HospitalInspections.org

Based on observation, interview, record review, policy review, review of the United States Pharmacopoeia (USP) Chapter 797 and the review of the United States Department of Health and Human Services Food Code (USDA Food Code), the facility failed to:
- Ensure that staff followed the facility's policy and the infection prevention standards for compounded sterile preparations. (C-276)
- Ensure that staff followed infection control policies and infection prevention standards. (C-278)
- Ensure that staff followed infection control policies and infection prevention standards for food storage. (C-279)
- Follow the standards of practice and provide consistent wound care for four current patients (#6, #7, #8 and #9) of five current patients receiving wound care. (C-294)

The cumulative effect of these failures resulted in non-compliance with 42 CFR 485.635 Condition of Participation (CoP): Provision of Services. The facility census was eight.


Refer to the 2567 for additional information.

Based on observation, interview, policy review and review of the United States Pharmacopoeia (USP) Chapter 797 for compounded sterile preparations (CSPs, medications or solutions that were prepared in a way to prevent contamination), the facility failed to ensure that staff followed the facility's policy and the infection prevention standards when they failed to:
- Ensure the work area (buffer area, sterile zone in the pharmacy where CSPs were prepared) was kept uncluttered and free from particle-generating (potential contaminants) materials.
- Document and clean the buffer area on days that medications were compounded.
- Document and clean the primary engineering controls (PEC, a device that provides an environment for compounding medications) daily, and/or before processing CSP.
- Have documented growth media (test to ensure proper cleaning technique) sampling.
- Have documented proper garbing/procedure (shoe covers, hair and beard covers, mask, gown, gloves) including successful glove fingertip test (test to ensure staff who process CSPs were able to prevent contamination of the CSP).

These failed practices had the potential to increase the risk of cross contamination in CSPs that could result in patient harm and/or death, which placed all patients who received CSPs at risk. The facility performed approximately two to three CSPs per day. The facility census was eight.

Findings included:

1. Review of the USP, Chapter 797, dated 2008, showed that:
- Particle shedding objects (pencils, corrugated cardboard, paper, and cotton items) were prohibited in the buffer area.
- The buffer area floors should be cleaned daily, walls monthly, ceilings monthly, storage shelving monthly, and documented on a cleaning log.
- Document and clean the PEC daily, and/or before processing CSP.
- Sampling plans that included surface disinfection sampling (growth media requirements) were to be performed on a periodic basis, at a minimum, annually.
- Low risk compounding required proper garbing/procedures (shoe covers, hair and beard covers, mask, gown, gloves) including successful glove fingertip test.

Review of the facility's policy titled, "Compounding & Dispensing of Sterile and Non-Sterile Medication," reviewed 01/2019, showed no general operational guidelines for the disinfection of the buffer area that followed the recommended guidelines by USP Chapter 797, which were enforceable by regulation. The policy stated that records shall be maintained and quality control, including end-product testing, shall be performed when appropriate.

Observation on 10/09/19 at 10:30 AM, in the pharmacy and the pharmacy buffer room, showed the following:
- The PEC (Laminar Flow Hood, enclosed work bench which prevents contamination of medications when the medication is mixed or prepared) was housed in a separate room outside of the pharmacy (buffer area).
- In the buffer area were opened cardboard boxes (particle shedding material).
- In the buffer area was a second, out of service PEC hood, next to the functional PEC, with visible dust.
- There was visible dust and discolored cardboard containers on top of the functional PEC.
- There was visible black residue in the corners of the floor.
- There was particles of paper on the counter next to the functional PEC.

2. Record review showed there was no log that demonstrated when the buffer area and the PEC had been cleaned, and there was no documented successful glove fingertip test, garbing procedures or surface sampling of staff that performed CSPs.

During an interview on 10/09/19 at 10:50 AM, Staff T, Pharmacist, stated that he:
- Performed approximately two to three CSPs daily.
- Did not need to follow the regulations, like USP 797, because the regulations were only recommendations and not required.
- Was not familiar with growth media sampling and did not have a documented growth media sampling.
- Did not garb when performing CSPs.
- Was not familiar with gloved fingertip testing and did not have a documented successful glove fingertip test.
- Did not have a cleaning log for the buffer area.
- Did not have a cleaning log for the PEC.
- Was unaware that sampling plans should have been performed at a minimum, annually and documented.

3. During an interview on 10/09/19 at 1:10 PM, Staff Y, Housekeeping, stated that she:
- Cleaned in the pharmacy and was familiar with the buffer area.
- She did not clean the walls, shelves, or ceiling monthly.
- She would mop the floors, however, housekeeping would not mop every day because Staff T, Pharmacist, would tell them that the buffer area did not need to be mopped daily.
- She had never been educated to clean the buffer area daily for the floors, monthly for the walls, shelves, ceilings, and document on a log.

