospitals inability to ensure the provision of quality pharmaceutical services safely and effectively.

Based on observation, record review, and staff interview, the facility failed to ensure that current and accurate records for controlled substance were kept. There were no current records for controlled substance in Classes IV (four) and V (five).
Findings:
On 8/30/10 at approximately 4 pm in an interview, Pharmacist A stated that the facility did not have a system for tracking controlled substances in Class V, but some medication in Class IV (four) were tracked.
On 8/31/10, at noon, Pharmacist A was asked for the record for tracking lorazepam and clonazepam, both are Class IV controlled substance. The pharmacist stated that the facility did not keep perpetual inventory for these medications. There was no system to track what came into the pharmacy or what went out. When asked about method for identifications of theft or abuse, she stated that they would not be able to detect.
A review of the facility's policy titled, "Controlled Substance Management- Reconciliation and Disposal," dated 5/5/08, revealed no specifics to how the controlled substances were managed in the pharmacy.

Based on observation, review of clinical records, policies, and procedures, and interview of staff, the facility failed to develop or implement policies and procedures to ensure safe use of medications. The facility failed to ensure the following:
*Use of high-risk medications, or medication with boxed warning was safe and consistent with directions from manufactures. Fentanyl patches (Duragesic) were not used in a way that would ensure minimal risk of clinically significant hypoventilation with the associated risk of death. Droperidol, medication used for nausea and vomiting, was not used in accordance with the manufacturer ' s guidelines for screening and monitoring to minimize the risk of patient developing fatal arrhythmia
*Monitor medications to achieve therapeutic goal and or prevent toxicity.
*Implementation of the pain assessment policy.
*Medication use and distribution after pharmacy business hours were governed by current policies and procedures.
*Storage of controlled substance in the emergency department promoted safe use, and policy-governing monitoring of refrigerated medications was developed and implemented.
*Adoption of a comprehensive recall policy to ensure that recall notices for medications were received and acted on.
*Clarify unclear orders consistent with policy.
*Pharmacy space and work area assured minimal interruption for order processing or medication filling.
Findings:
1. The facility failed to ensure that high-risk medications or medication with boxed warning was used in a safe manner consistent with directions from manufactures. Fentanyl patches (Duragesic) were not used in a way that would ensure minimal risk of clinically significant hypoventilation with the associated risk of death. Droperidol was not used in accordance with the manufacturer ' s guidelines for screening and monitoring to minimize the risk of patients developing fatal arrhythmia.
Review of clinical records revealed that two out of three patients received fentanyl patches inappropriately. Patient 23 was prescribed fentanyl patch for acute pain related to bone fracture with no evidence that the patient was opiate tolerant (received at least 60 mg of oral morphine or equivalent for one week). Although Patient 22 had no evidence of being opiate tolerant, fentanyl was started on the day of admission. Both patients were elder (85 and 84 years old) and had respiratory conditions, which exposed them to the increased risk of life-threatening hypoventilation associated with fentanyl patch use.
The fentanyl transdermal system also called a fentanyl patch contains fentanyl, a potent synthetic opiate medication used to treat pain. This medication has a boxed warning which is the most serious warning required by the Food and Drug Administration to be placed in the product labeling for a medication. Boxed warnings document potential problems that can lead to serious injury or death. The boxed warning for the fentanyl patch documents that it has an associated risk of fatal overdose due to respiratory depression. It is indicated for the management of persistent moderate to severe chronic pain that requires continuous around-the-clock opioid (narcotic pain relievers derived from or having the pain relieving action of opium) administration for an extended period of time and that cannot be managed by other pain medications. Use of the patch is contraindicated in the treatment of postoperative pain. The boxed warning also documents that it should only be used in patients who are opioid-tolerant which is defined in the boxed warning as those patients who have taken at least 60 mg of oral morphine, 30 mg of oral oxycodone, or 8 mg of oral hydromorphone (opiate medications used to treat pain) daily for a week or longer or an equianalgesic dose of another opiate medication, and that use of this patch to treat patients who are not opioid-tolerant is contraindicated because serious or life-threatening respiratory depression can occur.
On November 5, 2007, the California Department of Public Health (CDPH) released an All Facilities Letter (used to notify healthcare institutions licensed by the CDPH of recurring problems that had resulted in licensing and federal noncompliance determinations) entitled MEDICATION SAFETY: USE OF MEDICATIONS WITH "BOXED WARNINGS. " This letter documented that: "It is the Department's expectation that appropriate safeguards for all medications are in place that acknowledge and manage each the medication's inherent risks with its benefits. Medications that have a boxed warning pose an additional challenge to promote safe use in light of their potential for serious adverse consequences. "
2. On 9/1/10, at 9:25 am, review of the clinical record for Patient 23 revealed that Patient 23 was an 85-year-old female with multiple medical conditions including COPD, (chronic obstructive pulmonary disease). She was admitted because of pain related to fractured tibia as result of fall on 8/24/10. There was no documented evidence that Patient 23 was receiving any opiates prior to admission. On admission, on 8/24/10, she had orders for acetaminophen 325 mg every 4 hours as needed for mild pain, Vicodin 5/500 one table every 4 hours as needed for moderate pain. Vicodin is a combination medication that contains acetaminophen and hydrocodone. On 8/28/10, only 4 days after admission, Patient 23 was prescribed fentanyl patch 25 micrograms for pain.
There was no documented evidence that the pharmacist who processed the order questioned fentanyl patch appropriateness especially considering patient's age of 85 year old or her condition of COPD.
On 9/1/10 at 3:15 pm, the prescribing physician, Physician X, when asked if pharmacy staff called him about fentanyl patch orders, he stated that he has not been called. As for Patient 23, Physician X stated on telephone interview that the patient had nausea and that was reason for giving her pain medication via transdermal route. When the morphine equivalent dose to fentanyl 25 mcg was mentioned, Physician X said that there was no way that Patient 23 would have tolerated 60 milligrams of morphine per day. Fentanyl is one of several opioid medications that share the same side effect profile such as, nauseas, vomiting, rash, hypotension, CNS, and respiratory depression. Despite the boxed warning, Patient 23 received fentanyl patch to control acute pain, although she had not received around the clock opioid pain relieving medications at doses specified in the product labeling for at least a week before admission to the hospital or during her hospital stay.
3. On 9/1/10 at 4 pm, the clinical record for Patient 22 was reviewed with the Director of Pharmacy and a facility nurse. The record revealed an 84-year-old female that came to the hospital on 8/19/10 for severe pain. On admission orders, dated 8/19/10, and timed 1915, the patient was prescribed Fentanyl Patch 25 micrograms. Patient 22 was receiving Celebrex (pain medication) 200 two times every day and Darvocet N-100 (a combination of acetaminophen 650 mg and propoxyphene 100 mg) every 6 hours when needed. Fentanyl was prescribed for Patient 22 despite the warning in the package insert: "Elderly have been found to be twice as sensitive as younger patients to the effects of fentanyl ... When choosing a dose, take into consideration the following patient factors: age, weight, physical status, underlying disease states, other drugs used ..." Concerns related to adverse effects included: "Risk of respiratory depression increased in elderly patients, debilitated patients, and patients with conditions associated with hypoxia or hypercapnia..." Patient 22 is an 84 year old and has a history of COPD.
On 9/1/10 at 4:20 pm, Pharmacist B, after reviewing the pharmacy computer records, stated on interview that Patient 22 had a history of chronic pain for three weeks, but no evidence of chronic opiate use.
Despite the boxed warning that fentanyl is not indicated to control pain in patients who had not received around the clock opioid pain relieving medications at doses specified in the product labeling for at least a week, Patient 22 received fentanyl patch.
4. Due to facility's failure to have a system in place to protect patients from receiving fentanyl patches when it is contraindicated and put them at risk for respiratory depression, Immediate Jeopardy (IJ) was called on 9/1/2010 at 5:45 pm. Hospital management staff presented a plan of corrective action on 9/1/10 at 7:25 pm to ensure appropriate use of fentanyl patches in all patients, the plan included the following elements:
a. Fentanyl patches will not be dispensed to patients who are not opioid tolerant (opioid tolerant = patient has been taking another opioid at a dose comparable to a fentanyl patch for at least 7 days)
b. Fentanyl patches will not be dispensed for the management for post operative pain
c. Fentanyl patches will not be dispensed for the management of mild pain or intermittent pain.
d. Fentanyl patches will not be dispensed for the management of acute pain or if opioid analgesia is only needed for a short period of time.
e. Should disagreement be encountered with caregivers/ providers, the chain of command will be utilized.
The plan also indicated that all pharmacists that worked at Feather River Hospital would be trained through one-one communications on the elements in the order necessary to fill an order for fentanyl patch. The action plan also included distribution of memorandum to Medical Staff on 9/2/2010 and a preprinted physician order for fentanyl patches approved by MEC (Medical Executive Committee) on 9/2/10.
Verification of implementation of the action plan was completed on 9/7/10 and the IJ was abated on that day at 4:25 p.m for the use of the fentanyl patches.
5. Droperidol, also known as Inapsine, is used for nausea and vomiting, has a boxed warning about the risk of fatal arrhythmia. Review of three records for patients receiving droperidol revealed that in two out of three records droperidol was used inconsistent with the manufacture's guidelines or the direction stipulated by the Food and Drug Administration in the boxed warning for screening and monitoring to minimize the risk of patients developing fatal arrhythmia
In December of 2001, the FDA (Food and Drug Administration ) and Akorn (the pharmaceutical manufacturer of Inapsine (droperidol)) sent a "Dear Healthcare Professional" letter to Anesthesiologists and other healthcare professionals in the U.S. The letter addressed the added black box warning and the strengthened warning and precaution sections in the labeling for Inapsine, a tranquilizer used as a premedication for anesthesia, as treatment for nausea after anesthesia, and for sedation of agitated patients.

It stated, "Cases of QT prolongation and/or torsades de pointes have been reported at doses at or below recommended doses. Some cases have occurred in patients with no known risk factors for QT prolongation and some cases have been fatal." QT interval represents the duration of ventricular depolarization and subsequent repolarization. A delay in cardiac repolarization creates an electrophysiological environment that favors the development of cardiac arrhythmias, including torsades de pointes (TdP). Torsades de pointes is a potentially fatal arrhythmia."

