The information below comes from the statement of deficiencies compiled by health inspectors and provided to AHCJ by the Centers for Medicare and Medicaid Services. It does not include the steps the hospital plans to take to fix the problem, known as a plan of correction. For that information, you should contact the hospital, your state health department or CMS. Accessing the document may require you to file a Freedom of Information Request. Information on doing so is available here.

SSM HEALTH ST CLARE HOSPITAL - FENTON 1015 BOWLES FENTON, MO 63026 June 22, 2011
VIOLATION: ADMINISTRATION OF DRUGS Tag No: A0405
Based on observation, interview, record review, and policy review, the facility failed to ensure medications were administered as ordered by the physician; failed to follow hospital policy with regard to administration technique; and failed to use ready to administer packaging for medications for one (#10) of one patients with gastric tube (G-Tube, a tube surgically placed into a patient's stomach via the abdomen used for feeding and administration of fluids and medications) observed during medication administration. The facility census was 134.

Findings included:

1. Record review of the facility's policy titled, "Medication Administration," implemented 01/2010, showed the following direction: Verify medications against the original order and/or the MAR (Medication Administration Record) immediately prior to administration utilizing the "5 Rights of Medication Administration": right patient, right drug, right dose, right route, and right time.

Record review of a document provided by the facility as "guidelines" titled, "Mosby's Nursing Skills ? Medication Administration: Nasogastric Tube (a tube passed through the nose into the stomach for removing stomach contents or administering fluids or medications) or Enteral Tube (a tube passed through the abdomen directly into the intestines for administering fluids or medications) showed the following direction:
- Crush tablets using a pill-crushing device to grind pills into a fine powder. Dissolve in at least 30 ml (milliliters, a unit of measure) of warm water.
- Open capsule, or pierce gelcap with sterile needle, and empty contents into 30 ml of warm water. Gelcaps can also be dissolved in warm water.
- Check placement of feeding tube by observing gastric contents and checking pH of aspirate contents. Gastric pH should be 4 or less.

2. Observation on 06/21/11 at 08:45 AM showed Staff S, Registered Nurse (RN) preparing to administer the following 9:00 AM medications to Patient #10 per G-tube:
- Tramadol (used to relieve pain) 50 mg (milligrams, a unit of measure) tablet;
- Pepcid (used to decrease the amount of acid in the stomach) 20mg tablet;
- Lisinopril (used to treat high blood pressure) 10 mg tablet;
- Methocarbamol (muscle relaxant) 750 mg tablet;
- Multivitamin, one tablet;
- Vitamin C, 500 mg tablet;
- Colace (stool softener) 100 mg gelcap.

Staff S checked each medication against the Medication Administration Record (MAR) as medications were removed from the medication cabinet. He/she placed the Colace gelcap into warm water to help dissolve it and set it aside. Staff S discontinued Patient #10's tube feeding, and then used tap water to flush the tubing. Staff S checked for G-tube placement by injecting approximately 30 ml of air and listening for a "whoosh," then attempted to aspirate gastric contents and was unsuccessful. Staff S did not check gastric pH before proceeding to administer medications per G-tube.

Staff S crushed each medication tablet just prior to administration using a disposable pill crusher that did not provide uniform contact with the tablet to ensure the tablet was evenly crushed. After each tablet was crushed, Staff S placed the barrel of the irrigating syringe onto the stopcock of the G-tube, filled the barrel with tap water, and poured in the crushed medication. He/she then rotated the barrel in a circular manner to attempt to dissolve the powder as it washed down the tube. Several times, particles were too large to easily wash down the tube and additional water had to be used. At 9:30 AM, Staff S removed excess water from the cup containing the gelcap, placed the gelcap between two medication cups, and applied pressure to try and rupture the gelcap so the contents could be dissolved and administered. The gelcap had not softened enough to allow it to be ruptured, so more warm water was added to the cup ? which caused the Colace to be administered late.

3. Review of Patient #10's medical record showed a physician order dated 06/15/11, for the Colace and Pepcid to be given orally, rather than through the G-tube.

