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300 WEST HUTCHINGS STREET

WINTERSET, IA 50273

No Description Available

Tag No.: C0222

I. Based on observation, documentation review, and staff interview, the facility failed to ensure expired high and low level glucometer control solutions (used to verify the glucose monitor is working accurately) were not available for use with the Accu-Chek glucometer (#2) located in the nursing area. The facility had a second glucometer (#1) that was out of service since 2/22/13. At the time of the survey, 1 inpatient (#12) required glucose monitoring using glucometer #2. The Quality Control log showed staff ran controls using expired control solution 8-times on glucometer #1 and 14-times on glucometer #2 from 2/14/13 to 2/27/13.

Verifying accuracy of the glucometer requires two glucose control solutions, a high-level solution and a low-level solution. Each glucose control solution contains a known amount of glucose. Staff uses these solutions to perform quality control checks to ensure the glucometer is working properly and that the blood glucose results are reliable. Expired solutions may no longer contain the known amount of either high or low level glucose therefore; expired solutions are no longer a reliable way of verifying the glucometer is working accurately.

Findings include:

1. Review of manufacturer's information printed on the Accu-Chek control solution bottles stated, "Glucose Controls will remain stable until Manufacturer's Expiration Date or 'opened' expiration date, whichever comes first."

Review of facility policy titled "Glucometer Quality Control," dated March 23, 2000, revealed, in part. "...Quality control is performed on the glucometer every day of use. A high and low control is ran and recorded in the quality control log ....The controls are stable for three months after opening, or until the expiration date. Any outdated control solution should be discarded ...."

Review of facility document titled " Quality Control Log " showed staff documented the lot numbers, date opened, date expired (after opened), and the manufacturer ' s expiration date, for the high and low level control solutions, as well as, the dates staff conducted the control tests. The Quality Control Log showed staff used the expired control solutions to verify the accuracy of glucometer #1 8-times from 2/14/13 to 2/22/13. Staff used expired control solutions to verify the accuracy of glucometer #2 14-times from 2/14/13 to 2/27/13.

2. Tour of the Medication Room, located on the Nursing Unit, on 2/25/13 at 11:45 AM with the Director of Nursing (DON), revealed 2 opened bottles of Accu-Chek glucose quality control solution available for use. One Level 1 (lo) Accu-Chek solution dated as opened on 11/13/12, the opened expiration date was 2/13/13, and 1 Level 2 (hi) Accu-Chek control solution dated as opened on 11/13/12 and the opened expiration date was 2/13/13.

3. During an interview on 2/25/13 at 11:45 AM, the DON confirmed the Accu-Chek control solutions were outdated and should have been discarded 2/13/13.

II. Based on observation, policy review, and staff interview, the facility failed to ensure Medical Imaging staff stored their portable oxygen cylinder upright in a stand or secured with a chain against a wall in accordance with facility policy. The Medical Imaging Department had 1 Medical Imaging storage area where staff stored 1 portable oxygen cylinder. Radiology staff performed an average of 407 procedures per month in the general x- ray room.

All compressed gases, including oxygen, are hazardous because of the high pressures inside the cylinders. Gas can be released deliberately by opening the cylinder valve, or accidentally from a broken or leaking valve or from a safety device. Escaping gas will propel the cylinder with enough force to penetrate cinder block walls. To prevent ballistic missile type injury all cylinders, even empty ones, should be handled as if they are pressurized.

Failure to secure oxygen cylinders increases the risk of knocking over the cylinder causing the valve to break and the cylinder becoming an uncontrolled rocket or pinwheel inflicting severe damage and/or injury.

Findings include:

1. Tour of the Medical Imaging area on 2/25/13 at 2:40 PM, with the Medical Imaging Manager, revealed 1 (of 1) full Oxygen cylinder stored standing, unsecured, on the floor of the storage room.

2. Review of facility policy titled "Oxygen cylinders: Procedure for Safe handling of O2 cylinders," dated 1/2000, revealed the following, in part. "...Procedure for safe handling of oxygen cylinder. Storage: Cylinders containing compressed gas are to be stored on a stand or secured with chain against a wall...Cylinders should never be stored in an upright position while unsecured .... "

3. During an interview on 2/25/13 at 2:40 PM, the Medical Imaging Manager acknowledged the full oxygen cylinder was stored unsecured on the floor of the storage room.

EMERGENCY PROCEDURES

Tag No.: C0229

Based on document review and staff interview the facility failed to consider the facilities' usual supply on hand and the potential need for water and fuel during an interruption in service, as part of the planning for emergency fuel and water agreements. The Chief Clinical Officer identified a census of 8 patients and an average daily census of 5 patients.

