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Based on observation, interviews, and review of clinical records and facility documents, the Governing Body:

1) Failed to maintain an ongoing Quality Assessment Performance Improvement program (refer to A0263).

2. Failed to protect, promote and exercise patient rights (refer to A0091, A0130, A0131).

3. Failed to maintain an infection control program that ensured an environment free from the potential of cross contamination (refer to A0747).

4. Failed to provide nursing care and medication administration in an effective and safe manner to meet patient needs (refer to A0385).

5. Failed to maintain an environment to ensure patient safety and patient needs are met (refer to a 701).

6. Failed to provide food and nutritional services to prevent potential cross contamination and meet patient needs (refer to 618).

These practices do not provide for the safety and well being of patients.

Based on interviews and clinical record review it was determined that the administrative staff did not ensure the medical staff and emergency room personnel complied with federal emergency service regulations at all times, for two (#1, #33) of thirty three records reviewed. This practice may cause a delay in treatment in a patient with an emergency medical condition.

Findings include:

1. Interview with patient #1 on 2/8/10 at approximately 12:30 p.m. while touring the Emergency Department revealed the patient presented as a walk in. The interview revealed the patient presented with a chief complaint of dizziness and urination frequency. The patient stated s/he walked in and the first person seen was at the registration window. The interview revealed the patient was asked for their payment source and insurance card at the time. Patient #1 indicated s/he presented the insurance information prior to triage and prior to seeing the physician.

Interview with the Emergency Department Registration Manager on 2/8/10 at approximately 12:50 p.m. revealed the patient presented as indicated, was walking away from the window, asked the registration clerk if the insurance information was needed, was told yes, and the patient returned to the window prior to any care being provided.

2. Patient #33's Emergency Department (ED) documentation noted a request to transfer for urological services from another acute care facility. The on call urology physician was contacted. The urologist inquired if the patient had insurance. He was advised that the patient did not have insurance and the on call urologist refused to accept the patient. The house supervisor accepted the patient as an ED to ED transfer and the patient was admitted.

Based on clinical records review and review of patient rights information provided by the administrative staff it was determined that the patient's right to participate in the development and implementation of their plan of care was not proved for thirty three (#1-#33) of thirty three records reviewed. This practice does not ensure the patients' right to make informed decisions is maintained.

Finding include:

1. Review of clinical records #1 through #33 revealed the "Bill of Rights and Responsibilities", no date or number, was singed by the patient or appropriate patient representative and placed in the clinical record. Review of the Bill of Rights and Responsibilities, no date or number, presented by the facility's administrative staff on 2/8/10 revealed the same form. The form did not show evidence of the patient's right to participate in the development and implementation of their plan of care.

Based on clinical records review and review of patient rights information provided it was determined that the patient's right to be able to request or refuse treatment was not proved for thirty three (#1- #33) of thirty three records reviewed. This practice does not ensure the patients' right to make informed decisions is maintained.

Finding include:

1. Review of clinical records #1 through #33 revealed the "Bill of Rights and Responsibilities", no date or number, was singed by the patient or appropriate patient representative and placed in the clinical record. Review of the Bill of Rights and Responsibilities, no date or number, presented by the facility's administrative staff on 2/8/10 revealed the same form. The form did not show evidence of the patient's right to be able to request or refuse treatment.

Based on staff interview and document review, the facility:
1. Failed to implement an ongoing program that shows measurable improvement in indicators for areas of reduction of medical errors, infection control monitoring, environmental safety, and adverse patient outcomes (refer to A0265).

2. Did not identify and take measures to reduce medical errors (Refer to A0266.

3. Failed to measure, analyze, and track adverse events or other identified system failures in Nursing, Pharmacy, Dietary, and the Surgical departments (refer to A0267).

4. Failed to use data collected from grievances to monitor of effective and safe patient care (refer to A0275).

5. Failed to set priorities for its performance improvement activities that focus on problem-prone areas specific to the services offered (refer to A0285).

6. Failed to ensure mechanisms that include feedback and learning. throughout the hospital (refer to A0288).

7. Failed to use data to identify opportunities for improvement and changes that will lead to improvement, in that the county health department kitchen sanitation inspection reports were not used to prevent further sanitation violations and prevent repeat violations (refer to A276).

Based on interview and review of the Performance Improvement plan and meeting minutes the facility failed to implement an ongoing program that shows measurable improvement in indicators for areas of reduction of medical errors, infection control monitoring, environmental safety, and adverse patient outcomes. This practice does not provide for action plans to be developed to improve patient outcomes.

Findings include:

Review of the 2010 Performance Improvement (PI) plan indicated the committee along with the administration, the medical staff, and corporate shall set priorities for Performance Improvement that will include monitoring medication administration, and patient satisfaction. The plan provided for evaluation of contracted services and complications as a result of surgery or a procedure. The plan indicated the PI department will ensure appropriate documentation and tracking of PI projects.

1. Patient #17's History and Physical included Benign prostatic hypertrophy, cardiomyopathy, heart failure, atrial fibrillation, and was status post implantable cardioverter-defibrillator (ICD) revision in 2008. The documentation noted no abnormal concerns.

Review of Cardiology consult dated 1/22/10 revealed a consult for Preoperative evaluation. The documentation noted no chest pain, pressure or tightness. and no ICD discharges or congestive heart failure symptoms. Cardiology physician note dated 1/25/10 noted the patient was cleared for surgery. Urology Operative report dated 1/26/10 indicated a complication of an Intraoperative bladder laceration. The documentation noted the initial irrigation via a urinary catheter was not satisfactory and the physician terminated the flow of continuous irrigation. The urinary catheter was replaced, the irrigation was still not working, and the patient developed significant abdominal distention.
Peri operative note completed by the Registered Nurse (RN) revealed irrigations of Normal Saline 3000 milliliter (ml)bags x 15 for a total of 45,000 ml was used.

Interview with Surgery Director on 2/11/10 at 10:00 a.m. confirmed the above. The interview noted 6 irrigation canisters and 2 suction canisters were charged to patient but was unsure if they were used or not. The peri operative documentation showed an Output of 200 ml (no documentation of the type of output)and 500 ml estimated blood loss. There was no evidence of how much irrigation fluid was used on returned. Post Anesthesia Care Unit documentation noted the patient was received at 3:02 p.m. with abdominal distention. Review of Post operative x-rays and lab results showed a- BNP (laboratory study to determine Congested Heart Failure (CHF) dated 1/27/10 of 1140 (Results > 400 = CHF highly probable. Physician progress notes dated 1/27/10 and 1/28/10 indicated the patient was in Congestive Heart Failure. There was no evidence of the operating room Registered Nurse monitoring the amount of fluid that was used for irrigation or the about of irrigation that was returned in a patient who had complication of a bladder laceration during the procedure with the irrigation fluids being placed in the abdominal and pelvic cavity instead of the bladder.
Interview with Interim Risk Manager, Performance Improvement Coordinator, and Chief Nursing Officer on 2/10/10 at approximately 3:40 p.m. revealed the above record had not been reviewed for the surgical complication or lack of nursing documentation concerning the possible of 45.000 ml being infused into a patient abdominal cavity and the patient developing CHF. The interviews noted the physician had been involved in other urological complication during surgery that were not being monitored by Performance Improvement.

2. Review of the Infection Control Plan (2009-2010) and meeting minutes did not show evidence of surveillance rounds being conducted to identify areas of potential cross contamination in dietary or patient care areas or staff compliance with handwashing.

3. Review of clinical records revealed the frequent use of "patient preference" when medications were not given or given late. Interview with the Director of Pharmacy on 2/10/10 at approximately 3:30 p.m. revealed a report is run daily from the automated medication dispensing machine and is given to the nursing department manager for investigation.

