HospitalInspections.org

Based on review of patient rights documents and staff interview, the hospital failed to have accurate State agency contact information for the filing of grievances in their "Patient Handbook". This occurred during 1 of 1 reviews of patient rights data (Patient Handbook). This has the ability to affect 21 in-patients and 8 out-patients currently in the hospital.

Findings include:

Per review on 11/12/13 beginning at 1:30 p.m., of the Patient Rights and Responsibilities listed in the "Patient Handbook", the phone number listed to file a complaint with the State of Wisconsin is listed as 608-243-2024; per call to this phone number, message states, "the number you reached has been disconnected".

In interview with QA Director B on 11/12/13 at 1:45 p.m., it was stated that the number is not accurate.

Based on staff interview and hospital policy review, the hospital failed to ensure the grievance policy contained specific time frames for grievance resolution. This occurred in 1 of 1 staff interviews (QA Director B). This has the ability to affect 21 in-patients and 8 out-patients currently in the hospital.

Findings include:

Per review on 11/12/13 beginning at 1:30 p.m., of the policy titled "Patient/Family Concerns, last revised 7/2013", it states: "All complaints/grievances or concerns will be reviewed and a response to the complainant with the necessary documentation listed below sent as soon as possible following the receipt of the complaint.". This policy does not contain specific time frames for follow up with complainant after complaint is filed and after investigation is complete.

Per interview with QA Director B on 11/12/13 beginning at 1:45 p.m., "Patient/Family Concerns policy does not contain specific time frames for complaint/grievance process.

Based on staff interview (S), medical record review and facility policy review, the hospital staff failed to ensure that 2 of 3 (#s 27, 28) medical records reviewed documenting patient restraint use, had care plans for restraint use per facility policy. This occurred in a total sample of 33 patients, and has the ability to affect 21 in-patients and 8 out-patients currently in the hospital.

Findings include:

Per review of facility policy on 11/12/13 at 10:00 p.m. entitled Nursing Care Plan, policy number: COL-1146, dated as revised 7/13, stated in part that Nursing Care Plans will be utilized in all patient care areas for each patient. The Care Plan will be initiated with 8 hours of admission, individualized, when problems are noted, and care plans will be reviewed and updated each shift reflecting the needs of the patient.

1) Per review of Pt. #27's medical record on 11/12/13 at 8:50 a.m., Pt. #27 was admitted on 9/14/12 at 7:50 a.m. for sudden onset of weakness of the lower extremities including diagnosis of Developmental Disability and Bipolar Disorders. Pt. #27 was placed in wrist restraints on 9/17/12 at 11:00 a.m. and the restraints were discontinued on 9/18/12 at 2:00 p.m. Restraints were placed to prevent patient from pulling out a NG (Nasogastric tube). The care plan does not address the use of restraints.

2) Per review of Pt. #28's medical record on 11/12/13 at 10:45 a.m., Pt. #28 was admitted on 7/26/13 at 9:21 p.m. following a fall, generalized weakness and acute Delirium. Pt. #28 was placed in wrist restraints on 7/30/13 at 4:30 p.m. that were discontinued on 7/30/13 at 11:50 p.m. Restraints were placed due to severely aggressive behavior. The care plan does not address the use of restraints.

On 11/12/13 at 10:00 a.m., RN S confirmed the above findings and stated that staff should be updating the care plan at least once a shift.

Based on facility policy review and medical records review, the hospital staff failed to follow time limits on orders for the use of restraints for Violent and or Self Destructive Behaviors in 1 of 2 (#28) MR's reviewed. This occurred in a total sample of 33 patients, and has the ability to affect 21 in-patients and 8 out-patients currently in the hospital.

Finding include:

Per review on 11/12/13 at 10:00 a.m. of facility policy titled Restraints-Use of Physical Protective Devices, policy # COL-1131- revised 6/2011, states in part when orders are written for Violent and or Self Destructive Behaviors restraint orders are valid for 4 hours for patients 18 and older.

Per review on 11/12/13 at 10:45 a.m. of Pt. #28's MR (age 87) revealed that an order was obtained for Violent and or Self Destructive Behaviors on 7/30/13 at 4:30 p.m. No reorder was noted in MR, restraint was discontinued on 7/30/13 at 11:50 p.m.

The above findings were confirmed with RN S at time of MR review above.

Based on facility policy and medical record review, the hospital failed to order restraints for Non-Violent and Non-Self Destructive patients per facility policy in 1 of 3 (#27) MR's reviewed, of patients who required the use of restraints. This occurred in a total sample of 33 patients, and has the ability to affect 21 in-patients and 8 out-patients currently in the hospital.

Finding include:

Per review on 11/12/13 at 10:00 a.m., of facility policy titled Restraints-use of Physical Protective Device, policy # COL-1131- revised date 6/2011, stated in part that for a patient requiring orders for a restraint for nonviolent and non self destructive behaviors utilize restraints beyond 24 hours, a new order must be entered in the medical record based on a face to face patient assessment by a physician. The order is required once each calendar day.

Per review on 11/12/13 at 8:50 a.m. of MR of Pt. #27 revealed that restraints were placed on 9/14/12 at 11:00 a.m. and an order was obtained on 9/14/12 at 11:14 a.m. Restraint was discontinued on 9/17/12 at 2:00 p.m. No evidence noted of restraint being reordered after 24 hours.

The findings were confirmed by RN S at time of MR review above.

Based on staff interview (S), medical record review and facility policy review, the hospital staff failed to ensure that 3 of 3 (# 27, 28, 29) medical records reviewed documenting restraint use included assessments and interventions required per facility policy. This occurred in a total sample of 33 patients, and has the ability to affect 21 in-patients and 8 out-patients currently in the hospital.

Findings include:

Per review of facility policy on 11/12/13 at 10:00 a.m. titled Restraints- Use of physical protective devices, policy number: COL-1131- dated as revised 6/11, stated in part under monitoring and assessments: two categories: Nonviolent and Non Self Destructive Behavior- require assessments to be completed and range of motion needs to be provided to restrained limbs every two hours or more frequently if required by patient's needs. Violent and or Self Destructive Behaviors- requires continuous observation, assessments to be completed every 15 minutes monitoring for injury, nutrition, circulation of extremities, vital signs, repositioning and skin assessment.

1) Per review of Pt. #27's medical record on 11/12/13 at 8:50 a.m., Pt. #27 was admitted on 9/14/12 at 7:50 a.m. for sudden onset of weakness of the lower extremities including diagnosis of Developmental Disability and Bipolar Disorders. Pt. #27 was placed in wrist restraints on 9/17/12 at 11:00 a.m. Order was obtained on 9/16/12 at 11:14 a.m. for Non-violent and Non-Self Destructive Behavior. Restraints were placed to prevent patient from pulling out a NG (Nasogastric tube). Assessments indicate that restraints were released and range of motion was completed on 9/17/12 at 12:17 a.m., 2:00 a.m., 4:25 p.m., 6:35 p.m. and 9:27 p.m.; and on 9/18/12 at 12:13 a.m., 2:00 a.m., 3:33 a.m., 6:58 a.m., 8:00 a.m., 10:00 a.m. and 12:00 p.m., they were removed at 2:00 p.m. Restraints were discontinued on 9/18/12 at 2:00 p.m.

