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Based on observation, interview, record review and policy review, the facility failed to ensure that:
- Policies were reviewed and approved annually by appropriate staff members. (C 272)
- Pharmacy staff followed the infection prevention standards for The United States Pharmacopeia (USP) for compound sterile preparations (CSP). (C 276)
- The integrity of the contents of three of three crash carts (a set of trays/drawers/shelves on wheels used in hospitals for transportation and dispensing of emergency medications/equipment for life saving protocols). (C 276)
- Crash cart medications were secured when access to disposable plastic locks (allows facility to identify if cart security was breeched) were not controlled. (C 276)
- Medication refrigerator temperatures were monitored and recorded daily. (C 276)
- The pharmacy performed periodic evaluation of its services for quality purposes. (C 276)
- 26 Laryngoscope blades (instrument that allows the visualization of vocal cords while a breathing tube is inserted) were clean and ready for use in crash carts, located on three medical units. (C 278)
- Two non-rebreather masks (devices used to assist in the delivery of oxygen), one opened lubricant jelly, and an unpackaged stack of two inch gauze located inside two crash carts on medical units, were ready for use. (C 278)
- One crash cart was free of dust and debris of four crash carts observed. (C 278)
- Pill cutters and the medication dispensing cabinet were kept clean. (C 278)
- 11 expired medications were removed and not available for use. (C 278)
- Four expired supplies were removed and not available for use. (C 278)
- Perform hand hygiene before and after glove use, after touching inanimate objects (non-living objects, such as keyboards, tables, etc.), and between patient tasks, for one patient (#1) of one patient observed. (C 278)
- Appropriate Personal Protective Equipment, (PPE, items such as gowns, gloves, and masks worn to prevent the spread of infection) were worn in a droplet isolation (used to prevent the spread of a contagious disease, spread through droplets generated during coughing, sneezing, talking and during the performance of certain procedures) room for one patient (#5) of one patient reviewed in an isolation room. (C 278)
- Intravenous catheters (IV, small plastic tube placed in a vein for delivery of fluids and medications) were labeled with date, time of insertion, and initials for five patients (#2, #3, #4, #5 and #11) of 11 patients observed. (C 278)
- Repackaged, refrigerated foods were dated to provide notice of when to discard, in the patient nourishment refrigerator of the main nurse's station. (C 278)
- Food items were labeled, dated, and staff initials were placed on frozen food packages in the kitchen freezers.
(C 278)
- A care plan for fall risk was implemented for four patients (#2, #3, #4 and #5) of four patients reviewed that were at risk for falls. (C 298)
- A care plan for fall risk was updated for one patient (#10) of one patient reviewed after a patient fall. (C 298)
- A care plan for skin management was implemented for one patient (#1) of one patient reviewed with pressure sores (injury to skin resulting from prolonged pressure). (C 298)

The cumulative effect of these failed practices resulted in the facility's non-compliance with requirements of the Condition of Participation: Provision of Services. The facility census was 11.

Refer to the 2567 for additional information.

Based on interview and policy review, the facility failed to develop and/or review policies on an annual basis. This had the potential to affect all acute care and swing bed patients treated or admitted to the facility, by failing to direct appropriate care and services. The facility census was 11.

Findings included:

1. Record review of the following facility policies showed that:
- "Correct Site, Correct Procedure, and Correct Patient for Invasive or Surgical Procedures," was last reviewed on 02/22/13.
- "Rotation of Stock," in the Dietary Department, was effective on 02/2000, with no reviewed or revised date.
- "Visitors/Traffic Control," was last reviewed on 11/23/04.
- "Patient Rights and Responsibilities," was last reviewed on 02/01/11.
- "Laminar Flow Hood Maintenance," was last reviewed on 09/27/13.
- "Crash Carts," was last reviewed on 03/06/13.
- "Pharmacy Unit Inspection," was last reviewed on 09/25/13.
- "Cleaning of Anesthesia Supplies," was last reviewed on 04/04/07.
- "Sterile Supply Expiration Process," was effective on 04/17/03, with no reviewed or revised date.
- "Refrigerated Drug Storage," was last reviewed on 09/25/13.
- "Labeling Standards," was last reviewed on 06/18/08.
- "Prescribing/Ordering Controlled Drugs," was last reviewed on 09/17/13.
- "Dish Machine Temperature and Chlorine Check," was last reviewed on 04/05/10.
- "Informed Consent," was last reviewed on 10/07/09.
- "ER Supply and Charge System," effective 07/18/00, with no reviewed or revised date.
- "Forms and Forms Committee," was last reviewed on 01/30/08.
- "Skin Assessment," was last reviewed on 01/28/15.

2. During an interview on 03/06/18 at 9:45 AM, Staff V, Director of Medical Records, stated that the facility did not have a formal review committee. that each department was responsible for annual review of their policies, but there was not enough time to review all of the policies annually.

During an interview on 03/06/18 at 1:15 PM Staff P, Director of Respiratory Therapy, stated that they try to review all policies once a year but there just wasn't enough time.

During an interview on 03/07/18 at 9:40 AM Staff E, Administrator, stated that he had the directors review their policies and send any requested changes to him, and added that there was not a formal review committee.

During an interview on 03/07/18 at 11:15 AM Staff L, Director of Dietary Services, stated that if policy changes were needed, she sent a request to Staff E, and when approved, she educated her staff on the changes. Stall L stated that she did not document the policy reviewed or revised dates.




