HospitalInspections.org

Based on interview and record review, the hospital failed to provide informed consent for two out of (49) patients (2 and 14). Patient 2 had two procedures that required a consent and neither consent listed the doctors who would be performing the procedures. One consent did not specify which lung the procedure was to be performed on, the left or right lung. For Patient 14 the consent did not include which knee required replacement. This had the potential to result in a violation of Patient 2 and 14 's patient rights and not being fully informed of their medical care.

Findings:

The clinical records for Patients 2 and 14 were reviewed on July 29, 2010 at 10:30 AM. The form for Patient 2 named "Authorization for Consent to Surgery or Special Procedure" dated November 28, 2009 listed the procedure as "Radiology thoracentesis with CT guided". Under "the procedure listed above will be performed by Dr.______" the line was blank. The consent did not specify which lung would receive the thoracentesis. Another "Authorization for Consent to Surgery or Special Procedure" for Patient 2 dated December 3, 2009 listed the procedure as "Central Line Placement". Under "the procedure listed above will be performed by Dr. ______" the line was blank. The "Authorization for Consent to Surgery or Special Procedure" for Patient 14 under operation or procedure read, "Total Knee Replacement." It did not specify which knee.

During an interview with the Chief Nursing Officer (CNO) on July 29, 2010 at 11 AM, she stated the Authorization for Consent to Surgery or Special Procedure should contain the doctor's name who will be performing the surgery or procedure and which part of the body, as in the left or right side.

The hospital policy and procedure titled "Consent/Informed Consent" dated September 2008 read, "Consent for must be completed and include the complete and correct name of the surgery, procedure or test and name of physician performing the surgery, procedure or test."

Based on observation, interview, and record review, the hospital failed to protect the privacy of two patients (23 and 42) while in the hallway of the emergency department, which had the potential to result in a violation of their patient rights.

Findings:

During an observation of the Emergency Department (ED) with the ED Director on July 26, 2010 at 10 AM, three patients were on gurneys and placed along the wall in areas marked 4B, HW4A, and HW3. Patient 42 was in the area marked 4B which was located across from the nurses station. The doctor was asking Patient 42 about her medical history, in a normal voice level, while he was examining her. She responded with a list of medical conditions and current symptoms. During this time, the nurse was attempting to place an intravenous catheter in her right hand. No privacy divider was in place. In the hallway was two ambulance staff, other patients, family members, and other hospital staff. On the other side of the nurses station was a large room that consisted of four smaller rooms with vacant beds. When the ED Director was asked about placing the patients in the hallway instead of vacant beds, she stated two beds were left open in case a patient came in with chest pain, or a stroke and had to be placed in a bed right away. She was not sure why the patients were in the hallway instead of occupying the vacant beds.

During an interview with the ED Director on July 27, 2010 at 8:30 AM, she stated when patients were in the hallways, the doctor tries to speak in a lower voice and a privacy divider are placed during the examination or during any procedure. When asked to see the privacy divider, she located one in the back of the equipment room by the ambulance entrance that was located at the back of the ED. The privacy curtain was behind several medical equipment which had made it difficult for the staff to access it. She stated she thought there was another privacy screen somewhere but was unable to locate it.

During an interview with Patient 23 on July 27, 2010 at 2:10 PM, she stated she was in the ED for two hours in the hallway and the area was very crowded. She stated the doctor asked her about her medical history and pulled up the sheet exposing her legs to look at the swelling in her feet without a privacy screen. She stated a woman with a baby was in the gurney next to her's during an examination. She stated she could hear the conversation between the mother and the doctor. She stated she thought it had to be that way because they were busy.

The hospital's policy and procedure titled "Analysis & Management of Patient Flow" dated April 20, 2010 read, "The following guidelines will be implemented if it becomes necessary to temporarily place a patient in an overflow location - including corridors. Placement of a patient in an overflow location is considered a last resort and should be deployed only after designated bed locations have been filled. Patients should be removed from overflow locations and placed in designated beds as soon as they become available. Patients will be placed in corridor locations as a temporary measure only. The unnecessary use of corridors to hold patients or to provide care is prohibited. Placement of a patient in a corridor location is considered a last resort and should be deployed only after designated bed locations have been filled. A comparable level of care will be provided to patients placed in corridor locations. Sufficient equipment, supplies, and services will be available and provided to the same extent as if the patient was placed in a designated bed." The policy did not indicate if privacy was also included in "comparable level of care".

Based on observation, interview, and record review, the hospital failed to evaluate a patient's (46) need for a lesser restrictive restraint. This had the potential to cause harm to restrict his freedom of movement.

Findings:

On July 28, 2010 at 10:30 AM, accompanied by Registered Nurse (RN) 5, observed Patient 46 sleeping in bed with both wrists tied to bed rails. He had three half side rails up and a pair of hand mittens next to his bed. Patient 46 did not open his eyes during the observation. RN 5 was asked the indication for use of three side rails, she stated she was unaware that the patient had all three rails up or the reason the hand mittens at bedside.

On July 28, 2010 at 10:40 PM, Patient 46's clinical record was reviewed. The soft wrist restraint (a soft belt to tie a patient's wrist to bed) was initiated on June 24, 2010 when Patient 46 became agitated while placed on a mechanical ventilation device. He came off the mechanical ventilation device on July 7, 2010. However, there was no documentation to indicate the need for soft wrist restraint was re-evaluated. During further review of the physician's orders, Patient 46 had restraint orders for soft wrist restraint and side rails from July 17 to 22, 2010. On July 23, 2010, the order was changed to soft wrist only. This order was renewed for July 24 and 25, 2010. On July 26, 2010, the order was changed to mittens and soft wrist, and the order was renewed for the following two days, July 27 and 28, 2010.

On July 28, 2010 at 3:50 PM, during an interview, the facility's Nursing Quality Specialist stated the mittens were considered a lesser restricted device in this hospital and the patient should have been evaluated. She was unable to find any documentation to show Patient 46 was ever re-evaluated for the mittens.

Based on interview and record review, the hospital failed to refrain a physician (A) from writing "as needed" restraint orders for a patient (22), which had the potential to result in Patient 22 being restrained unnecessarily.

Findings:

The clinical record for Patient 22 was reviewed on July 27, 2010 with Registered Nurse (RN) 9. On the "Physician's Orders" dated July 19, 2010 at 7:15 PM, Physician A had ordered, "Soft restraints as needed."

A clarification order or a discontinue order was not found in the clinical record and this was verified by RN 9. RN 9 stated he would expect the nurse who signed off on the order to call the doctor for a clarification or a discontinue order.

During an interview with the Nursing Quality Specialist on July 29, 2010 at 2 PM, the Physician's Orders dated July 19, 2010 for Patient 22 was reviewed. She stated doctors should not write an "as needed" restraint orders.

The hospital's policy and procedure titled "Restraint and Seclusion" dated April 8, 2010 read, "Orders for the use of restraint or seclusion must never be written as a standing order or on an as needed basis."

Based on interview and record review, the hospital failed to insure that seven of the hospital's nine contracted licensed nurses (Registered Nurse 12, 13, 14, 15, 16, 17, and 18) had received the hospital's restraint policy and procedure training, which had the potential of causing harm to patients.

Findings:

The training records for the hospital's nine contracted Registered Nurses (RN) 12-18 were reviewed on July 27, 2010 at 2:55 PM and on July 28, 2010 at 8:50 AM with the Nursing Staff Coordinator (NSC). The records indicated these seven RN's had not received the hospital's training on the restraint policy and procedures. This was verified with the NSC.

During an interview with the Chief Nursing Office (CNO) on July 27, 2010 at 4 PM, she stated the hospital's computer education system does not track non-employees for compliance to the mandatory training and the contracted RNs were considered non-employees. She stated, "They fell through the cracks."

During an interview with RN 4 on July 29, 2010 at 8:15 AM, he stated he has worked for the hospital for about ten months but does not remember receiving restraint training. He stated, "I think I did but I might have forgot to sign on the sign-up sheet."

The hospital's policy and procedure titled "Restraint and Seclusion" dated April 8, 2010 read, "All staff designated by the hospital as having direct patient care responsibilities, including contract or agency personnel must demonstrate the competencies specified in this policy prior to participating in the application of restraints, implementation of seclusion, monitoring, assessment, or care of a patient in restraint or seclusion. Training should be targeted to the specific needs of the patient populations being served, and to the competency level of staff. Training and competence must be established: Upon hire as part of the initial orientation process, before participating in the use of restraint and seclusion, and on an annual basis thereafter."

Based on observation, interview, and record review, the hospital failed to implement measures to ensure medical records were completed, which had the potential to result in medical records lacking vital patient care information, and making it unavailable for patient care.

The hospital failed to employ adequate staff to ensure completion of medical records was done timely and according to their bylaws. (A432)

The hospital failed to ensure medical records were completed within fourteen days following the discharge of patients. (A438)

The hospital failed to ensure medical records were completed within fourteen days and verbal/telephone orders were authenticated within 48 hours. (A450)

The hospital failed to ensure verbal/telephone orders were authenticated within 48 hours. (A457)

The hospital failed to provide informed consent for invasive procedures. (A466)

The cumulative effects of these systemic failures resulted in the failure of the hospital to ensure completeness of patient records as required in accordance with the regulations.

Based on observation, interview, and record review, the hospital failed to employ adequate staff to ensure completion of medical records was done timely according to its bylaws.

Findings:

During an interview with the Health Information Manager (HIM) on July 28, 2010 at 1:30 PM, she stated the hospital had started scanning the records into the computer system after the patients have been discharged. She stated the Medical Records Department was about 40 days behind in the scanning process. She stated she had recently employed two temporary staff and was attempting to hire more staff to help with the back log. At 1:40 PM, accompanied by the HIM, a small room in the Medical Records Department was inspected. She stated the records that were on the shelves were "very delinquent" and the doctors had been called to come and authenticate those records. She counted 189 records with the year of 2009 waiting for authentication.

The hospital's medical record "Delinquency Report" dated July 28, 2010 was reviewed with the HIM on July 29, 2010 at 9 AM. This report indicated 569 records were 30 days over due, 620 records were 60 days overdue, 400 records were 90 days overdue, and 739 records were more than 90 days overdue. For a total of 2328 medical records had not been completed with in fourteen days. The last page of the report showed ten medical records over 300 days past due.

