HospitalInspections.org

Based on observation, review of documentation and interview it was determined that the hospital failed to ensure that emergency equipment was immediately operational.

Findings were:

Emergency equipment was was not immediately operational. During a tour of the new born nursery on the afternoon of 6/03/2019 it was observed that there was visible dust on the lid of the new born intubation box. Inside the box was a laryngoscope. The surveyor asked staff #3 if they could demonstrate the operation of the the laryngoscope. Staff #3 attempted to operate the laryngoscope and the light did not work. When staff #3 changed the batteries the laryngoscope light then worked. The inside cover of the new born intubation box had a checklist sheet which indicated it had last been checked on 5/18/16. No other more current documentation was found by or provided to the surveyor indicating that the new born intubation box had been checked more recently.

The above findings were confirmed in an interview with staff # 3 on the the afternoon of 6/03/2019.

During a tour of the emergency department on the morning of 6/14/2019 an examination the pediatric crash cart revealed a Zoll AED Pro Defibrillator. When the surveyor asked staff #2 to demonstrate if the AED worked, it was found that the AED was inoperable. Additionally there was no checklist found documenting that staff routinely checked the crash cart. Also found in pediatric crash cart was an expired Illinois Bone Marrow Needle, the packaging listed the expiration date as 2018/10/11. In an interview with staff #2 on the morning of 6/04/2019 it was confirmed that the AED on the pediatric crash cart did not work and that there was not documentation of a check sheet for the crash cart. Additionally it was also confirmed in the same interview that the bone marrow needle found in the pediatric crash cart was expired.

Based on review of documentation and interview it was determined that the hospital failed to ensure that the physical plant and environment was maintained in a manner to protect and protect patient safety as multiple issues were revealed during the 6/03/-6/05/2019 onsite re-certification survey.

Findings were:

The hospital failed to ensure that the physical plant and environment was maintained in a manner to safeguard and protect pateint safety.

Cross refer to:
CFR 485.618(b) Equipment, Supplies And Medication
CFR 485.623(b)(3) Maintenance
CFR 485.623(b)(4) Maintenance
CFR 485.635(a)(3)(vi) Patient Care Policies
CFR 485.638(b)(1) Protection of Record Information

Based on observation, and interview it was determined that the hospital failed to ensure that expired supplies were identified and removed so as not to potentially be used in the care of patients.

Findings were:

Multiple expired supplies were found in the surgical services area to include:

In the endoscopy suite area there were 4 each Allergan Lap Band System Access Port Needle 20G x 89 mm (3.5in.), the expiration date on these packages was 2016-12. Additionally visible dust observed on the top of the HEPA room Air Purifier RS 1000 unit located in the endoscopy suite. When the surveyor ran their hand over the top of this machine a significant amount of dust was observed.

Additional observations in the endoscopy procedure room included:
The cabinet storing scopes was noted to have pan/basin in the bottom to collect any moisture from the scopes drying. The basin was noted to have a brown discoloration and debris visible, indicating it had not been cleaned recently, present a risk of contamination to the scopes stored in this closet

In the surgical sterile core area expired supplies were found to include:

4 each Smith & Nephew Smartstitch M Connector, the expiration date was 2018-11-30

9 each Stryker T5 Hold W/peel away face shield, expiration dates were 2018-09-01

4 each Smith & Nephew 2.9mm Incisor Mini Blade 7cm long, expiration dates were 2015-08

8 each Smith & Nephew Versabond Radiopaque Bone Cement, expiration dates were 2019-04-30

In the surgical medication refrigerator there was an unopened 1000 ml bottle of 0.9% Sodium Chloride Irrigation Solution with an expiration date of 5/19

Review of hospital policy entitled:

In an interview with staff member # on the afternoon of 6/03/2019 the above findings were confirmed.

Based on observation, review of documentation and interview it was determined that the hospital failed to ensure that the kitchen area was maintained as there were multiple issues were found during the onsite survey on 6/03/2019 to 6/05/2019.

Findings were:

The kitchen was dirty, had not been maintained and expired food products were found. These included:

Food items available for consumption did not have date prepared indicated on them: 1 sheet pan of cornbread, 6 individual servings of brownie, and 1 cake piece portion

6 muffin tins were observed stacked with visible black gum-like substance on the underside of the tins in contact with the tins stacked on top. This build up prevents effective cleaning of these pans and increases the risk of contamination

A light fixture directly over a food prep area had what appeared to be numerous dead bug carcasses present inside the fixture

In the dry storage area standing water was observed throughout on the floor. Per staff member # this was a result of the rain from the previous evening. The presence of moisture and water presents an opportunity for mold and bacterial growth in this area

In the dry storage where clean patient supplies were kept, external shipping boxes were noted stored on shelves. Storage of supplies in this manner could potentially allow for dirt, debris, and or pests from the outside shipping containers to contaminate clean supplies stored nearby. Mice, insects, vermin, dirt with pathogenic organisms can be carried into a hospital within the cardboard boxes used as external shipping cartons

Spilled food debris (dried macaroni) was observed on the floor of the kitchen

Food debris was observed on the floor of the walk in cooler

The area behind the range had what appeared to be a piece of sheet metal laying on the floor and the floor and back of the range appeared dirty

The two-door stainless steel oven was dirty. When the surveyor ran their hand over the top of the oven a significant amount of sticky dust was observed on the surveyor's hand

Dirty tin foil was observed in the kitchen ovens and there were four dark sticky spots (approximately 1/2" to 1" on the floor in front of the oven)

