HospitalInspections.org

Based on policy review, Association for the Advancement of Medical Instrumentation (AAMI) standard review, water culture results review, RO (Reverse Osmosis) Disinfection Log review, staff interview, review of quality performance meeting minutes, review of operating room temperature and humidity logs, observations as referenced in the Life Safety Report of survey completed 01/13/2010, review of manufacturer recommendations for use of cleaning solution, observations during tour and review of operating room temperature and humidity logs, the hospital's Governing Body failed to have oversight and ensure systems were in place to ensure an effective quality assurance program, maintenance of the facility and an effective infection control program to ensure the safety of patients.

The findings include:

1. The hospital failed to implement and maintain an effective quality assessment and performance improvement program to ensure the safety of patients.

~cross refer to 482.21 QAPI Condition: Tag A0263

2. The hospital failed to develop and maintain the facility in a manner to ensure the safety of patients.

~cross refer to 482.41 Physical Environment Condition: Tag A0700

3. The hospital failed to have a system in place to ensure the prevention, control and investigation of infections.

~cross refer to 482.42 Infection Control Condition: Tag A0747

Based on medical record review and administrative staff interview the hospital staff failed to report the death of a patient that occurred within 24 hours after the patient had been removed from restraints to the Centers for Medicare Services (CMS) for 1 of 1 sampled patients that expired within 24 hours of restraint (#20).

The findings include:

Review of hospital policy entitled "Restraint and Seclusion", last revised on 6/11/2009, revealed, "...REPORTING DEATHS ASSOCIATED WITH RESTRAINT/SECLUSION...Hospitals must report deaths associated with the use of restraint or seclusion for the following situations: 1. Each death that occurs while patient is in restraint or seclusion. 2. Each death that occurs within 24 hours after the patient has been removed from restraint or seclusion; or 3. Each death known to the hospital that occurs within on week after restraint or seclusion where it is reasonable to assume that the use of restraint or seclusion contributed directly or indirectly to the patient's death....Documenting Death Report...The staff must document in the patient's medical record the date and time the patient death was reported to the Centers for Medicare & Medicaid Services (CMS)."

Closed record review for Patient #20 revealed a 61 year old female admitted on 01/07/2010 for treatment of CVA (stroke) and CHF (congestive heart failure). Medical record review revealed the patient had been placed in SPD (soft protective device) bilateral wrist restraints to prevent patient from pulling at IV (intravenous tubings) per physician's order on 01/08/2010 at 0948. Review revealed the patient remained in restraints until 1500 on 01/09/2010, when restraints were removed. Review revealed at 1555 on 01/09/2010 the patient expired. Further record review failed to reveal any available documentation of the date and time the death of Patient #20 was reported to CMS.

Interview with the Risk Manager on 01/14/2010 at 1410 revealed nursing staff on the units were supposed to fill out an incident report regarding deaths of patients within 24 hours of restraint and send it to Risk Management. Interview revealed Risk Management is responsible for reviewing the incident report and notifying CMS of all deaths associated with the use of restraints. Interview with the Risk Manager on 01/14/2010 at 1415 revealed an incident report had not been filled out, so Risk Management was not aware of the death of the patient who had been in restraints. Interview confirmed there was no available documentation that Patient #20's death was reported to CMS.

Based on policy review, Association for the Advancement of Medical Instrumentation (AAMI) standard review, water culture results review, RO (Reverse Osmosis) Disinfection Log review, staff interview, review of quality performance meeting minutes and review of operating room temperature and humidity logs, the hospital failed to implement and maintain an effective quality assessment and performance improvement program to ensure the safety of patients.

The findings include:

1. The hospital failed to monitor quality and assess hospital processes to ensure the health and safety of patients by failing monitor quality of hemodialysis services.

~cross refer to 482.21(a)(2) QAPI Standard: Tag A0267

2. The hospital failed to ensure a safe operating room environment by failing to respond to repeated humidity readings that were outside the acceptable range

~cross refer to 482.21(b)(2) QAPI Standard: Tag A0275

Based on policy review, Association for the Advancement of Medical Instrumentation (AAMI) standard review, water culture results review, RO (Reverse Osmosis) Disinfection Log review, staff interview and Performance Improvement Meeting Minutes, the hospital failed to monitor quality and assess hospital processes to ensure the health and safety of patients by failing monitor quality of hemodialysis services and blood administration.

The findings include:

Review of current hospital policy entitled "RO Fluid Culture and Dialysate Fluid Culture" dated 03/31/2008 revealed, "The RO fluid (water used for hemodialysis) and dialysate fluid will be cultured every month on each machine to ensure there is no bacterial growth....Notify nephrologist PRN (as needed) for abnormal results (results exceeding AAMI standards), and disinfect RO machine per RO manual instructions. Then repeat the water test per policy."

Review of current AAMI Standard #RD52:2004 entitled "Dialysate for Hemodialysis" dated 08/09/2004 revealed, "...4.1.2 Bacteriology of water Product water used to prepare dialysate or concentrates from powder at a dialysis facility, or to process dialyzers for
reuse, shall contain a total viable microbial count lower than 200 CFU/mL (colony forming units per milliliter) and an endotoxin concentration lower than 2 EU (endotoxin units)/mL. The action level for the total viable microbial count in the product water shall be 50 CFU/mL, and the action level for the endotoxin concentration shall be 1 EU/mL. If those action levels are observed in the product water, corrective measures shall promptly be taken to reduce the levels....the user is responsible for continued monitoring of the water bacteriology of the system and for complying with the requirements of this standard, including those requirements related to action levels."

Review of water culture results from 01/01/2009 through 12/31/2009 revealed no documentation that endotoxin cultures of water used for hemodialysis were done during 2009. Review revealed results of monthly bacterial water cultures for each portable RO machine used at the hospital were sent via electronic mail to the hemodialysis nurse and Infection Control Practitioner. Review of RO Disinfection Log revealed documentation of each RO disinfection. Further review of the water culture results and the RO Disinfection Log revealed bacterial culture results of RO water was greater than 50 CFU/mL (action level per AAMI Standard) on the following dates with the action taken by the facility as noted:
· Machine #8151 - Results of 2,000 CFU/mL received on 01/29/2009 - Action: RO Renalin Disinfection on 02/03/2009 and redraw of water sample for culture (5 days later);
· Machine #8151 - Results of 70 CFU/mL received on 04/15/2009 - Action: RO Renalin Disinfection on 04/29/2009 and redraw of water sample for culture on 04/30/2009 (15 days later);
· Machine #8152 - Results of 130 CFU/mL received on 06/10/2009 - Action: RO Renalin Disinfection on 06/17/2009 and redraw of water sample for culture on 07/08/2009 (28 days later) and
· Machine #3218 - Results of 100 CFU/mL received on 11/23/2009 - Action: RO Renalin Disinfection on 11/23/2009 and redraw of water sample for culture on 12/08/2010 (15 days later).