Review of PI meeting minutes for 2009 and 2010 did not reveal evidence of this being addressed. Interview with the Chief Nursing officer on 2/10/10 at approximately 3:50 p.m. revealed the selection is made by the nurse and only interviews with the nurse administering the medication would show if the medication was given late, not given, or if it was truly a patient preference. The interview revealed the facility is now beginning to tack and trend this information. The interview revealed no evidence of documented findings or action plan.

4. Review of Risk Management and Patient Safety meeting minutes for 2009 and 2010 did not show evidence of environmental concerns being identified relative of chemical storage in the outpatient care area or environmental cleaning rooms not being secured.

5. Review of two of two non employee Registered Nurse first shift worked 9/19/09 and 2/5/10 did not reveal evidence of an evaluation of clinical activities. Interview with the Chief Nursing Officer on 2/9/10 at approximately 2:30 p.m. revealed non employee licensed staff are evaluated only if they work for ninety days period. The interview noted the Registered Nurse whose first shift was on 9/19/09 provided care for four weeks and has returned for another four week period. There was no evaluation from the first four week period since it was not a ninety day period.

6. Interview with the Interim Risk Manager on 2/11/10 at approximately 10:45 a.m. revealed evidence that grievances having been tracked, trended, or analyzed prior to January 2010 could not be located.

Based on interviews and review of clinical records and documentation the facility did not identify and take measures to reduce medical errors for one (#17)of 33 patients. This practice does not lead to improved patient care.

Findings include:

1. Patient #17's History and Physical included Benign prostatic hypertrophy, cardiomyopathy, heart failure, atrial fibrillation, and was status post implantable cardioverter-defibrillator (ICD) revision in 2008. The documentation noted no abdominal concerns. Review of Cardiology consult dated 1/22/10 revealed a consult for Preoperative evaluation. The documentation noted no chest pain, pressure or tightness. and no ICD discharges or congestive heart failure symptoms. Cardiology physician note dated 1/25/10 noted the patient was cleared for surgery. Urology Operative report dated 1/26/10 indicated a complication of an Intraoperative bladder laceration. The documentation noted the initial irrigation via a urinary catheter was not satisfactory and the physician terminated the flow of continuous irrigation. The urinary catheter was replaced, the irrigation was still not working, and the patient developed significant abdominal distention.
Peri operative note completed by the Registered Nurse (RN) revealed irrigations of Normal Saline 3000 milliliter (ml)bags x 15 for a total of 45,000 ml was used. Interview with Surgery Director on 2/11/10 at 10:00 a.m. confirmed the above. The interview noted 6 irrigation canisters and 2 suction canisters were charged to patient but was unsure if they were used or not. The peri operative documentation showed and Output of 200 ml (no documentation of the type of output) and 500 ml estimated blood loss. There was no evidence of how much irrigation fluid was used on returned. Post Anesthesia Care Unit documentation noted the patient was received at 3:02 p.m. with abdominal distention. Review of Post operative x-rays and lab results showed a- BNP (laboratory study to determine Congested Heart Failure (CHF) dated 1/27/10 of 1140 (Results > 400 = CHF highly probable. Physician progress notes dated 1/27/10 and 1/28/10 indicated the patient was in Congestive Heart Failure. There was no evidence of the operating room Registered Nurse monitoring the amount of fluid that was used for irrigation or the about of irrigation that was returned in a patient who had complication of a bladder laceration during the procedure with the irrigation fluids being placed in the abdominal and pelvic cavity instead of the bladder. Interview with Interim Risk Manager, Performance Improvement Coordinator, and Chief Nursing Officer on 2/10/10 at approximately 3:40 p.m. revealed the above record had not been reviewed for the surgical complication or lack of nursing documentation concerning the possible of 45.000 ml being infused into a patient abdominal cavity and the patient developing CHF.
2. Review of Medical Executive Committee monthly meeting minutes from 2009 and 2010 revealed corporate dashboard results were presented but no evidence of facility department specific quality assurance performance improvement projects or patient adverse events.

Based on interview and review of 2009 and 2010 Performance Improvement (PI) meeting minutes the facility failed to measure, analyze, and track adverse events or other identified system failures in Nursing, Pharmacy, Dietary, and the Surgical departments.

Findings include:

1. Review of clinical records revealed the frequent use of "patient preference" when medications were not given or given late. Interview with the Director of Pharmacy on 2/10/10 at approximately 3:30 p.m. revealed a report is run daily from the automated medication dispensing machine and is given to the nursing department manager for investigation. Review of PI meeting minutes for 2009 and 2010 did not reveal evidence of this being addressed. Interview with the Chief Nursing Officer on 2/10/10 at approximately 3:50 p.m. revealed this selection is made by the nurse and only interviews with the nurse administering the medication would show if the medication was given late, not given, or if it was truly a patient preference. The interview revealed the facility is now beginning to track and trend this information. The interview revealed no evidence of documented findings or action plan. There was no evidence of the pharmacy being involved in ongoing monitoring or identifying trends of "patient preference".
2. Interview with the Interim Risk Manager on 2/11/10 at approximately 10:45 a.m. revealed evidence that grievances having been tracked, trended, or analyzed prior to January 2010 could not be located.

3. Review of an adverse patient incident that occurred on 1/26/10 had not been reviewed. Interview with Interim Risk Manager, Performance Improvement Coordinator, and Chief Nursing Officer on 2/10/10 at approximately 3:40 p.m. revealed the record had not been reviewed for the surgical complication or lack of nursing documentation concerning the possibility of 45.000 milliliters being infused into a patient abdominal cavity and the patient developing Congested Heart Failure. The interviews noted the physician had been involved in other urological complication during surgery.

Based on interview and review of Performance Improvement (PI) meeting minutes for 2009 and 2010, the facility failed to use data collected from grievances to monitor of effective and safe patient care. This practice does not provide for improved patient care.

Findings include:

1. Interview with the Interim Risk Manager on 2/11/10 at approximately 10:45 a.m. revealed evidence that grievances had been tracked, trended, or analyzed prior to January 2010 could not be located and possibly not assessed.

Based on record review and staff interview, the hospital failed to use data to identify opportunities for improvement and changes that will lead to improvement, in that the county health department kitchen sanitation inspection reports were not used to prevent further sanitation violations and prevent repeat violations. This practice does not identify opportunities for improvement and changes that will lead to improvement for kitchen sanitation and food safety for the hospital patients and staff.

Findings include:

The hospital receives kitchen sanitation inspections from the local county health department on a quarterly basis. The hospital had inspections on 3/24/09 and 7/15/09. A review of these reports showed the same violation was identified twice, about a stove drip pan.
Interview with the Food Service Director on 2/09/10 at 9:53 a.m., revealed that these health department sanitation inspection violations were corrected by staff in-service. The Food Service Director was asked what happens to the results of these inspections after that and she said the reports are filed in her office. She was asked if these are brought forward to the Quality Assurance and Performance Improvement (QAPI)committee or infection control program and she replied that they were not. Therefore, the hospital-wide QAPI program did not use this data to identify opportunities for improvement and changes that would lead to improvement .

Based on Performance Improvement (PI) meeting minutes and interviews it was determined that the facility failed to set priorities for its performance improvement activities that focus on problem-prone areas specific to the services offered. This practice does not allow for areas of improvement to be identified.

Findings include:

1. Review of an adverse patient incident that occurred on 1/26/10 had not been reviewed. Interview with Interim Risk Manager, Performance Improvement Coordinator, and Chief Nursing Officer on 2/10/10 at approximately 3:40 p.m. revealed the record had not been reviewed for the surgical complication or lack of nursing documentation concerning the possibility of 45.000 milliliters being infused into a patient abdominal cavity and the patient developing Congested Heart Failure. The interviews noted the physician had been involved in other urological complication during surgery. Review of PI meeting minutes for 2009 and 2010 did not show evidence of the urological services being identified as an area for improvement.