A black box warning is the strongest warning the FDA requires a pharmaceutical The following BOX WARNING has been added:
Cases of QT prolongation and/or torsades de pointes have been reported in patients receiving Inapsine at doses at or below recommended doses. Some cases have occurred in patients with no known risk factors for QT prolongation and some cases have been fatal.
Due to its potential for serious proarrhythmic effects and death, Inapsine should be reserved for use in the treatment of patients who fail to show an acceptable response to other adequate treatments; either because of insufficient effectiveness or the inability to achieve an effective dose due to intolerable adverse effects from those drugs (see Warnings, Adverse Reactions, Contraindications, and Precautions).
Cases of QT prolongation and serious arrhythmias (e.g., torsades de pointes) have been reported in patients treated with Inapsine. Based on these reports, all patients should undergo a 12-lead ECG (electrocardiograph) prior to administration of Inapsine to determine if a prolonged QT interval (i.e., QTc greater than 440 msec for males or 450 msec for females) is present. If there is a prolonged QT interval, Inapsine should NOT be administered. For patients in whom the potential benefit of Inapsine treatment is felt to outweigh the risks of potentially serious arrhythmias, ECG monitoring should be performed prior to treatment and continued for 2-3 hours after completing treatment to monitor for arrhythmias
Inapsine is contraindicated in patients with known or suspected QT prolongation, including patients with congenital long QT syndrome.
Inapsine should be administered with extreme caution to patients who may be at risk for development of prolonged QT syndrome (e.g., congestive heart failure, bradycardia, use of a diuretic, cardiac hypertrophy, hypokalemia, hypomagnesemia, or administration of other drugs known to increase the QT interval). Other risk factors may include age over 65 years, alcohol abuse, and use of agents such as benzodiazepines, volatile anesthetics, and IV opiates. Droperidol should be initiated at a low dose and adjusted upward, with caution, as needed to achieve the desired effect.
6. On 0/7/10 at approximately 10 am, review of the clinical record for Patient 84 revealed a 31-year-old patient that underwent a surgical procedure on 6/30/10. Review of the clinical record with facility staff revealed no evidence that a 12 lead EKG (electrocardiogram) was ordered or performed. EKG is a test that records the heart's electrical activity, rate, and rhythm. Patient 84 was administered droperidol in the in the operating room shortly before the end of the case. There was no evidence of 12 lead EKG monitoring after the administrations as required by the FDA and the manufacturer of the drug and outlined in the boxed warning. Review of the facility policy for "High Risk Medication Administration," dated 3/09 revealed the followings:
a. Haloperidol and droperidol can cause QTc prolongation, increasing the risk of TdP.
b. Patients receiving haloperidol or droperidol must have cardiac monitoring .
c. Cardiac monitoring requirements for Droperidol:
A 12- lead ECG must be obtained and reviewed by a physician prior to first dose. Patients with a prolonged QTc interval ... should not receive droperidol.
An ECG monitoring (telemetry) is required for 2-3 hours after each dose to monitor for arrhythmia related to QTc interval prolongation (i.e. Tdp) "
7. On 0/7/10 at 12 noon, a review of the clinical record for Patient 21 revealed a 61-year-old patient that underwent a surgical procedure on 4/28/10, and received droperidol in the operations room.
Review of the Post Anesthesia Physician's Orders for Patient 21, revealed four different choices for treating nausea and vomiting. The fourth option, unselected, was for droperidol, "Droperidol (Please see Droperidol protocol sheet)."
The Director of Pharmacy was asked about the protocol, and he contacted Admin Q to help locate the form. On 9/7/10, between 10:30 am and 10: 55 am, and in the presence of the Director of Pharmacy, three registered nurses in PACU and Same Day Surgery (LN 104, LN 105, and LN 106) were interviewed about the "Droperidol protocol sheet." Only one was able to find the protocol. One of the nurses in PACU looked in different filing places and called the assistant director of the department in efforts to find the form, but was unsuccessful.
On 9/7/10, between 10 am and 12 noon, the availability of droperidol in PACU and the night locker was confirmed. Droperidol use in accordance with the boxed warning was not done as evidenced by the followings:
a. Two out of three nurses in PACU where droperidol was available for use did not know where to find the protocol for its use.
b. Droperidol was used in OR in two of three records reviewed. Of these two records, only one had an EKG done, and that was one week before surgery.
c. The facility's policy for screening for QTc prolongation before droperidol use was not implemented.
d. Droperidol was available in the night locker in the absence of oversight for tracking and accountability.
The above issues presented an increased risk for patients developing fatal arrhythmias when given droperidol without proper screening or monitoring.
Because of the facility's failure to implement their policies and procedures for high risk medications and protect patients from receiving medications that put them at risk or fatal arrhythmia by using droperidol in a manner inconsistence with manufacturer's labeling and the direction stipulated by the Food and Drug Administration in the boxed warning, Immediate Jeopardy (IJ) was called on 9/7/201 at 3:30 pm. Hospital management staff presented a corrective action plan on 9/7/10 at 4:45 to ensure patient safety; the plan stated:
"As of 9/7/2010, the Interim Director of Pharmacy has removed droperidol from all areas within the hospital, and it is no longer available for patient care use. A memo was sent from the Chief of Staff to all medical staff on 9/7/2010." The Chief of Staff approved the removal of droperidol from the hospital.
Following verification of the facilities plan of action, the facility demonstrated droperidol was no longer within the facility and was not available for patient use, The IJ was abated on 9/8/10 at 5:30 pm.
8. The facility failed to monitor blood level of Digoxin (heart medication) and levothyroxine (thyroid replacement) to ensure efficacy and prevent toxicity for Patient 24.

a. On 9/1/10, at 9:25 am, Patient 24 was observed receiving morning medications. Review of the clinical record, at approximately 11 am, revealed that Patient 24 was 93 year old was admitted, on 8/30/10, for unstable angina (chest pain). Patient 24 was receiving digoxin (a medication used in heart failure).

Digoxin is classified as a high alert medication, which means that it has heightened risk of causing significant patient harm when used in error. Digoxin is also a medication with narrow therapeutic index, which means the therapeutic blood level and the toxic level are very close. Therefore, a small change in blood levels can cause changes in the effectiveness or produce toxicity of that drug. Monitoring the blood level of digoxin is essential to guide therapy and prevent toxicity.

Patient 24 was receiving digoxin, 250 micrograms every day prior to admission. There was no documented evidence that a digoxin level was checked to have as a base line or to rule out digoxin toxicity. Review of the clinical record and the electronic records with nursing and management staff revealed no digoxin level. In addition, there was no physician order to obtain a level either. Interview with the pharmacist, on the same day, revealed no additional information related to checking digoxin level or the presence of a physician order to get one.

b. Patient 24 was also receiving levothyroxine 100 micrograms every day for treatment of hypothyroidism. Too much levothyroxine can cause tremor, increase in heart rate and blood pressure and can cause irregular heartbeat, arrhythmias. Not treating hypothyroidism or giving too little levothyroxine does not achieve the intended effects, and is basically not treating. Monitoring is essential to guide therapy and prevent toxicity. Review of the clinical record and the electronic records with nursing and management staff revealed no documented evidence of any thyroid function tests being monitored or any orders to do so.

9. On 8/31/10, at approximately 11 am, the record for Patient 25 was reviewed and revealed an order for Methadone, a medication used to treat pain, to be given three times every day. Review of the record with a facility nurse revealed no documented evidence of pain assessment to evaluate the efficacy of the medication administered. Facility licensed nurse (LN 100) stated on interview that they only evaluate pain when pain medication is given on as needed bases, but not when a routine or scheduled medication is administered.

According to the Board of Registered Nursing's Pain Management Policy, "The nursing function of appropriate pain management includes, but is not limited to: assessing pain and evaluating response to pain management interventions ... "

Review of the facility policy for "Acute and Chronic Pain Management, " revised 2/07, revealed direction to documentation of "..reassessment of pain and/or sedation.." The policy also included, "The patient response to pain medication must be documented on the PRN (as needed) Record Sheet, in nurse's notes, on the medication administration record, or on the procedure record as appropriate." In addition, the facility policy for "High Risk Medication Administration," dated 3/09, listed "opiate analgesics (i.e. morphine, oxycodone, hydromorphone, hydrocodone, etc.)" as one of the high-risk medications. The policy had specific guidelines for opiate analgesic use that required documentation of "assessment and reassessment of pain level before and after medication intervention."
On 8/20/10, the day of admission, Patient 25 received one dose of Dilaudid (hydromorphone) and two doses of fentanyl in the emergency department; however, there was documentation of pain assessment only for one of the three doses.
10. The facility failed to ensure tracking and accountability of medication removed from night locker. On 8/31/10, at 11:45 am, during a tour of the night locker, it was observed that facility allowed access to a long list of medications. The list of what was available to nursing staff after pharmacy hours was about 400 medications. Medication storage in the night locker presented increased risk of medication error as follow.
a. Medications were stored in a manner that presented an increased risk for selection error, as different mediations or medications of varying strength were stored in the same bin that had small dividers. This was particularly dangerous as selection error could easily occur resulting in administration of the wrong medication or the wrong dose.
b. There was no system for tracking or accountability. There was no par level of medications stored in the night locker. Thus, it was impossible to account for the number of tables removed. In addition, nursing supervisors have key access to the night locker; therefore, the pharmacy department will only know about entries to the night locker or removal of medications if and only if the nursing supervisor documented what was removed. The pharmacy department would have no way of identifying entries, multiple entries, or multiple medications removal if the supervisor selected not to document or was in a rush and did not document.
c. The facility's policy and procedure for accessing medication after hours titled, "Pharmacy Access Orientation, Nursing Supervisor," dated 11/06, was not implemented and did not match the staff's actual practice. The policy indicated that, "A current list of nursing administrative supervisors who are approved for access to the pharmacy night locker will be kept in the pharmacy." It also indicated, "The pharmacy access competency will be repeated yearly." However, the list in the pharmacy was not current and there was no evidence of any yearly competency.
On 8/31/10, at approximately 4 pm, Pharmacist A stated on interview that five to six nursing supervisors had access to night locker. On 9/7/10, at 10 am, Pharmacist A presented a list, dated 9/02, that had 17 names of nursing supervisors. At that time, Pharmacist A crossed seven names off that list indicating that they no longer worked in the hospital. Later the same morning, a nurse supervisor crossed off three additional names and added one to the list.
The facility had policies with conflicting information. Review of the policy titled, "Pharmacy Access Orientation, Nursing Supervisor," dated 11/06, revealed reference to "Appropriate access to the main pharmacy versus pharmacy night locker. " However, another policy dated 9/07, titled " Medication, After Hours Access" indicted that "Only a pharmacist may retrieve medications from the main pharmacy after hours."
d. There were too many medications to choose from with no restrictions to what could be administered. Any of the medications selected would be administered to patient without the advantage of having a pharmacist evaluate these orders before administration.
11. The facility failed to ensure that medications were stored in a manner to reduce medication errors and promote safe use. Look alike opiate (pain medication) syringes were stored side by side in a crowded medication cabinet. Medication that required refrigeration were not effectively monitored as fluctuations of temperatures and out of range temperature alerts were not acted on timely, and the policy addressing monitoring responsibility was implemented.
a. During inspection of the medication storage in the emergency department, it was observed that medication storage did not promote or facilitate safe use. In the controlled substance cabinet on the bottom shelf, three clear plastic bags containing syringes with red markings and black writing were stored side by side. These were morphine 2 and 4 milligrams, and Dilaudid; both are opiate type medications used for pain. However, Dilaudid is about five times stronger than morphine. Selecting and administering 2 milligrams of Dilaudid for example instead of 2 milligrams of morphine meant a fivefold overdose which will predispose a patient to decrease in blood pressure, respiratory depression, increased sedation, and change the level of consciousness.

Look alike sound alike medications are known to cause medication errors. According to the Institute for Safe Medication Practices published in 2004, look-alike/sound-alike drug names" are a serious problem in health care, accounting for 29% of medication dispensing errors " The same article stated, "Medication errors involving look-alike/sound-alike drug name mix-up can cause serious patient harm. It is often difficult to detect the error, as the dispensed medication is presumed to have been prescribed for the patient."
The Joint Commission addressed the same issue in 2001 and had specific recommendations for minimizing risk and preventing potential errors, which included direction not to store problem medications alphabetically by name. They also recommended to "Store such identified medications out of order, or in an alternate location."

b. On 8/31/10 at 9:00 am, the facility system for monitoring refrigerated medications was evaluated. Electronic remote monitoring system was started recently according to the Director of Pharmacy. This system allowed central monitoring of all refrigerators where temperature readings and fluctuation can be seen on computer screen. The system also alerts viewers by flashing a red icon on the screen. On the computer screen, in the office of the Director of Pharmacy, there were several alarms, when evaluated closely, it was discovered that these alarmed were not current. Some of these alarms went as far back as five days 8/24/10, without being evaluated. The Director of Pharmacy stated that the system was not fully implemented and paper monitoring (temperature log) was still in effect.
On 9/7/10 at 9:45 am, facility staff (Staff 888), from engineering, stated on an interview that there was no specific system to identify who is alerted when an alarm indicates an out of range temperature or who would be primarily responsible to act. A review of the list of alarms revealed several ones that were not acted on until 8/30/10. Some of these alarms dated back to 8/26/10, and some indicated that the temperature was out of range for 12 hours. When asked for a policy governing this aspect of monitoring, the Director of Pharmacy stated that the policy for this system has not been approved.
12. On 8/31/10 at approximately 4 pm in an interview, Pharmacist A stated that "clerks start the process" for collecting recalled medications. The facility's policy for "Medication, Recalled or Discontinued," dated 11/08, was evaluated. The policy required the pharmacist technician to be responsible for initiating action for recalled medications. The policy stated, "The pharmacy technician will deliver the recall notification to the Director of Pharmacy or to the pharmacist on duty in the absence of the director. "

The policy did not specify the source for obtaining recalled notices. However, interview with a pharmacist technician revealed that the hospital mainly relied on the drug wholesaler to obtain the recalled notices. On 1/10, the Board of Pharmacy published a document "Addressing Drug and Device Recalls in Hospitals" in which they suggested several methods of obtaining recall information such as:

a. Redundant notification systems should be established to ensure the facility receives recall notices. Facilities are encouraged to subscribe to more than one method available for product recalls. Sole reliance on recall notification via the US Postal Service is not acceptable.

b. Recall notices can arrive at hospitals via fax, certified letter, standard mail, emails from manufacturers, wholesalers, or notices with invoices for other drugs. Listserves of the FDA (http://www.fda.gov/Safety/MedWatch/default.htm, the California Board of Pharmacy and other entities can provide recall information.

c. Closely working with the hospital 's drug wholesalers will improve notice and distribution of recall information.