The Medical Record staffing list titled "Health Information Management Department" indicated there were 32 full time staff members, two part-time staff members, six temporary staff members, and two open positions.

Based on interview and record review, the hospital failed to ensure medical records were completed within fourteen days following the discharge for 2328 patients. The hospital failed to maintain the integrity of a patient record (36) which had caused inaccurate filing of medical information.

Findings:

1. During an interview with the Health Information Manager (HIM) on July 28, 2010 at 1:30 PM, she stated the hospital had a compliance problem with the physicians authenticating records. She stated the hospital had started scanning the records into the computer system after the patients have been discharged. The records that needed the doctors to sign or complete were sent to the doctors via computer for their electronic signatures. She stated the medical records department was about 40 days behind in the scanning process. During this time, a small room in the Medical Records Department was inspected with the HIM. She stated the records that were on the shelves were very delinquent and the doctors had been called to come and authenticate those records. She counted 189 records with the year of 2009 waiting for authentication.

The hospital's medical record "Delinquency Report" dated July 28, 2010 was reviewed with the HIM on July 29, 2010 at 9 AM. This report indicated 569 records were 30 days over due, 620 records were 60 days overdue, 400 records were 90 days overdue, and 739 records were more than 90 days overdue. For a total of 2328 medical records had not been completed within fourteen days. The last page of the report showed ten medical records over 300 days past due.

The hospital's Medical Staff Bylaws, effective November 11, 2009, article VIII Section 8.7 (d) read, "Physicians must complete all medical records within fourteen (14) days after discharge of the patient. Failure to comply will result in relinquishment of admitting privileges..."



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2. On July 26, 2010 at 12:30 PM, Patient 36's medical record was reviewed. During the medical record review, a progress note dictated on July 25, 2010 at 11:58 PM was noted as belonging to Patient 43. It was also noted that name label indicating the document belonged Patient 36 had been placed in the bottom right hand corner of the progress note.

During a concurrent interview, the surgical intensive care unit, Charge Nurse (RN 7) stated that someone had placed an incorrect name label on the progress note and the document was then filed in the wrong chart.

Based on interview and record review, the hospital failed to: 1) ensure medical records were completed within fourteen days following the discharge of 2328 patients, and 2) ensure physicians authenticated verbal/telephone orders within 48 hours of the orders written for eighteen out of twenty-four patient (1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, and 18) records reviewed.

Findings:

The hospital's medical record "Delinquency Report" dated July 28, 2010 was reviewed with the HIM on July 29, 2010 at 9 AM. This report indicated 569 records were 30 days over due, 620 records were 60 days overdue, 400 records were 90 days overdue, and 739 records were 91 plus overdue. For a total of 2328 medical records had not been completed within fourteen days. The last page of the report showed ten medical records over 300 days past due.

The clinical records for discharged Patients 1, 2, 3, 4, 5, 6, 7, 8, 9 ,10, 11, 12, 13, 14, 15, 16, 17, 18 were reviewed on July 29, 2010 at 10:30 AM and July 30, 2010 at 8 AM. All the reviewed clinical records contained verbal orders that had not been authenticated by the prescribing physician within 48 hours.

The list includes:

For Patient 1: Six verbal/telephone orders were not authenticated by the prescribing physician for the dates June 13, 2010 at 12:45 AM; June 13, 2010 at 3:19 AM; June 13, 2010 at 5:55 PM; June 14, 2010 at 12:40 PM; June 15, 2010 at 12 PM; June 16, 2010 at 3:55 PM. Two verbal/telephone orders for June 13, 2010 at 12:45 AM were signed by the prescribing physician but were not dated or timed.

For Patient 2: Three verbal/telephone orders were not authenticated by the prescribing physician for the dates December 2, 2009 at 4 AM; December 3, 2009 at 6 PM; December 13, 2009 at 9:05 AM.

For Patient 3: Three verbal/telephone orders were not authenticated by the prescribing physician for the dates July 15, 2010 at 6 AM; July 17, 2010 at 3:50 AM; July 17, 2010 at 4:35 AM.

For Patient 4: One verbal/telephone order was not authenticated by the prescribing physician for the date July 17, 2010 at 10:25 AM.

For Patient 5: Ten verbal/telephone orders were not authenticated by the prescribing physician for the dates July 14, 2010 at 3:10 AM; July 14, 2010 at 11 AM; July 14, 2010 at 3 PM; July 15, 2010 at 3:20 PM; July 18, 2010 at 2:50 PM; July 19, at 6:15 PM; July 19, 2010 at 8 PM; July 20, 2010 at 5 PM; July 20, 2010 at 11:25 PM; July 21, 2010 at 8:30 AM.

For Patient 6: Two verbal/telephone orders were not authenticated by the prescribing physician for the dates July 12, 2010 at 5:15 PM; July 12, 2010 at 9:03 PM.

For Patient 7: Two verbal/telephone orders were not authenticated by the prescribing physician for the dates July 13, 2010 at 5:09 PM; July 13, 2010 at 6:32 PM.

For Patient 8: Seven verbal/telephone orders were not authenticated by the prescribing physician for the dates July 12, 2010 at 12:35 AM; July 12, 2010 at 2 AM; July 12, 2010 at 8:30 AM; July 12, 2010 at 9 AM; July 13, 2010 at 11:05 AM; July 13, 2010 at 11:16 AM; July 16, 2010 at 8:35 AM.

For Patient 9: Two verbal/telephone orders were not authenticated by the prescribing physician for the dates July 12, 2010 at 9:45 PM; July 13, 2010 at 8 AM.

For Patient 10: Six verbal/telephone orders were not authenticated by the prescribing physician for the dates July 13, 2010 at 9:10 AM, July 16, 2010 at 5 PM; July 17, 2010 at 5:40 PM; July 18, 2010 at 9 PM;
July 23, 2010 at 3 PM; July 23, 2010 at 3:45 PM.

For Patient 11: Four verbal/telephone orders were not authenticated by the prescribing physician for the dates July 13, 2010 at 3 AM; July 13, 2010 at 1:40 PM; July 13, 2010 at 10:28 PM; July 15, 2010 at 1 AM.

For Patient 12: One verbal/telephone order was not authenticated by the prescribing physician for the date July 15, 2010 at 8:30 PM.

For Patient 13: Three verbal/telephone orders were not authenticated by the prescribing physician for the dates July 15, 2010 at 8 PM; July 15, 2010 at 8:30 PM; July 17, 2010 at 12:27 PM.

For Patient 14: Three verbal/telephone orders were not authenticated by the prescribing physician for the dates July 14, 2010 at 12:45 PM; July 14, 2010 at 5 PM; July 16, 2010 at 10:03 PM.

For Patient 15: Two verbal/telephone orders were not authenticated by the prescribing physician for the dates July 14, 2010 at 7:50 AM; July 15, 2010 at 11 PM.

For Patient 16: One verbal/telephone order was not authenticated by the prescribing physician for the date July 14, 2010 at (no time was written by the nurse for this order).

For Patient 17: One verbal/telephone order was not authenticated by the prescribing physician for the date September 26, 2009 at 2:20 PM.

For Patient 18: Two verbal/telephone orders were not authenticated by the prescribing physician for the dates September 15, 2009 at 10 AM; September 19, 2009 at 6 PM.

The hospital's Medical Staff Bylaws, effective November 11, 2009, Article VIII Section 8.7 (d) read, "Physicians must complete all medical records within fourteen (14) days after discharge of the patient."

The hospital's Medical Staff Bylaws dated November 11, 2009, under "Medical Staff Rules and Regulations, Policy: Medical Records, Section D" read, "Orders for medication and biologicals, including respiratory aerosols, given over the telephone or orally in emergency situations will be signed, dated and timed by the prescribing or covering physician within forty-eight (48) hours."

Based on interview and record review, the hospital failed to ensure verbal/telephone orders for Patients 1 through 18, 34, 35, 36, 38, and 44 were authenticated by the physicians within 48 hours of when the order was received.

Findings:

The clinical records for discharged Patients 1, 2, 3, 4, 5, 6, 7, 8, 9 ,10, 11, 12, 13, 14, 15, 16, 17, 18 were reviewed on July 29, 2010 at 10:30 AM and July 30, 2010 at 8 AM. All the reviewed clinical records contained verbal orders that had not been authenticated by the prescribing physician.

The list includes:

For Patient 1: Six verbal/telephone orders were not authenticated by the prescribing physician for the dates June 13, 2010 at 12:45 AM; June 13, 2010 at 3:19 AM; June 13, 2010 at 5:55 PM; June 14, 2010 at 12:40 PM; June 15, 2010 at 12 PM; June 16, 2010 at 3:55 PM. Two verbal/telephone orders for June 13, 2010 at 12:45 AM were signed by the prescribing physician but were not dated or timed.

For Patient 2: Three verbal/telephone orders were not authenticated by the prescribing physician for the dates December 2, 2009 at 4 AM; December 3, 2009 at 6 PM; December 13, 2009 at 9:05 AM.

For Patient 3: Three verbal/telephone orders were not authenticated by the prescribing physician for the dates July 15, 2010 at 6 AM; July 17, 2010 at 3:50 AM; July 17, 2010 at 4:35 AM.

For Patient 4: One verbal/telephone order was not authenticated by the prescribing physician for the date July 17, 2010 at 10:25 AM.

For Patient 5: Ten verbal/telephone orders were not authenticated by the prescribing physician for the dates July 14, 2010 at 3:10 AM; July 14, 2010 at 11 AM; July 14, 2010 at 3 PM; July 15, 2010 at 3:20 PM; July 18, 2010 at 2:50 PM; July 19, at 6:15 PM; July 19, 2010 at 8 PM; July 20, 2010 at 5 PM; July 20, 2010 at 11:25 PM; July 21, 2010 at 8:30 AM.

For Patient 6: Two verbal/telephone orders were not authenticated by the prescribing physician for the dates July 12, 2010 at 5:15 PM; July 12, 2010 at 9:03 PM.

For Patient 7: Two verbal/telephone orders were not authenticated by the prescribing physician for the dates July 13, 2010 at 5:09 PM; July 13, 2010 at 6:32 PM.

For Patient 8: Seven verbal/telephone orders were not authenticated by the prescribing physician for the dates July 12, 2010 at 12:35 AM; July 12, 2010 at 2 AM; July 12, 2010 at 8:30 AM; July 12, 2010 at 9 AM; July 13, 2010 at 11:05 AM; July 13, 2010 at 11:16 AM; July 16, 2010 at 8:35 AM.