Based on interviews and review of documentation, the facility failed to ensure [mechanisms that include feedback and learning throughout the hospital. This practice does not provide for improved quality of care in all areas.

Findings include:

1. Interview with the Performance Improvement (PI) Coordinator and Laboratory Director on 2/10/10 at approximately 3:40 p.m. revealed the Laboratory was tracking and trending critical lab value for 2009 with improvement. Review of of PI meeting minutes for 2009 did not show evidence of the study being conducted.

Interview with the Performance Improvement Coordinator revealed no knowledge of the dietary reach in freezer having been out of range since 3/09. Interview with Department heads from Pharmacy, Laboratory, Surgery, Infection Control, Outpatient Services, and the Emergency Department revealed studies that had occurred in 2009 and 2010 that were not reflected in the Performance Improvement meeting minutes that could provide learning opportunities throughout the facility.

Based on staff interviews and review of clinical records it was determined that the facility did not ensure the Nursing care and services met the needs of the dialysis patients. The facility:

1. Failed to evaluate and supervise care for (#17 #2, #3, #5) of thirty three records reviewed (refer to A0395).

2. Failed to provide for an evaluation of the clinical activities for two of two non employee licensed nurses reviewed.

3. Failed to provide medication administration according to physicians orders for 4 (#11, #13, #2, #4) of 33 patients. This practice does not promote for the safe administration of medications.

The practice does not ensure the patients; safety, highest level of practicable well being, and goals are achieved.

Based on interviews and review of clinical records, policies, and procedure it was determined that the the Registered Nurse failed to evaluate and supervise care for six (#17, #2, #3, #5, #13, #22) of thirty three records reviewed. This practice does not provide for safe nursing care, may cause a delay in discharge, or ensure that patient goals are met.

1. Patient #17's History and Physical cardiomyopathy, heart failure, atrial fibrillation , and was status post implantable cardioverter defibrillator (ICD) revision in 2008. The documentation noted no abdominal concerns. Review of Cardiology consult dated 1/22/10 revealed a consult for Preoperative evaluation.. The documentation noted no congestive heart failure (CHF) symptoms. Urology Operative report dated 1/26/10 indicated a complication of Intraoperative bladder laceration. The documentation noted the initial irrigation via the urinary catheter was not satisfactory and the physician terminated the flow of continuous irrigation. The urinary catheter was replaced, the irrigation was still not working, and the patient developed significant abdominal distention.
Peri operative note completed by the Registered Nurse (RN) revealed Irrigations of Normal Saline 3000 milliliter (ml)bags x 15 for a total of 45,000 ml was used. Interview with Surgery Director on 2/11/10 at 10:00 a.m. confirmed the above. The interview noted 6 irrigation canisters and 2 suction canisters were charged to patient but was unsure if they were used or not. The peri operative documentation showed and Output of 200 ml (no documentation of the type of output) and 500 ml estimated blood loss. There was no evidence of how much irrigation fluid was used on returned. Post Anesthesia Care Unit documentation noted the patient was received at 3:02 p.m. with abdominal distention. Review of Post operative lab results showed a BNP (used to determine CHF)dated 1/27/10 of 1140 (Results > 400 = CHF highly probable. Physician progress note dated 1/27/10 and 1/28/10 indicated the patient was in CHF. There was no evidence of the operating room Registered Nurse monitoring the amount of fluid that was used for irrigation or the amount of irrigation that was obtained in a patient who had complication of a bladder laceration during the procedure with the irrigation fluids being placed in the abdominal and pelvic cavity instead of the bladder.

2. Patient #17's physician orders dated 1/27/10 at 10:00 a.m. instructed for an Incentive Spirometer every 2 hours while awake. Respiratory documentation noted the initial treatment/training was done at 2:30 p.m. Review of nursing documentation did not show evidence of the nursing staff ensuring the patient was utilizing the incentive inspironmeter as ordered. Interview with the Director of the Intensive Care unit on 2/11/10 at 1:00 p.m. confirmed the findings that nursing was responsible for the continued use of the inspironmeter and there was no evidence of the care being provided.
3. Patient #2's physician orders dated 1/12/10 5:20 p.m. instructed for blood glucose levels to be obtained before meals and at bedtime with insulin coverage to be per the sliding scale. Review of the Medication Administration Record (MAR)did not show the bedtime blood glucose was obtained on 1/12/10. MAR documentation at 12:20 a.m. indicated the blood sugar level was low. Review of the MAR did not show evidence of the blood glucose levels being obtained. Interview with the Chief Nursing Officer on 2/8/10 at approximately 3:20 p.m. confirmed the findings.

4. Patient #3 physician orders dated 1/31/10 date 7:34 a.m. instructed for Sequential Compression Device (SCD)and Ted hose to be applied. Review of nursing notes did not show evidence of the SCD or Teds hose being applied until 9:00 p.m. There was no documentation of the Ted hose being applied. Interview with the Chief Nursing Officer on 2/8/10 at approximately 3:20 p.m. confirmed the findings.

5. Patient #5's physician orders date 1/25/10 at 8:00 p.m. instructed for neurological checks every two times three. Review of nursing documentation dated 1/25/10 revealed the checks were preformed at 8:00 p.m. and 10:00 p.m. There was no evidence of the check being performed at 12:00 a.m. Interview with the Chief Nursing Officer on 2/9/10 at 2:30 p.m. confirmed the above findings.

6. Patient #13 was admitted on 2/01/10 for hypertension and was on dialysis. Review of the physician orders revealed an order on 2/05/10 for orthostatic blood pressure lying and standing every morning and to record. Review of the nursing notes and vital sign records revealed no documentation of orthostatic blood pressures. Interview on 2/09/10 at 11:45 a.m. with the primary registered nurse assigned care of this patient confirmed no documentation of orthostatic blood pressure. She stated she was not aware of a physician order for orthostatic blood pressure.

7. Patient #13's history and physical revealed a history of renal failure, dialysis, and diabetes. Physician order on 2/01/10 instructed for accuchecks (blood glucose test) every 6 hours with low sliding scale coverage. Documentation on 2/04/10 at 12:09 p.m. revealed the patient's accucheck was 39 (70-110). Nursing notes revealed the patient was given juice and crackers and the accucheck was re-checked at 12:34 p.m. with a blood glucose result of 49. Nursing notes revealed the physician was notified and orders were received at 12:45 p.m. Physicians order on 2/04/10 at 12:45 p.m. was to give 1 ampule of D50 (Dextrose 50%) intravenous now and re-check blood glucose in 1 hour. MAR (Medication Administration Record) revealed the D50 was administered at 12:58 p.m. The primary RN (registered nurse) assigned care of this patient was interviewed on 2/09/10 at 11:45 a.m. and asked for the facility's protocol for a patient with hypoglycemia (low blood sugar). She stated she was not aware of a protocol. The CNO (Chief Nursing Officer) was interviewed on 2/04/10 at 11:40 a.m. and asked for a copy of the protocol or policy and procedure for a patient with a hypoglycemic episode. She confirmed the facility does not have a protocol or policy and procedure for a patient with a hypoglycemic episode.

8. Patient #22's had an order for a wrist restraint on 2/01/10 at 1:00 a.m., which was signed by a physician. The form used to order restraint had wrist restraints checked. The restraint order form had a place on the form to circle "L" for left and "R" for right wrist restraint, but neither of these were circled. The form also indicated that the reason for the wrist restraint was because the patient was a high risk for falls, not because the patient was at risk for pulling/removing tubes for medical necessity. The corresponding nurse progress note indicated that the patient pulled out the urinary catheter tube, the physician was called and the catheter was discontinued. On 2/10/10 at 10:25 a.m., interview with the Chief Nursing Officer (CNO) indicated after she reviewed the record, patient #22 had a peripheral intravenous (IV) access at the time of the wrist restraint. She also stated that the form should have noted that bilateral wrist restraints were used by the nurse and that the reason for restraint was to prevent the patient from pulling out any tubes.
