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37921

Based on observation, interview, record review, policy review, and review of the United States Pharmacopeia (USP) Chapter 797, the facility failed to ensure that the pharmacy staff followed USP standards for compound sterile preparations (CSP), failed to ensure medication integrity and failed to ensure quality services were provided by the pharmacy, when they failed to:
- Provide a segregated compounding area (SCA, a separate area designated for hazardous drug compounding).
- Decrease the chance of contamination by placing the Biological Safety Cabinet (BSC, a negative pressure unit used to compound hazardous medications), which is the Primary Engineering Control (PEC, a device or room that provides an environment for compounding medications) in an unclean environment and not the required ISO class 7 (cleanroom classification with class 1 being the least protective and class 9 being the most protective) environment.
- Clean the inside of the BSC per regulations.
- Remove all paper products and contaminated items from the SCA.
- Clean the SCA daily and perform a terminal clean (a thorough, deep-cleaning of a room to include the ceiling, walls and floors) of the SCA monthly.
- Produce required compounded medication log.
- Perform gloved fingertip sampling tests (tests performed to ensure that compounding personnel can successfully complete hand hygiene, gowning, and gloving without contaminating the gloved hands) on Staff O, Pharmacist (staff who performed the compounding of hazardous medications) for initial certification and yearly.
- Perform media fill testing (test performed to evaluate the technique of compounding personnel to ensure production of sterile compounds without microbial contamination) for initial certification and yearly.
- Perform surface sampling (a swabbed sample of the compounding area surface to detect bacteria) periodically and collaborate with the infection control officer to develop an appropriate testing plan.
- Produce required cleaning log of the ISO class 7 environment for the location of the BSC.
- Ensure the integrity of the contents of three of three crash carts (a set of trays/drawers/shelves on wheels used in hospitals for transportation and dispensing of emergency medications/equipment for life saving protocols).
- Ensure crash cart medications were secured when access to disposable plastic locks (allows facility to identify if cart security was breeched) were not controlled.
- Monitor medication refrigerator temperatures and record daily.
- Ensure that the pharmacy performed periodic evaluation of its services for quality purposes.
These failures had the potential to increase the risk of cross contamination with infection, increase the risk of harm to any patients who received compounded or refrigerated medications, and had the potential to allow unauthorized persons to access medications in the crash carts. The facility census was 11.

Findings included:

1. Record review of the USP, Chapter 797, dated 2013, showed that:
- The BSC must be located in an SCA in an ISO Class 7 environment.
- The pharmacy must provide a record of compounding mixtures (compounding log).
- Particle shedding objects (pencils, corrugated cardboard, paper towels, and cotton items) are prohibited in the SCA.
- SCA floor cleaning requirements were to clean the floors and walls daily, ceilings and storage shelves monthly, and document on a cleaning log.
- Gloved fingertip sampling required for initial testing and retested yearly for all compounding personnel.
- Media-fill testing required for initial testing and retested yearly.
- Surface sampling required periodically and monitored for further action coordinated with the infection control officer.

2. Although requested, the facility failed to provide a policy on sterile compounding and a compounding mixtures log.

3. Observation on 03/06/18 at 9:30 AM in the pharmacy, showed the following items in the SCA:
- The BSC in a room with no door or line of demarcation and open to the pharmacy;
- Two clothing hooks with jackets (contaminated objects) hanging;
- One purse (contaminated object) on the table;
- Shelving with multiple cardboard (particle shedding) boxes with medications;
- Under shelf multiple cardboard boxes with medications;
- Paper hanging on the wall across from the BSC;
- Boxes stored on the right side of the BSC;
- Metal filing cabinet; and
- Chair pushed under the BSC.

Observation on 03/06/18 at 9:40 AM in the inside of the BSC showed:
- The back wall had splash marks;
- The bottom had smears; and
- The right wall had splash marks.

4. Although requested, the facility failed to provide a cleaning log for the SCA.

5. Although requested, the facility failed to provide a gloved fingertip sampling log, media-fill testing log and a surface sampling log.

During an interview on 03/08/18 at 1:30 PM, Staff O, Pharmacist, stated that he was aware that the BSC was supposed to be in an ISO class 7, but the pharmacy board told him that since he was not mixing medications for outpatients, and only mixed medications for inpatients, his BSC setting was appropriate. Staff O also stated that he did not perform gloved fingertip sampling, media-fill testing or surface sampling.

6. During an interview on 03/06/18 at 9:30 AM, Staff N, Pharmacy Technician, stated that there were no cleaning logs and that housekeeping only cleaned the floors.

During an interview on 03/08/18 at 12:50 PM, Staff J, Infection Preventionist, stated that he was not allowed in the pharmacy, did not check the BSC and performed no routine samplings.

7. Although requested, the facility failed to provide a policy on crash cart security

Observation on 03/05/18 at 3:20 PM, of the Medical Unit's unlocked medication room, showed a crash cart which was secured with a yellow, plastic, numbered lock. On the counter in the same medication room, was a container of approximately 20 yellow, plastic, numbered locks, used to secure the crash cart.

During an interview on 03/05/18 at 3:25 PM Staff K, Registered Nurse (RN), stated that after the crash cart was opened the RNs would restock the items taken out and lock the cart with a new yellow lock. Staff K stated that when they ran out of locks they would get more from Pharmacy, and to her knowledge, there was no requirement to use the next number or where the numbers began or ended. She stated that it was possible for someone to break the lock from the crash cart and remove medications and then replace the lock with one obtained from the container.

Observation on 03/06/18 at 9:40 AM in the Emergency Department (ED) showed an Adult and Pediatric crash cart both secured with yellow, plastic, numbered locks.

During an interview on 03/06/18 at 9:45 AM, Staff I, ED RN, stated that the replacement locks for the crash cart were located in a container in the unlocked medication room behind the nurse's station. Staff I showed the surveyor the container with about ten locks inside, and stated that when they needed more they would get them from the Pharmacy.

During an interview on 03/08/18 at 10:30 AM, Staff O, Pharmacist, stated that Staff N, Pharmacy Technician, kept a log for the yellow, plastic, numbered crash cart locks.

During an interview on 03/06/18 at 2:30 PM Staff N, Pharmacy Technician, stated that she did not keep a record of the yellow, plastic locks, the numbers, or to whom they were dispensed. Staff N stated, "Why would we keep a record? The nurses can go to central supply and get as many as they want."

The unsecured plastic locks had the potential to allow staff to access the medications in the crash cart without accountability. This rendered the medications unsecured.

8. Record review of the facility's policy titled, "Refrigerated Drug Storage," dated 09/25/13 showed that drug storage refrigerators should be inspected daily by the pharmacy technician or pharmacist, and a daily log of temperature readings would be maintained.

Observation on 03/05/18 at 3:15 PM, of the nurses station medication room, showed a refrigerator temperature log hung on the outside of the medication refrigerator. The log was dated 01/01/18 to 03/05/18. The temperature was not recorded on nine of those 64 dates.

During an interview on 03/05/18 at 3:20 PM Staff K, RN, stated that the pharmacist usually checked and recorded the temperature, and that the missed dates must have been on the weekend because he didn't work on the weekend.