For Patient 9: Two verbal/telephone orders were not authenticated by the prescribing physician for the dates July 12, 2010 at 9:45 PM; July 13, 2010 at 8 AM.

For Patient 10: Six verbal/telephone orders were not authenticated by the prescribing physician for the dates July 13, 2010 at 9:10 AM, July 16, 2010 at 5 PM; July 17, 2010 at 5:40 PM; July 18, 2010 at 9 PM; July 23, 2010 at 3 PM; July 23, 2010 at 3:45 PM.

For Patient 11: Four verbal/telephone orders were not authenticated by the prescribing physician for the dates July 13, 2010 at 3 AM; July 13, 2010 at 1:40 PM; July 13, 2010 at 10:28 PM; July 15, 2010 at 1 AM.

For Patient 12: One verbal/telephone order was not authenticated by the prescribing physician for the date July 15, 2010 at 8:30 PM.

For Patient 13: Three verbal/telephone orders were not authenticated by the prescribing physician for the dates July 15, 2010 at 8 PM; July 15, 2010 at 8:30 PM; July 17, 2010 at 12:27 PM.

For Patient 14: Three verbal/telephone orders were not authenticated by the prescribing physician for the dates July 14, 2010 at 12:45 PM; July 14, 2010 at 5 PM; July 16, 2010 at 10:03 PM.

For Patient 15: Two verbal/telephone orders were not authenticated by the prescribing physician for the dates July 14, 2010 at 7:50 AM; July 15, 2010 at 11 PM.

For Patient 16: One verbal/telephone order was not authenticated by the prescribing physician for the date July 14, 2010 at (no time was written by the nurse for this order).

For Patient 17: One verbal/telephone order was not authenticated by the prescribing physician for the date September 26, 2009 at 2:20 PM.

For Patient 18: Two verbal/telephone orders were not authenticated by the prescribing physician for the dates September 15, 2009 at 10 AM; September 19, 2009 at 6 PM.

During an interview with the Health Information Manager (HIM) on July 28, 2010 at 1:30 PM, she stated the hospital had a compliance problem with the physicians authenticating their verbal/telephone orders.

The hospital's policy and procedure titled "Giving/Receiving/Authenticating Written, Verbal, and Telephone Orders" dated May 2010 read, "Verbal and telephone medication orders shall be signed, dated and timed by the prescribing physician within 48 hours."

The hospital's Medical Staff Bylaws dated November 11, 2009, under "Medical Staff Rules and Regulations, Policy: Medical Records, Section D" read, "Orders for medication and biologicals, including respiratory aerosols, given over the telephone or orally in emergency situations will be signed, dated and timed by the prescribing or covering physician within forty-eight (48) hours."





16501

On July 26, 2010 at 12:30 PM, the medical records for Patients 36, 38, and 44, were reviewed and the following was noted:

a. Patient 38 was admitted to the medical unit on July 1, 2010.

A review of the physician order section of the medical record disclosed that 44 verbal or telephone orders were either not, signed, dated or timed when signed by the prescribing physician.

b. Patient 36, was admitted to the surgical intensive care unit (SICU), on July 13, 2010, at 3:15 PM.

A review of the physician order section of the medical record disclosed that 22 of 27 verbal/telephone orders were not signed, dated, or timed by the prescribing physician within 48 hours.

During an interview on July 27, 2010 at 3 PM, the Nurse Manager for the third floor medical unit, stated that they were aware of the problem with physicians dating and timing their orders, but so far the hospital had not been successful in changing physician practice.

c. Patient 44 was admitted to the medical unit on July 21, 2010.

A review of the physician order section of the medical record disclosed that nine of nine verbal or telephone orders were either not signed, dated, or timed by the prescribing physician within 48 hours.



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The clinical record for Patient 34 was reviewed on July 29, 2010 at 2:25 PM. The physician's orders were reviewed. Between July 15, 2010 and July 19, 2010 two of nine physician's orders were not signed, dated and timed by the prescribing physician on July 15, 2010 at 8:50 PM and on July 16, 2010 at 8:30 PM.

The clinical record for Patient 35 was reviewed on July 30, 2010 at 8:15 AM. The physician's orders were reviewed. Between July 15, 2010 and July 18, 2010 five of 12 physician's orders were not all signed, dated and timed by the prescribing physician on the following dates: July 15, 2010 at 5:43 AM, July 15, 2010 at 4:10 AM, July 16, 2010 at 1 PM, July 17, 2010 at 11 PM, and July 18, 2010 at 1:10 PM.

Based on interview and record review, the hospital failed to provide informed consent for two out of (49) patients (2 and 14). Patient 2 had two procedures that required a consent and neither consent listed the doctors who would be performing the procedures. One consent did not specify the location the procedure was to be performed on, the left or right lung. For Patient 14 the consent did not include which knee required replacement. This had the potential to result in a violation of Patient 2 and 14 's patient rights and in them not being fully informed of their medical care.

Findings:

The clinical records for Patients 2 and 14 were reviewed on July 29, 2010 at 10:30 AM. The form for Patient 2 named "Authorization for Consent to Surgery or Special Procedure" dated November 28, 2009 listed the procedure as "Radiology thoracentesis with CT guided". Under "the procedure listed above will be performed by Dr.______" the line was blank. The consent did not specify the location where of the thoracentesis. Another "Authorization for Consent to Surgery or Special Procedure" for Patient 2 dated December 3, 2009 listed the procedure as "Central Line Placement". Under "the procedure listed above will be performed by Dr. ______" the line was blank. The "Authorization for Consent to Surgery or Special Procedure" for Patient 14 under operation or procedure read "Total Knee Replacement. It did not specify which knee.

During an interview with the Chief Nursing Officer on July 29, 2010 at 11 AM, she stated the Authorization for Consent to Surgery or Special Procedure should contain the doctor's name who will be performing the surgery or procedure and which part of the body, as in the left or right side.

The hospital policy and procedure titled "Consent/Informed Consent" dated September 2008 read, "Consent for must be completed and include the complete and correct name of the surgery, procedure or test and name of physician performing the surgery, procedure or test."

Based on interview and record review, the hospital failed to: 1) obtain competences for their pharmacist staff to ensure the safe administration of medications in circumstances where pharmacists calculate and adjust doses, with the potential for providing unsafe and ineffective treatment. 2) follow their policy entitled Standards Of Care For Parenteral Nutrition Support (Policy No. 02-01-035) when one of 49 sampled patients (43) with elevated triglycerides (a type of fat in the bloodstream and fat tissue) upon admission received central parenteral nutrition (a method to feed a person intravenously) with intralipids (fat), without monitoring triglyceride levels.

Findings:

1. On July 26, 2010 at 2:05 PM, Pharmacist A stated all pharmacy staff were competent to provide clinical services for the following medications: warfarin (blood thinning medication), heparin (blood thinning medication), low molecular weight heparin (blood thinning medication), and renal dosing (adjust doses to reduce potential for toxicity for patients that have poor kidney function). The pharmacists were currently providing these clinical services which involve calculating, adjusting doses, and providing safe and effective treatment. When Pharmacist A was asked to provide documentation to demonstrate staff pharmacists were competent to provide these clinical services, he was unable to provide documentation that the staff had been examined annually for competency in adjusting doses of medications or initiating drug therapy for these clinical services under approved protocols.

On July 26, 2010 at 2:13 PM, during the interview with Pharmacist A, stated the annual competency examination had been developed. However, it was not yet fully implemented. The examination would still need to be put into the testing program, according to Pharmacist A.

Pharmacists were providing clinical services without supervision and documentation that ensured they were competent in providing these services.

ASHP (American Society of Health-System Pharmacists) has published, "Guidelines on Preventing Medication Errors in Hospitals," approved June 23, 1993, which states that policies and procedures should be developed which ensure proper evaluation of competency and supervision.



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2. On July 27, 2010 at 2:07 PM, Patient 43's medical record was jointly reviewed with the Assistant Director of Nutritional Services.

Patient 43's history and physical was completed by a physician on July 5, 2010 indicated, "Triglycerides grossly elevated at 669 ..." The history and physical also indicated that the patient had diabetes mellitus type 2.

On July 8, 2010, the Clinical Dietitian 7 completed a Nutrition Initial Assessment for Patient 43 that indicated, "Recommendations: Initiate CPN [central parenteral nutrition] ...elevated Trig [triglycerides] values on admission 7/5; RD [Registered Dietitian] to monitor with CPN infusion ..."

On July 27, 2010 at 2:54 PM, the Assistant Director of Nutritional Services reviewed Patient 43's electronic medical record and chart medical record and acknowledged that the CPN order included intralipid infusion. The Assistant Director of Nutritional Services stated that there was no documentation of a triglyceride laboratory values in the medical record. The Assistant Director of Nutrition Services stated, "I would have expected a weekly triglyceride to have been completed as indicated on the CPN protocol. Pharmacy would have been responsible to run the lab."

On July 27, 2010 at 3 PM, Pharmacist C reviewed Patient 43's medical record and stated the electronic medical record did not contain a triglyceride laboratory value. Pharmacist C stated, "Due to the patient's history and physical of hyperlipidemia and diabetes, a triglyceride level should have been ordered according to our policy."

On July 28, 2010 at 9:45 AM, Pharmacist C was asked who was responsible for ordering the triglyceride laboratory value, and he stated, "It is the pharmacist's or physician's responsibility to order the triglyceride lab per their policy and procedure."

According to the "Nutrition Services Flowsheet view" in Patient 43's medical record, the patient was nutritionally assessed by an RD four more times from a period of July 12, 2010 to July 22, 2010. A triglyceride laboratory value was not available in the medical record.

According to the hospital's policy entitled Policy: Standards Of Care For Parenteral Nutrition (PN) Support (Policy No. 02-01-035), "Nutrition Support Services (NSS) shall comprise of the physician, pharmacist, clinical dietitian, and nursing. The pharmacist and clinical dietitian shall work in close collaboration to coordinate PN support, under the supervision of the physician, and communicate with nursing." The policy further indicated, "Monitoring Guidelines for Central PN; 1 weight, labs, and nutritional response shall be monitored, and the physician alerted when there is potential for an adverse patient event ..., First 24 hours; Lipid - Administer if patient can tolerate adequate volume and lipid clearance is adequate (serum triglyceride levels less than 400 mg/dl or 4.5 mmol/L), 24 to 48 hours; Lipid - Check serum triglyceride levels; Continue intralipids if serum triglyceride levels are maintained at less than 400 mg/dl during continuous lipid infusion and less than 250 mg/dl 4 hours after infusion." This same policy indicated that a lipid panel would be obtained for a baseline prior to hanging lipids for patients with diabetes mellitus ..., and weekly thereafter which may be ordered more or less frequently as deemed necessary per clinical judgment."