Interview on 01/13/2010 at 1530 with RN #1 (a hemodialysis nurse) revealed Machine #8151, Machine #8152 and Machine #3218 were "probably not" removed from service on 04/15/2009, 06/10/2009 and 11/23/2009, respectively, when bacterial culture results were between 70 and 130 CFU/mL because the hospital's action level was greater than 200 CFU/mL. Interview revealed when water bacterial culture results are greater than 200 CFU/mL the nurse removes the machine from service and disinfects the RO with Renalin. Interview revealed there was no defined expected timeframe for the recollection of water samples to recheck the bacterial count in the water. Interview revealed no action was required if results were less than 200 CFU/mL. Further interview revealed water samples are sometimes collected before disinfection and sometimes after disinfection. Interview revealed endotoxin tests were not done on water samples. Interview revealed the nurse was not aware the current AAMI Standard of practice required action for bacterial counts greater than 50 CFU/mL and endotoxin testing of water used for dialysis.

Review of Performance Improvement monthly meeting minutes from June 2009 through January 2010 revealed no evidence of quality monitoring of hemodialysis services or blood administration processes.

Interview on 01/14/2009 at 1345 with the Chief Nursing Officer (CNO) revealed the Medical Director (Nephrologist) had a large role in quality oversight of hemodialysis services. Interview revealed the CNO was unaware before the survey that hemodialysis staff were not following current standards of practice regarding endotoxin and bacterial cultures of water used for hemodialysis. Interview revealed, "We probably depended on (the Medical Director) too much for oversight of dialysis." Further interview revealed the process of blood administration, including the evaluation of staff's adherence to the blood transfusion policy, was not monitored.

Interview on 01/14/2009 at 1330 with the Director of Performance Improvement revealed, "Infection Control monitors water cultures and reports (findings) to the Quality Council quarterly." Interview revealed the Director was unaware before the survey that hemodialysis staff were not following current standards of practice regarding endotoxin and bacterial cultures of water used for hemodialysis. Interview revealed there was no follow up by the Quality Council to determine if appropriate actions were taken by hemodialysis staff and Infection Control when bacterial cultures of hemodialysis water were high. Interview revealed there was no process to monitor the safety and effectiveness of hemodialysis services. Further interview revealed the process of blood administration, including the evaluation of staff's adherence to the blood transfusion policy, was not monitored by Quality.

Based on review of operating room policy, operating room temperature and humidity logs, quality performance meeting minutes and staff interviews, the hospital failed to ensure a safe operating room environment by failing to respond to repeated humidity readings that were outside the acceptable range in 6 of 6 operating rooms (OR#1, OR#2, OR#3, OR#4, OR#5 and cystoscopy).

The findings include:

Review of the "Fire in the Operating Room" policy revised February 14, 2007 revealed "G. The humidity in the Operating Rooms should be at 30%-60%."

Review of OR logs from July 2009 through January 2010 revealed temperature and humidity readings were documented daily when surgery was scheduled. Further review of the logs revealed "Acceptable Humidity Range for OR Rooms: 30%-60%."

Review of the logs revealed OR #1 had humidity readings below 30% on 2 of 21 days in October 2009, 1 of 19 days in November 2009, 14 of 21 days in December 2009 and 8 of 8 days in January 2010; and above 60% on 1 of 22 days in July 2009.

Review of the logs revealed OR #2 had humidity readings below 30% on 1 of 21 days in October 2009, 2 of 19 days in November 2009, 16 of 21 days in December 2009 and 7 of 8 days in January 2010; and above 60% on 7 of 22 days in July 2009 and 8 of 21 days in August 2009.

Review of the logs revealed OR #3 had humidity readings below 30% on 15 of 22 days in July 2009, 7 of 21 days in August 2009, 21 of 21 days in September 2009, 21 of 21 days in October 2009, 18 of 19 days in November 2009, 21 of 21 days in December 2009 and 8 of 8 days in January 2010.

Review of the logs revealed OR #4 had humidity readings below 30% on 3 of 21 days in October 2009, 5 of 19 days in November 2009, 15 of 21 days in December 2009 and 8 of 8 days in January 2010; and above 60% on 2 of 22 days in July 2009.

Review of the logs revealed OR #5 had humidity readings below 30% on 2 of 21 days in October 2009, 1 of 19 days in November 2009, 14 of 21 days in December 2009 and 8 of 8 days in January 2010; and above 60% on 5 of 22 days in July 2009, 11 of 21 days in August 2009 and 2 of 21 days in September 2009.

Review of the logs revealed OR #6 (Cysto Room) had humidity readings below 30% on 1 of 21 days in October 2009, 12 of 21 days in December 2009 and 8 of 8 days in January 2010; and above 60% on 2 of 22 days in July 2009.

Review of Performance Improvement monthly meeting minutes from June 2009 through January 2010 revealed no evidence of discussion regarding humidity readings in the operating rooms.

Interview during tour of the surgical suite on 01/12/2010 at 1240 with surgical administrative staff revealed humidity levels in the operating rooms were consistently low. Interview revealed the operating room staff monitor the temperature and humidity readings in the operating rooms each day surgery is scheduled and track the information on a log. Interview revealed that plant operations also monitor the humidity readings in the operating rooms. Interview revealed there was an "air handler project" that was being planned to correct the humidity problem. Further interview on 01/14/2010 at 0910 with surgical administrative staff revealed the problem with low humidity readings in the operating rooms was identified around one to two years ago and plant operations staff had determined that there was a need to replace the air handlers. The interview revealed that quotes had been obtained for replacement of the air handlers, but no start date for the project had been identified. Interview revealed that the humidity levels could be adjusted in each of the operating rooms by plant operations. Interview further revealed that the medical staff like the temperature and humidity levels to be low because it is a more comfortable for the staff who are donning surgical attire. Interview further revealed that the Chief of Surgery had not been made aware of the identified concerns related to the low humidity readings. The interview confirmed the humidity readings in all six of the operating rooms were consistently below the acceptable range.

Interview on 01/14/2010 at 1100 with plant operations staff revealed the problem with humidity readings outside of acceptable range was identified around two years ago. Interview revealed a project to upgrade the air handlers to maintain safety in the operating rooms had been approved. Interview revealed that plant operations staff can attempt to adjust the temperature and humidity in each operating room and that the adjustment is only done when requested by operating room staff. The interview revealed that the medical staff like the operating rooms at a lower temperature and humidity and complain when it is too hot. Interview revealed no formal meetings have been held with operating room staff to discuss the identified problem with humidity levels in the operating rooms. The interview revealed that low humidity in the operating rooms is a fire risk. Interview confirmed that humidity readings in all six of the operating rooms were consistently below the acceptable range.

Interview on 01/14/2010 at 1345 with administrative staff revealed performance improvement meetings were conducted monthly and included environment of care and safety teams that were comprised of interdisciplinary staff members and physicians. The interview revealed there had been no discussion in the meetings related to the consistently low humidity readings in the operating rooms.

Based on policy review, personnel file review and staff interview the hospital failed to assure qualified and competent staff were assigned to provide hemodialysis treatments for 2 of 2 hemodialysis registered nurses (RNs) reviewed (RN #1 and RN #2).

The findings include:

Review of current hospital policy entitled "Dialysis Registered Nurses" reviewed on 01/24/2008 and 01/11/2010 revealed, "The Dialysis patient is cared for by Registered Nurses who have training, experience, and documented current competency in the nursing care of patients with acute renal failure and end-stage renal disability and in hemodialysis techniques."