The stainless steel steamer had visible dust on the top. When the surveyor ran their hand over the top of the oven a significant amount of sticky dust was observed on the surveyor's hand

The top of the ice machine was dirty. When the surveyor ran their hand over the top of the oven a significant amount of sticky dust was observed on the surveyor's hand

A commercial bread mixer, model GP620B had visible dust on the horizontal section of the mixer and when the surveyor ran their hand over the top of the oven a significant amount of sticky dust was observed on the surveyor's hand

Clear plastic bin containing cocoa powder had a cracked lid, the lid had visible dust on it and the date on the lid was listed as 8-7-14

4 oz bottle of Raspberry Bakery Emulsion with a Best By date of Aug 2015

Bottle of Coluvita Champagne Wine Vinegar with a BBD (best by date) of 12/2016

The floor in the dry food storage room had areas which were wet

14 each 12 fluid oz cans of Nestle Carnation Evaporated Milk with Best By date of 5/17/19

2 each Gold Medal Baking Mixes Cream Cheese artificially flavored icing mix, 4 pounds. The best if used by date was 08 March 2019

A large live toad was observed on the kitchen floor under the soft drink dispensing stand

In an interview with staff #1 on the afternoon of 6/03/2019 the above findings were confirmed.

Review of hospital policy entitled: "Food Storage" with an effective date of 01/02/2012 stated: "Food is stored in compliance with applicable Federal, State, and local regulations regarding sanitary storage conditions. Routine checks will be made by he Director of Nutritional Services regarding maintenance, temperature, and functionality of storage areas within the department." The same policy also stated: "3. Non Perishable Storage - a. Organized, well lit and dry location will be used for non-perishable items." This policy had an area where the approved and reviewed by/date could be documented. This area was blank.

Review of hospital policy entitled: "Sanitation" with an effective date of 01/02/2012 stated: "1. Personnel - a. Employee will comply with health code set forth by the State of Texas Department of Health Services." "4. Cleanliness - a. Staff will be held to a high professional standard regarding entire department." "b. Failing to meet standards of cleanliness set forth may be considered punishable offenses and treated within the department as such." "c. The Director and/or Supervisor will inspect cleanliness of entire department as a whole 1x/week and additionally as needed." This policy had an area where the approved and reviewed by/date could be documented. This area was blank. In an interview with staff member #8 on the morning of 6/04/2019 the surveyors were told that there was no documentation available for review indicating that there had been an weekly inspection of the cleanliness of the entire department.

Review of hospital policy entitled: "Sanitation Inspection" with and effective date of 01/02/2012 stated: "The Director of Nutritional Services and/or Dietary Supervisor will conduct weekly inspections of the department's sanitation/cleanliness." The policy also stated: "1. Director/Supervisor will conduct a routine inspection using the Sanitation Inspection sheet." "a. Any problem areas found will be noted and corrective action taken immediately as follows within 8 hours..." This policy had an area where the approved and reviewed by/date could be documented. This area was blank. In an interview with staff member #8 on the morning of 6/04/2019 the surveyors were told that there was no documentation available for review indicating that there had been routine inspections using the sanitation inspection sheet.

Review of hospital job description for "Director of Nutrition & Facilities" stated on page one under the job qualifications: "B. Licensure, Registry or Certification: Required: Certified Dietary Manager". This job description had been signed by staff #8 on 11/5/18. In an interview with staff #1 on the morning of 6/04/2019 the surveyors were told that staff #8 is not a certified dietary manager.

Based on observation, review of documentation and interview it was determined that the hospital's governing body failed to ensure that there was sufficient oversight of hospital operations as demonstrated by multiple issues found during the onsite survey conducted on 6/03/2019 to 6/05/2019.

Findings were:

The hospital's governing body failed to ensure that there was sufficient oversight of hospital operations as demonstrated by multiple issues found during the onsite survey conducted on 6/03/2019 to 6/05/2019 to include:

Anesthesia work room found unsecured, the room contained unsecured medications and medical supplies and identifying patient information which potentially could be accessed by unauthorized individuals.

Multiple issues found it in the hospital surgical department related to the sterilization of surgical instruments and correct operation and maintenance of sterilizers.

Multiple expired supplies found in the endoscopy suite and the surgical sterile core area and the emergency department.

Emergency supplies were not immediately operational. The light for the laryngoscope in new born intubation box did work when surveyor asked if staff could demonstrate the laryngoscope. Last documented check of the new born intubation box was: 5/18/16.
AED on Pediatric crash cart not working. Expired pads found on the AED in the CT room.

Kitchen area found to be dirty, with multiple expired food products. The Director of Nutrition and Facilities was not a certified dietary manager per the hospitals own job description for this position.

Nursing competencies not available for a RN (Registered Nurse) and incomplete for two other nurses.

In an interview the staff #1 and #2 on the afternoon of 6/03/2019 and again on 6/04/2019 the above findings were confirmed

Based on review of documentation and interview it was determined that the hospital failed to appropriate provision of services.