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Based on interview and review of personnel files it was determined the Chief Nursing Officer failed to provide for an evaluation of the clinical activities for two of two non employee licensed nurses reviewed. This practice does not promote patient safety.

Findings include:

1. Review of two non employee Registered Nurses (RN) whose first shift worked on 9/19/09 (RN #1) and 2/5/10 (RN #2) did not reveal evidence of an evaluation of clinical activities. Interview with the Chief Nursing Officer on 2/9/10 at approximately 2:30 p.m. revealed non employee licensed staff are evaluated only if they work for a ninety days period. The interview noted the Registered Nurse #1 whose first shift was on 9/19/09 provided care for a four weeks contract period and has returned for another four week period. There was no evaluation from the first four week period since it was not a ninety day period. The interview noted RN #2 had not been there for ninety days and would not be evaluated until that time

Based on record review and interview, it was determined that the Nurses did not provide medication administration according to physicians orders for 4 (#11, #13, #2, #4) of 33 patients. This practice does not promote for the safe administration of medications.

Findings include:

1. Patient #13 physician orders dated 2/04/10 for a PICC (peripherally inserted central catheter) instructed to flush with 10 ml (milliliter) NS (Normal Saline) every shift and before and after medication administration. Review of the MAR (Medication Administration Record) and nursing notes revealed no documentation of NS flush every shift or before and after medication administration. Interview on 2/09/10 at 11:45 a.m. with the primary Registered Nurse assigned care of the patient confirmed no documentation of the NS flush.

2. Patient #11 physician order dated 2/06/10 at 3:00 p.m. instructed for IV (Intravenous) Vancomycin 1.5 gm (grams) every 12 hours. Review of the MAR revealed on 2/09/10 the dose scheduled for 8:00 a.m. was not given. The reason documented on the MAR was "delayed". An entry on the MAR at 5:41 p.m. stated "omitted". Review of nursing documentation revealed no further explanation for the medication to be omitted. Interview with the charge nurse and pharmacist on 2/10/10 at 2:25 p.m. confirmed the 8:00 a.m. scheduled Vancomycin was not given as ordered by the physician.



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3. Patient #2's physician orders dated 1/12/10 instructed for Plavix daily and Lopressor twice a day. Review of the Medication Administrating Record (MAR) dated 1/12/10 at 2:46 p.m. indicated the medication was not administered due to patient preference. Review of the nursing documentation revealed the patient refused the medication until the patient spoke with the physician. There was no evidence of the physician being notified. Review of the MAR dated 1/13/10 for the Plavix revealed the patient took their own medication. There was no evidence of a physician order for the patient to take their own mediations. Review of policy and procedure "Care of the Patient Medication Administration 13-01.03 dated 6/08 indicated a physician order is required for a patient to take their own medications.

4. Patient #4's physician orders date 1/14/10 at 3:00 a.m. instructed for Lasix, Lopressor, and Lisinopril daily. Review of the MAR dated 1/14/10 revealed the medications were not administered as ordered. Interview with the Chief Nursing Officer on 2/8/10 at approximately 3:20 p.m. confirmed the findings.

Based on record review and staff interview the facility failed to obtained consent for one (#19)of 33 reviews Blood transfusions were not administered with proper informed consent. This practice does not ensure a patient's right to informed consent is maintained.

Findings:

1. Patient #19 was admitted on 2/01/10, had end stage renal disease and hemodialysis treatments. There was a written consent form dated 2/01/10 for blood transfusion therapy. This form did not specify which blood product the patient was to receive, and the form was signed by the patient and witness. Physician's order dated 2/01/10, indicated to transfuse 2 units of PRBC (packed red blood cells). Interview with a nurse on the unit confirmed the consent form was not complete.

Based on observation and interview, the facility failed to properly store laboratory reports in a location where they were protected from water damage. This practice does not ensure records are secure for future needs.

Findings:

During tour of the laboratory department, on 2/10/10 between 9:20 a.m. and 10:00 a.m., there were 4 covered file boxes of stored printed laboratory reports stored on a cart. The cart was located between the employee bathroom and the supply room. The cart was stored close enough to an emergency shower and eye wash station that it was possible for these records to be splashed if the shower was used.

Based on observation, interview, and record review the facility failed to ensure that all drugs and biologicals were kept in a secure area. Not appropriately securing and locking medications could lead to medication diversion or accidental ingestion.

Findings include:

1. Observations were conducted of the Outpatient Clinical Wound Care Department with the Wound Care Program Director on 2/09/10. An observation was made of the Clean Holding Room with the Wound Care Program Director and the Registered Nurse on 2/09/10 at 10:00 a.m. and again at 10:45 a.m. Medications were being stored in an unlocked cabinet in the unlocked room. The room was in the same hall, and near the three patient treatment rooms. Items found unsecured included three 30 cc (cubic centimeters) bottles of Lidocaine HCL (Hydrochloride) 2% and one tube of Econazole Nitrate Cream 1%. It was also verified that Lidocaine Viscous was also routinely stored in there but that the Registered Nurse currently was using the last container.
The Director and the Registered Nurse verified that the cabinet and the door are not usually locked.
Non licensed staff and a patient with Dementia were observed to be present in that same hall during the time of the observations.

Record review of the facility policy and procedure revised January 2010 for the Department of Pharmacy and titled Security of Staff and Drugs stated that "Security of drug storage areas shall be kept in locked storage" and that "Access to drug storage areas is limited to pharmacy personnel and persons authorized to handle and administer these drugs. Medication rooms shall be locked."

2. Observations were conducted of the Outpatient Center for Therapy and Wellness with the Interim Director on 2/09/10 at 2:30 p.m. An observation of the Private Patient Treatment Room revealed a 1000 cc (cubic centimeters) sized bottle of Sterile Water for Irrigation. The used bottle had not been dated when opened and had approximately 900 cc were remaining. The observation was confirmed with the Physical Therapist who was working on 2/09/10 at 2:30 p.m. The Therapist verified that she had not opened the bottle but that it should have been dated as to when it had been opened.

Record review was conducted of the facility policy and procedure, with the Effective Date of 4/01/05, for the Department of Pharmacy and titled " Infection Control Multiple Use Sterile Drugs " . The policy and procedure included that " Multiple-use containers of sterile drugs shall be dated when first opened or entered.

Based on observation and staff interview, the hospital did not ensure proper storage of radiation monitoring badges when not in use. This practice does not provide for patient and staff safety.

Findings:

During tour of the Medical Imaging Department on 2/09/10 at 11:35 p.m. there were about a dozen employee radiation monitoring badges, a radiologist. and a control monitoring badges that were not in use. They were stored on a rack on a wall behind the door entry to the Medical Imaging Department. The entrance was not secured from the corridor. The radiation monitoring badges were identified with the user's names. The interim Director of the Medical Imaging Department was informed at this time.

On 2/10/10 at 2:13 p.m. when walking down the corridor near the Medical Imaging Department, the entrance door was propped open as the housekeeper was cleaning in the department. The radiation monitoring badges were not protected from loss or tampering. The hospital Chief Operating Officer was informed at the time.

Based on record review and staff interview, the facility failed to have written policies approved by the medical staff and a pathologist that state which tissue specimens require a macroscopic examination and which tissue specimens require both macroscopic and microscopic examination. This practice does not ensure accuracy of testing for laboratory testing.