The facility policy for recall medication was not comprehensive to ensure that recalled notifications were obtained timely and acted on.

13. On 8/31/10, at approximately 11 am, the record for Patient 25 was reviewed; it revealed that Patient 25 was in the emergency department on 8/20/10 at 12:48. There were physician order written for Dilaudid 1 mg (not timed), Zofran 4 mg (antiemetic medication) not timed, and there was an order for fentanyl 50 mcg that was also not timed. Then, there was the last order timed (1700) written for "may repeat x1." The hand written one looked like a nine. It was not clear if the "may repeat order" was for Dilaudid, Zofran, fentanyl or for the complete sequence of orders. There was no documented evidence that the order was clarified.

Review of the facility's policy for "Medication Orders," dated 1/08, revealed the following: "Medication orders that are incomplete illegible, or unclear will not be processed by Nursing or Pharmacy until the order has been clarified."

14. Between 8/31/10 through 9/8/10, multiple visits were made to the pharmacy and the lack of workspace for pharmacist and technicians was observed. Pharmacists were side by side on both sides of a workstation (table) that extended almost the full length of the pharmacy. The table housed computer workstations, fax machines, and other resources. A phone call or an interruption to one pharmacist could mean interruptions to the others, because pharmacists were essentially next to one another. In addition to the area being always crowded that created an increase potential for interruption leading to errors in processing orders.
Right behind the pharmacy door, there was a workstation for filling medications. Interruptions were constant by answering the door, by incoming, and outgoing traffic. Such condition would create an increased potential for errors in filling medications.

Based on observation and staff interview, the facility failed to ensure that medication were stored in a locked and a secure areas: intravenous fluids were stored on an open rack in the hallway in the emergency room where it was accessible to patients, visitors, and other unauthorized personal.
Findings:
On 8/31/10, at 2:30 pm, during tour of the emergency department, intravenous fluids (IV) were stored on an open rack in the hallway in front of patients' rooms. They were accessible to anyone within the area, patients, visitors or facility personal. Facility nurse, (LN Y) and the Director of Pharmacy indicated that these medications have been stored in that manner because of limited space caused by construction.
On 9/7/10, at 11:05 am, on a second visit to the emergency department, the intravenous fluids were stored in the same manner, still accessible to unauthorized personal.

Based on food storage observation, dietary staff interview and dietary document review the hospital failed to ensure that Dietary Management Staff provided effective oversight to food services to ensure safe food handling practices as evidenced by 1) lack of provision of safe food handling practices at the Bistro Café; 2) lack of effective systems to ensure freshness of foods; 3) meal preparation methods that conserved the nutritive value and flavor of pureed foods; 4) maintain food and water supplies for the disaster menu per hospital policy/procedure. Failure to maintain effective food service systems may result in patients being exposed to food borne illness, menus with decreased nutritional value/palatability and inadequate food supplied, all of which may further compromise patients' medical status.

Findings:

1. During review of food handling practices in the bistro café on 8/31/10 beginning at 1:30 pm, the following was noted:

In the refrigerated deli unit the following food temperatures were noted: cucumbers - 50°F; vegetarian burger - 48°F; hummus - 52°F; bean/corn salsa -52°F; tomatoes - 51°F. It was also noted that the refrigerator temperature was 52°F.

In a concurrent interview with Bistro Staff AA, it was noted that there were no systems in place to ensure safe food handling practices related in particular to the storage and cool-down of potentially hazardous foods or the potential cross contamination of surfaces due to excessive chemical concentrations (Cross Reference 749). In a follow up interview on 9/7/10 at 9:50 am, Cook U confirmed that there were no established systems to ensure food safety.

In an interview on 8/31/10 at 2:30 pm, Administrative Staff S was asked to describe food service locations/services with patient access. She stated that she had oversight for the in-patient hospital food service as well as the cafeteria within the hospital. She stated that there was also a Bistro café that was used by out-patients of the state licensed wellness program; however the nutrition services department provided no oversight to this location.

In an interview on 8/30/10 at 10:30 am, Administrative Staff T confirmed the Bistro did open in 2/10; however, as the Registered Dietitian provided no oversight/guidance of food production practices by these hospital staff members.

In an interview on 9/2/10 at 4:00 pm, Administrative Staff E was asked to describe the oversight of food production practices in the Bistro. He acknowledged that while they had obtained a county permit to operate a food establishment, there was no oversight by hospital staff.

2. During initial tour on 8/30/10 beginning at 1:25- 3:30 pm the following was noted:

a. In the dry storage area, there were outdated spices that included delivery dates as follows: coriander - 1/25/07; ginger - 10/1/08; mustard - 12/21/06; marjoram - 122/17/07; gumbo spice 5/12/08; pickling spice 1/3/08; tarragon leaves 7/30/07. Additionally, in the cooks area there were spices such as white pepper and basil with delivery dates of 3/08 and 9/08 respectively that were currently in use.

In a concurrent interview with Administrative Staff S, the surveyor asked her to describe the holding time for spices; to which she replied that she was not sure that most items would be held from 3-7 days per hospital policy. She also stated that spices could probably be held for a longer timeframe.

b. In the walk in refrigerator, there was sweet chili sauce and salsa that were, open with no date; garlic spread opened 5/26 and whole shallots opened 8/2. In a concurrent interview, Administrative Staff S was unable to describe the amount of time that these foods would be held.

On 9/1/10 at 9:30 am, in a concurrent interview and a review of an undated hospital policy titled, "Storage Times for Perishable Foods," Administrative Staff S acknowledged while the hospital had a policy for perishable food items; there was no policy that guided staff for hold times for non-perishable food items or items that may have a longer manufacturer's recommended shelf life. The policy did outline hold times for items such as mayonnaise cheese; however the policy did not fully address all food items utilized in preparation of patient food items.

c. In the walk in refrigerator there was a rack of individually plated pieces of pie that were no covered. It was also noted that the rack was placed directly beneath the blower which may result in cross contamination of uncovered items..

In a concurrent interview, Administrative Staff S stated that this was the regular standard of practice for storage of items that would later be placed on the patient tray line. She stated that the lower trays would be covered by the upper trays; however, also acknowledged the top tray would be exposed during storage.

d. In the walk in freezer, there were 5-gallon containers of vanilla, strawberry and chocolate ice cream that were opened and undated. In a concurrent interview, Administrative Staff S stated it was the hospital's policy to label/date all opened items.

3. During food production observations on 8/31/10 beginning at 11:15 am, the following was noted: Cook V was observed preparing pureed entrée for the noon meal. He was observed placing one serving in the blender after which he placed two-3 ounce ladles of water to thin the item, which resulted in a thickened creamed soup consistency.

In a concurrent interview with the staff member, the surveyor asked him how many pureed diets there were for the noon meal to which he replied "one or two." He was also asked if this was his usual method for preparation of pureed items; to which he stated that it was.

In an interview on 9/7/10 at 10:30 am, Administrative Staff T was asked if the hospital had a policy guiding staff on the preparation of pureed items, to which she replied she was unsure. She also stated that the hospital provided staff training on pureeing items, focusing on the consistency of the items. She further stated that they had not guided staff on the quantity and types of fluids to be used, should foods require thinning.

On 9/7/10 at 11:0 am, a review of hospital document titled, "Texture-Modified Pureed Diet" intended as a patient education tool guided that protein based items should use stock/broth rather than water to thin foods. Thinning foods with water decreases the amount of nutrients available per portion.

4. Review of the mass casualty plan related to food service was completed on 8/31/10 beginning at 4:15 pm. In a concurrent interview, Administrative Staff S was asked to describe the basis elements of the disaster food plan.

Administrative Staff S was asked to point out items such as the various types of beans, the canned vegetarian stew as well as the juices. She replied that she was unsure of where the items were located. It was noted that some of the items such as the spaghetti sauce as well as some of the beans were present; however the hospital was unable to fully demonstrate that all of the items which were on the planned menu were present in the designated quantities (Cross Reference 701).

Administrative Staff S was also asked to describe the amount of water required to implement the planned disaster menu. She replied that she did not know. Concurrent review of the 3-day disaster menu which items such as reconstituted dry milk, juices, tea, coffee, hot chocolate, soup, cooked pasta and cooked rice revealed that the hospital did not have adequate water to prepare the designated disaster menu (Cross Reference 703). There was no documentation that Administrative Staff S ensured that the supplies to implement the hospitals' disaster meal plan were readily available.

On 9/2/10 at 4:30 pm, a review of the personnel file for Administrative Staff S revealed that in 2007 she had completed a state approved training course qualifying her as a Dietary Services Supervisor and well as a national safe food handling certificate; however there was no additional documentation of training related to dietetic services. Review of hospital document titled, "Director Evaluation for year 2009" for Administrative Staff S revealed that the document was completed as a self evaluation, which was approved by the Vice President of Ancillary Services, reviewed elements such as the hospital mission and strategic plan, participation in departmental meetings management skills, communication, human resources and process management as well as several other administrative elements; however, there was no evaluation of competency assessment related to the implementation and management of dietetic services.

In a follow up interview on 9/7/08 at 11:00 am, Administrative Staff E stated that on a quarterly basis he met with Administrative Staff S and reviewed core competencies related to the position. As with the evaluation the core competencies were related to administrative functions of the nutrition services department such as customer satisfaction, leadership, financial success, revenue and expenses. The surveyor also asked Administrative Staff E whether the director position was responsible for the administrative operations of the department as well as ensuring safe food handling practices, to which he replied that it was.

Concurrent review of the job description for the Director of Nutritional services, dated 4/10, revealed that the position was continually responsible for all aspects of nutritional services as well as responsible to develop all nutritional competencies in collaboration with the food safety officer. The position description also noted that the employee in the position "demonstrates broad experience and working knowledge in food production/service."

Based on food production observations, dietary staff interview and dietary document review, the hospital failed to ensure staff competency as evidenced by implementation of patient food services in an unsafe manner. Failure to ensure staff competency may result in patients being exposed to unsafe food handling practices resulting in foodborne illness.

Findings:

During review of food handling practices in the bistro café on 8/31/10 beginning at 1:30 pm, the surveyor identified numerous issues surrounding safe food handling practices (Cross Reference 749, Examples 1 and 2).

In an interview with Administrative Staff Z, who provided oversight to the wellness center, was asked to describe the training and orientation of Bistro Café staff in relationship to food service. She stated that to her knowledge the training was limited to the basic hospital orientation. She also stated that orientation documentation would be maintained by the coordinator for the volunteers and human resources for the employees.

On 9/2/10 at 3:45 pm, a review of orientation documents for the volunteers that worked in the Bistro café revealed that while the hospital provided an administrative orientation that included organizational, spiritual, expectations and employee health, including hand washing, there was no orientation/training for safe food handling practices relative to the positions that the volunteers held.

A concurrent interview with Administrative Staffs Z and OO and review of employee files for Bistro café staff revealed that there was no documentation of training, orientation or competency related to food service. The documented training was limited to fire safety and the hospital incident command system in addition to other topics that were related solely to the administrative functions of the positions.