Based on observation, interview and record review, the hospital failed to: 1) Post content lists of medication outside the emergency carts. This failure could potentially increase risks for adverse outcomes for patients during medical emergencies. 2) The hospital failed to develop policies and procedures to ensure the safe use of fentanyl transdermal patches. This failure could potentially expose patients to avoidable life threatening adverse effects of medication.

Findings:

On July 27, 2010 at 10:30 AM, inspection of the two red emergency Crash Carts 54 and 11 located in the emergency department (ED) showed that neither of them had the appropriate medication content lists posted on the outside. During interview with the Registered Nurse (RN) 6 in the ED at 11 AM, he was not aware of any medication content lists posting requirement. When he was asked as to where he would locate drug content lists for the emergency carts, he stated, "I would have to look it up in the computer. I believe the content lists should be located in the system's W drive." Further inspection of other nursing units' emergency carts did not show any of them had the appropriate medication listings on the outside of the emergency crash carts.

According to the California Code of Regulation, Title 22, Section 70263(f)(2), "The emergency drug supply shall be stored in a clearly marked portable container which is sealed by the pharmacist in such a manner that a seal must be broken to gain access to the drugs. The contents of the container shall be listed on the outside cover and shall include the earliest expiration date of any drugs within."

During the clinical record review on July 28, 2010 at 1:35 PM, it was noted that Patient 49 was admitted to the hospital's medical/surgical unit on July 26, 2010 at 2:29 PM. Morphine CR (control released narcotic pain relief medication) 30 mg by mouth every 8 hours as needed for pain and fentanyl 25 mcg/hour transdermal patch (topical narcotic pain relief medication) every 3 days were prescribed for Patient 49 to control pain by Physician X on July 27, 2010. Further review of the admission record showed that Patient 49 was not on any home medication prior to hospital admission. In interview with Patient 49 on July 28, 2010 at 1:48 PM, she denied the use of any narcotic pain medication from home. Review of the Patient 49's MAR (Medication Administration Record) showed that Patient 49 was administrated fentanyl 25 mcg/hour transdermal patch on July 27, 2010 at 5:30 PM.

According to the manufacturer's prescribing information, a Black Box warning was issued on fentanyl patches which indicated that (1) fentanyl patch is indicated for management of persistent, moderate to severe chronic pain. (2) fentanyl patch should ONLY be used in patients who are receiving opioid therapy, who have demonstrated opioid tolerance, and who require a total daily dose at least equivalent to fentanyl transdermal system 25 mcg/hour. Patients who are considered opioid-tolerant are those who have been taking, for a week or longer, at least 60 mg of morphine daily, or at least 30 mg of oxycodone daily, or at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid. (3) Fentanyl transdermal system is ONLY for use in patients who are already tolerant to opioid therapy of comparable potency. Use in non-opioid tolerant patients may lead to fatal respiratory depression.

FDA (United States Food and Drug Administration) issued a public health advisory in July 2005 emphasizing the safe use of fentanyl transdermal patch. The fentanyl patch is a potent narcotic (opioid) pain medicine applied to the skin for treating persistent moderate to severe pain in opioid-tolerant patients who needed to be on a narcotic pain medicine around-the-clock. Despite the advisory issued in July 2005, FDA continued to receive reports of death and life-threatening side effects in patients who were prescribed fentanyl patches. On December 21, 2007, the FDA again issued a public health advisory to alert patients, caregivers, and healthcare professionals of important information on the safe use of fentanyl transdermal patch. On the public health advisory, FDA indicated that the fentanyl patches were only intended for treating persistent, moderate to severe pain in patients who were opioid-tolerant, meaning those patients who took a regular, daily, around-the-clock narcotic pain medicine. Patients who were opioid-tolerant were more resistant to the dangerous side effects of narcotic pain medicines than patients who only occasionally took these medicines. For patients who were not opioid-tolerant, the amount of fentanyl in one fentanyl patch of the lowest strength is large enough to cause dangerous side effects such as respiratory depression (severe trouble breathing or very slow or shallow breathing) and death.

In the interview with Pharmacist B on July 28, 2010 at 3 PM, he acknowledged that Patient 49's clinical record did not fit the opioid tolerant profile based on the amount of opioid usage prior to the administration of the fentanyl 25 mcg/hour patch. Pharmacist C on July 28, 2010 at 3:23 PM, said that the hospital did not have a policy and procedures regarding the use of fentanyl patches; he said it had guidelines. Review of the fentanyl transdermal (Duragesic) guideline on July 28, 2010 at 4:02 PM did not show any procedure for determining whether a patient was opioid tolerant.

Based on interview and record review, the hospital failed to consistently monitor radiation badges which had the potential to expose its staff to additional radiation.

Findings:

On July 27, 2010 at 9 AM, during an interview, the RISPACS Coordinator (a coordinator who is in charge of radiation badges) stated she was responsible for collecting and distributing the radiation badges quarterly to the department managers. She expected the managers to collect the old ones and return them to her. After she had collected the old badges, she sent them out for radiation testing. When the badges were not returned, the individual department was responsible to follow up with its own staff.

On July 27, 2010 at 9:40 AM, the hospital's "Radiation Exposure Summary" for the first quarter, 2010 was reviewed. a total of 12 staff did not return their radiation badges for testing. Six of them worked in the Surgical Department. At 9:45 AM, the RISPACS Coordinator stated she was responsible for the Radiology Department and was able to retrieve unreturned badges for testing. However, she was not aware how other Surgery Departments collected their unreturned badges. Consequently, she was unable to track the level of radiation exposure on those staff who did not return their badges.

On July 27, 2010 at 10:20 AM, during an interview, the Director of Surgical Services stated the Surgical Department would notify the staff to return their badges but did not have a system in place to ensure complete compliance.

Based on food service observation, interview and record review, the hospital failed to ensure safe food handling practices as evidenced by: 1) Raw meat was stored over ready to eat foods, 2) The ice-machine had not been sanitized, 3) There was dust accumulated over the fans inside the walk-in refrigerator, and over the cooking ranges; and, 4) Dietary staff did not wash their hands after handling dirty dishes, and after touching a garbage can before returning to prepare food for patients.

Findings:

1. On July 26, 2010 at 9:15 AM, a joint observation with the Assistant Director of Nutritional Services was made of chicken that was thawing over ready to eat food that included sliced roast beef, located in the walk-in refrigerator that was designated for meats. In another walk-in refrigerator, that was designated for dairy items, according to Dietary Staff 1, there was raw bacon turkey and raw beef chorizo over pre-cooked pastrami, and over packages of tortillas. The Assistant Director of Nutritional Services acknowledged that raw meats should not be stored over pre-cooked or ready to eat foods.

According to standards of practice in the food service industry, food shall be protected from cross contamination by separating raw animal foods from ready-to-eat food. (Food Code 2009; 3-302.11)

2. On July 26, 2010 at 10:30 AM, a white paper towel was wiped along the rim of the ice dispensing chute on the inside of the ice-machine bin. The paper towel was jointly observed with the Assistant Director of Nutritional Services to have a brown and orange residue on it, and the Assistant Director of Nutritional Services stated, "It needs to be cleaned." The Assistant Director of Nutritional Services and Dietary Staff 1 stated that dietary staff did not have any role in the cleaning and sanitizing of the ice-machine, including the ice-machine bin.

On July 26, 2010 at 10:52 AM, Plant Operations Staff 2 walked into the kitchen, while chewing gum, and opened up the panel exposing the internal cover of the ice-making apparatus. The Assistant Director of Nutritional Services was present during the interview with Plant Operations Staff 2. Plant Operations Staff 2 stated that he cleaned the ice-machine with a de-scale product which he used for the top part of the ice-making apparatus, and the ice-machine bin. Plant Operations Staff 2 stated he used hot water from a bucket to rinse off the de-scale product from the bin of the ice-machine. He would proceed to dry the ice-machine bin with a terry clothe towel that he would obtain from the kitchen, or from his plant operations storage room. When Plant Operations Staff 2 was shown where the paper towel was swiped that contained the brown and orange residue he stated, "I usually do not clean the chute."

The Plant Operations Staff 2 stated that there were no other procedures or products used on the ice-machine. When asked if he ever sanitized the ice-machine he stated that all he used on the ice-machine was the de-scale product, and that is how he knew the ice-machine was clean. Plant Operations Staff 2 did not sanitize the ice-machine.

According to the preventive maintenance (PM) guidance provided by the Plant Operations department to Plant Operations Staff 2, after the ice-machine was cleaned with a cleaning product a sanitizing step should occur using, " ...dilute approximately 1.5 fl. oz. of sodium hypochlorite solution with 3 gal. of water ..." A PM document for the ice-machine in the kitchen was signed as completed by Plant Operations Staff 2 on May 12, 2010. Based on interview with Plant Operations Staff 2 he did not complete the sanitizing portion for the ice-machine since he had been assigned to do the ice-machine in the kitchen. The Assistant Director of Nutritional Services stated that she would estimate that he had been assigned to clean the ice-machine in the kitchen for the last year and a half.

On July 27, 2010 at 3:52 PM, the Plant Operations Director acknowledged that Plant Operations Staff 2 only used a de-scale product as he thought the product was the same to clean as to sanitize. The Plant Operations Director acknowledged that the sanitizing piece of the ice-machine had not occurred.

According to the manufacturer's instructions for the ice-machine in the kitchen, after the machine had been de-scaled, a sanitizing step should occur, "Dilute approximately 1.5 fl. oz. of a 5.25% Sodium Hypochlorite solution (chlorine bleach) with 3 gal. of water ..., #8 Rinse the parts sanitized above, using water, #9 Place the parts rinsed above back in position ..." The manufacturer's guidelines did not indicate to use a terry clothe towel after the ice-machine bin had been sanitized, and rinsed with water, in order to dry the water. The standards of practice in the food service industry would be to air dry kitchen equipment after sanitizer or after a sanitizer had been rinsed off if that is what a manufacturer's guidelines would indicate. (Food Code 2009; 4-901.11, 4-904.14)

3. On July 26, 2010 at 9:10 AM, inside two walk-in refrigerators, that contained produce and dairy, there was extensive fury brown substance on the ceiling over the fans, and Dietary Staff 1 stated, "Those are dust bunnies."

