HospitalInspections.org

Based on document review and interview, the facility failed to ensure that a service provided under contract was subject to the same hospital-wide quality assessment and performance improvement (QAPI) evaluation as other services provided directly by the hospital.

Findings:

During a tour of the Material Management Department on 7/21/10 at approximately 10:43 AM, with the Director of Pharmacy (DOP), and the Director of Material Management (DMM) contract documents pertaining to the acquisition, storage, and disposition of intravenous (IV) solutions were reviewed.

As a contracted service provided sto the hospital, an evaluation of its performance is necessary to determine if it meets the needs of the patients/operations on an ongoing basis.

In a concurrent interview with the DMM, she reported that evaluative reports of the service provided are kept in the department and not sent to the facility's quality assessment and performance improvement and subsequent medical staff committees to the governing board.

Based on interviews and record reviews it was determined that the hospital failed to meet the Condition of Patient Rights by failing to do the following:

1. The survey team identified an immediate jeopardy situation on 7/21/10 at 2:20 PM, as a result of the facility's failure to provide patients with a safe environment when the patients' meal trays were served with hot metal wax bases without the underliners to protect the patients from being burned. In addition to the survey team, the interim CNO (Chief Nursing Officer) was present at the time the immediate jeopardy was called.

The survey team removed the immediate jeopardy situation on 7/22/10 at 11:05 AM, based on an acceptable plan of correction. (Refer to A0144)

2. For two patient grievances, the governing body failed to ensure the effective operation of the grievance process, creating the risk of an ineffective grievance process and substandard patient care. (Refer to A0119)

3. For Patient 61, the facility failed to ensure that the patient's right to make an informed consent for blood transfusion was protected, by not being fully informed of the risks and benefits of the blood transfusion. This failure had the potential to give a treatment to the patient that the patient would not have consented to if the patient had been fully informed of the risks, benefits and alternatives to the blood transfusion. (Refer to A0131)


4. For 1 Patient 75, the facility failed to give the patient the opportunity to provide her advance directive to the facility so that she had the right to make decisions concerning her medical care including the right to accept or refuse medical care. This failure resulted in a missed opportunity for the patient to make her medical care wishes known. (Refer to A0132)

5. The facility failed to ensure that the use of restraints was in accordance with the order of a physician or other licensed independent practitioner (LIP) who was responsible for the patient, and for 38 sampled patients and for all patients who required restraints in a universe of 200 patients. The facility failed to ensure that the physician's order for restraint included the specific type of restraint and did not allow the nurse to decide between a list of "soft" restraints that included, mittens, soft belt, soft vest, soft wrist, and soft ankle. This failure had the potential for any patient who required restraints to have an inappropriate type of restraint for their medical condition or to have more than one type of restraints applied at a time. This failure also resulted in Patient 66 having more than one type of restraint applied without a valid physician's order. (Refer to A0168)

The cumulative effect of the systemic practices in protecting each patient's rights resulted in the hospital's inability to assure a safe environment, free of hazards, the effective operation of the grievance process, the right of patients to make decisions concerning their medical care, and to protect patient's rights to be free of unnecessary restraint.

Based on interview and record review, for two patient grievances the governing body failed to ensure the effective operation of the grievance process for two patients (Patients 304 and 305), because it failed to ensure that Patient 304 and 305's complaints were reviewed by the responsible parties per facility policy, creating the risk of an ineffective grievance process.

Findings:

1. On 7/20/10 and 7/21/10 the complaint of Complainant 1 was reviewed. Complainant 1 stated that Patient 304, her elderly, demented mother, had repeatedly come to the facility's emergency room seeking narcotics. She stated that although Patient 304 had just had a Fentanyl (narcotic) patch placed on her at the nursing facility, and she spoke with staff members in the ER on 4/3/10 to try to prevent narcotics being given to her, that her mother received narcotics from the physician in the ER on 4/3/10,. Complainant 1 felt that the additional narcotics administered in the ER placed her mother in danger.

During a review of the complaint with the Director of Quality on 7/21/10 at 3:30 PM, she stated that an apology letter had been sent to the complainant. She stated that complaint had not been directed to the Emergency Department for review, even though the complainant communicated her concerns to nursing staff, who promised to discuss it with Patient 304's nurse. And there was no evidence that the complaint had been directed to medical staff leadership or the peer review process for review, even though the complainant expressed a concern about the patient being over-medicated by the ER physician.

During a review of the tracking sheet for the complaint regarding Patient 304's care, the hospital policy, "Complaints/Grievances", reviewed and revised 4/10, page four, read, "Management of Grievances Arising From Patient Care, A. It is the responsibility of the Department Director, Administrator, or designee, to review and evaluate all written and verbal grievances from a patient or family member related to issues within their scope of responsibility and initiate appropriate action to investigate and resolve the grievance." and on page 5, "Management of Grievances Arising From Dissatisfaction with a Practitioner" section A.2.b., "for a clinical complaint, inform the patient that the review will take place by the established medical staff review process." The facility was unable to provide evidence that it followed its own policy in reviewing and addressing the complaint about care provided in the emergency department to Patient 304.

2. On 7/20/10 and 7/21/10 the complaint of Patient 305 was reviewed. Patient 305 came to the hospital 4/16/10 for an outpatient colonoscopy. Patient 305 voiced multiple concerns in his complaint, including that he had been discharged with a rectal tube in place and heart monitoring pads still on his chest, the physician failed to communicate the results of his evaluation and the reason he was told to see a surgeon, the impression that there were too many patients for the number of staff and that the environment was dirty.

During a discussion with the Manager of Quality on 7/21/10 at 3:30 PM, she stated that a refund had been issued to the complainant, and the concerns regarding environmental cleanliness had been addressed.

The Manager of Quality was unable to provide evidence that the majority of the issues raised by Patient 305 had been addressed. The Manager of the GI Lab stated that the issues had been discussed at a GI Division staff meeting, but was unable to provide documentation of the discussion, or any specific procedure changes or educational activities for the staff that had occurred as a result of the complaint. The Manager of Quality stated that the complaint had been forwarded to the GI Division for review by the service chief. However, there was no evidence that the review occurred. The "Interdepartmental Primary Peer Review" document for the incident that had been forwarded to the GI Division 5/11/10 was seen on 7/21/10 and was still blank, and the meeting minutes from the 7/10 GI Division meeting were reviewed and contained no review of Patient 305's treatment, although the care of other patients from April and May were discussed at that meeting.

Based on interview and record review the facility failed to ensure that 1 of 38 sampled patients, (Patient 61), right to make an informed consent for blood transfusion was protected by not being fully informed of the risks and benefits of the blood transfusion. This failure had the potential to give a treatment to the patient that the patient would not have consented to if the patient had been fully informed of the risks, benefits and alternatives to the blood transfusion.

Findings:

A review of the medical record for Patient 61 revealed that he was admitted to the hospital on 7/15/10 with diagnoses that included severe infection.

A review of the facility form titled, " Consent Blood Transfusion " , dated 7/18/10, revealed an area on the form that stated " Physician Statement " . The statement was in bold type and underlined and stated " I have discussed with the patient he risks and benefits of blood transfusion and alternative therapies ... " This area had a place for the physician ' s signature and the form was not signed.

A review of the physician ' s progress notes for admission on 7/15/10 to the review date of 7/20/10 revealed no physician documentation that the physician discussed the risks, benefits, and alternative therapies with the patient.

Further review of the medical record revealed that the patient received two units of blood on 7/18/10.

An interview was conducted with the nurse manager (NM) of the unit on 7/20/10 at 11 AM and she confirmed that the patient had received blood and that there was no documentation by the physician that the patient had been given the risks, benefits, and alternatives to a blood transfusion.

Based on interview and record review, the facility failed to ensure that 1 of 38 sampled patients (Patient 75) in a universe of 200, was given the opportunity to provide her advance directive to the facility so that she had the right to make decisions concerning her medical care including the right to accept or refuse medical care. This failure resulted in a missed opportunity for the patient to make her medical care wishes known.

Findings:

Review on 7/21/10 of Patient 75's medical record, showed that the patient was admitted to the facility on 7/17/10 with a diagnosis of congestive heart failure, exacerbation (a worsening).

Review of the admitting information dated 7/17/10 showed that the patient had signed an advance directive.
There was no copy of an advance directive in the patient's chart to inform the medical team of the patients wishes regarding her medical care.

Recview of the nurses admission assessment dated 7/17/10 showed that the patient was unable to respond to the question of whether or not she had an advance directive.

In an interview with Patient 75's nurse on 7/21/10 at 10:40 AM, she stated that the patient is now able to make her wishes about an advance directive known. The patient's nurse further stated that they would address the patient's need for an advance directive if the patient became unstable.

Review of a hospital policy dated 11/09 and titled Advance Directive showed the following:
If a patient is unable to respond, the nurse documents this. Once s/he is able to respond, offer the patient information and document the same.

There was no documentation in the record since admission, that the patient was asked about an advance directive.

Based on observations, staff interviews and record reviews, the facility failed to provide patients with a safe environment when meal trays were served to the patients with exposed, hot bases without the protective underliners for the plates to protect patients from burn injuries. This failure had the potential to cause thermal (heat) burns in 51 patients in a universe of 133 patients.


Findings:

During trayline observation on 7/20/10 at 1:09 PM, it was noted that fourth floor patient trays were being assembled with hot metal bases resting directly on the trays with no underliners. One metal wax base was checked for temperature by touching it and it was noted to be too hot to touch without being burned.

According to Dinex, the manufacturer of the metal wax base, the base is constructed of two, 20-gauge stainless steel shells, automatically seam welded and hermetically sealed. The interior of the base consisted of a wax core, which heats quickly but dissipates heat slowly for optimum temperature retention. It further noted that the wax base kept food hot for 90 minutes when used in conjunction with heated plates, Dinex insulated domes and Dinex underliners. The Dinex catalogue stated that non-insulated underliners were used to hold the wax bases to, "protect the patient and the tray from the heated base."

According to the American Red Cross Home Safety Lesson Plan for Burns (copyright 2007), "When skin is exposed to temperatures of greater than 118 degrees F (Farenheit), it can burn (thermal burns)."

During an interview with the Director of Food and Nutrition Services (DFNS) on 7/20/10 at 1:10 PM, she stated that the facility didn't have enough of the underliners to place them on all the trays with the hot metal wax bases. She stated that the bases were not hot enough to cause burns when the meal tray reached the patient. When asked if the facility had done any monitoring of the temperature of the metal wax base when it reached the patient, she stated that they had not.

On the fourth floor at 1:20 PM when the trays were being delivered to the patients, the temperature of the metal wax base was again checked by touching it. The metal wax base remained too hot to touch even as it was being served to patients, which was confirmed by the DFNS. She then stated that she would order more underliners so that there would be enough and that no meal tray would need to be served without the underliner.

On 7/21/10 at 1:07 PM, meal trays were again being served to patients on the fourth floor without the underliners to protect the patients from exposure to the hot metal wax bases. The temperature of a hot metal wax base was measured by the surveyor as trays were being served to the patients, it registered 121.9 degrees Farenheit.

During a concurrent interview the DFNS again stated that she had ordered the underliners. When asked for a more immediate correction of the safety risk, the CNM (Clinical Nutrition Manager), who was also present, stated that the alert patients would be warned about the hot metal wax bases and the non-alert patients would have the metal bases removed from their trays. The facility failed to initiate an immediate plan that would protect all patients from thermal burns from the hot metal wax bases.

The survey team identified an immediate jeopardy situation on 7/21/10 at 2:20 PM, as a result of the facility's failure to provide patients with a safe environment when the patients' meal trays were served with hot metal wax bases without the underliners to protect the patients from being burned. In addition to the survey team, the interim CNO (Chief Nursing Officer) was present at the time the immediate jeopardy was called.

The team accepted a written plan of action for the immediate jeopardy situation on 7/21/10 at 5:30 P M. The facility implemented a plan of action as follows: effective immediately, at no time will a hot meal be served to a patient without the protective underliner around the metal base; policy #8320-06570 entitled, "Patient Tray Line Standards" was revised to reflect the patient trays would never be served without the protective underliner around the metal base; all Nutritional Services Tray Line Servers and Supervisors currently on duty were educated to the change in policy and procedure; remaining Nutrition Services Tray Line Servers and Supervisors would be educated on change in policy and applicable meal service restrictions prior to the start of the subsequent shift until all applicable staff was educated; additional protective underliners were ordered for use with every hot meal service to arrive 7/21/10 at 8:00 PM; and the new hire orientation/competency was revised to reflect change in meal service restriction.

The dinner meal service was observed on 7/21/10 between 5:15 and 6:30 PM by the survey team to confirm no hot metal wax bases were served without the protective underliner. During an interview with FSW 1 on 7/21/10 at 5:05 PM, she stated that she was the Starter (she set up the plates on trayline, including the hot metal wax bases and the underliners) for dinner. She further stated that it was not the practice of the facility to use the underliners at all until recently, a couple of months ago, she thinks. She further stated that the facility never had enough of the underliners to use on all hot meal trays. She was further able to verbalize the policy changes that were just put into place.

