HospitalInspections.org

Based on observation, interview and record review, the facility failed to follow Pharmacy policy and procedure for secure storage of home medications (medications brought into the facility by patients from home) for one current patient (#8) and three discharged patients (#11, #12 and #13) on the Medical/Surgical (Med/Surg) Unit. The Med/Surg patient census was six and the facility census was 15.

Findings included:

1. Record review of the Pharmacy policy and procedure titled, "Patient's Own Medications and Bedside Medications" revised 07/09, showed the following:
-The following procedure should be employed if the medications are to be stored in the pharmacy or the patient is to use their home supply of medications.
-Storage of Patient Medication: If medications cannot be returned home with a family member, nursing should document the patient's medications on a Home Medication Log form including the name, strength and quantity of each medication present. This form should be signed by both the patient and nurse when possible. If the patient is unable to sign the log, a family member or another employee should verify the counts and sign as a witness. Next, the medications should be secured in a personal belongings bag and sent to the pharmacy. If the personal belonging bag is sealed, pharmacy will not perform any counts. If the personal belonging bag is open, pharmacy will recount controlled substances and verify the name, strength and quantity of each medication contained in the bag. Finally, pharmacy will secure the medications in a locked cabinet until patient discharge or family is available to pick up the medications.
-Furthermore, the hospital is responsible for insuring the safety of the medication, even if the patient self-administers.

2. Observation on 12/11/12 at 9:20 AM in the Med/Surg medication room showed a locked black metal box sitting on the counter and also on the counter, a plastic bag containing a plastic pill sorter with six pills in each division marked for the days of the week.

3. During an interview on 12/11/12 at 9:20 AM, Staff L, Registered Nurse (RN), Nurse Supervisor, stated that the black box belonged to Patient #8 and that the patient has the only key. She stated she did not know the contents of the box. Staff L stated the plastic bag with the plastic pill sorter belonged to Patient #11 discharged on 12/04/12 and the medication had not been returned to him upon discharge.

4. Record review of Patient #8's medical record showed it did not contain a Medication Log Form listing the medications in the locked black metal box.

5. During an interview on 12/11/12 at 1:40 PM, Staff M, R.Ph. (Registered Pharmacist), Director of Pharmacy, stated that patients' home medications should all be brought to the Pharmacy for validation and re-labeling, if necessary. He stated that the admitting nurse is supposed to fill out the Medication Log Form and bring the medication to the pharmacy. He stated the Medication Log Form then prompted the return of the medication to the patient upon discharge.

6. During an interview on 12/11/12 at 2:10 PM, Patient #8 stated that the box was brought to the hospital for safe keeping while she was there and the box was opened with the admitting nurse, Staff N, RN. She stated the box contained several controlled medications:
-Oxycodone, a narcotic pain reliever similar to Morphine used to treat severe pain;
-Xanax, a Benzodiazepines Sedative-hypnotic used to treat anxiety;
-Percocet, painkiller containing Oxycodone and Acetaminophen (Tylenol); and
-"Important papers".

7. Several attempts were made to contact the admitting nurse, Staff N, RN, for interview however, she did not return to work and would not respond to five telephone calls made over the course of the survey.

8. Observation on 12/11/12 at 1:55 PM in the Pharmacy showed two bags of medication stored in the locked and secured control substances closet (only accessible to department pharmacists). One bag contained Xanax for Patient #12 discharged on 12/01/12 and the other bag contained two medications for discharged Patient #13.

9. During an interview on 12/11/12 at 1:55 PM, Staff M, R.Ph., stated that the medications should have been returned to the patients upon discharge.

Based on observation, interview and facility policy review the facility failed to:
-Label opened multi-dose medication (MDV) with the date opened and the initials of the staff member who opened the medication in the Emergency Department (ED) storage room and in the Medical/Surgical (Med/Surg) Medication Room;
-Ensure that expired medications were not available for patient use in the ED and the Med/Surg crash carts (carts with medications used for patients during an emergent episode such as a heart attack) .
-Ensure that medications are stored according to manufacturers guidelines.
-Maintain security and integrity of the crash cart on the Med/Surg Unit by contacting Pharmacy and requesting a replacement medication and a new lock after an emergency;
The average daily number of patient visits in the ED was 30. This deficient practice placed patients at risk to receive outdated, unusable drugs. The facility census was 15.

Findings included:

1. Record review of the facility policy titled, "Handling Multiple Dose Vials (MDV)" dated 07/09 showed:
- All multiple dose medications must be dated and initialed by the staff at the time the container was opened.
- When using a MDV for a subsequent dose, the nurse should verify that the vial is not expired (for most medications - 28 days after opening).
- If an open vial is found undated, the product should be discarded.

2. Review of the Centers for Disease Control (CDC) and Prevention recommendations for multi-dose vials, dated 02/09/11 showed medication vials should always be discarded whenever sterility is compromised or questionable.