During an interview on 10/10/19 at 9:30 AM, Staff GG, Environmental Service Manager, stated that:
- He was responsible for oversight of the housekeepers.
- The housekeepers were responsible for cleaning the pharmacy area.
- He was unfamiliar with the cleaning requirements of USP 797, and had not educated staff to the cleaning requirements.
- He had not performed environmental rounds within the pharmacy.

During an interview on 10/09/19 at 11:30 AM, Staff G, Infection Preventionist, stated that all departments should follow the accepted standards of practices and current regulations to prevent cross contaminations.

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:
- Ensure outdated supplies and medications were removed from potential patient use from storage areas on one unit (Radiology) of three storage areas observed;
- Ensure the cleanliness of the Workstation on Wheels (WOW, computer, supplies, and medications on wheels) for two patients (#1 and #2) of two patients observed;
- Ensure storage areas which contained patient supplies were secured in a manner to prevent unauthorized access. This had the potential to allow unauthorized access to supplies that were used during patient care for two patient care areas (Emergency Department [ED] and Medical Unit) of two patient care storage areas observed.

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 eight.

Findings included:

1. Review of the facility's undated policy titled, "Departmental Inventory Check for Expiration Dates," showed the following directives for staff:
- It will be the policy of Samaritan Hospital for each department to conduct an inventory of the drugs and supplies to ensure all outdated (expired) items are removed from stock.
- The inventory should be conducted on the last working day of the month.
- The completed check/inventory sheet should be sent to Pharmacy for drugs and Central Supply for supplies.
- Disposal of the expired products should be according to standard practice.
- If in doubt how the products/drugs should be disposed, contact either Pharmacy or Central Supply.

Observation on 10/08/19 at 2:15 PM in the Radiology Department showed the following expired supplies:
- Barium Sulfate (used to coat the inside of the esophagus, stomach or intestines which allows them to be seen more clearly on x-ray) tablets with an expiration date of 05/2016;
- Hand Sanitizer 33.8 fluid ounces with an expiration date of 05/2014;
- Four, 18 gauge, one inch needles with an expiration date of 02/2019;
- Three packages of Injector tubing with an expiration date of 10/2015;
- A box of 60 milliliter (ml, a measurement of liquid) syringes with an expiration date of 07/2014;
- Five alcohol pads with an expiration date of 08/2014;
- 22 prefilled disposable barium enema kits with an expiration date of 08/2018;
- Five packaged 200 ml. contrast syringes with an expiration date of 01/2017;
- Test strips used to determine if the cidex solution (a high level disinfectant used to sterilize vaginal probes) was efficiently destroying microorganisms had an expiration date of 09/29/19.

During an interview on 10/08/19 at 2:30 PM, Staff M, Radiology Director, stated that staff were assigned to check for outdated supplies every month. She would expect staff to remove all outdated supplies from the department.

During an interview on 10/09/19 at 11:30 AM, Staff G, Infection Preventionist, stated that all expired supplies and medication should be removed from patient use.

2. Although requested, the facility failed to provide a policy regarding the disinfection of the WOWs.

Observation on 10/07/19 at 2:20 PM showed Staff D, Registered Nurse (RN), failed to disinfect the WOW before she entered Patient #2's room and failed to disinfect the WOW after she exited the patient's room. Staff D then left the WOW in the hallway unattended which put other staff, patients and visitors at risk of cross contamination and infection.

Observation on 10/07/19 at 2:30 PM showed Staff D, RN, failed to:
- Disinfect the WOW before she re-entered Patient #2's room;
- Remove gloves after she touched an intravenous (IV) access and before she documented on the computer located on the WOW;
- Disinfect the WOW before she touched it with her hands after hand hygiene was performed; and
- Disinfect the WOW after she exited the patient's room.

Observation on 10/07/19 at 2:35 PM, showed Staff D pushed the WOW to the Nurse's station and plugged it in where numerous staff members had the potential to come into contact with infectious material that remained on the WOW, after the WOW had been taken into a patient's room during patient care.

During an interview on 10/07/19 at 10:20 AM, Staff D, RN, stated that she had not been directed to clean the WOWs before she entered a patient's room or after she left a patient's room. Staff D stated that she would have cleaned the WOW if it had been visibly soiled.

Observation on 10/08/19 at 9:10 AM, showed Staff E, RN, failed to:
- Disinfect the WOW before she entered Patient #1's room;
- Remove gloves before she documented on the computer after she touched the patient:
- Disinfect the WOW before she touched it with her hands after hand hygiene was performed; and
- Disinfect the WOW after she exited the patient's room.

Observation on 10/08/19 at 9:50 AM, showed Staff E, then pushed the WOW to the nurse's station and plugged it in where numerous staff members had the potential to come into contact with infectious material that remained on the WOW after the WOW was taken into a patient's room and care was provided.

During an interview on 10/08/19 at 11:30 AM, Staff E, RN, stated that she was not aware of any policy or procedure that directed the staff on how and when the WOWs should be cleaned. She normally cleaned her WOW only when she started her shift.