Findings included:

1. Based on observation, review of documentation and interview it was determined that the hospital failed to ensure the system for identifying, reporting, investigating and controlling infections and communicable diseases of patients and personnel was enforced. The facility also failed to ensure that a sanitary environment was maintained. Cross refer to CFR 485.635(a)(3)(vi)PATIENT CARE POLICIES.
2. Based on observation, review of documentation and interview it was determined that the hospital failed to ensure dietary services were organized, and staffed in a manner to ensure patients nutritional needs were met according to recognized dietary practices. Cross refer to CFR 485.635(a)(3)(vii) PATIENT CARE POLICIES.
3. Based on review of documentation and interview it was determined that the hospital failed to ensure that there was documentation of annual nursing competencies and that competencies were completed. Cross refer to CFR 485.635(d), (d)(1)NURSING SERVICES.

Based on observation, review of documentation and interview it was determined that the hospital failed to ensure the system for identifying, reporting, investigating and controlling infections and communicable diseases of patients and personnel was enforced. The facility also failed to ensure that a sanitary environment was maintained.

Findings were:

The facility-based document titled "Infection Prevention and Control Program" stated in part, "Coon Memorial Hospital Infection and Control Program ensures that this organization develops, implements and maintains an active, organizational-wide program for the prevention, control and investigation of infections and communicable diseases in order to reduce the risks of endemic and epidemic infections in patients, visitors and healthcare workers, and to optimize use of resources ... Elements of the Infection Prevention and Control Program include: Identifying risks in the healthcare organization through a risk assessment annually and when significant changes occur in the organization ... Infection control process for the Environment of Care ..."

In an interview with the Director of Infection Control Staff #13, she was asked to provide evidence of an infection control program but was unable to provide any documentation. However, she was able to provide a blank facility-based document titled "Infection Control Monthly Surveillance Report." Staff #13 was asked if she had ever used this document, and she stated "no I have not."

The hospital failed to ensure a sanitary environment was maintained as multiple infection control issues were found during the 6/03/2019 to 6/05/2019 onsite survey. These issues included:

During of tour of the facility on 06/04/18 revealed the following infection control issues:
In the Pain Treatment Room:

* On a desk in the unlocked room 7 vials of Ropivacaine Hydrochloride Injection 0.2 % were observed unsecured and easily accessible.

* The supply closet contained the following expired items were available for use: 1 Quicktrach Emergency Cricothyrotomy device with an expiration date of 11/2017 and 2 Whitacre 25 gauge Needles with an expiration date of 03/2018.

* Water damage was observed to 2 ceiling tiles. Ceiling tiles with water stains can harbor mold and may crumble, contaminating items below.

In the Recovery Area:

The Recovery/Infusion area had Coban dressing wrapped around a mobile computer work station, making it impossible to clean. Additionally, a chair with cracked vinyl on the surface of the head rest was present

* Multiple ceiling tiles were observed with water damage present. Ceiling tiles with water stains can harbor mold and may crumble, contaminating items below.

* 2 electrical outlets were observed to be missing plate cover had open gaps around it which opened to the wall space behind it. This allowed for the possible entry of dust, debris and pests into the patient area from the wall space behind.

The Surgical Suite findings included:

* The Procedure Room in the Surgical Area had Coban dressing wrapped around IV post, in an attempt to secure Bear Paw Warmer to pole.

* OR Suite A had a rusted baby bassinet present, making it impossible to clean.

* OR Suite B had three packages of Pen Rose Latex Drains, with the expiration date 02/2019.

* The PACU Area had 1 Exergen Temporal Scanner with tape on it, making it impossible to clean.

In the Nourishment Area near Patient Rooms:

* 2 containers of undated fruit were observed in the refrigerator. Without a date indicated it is unknown when this fruit was prepared for patient consumption.

* Dust was observed on high horizontal areas including on the hot plate and grill stored on top pf the refrigerator, this indicates ineffective cleaning of these areas.

* A chipped area of laminate approximately 3 X 2 inches in size was observed on the edge of the counter near the microwave, preventing effective cleaning of this area.

In the endoscopy procedure room:

* The cabinet storing scopes was noted to have pan/basin in the bottom to collect any moisture from the scopes drying. The basin was noted to have a brown discoloration and debris visible, indicating it had not been cleaned recently, present a risk of contamination to the scopes stored in this closet.

Hospital Inpatient Area:

Room 109 (Isolation Room)
* There was a portion of ceiling tile missing surrounding the sprinkler. This allowed for potential entry of dust, debris and pests into the patient room from the ceiling space behind.

* The "Long-hallway" inpatient area, room #102 had a chair sitting in the room with a tear in the cloth, making it impossible to clean.

The Emergency Department

*Trauma room 1 in the Emergency Department had two packages of Petrolatum Cision Dressing, expired on 4/2019, two packages of Covidien Petrolatum Gauze strips, with an expiration date of 2/2019, and one Lazarus Nelson Peritoneal Lavage Tray, expiration 4/30/2019 and a Multi-lumen Central Venous Catheterization Kit, expiration 2/28/2019.

*Trauma room 2 in the Emergency Department had two Lazarus Nelson Peritoneal Lavage Trays, expiration 4/30/2019, and a 241 Blood Fluid warming, expiration 3/2015.

Central Supply Closet:

*One box of Ethicon Coated Vicryl Sutures, expiration date 01/2019.

*In the central supply closet where clean patient supplies were kept, external shipping boxes were noted stored on shelves. Storage of supplies in this manner could potentially allow for dirt, debris, and or pests from the outside shipping containers to contaminate clean supplies stored nearby. Mice, insects, vermin, dirt with pathogenic organisms can be carried into a hospital within the cardboard boxes used as external shipping cartons.

In the Kitchen Area:

* The following food items available for consumption did not have date prepared indicated on them: 1 sheet pan of cornbread, 6 individual servings of brownie, and 1 cake piece portion.