4. During an interview on 06/21/11 at 9:55 AM, Staff G, Clinical Nurse Supervisor, stated that the nurse receiving the physician order for Colace and Pepcid per mouth should have noticed that the route of administration was incorrect and asked the physician to correct the order. Staff G also stated that the Pharmacy should have questioned the order with either the physician or the nursing staff. Staff G further stated that nurses administering the medications should have questioned the route and asked for clarification.

5. During an interview on 06/21/11 at 10:10 AM, Staff D, Executive Director of Nursing, stated that crushed medications should be dissolved in fluids before attempting to administer them via G-tube. During an interview on 06/21/11 at 3:10 PM, Staff D stated that nurses routinely check G-tube placement by aspirating gastric contents and auscultation (using a stethoscope to listen for internal sounds, such as the sound of air or fluid through a tube). Staff D stated the facility's medication administration policy did not address specific routes of medication administration, and said nurses were instructed to reference the Mosby Manual for administration "guidelines."

6. During an interview on 06/21/11 at 10:15 AM, Staff H, Director of Pharmacy, stated that the Pharmacy did not know the specifics of each patient's condition, and relied on the physician or the nurse to notify them that a patient had a G-tube. Staff H stated that the Pharmacy should have recognized that the patient had a G-tube based on multiple physician orders to give medications via G-tube, however they didn't in this case. Had that happened, the Pharmacy would have sent medications to the floor that were in liquid form and ready to administer versus nursing staff having to crush and dissolve them prior to administration. Staff H stated that the facility rarely had patients with G-tubes, which may have contributed to overlooking the order discrepancy.
VIOLATION: ADMINISTRATION OF DRUGS Tag No: A0405
Based on observation, interview, record review, and policy review, the facility failed to ensure medications were administered within 30 minutes of the scheduled time for one patient (#10) of eight patients observed during medication administration. The facility census was 134.

Findings included:

1. Record review of the facility's policy titled, "Medication Administration," implemented 01/2010, showed the following direction: Medications should be given within 30 minutes before or after the scheduled time.

Record review of the facility's policy titled, "Occurrence Reporting Policy," effective 10/31/07, showed the following definition and direction:
- Occurrence/Event ? Any error, omission, commission, circumstance, or event that deviates from the standard practice of medicine that reaches a patient regardless of whether or not it causes harm to the patient. Medical occurrences can result from defect, failure and error within the system.

Record review of the facility's Pharmacy policy titled, "Medication Error Reporting Policy," last revised 12/10, gave the following direction:
- Medication errors are the administration of the wrong medication or dose of medication, drug, diagnostic agent, chemical, or treatment requiring the use of such agents to the wrong patient or at the wrong time or the failure administer such agents at the specified time or in the manner prescribed or normally considered as accepted practice.
- Medication errors may entail:
- Administration at the wrong time: Timely is defined as 60 minutes before or after the time that the dose is scheduled to be given, except the following drugs have to be administered within 30 minutes of the scheduled time:
- Every four hour antibiotics;
- Tacrolimus (used to prevent transplant rejection);
- Anti-parkinson medications.
- Administration by the wrong route.
- Near Miss is reported when a health care professional ALMOST makes an error, or makes note of the potential for error, due to human or system issues.
- For errors related to timeliness of administration, only those errors which may be clinically significant and may have an impact on the care of the patient need to be reported.

2. Observation on 06/21/11 at 08:45 AM showed Staff S, Registered Nurse (RN) preparing to administer the following 9:00 AM medications to Patient #10:
- Colace (stool softener) 100 milligram (mg, a unit of measure) gelcap;
- Vancomycin (antibiotic) 1000 mg per intravenous (IV) piggyback;
- Acyclovir (used to treat viral infections) 450 mg per IV piggyback.

Staff S placed the Colace gelcap into warm water to help dissolve it and set it aside while he/she administered a number of other medications to the patient through a gastric tube. At 9:30 AM, Staff S removed excess water from the cup containing the gelcap, placed the gelcap between two medication cups, and applied pressure to try and rupture the gelcap so the contents could be dissolved and administered. The gelcap had not softened enough to allow it to be ruptured, so more warm water was added to the cup ? which caused the Colace to be administered late.

