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Based on observation, interview, and record review the hospital failed to follow Federal, State, and Local Laws by failing to ensure that the procedure for policy and protocol development met Title 22 regulations for pharmacy services, nursing services, and the definition of an outpatient.

The hospital failed to develop and implement policies and procedures that ensure the safe and appropriate provision of pharmaceutical services as specified in California Code of Regulations, Title 22 , Division 5, Section 70263(c)(1) that stated, "Policies shall be approved by the governing body. Procedures shall be approved by the administrations and medical staff where such is appropriate."

The hospital failed to ensure that policies and procedures developed by nursing services were approved by the governing body as specified in California Code of Regulations, Title 22 , Division 5, Section 70213(a)(4) that stated, "The hospital administration and the governing body shall review and approve all policies and procedures that relate to the nursing service..."

The hospital also failed to ensure to develop and implement policies and procedures to ensure the safety of the patient as specified in California Code of Regulations, Title 22 , Division 5, Section 70053(a)(2). The hospital failed to ensure that the definition of an outpatient was limited to a patient who does not remain in the hospital over 24 hours.

The cumulative effect of these systemic failures resulted in the hospital's inability to provide patient care in an safe environment according to Federal, Sate, and Local Law.

Findings:

1. During an observation on 8/30/10 of the Medical Intensive Care Unit (MICU), a Healthcare Logistics? Pill Crusher was observed containing a tan colored powdery residue on its surface and crushing mechanism. RX42 stated that he was unable to identify the residue but that the pill crusher should have been cleaned after its last use. RX42 was asked for a Policy and Procedure related to the use and maintenance of the device.

During an observation of the Neurology Unit (6 th floor/6200), a Lucas? duffel bag was observed locked in the bottom of an automated dispensing cabinet. Within this bag was a Plano? plastic container that had 2 pre-filled syringes of epinephrine (a heart drug), 2 pre-filled syringes of atropine (a cardiac drug) and 1 pre-filled syringe of lidocaine (also a cardiac drug). Although the container was sealed with a break away lock, there was no indication of content on this container or else where on or in this duffel bag. A Policy or Procedure was requested from RX42 that addressed labeling and storage of emergency medications.

On 9/1/10, RX 43 provided documents titled "Tablet Crushing or Splitting in Patient Care Areas," "Emergency Boxes" and "Medication Inspections." On the top of these documents were found "Department: Pharmacy" and "Category: Patient Care" in addition to internal document codes and effective dates. The effective date listed on all three documents was "9/2010". Notation at the top of these pages states "Replaces: New" for "Tablet Crushing or Splitting in Patient Care Areas" and "Replaces: [no notation]" for "Emergency Boxes. At the bottom of each page was "Approved:" a signature line with the signature of RX 43 and a date line that stated "9/1/2010." The document "Tablet Crushing or Splitting in Patient Care Areas" was also signed by the "Senior Vice President & Administrator, University Hospital".

On 9/2/10 at 1: P.M., a group interview with senior administrative representatives was held where a document titled "Documents for Management of Medical Center Operations and for Delivery of Clinical Patient Care" was reviewed. The Director of Patient Safety stated that although this document had been approved by the facility medical staff and Pharmacy and Therapeutics Committee (P&T), the document was "not yet official" and was in use to see "if it works". A definition on this document titled "Patient Care Protocol" labeled documents with this category (as those listed above) as those "that use the nursing process to delineate the minimum standard of care for a patient..." This document also cited: "Authority: Nursing Clinical Practice Council." There was no indication that the documents submitted as Pharmacy Policies or Procedures had been evaluated or approved by the facility's Governing Body or Pharmacy and Therapeutics Committee as specified in California Code of Regulations, Title 22 , Division 5, Section 70263(c)(1). There was also no documentation provided that indicated delegation of this authority to a committee of equivalent composition.

2. On 8/31/10 the survey team requested policies regarding safe patient care. The policies requested were fall prevention, pressure ulcer prevention and care, and pain management. The team was given "Patient Care Protocols" that had the reference of "Mosby's Nursing Skills" (a nursing care book).

An interview was conducted with the Chief Patient Care Director (CPCD) and the Manger for Nursing Research (MNR) on 8/31/10 at 1:30 PM. They stated that the committee "Clinical Practice Council" approved all nursing care protocols. They stated that the committee consisted of nursing personnel and other disciplines (such as nutrition care, respiratory (breathing) care, pharmacy, and quality) as appropriate for the protocols.

The CPCD stated that the protocols were based on the nursing care book, "Mosby's Nursing Skills"; however, the committee was able to personalize the cares for the hospital. She stated that the protocols were to direct the nurse for patient care, such as the "how" to perform nursing care procedures. She stated that the protocols were not necessarily connected to a hospital policy. She confirmed that the hospital did not have an actual policy, for fall prevention, pressure ulcer prevention and care, and pain management. The CPCD confirmed that these issues in particular were patient safety issues and not just "how" to perform nursing care.

A review of the document titled "Documents for Management of Medical Center Operations and For Delivery of Clinical Patient Care", no date, revealed the following definitions:

"Medical Center Policy:

Definition: A directive or formal statement of principles that define authority, responsibility, and limitations for various persons or entities in the Medical Center, according to bylaws approved by the Board of Trustees (Governing Body)...To be considered a policy, the document must meet at least one of the following criteria;

...The document addresses patient safety issues...

Authority: A review and approval process of the chief experts and stakeholders of each policy, and signatures of pertinent clinical and administrative persons; MSEC (Medical Executive Committee, a group of physicians) for policies related to patient care; Board approval for policies related to major financial issues, major HRN (personnel) issues, major risk management issues, and patient care."

"Patient Care Protocol:

Definition: A document that uses the nursing process to delineate the minimum standard of care for a patient, whether for general care purposes or for a specific disease process or condition.

Authority: Nursing Clinical Practice Council."

This document also described the definition, scope and authority for " Administrative Procedure, Guidelines, Operational Guidelines, Clinical Pathway, Clinical Guideline, Bundled Clinical Directives, Physician Assistant Practice Protocol, Patient Care Technique, Standardized Procedure, Standing Orders - Emergency, Standing Orders - Non-emergent, Emergency Measures - clinical, and Emergency Measures - Non-Clinical " . There were three of the procedures that required Governing Body approval these were Policy, Administrative Procedure, and Physician Assistant Practice Protocol.

This document was not signed by the Governing Body.

An interview was conducted on 9/2/10 at 1 PM with the Director of Patient Safety (DPS), the President of the Medical Staff, the Chair of Bylaws, the CPCD, and the Director of Pharmacy. The team stated that this document was an informational document to help define the hospital's procedure for developing policies, procedures, and guidelines. The DPS stated that this process started about 1.5 years ago because the hospital had over 500 policies. The team stated that the document had been reviewed by the Medical Staff and signed as "Approved: Medical Staff Executive Committee, May 2010"; however, it was just approved in concept and the Medical Staff Committee wanted changes to be made before final approval.

An interview was conducted on 9/3/10 at 11:15 AM with the DPS and the Medical Director of Patient Safety (MDPS). They confirmed that the Governing Body did not give the Nursing Clinical Practice Council the authority to develop policy or procedure. They confirmed that the hospital's document for defining policy, procedure and guidelines was not approved by the Governing Body. The DPS confirmed that the nursing protocols that were approved by the Nursing Clinical Practice Council had not been approved by the Governing Body or the Medical Staff as specified in California Code of Regulations, Title 22, Division 5, Section 70213(a)(4).They confirmed that the hospital did not have an actual policy for prevention of patient falls, pressure ulcer prevention and care or pain management and that these issues in particular were patient safety issues.

3. A tour of a medical unit at the East Campus of the hospital on 8/31/10 at 9:45 AM was conducted. An interview was conducted with the charge nurse of the unit, RN 62 at the same time, she stated that the unit takes care of medical patients and "observation" patients. RN 62 stated that observation patients were outpatient status and that the patients could be on the unit from 1 to several days. She stated that there were no policies or procedures that outlined the length of stay for the observation patients on the unit. RN 62 explained that patients were admitted to "observation" status usually from either the urgent care clinic or from physician's offices. She stated that these patients were patients who may not meet admission criteria, but the physician felt that they needed to monitored in a hospital setting. She stated that the unit had 14 patients that day and that 3 of these patients were on observation status.

A review of the charge nurse report was conducted and revealed that 2 of the patients were listed. The third patient was a new admission. A review was conducted of one of the patients who was listed on the charge nurse report, for Patient 85, the following was noted:

Patient 85 was an 82 year old who was admitted as an observation patient on 8/29/10 at 11:36 PM with listed problems including vomiting, nausea, diarrhea, generalized pain, hypotensive (low blood pressure) and end stage kidney disease requiring hemodialysis. The patient remained on outpatient status at the time of review on 8/31/10 at 10:30 AM.

This represented over 24 hours as an observation patient.

In an interview with the Nurse Manager (NM) of the unit conducted on 8/31/10 at 11 AM. She stated that there were no policies about what type of patients would be on observation status or admission status. She stated that it was up to the physician to decide. The NM stated that patients usually did not stay for over 3 days on observation status. The NM stated that there were no policies regarding the length of time the patient could be on observation status.

An interview was conducted with the Director of Patient Safety and Reliability (DPSR) on 9/1/10 at 2 PM. She stated that the hospital had 2 units that took observation patients for over 24 hours. The units were 1300 and 8300, both units were listed as medical units in the hospital. The DPSR stated that most of the observation patients on 1300 came from physician ' s offices or from urgent care and that most of the observation patients on 8300 came from the emergency department. She stated that the hospital does not have any policies that govern the type of patients that can be admitted as an observation patient or that govern the length of stay for observation patients. She stated that this was a relatively new process for the hospital and that the units had been accepting observation patients for about 1.5 years.

A list of the number of observation patients on each unit was requested and the following was presented:

Unit 8300 presented data collection for the time period of 12/27/10 to 8/23/10. The data revealed that over 240 days the unit had 1655 patients with an average length of stay from
22 hours and 34 minutes to 28 hours and 9 minutes.

Unit 1300 presented data collection for the time period of 8/25/10 through 9/1/10. The data presented noted the following:

8/25/10 - Inpatients- 12, Observation Patients- 3
8/26/10 - Inpatients- 12, Observation Patients- 3
8/2710 - Inpatients- 11, Observation Patients- 2
8/28/10 - Inpatients- 11, Observation Patients- 0
8/29/10 - Inpatients- 11, Observation Patients- 0
8/30/10 - Inpatients- 17, Observation Patients- 6
8/31/10 - Inpatients- 16, Observation Patients- 6
9/1/10 - Inpatients- 15, Observation Patients- 3

The average length of stay for the observation patients was documented as 31 hours.

An interview was conducted with the Chief Patient Care Director (CPCD) on 9/7/10 at 2 PM. She confirmed that the length of stay presented by observation patient was an average and that individual length of stay could be shorter or longer. She confirmed that the average length of stay for both units was over 24 hours. She stated that there were no limits on the length of time a patient could stay in the hospital as an observation patient and that it was at the discretion of the physician. The CPCD confirmed that a patient ' s length of stay as an outpatient could be well over the 24 hour period of time as defined by Title 22.

Based on record review and interview the hospital failed to have an effective governing body responsible for the conduct of the hospital as an institution by failing to:

1. Ensure that the medical staff was accountable to the governing body for the quality of care provided to one patient when a Tracheostomy Brush (Straight metal brush with soft plastic bristles for cleaning the inside of tracheostomy tubes.), was left in Patient 80 ' s Right Lung and not identified upon admission to the facility from 9/24/09 to 10/1/09 and not identified upon discharge. (Refer to A 347)

2. Ensure that it's radiologic services met acceptable standards of practice by failing to ensure that it's policy and procedure pertaining to the Radiology Department's Communication standard was implemented by failing to ensure that the finding of a possible foreign body on x-ray was communicated directly to the ordering physician as per the facility's Policy and failing to recommend follow up or additional studies to clarify the impression of a foreign body on the chest x-ray as per the facility's Policy. (Refer to A 529)


3. Ensure that surgical services were provided in accordance with acceptable standards of practice by failing to ensure that OR staff implemented the facility's policy and procedure regarding surgical counts for one patient by failing to communicate that an instrument had a broken fragment that was left inside the surgical site, failing to obtain an intraoperative x-ray per the facility's policy to search for the retained foreign body prior to Patient #13 leaving the OR, which required a second surgical procedure to remove the retained foreign body a few days later once it was identified on an post surgical MRI. The hospital also failed to ensure that O.R. Staff completed part 4 of the facility's post surgical checklist in which any complication or concern during surgery was discussed. (Refer to A 951)


4. Follow Federal, State, and Local Laws by failing to ensure that the procedure for policy and protocol development met the Title 22 State regulations for pharmacy services, nursing services, and the definition of an outpatient.

a). Develop and implement policies and procedures that ensure the safe and appropriate provision of pharmaceutical services as specified in California Code of Regulations, Title 22 , Division 5, Section 70263(c)(1). (Refer to A020)

b). Ensure that policies and procedures developed by nursing services were approved by the governing body as specified in California Code of Regulations, Title 22 , Division 5, Section 70213(a)(4) .(Refer to A020)

c). Develop and implement policies and procedures to ensure that the definition of an outpatient was limited to 24 hours, to ensure the safety of the patient as specified in California Code of Regulations, Title 22 , Division 5, Section 70053(a). (Refer to A020)

5. Develop and implement policies and procedures that ensure the safe and appropriate provision of pharmaceutical services. (Refer to A 491)
a). Ensure pharmacist oversight existed during the flow of expired controlled substances from the removal from the patient care area to the pickup and destruction. (See A-494)
b). Develop and/or implement policies and procedure that provide for pharmaceutical services that ensure patient safety through the appropriate control and distribution of medications and medication-related devices. (See A-500)

6. Have an organized nursing service by failing to ensure that policies that directed nursing services and the operation of nursing care were approved by the governing body and medical staff to help ensure safe patient care. This failure had the potential to result in nursing's inability to deliver nursing care in a safe environment. (Refer to A 385)

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

Complaint #236532

Based on interview and record review the hospital failed to ensure that the staff in the proton treatment center were educated on the hospital's policy regarding the grievance process. This failure had the potential to affect any patient receiving care in the proton treatment center by failing to ensure their right to file a grievance and caused 1 of 90 sampled patients (Patient 114) to have a delay in an investigation into the grievance submitted by the patient ' s responsible party.

Findings:

A review of a record of telephone conversations between Patient 114 ' s responsible party and staff at the proton treatment center was conducted. The record revealed that on 8/4/2009, the responsible party for the patient lodged a verbal complaint with a Registered Nurse (RN) who works in the treatment center. The complaint was that the patient received too much radiation during a treatment in 2006 and that now he was having medical problems due to the over radiation. The document also recorded that the patient ' s responsible party stated that "(name) believes her (relative) would die soon unless he is diagnosed and treated. " The RN documented that she would discuss the information with the patient ' s physician that had oversight of Patient 114 ' s treatment and an administrator of the treatment center. There was no evidence of this discussion taking place.

There was no record of a conversation between the physician and the responsible party or other evidence that the complaint was either resolved or not resolved.

There was no evidence that the proton treatment staff submitted that complaint as a grievance.

An interview was conducted with the Service Line Manager of Radiology (SLMR) on 9/7/10 at 1:30 PM. She stated that the patient ' s representative had many complaints regarding the patient ' s treatment and regarding her inability to get the patient ' s medical records for review. She stated that the treatment center staff did not submit any of the complaints for review through the grievance process.