During an interview on 10/08/19 at 11:33 AM, Staff C, Medical Surgical Unit Director, stated that there was not a policy or procedure that directed the staff on how and when the WOWs should be cleaned. The WOWs were not expected to be cleaned before staff entered a patient's room or when staff exited a patient's room.

During an interview on 10/08/19 at 11:35 AM, Staff B, Director of Nursing (DON), stated that there was not a policy or procedure that directed the staff on how and when the WOWs should be cleaned. The WOWs were expected to be cleaned only if they were visibly soiled, or the staff thought the WOW was soiled.

During an interview on 10/09/19 at 11:45 AM, Staff G, Infection Prevention Nurse and Employee Health Nurse, stated that:
- There was not a policy or procedure that directed staff on the disinfection of the WOWs.
- She expected the WOWs to be disinfected between patients.
- Computers were not to be touched with gloved hands after care was provided to a patient.

During an interview on 10/10/19 at 9:10 AM, Staff HH, Doctor of Osteopathy (DO), Chief of Staff, stated that he was unsure if there was a directive for the disinfection of the WOWs, and would have expected the WOWs to be disinfected at a minimum of once a day.

During an interview on 10/10/19 at 9:20 AM, Staff GG, Environmental Services Manager, stated that his staff had never disinfected the WOWs.

3. Although requested, the facility failed to provide a policy for the storage of sharps (devices with sharp points or edges that can puncture or cut skin), or how storage areas which contained patient supplies, were secured in a manner to prevent unauthorized access.

Observation on 10/08/19/ at 3:25 PM in the ED main storage area, showed a door with no lock to secure the storage area. The main storage area contained a suture cart (cart that contains items used to close or repair a wound) which contained items such as cautery pens (medical supply with a heated metal tip, used to control bleeding), skin staplers (stapler used on skin to close a wound) and sterile (without germs) wound dressing supplies.

During an interview on 10/08/19 at 3:50 PM, Staff JJ, RN, stated that the ED supply room door did not have a lock and was unsecured.

During an interview on 10/08/19 at 4:00 PM, Staff B, Director of Nursing (DON), acknowledged the ED storage area was unsecured.

Observations on 10/08/19 at 3:00 PM, in the unlocked Staff Supply Room located on the Medical Surgical Unit showed an unlocked wound cart that contained the following:
- One full opened box of 22 gauge one inch needles;
- One full opened box of 20 gauge one inch needles; and
- One opened box of 27 gauge one inch needles.

During an interview on 10/08/19 at 3:20 PM, Staff E, RN, stated that:
- The supply room was never locked.
- The wound cart was never locked.
- There were multiple sharps stored on the wound cart.

During an interview on 10/09/19 at 11:35 AM, Staff G, Infection prevention and Employee Health Nurse, stated that most hospitals had a secured locked area for supplies and she had wished that all areas were secured with no unauthorized access.

During an interview on 10/10/19 at 10:20 AM, Staff B, DON, stated that she expected that all needles were locked up.



37921




39562




41474

Based on observation, interview, policy review, and review of the United States Department of Health and Human Services Food Code (USDA Food Code), the facility failed to ensure that staff followed infection control policies and infection prevention standards when they failed to:
- Ensure that the dietary staff labeled ready-to-eat foods with a date to be consumed, that were prepared onsite or commercially prepared and opened, for refrigerated, frozen food, and dry storage areas .
- Ensure that expired food was not available for use for patient/staff consumption.
- Ensure patient nutrition items were stored separately from staff food preparation items in the Kitchen refrigerators.

These deficient practices placed all patients at risk for unsanitary food service and cross contamination of food. The facility census was eight.

Findings included:

1. Review of the "USDA Food Code," updated on 09/09/16, stated that a food shall be discarded if the food was not consumed before the expiration date and if it was in a container or package which does not bear a date.

Review of the "ServSafe essentials" (7th edition), showed that:
- Ready-to-eat foods that have been prepared onsite, or commercially prepared and opened, must be labeled with a used by date to be consumed.
- All food will be labeled with received by dates and used by dates from the manufacturer if in the original container.
- If foods were removed from original containers or open, the product will be appropriately labeled and dated.

Review of the facility's policy titled, "Storage," reviewed 01/2019, showed that a system of storage was set up to maintain quality of products from receiving time until use. A first in, first out system was to be followed.

Observation on 10/07/19 at 3:25 PM, in the refrigerator and freezer of the unlocked Staff Supply Room on the Medical Surgical Unit, showed the following:
- A Styrofoam cup with a plastic lid labeled "SBY 7/2-7/9".
- An container labeled "S.F. Choc PRO 8-27" in the freezer.
- Numerous undated and unlabeled popsicles in the freezer.
- A zip-lock bag of ice labeled with a patient information sticker dated 07/11/19 and timed "10:24".
- A diet Coke in the refrigerator that expired on 08/26/19.