Based on medical record review, dietary staff interview, and dietary document review, the hospital failed to ensure the presence of an effective diet manual that accurately reflected the regular and therapeutic diets that were routinely ordered at the hospital. Lack of an effective diet may result in physicians ordering diets that do not fully meet the nutritional needs of patients, further compromising medical status.

Findings:

1. Patient 3 was admitted with diagnoses including diabetes and weight loss. Medical record review was conducted on 9/2/10 beginning at 8:30 am. Admission diet order, dated 8/30/10, included an 1800 calorie renal diet.

In a concurrent interview, Administrative Staff T was asked to describe how the hospital ensured the delivery of the Patient 3's physician ordered diet. She stated that the hospital no longer used caloric diets, rather combined the 1500, 1800 and 2000 physician ordered diets into a standard carbohydrate controlled diet. Administrative Staff T also stated that the hospital utilized the online ADA Nutrition Care Manual as the diet manual. Administrative Staff T was asked to demonstrate that the nutrition care manual guided physicians and nursing staff that combining the three physician ordered calorie levels equated to the hospitals standard consistent carbohydrate diet.

Concurrent review of the online nutrition care manual revealed that the consistent carbohydrate diet documents were intended as a patient education tool rather than descriptive guidance that was specific to the therapeutic diet spreadsheets which are used as a basis for meal production.

Review on 9/7/10 at 11 am, an undated hospital document titled, "Nutrition Care Manual" revealed that this document was used as a "reference by physicians, dietitians and nutrition services and nursing staff" and was used as a basis for planning the standardized and modified diets; however, the nutrition care manual was not specifically tailored to accurately reflect the hospital's therapeutic diet spreadsheet.

It was also noted that while the policy had several addendums, such as a description of a soft diet, mechanical soft diet and pureed diet, it specified foods to use/avoid as well as contained recipes for patients to prepare these diets once leaving the hospital.

Review on 9/8/10 at 9 am, the American Dietetic Association Nutrition (eatright.org, 2010) description revealed that the online manual provides research based nutrition care information for diseases, printer friendly client education and electronic calculators among several other features. There was no indication that this manual was intended as a diet manual. It was also noted that the policy contained a cross walk pathway to the nutrition care manual; however, the cross walk referenced the patient education materials rather than the guidance used for ordering and preparing patient diets.

Based on food storage observations, dietary staff interview, and dietary document review, the hospital failed to ensure that par levels of designated foods to be utilized during a widespread disaster were maintained. Failure to maintain the hospital designated food supply may result compromising the nutritional and medical status of patients during a disaster.

Findings:

Review of the mass casualty plan related to food service was completed on 8/31/10 beginning at 4:15 pm. In a concurrent interview, Administrative Staff S was asked to describe the basis elements of the disaster food plan. She stated that on a quarterly basis a dietary employee was responsible for reviewing the inventory of the food/water supply.

Concurrent review with Administrative Staff S of the undated hospital policy titled, "Disaster Plan, Food Preparation and Service" revealed that the hospital planned on feeding patients, staff and volunteers for a period of three days. It was also noted that the menu included items such as several varieties of soup, red beans and rice, black beans and rice, canned vegetarian stew and pinto beans and rice. It was noted that the inventory work sheet guided staff the number of cases to have on hand, as well as any additional cases were needed. It was also noted that the inventory indicated that all items were present.

Administrative Staff S was then asked to point out items such as the various types of beans, the canned vegetarian stew as well as the juices. She replied that she was unsure of where the items were located. It was noted that some of the items such as the spaghetti as well as some of the beans were present; however the hospital was unable to fully demonstrate that all of the items which were on the planned menu were present in the designated quantities.

Based on water storage observations, dietary staff interview, and dietary document review, the hospital failed to ensure a potable water supply to meet the needs of the menu in the event of a disaster. Failure to ensure adequate water to meet the menu needs may result in patients being put at risk for dehydration and compromised nutritional status, further complicating patients' medical condition.

Findings:

Review of the mass casualty plan related to food service was completed on 8/31/10 beginning at 4:15 pm. In a concurrent interview, Administrative Staff S was asked to describe the basis elements of the disaster food plan. She stated that on a quarterly basis a dietary employee was responsible for reviewing the inventory of the food/water supply. Administrative Staff S also pointed out the water supply intended to be used in food service which consisted of 30 cases of water, each containing 24-16 ounce bottles, which equated to 90 gallons of water. Administrative Staff S was asked to describe the amount of water required to implement the planned disaster menu. She replied that she did not know. Concurrent review of the undated 3-day disaster menu included items such as reconstituted dry milk, juices, tea, coffee and cocoa, soup, cooked pasta and cooked rice.

In a follow up interview on 9/7/10 at 9:30 am, Administrative Staff S stated that in order to prepare the disaster menu as planned would require 681 gallons of water. She also stated that she had reviewed other sources that would be available to the hospital in the event of a disaster. She stated that while there was a well on adjacent property, she realized that it would likely not be accessible due to the difficulty in transporting the water from the well location.

Based on food storage observations, dietary staff interview and dietary document review, the hospital failed to ensure comprehensive maintenance of one refrigeration unit at the Bistro café. Failure to maintain refrigeration units may result in the growth of bacteria associated with food borne illness. Food borne illness may result in nausea, vomiting, gastrointestinal distress, compromised medical status and in severe instances death.

Findings:

During review of food handling practices in the Bistro café on 8/31/10 beginning at 1:30 pm, the following was noted. The thermometer in under-counter refrigerator read 52°F. In a concurrent interview, Bistro Staff AA stated that she usually came to work at 10:30 am and her primary responsibility was to assemble the food items once they were cooked. She also stated that Cook U usually came in at 7:00 am, at which time the refrigerator temperatures were checked.

In an interview on 9/7/10 at 9:30 am, Cook U stated that the refrigerator temperatures were checked first thing in the morning. He also stated that he would take additional action if he happened to notice that the temperature was elevated. He acknowledged there was no system in place to ensure that the refrigerator maintained food temperatures while it was in use.

Undated hospital policy titled, "Safe Handling of Potentially Hazardous Foods" guided staff that "The temperature of a refrigerator is kept at or below 40°F ..." The policy also guided staff to log temperatures in kitchen refrigerators twice daily.

Based on observation, interview, medical record, and document review, the hospital failed to develop and implement systems for identifying, reporting, and controlling infections and communicable diseases of patients and healthcare workers (HCW), and failed to ensure safe food handling practices were implemented to minimize the risk of foodborne illness.

* Failing to ensure that glucometers (machines used to test blood sugar) were cleaned and disinfected after each patient, the hospital placed patients and staff at risk of being exposed to bloodborne pathogens that cause HBV (hepatitis B virus), HCV (hepatitis C virus), and HIV (virus that causes AIDS).
* To reduce the incidence of exposing patients, health care workers (HCW), and visitors, to infectious diseases, such as tuberculosis (TB), the hospital failed to annually screen all HCW for evidence of TB.
* To reduce the incidence of blood stream related infections due to use of central venous catheters (CVC) the hospital failed to ensure that the physician performed a daily assessment of the CVC to determine if continued use was medically necessary.
* The hospital placed female patients who had vaginal endocavitary (that have direct contact with mucous membranes) ultra-sound procedures at risk of contacting communicable and infectious diseases by failing to ensure that the endocavitary probes, were cleaned and reprocessed as a semi-critical instruments.
* The hospital failed to ensure that the physicians notified 2 out of 3 patients (Patient 12 and 13), that their screening for methicillin resistant staphylococcus aureus (MRSA) was positive.* The hospital failed to ensure that 3 out of 4 patients (Patients 14, 15, and 16) were screened for evidence of MRSA, when readmitted to the hospital within 30 days.
* The lack of effective temperature control of potentially hazardous foods while under refrigeration.
* The lack of effective cool-down monitoring of potentially hazardous foods.
* The facility having a construction design that may result in the cross contamination from a storm drain in the dry storage area.
* The lack of an air gap in food production sinks.
* The use of a meal delivery process that may result in cross contamination of a patient meal tray.
* The hospital failed to ensure that non-disposable blood pressure cuffs used in the Cancer Clinic were cleaned before and/or after each patients use increasing the risk of cross contamination of patients with a decreased ability to fight infection as a result of their cancer treatments.
* The lack of effective food safety and infection control systems may result in food borne illness or contamination of patient foods. Transmission of infections and/or contamination may further compromise the nutritional and medical status of patients.

Findings:

1. The hospital placed patients at risk of being exposed to bloodborne pathogens by failing to ensure that glucometers (machines used to test a patients' blood sugar level) were cleaned and disinfected after each patient.

On 8/30/10 beginning at 1:30 pm, a tour was conducted of the inpatient and outpatient areas of the hospital. During the tours, nursing staff was asked about the process for cleaning the glucometer. The following responses were provided by nursing staff:

a. The Intensive Care Unit (ICU) Charge Nurse stated that the glucometer was cleaned once a week using Sani Cloth - HB.
b. The Surgical Unit Charge Nurse stated that the glucometer was cleaned every night using Gluco Chlor (bleach solution) wipes.
c. The Definitive Care Unit Charge Nurse stated was cleaned every night using Gluco Chlor wipes.
d. Medical Unit Charge Nurse sated that glucometer was cleaned once a day using alcohol swabs.
e. The Outpatient Surgery Charge Nurse stated that the glucometer was cleaned when it was was soiled using Sani-Wipe HB.

On 8/3/10 at 4:45 pm, the hospital's 11/10/08 policy and procedure titled, "Blood glucose, sure step flexx meter" was reviewed. On Page 5 of the policy and procedure, nursing staff were directed to clean the monitor every 24 hours using an alcohol wipe and to clean the inside of the test strip holder using a bleach wipe. Nursing staff were also directed to never use alcohol inside the test strip holder.

On 8/31/10 at 10:15 am, the Infection Preventionist (IP), was interviewed. When asked about the frequency of cleaning the glucometer, the IP stated that the hospital did not have an approved policy directing how frequent the glucometer was to be cleaned. When asked about the disinfectant nursing staff should use to clean the glucometer, the IP stated that alcohol and Sani-Wipe HB should not be used. The IP stated that Gluco Chlor should be used to clean the glucometer.

In 4/ 2010, the American Journal of Infection Control published an article written by the Association for Professionals in Infection Control and Epidemiology (APIC). On page 171, under the section titled, "Blood glucose monitoring devices" direction was given, "Assign a glucometer to each individual if possible. Clean and disinfect glucometers if they must be shared between patients..." Thoroughly clean all visible soiled or organic material (eg. blood) from the glucometer before disinfection. Disinfect the exterior surfaces of the glucometer after each use following the manufacturer's directions. Use an Environmental Protection Agency-registered disinfectant effective against HBV, HCV, and HIV, or a 1:10 bleach solution (1 part bleach to 9 parts water)."

2. The hospital failed to ensure physician's and allied healthcare practitioners were screened for TB annually.

On 8/31/10, at 1 pm, a request was made to review a list of the dates of tuberculosis (TB), screening for physicians and allied health practitioners (Nurse Practitioners and Physician Assistants) who were not employed by the hospital.

During an interview on 8/31/10 at 1:40 pm, the Medical Staff Coordinator stated that the physicians and allied health practitioners, who were not hired by the hospital, were not required to provide evidence of TB screening at the time of initial appointment. The Medical Staff Coordinator stated that physicians and allied health practitioners were required to show evidence of TB screening during their reappointment process every two years.

During this interview on 8/31/10 at 1:40 pm, the Medical Staff Coordinator stated that the hospital's TB risk assessment was "low" and in according to the 2005, TB Guidelines, CDC (Centers for Disease Control and Prevention) recommended that TB screening should be performed every two years. When asked to clarify if physicians and allied health professionals were screened annually for TB, the Medical Staff Coordinator stated, "No, they are screened every other year."

On 8/31/10 at 2 pm, a list of physicians and allied health professionals including the dates of their most recent TB screening dates was provided by the Medical Staff Coordinator. The document was reviewed and showed that 86 out of 155 members of the medical staff and allied health practitioners were past due in for being screened for TB (annually). It was also noted that some physicians and allied health practitioners TB skin tests were due in 2000, 2001, 2005, 2006, 2007, 2008 (past the two year period of reappointment).