A review was conducted of the hospital policy titled " Patient Complaints and Grievances " , dated 8/2009, revealed that " A patient ' grievance ' is defined as a formal or informal written or verbal complaint that is made to the hospital by a patient or the patient ' s representative, when a patient care issue cannot be resolved promptly by staff in the patient care service department. If a complaint cannot be resolved promptly by staff present or is referred to Patient Relations or Medical Center Administration, it is to be considered a grievance. "

An interview was conducted with a Chief RN from Patient Safety and Reliability (RN PSR) on 9/8/10 at 11 AM. She stated that the complaint from Patient 114 ' s representative was filed as a grievance when a letter was received from the patient ' s representative on 10/30/09. She stated that the staff in the proton treatment center did not identify the patient ' s complaint as a grievance and that according to the hospital ' s policy it should have been investigated as a grievance much earlier. RN PSR stated that the hospital had not trained the staff in the proton treatment center to identify a complaint that could not be resolved promptly, as a grievance.

Based on observation, interview, and record review the facility failed to ensure that each patient had the right to formulate an advance directive for 2 of 90 sampled patients (Patients 82 and 119) and potentially for all patients in an observation unit with a capacity of 26. The hospital failed to:

1. Follow their policy for advance directives on one unit of the hospital. This unit was an observation unit and patients were considered by the hospital as out patients, even though they were admitted to observation in inpatient beds. The failure resulted in 1 out of 1 patient reviewed in the unit, Patient 82, not having advanced directive information in the medical record. This failure had the potential to result in all patients on the unit, a potential capacity of 26 patients, to not have their wishes for health care decisions honored by health care staff and practitioners.

2. Protect the rights of Patients 119, by failing to ensure compliance with advance directive notice requirements.

Findings:

1. On 9/2/10 at 11 AM an observational tour was conducted on unit 4300 accompanied by the Nurse Manger (NM) of the unit. The unit was described by the NM as an ambulatory unit where patients were admitted as out patients usually after a procedure. She stated that many patients were discharged the same day that they are admitted; however, some patients stay overnight.

A review of the medical record for Patient 82 was conducted. The patient was admitted to the unit on 9/1/10 for pacemaker generator replacement. According to the physician's notes, dated 9/1/10, the patient had the procedure done the same day. The "common risks and side-effects" of the procedure as documented on the "Procedures/Surgery/Sedation Informed Consent Progress Note" were "Heart Attack, Stroke, Kidney Failure, Arrhythmias (abnormal heart rhythm)/Cardiac Arrest (means the heart stopped beating), Emergency Heart Surgery, Bleeding, Pain at angio (when a catheter may be inserted) Site, Allergic Reaction, X-ray Burn to Skin, Blood Clot to Lungs, Serious Infection, Collapsed Lung"

Further review of the records revealed that there was no information that documented the patient's right to have an advanced directive or to have information provided by the hospital regarding advanced directives. On the form titled "Procedures/Surgery/Sedation Informed Consent Progress Note" there was an area for documenting if the patient had an advance directive or limitation of treatment order; however, this area was blank.

An interview was conducted on 9/2/10 at 11:15 AM with the Registered Nurse , RN 82, taking care of Patient 82. She confirmed that there was no advance directive information in the patient's medical record. RN 82 stated that the nurses on 4300 did not follow up on advance directive information, the physicians or nurse practitioners were responsible on this unit to obtain the information.

A review of the hospital policy, titled,"Patients' Rights Regarding Advance Directives and Acceptance/Refusal of Medical Care", dated 12/2009, revealed the following:

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

2.1 maintain written policies and procedures to ensure that every adult or emancipated minor patient receiving medical care by or through the organization is provided written information at the time of admission concerning an individual's right under state law to make decisions regarding his or her medical care...

3. The duties of caregivers shall be as follows:

3.1 provide timely, written information to adult and emancipated minor patients of an individual's rights under federal and state law to make decisions regarding medical care, including the right to accept or refuse treatment and the right to formulate advance directives.

3.2 provide the patient with an advance directive form if the patient indicates the desire to execute an advance directive.

3.3 made responsible attempts to obtain a copy of the advance directive if the patient's family or gent indicates that one has been executed..."

An interview was conducted with the NM of the unit on 9/2/10 at 11:25 AM. She confirmed that unit 4300 did not follow the hospital policy for advance directives. She stated that the patients on the unit were admitted to the hospital as out-patients; however, she confirmed that the patients were housed in in-patient beds. She also stated that patients who are admitted to the unit are generally patients who are having procedures done and she confirmed that these patients are at a high risk of having an event that may require determining what level of care the patient had requested.



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2. Record review revealed Patient 119 was a 19 year old female admitted to the facility on 8/31/10 with diagnoses including fever, chills, and lower back pain.

Record review of the facility's Advance Directive form filed in the medical record for Patient 119 was noted to be blank. There was nothing documented on the form.

During an interview on 9/2/10 at 2:25 PM with CN 62 who was in charge, she confirmed the advance directive requirement for Patient 119 was not completed during this admission. She was unable to give an explanation as to why the directive was not completed. CN 62 further stated that Patient 119 was discharged on 8/21/10 after delivery of her baby and was readmitted on 8/31/10 for a fever. CN 62 stated it was her understanding that the patient should be given advance directive notice requirements every time they are admitted.

During an interview on 9/2/10 at 2:35 PM with RN 61, she stated that Patient 19 was admitted for a postpartum (after delivery, following childbirth) fever. RN 61 confirmed that Patient 119 was not given advance directive notice requirements. She further stated the nurse that admitted the patient should have completed the form and confirmed that it was not done. She also acknowledged that if the admitting nurse was unable to give the patient the advance directive notice requirement, this information should have been passed along during shift report to ensure compliance with the regulation.

Based on interview and record review the facility failed to ensure that their policy and procedure for restraints was followed for 1 patient (Patient 71) in a universe of 90 patients. This failure had the potential for Patient 71 to have an unnecessary restraint.

Findings:

Review on 9/2/10 of Patient 71's medical record, showed that the patient had a soft right wrist restraint on 8/29/10 through 9/1/10.

Review of the nursing documentation of the alternative measures attempted, the patient's need for the restraint, and the assessment and observation of the patient in the restraint dated 8/29/10 from midnight until 7:00 AM was blank.

In an interview with RN 71 on 9/2/10 at 10:25 AM, he stated, when asked why there was a gap in his restraint documentation, "I was probably with another patient."

Review of the facility policy and procedure titled Restraints and Safety Devices dated 2/2009 showed that "Assessment, re-assessment, monitoring, and care of the restrained patient shall be performed according to established patient care protocol...."

Based on interview and record review, the facility failed to ensure that the Medical Staff provided quality of care for a patient by:
Failing to ensure that the medical staff was accountable to the governing body for the quality of care provided to one patient when a Tracheostomy Brush (Straight metal brush with soft plastic bristles for cleaning the inside of tracheostomy tubes.), was left in Patient 80 ' s Right Lung and not identified upon admission to the facility from 9/24/09 to 10/1/09 and not identified upon discharge. (A 347)

This failure resulted in Patient 80 being discharged to long term care with a foreign body in the right lung, which resulted in a re-admission to the facility with obstructive pneumonia secondary to a foreign body in the right lung and acute respiratory (breathing) failure.

The cumulative effect of this systemic problem resulted in the facility ' s failure to deliver care in compliance with the Condition of Participation for Medical Staff and failure to provide care to their patients in a safe environment.

Complaint number: CA00220296

A-347

Based on interview and record review, the facility failed to ensure that the medical staff was accountable to the governing body for the quality of care provided to one patient when a Tracheostomy Brush (Straight metal brush with soft plastic bristles for cleaning the inside of tracheostomy tubes.), was left in Patient 80 ' s Right Lung and not identified upon admission to the facility from 9/24/09 to 10/1/09 and not identified upon discharge. This failure resulted in Patient 80 being discharged to long term care with a foreign body in the right lung, which resulted in a re-admission to the facility with obstructive pneumonia secondary to a foreign body in the right lung and acute respiratory failure.

Findings:

A record review was initiated on 9/2/10 at 9:00 p.m. Patient 80 was admitted to the facility on 9/24/09 with a diagnosis of multiple sclerosis, quadriplegia, tracheostomy dependent with fever, increased oxygen requirement in respiratory failure and pneumonia per the Discharge Summary dated 10/3/09.

Radiologist (Rad) 1 documented in the chest x-ray Report, dated 9/24/09 at 12:34 a.m. that "A 9-cm portion of what appears to be a J-wire is seen extending in the region of the right atrium." Rad 1 documented in the impression " An orphaned J-wire is seen terminating in what appears to be in the right atrium. " Rad 1 documented in the Chest x-ray Report, dated 9/24/09 at 3:08 a.m. " the portion of what appears to be a J-wire is again noted as previously described. " Rad 2 documented in the Chest x-ray Report under impression, dated 9/24/09 at 2:44 p.m. " Possible aspirated foreign body such as an opened paper clip within the trachea and right mainstem bronchus, stable from earlier in the day. " Rad 3 documented in the Chest x-ray Report, dated 9/24/09 at 8:21 p.m. " Possible aspirated foreign body such as an open paper clip within the trachea and right main and bronchus is again seen, stable from earlier examination. " Rad 4 documented in the Chest x-ray Report, dated 9/25/09 at 2:56 a.m. " A wire is seen overlying the right side of the mediastinum and is unchanged in position since the previous study. " Rad 4 documented in the Chest x-ray Report, dated 9/25/09 at 7:26 a.m. " There is a wire overlying the right side of the mediastinum whtich is unchanged in position since the previous study. " Rad 5 documented in the Chest x-ray Report, dated 9/26/09 at 9:14 a.m. " There is a metallic wire device which projects over the right cardiac margin which was seen on prior examination and is of uncertain etiology. " Rad 5 documented in the Chest x-ray Report, dated 9/27/09 at 7:54 a.m. " The metallic wire device over the right cardiac margin, is in unchanged position and is of uncertain etiology. " None of the 8 chest x-ray reports for patient 80 from 9/24/09 to 9/27/09 contained documentation that Rad 1-5 communicated directly with the ordering physician regarding the impression of a possible foreign body. In addition, none of the x-ray reports had any documentation by the radiologist 1-5 regarding recommending follow up or additional diagnostic studies to clarify or confirm the impression of a foreign body on the chest x-rays.


On 9/2/10 a review of Patient 80 ' s physician progress notes dated 9/24/09 at 5:30 a.m. that CXR (chest x-ray) was " Pending " . The progress note dated 9/25/09 at 6:30 a.m. indicated that MD2 documented under radiology " worsening RLL " underneath that is a lung diagram with a lower portion of the right lobe shaded. There is no documentation of the radiology report of Patient 80 ' s chest x-ray impression of a possible foreign body or a drawing of it on the lung diagram. The progress note dated 9/26/09 at 9:40 a.m. did not contain any documentation of the chest x-ray report and the lung diagram was left blank. The MICU transfer note dated 9/26/09 at 3:35 p.m. indicated " CXR not very convincing of PNA. " There is no documentation of any wire or impression from the x-ray report of a possible foreign body. The MOD accept note dated 9/26/09 indicated that " PNA on CXR R-infrahilar. " There is no further documentation of the radiology report of a questionable foreign body. Progress notes dated 9/2709, 9/28/09, 9/29/09, 9/30/09 and 10/1/09 did not contain any documentation regarding the chest x-ray reports or any acknowledgement of communication from the radiologist regarding a possible foreign body or recommendation of additional imaging to clarify a possible foreign body in the chest.

On 9/2/10 a review of patient 80 ' s discharge summary dated 2/20/10 indicated that Patient 80 was admitted to the facility on 2/9/10 with " postobstructive pneumonia secondary to foreign body in the right bronchus. " The discharge summary indicated that " Patient 80 was admitted from a subacute facility and while in transit via ambulance was found to have acute respiratory distress and had oxygen desaturations into the 80 ' s. Chest x-ray later revealed a foreign body in the right bronchus. "

On 9/2/10 a review of Patient 80 ' s bronchoscopy procedure comments dated 2/17/10 at 5:11 p.m. indicated that " fiberoptic passed via armored tube and visualized pipe cleaner in right mainstem. Attempts x 3 to rotate ETT to enter left main stem were unsuccessful. Armored tube removed to be replaced with another armored ETT, upon removal of 1st armored ETT which was done without resistance; pipe cleaner was noted to be attached to ETT through Murphy eye. Clean armored ETT placed via stoma and fiberoptic passed to evaluate bronchus. Scant amount of bleeding and copious secretions noted. Surgeons concurred that minimual trauma was apparent and no significant bleeding. Decision made to terminate procedure and wake patient.

A review of the facility's 2010-2011 Medical Staff Rules and Regulations on 9/2/10 indicated that " All patients admitted to the Medical Center shall have a member of the Medical Staff with the prerogative or privilege to admit patients and who is identified as the " attending " (or " attending Medical Staff member " or " Attending Practitioner " ) responsible for their (the patient ' s) medical care. "

On 9/2/10 at 9:30 A.M., an interview was conducted with MD5 who is a hospitalist at the facility. MD5 acknowledged that there was no documentation on any of the progress notes regarding the radiology report of a questionable foreign body. MD5 further stated that the Medicine residents tend to read only the impression from the x-ray reports and do not typically read the entire body of the x-ray report because they are usually busy. MD5 acknowledged that the mention of a questionable foreign body was documented in the impression of 2 out of 8 chest x-ray reports.

Based on interview and record review the hospital failed to have an organized nursing service by failing to:

1. Ensure that policies that directed nursing services and the operation of nursing care were approved by the governing body and medical staff to help ensure safe patient care. This failure had the potential to result in nursing's inability to deliver nursing care in a safe environment. (Refer to A 386)

2. Ensure that physician orders for a psychiatry consult were followed in a timely manner. This failure resulted in a patient waiting 4 days for the psychiatry consult to be done. (Refer to A 392)

3. Ensure that a registered nurse supervised and evaluated the nursing care for each patient.

a). For Patient 64, who was diagnosed with esophageal CA (cancer) and had a recent loss of his wife to breast cancer, the facility failed to ensure that nursing completed the assessment to direct an evaluation by social services after depression was documented on the Admissions System Assessment completed upon admission. This failure had the potential for the patient to suffer worsening depression without evaluation by social services. (Refer to A 395)

b). For Patient 104, the hospital failed to ensure that nursing followed physician's orders for monitoring of puncture sites for the patient with a risk for bleeding. The hospital also failed to ensure that nursing clarified an order from a physician regarding a protocol that the hospital did not have. These failures had the potential for the patient to have a blood loss or increased hematoma (collection of blood under the skin) without prompt recognition by nursing. (Refer to A 395)

c). For Patient 81 the facility failed to ensure that a licensed nurse included a measurement of a pressure ulcer to the coccyx as a component of the assessment when the pressure ulcer was initially identified. This failure had the potential to result in the facility not having initial data to track the progression or improvement of the pressure ulcer, prior to the consultation with a wound care nurse. (Refer to A 395)

d). For Patient 73, the facility failed to ensure that licensed staff performed an independent double check when changing a bag of intravenous Heparin, prior to administration to the patient as noted in the facility's guideline for administering high risk medications. This failure had the potential to result in a medication error. (Refer to A 395)

e). For Patient 76 the facility failed to ensure that licensed staff started an insulin drip as ordered by the physician as ordered. This failure had the potential to result in Patient 76 having an elevated blood glucose level that would not have been treated with medication as ordered by the physician. (Refer to A 395)

4. Ensure that nursing services developed and kept current a nursing care for each patient.

a). For Patient 104, the hospital failed to ensure that nursing included in the care plan a physician's order for monitoring of puncture sites for a patient with a risk for bleeding. This failure had the potential for the patient to have a blood loss or increased hematoma (collection of blood under the skin) without prompt recognition by nursing. (Refer to A 396)

b). For Patient 84, the hospital failed to ensure that nursing developed a care plan for the patient's pressure ulcer and that all problems listed had corresponding interventions. This failure had the potential for the patient to have delayed healing of the pressure ulcer and to have his other listed problems progress without prompt recognition and intervention by nursing. (Refer to A 396)

5. Ensure that a high risk medication had an independent double check prior to administration of the medication for Patient 73. This failure had the potential to result in a medication error.(Refer to A 405)

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

Based on interview and record review the hospital failed to ensure that policies that directed nursing services and the operation of nursing care were approved by the governing body and medical staff to help ensure safe patient care. The hospital had a process for developing nursing care protocols where the development of the protocols was done in a nursing committee and approved by the nursing committee without authority from the medical staff or the governing body. Several of the nursing care protocols involved patient safety such as fall prevention, pressure ulcer prevention and care, and pain management. This failure had the potential to result in nursing's inability to deliver nursing care in a safe environment in a universe of 505 patients.