2) Per review of Pt. #28's medical record on 11/12/13 at 10:45 a.m., Pt. #28 was admitted on 7/26/13 at 9:21 p.m. following a fall, generalized weakness and acute delirium. Pt. #28 was placed in wrist restraints on 7/30/13 at 4:30 p.m. Restraints were placed due to severely aggressive behavior and an order was obtained for Violent and Self Destructive Behaviors. There is no documentation noted of continuous observation. Assessments indicate that restraints were released and range of motion was completed on 7/30/13 beginning at 4:30 p.m. Assessments were completed on 7/30/13 at 6:00 p.m. and 8:00 p.m. but documentation does not indicate that the restraints were removed or that range of motion was performed. Assessment completed and restraints released at 10:00 p.m., at restraints were discontinued on 7/30/13 at 11:50 p.m.

3) Per review of Pt. #29's medical record on 11/12/13 at 1:45 p.m., Pt. #29 was admitted on 3/29/13 at 12:58 p.m. following Heroin overdose. Pt. #29 was placed in wrist restraints on 1:00 p.m. with Physician at bedside at 1:00 p.m. Restraints were placed due to violent behavior and an order was obtained for Violent and Self Destructive Behaviors on 3/29/13 at 2:51 p.m. Police remained at bedside. Documentation of staff at bedside throughout Emergency room stay and 15 minutes vital signs assessments were completed, however assessments did not include circulation and range of motion assessments of extremities. Restraint assessment completed at 1:00 p.m. stated restraint applied, 2:00 p.m. assessment states restraints rotated, 3:00 p.m. assessment states restraints on, and at 4:00 p.m. restraints were rotated. Pt.#29 was transferred to ICU at 4:02 p.m. and restraints were discontinued at 4:45 p.m.

On 11/12/13 at 10:00 a.m., RN S confirmed the above findings and stated that staff should be documenting that restraints are removed and range of motion is completed at least every two hours per policy.

On 11/12/13 at 1:50 p.m., RN S stated that staff entered the wrong order for Pt. #28 and #29. RN S stated the orders should have been for Non-violent and Non-Self Destructive Behaviors instead of Violent and Self Destructive Behaviors.

Based on facility policy and medical record review, the hospital failed to follow it's policy in performing face to face initial evaluation within 1 hour for patients requiring restraint use for Violent and Self Destructive Behavior. This occurred in 1 of 2 (#28) medical records reviewed. This occurred in a total sample of 33 patients, and has the ability to affect 21 in-patients and 8 out-patients currently in the hospital.

Findings include:

Per review on 11/12/13 at 10:00 a.m. of facility policy titled Restraints-Use of Physical Protective Devices, policy #: COL-1131, revised date 6/2011, it states in part that when a restraint is ordered for Violent and or Self Destructive Behaviors, the initial Physician face to face evaluation is required within one hour of the initiation of restraint.

Per record review on 11/12/13 at 10:45 a.m. for Pt. # 28, it revealed that on 7/30/13 at 4:30 p.m. wrist restraints were placed and an order was obtained for Violent and Self Destructive Behaviors. A face to face evaluation by physician was completed on 7/30/13 at 10:21 p.m.

The above findings were confirmed with RN S at time of MR review above.

Based on facility policy review, medical record review and staff interviews, the hospital failed to ensure nursing care plan development based on their medical needs containing measurable goals and individualized nursing interventions. This occurred in 11 of 33 sampled patients records reviewed (Patient #'s 1, 2, 10, 11, 22, 23, 25, 27, 28, 29 and 33), and 3 of 3 staff interviews (Staff S, U and SS). This occurred in a total sample of 33 patients, and has the ability to affect 21 in-patients and 8 out-patients currently in the hospital.

Findings include:

Per review of facility policy on 11/12/13 at 10:00 a.m. titled Nursing Care Plans, policy number: COL-1146, dated as revised 7/13, stated, "1. A computerized nursing care plan will be initiated by an RN within 8 hours of admission. 2. The nursing care plan will identify a nursing plan of care for the individualized patient's problems whenever they are noted. 3. The nursing care plan should be reviewed each shift and updated as necessary by nursing personnel with revisions reflecting the re-assessment of needs of patients including his/her learning needs. 4. All staff using the computerized nursing care plans are responsible for interdisciplinary collaboration to establish goals and appropriate interventions, as well as ongoing evaluations and revisions."

1) Per review of Pt. # 27's medical record on 11/12/13 at 8:50 a.m., Pt. # 27 was placed in wrist restraints on 9/17/13 at 11:00 AM to prevent patient from pulling out a NG (Nasogastric tube). The care plan does not address interventions or goals regarding the use of wrist restraints, Foley catheter, nasogastric tube or falls risk. The care plan had a goal that stated "Drains expected amounts of fluid from chest tube", however pt. #27 did not have a chest tube. A goal on the care plan stated "evidence of no significant weight fluctuations", an immeasurable goal.

2) Per review of Pt. # 28's medical record on 11/12/13 at 10:45 a.m., Pt. #28 was admitted on 7/26/13 at 9:21 p.m. following a fall, generalized weakness and acute delirium. Pt. #28 was placed in wrist restraints on 7/30/13 at 4:30 PM due to severely aggressive behavior. The care plan does not address use of wrist restraints or potential for falls.

3) Per review of Pt. # 29's medical record on 11/12/13 at 1:45 p.m., Pt. #29 was admitted on 3/29/13 at 12:58 p.m. following an overdose of heroin. Pt. #29 was placed in wrist restraints due to violent behavior on 3/29/13 at 1:35 p.m., while in the ER, and transferred to ICU (intensive care unit) at 4:04 p.m. while restrained. The care plan does not address the use of wrist restraints.

In an interview on 11/12/13 at 11:30 p.m. stated that care plans should be updated at least each shift and the use of restraints should be addressed on the care plans. On 11/12/13 at 3:00 p.m., RN S confirmed the above findings upon review of records.



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4) Per review of Pt. #22's medical record with RN NN beginning at 1:45 p.m. on 11/12/13, the following was noted: Pt. #22 was admitted on 11/10/13 with a fractured hip and surgical repair of the fracture. The plan of care addresses that Pt. #22's pain will be at a tolerable level. What is tolerable is not identified and this goal is not measurable.

5) Per review of Pt. #23's medical record with RN OO beginning at 2:20 p.m. on 11/12/13, Pt. #23 was admitted on 11/8/13 with perforated diverticuli and surgical intervention of stoma repositioning. The plan of care lacks stoma interventions and states that Pt. will maintain weight within 10% of ideal body weight. There is no measurable goal weight identified.

6) Per review of Pt. #25's medial record with RN OO beginning at 2:50 p.m. on 11/12/13, Pt. #25 was admitted on 11/2/13 with a small bowel obstruction, had exploratory laparotomy surgery, and placement of a naso-gastric tube. The plan of care does not address interventions and a goal for the surgical site and does not address the naso-gastric tube.

The information above was confirmed by RN OO at time of record review.



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7) Per review of Pt. #1's MR on 11/12/13 at 11:30 a.m., Pt. #1 was admitted on 11/9/13 for weakness, Urinary Tract Infection, Sepsis, fever and hematuria. Pt #1 is also diabetic. Pt #1's care plan does not address a urinary problem or a diabetic problem.