Observation on 03/06/18 at 9:40 AM, of the medication room in the ED, showed a refrigerator temperature log hung on the outside of the medication refrigerator. The log was dated 01/01/18 to 03/06/18. The temperature was not recorded on 22 of those 65 dates.

During an interview on 03/06/18 at 9:50 AM Staff I, RN, stated that the pharmacy checked and recorded the temperature. Staff I stated that the RNs did not check behind them.

During an interview on 03/07/18 at 3:20 PM Staff F, Assistant Administrator, stated there should be a process to monitor the refrigerator temperatures more closely and that medications can be compromised if the temperatures were not in range.

9. Record review of the facility department director's meeting minutes, dated 12/27/17, showed that Staff E, Administrator, reminded the department directors to complete their 2017 department's goals/quality assurance (QA, systematic process of determining services meet specified requirement) and submit by 01/12/18.

Record review of the facility's quality improvement meeting minutes, dated 02/01/18, showed that all directors were reminded to turn in 2017 QA projects for their departments.

Record review of the facility's house wide QA department list, for 2017, showed that the pharmacy had not completed any QA projects for the fiscal year.

Even though requested, the pharmacy department could not produce any completed QA projects for 2017.

During an interview on 03/07/18 at 9:45 AM, Staff V, Medical Records Director, stated that:
- She was responsible for the Quality Department;
- Each department was responsible to set goals, and perform QA annually;
- Each department was to report the QA projects to her; and
- The pharmacy had not performed any QA projects for 2017.

During an interview on 03/07/18 at 3:40 PM, Staff N, Pharmacy Technician, stated that she had not performed any QA projects for 2017.

During an interview on 03/07/18 at 3:45 PM, Staff F, Assistant Administrator, stated that:
- She was the director responsible for pharmacy;
- The pharmacy department had not completed any QA projects for 2017; and
- Staff N should have performed QA projects for 2017.





















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37921

Based on observation, interview and policy review, the facility failed to ensure that staff followed infection control policies and infection prevention standards when they failed to:
- Maintain the cleanliness of 26 laryngoscope blades (equipment that allowed visualization of the vocal cords while a breathing tube was placed) out of 26 observed and stored in crash carts (a set of trays/drawers/shelves on wheels used for transporting and dispensing emergency medication/equipment for emergency life support) located on three medical units.
- Maintain the cleanliness of two non-rebreather masks (devices used to assist in the delivery of oxygen), one opened lubricant jelly, and an unpackaged stack of two inch gauze pads located inside two rash carts on medical units.
- Ensure one crash cart was free of dust and debris of four observed.
- Ensure that 11 expired medications were removed and not available for use.
- Ensure that four expired supplies were removed and not available for use.
- Maintain cleanliness of pill cutters and the medication dispensing cabinet.
- Perform hand hygiene before and after glove use, after touching inanimate objects (non-living objects, such as keyboards, tables, etc.), and between patient tasks, for one patient (#1) of one patient observed.
- Appropriately wear Personal Protective Equipment, (PPE, items such as gowns, gloves, and masks worn to prevent the spread of infection) in a droplet (disease spread through droplets generated during coughing, sneezing, talking, and during the performance of certain procedures) isolation room for one patient (#5) of one patient reviewed in an isolation room.
- Label the intravenous catheter (IV, small plastic tube placed in a vein for delivery of fluids and medications) site dressing with date, time of insertion, and initials for five patients (#2, #3, #4, #5 and #11) of 11 patients observed.
- Ensure repackaged, refrigerated food was dated to provide notice of when to discard, in the patient nourishment refrigerator of the main nurse's station.
- Ensure the name of the food item, the date the item was made or package opened, and staff initials was placed on frozen food packages in the kitchen freezers.
These failed practices had the potential to expose all patients, visitors and staff to cross contamination and increased the potential to spread infection. The facility census was 11.

Findings included:

1. Record review of the facility's policy titled, "Infection Control," dated 04/02/03, showed the direction for staff to make every effort to prevent infection and to follow infection control measures required by law and professional standards.

Record review of the facility's policy titled, "Cleaning of Anesthesia Supplies," dated 04/04/07, showed that surgery personnel are responsible for the proper processing of anesthesia reusable supplies (laryngoscope blades).

Record review of the facility's policy titled, "Crash Carts," dated 03/06/13, showed the direction for staff to check for outdates on emergency medications monthly and notify the pharmacy immediately of outdated medications.

Record review of the facility's policy titled, "Unit Inspection," dated 09/25/13, showed that medications were not to be kept in stock after the expiration date and emergency crash cart medications were to be available, complete and within the expiration period.

2. Observation on 03/05/18 at 3:00 PM showed the medical floor's crash cart contained the following:
- An opened tube of lubricating jelly;
- An opened package of one airway adapter (plastic piece placed on end of breathing tube so different types of equipment can be attached to it);
- An opened package containing a non-rebreather mask;
- Six unpackaged laryngoscope blades in a tub touching batteries, tape and lubricating jelly;
- An unpackaged stack of gauze laying in a tray;
- Dust on the top of the crash cart;
- Two arterial blood sampling kits with the expiration date of 08/2017;
- One bottle of 100 milligrams (mg, unit of measure) per 10 milliliters (ml, unit of measure), furosemide (medication used in an emergency for reducing the fluid in the body) with the expiration date of 01/2018; and
- Two bottles of 1 ml Narcan (medication used in an emergency to treat specific drug overdoses) with the expiration date of 01/2018.

Observation of the surgery crash cart on 03/07/18 at 9:30 AM showed one unpackaged laryngoscope blade in the first drawer.

Observation of the Emergency Department crash carts on 03/06/18 at 3:15 PM showed nine laryngoscope blades in a basin in the top drawer of the adult cart. There were ten blades in a basin in the top drawer of the pediatric (infant/children) cart. The blades were not packaged in any manner that would indicate that they were cleaned or sterilized.

Observation on 03/05/18 at 3:30 PM in the medical supply room, showed one three by nine inch vaseline gauze with the expiration date of 02/2018 and one ½ inch iodoform (sterile gauze used to fill in skin wounds to help in healing) dressing, undated, with no label.

3. During an interview on 03/05/18 at 3:20 PM, Staff F, Assistant Administrator, stated that the laryngoscope integrity was the responsibility of respiratory therapy staff, and nursing and Central Supply staff were responsible for the other items.

