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Based on staff interview and medical record review, it was determined that the facility failed to ensure a copy of the patient's rights is provided to each patient receiving services.

Findings include:

1. Upon review of Medical Record #27 on 1/7/19, the following was noted:

a. On the "General Consent" form, a box was checked indicating that the Patient Rights notice was given to the patient.

b. There was no evidence in the medical record indicating that the Patient Rights were reviewed or given to the patient.

2. Upon interview, Staff #75 stated that he/she does not provide the patients with a copy of the Patient Right's.

3. The above findings were confirmed with Staff #76.

Based on staff interview, medical record review and review of facility documents, it was determined that the facility failed to ensure that a written consent for prescribing and administrating medication is obtained.

Findings include:

Reference: Facility policy "Medication Administration Policy, BH (Child & Adolescent Partial Hospitalization Bridgeton, Elmer, Woodbury)" states, "... VII. Medication Consent a. Prior to prescribing/administering any medication, a parent or legal guardian shall sign a consent form for the prescription/administration of medication. ..."

1. Upon review of Medical Record #28, the following was noted:

a. Patient #28 was prescribed Albuteral inhaler two (2) puffs every four (4) hours PRN (as needed) for wheezing, by Staff #87 on 11/5/18 and Strattera 40mg by mouth every AM, by Staff #87 on 1/3/19.

i. The facility failed to obtain parent or legal guardian consent.

2. Upon review of Medical Record #33, the following was noted:

a. Patient #33 was prescribed Benadryl 25mg by mouth every six (6) hours PRN agitation/aggression, by Staff # 87 on 1/7/19.

i. The facility failed to obtain parent or legal guardian consent.

3. The above findings were confirmed with Staff #87.

Based on staff interview and document review, it was determined that the facility failed to ensure that the duties of the administrator in charge was reflected in the job description of the staff member.

Findings include:

Reference 1: The facility policy and procedure, "Administrative Coverage, Twenty-Four Hours," stated, "...RESPONSIBILITY A. Administrators On-Call B. Evening, night, and weekend supervisors... C. Site administrator and Site Director of Patient Care Services... PROCEDURE A. Normal business hours (8 AM - 5 PM) 1. Hospital staff should contact the respective site's administrative office. The office secretarial staff will locate the appropriate administrative person (i.e., Site COO, Site VP of Patient Care Services or the On-Call Administrator). B. Weekends, Holidays and Evening/Night shift (5 PM-8 AM): 1. The Nursing Supervisor will serve as the "In Charge" Administrator at each facility. The Vineland nursing supervisor is also responsible for the Bridgeton campus and the first call for any site issues at that campus. 2. The "In Charge" Administrator will be responsible to act on behalf of Administration whenever the need arises. ... C. Hospital Administrator On Call: 1. A member of the administrative staff is on-call for all hospital locations as per a published schedule, and available to the "In Charge" Administrator, or others as needed..... D. Departmental Authority 1. Each department manager is responsible for the complete management of the respective department. Some managers are responsible for the departments in all locations as depicted on the organization chart....."

Reference 2: Job Description, "Nurse Manager," states,"...MAJOR FUNCTION: Responsible on a 24 hour basis for a nursing unit at one location....."

1. On 1/7/19 at 0956, during an interview, Staff #1 identified himself/herself as a nursing supervisor in charge at the facility for that day.

a. Staff #1 also identified himself/herself as the nurse manager of a medical/surgical unit within the facility.

b. Staff #1 confirmed that Nurse Managers operate as supervisors of the facility, daily, utilizing a rotating schedule.

i. Upon review of the "Supervisors IMC Elmer 12/3/18/-1/5/19" document, provided by Staff # 9, it was determined that the 7 AM-7 PM shift was assigned to Assistant Nurse Managers thirteen (13) of fourteen (14) days.

b. Staff #9 confirmed that the facility's Nurse Managers act as the "In-Charge Administrator" during the day, Monday through Friday. This was not reflected in the schedule reviewed or per Reference A.

2. Upon review of the personnel files for Staff #1, Staff #16, and Staff #50, a job description was in place titled, "Nurse Manager."

a. In three (3) of three (3) files reviewed, the job description did not indicate that a nurse manager would be required to be the acting supervisor on duty for the facility on a rotating basis.

b. In three (3) of three (3) files reviewed, there was no job description for "Nursing Supervisor."

c. In three (3) of three (3) files reviewed, there was no job description for "In-Charge Administrator."

3. Upon interview on 1/9/19 with Staff #64 confirmed that the personnel files for any of the facility's nurse managers would not contain information regarding the on-call nursing supervisory or In-Charge administrative duties required of a nurse manager.

Based on observation, staff interview, and document review, it was determined that the facility failed to ensure that orders for titrated medications were complete.

Findings include:

Reference: Facility "Medical Staff Bylaws; Structure" states, "... Titration orders may be used. All titration orders will specify the following: (a) medication name and route; (b) initial or starting rate of infusion... (c) incremental units the rate can be increased or decreased... (d) maximum rate (dose) of infusion; and (e) objective clinical endpoint for the titration..."

1. On 1/9/19, review of Medical Record #34 indicated an order for Morphine 5mg/mL "... injection, IV [intravenous], 0.4mL/hr, ...Start at [2] mg/hr, increase by [1] mg/hr every hour to a MAX of [blank space] mg/hr..."

a. This order did not contain the maximum rate or dose to be administered.

b. This finding was confirmed by Staff #117.

Based on observation, document review, and staff interview conducted on 1/8/19, it was determined that the facility failed to ensure that medications are prepared in accordance with manufacturer's package labeling.

Findings include:

Reference: Manufacturer's package insert for Omnipaque 370, 500 ml (milliliter) Pharmacy Bulk Package states, "Directions For Use: a. The transfer of OMNIPAQUE (Iohexol Injection) from the Pharmacy Bulk Package is restricted to a suitable work area, such as a laminar flow hood. b. The container closure may be penetrated only one time, utilizing a suitable transfer device and aseptic technique. ..."

1. On 1/8/19 at 2:30 PM, one (1) 500 ml (milliliter) Omnipaque, Pharmacy Bulk Package bottle, was found spiked and hanging on an IV (intravenous) pole in the CT (Computerized Tomography) Room labeled "1/8 , 11:00 AM (indicating the preparation time) and initials of preparer."

a. The use of a Pharmacy Bulk Package for multiple doses in the CT Room is not in accordance with manufacturer guidelines as indicated in the above reference.

Based on observation, staff interviews, and document review, it was determined that the facility failed to ensure the implementation of policies and procedures that address the control and distribution of drugs and biologicals from the Omnicell, an Automated Medication System (AMS).

Findings include:

Reference: Facility policy titled "Automated Medication Systems" states, "...Monitoring. Several components of AMSs will be routinely monitored to ensure accurate delivery of medications. These functions will be performed in conjunction with the monthly Nursing Station Inspections. These include: a. Correct bin is electronically selected by the AMS when entered by the User; b. Correct medications in the AMS bin; c. Correct strength of the medication is in the AMS bin; d. Controlled substance balances are correct... If a discrepancy in inventory is observed, that level will be corrected and immediately resolved..."