Findings:

On 8/31/10 the survey team requested several policies regarding safe patient care. The policies requested were fall prevention, pressure ulcer prevention and care, and pain management. The team was given "Patient Care Protocols" that had the reference of "Mosby's Nursing Skills" (a nursing care book).

An interview was conducted with the Chief Patient Care Director (CPCD) and the Manger for Nursing Research (MNR) on 8/31/10 at 1:30 PM. They stated that the committee "Clinical Practice Council" approved all nursing care protocols. They stated that the committee consisted of nursing personnel and other disciplines (such as nutrition care, respiratory (breathing) care, pharmacy, and quality) as appropriate for the protocols.

The CPCD stated that the protocols were based on the nursing care book, "Mosby's Nursing Skills"; however, the committee was able to personalize the cares for the hospital. She stated that the protocols were to direct the nurse for patient care, such as the "how" to perform nursing care procedures. She stated that the protocols were not necessarily connected to a hospital policy. She confirmed that the hospital did not have an actual policy for fall prevention, pressure ulcer care, and pain management. The CPCD confirmed that these issues in particular were patient safety issues and not just "how" to perform nursing care.

A review of the document titled "Documents for Management of Medical Center Operations and For Delivery of Clinical Patient Care", no date, revealed the following definitions:

"Medical Center Policy:

Definition: A directive or formal statement of principles that define authority, responsibility, and limitations for various persons or entities in the Medical Center, according to bylaws approved by the Board of Trustees (Governing Body)...To be considered a policy, the document must meet at least one of the following criteria;

...The document addresses patient safety issues...

Authority: A review and approval process of the chief experts and stakeholders of each policy, and signatures of pertinent clinical and administrative persons; MSEC (Medical Executive Committee, a group of physicians) for policies related to patient care; Board approval for policies related to major financial issues, major HRN (personnel) issues, major risk management issues, and patient care."

"Patient Care Protocol:

Definition: A document that uses the nursing process to delineate the minimum standard of care for a patient, whether for general care purposes or for a specific disease process or condition.

Authority: Nursing Clinical Practice Council."

This document was not signed by the Governing Body.

An interview was conducted on 9/2/10 at 1 PM with the Director of Patient Safety (DPS), the President of the Medical Staff, the Chair of Bylaws, the CPCD, and the Director of Pharmacy. The team stated that this document was an informational document to help define the hospital's procedure for developing policies, procedures, and guidelines. The DPS stated that this process started about 1.5 years ago because the hospital had over 500 policies. The team stated that the document had been reviewed by the Medical Staff and signed as "Approved: Medical Staff Executive Committee, May 2010"; however, it was just approved in concept and the Medical Staff Committee wanted changes to be made before final approval.

An interview was conducted on 9/3/10 at 11:15 AM with the DPS and the Medical Director of Patient Safety (MDPS). They confirmed that the Governing Body did not give the Nursing Clinical Practice Council the authority to develop policy or procedure. They confirmed that the hospital's document for defining policy, procedure and guidelines was not approved by the Governing Body. They confirmed that the hospital did not have a policy for prevention of patient falls, pressure ulcer prevention and care, or pain management and that these issues in particular were patient safety issues.

Based on interview and record review, the facility failed to ensure that physician orders for a psychiatry consult were followed in a timely manner for 1 of 90 sampled patients (Patient 63). This failure resulted in the patient waiting 4 days for the psychiatry consult to be done.

Findings:

Record review revealed Patient 63 was a 61 year old male admitted to the facility on 8/16/10 with diagnoses that included nausea, vomiting, and diarrhea.

Record review of the Physician Orders, dated 8/27/10 at 3:45 PM, revealed an order for a psychiatry consult.

Record review of the Psychiatry Consult completed on 8/31/10 at 1:00 PM revealed that Patient 63 was consulted for depression. During review of the psychiatry consult notes, it was noted that Patient 63 had a stroke two months ago and had developed trouble swallowing and slurred speech as a result of the stroke. Further review of the consult notes revealed that the patient had been in rehabilitation until he developed a GI (gastro-intestinal) bleed and was admitted to the facility. Patient 63's caregiver reported during the consultation that the patient had been confused, not sleeping well and had seemed depressed, though this was denied by the patient.

Further review of the Psychiatry Consult notes revealed that the primary team reported that the patient expressed some passive suicidal ideation. Patient 63 was started on Zoloft (antidepressant medication) 25 mg (milligrams) every day.

Record review of the facility's Medical Staff Rules and Regulations (2010-2011) revealed the following:

"9. Consultations. d) The consulting medical staff member is responsible for responding promptly to the request for consultation."

During an interview with the Director of Patient Safety and Reliability (DPSR) on 9/1/10 at 10:12 AM, she confirmed that the facility's bylaws specified that consultations should be done promptly and acknowledged that the bylaws had not defined promptly. When questioned about the consult being ordered on 8/27/10 and not being done until 8/31/10 after being brought to the attention of the facility by the surveyor, she stated that this was not prompt in her opinion.

2. A review of the medical record for Patient 104 revealed that she was admitted to the hospital on 9/5/10 with diagnosis that included history of a stroke (lack of oxygen to the brain) and being non-responsive on this admission.

A review of the physician ' s orders, dated 9/6/10, revealed an order that stated, " Bleeding Precautions " and further documented for nursing to observe puncture sites for bleeding or hematoma. There was no other order written for clarification of this order through the review date of 9/7/10.

Further review of the physician ' s orders, dated 9/6/10, revealed that the patient was placed on a medication, Lovenox, a blood thinner.

A review of the nursing documentation from admission, 9/5/10, to the review date of 9/7/10 revealed that there was no documentation regarding observation of the patient ' s puncture sites.

A review of the plan of care for the patient revealed that there was no care plan regarding the bleeding precautions or direction to nursing to observe puncture sites.

An interview was conducted with Nursing Educator 60 on 9/7/10 at 11:15 AM. She confirmed that there was no nursing documentation regarding observation of puncture sites and no indication in the care plan regarding puncture sites or bleeding precautions. She stated that the hospital does not have a protocol for bleeding precautions. She stated that the nursing staff should have contacted the physician for clarification of the order. NE 60 stated that nursing should have been documenting the monitoring of the puncture sites as ordered by the physician.







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3. The clinical record for Patient 81 was reviewed on 9/3/10 at 10:45 AM with Register Nurse (RN) 63. The clinical record indicated that Patient 81 was admitted to the facility on 7/16/10 at 19:29 (7:29 PM) with a diagnosis of stroke.

The skin assessment flow sheet, noted that Patient 81 had a pressure ulcer to the coccyx area that was first identified on 8/12/10. The registered nurse who initially identified the pressure ulcer to the coccyx documented the following:

Type : " Ulcer/Nonblanchable Erythema "
Ulcer Location: " Coccyx/Sacrum "
Stage: " Stage II "
Surrounding Tissue: " Warm, Intact
Drainage/ Exudate: " None "
Drainage Amount: " None "

There was no documentation noting the size of the wound, so that the progression or improvement of the wound could be tracked.

Further review of the clinical record noted that on 8/16/10 at 10:06 AM, the Wound Ostomy Care Nurse (WOCN) had assessed Patient 81 ' s wound to the coccyx, which is 4 days after the wound had been identified by Staff RN 64.

The documented assessment of the WOCN included, but was not limited to the following:

" Ulcer Location #2: Coccyx/Sacrum "
" Wound Length: 0.5 cm "
" Wound Width 0.4 cm "
" Wound Etiology #2: Pressure
" Skin Ulceration 2: Stage II
" Wound Present on Admission 2: No "
" Wound Drainage: Serous "
" Photograph Taken #2: Photograph Taken "

There was no evidence of documentation or photograph that could be used to determine the size of Patient 81 ' s pressure ulcer to the coccyx, when it was first identified on 8/12/10, to determine if the would had progressed or improved by 8/16/10, when the wound was assessed buy the WOCN. The clinical record indicated that there were not wound measurements documented in the clinical record prior to 8/16/10.

During an interview with RN 63 on 9/3/10 at 11:10 AM, RN 63 verified that the registered nurse who identified the wound, should have documented the size of the pressure ulcer to the coccyx as part of the initial assessment of the wound, inorder to track the healing or non- healing of the wound.

The " Mosby ' s Nursing Skills " for the treatment of pressure ulcers was provided by the facility as their guidelines for assessing and treating pressure ulcers. Review of the " Mosby ' s Nursing Skills " for the treatment of pressure ulcers, " Extended Text " , noted the following:

" Assessment "
" b. Measure the wound dimensions. Measure using a wound measurement guide. Measure two dimensions, length by perpendicular width. "

" 3. Compare subsequent ulcer measurements " .
Rationale: Allows comparison of serial measurements to assess wound healing.

4. The clinical record for Patient 73 was reviewed on 8/30/10 with Registered Nurse (RN)72 approximately 2:10 PM. The clinical record for Patient 73 noted that Patient 73 was a 15 year old male admitted to the facility ' s Children ' s Hospital on 8/13/10 with diagnoses that included fever and back pain.

Review of the physicians orders noted that Patient 73 had an order dated 8/19/10 for heparin 25,000 units within 5% Dextrose in water to run at a rate of 15units/kg/hr (units, pre kilogram, per hour), which for Patient 73 was a rate of 10 ml/hr (milliliters per hour).

Review of the Medication Administration Record (MAR) dated 8/23/10 to 8/24/10 noted that Patient 73 had a bag of intravenous heparin 25,000 units within 5% Dextrose changed at 1113 (11:13 AM) and 0234 (2:34 AM). The MAR noted that only one licensed nurse signed for the 2:34 AM heparin bag change.

Review of the facility " Operating Policy " titled " Medication Administration and Errors " effective date 5/2010 noted the following:
" 10. All high risk medications shall be managed according to established guidelines " .
Review of the facility " Guideline " titled " Administration of High Risk Medications " with the effective date 5/2010 noted the following:
" 1. The following high risk medications shall require an independent double check prior to administration to a patient:
1.2 IV Heparin (excluding Heparin flush less than or equal to 100 units/mL) and other IV administered anticoagulants or thrombolytics "
" 2. The following are additional requirements for double checking in Children ' s Hospital:
2.2 Within one hour of starting continuous medication drip infusion or changing bag/syringe:
a. Initiation of continuous medication infusions (excluding maintenance IV fluids) syringe/bag and infusion pump programming must be independently double checked at or near the initiation of the infusion.
b. Syringe/bag changes require an independent double check at or near the change of the syringe/bag " .

During an interview with Administrative Staff 72 on 8/30/10 at 3:15 PM, Administrative Staff 72 verified that there was no documentation on the MAR that indicated that a double independent check had been performed when the bag of Heparin was change on 8/24/10 at 2:34 AM. Administrative Staff 72 stated that a double independent check should had been performed by licensed staff and documented on the MAR for each heparin bag change as noted in the facility ' s guidelines.

5. The clinical record for Patient 76 was reviewed on 8/31/10 at 10:07 AM with Registered Nurse (RN) 76. The clinical record noted that Patient 76 was a 17 year old male admitted to the facility on 8/23/10 with diagnosis that included cardiogenic shock (A state where the heart has been damaged so much that it can not pump blood effectively to the body.) and heart failure.

Review of Patient 76 ' s " Physician Orders " dated 8/27/10 at 1600 (4:00 PM) noted the following:

" Insulin gtt (drip) 5 units/? (per hour) titrate to keep blood sugar 120 -180
100 units insulin Humalin in 60 mL (milliliters) NS (normal saline).

Review of Patient 76 ' s laboratory results noted the following glucose (blood sugar) levels.

8/27/10 at 05:00 AM = 186 mg/dL (milligram per decileter)
8/27/10 at 18:40 (6:40 PM) = 182 mg/dL
8/27/10 at 21:35 (9:35 PM) = 132 mg/ dL
8/28/10 at 05:57 AM = 190 mg/dL
8/28/10 at 07:06 AM = 173 mg/dL
8/28/10 at 06:04 AM = 177 mg/dL
8/28/10 at 15:05 (3:05 PM) = 112 mg/dL

Review of Patient 76 ' s Medication Administration Record (MAR) form 8/27/10 to 8/29/10 provided no documented evidence that the licensed staff had stared the insulin drip as ordered by the physician to maintain the patient ' s blood sugar between 120 - 180. Patient 76 ' s blood glucose was above the acceptable range of 180 mg/dL on 8/27/10 at 18:40, on 8/28/10 at 05:57 AM. There was no documentation in the clinical record that licensed staff had discussion with the physician regarding Patient 76 ' s blood glucose after the order was written, nor was their any evidence in the clinical record that the physician had discontinued the insulin drip or placed it on hold.

During an interview with RN 76 on 8/31/10 at 10:30 AM, RN 76 verified that the licensed staff had not carried out the physician ' s order for the insulin drip, and that there was no documented evidence in the clinical record that noted that the physician had been notified that the order had not been carried out.







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Based on interview and record review, the facility failed to ensure a registered nurse supervised and evaluated the nursing care for each patient for 5 of 90 sampled patients (Patient 64, 104, 81, 73 and 76).

1. For Patient 64, who was diagnosed with esophageal CA (cancer) and had a recent loss of his wife to breast cancer, the facility failed to ensure that nursing completed the assessment to direct an evaluation by social services after depression was documented on the Admissions System Assessment completed upon admission. This failure had the potential for the patient to suffer worsening depression without evaluation by social services.

2. For Patient 104, the hospital failed to ensure that nursing followed physician's orders for monitoring of puncture sites for the patient with a risk for bleeding. The hospital also failed to ensure that nursing clarified an order from a physician regarding a protocol that the hospital did not have. These failures had the potential for the patient to have a blood loss or increased hematoma (collection of blood under the skin) without prompt recognition by nursing.

3. For Patient 81 the facility failed to ensure that a licensed nurse included a measurement of a pressure ulcer to the coccyx as a component of the assessment when the pressure ulcer was initially identified. This failure had the potential to result in the facility not having initial data to track the progression or improvement of the pressure ulcer, prior to the consultation with a wound care nurse.

4. For Patient 73, the facility failed to ensure that licensed staff performed an independent double check when changing a bag of intravenous Heparin (a medication used to help prevent blood clots), prior to administration to the patient as noted in the facility's guideline for administering high risk medications. This failure had the potential to result in a medication error that could lead to the patient developing a blood clot or having excessive bleeding.

5. For Patient 76 the facility failed to ensure that licensed staff started an insulin drip as ordered by the physician as ordered. This failure had the potential to result in Patient 76 having an elevated blood sugar level that had the potential to result in excessive fluid loss, coma, and death.