Failure to ensure emergency water and fuel available to meet the CAH's critical functions during an emergency/crisis situation could potentially cause a lack of necessary resources to provide adequate patient care during an emergency.

Findings include:

1. Review of a policy titled "Failure of Essential Utilities." last revised in 4/08, stated in part "...Water:...If a prolonged outage is going to occur, maintenance will line up the following: Contact the fire department to haul water. Water will be obtained from the Winterset Treatment Plant..."

Review of a an email from Winterset Oil Company, dated 9/1/09, stated in it's entirety "To Whom it May Concern: Our company is the fuel supplier for the backup generators and boiler for Madison County Memorial Hospital."

Review of an untitled document, dated 11/15/12, stated in it's entirety "To Whom it May Concern: Fareway Store 6831 will provide potable water for the hospital in case of an emergency in Madison County."

2. During an interview on 2/26/13 at 3:00 PM, the Facilities Manager reported the facility had one generator for backup electrical power and the diesel fuel storage tank contained approximately 2000 gallons of fuel. He said he was not sure how long this amount of fuel would last under full load, but reported these calculations had been made and would provide the information, after it was located. The Facilities Manager acknowledged the written agreement with Winterset Oil Company, lacked details regarding the amount of fuel and time frames for delivery, the company was willing to meet. In addition, the Facilities Manager acknowledged the written agreement for potable water with Fareway Stores lacked these details as well. The facilities Manager reported he had a conversation with the store manager, at the time of the agreement, and was told Fareway would provide the facility with the bottled water currently in the store and could provide a truckload of water by the next day.

During a follow-up interview on 2/27/13 at 9:20 AM, the Facilities Manager reported he located the calculations for the length of time the emergency generator fuel storage would last, which was approximately 50 hours on full load. He acknowledged the facility did not have calculations of the facility's potable and non-potable water needs, in the event of a prolonged water service interruption and that the facility did not have a written agreement with the fire department or city water treatment plant for the provision of non-potable water.

PATIENT CARE POLICIES

Tag No.: C0278

Based on observation, document review, and staff interviews, the facility failed to have a system in place that assured Medical Imaging staff in the Computed Tomography room (CT- computer-processed X-rays that produce tomographic images or 'slices' of specific areas of the body.) used intravenous (IV) solution bags labeled "single-dose" for only 1 patient per bag and tubing labeled "single use only. For Use With One Container of Media Only" for only 1 container of contrast media. The Medical Imaging Department had an average of 6 CT procedures, using the IV solution and tubing set, per week.

Failure to ensure staff uses a separate single-dose or single-use bag of IV solution for each patient increases the risk of transmitting infectious diseases between 1 patient and another, or between a patient and healthcare personnel during preparation and administration of IV solutions.

Findings include:

1. Single-dose or single-use vials and/or IV solutions are intended for use in a single patient for a single case, procedure, or injection. Single-dose or single-use vials and solutions are labeled as such by the manufacturer and typically lack an antimicrobial preservative.

According to the Centers for Disease Control (CDC), healthcare staff may not administer medications from single-dose or single-use vials, ampoules, or bags or bottles of intravenous solutions to more than one patient (e.g, do not use a bag of saline as a common source supply for multiple patients). The CDC also says, do not use fluid infusion or administration sets (e.g., intravenous tubing) for more than one patient.

2. Observation, during tour of the Medical Imaging, area on 2/25/13 at 3:00 PM, with the Medical Imaging Manager, revealed 1 (of 1) 1,000 milliliter (ml) " single-dose " bag of intravenous (IV) 0.9% normal saline (A solution of sodium chloride and water used for IV infusion.). Additional observation showed, attached to the IV bag, " single use only " tubing that transfers the fluid from the IV bag to the contrast infusion set used to inject contrast media into a patient's veins. Staff had not dated the IV bag showing when they had hung the bag and attached the tubing. The IV bag had approximately 100 cubic centimeters (cc) of 0.9% normal saline remaining in the bag.

3. Review of the product label printed directly on the 1,000 ml 0.9% Sodium Chloride IV solution bag showed, the bag of IV solution was a "single-dose container."

Review of facility policies showed they did not have a policy that addressed single-dose IV solutions.

4. During an interview on 2/25/13 at 3:00 PM, the Medical Imaging Director confirmed staff used the 1,000 ml 0.9% Sodium Chloride IV solution bag and tubing hanging in the CT room for more than one patient and may use the same setup for a week.

During an interview on 2/26/13 on 9:10 AM, the Pharmacist stated the 1,000 ml IV solution bags used in CT should be used as single dose only and a new IV solution bag should be used for each new patient procedure. Staff should not use IV solution bags for one week and Radiology staff should have followed the same nursing services policies/procedures.