During an interview on 03/06/18, Staff P, Respiratory Therapy Director, stated that she was not in charge of any crash carts and was not responsible for the laryngoscope blades.

During an interview on 03/06/18 at 3:25 PM Staff S, Registered Nurse (RN), stated that the blades were cleaned after use, but there was no way to ensure they were clean. "We probably should have them sterilized."

4. Although requested, the facility failed to provide a policy on how and when to clean the pill cutters.

Observation in the medication room of the main nurse's station on 03/05/18 at 3:20 PM showed two pill cutters with white powder residue on the blades and tablet debris in the base of the cutter.

During an interview on 03/05/18 at 3:25 PM Staff K, RN, stated that the pill cutters should be cleaned after every use, and "it's obvious that someone forgot and that could be dangerous."

5. Although requested, the facility failed to provide a policy on keeping the environment clean and who is responsible to clean the top of the medication dispensing cabinet.

Observation in the ED medication room on 03/06/18 at 9:30 AM showed the top of the medication dispensing cabinet was visibly dirty.

During an interview on 03/06/18 at 9:35 AM Staff I, RN, stated that housekeeping should clean the top of the medication dispensing cabinet and it was "really disgusting."

During an interview on 03/06/18 at 9:40 AM, Staff M, Director of Ancillary Services (included housekeeping) stated that the top of this cabinet was "nasty." "We need to do a better job cleaning areas that can't be easily seen.

6. Record review of the facility's policy titled, "Manufacturer Supplies Expiration Procedure," dated 04/17/03, showed directives for staff to:
- Check for expiration dates on a regular basis of all items throughout the hospital;
- Check for expiration dates in each department; and
- Return to Materials Management Department any items that have reached the expiration date.

Observation in the ED medication room on 03/06/18 at 9:45 AM showed a container of Iodoform packing strips that showed an expiration date of 06/2017.

During an interview on 03/06/18 at 9:50 AM Staff I stated that the product was expired and should not be in the department. Staff I stated that she was not sure why that item was there because that was not where it was usually stored.

7. Observation on 03/06/18 at 1:10 PM through 1:15 PM, in the radiology department, showed two radiology reaction trays with the following expired medications:
- Two vials of Dexamethasone (medication used in an emergency for reactions) 4 mg/ml with expiration date of 02/2018;
- Two vials of Solumedrol (medication used in an emergency for reactions) 125 mg with expiration date of 01/2018; and
- One bag of 500 ml normal saline (fluids to facilitate the delivery of medications) with expiration date of 12/2017.
CT reaction tray:
- Two vials of Dexamethasone 4 mg/ml with expiration date of 02/2018; and
- One 500 ml Dextrose solution (fluids to facilitate the delivery of medications) with expiration date of 12/2017.

During an interview on 03/06/18 at 1:15 PM, Staff N, Pharmacy Technician, stated that she placed a sticker on the outside of the radiology reaction trays, dated with the first medication expiration date, so that radiology staff could bring the trays to pharmacy before the medications expired. Staff N added that it was the radiology staffs' responsibility to prevent potential use of the expired medication on patients.

During an interview on 03/06/18 at 1:30 PM, Staff M, Director of Radiology, stated that it was his responsibility to bring the reaction trays down to pharmacy, and added that it was unacceptable to have expired medications readily available for patient use.

8. Record review of the facility's policy titled, "Hand Hygiene," revised 03/31/11, showed the directives for personnel to wash their hands, to prevent the spread of infections:
- Before applying and after removing gloves;
- When the hands are obviously soiled; and
- Between the handling of individual patients.

Observation on 03/06/18 at 10:15 AM, showed Staff C, Licensed Practical Nurse (LPN), changed Patient #1's wound dressing. Staff C failed to perform hand hygiene before she put on gloves, removed the patient's soiled dressing, removed and discarded her right glove (left was also contaminated), failed to perform hand hygiene, placed a clean glove on her right hand, and proceeded to clean the wound. Staff C then removed both gloves, failed to perform hand hygiene, opened the items needed to dress the wound, touched the table and then put on sterile gloves to dress the wound without hand hygiene.

During an interview on 03/06/18 at 10:25 AM, Staff C stated that she missed opportunities for hand hygiene, and added that she should have performed hand hygiene every time she removed or put on her gloves.

During an interview on 03/08/18 at 11:45 AM, Staff F, Assistant Administrator, stated that staff should remove both gloves when contaminated, and added that staff should perform hand hygiene every time they remove or put on gloves.

During an interview on 03/08/18 at 1:30 PM, Staff J, Infection Preventionist, stated that staff should remove both gloves when contaminated, and preformed hand hygiene before and after glove use.

9. Record review of facility's policy titled, "Guidelines for Isolation Precautions," revised 01/01/15, showed the following directives to contain adequate precaution for infection transmitted by droplet and contact routes of transmission:
- Droplet transmission theoretically, is a form of contact transmission (disease spread through direct or indirect contact with a contaminated surface);
- Gowns are worn to prevent contamination of clothing and protect the skin of personnel from blood and body fluid exposures; and
- Consult wall charts for detailed instructions.

Record review of a wall chart titled, "Infection Control Isolation Precaution Guideline" showed Mycoplasma (pneumonia) was a droplet precaution.

Record review of a wall chart titled, "Appendix I: Required Elements of Isolation/Precautions Categories" showed the appropriate PPE for droplet precautions was:
- Gloves;
- Mask; and
- Gown (for contact with a patient within six feet).

Record review of Patient #5's History and Physical (H&P) dated 03/05/18, showed that she was a 56 year old female admitted to the facility with Mycoplasma Pneumonia (contagious bacterial infection of the lungs).

Observation and concurrent interview on 03/05/18 at 2:45 PM showed Patient #5 in a droplet isolation room precautions room (room designated to stop the spread of germs). Staff G, RN, put on a mask and gloves and entered the room. Staff G stated that the facility did not require the staff to wear a gown with droplet precautions. Staff G administered medication through the patient's IV, and touched and spoke with the patient.

Observation on 03/05/18 at 2:50 PM, in Patient #5's room, showed Staff H, PCT, did not wear a gown while he talked to the patient within arm's length.

During an interview on 03/05/18 at 2:55 PM, Staff H, PCT, stated she was instructed that with droplet precautions, the staff were not required to wear a gown in the room.

