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Tag No.: A0491
Based on interview, record review, and policy review, the facility failed to ensure that storage areas outside of the pharmacy were maintained according to hospital policy, when four refrigerators (two in the Intensive Care Units (ICU), one in the Critical Care Unit (CCU) and one in the Neonatal Intensive Care Unit (NICU) of four refrigerators storing patient medications fell outside of the expected temperature ranges and were not promptly addressed by pharmacy staff. This had the potential to lead to decreased effectiveness or ineffectiveness of the medications stored in the refrigerators, which could affect all patients. The facility had 26 medication refrigerators. The pharmacy dispenses approximately 60,000 medications per month. The facility census was 106.
Findings included:
1. Record review of the facility's policy titled "Medication: General Practices" revised 04/30/12, showed that all medications to be administered to a patient during hospitalization, including any brought to the hospital, will be stored in accordance with the manufacturer's specifications adhering to recommendations regarding temperature and exposure to light. The United States Pharmaceutical Convention, Incorporated (Inc.) guidelines will be adhered to. Cold: Any temperature not exceeding 46 degrees Fahrenheit (F - temperature measurement). The refrigerator is a cold place in which the temperature is maintained thermostatically between 36 - 46 degrees F.
2. Record review of the Intensive Care Unit (ICU) 2 refrigerator temperature history showed that between 04/08/14 at 9:13 PM and 04/09/14 at 4:37 PM, the temperature of the refrigerator ranged between 29.51 degrees F and 35.65 degrees F. Documentation showed that pharmacy staff failed to adjust the refrigerator thermostat until 04/09/14 at 9:00 AM, almost 12 hours after the temperature fell below the recommended range. The refrigerator continued to be out of range until 4:37 PM, over 18 hours after the temperature fell below the recommended temperature for medication storage.
3. Record review of the Main Hospital 2/Critical Care Unit refrigerator temperature history showed that between 03/21/14 at 7:47 PM and 03/23/14 at 12:39 PM, the temperature of the refrigerator ranged between 32.9 degrees F and 35.76 degrees F. Documentation showed that pharmacy staff failed to adjust the temperature until 03/22/14 at 8:02 AM, greater than 12 hours after the refrigerator's temperature dropped below the recommended temperature for the medication storage. The refrigerator continued to be out of range until 12:39 PM, approximately 41 hours after the temperature fell below the recommended temperature for medication storage.
4. Record review of the ICU 1 refrigerator history showed that between 03/21/14 at 12:29 AM and 03/21/14 at 1:50 PM, the temperature of the refrigerator ranged between 33.0 degrees and 35.86 degrees F. Documentation showed that the pharmacy staff failed to adjust the thermostat until 03/21/14 at 12:04 PM, greater than 11 hours after the refrigerator's temperature dropped below the recommended temperature for the medication storage.
5. Record review of the Neonatal Intensive Care Unit (NICU) refrigerator history showed that between 02/15/14 at 11:15 PM and 02/16/14 5:35 PM, the temperature of the refrigerator ranged between 33.45 degrees F and 35.76 degrees F. Documentation showed that the pharmacy staff failed to adjust the thermostat until 02/16/14 at 9:06 AM, greater than nine hours after the refrigerator's temperature dropped below the recommended temperature for the medication storage. The refrigerator continued to be out of range until 5:35 PM, over 18 hours after the temperature fell below the recommended temperature for medication storage.
6. During an interview on 05/06/14 at 2:50 PM, Staff TT, Pharmacy Technician, stated that the refrigerator temperatures were monitored by a computer program that logged the temperatures electronically. Staff TT stated that when the refrigerator temperatures fell out of range, either too high or too low, a notification was sent to a pager that was worn by one of the pharmacy technicians on duty, who would investigate and attempt to correct the out of range temperature by adjusting the thermostat. Staff TT added that pharmacy technicians work until 10:00 PM, and from that time until 7:00 AM the following day, the pager sat on a counter and was not addressed by the pharmacist on duty overnight because the pharmacist was alone and could not leave the pharmacy. Staff TT stated that when the pharmacy technicians returned to work in the morning, they addressed the out of range temperatures that occurred between 10:00 PM and 7:00 AM, at that time.