While observing tray line on 7/21/10 at 5:15 PM, the DFNS stated that the facility had only recently started using the underliners. She further stated that she had ordered some underliners on 2/11/10 as a trial because she had recognized that the hot metal wax bases could be a problem and cause patient burns. She stated that she recognized that it was a potential for burn injuries to the patients and was trying a solution by ordering the bases, but there weren ' t enough underliners for all the hot meals served. She further stated that 51 trays had been served at lunch on 7/21/10 with exposed hot metal wax bases.

During the same trayline observation at 5:45 PM, it was observed that the pediatric patients did not receive the hot metal wax bases on their tray. Upon questioning, FSS 1 stated that it had not been the practice of the facility to give the metal wax bases to the pediatric patient due to the risk for injury from burns. She was checking the trays at the end of trayline and she was able to verbalize the new policy changes.

The breakfast meal service was observed on 7/22/10 between 7:15 and 8:30 AM by the survey team to confirm no hot metal wax bases were served without the protective underliner. It was also confirmed by the survey team that the facility had obtained the additional underliners for use with the hot metal wax bases so that no hot meal would be served to the patients without one.

During a concurrent interview with FSW 2 at 7:15 AM, she stated that she was the Starter on trayline for breakfast. She was able to verbalize to policy changes that were just put into place. At 7:45 AM, an interview was conducted with FSS 2 who was checking trays at the end of tray line. She was also able to verbalize the new policy changes.

The survey team removed the immediate jeopardy situation on 7/22/10 at 11:05 AM, based on implementation of the plan.

Based on observation, interview and record review the facility failed to ensure that the use of restraints was in accordance with the order of a physician or other licensed independent practitioner (LIP) who was responsible for the patient, and for 38 sampled patients and for all patients who required restraints in a universe of 200 patients. The facility failed to ensure that the physician's order for restraint included the specific type of restraint and did not allow the nurse to decide between a list of "soft" restraints that included, mittens, soft belt, soft vest, soft wrist, and soft ankle. This failure had the potential for any patient who required restraints to have an inappropriate type of restraint for their medical condition or to have more than one type of restraints applied at a time. This failure also resulted in Patient 66 having more than one type of restraint applied without a valid physician's order.

For Patient 72 the facility failed to ensure that an order was obtained prior to the implementation of the non-emergent use of a soft mitten hand restraint.

For Patient 72 the facility failed to obtain an order for the use of full bed side rails physical restraints.

These failures resulted in Patient 72 being physically restrained without a physician's order and with out notification to the physician who was responsible for Patient 72's care which had the potential to result in Patient 72 being unnecessarily restrained.

Findings:

1. A review on 7/20/10 at 2:00 PM of the medical record for Patient 66 showed that the patient was admitted to the facility on 7/16/10 with a diagnosis of sepsis (an overwhelming infection).

Review of the physician's orders showed that there were restraint order stickers placed in the physcian orders that were not complete, as follows:

A. 7/17/10, there was no time, no clinical justification for restrraints, no type of restraint, but there was a physician signature..

B. 7/18/10, there was no time, no clinical justification for restraints, no type of restraint, but there was a physician signature.

C. 7/19/10 at 7:00 AM, Clinical Justification for Restraints-Behavior interfering with medical care (no further description of behavior), Type of Restraint-Soft Restraint(s), there was no physician signature or Telephone order documented.

A review of nursing documentation showed the following:

A. From 7/17/10 at 8:00 AM until 10:44 PM, the patient was placed in Left and Right upper extremity restraints, and a vest restraint. At 8:00 PM through 10:00 PM, the nurse documented that a full body restraint was on the patient-full bed side rails.

B. From 7/18/10 at midnight until 4:34 AM, the patient was in Left and Right upper extremity restraints, and a vest restraint. From midnight through 6:00 AM the patient had full side rails. Then at 6:00 AM, the patient had Left and Right upper extremity restraints, and a Left lower extremity restraint. At 8:00 AM until 11:10 PM, the patient had Left and Right upper extremity restraints. (The nurse was deciding what type of restraint to place on the patient).

C. From 7/19/10 at midnight through 8:00 PM the patient was in Left and Right upper extremity restraints. At 8:00 PM, mitten restraints were added in addition to the upper extremity restraints. ( The nurse was deciding what type of restraint to place on the patient)

There was no documentation of how the nurse determined which restraint to use on the patient.

In an interview on 7/20/10 at 10:15 AM, with the Intensive Care Unit Nurse Manager (ICUNM), he stated, when asked how the nurse would know what type of restraint to place on a patient when the physician order just has soft restraints, "I think it means soft wrist restraints." When shown the physician orders and nursing documentation for Patient 66, the ICUNM acknowledged that the nurses are chosing the type of restraint to place on a patient without a physicians order.

A review of the hospital policy titled, "Restraints", dated 7/08, showed that the soft restraints were listed as:

A. Mittens
B. Soft belt
C. Soft Vest
D. Soft wrist or ankle

The hospital restraint policy further shows, "For medical restraint use beyond the first 24 hours, the physician will examine the patient at least once per calendar day to determine if restraints continue to be clinically justified and write a medical restraint order in the patient's medical record."

2. A review of the medical record for Patient 63 revealed that she was admitted to the facility on 7/15/10 with diagnoses that included altered mental status.

A review of the physician's orders revealed that the patient had orders for physical restraints as follows:

7/16/10 at 5:30 PM - Posey vest - Clinical Justification, confusion (added to the pre-printed form trying to climb out of bed) and potential for injury
7/17/10 at 12 noon - soft restraints - Clinical Justification, confusion (no further description of behavior) and potential for injury
7/18/10 at 12 noon - soft restraints - Clinical Justification, confusion (no further description of behavior) and potential for injury
7/19/10 at 11:50 AM - soft restraints - Clinical Justification, confusion (no further description of behavior) and potential for injury

A review of the nursing documentation from 7/16/10 through 7/19/10 revealed that the patient had been placed in a vest restraint (Posey restraint) for this time period.

The physician's order for restraints was only specific on 7/16/10 with the order of the vest restraint.

The nursing documentation for 7/17/10, 7/18/10, and 7/19/10 (when there was no specific restraint ordered) was reviewed. The nursing documentation did not define the behaviors that caused the patient to require continued restraint usage. There was no documentation of how the nurse determined which soft restraint to use.

An interview was conducted with the nurse manager (NM) of the unit on 7/20/10 at 10 AM. She stated that the nurse goes from the least restrictive soft restraint to the most restrictive according to the hospital policy.

A review of the hospital policy titled, "Restraints", dated 7/08, revealed that the soft restraints were listed as:

A. Mittens
B. Soft belt
C. Soft Vest
D. Soft wrist or ankle

In the same interview with the NM, she stated that the nurse should document how she determined which restraint to use and should follow the order of the restraints as listed in the policy. She confirmed that there was no documentation in Patient 63's nursing notes that described the behaviors that lead to the patient requiring a soft vest. She confirmed that in the first physician's order it was stated that the patient was attempting to climb out of bed and that would make a soft vest reasonable; however, for the other 3 days there was no clinical justification for the nurse to determine which type of restraint to use. She stated that the hospital was changing their restraint policy; however, a review (with the NM) of the proposed policy revealed that the new policy did not give clear direction as to the type of restraint used. The NM stated that the policy should be clear on which type of restraint was used.





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3. Review on 7/21/10 of Patient 74's record, showed that the patient was admitted to the hospital on 7/6/10 with diagnoses that included pneumonia.

Review of the physician orders for restraint dated 7/21/10, showed that there was no time the order was written, in addition there was no order for the type of restraint that the patient required.

In an interview on 7/21/10 at 10:00 AM with Staff RN 74, she acknowledged that the physician order for restraint was incomplete, and that the nurse would not know what type of restraint to use on the patient.



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4. (a). The Electronic Medical Record (EMR) for Patient 72 was reviewed on 7/20/10 at 2:15 PM. The clinical record indicated that Patient 72 was a 90 year old female admitted to the facility on 7/19/10 with diagnosis that included generalized weakness.

An observation of Patient 72 was made on 7/20/10 at 2:05 PM. It was observed that Patient 72 had a mitten restraint on her right hand and all four side rails up on her bed. The patient was awake, alert and able to make eye contact, but Patient 72 did not verbally respond when questions were addressed to her.

Further review of Patient 72's clinical record noted that the initiation time of the use of restraints on Patient 72, was on 7/19/10 at 1900 (7:00 PM). The " Restraint Initiation-Text" dated 7/19/10 at 7:00 PM noted the following:

"Right Upper Extremity Restraint" "Type: Mitten"

There was no documented evidence in the clinical record that noted, that Registered Nurse 61 had obtained a physician's order for the use of the restraint prior to the initiation of the mitten as a restraint and there was no documented evidence that noted that the use of the mitten was emergent, and therefore needed to be used prior to obtaining and order from the physician.

Further review of the EMR revealed an order history for the initiation of a "soft" restraint. The order had been entered into the system by RN 61 on 7/20/10 at 3:14 AM. There was no documentation within the order history that indicated that the order for the restraint was a telephone or verbal order from the physician. The order history noted that the electronic order had not been activated by (electronically signed) the physician until 7/20/10 at 14:24 (2:24 PM), which is 19 hours after RN 61 documented the use of soft mitten restraint had been initiated.

Review of Patient 61's manual medical record revealed that Patient 61 also had a pink sticker "Medical Restraint Order" for a "soft" restraint. The order had been written as a telephone on 7/20/10 at 7:00 AM, which was 12 hours after the initiation of the restraint. The "Medical Restraint Order" was signed by the physician on 7/20/10 at 1:00 PM, which is 18 hours after the mitten restraint was initiated.

During an interview with RN 62 on 7/20/10 at 1:30 PM, RN 62, who was in charge of patient 72's care on 7/20/10, stated, "We can decide what type of soft restraint we put on the patient and we notify the doctor as soon as possible, but it has to be within, in 12 hours."

The facility policy and procedure titled "Restraints" dated 11/09 was reviewed on 7/20/10 at approximately 2:30 PM. The policy noted the following:

"Within 12 hours of medical restraint application, notify the patient's physician of the justification/imitation for restraints and obtain a physician's order (verbal or written) for medical restraints. (Note: Notify the physician immediately if the initiation of the restraint is based on a significant change in the patient's condition."

During an interview with Nurse Manager 60 (NM 60) on 7/20/10 at 2:45 PM, NM 60 stated that the facility was aware that the facility policy and procedure was not in compliance with current regulations. NM 60 stated that RN 62 had stated the procedure from the use of restraints according to the policy that the facility had already identified as non-compliant with state and federal regulations. During the interview NM 60 stated that waiting 12 hours to notify the physician and obtain an order was not appropriate and was not compliant with current regulations. NM 60 verified that there was no documented evidence that RN 61 had notified a physician about Patient 72's need for a physical restraint.


4. (b). The clinical record for Patient 72 was reviewed on 7/20/10 at 2:15 PM. The clinical record indicated that Patient 72 was a 90 year old female admitted to the facility on 7/19/10 with diagnosis that included generalized weakness.

An observation of Patient 72 was made on 7/20/10 at 2:05 PM. It was observed that Patient 72 had all four side rails up on her bed.

During an interview with RN 62 on 7/20/10 at 1:30 PM, RN 62, who was in charge of patient 72 ' s care on 7/20/10, verified that Patient 72 was able to walk with assist.

Review of Patient 72's clinical record noted that the initiation time of the use of restraints on Patient 72, was on 7/19/10 at 1900 (7:00 PM). The "Restraint Initiation-Text" dated 7/19/10 at 7:00 PM noted the following:

"Restraint Type Full Body: Side Rails Full"

Review of Patient 72's physician's orders revealed that Patient 72 did not have an order for the use of full side rails to be used a physical restraint.

The facility policy and procedure titled "Restraints" dated 11/09 was reviewed on 7/20/10 at approximately 2:30 PM. The policy noted the following:

"Within 12 hours of medical restraint application, notify the patient's physician of the justification/imitation for restraints and obtain a physician's order (verbal or written) for medical restraints. (Note: Notify the physician immediately if the initiation of the restraint is based on a significant change in the patient's condition."

During an interview with NM 60 on 7/20/10 at 2:45 PM, NM 60 verified that the clinical record noted that Patient 72 was able to walk with assist and the full bed side rails had been used to prevent the patient from getting out of bed. NM 60 verified there was no documented evidence in the clinical record that Patient 72 had an order for the use of side rails as a physical restraint. NM 60 stated RN 61 should have obtained an order from a physician to use the side rails as a physical restraint.

Based on interview and record review, the facility failed to ensure quality assurance monitoring of hospital processes of care such as 1. wound care, 2. restraint utilization and 3. dietary planning and interventions, resulting in the risk of substandard patient care for all patients utilizing the facility.