8) Per review of Pt. #2's MR on 11/12/13 at 1:30 p.m., Pt. #2 was admitted on 11/9/13 for hematuria, urinary retention, and bladder cancer. Pt. #2's care plan does not address any urinary problem.

9) Per review of Pt. #10's MR on 11/12/13 at 11:00 a.m., Pt. #10 was admitted on 11/18/12 for for End Stage Renal Disease, Dialysis, fever and vomiting. Pt. #10's care plan does not address renal disease or Dialysis.

10) Per review of Pt. #11's MR on 11/12/13 at 10:30 a.m., Pt. #11 was admitted on 11/12/13 for severe Sepsis, Cellulitis, ulcers to the right lower extremity and acute Kidney Failure. Pt. #11's care plan does not address ulcers or kidney failure.

On 11/12/13 at 1:30 p.m., Clinical Systems Analysis U stated that the care plans were not complete for Pts. #1, 2, 10 and 11.



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11) On 11/12/13 at approximately 10:45 a.m. clinical record review of Patient #33 was conducted with OB charge RN SS. The infant delivery record show blood loss of 400 mls. The 11/11/13 post delivery labwork shows low red blood cell count (2.75), low hemoglobin (8.0) and hematocrit (24.0). Review of the current care plan documents no evidence of care planning for post delivery anemia.

OB RN SS stated, at time of record review above, that she agreed that patient labs reflect low blood counts and that she could "find no care plan for post delivery anemia" in the medical record.

Based on tour observations and staff interview, the hospital failed to ensure that 1 of 13 total hospital departments (Medical Records Department) observed, maintained confidentiality and prevented alteration or destruction of patient records. This occurred in a total sample of 33 patients, and has the ability to affect 21 in-patients and 8 out-patients currently in the hospital.

Findings include:

Per interview and observational tour on 11/11/13 at 1:30 p.m. with Environmental Services (EVS) Lead T, EVS T stated that housekeeping begins to clean the Medical Records department when staff is present but continues to clean the area after all medical records staff has left for the day. This allows housekeeping staff to have free access to unlocked confidential patient information.

Infection Prevention (IP) RN E was present at interview with EVS Lead T.

Based on observation and staff interviews, the hospital failed to ensure medications and biologicals in crash carts in 2 of 7 crash carts observed (ICU, pediatric nursing unit) in 15 total hospital departments were secured or locked as appropriate. This occurred with a total sample of 33 patients, and has the ability to affect 21 in-patients and 8 out-patients currently in the hospital.

Findings include:

1) Per document policy titled "Medication management" policy # COL-1126 dated 5/22/2013 reviewed on 11/12/13 at 2:00 p.m. under "III. Medication Storage A...Medications will be stored in a secured area to prevent diversion. Medications removed from the pharmacy should be placed in an approved storage area as soon as possible. Storage areas may include locations such as the Pyxis, medication refrigerator, patient specific bin, and secure medication room."

Per policy review titled "Watertown Memorial Hospital Adult Code Blue Carts" reviewed on 11/12/13 at 2:00 p.m., the code blue carts contain the following medications: Amiodarone, Atropine, Calcium Chloride, Dextrose, Dilantin, Diphenhydramine, Dopamine, Epenephrine, Lidocaine, Magnesium Sulfate, Naloxone, Procainamide, Sodium Bicarbonate, Sodium Cloride and Vasopressin. Syringes and needles are also in the drawers of the cart.

During a tour of the pediatric nursing unit on 11/11/13 at 11:20 a.m. accompanied by Clinical Resource Leader C noted crash cart containing medications with a breakaway lock in the hallway across from the "toy room".

Per interview with Clinical Resource Leader C, she stated, at the time of the tour, the crash cart is not always in view of the staff.



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2) During tour of ICU/3N on 11/11/13 at 11:00 a.m., a crash cart was noted in the ICU department. The crash cart was locked with a plastic breakaway lock. During the tour ICU/3N did not have any inpatients. There was one outpatient who was coming in twice a day for intravenous antibiotics lasting for four hours. There was one nurse observed on the unit to care for the out-patient. During the time of this out-patient treatment, access to ICU/3N is not restricted to public access. The crash cart is not in constant monitoring of staff and the one nurse assigned to administer care to the out-patient at all times. This situations could potentially allow for unauthorized access to medications and or biologicals stored in the emergency crash cart.

Infection Prevention Nurse (IPN) E confirmed, at time of tour, that ICU/3N did not have any inpatients at this time and that an outpatient was receiving treatment on that unit. IPN E also confirmed that the crash cart is not under constant monitoring of staff.

Based on observation, WI (Wisconsin Food Code) standards of practice, facility policy and staff interview, the hospital failed to ensure that 7 of 7 total kitchen staff (G, H, I, J, K, L, M) observed were wearing proper hair restraints in the kitchen and food preparation areas. This was observed in 1 of 2 food preparation areas (patient food preparation area), and has the ability to affect 21 in-patients and 8 out-patients currently in the hospital.

Findings include:

Per 11/12/13 review of the Wisconsin Food Code dated June 2013, "FOOD EMPLOYEES shall wear hair restraints such as hats, hair coverings or nets, beard restraints, and clothing that covers body hair, that are designed and worn to effectively keep their hair from contacting exposed FOOD; clean EQUIPMENT, UTENSILS, and LINENS; and unwrapped SINGLE-SERVICE and SINGLE-USE ARTICLES."

Facility policy reviewed on 11/12/13 at 3:00 p.m. titled "Infection Control Policy, Department Dietary, dated 1/2013 states under "2. All employees shall wear a clean uniform daily. Hair nets are to be worn while preparing or serving food while in the kitchen area."

During a observational tour of the kitchen on 11/11/13 at 1:20 p.m. accompanied by Executive Chef G, the following staff were observed in the kitchen and food preparation areas without hair restraints which covered all hairs on their heads: Market Chef H, Line Chef I, Porter J, Nutrition Liaison K, Market Chef L, Market Chef M, Executive Chef G. Executive Chef G was observed in kitchen without facial hair covered.

Per interview with Executive Chef G on 11/11/13 at 1:20 p.m. it has never been the practice to wear hear nets or beard nets in the kitchen. Per Executive Chef G, this facility follows the Wisconsin Food Code as their standard of practice.

Based on observation, staff interviews and review of maintenance documents, the hospital failed to construct and maintain the building systems to ensure a safe physical environment. The cumulative effects of these environment deficiencies resulted in the hospital's inability to ensure a safe environment for the patients. Therefore 42 CFR 482.41- Condition of Participation: Physical Environment IS NOT MET. This deficiency occurred in 17 of the 22 smoke compartments, and has the ability to affect 21 in-patients and 8 out-patients currently in the hospital.

FINDINGS INCLUDE:

It was observed that the facility had the following life safety deficiencies. K11 (common walls), K12 (construction types), K17 (corridor walls), K22 (exit signs), K29 (hazardous room), K33 (stairs), K46 (emergency lights), K62 (fire protection sprinkler maintenance), K64 (portable fire extinguishers, K76 (medical gases) and K147 (electrical code). Please refer to the full description at the cited K-tags: This observed situation was not compliant with CFR 482.41.