1. On 1/8/19 at 11:25 AM in the Post Anesthesia Care Unit, the Omnicell on hand quantity indicated that there was one (1) vial of Humulin R located in the refrigerator.

a. Upon further review, it was determined there was no Humulin R in the Omnicell refrigerator.

b. Upon interview, Staff #26 stated that the Humulin R may have been removed from the Omnicell refrigerator incorrectly.

c. This finding was confirmed by Staff #25 and Staff #26.

2. On 1/9/19 at 10:30 AM in the Emergency Department Medication Room, two (2) of four (4) Omnicell pockets audited, did not have the correct quantity of medications on hand.

a. The above finding was confirmed with Staff #16.

3. On 1/9/19, review of Medical Record #34 and the Omnicell Transaction by Patient Report, indicated that "Morphine PCA 5mg/mL 20mL INJ" was administered and wasted appropriately, but there was no evidence of the removal of the medication from the Omnicell.

a. The facility could not provide evidence of the removal of the Morphine PCA 5mg/mL from the Omnicell for Patient #34.

b. The above finding was confirmed with Staff #117.

Based on observation and staff interview, it was determined that the facility failed to ensure all drugs were kept in locked storage areas.

Findings include:

1. Upon tour of the outpatient wound care center on 1/8/19, the following was noted:

a. There was an unlocked metal cabinet in the hallway, outside of the patient treatment rooms.

i. The unlocked cabinet contained multiple topical medications used for wound care.

2. The above finding was confirmed with Staff #44.

A. Based on observation, staff interview, and document review, it was determined that the facility failed to ensure implementation of policies and procedures that address storing medications according to manufacturer's instructions.

Findings include:

Reference #1: The manufacturer's package insert for Bacitracin for injection 50,000 units states, "Store the unreconstituted product in a refrigerator 2° to 8°C (36° to 46°F)."

Reference #2: Facility policy titled " Medication area Inspection" states,"... Drugs shall be stored at appropriate temperatures ..."

1. On 1/8/19 at 10:30 AM, in the sterile hallway outside of Operating Room #2, one (1) vial of Bacitracin for injection 50,000 units was found stored in a cabinet at room temperature, not refrigerated as required by the manufacturer. The time the Bacitracin was removed from the refrigerator could not be determined.

a. The above finding was confirmed with Staff #25, Staff #26, and Staff #57.

2. On 1/8/19 at 11:25 AM in the Post Anesthesia Care Unit (PACU), Staff #30 was observed returning medication to the Omnicell.

a. Staff #30 removed two (2) vials of Bacitracin for Injection 50,000 units from his/her scrubs and returned the medication to the refrigerator.

b. Staff #30 confirmed that the two (2) vials of Bacitracin for Injection 50,000 units were removed from the refrigerator and stored at room temperature for the orthopedic case he/she just completed, but were not needed.

c. Staff #25 and Staff #26 confirmed this finding.

B. Based on observation, staff interviews, and document review, it was determined that the facility failed to ensure the development and implementation of policies and procedures that address the beyond use dating of glucometer test strips.

Findings include:

Reference: The manufacturer's instructions for use for the StatStrip glucometer test strips states, "... Once opened, the StatStrip Glucose Hospital Meter Test Strips are stable for 180 [one-hundred eighty] days or until the expiration date, whichever comes first."

1. On 1/8/19 at 10:00 AM in the Preoperative area, an opened container of StatStrip glucometer test strips was found open and in use, without a beyond use date written on the label.

a. Staff #60 could not determine the date in which the container was opened, or the beyond use date.

b. Upon interview, Staff #60 stated that the opened test strips would expire on the manufacturer's expiration date printed on the package, not one-hundred eighty (180) days after opening, as per the manufacturer's instructions.

c. This finding was confirmed by Staff #26, Staff #57, and Staff #60.

2. On 1/8/19 at 1:40 PM, in the Intensive Care Unit (ICU), an opened container of StatStrip glucometer test strips was found open and in use, without a beyond use date written on the label.

a. Staff #48 could not determine the date in which the container was opened, or the beyond use date.

b. Upon interview, Staff #48 stated that the test strips expire sixty (60) days after they are opened.

c. This finding was confirmed by Staff #48 and Staff #117.

3. On 1/8/19, the facility was unable to provide a policy and procedure that addressed the need to indicate a beyond use date on opened StatStrip glucometer test strips.

Based on staff interviews and document review, it was determined that the facility failed to ensure the development and implementation of policies and procedures that address automatic stop orders for drugs and biologicals not specifically prescribed as to time or number of doses.

Findings include:

Reference: Facility policy titled "Automatic Stop Orders for Medications" states, "...The following drugs and categories shall posses automatic stop orders as follows: Injectable Narcotics (CII'S) excluding infusions... 3 days; Intrathecal Infusions... 5 days; Antibiotics: Azithromycin IV/PO ... 6 days; The following drug must be re-ordered as per protocol (in order sets): Albumin, Antineoplastics, Epidural..., Heparin/Agatroban infusions, ...Opiates infusions, TPN/PPN/Procalamine, 3% NaCl, Warfarin..."

1. On 1/9/19, review of the "Automatic Stop Orders for Medications" policy, indicated that there were no automatic stop orders in place for all medications and biologicals.

2. On 1/9/19 at 11:35 PM, the above finding was confirmed with Staff #117.

Based on staff interviews and review of facility documents, it was determined that the facility failed to ensure the development and implementation of policies and procedures that address the reporting of controlled drug losses to the appropriate authorities.

Findings include:

1. On 1/9/19, the facility was unable to provide a policy that addressed the need to report possible or confirmed Controlled Dangerous Substances (CDS) losses to the appropriate authorities within the designated timeline.

2. On 1/9/19 upon interview, Staff #117 could not provide the list of authorities the facility is required to report suspected or actual CDS losses to.

Based on observation and staff interview conducted on 1/8/2019, it was determined that the facility failed to ensure compliance with Federal requirements for food and dietary personnel as well as food service standards, laws and regulations. The governing authority failed to ensure that the Food Service Director provided oversight for the department on a daily basis.

Findings include:

1. The facility failed to ensure that the Director of Food & Nutrition Services provided effective daily management of the Food Service Department in accordance with Federal, State, and Local Regulations.
(Refer to Tag A 619 and Tag A 620)

A. Based on observation, document review and staff interview, it was determined that the facility failed to ensure that specific food and dietetic service organization requirements are met.

Findings include:

Reference #1: The facility policy and procedure titled "Test Trays (Food & Nutrition)" states, "...I. POLICY: it is the policy of the Food and Nutrition Department to conduct tray assessments on a regular scheduled basis. ...III. RESPONSIBILITY: It is the responsibility of the Food and Nutrition Director, Production Manager, and/or Supervisors to establish tray assessment study dates, implement the procedure, compile the results and assist in developing the corrective action plan. ..."

Reference #2: The facility policy and procedure titled, " Meal Rounds (Food & Nutrition) states, "...I. POLICY: It is the policy of the department to conduct timely meal rounds to view patient acceptance and consumption of food trays. ..."

1. Upon request, Staff #38 was unable to provide evidence that the dietetic management established tray assessment study dates or implemented the procedure in 2018 or 2019.

a. Upon interview Staff #38 stated that dietetic management does not document the results of test trays.

i. A blank test tray assessment form was provided by Staff #94 on 1/9/19. Staff #94 stated that the facility use to conduct meal tray assessments, however have not conducted test trays in over a year that he/she can remember.

