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Based on observation, interview, record review, and policy review, the facility failed to ensure that staff followed the facility's policy and the infection prevention standards for the United States Pharmacopeia (USP) for compounded sterile preparations (CSPs) when they failed to:
- Insure the work areas (buffer area) were kept uncluttered.
- Clean the buffer area on days that multiple medications were compounded;
- Clean the primary engineering controls (PEC, a device that provides an environment for compounding medications) daily, and/or before sterile compound process;
- Place the PEC in a buffer area free from cross drafts that may interfere with airflow;
- Remove a water source (sink or floor drains) from the buffer area that contains the PEC; and
- Perform proper aseptic and garbing procedures during CSPs.

These failed practices had the potential to increase the risk of cross contamination that may result in patient harm and/or death from the inappropriate quality in CSPs. The facility performs four to eight CSPs per month. The facility's census was seven.

Findings included:

1. Record review of the USP, Chapter 797, dated 2013, showed that:
- Particle shedding objects (pencils, corrugated cardboard, paper towels, and cotton items) are prohibited in the buffer area;
- The PEC cannot be in location of a storage area;
- The PEC should be cleaned daily, and prior to compounding (to include behind the PEC, top and exterior of PEC, return air vents, and exterior of trash cans);
- The buffer area floors should be cleaned daily, walls monthly, ceilings monthly, storage shelving monthly, and documented on a cleaning log.
- The PEC should be placed out of cross drafts that may interfere with airflow; and
- The buffer area cannot contain a source of water.

2. Observation on 02/14/17 at 2:45 PM showed the following:
- Multiple dead insects;
- Overflowing trash can;
- Overflowing red hazards waste can (materials that can be harmful and should never be placed in regular trash) with white powder on outside of the can, open to air, and without a secure lid;
- A sink next to the PEC;
- An air vent directly above the front of the PEC, where air had the potential to blow directly down on the personnel compounding, and into the PEC;
- Dusty return air vent on the PEC; and
- Multiple medication storage, which contained cardboard and paper.

During an interview on 02/14/17 at 3:00 PM, Staff F, Pharmacy Technician (PHT), stated that:
- The dead insects were "drain flies";
- There were 13 "drain flies" in the buffer area, including on the counter next to a box of non sterile gloves (gloves that may harbor unintended physical contaminants);
- On the return vent, it was "dust" and she never cleaned the outside of the PEC; and
- She was unfamiliar with any cleaning log for the buffer area.

During an interview in the buffer room, on 02/14/17 at 3:25 PM, Staff G, RN, Infection Control Nurse, stated that the "drain flies", overflow trash can, overflow hazards waste can, "dust" on the return vent, and the air vent above the PEC "could be an infection control issue".

During an interview in the buffer room, on 02/15/17 at 2:45 PM, Staff I, Maintenance Supervisor, stated that the water source and the air vent above the PEC was active (currently being used), and he could see the air vent had the potential to cause air flow changes in the PEC.

Even though requested, the facility failed to provide a documented cleaning record for the buffer area.

3. Record review of the facility's policy titled, "Sterile compounding," dated 04/2005, showed that:
- All solutions, drugs, supplies, and equipment must be stored according to USP requirements;
- The PHT may mix sterile compounds, with the Pharmacist assessing the PHT's aseptic technique;
- Since the facility only had one Pharmacist, the Laboratory and/or the Infection control nurse will assess the Pharmacist ability in aseptic technique.

4. Record review of the USP, Chapter 797, dated 2013, showed that all personnel entering the buffer area needed to be garbed (hair cover, face mask, shoe covers, non-shedding gown, and put on sterile gloves).

5. Observation with concurrent interview on 02/14/17 at 3:10 PM, in the buffer room, during a demonstration of CSPs, Staff F, PHT, failed to perform proper garbing procedure. Staff F, PHT stated that she had never used sterile gloves, only the non sterile gloves on the counter. Stated that she had never been trained on proper garbing procedures, and had never put on a hair net, face mask, shoe covers, and/or non-shedding gown during CSPs, and performs CSPs without the Pharmacist in the buffer area.

6. Record review of the medication compounding log for 11/23/16 through 02/14/17 showed that the following medications were compounded:
-14 Immunosuppressant drugs;
- Five Antibiotics; and
- One Anticonvulsant.

During an interview on 02/15/17 at 8:30 AM, Staff K, Laboratory Manager, stated that:
- If the laboratory was responsible for assessing aseptic technique, it would be her responsibility;
- She was unfamiliar with procedures on CSPs; and
- She had not observed any pharmacy personnel performing CSPs.

During an interview on 02/16/17 at 8:45 AM, Staff G, RN, Infection Control Nurse, stated that she was unfamiliar with procedures on CSPs, and she had not observed any pharmacy personnel performing CSPs.

During a telephone interview on 02/15/17 at 10:25 AM, Staff J, Pharmacist, Pharmacy Director, stated that:
-The normal procedure included a call from the Pharmacist from an offsite location, instructing the PHT for mixture of the solution, the PHT would start the CSPs, the Pharmacist would enter the facility, and check the final product;
- Laboratory and/or the Infection Control nurse had never checked the Pharmacist aseptic technique with CSPs; and
- The facility's policy and procedures regarding CSPs were outdated, and needed to be updated to comply with USP guidelines.

Based on interview, record review, policy review and Medical Staff Bylaw review, the facility failed to ensure a history and physical (H&P) was recorded, and on the patient record, within 24 hours of admission for two (#1 and #2) of four patients' records reviewed. This practice had the potential to affect all patients admitted to the facility, preventing needed medical history information to be available to the medical and nursing staff. The facility census was seven.