7. During an interview on 05/06/14 at 3:00 PM, Staff KK, Director of Pharmacy, stated that the refrigerator temperatures were to be maintained between 36-46 degrees F. Staff KK added that the pharmacist on duty at night could and does leave the pharmacy to deliver medications to the floor, which indicated that the pharmacist could also investigate and attempt to correct the out of range temperatures in the medication refrigerators.
8. Record review of all electronic refrigerator temperature history logs showed that the expected temperature ranges were set between 35 to 47 degrees F, and not 36 to 46 degrees F, as per hospital policy and Staff KK's interview. This indicated that the out of temperature range notification would not be sent to the pager when the refrigerator temperatures were 35 to 35.9 degrees F and 46 to 47 degrees F.
Tag No.: A0505
Based on observation, interview, record review, and policy review, the facility failed to ensure that medications not prescribed by a physician were not available for patient use in six patients (#9, #10, #12, #13, #16 and #22) out of sixteen patients reviewed on the medical surgical and obstetrical units. The medications were not labeled with the appropriate patient's identifying information. This deficient practice had the potential to affect all patients within the facility. The facility census was 106.
Findings included:
1. Record review of the facility's policy titled, "Drug Distribution" revised 04/30/12, showed the following procedures were followed to ensure safe, accurate and controlled dispensing of medications to patients outside of the pharmacy:
- All medications were labeled according to Missouri Board of Pharmacy regulations which included, at a minimum, drug name, strength, lot number, and expiration date.
- Medication (s) delivered to Nurse Servers (cabinets used by staff for storage of patient care supplies and medications) were placed in individual plastic bags with an affixed label indicating the specific patient's name, room number, drug, drug strength, dosage form and quantity.
- Pharmacy staff ensured respective patient care areas and Nurse Servers contained only medications ordered for the patient (medications ordered by a physician, and adequate amount of medication was available in the Nurse Server).
2. Observation on 05/06/14 at 10:00 AM through 11:15 AM on the Obstetrics Unit showed the following medications in Nurse Servers not labeled and not placed in individual plastic bags with an affixed label which indicated the specific patient's name, room number, drug, drug strength, dosage form and quantity:
- Nubain, (used to treat moderate to severe pain) one- pre-filled syringe for intravenous (IV, in the vein) administration, for room # 2041, no patient was observed in the room;
- Prenate RX Only, (prescription strength vitamin and mineral supplement) one tablet, Docusate Sodium 100 mg (mg = milligram, a unit of measure) one tablet (used to soften stool and improve bowel movements), for room # 2033, no patient was observed in the room;
3. Record review of the facility's census sheet dated 05/06/14 and timed 7:58 AM showed no current patients assigned to patient rooms #2041 or room #2033. The census at 10:00 AM through 11:15 AM was confirmed by Staff M, Director of Patient Care Services and Staff C, CNO.
4. Observation on 05/06/14 at 10:00 AM through 11:15 AM on the Obstetrics Unit showed the following medications in Patient #22's Nurse Servers not labeled and not placed in a individual plastic bag (s) with an affixed label which indicated the patient's name, room number, drug, drug strength, dosage form and quantity; Promethazine, (used to treat nausea and vomiting after surgery) two - 25 mg vials (contains IV medication to be mixed in a fluid for IV administration).
Record review of Patient #22's physician orders showed no medication order for Promethazine IV for Patient #22. Staff C, Chief Nursing Officer (CNO), confirmed the patient did not have a current order for Promethazine IV administration.
5. During an interview on 05/06/14 at approximately 10:45 AM, Staff K, Registered Nurse (RN), stated that nursing staff used the Nurse Servers to obtain the patient specific medications which had been delivered from the pharmacy .
6. Observation on 05/06/14 at approximately 12:45 PM showed one Senokot Senna (medication used to treat constipation), one Flomax 0.4mg (medication used for difficulty in urination), one Sertraline 50mg (medication used to treat depression), and one Oxybutynin 5mg (medication used to treat urinary retention) in Patient #9's nurse server in Room 4031. These medications had no patient identifying information.