During an interview on 2/27/13 at 9:15 AM, the Director of Nursing (DON), responsible for infection control, stated she was not aware that CT staff used the 1,000 ml 0.9% Sodium Chloride IV solution bags for more than one patient. According to the DON, staff should use each the IV bag for only one patient.

During an interview on 2/27/13 at 1:55 PM, the Medical Imaging Director stated the facility did not have a policy/procedure related the use of 1,000 ml 0.9% Sodium Chloride IV solution bags for more than one patient in the CT room.

No Description Available

Tag No.: C0283

I. Based on observation, document review, and staff interview, the facility failed to maintain x-ray emitting equipment in 1 of 1 x-ray room in a manner that ensured the safety of personnel operating the equipment. The length of the x-ray emitting control cord could allow personnel operating the x-ray equipment to enter into the field of exposure. (Medical Imaging) The facility reported an average of 407 x-rays completed every month with this equipment.

Failure to ensure the length of the x-ray exposure cord would prevent personnel operating the x-ray equipment from entering the field of exposure while taking an x-ray could potentially result in unnecessary radiation exposure to staff possibly causing illness or cancer.

Findings include:

1. Observation, during tour of the Medical Imaging, area on 2/25/13 at 2:40 PM, with the Medical Imaging Manager revealed a 14-foot long x-ray emitting equipment control cord in the General X-ray Room that could extend outside the safety barrier for the personnel operating the equipment.

2. Review of policy/procedure titled "Radiation Protection of Radiology Staff," dated 3-1-01, revealed, in part, "...Basic rules of radiation safety for radiation workers:... Always be aware of the location of the primary x-ray beam... Staff should position themselves 6 feet or more from the x-ray tube when producing a radiograph...."

The policy/procedure failed to address the length of the exposure cord that could allow the personnel operating the x-ray equipment to enter into the field of exposure.

3. During an interview on 2/25/13 at 2:40 PM, the Medical Imaging Director confirmed the x-ray emitting equipment control cord in the General x-Ray Room could extend outside the safety barrier for the personnel operating the equipment. The Medical Imaging Director stated they knew they were not to extend outside the safety barrier when completing an x-ray procedure.

II. Based on observation, document review, and staff interviews, the facility failed to provide a dosimeter badge (radiation detecting device) to all staff exposed to radiation in the operating room during surgical procedures utilizing C-Arm fluoroscope. The facility had 2 C-Arm fluoroscopes and performed 37 C-Arm procedures in the operating room during 2012.

Failure to provide dosimeter badges to all staff in the operating room during operation of the C-Arm fluoroscope could potentially result in staff's exposure unknown, possibly excessive amounts of ionizing radiation, potentially causing illness or cancer.

Findings include:

1. Observations, during tour of the Surgery Department, on 2/26/13 at 2:10 PM showed the facility had 2 C-Arm Fluoroscope machines. Tour of the main and little operating room (OR) revealed a dosimeter badge on the wall in each room.

2. Review of an undated policy/procedure titled "Use of the C-Arm in the OR" revealed, in part, "...The scrub and circulating nurse will prepare for use of the c-arm by:...Have a badge in the room (monitored and managed by x-ray department)...."

Review of policy/procedure titled "Radiation Monitoring - Personnel," dated 10-2-2012, revealed, in part, "...All individuals working with or in an area near radiation on a routine basis shall be issued a film badge or body badge...Areas in Surgery Department where the C-Arm is routinely used for fluoroscopic guidance will be monitored by badge which is located on the wall...."

3. During an interview on 2/25/13 at 2:40 PM, the Medical Imaging Director stated the OR staff, including physician, anesthesia, and nursing staff, were not issued dosimeter badges to wear during surgeries when the C-Arm was in use. The Medical Imaging Director further stated dosimeter badges have been placed in the operating rooms to detect radiation in the operating rooms.

During an interview on 2/26/13 at 2:55 PM, the Surgery Manager acknowledged they used 2 C-Arms in the operating rooms. The Surgery Manager stated the OR staff were not issued dosimeter badges to wear during surgeries when the C-Arm was in use.

During an interview on 2/27/13 at 1:25 PM, the Surgery Manager reported the OR staff that were in the room when the C-Arms were used in the OR included radiology technologist, surgeon, anesthesia staff, 1 to 2 scrub staff, and 1 circulating nurse.

No Description Available

Tag No.: C0322

Based on policy/procedure review, medical record review, and staff interview, the facility failed to have a system in place to assure the pre-anesthesia risk assessments occurred prior to surgery for 9 of 9 patients. (Patients #'s 1, 2, 3, 4, 5, 6, 7, 8 and 9) requiring anesthesia for a surgical procedure. The facility had an average of 35 procedures requiring anesthesia per month.