Based on observations and staff interviews, the hospital failed to ensure biohazardous materials in storage areas on patient care units are secured from patient and visitor access. This occurred in 3 of 4 inpatient areas toured (ICU, 2 North, Pediatric Unit) and has the ability to affect 21 in-patients and 8 out-patients currently in the hospital.

Findings include:

1) During a tour on 11/11/13 at 11:00 a.m. of the ICU/3N, a "soiled utility room" labeled with a biohazard sign has an unlocked door. There are biohazardous materials in biohazardous containers stored in this room.

Infection Prevention Nurse (ICN) E stated at time of discovery the soiled utility room is not a locked room that prevents access to patients and visitors.



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2) During at tour of the 2 North nursing unit on 11/11/2013 at 10:35 a.m. accompanied by Clinical Resource Leader C, it was observed that "soiled utility room" was unlocked. This room has access from both sides of the nursing hallway and both doors do not have locks. This room contains cleaning chemicals and biohazard materials.

Clinical Resource Leader C stated in interview, at time of tour that this room contains biohazard materials and chemicals and is unlocked from both sides.

3) During at tour of the Pediatrics unit on 11/11/2013 at 11:00 a.m. accompanied by Clinical Resource Leader C it was observed that "soiled utility room" was unlocked. This room contains cleaning chemicals and biohazard materials.

Clinical Resource Leader C stated in interview at time of discovery that this room contains biohazard materials and chemicals and is unlocked.

Per interview on 11/12/13 at 1:40 p.m. with Director of Quality B, she stated the hospital does not have a policy for the safe storage of biohazardous materials.

Based on observation, staff interviews and review of maintenance documents, the facility failed to construct and maintain the building systems to ensure a safe physical environment due to the cumulative effects of environment deficiencies and resulted in the hospital's inability to ensure a safe environment for the patients, which is a Condition of Participation. This deficiency occurred in 17 of the 22 smoke compartments, and would affect all of the 21 in-patients and 8 out-patients currently in the facility.

Findings include:

It was observed that the facility had the following life safety deficiencies. K11 (common walls), K12 (construction types), K17 (corridor walls), K22 (exit signs), K29 (hazardous room), K33 (stairs), K46 (emergency lights), K62 (fire protection sprinkler maintenance), K64 (portable fire extinguishers, K76 (medical gases) and K147 (electrical code). Please refer to the full description at the cited K-tags: This observed situation was not compliant with CFR 482.41.

Based on observations, review of facility policy and staff interviews, the hospital failed to ensure effective hand hygiene before and after patient contact was performed in 3 of 18 patient observations of care (Patient #'s 3, 4 and 34); and failed to ensure all patient care equipment (glucometers and staff laptop computers) shared between patients was disinfected between patient uses in 2 of 18 patient observations of care (Patient #'s 1, 3 and 4). This occurred with a total sample of 33 patients, and has the ability to affect 21 in-patients and 8 out-patients currently in the hospital.

Findings include:

Per review of facility policy on 11/12/13 at 10:00 a.m. titled "Vascular Access/Intravenous Therapy, policy number: COL-1125, effective date 6/2013", it's states "I. Scrupulous hand hygiene before and after contact with a vascular access device and prior to insertion".

1) Per observation on 11/11/13 at 11:05 a.m. of RN F initiating intravenous (IV) antibiotics to Pt. #34. RN F completed the initiation of blood draw and IV antibiotics and left room without performing hand hygiene.

Infection Prevention Nurse (IPN) E confirmed that RN F did not perform hand hygiene when leaving patient's room. IPN E stated that hand hygiene should be completed with patient care upon entering and exiting all patient rooms.




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2) On 11/11/13 at 11:00 a.m., observation of RN O administering IV (intravenous) antibiotics to Pt. #4 in the ER reflects RN O brought a laptop computer into Pt #4's room. RN O did not disinfect the laptop prior to bringing it into Pt #4's room. RN O performed hand hygiene, typed on laptop (potentially recontaminating hands), then proceeded to connect antibiotic IV fluids and connect lines to Pt. #4's IV without first performing hand hygiene. RN O, then typed on laptop, scanned medication, and spiked bag of IV antibiotics and connected to Pt #4's IV lines, without performing hand hygiene between using keyboard and performing patient care tasks. After administering medication, RN O carried laptop out of room, placed laptop on counter near nurses station and proceeded to perform hand hygiene. RN O did not disinfect laptop after removing it from Pt. #4's room.

Per interview with VP N on 11/11/13 at 11:30 a.m., VP N stated hospital staff should be performing hand hygiene before and after keyboard contact, and laptops should be disinfected between patients.

3) On 11/11/13 beginning at 11:35 a.m., observed CNA Q performing blood glucose check on Pt. # 3. CNA Q did not perform hand hygiene upon entering the room. CNA Q placed glucometer container on Pt. #3's bed side table. CNA Q donned gloves without performing hand hygiene, then proceeded to remove glucometer and supplies from box and perform finger stick on Pt. #3 without first cleaning Pt. #3's finger with alcohol wipe. With gloved hands, CNA Q proceeded to place glucometer back into container. CNA Q exited Pt #3's room and placed glucometer container on counter outside of Pt. #3's room, CNA Q did not disinfect glucometer or outer surface of glucometer container before or after exiting Pt. #3's room.

These findings were confirmed with VP N on 11/11/13 at 11:45 am.


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Per policy review titled "Whole Blood Glucose Testing - Precision Xceed Pro" dated 6/13/2013, that was reviewed on 11/11/2013 at 1:00 p.m., it states under "Maintenance...Clean the meter using a SANI-CLOTH before and after patient testing. Clean or replace the port insert if there is visible blood."

4) On 11/11/2013 at 11:35 p.m. observation of LPN D bring a plastic case containing blood glucose meter, lancets, gauze pads and alcohol wipes into Patient #1's room. LPN D neglected to clean the meter using a SANI-WIPE before obtaining Patient # 1's blood glucose. After completing the blood glucose test, LPN D put the meter back in the case without cleaning it with a SANI-WIPE. LPN D then put plastic case containing the un-cleaned meter in the clean utility room.

On interview, at the observation time above, when asked when the meter and the plastic case will get cleaned LPN D stated "I think they are cleaned at night when they do the quality checks."

Per interview with Clinical Resource Leader C on 11/11/2013 at 12:30 p.m., Leader C states the blood glucose meters should be wiped down with a SANI-CLOTH before and after patient uses.

Based on policy review and staff interview, the hospital failed to ensure that data received from OPO was reviewed in order to provide educational opportunities to hospital staff. This occurred in 1 of 2 total OPO staff interviews (Staff B). This occurred with a total sample of 33 patients, and has the ability to affect 21 in-patients and 8 out-patients currently in the hospital.

Findings include:

Per review of policy titled "Organ/Tissue Donation" dated 9/2010 on 11/12/2013 at 9:15 a.m., it states "11. Performance Improvement and Compliance: The hospital maintains a log of potential donors who have been referred to UW OPO. There is a review of the hospital's total deaths by a UW representative to ensure proper identification and notification of potential donors. UW OPO provides a quarterly report of the hospitals's compliance to notification that is part of the performance improvement death report."