2. Upon request, Staff #38 was unable to provide evidence that meal rounds were conducted in 2018 or 2019.

a. During interview, Staff #38 stated that the dietetic services does not document results of meal rounds. Staff #38 was unable to provide information regarding the time meal rounds are conducted.

3. The above findings were confirmed with Staff #38, Staff #39 and Staff #94.

B. Based on observation and staff interview, it was determined that the Food and Nutrition Department failed to provide oversight to the outpatient Children's Partial Program.

1. The facility has an outpatient Children's Partial Program, were food is served from the Main Kitchen for lunch.

a. Upon interview, Staff #38 stated that the dietetic services or management, does not check test trays, conduct meal rounds or provide menu modifications for food allergies for the outpatient Children's Partial Program.

2. The above findings were confirmed with Staff #92.

Based on observation, staff interviews, facility document review, the New Jersey State Sanitary Code, Sanitation in Retail Food Establishments and Food and the Beverage Vending Machines (N.J.A.C. 8:24), it was determined that the facility failed to ensure that the Food Service Director conducted daily management of the Food Services Department.

Findings include:

Reference #1: Food Service Director position description states, "...MAJOR FUNCTION: Plans, directs, organizes, coordinates all food service and clinical nutritional services at all South Jersey Hospitals. ...17. - Ensures compliance with federal, state, local, and voluntary regulatory agencies, e.g. NJ DHHS, JCAHO, CAP, NRS, etc..30. Provides Coordination of Services Within the South Jersey Hospital System to provide Optimal Food Service and Clinical Nutritional Support to Internal and External Customers and Patients. ..."

Reference #2: N.J.A.C. 8:24-4.8(k) (l) states, "A test kit or other device that accurately measures the concentration in mg/L of sanitizing solutions shall be provided. 8:24-4.8(i) states, "Concentration of the sanitizing solution shall be accurately determined by using a test kit or other device. ...Concentration of the sanitizing solution shall be accurately determined by using a test kit or other device. ..."

Reference #3: County Department Health and Human Services retail Food inspection report of 11/1/2018 states, "...NJAC 8.24 4.81 Sanitizer level in compartment sink is low. ..."

Reference #4: N.J.A.C. #8:24-6.5(b) states, "The physical facilities shall be cleaned as often as necessary to keep them clean. ..."

Reference #5: N.J.A.C. 8:24-4.5(a) states, "The Equipment and equipment components shall be maintained in a state of repair and condition that meets the requirements specified under N.J.A.C. 8:24-4.1 and 4.2."

Reference #6: N.J.A.C. 8:24-6.5(f) states, "After use, mops shall be placed in a position that allows them to air-dry without soiling walls, equipment, or supplies."

Reference #7: The facility policy and procedure titled, "Dating, labeling, and Storage of Foods, Chemicals, and Supplies (Food & Nutrition)" states, "...III. To prevent spoilage and maintain fresh, wholesome, high quality products at all times. ...Ensures compliance with Regulatory Agencies. ...Perishable Food Storage: 1. Perishables must be stored on shelves 12" from the floor (but less than 10" from ceiling) in designated walk - in refrigerators/freezers. Additionally, can goods, boxes, etc. will not be stored on the floor. ..."

1. Upon interview, Staff #38 stated that he/she is present one (1) day per week at the facility. Staff #38 does not provide day to day management of the Food Service Department. (Refer to Reference #1)

2. Upon tour of the Main Kitchen Ware Washing area on 1/8/19, the following was observed: (Refer to Reference #2 and #3)

a. The facility had a three (3) compartment sink for manually washing pots and pans. The facility failed to monitor the concentration of the sanitizing solution.

i. Upon interview Staff #38 stated that the facility did not wash pots in the three-compartment sink as food was cooked in small batches, eliminating the need for using large pots and pans.

ii. Staff #38 stated that the small pots and pans used for cooking were washed in the main ware washing machine, therefore there was no need to use the sanitizing solution.

3. Upon tour of the Main Kitchen Ware Washing area on 1/9/19, the following was observed:
(Refer to Reference #2 and #3)

a. Staff #95 stated that he/she was the designated pot washer and he/she washed pots and pans in the three-compartment sink daily.

i. Staff #95 was unsure of the amount of water level needed in the sink or the amount of sanitizer to be used.

ii. Staff #95 stated that he/she does use the test kit to measure the sanitizing solution concentration.

iii. Upon request, Staff #95 was unable to provide a log for checking the pot washing sanitizing solution concentration.

4. During a tour of the Main Kitchen on 1/8/19, the following observations were noted:
(Refer to Reference #5 and #6)

a. One (1) broom and two (2) mops were placed on the floor, (not in a position to allow for air drying), in the pathway from the kitchen to the cafeteria.

b. The gaskets to the food warmer had brown gray debris, preventing a tight seal.

c. The basement storage area had three (3) boxes close to the ceiling and touching a ceiling pipeline, four (4) cardboard boxes on the floor, filled with paper products, and several boxes of paper products on storage racks less than two (2) inches from the ceiling.

5. Upon tour of the facility, the following was observed:
(Refer to Reference #4 and #7)

a. The refrigerator in the Cafeteria had a packet of pepper-jack cheese, opened 12/19/18, with no use by date label.

b. The pantry on Unit 2 East, had a container of Thick n Easy (food thickener) which had an expiration date of 1/4/18.

c. The pantry on Unit 2 South, had a container of Thick n Easy (food thickener) which was opened on 12/5/18, with no use by date.

i. The microwave located in the pantry on Unit 2 South, was visibly dirty with food particle residue on the inside. The microwave had an inspection sticker date of 10/14/15.

ii. Upon interview, Staff #50 stated that the nurses aides and housekeeping staff are responsible for cleaning the pantry area.

d. The pantry in the ICU had an open container of Thick n Easy (food thickener) with no label or expired date.

i. In the ICU pantry, there was a water bottle which contained a creamy white substance. There was a label with a patient name and dated 11/22/18.

ii. Upon interview, Staff #49 stated that the patient had been discharged.

e. Upon request, the facility was unable to provide evidence of a policy and procedure for the labeling of food products.

6. The above findings were confirmed with Staff #36, Staff #38 and Staff #39.

A. Based on observation and staff interview on 1/8-1/9/18, it was determined the facility failed to ensure that a safe and sanitary environment is maintained for patients, staff and the general public.

Findings include:

1. During tours conducted on 1/8/19 and 1/9/19, the following were noted:

a. The doors to all of the operating rooms in the surgical suite had surface damage and exposed uncleanable wood-like base material.

b. The three (3) surgical scrub sink alcoves located off the restricted hallway exhibited wall and floor surface damage which would prevent cleaning.

c. Open, exposed, non-cleanable surface seams, were found on the monolithic flooring within the clean and dirty-side processing rooms.

d. The floor surface inside the 'dirty side' processing room, was worn and stained with a black-like substance, particularly near the ultrasonic cleaner.

e. The supply cart located within OR #3 had a rust-like substance and uncleanable exposed base material on its surface.

f. The spray fireproofing applied to the ceiling in the lower level kitchen store room was detached, allowing fibrous material to infiltrate the area.

g. Wall surface damage was found in the dishwashing room and slop-sink niche, next to the kitchen exterior exit.