Findings:

During tour of the laboratory department on 2/10/10 at approximately 9:50 a.m. the Laboratory Director was interviewed about whether they have a written policy approved by the medical staff and a pathologist that state which tissue specimens require a macroscopic examination and which tissue specimens require both macroscopic and microscopic examination. She replied that they did not because the hospital's pathology services are contracted and that the laboratory does not touch the pathology specimens. The Laboratory Director was given an opportunity to look further for a written policy. Various written laboratory policies were provided throughout the rest of the day, but none of them addressed which tissue specimens require a macroscopic examination and which tissue specimens require both macroscopic and microscopic examination. The Laboratory Director was interviewed again at 11:30 a.m. on 2/10/10, and she stated that the policy information was included in the pathology services contract. Review of the contract on 2/10/10 revealed there was no information that addressed which tissue specimens require a macroscopic examination and which tissue specimens require both macroscopic and microscopic examination. No further written policies were provided during the survey.

Based on observation, staff interview and review of administrative records, policies and procedures, and kitchen temperature monitoring logs, it was determined that the hospital was not staffed by adequate personnel to ensure the nutritional needs of patients were met in accordance with practitioners' orders and acceptable standards of practice. The facility:

1. Failed to ensure that patients diet orders were provided as prescribed by the practitioner (refer to A630).

2. Failed to ensure that staff were competent in their duties in regards to food handling and kitchen sanitation to prevent the potential for food borne illness (refer to A622, and A747)

These practices do not ensure the provision of quality food service regarding food safety, kitchen sanitation, and patient diets.

Based on observation, staff interview, and record review, the Food and Nutrition Services staff did not demonstrate competency in their respective duties related to food handling, kitchen sanitation, and preparation of diets. This practice does not ensure that patients are protected against food borne illness and that their nutritional needs are met.

Findings include:

1. The hospital did not ensure that the kitchen reach-in production freezer maintained proper temperature to ensure that food was stored at safe temperature. During tour of the hospital kitchen on 2/08/10 at 11:13 a.m., the temperature on the exterior digital display of the double door Traulsen reach-in freezer unit located near the tray line was 37° Farenheit (F). There were no thermometers inside the unit. The food stored in the freezer felt solidly frozen at the time. There were dinner rolls, individual containers of ice cream, and bags of frozen French Fries stored in this unit. The Food Service Director was asked what was the maximum temperature of the freezer should be and she replied (+)10° F.
On 2/09/10 at 9:53 a.m. The same freezer unit was examined again and the exterior digital display was flashing with the letters "def" (defrost). There were two thermometers located inside the freezer, a dial-type and red liquid filled type and both read 40°F. The ice build up on the interior ceiling of the unit was melting. The Food Service Director was informed at the time. The refrigeration temperature log was requested and reviewed. The temperature on the log for 2/09/10 was recorded as (+) 15.1° F. The temperature log form indicated that the freezer temperature should be between the minimum temperatures of (-)10° F and maximum temperature of 0° F. All of the recorded temperatures for the freezer unit were above the maximum temperature of 0° F for the month of February 2010. These recorded temperatures ranged from 14.5 to 17.9° F. This was discussed with a the Food Service Director at the time. The Food Service Director then communicated this to the kitchen staff person that this should be reported. The Food Service Director proceeded to put in a work order for the freezer. No corrective action for the freezer had been taken until the surveyor intervention. The Food Service Director was asked for the temperature logs prior to February. These were reviewed back as far as March 2009, and the freezer temperature was not found to be 0° F or below for the past 11 months. There were a few instances in which the temperature was above 32° F, but none of the temperatures were above 41° F. The freezer temperatures were recorded once a day when the kitchen is opened in the morning at approximately 7:00 a.m.
On 2/11/10 at 8:40 a.m., the Director of Plant Operations was interviewed about the kitchen freezer. According to the Director of Plant Operations, the hospital did not have a preventative maintenance program for the kitchen refrigeration units. He also stated that he was not alerted to any problems with the freezer in the past year, from the time he was hired for this position. The Director of Plant Operations added that a service company was called and checked out the freezer unit yesterday, and they found that the freezer compressors were functioning properly, but the temperature sensor malfunctioned. A new digital display unit part is on order. The Director of Plant Operations indicated that he will add a preventative maintenance program for the kitchen refrigerators monthly and will do weekly checks on the specific reach-in freezer until the problem is resolved.

2. The Food and Nutrition Services staff did not take measure to minimize potential cross contamination of food and food contact surfaces. During the tour of the kitchen on 2/08/10 at 10:43 a.m., a cook was asked to check the internal temperature of hot food held in a hot food holding cabinet. The cook was asked if the thermometer was sanitized before inserting it the food. He replied that it was earlier. He was asked to demonstrate this process. He took the thermometer and washed it in soapy water in a sanitizer bucket near a preparation sink, used a spray bottle of quaternary ammonium sanitizing solution to spray the thermometer probe. He said that he had to wait until the probe dried before use. Interview with the Food Service Director on 2/09/10 at 9:53 a.m. about the facility policy regarding the proper sanitizing of thermometers. She explained that the thermometer probes should be washed, rinsed and sanitized in quaternary solution, air dry and swab with disposable alcohol wipe.

During the kitchen tour on 2/08/10 at 10:43 a.m., a staff person was wearing gloves during food preparation. and picked up a pen and wrote on a form; then touched her forehead; went to drop a basket of fries in the fryer; and then went to get a clean pan. She did not change her gloves after touching her face. At 11:15 a.m., there was a sanitizer bucket with several preparation utensils, such as a whisk and scoop stored in soapy water in one basin of the two compartment preparation sink. There was also a spray bottle of quaternary ammonium solution stored on the preparation counter.
At approximately 11:30 a.m., a staff person was cleaning the preparation counter while another staff person was mixing gravy in a container next to this activity. At 11:35 a.m., a staff person brought a bag of raw frozen chicken breasts to thaw under cold running water in the preparation sink. The staff person was wearing gloves during this task. She left to do another task and returned with a new pair of gloves, but did not wash her hands before donning clean gloves. This same employee removed a cutting knife from the preparation sink where the chicken was defrosting under cold water, left the area, returned with the knife, wiped it with a paper towel, and placed it back into the knife holder. At 12:35 p.m., there was a kitchen staff person cleaning a stainless steel cart near the fryer in the preparation area. There was food preparation occurring in this area at the time.

3. The Food and Nutrition Services staff did not ensure that the kitchen equipment and areas were kept sanitary and did not ensure that all equipment was properly cleaned and sanitized.

During the kitchen tour on 2/08/10 at 10:43 a.m., the following observations were made:
There were multiple sheet pans, at least 10 or more, observed with an accumulation of carbon/grease build up on bottom and sides. The manual can opener base was soiled with black mold-like residue in the salad preparation area. In the main preparation area, the manual can opener shaft holder had an accumulation of food residue. There were several cutting boards with multiple stains that could not be removed. The exterior surface of the kitchen garbage cans were observed to be soiled with a black substance. The two tiered cart located next to the soiled end of the three compartment sink was heavily soiled.
There were several clean and sanitized plastic food storage containers with old adhesive labels remaining on the exterior surface observed in the walk-in refrigerators. There were several ceiling tiles near the ceiling vent which had a a spray pattern of dust. There were clean and sanitized pots and pans which were stored on stainless steel carts that were soiled in the dish machine area. Access to the hand wash sink in the dish machine area was blocked by these carts.
The mop bucket and wringer located in the utility closet was heavily soiled with a black substance. Staff person washing dishes manually in the three compartment sink did not properly sanitize pots and pans in the chemical sanitizing solution. He dipped the pans and pots for about 5 seconds maximum, rather than completely immersing them for a minimum of 30 seconds. The Food Service Director observed this at the same time.