Review of current hospital policy entitled "Orientation and Continuing Education - Hemodialysis" reviewed 09/03/2008 revealed, "...The Nephrologist or designee contributes to the inservice education of the Hemodialysis staff....The Hemodialysis staff will attend continuing education programs during the year. Documentation of attendance of these programs is kept by the Corporate Education Department...."

Interview on 01/13/2010 at 1620 with administrative nursing staff revealed the hospital employed two RNs that provided hemodialysis to patients (RN #1 and RN #2). Interview revealed the hemodialysis nurses had previous hemodialysis experience before employment at the hospital and their competencies were verified during orientation. Interview revealed the administrative nurse was not sure if the hemodialysis RNs had received any further hemodialysis specific education or had their competencies validated after orientation.

1. Personnel file review for RN #1 revealed a "Hemodialysis, Registered Nurse" job description. Review of the job description revealed, "...Patient Care 1. Provide direct patient care for assigned patients....2. Perform all technical aspects of dialysis procedures for assigned patients as prescribed....Staff Related....2. Acquire information and knowledge in current practice related to dialysis principles and techniques by participating in scheduled inservice classes...." File review revealed documentation of a Dialysis Skills Performance Checklist dated 2002. File review revealed no documentation of dialysis specific education or validation of competencies since 2002 (8 years before review).

Interview on 01/14/2010 at 1030 with the Director of Human Resources confirmed there was no available documentation in RN #1's file of dialysis specific education or validation of competencies since 2002 (8 years before review).

2. Personnel file review for RN #2 revealed a "Hemodialysis, Registered Nurse" job description. Review of the job description revealed, "...Patient Care 1. Provide direct patient care for assigned patients....2. Perform all technical aspects of dialysis procedures for assigned patients as prescribed....Staff Related....2. Acquire information and knowledge in current practice related to dialysis principles and techniques by participating in scheduled inservice classes...." File review revealed documentation of a Dialysis Skills Performance Checklist dated 2004. File review revealed no documentation of dialysis specific education or validation of competencies since 2004 (6 years before review).

Interview on 01/14/2010 at 1030 with the Director of Human Resources confirmed there was no available documentation in RN #2's file of dialysis specific education or validation of competencies since 2004 (6 years before review).

Based on review of hospital policy and procedures, closed medical record review and staff interviews, nursing staff failed to administer blood transfusions according to hospital policy for 4 of 9 sampled patients that received a blood transfusion (#14, 15, 23 and 21).

The findings include:

Review of facility's policy entitled, "Blood Transfusion of Blood Components," Policy ID: SMHPCMANU7700161, Approved by: Provision of Care and Treatment Services, date 5/8/2008, reads, in section, "ESSENTIAL PRECAUTIONS REGARDING ADMINISTRATION OF RED BLOOD CELLS (packed cells)....1. Vitals signs should be taken immediately prior to starting blood/blood components and should be rechecked in 10 - 15 minutes, one (1) hour into the transfusion, and at the completion of the transfusion....For platelet or plasma (FFP) transfusion, the same blood transfusion procedure should be followed...."

1. Closed record review of patient #14 revealed a 70 year old patient admitted on 06/29/2009 for treatment for a fractured and dislocated ankle. Review revealed the patient had two (2) blood transfusions on 07/02/2009. The first transfusion was initiated at 0945 and completed at 1315. The second transfusion was initiated at 1610 and completed at 2100.
Record review revealed the patient's vital signs (VS) were taken as follows:
Transfusion #1:
a. July 02, 09 at 03:28
b. July 02, 09 at 7:58
c. July 02, 09 at 15:01
Transfusion #2:
a. July 02, 09 at 19:20
b. July 02, 09 at 21:23
c. July 02, 09 at 23:36

Record review revealed no evidence the patient's vital signs were monitored according to policy immediately prior to starting the blood, 10 - 15 minutes after the blood was started, one hour into the transfusion and at the completion of the transfusion.

Interview on 01/14/2010 at 1307 with the Director of Nursing Education confirmed nursing staff did not follow the facility's policy and procedure. Interview revealed patient vital signs were being taken and recorded on a separate sheet of paper while in the patient's room. Interview revealed these results were later entered into the patient's electronic record. Interview revealed in some instances the results were not entered, resulting in gaps in the record.

2. Closed record review of patient #15 revealed a 52 year old patient admitted on 10/01/2009 for treatment for a fracture right hip. Review revealed the patient had a blood transfusion of Packed Red Blood Cells (PRBC) on 10/04/2009. The transfusion was initiated at 1315 and completed at 1700. Record review revealed the patient's vital signs (VS) were taken as follows:
a) 10/04/09 at 1315
b) 10/04/09 at 1330
c) 10/04/09 at 1415
d) 10/04/09 at 1800

Record review revealed no evidence the patient's vital signs were assessed according to policy at the completion of the transfusion.

Interview on 01/14/2010 at 1307 with the Director of Nursing Education confirmed nursing staff did not follow the facility's policy and procedure. Interview revealed patient vital signs were being taken and recorded on a separate sheet of paper while in the patient's room. Interview revealed these results were later entered into the patient's electronic record. Interview revealed in some instances the results were not entered, resulting in gaps in the record.


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3. Closed record review for Patient #23 revealed a 73 year old patient admitted on 10/03/2009 for treatment of respiratory distress. Record review revealed the patient received 2 units of Fresh Frozen Plasma (FFP) while hospitalized. Record review revealed FFP unit #1 was administered on 10/03/2009. Review of nursing documentation revealed FFP unit #1 was initiated at 2135 and completed at 2245. Further review of nursing documentation revealed no evidence the patient's vital signs were taken during the infusion of FFP unit #1 according to policy. Further record review revealed FFP unit #2 was administered on 10/04/2009. Review of nursing documentation revealed FFP unit #2 was initiated at 0615 and completed at 0655. Further review of nursing documentation revealed no evidence the patient's vital signs were taken during the infusion of FFP unit #2 according to policy.

Interview on 01/14/2010 at 1100 with regulatory compliance staff revealed no available documentation that the nursing staff assessed vital signs during the administration of the FFP on 10/03/2009 and 10/04/2009. Interview confirmed nursing staff did not follow the hospital's blood transfusion policy for Patient #23.

4. Closed record review for Patient #21 revealed a 78 year old admitted on 12/09/2009 for Coumadin Toxicity. Record review revealed the patient was transfused packed red blood cells (PRBC) on 12/12/2009. Record review revealed the transfusion was initiated at 1630 and completed at 1950. Review of nursing documentation for the transfusion of the PRBC revealed the patient's vital signs (VS) were assessed on 12/12/2009 at 2000. Further record review failed to reveal documentation vital signs were assessed at 1630 (start of transfusion), 1645 (15 minutes after start of transfusion), and 1730 (completion of transfusion) per hospital policy.

Interview on 01/14/2010 at 1100 with the nursing management staff revealed no available documentation of the assessment of vital signs during the administration of the PRBC on 12/12/2009 for Patient #21. Interview confirmed the nursing staff failed to follow hospital policy.

Based on hospital policy reviews, document review, observations during tour, and staff interviews, the hospital failed to ensure unauthorized individuals cannot gain access to confidential health information stored in patient medical records by failing to limit access to the Health Information Management (HIM) Department.