Per interview on 11/12/2013 at 8:30 a.m. with Director of Quality B the facility receives a quarterly report from UW OPO contain a log of potential donors but they do not reconcile this information with the deaths at their facility. The facility does not perform audits on death records to ensure proper identification and notification of potential donors.

Per interview on 11/13/2013 with Director of Quality B, she stated the analysis and interventional planning for OPO data collected has not been done.

Based on observations, interviews and record reviews, the hospital's surgical services failed to ensure that the surgical service, including all hospital staff that has access to the surgical services department, adhere to current professional SOP. Surgical services failed to initiate or update surgical policy, and monitor and/or enforce policy compliance in 10 of 10 policy areas and/or hospital logs reviewed (Unauthorized Access, Surgical Time Out, Single Use items, Sterilization processes and manufactured product integrity, PPE, Endoscopy cleaning, IC, HH, Medication Administration and OR traffic). Surgical service failed to ensure 9 of 12 (#12, 13, 14, 15, 16, 17, 22, 23, and 25) patient records have complete; and accurate surgical records, that met time and P&P requirements; or maintain 1 of 1 required OR registers. This occurred with a sample of 12 total surgical patients, in a total patient sample of 33 patients, and has the ability to affect 21 in-patients and 8 out-patients currently in the hospital.
Findings include:
1) On 11/11/13 10:35 AM through 11/12/13 at 4:00 PM, observations, interviews and record reviews were conducted with OR Supervisor W and Director of Pharmacy X, and it was confirmed that 10 of 10 OR P&P and/or OR logs were not monitored for compliance, completeness or accuracy to ensure staff followed the most current professional standards of practice for the health , safety and welfare of all surgical patients receiving surgical services. (Reference A 951)
2) On 11/12/13 at 8:35 AM, OR RN and electronic medical records expert GG, confirmed the surgical department does not maintain a complete and accurate OR Register, and stated the surgical department would have to individually pull each surgical patient's record to obtain the missing information. (Reference A 958)
The cumulative effects of the systemic failures, prevents Surgical Services from providing surgical care in a safe and effective manner.

Based on observation, interview and record reviews, the hospital's surgical service failed to develop, enforce and or monitor policies that governed the safety, health and welfare of surgical patients, in 10 of 10 following areas:
1) develop, enforcement and monitor policy for unauthorized access to OR;
2) development of policy using MFRs and instructions for 3 of 3 total single use items observed (scope brushes, oxygen connectors and foam supports);
3) development of policy for the storage of sterile packages for 4 of 4 products (Kimguards, IV extension tubing, urology supplies and unwrapped IV fluid bags);
4) development and enforcement of policies to ensure that 5 of 10 surgical staff observed (II, Y, Z, MM and LL) wore PPE appropriately;
5) development of endoscopic cleaning policies based on manufacturer's guidelines;
6) development and monitoring of surgical-based environmental infection control policies for storage of disinfectant solutions, intact surfaces, disinfectant contact times and equipment cleaning during room turnover, occurring in 1 of 1 total environmental cleaning solutions observed (Super Sani wipes), and 3 of 3 total rooms observed (SDS unit, OR #2, Minor OR), and that 1 of 2 staff observed ( Staff EE) to perform OR room disinfection.
7) develop and monitor policies for accepted hand hygiene standards of practice in the surgery unit, observed in 3 of 10 total surgical staff surgical staff ( (Z, Y and AA);
8) develop surgical medication administration aseptic technique policies for vials, observed with 2 of 2 total surgical staff ( Z and CC):
9) development of policy or procedures to minimize OR traffic in an attempt to prevent unnecessary contamination.
10) enforcement and monitoring of "Site Marking and Time out" policy, in 9 of 12 total patient surgical records reviewed (#'s 12, 13, 14, 15, 16, 17, 22, 23 and 25).
This occurred with a total sample of 33 patients, and has the ability to affect 21 in-patients and 8 out-patients currently in the hospital.

Findings include:
Unauthorized/Restricted Access to the Operating Room:
On 11/11/13 at 2:30 PM, during an interview with OR Supervisor W and Director of Pharmacist X about badge access and restricted access to the OR, a volunteer mail person was observed walking into the OR to deliver mail. OR Supervisor W stated the OR employed 80 surgical staff (Physicians, Anesthesiologists, RNs PAs, PCPs EVS, STs and CRCSTs), both direct care and contracted, that included EVS.

OR Supervisor W was asked to provide a log of hospital employees who had entered the OR after the OR was closed:
On 11/12/13 at 2:40 PM during record review of the badge access logs, on the day of 11/11/13, there were 19 attempts or entries made in the OR after hours. Six (6) of the 19 were surgical staff.

On the day of 11/09/13 the access logs identified 25 hospital staff accessed the OR. Four (4) of the 25 staff were surgical staff. Of the remaining 21 entries, 1 was maintenance, 1 was pharmacy and 1 was radiology. 18 hospital staff entries could not be accounted for.

On the day of 11/08/13 the badge access log noted 10 OR entries. Four (4) of the 10 were surgical staff. Of the remaining 6 entries, 1 was from environmental services, and 1 was from laboratory. Four (4) hospital staff entries could not be accounted for.

Because of the size of the length of the afterhours OR access logs, an over view of the badge access log findings are as follows:
From 11/11/3103 back to 10/10/2013, the OR badge access for after hours and weekends, identified 762 attempts or actual access entry were made in the OR. One hundred twenty six (126) of 762 entries were identified by OR Supervisor W, as surgical staff. Of the remaining 636 hospital staff that accessed the OR, OR Supervisor W could not be sure but identified 41 of the hospital staff from radiology, maintenance, environmental services, respiratory therapy, laboratory, and the obstetric unit that may have entered the OR by request/need. This leaves 595 hospital staff entering the restricted and semi restricted OR environment, without defined need to be there.

OR Supervisor W stated that as supervisor, she is responsible to ensure policies and procedures are in place and followed to ensure the integrity and sterility of the OR, including defining restricted areas, and preventing unauthorized access.

On 11/13/13 at 11:58 AM , VP Patient Care/CNO N, emailed two documents: (1) the total number of hospital staff who had badge access (2) the number of hospital staff who had badge access to the OR.

The following was confirmed during the review of badge logs sent by VP Patient Care/CNO N: 1,122 hospital employees have badges; 558 hospital employees had badge access to the OR.
On 11/13/13 at 3:38 PM, in a telephone interview, OR Supervisor W confirmed the OR employed 80 surgical staff, and stated surgical services had not trained the 487 hospital employees in OR procedures and restrictions, who had badge access.

In an interview conducted on 11/11/13 at 2:30 PM, OR Supervisor W stated she has tried to limit access, because when OR staff return, it is evident that hospital employees have entered the OR because things are missing, or moved from the sterile storage and other OR areas. OR Supervisor W stated, she has not been able to limit or restrict access with badge entry to ensure only the OR staff, or hospital staff on a needs basis are allowed to enter the OR. OR Supervisor W stated that unrestricted access provided safety, infection control and sterility risks, when untrained unsupervised hospital employees were allowed access to the OR.