Findings

For 2 patients, Patient 62 and Patient 67, the hospital failed to ensure that nursing developed a plan of care for the patient with a pressure ulcer (refer to tag A-396). This failure contributed to the progression of the Stage III pressure ulcer to a Stage IV pressure ulcer (Pressure ulcers are staged from Stage I, with the least tissue damage to Stage IV with the most tissue damage.) in Patient 62, and had the potential to delay assessment and treatment of the hospital acquired pressure ulcer in Patient 67.

Review of the hospital policy titled "Skin, Assessment and Intervention, Adult, dated 11/08, revealed that a patient who presents with or who develops a skin break down will have a written "Interdisciplinary Plan of Care" developed.

An interview was conducted with the wound care nurse on 7/19/10 at 11 AM. She confirmed that there was no plan of care developed to direct the care for Patient 62. She stated that plan of care should have been started on admission to help direct the nursing care of the patient.

An interview was conducted with the nurse manager of the unit on 7/20/10 at 2:30 PM and she confirmed that the documentation in Patient 67's medical record did not include a plan of care for treating the actual ulcer. The nurse manager confirmed that this pressure ulcer was a hospital acquired Stage II pressure ulcer and should have had a plan of care developed when the pressure ulcer was identified.

During an interview with members of the Quality Assurance Committee on 7/21/10, they stated that a sample of patients had assessments and interventions for pressure ulcers audited monthly. They stated that they were not certain how the sample was selected, and that the ulcer care was audited by direct observation, which they agreed could affect the validity of the sampling.

2. During a review of a sample of medical records on 7/19-7/22/10, 4 patient records included inadequately documented restraint orders (refer to tag 168). The errors noted included restraint order sheets with no time, no type of restraint specified or a general category specified instead of a particular restraint, no justification for the restraint, or no physician signature. For one patient there were no restraint orders found.

During an interview with members of the Quality Assurance Committee on 7/21/10, they were unable to explain the multiple errors that were found in the restraint ordering and documentation process, and had not been aware of those problems.

Based on observation, interview and record review, for three physicians, the medical staff failed to enforce the Rules and Regulations referenced by the Medical Staff Bylaws, creating the risk of substandard patient care by physicians in the facility.

Findings:

1. On 7/20/10 and 7/21/10 the complaint of Patient 305 was reviewed. Patient 305 came to the hospital 4/16/10 for an outpatient colonoscopy. Patient 305 voiced multiple concerns in his complaint, including that he had been discharged with a rectal tube in place.

Patient 305 ' s medical record was reviewed with the Manager of the GI lab on 7/21/10. She stated that Patient 305 should not have been sent home with a rectal tube in place. She stated that there was no indication in the patient ' s medical record that the physician who had placed the tube had ordered its removal. She stated that there had been no verbal order to nursing staff to remove it, and that there was a place available in the record for the physician to record a written order to remove a rectal tube, but no order had been recorded.

During a review on 7/23/10 of the Medical Staff Rules and Regulations, page four, section " B) In-Hospital Orders " read, " 1. All entries, including orders, shall be in writing; and dated and timed. "

2. On 7/23/10, in the GI laboratory, the medical record of Patient 306 was reviewed with the GI Lab Manager and GI lab nurse. The handwritten portion of the medical record written by the physician, including the handwritten assessments produced by the physician, could not be deciphered by the surveyor or by those staff members. The admitting diagnosis, history and physical, and post-operative diagnosis listed on the " Endoscopic Services History & Physical " form were all completely or partially illegible, as were parts of the " Pre/post Anesthetic/Sedation Evaluation " form.

During an interview with the Director of the Medical Staff on 7/23/10 at 3:25 PM, she stated that MD 1 had not been counseled about his handwriting.

During a review on 7/23/10 of the Medical Staff Rules and Regulations, page 3, read " The attending physician shall be responsible for the preparation of a complete medical record for the patient. "

3. During a review of the record of Patient 303, no time was seen on the verbal orders submitted for medications and treatments in the intensive care unit (ICU). The record indicated that the patient arrived in the ICU after surgery at approximately 4:00 PM on 7/16/10. Patient 303 ' s blood pressure dropped to 84/50 at 4:15 PM, and RN 301 documented that Plasmatine was given soon after for blood pressure support. The order for Plasmatine was entered in the computer at 5:16 PM.

During an interview with RN 301 on 7/20/10 at 2:11 PM, she stated that the patient arrived in the ICU without orders for medication and treatments. She stated that she telephoned the physician and obtained orders.

During a review on 7/23/10 of the Medical Staff Rules and Regulations, page four, " Admission to Critical Care (ICU/CCU) " read, " 1. All patients going to ICU/CCU must have admitting orders appropriate to their care and management prior to being transferred or admitted to these units. "

Based on observation, interview, and record review the facility failed to have a well organized nursing service to provide 24-hour nursing services to all patients by:

1. Failing ensure that the nursing policies for patients with pressure ulcers met the standards of the National Pressure Ulcer Advisory Panel (NPUAP) for assessment and for including a dietary aspect to wound care. This failure had the potential to negatively effect the wound healing of any patient with a pressure ulcer.

A. For Patient 62, this failure caused a delay in full assessment of a Stage IV pressure ulcer. The pressure ulcer was assessed by nursing as a Stage III in the Emergency Department (ED) 7/16/10 at 10:45 PM and as a Stage IV by the wound care nurse (WCN) on 7/19/10 at 3 PM, after surveyor review of the medical record.

B. For Patient 62, this failure caused the patient with a Stage IV pressure ulcer, who was admitted on 7/16/10 and discharged 7/21/10, to not have an assessment by a registered dietitian during her hospital stay.

C. For Patient 74, this failure caused a delay in a full assessment of his multiple skin issues, a Stage III pressure ulcer on his scrotum, a Stage III/unstageable pressure ulcer on his coccyx, a Stage II pressure ulcer on his left shoulder, an unstageable ulcer on his right shoulder, an unstageable pressure ulcer on his right ischium, and .a Stage II pressure ulcer on his right hip. This failure had the potential to delay correct treatment of the patient's ulcers. (Refer to A0386)

2. The hospital failed to ensure that the physician's orders for restraints contained a specific type of restraint and did not give the nurse the authority to choose the type of soft restraints that the patient needed. This failure had the potential to cause patients to be placed in several different types of restraints (wrist restraints, ankle restraints, vest restraints and mittens were all considered "soft" by the facility) without a full evaluation of the restraint that was necessary and placed the authority for determination of the type of restraint on the nurse. (Refer to A0386)

3. The hospital failed to ensure that a registered nurse performed and documented an initial assessment of a hospital acquired stage II pressure ulcer according to accepted standards of care.

A. For Patient 76, Registered Nurse 60 (RN 60) failed to perform and document an assessment of a Stage II hospital acquired pressure ulcer, to the coccyx (tail bone) that included the ulcer's included length, width and presence of drainage. This failure had the potential to result in an unidentified progression of Patient 76's pressure ulcer.

B. For Patient 62, the hospital failed to ensure that a registered nurse (RN) supervised and evaluated the nursing care for the patient. The hospital failed to ensure that the patient with a Stage III pressure ulcer on admission had a complete assessment of the wound with nursing interventions and evaluation to help ensure that the pressure ulcer did not progress. (Pressure ulcers are staged from Stage I, with the least tissue damage to Stage IV with the most tissue damage.) This failure lead to the progression of the Stage III pressure ulcer to a Stage IV.

C. For Patient 67, the hospital failed to ensure that nursing followed the hospital policy for notification to the wound care nurse regarding the development of a hospital acquired Stage II pressure ulcer. This failure had the potential to delay assessment and treatment of the hospital acquired pressure ulcer. (Refer to A0395)

4. For Patient 62, the hospital failed to ensure that nursing notified the ordering physician of their inability to complete an order to "inform" a consulting physician of the need to see the patient. The hospital required physician to physician consults; however, nursing did not follow the physician's order or did not clarify the order. This failure contributed to a consult from a kidney specialist that was not completed timely (over 26 hours late) according to hospital rules and regulations. (Refer to A0395)

The cumulative effect of these systemic problems resulted in the facility's failure to deliver patient care in a safe manner and in compliance with the Condition of Participation for Nursing Services.

Based on interview and record review the hospital failed to ensure that nursing services was well-organized to meet the needs of all patients with pressure ulcers and all patients who needed physical restraints in a universe of 200 patients.

The hospital failed to ensure that the nursing policies for patients with pressure ulcers met the standards of the National Pressure Ulcer Advisory Panel (NPUAP) for assessment and for including a dietary aspect to wound care. This failure had the potential to negatively effect the wound healing of any patient with a pressure ulcer.

For Patient 62, this failure caused a delay in full assessment of a Stage IV pressure ulcer. The pressure ulcer was assessed by nursing as a Stage III in the Emergency Department (ED) 7/16/10 at 10:45 PM and as a Stage IV by the wound care nurse (WCN) on 7/19/10 at 3 PM, after surveyor review of the medical record.

For Patient 62, this failure caused the patient with a Stage IV pressure ulcer, who was admitted on 7/16/10 and discharged 7/21/10, to not have an assessment by a registered dietitian during her hospital stay.

For Patient 74, this failure caused a delay in a full assessment of his multiple skin issues, a Stage III pressure ulcer on his scrotum, a Stage III/unstageable pressure ulcer on his coccyx, a Stage II pressure ulcer on his left shoulder, an unstageable ulcer on his right shoulder, an unstageable pressure ulcer on his right ischium, and .a Stage II pressure ulcer on his right hip. This failure had the potential to delay correct treatment of the patient's ulcers.

The hospital failed to ensure that the physician's orders for restraints contained a specific type of restraint and did not give the nurse the authority to choose the type of soft restraints that the patient needed. This failure had the potential to cause patients to be placed in several different types of restraints (wrist restraints, ankle restraints, vest restraints and mittens were all considered "soft" by the facility) without a full evaluation of the restraint that was necessary and placed the authority for determination of the type of restraint on the nurse.

Findings:

1 a). Review of the hospital policy titled " Skin, Assessment and Intervention, Adult", dated 11/08, revealed that a patient who presents with or who develops a skin break down will be assessed and have written documentation on admission and with each dressing change, and will have the " Pressure Ulcer Treatment Protocol " implemented. There was no direction given to the nurse as to what the assessment should include. There was no description in the policy of recommendations set by the "National Pressure Ulcer Advisory Panel" (NPUAP) that a pressure ulcer should be assessed weekly to allow the health care professional to observe complications early and to determine if a change in treatment was needed. According to the NPUAP an assessment should include, length and width of the ulcer, depth and tunneling of the ulcer, presence of any drainage, appearance of the tissue, and the surrounding skin.

Further review of the hospital policy titled "Skin, Assessment and Intervention, Adult", dated 11/08, revealed that there was no direction for the registered dietician (RD) to be notified when a patient had a pressure ulcer. A review of the pressure ulcer protocol treatment protocol revealed that there was no mention of notification to dietary for a nutritional assessment when a patient was identified as having a pressure ulcer. According to the NPUAP's recommendations the patient with a pressure ulcer should have a referral to the dietitian for early assessment of and intervention for nutritional problems. The NPUAP also recommended that the patient be assessed for the adequacy of total nutrient intake so recommendations could be made to enhance healing.

An interview was conducted on 7/21/10 at 4:30 PM with WCN 1 and WCN 2. They acknowledged that the hospital policy and wound care protocol did not address a complete assessment of pressure ulcers and did not address a dietary component of patient care with a pressure ulcer. The wound care nurses both stated that they were aware of the importance of a complete assessment to address the condition of the wound on discovery and the importance of nutritional assessment by a RD to aid in healing.

1 b). A review of the medical record for Patient 62 revealed that she was admitted to the hospital on 7/16/10 at 11:12 PM with diagnoses that included urinary tract infection, kidney failure, dialysis, and history of a stroke.

A review of the nursing admission assessment, completed on 7/17/10 at 4:42 AM, revealed that the patient's skin was not intact. The document noted that she had a pressure ulcer on her "coccyx" (tailbone area) that the admitting nurse was not able to visualize because a dressing covered the pressure ulcer. The pressure ulcer was documented as a Stage III. (Pressure ulcers are staged from Stage I, with the least tissue damage to Stage IV with the most tissue damage.)

Further review of the medical record revealed that Patient 62 was seen in the Emergency Department (ED) prior to being admitted to the hospital on 7/16/10. A review of the nursing notes from the ED revealed that on 7/16/10 at 10:45 PM the nurse documented that the patient had a pressure ulcer on the coccyx. The nurse documented that the pressure ulcer was a Stage III and that a " Comfeel " dressing was applied to the site. (This type of dressing obscured the site for assessment and can be left in place for several days.) There was no further assessment of the pressure ulcer site in the ED, such as width, length, depth, color, or appearance. There was documentation that a picture was taken of the ulcer.

A review of the nursing documentation from admission on 7/17/10 through surveyor review on 7/19/10 at 10:30 AM revealed that their was no nursing documentation that fully described the pressure ulcer. The nurses documented that the pressure ulcer was a Stage III and that it was covered by a dressing. There was also no documentation regarding the surrounding skin.