4. The Food and Nutrition Services staff did not ensure that diet were prepared according to physician's orders. During the lunch tray line on 2/08/10 at 12:35 p.m., the food items for the lunch meal were reviewed and compared to the prepared menu extensions. The menu had an extension for a GI (gastrointestinal) soft diet and a mechanical soft diet. The menu for the GI (gastrointestinal) soft diet indicated that carrots were to be served. There were no carrots observed on the tray line steam table, only broccoli. The Food Service Director was asked the time if carrots were prepared and she replied that they weren't. There was a patient tray on the tray line which called for a GI soft diet and was served broccoli. The Food Service Director was asked about serving broccoli, instead of carrots for the soft diet. She replied that this could be the patient's choice. She was asked how would you know if it is the patient's choice from the patient tray slip and she said it would be written on the tray slip. The tray slip was reviewed, and there was no preference written on it for broccoli.
During observation of tray service on the second floor at 1:10 p.m., the meal tray was observed to be served to patient #22. Patient #22's tray slip indicated a soft diet and broccoli was served rather than carrots. The tray slip did not indicate any food preferences on it.
Patient #22's physician order instructed for a soft and cardiac diet on 2/10.
Interview with the hospital Registered Dietitian on 2/11/10 at approximately 8:30 a.m. indicated that when a physician orders a "soft" diet, the patient is served a GI soft diet, not a mechanical soft diet. She stated that a GI soft diet was supposed to receive carrots, rather than broccoli for the Monday lunch meal according to the hospital menu and the carrots should have been prepared for this meal.

Based on observation, record review and interview, the facility failed to ensure that one (#22) of 33 patients diet order was provided as prescribed by the practitioner. This practice does not ensure patient goals and safety are met.

Findings:

During the lunch tray line on 2/08/10, the food items for the lunch meal were reviewed and compared to the prepared menu extensions. The menu had an extension for a GI (gastrointestinal) soft diet and a mechanical soft diet. The menu for the GI (gastrointestinal) soft diet indicated that carrots were to be served. There were no carrots observed on the tray line steam table, only broccoli. The Food Service Director was asked at that time if carrots were prepared and she replied that they weren't. There was a patient's tray on the tray line which called for a GI soft diet and was served broccoli. The Food Service Director was asked about serving broccoli, instead of carrots for the soft diet. She replied that this could be the patient's choice. She was asked how would you know if it is the patient's choice from the patient tray slip and she said it would be written on the tray slip. The tray slip was reviewed, and there was no preference written on it for broccoli.
During observation of tray service on the second floor, the meal tray was observed to be served to patient #22. Patient #22's tray slip indicated a soft diet and broccoli was served rather than carrots. The tray slip did not indicate any food preferences on it.
Review of patient #22's physician orders noted a soft diet and a cardiac diet.
Interview with the hospital Registered Dietitian on 2/11/10 indicated that when a physician orders a "soft" diet, the patient is served a GI soft diet, not a mechanical soft diet. She stated that a GI soft diet was supposed to receive carrots, rather than broccoli for the Monday lunch meal according to the hospital menu and the carrots should have been prepared for this meal.

Based on observation, interview, and record review the facility did not ensure that a safe and clean environment was maintained. The facility did not maintain a system for patients to have immediate nurse call access. Failed to maintain equipment. Failed to properly store hazardous materials. Failing to maintain a safe and clean environment could lead to the spread of infection and the ingestion of poison.

Findings include:

1. Observation was made of the Acute Care Unit with the Nurse Manager on 2/08/10 at 10:45 a.m. A Biohazards Room was observed to contain one large gray bucket with soiled bagged items inside. The bucket was so full that the lid would not close.

2. Observation was made of the Post Surgical Unit with the Performance Improvement Coordinator on 2/08/10 at 11:00 a.m. The Patient Nutrition Room contained a heavily soiled microwave.

3. Observation was made of the Progressive Care Unit on 2/08/10 at 11: 20 a.m. A patient's room was observed to have a suction machine canister that was 2/3 full of a light green colored liquid. The Registered Nurse, who was also present during the observation, indicated that the liquid was probably a combination of mouth cleaner and sputum.

4. Observation was made of the Post Surgical Unit with the Performance Improvement representative on 02/08/10 at 11:25 a.m. The Patient Nutrition Room was observed to contain a microwave. The inside of the microwave was heavily damaged with the majority of inside paint missing and the remaining paint was bubbled.

5. Observation was made of the Emergency Department on 2/08/10 at 12:10 a.m. with the Emergency Department Director. The Supply and Equipment Room was observed. Observation noted an opened Irrigation Tray. Manufacturer documentation on the package indicated that it was sterile until opened. The ceiling tile in the room had evidence of a water leak.

6. Observation was made of the Intensive Care Unit on 2/08/10 at 1:00 p.m. with the Intensive Care Unit Director. The Medication Room was observed to contain patient care items being stored immediately on the counter of one side of the hand washing sink, including under the sink paper towel holder. The items were observed being stored in the direct vicinity where they would potentially become wet and contaminated.

7. During tour of the intensive Care Unit on 2/8/10 at approximately 12:55 p.m. the medication room was observed. The observation revealed a bath basin with residue on the bottom and sides next to the hand washing sink. Interview with the Intensive Care Unit Director during the tour revealed the basin was used to place medications that were to be returned to pharmacy. The observation revealed the potential for the medications and basin to become wet during the use of the sink.

8. Observations were conducted of the Outpatient Clinical Wound Care Department with the Wound Care Program Director on 2/09/10 at 9:45 a.m. The Environmental Services Closet was found to be on the same hall as patient treatment rooms and at the opposite end of the nursing station. The door to the room was observed to have a key in the key lock of the door handle. The door was readily accessible. Inside the closet were various bottle of cleaning agents. Warnings on the bottles included " Avoid contact with eyes and skin " and " Do not drink or inhale " . The Director was interviewed during the observation. She verified that the key was in the door handle and that the Environmental Cleaning Representative comes in the afternoon and currently was not in the building. She verified the key should not have been stored in the door handle.

9. Observations were conducted of the Outpatient Center for Therapy and Wellness with the Interim Chief Executive Office on 2/09/10 at 2:46 p.m. An observation of the Environmental Services Closet revealed it was located in the near vicinity to the water fountain and the patient bathroom. The closet was not locked and was found to contain numerous cleaning chemicals that were readily accessible. The Interim Chief Executive Officer confirmed the findings

10. Observation was made of the outpatient Women ' s Wellness Center on with the Registered Radiologist Technician (RRT) and the Outpatient Director on 2/10/10 at 8:55 a.m. The Storage Room contained a table/stand with a mini refrigerator identified by the RRT as being used to store fluids for patients including juices, soda, water, and coffee creamer. On top of the refrigerator was a 22 ounce spray bottle of a cleaning agent. The bottle included manufacturer statements, Keep out of Reach of Children and Caution, Hazardous to Humans and Animals. The RRT confirmed that she uses the cleanser to clean that area and keeps the bottle on top of the refrigerator.

Review of the facility ' s policy and procedure titled Chemical Storage Practices with effective date of 5/08 was reviewed. The document noted under " The following procedures are basic guidelines for the safe handling and storage of hazardous chemical and materials". Storage Practices included, "The storage area should be secure, and out of the normal traffic pattern ... " .

11. Observation was made of the Emergency Department on 2/08/10 at 12:10 a.m. with the Emergency Department Director. Patient #1 was observed alone in bed in a private patient area. The call light was not within the reach of the patient. The call light was observed being stored at its base against the wall several feet behind the patient's bed. The patient was interviewed during the observation and was asked how s/he would call for the nurse if assistance was needed. S/he indicated that s/he was not sure and then indicated that s/he would need to yell for help. This finding was confirmed with the Emergency Department Director.

12. Observation was made of the outpatient Women ' s Center for Wellness on 2/10/10 at 8:50 a.m. with the Interim Director, the Outpatient Director, and the Registered Radiologist Technician. It was verified that that neither of the two patient bathrooms at the center contained a nurse call system.

Based on observation and staff interview, the hospital failed to maintain equipment and supplies to ensure an acceptable level of safety and quality. The facility did not ensure that a kitchen reach-in freezer was maintaining proper temperature, did not maintain enough non-perishable food supply for emergency/disaster situations according to State law; and maintain food supplies within the manufacturer's use-by date. This has the potential to affect all patients who eat orally.