Observations on 10/07/19 at 3:25 PM, in the cabinet above the sink of the Staff Supply Room on the Medical Surgical Unit, showed the following:
- A container that appeared to have peanut butter in it with no date or label of when it was placed in the container, or when it expired.
- Numerous packages of crackers in a drawer with no date or label of when they were placed in the drawer, or when they expired.
- A container in a cabinet labeled as a thickener (thickens the consistency of liquids to prevent choking), with no date or label of when it was placed in the container or when it expired.
- A container labeled as a protein supplement, dated 06/06/19.
- A container labeled instant breakfast with an expiration date of 08/04/13.
- A box of thickened water with a use by date of 03/28/18.
- A drawer with numerous packets of salt, pepper, creamer, sugar, equal, sweet plus, ketchup, mustard, jelly, mayonnaise, beef bouillon and syrup with no dates of when they were placed in the drawer or when they expired.

During an interview on 10/08/19 at 3:20 PM, Staff E, RN, acknowledged that there were several expired goods in the refrigerator, freezer and cabinets. Staff E stated that there would be no way to know how long the items had been in the refrigerator or cabinets, or how long they were good.

Observation on 10/08/19 at 2:15 PM in the Radiology Department storage area showed the following:
- Two clear plastic jars that contained a white powdery substance with no date, and labeled as a thickener.
- Four packets of thickener with an expiration date of 08/2019.
- A small opened box of cereal with no expiration date.
- A small unopened box of cereal with no expiration date.
- Five packets of crackers with no expiration date.

Observation on 10/08/19 at 1:50 PM, in the serving area of the kitchen, showed the following:
- Three plates of prepared hard boil eggs with no prepared by date or used by date.
- Five cinnamon rolls with no received by date or used by date.
- One honey bun cake with no received by date or used by date.

Observation on 10/08/19 at 2:00 PM, in the pass through refrigerator in the kitchen, showed the following:
- One open bag of parsley with no received by date or used by date.
- One open bottle of pancake syrup with no received by date, open date, or used by date.
- Six plates of prepared hard boil eggs with no prepared by date or used by date.

Observation on 10/08/19 at 2:15 PM, in the dry storage area of the kitchen, showed the following:
- One box of wheat cereal, open to air, with no received by date or used by date.
- One box of cook and serve cereal, open to air, with no received by date or used by date.
- Two open containers of cereal, with no received by date, open date, or used by date.
- One open bag of mash potatoes, with no received by date, open date, or used by date.
- One open bag of rice, with no opened date, or used by date.
- One open bag of spaghetti noodles, with no opened date, or used by date.

Observation on 10/08/19 at 2:52 PM, in the reach in freezer, in the kitchen, showed the following:
- Five bags of prepared bacon with no prepared by date or used by date.
- Two bags of prepared ham with no prepared by date or used by date.
- Ten prepared pork loins with no prepared by date or used by date.
- One container of meatloaf with no prepared by date or used by date.

Observation on 10/08/19 at 2:57 PM, in the dry cereal storage area of the kitchen, showed two open containers of cereal, with no received by date, opened date, or used by date.

Observation on 10/08/19 at 3:02 PM, in the south wall refrigerator in the kitchen, showed the following:
- One opened gallon of milk with no received by date, opened date, or used by date.
- One opened container of whipped toppings with no used by date.
- One tray that was labeled "employee tray" that contained a, open drinking glass with a straw, reusable water bottle that was labeled with Staff II, Dietary Aide's name, one open bottle of coffee creamer that was labeled "everyone", one caramel frosting (used by employees for snacks) and one chocolate frosting (used by employees for snacks).

During an interview on 10/08/19 at 3:05 PM, Staff II, Dietary Aide, acknowledged that the reusable water bottle with her name on the bottle belonged to her, and stated that employee foods should not be stored in areas with foods that were used for patients.

Observation on 10/08/19 at 2:35 PM, in the walk in freezer, in the kitchen, showed the following:
- One opened bag of veal with no received by date, opened date, or used by date.
- Three boneless turkey breast with no received by date or used by date.
- One opened bag of fish with no received by date, opened date, or used by date.
- Seven bags of chicken breast with no used by date.

During an interview on 10/08/19 at 3:15 PM, Staff S, Dietary Manager, stated that the staff were to follow ServSafe practices and were to label and date all foods that were stored in the dry storage area, kitchen, refrigerators and freezers. Employee foods should not be stored in patient food storage areas.

During an interview on 10/10/19 at 10:20 AM, Staff B, Director of Nursing (DON), stated that they did not use expired goods, and that she would expect if nurses found outdated foods, they would discard them or put the items on a cart to be returned to dietary.

During an interview on 10/09/19 at 11:30 AM, Staff G, Infection Preventionist, stated that all departments should follow the accepted standards of practices and current regulations to prevent cross contaminations.



39562




41474

Based on observation, interview, and record review, the facility failed to follow the standards of practice and provide consistent wound care for four current patients (#6, #7, #8 and #9) of five current patients receiving wound care, and failed to obtain physician's orders for wound treatments for two current patients (#8 and #9) of five current patients who received wound care. These failures had the potential to cause delayed wound healing and adverse outcomes for all patients receiving wound care. The facility census was eight.