* 6 muffin tins were observed stacked with visible black gum-like substance on the underside of the tins in contact with the tins stacked on top. This build up prevents effective cleaning of these pans and increases the risk of contamination.

* A light fixture directly over a food prep area had what appeared to be numerous dead bug carcasses present inside the fixture.

*A chipped tile was visible on the kitchen floor parallel to the food preparation area, making it impossible to clean.

* An unidentified rusted metal device was seen hanging from the kitchen counter. The kitchen manager was asked what the purpose of the devise was and she stated in part, "There used to be a drawer there, but it can be removed right now."

* The kitchen refrigerator revealed, a box of uncovered onions containing 1 onion with what appeared to be green mildew, and 2 soft brown spoiled onions. Additionally, a package of blueberries was seen with mildew.

* In the dry storage area standing water was observed throughout on the floor. Per staff member # this was a result of the rain from the previous evening. The presence of moisture and water presents an opportunity for mold and bacterial growth in this area.

*The dry food supply closet contained 20 bags of Chiffon Cheesecake Mix, with best if used by date of 12/18, 12 bags Custard Mix, with a best if used by date of 2/18, 9 bags of Cookie Mix with a best if used by date of 4/19, and 2 boxes of Raisins with a best if used by date of 4/24/2019. Additionally, a unlabeled plastic container with what appeared to be bread crumbs was uncovered.

* In the dry storage where clean patient supplies were kept, external shipping boxes were noted stored on shelves. Storage of supplies in this manner could potentially allow for dirt, debris, and or pests from the outside shipping containers to contaminate clean supplies stored nearby. Mice, insects, vermin, dirt with pathogenic organisms can be carried into a hospital within the cardboard boxes used as external shipping cartons.

Based on observation, review of documentation and interview it was determined that the hospital failed to ensure dietary services were organized, and staffed in a manner to ensure patients nutritional needs were met according to recognized dietary practices.

Findings Include:

Review of hospital policy entitled: "Sanitation" with an effective date of 01/02/2012 stated: "1. Personnel - a. Employee will comply with health code set forth by the State of Texas Department of Health Services." "4. Cleanliness - a. Staff will be held to a high professional standard regarding entire department." "b. Failing to meet standards of cleanliness set forth may be considered punishable offenses and treated within the department as such." "c. The Director and/or Supervisor will inspect cleanliness of entire department as a whole 1x/week and additionally as needed." This policy had an area where the approved and reviewed by/date could be documented. This area was blank. In an interview with staff member #8 on the morning of 6/04/2019 the surveyors were told that there was no documentation available for review indicating that there had been an weekly inspection of the cleanliness of the entire department.

Review of hospital job description for "Director of Nutrition & Facilities" stated on page one under the job qualifications: "B. Licensure, Registry or Certification: Required: Certified Dietary Manager". This job description had been signed by staff #8 on 11/5/18. In an interview with staff #1 on the morning of 6/04/2019 the surveyors were told that staff #8 is not a certified dietary manager.

Based on review of documentation and interview it was determined that the hospital failed to ensure that there was documentation of annual nursing competencies and that competencies were completed.

Findings were:

A review of nursing personnel/competency files revealed that the hospital failed to ensure that there was documentation of annual nursing competencies and that competencies were completed. Review of file for staff #23; an RN (Registered Nurse) revealed no documentation of annual nursing skills competency for 2018. Review of file for staff #21 revealed a form related to the 6 rights of medication administration, this form was dated 11/19/18. The evaluator was to circle either: "Pass" or "Fail". Neither choice had been circled by the evaluator. Continued review of the file for staff #21 revealed a form related to decontamination shower, this form was dated 11/19/18. The evaluator was to circle either: "Pass" or "Fail". Neither choice had been circled by the evaluator.

Review of file for staff #24 revealed a 4 page form related to an accessing implanted venous access device. This form was dated 11-20-2018 and the The evaluator was to circle either: "Pass" or "Fail". Neither choice had been circled by the evaluator.

Review of hospital policy entitled: "Annual skills competency checkoff" with an approved date of 12/21/2017 stated: "This evaluation is vital to Coon Memorial Hospital in ensuring excellent, competent care." In an interview on the afternoon of 6/04/2019 with staff members #2 and #3 the above findings were confirmed.

Based on observation, and interview it was determined that the hospital failed to ensure that anesthesia services were provided in a well organized manner as medications and medical supplies, identifying patient information as well as a full sharps container were found unsecured and the potential for unauthorized access existed.

Findings were:

Medications, medical supplies, identifying patient information and a full sharps container were found unsecured and the potential for unauthorized access existed. During a tour of the hospital on the afternoon of 6/03/2019 at approximately 3:00 the door the anesthesia/pain management area was found to be unsecured (this door can be locked). An anesthesia cart was found inside with an expired Endotracheal Tube cuffed with stylette, size 4.0mm. The expiration date on the packaging was 2017-08. This same anesthesia cart contained needles and syringes.

In the anesthesia supply room which was adjacent to the area where the anesthesia cart was found there was a package of Dexamethasone Sodium Phosphate vials (10 mg/ml). Two expired Argon Single Transducer sets were found, with expiration dates of 06/2018 and 02/2018. Also found in this room was an Endotracheal Tube Murphy eye, high volume low cuff size 8.0. The expiration date on the packaging was 2016-01. Two each Invisishield Probe cover kit, the expiration date on these probe kits was 11/2017.