Findings:

1. The hospital did not ensure that the kitchen reach-in production freezer maintained proper temperature to ensure that food was stored at safe temperatures. During tour of the hospital kitchen on 2/08/10 at 11:13 a.m., the temperature on the exterior digital display of the double door Traulsen reach-in freezer unit located near the tray line was 37° Farenheit (F). There were no thermometers inside the unit. The food stored in the freezer felt solidly frozen at the time. There were dinner rolls, individual containers of ice cream, and bags of frozen French Fries stored in the unit. The Food Service Director was informed at that time. The Food Service Director was asked what should be the maximum temperature of the freezer and she replied (+)10° F.
On 2/09/10 at 9:53 a.m., the same freezer unit was examined again and the exterior digital display was flashing with the letters "def" (defrost). There were two thermometers located inside the freezer, a dial-type and red liquid filled type and both read 40°F. The ice build up on the interior ceiling of the unit was melting. The Food Service Director was informed at the time. The refrigeration temperature log was requested and reviewed. The temperature on the log for 2/09/10 was recorded as (+) 15.1° F. The temperature log form indicated that the freezer temperature should be between the minimum temperatures of (-)10° F and maximum temperature of 0° F. All of the recorded temperatures for this freezer unit were above the maximum temperature of 0° F for the month of February 2010. These recorded temperatures ranged from 14.5 to 17.9° F. This was discussed with a the Food Service Director at the time. The Food Service Director then communicated this to the kitchen staff person that this should be reported. The Food Service Director was advised to remove the food from this freezer until the equipment was working properly. The Food Service Director proceeded to put in a work order for the freezer. No corrective action for the freezer had been taken until the surveyor intervention. The Food Service Director was asked for the temperature logs prior to February. These were reviewed back as far as March 2009, and the freezer temperature was not found to be 0° F or below for the past 11 months. There were a few instances in which the temperature was above 32° F, but none of the temperatures were above 41° F. The freezer temperatures were recorded once a day when the kitchen is opened in the morning at approximately 7:00 a.m..
On 2/11/10 at 8:40 a.m., the Director of Plant Operations was interviewed about the kitchen freezer. According to the Director of Plant Operations, the hospital did not have a preventative maintenance program for the kitchen refrigeration units. He also stated that he was not alerted to any problems with the freezer in the past year, from the time he was hired for this position. The Director of Plant Operations added that a service company was called and checked out the freezer unit yesterday, and they found that the freezer compressors were functioning properly, but the temperature sensor malfunctioned. A new digital display unit part is on order. The Director of Plant Operations indicated that he will add a preventative maintenance program for the kitchen refrigerators monthly and will do weekly checks on specific reach-in freezer until the problem is resolved.

2. The hospital did not maintain enough non-perishable food supply for emergency/disaster situations according to State law. During a tour of the hospital kitchen and dry food storage area on 2/08/10 at 12:23 p.m. , there did not appear to be a one week supply of non-perishable food on hand to serve the hospital's current census of 56 patients. There was very little protein-type foods available in the storeroom and no non-perishable foods representing the milk group. The Food Service Director stated at that time she could call her food vendor to have this supply delivered in the event of a disaster. The hospital's food service contract written policy, titled "Fire and Emergency Preparedness", issued on May 1995 and revised on February 2006 was reviewed. This policy stated that "As required by State/Local regulations, maintain a 3 day supply of perishable food, a 3 day supply of non-perishable food , a 3 day supply of 3 gallons of water per person per day and a 3 day supply of disposable ware." "You must review your account's disaster poly and if it exceeds these amounts, please follow the account's disaster plan guidelines". State law, 59A-3.2085(1)(i)(6), requires that "The dietetic department, service or other similarly titled unit is guided by written policies and procedures that cover food procurement, preparation and service. Dietetic department policies and procedures are developed by the director of the dietetic department with nutritional care policies and procedures developed by a registered dietitian, subject to annual review, revised as necessary, dated to indicate the time of last review, and enforced. Written dietetic policies shall include at least the following: A requirement that a supply of non-perishable foods sufficient to serve a hospital's patients for at least a one week period be available".

3. The hospital did not maintain food supplies within the manufacturer's use-by date to ensure quality and freshness. During tour of the hospital central supply area on 2/09/10 at 10:21 a.m., there were 2 cases of Ensure Pudding that were stored in the area beyond the manufacturer's use by date of November 2009. The Central Supply Director at that time stated that they audit the use by dates monthly; however, the kitchen staff pull this product from the area to send on patient trays.

Based on observation, interview, and record review the facility failed to ensure that measures were implemented to prevent the spread of infection. Failing to ensure that instruments utilized for invasive procedures are not rusted, storing staff, visitors, and patient food/fluid items together, and also failing to sanitize hands between patient contacts could lead to the spread of infection and disease.

Findings include:

1. Observation was made of the Endoscopy area on 2/08/10 at 3:45 p.m. with the Director of Surgery. Multiple elongated tube type scopes were observed hanging vertically in the drying area. An absorbent pad was at the bottom of the drying area. Observation of the pad revealed a yellow/brown colored spot with the appearance of a dried liquid. The size of the spot was the approximate size of the end of the scopes.

An interview was conducted during the observation with the Director of Surgery on 02/08/10 at 3:45 p.m. The Director confirmed the spot resembled the appearance of rust.

2. Observation and interview was conducted of the Outpatient Clinical Wound Care Department with the Program Director and the Registered Nurse on 2/09/10 at 9:50 a.m. A refrigerator was observed containing various items. The Program Director verified that staff and patient items were stored together in the refrigerator. Items observed included a Sippy Cup that was 1/3 full of fluid and was not dated or labeled. The mouth piece was soiled and open to air. The touring staff indicated that the Sippy Cup had belonged to the child of family who had accompanied the patient to the center the day before. The refrigerator also contained a bottle of BBQ Sauce that had approximately 2/3 of its contents remaining. The bottle was not dated as to when it had been opened and was not labeled as to whom it belonged. Manufacturer's numbers resembling a date were stamped on the bottle of " 071201 " . The touring staff indicated that the bottle may have belonged to a staff member. The refrigerator additionally contained various facility juices and a lunch bag. The touring staff verified that the juices are given to the patients and that the lunch bag belonged to a staff member.

3. An observation was made of the PTA (Physical Therapy Assistant) providing physical therapy consecutively to three different patients #29, #30, and #31 at the outpatient Center for Therapy and Wellness on 2/09/10 from 3:05 p.m. to 3:35 p.m. The PTA did not consistently sanitize her hands in between each individual patient contact.
Record review of patient #29 revealed a completed facility form titled " Evaluation Plan of Care " dated 11/18/09. The form contained a section titled "Precautions" and "Other" in which it was indicated that the patient had a history of Hepatitis C.
The PTA was also observed using the lid to a soiled linen container as a work space table top while providing direct care to patient #29.
An interview was conducted with the Administrator during the observation on 2/09/10 at 3:30 p.m. The Administrator verified that staff should sanitize their hands in between each contact with different patients. She also verified that using the lid to a soiled linen container as a work space table top was not appropriate.

Record review was conducted of the facility policy revised December 2005 from the Department of Infection Control and titled "Hand Hygiene" . The policy's " Purpose " stated " To prevent the spread of infection between patients, personnel and visitors. The most common mode of transmission of pathogens is via hands. Substantial evidence demonstrates hand hygiene reduces the incidence of infections." The "Definitions" identified "Hand hygiene" as "Performing antiseptic hand wash or alcohol-based handrub" . "Indications" for "hand hygiene" included "Before any patient contact".