On 8/31/10 at 3 pm, CDC's 2005, "Guidelines for preventing the transmission of Mycobacterium tuberculosis in health care settings, was reviewed. In the guidelines, CDC recommended that all HCW be screened at the time of hire, using a two-step process, and that all HCWs be screened annually for presence of TB.

On 9/1/10 at 12 noon, a letter dated addressed to Members of Licensing and Certification, 9/23/08, addressed evaluations of the risk for transmission of TB, if the healthcare setting is low. Direction in the letter sent to Licensing and Certification directed, "A facility is classified as low risk if persons with TB disease are not expected to be encountered and therefore, exposure to Mycobacterium tuberculosis (MBT) is unlikely or HCWs will never be exposed to persons with active TB or to clinical specimens that might contain MBT. After much discussion, CTCA (California Tuberculosis Controllers Association), requested an opinion from the Occupational Health Branch (OHB)....on reducing the interval of TB testing in HCWs in "Low risk" health care setting.......The last sentence of the two paragraph letter provides clarification that, "At the fall 2007 CTCA TB meeting, a motion for vote was made on this issue and CTCA recommends the interval for serial TB testing of HCWs to be at least every 12 months."

3. CDC has determined that use on CVC increases the risk of patients developing device related blood stream infections.

a. On 8/30/10 at 1:45 pm, Patient 17's medical record was reviewed. Documentation in the medical record showed that the patient was admitted to the intensive care unit (ICU), on 7/16/10.

Documentation in the clinical notes section of the medical record showed that the patient had a CVC inserted in his right arm on 7/22/10. Documentation in the clinical notes section of the medical record read that the CVC was removed on 8/20/10, and the tip of the catheter was cultured. Documentation in the clinical notes section also showed that on 8/20/10, a second CVC was inserted in the patient's left arm.

A review of the physician's progress notes after the CVC was inserted, contained no evidence showed that the physician had performed a daily assessment of the CVC and determined that continued use of the CVC was medically necessary for the total of 39 days the patient a CVC.

b. On 9/1/10 at 9:45 am, Patient 19's medical record was reviewed. Documentation in the medical record showed that the patient was admitted to the ICU on 7/12/10 and was discharged on 7/20/10.

Documentation in the clinical notes section of the medical record showed that the patient had a CVC inserted on 7/13/10. Documentation also showed that the CVC was removed on 7/20/10.

A review of the physician's progress notes contained no information that the physician had performed a daily assessment of the CVC and determined that continued use of the CVC was medically necessary for the six days the patient had a CVC.

c. On 9/1/10 at 10 am, Patient 20's medical record was reviewed. Documentation in the medical record showed that the patient was admitted to the ICU on 7/13/10 and was discharged on 7/23/10.

Documentation in the clinical notes section of the medical record showed that the patient had a CVC inserted on 7/14/10. Documentation also showed that the CVC was removed prior to discharge on 7/22/10.

A review of the physician's progress notes contained no information that the physician had performed a daily assessment of the CVC and determined that continued use of the CVC was medically necessary for the seven days the patient had a CVC.

d. On 9/1/10 at 10:15 am, Patient 31's medical record was reviewed. Documentation in the medical record showed that the patient was admitted to the ICU on 7/14/10 and was discharged on 7/21/10.

Documentation in the clinical notes section of the medical record showed that the patient had a CVC inserted on 7/14/10, removed on 7/19/10.

A review of the physician's progress notes contained no information that the physician had performed a daily assessment of the CVC and determined that continued use of the CVC was medically necessary for the four days the patient had a CVC.

On 9/1/10 at 3 pm, the hospital's 5/11/09, policy and procedure titled, "Central venous catheters: short-term CVCs, PICC lines, tunneled catheters........, Maintenance and Complications" was reviewed. The policy and procedure contained no evidence that the physician was to perform a daily assessment and determine continued use of the CVC was medically necessary.

On 9/1/10 at 3:30 pm, the IP was interviewed. The IP was asked how the hospital ensured that the physician performed a daily assessment to determine that continued use of the CVC was medically necessary. The IP stated that she was told by the Director of the ICU that the registered nurses were to ask the physician every day, and the nurse documented the physician's response in their clinical notes. When asked if this practice was in accordance with the regulation which directed the individual who performed the daily assessment to determine medical necessity be an individual who had the authority to order the insertion or removal of the CVC, the IP stated, "No, it did not."

4. On 8/30/10 at 1:30 pm, a request was made for a copy of the hospital's procedure for cleaning (reprocessing), vaginal ultra sound probes.

During an interview on 8/31/10 at 10:15 am, the IP stated that the hospital did not have an approved policy and procedure that ensured vaginal ultra sound probes were considered semi-critical instruments and were cleaned, disinfected, and reprocessed accordingly. The IP stated originally the hospital planned to use Virex 265 to disinfect the vaginal utra sound probes, but had changed their minds. The IP stated that the hospital was going to use Cidex- OPA instead.

On 8/31/10 at 11 am, the hospital's unapproved policy and procedure titled, "Utra sound transducers, external and internal" was reviewed. Direction in the unapproved policy and procedure was to clean the probe with soap and water to remove gel and debris, then submerge the probe in Virex 256 for 10 minutes, then rinse the probe under running water and dry with a clean dry wash cloth.

5. The hospital failed to ensure that a physician notified patients or their responsible person(s) that their screening was positive for MRSA.

a. On 9/2/10 at 10:30 am, Patient 12's medical record was reviewed. Documentation in the medical record showed that the patient was admitted to the ICU on 7/6/10.

Documentation in the laboratory section of the medical record showed that Patient was screened for MRSA on 7/7/10 at 4:27 pm, and the results were positive.

A review of the physician's progress notes section of the medical record contained no evidence that the patient or her representative was notified of the positive MRSA screen. It was noted that an undated page in the progress notes had been pre stamped, with a stamp, indicating that the MRSA screen was positive. The stamp had spaces for the physician to complete, date, time and sign. It was noted that the hospital stamp was not completed by the physician.

b. On 9/2/10 at 10:45 am, Patient 13's medical record was reviewed. Documentation in the medical record showed that the patient was admitted to the ICU on 7/9/10.

Documentation in the laboratory section of the medical record showed that Patient 13 was screened for MRSA on 7/11/10 at 1 pm, and the results were positive.

A review of the physician progress notes section of the medical record contained no evidence that the physician had notified the patient or their responsible person that the MRSA screen was positive.

During a concurrent medical record review, on 9/2/10 at 10:40 am, the PI verified that the medical records contained no evidence that the physicians had notified Patients 12 and 13, that their screenings for MRSA was positive.

On 9/2/10 at 11 am, the hospital's 12/08, policy and procedure titled, "Methicillin-resistant staphylococcus aureus (MRSA) active surveillance / screening cultures" was reviewed. On Page 2 of the policy and procedure, under Item F, direction was given that, "Patients with a positive MRSA culture will be informed of the positive culture by a physician."

6. The hospital failed to ensure that patients readmitted to the hospital within 30 days were screened for presence of MRSA.

a. On 9/2/10 at 10 am, Patient 14's medical record was reviewed. Documentation in the medical record showed the patient was admitted to the hospital on 6/27/10 and was discharged on 6/29/10. Documentation in the medical also showed that the patient was readmitted to the hospital on 7/15/10 and discharged on 7/18/10.

A review of the laboratory section of the medical record contained no evidence that the patient was screened for MRSA after the second admission to the hospital.

b. On 9/2/10 at 10:10 am, Patient 15's medical record was reviewed. Documentation in the medical record showed the patient was admitted to the hospital on 8/14/10 and discharged on 8/20/10. Documentation in the medical record also showed that the patient was readmitted to the hospital on 8/25/10, and that the patient remained hospitalized.

A review of the laboratory section of the medical record contained no evidence that the patient was screened for MRSA after the second admission to the hospital.
8
c. On 9/2/10 at 10:20 am, Patient 16's medical record was reviewed. Documentation in the medical record showed that the patient was admitted to the hospital on 7/23/10 and discharged on 7/31/10. Documentation in the medical record also showed that the patient was readmitted to the hospital on 8/10/10 and discharged on 8/14/10.

A review of the laboratory section of the medical record contained no evidence that the patient was screened for MRSA after the second admission to the hospital.

During a concurrent interview, the IP verified that the three patients were not screened for MRSA after being readmitted to the hospital within 30 day.

On 9/2/10 at 11 am, the hospital's 12/08 policy and procedure titled, "Methicillin-resistant staphylococcus aureus (MRSA) active surveillance / screening cultures" was reviewed. On Page 2, under Item 1, direction was given that, patients previously discharged from a general acute care hospital within 30 days prior to the current hospital admission were to be screened for MRSA.



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7. During review of food handling practices in the Bistro café on 8/31/10 beginning at 1:30 pm, the following was noted:

a. In the refrigerated deli unit the following food temperatures were noted: cucumbers - 50°F; vegetarian burger - 48°F; hummus - 52°F; bean/corn salsa -52°F; tomatoes - 51°F. It was also noted that the refrigerator temperature was 52°F.

In a concurrent interview, Bistro Staff DS AA was asked to describe the foodservices being offered. She stated that the café was open from approximately 11 am until 2 pm, weekdays. She also stated that the items from the deli unit would be utilized to prepare cold food items. The surveyor asked her to describe what would happen to the items at the end of the shift. She replied that if there was a measurable amount of food left over it would be covered and left in the deli unit overnight after which it would be used the following day. The surveyor also asked how the temperatures of the items would be monitored. She replied that the chef recorded the temperature of the refrigerator at the beginning of each day, at approximately 7 am.

The surveyor also asked if the café had any policies/procedures that were used, to which she replied that to her knowledge there were not. Undated hospital policy titled, "Safe Handling of Potentially Hazardous Foods" guided staff that "after heating or serving potentially hazardous food is cooled rapidly ...From 140°F to 70°F within two hours ...From 70°F to 40°F within four hours."

b. In the 2-door reach-in refrigerator, it was noted that there was a salad, identified by Bistro staff as pasta salad, as well as a potato salad both of which were labeled 8/26. In an interview on 8/31/10 at 1:45 pm, Bistro Staff DS AA confirmed these items were prepared several days ago. The surveyor asked her to describe how they ensured that these items continued to be safe to use. She stated that after the food was prepared it would be covered and dated which would allow it to be continued to be used. The surveyor asked if there were any additional actions that would be taken. She replied that to her knowledge there was not; however the chef, who was responsible for food production, may take additional precautions she was unaware of. It was also noted that there was an undated container labeled avocado dressing that was a dark blue color. In a concurrent interview, Bistro Staff DS AA stated that the item was not avocado dressing, rather was blueberry sauce.

In a concurrent review of Bistro food production records, it was noted that there was a clip board hanging near the work area titled, "Cool-down log " that had a blank cool-down log. In an interview, Administrative Staff T stated that the Bistro did open in 2/10; however there was no oversight of food production practices by hospital staff.

In an interview on 9/2/10 beginning at 9:50 am, Cook U was asked to describe how he ensured that foods which were previously prepared and/or stored for later use were safe to be used. He stated that he would monitor the cool down by periodically taking food temperatures. The surveyor asked if he had documentation of the cool-down process. He presented the surveyor with a cool-down log that was dated 9/1/10. The surveyor asked if there were previous cool-down logs, to which he replied "No." Cook U was also asked to describe how he ensured that foods which were held in the deli refrigerator were safe to be stored there for an extended period of time. He stated that there was a thermometer in the under counter refrigerator that was checked every morning at 7 am. The surveyor also asked if he monitored food temperatures in any of the units, to which he replied "No."

Cook U was also asked if there were any policies/procedures related to safe food handling practices. He stated the Bistro opened in 2/10 and in mid-August he was given policies related to food safety. In a follow up interview on 9/2/10 at 3:30 pm, Administrative Staff S stated that on 9/1/10 that she had printed out several food handling policies and gave them to Cook U. She acknowledged that the Bistro did not have any policies related to food handling practices prior to 9/1/10.