The findings include:

Review of hospital policy "Storage and Security of Medical Records," reviewed October 2009, revealed "All medical records shall be housed in physically secure areas under the immediate control of the Medical Records Director. Areas housing health information shall be restricted to authorized personnel. ..."

Review of hospital policy "Availability of Prior Medical Records," reviewed October 2009, revealed "...Records that are needed after department hours are obtained by the House Supervisor, the ER ward secretary, or admitting personnel. ..."

Observation during tour on 01/12/2010 at 1300 of the Health Information Management (HIM) Department (medical records) revealed the main entry to the department was located on a main hallway. Observation revealed the department's main entry door to be secured with a single keylock located in the door handle. Observation revealed the main entry door opened into the main department. Further observation revealed medical records stored on shelves at work stations and on larger roller shelf units with in the department.

Interview with HIM Director on 01/12/2010 at 1300 revealed the hours of operation for the department is 24 hours per day from Sunday at 2300 until Friday at 2100, and on Saturday and Sunday 0800 to 1700. Interview revealed a HIM staff member is not present in the department after hours. Interview revealed the nursing supervisors and the emergency department (ED) unit secretaries are authorized to access the department after hours to obtain medical records. Interview revealed the main entrance to the department is locked after hours and can be accessed with a master key. Interview revealed a master key is issued to the nursing supervisors, and a key is located in the ED for use by the ED unit secretaries. Interview revealed the master key that fits the HIM department also fits multiple locks throughout the hospital. Interview revealed the HIM Director was unsure of the number of master keys issued to other non-HIM staff.

Review on 01/12/2010 of a document titled "Keys - Access to Medical Record Department" provided by the HIM Director on 01/12/2010 at 1600, revealed "These are Master Keys in Order to perform Job Functions/Duties." Further review revealed thirty-one (31) master keys issued to Non-HIM personnel in the following departments: Emergency Department (1); Nursing House Supervisor (1); Housekeeping (6); Maintenance (7); Executive Leadership (7); Biomedical (3); Pharmacy (1); Security (2); and Information Technology (3).

Follow-up Interview with the HIM Director on 01/13/2010 at 0900 revealed she was unaware of the master keys issued to the pharmacy department, biomedical engineering department and Information Technology (IT) Department. Interview revealed she could not think of any reason why pharmacy, biomedical engineering, or IT personnel would need access to the HIM department after normal hours of operation. Further interview revealed house keeping staff could perform their duties during normal hours of operation. Interview revealed the current hospital policy gives authorization to the Nursing Supervisors and the ED unit Secretaries for access to medical records after the normal hours of operation. Further interview confirmed the Non-HIM staff members who were issued master keys, did have access to the HIS department after the normal hours of operation, and to the confidential protected health information contained in the medical record. Further interview confirmed the hospital failed to follow policy regarding accessibility and security of medical records.

Based on policy and procedure reviews, "ServSafe Essentials" manual review, observations during tour, and staff interviews, the hospital's dietary staff failed to carry out their respective duties in a competent manner to ensure: potentially hazardous foods were not served to patients and were maintained at safe temperatures; refrigerated/frozen leftover foods were discarded; and cookware and serving utensils were cleaned and stored in a sanitary condition.

The findings include:

Observation during tour on 01/13/2010 from 1000 to 1145, of the main kitchen revealed:

At the main kitchen patient tray line:
1. Review on 01/13/2010 of the hospital's current dietary procedures for "Temperatures" (no date or policy number) provided by the Food Service Director, revealed "Cold Foods Should be 41 Degrees or Below."

Observation during tour on 01/13/2010 at 1130, of the main kitchen's patient tray line revealed an individual serving of potato salad being stored on a counter surface. Observation revealed the potato salad was not being stored on ice. Observation revealed the temperature of the potato salad (cold food) was 43 degrees (F) Fahrenheit (elevated temperature).

Interview with dietary management staff during tour on 01/13/2010 from 1000 to 1145 revealed the potato salad contained egg by-products (mayonnaise). Interview revealed the potato salad was available for patient consumption. Interview revealed the temperature of the potato salad should be below 41 degrees Fahrenheit to ensure safety. Interview confirmed the temperature of the potato salad was 43 degrees Fahrenheit (elevated temperature).

In refrigeration/freezer storage areas:
2. Review on 01/13/2010 of the hospital policy "Food Storage" policy ID: SMHFOODSV74501229, dated 04/02/2007, revealed "Purpose: to ensure the proper and sanitary storage of foods to prevent contamination and/or spoilage. ...4. All leftovers are used in 2-3 days of the original cooking. 5. All cooked meats are used in 5-7 days of the original cooking."

Observation during tour on 01/13/2010 at 1015 of the inside of Freezer B, revealed shelves with one (1) metal container covered with aluminum foil, labeled "Spaghetti Sauce" dated 12/07/2009 (37 days); one (1) metal container covered with aluminum foil, labeled "Dressing" dated 12/23/2009 (21 days); and one (1) metal container covered with aluminum foil, labeled "Stew Beef" dated 12/25/2009 (19 days) being stored.

Interview with dietary management staff during tour on 01/13/2010 from 1000 to 1145 revealed leftover foods are to be used within 3-5 days after the original cook date, depending on the food item. Interview revealed left over foods are placed into the refrigerator or freezer for storage until used. Interview revealed the leftovers in the three metal containers should have been discarded after 3-5 days.

In the Food Preparation areas:
3. Review on 01/13/2010 of the hospital's current dietary procedures for "Storing Dishes" (no date or policy number) provided by the Food Service Director, revealed "Once utensils, tableware, and equipment have been cleaned, sanitized and air dried, they must be stored in a way that will protect them from contamination:..."

Observation at 1100 of two clean dry storage racks, stored in close proximity to the triple "pot" sink and washing area, revealed cookware/utensils being stored for later use to prepare food. Further observation revealed visible clear liquids on the outer and inner surfaces of greater than 8 cookware items and utensils being stored on the racks.

Interview with dietary management staff during tour on 01/13/2010 from 1000 to 1145 revealed the cookware and utensils on the dry storage racks were considered clean and ready for use. Interview revealed the dietary staff are to inspect the items after being washed, make sure they are clean and air dried before stacking and storing the items on the clean storage racks. Interview confirmed the presence of visible clear liquids on outer and inner surfaces of the cookware and utensils.

4. Review on 01/13/2010 of National Restaurant Association, 2008, Fifth Edition "ServSafe Essentials" training manual provided by the Food Service Director, revealed page 11.4 "...Heat Sanitizing ...One way to sanitize items is to soak them in hot water. For this method to work, the water must be at least 171 (degrees) F (77 C). The items must be soaked for 30 seconds. ..."

Observation at 1055 of the triple compartment "pot" sink revealed a dietary staff member washing and rinsing cookware in the triple compartment sink. Further observation revealed the dietary staff member submerged the cookware into the hot water compartment (#3) and remove the item and place it on the adjacent counter surface to air dry. Observation revealed the dietary staff member only submerged the cookware for approximately 5-10 seconds (instead of the required minimum 30 seconds for sanitization). Interview with dietary management staff during tour revealed the triple compartment "pot" sink uses heat sanitizing instead of chemical sanitizing.