Record review of Patient #9's physician orders showed no current or discontinued orders for Senokot, Flomax, Sertraline, or Oxybutynin medications. The medications located in the nurse server had the potential to be administered to the patient.
7. Observation on 05/06/14 at approximately 1:05 PM showed one Hydralazine 25 mg (medication used to treat high blood pressure) and one Amlodipine 5 mg (medication used to treat high blood pressure and chest pain) in Patient #10's nurse server in Room 4032. The medications had no patient identifying information.
Record review of Patient #10's physician orders showed no current or discontinued orders for Hydralazine or Amlodipine. The medications located in the nurse server had the potential to be administered to the patient.
8. Observation on 05/06/14 at approximately 1:50 PM showed one Cipro 400 mg (medication used to treat infections), one Flagyl 500 mg (medication used to treat infections), and one Hydrochlorathiazide 25 mg (medication used to treat high blood pressure) in Patient #12's nurse server in Room 4035. The medications had no patient identifying information.
Record review of Patient #12's physician orders showed no current or discontinued orders for Cipro, Flagyl, or Hydrochlorathiazide. The medications located in the nurse server had the potential to be administered to the patient.
9. Observation on 05/06/14 at approximately 2:00 PM showed one Meropenem for injection package (medication used to treat infections) and one Pramipexole Dihydrochloride (medication used to treat symptoms of a neurological disorder) in Patient #13's nurse server in Room 4036. The medications had no patient identifying information.
Record review of Patient #13's medical record showed no current or discontinued orders for Meropenem or Pramipexole. The medications located in the nurse server had the potential to be administered to the patient.
10. Observation on 05/06/14 at approximately 3:10 PM showed one Budesonide 0.5 mg/2ml nebulizer (medication used to treat asthma and other breathing disorders) in Patient #16's nurse server in Room 4040. The medications had no patient identifying information.
Record review of Patient #16's physician orders showed no current or discontinued orders for Budesonide. The medications located in the nurse server had the potential to be administered to the patient.
11. During an interview on 05/06/14 at approximately 3:45 PM, Staff T, RN, stated that the medications were not supposed to be there, they may have been left from a previous admission, and it was hard to keep up due to the high turnover of patients.
12. During an interview on 05/07/14 at approximately 10:30 PM, Staff CCC, Quality Resource Analyst, stated that medications were to be labeled with patient identifying information if they were not given by the nurse who acquired the medications from the unit dose dispensing machine.
13. During an interview on 05/06/14 at approximately 11:45 PM, Staff C, CNO stated that the nursing staff was responsible for removing medications from the nurse servers when a patient was discharged or the medication order had been changed in any way. She stated that she did not know why the nursing staff had not removed the medications or why the medications were not labeled per policy.
14. During an interview on 05/06/14 at 12:45 PM Staff KK, Director of Pharmacy, stated that all medication in the facility should have been labeled per policy and he was not aware of medications in patient nurse servers that were not labeled. He stated that the pharmacy staff did not monitor medications located in the nurse servers for appropriate labeling or ensure patients have current physician orders for medications in the nurse servers. He stated that he was ultimately responsible for all medication management in the facility.
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Tag No.: A0631
Based on observation, interview and policy review, the facility failed to ensure nursing personnel were aware the approved nutrition manual was available to them for reference. This deficient practice had the potential to affect the therapeutic accuracy of diets served to patients. The facility census was 106.
Findings included:
1. Record review of the facility's policy titled, "Nutrition Care" revised 05/01/12, showed that the facility's nutrition care manual serves as a reference for nutrition care and is available to all medical, nursing, and food service personnel.
2. Observation on 05/05/14 at 2:42 PM, on the Medical Telemetry Unit, showed Staff V, Registered Nurse (RN); Staff W, RN; Staff X, Unit Clerk; and Staff Y, Unit Manager; attempted to locate the nutrition manual. The staff presented food menus, and Staff Y presented a spreadsheet of diet specific food options to the surveyor, but all were unable to locate the nutrition manual.
3. During an interview on 05/05/14 at 2:52 PM on the Medical Surgical Unit, Staff Z, Unit Clerk, was unable to explain what the nutrition manual was or where it was located.