On July 26, 2010 at 1:45 PM a joint observation with the Assistant Director of Nutritional Services was made of extensive fury brown substance located around the vent and filter area above the cooking range. Dietary Staff 1 stated that he had thought the area was cleaned weekly, then stated the area was cleaned two weeks ago on a Sunday. Near the cook's station area, there was a bulletin board that contained a "Monthly Cleaning Schedule" that was blank, with no date for completion, under the column of "Hood screens and grease trap." The Assistant Director of Nutritional Services stated that the lead PM supervisor was responsible to ensure that dietary staff cleaned the area above the stove range.

On July 26, 2010 at 1:50 PM, the Lead PM Supervisor observed the build up of the brown fury substance, and stated, "Dietary doesn't do anything with that [the area above the stove range], that is plant operations."

On July 26, 2010 at 2:33 PM, the Assistant Director of Nutritional Services stated that a "Supervisor's Report" reflected that the cleaning of hoods and filters was last cleaned on June 8, 2010.

The Assistant Director of Nutritional Services, Dietary Staff 1 and Plant Operations Staff 2 acknowledged that there was a build up of dust directly above the stove range.

According to standards of practice in the food service industry, food shall be protected from contamination by storing the food where it is not exposed to dust. (Food Code 2009; 3-305.11) Nonfood-contact surfaces of equipment shall be kept free of an accumulation of dust, dirt, food residue, and other debris. (Food Code 2009; 4-601.11)

4. On July 26, 2010 at 10:20 AM, during a joint observation with the Assistant Director of Nutritional Services, Dietary Staff 3 was observed handling dirty dishes with gloved hands. Dietary Staff 3 then proceeded to handle clean dishes, without washing his hands and changing his gloves.

On July 26, 2010 at 10:51 AM, Dietary Staff 4 touched a garbage can with her gloved hands. She then changed her gloves, without washing her hands. Dietary Staff 4 then proceeded to serve a ready-to-eat dessert into individual serving dishes for patients.

According to the hospital's policy and procedure entitled General Ware Washing (Policy No. 03-04-010), "Before handling clean dishes or utensils, wash your hands ..."

According to standards of practice in the food service industry, food employees shall wash their hands during food preparation, as often as necessary to prevent contamination when changing tasks, and before donning gloves for working with food. (Food Code 2009, 2-301.14, 2-301.12)

Based on interview and record review, the hospital failed to provide one of 49 sampled patients (42) a therapeutic diet in accordance with the prescribed diet order by the physician.

Findings:

On July 27, 2010 at 8:43 AM, Patient 42's medical record was jointly reviewed with the Assistant Director of Nutritional Services. Patient 42's physician prescribed "Diet: 2 gm [gram] Na+ [sodium] 2 gm K+ [potassium] 1500 ml [fluid restriction] 1.5 gms/kg [kilogram] /d [day] protein 1600 ADA [American Diabetes Association]", according to Physician's Orders dated July 18, 2010.

According to the hospital's electronic computer program a diet order was electronically entered on July 18, 2010 which was "60 gm protein, 2 gm sodium, consistent carbohydrate diet = (1600-2000), 2 gm potassium, 1500 mL/day."

On July 27, 2010 at 9:30 AM, the Assistant Director of Nutritional Services stated that based on the patient's actual body weight upon admission, and the physician's diet order to provide "1.5 gm /kg/d protein" that it would have calculated to provide the patient with 86 grams of protein/d. She stated that an 80 gram protein should have been entered instead of the 60 gm protein that was entered into the medical record.

On July 23, 2010 Clinical Dietitian 5 completed a Nutrition Initial Assessment for Patient 42. Clinical Dietitian 5 indicated, "Recommend changing diet to Renal diet 80 g protein to meet protein needs ..., discussed/agreed upon with nursing, discussed/agreed upon with patient." At that time, Patient 42 had been in the hospital for five days without receiving a therapeutic diet as prescribed by the physician.

Clinical Dietitian 5 indicated on her nutrition assessment that she would provide a dietitian follow-up five days later, despite the discrepancy in the therapeutic diet order that was currently being provided.

Nine days after Patient 42 was admitted to the hospital, the patient still had not received a therapeutic diet as prescribed by the physician.

On July 27, 2010 at 9:56 AM, Registered Nurse (RN) 2 stated that it was the nurse's responsibility to ensure that physician's orders are entered correctly into the hospital's electronic medical record. RN 2 stated that if she had received the physician's order of "1.5 gms/kg/d protein, I would have asked the RD (Registered Dietitian) to calculate the order to clarify for accuracy."

Patient 42 did not receive a "Diet: 2 gm Na+, 2 gm K+, 1500 ml, 1.5 gms/kg /d protein, 1600 ADA" as prescribed by the physician.

Based on interview and record review, the hospital failed to customize their on-line diet manual to be hospital specific to ensure that therapeutic diet orders were approved by the hospital's staff of physicians, and in conformance with physician diet orders.

Findings:

On July 26, 2010 at 2:05 PM, the Assistant Director of Nutritional Services stated that the hospital's diet manual was an on-line "American Diabetic Association (ADA) Nutrition Care Manual." She stated that the on-line ADA Nutrition Care Manual had not been customized to indicate how the physicians wrote their therapeutic diet prescriptions that was routinely ordered, and how they defined the various therapeutic diets that were implemented at their hospital.

The hospital's Dietary Orders Report, printed on July 28, 2010, indicated there were physician prescribed diet orders that included cardiac diet, renal diet, consistent carbohydrate diet, clear liquid diet, sodium restricted diet, mechanical soft diet, and pediatric diet. The Assistant Director of Nutritional Services was unable to utilize the on-line ADA Nutrition Care Manual to demonstrate how the hospital would prepare the patient diets to meet those diet orders. The Assistant Director of Nutritional Services had a carbohydrate meal pattern plan available in the dietary department. She stated that dietary staff used the carbohydrate meal pattern to guide accuracy of meal selection during menu reviews. This actual practice of how the consistent carbohydrate diet order was implemented on a patient's tray was not incorporated into the hospital's diet manual.

On July 28, 2010 at 10:20 AM, the Assistant Director of Nutritional Services had a hard copy book in her hand that indicated "Diet Manual", and stated that it was the hospital's diet manual. The Assistant Director of Nutritional Services was able to utilize that hard copy diet manual to demonstrate specific nutrition tools that were available to dietary staff on how to implement a patient's meal tray for such therapeutic diet orders as various renal patterns, and various diabetic carbohydrate meal patterns. She stated the hard copy was only available to dietary staff, and the detailed information was not incorporated into the on-line ADA Nutrition Care Manual that was available to the interdisciplinary members' hospital wide.

On July 28, 2010 at 10:25 A.M., the Assistant Director of Nutritional Services provided a document that indicated, "Policy: Diet Orders" with the word "DRAFT" on top of the page. This draft document did contain a list of routinely prescribed diet orders with definitions of the diet orders as they would be implemented at the hospital. The Assistant Director of Nutritional Services looked on the hospital's intranet on-line policies and procedures, and acknowledged that the policy and procedure with defined diet orders was in draft form only, and was not currently available on-line to the interdisciplinary team members.

According to the hospital's policy entitled Nutrition Care Manual (Policy No. 02-02-001) the policy summary/intent was "to establish the American Dietetic Association Nutrition Care Manual as the accepted and approved diet manual." The policy further indicated, "Nutritional Services staff who plan diets are expected to consistently utilize the Nutrition Care Manual as their guide for patient meals, therapeutic diets and delivery of safe quality food ..."

Based on observation, interview, and record review, the hospital failed to comply with the California Code of Regulation, Title 22 70239(a)(1), to provide minimum required footage in three of its 21 recovery rooms. Such failure posed potential hazard to patients' health and safety post-operatively.

Findings:

On July 19, 2010 at 1:40 PM, during a tour of the post-operative area, noted Room 19, 20, and 21 were smaller than the rest of the rooms. At 1:46 PM, the Director of Surgical Services stated these three rooms were being used to recover patients after receiving gastrointestinal endoscopic procedures. These patients would be recovered on gurneys abut approximately, one third of the gurney would be extended to the hallway.

On July 30 2010 at 10 AM, the Director of Plant Operations measured the footage of each room. He reported Room 19 and 20 both were 54.19 square feet, and Room 21 was 74.45 square feet.

On July 30, 2010 at 11 AM, Title 22 of the California Code of Regulation, Section 70239(a)(1) was reviewed. This regulation required "Floor area of at least 7.5 square meters (80 square feet) per bed..." The Director of the Plant Operations was informed of the above findings at this time.

Based on observation, interview, and document review, the hospital failed to provide an environment that reduced the risk of transmission of infectious and communicable diseases as evidenced by:

1. Failure to annually screen healthcare workers (HCW) for tuberculosis, the hospital placed all patients, HCW, and visitors at risk of exposure to mycobacterium tuberculosis (infectious and communicable lung disease), resulting in declaration of Immediate Jeopardy. (Refer to A Tag 747, item 1)

2. Failure to ensure that glucometers (machines used to test a patient blood glucose) were cleaned and disinfected between each patient using a disinfectant that reduces the risk of transmitting bloodborne pathogens. (Refer to A Tag 748, items 2 and 10)

3. Failure to ensure that endocavitary (vaginal) probes were cleaned and disinfected in accordance with recommendations for the reprocessing of semi-critical equipment. (Refer to A Tag 748, item 3)

4. Failure to ensure nursing staff had a hooper for the disposal of body fluids without transporting the body fluids by elevator, from the 3rd floor to the fourth floor. (Refer to A Tag 748, item 4 a)

5. Failure to ensure that construction areas were sealed off to prevent paint fumes from penetrating into patient occupied rooms. (Refer to A Tag 748, item 4 b)

6. Failure to ensure that medical records of patients who screened positive for Methicillin Resistant Staphylococcus Aureus (MRSA), contained evidence demonstrating that the patient or their representative were notified that they were positive for MRSA by their physician. (Refer to A Tag 748, items 5 and 11)

7. Failure to provide evidence that the physician performed a daily assessment demonstrating medical necessity for the continued use of central venous catheters for patients in the intensive care unit. (Refer to A Tag 748, item 6)

8. Failure to implement their surgical attire to reduce the incidence of post operative surgical site infections. (Refer to A tag 748, item 7)

9. Failure to ensure that items manufactured for single patient use were not used for multiple patients. (Refer to A Tag 748, item 8)

10. Failure to ensure that clean patient care items and equipment was not stored together with soiled patient care items and equipment. (Refer to A Tag 748, item 9)

Findings:

1. The hospital allowed HCW to provide direct patient care, without ensuring that all HCW were screened for Mycobacterium tuberculosis (TB), to reduce the risk of exposing patients, staff, and visitors to TB.