Interview with dietary staff member #1 on 01/13/2010 at 1145 revealed his normal routine was to wash and scrub the cookware to remove food particles, then place the cookware into the washing detergent (compartment #1) to wash. After the washing completed, he would "dip" the cookware into the rinse water (compartment #2), and then he would "dip" the cookware into the hot water (compartment #3) and place the cookware on the adjacent counter surface to dry. Interview revealed he did not submerge the cookware into the compartment #3 for a specific amount of time, usually he just "dipped" the cookware for "a few seconds." Interview revealed the staff member was unaware items washed in the triple compartment sink were required to be submerged in compartment #3 for a minimum of 30 seconds in order for them to be sanitized.

Follow-up interview with dietary management staff on 01/14/2010 at 0910 revealed she attended a ServSafe course in October 2009. Interview revealed she utilizes the information/standards in the manual to develop policy and procedure for the Food Services Department. Interview revealed she was unaware cookware was required to soak in compartment #3 for at least 30 seconds to be considered sanitized. Interview revealed she needs to educate the employees and update the policies and procedures. Interview revealed the facility did not maintain a log on the triple compartment sink to ensure the temperature in the third compartment was maintained at 171 degrees or higher.

5. Review on 01/13/2010 of the hospital's current dietary procedures for "Ice Scoop" (no date or policy number) provided by the Food Service Director, revealed "The ice scoop is not to be left in the ice maker at any time. The scoop is to be placed in a plastic bag on the table below the meat slicer."

Observation at 1035 of the Large Ice Maker, revealed ice stored in the the storage compartment. Further observation revealed a metal ice scoop, pushed down into the ice and being stored.

Interview with dietary management staff during tour on 01/13/2010 from 1000 to 1145 revealed, the ice scoop is not to be stored in the ice machine. Interview confirmed the dietary staff failed to follow correct dietary procedures.

Based on observations as referenced in the Life Safety Report of survey completed 01/13/2010, review of manufacturer recommendations for use of cleaning solution, observations during tour, staff interviews, review of operating room policies, operating room temperature and humidity logs, the hospital failed to develop and maintain the facilities in a manner to ensure the safety of patients.

The findings include:

1. The hospital failed to ensure the safety and well-being of patients by failing to meet the applicable provisions of the Life Safety Code of the National Fire Protection Association (NFPA).

~Cross-refer to 482.41(b)(1)(2)(3) Physical Environment Standard Tag A-0710.

2. The hospital failed to develop and maintain a safe physical plant and overall safe environment to assure the safety and well being of patients.

~Cross-refer to 482.41(a) Physical Environment Standard Tag A-0701.

3. The hospital failed to ensure the safety of patients by failing to ensure the proper function of emergency power and lighting systems.

~Cross-refer to 482.41(a)(1) Physical Environment Standard Tag A-0702.

4. The hospital staff failed to monitor the temperature of the high-level disinfectant used for equipment in the surgical suite.

~Cross-refer to 482.41(c)(2) Physical Environment Standard Tag A-0724.

5. The hospital failed to ensure humidity levels in 6 of 6 operating rooms were maintained within an acceptable range.

~Cross-refer to 482.41(c)(4) Physical Environment Standard Tag A-0726.

Based on observations as referenced in the Life Safety Report of survey completed 01/13/2010, the hospital failed to develop and maintain a safe physical plant and overall safe environment to assure the safety and well being of patients.

The findings include:

Based on observation in Building 1 on January 12, 2010 at approximately 1145 onward, oxygen bank areas are exposed to extremes of weather without canopies.

~cross-refer to Life Safety Code Standard - NFPA 101, Tag K0076.

Based on observations as referenced in the Life Safety Report of survey completed 01/13/2010, the hospital failed to ensure the safety of patients by failing to ensure the proper function of emergency power and lighting systems.

The findings include:

1. Based on observation in Building 1 on January 12, 2010 at approximately 1145 onward, oxygen bank areas are exposed to extremes of weather without canopies.

2. Based on observation in Building 2 on January 12, 2010 at approximately 0945 onward, there are no unitary lights in the corridors serving the cardiac rehabilitation unit.

~cross-refer to Life Safety Code Standard - NFPA 101, Tag K0046.

Based on observations as referenced in the Life Safety Report of survey completed 01/13/2010, the hospital failed to ensure the safety and well-being of patients by failing to meet the applicable provisions of the Life Safety Code of the National Fire Protection Association (NFPA).

The findings include:

Building 1:

1A. Based on observation, on January 12, 2010 at approximately 1100 onward, there are incomplete special locking arrangements used in the Labor/Delivery Unit and locks are not equipped with a master release switch and release switches not greater than three from the exit access doors as stated in required codes. Locks did release during activation of the facility fire alarm system.

Note: The facility is not equipped with a complete sprinkler system or detection system as required by codes when utilizing special locking arrangements.

1B. Based on observation, on January 12, 2010 at approximately 1145 onward, there is no guardrail between the required exit discharge path and the loading dock area.

~cross-refer to Life Safety Code Standard - NFPA 101, Tag K0032.

2. Based on observation, on January 12, 2010 at approximately 1145 onward, there are holes in the corridor wall in the following areas: communication closet near medical surgery (emt conduit is not sealed above the ceiling) and communication room near room 2107.

~cross-refer to Life Safety Code Standard - NFPA 101, Tag K0017.

3. Based on observation, on January 12, 2010 at approximately 1145 onward, there are latching hardware devices installed greater than forty-eight inches above the finished floor in the following areas: Behavioral Health - observation room and Same Day Surgery - exit access door from the suite.

~cross-refer to Life Safety Code Standard - NFPA 101, Tag K0018.

4. Based on observation, on January 12, 2010 at approximately 1145 onward, hazardous areas in the following areas are incomplete:

a. central supply room near sterile room - duct penetrations of enclosure walls are not equipped with fire dampers;

b. pantry(day stock in kitchen area) - room is greater than one hundred square feet without minimum one hour rated enclosure. Fire doors are not three quarter hour rated with listed hardware and

c. elevator equipment room serving elevators #1, and #2 - large gaps around ceiling fire damper assembly.

~cross-refer to Life Safety Code Standard - NFPA 101, Tag K0029.

5. Based on observation, on January 13, 2010 at approximately 0930 onward, the relative humidity monitors in operating room #2, and #5 are indicating humidity levels below 35%. Humidity levels in operating room #2, and #5 are 16% and 25% respectively.

~cross-refer to Life Safety Code Standard - NFPA 101, Tag K0078.

6. Based on observation, on January 12, 2010 at approximately 1145 onward, the essential electrical system is incomplete due to the following:

a. generator annunciator panel at ER reception area - panel doesn't monitor all malfunctions of the emergency generator as required by NFPA 99. Panel did not indicate emergency power system supplying load during loss of normal power to the Life Safety Branch automatic transfer switch; and

b. lack of task lighting with battery backup at the generator set locations.

~cross-refer to Life Safety Code Standard - NFPA 101, Tag K0106.