During an interview on 03/08/18 at 9:20 AM, Staff HH, PCT, stated that she had been taking care of Patient #5 and never wore a gown.

During an interview on 03/06/18 at 9:15 AM, Staff D, RN, stated that staff should follow droplet precautions instructions for PPE, and added that she was not educated to wear a gown in the room during droplet precautions.

During an interview on 03/08/18 at 11:45 AM, Staff F, Assistant Administrator, stated that she expected all staff to adhere to the facility's policies. Whether the staff wore a gown or not with droplet precautions, was the decision of the infection preventionist and the physician.

During an interview on 03/08/18 at 1:30 PM, Staff J, Infection Preventionist, stated that with droplet precautions the staff should wear gloves, mask, and a gown. Staff J added that the facility conducted a Continuous Quality Improvement (CQI, monitor a process or procedure for improvement) and found that the nurses were "less attentive" to the patient when they had to put a gown on, so the facility decided for the nurse to use "common sense" whether or not to wear a gown.

During an interview on 03/08/18 at 9:00 AM, Staff GG, Physician, stated that with droplet precautions, the staff should wear a gown in the room to prevent cross contamination from one patient to the other.

10. Record review of the facility's policy titled, "Peripheral IV Management," revised 08/05/16, showed directions to change the transparent (see through) dressing every 96 hours and/or when the catheter (also known as IV) is removed or replaced, or when moist/soiled/not adhering. Date, time and initial dressing.

Observation on 03/05/18 at 2:40 PM, showed Patient #5's left forearm IV dressing was not labeled with date, time, or initials.

During an interview on 03/05/18 at 2:45 PM, Staff G, RN, stated that Patient #5's IV dressing was not labeled but should have been, as directed in the policy.

Observation on 03/06/18 at 9:15 AM, showed Patient #2's right antecubital (AC, the depression area in front of the elbow) IV dressing was not labeled with date, time, or initials.

During an interview on 03/06/18 at 9:20 AM, Staff D, RN, stated that Patient #2's IV dressing was not labeled and the IV dressing should have been labeled.

Observation on 03/06/18 at 9:30 AM, showed Patient #3's left AC IV dressing was not labeled with date, time or initials.

During an interview on 03/06/18 at 9:45 AM, Staff G, RN, stated that Patient #3's IV dressing was not labeled and the policy only directed the nurses to chart in the Electronic Health Record (EHR), and not on the dressing.

Observation on 03/06/18 at 9:35 AM, showed Patient #4's left AC IV dressing was not labeled with date, time or initials.

During an interview on 03/06/18 at 9:35 AM, Staff D, RN, stated that Patient #4's IV dressing was not labeled and the IV dressing should have been labeled.

Observation on 03/06/18 at 2:00 PM, showed Patient #11's right chest port (a small disc made of plastic or metal that sits just under the skin for medication or fluid infusions) dressing was not labeled with a time.

11. Although requested, the facility failed to provide a policy on how repackaged food should be identified and dated.

Observation of the patient nourishment refrigerator in the nurse's station on 03/05/18 at 2:45 PM showed:
- An undated plastic wrapped plate with three slices of ham;
- An undated plastic wrapped plate with three slices of turkey;
- An undated plastic wrapped plate with ten slices of cheese; and
- Four pieces of angel food cake in a closed plastic bag dated 02/01/18.

During an interview on 03/05/18 at 2:55 PM Staff L, Director of Dietary Services, stated that items repackaged and covered in plastic wrap should be discarded in five days. Staff L stated that the items in the refrigerator were used so fast that they were not usually dated, but without a date staff would not know when to discard them. Staff L added that the angel food cake was probably replenished into a bag that was previously dated 02/01/18, and stated that the cake should have been placed into a new bag and dated appropriately.

12. Record review of the facility's policy titled, "Freezing Prepared Food," dated 11/01/12, showed directive for staff to put the name of the food item, the date the item was made, and staff initials on the container or bag of food placed in the freezer.

Record review of the facility's policy titled, "Rotation of Stock," dated 02/2000, showed that boxes and cartons of frozen food should be dated at the time of delivery.

Observation on 03/07/18 at 10:45 AM in the facility walk-in freezer, showed a bag of chicken strips with no name, date or staff initials laying on top of a closed box.

Observation on 03/07/18 at 11:00 AM in the freezer of the facility meal prep area, showed the following food items with no name, date or staff initials:
- Two bags of breadsticks;
- Two bags of biscuits;
- Five small plastic bags of a reddish brown sauce;
- Two small squares of vegetable lasagna wrapped in plastic;
- One fish patty in a plastic bag;
- Large opened bag of french fries;
- Large opened bag of tater tots;
- Opened bag of carrots;
- Opened bag of mixed vegetables; and
- An opened bag of broccoli.

During an interview on 03/07/18 at 11:30 AM, Staff L, Director of Dietary, stated that the frozen food items in the kitchen meal prep freezer are used quickly and staff don't usually put a date on those items. Staff L added that boxes of frozen food items in the walk-in freezer were always dated, but staff did not date the bags of frozen food if it was taken out of the box and not used.










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Based on observation, interview and record review, the facility failed to:
- Implement a fall risk care plan for four patients (#2, #3, #4 and #5) of four patients reviewed who were at risk for falls;
- Update a fall risk care plan for one patient (#10) of one patient reviewed after a patient fall; and
- Implement a skin management care plan for one patient (#1) of one patient reviewed with pressure sores (injury to skin resulting from prolonged pressure.)
These failures affect the delivery of care on all patient admitted to the facility. The facility census was 11.

Findings included:

1. Record review of facility's policy titled, "Care Planning," revised 10/24/17, showed the directives for staff to provide guidelines for initiating and the use of multidisciplinary care plans that included:
- Each patient's care is based on identified patient care needs and patient care standards and is consistent with the therapies of other disciplines;
- The care plan is to be initiated and dated by staff who is caring for the patient;
- Patient's progress is periodically evaluated against care goals and the plan of care (care plan) when indicated, then the plan or goals are revised; and
- Care plans are available within the Electronic Health Record (EHR) and are to be individualized to the patient.

Record review of facility's policy titled, "Fall Precautions," revised 01/06/17, showed the directive for staff to protect patients from any incidents of falling by identifying risk patients (magnetic leaf, yellow arm band, yellow socks) by providing a systemic approach to implementing, monitoring, and documenting in the EHR. These interventions will then be incorporated into the care plan.