On July 29, 2010 at 10 AM, the Employee Health Nurse was interviewed. During the interview the Employee Health Nurse was asked to explain the process used to screen employees for Mycobacterium tuberculosis. During the interview, the Employee Heath Nurse was asked how many HCW were overdue completing their TB screening. The Employee Health Nurse stated that she would print a report showing those employees whose annual TB screening was overdue.

On July 29, 2010 at 11 am, the report listing the employees who were due and overdue in completing their TB screening was provided and reviewed. It was noted there were 45 HCW representing inpatient and outpatient care areas in the hospital. It was also noted that 20 HCWs' TB screenings were overdue from more than 60 days up to 15 months.

On July 29, 2010 at 11:05 AM, a request was made for a payroll report listing hours worked for HCW employees.

On July 29, 2010 at 1:30 PM, a report documenting the hours these HCWs had worked from June 2, 2010 through July 24, 2010, was provided and reviewed. Documentation in that report showed that 20 of 33 employees had worked during that time.

b. It was noted that housekeeping and janitorial staff were also listed as being due or overdue completing their TB screening.

During an interview on July 29, 2010 at 11:10 AM, the Employee Health Nurse stated that all of the housekeepers and janitorial staff were employed by the company contracted to provide housekeeping services. The Employee Health Nurse stated that a couple of months ago, the hospital changed to a new housekeeping company. The Employee Health Nurse also stated that she did not think that the list of housekeeping staff was current.

On July 29, 2010 at 11:15 AM, a request was made for a list of all housekeeping and janitorial staff including their TB screening completion dates.

On July 29, 2010 at 1:30 PM, the Employee Health Nurse provided a list of housekeeping staff provided by contractual agreement. It was noted that list contained 80 housekeeping, plus a separate list of three housekeeping managers. The housekeeping staff list showed that all 80 housekeeping staff, (excluding the three salaried managers), had worked at the hospital from May 28, 2010 through July 28, 2010. The list of housekeeping staff was compared to the documents listing the housekeepers which were screened for TB. The comparison (the list of contracted housekeepers with the list housekeepers who had current TB screening), disclosed that the hospital had no documentation showing that 67 of 80 housekeeping staff had been screened for TB at the time of employment or annually.

On July 29, 2010 at 2:30 PM, the employee health services reports for:

July 2009 - September 2009, October 2009-December 2009, January 2010-March 2010, and April 2010-June 2010, were reviewed. Documentation in all four of the employee health reports disclosed the total number of TST (tuberculosis skin test, a test commonly used to screen for exposure to TB) administered, the total number screened by symptom review (a list of symptoms that could indicate active TB), and the number of TB conversions (TST results converted from negative to positive). The four employee health reports contained no documentation showing that the number of employees with overdue TST or symptom review (symptom review is used in place of a TST for individuals who either have a history of TB or have been vaccinated with BCG vaccine (BCG vaccine causes a positive TST) to prevent the spread of TB in countries where TB is prevalent).

An Immediate Jeopardy was declared because the hospital failed to screen 33 HCW for the presence of Mycobacterium tuberculosis and 67 housekeeping and janitorial workers. The failure to screen its employees for Mycobacterium Tuberculosis had placed all patients, staff and visitors at risk of exposure to infectious and communicable diseases. The failure of such hospital practices resulted in declaring the Immediate Jeopardy. The Immediately Jeopardy situation was presented to the Chief Executive Officer, Chief Nursing Officer, and Director of Accreditation/ Special Projects on July 29, 2010 at 4:25 PM.

On July 30, 2010 at 8:40 AM, the Infection Preventionist (IP), was interviewed. During the interview, the IP was asked to explain why its employees and contractual staff were not screened annually for TB. The IP explained that she and the Employee Health Nurse were aware of the employees with overdue TST or symptom review. The IP stated that administration was also aware of the employees with overdue TST or symptom review, but did not want to take those employees off the schedule because it might result in a staffing shortage.

Based on documents demonstrating implementation of the hospital's Plan of Action, the Immediate Jeopardy was abated with the Chief Nursing Officer on August 2, 2010 at 11:30 AM.

c. On July 28, 2010 at 3 PM, the health files for 22 physicians (A, B, C, D, E, F, G, H, I, J, K, L, M, N, O P, Q, R, S, U, V, and W), and Physician Assistant (PA) 1's , (PA T), were reviewed. During the health file reviews the following documentation was noted:

Physician B's TST was done on April 30, 2009.
Physician D's TST was administered on February 5, 2008, but did not return to have the TST interpreted.
Physician E's TST was administered on February 5, 2008, but did not return to have the TST interpreted.
Physician F's TST was done on December 12, 2008.
Physician I's TST was done sometime in 2008.
Physician L's TST was done on May 15, 2009.
Physician O's TST was done on April 24, 2009.
Physician P's TST was done on July 21, 2009.
Physician R's TST was done in June 2008.
Physician U's TST was done in 2008.
Physician W's TST was done on April 22, 2008.

In addition it was noted that the following physicians who were documented as positive reactors, did not have documentation showing that an annual symptom review was completed for:

Physician C, after 2008
Physician G, after 2008
Physician H, in 2009
Physician J, in 2009
Physician M, in 2009
Physician Q, in 2009
Physician S, in 2009
Physician V, in 2009

The health file for PA T, contained no documentation showing that a TST, or chest X-ray with symptom review, was done at the time of initial appointment.

On July 28, 2010 at 3:30 PM, the Medical Staff Coordinator was interviewed. During the interview the Medical Staff Coordinator stated she was aware that TB screening for the medical staff and allied health members was going to be an issue. The Medical Staff Coordinator stated that the hospital had required the medical staff and allied health members to provide evidence of TST, or chest X-ray, at the time of initial appointment, and every two years during re-appointment.

On July 28, 2010 at 5 PM, the 2009, "Medical staff bylaws and rules and regulations," were reviewed. The two documents contained no direction that required members of the medical and allied health professional staff be screened for TB, either by TST or chest X-ray with a symptom review if the individual's TST was positive.

On July 29, 2010 at 8 AM, the hospital's 8/09 policy and procedure titled, "Employee tuberculosis (TB), screening" was reviewed. On page three, of the policy and procedure, direction is given under item 2, 1, "Employees will be sent two (2), notices informing them of his/her required TB screening. The first notice will be sent to the employee's department to remind them TB screening is to be completed within thirty (30) days from the date of the letter." Further direction is given under item 2, c, that "Employees failing to complete TB screening within sixty (60) days from the date of the first notification will be removed from the work schedule until testing has been completed."

On July 29, 2010 at 8:15 AM, the hospital's 5/10, "Infection Control Plan" was reviewed. On page 9, item 12, direction is given to, "Support employee health program by: a. Requiring compliance with annual TB surveillance, either by skin testing or symptom surveillance."

In 2005, Centers for Disease Control and Prevention (CDC) released in a document titled, Guidelines for Preventing the Transmission of Mycobacterium tuberculosis in Health-Care Settings, recommended: HCW refer to all paid and unpaid persons working in healthcare settings who have the potential for exposure to Mycobacterium tuberculosis (M. tuberculosis), through air space shared with persons with infectious TB disease. Part time, temporary, contract, and full-time HCW should be included in TB screening programs. All HCW who have duties that involve face-to-face contact with patients with suspected or confirmed TB disease (including transport staff), should be included in a TB screening program. The following are HCW who should be included in a TB screening program: It was noted that list of HCW included, Physicians (assistant, attending, fellow, resident, or intern), nursing staff, housekeeping staff, radiology staff, and social workers.

CDC also recommended in the 2005, guidelines that all HCW should receive baseline TB screening upon hire, using two-step TST or a single BAMT (blood assay for Mycobacterium tuberculosis) to test for infection with M. tuberculosis. After baseline testing for infection with M. tuberculosis, HCW should receive TB screening annually (i.e., symptom screen for all HCW and testing for infection with M. tuberculosis for HCW with baseline negative test results). HCW with a baseline positive or newly positive test result for M. tuberculosis infection or documentation of previous treatment for latent tuberculosis infection (LTBI meaning that a patient is infected with TB but has no symptoms), or TB disease should receive one chest radiograph result such as chest x-ray to exclude TB disease. Instead of participating in serial testing, HCW should receive a symptom screen annually. This screen should be accomplished by educating the HCW about symptoms of TB disease and instructing the HCW to report any such symptoms immediately to the occupational health unit.

On August 2, 2010 at 11:30 AM, the Immediate Jeopardy was abated after the Chief Nursing Officer, provided documentation showing that the hospital had implemented their Plan of Action.

2. Failure to Ensure that the glucometer was cleaned between each patient, with a disinfectant that destroys bloodborne pathogens. (Refer to A tag 748, item 1)

3. Failure to ensure that ultra sound probes that come into contact with mucous membranes were disinfected using a semicritical process. (refer to A tag 748, item 3)

4. Failure to ensure that nursing staff had a process for disposing of body fluids without transporting the body fluids by elevator to a different nursing unit. (Refer to A tag 748, item 4, a)

5. Failure to ensure that construction areas were fully enclosed as directed in hospital policy and procedure. (Refer to A tag 748, item 4, b)

6. Failure to ensure that a physician notified the patient or the patients representative that a screening culture for methicillin resistant staphylococcus aureus (MRSA), was positive. (Refer to A tag 748, item 5)

7. Failure to ensure to provide documentation that a physician had assessed use of a central venous catheter, and determined that the continued use was medically necessary. (Refer to A tag 748, item 6)

8. Failure to ensure that hospital's policy and procedure for surgical attire was implemented, and that a policy and procedure for personal protective equipment was developed and implemented. (Refer to A tag 748, item 7)

9. Failure to ensure that items labeled by the manufacturer for single patient use, were only used for one patient. (Refer to A tag 748, item 8)

The cumulative effects of these systemic problems resulted in the hospital's inability to ensure that healthcare was provided in a sanitary environment and that all patients, staff, and visitors were at risk of exposure to infections and communicable diseases.