7. Based on observation, on January 12, 2010 at approximately 1145 onward, electrical systems in the following areas are incomplete:

a. operating room #2 - surgical light contains armored cable that does not terminate in a junction box required to maintain continuity of grounding system;

b. central supply room beside sterile room - storage within three feet of transformer and electrical switches and

c. occupational health - patient room 2118 is utilizing a multi-outlet power tap.

~cross-refer to Life Safety Code Standard - NFPA 101, Tag K0147.

Building 2:

Based on observation, on January 13, 2010 at approximately 0945 onward, fire doors in the following areas are noncompliant:

a. east stairway near elevator - door will not self-close and latch.

b. first floor exit passageway - doors are blocked open by kickstops and wedges.

~cross-refer to Life Safety Code Standard - NFPA 101, Tag K0030.

Based on review of manufacturer recommendations for use of cleaning solution, observations during tour and staff interviews, the hospital staff failed to monitor the temperature of the high-level disinfectant used for equipment in the surgical suite.

The findings include:

Review of the manufacturer's package insert for the high-level disinfectant Cidex Plus (a glutaraldehyde solution used to disinfect surgical instruments) revealed "A) Indications for Use...High Level Disinfectant: Cidex Plus 28 day solution is a high level disinfectant when used or reused, according to Directions for Use, for up to a maximum of 28 days at 25 degrees C (Celsius) with an immersion time of at least 20 minutes... D) Directions for Use... During the use of Cidex Plus Solution, it is recommended that a thermometer and timer be used to ensure that the optimum usage conditions are met."

Observation during tour on 01/12/2010 at 1240 of the surgical suite revealed Cidex Plus in a basin in the sub-sterile room. Observation revealed no thermometer in the basin of Cidex Plus. Review of the monitoring log of the Cidex Plus revealed no documentation that the temperature was monitored.

Interview on 01/12/2010 at 1240 with a surgical technician revealed the Cidex Plus was used to disinfect endoscopes (scopes used for surgical patients). Interview further revealed "I didn't know we were supposed to check the temperature."

Based on review of operating room policies, operating room temperature and humidity logs and staff interviews, the hospital failed to ensure humidity levels in 6 of 6 operating rooms were maintained within an acceptable range (OR#1, OR#2, OR#3, OR#4, OR#5 and cystoscopy).

The findings include:

Review of the "Fire in the Operating Room" policy revised February 14, 2007 revealed "All OR (operating room) personnel are to be knowledgeable of elements which support combustion in the Operating Room. The three elements: an ignition source, a fuel source, and an oxidizer are abundant during operative and invasive procedures. Personnel should be educated and trained of what to do in the event of a fire in the Operating Room.... X. Use of OR equipment: G. The humidity in the Operating Rooms should be at 30%-60%."

Review of OR logs from July 2009 through January 2010 revealed temperature and humidity readings were documented daily when surgery was scheduled. Further review of the logs revealed "Acceptable Humidity Range for OR Rooms: 30%-60%."

Review of the logs revealed OR #1 had humidity readings below 30% on 2 of 21 days in October 2009, 1 of 19 days in November 2009, 14 of 21 days in December 2009 and 8 of 8 days in January 2010; and above 60% on 1 of 22 days in July 2009.

Review of the logs revealed OR #2 had humidity readings below 30% on 1 of 21 days in October 2009, 2 of 19 days in November 2009, 16 of 21 days in December 2009 and 7 of 8 days in January 2010; and above 60% on 7 of 22 days in July 2009 and 8 of 21 days in August 2009.

Review of the logs revealed OR #3 had humidity readings below 30% on 15 of 22 days in July 2009, 7 of 21 days in August 2009, 21 of 21 days in September 2009, 21 of 21 days in October 2009, 18 of 19 days in November 2009, 21 of 21 days in December 2009 and 8 of 8 days in January 2010.

Review of the logs revealed OR #4 had humidity readings below 30% on 3 of 21 days in October 2009, 5 of 19 days in November 2009, 15 of 21 days in December 2009 and 8 of 8 days in January 2010; and above 60% on 2 of 22 days in July 2009.

Review of the logs revealed OR #5 had humidity readings below 30% on 2 of 21 days in October 2009, 1 of 19 days in November 2009, 14 of 21 days in December 2009 and 8 of 8 days in January 2010; and above 60% on 5 of 22 days in July 2009, 11 of 21 days in August 2009 and 2 of 21 days in September 2009.

Review of the logs revealed OR #6 (Cysto Room) had humidity readings below 30% on 1 of 21 days in October 2009, 12 of 21 days in December 2009 and 8 of 8 days in January 2010; and above 60% on 2 of 22 days in July 2009.

Interview during tour of the surgical suite on 01/12/2010 at 1240 with surgical administrative staff revealed humidity levels in the operating rooms were consistently low. Interview revealed the operating room staff monitor the temperature and humidity readings in the operating rooms each day surgery is scheduled and track the information on a log. Interview revealed that plant operations also monitor the humidity readings in the operating rooms. Interview revealed there was an "air handler project" that was being planned to correct the humidity problem. Further interview on 01/14/2010 at 0910 with surgical administrative staff revealed the problem with low humidity readings in the operating rooms was identified around one to two years ago and plant operations staff had determined that there was a need to replace the air handlers. The interview revealed that quotes had been obtained for replacement of the air handlers, but no start date for the project had been identified. Interview revealed that the concern with low humidity levels in the operating rooms was an increased risk of fire. Interview revealed that the humidity levels could be adjusted in each of the operating rooms by plant operations. Interview further revealed that the medical staff like the temperature and humidity levels to be low because it is a more comfortable for the staff who are donning surgical attire. Interview further revealed that the Chief of Surgery had not been made aware of the identified concerns related to the low humidity readings. The interview confirmed the humidity readings in all six of the operating rooms were consistently below the acceptable range.

Interview on 01/14/2010 at 1100 with plant operations staff revealed the problem with humidity readings outside of acceptable range was identified around two years ago. Interview revealed a project to upgrade the air handlers to maintain safety in the operating rooms had been approved. Interview revealed that plant operations staff can attempt to adjust the temperature and humidity in each operating room and that the adjustment is only done when requested by operating room staff. The interview revealed that the medical staff like the operating rooms at a lower temperature and humidity and complain when it is too hot. Interview revealed no formal meetings have been held with operating room staff to discuss the identified problem with humidity levels in the operating rooms. The interview revealed that low humidity in the operating rooms is a fire risk. Interview confirmed that humidity readings in all six of the operating rooms were consistently below the acceptable range.

Based on policy review, Association for the Advancement of Medical Instrumentation (AAMI) standard review, water culture results review, RO (Reverse Osmosis) Disinfection Log review, staff interview and observation, the hospital failed to have a system in place to ensure the prevention, control and investigation of infections.

The findings include:

1. The hospital's infection control officer failed to ensure control of infections and communicable diseases by failing to ensure endotoxin cultures were done of water used for hemodialysis and timely redraws of hemodialysis water samples were done after high bacteria cultures were obtained per AAMI standards and by failing to ensure RO equipment that produced water with high bacterial cultures was unavailable for hemodialysis treatments.

~Cross refer to 482.42(a) Infection Control - Tag A0748.

2. The hospital's infection control officer failed to have a system to control infections and communicable diseases as evidenced by failure to ensure staff used personal protective equipment (PPE) per to policy for 1 of 2 sampled patients on contact isolation precaution (#45) and stored wound care supplies per policy in 1 of 5 sampled wound care treatment rooms.