An interview was conducted with the wound care nurse on 7/19/10 at 11 AM. She confirmed that the nursing documentation did not meet professional standards set by the NPUAP. She stated that all of these things should have been started on admission. The wound care nurse stated that because the patient came through the ED, a dressing was applied at that time and the wound was not able to be visualized by the admitting nurse. She confirmed that the nurse in the ED should have documented the full assessment.

An observation of the pressure ulcer was conducted with the wound care nurse on 7/19/10 at 2 PM. The pressure ulcer was measured and had tunneling of 3.5 centimeters. The wound care nurse stated that for an ulcer with tunneling, it was important to pack it, to prevent it from closing up on the outside and continue to grow deeper on the inside. She confirmed that there was no previous packing of the tunneling ulcer.

A review of the wound care nurses documentation of the ulcer revealed that the ulcer was now a Stage IV ulcer. The wound care nurse confirmed the pressure ulcer as a Stage IV ulcer on 7/19/10 during the dressing change.

1 c). A review of the medical record for Patient 62 revealed that she was admitted to the hospital on 7/16/10 at 11:12 PM with diagnoses that included urinary tract infection, kidney failure, dialysis, and history of a stroke.

A review of the nursing admission assessment, completed on 7/17/10 at 4:42 AM, revealed that the patient's skin was not intact. The document noted that she had a pressure ulcer on her "coccyx" (tailbone area) that the admitting nurse was not able to visualize because a dressing covered the pressure ulcer. The pressure ulcer was documented as a Stage III. (Pressure ulcers are staged from Stage I, with the least tissue damage to Stage IV with the most tissue damage.)

A review of the nursing admission assessment, dated 7/17/10 at 4:42 AM, revealed that there was no nutritional screen completed by the admitting nurse. A review of the screen revealed that there was an area where a pressure ulcer could have been documented.

A review of the medical record for Patient 62, a patient with a Stage IV pressure ulcer, revealed that there was no assessment conducted by a registered dietician for Patient 62 during her hospitalization, from admission on 7/16/10 to discharge on 7/21/10.

An interview was conducted on 7/22/10 at 10 AM with the Clinical Nutrition Manager (CNM). She confirmed that there was no nutrition assessment completed for Patient 62. She stated that the nursing admission assessment was not fully filled out and there was no mention of the pressure ulcer on the nutritional screening from nursing. The CNM stated that the hospital relies on nursing to request a consult for a patient who was high risk and that no one in nursing sent a request for a nutritional evaluation for Patient 62.




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2. Review on 7/21/10 of Patient 74's record, showed that the patient was admitted to the hospital on 7/6/10 with diagnoses that included pneumonia.

Review of the hospital policy titled " Skin, Assessment and Intervention, Adult", dated 11/08, revealed that "a patient who presents with or who develops a skin break down will be assessed and have written documentation on admission and with each dressing change, and will have the " Pressure Ulcer Treatment Protocol " implemented." There was no direction given to the nurse as to what the assessment should include. There was no description in the policy of recommendations set by the National Pressure Ulcer Advisory Panel (NPUAP) that a pressure ulcer should be assessed weekly to allow the health care professional to observe complications early and to determine if a change in treatment was needed. According to the NPUAP an assessment should include, length and width of the ulcer, depth and tunneling of the ulcer, presence of any drainage, appearance of the tissue, and the surrounding skin.

Review of the emergency room nursing notes dated 7/6/10, the nurse documented that Patient 74 had "multiple/various stages of breakdown throughout his body. Scrotum has a Stage IV ulcer...Pictures taken of all skin breakdown areas.Also note foul smell...Pressure ulcers present on the coccyx, drainage noted, which is serosanguinous (clear blood tinged fluid), which is yellow, depth is Stage IV, wound is approx(imately) 4 inches in diameter..".

The nurse did not describe each ulcer individually with an assessment of the surrounding tissue, measurements of each ulcer, appearance of the ulcers, and if there was drainage. (except for the coccyx pressure ulcer-drainage is mentioned and the approximate size of the pressure ulcer.) There was not a full assessment of the patients pressure ulcers until the next day on 7/7/10 at 1:30 PM by the wound care nurse.

Review of the admission assessment dated 7/6/10 at 6:00 PM, there was no docmentation of the pressure ulcers' size.

Review of the wound care nurses notes dated 7/7/10 at 1:30 PM, showed that the patient had a Stage III pressure ulcer on his scrotum, a Stage III/unstageable pressure ulcer on his coccyx, a Stage II pressure ulcer on his left shoulder, an unstageable ulcer on his right shoulder, an unstageable pressure ulcer on his right ischium, and .a Stage II pressure ulcer on
his right hip.

In an interview on 7/21/10 with Staff RN 74, she acknowledged that the patient's pressure uilcers should have been fully assessed by the emergency room nurse or the admitting nurse during the day of admission.

3. A review on 7/20/10 at 2:00 PM of the medical record for Patient 66 showed that the patient was admitted to the facility on 7/16/10 with a diagnosis of sepsis (an overwhelming infection).

Review of the physician's orders showed that there were restraint order stickers placed in the physcian orders that were not complete, as follows:

A. 7/17/10, there was no time, no clinical justification for restrraints, no type of restraint, but there was a physician signature..

B. 7/18/10, there was no time, no clinical justification for restraints, no type of restraint, but there was a physician signature.

C. 7/19/10 at 7:00 AM, Clinical Justification for Restraints-Behavior interfering with medical care (no further description of behavior), Type of Restraint-Soft Restraint(s), there was no physician signature or Telephone order documented.

A review of nursing documentation showed the following:

A. From 7/17/10 at 8:00 AM until 10:44 PM, the patient was placed in Left and Right upper extremity restraints, and a vest restraint. At 8:00 PM through 10:00 PM, the nurse documented that a full body restraint was on the patient-full bed side rails.

B. From 7/18/10 at midnight until 4:34 AM, the patient was in Left and Right upper extremity restraints, and a vest restraint. From midnight through 6:00 AM the patient had full side rails. Then at 6:00 AM, the patient had Left and Right upper extremity restraints, and a Left lower extremity restraint. At 8:00 AM until 11:10 PM, the patient had Left and Right upper extremity restraints. (The nurse was deciding what type of restraint to place on the patient).

C. From 7/19/10 at midnight through 8:00 PM the patient was in Left and Right upper extremity restraints. At 8:00 PM, mitten restraints were added in addition to the upper extremity restraints. ( The nurse was deciding what type of restraint to place on the patient)

There was no documentation of how the nurse determined which restraint to use on the patient.

In an interview on 7/20/10 at 10:15 AM, with the Intensive Care Unit Nurse Manager (ICUNM), he stated, when asked how the nurse would know what type of restraint to place on a patient when the physician order just has soft restraints, "I think it means soft wrist restraints." When shown the physician orders and nursing documentation for Patient 66, the ICUNM acknowledged that the nurses are chosing the type of restraint to place on a patient without a physicians order.

A review of the hospital policy titled, "Restraints", dated 7/08, showed that the soft restraints were listed as:

A. Mittens
B. Soft belt
C. Soft Vest
D. Soft wrist or ankle

The hospital restraint policy further shows, "For medical restraint use beyond the first 24 hours, the physician will examine the patient at least once per calendar day to determine if restraints continue to be clinically justified and write a medical restraint order in the patient's medical record."

4. Review on 7/21/10 of Patient 74's record, showed that the patient was admitted to the hospital on 7/6/10 with diagnoses that included pneumonia.

Review of the physician orders for restraint dated 7/21/10, showed that there was no time the order was written, in addtion there was no order for the type of restraint that the patient required.

In an interview on 7/21/10 at 10:00 AM with Staff RN 74, she acknowledged that the physician order for restraint was incomplete, and that the nurse would not know what type of restraint to use on rhe patient

2. A review of the medical record for Patient 62 revealed that she was admitted to the hospital on 7/16/10 at 11:12 PM with diagnoses that included urinary tract infection, kidney failure, dialysis, and history of a stroke.

A review of the nursing admission assessment, completed on 7/17/10 at 4:42 AM, revealed that the patient ' s skin was not intact. The document noted that she had a pressure ulcer on her " coccyx " (tailbone area) that the admitting nurse was not able to visualize because a dressing covered the pressure ulcer. The pressure ulcer was documented as a Stage III.

Further review of the medical record revealed that Patient 62 was seen in the Emergency Department (ED) prior to being admitted to the hospital on 7/16/10. A review of the nursing notes from the ED revealed that on 7/16/10 at 10:45 PM the nurse documented that the patient had a pressure ulcer on the coccyx. The nurse documented that the pressure ulcer was a Stage III and that a " Comfeel " dressing was applied to the site. (This type of dressing obscured the site for assessment and can be left in place for several days.) There was no further assessment of the pressure ulcer site in the ED, such as width, length, depth, color, or appearance. There was documentation that a picture was taken of the ulcer.

According to the National Pressure Ulcer Advisory Panel (NPUAP) a pressure ulcer should be assessed weekly to allow the health care professional to observe complications early and to determine if a change in treatment was needed. The assessment should include, length and width of the ulcer, depth and tunneling of the ulcer, presence of any drainage, appearance of the tissue, and the surrounding skin.

A review of the nursing documentation from admission on 7/17/10 through surveyor review on 7/19/10 at 10:30 AM revealed that their was no nursing documentation that fully described the pressure ulcer. The nurses documented that the pressure ulcer was a Stage III and that it was covered by a dressing. There was also no documentation regarding the surrounding skin.

A review of the " Pressure Ulcer Protocol " for a patient with a Stage III pressure ulcer revealed that the wound should be irrigated with sterile normal saline (fluid commonly used for irrigation), apply dressing (dressings described and included " Comfeel " dressing), timeframe for changing the dressing, and to contact the wound care nurse to evaluate and treat the ulcer (written in bold type).

Review of the hospital policy titled " Skin, Assessment and Intervention, Adult, dated 11/08, revealed that a patient who presents with or who develops a skin break down will have the following:

All wounds and pressure ulcers will be assessed and have written documentation on admission and with each dressing change,
The " Pressure Ulcer Treatment Protocol " implemented,
A written " Interdisciplinary Plan of Care " developed,
Notification to the physician,
RN (registered nurse) will document all actual interventions and treatments,
Notification to the wound care nurse of all Stage III, Stage IV, unstageable (an ulcer that could not be staged due to either necrotic {dead} tissue or slough), and all hospital acquired ulcers.

Review of the nursing documentation, the physician's progress notes, and physician or protocol order sets from admission on 7/16/10 until surveyor review on 7/19/10 at 10:30 AM revealed the following:

There was no documentation regarding notification to the physician of the (Stage III) pressure ulcer.
There was no " Pressure Ulcer Protocol " entered for Patient 62.
There was no documentation of irrigation of the wound.
There was no notification to the wound care nurse.
There was no " Interdisciplinary Plan of Care " for an actual skin breakdown developed for the patient.

An interview was conducted with the wound care nurse on 7/19/10 at 11 AM. She confirmed that there was no notification by nursing for her to see the patient, that no pressure ulcer protocol had been implemented, that there was no notification to the physician that the patient had a Stage III pressure ulcer, that the nursing documentation did not meet professional standards set by the NPUAP, and that there was no plan of care developed to direct the care for Patient 62. She stated that all of these things should have been started on admission. The wound care nurse stated that because the patient came through the ED, a dressing was applied at that time and the wound was not able to be visualized by the admitting nurse. She confirmed that the nurse in the ED should have documented the full assessment. The wound care nurse reviewed the picture taken by the ED nurse and confirmed that the picture was such a poor quality that it was not possible to tell the condition of the wound on admission.

An observation of the pressure ulcer was conducted with the wound care nurse on 7/19/10 at 2 PM. The pressure ulcer was measured and had tunneling of 3.5 centimeters. The wound care nurse stated that for an ulcer with tunneling, it was important to pack it, to prevent it from closing up on the outside and continue to grow deeper on the inside. She confirmed that there was no previous packing of the tunneling ulcer.

A review of the wound care nurses documentation of the ulcer revealed that the ulcer was now a Stage IV ulcer. The wound care nurse confirmed the pressure ulcer as a Stage IV ulcer on 7/19/10 during the dressing change.

3. Review of the medical record for Patient 67 revealed that she was admitted to the hospital on 7/14/10 with diagnoses that included urinary tract infection and altered level of consciousness.

A review of the nursing admission assessment, dated 7/14/10, revealed no mention of a pressure ulcer on the patient's right buttock.

Review of the nursing skin assessment sheets revealed that on 7/18/10 at 8 PM the nurse documented that the patient had developed a Stage II pressure ulcer with a blister on her right buttock.

A review of the physician's progress notes and physician's orders from 7/14/10 until the date of review, on 7/20/10, revealed that there was no mention of a pressure ulcer on the right buttock.

A review of the interdisciplinary care plan for the patient revealed that there was no care plan developed for the care of the pressure ulcer.

A review of the medical record from admission to review on 7/20/10, revealed that there was no notification to the wound care nurse documented in the record.