On the window ledge near the C arm machine was a 103.5 ml bottle of Gebauers Ethyl Chloride Fine Pinpoint Spray Topical Anesthetic Skin Refrigerant, the expiration date was 05/17. On the console of the C arm machine was a spiral bound notebook with had several patient labels which had been stuck to the pages of the notebook, approximately two hundred labels were stuck to the pages of the notebook.

Also noted was a large sharps container sitting on the floor was approximately ¾ full and the lid was loose. In an interview conducted with staff #2 during the tour of the anesthesia area , the survey team was told that the sharps containers should be changed when ½ full. Additionally, one of the ceiling mounted light fixtures by the door was observed to not be working.

In an interview with staff #2 on the afternoon of 6/03/2019 the above findings were confirmed

Based on review of documentation and interview it was determined that the hospital failed to ensure that the surgical services department was maintained in a manner to protect and protect pateint safety as multiple issues were revealed during the 6/03/-6/05/2019 onsite re-certification survey.

Findings included:

1) Based on a review documentation and interview the facility failed to ensure the sterilization of all supplies and equipment shall be under the supervision of a person qualified by education, training and experience.

The facility identified staff member #5 as the individual responsible for sterilizing scopes at the facility and staff member #15 as the individual responsible for sterilizing surgical instruments.

Review of the personnel files for staff members #5 and 15 revealed no documented education and/or training in sterilization for these employees.

In an interview with staff member #5, on 06/04/19 at 1:25 PM, stated they had been in that position since 2006. The employee indicated they had been cleaning scopes at the facility since 2006. They were asked what training they received for scope cleaning. The employee replied, "just from whoever was here before. The employee was initially trained on a different system, "we had the original Steris System 1 and got the 1 E later on." The employee received training on the Steris E1, "When they came in and installed it, it's basically the same ...There's a poster up on the wall (with instructions for the system)."

In an interview with staff member #15 on 06/05/19 at 09:35 AM they stated that had been performing instrument sterilization at the facility for over 15 years. This staff member was identified by the facility as being in charge of instrument sterilizing and autoclave use at the facility.

2) Based on a review of documentation and interview the facility failed to ensures that equipment shall be maintained and operated to perform, with accuracy, the sterilization of the various materials required. As evidence by failing to ensure that scope clearing was documented per manufacturer recommendations.

The facility utilizes the SYSTEM 1 E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM to clean scopes. The Operation Manual for the SYSTEM 1 E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM stated in part,
"QUALITY ASSURANCE

Part 1:Documentation

Documentation is a critical element in any Quality Assurance Program. The printout that is provided for every cycle is a record containing the key points recommended by the Association for the Advancement of Medical Instrumentation (A.A.M.I.), the Association of Operating Room Nurses (A.O.R.N.), and the International Association of Healthcare Central Service Material Management (I.A.H.C.S.M.M.).

The printouts should be saved as part of your total Quality Assurance Program. Depending on your state, regional, and your hospital and departmental policies, you may wish to make a copy of the printout for long term records. If a printout is missing for a load for any reason, the load must be reprocessed using a fresh container of S40 Sterilant Concentrate. If a printout is missing for a load due to a printer problem or missing printer paper, refer to Section 9, Maintenance, or call Customer Service.

PRINTOUT PROVIDED FOR A COMPLETED LIQUID CHEMICAL STERILIZATION CYCLE
DATE: Current date.
CYCLE START: Time cycle started.
OPERATOR ID: Space for the operator's name or initials.
DEVICE ID: Record your specific device or load identification.
PROCEDURE ID: Record your specific procedure identification.
PATIENT: Record your specific patient's identification.
PHYSCN: Record your specific physician's identification.
REMARKS: Space to include any information deemed appropriate by departmental policy such as devices processed, procedure, patient name, etc. This space can also be used to document filter changes and service on the processor...

MAINTENANCE
» Part 1:
Daily Cleaning and Checks
STEP 1
CLEAN EXTERNAL SURFACES
Wipe the processor with a soft cloth dampened with 70% isopropyl alcohol...

STEP 3 CLEAN PROCESSING TRAY
Processing Tray/Container:
Wipe the inner surface and seal, processing tray/container, and accessory rack with a soft cloth dampened with 70% isopropyl alcohol."

During a tour of the scope reprocessing area on 06/04/19, staff member #5 who reprocesses scopes for the facility was asked to provide the Scope Cleaning Log for review.

Review of the Scope Cleaning log revealed the following:
* The log only contained date, pt sticker, scope ID, and a check mark that System 1E was utilized to clean the scopes.
* The log was missing a date, scope ID, and system for 1 patient.
* The following dates did not have that System 1E was used to clean the scopes checked off: 12/12/18, 12/13/18, 01/11/19, 02/07/19, 02/22/19, 02/26/19, 03/07/19, 03/08/19, 03/11/9, 03/13/19, 03/21/19, 05/06/19, 05/08/19, 05/10/19, 05/18/19, 05/20/19, and 05/22/19.

On 06/04/19 staff member #5 was asked to provide the print outs for May 2019 from the Steris System 1E Liquid Chemical Serilant Processing System. The staff member provided several continuous rolls of receipt paper. Review of this print out roll revealed the following:
* The current documentation did not include Operator ID or Load ID. There was no indication of which scope was being cleaned. Several dates there were multiple scope processed at at time.
* Staff member #5 verified that the current printout documentation from the Steris 1E machine did not include the device number or operator identification.