Single Use Items:
1) On 11/12/13 at 9:25 AM, RN CC was observed cleaning a colonoscope. RN CC picked up a "Con-Med Channel master scope cleaning brush", that was coiled and sitting on the sink above a wet spot, to clean the scope.
In interview, at the time and date of the observation, RN CC was asked if the scope cleaning brush was single use or multiple use. RN CC replied the brush was single use, and stated, endoscopy staff used to have multiple use brushes but went to a single use brushes. RN CC stated that scope-cleaning staff can use the single use scope cleaning brush two times before it needs to be discarded.
Director of Pharmacy X, at the time and date of the above observation, reviewed the manufacturer's recommendations and stated the scope cleaning brush was a "single use" item, to be used one time only.

2) On 11/12/13 at 12:20 AM during the observation of a terminal cleaning, tubing with a taped on connector plugged into an oxygen post on the OR tower, was noted to have a tape sign stating "do not throw away". The tape was dark and discolored. EVS staff DD wiped down the tubing and tape during the terminal clean, and left it attached to the OR tower.
In interview, at time and date of the observation, when asked how long the tubing had been there, EVS staff DD, could not define the length of time, and stated it had "been there a while".
In interview, at time and date above, Director of Pharmacy X, was asked to provide MFRs to determine if the tubing was for single use or multiple patient use. On 11/12/13 at 2:50 PM, Director of Pharmacy X provided the MFR for the tubing that stated "single use ". Director of Pharmacy X, stated "surgical service did not follow manufacturer's recommendations".

3) On 11/11/13 at 2:40 PM in OR suite #2, OR Supervisor W and Director of Pharmacist X, observed and confirmed in interview, the following:
An uncoated foam head positioner in a thin plastic unsealable bag, was wiped down, and covered in a pillowcase to be used for the next patient.
Supervisor W stated the uncoated foam head positioners are reused indefinitely, because staff put them in an unclosed plastic bag and the bag is wiped down the plastic bag. W confirmed the plastic bag was not sealable.
OR Supervisor W confirmed that surgical services did not have a policy or the MFR to determine if the foam head positioners were single use or multiple patient use.
Internet search of 3 companies that manufacture uncoated foam head positioners identified the foam head positioners as " single use " .




Manufacturer Sterile packaging:

1) On 11/11/13 between 2:45 PM and 3:00 PM, OR Supervisor W and Director of Pharmacist X observed the following:

Sterilized Kimguard wrapped instruments caskets and other sterile products wrapped in Kimguard were stacked one on top of the other, sitting on a wire rack in the sterile storage supply room in the OR.

Sterilized Kimguard wrapped instruments caskets and other sterile products wrapped in Kimguard, stacked one on top of the other sitting on a wire rack in the Sterilization Processing room.

On 11/11/13 at 2:45 PM ST HH was asked about the process of stacking Kimguard wrapped sterile supplies. ST HH stated, yes, it was an acceptable practice to stack Kimguard wrapped hospital sterilized supplies. ST HH stated, the stack should be no more than 2 items. ST HH was asked for the Kimberly Clark MFR on Kimguard, and stated the surgical department did not have the MFR, and would contact the company.

On 11/11/13 at 2:55 PM, ST HH provided and reviewed a copy of the MFR on Kimguard. ST HH, in interview and review of MFR document stated and noted on page 6 of the 7 page document, that the MFRs do not support stacking of Kimguard wrapped sterile instrument caskets because it compromises the integrity of the package, therefore compromising sterility of the content.

On 11/11/13 at 2:55 PM during an interview, ST HH and OR Supervisor W confirmed their current P&P did not meet MFRs ensuring the integrity and sterility of the Kimguard product.

2) On 11/11/13 between 10:35 AM and 11:45 AM, during a tour of the SDS unit clean supply room, OR Supervisor W and Director of Pharmacist X observed a 3 room set- up (that contained manufactured sterile IV extension tubing) rubber-banded.

OR Supervisor W stated she was" not aware of rubber banding sterile packaging would compromise its integrity".

3) On 11/12/13 from 7:00 AM through 8:30 AM, during an observation of a urology surgical procedure, Director of Pharmacist X observed and confirmed that surgical staff were bringing in a open 4 shelved wire cart of filled with sterile urology supplies in the room.

During verification of the observation, and interview on 11/12/13 at 7:20 AM, ST KK stated for urology cases the open wire rack with the manufacturer's sterile packaged urology products are wheeled in to the OR assigned to urology cases, and kept there for the day. ST KK stated the open wire rack with the manufacturer's sterile packaged urology products are wheeled into other ORs if cases get switched to another room.
ST KK confirmed, this open wire rack of sterile urology products sits in the OR suite between patients and between patient cleanings, and then is wheeled back into the sterile supply room.

These sterile products were potentially exposed to biohazardous fluids, dust and debris from patient surgical cases performed in the suite holding these unprotected packages.

4) Minimum standards from the CDC, referencing storage of sterile products states: "Although some hospitals continue to date every sterilized product and use the time-related shelf-life practice, many hospitals have switched to an event-related shelf-life practice. This latter practice recognizes that the product should remain sterile until some event causes the item to become contaminated (e.g., tear in packaging, packaging becomes wet, seal is broken) 968. Event-related factors that contribute to the contamination of a product include bioburden (i.e., the amount of contamination in the environment), air movement, traffic, location, humidity, insects, vermin, flooding, storage area space, open/closed shelving, temperature, and the properties of the wrap material 966, 969 ". Obtained at

Perioperative Standards and Recommended Practices for Inpatient and Ambulatory Setting, 2013 Edition states:
" RP Packaging Systems: Recommendation VIII... Sterilized packages should be considered sterile until an event occurs to compromise the package barrier integrity ...2. Sterile packages should be stored under environmentally controlled conditions. Sterile storage area temperature should be controlled and not exceed 75 degrees (24 C). The humidity should not exceed 70%. There should be a minimum of four air exchanges per hour, and the air flow should be under positive pressure in relation to adjacent areas. 3. The end user should visually inspect the package or container before opening for package integrity (e. free of holes in fabric/paper, effective seal in containers). "

On 11/12/13 at 8:25 AM, OR PCP FF brought a 3000 cc bag of fluid that was removed from its original packaging into the OR, but was no longer needed.

At the time of the observation, OR PCP FF was asked if she had opened the package, and responded "yes". OR staff were asked if there were MFRs recommendation for how long the MFR would support the use of the fluid once removed from its original packaging, OR PCP FF replied "24 hours" but was not sure. RN Y, also in the room did not respond, and Director of Pharmacy X did not know.

Director of Pharmacy X contacted the MFR of the fluid products and brought verbal recommendations from the MFR stating the MFR would support the use of the product for 30 days once removed from the original packaging and confirmed surgical services currently did not have P&P to ensure sterility of manufactured package contents.

Personal Protective Equipment (PPE):

1) On 11/12/13 at 2:55 PM, during an observation of ST II decontaminating instruments, the waterproof PPE gown worn was not tied in the back.

2) On 11/12/13 at 8:30 AM, during room turn over RN Y donned one glove leaving her other hand bared and attempted to remove soiled surgical drapes, touching the soiled drape with her ungloved hand.

3) On 11/12/13 between 8:30 AM and 1:00 PM, Anesthesiologist Z, and Atrium Representative MM were observed with surgical masks hanging around their necks.
Z was observed walking through the OR, then to the staff lounge with the mask around Zs neck. MM was sitting eating in the staff lounge and later walking into the sterile supply room with the mask still hanging around MMs neck.