Findings:

1. Record review revealed Patient 64 was a 61 year old male admitted to the facility on 8/23/10 with a diagnosis of esophageal cancer.

Record review of the Admissions Systems Assessment completed on 8/23/10 at 5:22 AM revealed the following assessments:

Neurological section: Depression.

Gastro-intestinal section: History of esophageal cancer with chemotherapy and radiation.

Psychosocial section: Suicide Risk Screen: No diagnosis/complaint of an emotional or behavior disorder.

Record review of the Computerized Adult Admission Assessment - Nursing, dated 8/23/10 at 10 PM in the Social Work Section, revealed that no social service referral was needed at this time.

Record review of some of the options to select in the Social Work referral section included the following: "Family in crisis, Impairment in decision making capacity, Lifestyle crisis due to medical changes, Other, ....". There were no selections made in this section.

Record review of the Spiritual Care Assessment completed by the Chaplain revealed the following assessments:

8/24/10 at 1:26 PM: Spiritual support offered for patient. No social service referral needed at this time.
8/30/10 at 10:57 AM: Spiritual support offered for patient. No social service referral needed at this time.
9/1/10 at 11:54 AM: Spiritual support offered for patient. No social service referral needed at this time.

Record review of the History and Physical, dated 7/27/10 1:14 PM revealed a report that indicated that Patient 64 had a past medical history of hypertension (high blood pressure), gastroesophageal reflux disease (GERD: Severe or chronic acid reflux in which stomach acid splashes up from the stomach into the esophagus), and depression due to the recent loss of his wife to metastatic breast cancer.

Further review of the History and Physical, in the section Review of Systems, revealed the following: "Psychiatric: Positive for depression."

Record review of the Nutritional Support Team's Progress Notes, dated 8/25/10 at 3:45 PM revealed documentation that Patient 64 had a past medical history of hypertension, GERD, and depression in which his wife recently died due to breast cancer.

During an interview with MSW 60 (Masters of Social Work) on 9/2/10 at 9:47 AM, he indicated that no referral was needed at this time and that there had been no requests made for a social services referral since the patient's admission.

During an interview with CN 61 (Charge Nurse) on 9/2/10 at 9:50 AM, she stated that if any boxes were checked in the Psychosocial section of the Admissions System Assessment, then a social services referral would be automatically generated. CN 61 also stated that Unit 8100 (an intensive care unit of the hospital) does not complete the Admissions System Assessment and that the assessment must have been completed on another unit. CN 61 further stated that she needed to find out who completed the form and documented depression on it and determine if it was preoperatively or postoperatively.

During further interview with CN 61, she acknowledged that this information should have been passed along during report to ensure that Patient 64 received necessary services and follow up. She also confirmed that this information was not included in Patient 64's care plan to ensure that the depression that was documented in the Systems Assessment was addressed.

Based on interview and record review the hospital failed to ensure that nursing staff developed and kept current a nursing care plan for each patient for 2 of 90 sampled patients.

1. For Patient 104, the hospital failed to ensure that nursing included in the care plan a physician's order for monitoring of puncture sites for a patient with a risk for bleeding. This failure had the potential for the patient to have a blood loss or increased hematoma (collection of blood under the skin) without prompt recognition by nursing.

2. For Patient 84, the hospital failed to ensure that nursing developed a care plan for the patient's pressure ulcer and that all problems listed, fluid volume and anxiety, had corresponding interventions. This failure had the potential for the patient to have delayed healing of the pressure ulcer and to have his other listed problems progress without prompt recognition and intervention by nursing.

Findings:

1. A review of the medical record for Patient 104 revealed that she was admitted to the hospital on 9/5/10 with diagnosis that included history of a stroke (lack of oxygen to the brain) and being non-responsive on this admission.

A review of the physician ' s orders, dated 9/6/10, revealed an order that stated, " Bleeding Precautions " and further ordered for nursing to observe puncture sites for bleeding or hematoma.

Further review of the physician ' s orders, dated 9/6/10, revealed that the patient was placed on a medication, Lovenox, a blood thinner.

A review of the nursing documentation from admission, 9/5/10, to the review date of 9/7/10 revealed that there was no documentation regarding observation of the patient ' s puncture sites.

A review of the plan of care for the patient revealed that there was no care plan regarding the bleeding precautions or direction to nursing to observer puncture sites.

An interview was conducted with Nursing Educator (NE) 60 on 9/7/10 at 11:15 AM. She confirmed that there was no nursing documentation regarding observation of puncture sites and no indication in the care plan regarding puncture sites or bleeding precautions. NE 60 stated that nursing should have been documenting the monitoring of the puncture sites as ordered by the physician and the need for observation should have been included in the care plan.

2. A review of the medical record for Patient 84 revealed that he was admitted to the hospital on 9/1/10 with diagnoses that included a stage II pressure ulcer (pressure ulcers are staged from I to IV, with I being the least invasive).

On 9/2/10 the care plan for Patient 84 was reviewed. There was no plan for the care of the patient ' s pressure ulcer.

Further review of the care plan revealed that there were two problems documented on the " Needs/Problem List " , fluid volume overload and anxiety. There were goals set for these problems; however, there were no listed interventions that guided nursing on how to obtain those goals.

An interview was conducted with the charge nurse of the unit, RN 84, on 9/2/10 at 3 PM. She confirmed that the patient had a stage II pressure ulcer and that there was no care plan completed by nursing for the pressure ulcer. RN 84 also stated that the nursing staff had not documented interventions for the two problems on the problem list. She confirmed that nursing should develop a plan of care to help ensure that the needs of the patient are met.

Based on interview and record review the facility failed to ensure that a high risk medication had an independent double check prior to administration of the medication to 1 of 90 sampled patients. For Patient 73, the facility failed to ensure that licensed staff performed an independent double check when changing a bag of intravenous Heparin (blood thinner), prior to administration to the patient as noted in the facility's guideline for administering high risk medications. This failure had the potential to result in a medication error that could lead to the patient suffering a blood clot or excessive bleeding.

Findings:

The clinical record for Patient 73 was reviewed on 8/30/10 with Registered Nurse 72 at approximately 2:10 PM. The clinical record for Patient 73 noted that the Patient 73 was a 15 year old male admitted to the facility's Children's Hospital on 8/13/10 with diagnoses that included fever and back pain.

Review of the physicians orders noted that Patient 73 had an order dated 8/19/10 for heparin 25,000 units within 5% Dextrose in water to run at a rate of 15 units/kg/hr (units, pre kilogram, per hour), which for Patient 73 was a rate of 10 ml/hr (milliliters per hour).

Review of the Medication Administration Record (MAR) dated 8/23/10 to 8/24/10 noted that Patient 73 had a bag of intravenous heparin 25,000 units within 5% Dextrose changed at 1113 (11:13 AM) and 0234 (2:34 AM). The MAR noted that two licensed nursed signed for the 11:13 AM heparin bag change, but only one licensed nurse signed for the 2:34 AM heparin bag change.

Review of the facility "Operating Policy" titled "Medication Administration and Errors" effective date 5/2010 noted the following:
"10. All high risk medications shall be managed according to established guidelines " .
Review of the facility "Guideline" titled "Administration of High Risk Medications" with the effective date 5/2010 noted the following.

"1. The following high risk medications shall require an independent double check prior to administration to a patient:
1.2. IV Heparin (excluding Heparin flush less than or equal to 100 units/mL) and other IV administered anticoagulants or thrombolytics "

"2. The following are additional requirements for double checking in Children's Hospital:
2.2 Within one hour of starting continuous medication drip infusion or changing bag/syringe:
a. Initiation of continuous medication infusions (excluding maintenance IV fluids) syringe/bag and infusion pump programming must be independently double checked at or near the initiation of the infusion.
b. Syringe/bag changes require an independent double check at or near the change of the syringe/bag."

During an interview with Administrative Staff 72 on 8/30/10 at 3:15 PM, Administrative Staff 72 verified that there was no documentation on the MAR that indicated that a double independent check had been performed when the bag of Heparin was change on 8/24/10 at 2:34 AM. Administrative Staff 72 stated that a double independent check should had been performed by licensed staff and documented on the MAR for each heparin bag change as noted in the facility's guidelines.

Based on medical record review and staff interview the hospital failed to:

A. Have complete medical orders for 2 patients of 90 sampled patients, (Patient 22, and Patient 21) when physician orders were written and did not include the route of administration or incorrect route of administration without nursing clarification. There was the potential of enteral and nutrition physician orders being administered by the wrong route and compromise patient care.

B. Ensure that their policies for documenting error in the medical record were followed for one of 90 sampled patients (Patient 104). This failure had the potential to cause a physician's order to be misread and cause a medical error in the patient's care.

Findings:

1. Medical record was reviewed 8/31/10 at 2:00 PM, on unit 5300. Patient 22 was admitted 7/14/10 with swollen thigh and diagnosed with left femur fracture. Patient had physician orders for regular diet by mouth and NGT (nasogastric tube feeding with enteral feeding tube to stomach).

Review of physician orders dated 8/20/10 at 1000 " Boost Kids Essential 1.5. " Review of physician orders did not reveal clarification of delivery route. Interview with Staff 37 stated that she did not know why there was no clarification of the order.

Physician order 8/20/10 at 1000 for Boost (nutrition supplement) ok 3 cans noc (night) ggt (gastrostomy tube enteral feeding tube into the stomach) from 1900-0500 with 90 ml hour.

Review of the physician orders did not reveal clarification of delivery route as written in the physician orders.

Interview with Staff 37 confirmed that the Patient 22 had a nasogastric feeding tube and did not have a gastric feeding tube. Staff 37 stated that she did not know why the order was not clarified with the physician.

2. Medical record reviewed 8/31/10 at 10:00 AM. Patient 21 was admitted 8/25/10 with cardiovascular accident and left hemiplegia.

Review of Medication Reconciliation form dated 8/26/10 showed " Beneprotein (protein supplement) 6 gram PO (orally by mouth) TID (three times per day). Review of the MAR (medication administration record) dated 30 August to 31 August showed the Beneprotein order for PO (my mouth) administration.

Review of physician order dated 8/27/10 stated " change ngt (nasogastric tube) (enteral feeding tube) medications orders to PEG (gastrostomy feeding tube) medication administration. "

Interview on 8/31/10 at 10:00 AM, with Staff 38, the RN responsible for administration of Patient 22 ' s medications stated that on 8/27/10 she had requested the physician to change the medication orders to the gastrostomy route the patient had. She stated that she had not included a clarification to the physician to also include a change from by mouth administration to gastrostomy tube. Staff 38 confirmed that she was giving the beneprotein to the parent by his gastrostomy tube route.




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3. A review of the medical record for Patient 104 revealed that she was admitted to the hospital on 9/5/10 with diagnosis that included history of a stroke (lack of oxygen to the brain) and being non-responsive on this admission.

A review of the physician ' s orders, dated 9/6/10, revealed a group of orders regarding a transfer from the intensive care unit to an intermediate care unit. The order included instructions for nursing care, the patient condition, and activity. The order group had a large X over the entire order. There was an initial indicating who made the X; however, there was no signature, time, or date of when the X was made.

A review of the hospital policy titled, " Correction of Mistaken Entries and Omission in the Medical Record " , dated 7/2010, revealed that if a correction needed to be made in the medical record a " single line " should be drawn through the mistaken entry. The policy also documented that the current date, time, and signature were required.

An interview was conducted with Nursing Educator 60 on 9/7/10 at 11:15 AM. She stated that the physician did not follow the hospital policy for the documentation of mistaken entries in the medical record.

Based on observation, interview and record review, the facility failed to meet the needs of the patient by not promoting a safe medication use process.

Findings:
1. The facility failed to develop and implement policies and procedures that ensure the safe and appropriate provision of pharmaceutical services. (See A-491)

2. The facility failed to ensure pharmacist oversight existed during the flow of expired controlled substances from the removal from the patient care area to the pickup and destruction. (See A-494)

3. The facility failed to develop and/or implement policies and procedure that provide for pharmaceutical services that ensure patient safety through the appropriate control and distribution of medications and medication-related devices. (See A-500)

4. The Pharmacist failed to supervise the packaging of compounded sterile products by allowing the bulk preparation of unit of use (individual) syringes by a licensed nurse in a non-sterile environment. (See A-501)

5. The facility failed to have an effective system in place for easily identifying and removal of expired IVPBs by not including on the IV labels the expiration date. (See A-500)

6. The facility failed to review the content of the facility ' s Automated Dispensing Cabinets (ADCs) annually as per its policy and procedure. (See A-500)

7. The facility failed to clarify a range order with the prescribing physician as per the facility ' s policy and procedure and ensure range orders were not used. (See A-500)

8. The facility failed to ensure consistency in the facility ' s practice of unit of use preparation of drug doses for NICU patients. (See A-500)

9. The facility failed to ensure expired medications were not available for patient use. (See A-505)

The cumulative effect of these systemic problem resulted in the facility's failure to deliver care in compliance with the Condition of Participation for Pharmaceutical Services and failure to provide care to their patients in a safe environment.

Based on observation, interview and record review, the facility failed to develop and implement policies and procedures that ensure the safe and appropriate provision of pharmaceutical services, such as maintenance of devices used for medication administration and labeling and storage of emergency medications. The potential results of this deficient practice were that staff would not have guidelines to follow that were approved by the Governing Body or delegate and that patients would receive medications that were contaminated or otherwise changed in their effectiveness.

Findings:

During an observation on 8/30/10 of the Medical Intensive Care Unit (MICU), a Healthcare Logistics? Pill Crusher was observed containing a tan colored powdery residue on its surface and crushing mechanism. RX42 stated that he was unable to identify the residue but that the pill crusher should have been cleaned after its last use. RX42 was asked for a Policy and Procedure related to the use and maintenance of the device.

During an observation of the Neurology Unit (6th floor/6200), a Lucas? duffel bag was observed locked in the bottom of an automated dispensing cabinet. Within this bag was a Plano? plastic container that had 2 pre-filled syringes of epinephrine (a heart drug), 2 pre-filled syringes of atropine (a cardiac drug) and 1 pre-filled syringe of lidocaine (also a cardiac drug). Although the container was sealed with a break away lock, there was no indication of content on this container or else where on or in this duffel bag. A Policy or Procedure was requested from RX42 that addressed labeling and storage of emergency medications.

On 9/1/10, RX43 provided documents titled "Tablet Crushing or Splitting in Patient Care Areas," "Emergency Boxes" and "Medication Inspections." On the top of these documents were found "Department: Pharmacy" and "Category: Patient Care" in addition to internal document codes and effective dates. The effective date listed on all three documents was "9/2010". Notation at the top of these pages states "Replaces: New" for "Tablet Crushing or Splitting in Patient Care Areas" and "Replaces: [no notation]" for "Emergency Boxes. At the bottom of each page was "Approved:" a signature line with the signature of RX43 and a date line that stated "9/1/2010." The document "Tablet Crushing or Splitting in Patient Care Areas" was also signed by the "Senior Vice President & Administrator, University Hospital".

On 9/2/10 at 1: P.M., a group interview with senior administrative representatives was held where a document titled "Documents for Management of Medical Center Operations and for Delivery of Clinical Patient Care" was reviewed. [Virginia] stated that although this document had been approved by the facility medical staff and Pharmacy and Therapeutics Committee (P&T), the document was "not yet official" and was in used to see "if it works". A definition on this document titled "Patient Care Protocol" labeled documents with this category (as those listed above) as those "that use the nursing process to delineate the minimum standard of care for a patient..." This document also cited: "Authority: Nursing Clinical Practice Council." There was no indication that the documents submitted as Pharmacy Policies or Procedures had been evaluated or approved by the facility's Governing Body or Pharmacy and Therapeutics Committee as specified in California Code of Regulations, Title 22 , Division 5, Section 70263(c)(1). There was also no documentation provided that indicated delegation of this authority to a committee of equivalent composition.