4. During an interview and concurrent observation of the current and approved nutrition manual on 05/05/14 at approximately 2:53 PM, Staff AA, Nutrition Manager, stated that the nutrition manual was an online application and available to all staff at every computer throughout the hospital. Staff AA added that nursing staff typically used a nursing program to resource information related to patient diets, and therefore did not know about or utilize the nutrition manual.
Tag No.: A0724
Based on observation and interview the facility dietary staff failed to clean a can opener and the kitchen environment. The failure to keep the kitchen equipment and environment clean poses a health risk to all patients that received food from the kitchen. The facility census was 106.
Findings included:
1. Record review of email from 05/14/14 at 9:55 AM showed Staff D, Director of Quality Resources, confirmed that the facility does not currently have a policy on cleaning the kitchen equipment and environment.
2. Review of the Food and Drug Administration (FDA), 2005 Food Code, Chapter 4-601.11 showed the following direction: Equipment, food contact surfaces, non-food contact surfaces and utensils shall be clean to sight and touch.
3. Observation on 05/07/14 at 1:30 PM, in the facility kitchen, showed a table mounted can opener in the food preparation area with dried, blackened, tar like debris on the blade and gears behind the blade. In addition, two ceiling mounted return air vents, each two feet long by two feet wide, were covered with gray lint and grease debris thick enough to accumulate on finger if slid across the vent.
4. During an interview on 05/07/14 at 1:45 PM Staff XX, Executive Chef, confirmed that the table mounted can opener in the food preparation area and the ceiling air vents were soiled and all should be cleaned.
Tag No.: A0749
Based on observation, interview, record review and policy review, the facility failed to ensure:
- Intravenous (IV - in the vein) tubing was labeled to ensure tubing was discarded and replaced according to facility policy for five patients (#17, #18, #24, #31 and #32) of seven patients' IV tubing observed.
- Staff removed personal protective equipment (PPE) and washed their hands prior to exiting one patient (#37) of one patient's contact precautions (precautions used when a patient has a known or suspected infection that is high risk for spreading) room observed.
- Staff wore PPE in a manner to minimize contamination during a sterile procedure for one patient (#33) of one patient sterile procedure observed.
These failed practices had to potential to lead to increased risk of infection to all patients, staff and visitors. The facility census was 106.
- Staff maintained patient care items and patient care areas in a manner to prevent infection and cross contamination (re-infection) by proper storage and disposal of wound care supplies and instruments for one patient (#24) of one patient's wound care supplies observed.
Findings included:
1. Record review of the facility's policy titled "Intravenous Access Device Care and Maintenance" revised 04/13, showed that IV tubing will be changed and labeled with appropriate day of change every 96 hours.
2. Observation on 05/05/14 at 2:57 PM, showed Patient #17 with an IV antibiotic. The IV tubing was not labeled to indicate the date the IV tubing was changed or when it should be changed.
3. During an interview on 05/05/14 at 3:37 PM, Staff M, Director of Patient Care Services, stated that IV tubing should be labeled and changed every three days.
4. Observation and concurrent interview on 05/05/14 at 3:42 PM, showed Staff CC, Registered Nurse (RN), enter Patient #31's room to place an IV label on unlabeled IV fluids. Staff CC stated that the patient was admitted "last night", but the IV tubing was not labeled.
5. Observation and concurrent interview on 05/05/14 at 3:42 PM, showed Patient #32 with unlabeled IV fluids. Staff DD, RN, stated that she admitted the patient, but didn't label the IV tubing with the change date. Staff DD added that IV tubing was "good for 96 hours" (four days).
6. Observation and concurrent interview on 05/06/14 at 8:48 AM, showed Patient #18 with unlabeled IV tubing. Staff GG, RN, confirmed the tubing was unlabeled and stated that it should be labeled with a change date label.
7. Observation on 05/06/14 at 3:55 PM on the Progressive Care Unit (PCU) showed Patient #24 IV tubing unlabeled and connected to her IV catheter in her arm.
8. During an interview on 05/06/14 at 3:55 PM Staff NN, RN, who was assigned care for Patient #24 stated that she didn't know why the IV tubing was not labeled and did not know how long the tubing had been in use.