4) RN LL was observed in the staff lounge and walking through the hospital hallways and into the sterile supply room with a mask on his forehead.

These observations, of surgical staff leaving their masks on were also observed by OR Supervisor W and Director of Pharmacy X. W stated that "masks needed to be removed after each case".

OR Supervisor W and Director of Pharmacy X were asked to provide the Surgeries P&P for PPE use. On 11/12/13 at 3:00 PM Director of Pharmacy X provided a hospital wide Guidelines for Isolation # 1708, that included the use of PPE, and confirmed, the P&P was not department specific. Director of Pharmacy X stated surgical services did not have a current P&P service specific based on current OSHA, IC or AORN standards of practice for surgical practice attire and the recommendation and requirements to application and removal of PPE.

Endoscope Cleaning Process:

On 11/12/13 at 9:25 AM during an observational interview and review of MFRs of a scope cleaning. RN CC was also asked about the alcohol used after the scope cleaning process. RN CC stated scope cleaning staff could use either 15 or 30 cc of alcohol. RN CC stated CC used 15 cc down each scope port.

The MFRs and scope cleaning policy was requested. Director of Pharmacy X, produced a scope cleaning policy. The policy does define a 30 cc alcohol flush. Director X stated the policy was facility-produced and did not include the MFRs for scope cleaning. On 11/12/13 at 4:15 PM, Director of Pharmacy X reviewed a hospital competency for scope cleaning, and stated that the competency was not based on a MFRs or current SOP, but was a "home grown" competency.

Environmental Infection Control:

1) On 11/12/13 from 7:00 AM through 8:30 AM, during an observation of a scheduled surgical case, Director of Pharmacist X observed and confirmed in interview, the following:

The bucket of Super Sani wipes used to clean the OR between patient cases was left open to the air.

Director of Pharmacist X stated per the MFRs, to be effective a required a 2-minute contact time is needed. Director of Pharmacist X confirmed that if the wipes were left open to air they would dry out, therefore staff could not ensure the quality of the cleaning product or adequate contact time.

2) On 11/11/13 at 10:35 AM in the SDS unit, holes were noted in the walls of a patient room.

3) On 11/12/13 at 7:00 AM, the walls in OR #2 were not intact.

4) On 11/12/13 at 12:30 PM, plaster was noted on the walls of the Minor OR procedure room, and the wall were not intact.

5) During the observation of a terminal clean at 11/12/13 at 12:30 PM, EVS staff EE during the washing of the OR Minor Room walls, was observed not saturating the mop head. During the cleaning of the remaining 2 OR walls, observation of contact time was between 3-5 minutes, depending if the solution had just been put on the mop head or the if EE was almost finished washing down the wall.

In interview at time of observation, EE stated the Velcro attached mop head would not hold it's grip if the mop head was saturated, while washing the walls.

DD confirmed OR EVS decided put the cleaning solution in a bottle to pour the 3M cleaning solution onto the mop head, that way it would not fall off the mop. DD stated the contact time required to make this products affective for terminal cleaning was "10 minutes". On 11/12/13 at 3:00 PM, IP E provided a copy of the 3M MFR that confirmed a 10 minutes contact time for general terminal.

6) Observation on 11/11/13 at 2:40 PM in OR suite #2 with OR Supervisor W and Director of Pharmacist X confirms the following: During a room turn over, the Anesthesia computer and table top was not wiped down.

Hand Hygiene:

From 11/12/13 between 7:00 AM and 10:00 AM during observations and interview, the following breaks in hand hygiene in the main OR were observed:

1) On 11/12/13 at 7:00 AM after patient induction, Anesthesia Z removed the gloves used for the induction of general anesthesia, touch the patient head, the anesthesia cart, syringes, and anesthesia supplies before donning another pair of clean gloves without performing hand hygiene. Anesthesiologist had to leave the immediate patient care area to walk to the OR sidewall to obtain alcohol hand gel.

2) At 8:25 AM, RN Y had one glove on and one glove off and attempted to remove a soiled drape tucked under the patient during surgery to catch back flow from the cystoscope, without hand hygiene donned the second glove.

3) At 8:25 AM, after Physician AA finished surgery, AA removed PPE and without hand hygiene left the OR suite through the door entering directly into the sterile supply room.

On 11/12/13 at 3:00 PM, Director of Pharmacy X provided the most current hand hygiene P&P # 3006 approved by infection control last revised 5/13 titled: " Hand Hygiene Policy-Facility Wide " a one (1) page policy that uses CDC and AORN SOP.
Director of Pharmacy X, stated after reviewing the hand hygiene policy that the policy was incomplete, and did not include all the CDC recommendations including the surgical services recommendations.

Medication Administration:

1) Anesthesiologist Z opened 4 vials of medication without cleaning the septum and injected the medication without cleaning the port.

2) On 11/12/13 at 9:00 AM, during conscious sedation administration, RN CC was observed opening 3 new vials of medication without cleaning the septum or cleaning the port each time.

Director of Pharmacist X confirmed they follow the CDC SOP "Parenteral medications should be accessed in an aseptic manner. This includes using a new sterile syringe and sterile needle to draw up medications while preventing contact between the injection materials and the non-sterile environment. Proper hand hygiene should be performed before handling medications and the rubber septum should be disinfected with alcohol prior to piercing it. " Obtained from http://www.cdc.gov/injectionsafety/providers/provider_faqs_med-prep.html

Director of Pharmacist X stated not cleaning the septum of prior to extracting the medication was not acceptable per current CDC SOP.

During an interview and P&P review on 11/12/13 at 2:50 PM, Director of Pharmacist X provided two current medication P&Ps; #COL-1126, 26 pages, last revised 5/22/13, titled " Medication Management " and #25, 15 page policy last revised email date 09/06/13 dw, titled " Sterile Pharmaceuticals and Cytotoxic Products " and confirmed neither P&P adhered to the minimum CDC SOP, that requires aseptic technique use to draw up medication.

On 11/12/13 at 2:50 PM, Director of Pharmacist X confirmed there was no P&P for the surgical service to define aseptic technique when drawing up medication from a vial.

OR Traffic:

AORN Perioperative Standards and Recommended Practices for Inpatient and Ambulatory Setting, 2013 Edition states:
Under RP for Traffic Patterns in the Perioperative Practice Setting, Recommendation I " Traffic patterns should be designed to facilitate movement of patients and personnel into, through, and out of defined areas within the surgical suite. Signs should clearly indicate the appropriate environment controls and surgical attire required. "
Traffic Patterns in the Perioperative Practice Setting, Recommendation IV " The movement of clean and sterile supplies and equipment should be separated from the contaminated supplies, equipment, and waste by space, time, or traffic patterns. 1. Surgical supplies prepared for surgical procedures outside the surgical suite (e.g. in central processing) should be transported to the surgical suite to maintain cleanliness and sterility and to prevent physical damage. Protecting items from contamination, physical damage, and loss during transportation facilitates their safe use ...3. When there is a clean core, the movement of supplies should be from the clean core through the operating or procedure room to the peripheral corridor. " Recommendation VI Policies and procedures for traffic patterns for patient, personnel, supplies and equipment should be developed, reviewed periodically, revised as necessary, and kept readily available in the practice setting. "

Observations on 11/11/13 between 10:35 AM and 11:45 AM, with OR Supervisor W and Director of Pharmacist X, confirmed in interview the following:

1) The sterile core room had no signage indicating it was a restricted or semi restricted area. The sterile supply room was connected to the 4 surgical suites. Each surgical suite had a door to the patient transport/main corridor and area and a door to the sterile core.
Staff were observed congregating in the sterile core/supply room, waiting for a case to start or finish, using the computer, standing and talking.