2. Observation on 03/05/18 at 2:15 PM, in Patient's #5's room, showed the patient had magnetic fall leaf on the door, and did not wear a yellow arm band or yellow socks.

During an interview on 03/05/18 at 2:20 PM, Patient #5 stated that she used a cane for assistance when she walked.

Record review of Patient #5's History and Physical (H&P) dated 03/05/18, showed that she was a 56 year old female admitted to the facility on 03/04/18. She had shortness of breath for four to five days, accompanied with dyspnea (difficulty breathing on exertion), trace (small) edema (swelling) in her arms and legs and muscle weakness. She walked with moderate assistance (help from one or more staff) and a gait belt (large tightly woven belt placed around the waist of a patient to assist the patient in walking).

Record review of Patient #5's fall risk assessment dated 03/05/18 at 10:00 AM, showed that the patient was a moderate fall risk.

Record review of Patient #5's care plan on 03/05/18 at 2:30 PM showed was no care plan, interventions, or goals related to fall risk.

During an interview on 03/05/18 at 3:10 PM, Staff G, Registered Nurse (RN), stated that:
- Patient #5 was a moderate fall risk;
- The patient did not have fall risk care plan; and
- The nurse was responsible for care plan.

3. Observation on 03/06/18 at 9:15 AM, in Patient's #2's room, showed the patient had magnetic fall leaf on the door, and wore a yellow arm band and yellow socks.

Record review of Patient #2's H&P dated 03/06/18, showed that he was a 65 year old male admitted to the facility on 03/05/18. He was post-surgical (after surgery), with a left arm splint (prevents or limits movement), slurred words and his right arm was slow with jerking movement.

Record review of Patient #2's fall risk assessment dated 03/05/18 at 9:21 PM, showed that the patient was a high fall risk.

Record review of Patient #2's care plan on 03/06/18 at 9:30 AM showed no care plan, interventions, or goals related to fall risk.

During an interview on 03/06/18 at 9:45 AM, Staff G, RN, stated that if a patient was at risk for falls, the nurse should add a fall risk care plan.

4. Observation on 03/06/18 at 9:25 AM, in Patient's #3's room, showed the patient had magnetic fall leaf on the door, and wore a yellow arm band and yellow socks.

Record review of Patient #3's H&P dated 02/27/18, showed that she was a 73 year old female admitted to the facility on 02/27/18. She required oxygen at all times, was short of breath with minimal activity, and had swelling in her legs.

Record review of Patient #3's fall risk assessment dated 03/05/18 at 10:00 PM, showed that the patient was a high fall risk.

Record review of Patient #3's care plan on 03/06/18 at 9:35 AM showed no care plan, interventions, or goals related to fall risk.

During an interview on 03/06/18 at 10:00 AM, Staff D, RN, stated that Patient #3 did not have a fall risk care plan and added that the nurses were to add fall risk to the care plan if the patient was at risk for falls.

5. Observation on 03/06/18 at 9:27 AM, in Patient's #4's room, showed the patient had magnetic fall leaf on the door, and wore a yellow arm band and yellow socks.

Record review of Patient #4's H&P dated 03/06/18, showed that she was a 69 year old female admitted to the facility on 03/06/18. She had shortness of breath for two days with hypoxia.

Record review of Patient #4's fall risk assessment dated 03/06/18 at 7:30 AM, showed that the patient was a high fall risk.

Record review of Patient #4's care plan on 03/06/18 at 9:40 AM, showed no care plan, interventions, or goals related to fall risk.

During an interview on 03/06/18 at 10:00 AM, Staff D, RN, stated that Patient #4 did not have a falls risk care plan but should have.

During an interview on 03/08/18 at 11:45 AM, Staff F, Assistant Administrator, stated that if a patient was at risk for falls, the nurses should have added a fall risk care plan.

6. Observation on 03/05/18 at 3:30 PM, in Patient #10's room, showed the patient had a magnetic fall leaf on the door, and wore a yellow arm band.

Record review of Patient #10's H&P dated 11/30/17, showed that he was a 54 year old male admitted to the facility swing bed unit on 11/30/17, with minimal use of his left leg.

Record review of Patient #10's fall risk assessment dated 11/30/17 at 4:34 PM, showed that the patient was a high fall risk.

Record review of Patient #10's care plan showed no care plan related to fall risk was documented until 01/07/18.

Record review of Patient #10's medical record dated 01/29/18 at 5:27 AM, showed that he had fallen in the shower when his left knee gave out and he fell to the floor.

During an interview on 03/05/18 at 3:35 PM, Patient #10 stated that he had fallen in his hospital room shower a couple weeks ago.

Record review of Patient #10's Swing Shift Assessment dated 01/29/18 at 7:00 AM and 10:00 PM, showed that the patient did not have a fall history during this admission.

Record review of Patient #10's care plan showed that risk of falls was not updated until 02/18/18, 20 days after the patient had fallen.

During an interview on 03/06/18 at 11:00 AM, Staff F, Assistant Administrator, stated that her expectation of nursing staff was to update the care plan the day a patient event occurred, and to update the swing shift assessment if the patient was in a swing bed.

7. Record review of facility's policy titled, "Skin Assessment," revised 01/28/15, showed the directives for skin assessment, assessment of the patient's skin integrity, and the care or treatment as:
- The licensed nurse assigned to the patient is responsible for completing the wound care assessment and identifying any abnormalities in skin condition;
- The Braden Scale (scale used to determine the potential risk for skin injury or wounds) will be completed on each Patient;
- A total score of 15 or less is considered "at risk", and a care plan will be initiated addressing skin management; and
- To update the "Skin Integrity Risk" care plan every shift or as needed for the patient's condition.

Observation on 03/06/18 at 10:10 AM, showed Patient's #1, with dressing covered pressure sores on his right hip, and gluteus (buttock).

Record review of Patient #1's H&P dated 02/12/18, showed that he was a 56 year old male admitted to the facility on 02/12/18 with pressure sores on his right ischium (hip), right groin (area between abdomen and thigh) and left and right gluteus.

Even though requested the facility failed to provide Braden Scale risk assessment for Patient #1.

Record review of Patient #1's care plan on 03/06/18 at 12:35 PM, showed no care plan, interventions, or goals related to skin integrity risk.