3. The United States Pharmacopeia (USP) [the officially recognized authority and standard on the description of drugs, chemicals, and medicinal preparations in the United States] General Chapter 797 [16] recommends the following for multi-dose vials of sterile pharmaceuticals:
- If a multi-dose has been opened or accessed (e.g., needle-punctured) the vial should be dated and discarded within 28 days unless the manufacturer specifies a different (shorter or longer) date for that opened vial.
- If a multi-dose vial has not been opened or accessed (e.g., needle-punctured), it should be discarded according to the manufacturer's expiration date.

The manufacturer's expiration date refers to the date after which an unopened multi-dose vial should not be used. The beyond-use-date refers to the date after which an opened multi-dose vial should not be used. The beyond-use-date should never exceed the manufacturer's original expiration date.

4. Record review of the facility's policy titled, "Cardiopulmonary Resuscitation/Code Blue Protocol" dated 07/09 showed for stocking emergency carts:
- A fully equipped cart is located on or near each Nursing Unit and patient procedure department.
- Contents in the cart should be checked monthly and maintained for use.
- The Cart is restocked after each use.
- Medications and supplies are checked for outdates.

5. Record review of the Pharmacy Policy and Procedure titled, "Out Dated Medications" revised 07/09, showed the following direction to staff:
-A procedure will be set in place to insure that medications are routinely checked in all medication storage areas to insure they are not expired.
-All medications in the pharmacy and other drug storage areas will be checked monthly for expiration dates by the pharmacist or his/her designee.
-Assigned staff will date and initial the expiration check sheet for pharmacy each month when the employee checks for outdated stock. Medication should be pulled through the end of the month in which stock is being checked.
-All outdated (beyond use date) medications will be separated from active stock until they are boxed and sent at regular intervals to a reverse distributor which specializes in the return of outdated medication to the manufacturer.
-All controlled substances that outdate will be placed in a locked cabinet separated from the active stock until it can be sent with the other outdated stock.

6. Record review of the Pharmacy Policy and Procedure titled, "Code Carts" dated 01/08, and last reviewed 08/12 showed the following direction:
-There are four crash carts located throughout the hospital (ER, M/S [Med/Surg], OR/PACU [operating room/post-anesthesia care unit] and Pain Clinic). These carts must be inspected for integrity daily and maintained and checked for outdated medications on a monthly basis to insure emergency drugs are available should the need arise.
-Carts are checked by personnel in the department that houses the code cart each day that the area provides patient care to insure that the cart is locked and intact.
-Once a month, department personnel open the crash cart and check the contents to insure all stock is in date. Expired and damaged medications are removed and returned to pharmacy for replacement stock. After verifying the stock is intact, the cart is resealed using a numbered lock provided by the pharmacy department.
-After an emergency occurs, the nursing department is responsible for completing a crash cart charge sheet. This sheet will be used by pharmacy for charging and restocking the crash cart. If the code occurs after hours, pharmacy will restock the cart the following morning. When the cart is completely stocked, the cart is resealed using a numbered lock provided by the pharmacy department.

7. Observation on 12/11/12 at 9:40 AM in the ED, medication storage room showed:
- Xylocaine 2% (used to numb area of the body) MDV dated 11/06/12 (28 days from the opened date showed the medication expired on 12/04/12).
- 1% Xylocaine (used to numb area of the body) MDV opened with no label or date opened.
- Sterile water (used to dilute medication) MDV dated 11/09/12 (28 days from the opened date showed the medication expired on 12/07/12).

8. During an interview on 12/11/12 at time of medication observation, Staff D, Registered Nurse (RN), stated that all opened medications should be dated and labeled and medications should not be used after 28 days. Staff D stated using medications after 28 days increased the risk of patients receiving medications that could be contaminated.

9. Observation on 12/11/12 at 2:45 PM in the ED of the medication supplies on the emergency drug cart showed:
- Amidate (produces sleep) 40 milligram (mg-unit of measure) an expiration date (beyond use date) of November, 2012.
- Verapamil (to treat high blood pressure and chest pain) 5 mg with an expiration date of November - year is missing on the label.
- Vecuronium Bromide, three bottles, (used to relax skeletal muscles) 10 mg. Product label states "protect from light". Bottles in drawer of cart, unprotected from light exposure, when drawer opened.

10. During an interview on 12/11/12 at approximately 2:50 PM, Staff B, RN, Quality Assurance, stated Amidate medication should have been removed from the emergency medication cart at the end of November when the medication expired.

11. During an interview on 12/12/12 at 8:55 AM, Staff M, Pharmacist, stated that the medication had been left as a last resort on the emergency cart, due to drug shortages. Staff M stated that in a life and death situation, it would be the physician's decision whether to use the expired drug or not. Staff M stated that he would not have concerns using the drug on his family. Drug information provided by Staff M for Vecuronium Bromide stated "Protect from light. Retain in carton until time of use".