Review of the hospital policy titled " Skin, Assessment and Intervention, Adult, dated 11/08, revealed that a patient who presents with or who develops a skin break down will have the following:

All wounds and pressure ulcers will be assessed and have written documentation on admission and with each dressing change,
The " Pressure Ulcer Treatment Protocol " implemented,
A written " Interdisciplinary Plan of Care " developed,
Notification to the physician,
RN (registered nurse) will document all actual interventions and treatments,
Notification to the wound care nurse of all Stage III, Stage IV, unstageable (an ulcer that could not be staged due to either necrotic {dead} tissue or slough), and all hospital acquired ulcers.

An interview was conducted with the nurse manager of the unit on 7/20/10 at 2:30 PM and she confirmed that the documentation did not include a plan of care, notification to the physician, or notification to the wound care nurse. The nurse manager confirmed that this pressure ulcer was a hospital acquired Stage II pressure ulcer and should have had notification sent to the wound care nurse to evaluate the treatment of the wound.

An interview was conducted with WCN 1 and she stated that she was not notified that the patient had a hospital acquired Stage II pressure ulcer.

4. A review of the medical record for Patient 62 revealed that she was admitted to the hospital on 7/16/10 at 11:12 PM with diagnoses that included urinary tract infection, kidney failure, dialysis, and history of a stroke.

A review of the physician ' s orders revealed that on 7/17/10 at about 6 PM the physician ordered a consult from a physician who specialized in kidney failure and dialysis. The order stated " inform (MD name) of (patient ' s room number) regarding dialysis " .

A review of the medical record revealed that the kidney specialist did not see the patient until 7/20/10 at about 9 AM.

A review of the hospital ' s medical staff rules and regulations, dated 6/28/10, revealed that the patient ' s physician was responsible for securing prompt consultations. The rules and regulations further stated that consolations shall be performed within 36 hours of the request or sooner as appropriate to the patient ' s condition.

An interview was conducted with the nurse manager (NM) of the unit on 7/20/10 at 10 AM. The NM confirmed that the consult was not completed timely (over 26 hours late) according to hospital rules and regulations. She stated that consults are done physician to physician, so the order to notify a physician would not have been done. The NM stated that nursing should have told the physician to call his consulting physician himself. She was asked if there would be a record kept of when consults were ordered, so follow up could be conducted by the hospital and she stated no. She stated that each nurse was responsible for following up with the primary physician, if consults were not done timely. She stated that there was no record that this had been done for Patient 62.




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Based on interview and record review the facility failed to ensure that a registered nurse performed and documented an initial assessment of a hospital acquired stage II pressure ulcer according to accepted standards of care.

For Patient 76, Registered Nurse 60 (RN 60) failed to perform and document an assessment of a Stage II hospital acquired pressure ulcer, to the coccyx (tail bone) that included the ulcer's included length, width and presence of drainage. This failure had the potential to result in an unidentified progression of Patient 76's pressure ulcer.

For Patient 62, the hospital failed to ensure that a registered nurse (RN) supervised and evaluated the nursing care for the patient. The hospital failed to ensure that the patient with a Stage III pressure ulcer on admission had a complete assessment of the wound with nursing interventions and evaluation to help ensure that the pressure ulcer did not progress. (Pressure ulcers are staged from Stage I, with the least tissue damage to Stage IV with the most tissue damage.) This failure lead to the progression of the Stage III pressure ulcer to a Stage IV.

For Patient 67, the hospital failed to ensure that nursing followed the hospital policy for notification to the wound care nurse regarding the development of a hospital acquired Stage II pressure ulcer. This failure had the potential to delay assessment and treatment of the hospital acquired pressure ulcer.

For Patient 62, the hospital failed to ensure that nursing notified the ordering physician of their inability to complete an order to "inform" a consulting physician of the need to see the patient. The hospital required physician to physician consults; however, nursing did not follow the physician's order or did not clarify the order. This failure contributed to a consult from a kidney specialist that was not completed timely (over 26 hours late) according to hospital rules and regulations.

Findings:

1. The clinical record for Patient 76 was reviewed on 7/21/10 at 1:10 PM with Clinical Nurse 1 (CN 1). The clinical record noted that Patient 76 was a 47 year old male admitted to the facility on 6/11/10 with diagnosis the included respiratory failure with tracheotomy, percutaneous endoscopic gatrostomy tube placement ( tube placed in the stomach to allow the infusion of liquid nutrition), amputation to both upper an lower extremities and end stage renal disease.

Patient 76's itegumentry (skin) assessments were reviewed on 7/21/10 at 1:10 PM with CN 1. The skin assessments noted that on 6/24/10 at 2300 (10:00 PM) Registered Nurse 60 documented that Patient 76 had developed a Stage II pressure ulcer to the coccyx area.
Review of the skin assessmenents from 6/11/10 to 6/24/10 revealed that RN 60 was the first registered nurse to identify the Stage II to the coccyx area on 6/24/10 at 10:00 PM.

Documentation by RN 60 noted that the wound was cleansed with sterile saline and a hydrocolloid dressing was applied. The initial assessment of the stage II pressure ulcer to the coccyx, documented by RN 60 on 6/24/10 at 2300 did not include the length, and width, to determine the size of the wound.

Review of the wound care documentation by Wound Care Nurse 1 (WCN 1) dated 6/25/10 noted that the re-assessment of the wound included, length, and width to determine the size of the wound, that was not documented with the initial assessment by RN 60.

The National Pressure Ulcer Advisory Panel (NPUAP), Pressure Ulcer Reference Guide was reviewed on 7/24/10 at 3:00 PM. According to the NPUAP a care provider should, "Assess the pressure ulcer initially and re-assess it at least weekly, documenting findings." "Assess and accurately document physical characteristics such as location, Category/Stage, size, tissue type(s), wound bed and periwound condition, wound edges, sinus tracts, undermining, tunneling, excudate, necrotic tissue, odor, presence of granulation tissue, and epithelialization."

During an interview with CN 1 on 7/21/10 at 2:50 PM, CN 1 verified that RN 60 had not included length, width and drainage in the initial assessment of Patient 60's pressure ulcer to the coccyx area. During the interview CN 1 stated that measurements of wounds should be documented every Wednesday and upon identification of the wound. CN 1 verified that RN 60 had not included measurements of the initial assessment of Patient 60's pressure ulcer to the coccyx when it was first identified on 6/24/10 at 2300.

Based on interview and record review the facility failed to ensure that nursing staff delvelped and kept current a nursing care plan for 2 of 38 sampled patients.

For Patient 62, the hospital failed to ensure that nursing develped a plan of care for the patient with a pressure ulcer. (Pressure ulcers are staged from Stage I, with the least tissue damage to Stage IV with the most tissue damage.) This failure contributed to the progression of the Stage III pressure ulcer to a Stage IV.

For Patient 67, the hospital failed to ensure that nursing develped a plan of care for the patient with a hospital acquired pressure ulcer. This failure had the potential to delay assessment and treatment of the hospital acquired pressure ulcer.

Findings:

1. A review of the medical record for Patient 62 revealed that she was admitted to the hospital on 7/16/10 at 11:12 PM with diagnoses that included urinary tract infection, kidney failure, dialysis, and history of a stroke.

A review of the nursing admission assessment, completed on 7/17/10 at 4:42 AM, revealed that the patient ' s skin was not intact. The document noted that she had a pressure ulcer on her " coccyx " (tailbone area) that the admitting nurse was not able to visualize because a dressing covered the pressure ulcer. The pressure ulcer was documented as a Stage III.

Review of the hospital policy titled "Skin, Assessment and Intervention, Adult, dated 11/08, revealed that a patient who presents with or who develops a skin break down will have a written "Interdisciplinary Plan of Care" developed.

Review of the nursing documentation from admission on 7/16/10 until surveyor review on 7/19/10 at 10:30 AM revealed that there was no " Interdisciplinary Plan of Care " for an actual skin breakdown developed for the patient.

An interview was conducted with the wound care nurse on 7/19/10 at 11 AM. She confirmed that there was no plan of care developed to direct the care for Patient 62. She stated that plan of care should have been started on admission to help direct the nursing care of the patient.

2. Review of the medical record for Patient 67 revealed that she was admitted to the hospital on 7/14/10 with diagnoses that included urinary tract infection and altered level of consciousness.

A review of the nursing admission assessment, dated 7/14/10, revealed no mention of a pressure ulcer on the patient's right buttock.

Review of the nursing skin assessment sheets revealed that on 7/18/10 at 8 PM the nurse documented that the patient had developed a Stage II pressure ulcer with a blister on her right buttock.

A review of the interdisciplinary care plan for the patient revealed that there was no care plan developed for the care of the pressure ulcer.

Review of the hospital policy titled " Skin, Assessment and Intervention, Adult, dated 11/08, revealed that a patient who presents with or who develops a skin break down will have a written " Interdisciplinary Plan of Care " developed.

An interview was conducted with the nurse manager of the unit on 7/20/10 at 2:30 PM and she confirmed that the documentation did not include a plan of care for treating the actual ulcer. The nurse manager confirmed that this pressure ulcer was a hospital acquired Stage II pressure ulcer and should have had a plan of care developed when the pressure ulcer was identified.

Based on document review, interview, and policy and procedure review, the facility failed to ensure, for 1 of 38 sampled patients (Patient 68), that the physician in charge of patient 68's care reordered two medications that were stopped before Patient 68's surgical procedure.

Findings:

A review of Patient 68's order information for morphine 3 milligram (mg) IVP (IV push) Q2h (every two hours) PRN (as needed) and tramadol (Ultram) 50 mg PO (by mouth) Q4h (every 4 hours) routinely ordered on 7/19/10 at 8:13 AM and 8:21AM respectively revealed that both drugs were 'suspended' same as 'stopped' on 7/19/10 at 10:18 AM. RN 68 resumed suspended orders on 7/19/10 for morphine and tramadol at 3:05 PM..

A review of the facility's policy and procedure on 7/21/10 at approximately 3:40 PM titled, "Orders Physician " documents, " Following the procedure that required suspending orders, the physician must provide new orders for care including medication orders. " In addition " Resume ... term given to an individual order that re-orders the previously suspended order back to an active state directly by a physician or on behalf of a physician order. " Licensed staff was unable to locate restart orders by the physician prior to the resumption of orders for both drugs (morphine and tramadol).

Interviews on 7/21/10 at 3:40 PM with nurse management and pharmacy management revealed that physician orders for the resumption of the medications (morphine and tramadol) were not available for review.

Based on interview and record review, the facility failed, for 1 of 38 sampled patients (Patient 303), to ensure that verbal orders were timed, creating the risk of substandard patient care for that patient.

Findings:

During a review of the record of Patient 303, no time was seen on the verbal orders submitted for medications and treatments in the intensive care unit (ICU). The record noted that the patient arrived in the ICU after surgery at approximately 4:00 PM on 7/16/10. Patient 303 ' s blood pressure dropped to 84/50 at 4:15 PM, and RN 301 documented that Plasmatine was given soon after for blood pressure support. The order for Plasmatine was entered in the computer at 5:16 PM. The space for " time " on the pre-printed head of the order sheet was left blank. The verbal orders had been signed by the physician, but no time or date accompanied that signature.

During an interview with RN 301 on 7/20/10 at 2:11 PM, she stated that the patient arrived in the ICU without orders for medication and treatments. She stated that she telephoned the physician and obtained orders, including the order for Plasmatine. She concurred that she did not write the time on the orders obtained, and that she should have recorded the time.









During a review of the Medical Staff Rules and Regulations (approved 6/29/10) on 7/23/10, section B1 " In-Hospital Orders " stated, " All entries, including orders, shall be in writing; and dated and timed. "

Based on observation, interview, and policy and procedure review, the facility failed to ensure the following:

1. Document (log) the temperatures of the warming cabinet located in the surgery department.
2. That Keppra, a medication used for seizures was administered to Patient 67 in a timely manner.
3. That Flomax (tamsulosin) was administered to Patient 41 in a timely manner.
4. That the specific treatment modality was clearly defined by the physician for morphine and Dilaudid to ensure safe use of drugs.

Findings:

1. During a tour of the Surgery Department on 7/22/10 at approximately 3:10 PM with the Director of Pharmacy (DOP), it was observed that a warmer used to warm intravenous (IV) solutions temperatures were not logged, i.e. frequently assessed on a daily basis.

According to licensed staff, the IV solutions in the warmer were dated 14 days. A frequency of temperature assessment demonstrates that a hospital has implemented a system (e.g. policy and procedure) to ensure safe use of medications stored beyond the manufacturer recommended temperatures; in that the IV solution has been stored properly, and has retained its designated potency, sterility, and is absent of contaminants or is otherwise not considered unusable.

To promote safe storage of medication there should be control systems implemented that allow a hospital to demonstrate that warmed medications have been stored within the prescribed temperature range at all times from the point of acquisition to disposition (e.g. administration, wastage or return to manufacturer).
Moreover, the equipment utilized for temperature assessment must be functioning properly and periodically assessed for accuracy of temperature assessment.
Documentation (logging) of a warming cabinet temperatures is one method to promote safe storage of medications which should be augmented by visual inspection of the medications for particulate matter or discoloration.