In an interview on 9/2/10 at 4:00 pm, Administrative Staff E was asked to describe the oversight of food production practices in the Bistro, acknowledged that they had obtained a county permit to operate a food establishment; however there was no oversight by hospital staff.

8. During review of sanitation practices in the café Bistro Staff DS AA was asked how they cleaned food production surfaces. She stated that the surfaces were cleaned with a sanitizer solution that was automatically mixed with water and dispensed through a unit mounted to the wall. The surveyor asked if how she ensured that enough chemical was mixed with water. She replied that the vendor came every few months and checked the unit. The surveyor also asked if the café staff had the ability to check the solution strength, to which she replied they did not.

The surveyor held a reagent strip in the sanitizer solution for the recommended 10 seconds, resulting in a dark navy color, which represented greater than 500 ppm. It was noted that the range of colors on the strip were from 0 to 500 parts per million (ppm), with manufacturer's guidance noting an acceptable range of 150-400 ppm.

9. In a review of the dry storage area on 8/30/10 beginning at 4 pm, it was noted that there was a storm drain pipe running in the vicinity of food storage racks. In a concurrent interview, Administrative Staff S stated that during the past year the hospital had completed a renovation of the loading dock which included creating the dry storage area. She further stated that the foods were placed in the new room in early June. The standard of practice would be to ensure that waste water, including rainwater would be drained in a manner that would not put the hospital's food supply at risk for potential contamination (Food Code, 2009).

10. During general food production observations beginning on 8/30/10 at 3:30 pm, it was noted that there were two main food production areas; each of which had twofood production sinks. In a concurrent interview, Cook W was asked if he were required to wash food items prior to preparation she indicated she would use one of the two production sinks in the cold food prep area. On 8/31/10 at 11:00 am, a follow up observation revealed that Cook U was draining pasta in one of the production sinks in the cook's area.

On 8/30/10 at 2:40 pm, Engineering Staff (ENG PP) was asked to remove the stainless steel panels surrounding each of the four sinks. It was noted that each of the four sinks were directly plumbed into the waste water system without the benefit of an air gap (a space in the pipes). The standard of practice would be to provide an air gap in food production sinks to prevent cross contamination of food production surfaces in the event of failure of the waste water system (Food Code, 2009).

11. During review of food delivery practices on 8/31/10 at 11:55 am, it was noted that hospital dietary staff were responsible for delivering meals to patients. Observation revealed that dietary staff entered a patient room and confirmed the name of the patient. It was also noted that there were two urinals on the over bed table. It was additionally noted that the patient requested dietary staff to remove the urinals. She stated she was not allowed to touch patient supplies, after which she continued to place the meal tray on a pull-out section of the over bed table while the urinals were still present.

In an interview on 9/2/10 at 4:30 pm, with Administrative Staff C she acknowledged that this practice may allow for cross contamination of the meal tray as well as other patient items.


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12. During an observation on8/31/10 at 10 am, a licensed nurse (LN EE) was observed obtaining a blood pressure from Patient 62, then folding the blood pressure cuff and placing it in a basket connected to the intravenous (IV) pole which held the automatic blood pressure machine without cleaning the cuff. At 10:30 am, LN EE was observed taking the blood pressure of a new patient that had just arrived with the same blood pressure cuff used previously on Patient 62. LN EE did not clean the patient contact area of the blood pressure cuff prior to using it for the new patient.

During an interview on 8/31/10 at 10:45 am, LN EE stated the blood pressure cuffs were not cleaned between each patient. LN EE stated the blood pressure cuffs were cleaned at the end of each day or after the last patient was gone. LN EE stated the blood pressure cuff used in the medical oncology infusion area was used, at a minimum, before and after the infusion for each patient and that the unit averages between 15 and 20 patients per day.

During an interview on 8/31/10 at 10:55 am, an administrative nurse (Admin DD) stated another blood pressure cuff was used in the physician examination area on the same floor and also was not cleaned before and/or after each patient. Admin DD stated the examination/evaluation area had an average of an additional 10 to 20 patients per day.

During document review on 9/2/10, a facility poilicy titled, "Cleaning, Equipment" (approved 03/24/08, revised/effective 9/08) indicated that under general (moveable) equipment, the nursing staff was responsible for disinfecting patient contact points between patients.

Based on observation, interview and document review the facility failed to ensure that preparation of radio pharmaceuticals was always done under the direct supervision of an appropriately trained registered pharmacist or doctor of medicine or osteopath.

Findings:

On 9/7/10 at 2:30 pm the nuclear medicine laboratory was toured and the senior Nuclear Medicine Technologist (NMT RR) was interviewed. NMT RR explained the steps taken for preparation of radio pharmaceuticals by the nuclear medicine technicians. NMT RR demonstrated, in the preparation area, the steps he would take preparing a radio pharmaceutical. He also explained that during hospital weekdays hours preparation of radio pharmaceuticals was done when the Radiation Oncologist (Phy SS) was usually in the building, but not necessarily in the nuclear medicine laboratory.

However, for studies performed after hours, neither a qualified physician nor a qualified pharmacist was available to supervise preparations of radio pharmaceutical used for emergency studies. NMT RR provided a document from The Joint Commission which allowed for preparation of radio pharmaceuticals without "direct" supervision. A hospital policy/procedure that specifically allowed indirect supervision of radio pharmaceuticals was not provided.

Based on observation, interview, and policy review, the hospital failed to ensure that the on-site and off-site outpatient facility staff understood the emergency procedures for treatment of anyone in need of emergency treatment and that their emergency responses were to be integrated with the hospital's main emergency department.

Finding:

1. Observation tours of five off-site outpatient facilities were completed on 8/31/10 from 10:45 am to 5 pm and 9/1//10 from 10:15 am to 12 pm.

a. During an interview on 8/31/10 at 11:30 am, a sleep clinic staff member (SCT KK) stated the outpatient sleep clinic tested patients for problems patients may have during their sleep that may impact the patients health and well being. He stated the clinic had the capability to test four patients each night and that the clinic operated six nights a week.

When asked what the staff on duty would do in the case of an emergency requiring an urgent access to a higher level of care, SCT KK replied the technologists on duty would call 911 for transport to the hospital emergency department (ED). SCT KK stated the technologists that work in the sleep clinic are required to have at least the basic cardiopulmonary resuscitation (CPR) training and a class on arrhythmias (abnormal heart rhythms) and what they would look like on the electrocardiogram (EKG) monitors. SCT KK stated they had no emergency equipment within the facility, and that there was no registered nurse on duty in the facility when patients were being tested during sleep.

b. During an interview on 8/31/10 at 1:30 pm, a supervisory staff member (Admin JJ) of an off-site outpatient services facility stated their suite of services included a lab drawing station, basic x-ray services, EKG availability, ultrasound, a DEXA machine to measure bone density, and mammography. Admin JJ stated a registered nurse was on-site Mondays and a registered nurse and radiologist were available for guided breast biopsies and stereotactic breast biopsies on Wednesdays.

During an interview on 8/31/10 at 3:45 pm, an administrative staff member for Medical Imaging (Admin GG) when asked what the staff were instructed to respond to a real medical emergency stated the staff members were instructed to call 911. Admin GG stated the outpatient staff were only required to have the basic life saving (BLS) course.

Neither Admin GG nor Admin JJ mentioned the availability of an AED (Automated External Defibrillator - a portable machine for use in general public areas to diagnose abnormal heart rhythms and automatically deliver electrical shock to the heart in an attempt restore the heart's normal function) in the outpatient suite. No AED was observed within the tour of this out-patient department.

c. During an interview on 8/31/10 at 3:50 pm, an outpatient rehabilitation (rehab) administrative staff member (Admin HH) stated that in the case of an emergency staff would dial 911 and provide basic life saving if necessary. Admin HH also stated the rehab staff had been trained in the use of the AED which was available across the courtyard in the out-patient services suite.

d. During an interview on 8/31/10 at 4:20 pm, an administrative staff member (Admin II) for the out-patient coagulation clinic stated that in case of emergency staff were to call 911 and provide basic life saving care if needed. Admin II stated if a patient was bleeding the staff members had gauze pads available to apply pressure.

Admin II stated there four nurse practitioners (NP) and three licensed vocational nurses (LVN) that worked in the clinic but did not state any of the nurses would complete a full assessment of the emergent patient's condition or report the findings to the main facility ED.

During an interview on 9/1/10 at 10:15 am, Admin II stated the clinic had an emergency box that only contained rescue breathing appliances and that the clinic did not have any emergency medications or emergency cart available. When asked if the staff would communicate with the main facility emergency room, Admin II stated they would not call the ED directly but provide the patient status information to the emergency medical technicians (EMTs) responding to the clinic for transport to the facility.

e. During an interview on 9/1/10 at 11 am, an advanced nursing staff member (MID MM) stated the Midwifery Clinic included the full scope of midwifery services from prenatal care (care of mother and unborn child) to post partum care (care of mother and baby after birth), well women checks, testing for STD's (sexually transmitted diseases), to delivery of the baby in the main hospital. MID MM stated the clinic provides no emergency treatment and if a mother needed emergency care, the staff would call 911.

MID MM stated the clinic had no emergency medications and no sterile birth packs for use in a delivery. MIN MM stated basic instruments were available in the clinic and she felt she could deliver a baby "if necessary" but would transfer as soon as possible.

During an interview on 9/1/10 at 11:30 am, a medical assistant (MA NN) stated that in case of emergency she would call 911 and call for the nurse mid-wife. MA NN stated she did not know of anyone else that would need to be contacted and did not know about the paperwork for documentation.

During document review on 9/1/10, a policy and procedure (P&P) titled, "Compliance with Emergency Medical Treatment and Active Labor Act (EMTALA)" indicated that off-campus sites that were not dedicated emergency rooms "will coordinate with the Emergency Department" and that staff would then complete an "Unusual Occurrence Form" to document the encounter. Staff members at all of the above off-campus sites for out-patient services did not verbalize any instruction or understanding of coordinating the emergency care of out-patients with the main ED and no staff member verbalized the follow-up documentation to record the event and or disposition of the patient.

2. On 8/31/10 from 9:05 to 11 am, the on-campus site of the out-patient Cancer Clinic was toured and activities observed with an administrative manager (Admin LL). During the tour, Admin LL stated the clinic had a crash cart team (nurses assigned to take a rolling cart filled with emergency supplies, a monitor, and defibrillator) that would respond to an emergency situation for the patients within the clinic.

When Admin LL was asked what the staff would do after activating the code system, Admin LL stated 911 would be called for transport to the Emergency Department (ED) of the main hospital. When asked why 911 would be called when the main hospital was right next door using the same sidewalk, Admin LL stated it was easier to transport by ambulance.

Admin LL stated the ED staff do not respond to the code because it is not transmitted to the main ED. She stated if the patient needed to be transferred then the ambulance was used. Admin LL stated the ED was not contacted prior to the 911 call and stated no documentation would be done other than emergency treatment notes or notes in the patient's chart.

During record review on 9/1/10, a facility's policy and procedure (P&P) titled, "Emergency Medical Screening services for Patients at Areas or Departments Located on the Hospital Campus That Are Not Contiguous to the Main Hospital Building(Not Dedicated Emergency Departments," original dated 3/24/08, indicated the entire main hospital campus included structures, the parking lot, sidewalk, and driveway within "250 yards" of the main hospital building.

The above P&P indicated that upon presentation of an emergency, an employee shall "immediately contact the emergency department." Admin E stated he was unaware the ED needed to be contacted prior to 911 being called.

Based on interview and record review, the facility failed to have the appropriate professional staff for the outpatient sleep lab by not having a registered nurse available to supervise and evaluate the nursing care for each patient during their test period.

Findings:

During an interview on 8/31/10 at 11:30 am, a Sleep Clinic staff member (SCT KK) stated the clinic was staffed by one somnolography technologist for each two patients, and that the clinic had the capacity for four patients each night. SCT KK stated the clinic operated six nights a week with technologists (no registered nurses) in attendance.