Based on observation, interview, and document review, the hospital failed to ensure that policies and procedures governing infections and communicable diseases were developed, and/or implemented as approved.

Findings:

1. The hospital failed to ensure healthcare workers were screened for Mycobacterium tuberculosis (TB) in accordance with their hospital policy and procedure, and as recommended by Centers for Disease Control and Prevention (CDC) (Refer to A Tag 747, item 1).

2. The hospital failed to ensure that machines used to test patients blood sugar levels was cleaned and disinfected after each patient, in accordance with nationally recognized standards of practice.

On July 26, 2010 at 9:45 AM, a tour was conducted of the cardiac catherization laboratory. During the tour, the Director of the Cardiac Catherization Laboratory (an area where procedures are done to examine heart condition) was asked to explain the process for cleaning the glucometer (machine used at the bedside to test a patient's blood sugar). The Director of the Cardiac Catherization Laboratory, stated that the glucometer was cleaned once a day using Cavi Wipes (a brand name of disinfectant disposable wipes).

On July 26, 2010 at 10:10 AM, a tour was conducted of the hospital's emergency department (ED) north area. During the tour the Registered Nurse (RN) 8 was asked to explain the process for for cleaning the glucometer. She stated that glucometer was cleaned once every 24 hours using Gluco Chlor (a specific kind of wipes that was approved by Environmental Protection Agency (EPA) to clean the glucometer).

On July 26, 2010 at 11 AM, a tour was conducted of the ED south area. During the tour the ED South Charge Nurse (RN 8) was asked to explain the process for cleaning the glucometer. RN 8 stated that the glucometer was cleaned once a shift, using an alcohol swab.

On July 26, 2010 at 12:30 PM, a tour was conducted of the surgical intensive care unit (SICU). During the tour the SICU Charge Nurse (RN 11) was asked to explain the process for cleaning the glucometer. RN 11 stated that the glucometer was cleaned once a day using Gluco Chlor wipes.

On July 27, 2010 at 2 PM, a tour was conducted of the neonatal intensive care unit (NICU). During the tour, the NICU Charge Nurse (RN 10) was asked to explain the process for cleaning the glucometer. RN 10 stated that the glucometer was cleaned once a shift using the bleach wipes.

On July 27, 2010 at 4:30 PM, the hospital's 4/07, policy and procedure titled, "Disinfecting equipment (non-critical)," was reviewed. It was noted that the policy and procedure did not include or specify the solution to be used, or the frequency for cleaning the glucometer.

On July 30, 2010 at 840 AM, the infection preventionist (IP), was interviewed. During the interview, the IP verified that the equipment cleaning policy and procedure did not define when to clean the glucometer or what solution to use.

On July 30, 2010 at 10 AM, the 2010 article by the Association for Professionals in Infection Control and Epidemiology, Inc. Published by Elsevier Inc. All rights reserved. (Am J Infect Control 2010;38:167-72.), was reviewed. Direction in the publication on page 171, was that: Assign a glucometer to each individual patient if possible. Clean and disinfect glucometers if they must be shared between multiple patients. Thoroughly clean all visible soil or organic material (eg, blood) from the glucometer before disinfection. Disinfect the exterior surfaces of the glucometer after each use following the manufacturer's directions. Use an Environmental Protection Agency-registered disinfectant effective against HBV (hepatitis B virus), HCV (hepatitis C virus) , and HIV (human immunodeficiency virus) or a 1:10 bleach solution (1 part bleach to 9 parts water).

3. The hospital failed to ensure that endocavitary probes that are inserted into a body cavity, and had contact with mucous membranes were considered semicritical devices (equipment that touches mucous membrane such as mouth or skin that is not intact) and were reprocessed using a high level disinfection process (this process destroys almost all micro-organisms).

On July 27, 2010 at 8:30 AM, the Director of Radiology was interviewed. During the interview, the Radiology Director was asked to explain the process for cleaning endo-cavitary (probes that are inserted inside a body cavity, such as the vagina) ultrasound (use of vibrations of sound but with frequencies above the range of human hearing) probes. The Director of Radiology stated that their current practice was to wipe off the bioburden (organisms remaining on the ultrasound probe), then spray T-Spray (A low level disinfectant) on the ultra sound probe to saturate it. The Director of Radiology stated that ultra sound staff would wait a few minutes, then dry and polish the probe. The Director of Radiology also stated they had started to use a disposable condom or sleeve to cover the endocavitary probe when performing procedures. When asked if the hospital had an approved policy and procedure for cleaning endocavitary probes, the Director of Radiology stated that they were in the process of developing a policy and procedure.

On July 27, 2010 at 4 PM, the "Guideline for disinfection and sterilization in healthcare facilities, published by Centers for Disease Control and Prevention (CDC), in 2008, was reviewed. On page 19 of the guidelines, CDC directed that, "Vaginal probes are used in sonographic scanning. A vaginal probe and all endocavitary probes without a probe cover are semicritical devices because they have direct contact with mucous membranes (e.g., vagina, rectum, pharynx). While use of the probe cover could be considered as changing the category, the guideline proposes use of a new condom/probe cover for the probe for each patient, and because probe covers can fail, the probe should also should be high level disinfected. The relevance of this recommendation is reinforced with the findings that sterile transvaginal ultra sound probe covers have a very high rate of perforation even before use. ......Studies underscore the need for routine probe disinfection between examinations. Although most ultra sound manufacturers recommended use of 2 percent glutaraldehyde (name of a chemical disinfectant) for high level disinfection on contaminated transvaginal transducers...."

4. The hospital failed to ensure that hospital staff had a hopper for disposal of body fluids and waste, and that the construction area was sealed off as directed in their, "Infection control during construction," policy and procedure.

a. On July 27, 2010 at 10:53 AM, a tour was conducted of the third floor medical nursing unit. During the tour, a request was made to inspect the soiled utility room. The Nursing Manager for the 3rd floor stated that during the construction, the cleaning and soiled utility room were combined. During inspection of the combined, cleaned and soiled utility rooms, it was noted that there was not a hopper (commercial grade toilet for discarding body fluids) in the room. When asked about the hopper, the Nurse Manager stated that during the construction, the third floor was using the fourth floor's hopper (nursing staff would transport body fluids on the elevator for disposal in the fourth floor hopper). When asked if nursing staff were transporting body fluids by elevator for disposal, the Nurse Manager stated that it had happened a few times. When asked how long this process had been going on, the Nurse Manager stated since the project stated, about a couple of months.

On July 27, 2010 at 4 PM, the hospital's plans for the burn unit, that were submitted to OSHPD (Office of Statewide Planning and Development) were reviewed. The documents provided contained no evidence that OSHPD approved for nursing staff to transport body fluids up one floor by elevator for disposal.

On July 30, 2010 at 8:40 AM, the IP, was interviewed. When asked if she was aware that the third floor had been transporting body fluid waste to the fourth floor, by elevator, for disposal? The IP stated that she was aware that nursing staff had transmitted body fluids from the third floor, by elevator, to the forth floor, and disposed of the fluids in the hopper on the fourth floor. When asked if she was aware of that the third floor nursing staff would not have a hopper during the construction, she stated that she found out about the lack of a hopper after the construction project started. When asked if the hospital established a system for disposing body fluids, without transporting the body fluids to the fourth floor, the IP stated no they had not.

b. On July 27, 2010 at 10:53 AM, a tour was conducted of the third flood medical nursing unit. During the tour, an open door was observed, in the hallway to the left of the elevators. Inspection behind the open door disclosed construction workers inside the area. It was noted that the construction area was not sealed off, and that dust and construction debris was visible in the air and floating outside the construction area.

During a concurrent interview, the Nurse Manager explained that the area under construction was going to be the new burn unit.

While touring the other side of the third floor patient rooms, (the other side of the construction area), the smell of paint fumes was noted. During the remainder of the third floor nursing unit tour, the patients in Rooms 3113, and 3115, turned on their nurse call lights and complained about the smell of paint fumes. It was noted that after the patients complained, the doors to Rooms 3113, and 3115, were closed.

On July 27, 2010 at 4:30 PM, the hospital's 5/10 policy and procedure titled, "Infection control during construction," was reviewed. On page three, under 4.a., direction was given that, "Airflow in the construction site will not be re-circulated and should be in a negative flow until completion of the project. Constant negative pressure within the zone should be monitored with an alarm device, which must be maintained and monitored both by construction personnel and a hospital facilities management representative. Air must flow from clean to dirty areas." On page three, under section b.1., direction was given that, "Project must be completely contained by impervious barriers." Under section b.2., direction was that, "Barriers should extend from the floor, beyond the false ceiling, to the underside of the floor above as appropriate."

5. The hospital failed to ensure that patients who screened positive for methicillin resistant staphylococcus aureus (MRSA), were notified, or the representative, of the positive results.

On July 26, 2010 at 12:30 PM, Patient 36's medical record was reviewed. Documentation in the medical record showed that the patient was admitted SICU, on July 13, 2010 at 3:15 PM.

A review of the laboratory section of the medical record showed that the patient was screened for MRSA on July 14, 2010. Documentation in the medical record showed that on July 16, 2010 at 10:30 AM, the patient's screening was positive for MRSA (any of several strains of a bacterium that are resistant to some antibiotics and may cause usually mild infections of the skin or sometimes more severe infection).

A review of the physician progress notes section of the medical record contained no documentation showing that the physician had notified the patient, or the patient's representative that the MRSA screening was positive.

During a concurrent interview, RN 11 stated that she was not aware that the physician was required to notify the patient or their representative that the MRSA screening was positive.

On July 26, 2010 at 4 PM, the hospital's 5/10, policy and procedure, titled, "Methicillin-resistant staphylococcus aureus (MRSA) active surveillance/screening cultures," was reviewed. On page of the policy and procedure, item F, direction was given that, "Patients with a positive MRSA culture will be informed of the positive culture by a physician."