In concurrent interviews with the surgery manager and DOP, they acknowledge that logging (documentation) of the warming temperatures is a method to ensure accuracy of temperature assessment.

2. During a medication observation pass (MOP) conducted on 7/20/10 at 8:40 AM, on a medical surgical unit, Keppra (levetiracetam) 500 mg (milligrams) scheduled to be administered to Patient 67 at the 9AM (MOP) was not available. RN 67 reported that it was reordered from the pharmacy.

Review of the clinical record on 7/20/10 at 10:23 AM, the medication was documented as not administered. When the pharmacy was contacted by nursing information staff to determine the delay, the pharmacy staff reported that a messenger was on the way to the unit with the medication.

In a concurrent interview with the nursing information staff, they confirmed that the medication Keppra was not available for administration to Patient 67 in a timely manner.

3. Review of the clinical record on 7/22/10 at 11:28 AM, revealed that Flomax (tamsulosin) 0.4 mg (milligrams) by mouth ordered to be administered at the 9 AM medication pass was documented as not administered on 7/22/10 at the time of review. Flomax may be used for symptomatic treatment of bladder outlet obstruction or dysfunction.

In a concurrent interview with the nursing information staff, they confirmed that the medication was not available for administration to Patient 41 in a timely manner.

4. A review of Patient 41's medical record was conducted on 7/22/10 at approximately 11:28 PM. The review revealed physician's orders dated 7/19/10, time at 7:49 PM for morphine 2 mg (milligram) I.V (intravenous) q4h (every 4 hours) PRN (as needed) pain, and Dilaudid 2 mg I.V q4h PRN pain. The intensity (moderate, severe) of pain was not described to determine which drug should be selected by nursing based on an assessment of moderate or severe pain.

Morphine and Dilaudid are equipotent in terms of analgesic (pain relief) effect, however,
2 mg of I.V. morphine is not equivalent to 2 mg of I.V. Dilaudid. Lexi-Comp ONLINE documents, "Note: Hydromorphone 1 mg I.V. is approximately equal to morphine 5 mg I.V." Therefore, 2 mg of I.V Dilaudid is approximately equal to morphine 10 mg I.V.

The established pain assessment scale for mild to severe pain is 1-10. Based on the patient's description of the pain and the nurse's interpretation of the physician ' s orders for morphine or Dilaudid, the nurse would determine which drug would be administered to Patient 41. Conceivably, the nurse could decide to give Dilaudid, the more potent narcotic based on dose. There ' s an inherent risk for medication error(s) since the specific treatment modality is not clearly defined by the physician.

In a concurrent interview with the Director of Pharmacy (DOP), and nursing staff, they acknowledged that the analgesic drug selection would be based on the nurse ' s interpretation.

Based on observation and interview, the facility failed to ensure that a glucometer used to test blood for glucose was stored in a secure area.

Findings:

During a tour with the Director of Pharmacy (DOP) on 7/20/10 at 1:05 PM, a LifeScan - Sure step Flex Unit (a glucometer) was observed on a treatment cart located in the hallway.

In a concurrent interview, the DOP acknowledged that the glucometer should be stored in a secure area.

Based on observation and interview, the facility failed to ensure that unlabeled (unusable) drugs were not available for patient use.

Findings:

During a tour of OR 4 (operating room 4) on 7/22/10 at 2:37 PM, pre-drawn unlabeled syringes of medications were found in an anesthesia cart. In addition, there was a partial bottle of Diprivan located on the top of the cart. Physician B stated that he intended to discard the syringes and Diprivan.

A review of the facility ' s policy and procedure (P&P) on 7/22/10 at approximately 3:30 PM, titled, "Medications: Surgical procedure, medication administration from sterile field" documents, "Expiration time of medication on sterile field is at the conclusion of procedure or manufacturer recommendations, whichever comes first. All containers on the sterile field are discarded at the conclusion of the procedure." The P&P further documents, "Any medication or solution found unlabeled is immediately discarded."

In concurrent interviews on 7/22/10 at 2:37 PM, with the surgery manager and DOP, they acknowledge that pre-drawn syringes, moreover, unlabeled pre-drawn syringes create a risk of incorrect or inappropriate administration of medications to patients.

Based on observations, staff interviews and record reviews, the hospital condition of participation for food and dietetic services was not met as evidenced by:

1. The Director of Food and Nutrition Services failed to ensure the daily management of the dietary services to provide patients, staff and visitors with safe and high quality food service due to:

a. patient meal trays were sent to patients with the hot metal bases exposed leading to the potential for burns. (cross refer A-144 and A-620)

b. flowers were stored in the refrigerators that were intended for the storage of food leading to the potential for cross contamination and food borne illness. (cross refer A-620)

c. the failure to ensure the proper cool down procedures were carried out and monitored for previously cooked potentially hazardous food which lead to the potentail for food borne illness. (cross refer A-620)

d. the failure to ensure that a can opener and pans used for cooking were maintained in a clean and sanitary manner which lead to the potential for cross contaimnation and food borne illness. (cross refer A-620)

e. the failure to ensure that expired prepared foods and nutritional supplement products were not stored in the food service department. (cross refer A-620)

2. The Director of Food and Nutrition Services and the Clinical Nutrition Manager failed to ensure the nutrition needs for 4 of 6 patients reviewed for nutrition care were met in accordance with recognized dietary practices and the hospitals policies and procedures. (cross refer A-630)

The cumulative effect of these systemic problems resulted in the hospital's inability to ensure safe food handling to prevent the potential for food borne illness; to ensure the safety of the patients; and to ensure nutrition care personnel were providing nutrition care according to State law.

Based on observations, interviews and document reviews the hospital failed to have a food service director who ensured the daily management of dietary services to provide patients, staff and visitors with safe and high quality food service by:

1. Failing to provide patients with a safe environment when meal trays were served to the patients with exposed, hot bases without the protective underliners for the plates to protect patients from burn injuries. This failure had the potential to cause thermal burns in 51 patients in a universe of 133 patients. (cross refer A-144)

2a. Failing to use the food storage refrigerator for only the storage of food.

b. Failing to ensure that the dietary service staff monitored and ensured the safe cool down of potentially hazardous food.

c. Failing to ensure dietary staff cleaned the can opener after each use.

d. Failing to ensure that facility cooks kept the pans and lids used for cooking patient meals clean and free of food particles and trash.

e. Failing to ensure that dietary staff discarded food items at the end of their "use by" date.

Findings:

1. During trayline observation on 7/20/10 at 1:09 PM, it was noted that fourth floor patient trays were being assembled with hot metal bases resting directly on the trays with no underliners. One metal wax base was checked for temperature by touching it and it was noted to be too hot to touch without being burned.

According to Dinex, the manufacturer of the metal wax base, the base is constructed of two, 20-gauge stainless steel shells, automatically seam welded and hermetically sealed. The interior of the base consisted of a wax core, which heats quickly but dissipates heat slowly for optimum temperature retention. It further noted that the wax base kept food hot for 90 minutes when used in conjunction with heated plates, Dinex insulated domes and Dinex underliners. The Dinex catalogue stated that non-insulated underliners were used to hold the wax bases to, "protect the patient and the tray from the heated base."

According to the American Red Cross Home Safety Lesson Plan for Burns (copyright 2007), "When skin is exposed to temperatures of greater than 118 degrees F (Farenheit), it can burn (thermal burns)."

During an interview with the Director of Food and Nutrition Services (DFNS) on 7/20/10 at 1:10 PM, she stated that the facility didn't have enough of the underliners to place them on all the trays with the hot metal wax bases. She stated that the bases were not hot enough to cause burns when the meal tray reached the patient. When asked if the facility had done any monitoring of the temperature of the metal wax base when it reached the patient, she stated that they had not.

On the fourth floor at 1:20 PM when the trays were being delivered to the patients, the temperature of the metal wax base was again checked by touching it. The metal wax base remained too hot to touch even as it was being served to patients, which was confirmed by the DFNS. She then stated that she would order more underliners so that there would be enough and that no meal tray would need to be served without the underliner.

On 7/21/10 at 1:07 PM, meal trays were again being served to patients on the fourth floor without the underliners to protect the patients from exposure to the hot metal wax bases. The temperature of a hot metal wax base was measured by the surveyor as trays were being served to the patients, it registered 121.9 degrees Farenheit.

During a concurrent interview the DFNS again stated that she had ordered the underliners. When asked for a more immediate correction of the safety risk, the CNM (Clinical Nutrition Manager), who was also present, stated that the alert patients would be warned about the hot metal wax bases and the non-alert patients would have the metal bases removed from their trays. The facility failed to initiate an immediate plan that would protect all patients from thermal burns from the hot metal wax bases.

The survey team identified an immediate jeopardy situation on 7/21/10 at 2:20 PM, as a result of the facility's failure to provide patients with a safe environment when the patients' meal trays were served with hot metal wax bases without the underliners to protect the patients from being burned. In addition to the survey team, the interim CNO (Chief Nursing Officer) was present at the time the immediate jeopardy was called.

The team accepted a written plan of action for the immediate jeopardy situation on 7/21/10 at 5:30 P M. The facility implemented a plan of action as follows: effective immediately, at no time will a hot meal be served to a patient without the protective underliner around the metal base; policy #8320-06570 entitled, "Patient Tray Line Standards" was revised to reflect the patient trays would never be served without the protective underliner around the metal base; all Nutritional Services Tray Line Servers and Supervisors currently on duty were educated to the change in policy and procedure; remaining Nutrition Services Tray Line Servers and Supervisors would be educated on change in policy and applicable meal service restrictions prior to the start of the subsequent shift until all applicable staff was educated; additional protective underliners were ordered for use with every hot meal service to arrive 7/21/10 at 8:00 PM; and the new hire orientation/competency was revised to reflect change in meal service restriction.

The dinner meal service was observed on 7/21/10 between 5:15 and 6:30 PM by the survey team to confirm no hot metal wax bases were served without the protective underliner. During an interview with FSW 1 on 7/21/10 at 5:05 PM, she stated that she was the Starter (she set up the plates on trayline, including the hot metal wax bases and the underliners) for dinner. She further stated that it was not the practice of the facility to use the underliners at all until recently, a couple of months ago, she thinks. She further stated that the facility never had enough of the underliners to use on all hot meal trays. She was further able to verbalize the policy changes that were just put into place.

While observing tray line on 7/21/10 at 5:15 PM, the DFNS stated that the facility had only recently started using the underliners. She further stated that she had ordered some underliners on 2/11/10 as a trial because she had recognized that the hot metal wax bases could be a problem and cause patient burns. She stated that she recognized that it was a potential for burn injuries to the patients and was trying a solution by ordering the bases, but there weren't enough underliners for all the hot meals served. She further stated that 51 trays had been served at lunch on 7/21/10 with exposed hot metal wax bases.

During the same trayline observation at 5:45 PM, it was observed that the pediatric patients did not receive the hot metal wax bases on their tray. Upon questioning, FSS 1 stated that it had not been the practice of the facility to give the metal wax bases to the pediatric patient due to the risk for injury from burns. She was checking the trays at the end of trayline and she was able to verbalize the new policy changes.

The breakfast meal service was observed on 7/22/10 between 7:15 and 8:30 AM by the survey team to confirm no hot metal wax bases were served without the protective underliner. It was also confirmed by the survey team that the facility had obtained the additional underliners for use with the hot metal wax bases so that no hot meal would be served to the patients without one.

During a concurrent interview with FSW 2 at 7:15 AM, she stated that she was the Starter on trayline for breakfast. She was able to verbalize to policy changes that were just put into place. At 7:45 AM, an interview was conducted with FSS 2 who was checking trays at the end of tray line. She was also able to verbalize the new policy changes.

The survey team removed the immediate jeopardy situation on 7/22/10 at 11:05 AM, based on implementation of the plan.

2. During the initial tour of the kitchen on 7/19/10 starting at 1:20 PM,

a. A large plastic trash can-like covered container was noted in the walk-in produce refrigerator. Upon further inspection, the container was noted to contain fresh flowers.

During a concurrent interview with the Director of Food and Nutrition Services (DFNS), she stated that the flowers were used to decorate patient trays. She further stated that the food service staff cuts the flowers and places one each in small vases that fit on the meal trays for each patient. She also stated that the flowers were sent on all meal trays except patients on Neutropenic (a condition where the patient has a decreased white cell production, placing them at a very high risk for infection) Diets.

Title 22 of the California Code of Regulations states that refrigerated space shall be maintained for the storage of frozen and chilled food. The flowers that the hospital used to decorate the patient trays were not food and they were being stored in the walk-in refrigerator that was used for the storage of food. This practice had the potential for cross contamination of flowers, and the water they were stored in, with food, leading to the potential for food borne illness.

b. A large pan of cooked chicken pieces was noted in the cook's refrigerator dated 7/18/10. According to the DFNS the date indicated was the date the chicken was cooked. The temperature of the chicken was measured by the surveyor and registered 42.5 degrees Fahrenheit (F). A second large pan of cooked chicken pieces was noted in the walk-in refrigerator also dated 7/18/10. The temperature of this chicken was 33.7 degrees F.