2. The above findings were confirmed with Staff #110.


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3. Upon tour of the emergency department (ED) on 1/7/19, the following was noted:

a. A cabinet was located in a space in between the double doors of the ambulance entrance, which contained clean linens for use by the emergency medical service (EMS) squads.

i. The lower shelf of the cabinet was visibly dirty with dust, dirt, and debris.

ii. Upon interview with Staff #16 and Staff #17, both were unable to provide a name or department of whom was responsible for the cleaning and upkeep of the area.

iii. The above finding was confirmed with Staff #16 and Staff #17.



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4. Upon tour of the surgical suite on 1/8/19, the following were noted:

a. There were stickers, tape, and adhesive residue in multiple locations, including:

i. the cabinets at the nurses' station, located in the sterile hallway

ii. the anesthesia Omnicells, located in OR #2 and OR #4

iii. the cabinets in the Endoscopy Procedure Room

iv. the airway cart in the sterile hallway

5. The above findings were confirmed with Staff #26 and Staff #57.



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B. Based on staff interview and facility document review, it was determined that the facility failed to ensure that equipment is cleaned in accordance with manufacturer's instructions.

Findings include:

Reference: The user manual for the Hydrocollator states, "... The tank should also be drained, cleaned, and inspected at minimum intervals of every two weeks."

1. Upon tour of the Woolwich Sports Rehab Care outpatient facility on 1/7/19, the following was noted:

a. The Hydocollator contained a brownish colored residue on the interior of the lid and white and brownish residue around the inside perimeter of the opening of the machine.

i. Upon interview, Staff #74 stated the Hydrocollator is drained and cleaned once per month.

2. The above findings were confirmed with Staff #76.

Based on observation and staff interview on 1/9/18, it was determined the facility failed to ensure that the water distribution system within the building is properly maintained and held in good order.

Findings include:

1. Upon tour of the facility on 1/9/19, the following were noted:

a. The emergency eyewash within the dirty-side processing room was not connected to a drain. There would be no means of disposing of it's wastewater once generated.

b. The metal cover for the pot washing sink grease trap was found lifted from its base creating a source of possible contamination within the kitchen area.

2. The above findings were confirmed with Staff #110.

Based on observation, staff interview and facility document review, it was determined that the facility failed to ensure the provision of a sanitary environment to avoid sources and transmission of infections and communicable diseases, and failed to ensure an adequate Infection Control Program that seeks to minimize infections and communicable diseases.

Findings include:

1. The facility failed to ensure that multi-dose containers accessed in an immediate patient care area were used for one patient and immediately discarded. (Refer to Tag A 749)

2. The facility failed to provide a functional and sanitary environment by adhering to professionally acceptable standards. (Refer to Tag A 749)

3. The facility failed to follow and implement nationally recognized infection control guidelines. (Refer to Tag A 749)

4. The facility failed to ensure that the person or persons designated as infection control professionals implemented policies and procedures governing control of infections and communicable diseases and addressing the responsibility of the Infection Control Committee. (Refer to Tag A 748)

Based on observation, staff interview and facility document review, it was determined that the facility failed to ensure that the person or persons designated as infection control professionals implemented policies and procedures governing control of infections and communicable diseases and addressing the responsibility of the Infection Control Committee.

Findings include:

Reference: Facility policy titled "Infection Control Committee, Responsibility of, INF.3 ADM. 031" states, "I. Policy A. ...The Infection Control Committee is a multi-disciplinary Committee whose goal is to facilitate quality patient care and help maintain a safe hospital-wide environment through its surveillance, prevention and control activities. B. ...5. Review and approve policies and procedures related to infection prevention and monitoring activities in all departments. ...These include, but are not limited to: a. Procedures related to asepsis, sanitation, disinfection and isolation. ...6. Provide consultation regarding the purchase of all equipment and supplies used for sterilization, disinfection, and decontamination purposes. In addition, cleaning procedures, agents, and schedules in use throughout the hospital are reviewed/approved. ..."

1. Upon request, a copy of the hospital approved cleaning and disinfecting agents was requested.

a. An untitled document without letter head was received that listed eight (8) cleaning and disinfecting agents. There was no evidence provided that these agents had been approved and/or reviewed by the infection control committee and professionals.

2. Upon tour of the Endoscope Reprocessing area, Staff #106 stated that Medline Single Detergent Enzymatic solution is a cleaning solution for soiled endoscopes and Cidex OPA solution is a disinfectant for soiled endoscopes.

3. Upon tour of the Emergency Department, Staff #107 stated that the room is cleaned and disinfected using PDI Super Sani Germicidal Disposable wipes.

4. The Medline Single Detergent Enzymatic solution, PDI Super Sani Germicidal Disposable wipes and Cidex OPA disinfectants were not listed on the document provided of the hospital approved cleaning and disinfecting agents.

5. The above findings were confirmed with Staff #100.

6. Review of the Endoscope Reprocessing Device, Medivator Disinfectant and the Filter Change Log sheet dated year 2018, revealed that water filters for 1 micron and 0.45 micron were changed last on 8/30/17 and on 1/22/2018.

a. There was no evidence that the water filters were changed every 3 months, as indicated by the manufacturer of the device.

7. Review of the 2017 Infection Prevention and Control Annual Program Evaluation and 2018 plan indicated that the goals for 2018: " ...To decrease the device related infection rate throughout the facilities."

a. Upon interview, Staff #24 confirmed that there was no oversight of the quality assurance monitoring for the endoscope reprocessing.

8. The above findings were confirmed with Staff #24 and Staff #100.

A. Based on observation and staff interview, it was determined that the facility failed to ensure that enteral tube feedings are prepared and administered according to manufacturer's directions.

Findings include:

Reference #1: Abbott Laboratories product information for Osmolite 1.5 Tubefeeding states, " ...Ready-To-Hang Container ..All liquid medical foods, regardless of type of administration system, require careful handling because they can support microbial growth. Follow these instructions for clean technique and proper setup to reduce the potential for microbial contamination. NOTE: Failure to follow the instructions for Use increase the potential for microbial contamination and reduces hangtime. DO NOT touch any part of the container or feeding set that comes into contact with the formula. ..."

Reference #2: The facility document titled, "Lippincott Procedures - Enteral tube feeding, gastric" states, " ...Visually inspect the enteral feeding formula for damage to the container...Compare the label on the enteral feeding container with the order in the patient's medical record. ...If using a closed system, open the enteral administration set tubing. ...Make sure that the enteral formula container is labeled with the patient's identifiers; formula name (and strength if diluted); date and time of formula preparation; date and time the formula was hung; administration route, rate of administration; administration duration(if cycled or intermittent); initials of who prepared, hung, and checked the enteral formula against the order; expiration date and time; closing weight; and notation "ENTERAL USE ONLY"

1. On 1/8/19, during a tour of the ICU, the following was noted:

a. Upon interview, Staff # 49 confirmed that Patient #10 had an enteral feeding infusing that was unlabeled and another unlabeled enteral feeding bag infusing water.

b. During interview, Staff #49 stated that he/she had opened the closed Ready-To-Hang tubefeeding container and poured the formula into the unlabeled enteral feeding bag.

i. During interview, Staff #49 stated there was an issue with the tubing and the tube-feeding pump, therefore the formula was transferred to an enteral feeding bag.