SCT KK stated the technologists prepared the patients for the sleep tests and monitored the patients for approximately six to seven hours until the required information was obtained. SCT KK stated the patient was then awakened and discharged from the clinic. SCT KK stated a registered nurse was not on-site before, during, or after the testing of patients in the sleep clinic, and that there was no registered nurse assigned to supervise the sleep clinic during its' hours of operation. SCT KK stated if an emergency arose they would call 911 and send the patient to the emergency room of the main hospital.

A registered nurse must evaluate the nursing care needs of each patient and provide an assessment prior to testing, provide ongoing assessments of the patient, as necessary, and supervise/evaluate the nursing care being provided for the patient during his/her stay. Underlying health problems may exist that the registered nurse may find in the initial evaluation/assessment. The facility may not rely on polysimnographic and/or respiratory technicians to conduct nursing duties in lieu of registered nursing staff.

During an interview on 8/31/10 at 11:45 am, a sleep study clinic manager (Admin QQ) and administrative staff member (Admin E) both verified the Sleep Study Clinic did not have a registered nurse that supervised, assessed, or evaluated the nursing care of the patients undergoing sleep study tests.

Based on interview and record review, the facility failed to ensure that the Preemptive Test guidelines/orders (allowed nurses to implement certain physician's orders prior to the completion of a Medical Screening Exam) had been approved by the Governing Body.

A review of the facility's policy titled, "Triage" dated 5/11/09, read as follows: "Triage nurse will order testing as outlined in the Preemptive Test guidelines (approved by ED medical staff) if there will be a delay in rooming a patient, and/or if MSE will not be initiated within 20 minutes of arrival/being placed in treatment room."

On 9/1/10, Admin R provided a copy of the facility's Preemptive Test Guidelines with a date at the bottom of the page of 2/10.

During an interview and concurrent policy review on 9/8/10 at 11:30 am, Administrative Staff G (Admin G) stated that the mention of the guidelines followed by "approved by ED medical staff" meant that the ED physicians' medical group only had approved the guidelines. Admin G stated that the guidelines were not approved by the Emergency Services Committee until 5/26/10, after which the guidelines then went to the Policy Committee. They had not yet been approved by the Governing Body Committee.

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

*Failure to perform a Medical Screening Exam (MSE) for Patient 46 whose length of stay in the ED exceeded five hours and for Patient 42 whose length of stay in the ED exceeded three hours.
*Failure to perform a triage exam for Patients 41 and 45, both of whom had a length of stay that exceeded one and one half hours, and for Patient 47 whose length of stay was almost one hour. Patient 41 returned to the ED the following day and was admitted to the facility.

Findings:

1a. A review of Patient 46's record on 9/2/10, disclosed that he presented to the ED with a complaint of chest pain on 6/16/10 at 11:41 am and was discharged at 5:35 pm. Following a triage assessment (short assessment performed by licensed staff to determine the order MSEs will occur) Patient 46 was assigned a Level 3 urgent (condition that may progress into an acute threat to life, limb, or bodily function without intervention) status and placed in a bed. Lab tests, a chest x-ray and EKG were done in accordance with the preemptive test guidelines. The last entry by a licensed nurse was timed at 2:51 pm. There were no further entries between 2:51 pm and the time Patient 46 was noted to be LWBS (left without being seen) at 5:35 pm. The length of stay was recorded as five hours and 35 minutes. Patient 46 did not received a MSE.

A facility policy titled, "Compliance with Emergency Medical Treatment and Active Labor (EMTALA)" dated 1/12/09, read as follows: "An MSE must be offered to any individual who comes to the ED for examination and treatment of a medical condition. The MSE must be provided within the capabilities of the Dedicated ED. . . . ". The policy read as follows: "Refusal of MSE - if a patient leaves the hospital before receiving an MSE, either with or without notice (elopement) to staff of his/her departure, staff should document the circumstances and reasons (if known) for the patient's departure and the time of departure."

The facility's policy titled, "Basic Assessment/Treatment in Emergency Department," dated 10/1/07, addressed on-going assessment as follows: "Patient's status should be noted at least every 60 minutes."

During an interview on 9/1/10 at 3 pm, Administrative Staff R (Admin R) stated that the facility had one physician and one physician's assistant, who worked daily from 10 am to 10 pm, to perform MSEs.

During an interview on 9/2/10 at 1:20 pm, Admin R confirmed that a MSE had not been done and a discharge note had not been written by the nurse for Patient 46. Admin R was asked to obtain additional information if possible. During a subsequent interview on 9/8/10 at 8:30 am, Admin R stated she had acquired no explanation or further information.

1b. A review of Patient 42's record on 8/31/10, disclosed that she presented to the ED with a complaint of an allergic reaction on 6/1/10 at 8:18 pm and was discharged at 11:31 pm. Following a triage assessment, Patient 42 was assigned a Level 3 urgent status and placed in a bed. Lab tests and a chest x-ray were done and an IV (intravenous line) were started. The last entry by a licensed nurse was timed at 10 pm. There were no further entries between 10 pm and the time Patient 42 was noted to be LWBS at 11:31 pm. The length of stay was recorded as three hours and 12 minutes. Patient 42 did not receive a MSE.

A facility policy titled, "Compliance with Emergency Medical Treatment and Active Labor (EMTALA)," dated 1/12/09, read as follows: "An MSE must be offered to any individual who comes to the ED for examination and treatment of a medical condition. The MSE must be provided within the capabilities of the Dedicated ED. . . . "

During an interview and concurrent record review on 8/31/10 at 2:20 pm, Licensed Nurse (LN) Y stated that the nurse who cared for the patient should have documented what time she discontinued the IV and what time the patient left. LN Y stated that the nurse should have documented if the patient got up and walked out or if the nurse went to the bedside and found the bed to be empty. LN Y confirmed that no MSE had been done.

During an interview on 9/1/10 at 2:45 pm, LN CC stated that she did not recall Patient 42 but said it was her usual practice to chart when she discontinued an IV and when the patient left. LN CC stated that the "LWBS" written on the bottom of the page was not in her handwriting and she thought that maybe a clerk saw Patient 42 when she left, wrote LWBS and took the patient out of the computer as being discharged.

Admin R was present during the interview with LN CC and stated that she also did not know who took Patient 42 out of the computer. Admin R stated that the physician on duty when Patient 42 presented to the ED was unavailable for interview.

2a. A review of Patient 41's record on 8/31/10, disclosed that she presented to the ED with a complaint of abdominal pain on 8/20/10 at 8:02 pm and was discharged at 9:51 pm. No triage assessment was done. LWBS was written in the chart. Length of stay was recorded as one hour and 49 minutes. Patient 41 returned to the ED less than 17 hours later, was admitted and remained hospitalized for three days.

A policy titled, "Triage," dated 5/11/09, read as follows: "The triage nurse will complete a triage assessment within 30 minutes of the patient's arrival unless otherwise indicated."

During an interview on 9/1/10 at 3 pm, Admin R acknowledged that the facility policy required triage assessments to be completed within 30 minutes, and this had not been done for Patient 41.

2b. A review of Patient 45's record on 9/2/10, disclosed that he was a six year old who presented to the ED with complaints of vomiting, diarrhea, and fever on 7/11/10 at 4:11 pm and was discharged at 6 pm. No triage assessment was done. LWBS was written in the chart. Length of stay was recorded as one hour and 49 minutes.

A policy titled, "Triage," dated 5/11/09, read as follows: "The triage nurse will complete a triage assessment within 30 minutes of the patient's arrival unless otherwise indicated."

During an interview on 9/2/10 at 1:20 pm, Admin R stated that she would have expected a temperature to be taken by the nurse. She had no explanation for why the temperature had not been taken or why a triage assessment had not been performed within 30 minutes.

2c. A review of Patient 47's record on 9/2/10 disclosed that she presented to the ED with a complaint of a headache on 8/7/10 at 12:37 pm. Patient 47 was called for a triage assessment at 1:30 pm, at which time "not in lobby" was written. This was 53 minutes after Patient 47 presented to the ED.

A policy titled, "Triage," dated 5/11/09, read as follows: "The triage nurse will complete a triage assessment within 30 minutes of the patient's arrival unless otherwise indicated."

During an interview on 9/2/10 at 1:20 pm, Admin R confirmed that triage should have been done within 30 minutes in accordance with their policy.

Based on food service observations, administrative and dietary staff interview, and administrative performance improvement document review, the hospital failed to ensure that the comprehensive dietary department performance improvement program included an evaluation of the current scope of service, as evidenced by a lack of evaluation to fully evaluate the depth and breadth of dietetic services.

Findings:

Review of performance improvement activities related to dietetic services beginning January 2010 revealed that while the department was contributing activities to the hospital's dietetic services, the activities did not include the food service activities in the Bistro café.

In an interview on 8/30/10 at 2:30 pm, Administrative Staff S was asked to describe food service locations/services with patient access. She stated that she had oversight for the in-patient hospital food service, as well as the cafeteria within the hospital. She stated that there was also a Bistro café that was used by out-patients of the state licensed wellness program; however, the nutrition services department provided no oversight to this location.

In an interview, Administrative Staff T confirmed the Bistro opened in February 2010; however, as the registered dietitian she provided no oversight/guidance of food production practices by these hospital staff members.

During an interview on 9/1/10 at 2 pm, the Infection Preventionist (IP) was asked about the report titled, "Infection control clinic surveillance." The IP stated that she had identified several issues related to unsanitary practices in the clinic areas, especially in the food preparation, storage, and overall cleanliness at the Lifestyle Bistro. The IP stated that in an attempt to change infection control (IC) practice at the clinics, she decided to make infection control rounds, and report the findings at the infection control meetings.

In an interview on 9/2/10 at 4:00 pm, Administrative Staff E, who participated in the hospital's quality assurance committee, was asked to describe the oversight of food production practices in the Bistro. He stated that the wellness center was the vision of a former employee who implemented the development of the café as part of that outpatient service. He also stated that the hospital obtained a county permit to operate a food establishment; however, there was no oversight by hospital staff and therefore, there was no mechanism for including this food service location in the hospitals' performance improvement program.

Based on observation, record review, and staff interview, the facility failed to identify medication errors. Patient 23 did not receive any doses of her osteoporosis medication, Actonel, that she was supposed to receive once every week. Even though a note to clarify and arrange to obtain the medication appeared daily on the MAR (medication administration records), there was no documented evidence of follow up or clarification for nine days.
Findings:
On 9/1/10, at 9:25 am, Patient 23 was observed receiving morning medications. Review of the clinical record revealed that Patient 23 had a physician order written on the day of admission, 8/24/10, for Actonel, a medication administered weekly for treatment and prevention of osteoporosis. The pharmacist processed the order on 8/24/10, and input instructions, which printed on the medication administration record to: "Clarify day of week ....obtain patient's own med; Obtain order to use own supply send to pharmacy for relabeling."
On Wednesday, 9/1/10 at 10:30 am, on follow up after the medication pass observation, the facility nurse (LN 103) did not know what day Patient 23 took Actonel or if the medication was available. There was no documented evidence in the clinical record that this issue was clarified. Licensed Nurse 103 checked with Patient 23, at 10:30 am, and found out that, the patient took Actonel once every week on Mondays, and that she did not have the medication with her. Nine days after admission, there was no documented evidence that Actonel was clarified or obtained, which resulted in a missed dose.