9. Record review of the facility's policy titled "Infection Prevention: Standard/Transmission Precautions and Isolation" revised 06/06/09, showed that when a patient is on contact precautions, staff should wear protective gowns and gloves when entering the patient's room, and the protective gown and gloves should be removed and hand hygiene performed before leaving the patient care environment.
10. Observation on 05/06/14 at 10:55 AM, showed Staff SS, Housekeeping, entered and exited Patient #37's contact isolation room three times to retrieve items from a housekeeping cart, which was located on the opposite side of the hall from the patient's room. Staff SS wore the same isolation gown and gloves each time she exited the patient's room. After Staff SS finished cleaning the room, she removed the gown and gloves, but did not perform hand hygiene, and walked down the hall and out of surveyor sight.
11. Record review of Patient #37's medical record showed that the patient was positive for Methicillin Resistant Staphylococcus Aureus (MRSA - highly contagious and difficult to treat infection) and on 05/02/14, a physician ordered contact isolation.
12. During an interview on 05/06/14 at 11:20 AM, Staff SS stated that she exited Patient #37's room with PPE on because she:
- Needs things from her housekeeping cart to clean the room.
- Must keep her cart in the hall.
- Had never been told she couldn't exit a contact isolation room with PPE on, then stated that she "probably shouldn't do that".
13. Record review of the facility's policy titled "Infection Prevention: Standard/Transmission Precautions and Isolation" revised 06/06/09, showed that personal protective equipment (PPE) such as gowns, should be fastened in the back of the neck and at the waist.
14. Observation and concurrent interview on 05/05/14 at 4:13 PM, showed Staff FF, RN, placed a peripherally inserted central catheter (PICC - small flexible tube used to administer medication or fluids, placed into a vein in the arm or leg that extends to the entry point of the upper right chamber of the heart) in Patient #33 during a sterile procedure. Staff FF's gown was not tied at the waist. Staff FF stated that the gown should have been tied at the waist.
15. During an interview on 05/06/14 at 10:45 AM, Staff Q, Infection Preventionist, stated that PPE gowns must be tied in the back when worn. In April 2014, Staff Q stated that she found one staff member that did not wear a gown for an isolation procedure.
16. Observation on 05/06/14 at 3:55 PM on the Progressive Care Unit (PCU) showed Patient #24 awake, alert and sitting in a chair in her room. The following observations were made of the patient and the room:
-The left lower leg was bandaged just below the knee and extended through to the toes.
- Located on top of the counter in an area designated as the medication preparation site, were multiple wound care and wound dressing supplies which included; one open (no protective covering) roll of gauze dressing material, one open (sterile seal was removed) container of approximately six, four inch square, gauze dressing pads, one roll of tape, one pair of disposable wound care scissors and one pair of disposable wound care forceps (a surgical instrument that resembles a pair of tongs used for grabbing, maneuvering, or removing bandages within or from the body).
- On the counter, underneath the dressing/bandage supplies, was a laminated notice, secured with many layers of tape, that provided direction to patients and staff not to place any items personal or otherwise in the area, that the area was a medication preparation site and was to be kept clean.
Re-use and placement of the used (contaminated) wound care instruments and wound care/dressing supplies increases the risk for cross contamination and infection during medication preparation and wound care to Patient #24.
17. During an interview on 05/06/14 at approximately 4:00 PM Patient #24 stated that she had received a lot of medications through her IV's for her leg infections. She stated that she received wound care and her infections were "very bad" and that she "had a big hole in (her) foot that the nurses were putting gauze into and taking it out" with the "tweezer like" instruments on the counter.
18. During an interview on 05/06/14 at 3:55 PM Staff NN, RN, who was assigned care for Patient #24 stated that the instruments used for wound care were usually wiped off and put back in a tub with other supplies and reused. Staff NN stated that the supplies should have been returned to the tub on the same counter (not just lying open on the counter outside of the tub). When asked by the surveyor if the wound care instruments were considered contaminated and posed a risk for cross contamination and re-infection, she stated that the instruments were disposable and should have been considered contaminated because they had been used on the patient and had come to the patient's room sealed and sterile. However, Staff NN stated that nursing staff were told to wipe them off and reuse them.
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