2. The above findings were confirmed with Staff #39.

3. On 1/9/19, during a tour of the ICU, the following was noted:

a. Upon interview, Staff #49 confirmed that Patient #10 had an enteral feeding infusing, in the Ready-To-Hang container, and another unlabeled enteral feeding bag infusing water.

4. During interview, Staff #48 stated that the facility uses "Lippincott Procedures" as a reference regarding the hanging of enteral feedings.

5. On 1/8/19, one (1) bottle of Pulmocare was found in the cabinet with an expiration date of 10/18. It was available for patient use.

6. The above finding was confirmed with Staff #36.



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B. Based on observation, staff interview and facility document review, it was determined that the facility failed to ensure that multi-dose containers of medications, that are accessed in the immediate patient care area, are discarded immediately after single patient use.

Findings include:

Reference: CDC guidelines for multidose vials website: http://www.cdc.gov/HAI/setting/outpatient/checklist/outpatient-care-checklist-observations.html>, titled "Infection Prevention Checklist for Outpatient Settings: Minimum Expectations for Safe Care" states, " ...Multi-dose vials to be used for more than one patient are kept in a centralized medication area and do not enter the immediate patient treatment area (e.g,. operating room, patient room/cubicle) (Note: If multi-dose vials enter the immediate patient treatment area they should be dedicated for single-patient use and discarded immediately after use.) ..."

1. During an observation, one (1) bottle of Omnipaque 350, 500 ml (milliliter) was found spiked and hanging on an IV (intravenous) pole in the immediate patient treatment area in the CT room.

2. Upon interview, Staff #108 stated that the bottle of Omnipaque 350 was prepared in the CT room on the morning of 1/8/19 at 1100 and administered for multiple patients throughout the day.

a. Omnipaque 350 is labeled "pharmacy bulk package." The package insert of Omnipaque 350 states, " ...Directions For Use: a. The transfer of OMNIPAQUE (Iohexol Injection) from the Pharmacy Bulk Package is restricted to a suitable work area, such as a laminar flow hood. b. The container closure may be penetrated only one time, utilizing a suitable transfer device and aseptic technique. ..."

3. Review of the facility policy and procedure titled "Multi-Dose vials/Containers" failed to address accessing multi-dose containers/vials in the immediate patient treatment area.

4. The above findings were confirmed with Staff #5, Staff #6 and Staff #7.

This finding resulted in an Immediate Jeopardy which immediately curtailed this practice. The Immediate Jeopardy was removed on 1/9/19, the day of survey, upon receipt of an acceptable plan of correction.

C. Based on observation, staff interview, and facility document review, it was determined that the facility failed to ensure implementation of policies and procedures addressing the monitoring of the endoscope storage cabinet.

Findings include:

Reference: Facility policy titled "Endoscopy Drying Cabinets" states, " ...Procedure: ...C. Drying Cabinet Process Monitoring: 1. Humidity Indicator Strips a. Monitoring will be done once every 24 hours, Monday-Friday ... b. Results will be recorded on the Humidity Recording Sheets. ..."

1. Review of the Endoscopy Drying Cabinet Log Sheet, dated 11/1/18 to 1/8/19, included initials of staff members.

2. Upon interview, Staff #109 stated he/she initialed the log indicating he/she checked the humidity card and that the endoscopes were tagged and dated.

a. There was no evidence documented on the log of the Humidity Indicator strip results.

D. Based on observation, staff interview, and facility document review, it was determined that the facility failed to ensure implementation of policies and procedures addressing endoscope reprocessing guidelines.

Findings include:

Reference #1: Facility policy titled "Endoscope Reprocessing Guidelines" states, " ...3. Manual Cleaning: ...a. Fill the sink with fresh water and appropriate amount of enzymatic detergent. b. Dilute and use according to the detergent manufacturer's instructions. ..."

Reference #2: The manufacturer's instructions for use for Medline Single Detergent Enzymatic solution states, " ...use 1 oz (ounce) of concentrated solution per gallon (3785 milliliter) of water. ..."

1. During an observation in the Endoscope Decontamination area on 1/8/19, Staff #106 stated for manual cleaning of an endoscope, he/she fills water to the black line in the sink, which is five (5) Gallons, and adds five (5) pumps of Medline Single Detergent Enzymatic solution to the water.

a. There was no indication to ensure that one pump equaled one (1) ounce of enzymatic solution.

b. Tubing was found attached to the Scope Buddy (an automated flushing aide) in a container containing a blue colored liquid.

i. Upon interview, Staff #106 stated that the blue colored solution was a mixture of 1200 ml (milliliters) of water and 1 pump of Medline Single Detergent Enzymatic solution.

ii. Staff #106 stated that the dilution should have been 1 pump to 2000 ml of water, instead of 1200 ml of water.

iii. The facility failed to ensure that the manufacturer's instructions for use for Medline Single Detergent Enzymatic solution are followed as referenced above.

2. On 1/9/19, Staff #109 stated he/she would mix seven (7) squirts of the Medline Single Detergent Enzymatic solution to five (5) gallons of water when he/she manually cleans a soiled endoscope. When asked if one (1) squirt was equal to one (1) ounce of the enzymatic detergent solution, Staff #109 did not know the answer.

3. The above findings were reviewed with Staff #24 and Staff #100.

Reference #3: Facility policy titled "Endoscope Reprocessing Guidelines" states, " ...8. Storage: a. Store in Custom Ultrasonic Cabinets. Endoscopes have a maximum storage time of 14 days. At this time, any endoscope in storage must be reprocessed. c. Store with scope protectors on tip of scope to prevent scope from touching the bottom of the cabinet with caps, valves and other detachable."

Reference #4: Society of Gastroenterology Nurses and Associates (SGNA), Standards of Infection Prevention in Reprocessing Flexible Gastrointestinal Endoscopes 2016 states, "...Endoscope Reprocessing Protocol ...9. Storage...Key considerations in storage include: ...d. Each facility should determine a method of documentation and traceability to the endoscope and reusable accessories..."

1. During an observation of the Procedure Room on 1/8/19, it was noted that an endoscope was tagged and dated 12/21/18. Upon interview, Staff #24 stated that the date indicated the day the endoscope was reprocessed.

a. The endoscope storage time exceeded the 14 day limit.

2. In the endoscope cabinet, each endoscope was not stored together with caps, valves, and other detachable's. Endoscope accessories were contained in a separate plastic container in the endoscope cabinet.

3. The above finding was confirmed with Staff #100.

4. In the endoscope cabinet, it was noted that endoscopes were stored with a gray colored sponge on the tip of each endoscope, potentially contaminating the endoscope.

a. Upon interview, Staff #24 and Staff #109 confirmed that the sponge is a cleaning tool for endoscopes, and was not aware that the sponge was also utilized as an endoscope tip protector.

Reference #5: Facility policy titled "Endoscope Reprocessing Guidelines" states, " ...9. Documentation b. Maintain Scope Buddy, Ultrasonic sink daily Quality Assurance log. c. Maintain Medivator disinfectant and filter logs. ..."