Based on record review and staff interview, the facility failed to set priorities for performance improvement that focus on high risk or problem prone areas as evidenced by the following:
* Medication Use Evaluation for fentanyl patches (Duragesic) was completed in 2008; however, there was no evidence that the results were used for performance improvement to reduce the risk of harm to patients and ensure that the medication was used appropriately.
* Ensure that look-alike medications were stored in a safe manner that facilitated reduction of medication error and ensured patient safety especially since this issue was addressed by qualify assurance before.
* Conduct random checks or audits to evaluate use of controlled substance and to detect possible theft, abuse, or misuse.
Findings:
1. On 9/8/10 at 10:30 am, Pharmacist B was interviewed regarding DUEs (Drug Use Evaluation). The "Duragesic (Fentanyl) Patch DUE" was evaluated. The study was conducted in 2008 and presented to the Pharmaceutical and Therapeutic committee in December of 2008. The study identified that the use of the patch was contraindicated 36% of the time; that was about one out of every three patients. The recommendation, at that time, was, "education be provided to both the nursing and medical staff on the appropriate initiation and titration of fentanyl patches."
On 9/1/10, review of clinical records for patients receiving fentanyl patches revealed that two out of three patients received fentanyl patch inappropriately. That was about 66% of patients. That meant the inappropriate use of fentanyl patches almost doubled since December 2008.
a. Patient 23 was prescribed fentanyl patch for acute pain related to bone fracture with no evidence that the patient was opiate tolerant (received at least 60 mg of oral morphine for one week).
b. Patient 22 had no evidence of being opiate tolerant, but fentanyl was started on the day of admission. Both patients were elder (85 and 84 years old) and had medical conditions, respiratory related conditions, which exposed them to the increased risk of life-threatening hypoventilation associated with fentanyl patch use.
The fentanyl transdermal system also called a fentanyl patch contains fentanyl, a potent synthetic opiate medication used to treat pain. This medication has a boxed warning which is the most serious warning required by the Food and Drug Administration to be placed in the product labeling for a medication. Boxed warnings document potential problems that can lead to serious injury or death. The boxed warning for the fentanyl patch documents that it has an associated risk of fatal overdose due to respiratory depression. It is indicated for the management of persistent moderate to severe chronic pain that requires continuous around-the-clock opioid (narcotic pain relievers derived from or having the pain relieving action of opium) administration for an extended period of time and that cannot be managed by other pain medications. Use of the patch is contraindicated in the treatment of postoperative pain. The boxed warning also documents that it should only be used in patients who are opioid-tolerant which is defined in the boxed warning as those patients who have taken at least 60 mg of oral morphine, 30 mg of oral oxycodone, or 8 mg of oral hydromorphone (opiate medications used to treat pain) daily for a week or longer or an equianalgesic dose of another opiate medication, and that use of this patch to treat patients who are not opioid-tolerant is contraindicated because serious or life-threatening respiratory depression can occur.
a. On 9/1/10, at 9:25 am, review of the clinical record for Patient 23 revealed that Patient 23 was an 85-year-old female with multiple medical conditions including COPD, (Chronic Obstructive Pulmonary Disease). She was admitted because of pain related to fractured tibia as result of fall (on 8/24/10). There was no documented evidence that Patient 23 was receiving any opiates prior to admission. On admission, on 8/24/10, she had orders for acetaminophen 325 mg every 4 hours as needed for mild pain, Vicodin 5/500 one table every 4 hours as needed for moderate pain. Vicodin is a combination medication that contains acetaminophen and hydrocodone. On 8/28/10, only 4 days after admission, Patient 23 was prescribed fentanyl patch 25 micrograms for pain.
There was no documented evidence that the pharmacist processed the order questioned fentanyl patch appropriateness especially considering patient's age, 85 year old, or her condition, COPD. On 9/1/10 at 3:15 pm, the prescribing physician (Physician X) when asked if pharmacy staff called him about fentanyl patch orders, he stated that he has not been called about these orders. As for Patient 23, Physician X stated on telephone interview that the patient had nausea and that was reason for giving her pain medication via transdermal route. When the morphine equivalent dose to fentanyl 25 mcg was mentioned, he said that there is no way that Patient 23 would have tolerated 60 milligrams of morphine per day. Fentanyl is one of several opioid medications that share the same side effect profile such as, nauseas, vomiting, rash, hypotension, CNS, and respiratory depression. Despite the boxed warning, Patient 23 received fentanyl patch to control acute pain although she had not received around the clock opioid pain relieving medications at doses specified in the product labeling for at least a week.
b. On 9/1/10 at 4 pm, the clinical record for Patient 22 was reviewed with the Director of Pharmacy and a facility nurse. The record revealed an 84-year-old female that came to the hospital on 8/19/10 for severe pain. Patient 22 was prescribed Fentanyl Patch 25 micrograms on admission, order dated 8/19/10 and timed 1915. Patient 22 was receiving Celebrex (pain medication) 200 two times every day and Darvocet N-100 (a combination of acetaminophen 650 mg and propoxyphene 100 mg) every 6 hours as needed. Fentanyl was prescribed for Patient 22 despite the warning in the package insert: "Elderly have been found to be twice as sensitive as younger patients to the effects of fentanyl ... When choosing a dose, take into consideration the following patient factors: age, weight, physical status, underlying disease states, other drugs used ..." It is also indicated under concerns related to adverse effects "Risk of respiratory depression increased in elderly patients, debilitated patients, and patients with conditions associated with hypoxia or hypercapnia." Patient 22 is an 84 year old and has a history of COPD.
On 9/1/10 at 4:20 pm, Pharmacist B stated on interview that Patient 22 had a history of chronic pain for three weeks but no chronic opiate use.
Despite the boxed warning that fentanyl is not indicated to control pain in patients who had not received around the clock opioid pain relieving medications at doses specified in the product labeling for at least a week, Patient 22 received fentanyl patch.
2. During inspection of the medication storage in the emergency department, it was observed that medication storage did not promote or facilitate safe use. In the controlled substance cabinet on the bottom shelf, three clear plastic bags containing syringes with red markings and black writing were stored side by side. These were morphine 2, 4 milligrams, and Dilaudid; both are opiate type medications used for pain. However, Dilaudid is about five times stronger than morphine. Selecting and administering 2 milligrams of Dilaudid for example instead of 2 milligrams of morphine means a fivefold overdose which will predispose a patient to decrease in blood pressure, respiratory depression, increased sedation, and change the level of consciousness.

Look alike sound alike medications are known to cause medication errors. According to the Institute for Safe Medication Practices published in 2004, Look-alike/sound-alike drug names " are a serious problem in health care, accounting for 29% of medication dispensing errors." The same article stated, "Medication errors involving look-alike/sound-alike drug name mix-up can cause serious patient harm. It is often difficult to detect the error, as the dispensed medication is presumed to have been prescribed for the patient."
The Joint Commission raised this issue since 2001 and had specific recommendations for minimizing risk and preventing potential errors, which included direction not to store problem medications alphabetically by name. They also recommended to "Store such identified medications out of order, or in an alternate location."
On 9/8/10 at approximately 2 pm, Administrator A presented several of the "FRH Info Minute" which was the facility's way of disseminating information to staff. Administrator A referred to lookalike and sound-alike medications as the hospital's strategy to reduce medication error. The tool, dated July 2009, was used to educated staff about the topic; Dilaudid and morphine were on top of the list. However, storing look a-like medications next to one another, as the case in the emergency department narcotic cabinet, is not conducive to medication error prevention or patient safety.
3. On 8/30/10, at approximately 4 pm, pharmacist A stated on interview, that the facility did not have a system for tracking controlled substances in class V (five), but some medication in class IV (four) were tracked. On 8/31/10 at noon, pharmacist A was asked for the record for tracking lorazepam and clonazepam, both are class IV controlled substance. The pharmacist stated that the facility did not keep perpetual inventory for these medications. There was no tracking for what was put on the shelf in the pharmacy or what went out. When asked about method for identifying theft or abuse, she stated that there was not any and that they would not be able to detect.
A review of the facility's policy titled, "Controlled Substance Management-Reconciliation and Disposal," dated 5/5/08, revealed no specifics to how the controlled substances are tracked and accounted for in the pharmacy.
In addition, there was no system to ensure that controlled substances dispensed to different patient care areas were validated. There were no random audits or periodic checks to ensure accountability of what was used for which patients or to identify trends for possible theft of abuse. For instance, evaluate use of controlled substance for frequent users, frequent wasters, and users with frequent errors in their documentation, or excessive use for short stay patients...etc.
Pharmacist A stated that they used to do these audits in the past, but they have not been done that recently. Policies for "Controlled Substance Management- Reconciliation and Disposal," dated 5/5/08, and "Narcotic Waste Documentation," dated 11/08,did not address audits or qualify assurance.

Based on observation, interview, and document review, the facility failed to ensure that:
* Medication labeled by the manufacturer' for single patient use, were used for only one patient.
* Medications were administered in accordance with physician order for Patient 23. Actonel, a medication to treat osteoporosis, was not administered as ordered and,
* Drugs and biologicals were not prepared and administered in accordance with Federal laws, and acceptable standards of practice.
Findings:

The hospital failed to ensure that medications were prepared and administered in accordance with physician orders, and with acceptable standards of practice. In addition, a vial of Propofol, labeled by the manufacturer for injection for single patient injection, was used for more than one patient, which placed patients at risk of contacting a fungal infection.

1. On 9/7/10 at 8:50 am, a tour was conducted of the surgical services area. During the tour, an inspection was conducted of the 3 out of 5 anesthesia carts and the following was noted:

a. In operating room (OR) 0, two syringes with clear solutions were noted in the top drawer of the anesthesia cart. One syringe contained 1 ml (milliliter), and was labeled as containing ephedrine. The second syringe contained 5 ml and was labeled as containing phenylephrine. Neither syringe was labeled as to strength of the medication inside the syringe, the date, time the medication was drawn up, the initials of the individual who drew up the medication, or the expiration date of the medications inside the syringes
.
During a concurrent interview, the Director of Surgical Services stated that OR room, "0" was dedicated for cesarian sections only. When asked when the last cesarian section was performed, the Director of Surgical Services, stated, 9/3/10, four days prior.

b. In OR 1, a syringe labeled as containing 50 mcg of Fentanyl, and a second syringe labeled as containing 15 ml of Propofol, was observed in the top drawer of the anesthesia cart. It was noted that the two syringes of medication were not labeled with the date, time, expiration date of the medication inside the syringes, or initials of the individual who drew up the medications.

In addition, a 50 ml vial containing approximately 10 ml of Propofol was also noted. A review of the manufacturer's label on the vial of Propofol directed that the medication was, "For single injection or infusion in an individual patient."

c. In OR 3, four syringes of medication were observed in the top drawer of the anesthesia cart. One syringe, unlabeled and contained 15 ml of a milky white substance, one syringe contained 2 ml of a clear solution, labeled as Zemuron, the third syringe contained 2 ml of a clear solution, labeled as Versed, and the fourth syringe contained 2 ml of clear solution labeled as Fentanyl. None of the four syringes were labeled with the strength of the medications inside the syringes, the date and time the medications were pre-filled, the initials of the individual who pre-filled the syringes, or the expiration date of the medications pre-filled in the syringes.

On 9/7/10 at 2 pm, a review of the hospital's medication administration policies and procedures contained no direction on how syringes that were pre-filled with medications were to be labeled.

d.. During an inspection of the anesthesia carts on 9/7/10 at 8:50 am, the following open multi-dose medication vials were observed open and not dated:
Lidocaine 2 % 20 ml,
Labetalol 100 mg / 20 ml, and
Flumazenil .5 mg / 5 ml.

CFR §482.25 (b) (3), requires if the single dose system is utilized, that each single unit dose package bears name and strength of the drug, lot and control number equivalent, and expiration date.

US Pharmacopoeia, 797, mandates that if multi dose medication vials are used, the vial will be discarded 28 days after opening, unless specified otherwise by the manufacturer, or sooner if sterility is questioned or compromised.


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2. On 9/1/10, at 9:25 am, Patient 23 was observed receiving morning medications. Review of the clinical record revealed that Patient 23 had a physician order written on the day of admission, 8/24/10, for Actonel, a medication used for treatment and prevention of osteoporosis and it is given one time every week. The pharmacist processed the order on 8/24/10 with the following instruction that printed on the medication administration record: "Clarify day of week ....obtain patient's own med; Obtain order to use own supply send to pharmacy for relabeling."
On Wednesday, 9/1/10 at 10:30 am, Licensed Nurse (LN) 103 did not know what day Patient 23 took Actonel or if the medication was available. There was no documented evidence in the clinical record that the issue was clarified. LN 103, checked with Patient 23 at 10:30 am, and found out that the patient took this medication once every week on Mondays and that she did not have the medication with her. Nine days after admission, there was no documented evidence that Actonel was clarified or obtained that resulted in a missed dose.