~Cross refer to 482.42(a)(1) Infection Control - Tag A0749.

Based on policy review, Association for the Advancement of Medical Instrumentation (AAMI) standard review, water culture results review, RO (Reverse Osmosis) Disinfection Log review and staff interview the hospital's infection control officer failed to ensure control of infections and communicable diseases by failing to ensure endotoxin cultures were done of water used for hemodialysis and timely redraws of hemodialysis water samples were done after high bacteria cultures were obtained per AAMI standards and by failing to ensure RO equipment that produced water with high bacterial cultures was unavailable for hemodialysis treatments.

The findings include:

Review of current hospital policy entitled "RO Fluid Culture and Dialysate Fluid Culture" dated 03/31/2008 revealed, "The RO fluid (water used for hemodialysis) and dialysate fluid will be cultured every month on each machine to ensure there is no bacterial growth....Notify nephrologist PRN (as needed) for abnormal results (results exceeding AAMI standards), and disinfect RO machine per RO manual instructions. Then repeat the water test per policy."

Review of current AAMI Standard #RD52:2004 entitled "Dialysate for Hemodialysis" dated 08/09/2004 revealed, "...4.1.2 Bacteriology of water Product water used to prepare dialysate or concentrates from powder at a dialysis facility, or to process dialyzers for
reuse, shall contain a total viable microbial count lower than 200 CFU/mL (colony forming units per milliliter) and an endotoxin concentration lower than 2 EU (endotoxin units)/mL. The action level for the total viable microbial count in the product water shall be 50 CFU/mL, and the action level for the endotoxin concentration shall be 1 EU/mL. If those action levels are observed in the product water, corrective measures shall promptly be taken to reduce the levels....the user is responsible for continued monitoring of the water bacteriology of the system and for complying with the requirements of this standard, including those requirements related to action levels."

Review of water culture results from 01/01/2009 through 12/31/2009 revealed no documentation that endotoxin cultures of water used for hemodialysis were done during 2009. Review revealed results of monthly bacterial water cultures for each portable RO machine used at the hospital were sent via electronic mail to the hemodialysis nurse and Infection Control Practitioner. Review of RO Disinfection Log revealed documentation of each RO disinfection. Further review of the water culture results and the RO Disinfection Log revealed bacterial culture results of RO water was greater than 50 CFU/mL (action level per AAMI Standard) on the following dates with the action taken by the facility as noted:
· Machine #8151 - Results of 2,000 CFU/mL received on 01/29/2009 - Action: RO Renalin Disinfection on 02/03/2009 and redraw of water sample for culture (5 days later);
· Machine #8151 - Results of 70 CFU/mL received on 04/15/2009 - Action: RO Renalin Disinfection on 04/29/2009 and redraw of water sample for culture on 04/30/2009 (15 days later);
· Machine #8152 - Results of 130 CFU/mL received on 06/10/2009 - Action: RO Renalin Disinfection on 06/17/2009 and redraw of water sample for culture on 07/08/2009 (28 days later) and
· Machine #3218 - Results of 100 CFU/mL received on 11/23/2009 - Action: RO Renalin Disinfection on 11/23/2009 and redraw of water sample for culture on 12/08/2010 (15 days later).

Interview on 01/12/2010 at 1400 with RN #2 revealed the nurse was one of two hemodialysis nurses at the hospital, with the other one being RN #1. Interview revealed the hospital had 2 hemodialysis machines with a portable RO on each one. Interview revealed two old machines were removed from service and replaced by two new machines in 09/2009. Interview revealed each RO was disinfected with Renalin once per month. Interview revealed the hemodialysis nurses collect water samples each month and send them to the laboratory for bacterial culture tests. Further interview revealed water samples are sometimes collected before disinfection and sometimes after disinfection. Interview revealed endotoxin tests were not done on the water samples. Interview revealed bacterial culture results are sent from the laboratory to the hemodialysis nurse, the nephrologist and the Infection Control Practitioner for review. Interview revealed no action was required if results were less than 200 CFU/mL. Interview revealed each RO was disinfected with Renalin when bacterial culture results were greater than 200 CFU/mL. Interview revealed bacterial culture results of greater than 200 CFU/mL also required recollection of water samples for testing to recheck the bacterial count in the water. Further interview revealed, "Sometimes we just recollect (the water sample) to see if it was a collection error....Infection Control reviews the reports and calls us to make sure we disinfect or redraw." Interview revealed the nurse was not aware the current AAMI Standard of practice required action for bacterial counts greater than 50 CFU/mL and endotoxin testing of water used for dialysis.

Interview on 01/13/2010 at 1530 with RN #1 revealed Machine #8151, Machine #8152 and Machine #3218 were "probably not" removed from service on 04/15/2009, 06/10/2009 and 11/23/2009, respectively, when bacterial culture results were between 70 and 130 CFU/mL because the hospital's action level was greater than 200 CFU/mL. Interview revealed when a water bacterial culture results are greater than 200 CFU/mL the nurse removes the machine from service and disinfects the RO with Renalin. Interview revealed there was no defined expected timeframe for the recollection of water samples to recheck the bacterial count in the water. Interview revealed no action was required if results were less than 200 CFU/mL. Further interview revealed water samples are sometimes collected before disinfection and sometimes after disinfection. Interview revealed endotoxin tests were not done on water samples. Interview revealed the nurse was not aware the current AAMI Standard of practice required action for bacterial counts greater than 50 CFU/mL and endotoxin testing of water used for dialysis.

Interview on 01/12/2010 at 1400 with the Director of Medical Services revealed the Director was responsible for the management of hemodialysis services. Interview revealed the Director depended on the Medical Director to identify problems with dialysis services, including water cultures. Interview revealed the Nephrologist that served as Medical Director until December 2009 was no longer at the hospital. Interview revealed two other Nephrologists currently are available to assist with hemodialysis services as needed. Interview revealed the Director was not aware the current AAMI Standard of practice required action for bacterial counts greater than 50 CFU/mL and endotoxin testing of water used for dialysis.

Interview on 01/14/2010 at 1030 with the Director of Infection Control revealed water culture results of water used for hemodialysis started being reported to Infection Control "about a year ago". Interview revealed, "I have not validated the process of water collection....I get a copy of the (bacterial culture) results via e-mail from the lab and it goes into the Infection Control minutes." Interview revealed the Director of Medical Services then reports culture results and any actions that were taken at Infection Control meetings. Interview revealed, "I have not provided any follow up of positive cultures, just reported some of them to the physician (Nephrologist)." Interview revealed the Director was not aware the current AAMI Standard of practice required action for bacterial counts greater than 50 CFU/mL and endotoxin testing of water used for dialysis. Further interview revealed the Director was not aware prior to the survey that the hospital's dialysis water culture policy did not include endotoxin testing. Interview revealed, "I have not reviewed that policy until now."

Based on hospital policy review, observations during tour and staff interviews, the hospital's infection control officer failed to have a system to control infections and communicable diseases as evidenced by failure to ensure staff used personal protective equipment (PPE) per to policy for 1 of 2 sampled patients on contact isolation precaution (#45) and stored wound care supplies per policy in 1 of 5 sampled wound care treatment rooms.

