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Based on the onsite recertification completed on December 13 and 14, 2016, the facility failed to comply with the regulations set forth for Life Safety and, therefore were cited under Life Safety Code tags K222, K321, K325, K341, K343, K351, K363, K372, K781, K920, and K923,. See Survey ID# HZC521 For full details of the cited deficiencies.

Based on the nature of standard level deficiencies referenced to the Condition, it was determined the Condition of Participation §485.635, Provision of Services was out of compliance.

C-0276- Standard: Rules for the storage, handling, dispensation, and administration of drugs and biologicals. These rules must provide that there is a drug storage area that is administered in accordance with accepted professional principles, that current and accurate records are kept of the receipt and disposition of all scheduled drugs, and that outdated, mislabeled, or otherwise unusable drugs are not available for patient use. The facility failed to ensure all medications intended for patient use were stored in a secured manner to avoid diversion or tampering. This failure resulted in unauthorized access to medications.

C-0278- Standard: A system for identifying, reporting, investigating and controlling infections and communicable diseases of patients and personnel. The facility failed to ensure a clean and sanitary patient care environment. Further, the facility failed to ensure staff responsible for monitoring laboratory temperature ranges, addressed the out of range alarms. This failure created the potential for transmission of bacteria, cross contamination, and missed identification of infections creating negative patient outcomes. Additionally, this failure created the potential for patients to experience illness due to exposure to food borne pathogens if expired/unsafe food was served to the patients.

Based on observations and interviews, the facility failed to ensure all medications intended for patient use were stored in a secured manner to avoid diversion or tampering.

This failure resulted in unauthorized access to medications.

FINDINGS:

POLICY

According to the policy, Medication Security, all drugs, except those intended for crash care use, will be stored in locked containers or areas. When unattended, the medication carts and medication rooms are locked.

According to the policy, Medication Management-After Hours Care, all drugs stored at the After Hours Care Clinic shall be accessible only to authorized personnel. All drugs except those intended for crash cart use, will be stored in the locked medication room. The RN or MD are the only staff members who shall have access to the medications.

1. The facility did not ensure medications stored at the After Hours Care Clinic were secured from unauthorized personnel.

a) On 11/29/16 at 5:15 p.m., a tour of the After Hours Clinic was conducted with the Director of Outpatient Clinics (Director #4). At 6:30 p.m., Housekeeper #7 was observed in the After Hours Clinic's medication room unsupervised. Housekeeper #7 cleaned the unlocked medication cart which contained multiple vials of intravenous medications, including an opened multidose vial of xylocaine with epinephrine; a anesthetic medication used to relieve pain and numb the skin. Furthermore, there were multiple unlocked drawers in the medication room which contained additional patient medications, including antibiotics, antinausea medications and anesthetics. Housekeeper #7 stated s/he did not have a key to the room. Housekeeper #7 stated s/he was usually let into the room and s/he cleaned the room alone.

At 7:05 p.m., Housekeeper #7 was observed mopping the floor in the medication room with the door open and no nursing staff present with him/her.

b) On 11/30/16 at 12:43 p.m., an interview was conducted with the Director of Pharmacy (Director # 12) who stated medication security involved all medications. Director #12 stated housekeepers were not allowed to have access to unsupervised medication rooms. S/he stated the risk of having unauthorized individuals in the medication room would be diversion or medication tampering.

c) On 11/30/16 at 2:18 p.m., an interview was conducted with the Chief Clinical Officer (CCO #1), the Senior Quality Improvement Analyst (Employee #2) and Director #4. Director #4 stated Housekeeper #7 should have been supervised while s/he was in the medication room. Director #4 stated normally the medication room was locked; however, the Registered Nurse working the night of 11/29/16, was busy and the medication room did not get locked.

d) On 12/01/16 at 10:59 a.m., an interview was conducted with the Assistant Director of Facilities (Director #11) and the Environmental Services Supervisor (Supervisor #7). Supervisor #7 stated cleaning staff were not supposed to go into medication rooms without supervision. After review of the observation on 11/29/16 at 6:30 p.m., Director #11 stated the expectation was housekeeping staff were supervised while in the medication room. S/he then stated the more access was limited, the more it narrows down the pool of possible suspects for medication diversion and the possible tampering of the medications.