During a concurrent interview with the DFNS she stated that there was no record of the cool down process for the chicken. She also stated that it was the practice of the facility to use the blast chiller to cool cooked potentially hazardous foods (PHF) rapidly. She stated that the blast chiller produced a print-out as a record and monitor of foods as they were chilled. She stated that the facility also maintained a written record of all foods chilled in the blast chiller. She was unable to locate a print-out or a record of the chicken pieces that were cooked and chilled on 7/18/10.

On 7/19/10, a review of the hospital policy and procedure titled "Cooling of Potentially Hazardous Foods" (reviewed 2/2010, and approved by the DFNS) was conducted. The policy showed that it was the department policy that all potentially hazardous cooked food that is to be refrigerated for later use, must be cooled to 70 degrees F or cooler within 2 hours after cooking, and cooled from 70 degrees F to 40 degrees or cooler within an additional 4 hours. Internal temperatures of the food must be taken. If food is not cooled within the specified time frames, the food will be discarded. It further stated the procedure was to use the Blast Chiller for cooling potentially hazardous cooked foods using the above temperature guidelines. Then record all temperatures in the Blast Chiller log book.

During a subsequent interview with the Chef on 7/20/10 at 10:30 AM, he stated that the cook who had cooked the chicken on 7/18/10 had fallen and injured herself and had to leave the facility shortly after cooking the chicken. He further stated that there was no record of the cooling down process for the chicken pieces and he was unable to verify if the chicken had been cooled down properly to ensure it was safe.

According to the 2009 "Food Code" cooked PHF shall be cooled within 2 hours from 135 degrees F to 70 degrees F and within a total of 6 hours from 135 degrees F to 41degrees F or less.

The DFNS was unable to explain why the temperature of the chicken in the cook's refrigerator was 42.5 degrees F when it had been cooked and cooled the previous day. The DFNS failed to ensure that the staff monitored and ensured the safe cool down of PHF.

c. A can opener and the base for the can opener in the cook's preparation area was noted to be crusted with dried food particles and coated with a sticky substance on the food contact surfaces.

According to the facility's cleaning schedule (undated) reviewed on 7/19/10, the AM Cook was responsible for cleaning and sanitizing the preparation area after breakfast and after lunch and the PM Cook was responsible for cleaning and sanitizing the preparation area after dinner.

During a concurrent interview the DFNS, she stated that it was the expectation for the staff to clean the can opener after each use. She verified that the can opener had not been cleaned, that the food particles were dried and that the sticky substance was also dried, not fresh.

According to the 2009 "Food Code" equipment food-contact surfaces and utensils shall be cleaned to sight and touch throughout the day at least every 4 hours.

d. Pans and lids used for cooking stored in the cook ' s prep area were noted to be coated with dried food particles and littered with trash.

According to the facility's cleaning schedule (undated) reviewed on 7/19/10, the AM Cook was responsible for cleaning and sanitizing the cook's station after breakfast and after lunch and the PM Cook was responsible for cleaning and sanitizing the cook's station after dinner.

During a concurrent interview with the DFNS, she stated that it was the expectation for the staff to keep the pans and lids used for cooking clean and free of food particles and trash. She verified that the pans and lids had not been cleaned, that the food particles were dried and that the trash was not fresh.

According to the 2009 "Food Code" equipment food-contact surfaces of cooking equipment and pans shall be kept free of encrusted grease deposits and other soil accumulation.

e. A container of prepared green salad found in the café prep refrigerator with a use by date of 7/18/10, a plastic bag of frozen fish sticks found in the walk-in freezer with a use by date of 2/22/10 and a case of 24 eight ounce cans of Renalcal (a specialty tube feeding formula for patients with kidney impairment) was found with an expiration date of 6/12/10 in the dry storage area.

During a concurrent interview with the DFNS, she stated that these products should have been discarded and she was unable to explain why they were still being stored. She further stated that it was all staff's responsibility to discard food items at the end of their use by date.

A review of the hospital's policy and procedure titled "Food Expiration Guidelines" (reviewed 5/2010) on 7/20/10, revealed that the purpose of the policy was to establish safe time frames for the expiration of food items so that items would be discarded according to the established time frames. It further stated that "Food items will be discarded after the 'use by' date."

Based on record reviews and staff interviews, the hospital failed to ensure that the nutritional needs of 4 of 9 patients reviewed for nutrition care were met in accordance with recognized dietary practices when:

1 For Patient 62, a patient with a Stage IV pressure ulcer (bed sore - pressure ulcers are staged from Stage I, with the least tissue damage to Stage IV with the most tissue damage), who was admitted on 7/16/10 and discharged 7/21/10, did not have a nutrition assessment by a registered dietitian (RD) during her hospital stay.

2. For Patient 22, a patient with bilateral (both) heel ulcers and a right malleolus (ankle) ulcer, who was admitted on 7/9/10, did not have a nutrition assessment by an RD until 7/16/10, seven days after admission.

3. For Patient 25, a patient who was NPO (nothing by mouth) or on a clear liquid diet (a diet that does not provide a significant source of nutrition - calories or protein) for 5 days, did not have a nutrition assessment by an RD.

4. For Patient 23, a patient who was on a ventilator (breathing machine) and a tube feeding with high nutrition needs and was scheduled to be re-evaluated by the RD in 5 days, did not get re-evaluated by the RD for 7 days.

Findings:

1. A review of the medical record for Patient 62, on 7/22/10, revealed that she was admitted to the hospital on 7/16/10 at 11:12 PM with diagnoses that included urinary tract infection, kidney failure, dialysis, and history of a stroke.

A review of the nursing admission assessment, completed on 7/17/10 at 4:42 AM, revealed that the patient's skin was not intact. The document noted that she had a pressure ulcer on her "coccyx" (tailbone area) that the admitting nurse was not able to visualize because a dressing covered the pressure ulcer. The pressure ulcer was documented as a Stage III. (Pressure ulcers are staged from Stage I, with the least tissue damage to Stage IV with the most tissue damage.)

A review of the nursing admission assessment, dated 7/17/10 at 4:42 AM, revealed that there was no nutritional screen completed by the admitting nurse. A review of the screen revealed that there was an area where a pressure ulcer could have been documented.

A review of the medical record for Patient 62, a patient with a Stage IV pressure ulcer, revealed that there was no nutrition assessment conducted by an RD during her hospitalization, from admission on 7/16/10 to discharge on 7/21/10.

An interview was conducted on 7/22/10 at 10 AM with the Clinical Nutrition Manager (CNM). She confirmed that there was no nutrition assessment completed for Patient 62. She stated that the nursing admission assessment was not fully filled out and there was no mention of the pressure ulcer on the nutritional screening form nursing. The CNM stated that the hospital relies on nursing to request a consult for a patient who was high risk and that no one in nursing sent a request for a nutritional evaluation for Patient 62.

2. A review of the medical record for Patient 22, on 7/21/10, revealed that she was admitted to the hospital on 7/9/10 at 5:42 PM with diagnoses of end stage kidney disease, bacteremia (bacterial infection in the blood) and chronic pain.

A review of the nursing admission assessment, dated 7/9/10, revealed that the patient was admitted with bilateral heel ulcers, a right medial (toward the middle) malleolus ulcer, multiple scabs to her bilateral legs and an open scab to her right arm.

A review of the nursing admission nutrition screen, dated 7/9/10, revealed that the box for listing skin problems was left empty and was not completed by the admission nurse. Therefore the ulcers were not communicated to the RD.

A review of the initial nutrition assessment indicated that it was not completed until 7/16/10, seven days after admission, at which time the RD recommended to add a nutritional supplement BID (twice a day), add a vitamin and mineral supplement, to increase the protein in the diet from 60 grams a day to 75 grams a day and recommended to check the albumin/prealbumin (a lab value that can be an indicator of nutritional status).

During an interview with the CNM and the Nurse Manager X for the patient on 7/21/10 at 12:20 PM, they both verified that "the ball was dropped" in not alerting the RD that Patient 22 had skin problems that required higher nutrition needs to promote healing. The CNM further stated that she had just identified the problem of lack of nursing communication to the RDs in hampering the timeliness of the nutrition assessments and interventions.

3. A review of the medical record for Patient 25, on 7/22/10, revealed she was admitted to the hospital on 7/13/10 at 12:53 AM with a diagnosis of arthritis of the right hip. She was scheduled to undergo right total hip arthroplasty surgery (hip replacement surgery) on 7/13/10.

A review of the physician's orders revealed that on 7/17/10 there was an order for the patient to be NPO (nothing by mouth). Further review of the orders revealed that there was no order for a diet until 7/21/10 when a clear liquid diet was ordered. The patient was without significant nourishment for 5 days.

A review of the Nutrition Screen, dated 7/19/10 at 5:08 PM, completed by the Registered Diet Technician (DTR), revealed that Patient 25 was NPO for 3 days. It further stated that the patient had notable nausea, and the plan was that the days of NPO would be monitored and the patient would be referred to the RD. No nutrition assessment by the RD was found in the medical record.

During an interview with the CNM on 7/22/10 at 3:30 PM, she stated that it was the expectation of the department that a nutrition assessment would be completed by the RD within 24 hours of a referral by the DTR. She further confirmed that there was no nutritional assessment completed by the RD at the time of the review, when the Patient had been without significant nourishment for 5 days.

4. A review of the medical record for Patient 23, on 7/21/10, revealed that he was admitted to the hospital on 7/12/10 at 2:06 AM with diagnoses including septic shock (an extreme immune system response to an infection that has spread throughout the blood and tissues), acute respiratory failure, end stage kidney disease and encephalopathy (a disorder or disease of the brain).

A review of the Adult Nutrition notes revealed that the Initial Nutrition Assessment was completed on 7/12/10 with a Nutrition Reassessment/Plan completed on 7/14/10. Review of the Reassessment/Plan dated 7/14/10 revealed that the estimated nutation needs for Patient 23 were 2210-2652 kilocalories and 106-150 grams of protein a day. Patient 23 was on a tube feeding that provided 2160 kilocalories and 97 grams of protein a day. It further stated that the patient tolerated the tube feeding well with minimal residuals (undigested feeding remaining in the stomach). The impression revealed that the patient was getting inadequate intake from the enteral (tube feeding) nutrition and did not meet the estimated nutritional needs. The plan was to increase the tube feeding to meet the estimated nutrition needs and for the RD to follow-up in 5 days.

A review of the physician's orders revealed that on 7/18/10 a nutrition consult was ordered. It also revealed that a diet and a nutritional supplement were ordered on 7/18/10. The tube feeding was also discontinued on 7/18/10.

According to the CNM, it was the expectation of the department that nutrition consults were to be completed by the RD within 24 hours.

The next Nutrition Reassessment/Plan was completed on 7/21/10 (7 days after the RD stated the follow-up should be within 5 days and 3 days after the nutrition consult and diet were ordered). The nutritional needs were re-estimated at this time to be 2622-3496 kilocalories and 114-140 grams of protein a day. These increased needs were based on the patient was on dialysis, had sepsis and his needs for wound healing. According to the reassessment the patient only ate 20 - 50 % of his meals on 7/20/10 and his nutritional status was compromised based on this inadequate intake and his protein restricted diet order.

During an interview with the CNM on 7/21/10 at 4:30 PM, she confirmed that Patient 21 did not receive the nutrition reassessment in a timely manner, that the patient was at increased nutrition risk due to his medical condition and due to the transition from tube feeding to oral feedings with inadequate intake. She further was unable to state why the reassessment and nutrition consult was not completed until 3 days after the patient had been transitioned from the tube feeding to an oral diet and the order for nutrition consult was received.

According to the hospital's policy and procedure titled "Nutrition Assessment, Reassessment and Plan of Care" (revised 6/2010) reviewed on 7/21/10, "The Nutrition Plan of Care must state an appropriate, specific time for reassessment to monitor the patient's response to the nutrition intervention."

Based on interview and record review, the facility failed to maintain documentation of:

1. preventive maintenance activities completed on the Narkomed 2B anesthesia machines in use in the operating rooms, and

2. preventive maintenance endoscope washers, creating the risk of substandard machine performance and an unsafe surgical environment.

Findings:

1. On 7/22/10 at 3:30 PM, the Director of Facilities was asked if there was a record of the specific maintenance activities or the results of specific test procedures that had been performed on a Narkomed 2B #58935 anesthesia machine in use in the OR, he stated that the only record of the maintenance activity performed was on the work order list. He was asked if there was evidence of specific parts being replaced on the machines, and he stated that parts that were replaced were recorded on the work order list.

The preventive maintenance recommended activities for the Narkomed 2B anesthesia machine, provided by the Director of Facilities on 7/22/10, were reviewed. The maintenance procedures were detailed on pages 6-11 through 6-39 of the machine's manual, and contained numerous specific activities to check the different parts and functions of the machine, with a requirement to document results of tests and machine displayed information at numerous steps in the maintenance sequence.