Reference #6: Facility policy titled "Cidex OPA Instructions/Use" states, " ...Procedure: Gowns, Gloves, goggles must be worn when coming into contact with Cidex OPA Solution. Mask or respirator is available if needed. A. Daily Test 1. Completion of the daily log sheet which includes; date, date test strips opened, date test strips discarded, lot number on test strips, pass or fail, temperature, changing of water container, container numbers, initials. B. Before Every Use ...5. Cidex OPA Solution may be used for up to 14 days. ..."

1. Review of the Medivator disinfectant and filter log sheet for the year of 2018, revealed the following:

a. On 2/28/18, the Cidex OPA solution (disinfectant) was changed. It is documented that the next change of the disinfectant occurred on 4/2/18, 19 additional days more than the allowable 14 days of use.

b. On 5/14/18, the Cidex OPA solution was changed. It is documented that the next change of the disinfectant occurred on 6/13/18, 16 additional days more than the allowable 14 days of use.

c. On 6/27/18, the Cidex OPA solution was changed. It is documented that the next change of the disinfectant occurred on 7/17/18, which exceeds by 6 additional days than the allowable 14 days of use.

d. On 9/12/18, the Cidex OPA solution was changed. It is documented that the next change of the disinfectant occurred on 9/28/18, 2 additional days more than the allowable 14 days of use.

e. On 10/24/18, the Cidex OPA solution was changed. It is documented that the next change of the disinfectant occurred on 11/26/18, 18 additional days more than the allowable 14 days of use.

f. On 11/26/18, the Cidex OPA solution was changed. It is documented that the next change of the disinfectant occurred on 12/18/18, 8 additional days more than the allowable 14 days of use.

2. The Disinfectant and Filter log sheet, dated 2018, indicated that the water filters for 1 micron and 0.45 micron is to be changed if the pressure is below 40 PSI or every 3 months. It is documented that the water filters were changed on 1/22/18. There is no evidence that the water filters for 1 micron and 0.45 microns, were changed since 1/22/18.

3. The Disinfectant and Filter log sheet, dated 2018, indicated that the water filter for 0.2 micron is to be changed every 6 months. It is documented that water filter was changed on 1/22/18. There is no evidence that the water filter for 0.2 microns, were changed since 1/22/18.

4. The Disinfectant and Filter log sheet, dated 2018 indicated that the air filter is to be changed every 3 months. It is documented that the air filter was changed on 2/28/18 and 6/27/18, 29 additional days more than the allowable 14 days of use.

Reference #7: Facility policy titled "Endoscope Reprocessing Guidelines" states, " ...1. PRE-CLEANING: The initial steps in the reprocessing protocols begin at the point of use. a. Have the following available: 1. Personal protective equipment (PPE) ..."

Reference #8: Facility policy titled "Cidex OPA Instructions/USE" states, "...III. Procedure Gowns, Gloves, Goggles must be worn when coming into contact with Cidex OPA Solution.

1. During an observation in the Endoscope Decontamination Area on 1/8/19, Staff #106 stated that he/she would wear a gown and gloves when reprocessing soiled endoscopes.

a. Staff #106 failed to address the use of goggles.

b. There were no goggles available in the Endoscope Decontamination area at the time of observation as confirmed with Staff #106.

2. The above findings were confirmed by Staff #24 and Staff #100.

E. Based on observation, staff interview, and facility document review, it was determined that the facility failed to ensure that flexible endoscopes and endoscope accessories are stored in a manner that minimizes contamination and protects the items from damage.

Findings include:

Reference: Association of periOperative Registered Nurses (AORN), Guidelines for Perioperative Practice, 2016 edition, pg. 722 states, "Recommendation IX Flexible endoscopes and endoscope accessories should be stored in a manner that minimizes contamination and protects the device or item from damage. ..."

1. During an observation in the Endoscope Reprocessing area, endoscope hookup accessories were found stored in two separate small black containers, labeled "EGD" and "COLONS," and were adjacent to the handwashing sink.

a. Each of the black containers had tape residue, which is rendered an uncleanable surface.

b. The accessories were not stored in a position that minimizes contamination from the handwashing sink.

c. The accessories were found commingled on top of the two black containers, which does not protect the accessories from damage or recontamination.

2. During an observation in the surgical corridor, an orange container was found on top of a cart. The orange container was taped and labeled to indicate that a high level disinfected bronchoscope was inside the container.

a. Upon interview, Staff #101 stated that the facility stored the high level disinfected bronchoscope, coiled in the container by the surgical corridor since the cart is transferred to units, if needed.

b. The bronchoscope was not stored in a manner that minimizes contamination and protects the device or item from damage.

3. The above findings were confirmed with Staff #100.

F. Based on document review and staff interview conducted on 1/9/19, it was determined that the facility failed to ensure the development of policies and procedures addressing the use and monitoring of the Scope Buddy, an automated flushing system.

Findings include:

1. Review of the facility policy and procedure titled "Endoscope Reprocessing Guidelines" does not include the specific procedures addressing the use of the Scope Buddy.

2. Upon interview, Staff #106 stated that the practice of the facility is to utilize the Scope Buddy as a flushing system when cleaning soiled endoscopes and to document on the "Quality Assurance Log Scope Buddy" sheet, with the results of the flow validation test and decontamination procedure at the end of each day.

a. Review of the "Patient Endoscope Reprocessing" log sheet indicated that an esophagogastroduodenoscope (EGD) was reprocessed on 12/11/18.

b. There is no evidence of quality assurance performed for the Scope Buddy on 12/11/18.

G. Based on observation, staff interview, and facility document review, it was determined that the facility failed to ensure implementation of policies and procedures addressing Bio-Hazardous Waste Management and the replacement of filled sharp containers.

Findings include:

Reference #1: Facility policy titled "Bio-Hazardous Waste Management" states, "III. Procedure: ...3. All patient rooms, soiled utility rooms, treatment rooms, surgical theatres and another other rooms used in the treatment of sick or injured individuals will be supplied with an approved sharps container. The frequency for collection of these sharps containers will be determined the the activity level of each specific area. ...5. Specific Areas of Concern: a. Emergency Room Regulated Medical Waste generated in the Emergency Treatment Department will be placed in specifically marked containers that are puncture resistant. ..."

Reference #2: Facility policy titled "Disposal of Needles/Syringes and Other Sharps INF.9.B" states, "... If sharps containers are noted by staff to be full between pickups or if any other problems or concerns occur, staff is responsible to notify environmental services..."

1. During an observation of the soiled utility room in the Emergency Department on 1/8/19, a sharps container was found overly filled with contaminated disposable sharps, exceeding the appropriate fill line of the sharps container.

a. Upon interview, Staff #107 stated that once the sharps container reaches the fill line, housekeeping is contacted and housekeeping will change the sharps container.

b. Upon request, Staff # 107 was not able to provide evidence that housekeeping was contacted nor the frequency for collection of contaminated sharps containers.

2. In the soiled utility room in the Emergency Department on 1/8/19, four containers containing a yellowish fluid and a reddish fluid were found inside the soiled instrument transport containers.

a. Upon interview, Staff #107 stated that the four containers were laboratory specimens and should not have been placed in the soiled instrument transport containers.

3. During an observation of the anesthesia work room, a sharps container was found overly filled with contaminated disposable sharps, exceeding the appropriate fill line of the sharps container.