In an interview on 06/04/19 staff member #5 was asked what kind of cleaning was performed on the Steris 1E Liquid Chemical Sterilant Processing System. Staff member #5 stated, "we clean it externally and wipe it down with hydrogen peroxide wipes." Staff member confirmed the inside of the Steris 1E was cleaned with hydrogen peroxide wipes also. Per manufacturer recommendations the machine is to be cleaned with 70% isopropyl alcohol not hydrogen peroxide.

The above findings were confirmed in an interview with staff member #5 on 06/04/19.

3) Based on a tour of the facility and interview, the facility failed to ensure that all articles to be sterilized shall be arranged so all surfaces will be directly exposed to the sterilizing agent for the prescribed time and temperature.

During a tour and observation in the Surgical Suite on 06/04/19 the following was noted:
* Over 50 hinged instruments were observed stored in the closed position. Approximately 10 hinged instruments with locking mechanism were observed with the locking mechanism in a closed and clamped position. The locking mechanism is a series of interlocking teeth on each handle that clamps and holds the hemostat handles in place with tension. It could not be determined that these surfaces were appropriately cleaned. When instruments are closed, the sterilizing agent cannot penetrate all surfaces to ensure complete sterilization of all surfaces of the instruments.
* The Centers for Disease Control and Prevention (CDC) article, GUIDELINE FOR DISINFECTION AND STERILIZATION IN HEALTHCARE FACILITIES, 2008, by William A. Rutala, Ph.D., M.P.H., David J. Weber, M.D., M.P.H., and the Healthcare Infection Control Practices Advisory Committee (HICPAC), found at: http://www.cdc.gov/ncidod/dhqp/pdf/guidelines/Disinfection_Nov_2008.pdf, states on page 74 that hinged instruments and instruments that close should be opened during the process of sterilization.

The above was confirmed in interviews with Staff member #5 on 06/04/19.

4) Based on a review of documentation and interview, the facility failed to ensure that biological indicators were included in at least one run each week of use for steam sterilizers.

Facility based policy entitled, "QUALITY CONTROL - AUTOCLAVE" stated in part,
"·A biological indicator shall be used to provide information on the whether the autoclave is killing a specified number of organisms during the sterilization process.
·Organisms that highly heat tolerant shall be used as biological indicators, such as l Geobacillus stearothermophilus. Biological indicators are commercially available...

PROCEDURE:
· Quality Control testing shall be performed weekly.
· Refer to manufacturer's recommendations .
· Place one chemical integrator and one dual species self-contained biological indicator in each configuration to be tested.
· Run each cycle to bested using the shortest exposure time for the temperature and configuration being tested.
· Remove Integrator and SCBI
· Interpret and record the integrator results
· Seal and activate the SCBI and incubate at 55-60 degrees Celsius for 24 hours.
· Interpret and record the results..."

The facility utilized a Steris Amsco Century V 136 H Prevacuum Steam Sterilizer to sterilize their surgical instruments. The Operation Manual for the Amsco® CenturyTM Medium Steam Sterilizers 26" x 37.5" (660 x 953 mm) provided to the surveyor for review stated in part,
"3.2 Control Measures for Verifying Sterilization Process

3.2.1 Biological Monitors

A live spore test utilizing B. stearothermophilus is the most reliable form of biological monitoring. This type of product utilizes controlled populations of a controlled resistance, so that survival time and kill time can be demonstrated.

To verify the process, insert the biological indicator in a test pack and place pack on the bottom shelf. Run test pack through a typical cycle. On completion, forward test pack and monitor to appropriate personnel for evaluation. Refer to AAMI guidelines to conduct routine biological monitoring."

Review of the sterilization logs for March through May 2019 revealed the following:
* Biological indicator testes were run on the following dates: 03/06/19, 03/19/19, 03/26/19, and 04/23/19.
* On 4/23/19 the biological indicator test result of negative or positive was not indicated. The start of the test at 1600 was documented, however there was no follow up 24 hours later documented.
* According to documentation no biological indicator tests had been performed since 04/28/19 at the facility.

In an interview with staff member #5 on 06/04/19, they stated they only sterilized instruments "every couple of weeks" and that staff member #15 does the majority of instrument sterilization at the facility. Staff member #15 was not available to for interview on 06/04/9. Staff member #5 were asked how often Biological indicators were run in the facility autoclave. This employee replied, "Once a week maybe."

This employee (staff member #5) was asked to provide the surveyor with a sample biological indicator for visual inspection. This employee returned stating there were not biological indicators available. Staff member #5 stated, "I think we ran out and have ordered some more." Staff member #5 provided the surveyor a purchase form for biological indicators dated 05/15/19. Staff member #5 stated that staff member #15 could answers questions regarding biological indicators more effectively when available the next day.

In an interview with staff member #15 on 06/05/19 at 09:35 AM they stated that had been performing instrument sterilization at the facility for over 15 years. This staff member was identified by the facility as being in charge of instrument sterilizing and autoclave use at the facility.

Staff member #15 was asked how often biological indicators are completed at the facility. They replied the facility uses "Set its we use and run with the 1st load of the week and control that what goes in there in the log."

Staff member #15 was shown on the sterilization logs where some biological indicator tests were not properly documented, missing the 24-hour time and date for the complete reading of the test. Staff member #15 verified that portions of the record were incomplete regarding the biological indicators tests for the autoclave.