6. The hospital failed to ensure that the physician responsible for the patients care performed a daily assessment of the central venous catheter (CVC, an intravenous access for injection), and determined that continued use of the CVC was medically necessary. CDC and CMS (Centers for Medicare and Medicaid Services) has determined that the incidence of blood stream infections increases when devices such as CVC are used in the care of patients.

On July 26, 2010 at 12:30 PM, Patient 36's medical record was reviewed. Documentation in the medical record showed that the patient was admitted to the SICU on July 13, 2010 at 3:15 PM.

Documentation in the progress notes section of the medical record showed that July 23, 2010 at 12:30 PM, the patient had a CVC inserted.

Additional review of the physician progress notes section of the medical record, contained no documentation that on July 23, 2010, July 24, 2010, July 25, 2010, and July 26, 2010, the physician responsible for Patient 36's care had assessed the CVC, and had determined that continued use of the CVC was medically necessary.

On July 27, 2010 at 8 AM, the hospital's 5/10, policy and procedure titled, "Management of central venous access devices (CVAD), was reviewed. On page two, item G, direction was given that, "Daily evaluation for continued need for the catheter will be performed in collaboration with the physician."

On July 27, 2010 at 10 AM, an interview was conducted with the Director of the intensive care unit (ICU). During the interview, the Director of the ICU was asked about the process used by the hospital, for a physician documenting that the CVC was medically necessary. The Director of the ICU stated that the hospital did not have process for the physician to document that use of the CVC was medically necessary. When asked, who was responsible for documenting that CVC was medically necessary, the Director of the ICU, stated that collaborating with the physician, the registered nurse, was responsible for documenting the continued use of the CVC was medically necessary.

The Federal regulations require that hospitals monitor and collect data on catheter related blood stream infections (CLABSI), and that the data be reported to CMS. State Health and safety Code 1288 requires that hospitals monitor, collect, and report infections related CVC use, to the National Healthcare Safety Network (NHSN) web site. California State Health and Safety Code also requires that an individual who can order the insertion or removal of a CVC, perform a daily assessment of the CVC, to determine if the continued use of the CVC is medically necessary.

7. The hospital failed to implement their approved surgical attire policy and procedure to reduce the risk of patients developing surgical site infections.

Immediately prior to entering the hospital on July 26, 2010 at 9 AM, three females, dressed in surgical attire, including hair and show coverings, we observed walking out of the main hospital entrance into the parking lot. It was noted that none of the three employees were wearing cover coats. It was also noted that the female walking in the middle had a surgical mask pulled down under her chin.

On July 26, 2010 at 12:40 PM, a female wearing surgical attire, including hair and show covers, was observed walking into and out of the SICU. It was noted that the female had a surgical mask pulled down under her chin.

During a concurrent staff interview, the SICU Charge Nurse (RN 7) stated that she ws uncertain if the female in surgical attire was nursing staff or a physician.

On July 26, 2010 at 12:45 PM, a male, wearing surgical attire, was observed entering the surgical ICU. It was noted that the male in surgical attire also wore a surgical mask that was pulled down under his chin.

During a concurrent interview, RN 7 identified the male in surgical attire as an anesthesiologist.

On July 28, 2010 at 9:14 AM, a tour was conducted of the pre and post operative care unit. During the tour, a male in surgical attire was observed leaving the surgical suite area. It was noted that the male was wearing a surgical mask that covered his mouth.

During a concurrent interview, the Director of Surgical Services, stated that she was working with surgical staff to remove surgical masks as they left the surgical suite. The Director of Surgical Services identified the male wearing the surgical mask as a member of the medical staff.

On July 28, 2010 at 11 AM, two males, in surgical attire, including hair and shoe coverings were observed leaving the main hospital entrance, and walked out to the front parking lot. It was noted that the two males were not wearing cover coats.

On July 28, 2010 at 1:20 PM, a tour was conducted of the restricted area in surgery. During the tour, two prison guards were observed escorting an inmate into a surgical suite. It was noted that one prison guard was not wearing shoe covers. It was noted that the second prison guard wore one shoe covering, and that the second shoe cover, only covered the sole of the guards' shoe. A female was observed walking in the hallways outside the surgical suites, with a surgical mask pulled under her chin.

During a concurrent interview, the Director of Surgical Services stated that removing surgical masks when leaving the surgical suite was a new process for the surgery department. The Director of Surgical Services was asked if the hospital had a policy and procedure specific to use of personal protective equipment (PPE, refers to protective clothing, helmets, goggles, or other garment designed to protect the wearer's body from hazardous materials). The Director of Surgical Services stated that the hospital did not have a policy and procedure directing surgical staff about the use of PPE, such as surgical masks.

On July 28, 2010 at 4:30 PM, the hospital's September 26, 2007, policy and procedure titled, "Scrubs," was reviewed. Under the procedure section, item 2, direction was given that, "Hospital owned scrubs should never be worn outside the facility or removed from the facility by anyone."

On July 29, 2010 at 7:30 AM, the "Perioperative standards and recommended Practices" published by AORN (Association of periOperative Registered Nurses), in 2010, was reviewed. On page 69, under recommendation III, item 2, AORN's recommendation was that, "Masks should be removed carefully by handling only the ties, and they should be discarded immediately. Masks should not be saved by hanging them around the neck or tucking them into a pocket for future use. The filter portion of a surgical mask harbors bacteria collected from the nasopharyngeal airway. Handling this portion of the mask after use can transfer bacteria to the hands and initiate potential cross contamination (a phenomenon that occurs when a material that does not itself contain any allergens is tainted with an allergen during handling)."

8. The hospital failed to develop and implement policies and procedures ensuring that single patient use items were only used for one patient.

On July 26, 2010 at 10:10 AM, a tour was conducted of the emergency department. During the tour, the storage locker in the trauma room was inspected. Inside the storage locker there were approximately white plastic pressure infusers were noted. A closer inspection of the white plastic pressure infusers disclosed that five of six of the pressure infusers were labeled by the manufacturer as, "For infection control purposes, recommended for single use only."

During a concurrent interview, the emergency department charge nurse (RN 12) stated that she was not aware that the pressure infusers were intended to used for one patient.

On July 26, 2010 at 12:40 PM, a tour was conducted of the SICU. During the tour, the cart containing supplies for hemodynamic monitoring (arterial, and thermal dilution catheters) was inspected. Inside the supply care it was noted that nine of 14 pressure infusers were labeled by the manufacturer as, "For infection control purposes recommended for single patient use."

On July 26, 2010 at 2:20 PM, a tour was conducted of the medical intensive care units I and II. During the tour, the cart containing supplies for hemodynamic monitoring was inspected. It was noted that eight of 10 of the available pressure infusers were labeled by the manufacturer as, "For infection control purposes recommended for single patient use."

During a concurrent interview, the Charge Nurse (RN 8) for the three intensive care units stated that she was not aware that the pressure infusers were to be used for one patient.



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9. During a tour of the fifth floor (post operative surgical unit) on July 26, 2010 at 10:05 AM, with Registered Nurse 1 (RN 1), a locked room labeled "soiled utility" was observed. There were items that were considered "dirty" but there was also an uncovered, stacking cart which contained clean patient equipment.

During a tour of the fifth floor (overflow telemetry unit) on July 26, 2010 at 10:50 AM, with RN 2, a locked soiled utility room was observed to contain a cart of clean pillows.

During an interview with RN 2 on July 26, 2010 at 10:50 AM, she stated the soiled utility room should only contain soiled items but due to limited storage space, the room was used for storage of the clean patient pillows.

10. During an interview with RN 1, on July 26, 2010 at 10:20 AM, she was asked the process for cleaning the Glucometer machines. She indicated, they were cleaned once a day with a chlorine based wipe.

During an interview with RN 2, on July 26, 2010 at 10:40 AM, she was asked the process for cleaning the Glucometer machines. She indicated, the machines were assigned to a nurse every shift and it was expected the nurse clean the machine every shift with a chlorine based wipe.

During an interview with RN 3, on July 16, 2010 at 1:50 PM, she was asked to explain the process for cleaning the Glucometer machines. She indicated, "I don't clean them, it might be night shift..." RN 3 also stated, "I think we use Caviwipes". During a subsequent interview, she indicated, after calling the Laboratory supervisor, she was instructed the outside of the machines were not cleaned routinely and were cleaned with "Caviwipes" and it was the night shift's responsibility to do the thorough cleaning.

11. The clinical record for Patient 31 was reviewed on July 27, 2010 at 11 AM. An "Inpatient MRSA (methicillin resistant staphylococcus aureus) Screening Checklist" was noted in the patient's clinical record. The checklist is used to screen new patient's who are at higher risk of having been exposed to MRSA. The checklist was blank. There was also documentation the patient had a positive MRSA culture. There was no documentation the patient or the patient's representative was notified of the positive MRSA culture.

During an interview with RN 4, on July 27, 2010 at 11:15 AM, she confirmed the MRSA screening checklist for Patient 31 was blank and should have been completed. During a subsequent interview, after reviewing the patient's clinical record she was unable to find documented evidence the patient or the patient's representative was notified of the positive MRSA culture.


The clinical record for Patient 30 was reviewed on July 27, 2010 at 10 AM. The patient was on contact isolation precautions for a positive MRSA culture. There was no documentation the patient or the patient's representative was notified of the positive MRSA culture.

During an interview with RN 4, on July 27, 2010 at 11:18 AM, after reviewing Patient 30's clinical record she could find no evidence the patient or the patient's representative was notified of the positive MRSA culture.

Based on interview and record review, the hospital failed to obtain a patient's (45) laboratory test results prior to his surgery which had the potential to place the patient at risk for complications.

Findings:

On July 29, 2010 at 1 PM, Patient 45's clinical record was reviewed. Patient 45 was 61-year-old and was admitted to the hospital on July 23, 2010 for a surgical procedure on outpatient basis. There was no laboratory test results in his record. This was verified by the Manager of Pre-Op and Post-Anesthesia Care Unit.

On July 30, 2010 at 9 AM, the hospital's "Pre-op Testing Algorithm" was reviewed. For patients between age 60 to 74, blood tests for complete blood count (CBC), Basic Metabolic Panel (BMP), Creatinine (Creat)/Blood Urea Nitrogen (BUN), and electrocardiogram (ECG) were necessary pre-operatively.