4. The above finding was confirmed with Staff #26.

H. Based on observation and staff interview conducted on 1/8/19, it was determined that the facility failed to ensure that all ratched instruments are sterilized in an open position.

Findings include:

Reference: AAMI Sterilization in Health Care Facilities, 2017 edition, ST 79, section 8.2 Instruments states, " ...d) Ratched instruments should be unlatched. Racks, pins, stringers, or other specifically designed devices can be used to hold the instruments in the open position. ..."

1. During an observation of the clean supply room in the Emergency Department, multiple peel pouched instruments, containing either nasal speculums and forceps, were observed sterilized in a closed position.

2. The above finding was confirmed with Staff #29 and Staff #107.

I. Based on observation, staff interview, and document review, it was determined that the facility failed to ensure implementation of policies and procedures addressing the traffic flow of items received in the sterile processing department.

Findings include:

Reference: Facility policy titled "Traffic Control & Security SPD" states, "Procedure: ...II. Traffic Flow of Items Received in Sterile Processing ...G. Clean or sterile items never exit through the decontamination area. ..."

1. During an observation, it was noted that cleaned transport containers were housed in the Decontamination Room.

a. Upon interview, Staff #105 stated that the transport containers are utilized to transport soiled instruments from the Operating Rooms. Once the containers are used, the containers are placed in a washer from the decontamination room (dirty area) and then washed. When the washing cycle is complete, the containers are taken out of the washer from the sterile room (clean area) of the sterile processing department. Staff #105 stated that from the sterile room, the containers are brought back into the decontamination room and stored in the decontamination room for later use.

2. The above finding were confirmed with Staff #100.

J. Based on observation, staff interview and document review conducted on 1/8/19, it was determined that the facility failed to ensure implementation of policies and procedures addressing the transport of soiled instruments and maintaining an infection control program in accordance with OSHA (Occupational Safety and Health Administration) guidelines.

Findings include:

Reference #1: Facility policy titled "Decontamination Process" states, " ... I. Soiled items should be contained during transport from the point of use to the decontamination/ preparation area. ...Containment may be accomplished by any means that adequately prevents inadvertent personnel contact with or exposure to the soiled items during transfer. These means include covered carts, plastic container with lids or other methods appropriate to the specific situation and/or environment. ..."

Reference #2: OSHA (Occupational Safety and Health Administration) 29 CFR part 1910.1030(d)(2)(xiii) states, " ...Specimens of blood or other potentially infectious materials shall be placed in a container which prevents leakage during collection, handling, processing, storage, transport, or shipping. ..."

Reference #3: OSHA 29 CFR part 1910.1030(g)(1)(i)(A) states, "Warning labels shall be affixed to containers of regulated waste, refrigerators and freezers containing blood or other potentially infectious material; and other containers used to store, transport or ship blood or other potentially infectious materials. ..."

1. During an observation in the Decontamination Room on 1/8/19, the following was noted:

a. A two tiered cart containing soiled items was observed. Upon interview, Staff #105 stated that a staff member had just transported soiled items using this cart.

i. Soiled instruments were on the bottom shelf of the cart, without containment and a biohazard warning label.

ii. Three suction canisters containing a red colored liquid, were placed on the top and bottom of the cart, without containment. The suction canisters did not contain a biohazard warning label.

iii. A plastic bottle containing a yellow colored liquid did not have a biohazard warning label.

b. A surgical table containing soiled instruments was observed, covered with a blue surgical disposable wrapper.

i. The soiled instruments were transported without a biohazard warning label.

2. In the dirty utility room of the Emergency Department (ED), a container containing a yellow and red fluid, was found inside the soiled instrument container.

a. Upon interview, Staff #107 stated that when instruments are utilized in the ED, the soiled instruments are then placed in a plastic zip-lock bag. The nurse will then carry the bag to the dirty utility room and place it in a soiled instrument container.

i. The plastic zip-lock bag is not in compliance with the OSHA guidelines as referenced above.

3. The above findings were confirmed with Staff #100, Staff #105 and Staff #107.

K. Based on observation, staff interviews, and facility document review, it was determined that the facility failed to ensure the development and implementation of policies and procedures that written manufacturers' instructions of the devices are followed.

Findings include:

Reference: AAMI Sterilization in Health Care Facilities, 2017 edition, section 7.3 states, "Manufacturers' written IFU [Instructions for Use]: The device manufacturer's current written IFU should be accessible, reviewed, and followed. If there are no written IFU in the labeling, then the manufacturer should be contacted and requested to provide a commented method of cleaning. .."

1. Upon review of the Sterilization Record log, dated 12/13/18, the following was noted:

a. K-Wires were sterilized at the temperature of 275 degrees Fahrenheit and exposure time of 20 minutes.

i. The manufacturer's instructions for use for K-Wires states, "270 degrees Fahrenheit, with an exposure time of 4 minutes."

b. Medtronic instruments were sterilized at the temperature of 275 degrees Fahrenheit.

i. The manufacturer's instructions for use for Medtronic instruments states, "273 degrees Fahrenheit."

2. Upon review of the Sterilization Record log, dated 12/10/18, the following was noted:

a. A Knee Retractor Tray was sterilized at the temperature of 275 degrees Fahrenheit and an exposure time of 5 minutes.

i. Upon interview, Staff #29 stated that the Knee Retractor Tray consisted of instruments manufacturer by Jarit/Integra and Zimmer.

ii. The manufacturer's instructions for use for Jarit/Integra instruments states, "sterilize temperature of 270 degrees Fahrenheit and an exposure time of 3 minutes."

iii. The manufacturer's instructions for use for Zimmer instruments states, "sterilize temperature of 270 degrees Fahrenheit and 4 minutes exposure time."

3. Upon interview, Staff #29 confirmed that the facility placed instruments together with the highest temperature and exposure time and not in accordance with the manufacturer's instructions for the devices.

4. The above findings were confirmed with Staff #5, Staff #6 and Staff #31.

L. Based on observation, staff interview, and facility document review, it was determined that the facility failed to ensure the development of policies and procedures addressing borrowed or loaned instrumentation, in accordance with acceptable standards of practice.

Findings include:

Reference: AAMI [Association for the Advancement of Medical Instrumentation] Sterilization in Health Care Facilities, 2017 edition, ST 79 section 5.2.3 Loaned or borrowed instrumentation states, " ...5.2.3.1. ...A formalized program between the health care organization and health care industry representative should be established for the receipt and use of loaned instrumentation. ..."

1. During an observation in the Decontamination Room, two (2) trays of Stryker instruments were noted.

a. Upon interview, Staff #105 stated that "those trays were loaned by the company."

b. Upon request of the loaner policy and procedure, Staff #29 stated the facility does not have one.

2. The above findings were confirmed by Staff #29.

M. Based on observation, staff interview, and facility document review, it was determined that the facility failed to ensure that sterile and high level disinfected items are stored in a manner that reduces the potential for contamination in accordance with acceptable standards of practice.

Findings include:

Reference: AAMI [Association for the Advancement of Medical Instrumentation Sterilization in Health Care Facilities, 2017 edition, ST 79 section 11.1.1 Storage Facilities states, "Sterile items should be stored under environmentally controlled conditions in a manner that reduces the potential for contamination. ..."