2. The facility failed to ensure IV fluids in the perioperative area were secured from unauthorized personnel.

a) On 11/28/16 at 3:05 p.m., a tour of the preoperative area was conducted with the Director of Perioperative Services (Director #10). The tour revealed 9 bags of 1000 milliliter Lactated Ringers (LR) intravenous fluids in an unlocked medication/storage room. Director #10 stated s/he did not know if the LR should be secured. Director #10 stated the housekeeping staff had access to the room when Periop staff were not present.

b) On 11/30/16 at 12:43 p.m., an interview was conducted with Director #12 who stated medication security involved all medications. Director #12 stated housekeepers were not allowed to have access to unsupervised medication rooms. S/he stated the risk of having unauthorized individuals in the medication room would be diversion or medication tampering. Director #12 considered LR a medication.

c) On 12/01/16 at 10:59 a.m., an interview was conducted with Director #11 and Supervisor #7. Director #11 stated the expectation was housekeeping staff were supervised while in the medication room. S/he then stated the more access was limited, the more it narrows down the pool of possible suspects for medication diversion and the possible tampering of the medications. Supervisor #7 stated housekeeping staff should not have access to intravenous fluids.

Based on observations, interviews, and document review, the facility failed to ensure a clean and sanitary patient care environment. Further, the facility failed to ensure staff responsible for monitoring laboratory temperature ranges, addressed the out of range alarms.

This failure created the potential for transmission of bacteria, cross contamination, and missed identification of infections creating negative patient outcomes. Additionally, this failure created the potential for patients to experience illness due to exposure to food borne pathogens if expired/unsafe food was served to the patients.

FINDINGS:

POLICY

According to the policy, Exposure Control Plan, all cardboard boxes that are used for storage must be stored off the ground.

According to the policy, TempTrak Temperature Monitoring System, a Temperature Alert is generated whenever a temperature falls outside the specific temperature range set up in the Alarm Profile. These are valid outliers and must be acknowledged as soon as possible.

1. The facility failed to ensure patient care supplies were secured in a manner to prevent possible contamination from staff who were not employed, monitored or trained by the facility's After Hours Clinic.

a) On 11/29/16 at 5:15 p.m., a tour of the Facility's After Hours Clinic was conducted with the Director of Outpatient Clinics (Director #4). The After Hours Clinic shared the same space with another patient care clinic (Clinic B). Clinic B occupied the office space when the After Hours Clinic was closed.

During the tour, the following was revealed:

In Room #2, linens, towels and patient gowns were found in an unlocked cabinet. Another unlocked drawer contained open packets of gauze, petroleum jelly, and additional patient care supplies. Inspection of the unsecured drawer attached to the patient exam table revealed disposable speculums and swabs.

Director #4 stated s/he thought the gowns belonged to the After Hours Clinic. Director #4 then stated the cabinets were left unlocked to allow Clinic B to use the After Hours Clinic's supplies. S/he stated the supplies were part of the gratis between the After Hours Clinic and Clinic B.

Three other exam rooms were found with open cabinets which stored similar patient care supplies, including opened gauze packages and culture swabs. Registered Nurse (RN) #6 who was also present for the tour, stated the gauze were used for patient suture removal.

In the procedure room (Room #4), a locked cabinet labeled with the After Hours Clinic name which contained laceration sutures, was unlocked by RN #6. RN #6 used the same key which opened the suture cabinet to open Clinic B's locked supply cabinets. After RN #6 realized the key opened both cabinets, s/he stated s/he could not ensure Clinic B staff would not access the suture cabinet.

b) On 11/30/16 at 2:18 p.m., an interview was conducted with Director #4, the Chief Clinical Officer (CCO #1), and the Senior Quality Improvement Analyst (Employee #2). Both Director #4 and CCO #1 stated Clinic B should not use the After Hours Clinic's supplies. However, both were unable to state a process was in place to ensure the supplies were only used by the After Hours Clinic staff.

c) On 12/01/16 at 11:38 a.m., an interview was conducted with the Infection Preventionist (IP) #3 who stated s/he thought the patient care supplies at the After Hours Clinic were separated from Clinic B's supplies. IP #3 stated the facility could not ensure the supplies were not used by Clinic B, unless the supply cabinets were locked. IP #3 stated there was not a process in place to monitor Clinic B's infection control practices.

2. The facility failed to ensure temperatures of an incubator used to store specimens for laboratory analysis were maintained within an acceptable defined range.

a) On 11/28/16 at 1:15 p.m., a tour of the Laboratory was conducted with the Director of Laboratory Services (Director #5) and CCO #1. While observing the facility's electronic temperature tracking system for equipment used in the laboratory, the temperature for the laboratory's incubator was documented at 38.7 degrees Celsius. Director #5 stated the normal temperature range for the incubator was between 34 and 37 degrees Celsius.