The findings include:

1. Review of hospital policy "Guidelines for Isolation Precautions in Hospitals" review date
January 2010, revealed "...Various types of gowns and protective apparel are worn to provide barrier protection and reduce opportunities for transmission of microorganisms in hospitals....Gowns are also worn by personnel during the care of patients infected with epidemiologically important microorganisms, to reduce the opportunity for transmission of pathogens from patients or items in their environment to other patients or environments during the care of patients that require direct body surface-to body surface contact....When gowns are worn for this purpose, they are removed before leaving the patients environment and hands hygiene is performed...."

Observation on 01/13/2010 at 1050 on the 3 South Floor of a medication pass revealed a staff nurse preparing to administer medications to a patient (#45) located in Room 307. Further observation revealed signage posted on the outer door identifying the patient as being on contact isolation precautions. Observation revealed the staff nurse donned personal protective equipment (gown, gloves) and entered the patient's room. Observation revealed the nurse made physical contact with the patient and proceeded to remove his identification band and exit the patient's room back into the hall way (clean). Observation revealed the nurse did not remove her gown or gloves (contaminated) upon exit of the room. Observation revealed the nurse placed the patient's identification band (contaminated) on top of the medication cart (clean). Further observation revealed the nurse subsequently removed her gloves (contaminated) at the medication cart, but failed to wash her hands with soap and water or use an alcohol based sanitizer after the gloves were removed. Observation revealed the nurse then proceeded to the clean utility room located down the hall to retrieve a cup of ice water. Further observation revealed the nurse failed to remove her contaminated gown before entry into the clean utility room. Continued observation revealed the nurse exited the clean utility room, donned a new pair of gloves, re-entered the patient's room and administered the medications.

Interview with nursing education and management staff on 01/13/2010 at 1050 during the observation revealed the patient was on contact isolation due to Methicillin Resistant Staphylococcus Aureus. Interview revealed the nurse should have removed her gown and gloves and washed her hands prior to exiting the patient's room. Interview revealed the nurse should not have placed the contaminated identification bracelet on top of the clean medication cart. The interviewed revealed the nurse should not have entered into the clean utility room wearing contaminated PPE. Interview confirmed the nurse did not follow the hospital's policy and procedure for PPE and contact precautions.

Interview with the infection control practitioner on 01/14/2010 at 1430 revealed the practitioner was aware of the observation made by the surveyor on 01/13/2010. Interview revealed "we need to go back to the basics." Interview confirmed the nurse did not follow proper procedure for PPE and contact precautions.



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2. Review of hospital policy entitled "Disposable Item Storage," last reviewed on 04/17/2008, revealed, "...3. Packaged, disposable items should be handled only with clean hands or clean gloves and should be in a drawer or far enough from the patient and water sources to prevent droplet contamination of the item."

During a tour of the outpatient wound care clinic on 01/14/2010 at 1400 it was observed in treatment room #2 that packages of 4x4 and 2x2 gauze used in dressing treatments and blue tray drapes were stored under the sink.

Interview with the infection control nurse at 1430 revealed this was inappropriate and patient care supplies should not be stored under the sink.

Based on hospital policy review, closed medical record review and staff interview, the hospital failed to ensure an informed consent was obtained prior to a surgical procedure for 1 of 9 surgical records reviewed (#13).

The findings include:

Review of the "Informed Consent for Examination and Treatment" policy revised 11/12/2009 revealed "Before any examination, administration of treatment, operative or invasive procedure, and/or administration of anesthesia (referred to herein as "treatment"), a valid informed consent must be obtained from the patient or other person authorized to make such a decision on the patient's behalf.... For an invasive or operative procedure or the administration of anesthesia, however, a specific informed consent must be provided to be signed by the patient or Representative, indicating that the physician has fully explained and discussed with the patient or Representative: A. The nature of the proposed treatment or the procedure, expressed in lay terminology; B. The risks, complications, and expected benefits or effects of the proposed treatment or procedure; C. Any alternative means of treatment and the requisite risks and benefits of such alternatives; and D. The patient's right to refuse the proposed treatment, and the associated risks of such refusal."

Closed medical record review of Patient #13 revealed a 75 year-old female admitted 12/04/2009 for acute cholecystitis (inflamed gallbladder). Review of the record revealed the patient had a laparoscopic cholecystectomy (gallbladder removal) performed on 12/04/2009 under general anesthesia as an outpatient. Record review revealed the administration of anesthesia started at 1125 and ended at 1233. Review of the "Consent for Operation/Procedure" form revealed the form was dated and timed on 12/18/2009 at 1215 and included surgical risks. Further review revealed the physician had signed the consent form and there was an "X" for the signature of the patient and no witness signature. Further review of the record revealed a signature by the patient beside an "X" on the consent for anesthesia form.

Interview on 01/14/2010 at 0930 with a surgical administrative staff member revealed the "X" on the consent forms were not the patient's signature and the patient was able to sign the consent form as evidenced by the patient's signature on the anesthesia consent form. The interview revealed that a separate surgical informed consent should be signed prior to the administration of anesthesia. The interview confirmed that there was no evidence that an informed surgical consent was obtained prior to surgery for Patient #13.

Based on review of medical staff by-laws, rules and regulations, medical record review and staff interviews, the hospital failed to ensure the completion of an operative report immediately following surgery for 2 of 9 surgical records reviewed (#12 and #13).

The findings include:

Review of current medical staff by-laws, rules and regulations revealed "11. A. Operative notes must be performed immediately. If operative note has not been performed day after procedure, Physician will be reminded by Medical records. If operative note has not been performed day after reminder, admitting privileges will be suspended. Physician will not be relieved his/her emergency call duties. Record of suspension will be placed in physician's peer review file."

1. Closed record review of Patient #12 revealed a 38 year-old female admitted as an outpatient on 12/01/2009 for an ovarian cyst. Review of the record revealed Patient #12 had an operative laparoscopy with right salpingo-oophorectomy (removal of tube and ovary) and left ovarian cystectomy (removal of cyst) procedure on 12/01/2009 with surgery beginning at 0915 and ending at 1014. Record review revealed a progress note dated 12/01/2009, not timed, that described the surgical procedure performed on 12/01/2009. Record review revealed no further documentation of an immediate operative note.

Interview on 01/14/2010 at 0930 with a surgical administrative staff member revealed the physician did not time the operative note in Patient #12's record, so the administrative staff was not sure if it was completed immediately following surgery or not.

2. Closed record review of Patient #13 revealed a 75 year-old female admitted as an outpatient on 12/04/2009 for acute cholecystitis (inflamed gallbladder). Record review revealed Patient #13 had a laparoscopic cholecystectomy (gallbladder removal) procedure on 12/04/2009 with surgery beginning at 1125 and ending at 1233. Record review revealed a progress note dated 12/04/2009, not timed, that described the surgical procedure performed on 12/04/2009. Record review revealed no further documentation of an immediate post operative note.

Interview on 01/14/2010 at 0930 with a surgical administrative staff member revealed the physician did not time the immediate operative note in Patient #13's record, so the administrative staff was not sure if it was completed immediately following surgery or not.