During an interview on 03/06/18 at 12:40 AM, Staff C, Licensed Practical Nurse (LPN), stated that Patient #1 did not have a care plan for skin integrity risk, and that nurses should have added skin integrity into the care plan.

During an interview on 03/08/18 at 11:45 AM, Staff F, Assistant Administrator, stated that patients with pressure sores should have a care plan addressing skin integrity risk.




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Based on observation, interview, record review, policy review and review of the Association of PeriOperative Registered Nurses (AORN) and the Association for the Advancement of Medical Instrumentation (AAMI), the facility failed to:
- Ensure that the Sterile Processing Department (SPD, where contaminated surgical equipment and instruments were cleaned) staff followed manufacture's guidelines for enzymatic cleaner (cleaning agent) concentration when soaking contaminated surgical instruments, prior to sterilization (process that eliminates viruses and bacteria).
- Maintain a sterile (free of harmful contaminants) environment in the operating room (OR) sterile processing clean room, by eliminating the residue and debris in two large sterilizers (machines that use high heat and steam to kill harmful organisms).
- Maintain a sterile environment in the OR decontamination (dirty) sterile processing room, by leaving multiple paper products (particle shedding products that can cause contamination) and contaminated personal items in the room.
- Maintain a sterile environment in the OR sterile processing clean and dirty room, which processes instruments used in all operating room (OR) suites, by failing to terminally clean (a cleaning method used in hospitals to control the spread of infection) the area daily.
- Remove jewelry before entering the surgical area.
- Perform appropriate hand hygiene and glove use while setting up a procedure table (table where instrument are placed in preparation for surgery or a hospital procedure).
- Perform a proper Time Out (a pause by the entire surgical/procedural team to confirm the correct patient, procedure and site) before a procedure.
- Ensure that the crash cart (cart stocked with emergency drugs and equipment used in life or death situations) defibrillator (a device that delivers a shock to the heart as treatment of life-threatening cardiac dysrhythmias) outside of the OR was maintained to ensure it worked properly.
- Ensure the surgical area crash cart was locked.
These failed practices had the potential to expose all patients, visitors and staff to cross contamination and increase the potential to spread infection as well as pose hazards to outcomes in emergency situations. The cumulative effect of these failures resulted in non-compliance with 42 CFR 485.639 COP: Surgical Services. The facility census was 11.

Findings included:

1. Record review of the facility's policy titled, "High Level Scope Disinfection," dated 06/21/10, showed the directive for staff to wash the endoscopes (an instrument that can be introduced into the body to give a view of the intestinal parts) with enzymatic detergent (cleaner used specifically with surgical instruments) solution.

Record review of the facility's enzymatic detergent's manufacturer's manual, showed the directive for staff to add 1/8 - two ounces (oz., unit of measure) of enzymatic detergent to one gallon (gal, unit of measure) of water for endoscope cleaning.

Observation and concurrent interview on 03/07/18 at 8:40 AM, in the sterile processing endoscopy room, showed Staff AA, Certified Surgical Technician (CST), prepared to clean a dirty endoscope, and mixed one pump of enzymatic detergent and an unknown amount of water. Staff AA stated that she cleaned them the way she was trained and was unaware of a specified measurement of enzymatic detergent and water.

This had the potential to lead to high levels of bioburden (the number of bacteria living on a surface that has not been sterilized) remaining on the surgical instruments, which could lead to contamination, infection, or surface breakdown of the instrument.

During an interview on 03/08/18 at 12:50 PM, Staff J, Infection Preventionist, stated that it was inappropriate for staff to not follow the manufacture's guidelines for the enzymatic detergent.

2. Record review of the AORN, "Terminal Cleaning In Sterile Processing," dated 2014. showed the directive that the sterile processing rooms were to be terminally cleaned daily, the same as the operating, delivery and invasive procedure rooms.

Record review of the AAMI, "Water For The Reprocessing Of Medical Devices," dated 08/2014, showed that the sterilizer's water hardness could affect the purity of the steam used and could carry over the excessive chemicals into the steam used for sterilization.

Record review of the facility's policy titled, "Operating Room Sanitation," showed the following:
- A monthly cleaning was to be done to the sterilizers and their loading carts/carriages.
- At the end of the day's operating schedule, the sterile processing area was to be terminally cleaned.
- In addition to the terminal clean, walls and ceilings in the sterile processing areas were to be cleaned monthly.

Record review of the manufacturer's daily cleaning recommendations for the facility's main sterilizer showed the following:
- Inspect cabinetry for signs of damage or misaligned parts.
- Remove and wash the bottom shelf and trays from the chamber.
- Rinse the chamber with distilled water to remove the detergent residue.
- Dry the chamber with a lint-free cloth.
- Check and wipe clean the door gasket with a damp cloth.

Observation on 03/07/18 at 8:30 AM, showed that the inside of the main sterilizer, had residue in the front, debris in the bottom tray and dark streaks on the back wall.

Record review of the manufacturer's cleaning recommendations for the facility's back-up sterilizer showed the following:
- Clean the door gasket daily.
- Take out and clean the tray holder and trays weekly.
- Descale the chamber, copper tubes and reservoir weekly.

Observation on 03/07/18 at 8:40 AM showed that the inside of the backup sterilizer had residue throughout with dark streaks on the back wall.

During an interview on 03/07/18 at 9:50 AM, Staff AA, CST, stated that she cleaned the outside of the sterilizers and was unaware of who cleaned the inside.

During an interview on 03/07/18 at 10:50 AM, Staff Z, Director of Maintenance, stated that he had not cleaned the inside of the sterilizers.

3. Observation on 03/07/18 at 8:35 AM, in the sterile processing dirty room, showed the following items:
- Three boxes (particle shedding) with supplies;
- Roller chair (contaminated object);
- No door;
- Paper (particle shedding) on wall; and
- Purse (contaminated object) on counter.

During an interview on 03/07/18 at 9:50 AM, Staff AA, CST, stated that she was unaware that boxes, paper and her purse, should not be in the sterile processing dirty room and unaware that the room needed a door. She also stated that housekeeping mopped at night and the area had no terminal cleaning process.

During an interview on 03/07/18 at 10:55 AM, Staff Y, Director of Environmental Services, stated that he was unaware that sterile processing had to be terminally cleaned.