4. During tour of the intensive Care Unit on 2/8/10 at approximately 12:55 p.m. the medication room was observed, The observation revealed a bath basin with residue on the bottom and sides next to the hand washing sink. Interview with the Intensive Care Unit Director during the tour revealed the basin was used to place medications that were to be returned to pharmacy. The observation revealed the potential for the medications and basin to become wet during the use of the sink.

5. Observation was made of the Intensive Care Unit on 2/08/10 at 1:00 p.m. with the Intensive Care Unit Director. The Medication Room was observed to contain patient care items being stored immediately on the counter of one side of the hand washing sink, including under the sink paper towel holder. The items were observed being stored in the direct vicinity where they would potentially become wet and contaminated.

6. Observation was made of the Emergency Department on 2/08/10 at 12:10 a.m. with the Emergency Department Director. The Supply and Equipment Room was observed. Observation noted an opened Irrigation Tray. Manufacturer documentation on the package indicated that it was sterile until opened. The ceiling tile in the room had evidence of a water leak.

7. The hospital did not ensure that the kitchen reach-in production freezer maintained proper temperature to ensure that food was stored at safe temperatures to prevent food borne illness. During tour of the hospital kitchen on 2/08/10 at 11:13 a.m., the temperature on the exterior digital display of the double door Traulsen reach-in freezer unit located near the tray line was 37° Farenheit (F). There were no thermometers inside the unit. The food stored in the freezer felt solidly frozen at the time. There were dinner rolls, individual containers of ice cream, and bags of frozen French Fries stored in the unit. The Food Service Director was asked what was the maximum temperature of the freezer should be and she replied (+)10° F.
On 2/09/10 at 9:53 a.m., the same freezer unit was examined again and the exterior digital display was flashing with the letters "def" (defrost). There were two thermometers located inside the freezer, a dial-type and red liquid filled type and both read 40°F. The ice build up on the interior ceiling of the unit was melting. The refrigeration temperature log was requested and reviewed. The temperature on the log for 2/09/10 was recorded as (+) 15.1° F. The temperature log form indicated that the freezer temperature should be between the minimum temperatures of (-)10° F and maximum temperature of 0° F. All of the recorded temperatures for this freezer unit were above the maximum temperature of 0° F for the month of February 2010. These recorded temperatures ranged from 14.5 to 17.9° F. This was discussed with the Food Service Director at the time. The Food Service Director proceeded to put in a work order for the freezer. No corrective action for the freezer had been taken until the surveyor intervention. The Food Service Director was asked for the temperature logs prior to February. These were reviewed back as far as March 2009, and the freezer temperature was not found to be 0° F or below for the past 12 months. There were a few instances in which the temperature was above 32° F, but none of the temperatures were above 41° F. The freezer temperatures were recorded once a day when the kitchen is opened in the morning at approximately 7:00 a.m.
On 2/11/10 at 8:40 a.m., the Director of Plant Operations was interviewed about the kitchen freezer. According to the Director of Plant Operations, the hospital did not have a preventative maintenance program for the kitchen refrigeration units. He also stated that he was not alerted to any problems with the freezer in the past year. The Director of Plant Operations added that a service company was called and found the temperature sensor malfunctioned. The Director of Plant Operations indicated that he will add a preventative maintenance program for the kitchen refrigerators monthly and will do weekly checks on the reach-in freezer until the problem is resolved.

The Food and Nutrition Services staff did not take measure to minimize potential cross contamination of food and food contact surfaces. During the tour of the kitchen on 2/08/10 at 10:43 a.m., a cook was asked to check the internal temperature of hot food held in a hot food holding cabinet. The cook was asked if the thermometer was sanitized before inserting it the food. He replied that it was earlier. He was asked to demonstrate this process. He took the thermometer and washed it in soapy water in a sanitizer bucket near a preparation sink, used a spray bottle of quaternary ammonium sanitizing solution to spray the thermometer probe. He said that he had to wait until the probe dried before use. Interview with the Food Service Director on 02/09/10 at 9:53 a.m. about the facility policy regarding the proper sanitizing of thermometers. She explained that the thermometer probes should be washed, rinsed and sanitized in quaternary solution, air dry and swab with disposable alcohol wipe.
During the kitchen tour on 2/08/10 at 10:43 a.m., a staff person was wearing gloves during food preparation. She picked up a pen and wrote on a form; then touched her forehead; went to drop a basket of fries in the fryer; and then went to get a clean pan. She did not change her gloves after touching her face. At 11:15 a.m. there was a sanitizer bucket with several preparation utensils, such as a whisk and scoop stored in soapy water in one basin of the two compartment preparation sink. There was also a spray bottle of quaternary ammonium solution stored on the preparation counter. At approximately 11:30 a.m., a staff person was cleaning the preparation counter while another staff person was mixing gravy in a container next to this activity. Additionally, at 11:35 a.m., a staff person brought a bag of raw frozen chicken breasts to thaw under cold running water in the preparation sink. The staff person was wearing gloves during this task. She left to do another task and returned with a new pair of gloves, but did not wash her hands before donning clean gloves. This same employee removed a cutting knife from the preparation sink where the chicken was defrosting under cold water, left the area, returned with the knife, wiped it with a paper towel and placed it back into the knife holder. At 12:35 p.m. there was a kitchen staff person cleaning a stainless steel cart near the fryer in the preparation area. There was food preparation occurring in this area at the time.

The Food and Nutrition Services staff did not ensure that the kitchen equipment and areas were kept sanitary and did not ensure that all equipment was properly cleaned and sanitized.
During the kitchen tour on 2/08/10 at 10:43 a.m., the following observations were made:
There were multiple sheet pans at least 10 or more observed with an accumulation of carbon/grease build up on bottom and sides.
The manual can opener base was soiled with black mold-like residue in the salad preparation area. In the main preparation area, the manual can opener shaft holder had an accumulation of food residue.
There were several cutting boards with multiple stains that could not be removed.
The exterior surface of the kitchen garbage cans were observed to be soiled with a black substance.
The two tiered cart located next to the soiled end of the three compartment sink was heavily soiled.
There were several clean and sanitized plastic food storage containers with old adhesive labels remaining on the exterior surface observed in the walk-in refrigerators. These were storing food.
There were several ceiling tiles near the ceiling vent which had a spray pattern of dust.
There were clean and sanitized pots and pans which were stored on stainless steel carts that were soiled in the dish machine area. Access to the hand wash sink in the dish machine area was blocked by these carts.
The mop bucket and wringer located in the utility closet was heavily soiled with a black substance.
A staff person washing dishes manually in the three compartment sink did not properly sanitize pots and pans in the chemical sanitizing solution. He dipped the pans and pots for about 5 seconds maximum, rather than completely immersing them for a minimum of 30 seconds. The Food Service Director observed this at the same time.

Review of the hospital-wide infection control program manual on 2/10/10, revealed that did not address that the hospitalized patients are a highly susceptible population to experience food borne disease and did not address measures to minimize this risk. The Food and Nutrition Services policies and procedures did address food safety, but this was primarily limited to the kitchen area, and not to other area of the hospital were food is stored and served. The hospital-wide program did not address county health department kitchen sanitation inspections and include measures to ensure that violations are prevented and not repeated through active hospital-wide infection control surveillance.

Based on observation and interview, the facility failed to obtain proper informed consent prior to surgical procedure for one (#21) of 33 patients. This practice does not allow the patient to make informed decisions.

Findings include:

1. Patient #21 had a consent form for an insertion of a triple lumen catheter for hyperalimentation signed and witnessed on 1/24/10 at 10:55 a.m. and another consent form for a CT guided drainage of an abdominal abscess signed and witnessed on 1/25/10. These forms did not include surgical risks specific to the procedure. The form listed general surgical risks common to most surgical procedures. The forms contained 2 pages, of which the first page of the abdominal surgical procedure was not complete and the second page of the triple lumen catheter insertion procedure was not complete.

Interview with the Nurse Manager at the time of the review confirmed the forms were not completed properly.