12. Observation on 12/11/12 at 9:10 AM in the Med/Surg medication storage room showed the crash cart was unlocked and had not been restocked or resealed using a numbered lock as directed by the facility policy and procedure.

13. During an interview on 12/11/12 at 9:10 AM, Staff L, RN, Nursing Supervisor, stated that she had opened the cart earlier for an emergency medication and had not had time to contact the pharmacy.

14. Observation on 12/11/12 at 9:10 AM showed the following expired (beyond use date) medications were found inside the crash cart:
-Two -four mL (milliliters) vials of Levophed (Norepinephrine [adrenaline] to give the body sudden energy in times of stress by increasing the heart rate and blood pressure) showed an expired date of 10/10/12;
-Two - 10 mL vials of Procainamide (used to treat irregular heartbeats and slow an overactive heart) with an expired date of 11/12/12;
-Two-two mL vials of Dilaudid (Hydromorphone-a narcotic used to treat severe pain) with an expired date of 01/02/12;
-Calcium Chloride (medication used to stimulate the heart) 10% injectable with an expired date of 12/10/12;
-Furosemide (used to treat fluid retention ) 10 mL vial with an expired date of 11/12;
-Amidate (anaesthetic agent used for the induction of general anesthesia and for sedation for short procedures) 40 mg (milligrams) with an expired date of 11/01/12;
-Dopamine (Norepinephrine [adrenaline] to give the body sudden energy in times of stress by increasing the heart rate and blood pressure) 400 mg in a 250 mL bag with an expired date of 08/12.

15. Record review of the expiration check sheet showed the form had been initialed by an RN and dated on 11/10/12 but the expired (beyond use date) medications had been left in the crash cart.

16. Observation on 12/11/12 at 9:20 AM, showed an eight ounce bottle of Lidocaine Viscous (numbs the lining of the mouth to relieve pain and/or discomfort) with a scant amount of medication in the bottom of the bottle in an unlocked cabinet in the Med/Surg medication room. The bottle did not have a date that it was opened and was not initialed by the person who had opened it.

17. During an interview on 12/11/12 at 9:20 AM, Staff L, RN, Nursing Supervisor, stated she did not know how or why the medication was in the cabinet.

18. During an interview on 12/11/12 at 1:40 PM, Staff M, R.Ph. (Registered Pharmacist), stated that the crash cart should have been locked and policy and procedure followed to restock and reseal the cart. He stated he was unaware that the expired medications were not being pulled from the cart and replaced as directed by the pharmacy policy and procedure. He had no explanation for the opened bottle of Lidocaine Viscous and questioned why the nurses had access to the medication and what administration purpose it was used.



27029

Based on observation, interview and policy review the facility failed to ensure:
- Staff followed the facility's policy and procedures for hand hygiene and the Disease Control and Prevention (CDC) 2002 Guidelines for Hand Hygiene in Health-Care during direct patient care for five patients (#8, #9, #38, #39 and #40) of five patients observed; and
- Staff kept fingernails trimmed and nail polish, if worn, was light in shade and not chipped. Failure to follow hand hygiene places patients at greater risk for infection from contact with unclean hands. The facility census was 15.

Findings included:

1. Record review of the facility's policy titled, "Hand Hygiene Procedure" dated 08/12 showed the following direction:
-Hand Hygiene is the single most important means of preventing the spread of infection. In order to provide the safest possible environment for patients and personnel, personnel should wash or sanitize their hands according to guidelines of this procedure:
-Before you begin any patient contact;
-Between patient contacts;
-Before and after contact with wounds and dressings;
-Before and after contact with your own face;
-After removing gloves;
-After touching environmental surfaces or equipment near patients (bedpans, commodes, computer keyboards;
-If moving from a contaminated body site to a clean body site during patient care;
-Use of gloves does not replace the need for hand cleansing by either hand rubbing or handwashing;
-When wearing gloves, change or remove gloves during patient care if moving from a contaminated body site to a clean body site within the same patient or to the environment; and
-Before handling medication and preparing food.
Other necessary information:
-Keep fingernails short (less than ¼ inch) so that they are easier to clean.

2. Record review of Center for Disease Control (CDC) 2002 Guideline for Hand Hygiene in Health-Care Settings showed the following directions:
- Keep natural nails tips less than ¼-inch long; and
- Chipped nail polish may support the growth of larger numbers of organisms on fingernails.