Findings included:

1. Although requested, the facility failed to provide a policy regarding wound assessments.

Review of Patient #6's medical record showed that:
- She was admitted to the facility on 08/29/19 for weakness following a prolonged hospital stay.
- Patient #6 had three wounds upon admission.
- There were no wound measurements documented in Patient #6's medical record upon her admission or throughout her hospitalization (over 38 days).

Review of Patient #7's medical record showed that:
- She was admitted to the facility on 09/12/19 for status post septic (life threatening condition when the body's response to infection injures its own tissues and organs) left knee, and Amyotrophic lateral sclerosis (ALS, a degenerative disease of the nerve cells that control muscular movement).
- She had a Stage 2 pressure injury (a shallow opening in the skin with red or pink tissue, or may present as a fluid filled blister) to her buttocks.
- There were no measurements documented for the Stage 2 Pressure injury to her buttocks upon admission or during her stay (over 24 days).

Review of Patient #8's medical record showed that:
- She was admitted to the facility on 10/02/19 for a fractured left vertebrae (small bones that form the backbone) after a fall.
- The nurses applied a preventative dressing (requires a doctor's order) on the patient's buttocks to prevent skin breakdown, but there was no order for the treatment in her medical record.
- There was documentation that an adhesive dressing was placed on Patient #8's right upper arm and right lower leg on 10/07/19 and 10/06/19, but there was no physician's order for the treatment.
- There were no wound measurements in Patient #8's medical record.

Review of Patient #9's medical record showed that:
- He was admitted on 09/20/19 with a large wound on the plantar aspect (the sole of the foot) of the right foot.
- There were no written orders by a physician for wound care.
- On 10/08/19 at 9:16 AM, on the daily assessment inquiry, the nurse documented an abdominal pad wrapped with an absorbent gauze roll, was applied to the wound.
- There were no measurements of the wound documented on the admission or throughout the patients stay (over 17 days).

Observation on 10/08/19 at 1:55 PM, showed Patient #9 with a white dressing around his right foot with dark discoloration to the bandage.

During an interview on 10/08/19 at 1:48 PM, Staff E, RN, stated that:
- There were no orders for a dressing for Patient #9's right foot wound.
- If physical therapy got Patient #9 out of bed, the nurses were to have placed a dry dressing to the right foot wound.
- Nurses were supposed to document a wound assessment that included wound measurements.
- Wound clinic measured the wounds once a week.
- There were no measurements for Patient #9's right foot wound upon his admission or throughout his stay (18 days).
- If wounds were not measured, it would have been hard to have determined if they had improved or worsened.

During an interview on 10/09/19 at 11:35 AM, Staff G, Infection prevention and employee health nurse, stated that:
- Doctors must sign off on wound dressings prior to placement.
- The staff unable to initiate wound treatments without a physician's order.
- She expected wound measurements to track a wound for progression.
- She expected documented wound measurements in the nurse progress notes.
- Wound measurements should be documented at the time of a patient's admission.

During an interview on 10/09/19 at 2:15 PM, Staff AA, Medical Doctor (MD), stated that:
- Swing Bed (Medicare program in which a patient can receive acute care, then if needed, Skilled Nursing care in the same facility) patients were frequently admitted to the hospital for wound treatment.
- Wounds should be measured ideally with each dressing change.
- He would have preferred, according to guidelines, that the nurses obtained an order for dressings and wound treatments.
- Nurses were not licensed to determine the type of dressing or treatment.
- If a nurse treated a wound without an order, he would have expected the nurse to have obtained an order and then had a physician sign the order at the first opportunity.

During an interview of 10/9/19 at 2:45 PM, Staff FF, MD, stated that he would expect the nurses on the Medical Surgical Unit to have followed the same rules as the wound clinic nurses would when wounds were measured.

During an interview on 10/10/19 at 8:40 AM, Staff HH, Chief of Staff, stated that if a patient was admitted strictly for wound treatment, he expected the wound to be measured once a week. He also expected a physician's order for any dressings that were applied to wounds.

During an interview on 10/10/19 at 9:40 AM, Staff Q, Doctor of Osteopathy (DO), General Surgeon, Operating Room (OR) Director, Anesthesia Director and Wound Center Director, stated that:
- He expected wounds to have been measured weekly.
- Wound measurement was a good way to track wound progression.
- He expected physician's orders to be obtained for all wound dressings.

During an interview on 10/10/19 at 10:20 AM, Staff B, Director of Nursing (DON), stated that:
- She expected wounds to be measured weekly.
- She expected a physician's order to be obtained for wound dressings.
- There was no policy on wound measurements or wound assessments.
- There was no policy on physician's orders for wound dressings.

Based on observation, interview and policy review, the facility failed to ensure that patient medical records were protected against unauthorized access (by individuals who were not providing care for those patients) in two areas, of two areas observed in the hospital. This deficient practice had the potential to permit unauthorized individuals access to both electronic and paper medical records located in those areas. The facility census was eight.