The manufacturer of the anesthesia machines was contacted on 7/23/10, and according to the manufacturer ' s representative, " The parts that may need to be replaced would be the Valve mount and Valve dome gaskets on the absorber. The ceramic disks may need to be replaced. The bellows may need to be replaced. The only part we recommend replacing once a year is the ventilator relief valve diaphragm assembly. "

The Director of Facilities supplied the work order list for the Narkomed 2B #58935. The work order list included the entry, " 150 minutes Completed All Scheduled Inspections " on 12/28/07, 3/26/08, 6/26/08, 9/28/08, 12/16/08, 3/26/09, 6/30/09, 9/21/09, 12/30/09, 3/9/10, and 6/22/10. There was no record, on the work order list, of parts on the machine being replaced since 2002. There was no documentation of which maintenance activities had been performed or outcomes of performance testing that was a part of the manufacturer ' s recommended maintenance sequence.

2. During a tour of the GI laboratory scope processing room on 7/22/10 at 11:35 AM, the process for cleaning and maintaining the Steris Reliance scope washers was reviewed with SP Tech 3. She stated that it was her responsibility to perform weekly cleaning of the endoscope washers. She stated that she cleaned the outside of the equipment and the inside of the door only once per week with alcohol. She stated that all other maintenance on the washers was coordinated by the facilities department.

During an interview with the Director of Facilities on 7/23/10 at 2 PM, he presented the endoscope washer work order data. The work order data did not include any weekly maintenance on the endoscope washers. The washers were obtained 9/15/09, and a safety check was performed on the units 5/23/10. The work order for 5/23/10 contained a list of preventive maintenance activities which was scratched out, with the notations, " does not apply to new units " and " still under warranty " and " ran a cycle, no leaks, all conditions normal " . On a second work order, the " O2 filter " was replaced 5/25/10. The Director of Facilities stated that he thought the extent of the inspections and preventive maintenance done on the machines by the facility was reflected on the work order forms, and he did not believe that the facilities department was doing weekly cleaning or maintenance on the units.

During a review of the endoscope washer manual, recommended cleaning included weekly:

1. Clean three draining holes at bottom of each control handle boot using a thin wire (such as a paper clip) or compressed air.
2. Clean two draining holes at bottom of Reliance CDS using a thin wire (such as a paper clip) or compressed air.
3. Once a week, clean venting orifice of two Allen hex screws from Reliance CDS as follows:
a. Remove two Allen hex screws from Reliance CDS.
b. Using compressed air, clean small orifice at center of each screw
c. Reinstall two Allen hex screws on Reliance CDS.
4. Once a week, verify punching rods inside Reliance CDS are not slack. Using a #2 Phillips head screwdriver, tighten three screws under Reliance CDS.

A review of the endoscope washer manual, section 4.1, " Preventive Maintenance Guide " , enumerated 4 pages of recommended preventive maintenance activities and the recommended schedule for completion, along with the note, " Preventive Maintenance is not covered under warranty " . Twenty three of the recommended inspections were to be performed three or more times per year.

In the manual, page 4-3, several different filters were described for the machines, including bacterial-retentive filters, which were to be changed every three months or more frequently, and dual pre-filters, to be checked six times per year, and a pressure regulator filter, an air supply filter cartridge, an air supply 5 micrometer filter cartridge and an air supply water separator filter cartridge. The facility was not able to supply evidence that the filtration checks and replacements were being carried out per the manufacturer ' s recommendations.

Based on interview and record review the hospital failed to identify one patient's (Patient 75) need of discharge planning. This failure had the potential to result in adverse health consequences after discharge of the patient.

Findings:

Review on 7/21/10 at 10:10 AM of Patient 75's medical record, showed that the patient was admitted on 7/17/10, was 93 years of age, had a diagnosis of congestive heart failure exacerbation (became worse), and had Parkinson ' s disease. On admission the patient was assessed as unable to respond.

Further review of the medical record showed that there was no discharge planning initiated for Patient 75.

In an interview on 7/21/10 at 10:30 AM with Case Manager 2 (CM2), the CM2 stated that they do a discharge planning assessment on all patients within 24 hours, and on Medicare patients within 48 hours. The CM2 further stated that Patient 75 should have a discharge plan. When CM2 was asked why there was no discharge planning assessment for this patient, the CM2 stated, "Didn't do it and it wasn't followed up."

Based on interview and record review, the facility failed to ensure cleaning and disinfection of instruments used in procedures and cleaning of the operating rooms between cases because it failed to ensure that: 1. the correct amount of powdered cleaner was used to clean medical equipment in the pasteurizer, 2. an enzymatic precleaning agent was used according to manufacturer's directions, 3. a high level disinfecting agent was used according to manufacturer's directions, 4. the instrument decontamination room was maintained with the temperature specified in the facility policy and 5. the disinfectant used to clean the OR between cases was wet on surfaced for the contact time required to disinfect, creating the risk of increased infections in patients and staff who came into contact with those instruments or used the operating room.

Findings:

1. During a tour of the sterile processing area on 7/20/10 at 11:40, SP Tech 2 was asked about the process for using the pasteurizer machine that is used to clean some medical equipment used in procedures. She stated that she used one scoop of the powdered cleaning agent Clean 505 per load. She stated that she was unsure how many gallons the pasteurizer held.

The manufacturer directions for the Clean 505 powdered cleaner were reviewed, and the directions indicated that the requirement was for two scoops of cleaner per 25 gallons of water.

Upon reading the directions, SP Tech 2 stated that she had been using the incorrect amount of powdered cleaner because she was using one and not two scoops per load, and that she believed the load was 25 gallons.

The pasteurizer manufacturer specifications, provided by the facility, were reviewed on 7/22/10, and read that the load basket was 25 gallons.

2. During a tour of the sterile processing area on 7/20/10 at 10:55 AM, SP Tech 1 was asked about the precleaning process used on ureteroscopes. She stated that she would use the enzymatic cleaner Prolystica concentrate, pouring a small amount of the cleaner into a cup and diluting it with water. When asked how she determined the correct amount of the cleaning agent to use, she agreed that she "eyeballed" the amount, and that she had no measuring devices or marked containers to ensure the proper concentration of the cleaner was used.

During a review of the Prolystica concentrate container label, the manufacturer directions cited specific dilution parameters, 0.6-0.8ml/liter, for correct preparation of the cleaning agent.

3. During a tour of the sterile processing area on 7/20/10 at 10:55 AM, SP Tech 1 was asked about the high level disinfection process. SP Tech 1 stated that items requiring manual high level disinfection were placed in Metricide for 20 minutes.

The bottle for Metricide was reviewed, and it read that a 45 minute contact time was required for high level disinfection.

According to federal law, EPA registered cleaning and disinfecting agents must be used in accordance with manufacturer's directions

4. During a tour of the decontamination area on 7/20/10 at 10:50 AM, the temperature and humidity log was reviewed. The log indicated that the temperature in the decontamination area was to be 60-65 degrees. The values handwritten onto the log indicated the temperature had been above 65 daily for the week, with the lowest temperature recorded as 67.8, and the highest as 68.9.

During an interview with SP Tech 1, she stated that she checked the temperature and humidity daily, and notified engineering if it was too high. However, she stated that she did not notify engineering daily, and she did not document her phone calls to engineering.

5. During an observation in the OR on 7/20/10 at 10 AM, Transport Tech 1 was observed cleaning the room between cases. OR Tech 1 used cloth and a mop to apply a cleaning chemical which was identified as Sani-Master. The surfaces were observed to take between 2 and 5 minutes to dry.

During a concurrent interview with OR Tech 1, he stated that he was unsure of the duration that the cleaning agent was supposed to be wet on the surfaces.

The manufacturer's label directions for use for Sani-Master were reviewed and they indicated the contact time for general disinfection of 10 minutes. The instruction read, "Solution must remain on the surface for 10 minutes, then wipe off or allow to air dry."

Based on interview and record review, the documented pre-anesthesia evaluations lacked the detail expected by professional standards, creating the risk of a poor health outcome for patients receiving anesthesia.

Findings:

During a review of the "Anesthesia Record" for general anesthesia of Patients 301 and 302 on 7/22/10, the Provider Documentation and Pre-induction Assessment portions of the record did not include details of an examination of the patients, such as a heart and lung examination or vital signs at the time that the examinations were done. The documentation of an exam consisted of only, "Patient Examined: Yes" .

During an interview with the OR Manager on 7/23/10 at 1:50 PM, she stated that the results of examinations by the anesthesiologists were recorded on the Anesthesia Record, and not elsewhere in the medical records.

During an interview with the Director of Anesthesia on 7/23/10 at 1:50 PM, he stated the anesthesiologists had been performing complete pre-anesthesia evaluations, including heart and lung exams, but that those elements were not being documented because the electronic medical record did not have space available for such documentation on the Anesthesia Record.

During a review of the hospital policy, Pain Management, Care of the Patient Receiving Anesthesia/Sedation, review date 6/08, section I.D.2. read "Complete a pre-anesthesia/sedation evaluation and document in the medical record prior to the administration of any agent."

Based on interview and record review, the documented post-anesthesia evaluations: 1. lacked the detail expected by professional standards and 2. the anesthesiologist failed to ensure that the patient had sufficiently recovered from anesthesia prior to completing a post-anesthesia evaluation, creating the risk of a poor health outcome for patients receiving anesthesia.

Findings:

1. During a review of the "Anesthesia Record" for general anesthesia of Patients 301 and 302 on 7/22/10, the Emergence/Note and PACU/ICU transfer note section of the record, timed 9:31 AM, did not include details of the evaluation, such as the type and level of pain or post-operative hydration level, nor a reference to a specific set of vital signs collected by nursing (the last set recorded on the same sheet were from 9:20 AM).

During an interview with the Director of Anesthesia on 7/23/10 at 1:50 PM, he stated that the anesthesiologists reviewed and concurred with the vital signs recorded by the nurse prior to completing the post anesthesia assessments, but agreed that there was no reference to any specific set of vital signs collected by the nurses or repetition of the vital signs by the anesthesiologists in the post-anesthesia notes.

During a concurrent interview with the OR Manager, she stated that revisions were planned to the electronic medical record system which would allow for detail about the post-anesthesia evaluations to be documented, but those revisions were not yet in place.

2. During a review on 7/22/10 of the Anesthesia Record of Patient 301 from 7/20/10, the record showed that the general anesthetic was stopped at approximately 9:20, and the anesthesiologist's post anesthesia evaluation was done in the PACU at 9:31, and that Patient 301's level of consciousness at the time of the assessment was "arousable/responsive". The note also included, "Pain assessed: yes" and "nausea and/or vomiting: no".

During a review of the PACU nursing notes for Patient 301, the patient's level of consciousness at 9:30 AM was recorded as "Not responding". At 9:45 AM the level of consciousness was recorded as "Arouses on calling".

During a review on 7/22/10 of the Anesthesia Record of Patient 302 from 7/16/10, the record showed that the anesthetic was stopped at approximately 9:40 AM, and the anesthesiologist's post anesthesia evaluation was done in the PACU at 10:17, and that Patient 302's level of consciousness at the time of the assessment was "Awake and alert".

During a review of the PACU nursing notes for Patient 302, the patient's level of consciousness at 10:15 was "arouses on calling".

During an interview with the Director of Anesthesia on 7/23/10 at 1:50 PM, he stated that the plan was to document the post anesthesia assessment after the patient had recovered from anesthesia sufficiently to participate in his or her care, but he realized this was not yet being done.

Based on interview and record review the facility failed to ensure that the Respiratory Care Manager met the qualifications as specified in the facility's job description for the position.

Findings:

The personnel file for the Respiratory Care Manager (RCM) was reviewed on 7/22/10 at approximately 1:30 PM.

Review of the position description titled, "Manager Respiratory Care" with the revision date 9/28/10, signed by RCMP on 4/22/09 noted the following:

"D. License/Certification:
Licensed by the State of California as a Respiratory Care Practitioner (RCP)
Registered Respiratory Therapist (RRT)
Current Basic Life Support (BLS) Certificate
Current Neonatal Resuscitation Program (NRP) Provider card "

Further review of the Respiratory Care Manager's (RCM) personnel, file revealed that there was no documented evidence that the RCM had a current NRP provider card.

During an interview with the RCM on 7/22/10 at approximately:45 PM, the RCM verified that she had signed the position description for "Respiratory Care Manager" on 4/22/09 that included the requirement NRP provider card for her position. During the interview, the RCM verified that she did not have a current NRP provider card, even though it was listed as a requirement on the job description. The RCM stated that she had not had a current NRP provider card since 2008.

During an interview with the Respiratory Care Director (RCD) on 7/23/10 at 1:45 PM, the RCD verified that the facility ' s expectation was that all employees met the qualifications as stated in there position descriptions.

The facility policy and procedure titled "Job Descriptions" was reviewed on 7/23/10 at 2:15 PM. The policy and procedure noted the following:

"Position descriptions provide information on the principle duties of a job, including the essential functions, and the skills and knowledge required to perform the job for purposes of job classification, recruitment of employees, and communication of job requirements to employees."