1. During an observation in the hallway of the surgical corridor, the following was noted:

a. The "surgical case picks" (i.e., sterile supplies and equipment picked for a surgical case) were left in the hallway uncovered.

b. Sterile supplies were stocked on a cart, immediately adjacent to the trash.

2. The above findings were confirmed with Staff #100.



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N. Based on observation, staff interviews, and review of facility documents, it was determined that the facility failed to ensure that policies and procedures regarding OR cleaning are developed and implemented in accordance with nationally recognized guidelines.

Findings include:

Reference #1: Facility policy, Surgical Services (PAT, SDS, OR, PACU and ENDO) Housekeeping states, "...A. The Director of Environmental Services is responsible to see that guidelines are adhered to and that they are updated annually if necessary. ..."

Reference #2: Association of periOperative Registered Nurses (AORN), Guidelines for Perioperative Practice, 2017 edition, pg. 17 states, "...Recommendation V. V.a.1. Areas and items that should be cleaned on a schedule include ...clean and soiled storage areas ...environmental services closets. ...Recommendation VI. ... VI.b.1. Cleaning should progress from clean to dirty areas. VI.b.2. Cleaning should progress from top to bottom areas. ..."

1. Upon interview, Staff #24 indicated that the facility follows AORN guidelines to govern infection control practices related to its ORs.

2. During a tour of the Surgical Suite on 1/7/19, the following was observed:

a. The floor of an EVS (environmental services) closet was visibly dirty with numerous stains on the floor.

b. During an observation of room cleaning between cases, Staff #28 was observed cleaning OR #4 after a surgical case.

i. He/she used one (1) cotton rag soaked in a Virex solution to clean the bottom portion of the OR bed, then proceeded to clean two (2) mayo stands, a stainless steel cart, and equipment cables and wires. He/she cleaned from the bottom areas to the top areas.

Reference #3: Association of periOperative Registered Nurses (AORN), Guidelines for Perioperative Practice, 2017 edition, pg. 21 states, "...Recommendation VIII. ...Perioperative and environmental services personnel should receive initial and ongoing education and competency verification on their understanding of the principles and the performance of the processes for environmental cleaning in perioperative areas. ..."

1. Upon interview, Staff #28 confirmed that he/she performs the OR room turnover cleaning and OR terminal cleaning.

2. Staff #28 was asked if he/she receives annual training on the principles of OR cleaning. Staff #28 stated that he/she has not received training on OR cleaning since his/her initial orientation "many years ago."

3. Upon interview, Staff #24 indicated that the EVS department is responsible for performing training and competencies for the EVS employees.

4. Review of Staff #28's 2017 Competency Checklist lacked evidence of job specific competency training of the Operating Room turnover cleaning or the Operating Room terminal cleaning.

5. The above findings were confirmed with Staff #5, Staff #6, and Staff #24.

O. Based on observation, staff interviews and review of facility documents, it was determined that the facility failed to adhere to professionally acceptable standards of practice for hand hygiene.

Findings include:

Reference #1: Guideline for Hand Hygiene in Health Care Settings: Recommendation of the Healthcare Infection Control Practices Advisory Committee[HICPAC] and the HICPAC/SHEA/APIC/IDSA Hand Hygiene Task Force, published in the CDC (Centers for Disease Control and Prevention) Morbidity and Mortality Weekly Report at MMWR 2002; 51 (No. RR-16) page 32 states, "Recommendations: 1. Indications for Handwashing and Hand antisepsis... I. Decontaminate hands after contact with inanimate objects...in the immediate vicinity of the patient. J. Decontaminate hands after removing gloves. ...2. Hand-hygiene technique ...B. When washing hands with soap and water, apply an amount of product recommended by the manufacturer to hands, and rub hands together vigorously for at least 15 seconds. ..."

1. During a tour of the Respiratory Services department on 1/9/19, Staff #70 confirmed that there were no patients currently in the facility that required a ventilator.

a. Upon interview, Staff #70 confirmed that respiratory staff are responsible for cleaning ventilators after patient use.

b. Staff #70 stated that when he/she cleans a dirty ventilator, he/she dons gloves then removes the disposable tubing attached to the ventilator. Staff #70 stated that he/she then transports the dirty ventilator down the hallway to the clean supply room. Staff #70 leaves the ventilator outside the clean supply room while he/she enters the clean supply room to obtain Sani-Wipes to clean the ventilator.

i. After cleaning the ventilator, Staff #70 stated that he/she re-enters the clean supply room to obtain new disposable equipment to place on the ventilator. When finished, Staff #70 stated that he/she places a plastic covering over the ventilator and places it into the respiratory equipment storage room.

c. There were no handwashing sinks or hand sanitizer visible in the hallway where Staff #70 indicated he/

Based on observation, staff interview and review of facility documents, it was determined that the facility failed to ensure that all medications required to treat Malignant Hyperthermia were immediately available for use.

Findings include:

Reference: The Malignant Hyperthermia Association of the United States (MHAUS) Guidelines, https://www.mhaus.org/healthcare-professionals/be-prepared/what-should-be-on-an-mh-cart/, states, " ...What should be on a MH (Malignant Hyperthermia) Cart? Drugs ...Regular insulin - 100 units/ml x 1 (refrigerated) ..."

1. Upon tour of the Operating Suite on 1/8/19, it was determined that the Malignant Hyperthermia cart did not contain regular insulin.

2. Upon interview, Staff #57 stated that the regular insulin required, was available in the Post Anesthesia Care Unit (PACU) Omnicell.

3. On 1/18/19 at 1125, the on hand quantity listed in the PACU Omnicell was one (1) vial of regular insulin, but upon inspection, there was no regular insulin present inside the Omnicell. There was no regular insulin immediately available to treat Malignant Hyperthermia.

4. The above findings were confirmed with Staff #26 and Staff #57.

Based on review of facility documents and staff interviews, it was determined that the facility failed to ensure that the Director of Respiratory Care Services is a doctor of medicine or osteopathy.

Findings include:

1. On 1/10/19, a request was made for the credentialing file of Staff #69, who was identified by Staff #67 as the physician who oversees the Respiratory Services Department.

2. Upon interview on 1/10/19, Staff #5 confirmed that Respiratory Services does not have a physician that oversees the department. He/she stated, "[Staff #69] is a pulmonologist, however, he/she is not the director of respiratory services. We do not have a physician who is in charge of respiratory services."

3. The above findings were confirmed with Staff #4, Staff #5, and Staff #6.

Based on review of personnel files, staff interview, and review of facility documents, it was determined that the facility failed to provide documentation of initial training in emergency preparedness, for physicians providing on-site services under arrangement, consistent with their expected roles.

Findings include:

Reference: Review of the facility "Medical Staff Bylaws;Structure" states "...16. B. Orientation of New Physicians: Each new physician will be provided an overview of the Medical Center and its operations. This orientation will include training in patient rights, a tour of the Medical Center, orientation to the Medical Center's security system and disaster plan, and review of procedures to follow in case of emergency. ..."

1. On 1/9/19, upon review of personnel files #14, #57, #113, #114, and #115, the following was noted:

a. The facility was unable to provide documented evidence that five (5) of five (5) personnel files reviewed, received training in emergency preparedness procedures.

2. The above finding was confirmed by Staff #62.