Findings included:

1. Review of the facility's policy titled, "Confidentiality," dated 04/14/03, showed that all members of the facility workforce and all others associated with the facility were responsible for protecting the confidentiality of protected health information that was obtained, maintained, used, disclosed, heard or viewed while carrying out their responsibilities on behalf of the facility.

Review of the facility's undated policy titled, "Workstation Use Policy," showed the following:
- Employees were to assume that all computer screens could be viewed by individuals who did not have access to confidential information that might be displayed on the screen.
- Each user must log off the system if they leave the computer terminal for any period of time.
- Each department must develop a policy on hard copy printouts, including who may generate such printouts, what may be done with the printouts, how to dispose of the printouts and how to maintain confidentiality of hard copy printouts.
- All supervisors were responsible for enforcing this policy.

Review of the 2018 Association of periOperative Registered Nurses (AORN) Guidelines showed that in the surgical area patient information must be secure, held confidential and protected from unauthorized disclosure. Access to patient health information must be limited to authorized individuals based on the health care role, responsibility and function.

Observations on 10/08/19 in the nurses station of the Medical Surgical Floor, showed protected patient health information visible on unattended computer screens during following times:
- 9:35 AM;
- 10:00 AM;
- 10:59 AM;
- 1:45 PM;
- 1:50 PM; and
- 1:54 PM.

During an interview on 10/08/19 at 1:54 PM, Staff C, Medical Surgical Director, stated that her expectation was for staff to lock a computer screen (also referred to as "locked out", process by which a computer display prevents viability of patient information) when they were away from the computer.

During an interview on 10/08/19 at 3:20 PM, Staff E, Registered Nurse (RN), on the Medical Surgical Floor, stated that computer screens should be logged out and timed out at the nurse's station when they were unattended.

Observation on 10/09/19 at 11:15 AM in the Surgical Department showed two large cardboard boxes of patient charts sitting out in the open behind the nurse's station. Patient names were visible when standing at the nurse's station. Information included in the charts were names, addresses, phone numbers and insurance information. There were a total of 337 patient charts in the boxes.

During an interview on 10/09/19 at 11:20 AM, Staff CC, Surgery Director, stated that the files were left sitting out at all times. The files contained patient information used for pain management.

During an interview on 10/10/19 at 10:20 AM, Staff B, Director of Nursing, stated the following:
- Unattended computers should be locked out unless it was a code blue (emergency situation where a patient's heart or breathing has stopped, and staff quickly respond with a process specific to restore the heartbeat or breathing), a fall, or something emergent.
- She had provided education to staff to not walk away from a computer with it unlocked.
- She confirmed that unauthorized personnel went behind the nurse's station and could see confidential information.
- Paper and electronic charts should be protected from visitors and staff.
- All staff should protect health information.


39562

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:
- Eliminate the residue and debris in two sterilizers (machines that use high heat and steam to kill harmful organisms) in the operating room (OR) Sterile Processing Department (SPD, area designated to clean and sterilize [process that eliminates viruses and bacterial] instruments or equipment that are used in procedures) clean room (where sterile instruments and equipment are packaged and/or prepared for use).
- Ensure that the Endoscopy (procedure to examine the interior of a hollow organ or cavity of the body with a lighted tube with a camera) Processing Department (where contaminated endoscopy equipment and instruments were cleaned) staff followed manufacture's guidelines for enzymatic cleaner (cleaning agent) concentration when soaking contaminated endoscopy scopes and instruments, prior to sterilization.
- Maintain a sterile environment in the SPD clean room, by allowing multiple paper products (particle shedding products that can cause contamination) and a laminate worktable with peeling tape around the edges, in the room.
- Limit the areas where staff who wore surgical attire were allowed, to protect personnel, patients, and visitors, from potential sources of cross contamination.
- Ensure that an informed consent was authenticated appropriately prior to the start of the procedure for seven discharged patients (#17, #19, #20, #21, #22, #23 and #24) of eight discharged patient records reviewed.
- Ensure that a physician provided oversight of the Certified Registered Nurse Anesthetist (CRNA) and signed the preanesthesia evaluation form prior to the start of a procedure for three discharged patients (#18, #21 and #23) of eight discharged patient charts reviewed.

These failed practices had the potential to compromise the safety and health of all patients undergoing procedures at the facility. The facility performed approximately 130 procedures per month. The facility census was eight.

The cumulative effect of these failures resulted in non-compliance with 42 CFR 485.639 Condition of Participation (COP): Surgical Services.

Findings included:

1. During an interview on 10/09/19 at 10:00 AM, Staff CC, Surgery Director, stated that the department followed the AORN and the AAMI guidelines.