Based on the inspection of the pharmacy Controlled Substance (CS) Room, interview, and document review, the facility failed to ensure pharmacist oversight existed during the flow of expired controlled substances from the removal from the patient care area to the pickup and destruction. This failure had the potential to effect a universe of 505 patients, hospital staff and visitors.

Findings:

On 8/30/10 at 10 AM, during inspection of the facility ' s main pharmacy ' s Controlled Substance (CS) Room, it was noted that in the room there were two totes on the bottom shelf containing various injectable controlled substances compounded by the pharmacy in IVPB (intravenous medications) or syringes such as fentanyl (narcotic pain medication), morphine (narcotic pain medication), hydromorphone (narcotic pain medication), and midazolam (drug used for sedation) that were expired.

During concurrent interview, PT51 stated that above medications and other expired controlled substances that were returned from the nursing unit as well as the ones that were identified as expired in the CS Room were placed separately on shelves by themselves and were removed from the CS Room once a week.

PT51 explained the above medications were removed from the designated area in the Pyxis (Automated Drug Dispensing Cabinet: ADC) MedStation and brought to the CS Room after they were expired accompanied by the facility ' s " DEA Surrender Inventory " form listing the name and quantity of the expired controlled substances.

PT51 stated that the pharmacy technician would sign the form and bring the expired controlled substances to the CS Room.

Review of the " DEA Surrender Inventory " form indicated that the form required the signature of the pharmacist or the pharmacy technician filling out the form.

PT51 confirmed that pharmacy technicians completed forms for the past month.

During the same inspection of the facility ' s main pharmacy ' s Controlled Substance (CS) Room, it was observed that the pharmacy maintained perpetual inventory of all the controlled substances on the computer located in the CS Room. It was noted that removal of expired controlled substances out of the inventory required documentation on the computer with additional staff as a witness. It was noted that the PT51 had documented on the computer to be the witness of herself.

During concurrent interview, PT51 stated that witnesses for removal of expired controlled substances were pharmacy technicians and stated that she was given the authority to be her own witness for this process.

During concurrent interview, Rx41 stated that two pharmacy staff was required for removal of expired controlled substances and witnessing oneself was not allowed.

PT51 stated that on a weekly basis, all expired controlled substances that were removed and quarantined were packaged in a box and sealed with tape and sent to another area and kept there until the boxes were picked up by the contracted company for disposition. This was done by the technicians.

On 8/31/10 at 1:15 PM, during an interview, Rx47 stated that the sealed boxes containing expired controlled substances were stored in the " cage " located in the loading dock and when the company came for pickup, one of the purchasing agents from the pharmacy would be present at the time of pick up and the driver working for the company would issue the duplicate copy of the DEA 222 Form that listed all controlled substances that were picked up. Rx47 stated purchasing agents were neither pharmacy technicians nor pharmacists.

Rx47 would receive the DEA 222 Form from the purchasing agents, mail one copy to the DEA and file the other copy for pharmacy record. Rx47 stated that as purchasing pharmacist, s/he had the oversight of the receiving and disposition of the controlled substances.

Rx47 stated that non-pharmacist would handle the task from the removal of the expired controlled substances, boxing and sealing of the controlled substances, to the pickup by the company for disposal and that the DEA Surrender Inventory form was not reviewed by the pharmacist and no auditing of the expired controlled substances were performed.

The facility ' s operating policy entitled " Medications Returned to Pharmacy from Patient Care Areas ", dated 5/2010, was reviewed. It stated:

" 2. Items returned to stock shall be inspected by a pharmacist or designee for product integrity and expiration date.

During an interview, on 8/30/10 at 2 PM, Rx44 stated the returned compounded IVPB ' s and syringes containing controlled substances were picked up by the pharmacy technicians and stored inside the designated drawer of the Pyxis MedStation located in the IV Room of the main pharmacy.

The facility delegated handling of the expired controlled substances duties solely to non-pharmacist staff without direct pharmacist involvement. This lack of oversight by the pharmacist and technician acting as a witness for herself in the absence of formulated policy and procedure related to removal and disposal of expired controlled substances have the potential for the drugs to be misplaced, diverted, and unaccounted for.

Based on observation, interview and record review, the facility failed to develop and/or implement policies and procedure that provide for pharmaceutical services that ensure patient safety through the appropriate control and distribution of medications and medication-related devices for a universe of 505 patients.

The facility also failed to implement guidelines for the provision of pharmaceutical services for 2 of 90 sampled patients (Patients 65 and 63). The facility failed to follow it's own acetaminophen (Tylenol) dosing guidelines. This failure had the potential to result in liver toxicity for Patients 63 and 65.

Findings:

1. During a tour of the Medical Intensive Care Unit (MICU) on 8/30/10 at 10:40 A.M., a HealthCare Logistics? pill crusher was observed covered with a tan colored powdery residue on both its surface and in the crushing mechanism. RX42 stated that this device should have been cleaned after its last use. No policy and procedure was available at this time. A document implemented on 9/1/10 titled "Tablet Crushing or Splitting in Patient Care Areas stated "After each patient use, all equipment shall be cleaned with 70% isopropyl alcohol, rinsed with water, and then dryed [sic] before it is used for the next patient."

2. On 8/30/10 at 2:35 P.M., in the entrance to area 6200 (neurology/medicine), a Lucas? brand bag containing a relatively small, translucent, rectangular, plastic Plano? tackle box was observed. There were no markings on the outside of this box but through the plastic could be observed boxes of medications including two pre-filled syringes of epinephrine (a cardiac drug), two pre-filled syringes of atropine (a cardiac drug), and one pre-filled syringe of lidocaine (also a cardiac drug). The Director of Patient Care services for the Medical Service Line, LN46, stated that the bag was used during the transportation in the event a supply or medication contained in this bag was needed.

On 8/30/10 at 3:05 P.M., two unsealed, unlabeled, black nylon containers were observed in an automatic dispensing cabinet on Pod 1 of the Pediatrics Unit. The Transport Coordinator, TC47, stated that these containers were used in various situations that could arise during the transport of patients. RX42 stated that they never considered these as "emergency kits". Included in these containers were lorazepam 4 milligrams per milliliter (mg/ml) injection (used for seizure and sedation), two 5 milliliter (ml) midazolam 1mg/ml injection (used for sedation), two containers of morphine sulfate 4 mg/ml injection (used for pain) and one vial of vecuronium 10 mg/vial injection (used to paralyze muscles) in addition to sterile water for injection (for reconstituting the vecuronium).

3. During an observation of the Operating Rooms on the East Campus on 8/31/10 at 2:20 p.m., a warmer used for storing intravenous solutions was observed to have a temperature of 104 degrees Fahrenheit (F?) (equivalent to 40 degrees Celsius (C?)). On the bottom shelf of this warmer, there was an observation of two tray labeled as "Spinal Support Trays". Labeling of these trays stated that they were to be stored at 20-25 C?. These trays contained a 5 milliliter vial of lidocaine (a medication for decreasing sensation) and a packet of povidone-iodine solution (used to cleanse the skin) for which stability information when stored outside of their normal storage conditions (room temperature) was not available. LN48 stated that these two kits were probably "placed there by anesthesiology." On 8/31/10 a review of the Pharmacy document "Use of Warmers for Pharmaceuticals", dated 2/2010, stated "Products shall be stored in warmers according to manufacturer's recommendations."

During an observation of the Post Anesthesia Care Unit (PACU) on the Eastern Campus on 8/31/10 at 2:40 P.M., a fluid warmer contained the intravenous fluid Isolyte-S, 1000 milliliter bags. The temperature of the warmer was 104 degrees Fahrenheit and the bags had the date 8/31/10 handwritten on a label on them. LN50, the area charge nurse, stated that a person from pharmacy had placed these bags there earlier this same day. He stated that at the current temperature of this warmer, the bags had an expiration date of 30 days.

A review of the Pharmacy document "Use of Warmers for Pharmaceuticals" stated that one method of tracking expiration dates of pharmaceuticals placed in warmers is by use of expiration date labels. A review of other warmers throughout the facility revealed dates up to 30 days beyond 8/31/10 placed on these intravenous solutions. RX44 stated that for an unknown reason, the pharmacy personnel that stocked the PACU solutions into the warmer placed the stocking date rather than the expiration date on these bags. RX44 stated the procedure was not properly followed and that he had reviewed the correct procedure with the pharmacy personnel who mislabeled these solutions.





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4. On 8/30/10 at 11 AM, during inspection of the facility ' s main pharmacy, it was noted that the unused pharmacy compounded IVPB ' s that were delivered to the nursing units that were later returned to the pharmacy IV room were kept until they were reused or expired.

Upon close inspection of the label on the IVPB ' s, it was noted that they had no expiration date on the label and instead, were " return by " dates.

During concurrent interview, Rx41 stated that " return by " date on the label indicated the IVPB was made upto 36 hours prior to the " return by " date and that the facility used " return by " dating to inform the nurse to return the IVPB ' s that were not used by that date.

Still in the pharmacy IV room was an IVPB bag containing piperacillin/tazobactam (Brand Name: Zosyn; an injectable antibiotic) 4.5 gm with the " return by " date of 5/27/10 at 2100 (9PM).

Based on his calculation, Rx41 stated that IVPB Zosyn was stable for 4 days from the time it was made, it should have been expired this morning and should not have been in the IV room.

Reconstituted vials of medications made into injectable IVPB forms are not as stable as vials that they were originally packaged and are given much shorter date of expiration compared with the original manufacturer ' s expiration date. The process in place failed to identify which bags were expired and should have been quarantined and which bags were still usable.

The facility had no policy and procedure on " return by " dating.

California Business and Professions Code Section 4076 stated the following:

" (a) A pharmacist shall not dispense any prescription except in a container that meets the requirements of state and federal law and is correctly labeled with all of the following ...
(9) The expiration date of the effectiveness of the drug dispensed ... "
The facility ' s operating policy entitled, " Storage of Pharmaceutical Materials " was reviewed and it stated:
" 3. Products shall be quarantined until destroyed or returned to maker if
3.1 outdated ... "

5. During interview on 8/30/10 at 10 AM, Pharmacist 2 stated that the selection of medications that were to be stocked in the ADCs (automated drug dispensing devices) throughout the facility were made based on input by the nursing and by physicians ' request and were reviewed by the pharmacy during Pharmacy and Therapeutics Committee (P&T) meetings.

The facility ' s P&T meeting minutes from May 2009 to May 2010 were reviewed on 8/31/10. There was no documentation of discussion of ADC review.

On 9/2/2010 at 9 AM, during an interview, Pharmacist 3 stated that the last time the ADC content was reviewed was in April 2009 and that it was due for a review.

The facility ' s Operating Policy entitled, " Storage and Automated Dispensing of Medications ", dated 8/2010, was reviewed. It had the following:
" ...5.1 All ADC inventory list shall be reviewed annually by the Pharmacy and Therapeutics Committee ... "

6. During chart review of Patient 50 on 8/31/10 at 10 AM, it was noted that there was a physician order written on 8/30/10 at 12:37 AM for morphine (a narcotic pain medication) 1 to 2 mg to be given intravenously every 2 hours as need for severe pain.

During concurrent interview, Rx45 stated that frequency ranges (for example: every 3 to 4 hours) of medication orders were not acceptable and should be clarified. However, dosing range (for example: 1 mg to 2 mg) was acceptable.

During concurrent interview, LN51 stated that the range order such as morphine 1 to 2 mg to be given every 2 hours would be carried out with the lower dose (1 mg) given first. Then, the patient would be evaluated in 15 minutes after which if the patient still had pain, another 1 mg would be given to the patient to equal the higher dose in the dosing range.

During concurrent interview, RX45 was unable to provide documentation the order was clarified with the prescribing physician.

The facility ' s order set entitled, " Adult Cardiology Adision Orders - Coronary Care Unit " was reviewed on 9/1/10 at 9:30 AM. The following was from the order set:

" 27. Darvocet-N 100, 1-2 tablets PO every 4 hours PRN moderate pain for ___ days
28. Temezapam 15 mg, 1-2 capsules PO every HS PRN sleep for ___ days ... "
The nationally recognized organization devoted to medication errors, Institute for Safe Medication Practices (ISMP), on its website published " Guidelines for Standard Order Sets " to help the pharmacy organizations with developing safe order communication and had the following:
" Content of medication orders
Orders Include:
...Metric dose/strength

Objective, organization-determined measures are associated with medication doses that vary based on the degree of the presenting symptom (e.g., morphine 2 mg IV every 3 hours for severe pain; morphine 1 mg IV every 3 hours for moderate pain) ... "

The facility ' s Operating Policy entitled, " Medication Administration and Errors " was reviewed and it stated the following:
" ...1. Written orders for medications shall be verified before administration. Incomplete, illegible, or unclear orders shall be clarified with the prescriber prior to dispensing of medications ...

12. When administering pain medications that are ordered with a dosage range, the clinician shall determine the specific dosage, based on several factors ... "

7. During inspection of drugs in cassettes containing medications specific for neonatal patients in the NICU (Neonatal Intensive Care Unit) on 8/30/10 at 3 PM it was noted that in the cassette for Patient 51, there was one 3-ml injectable heparin (blood thinner) 10 units/ml.

There was a physician order to use heparin 0.6 ml to flush the intravenous line.

During concurrent interview, LN52 stated to draw 0.6 ml from the 3-ml heparin 10 units/ml syringe supplied by the pharmacy, she would have draw out the dose using a smaller tuberculin syringe.

The nationally recognized hospital pharmacy organization, American Society of Health-Systems pharmacists (ASHP), on its website published the guideline titled, " ASHP Guidelines for Providing Pediatric Pharmaceutical Services in Organized Health Care Systems " was reviewed and it stated the following:

" ... Unit Dose Systems. The pediatric unit dose system must meet the original intent of these systems, which is to minimize errors and provide drugs to the patient care areas in ready-to-administer form. Multidose containers and stock medications should be avoided. An extemporaneous preparation service should facilitate the preparation and packaging of medications according to sound compounding principles ... "

During concurrent interview, LN53 stated that she could not think of any other medications supplied by the pharmacy in multi-use form other than heparin and and that all other medications were supplied in single unit of use form.

During concurrent interview, Rx45 could not explain why injectable heparin flush was not unit dosed and stated that all other medications were delivered to the patient care area in ready to administer unit dose form.

There were no policies or procedures pertaining to pharmacy unit dosing of medications used in NICU.


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8. Record review revealed Patient 65 was an 89 year old male admitted to the facility on 7/22/10 with diagnoses that included immobility, and neck/back pain.

During record review of the Physician Orders dated 8/16/10 at 5:20 PM, the following medication orders were noted:

Tylenol 650 mg by mouth every 6 hours as needed for fever. (If given, this would total 2600 mg of Tylenol in a 24 hour period).

Norco (a Tylenol combination product containing hydrocodone {narcotic pain medication} and Tylenol) 10/325 (10 mg hydrocodone and 325 mg Tylenol) by mouth every 4 hours as needed for pain. (If given, this would total 1950 mg of Tylenol in a 24 hour period.)

If both medications were to be given as ordered if needed for pain or fever, the doses would total 4550 mg which would exceed the facility's dosing guidelines of 3250 mg of Tylenol per day for an adult.

9. Record review revealed Patient 63 was a 61 year old male admitted to the facility on 8/16/10 with diagnoses that included nausea, vomiting, and diarrhea.