Staff member #15 was asked about the fact that biological indicators had not been performed in May 2019 according to the sterilization records. Staff member #15 verified the facility was out of Biological Indicators (BI) to run the tests. This staff member stated the BI had been unavailable at the facility for "A couple of weeks I guess there was a hang up with the orders and haven't gotten them ...The ones I had expired so I had to get rid of them."

Staff member #15 verified that biological indictors were to be completed weekly when instruments are being sterilized. The staff member verified that biological indicators had not been completed since the end of April 2019, no biological indicator tests had been completed for the entire month of May 2019 and into June 2019 up to the current date of 06/05/19.

Due to the above findings on 06/05/19 the surveyor informed staff member #1, the facility Chief Executive Officer that a potential Immediate Jeopardy was present at the facility. By failing to complete biological indicators the facility could not establish per their own policy that, "information on the whether the autoclave is killing a specified number of organisms during the sterilization process." Therefore the facility could not ensure that the instruments sterilized in May and June were effective sterilized.

The facility began to work to abate the immediate jeopardy. The facility provided the surveyor a note on 06/05/19 that indicated,
"On 6/5/19 the surveyor made me aware of issues with our surgical sterilization process due to the us not having the biological indicators for the sterilizer. These have been ordered and we are waiting on shipment. We took the following action listed below to resolve the issue immediately.
1. We pulled all instruments from service that had been processed from 5/1/19 to present. These will be sterilized again.
2. We contacted Cardinal Health, the vendor, to determine the status of the order and submitted a Fed Ex tracking number and information showing the biological indicators for the sterilizers will be delivered today.
3. A picture of the received box will be sent to the surveyor to confirm receipt."

The surveyor went to surgical suite on 06/05/19 and observed all the instruments sterilized from May 1, 2019 through June 5,2019 had been pulled to be re-sterilizer after the biological indicators are obtained and tests run. On 06/05/19 the facility also provided a evidence that the biological indicators had been delivered to the facility. By completing the above actions, the facility abated the potential immediate jeopardy situation on 06/05/19.

The above findings were confirmed on 06/05/19 in an interview with staff members #1 and #15.

5) Based on review of documentation and interview the facility failed to ensure that steam sterilizers were used according to manufacturer's written instructions.

The facility utilized a Steris Amsco Century V 136 H Prevacuum Steam Sterilizer to sterilize their surgical instruments. The Operation Manual for the Amsco® CenturyTM Medium Steam Sterilizers 26" x 37.5" (660 x 953 mm) provided to the surveyor for review stated in part,
"ROUTINE MAINTENANCE

7.1 Preventive Maintenance Schedule...

7.1.1 Clean Chamber Drain Strainer

Important: The chamber drain strainer must be cleaned at least once a day, preferably in the morning before running the first cycle...

7.2 Weekly Maintenance

7.2.1 Flush Chamber Drain"

In an interview on 06/05/19 staff member #15 was asked what routine maintenance was performed on the autoclave at the facility. The staff member replied, "We run biologicals. Sam form Steris comes and does maintenance on a regular schedule, every 2 months. He does maintenance on the 1E, autoclave, and generator."

Staff member #15 was asked how often they clean the drain strainer. She replied, "we check the drain strainer once every couple of weeks." Staff member #15 was asked how often the chamber was of the autoclave chamber was flushed. Staff member #15 confirmed that they do not flush the autoclave.

According to the manufacture recommendations the chamber drain strainer is to be cleaned daily and the chamber to be flushed weekly.

The above finding were confirmed with staff member #15 on 06/05/19.

6) Based on a review of documentation and interview, the facility failed to ensure that flash sterilizers shall be used for emergency sterilization of clean, unwrapped instruments and porous items only.

The Centers for Disease Control and Prevention (CC) website article, GUIDELINE FOR DISINFECTION AND STERILIZATION IN HEALTHCARE FACILITIES, 2008, by William A. Rutala, Ph.D., M.P.H., David J. Weber, M.D., M.P.H., and the Healthcare Infection Control Practices Advisory Committee (HICPAC), found at: , states on page 60 that "it [flash sterilization] is not recommended as a routine sterilization method because of the lack of timely biological indicators to monitor performance, absence of protective packaging following sterilization, possibility for contamination of processed items during transportation to the operating rooms, and the sterilization cycle parameters (i.e., time, temperature, pressure) are minimal...A few adverse events have been associated with flash sterilization. When evaluating an increased incidence of neurosurgical infections, the investigators noted that surgical instruments were flash sterilized between cases and 2 of 3 craniotomy infections involved plate implants that were flash sterilized849...Flash sterilization should not be used for reasons of convenience, as an alternative to purchasing additional instrument sets, or to save time817."

A statement from the Association for the Advancement of Medical Instrumentation (AAMI), Accreditation Association for Ambulatory Health Care (AAAHC), Association of periOperative Registered Nurses (AORN), Association for Professionals in Infection Control and Epidemiology (APIC), ASC Quality Collaboration, Association of Surgical Technologists (AST), and International Association of Healthcare Central Service Materiel Management (IAHCSMM). Immediate-Use Steam Sterilization. Undated. Found at: http://www.aami.org/publications/standards/ST79_Immediate_Use_Statement.pdf, stated in part, "Instrument inventories should be sufficient to meet anticipated surgical volume and permit the time to complete all critical elements of reprocessing."