Review of the 2017 AAMI Guidelines showed the following:
- Sterilizers should be inspected and cleaned daily to include door gaskets (rubber seal), the chamber drain screen (screen to trap debris when water exits through the drain), the internal chamber (inside of the sterilizer), and external surfaces.
- Weekly or other prescribed inspection and cleaning should be performed as specified by the manufacturer.
- Inspection and cleaning reduce the frequency of equipment malfunction and the risk of accidental contamination of sterile items.

Review of the facility's sterilizer manufacture's manual, dated 03/26/98, showed directives for staff on a daily basis to clean the inside of the chamber and loading equipment with a mild detergent solution, rinse with tap water and dry with a lint free cloth.

Observation on 10/09/19 at 10:15 AM, in an enclosed room next to the OR suites, was a small sterilizer used for immediate use steam sterilization. The inside of the chamber had rust colored stains on the bottom and sides of the sterilizer. The tray that the sterile packages sat on, inside the chamber, had rust and debris adhered to it.

Observation on 10/09/19 at 10:30 AM, in the SPD clean room, showed one large sterilizer. The inside chamber of the sterilizer had green stains and rust colored stains on the bottom and sides of the sterilizer.

During an interview on 10/09/19 at 10:35 AM, Staff CC, Surgical Director, stated that she did not know when the last time the inside of the sterilizers were cleaned. No staff in the surgery department cleaned the sterilizers.

During an interview on 10/10/19 at 9:30 AM, Staff GG, Environmental Services Manager, stated that housekeeping wiped down the outside of the sterilizers daily. Housekeeping did not clean the inside chamber of the sterilizers. He did not keep a log of any cleaning that was done in the surgery area.

During an interview on 10/09/19 at 11:30 AM, Staff G, Infection Prevention Coordinator, stated that her expectation of staff was to clean the sterilizers following recommended AAMI guidelines and to document when the cleaning was completed.

2. Review of the 2018 AORN Guidelines showed the following:
- If endoscopes (lighted tube with a camera, used to visualize the inside of organs) are not adequately cleaned, the disinfection or sterilization process can fail and increase the possibility for transmission of infectious microorganism (bacteria or viruses, too small for the naked eye) from one patient to another.
- Manual cleaning should be performed using a cleaning solution recommended by the endo-scope manufacturer.
- Enzymatic cleaners are often recommended for cleaning flexible endoscopes and other medical devices because they help remove proteins, lipids, and carbohydrates by breaking down large molecules into smaller, water-soluble molecules that are easily rinsed away after cleaning.

Review of the facility's policy titled, "Endoscope Cleaning," reviewed 01/2019, showed that all endoscopes shall receive mechanical cleaning prior to disinfection. Flexible endoscopes shall be cleaned with a manufacturer approved enzymatic cleaner immediately following use.

Observation on 10/09/19 at 10:45 AM in the Endoscopy Processing Room, showed a sink with a container of enzymatic cleanser on the counter.

During an interview on 10/09/19 at 10:50 AM, Staff DD, Licensed Practical Nurse (LPN), stated that she had cleaned scopes before and that the ratio of enzymatic cleaner to water was six pumps (one ounce, a unit of measure) to six gallons of water. There used to be a line inside the sink that showed the six-gallon mark, but it was not there anymore. It had been a while since she had cleaned a scope, so she was unsure how other staff measured the correct amount of water.

During an interview on 10/09/19 at 10:52 AM, Staff CC, Surgery Director, stated that she did not know how staff determined the correct ratio of water and enzymatic cleaner. Her expectation of staff would be to accurately measure the amount of water and enzymatic cleaner to properly clean the scopes.

3. Review of the 2017 AAMI guidelines showed the following:
- All surfaces (floors, walls, ceilings and cabinets) should be durable, smooth and cleanable.
- Surfaces that are durable, smooth and cleanable allow for ease of cleaning and assist in preventing buildup of dirt and debris in crevices.
- The clean work area/room is used for the preparation and assembly of instruments and other items to be sterilized.
- The clean work area/room should include space for a processing table, which should be made of nonporous materials (for example, stainless steel).
- Lint and airborne particles can carry microorganisms.
- Web edged (corrugated) boxes can collect dust and debris.

Observation on 10/09/19 at 10:25 AM, in the clean work area/room of the sterile processing department, showed the following:
- A laminate countertop that was held down with clear tape, which was rough and peeling away.
- Loose papers (particle shedding) on the countertop.
- Corrugated boxes on the shelves.
- Calendar and paper (particle shedding) hanging on the wall.

During an interview on 10/09/19 at 10:35 AM, Staff CC stated that paper products and boxes should not be in the clean work area.

During an interview on 10/09/19 at 11:30 AM, Staff G, Infection Preventionist, stated that all departments should follow the accepted standards of practice and current regulations to prevent cross contamination.

4. Review of AORN "Guideline for Surgical Attire", revised 2018, showed that surgical attire may become contaminated by contact with the external environment. Changing into clean surgical attire before entering the semi-restricted area(s) decreases the possibility of contamination with microorganisms present in the external environment. In addition, microorganisms can be carried on contaminated surgical attire and transferred to a variety of external environments (e.g., home, car, community).