During record review of the Medication Administration Record for the period of 8/22/10 at 7 AM through 8/23/10 at 6:59 AM the following physician orders were noted:

8/18/10 at 8:25 PM revealed an order for Tylenol liquid 650 mg (milligrams) by mouth every six hours as needed for fever. (If given, this would total 2600 mg of Tylenol in a 24 hour period).

8/23/10 at 12:40 PM revealed an order for Acetaminophen-Hydrocodone 1-2 tablets by mouth every six hours as needed for pain. (Norco 5/325=5mg of Hydrocodone and 325 mg of Tylenol). (If two tablets were given, this would total 2600 mg of Tylenol in a 24 hour period.)

If both medications were to be given as ordered if needed for pain or fever, the doses would total 5200 mg which would exceed the facility's dosing guidelines of 3250 mg of Tylenol per day for an adult.

A review of the facility's Acetaminophen (Tylenol) New Dosing Guidelines, dated January 2010, revealed the following, "FDA (Food and Drug Administration) Recommendations: Maximum adult daily dose 3.25 g (grams) ...". Note: 3.25 grams is also equivalent to 3250 milligrams.

During an interview 8/30/10 at 3:10 PM with RN 60, she stated the maximum daily dose for Tylenol for an adult patient was 3.25 grams (equivalent to 3250 milligrams). She stated that this was also clarified with the facility's pharmacy and micromedex (an online tool that provides referenced information about drugs and diseases). She confirmed that if the patient was to receive the ordered medications as needed for pain, the patient would exceed the maximum daily dose of 3.25 grams (3250 milligrams) as specified in the facility's Tylenol dosing guidelines. She also confirmed that there were no warnings on the Medication Administration Record indicating the potential to exceed the maximum daily dose.

Based on observation, interview and document review, the Pharmacist failed to supervise the packaging of compounded sterile products by allowing the bulk preparation of unit of use (individual) syringes by a licensed nurse in a non-sterile environment. This failure had the potential to effect a universe of 505 patients and had the potential to cause infection by preparation of products in a non sterile environment.

Findings:

During an observation of the Employee Health Department on 9/1/10 at 11:45 AM, a green, plastic container was observed on a countertop. Within this container were 11 syringes labeled as containing Tuberculin Purified Protein Derivative (Tubersol?), a biological product used as an aid in the diagnosis of tuberculosis infection. The individual syringes appeared to contain 0.1 milliliters of fluid, were labeled as being prepared on 8/30/10 and as expiring on 4/9/10. LN 41 stated that she routinely drew one vial at a time (50 syringes) because of the large amounts of product that she used in her daily operations. Although a refrigerator was available for storage, there were no facilities for the preparation of sterile products in the room being inspected. RX 44 said that he was unaware that LN 41 was bulk producing syringes for non-immediate use and that pharmacy should be preparing and labeling these syringes if the nurse so desired.

On 9/1/10, a document titled "Compounded Sterile Products (CPSs)", no date, was reviewed. This document was categorized as a "Patient Care" document for the Department of Pharmacy and stated the "Department Head shall:

1. Ensure that policies, procedures and operational guidelines are maintained, communicated and adhered to by all personnel responsible for compounding CSPs, including hazardous drugs, and packaging and labeling sterile medications." The document further delineated the responsibilities of the Pharmacy Supervisor, the Pharmacist, and the Technician. This document did not address the preparation of non-immediate use CSPs by non-Pharmacy personnel and no other documentation that addressed this subject was provided by the facility.

Based on observation and interview, the facility failed to:

1. Ensure that expired medications were not available for patient use. Expired medications have the potential to loose potency and/or change, so they have the potential to cause a patient to have a negative outcome.

2. Discard a syringe of medication as per manufacturer's recommendation that used medication must be discarded within 24 hours from 1 out of 6 operating rooms at the heart surgical hospital.

Findings:

1. During inspection of the pharmacy located in the Ambulatory Cancer Center on 8/31/10 at 1:30 PM, it was noted that following medications located in the pharmacy's refrigerator were expired:

One Aranesp (injectable drug for red blood cell production) Single Ject 300 mg/ 0.6 ml with the expiration date of 5/09 and one 10-ml vial of folic acid (injectable vitamin supplement) 5 mg/ml with the expiration of 5/10.

During concurrent interview, Pharmacist 1 acknowledged that above medications were expired and should have been removed from the refrigerator away from patient use.







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2. On 8/31/10 at 2:25 PM, while conducting a tour of operating room # 4 at the heart surgical hospital, a 20 milliliter (ml) syringe with 5 ml of a white liquid was observed on top of the anesthesia machine. The syringe was not dated as to when it was opened or labeled with the name of the medication.

An interview with the operating room director was conducted on 8/31/10 at 2:25 PM. She stated that the unlabeled syringe with the medication should not have been left on top of the anesthesia machine and should have been discarded after use.

Based on interview and record review, the facility failed to ensure that it's radiologic services met acceptable standards of practice by:


? Failing to ensure that it's policy and procedure pertaining to the Radiology Department ' s Communication standard was implemented when a Tracheostomy Brush (Straight metal brush with soft plastic bristles for cleaning the inside of tracheostomy tubes.), was left in Patient 80 ' s Right Lung following an admission to the facility from 9/24/09 to 10/1/09 and not identified upon discharge. (A-529)

? Failing to ensure that the finding of a possible foreign body on x-ray was communicated directly to the ordering physician as per the facility's Policy. (A-529)

? Failing to recommend follow up or additional studies to clarify the impression of a foreign body on the chest x-ray as per the facility's Policy. (A-529)

This failure resulted in Patient 80 being discharged to long term care with a foreign body in the right lung, which resulted in a re-admission to the facility with obstructive pneumonia secondary to a foreign body in the right lung and acute respiratory (breathing) failure.

The cumulative effect of these systemic problems resulted in the facility's failure to deliver care in compliance with the Condition of Participation for Radiologic Services and failure to provide care to their patients in a safe environment.

Complaint Number CA00220296

Based on interview and record review the facility failed to meet the needs of one of 90 sampled patients (Patient 80) by failing to ensure that it's policy and procedure pertaining to the Radiology Department's Communication standard was implemented when a Tracheostomy Brush (Straight metal brush with soft plastic bristles for cleaning the inside of tracheostomy tubes.) was left in Patient 80's Right Lung following an admission to the facility from 9/24/09 to 10/1/09 and not identified upon discharge. A Radiologist failed to ensure that the finding of a possible foreign body on x-ray was communicated directly to the ordering physician as per the facility's policy. In addition, the radiologist failed to recommend follow up or additional studies to clarify the impression of a foreign body on the chest x-ray. These failures resulted in Patient 80 being discharged to long term care with a foreign body in the right lung, which resulted in a re-admission to the facility with obstructive pneumonia secondary to a foreign body in the right lung and acute respiratory (breathing) failure.

Findings:

A record review was initiated on 9/2/10 at 9:00 PM Patient 80 was admitted to the facility on 9/24/09 with a diagnosis of multiple sclerosis (progressive disease affecting the nerves), quadriplegia(paralysis of the arms and legs), tracheostomy dependent (A tracheotomy is an artificial opening in the throat to assist with breathing.), fever, increased oxygen requirement in respiratory (breathing) failure and pneumonia per the Discharge Summary dated 10/3/09.

The Chest X-rays for Patient 80 were reviewed. The following was noted:

Radiologist (Rad) 1 documented in the chest x-ray report, dated 9/24/09 at 12:34 AM, that "A 9-cm (centimeter) portion of what appears to be a J-wire (wire used to assist physicians in placing medical devices into the body - used for guidance, then removed) is seen extending in the region of the right atrium (top part of the right side of the heart)." Rad 1 documented in the impression (radiologists interpretation) " An orphaned J-wire is seen terminating in what appears to be in the right atrium. "

Rad 1 documented in the Chest x-ray Report, dated 9/24/09 at 3:08 AM " the portion of what appears to be a J-wire is again noted as previously described. "

Rad 2 documented in the Chest x-ray Report under impression, dated 9/24/09 at 2:44 PM " Possible aspirated foreign body such as an opened paper clip within the trachea and right mainstem bronchus (large airway), stable from earlier in the day. "

Rad 3 documented in the Chest x-ray Report, dated 9/24/09 at 8:21 PM "Possible aspirated foreign body such as an open paper clip within the trachea and right main and bronchus is again seen, stable from earlier examination."

Rad 4 documented in the Chest x-ray Report, dated 9/25/09 at 2:56 AM "A wire is seen overlying the right side of the mediastinum (center of the chest) and is unchanged in position since the previous study. "

Rad 4 documented in the Chest x-ray Report, dated 9/25/09 at 7:26 AM "There is a wire overlying the right side of the mediastinum which is unchanged in position since the previous study."

Rad 5 documented in the Chest x-ray Report, dated 9/26/09 at 9:14 AM, "There is a metallic wire device which projects over the right cardiac margin which was seen on prior examination and is of uncertain etiology. "

Rad 5 documented in the Chest x-ray Report, dated 9/27/09 at 7:54 AM " The metallic wire device over the right cardiac (heart) margin, is in unchanged position and is of uncertain etiology."

None of the 8 chest x-ray reports for Patient 80 from 9/24/09 to 9/27/09 contained documentation that Rad 1-5 communicated directly with the ordering physician regarding the impression of a possible foreign body. In addition, none of the x-ray reports had any documentation by the radiologist 1-5 regarding recommending follow up or additional diagnostic studies to clarify or confirm the impression of a foreign body on the chest x-rays.

On 9/2/10 a review of Patient 80's physician progress notes dated 9/24/09, 9/2509, 9/26/09, 9/27/09, 9/28/09, 9/29/09, 9/30/09 and 10/1/09 indicated that there was no documentation of communication from the Radiologist to the ordering physician regarding the impression of a possible foreign body on Patient 80's chest x-ray. There was no documentation in the progress notes of any recommendation from the Radiologist for follow up or additional studies to clarify or confirm the impression of a possible foreign body on Patient 80's chest x-ray.

On 9/2/10 a review of Patient 80's discharge summary dated 2/20/10 indicated that Patient 80 was admitted to the facility on 2/9/10 with "postobstructive pneumonia secondary to foreign body in the right bronchus. "

A review of the facility's Radiology Communication Standard Operating Policy on 9/2/10 revealed that "In cases where there are unexpected or urgent findings which would immediately effect the patients' course of treatment, the radiologist will contact the ordering physician directly." In addition, under section II diagnostic imaging reports, Impression (conclusion or diagnosis) the policy indicates that "follow-up or additional diagnostic studies to clarify or confirm the impression should be suggested when appropriate"

On 9/2/10 at 9:30 AM, an interview was conducted with MD5 who is a hospitalist at the facility. He stated that upon review of Patient 80's progress note dated 9/25/09 at 6:30 AM that he can tell that the ICU attending physician MD2 had looked at patient 80 ' s chest x-ray because MD2 shaded out a portion of the lung diagram on the progress note. MD5 acknowledged that there was no documentation on any of the progress notes regarding the radiology report of a questionable foreign body. MD5 further stated that the Medicine residents tend to read only the impression from the x-ray reports and do not typically read the entire body of the x-ray report because they are usually busy. MD5 acknowledged that the mention of a questionable foreign body was documented in the impression of 2 out of 8 chest x-ray reports. He stated that he could not explain why the residents or MD2 did not document anything regarding mention of a possible foreign body or any request for follow up or additional studies for clarification.

On 2/26/10 at 9:15 AM, an interview was conducted with the Radiologist Quality Improvement Director (RQID). She stated that Patient 80's first two chest x-rays were read by Rad 1 who was an "older radiologist and is at an offsite location and that he probably doesn't even know who to call to notify about something like this". RQID further stated that she could not speak to the individual practice of every radiologist. She acknowledged that there was no documentation on any of the chest x-ray reports of direct communication to the ordering physicians and also that the progress notes did not have documentation of the questionable foreign body.

Based on food service observations, staff interview and document review the hospital failed to ensure safe food handling practices as evidenced by 1) not following established system for monitoring cool down: 2) lack of comprehensive sanitation of all hospital ice machines; 3) maintenance of freezers at zero degrees Fahrenheit (F); 4) maintain potentially hazardous food (PHF ) at 41 degrees F; 5) refrigerator internal thermometer maintained in working order, 6) failing to ensure that a comprehensive disaster meal plan to meet nutritional needs of patient's requiring a therapeutic diet.

These failures in maintaining safe food handling practices may result in potential for food borne illness and had the potential for not meeting the needs of patient's on a therapeutic diet during a disaster for a universe of 505 patients.

Findings:

1. On 8/30/2010 at 10:00 AM at Heart Surgery Hospital kitchen, 8 quart container of spaghetti was observed in the walk-in refrigerator. Staff 24 stated this product was prepared ahead for service during the week for the patient select menus. Staff 27 was identified as having prepared the spaghetti on Saturday and stated he placed the product in ice water and refrigerated. Staff 24 stated that products prepared ahead and the cool down was logged. There was no documentation of the cool down of the spaghetti prepared on Saturday.

Review on 8/30/19 at 10:30 AM, of the policy titled " Principles of cooling foods: showed the staff was to complete the nutrition services hot food cooling log and director of Nutritional Services/manger or designee was to review on a daily basis.

Staff 24, manager the Heart Surgery Hospital kitchen, stated that she had not reviewed the cool down logs since it was Monday and she had just started her work and was not in the kitchen on Saturday or Sunday during their production.

There was no system for management staff to review the cool down logs on a " daily basis " as specified in the policy.


2. On 8/30/10 at 10:00 AM, and throughout the survey, the cleaning and sanitizing of the hospital ' s approximately 70 ice machines were investigated. The ice machines were located hospital wide in medical units, kitchens and cafeterias and used for patient and the public. There were four main manufacturers of ice machines: Brand A, Brand B, Brand C, and Brand D.

A. On August 30 during the tour of the starting at 10:00 AM, the bin ice machine at the Heart Surgery Hospital was reviewed. The ice machine was Brand B. The staff stated that the bin was cleaned by dietary staff and the ice making part was maintained by a contract service.

The bin cleaning direction attached to the ice machine titled " Nutritional Services Equipment Training Manual: Ice Machine Cleaning " directed dietary staff to use a mild detergent- dishwashing detergent, and a liquid machine cleaner used for ice cream/beverage/equipment cleaner/ sanitizer " Nu-Calgon. " The posted cleaning directions for " monthly cleaning " required " sanitize with Triplet Plus Sanitizer. "

These same " Ice Machine Cleaning " directions were also posted on the kitchen ice machines at Main campus (Brand A and B) and East Campus (Brand B). These directions did not specify the Brand of ice machine or machines that these directions were prepared for.

On 8/31/10 at 8:15 AM, engineering Staff 21, Staff 22, and Staff 23 confirmed that the bin ice machines could be cleaned with a product they identified as " Simple Green " and a mild detergent. The engineering staff could not confirm that the manufacturer of Brand B or Brand C could be cleaned or sanitized with the products they identified or the products listed on the ice machine cleaning directions attached to the kitchen ice machines.

Review of the manufacturer ' s direction for the East Campus kitchen bin ice machine Brand B showed to " use an approved sanitizing solution or one ounce of household bleach in 2 gallons of warm water. "

Review of the manufacturer ' s directions for Heart and Surgical Hospital Brand C ice machine showed to use a "sanitizing solution on 1 ounce bleach with 2 gallons hot water or use 200 ppm (parts per million) Micro-Clor Cleaner of equivalent 5.25 percent sodium hypochlorite solution. "


B. During the meeting with Engineering Staff 21, Staff 22, and Staff 23 on 8/31/10 at 8:15 AM the contracted ice machine cleaning service was reviewed. The engineering Staff 21 stated that the ice machines in the kitchens on the main campus were on a contract.