Findings included:

1. Record review of the facility's policy titled, "Time Frame for Inpatient History and Physical," dated 04/16/12, showed a complete H&P shall be recorded within 24 hours of an inpatient admission.

2. Record review of the facility's (undated) Medical Staff Bylaws, showed the attending physician shall be responsible for completing the H&P within 24 hours of admission.

3. Record review of Patient #1's Swing Bed (SB-Skilled services in same facility) Activity Assessment dated 02/08/17, showed she was admitted on 02/07/17.

Record review of Patient #1's electronic medical record (EMR), on 02/14/17, seven days after admission, showed no H&P in the record.

4. Record review of Patient #2's Kardex (a summary of the patients overall condition, usually kept in pencil so ongoing changes can be made) dated 02/15/16, showed the patient was admitted on 02/10/17.

Record review of Patient #2's EMR, on 02/14/17, four days after admission, showed no H&P in the record.

During an interview on 02/14/17 at 1:55 PM, Staff A, Quality Director, stated that H&P's were not placed on the EMR until the physician signed them.

During an interview on 02/16/17 at 8:49 AM, Staff H, Director of Health Information Management, stated that the facility had two admitting physicians (Staffs Q and R), and they came to the facility daily if they had patients in the facility. Staff H stated that the physicians were required to have H&Ps dictated and on the record within 24 hours of admission. Staff H stated that she reviewed all medical records at discharge and notified the physicians of any unsigned/incomplete areas of the record, and continued to remind them until they were complete.

During an interview on 02/16/17 at 8:45 AM, Staff R, MD, stated that:
- He had training on attaching the H&P to the medical record;
- The H&P should be in the medical record within 24 hours; and
- No personnel from the facility had addressed him on the H&P not being placed in the medical record within the 24 hour time frame.


37921

Based on interview, record review and policy review the facility failed to develop an individualized, comprehensive care plan that included specific problems, measurable objectives/goals, and specific patient-centered interventions for three current (#1, #2, and
#3,) and one discharged (#17) of four Swing Bed (SB-skilled nursing care in the same facility) patients reviewed. This had the potential to affect all patients in the facility by failing to direct specific care needs, creating a lack of care and/or focus of care. The facility census was seven, five of which were SB patients.

Findings included:

1. Record review of the facility's nursing policy titled, "Nursing Documentation-Standards of Care," reviewed 04/2015, showed staff were to do the following:
- Update the problems on the care plan at the end of each shift.
- Prioritize each problem.
- Create a care plan which reflects interventions to meet the patient's needs.

Record review of the facility's SB policy titled, "Comprehensive Care Planning Conference," revised 05/2016, showed the following:
- Meetings will be held weekly so individual disciplines (Nursing, Social Services, Activities, Therapies, etc.), the patient and/or family members can collaborate and develop a care plan integrating the specific information.
- Nursing should utilize the diagnosis, general condition, and medication regimen.
- Physical therapy can recommend increased/decreased activities, in the Activities Coordinator's (AC) absence.

Record review of the facility's SB policy titled, "Activity Program," revised 04/2008, showed the Activity Director (AD), shall assess each SB patient and develop activities based on the comprehensive assessment. The AD shall develop a plan and activities that can be carried out.

2. Record review of current Patient #1's SB Activity Assessment dated 02/08/17, showed the following:
- She was admitted on 02/07/17 with an infection in her left eye.
- She had activity interests of arts/crafts, sews, watched television (TV), and reads.
- The patient lived alone and had frequent family visits.

Record review of the patient's Problem List/Plan of Care on 02/14/17, dated 02/08/17, showed staff failed to develop a care plan that addressed the patient's infection and/or activity interests.

3. Record review of current Patient #2's Kardex (a summary of the patients overall condition, usually kept in pencil so ongoing changes can be made) dated 02/15/16, showed the patient was admitted on 02/10/17 after a left hip fracture and surgical repair.

Record review of Patient #2's SB Activity Assessment dated 02/14/17, showed she had activity interests of arts/crafts, TV, coloring, and hobbies.

Record review of the patient's Problem List/Plan of Care on 02/14/17, dated 02/12/17, showed staff failed to develop a care plan that addressed the patient's activity interests.

4. Record review of current Patient #3's Kardex dated 02/15/17, showed the patient was admitted on 02/10/17 after a left hip fracture and surgical repair.

Record review of Patient #3's SB Activity Assessments from 02/10/17-02/14/17 showed the patient had activity interests of socializing, TV, current events, puzzles, and reading.

Record review of the patient's Problem List/Plan of Care on 02/14/17, dated 02/12/17, showed staff failed to develop a care plan that addressed the patient's activity interests.

5. Record review of discharged Patient #17's History and Physical dated 01/24/17, showed the patient was admitted to SB on 01/23/17 with a urinary tract infection.

Record review of Patient #17's Activity Assessment dated 01/25/17, showed the patient had activity interests of TV, religious activities, hobbies, and talking.

Record review of the patient's Problem List/Plan of Care on 02/15/17, dated 01/26/17, showed staff failed to develop a care plan that addressed the patient's activity interests.

During an interview on 02/15/17 at 9:50 AM, Staff B, Activity Coordinator (AC), stated that she discussed the patients' activity interests with the SB Director (Staff C), and Staff C did the care plan based on that discussion.

During an interview on 02/15/17 at 10:10 AM, Staff C, SB Director, stated that she did not do an activity care plan, and did not realize that she needed to.