During the same tour a review of the TempTrak Sensor History Log for the Incubator revealed the out of range alarm was to activate at temperatures below 34 degrees Celsius or above 37 degrees Celsius. Further review of the Log for 11/28/16 showed documentation of the Incubator's temperature to be above the normal range beginning at 9:15 a.m. until 1:30 p.m. (a total of 4 hours and 15 minutes), with a maximum temperature reaching 39 degrees Celsius (2 degrees above the normal range). Documentation on the Sensor Notes of the Log revealed the first time staff was aware of the alarm was at 1:27 p.m.

b) On 11/29/16 at 3:19 p.m., an interview was conducted with the Director of Laboratory Services (Director #5) who stated s/he expected staff to fix the out of range temperature for the incubator as soon as possible. Director #5 stated s/he did not follow the policy because leadership was not aware the alarm was on.

c) On 11/30/16 at 10:04 a.m., an interview was conducted with the Medical Director of the Laboratory (Director #9) who stated if there were out of range temperature issues with incubation, there was potential of false negative results for cultures. Director #9 stated the threat would be the microorganisms would not grow in the culture medium correctly. Director #9 stated s/he expected staff to address the temperature alarms as soon as possible.

3. The facility failed to ensure boxes containing supplies were stored off the ground.

a) On 11/28/16 at 2:07 p.m., a tour of the kitchen was conducted with the Director of Nutrition Services (Director #8). Five boxes were observed on the floor at the entrance of the kitchen. Director #8 stated the boxes were recently delivered to the kitchen and the delivery staff would sometimes put the boxes on the floor before the items in the boxes were removed and stored. The boxes contained napkins, gloves, and garbage can liners.

During the same tour, 2 boxes containing gloves and garbage can liners were found on the floor in the kitchen's mop closet. Director #8 stated staff probably set the boxes on the floor to store. This was in contrast to facility policy which stated all cardboard boxes that were used for storage must be stored off the ground.

b) On 12/01/16 at 11:38 a.m., an interview was conducted with IP #3 who stated the facility would like to see boxes stored off the floor in order to minimize the risk of vermin and possible contamination from water.

4. The facility failed to ensure food was labeled and dated with expiration or use by dates.

a) On 11/28/16 at 2:07 p.m., a tour of the kitchen was conducted with Director #8. Inspection of the Dry Storage revealed the following undated food items: 4 one gallon jars of coleslaw, 3 one gallon jars of mayonnaise and 3 thirty-six ounce bags of rice pilaf.

Inspection of the freezers revealed 1 bag of 12 frozen bread rolls and a box of popsicles with no expiration or use by date.

Director #8 stated the food orders arrive in big cases. S/he stated staff would then remove the items from the boxes for use.

During the same tour, an interview was conducted with a member of the kitchen staff (Employee #13), who stated s/he was responsible for storing food after it was delivered to the kitchen. Employee #13 explained that while unpacking boxes of food items, s/he would place a sticker on each item with the expiration date located on the box the food items were delivered in. Employee #13 further stated if there was no date of expiration located on a food item, there was no way to tell how long the food item was good for.

b) On 12/01/16 at 11:38 a.m., an interview was conducted with IP #3 who stated s/he was responsible for monitoring the infection control practices in the kitchen. IP #3 stated outdated food would pose some risk to patients for food bourne illnesses, gastrointestinal issues, and bacterial growth.

5. The facility failed to ensure supplies for patient use were protected from possible splash contamination during Gastrointestinal (GI) procedures and environmental cleaning.

a) On 11/28/16 at 3:45 p.m., a tour of the Endoscopy Procedure Room was conducted with the Director of Perioperative (Director #10) department. The tour revealed an uncovered supply cart in the procedure room which contained patient care supplies including: needles, forceps, suction equipment, tongue blades, unwrapped absorbent pads, oxygen equipment, gloves, masks, intravenous fluids, and equipment used on patients during endoscopic procedures.

Director #10 stated the supply cart in the Endoscopy Procedure Room was always left uncovered. Director #10 stated s/he did not know why the supply cart was kept uncovered, but it was possible the supplies could become contaminated during procedures.

b) On 12/01/16 1:09 p.m., an interview was conducted with IP #3. After review of the observation conducted on 11/28/16 at 3:45 p.m., IP #3 stated s/he thought it was acceptable for the supplies cart to be in the Endoscopy Procedure Room because of the distance between the cart and the procedure table. However, IP #3 then stated it would make sense for the cover of the cart to be pulled down.