4. Record review of the facility's policy titled, "Hand Hygiene," revised 02/02/18, showed the directive for staff to perform hand hygiene before applying and after removing gloves.

Record review of the facility's policy titled, "Perioperative Attire," revised 02/11/11, showed directives for staff to perform the following:
- Remove jewelry.
- Gloves should be selected and worn depending on the task to be performed.
- Sterile gloves must be worn when performing sterile procedures and unsterile gloves are worn for other tasks.
- Gloves must be changed after contact with contaminated items and when the task is complete.
- Hands will be washed after removing gloves.

Observation on 03/07/18 at 8:15 AM, in OR Room 1, showed the following:
- There was no sink or hand sanitizer to wash hands.
- Staff AA, CST, set up the room for an Esophagogastroduodenoscopy (EGD, examination of the inside of the stomach using a long flexible tube with a camera) and Colonoscopy (a procedure used to evaluate the inside of the large intestine).
- Staff AA, handled the clean EGD and Colonoscopy scopes (long flexible tubes) prior to insertion in the patient's body without donning gloves.
- Staff AA, wore a surgical hat with her hair partially covered, and her ears were visible with earrings that dangled.
- A towel was placed on the procedure table and a clean EGD scope was placed on the towel. The proximal end of the scope that entered the patient's body did not fit on the towel and touched the outside of the procedure table, an unclean surface.
- Staff AA, performed a suction test on the EGD scope and noticed it was not working. Staff AA put on gloves without performing hand hygiene, touched suction canister, removed one glove, did not perform hand hygiene, and performed a second suction test on the EGD scope.

During an interview on 03/07/18 at 9:45 AM, Staff AA stated that she normally wore gloves when setting up for procedures and that she should have worn gloves and removed her jewelry.

During an interview on 03/08/18 at 11:30 AM, Staff F, Assistant Administrator, stated that she expected staff to change both gloves, perform hand hygiene and follow current policies and procedures.

During an interview on 03/08/18 at 1:30 PM, Staff J, Infection Control Preventionist stated the following:
- Staff should wash hands or foam before and after wearing gloves.
- Staff should remove both gloves, not just one glove, perform hand hygiene and don new gloves.
- He was not aware that there was no sink or hand sanitizer in OR Room 1.
- Staff should have removed jewelry.
- He does not monitor surgery.

5. Record review of the facility's policy titled, "Correct Site, Correct Procedure, and Correct Patient for Invasive or Surgical Procedures (Surgical Site Identification)," revised 02/22/13, showed directives for staff to perform the following during a "Time Out'', prior to the procedure, in the location where the procedure was to be performed:
- Suspend all other activities;
- Involve all members of the surgical team;
- Address the following standard information: correct patient identity, consent form is present and accurate, agreement on the procedure to be done;
- Verify the patient's identity with two patient identifiers (full name, date of birth, etc.); and
- Use the surgical consent form for verification.

Observation on 03/07/18 at 8:45 AM showed the following:
- Patient #12 was wheeled on a gurney into the OR by Staff Q, Registered Nurse (RN), Surgery Director, and Staff CC, Anesthesiologist;
- Staff placed a blood pressure cuff on Patient #12's arm, oxygen saturation probe (measures the amount of oxygen in the blood) on his finger and nasal cannula (plastic tubing which transports oxygen) in the patient's nose for oxygen administration;
- Staff CC, began administering anesthesia (medication used to provide relaxation or sleep and/or pain relief during surgery) into patient #12's intravenous line (IV, in the vein);
- Staff JJ, Surgeon, entered the room, put on a gown and gloves, and inserted the EGD scope into Patient #12's mouth;
- After the procedure had started, the circulating nurse, Staff Q, RN, said the patient's name and the procedure that was being done;
- The patient's identity was not verified by using two patient identifiers and the procedure was not confirmed by using the consent form for verification; and
- All activity was not suspended during the Time Out.

Record review on 03/08/18, showed that discharged Patient #14 signed a surgical consent dated 01/17/18 for an EGD. Record review of Patient #14's intraoperative record, dated 01/18/18, showed an incomplete time documented for a Time Out.

During an interview on 03/07/18 at 1:00 PM, Staff Q, Surgery Director, stated that during a Time Out, the circulating nurse announced the timeout and said the patient's name and procedure that was done, and documented the time completed on the intraoperative record.

During an interview on 03/08/18 at 11:30 AM, Staff F, Assistant Administrator, stated that her expectation during a time out was for staff to stop what they were doing, identify the patient, state the procedure being performed and that everyone was in agreement (verified right patient, right procedure, right site, etc.) before the procedure started.

6. Record review of the facility's policy titled, "Crash Carts," dated 03/06/13, showed that it was the department director or charge nurse designee's responsibility to check the crash cart on a daily basis on each shift of operation, and ensure the defibrillator functioned safely.

Observation on 03/07/18 at 9:30 AM, outside of the OR, the screen on the defibrillator, located on the crash cart, read "Readiness Test Failed."

During an interview on 03/07/18 at 9:30 AM, Staff R, OR Licensed Practical Nurse (LPN), stated that the defibrillator worked fine and maintenance had checked it.

During an interview on 03/07/18 at 9:45 AM, Staff Q, Surgery Director, stated that the problem with the defibrillator was that the pads were a different brand.

During an interview on 03/08/18 at 11:30 AM, Staff F, Assistant Administrator, stated that she felt that the nurse should have ordered the proper pads for the defibrillator.

7. Record review of the facility's policy titled, "Medication Security," revised 09/23/13, showed that crash cart drugs were to be stored in containers closed with a seal that allowed the pharmacist to determine if the package had been opened. Medication security in the ancillary departments were in locked cabinets or drawers and the responsibility for security rested with the department director or designee.

Observation on 03/07/18 at 9:30 AM showed that the crash cart was not locked in the surgical area and had not been checked that day. All drawers could be opened and medications were accessible.

During an interview on 03/07/18 at 9:30 AM, Staff Q, Surgery Director, stated that she did not know why the crash cart was not locked. Her expectation of the surgical staff was to make sure the crash cart was checked daily and locked.

During an interview on 03/08/18 at 11:30 AM, Staff F, Assistant Administrator, stated that her expectation of nursing staff was to perform crash cart checks per policy, and to make sure the crash carts were locked.












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