Evaluating patients for anesthesia risk before surgery is essential in determining if the patient may have severe adverse reactions to the anesthesia. Failure to time the pre-anesthesia risk evaluations inhibits the facility's ability to determine, should there be a problem, if the qualified practitioner conducted the evaluation immediately prior to surgery as required by the regulation.

Finding include:

1. The facility policies and procedures for anesthesia lacked information requiring the anesthesiologist to document the time the pre-anesthesia evaluation occurred.

2. Review of the medical records for Patient #'s 1, 2, 3, 4, 5, 6, 7, 8, and 9 revealed no documented evidence that showed the anesthesiologist conducted the pre-anesthesia assessments prior to each patient's surgery.

3. During an interview on 2/27/13 at 1:30 PM, Staff C, Director of Surgery Services stated staff observe the anesthesiologist evaluating patients prior to surgeries. There is not an area on the anesthesia record to document the time of the pre-anesthesia assessment. The anesthesiologist does not document the time of the pre-anesthesia assessment.

During an interview on 2/27/13 at 1:50 PM, Staff D, CRNA (Certified Registered Nurse Anesthetist) stated he had no knowledge the pre-anesthesia assessment required documentation that showed what time the assessment was completed. Staff D stated he always times the post anesthesia assessment and would start timing the pre-anesthesia assessment.

No Description Available

Tag No.: C0361

Based on review of facility policies/procedures, documentation, and staff interview, the facility administrative staff failed to ensure that each swing bed patient is informed fully of their rights as required by the regulation. The administrative staff identified an average daily census of 2 swing bed patients and a current census of 2 swing bed patients.

Failure to present and explain to the swing bed patients and/or their legal representative of their rights in a language they can understand inhibits a patient or patient's representative ability to understand their rights as a patient during their hospitalization.

Findings include:

1. Review of the "Patient Rights and Responsibilities - Swing Bed," a document presented to swing bed patients upon admission containing patient rights for swing bed patients, failed to address the patient's right to access the clinical record, refuse treatment, choose a personal attending physician, or visitation by family or friends.

Review of the policy/procedure titled "Skilled/Swing Patient Bill of Rights," undated, failed to address the patient's right to access their medical record and visitation.

3. During an interview on 2/26/13 at 12:10 PM, Staff A, Chief Clinical Officer, stated we know the patient rights we have are outdated. We have identified they are not current with the changes regarding the patient visitation rights also. We are in the process of updating them.

During an interview on 2/26/13 at 9:15 AM, Staff B, Patient Liaison, stated the swing bed patients only receive the Swing Bed Patient Rights and not the acute patient rights on admit.

No Description Available

Tag No.: C1001

Based on document review, staff and patient interview, the facility failed to ensure patients (or support person where appropriate) were informed of their visitation rights, including the ability to receive designated visitors, but not limited to, a spouse, a domestic partner (including a same-sex domestic partner), another family member, or a friend for 2 of 2 active patient records reviewed. (Patients # 10 and 11) The facility had 1 Patient ' s Rights policy. The facility identified a current census of 5 acute inpatients at the time of the survey.

Failure to inform patients of their visitation rights could potentially result in the staff failing to extend visitation rights to all patient population.

Findings include:

1. Review of an undated document titled "Patient's Bill of Rights," provided to the patient upon admission, did not include the patient's right to receive designated visitors, including but not limited to, a spouse, a domestic partner (including a same-sex domestic partner), another family member, or a friend.

Review of an undated document titled "Patient Bill of Rights and Responsibilities" posted in each patient room did not include the patient's right to receive designated visitors, including but not limited to, a spouse, a domestic partner (including a same-sex domestic partner), another family member, or a friend.

Review of a policy/procedure titled "Patient's Rights," dated 9/2004, did not include the patient's right to receive designated visitors, including but not limited to, a spouse, a domestic partner (including a same-sex domestic partner), another family member, or a friend.

Review of documentation in patient's medical records revealed the following patients signed a document stating they received a copy of the Patient Bill of Rights:
- Patient # 10 - admitted 2/22/13
- Patient # 12 - admitted 2/24/13.

2. During interviews on 2/26/13 at 9:50 AM and 10:05 AM, Patient #'s 10 and 12 stated they were informed of their patient rights by a document provided to them when they were admitted.

During an interview on 2/26/13 at 9:15 AM, Staff A, Chief Clinical Officer, stated the facility knew the current patient rights were outdated. Staff A further stated they identified they were not current with the changes regarding the patient visitation rights and were in the process of updating them.