3. Observation on 12/11/12 at 10:00 AM showed Staff K, Registered Nurse (RN), during medication administration for Patient #8. Staff K did not perform hand hygiene, donned gloves, then typed on the computer keyboard and moved the keyboard mouse. Staff K removed one glove and picked up an ink pen and put the patient's medications into a paper cup. She then donned the same glove and did not perform hand hygiene. Then with the same gloves she touched the patient's medication during administration to the patient, touched the computer mouse, touched the medication drawer on the computer, wrote on the Medication Administration Record (MAR), and again touched the computer mouse. Staff K removed the gloves and performed hand hygiene but then touched the computer keyboard and mouse, then touched the patient's skin, bedside table, and the patient's bedding before leaving the room.

4. Observation on 12/12/12 at 8:26 AM showed Staff T, RN, during medication administration for Patient #38. Staff T administered the medications to the patient and then rubbed cream on the patient's legs. She removed the gloves and discarded them but did not perform hand hygiene before she typed on the computer keyboard. Staff T left the patient's room to get a blanket for the patient and returned to the room but did not perform hand hygiene when she entered or exited the patient's room.

5. Observation on 12/12/12 at 8:40 AM showed Staff T, RN, during medication administration for Patient #39. Staff T donned one glove on the left hand and removed the patient's medication from the computer drawer with her right (ungloved) hand. She scanned the patient's identification bracelet touching the patient's bedding and bare skin with both hands, did not perform hand hygiene and then donned a glove on her right hand. Staff T applied cream to the patient's arms and legs and then removed the gloves and discarded them but did not perform hand hygiene. She donned a new pair of gloves and applied cream to the patient's coccyx (a small triangular area at the base of the spinal column). She removed the contaminated glove from her right hand and did not perform hand hygiene before she touched the patient's bedding and picked up the jar of skin cream and placed it on the computer. She then removed the glove from her left hand and did not perform hand hygiene. She touched the patient's skin and IV (intravenous or within the vein) site and moved the computer to the door before she performed hand hygiene.

6. Observation on 12/12/12 at 9:05 AM showed Staff T, RN, during medication administration for Patient #40. Staff T scanned the patient's identification bracelet touching her bare skin, did not perform hand hygiene, then donned gloves. Staff T changed gloves after she administered eye drops to the patient's eyes but did not perform hand hygiene between the glove changes. She then administered oral medications to the patient and removed and discarded the gloves. She did not perform hand hygiene before she typed on the computer and moved the computer to the door.

7. During an interview on 12/12/12 at 9:15 AM, Staff T, RN, stated that she usually does perform hand hygiene in between glove changes but she just forgot. She could not verbalize what the facility's hand hygiene policy and procedure stated in regard to hand hygiene and glove wear.

8. Observation on 12/12/12 at 9:35 AM showed Staff R, RN, preparing to change an occlusive (an air- and water-tight) dressing of a PICC line (peripherally inserted central catheter is a form of intravenous access) for Patient #9. Staff R touched the patient's bare skin and dressing and did not perform hand hygiene before she donned gloves. She then removed the old occlusive dressing over the PICC line and discarded it and removed her gloves and discarded them but did not perform hand hygiene. Staff R then opened a sterile dressing package and donned sterile gloves. After cleaning the PICC site she put a piece of gauze over the site and placed the occlusive bandage over it sealing the dressing. This practice made it impossible to view the PICC site under the gauze and due to the improper hand hygiene and glove use could cause an infection at the PICC site to be undetected.

Staff R did not perform hand hygiene after removing the sterile gloves and wrote the date and time on the occlusive dressing. She then discarded the gloves and paper from the sterile dressing kit.

9. During an interview on 12/12/12 at 9:55 AM, Staff R stated that she hesitant about washing her hands and wasn't sure what to do.

10. During an interview on 12/12/12 at 10:00 AM, Staff A, Chief Nursing Officer (CNO) and Quality Assurance (QA), stated that the occlusive dressing would be removed from Patient #9 and reapplied to assure infection prevention and patient safety because the patient was being sent home.

11. During a concurrent interview on 12/12/12 at 10:15 AM, Staff A, CNO, QA, and Staff B, RN, QA, showed Quality Assessment and Performance Improvement (QAPI) Reports for 2012. The report showed 100% compliance in hand hygiene for the 1st, 2nd and 3rd quarters (the 4th quarter data was not yet available).

12. During an interview on 12/12/12 at 2:35 PM, Staff U, RN, Infection Control Officer, stated that she watched the nurses during hand hygiene to collect the data for the QAPI Reports. She stated that she watches the nurses go in and out of the rooms but did not observe them performing direct patient care. She said her hand hygiene monitoring and observations would have to be revised to capture direct patient care.

13. Observation on 12/11/12 at 10:45 AM, showed Staff E, Licensed Practical Nurse (LPN) with long nails. She wore dark nail polish with glitter particles and the polish was chipped.

14. During an interview concurrent with nail observation Staff E stated that her nail polish should not be chipped. Staff E stated that nail polish should not be colored, only clear and that it should come off. Staff E stated that nail polish is an infection control problem.



27029