On 06/21/11 at 9:27 AM Staff S initiated administration of the IV Vancomycin, and set the administration pump to deliver the infusion over 60 minutes, the recommended infusion speed. Staff S explained that the Acyclovir would be administered when the Vancomycin infusion was complete, which would be at approximately 10:30 AM, and stated the Acyclovir infusion would also take one hour.

3. During an interview on 06/21/11 at 9:55 AM, Staff G, Clinical Nurse Supervisor, stated that the electronic medical record system generates administration times for medications based on a standard time frame. Staff G said it was unusual for two, hour-long IV medications to be ordered at the same time, and acknowledged that one of the two medications would be initiated beyond the timeframe allowed by policy. However, Staff G stated this would not be considered an incident or reported as an occurrence, nor would the late administration of Colace.

4. During an interview at 10:10 AM, Staff D, Executive Director of Nursing, stated that the SSM system determined that medications administered beyond 30 minutes after the scheduled time would not be reported as incidents unless the medication was an antibiotic ordered every four hours or fell into specific categories of medications as defined by policy. Staff D acknowledged that the various policies listed above appeared to be in conflict in regard to acceptable timeframes for administration, however, the facility had determined that unless a medication error was considered significant, it would not be reported; and administering Colace or Acyclovir late did not meet the criteria.

5. During an interview on 06/21/11 at 10:15 AM, Staff H, Director of Pharmacy, stated that in this instance, administration of the IV Vancomycin took priority of administration of the IV Acyclovir due to laboratory testing at specific intervals after each dose, which assisted staff in determining dose requirements. Staff H stated that nursing staff had the capability of changing routine medication administration times in the Medication Administration Record (MAR) though it was considered unnecessary because neither of the two medications administered beyond 30 minutes after the scheduled administration time was a medication defined by policy as "reportable."
VIOLATION: NURSING CARE PLAN Tag No: A0396
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on interview, record review, and policy review the facility staff failed to develop and update the patient nursing care plans to ensure the patient's care needs and response to interventions were assessed daily for three current patients (#9, #13, #29) of six nursing care plans reviewed. This had the potential to affect all patients. The facility census was 134.

Findings included:

1. Record review of the facility's policy titled "Patients: Assessment and Documentation Timelines," last revised 05/11 showed the following direction:
- Initiation of Care Plan: A care plan is developed based on identified needs and is documented in the patient's medical record.
- The Plan of Care is the responsibility of the registered professional nurse and should be reviewed at least every 24 hours.
- Documentation will reflect the nursing interventions fulfilling the medical and nursing plan of care and the patient's response to therapy.
- Care Plan Initiations: 8-12 hours

2. Review of Patient #9's medical record showed the patient was admitted to the facility on [DATE] for complaints of chest pain of abrupt onset.

Record review on 06/21/11 of patient #9's Plan of Care showed on no mention of his/her identified (CAD) Coronary Artery Disease [disease of the major blood vessel to the heart].

During an interview on 06/21/11 at 9:45 AM, Staff C, Director of Intensive Care Unit (ICU), stated that he/she would have expected to see CAD on the care plan of a patient on the cardiac floor.

3. Review of Patient #13's medical record showed the patient was admitted to the facility on [DATE] for heart failure. He/she was in the ICU, where he/she had been placed in soft wrist restraints (soft material which fits around the patient wrists with an attached tie that limits the patient's ability to move his/her arms).

Review on 06/20/11 of patient #13's Plan of Care showed no mention of the wrist restraints.

During an interview on 06/20/11 at 2:00 PM, Staff L, Director of Nursing Operations, stated that there was no mention of restraints on the care plan, but there should have been.

4. Review on 06/22/11 of Patient #29's medical record showed the patient was admitted to the facility on [DATE] for fracture of the left arm. Other diagnoses included Chronic Obstructive Pulmonary Disease (COPD, a lung disease which makes it hard to breathe), Alcohol Abuse, Diabetes (a chronic disease characterized by excessively high levels of sugar in the blood), Alzheimer's Disease (a from of dementia with chronic changes in the brain) and an indwelling urinary catheter (a tube into the patient's bladder, used to drain urine).

Review of patient #29's Plan of Care showed no mention of any of these problems, and did not address any interventions or goals.