2) Prior to entering an OR suite for a survey observation, OR Supervisor W, Director of Pharmacist X entered the sterile core to wait with other staff to enter the OR suite, instead of entering from the transportation hallway.

3) Three (3) subsequent observations of high traffic and staff congregation in the Sterile Core occurred on 11/11/13 between 2:25 PM - 2:40 PM; and 11/12/13 at 7:00 AM and 11/12/13 at 8:30 AM.

Surgical Time Out:

1) On 11/12/13 between 10:00 AM and 10:50 AM, Director of Pharmacist X reviewed 6 surgical patient records (#12, 13, 14, 15, 16 and 17). These records did not identify that the primary physician was in the room during the surgical time out.

On 11/12/13 at 2:55 PM, Director of Pharmacy X provided a copy of the current surgical time out policy titled: "Site Marking and Time Out-The Universal Protocol", revised 6/13 and approved by the VP Patient Services. It states: "Time Out: a pause in the patient care in which there is a verbal check point that actively involves all individuals of the healthcare team who will be involved prior to the patient procedure.".

QA Director B stated in interview at time and date above, the physician is required to be in the room for time outs, and confirmed that because staff are not documenting when the physician enters or leaves the OR suite, surgical services could not validate the physician was present as required for the surgical "time out".




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Surgical Time Out

Review of 5 of 5 current inpatient records on 11/12/13 reveals that 3 of the 5 pts. had surgical intervention as follows:

2) Review of Pt. #22's medical record with RN NN beginning at 1:45 p.m. on 11/12/13, reveals that Pt. #22 was admitted on 11/10/13 with a fractured hip and had surgical repair. Review of the surgical records do not identify that the primary physician was in the room during the time out. When RN NN was questioned NN said, There is no documentation of physician presence in the time out.

3) Per review of Pt. #23's medical record with RN OO beginning at 2:20 p.m. on 11/12/13, the record reveals that Pt. #23 was admitted on 11/8/13 with perforated diverticuli and surgical intervention of colostomy repositioning. When RN OO was asked where the documentation was of the physician being present during the time out, OO said, "I don't think they do that."

4) Per review of Pt. #25's medical record with RN OO beginning at 2:50 p.m. on 11/12/13, the record reveals that Pt. #25 was admitted on 11/2/13 with a small bowel obstruction had surgical intervention of exploratory Laparotomy. There is no documentation of physician presence during time out.

Based on interviews and record reviews, the OR failed to maintain a complete OR register, in review of 2 of 2 total OR logs. This occurred with a total sample of 33 patients, and has the ability to affect 21 in-patients and 8 out-patients currently in the hospital.

Findings include:
On 11/11/13 at 11:45 AM, OR Supervisor W was asked to provide the "OR register" for review. OR Supervisor W stated she was not aware of an "OR register", has multiple logs but did not understand the purpose of maintaining an OR register with the minimum requirements listed.
On 11/12/13 at 8:30 AM, OR Supervisor W stated from the multiple logs the OR maintained for tracking and trending, W was not able to find the entire minimum OR register requirements, and would have to pull individual patient records.
On 11/12/13 at 8:40 AM RN-OR Meditech expert GG stated the two log/registers where this information could be found were titled, "Operating List" and "Daily Log" . The two (2) documents were reviewed on 11/12/13 between 8:40 AM and 8:50 AM.
RN-OR Meditech expert GG that there could not be found a complete OR register that included the minimum elements required. GG confirmed the missing elements from both documents included: names of staff that assisted the Physician, names of the circulator and surgical technicians (scrubs), pre-post diagnosis and patient age.
RN-OR Meditech expert GG stated the Surgical Service did not have a complete OR registers, and would have to review each individual patients chart for the missing information, if the surgical service had to do a look back.

Based on record reviews and staff interview, the anesthesia services failed to ensure 3 of 12 (15, 16 and 17) total surgical patients had a pre-operative anesthesia assessments completed prior to surgery. This occurred with a total sample of 33 patients, and has the ability to affect 21 in-patients and 8 out-patients currently in the hospital.

Findings include:
On 11/12/13 between 10 AM and 10:50 AM, 6 electronic anesthesia assessment patient records were review with Director of Pharmacy X, and the following were identified:
Patient #15, 16 and 17 had preoperative assessments dated and timed stamped after the surgical procedure was completed.
Director of Pharmacy X confirmed that the pre anesthesia assessment for patients #15, 16 and 17 were completed after the surgery was finished.
On 11/12/13 at 2:45 PM, Director of Pharmacy X provided and reviewed the document entitled " Surgical Services, Rules and Regulation, approved by the governing board on May 22, 2013. Page 3 states, " A pre-anesthesia evaluation completed and documented by an individual qualified to administer anesthesia, as specified in paragraph (a) of this section, performed within 48 hours prior to surgery or a procedure requiring anesthesia services " .
On 11/12/13 at 2:45 PM, Director of Pharmacy X agreed this does not comply with surgical services rules and regulations.

Based on records reviewed and interview, the anesthesia services failed to ensure the post-operative anesthesia evaluation was complete and met the hospitals P&P for 2 of 12 total (#17 and #22) surgical patients that required anesthesia. This occurred with a total sample of 33 patients, and has the ability to affect 21 in-patients and 8 out-patients currently in the hospital.

Findings include:
1) On 11/12/13 at 10:50 AM during surgical medical record review, Director of Pharmacy X confirmed Patient #17s required general anesthesia and an interscalene block (a nerve block of the brachial plexus to block pain to the shoulder and arm).
Post-operative anesthesia evaluation is written as follows: "No apparent anesthesia complication".
On 11/12/13 at 2:40 PM, Director of Pharmacy X, provided the most current surgical requirements, entitled " Surgical Services; Rules and Regulations " approved by the governing board May 22, 2013. On page 4, section VIII Post-Anesthesia Care B: states " At minimum, the post anesthesia follow up report must document (1) cardiopulmonary status; (2) level of consciousness; (3) any follow-up care and/or observations; and (4) any complications occurring during post anesthesia recovery.
On 11/11/13 at 3:15 PM, Director of Anesthesia JJ stated, the paper medical record system doesn ' t provide space to complete a comprehensive post-operative evaluation, and the electronic medical record system isn ' t set up to identify the required elements of a post-operative anesthesia evaluation for electronic documentation.
Director of Anesthesia JJ said, we are aware this is a problem and "we are working on it" .



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2) Review of Pt. #22's medical record with RN NN beginning at 1:45 p.m. on 11/12/13, the record reveals that Pt. #22 was admitted to this facility on 11/10/13 with a hip fracture and surgical repair. No post ansethesia record was noted in the repord for the hip surgery. When asked RN NN if could find a post anesthesia note, NN said, "No."