Review of the facility's policy titled, "Dress Code and Infection Control - Proper Clothing for the Operating Room" reviewed 01/2019, showed no directives for staff to remove non-essential surgical attire prior to leaving the restricted area to avoid cross contamination to other areas of the facility.

Observation on 10/09/19 at 12:30 PM, in the dining and the food service line area of the dietary department, showed a Certified Surgical Technician (CST) enter the area with protective lead apron (type of protective clothing that acts as a radiation shield) on. The CST walked across the dining area, entered the food tray line, where he obtained eating utensils, a food tray, and received his meal.

During an interview on 10/09/19 at 12:35 PM, Staff Z, CST, stated that he should have removed the protective lead apron prior to leaving endoscopy.

During an interview on 10/09/19 at 1:05 PM, Staff G, Infection Preventionist, stated that Staff Z should not have worn the protective lead apron into the dining area. Staff Z should have removed the protective lead apron prior to leaving endoscopy.

5. Review of the 2018 AORN guidelines showed the following requirements of informed consent:
- The date and time the patient or the patient's legal representative signed the consent document;
- The date and time and the signature of the person who witnessed the patient or the patient's legal representative signing the informed consent document; and
- The signature of the responsible health care provider who executed the informed consent discussion with the patient or the patient's legal representative.

Review of the facility's document titled, "Medical Staff Rules and Regulations," dated 11/12/08, showed the following:
- The attending physician shall be responsible for the preparation of a complete medical record for each patient.
- This record shall include evidence of informed consent.
- A written, signed, informed, surgical consent shall be obtained prior to the operative procedure except in those situations wherein the patient's life is in jeopardy.

Review of the facility's Medical Records Policy and Procedure Manual, reviewed 01/2019, showed that an informed consent signed by the patient, or if necessary his next of kin or legal guardian, shall be obtained before administration of anesthesia and performance of any surgical procedure and shall be dated and timed. The consent form shall show the name of the informant and shall be the physician.

Review of discharged Patients' #17, #19, #21, #22, #23 and #24 medical records, showed no time when the patient signed the informed consent, no date and time of the person who witnessed the patient signing the informed consent and no signature of the responsible healthcare provider who executed the informed consent discussion with the patient.

Review of discharged patient #20's medical record, showed no date and time when the patient signed the informed consent, no date and time of the person who witnessed the patient signing the informed consent, and no signature of the responsible healthcare provider who executed the informed consent discussion with the patient.

During an interview on 10/10/19 at 10:25 AM, Staff B, Director of Nursing, stated that the informed consent the facility used had a line for the date but not the time, and that her expectation of staff was to only date the informed consent.

6. Review of the facility's policy titled, "Organization of the Department of Anesthesia," reviewed 01/2019, showed that anesthesia services are provided by a group of qualified CRNAs especially trained in anesthesia.

Review of the facility's document titled, "Medical Staff Rules and Regulations," dated 11/12/08, showed that an Allied Health Professional (AHP) is an individual other than a licensed physician who functions in a medical support role to a physician or exercises independent judgement within the area of his or her professional competence and who is qualified by licensure, certification or other approval to render medical or surgical care under the supervision of a physician. AHPs are CRNAs.

Review of the facility's policy titled, "Preanesthesia Assessment," reviewed 01/2019, showed the following:
- The attending anesthetist will perform a preanesthesia assessment of each patient prior to ordering preoperative medication.
- The evaluation shall be completed prior to the patient being transferred to the operating room suite.
- The individual anesthetist is responsible for evaluating the patient preoperatively and documenting this evaluation on the appropriate form.

Review of the facility's Medical Records Policy and Procedure Manual, reviewed 01/2019, showed that a separate anesthesia record shall be prepared showing the type of anesthesia and the patient's condition throughout the operative procedure. This record shall be dated, timed and signed by the anesthetist and the surgeon.

Review of discharged patient #18's medical record, showed that a preanesthesia evaluation was performed by the CRNA on 08/20/19 at 11:00 AM, prior to the start of the procedure. Staff Q, General Surgeon, Medical Director of Surgery and Anesthesia and the physician supervising the CRNA, electronically authenticated the preanesthesia evaluation on 08/26/19, six days after the procedure.

Review of discharged patient #21's medical record showed that a preanesthesia evaluation was performed by the CRNA on 07/02/19 at 8:15 AM, prior to the start of the procedure. Staff Q, the physician supervising the CRNA, electronically authenticated the preanesthesia evaluation on 07/08/19, six days after the procedure.

Review of discharged patient #23's medical record showed that a preanesthesia evaluation was performed by the CRNA on 04/26/19 at 1:00 PM, prior to the start of the procedure. The physician supervising the CRNA signed the preanesthesia evaluation on 05/02/19, six days after the procedure.

During an interview on 10/10/19 at 10:15 AM, Staff Q stated that informed consents should be dated and timed. His normal practice was to sign the preanesthesia evaluation after the procedure.















37921