Facility based policy entitled, "Flash Sterilization- SURGICAL SERVICES" stated in part,
"PURPOSE:
This policy outlines the procedure for the adequate sterilization of surgical instruments and equipment using flash autoclave in the instance of emergency situations and/or when there is insufficient time to sterilize an item by the preferred prepackaged method and/or manufacturer's recommendation.

POLICY:
The use of flash sterilization shall be kept at a minimum....

· When an item is flash sterilized, it must be documented in the Flash Autoclave Log. The following information shall be documented:
· Item(s) flash sterilized
· Patient name
· Cycle parameters (temperature, duration of cycle)
· Date and time
· Staff member name
· Reason for flash sterilization..."

Review of the sterilization logs for March through May 2019 revealed the following:
* On 03/28/18 the log indicated a "Bone Tray #1" was flashed for 18 minutes and 56 seconds.
* The log did not indicate a reason for flashing this instrument tray per facility policy.
* In an interview on 06/05/19 staff member #15 was asked about the flashing of the bone tray on 03/28/19 according to the sterilization log. There was no reason documented for why this bone tray was flashed and not sterilized through a complete cycle. Staff member #15 verified the reason for flashing this set was not documented.
* Staff member #15 stated, "There weren't enough instruments. We have one for a major bone case. We have one main tray and a backup. Probably [orthopedic physician] came in and we had an extra case ...We run on minimal stuff (surgical instruments)."

Staff member #15 verified the above findings in an interview on 06/05/19. Staff member #15 also verified that the facility uses flash/immediate use sterilization for non-emergent purposes due to having and insufficient number of instruments for certain cases.

7) Based on interview the facility failed to ensure that a preventive maintenance record shall be maintained for each sterilizer.

In an interview on 06/05/19 staff member #15 was asked of there was a preventative maintenance log available for review for the sterilizer. Staff member #15 confirmed the facility did not keep a sterilization preventative maintenance log.


8) Based on observation, and interview it was determined that the hospital failed to ensure that surgical services well organized as multiple expired supplies were found in the surgical area.

Multiple expired supplies were found in the surgical services area to include:

In the endoscopy suite area there were 4 each Allergan Lap Band System Access Port Needle 20G x 89 mm (3.5 in.), the expiration date on these packages was 2016-12. Additionally visible dust observed on the top of the HEPA room Air Purifier RS 1000 unit located in the endoscopy suite. When the surveyor ran their hand over the top of this machine a significant amount of dust was observed.

Additional observations in the endoscopy procedure room included:
The cabinet storing scopes was noted to have pan/basin in the bottom to collect any moisture from the scopes drying. The basin was noted to have a brown discoloration and debris visible, indicating it had not been cleaned recently, present a risk of contamination to the scopes stored in this closet

In the surgical sterile core area expired supplies were found to include:

4 each Smith & Nephew Smartstitch M Connector, the expiration date was 2018-11-30

9 each Stryker T5 Hold W/peel away face shield, expiration dates were 2018-09-01

4 each Smith & Nephew 2.9mm Incisor Mini Blade 7cm long, expiration dates were 2015-08

8 each Smith & Nephew Versabond Radiopaque Bone Cement, expiration dates were 2019-04-30

In the surgical medication refrigerator there was an unopened 1000ml bottle of 0.9% Sodium Chloride Irrigation Solution with an expiration date of 5/19

Review of hospital policy entitled:

In an interview with staff member # on the afternoon of 6/03/2019 the above findings were confirmed.


Please Cross refer to:
CFR 485.623(b)(3) Maintenance

Based on observation and interview it was determined that the hospital failed to ensure the privacy of all patients were maintained.

The findings include:

The facility based policy "Notice of Privacy Practices" stated in part, " ...4. Our legal duty. We are required by law to protect the privacy of your health information, provide this notice about our privacy practices, follow the privacy practices that are described in this notice, and seek you [sic] acknowledgement of receipt of this notice ..."

A tour of the inpatient area referred to as the "Long-Hallway" revealed Patient #1, Patient #2, and Patient #3 had their full names posted outside of their room.

In an interview with the Chief Executive Officer, she asked, "What if we got consent from the patients to have their names outside of their room". The facility was unable to provide documentation of patients consent to disclose personal information.

Based on review of documentation (the hospital's emergency preparedness plan) and interview it was determined that the hospital failed to ensure that there was documentation available for review indicating the hospital's efforts to contact regional, State and Federal emergency preparedness such officials.

Findings were:

No documentation was found by or provided to the survey team indicating efforts by the hospital to contact regional, State and Federal emergency preparedness officials. In an interview with staff member #1 on the morning of 6/05/2019 it was confirmed that there was no documentation available for review indicating efforts on the part of the hospital to contact regional, State and Federal emergency preparedness officials.

Based on review of documentation (the hospital's emergency preparedness plan) and interview it was determined that the hospital failed to have a policy related to volunteers and specifically how volunteer health care professionals would be integrated into the hospital's operations during an emergency situation.

Findings were:

No policy was found or provided to the survey team indicating a process for the use of volunteers and specifically how volunteer health care care professionals would be integrated into the hospital's operations during an emergency situation. Upon request by the survey team the hospital was unable to provide documentation of a policy related to the use of volunteers and specifically how health care professionals would be integrated into the hospital's operations during an emergency situation. In an interview with staff #1 on the morning of 6/05/2019 it was confirmed that there was not any documentation available for review of a policy related to the use of volunteers and how volunteer health care professionals would be integrated into the hospital's operations during an emergency.