The e-mail dated August 31, 2010 and provided at 11:00 AM, showed the contract dated 2/1/2010 covered the Brands B and D ice machines located in the main campus kitchen. Review of this contract is an agreement for planned and emergency service and attached a list of equipment covered including three ice machines. The contract did not include specifications for the ice machine service to be provided that followed manufacturer ' s directions or requirements for documentation of specific cleaning and sanitizing procedures that would be completed. There were no specific requirements for ice machine cleaning schedules included in the contract.

Review of the contracted service ' s Planned Maintenance Check List dated 8/11/10 for Brands B ice machines showed a checked form covering the condenser, evaporator, and condenser motor. There was no documentation of any cleaning or sanitation procedures or chemicals used. Review of Planned Maintenance document dated 5/4/10 for Brands A and B showed machines were cleaned with lime-away (descaling product). There was no documentation of the sanitation product used.

Review of the manufacturers ' manuals for Brands A, B, C, and D showed specific requirements for cleaning and sanitizing the internal parts of the ice machines. The Brand B ice machine specified " only Brand D approved cleaner and sanitizer solution. "

3. On 8/30/2010 starting at 10:00 AM at Heart Surgery Hospital kitchen, the temperature by internal thermometer in the two door ice cream freezer was 20 degrees F.

Review of the refrigerator and freezer temperature check list showed the freezer temperature from 6/27 to 8/30/10 to range between 1 degree F and 19 degrees F with the exception of 3 zero degree F readings 7/30, 7/28, and 8/2.

The internal temperature of the counter freezer in the cafe area was 15 degrees F. Review of the refrigerator and freezer temperature check list showed the freezer temperature from 6/27 to 8/30/10 to range between 18 degrees F and 8 degrees F. The form did not state the policy for maintaining freezer temperatures at 0 degrees F or below or direct staff when to notify the manager and/or engineering of temperatures exceeding safe and established temperatures.

On 8/30/10 at 10:45 AM, Staff 30 stated that she recorded the freeze temperatures and these freezer temperatures were all right. She was asked what the appropriate temperature for a freezer would be but she was not able to verbalize.

Review of the policy on 8/31/10 at 9:00 AM, showed nourishment freezer " temperatures shall be maintained at 0 degrees F or below.

Staff 24, manager of the Heart Surgery Hospital food service, could not state why the freezer temperatures had been recorded above the 0 degree F with staff not reporting them for repair.

4. On 8/30/2010 starting at 10:00 AM at Heart Surgery Hospital kitchen, there was one container of shredded cheese at 48 degrees F, and one container of sliced tomatoes at 47 degrees F on the refrigerated sandwich prep unit. Staff 31 identified these foods as potentially hazardous and should be maintained at 41 degrees F or below or held by time as public health parameters system.

Review of the County Official Cal Code Inspection Report dated 4/8/10 reported violation of sliced cheese at 47 degrees F above refrigerated prep unit.

Staff 31 stated there was a corrective action plan that addressed the violations cited but did not know why these temperatures were still above 41 degrees F and in the danger zone of 41 degrees F to 135 degrees F.

5. On 8/30/2010 starting at 10:00 AM at Heart Surgery Hospital kitchen, Staff 26 was asked to demonstrate measurement of the concentration of the sanitizer in the three compartment sink. Staff 26 read the test strip after immersion in the quaternary sanitizer as " 200 ppm (parts per million). " The test strips measures concentration by the color change achieved with the degree of concentration as compared to a color chart. Staff 24 was asked if this was an accurate reading of the test strip. She stated that test strip read 100 ppm and below the acceptable standard for quaternary ammonia at 200 ppm. Staff 24 could not state why Staff 26 had not read the test strip accurately.

Review on 8/31/10 at 9:50 AM, of the Food Service Competency Three Compartment Sink for Staff 26, dated 6/10/10, showed he was confirmed competent in the operation of the three compartment sink including the reading of the test strip. There was a potential if the concentration of the sanitizer was not read correctly of not sanitizing the multiuse dishware and food borne illness from microorganisms for patients.

6. On 8/30/10 at 1:00 PM. At East Campus Hospital, Staff 36 was asked to demonstrate the measuring of the temperature at plate level of the high temperature dish machine. Staff 36 ran the hospital ' s min/max (minimum/maximum) digital thermometer thought the dish machine and was asked to read the temperature. Staff 36 was unable to read the thermometer or state the correct temperature to be achieved in the sanitizing process.

Review on 8/30/10 at 1:30 PM, Nutrition Services Competency Utensil Cleaning and Sanitizing dated 7/31/10, for Staff 36 showed he was signed competent for " all equipment and utensils ... " Review of this form did not show specific section for competency in using the min/max digital thermometer to ensure correct sanitizing temperature was achieved at plate level of 160 degrees F.
There was a potential, if the correct temperature is not achieved, of not sanitizing the multiuse dishware and food borne illness from microorganisms for patients.

7. On 8/30/10 at 3:00 PM, the pantry kitchen refrigerator for units 1300 and 1200 was reviewed. The internal thermometer read 30 degrees F. Staff 31 measured a sample of one pint milk temperature at 40 degrees F. Staff 31 acknowledged that the internal thermometer could be broken and not accurately display the correct refrigerator temperature.

Staff 31 confirmed at 3:00 PM that there was no notification to engineering to verify refrigerator function or thermometer accuracy.

There is a potential is thermometers are incorrect of food spoilage or food quality compromise.




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8. On 8/30/10 at 1:10 P.M., the Director of Nutritional Services stated that the hospital had a planned Emergency Menu in the event of no electricity, steam or gas to serve food for 3 days for 3, 995 people per day which included patients and staff.

The Director of Nutritional Services provided the hospital's policy (520/521 T-12/1.F) entitled EMERGENCY MENU MODIFICATIONS. That document indicated, "MENU MODIFICATIONS NO ELECTRICITY, STEAM OR GAS" ...Follow the scheduled menu using produced items as much as possible making modifications as needed based on the following guidelines and in collaboration with clinical Nutritional care Services."

The Emergency Menu that was listed on the policy (520/521 T-12/1.F) indicated a one day menu that did not list portion sizes or any therapeutic diets. The Director of Nutritional Services stated that the Emergency Menu policy (520/521 T-12/1.F) was the same Emergency Menu that was in place for the main hospital as well as for the following: the Children's Hospital, the University Medical Center East Campus, the University Behavioral Medicine Center, the Heart And Surgical Hospital, Adult Day Care Center and Off-site locations utilized for care during a disaster.

According to the hospital's diet census list that was printed on 8/31/10, there were patient's on a physician ordered diet that included 1500 calorie diabetic diet, 2 gram sodium diet, dysphagia diet thin liquids,(for people that had difficulty swallowing and who could only tolerate thin liquids), 60 gram (gm) protein restricted diet with 2 gm sodium, 2 gram potassium and 1 gram phosphorus diet (for patient's with kidney disease), 50 grams low fat diet, low cholesterol and 2 gram sodium diet. There were also full liquid diet orders, a variety of different calorie diabetic diet orders, a 2 gram sodium vegan diet order, low residue diet order and pureed diet order.

On 8/30/10 at 1:32 P.M., Administrative RD 21 stated, "We do not have therapeutic diet menus or portion sizes listed on our emergency menu."

The hospital did not have any planned mechanism on how to meet the nutritional needs of patient's that required therapeutic diet orders in the event of a disaster, which could compromise their medical status.

Based on observation, staff interview, and recipe and patient menu review, the hospital failed to ensure that the products prepared for service to patients followed the production recipes to provide planned nutrients, calories, and therapeutic nutrient restrictions. This faiulre had the potential for staff to not follow the prescribed therapeutic diet and not meet patient needs for a universe of all patients in the East Campus.

For Patient 22, the hospital failed to provide a therapeutic diet in accordance with the prescribed diet order by the physician.

Findings:

1. On 8/31/10 at 11:00 AM, during observation of lunch trayline at East Campus hospital, the lunch entree a staff prepared spinach quiche was baked in a rectangular pan and cut into 16 portions. The portions were unequal. The staff was requested to weigh two pieces of the quiche. One serving piece from the middle of the pan weighted 6 ounces and one small piece from the side of the pan weighed 3 ounces.

On 8/31/10 at 11:30 AM, the spinach quiche recipe was reviewed and showed that 15 portions were prepared and the serving size was 4.92 ounces. Review of therapeutic diets served the spinach quiche showed diets included Protein 60 gram, 2 gram sodium, one gram phosphorous, diabetic, and 1800 calorie, and 50 gram fat diets.

Interview on 8/31/10 with Staff 29 and 28 acknowledged that the portions were not equal but indicated that they would serve like this.



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2. On 9/1/10 at 2:25 P.M., Patient 22's medical record was jointly reviewed with RD 23. Patient 22's physician prescribed a low salt soft lactose (milk sugar) free vegetarian diet on 8/30/10, according to Physician Orders.

According to RD 23, the electronic medical record indicated that a diet order entry was done on 8/30/10 by an RN that indicated "Adult Soft Diet, Strict Vegan, 2 gram Low Sodium". RD 23 confirmed that the Food and Nutrition services department was providing the diet order as entered in the electronic medical record.

RD 23 acknowledged that the diet being provided by the Food and Nutrition services department was different than the physician prescribed diet for Patient 22. RD 24 acknowledged that there was potential that a treatment plan could be different for a patient on a lactose free vegetarian diet versus on a vegan diet which could include a vitamin B12 assessment, or education component. According to the physician's diet order, the Interdisciplinary Care Plan for nutrition, and the Learning/Education needs assessment/Education record that was in RD22's medical record, the interdisciplinary team was unaware that Patient 22 was receiving a strict vegan diet.

On 9/1/10 AT 3:11 P.M., LN 25 stated that the diet order that was entered electronically on 8/30/10 was not the same as the physician prescribed diet order that was written on 8/30/10 for Patient 22. LN 25 stated that the electronic medical record had a place in which nurses could enter very specific physician orders under the "comments" section, in times where the electronic medical record did not provide the specific diet order in the drop down menu.

According to the hospital's policy entitled Diet Orders (M-73), "A diet in compliance with the diet order shall be provided to the patient under the supervision of a dietitian/dietetic technician."

According to the hospital's policy entitled Diet Orders: Confirmation (M-73.A), "The Unit Secretary/Nurse signs off diet order transcribed from Physician's Order page of patient's medical record, checking for accuracy. Sends diet order to Nutritional Services by computer. Dietitian/Dietetic Technician verifies with the physician any diet order with which they have concerns or questions."

Patient 22 did not receive a low salt soft lactose free vegetarian diet as ordered by the physician.

Bases on observation interview and record review the facility failed to ensure that 1 of 3 crash carts on the 4800 units had an exterior inspection every 12 hours as directed in the facility ' s policy and procedure.

Findings:

The " Code Cart/Airway Kit/ Equipment Inspection Record " , for August 2010, for the code cart location 4819, was reviewed on 8/30/10 at 11:15 AM. The crash cart log for August located in the pediatric transplant unit noted that the crash cart had not had an external inspection by staff on the 7th and that 22nd.

During an interview with Nurse Manager 60 on 8/30/10 at 11:00 AM, Nurse Manager 60 stated that the 4800 unit was a pediatric hematology and transplant unit. The Nurse Manager stated that the 4800 unit provided intensive, intermediate or acute level care to pediatric patients.

During an interview with Charge Nurse 61 on 8/30/10 at 11:30 AM Charge Nurse 61 stated that the crash carts on the 4800 unit are checked by the nursing staff on every shift. During the interview Charge Nurse 61 verified that the log noted that during the month of August the crash labeled 4819 had not been checked on the AM shift on the 7th and the 22nd.

The facility policy and procedure titled " Inspecting and Exchanging Code Blue Carts " dated 07/2007, was reviewed on 8/30/10 at 1:10 PM. The policy noted the following:

" 1. Completes daily exterior inspection as follows: every 12-hour shift for intensive care units; minimum of every 24 hours for all other departments/units. "

" 1.1 Verifies expiration dates are current and written on orange ' Code Blue Inventory Card ' attached to front of code cart. "

" 1.2 Verifies code cart red lock is intact and number is documented. "

" 2. Records date, shift, all lock numbers, and signature on code blue cart check record. "

" 3. Verifies presence of standard white back board. "

" 4. Verifies presence of oxygen tank and visually inspects integrity of regulator. Verifies that the tank is full, has equal to or greater than 2000 pounds on PSI gauge reading, or is within the green area of a green/yellow/red gauge reading. (Call Respiratory Care if empty or not intact.) "

Based on interview and record review, the facility failed to ensure that it implemented it's infection control policy by failing to ensure that 2 of 90 sampled patients were screened upon admission for MRSA (Methicillin-Resistant Staphylococcus Aureus). This resulted in Patient 120, who was admitted to the Cardiac Intensive Care Unit (ICU), to not be screened for MRSA upon admission and resulted in Patient 121, who was on the observation unit for 2 days, to not be screened for MRSA as specified in the facility's policy. These failures had the potential to result in transmission of MRSA to other vulnerable patients, staff, and/or visitors if the screenings were performed and showed a positive result.

Methicillin-resistant Staphylococcus Aureus (MRSA) is a type of staph bacteria that is resistant to certain antibiotics. These antibiotics include methicillin and other more common antibiotics such as oxacillin, penicillin, and amoxicillin. More severe or potentially life-threatening MRSA infections occur most frequently among patients in healthcare settings. Patients vulnerable to infection include those with severe disease, especially those with compromised defenses from underlying medical conditions; recent surgery; or indwelling medical devices (e.g., urinary catheters or endotracheal tubes). Hospitalized patients, especially ICU patients, tend to have more risk factors than non-hospitalized patients do, and have the highest infection rates. (CDC-Centers for Disease Control and Prevention)

Findings:

Record review revealed Patient 120 was a 73 year old male admitted to the facility on 8/30/10 at 5:04 PM with a diagnosis of vomiting. Patient 120 was discharged on 8/31/10. There was no evidence that an MRSA screening was performed on the patient.

During an interview with the Patient Safety and Reliability Coordinator on 9/8/10 at 2:07 PM, she confirmed that there was no MRSA screening performed on Patient 120.

Record review revealed Patient 121 was a 64 year old male admitted to the Rapid Admissions Unit (RAU) on 8/25/10 at 5:52 PM with a diagnosis of chest pain. Patient 121 was discharged on 8/27/10. There was no evidence that an MRSA screening was performed on the patient .

During an interview with the Patient Safety and Reliability Coordinator on 9/8/10 at 2:13 PM, she confirmed that there was no MRSA screening performed on Patient 121.

During an interview on 9/8/10 at 1:45 PM with the facility's Infection Control Nurse (ICN), she stated that over 95 percent of the patient's admitted to the facility are screened for MRSA within 24 hours. The ICN stated that this allows her to determine which units are doing good and which are not. The ICN further stated that the facility's expectations for MRSA screenings were not identified.

A review of the hospital policy titled, "Active Surveillance Testing (AST) For Methicillin Resistant Staph Aureus (MRSA)", dated 1/2009, revealed the following:

"1. Admitting Registered Nurse staff will collect an AST specimen on all patient during the admitting process, no later than 24 hours."

2. On 8/30/10 at 10:00 AM, and throughout the survey, the cleaning and sanitizing of the hospital ' s approximately 70 ice machines were investigated. The ice machines were located hospital wide in medical units, kitchens and cafeterias and used for patient and the public. There were four main manufacturers of ice machines: Brand A, Brand B, Brand C, and Brand D.

On August 30 during the tour of the starting at 10:00 AM, the bin ice machine at the Heart Surgery Hospital was reviewed. The ice machine was Brand B. The staff stated that the bin was cleaned by dietary staff and the ice making part was maintained by a contract service.

The bin cleaning direction attached to the ice machine titled " Nutritional Services Equipment Training Manual: Ice Machine Cleaning " directed dietary staff to use a mild detergent- dishwashing detergent, and a liquid machine cleaner used for ice cream/beverage/equipment cleaner/ sanitizer " Nu-Calgon. " The posted cleaning directions for " monthly cleaning " required " sanitize with Triplet Plus Sanitizer. "

These same " Ice Machine Cleaning " directions were also posted on the kitchen ice machines at Main campus (Brand A and B) and East campus (Brand B). These directions did not specify the Brand of ice machine or machines that these directions were prepared for.

On 8/31/10 at 8:15 AM, engineering Staff 21, Staff 22, and Staff 23 confirmed that the bin ice machines could be cleaned with a product they identified as " Simple Green " and a mild detergent. The engineering staff could not confirm that the manufacturer of Brand B or Brand C could be cleaned or sanitized with the products they identified or the products listed on the ice machine cleaning directions attached to the kitchen ice machines.

Review of the manufacturer ' s direction for the East Campus kitchen bin ice machine Brand B showed to " use an approved sanitizing solution or one ounce of household bleach in 2 gallons of warm water. "

Review of the manufacturer ' s directions for Heart and Surgical Hospital Brand C ice machine showed to use a " sanitizing solution on 1 ounce bleach with 2 gallons hot water or use 200 ppm (parts per million) Micro-Clor Cleaner of equivalent 5.25 percent sodium hypochlorite solution. "


During the meeting with Engineering Staff 21, Staff 22, and Staff 23 on 8/31/10 at 8:15 AM the contracted ice machine cleaning service was reviewed. The engineering Staff 21 stated that the ice machines in the kitchens on the main campus were on a contract.

The e-mail dated August 31, 2010 and provided at 11:00 AM, showed the contract dated 2/1/2010 covered the Brands B and D ice machines located in the main campus kitchen. Review of this contract is an agreement for planned and emergency service and attached a list of equipment covered including three ice machines. The contract did not include specifications for the ice machine service to be provided that followed manufacturer ' s directions or requirements for documentation of specific cleaning and sanitizing procedures that would be completed. There were no specific requirements for ice machine cleaning schedules included in the contract.

Review of the contracted service ' s Planned Maintenance Check List dated 8/11/10 for Brands B ice machines showed a checked form covering the condenser, evaporator, and condenser motor. There was no documentation of any cleaning or sanitation procedures or chemicals used. Review of Planned Maintenance document dated 5/4/10 for Brands A and B showed machines were cleaned with lime-away (descaling product). There was no documentation of the sanitation product used.

Review of the manufacturers ' manuals for Brands A, B, C, and D showed specific requirements for cleaning and sanitizing the internal parts of the ice machines. The Brand B ice machine specified " only Brand D approved cleaner and sanitizer solution. "

Review on 8/31/2010 at 8:45 AM of the hospital ' s ice machine preventative maintenance (PM) documents showed an annual cleaning examples for Brand B showed using the " Brand B ice machine cleaner. " The Brand A PM showed to follow " manufacturer ' s recommendations. " Brand D PM stated to use the solution prescribed by the manufacturer for ice machine cleaner. There was no direction for product or sanitizing steps in the annual PMs.

The Engineering Staff 21, Staff 22, and Staff 23 could not show documentation that the PM directions for each Brand of ice machine followed the manufacturer ' s directions.

The engineering staff explained on 8/31/2010 at 8:45 AM that all of the hospital ice machines were on a monthly PM that included cleaning and sanitizing since some of the ice machine brands required cleaning and sanitizing annually and Brands D, C, and B required cleaning and sanitizing every six months.


Review of the monthly ice machine cleaning schedule example on 8/31/2101 at 8:45 AM did not document that the manufacturer ' s cleaning or sanitizing directions were followed during the maintenance procedure.



On 8/31/2102 at 10:00 AM, Staff 31 and Staff 32, registered sanitarians for the hospital were asked if the ice machine cleaning and sanitizing policies had been reviewed as part of the hospital wide infection control program. They stated that the ice machines had not been reviewed by the infection control committee or as part of their review.

On 9/1/2010 at 3:30 PM, unit 3800 one formula warming pieces of equipment was observed. These warmers function to warm infant formula or breast milk. Staff 35 stated the unit had two units that were on trial.


3. On 9/1/2010 at 3:30 PM, one formula warming unit had four wells with a sticker dated 2/4/2009. The four wells appeared covered in white scale. Staff 34 confirmed these wells appeared dirty and stated that she thought the plastic insert bags used to hold the infant formula bottles were to be changed every shift. Staff 34 also stated that she did not know how to clean the units. Staff 35 stated that the units were to be returned but had not been picked up and did not know how long these units had been in operation.

Review of the cleaning instructions on 9/1/2010 at 3:30 PM, stated " the chemical disinfection solutions, as well as rinsing and drying procedures for reusable medical equipment should take place in a manner to be consistent with hospital infection control guidelines. The directions also stated " 7. Use a new liner for every feeding. "

Staff 32 stated this equipment had not been reviewed in infection control committee when it was provided for a trial. Staff 35 was not able to state that the nursing staff using the equipment was following the correct procedure for replacing the liner bags each feeding per manufacturer ' s directions.


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3. Review on 9/8/10 of physical therapy (PT) employee files, showed that PT 1's required health screen was last done on 8/6/10.

In an interview with a human resource manager (HRM) on 9/8/10 at 1:20 PM, she stated that there was no current health screen for PT 1. She further stated, "We are out of compliance."




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Based on interview and document review the hospital failed to ensure that the infection control officer monitored the following:

1. The hospital failed to ensure that Tuberculosis (TB) Screening results were obtained for 10 out of 10 physician credential files. In addition, the hospital's Policy and Procedure for tuberculosis screening did not ensure that physicians were included in the screening which is a recommendation of the Advisory Committee on Immunization Practices (ACIP) for healthcare workers and the Occupational Health Branch of the California Department of Health Services.

2. The hospital failed to ensure approximately 70 ice machines were cleaned and sanitized according to manufacturer's directions and under policies approved by the infection control committee oversight.

3. The hospital failed to ensure two formula warming equipment were cleaned, sanitized, and operated per manufactures' directions and under policies approved by hospital infection control committee.

4. The hospital failed to implement their infection control system by failing to ensure that 1 employee's annual health screening was kept current out of 13 employee files reviewed, for the rehabilitation and laboratory services. This failure had the potential for the spread of infection to other employees and patients.

Findings:

1. On 8/31/10 at 9:00 A.M. 10 physician credential files were reviewed. The files did not contain TB screening results for the physicians on staff at the hospital.

On 9/1/10 at 10:10 A.M. the Policy and Procedure for employee health services was reviewed. The Policy indicated that all applicants shall be evaluated during the post job offer physical examination for TB by a two-step PPD and then tested annually with exceptions for a documented history of a positive TB test, a negative TB test within the last 12 months and a history of adverse reaction to TB testing. The policy did not indicate that physicians are included with employees in the TB testing.

An interview with the director of medical staff administration was conducted on 8/31/10 at 9:10 A.M. She acknowledged that the TB screening results have not been obtained for the physicians on staff at the hospital.

Entity reported incident # 213241

Based on interview and document review, the facility failed to ensure that surgical services were provided in accordance with acceptable standards of practice by:

1. OR staff failed to implement the facility ' s policy and procedure regarding surgical counts for one patient by failing to communicate that an instrument had a broken fragment that was left inside the surgical site. (See A-951)

2. Failing to obtain an intraoperative x-ray per the facility ' s P&P to search for the retained foreign body prior to Patient #13 leaving the OR, which required a second surgical procedure to remove the retained foreign body a few days later once it was identified on an post surgical MRI. (See A-951)

3. O.R. Staff failed to complete part 4 of the facility ' s post surgical checklist in which any complication or concern during surgery is discussed (See A-951)

4. Failing to have a policy and procedure to measure temperature and humidity for 4 out of 4 endoscopy procedure rooms. (See A-951)

The cumulative effect of these systemic problems resulted in the facility ' s failure to deliver care in compliance with the Condition of Participation for Surgical Services and failure to provide care to their patients in a safe environment.

Entity Reported Incident #213241


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

1. To ensure that it's policy and procedure pertaining to surgical counts was implemented, for one of 90 sampled patients (Patient 13), when a fragment of a footer from a craniotome (4 x 2 mm metal fragment that broke off from the L shaped base of a cutting instrument), was left in Patient 13 following a craniotomy. A Surgical Attending (MD 1), Surgical Residents (SR1 and SR2), Circulating RN (CRN) and Scrub Technician (ST) failed to ensure that an X-ray film was obtained to search for the retained metal fragment prior to the patient leaving the operating room suite. The OR staff failed to complete part 4 of the post surgical check off list that any complication or concern was discussed per the facility ' s Policy and World Health Organization ' s (WHO) recommendation. The fragment was found during an MRI (medical imaging using magnetic forces) the following day and the patient was taken back to the O.R. 3 days later to remove the foreign body.

2. To have policies and procedures regarding the temperature and humidity monitoring of 4 out of 4 endoscopy (a procedure done with a scope to look into the digestive tract) procedure rooms and the documentation of what action was taken when the humidity levels were out of range. As a result, there was no documentation of what action was taken to address high humidity levels that can potentially lead to an increased risk of infections, and low humidity that can potentially lead to increased risk of fire for patients undergoing endoscopy procedures.


Findings:

1. A record review was initiated on 9/2/10 at 10:50 AM Patient 13 was admitted to the facility on 12/7/09 with a diagnosis of right parietal brain mass (area of the brain) per the Discharge Summary dated 12/12/09. Per that same document, on 12/10/10 the patient underwent resection of the brain mass with right craniotomy (brain surgery) performed by the attending surgeon, MD 1.

MD 1 documented in the Operative Report, dated 12/10/09, that the operation performed was right craniotomy for tumor resection (taking out) with stealth guidance and microscope. The level of involvement of MD 1 was documented as "total" (MD 1 had total involvement in the surgery) . The report indicated, " the sponge and needle counts were correct at the end of the case " .

On 9/2/10, a review of the Perioperative (duration of the surgical procedure) Documentation Intra (during the actual operation) Operative, dated 12/10/09, indicated the intraoperative closing counts for Patient 13's brain surgery were correct, according to documentation by CRN. Per the Perioperative Nursing Record, Patient 13 was discharged from the OR to the PACU on 12/10/09 at 3:37 PM

A review of the MRI Report dated 12/11/10 revealed the following finding: "A large area of susceptibility artifact is now present obscuring the right posterior cerebral hemisphere (area of the brain) including the surgical bed. This artifact was not present on the preoperative MRI and review of the postoperative CT (computerized medical imagining scan) shows the likely source of this artifact is a new small metallic object just deep to the craniotomy site." The report indicated that the radiologist discussed the report findings with SR2 on 12/11/09 at 7:05 AM, 16 hours after the patient was discharged from the OR suite.

MD 1 documented in the Operative Report, dated 12/14/09, that the operation performed was right craniotomy for foreign body removal under conscious sedation (medications that sedate the patient, but not so heavily that they can not respond) with fluoroscopic guidance and the finding was a 4x2 mm (millimeter) metal object subdurally (an area just above the brain, but below the covering of the brain) that was successfully removed.

A review of the facility's equipment procedure titled " Care and Handling of Surgical Instruments ", dated 4/09, on 9/2/10 indicated that it applies to " Registered Nurse (RN), Surgical Technologist (ST), Medical Doctor (MD), Perioperative Technician (PT) and Sterile Processing Technician (SPT). The document indicated under " Method Intraoperative, Practice good instrument care and inspect instrument for integrity of component parts " .

A review of the facility's sponge, sharp and instrument count clinical procedure, dated 5/08, on 9/2/10 indicated "Nurse, surgical technologist and/or physician may ask for an x-ray if they feel uncomfortable with a count. Include in documentation."

On 9/1/10 at 2:20 PM an interview was conducted with the Quality Resource Nurse Coordinator (QRNC). Per QRNC she conducted an investigation and interviewed the Surgical Attending (MD1) the surgical residents (SR1and SR2), CRN and Surgical Technician (ST). Per QRNC the MD1, SR1 and SR2 stated that the craniotome was cutting slowly and when they examined the cutting instrument they noticed a small fragment was missing from the footer. Per QRNC the MD1, SR1 and SR2 attempted to perform a search of the surgical incision site for the missing fragment, however they could not find it and thought that the instrument had probably been handed to the surgical team already damaged. Per QRNC the SR1 handed the damaged craniotome to the ST and CRN and stated, " this is not working " . Per QRNC the MD1, SR1 and SR2 acknowledged that they did not tell the ST or CRN that the craniotome ' s footer was damaged. QRNC further stated that MD1, SR1 and SR2 acknowledged that they failed to complete part 4 of the facility ' s post surgical checklist that is based on the World Health Organization ' s recommended practice in which the OR staff discuss any complications or concerns during the surgery.

Per QRNC the ST acknowledged that she did not clarify that the craniotome was intact when the case started. The CRN also acknowledged that she did not clarify if the craniotome was damaged. Per QRNC the CRN replaced the craniotome with a new device and the case continued. QRNC stated that there was a failure of communication between the surgeons and ST and CRN to identify that the craniotome had a small piece had broken off and therefore the facility ' s policy and procedure on surgical counts was not implemented to ensure that an intraoperative x-ray was completed to search for the metal fragment that was left in Patient 13.

A review of the ST's employee file was conducted on 9/2/10 at 11:30 AM with the Clinical Educator RN (CE). Per CE the ST had been recently hired approximately 6 months prior to the craniotomy for Patient 13. ST ' s employee file indicated that she was oriented to " Care and handling of Surgical Instruments " on 6/4/09. ST ' s employee file also indicated that she was oriented to " check room, equipment for cleanliness, function " on 6/15/09, per CE this includes ensuring that equipment was functional and not damaged. Per ST ' s employee file, she was oriented to " Anspach X-Max " on 12/8/09, per CE this is the craniotome instrument that includes the proper assembly and identification of parts and inspecting for damage. The CE also stated that on page 3 of the OR nursing documentation form titled " Medication Administration & Intake/Output record " at the bottom the form indicates " complications " with several numerical numbers with " circle " next to the number list. CE stated that the CRN should have documented either #27 indicating machine disconnect or mechanical problem, or " O " for other in order to document an instrument failure or damage.

On 9/2/10 at 11 AM, an interview was conducted with the Director of peri-operative services (DPO). Per the DPO, the OR staff had failed to follow the facility's surgical count policy and procedure. The MD1, SR1 and SR2 failed to communicate to the CRN and ST that the craniotome had a broken footer. The CRN and ST failed to clarify that the craniotome was intact when the case started and failed to ask the MD1, SR1 and SR2 if the craniotome was damaged when it was handed back to them. Per the DPO, ST had only worked 6 months with the facility and did not " speak up " to the surgical team probably due to unfamiliarity with the OR staff.

This failure of communication that the equipment had a missing fragment intraoperatively led to a failure to identify that a fragment of the footer was left in the incision led to the failure to ensure that an X-ray film was obtained intraoperatively, prior to Patient 1 being discharge from the OR suite to the PACU.

2. During a tour of the 4 endoscopy procedure rooms on 8/30/10 at 3 PM, there were no temperature or humidity monitors observed.

On 8/30/10 at 3 PM the G.I. charge nurse was interviewed. He stated that there was no policy regarding temperature or humidity monitoring of the 4 endoscopy procedure rooms and that monitoring was not being done.