The information below comes from the statement of deficiencies compiled by health inspectors and provided to AHCJ by the Centers for Medicare and Medicaid Services. It does not include the steps the hospital plans to take to fix the problem, known as a plan of correction. For that information, you should contact the hospital, your state health department or CMS. Accessing the document may require you to file a Freedom of Information Request. Information on doing so is available here.

PEACEHEALTH ST JOHN MEDICAL CENTER 1615 DELAWARE STREET LONGVIEW, WA 98632 May 30, 2019
VIOLATION: PHARMACIST SUPERVISION OF SERVICES Tag No: A0501
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Based on observation, interview and document review, the hospital failed to ensure that syringes of medication and medication solutions were labeled according to hospital policy and procedure.

Failure to ensure medications syringes and medication solutions were labeled according to standards of practice and hospital policy risks medication errors and patient harm.

Findings included:

1. Document review of the hospital's policy titled, "Medication Administration Policy," policy number 100.2.222, reviewed 03/06/19, showed that all medications or solutions that are transferred from the original packaging to another container and not immediately used must be labeled with the drug name, concentration, amount, expiration date, time, and initials of person preparing. Any medications found unlabeled must be immediately discarded. All original containers from the medications or solutions must remain available for reference in the procedural area until the conclusion of the procedure and then the labeled containers must be discarded.

2. On 05/13/19 at 10:45 AM, Surveyor #5, the Chief Medical Officer (CMO) (Staff #501), the Operating Room Nurse Manager (Staff #502), and the Operating Room Charge Nurse (Staff #503) inspected a "Dental Cart" located in the sub-sterile room between Operating Room (OR) #1 and #2. Surveyor #5 observed improperly labeled medication and irrigation solutions including:

-1 partially used syringe containing a white material labeled with "RC Prep;"

-1 partially used syringe, containing a white material, unlabeled;

-One 250 mL bottle of sterile water with "bleach" written on the bottle;

-One 250 mL bottle of sterile water with a label that stated, "sodium hypochlorite," and "corrosive."

Surveyor #5 found no evidence of a bulk type container containing a white material.

3. At the time of the finding, Staff #502 and #503 stated they did not know what the syringes contained, and confirmed the labeling did not meet hospital policy.

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VIOLATION: SECURE STORAGE Tag No: A0502
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Based on interview and document review, the hospital failed to ensure that medications were kept secure from unauthorized use.

Failure to secure medications risks unauthorized use, medication errors, and patient harm.

Findings included:

1. Document review of the hospital's policy titled, "Medication Inspection Policy," policy number 1002.153, reviewed 08/09/18, showed that pharmacy will inspect all medication areas monthly to assure appropriate medication security.

Document review of the hospital's policy titled, "Medication Administration," policy number 100.2.222, reviewed 03/06/19, showed that medications are never to be left unsecured.

2. On 05/15/19 at 1:50 PM, Surveyor #5 and the Dialysis Nurse Manager (Staff #512) inspected an emergency cart located in the hospital's Outpatient Dialysis Center. Surveyor #5 asked Staff #512 to open the emergency cart. Surveyor #5 observed that the breakaway security lock was stretched out and Staff #512 was able to remove the metal slide and open the emergency cart without breaking the security lock. Surveyor #5 inspected the cart and observed 4 bottles of 30,000 unit/mL Heparin.

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3. At the time of the finding, Staff #512 confirmed the breakaway security lock was stretched out and verified that the emergency cart containing the Heparin was unsecured.
VIOLATION: UNUSABLE DRUGS NOT USED Tag No: A0505
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Based on observation, interview, and document review, the hospital failed to ensure that unusable or expired medications were not available for patient administration (Item #1), and failed to ensure that pharmaceutical services provided monthly inspections of all nursing care units within the hospital and other hospital-associated clinic pharmacy areas where medications were dispensed, administered or stored (Item #2).

Failure to ensure medication storage areas are devoid of outdated or otherwise unusable medications puts patients at risk for receiving medications with compromised sterility, integrity, or stability.

Findings included:

Item #1 Unusable and Expired Medication

1. Document review of the hospital's policy titled, "Procurement of Pharmaceuticals and Supplies Procedure," policy number 100.2.178, reviewed on 11/07/18, showed that a drug product that is expired shall be quarantined by Pharmacy Purchasing for review and/or recovery by the reverse distributor.

2. On 05/13/19 at 10:45 AM, Surveyor #5, the Chief Medical Officer (CMO) (Staff #501), the Operating Room Nurse Manager (Staff #502), and the Operating Room Charge Nurse (Staff #503) inspected a "Dental Cart" located in the sub-sterile room located between Operating Room (OR) #1 and #2. Surveyor #5 observed:

-One 250 mL bottle of Sterile water with "bleach" written on the bottle. The bottle of sterile water showed a manufacturer's expiration date of 02/14;

-23 1.7 mL syringes of Lidocaine HCL 2% (dental anesthetic) with a manufacturer's expiration date of 01/19;

-One 250 mL Sterile water with a label that stated, "sodium hypochlorite," and "corrosive." The bottle of sterile water showed a manufacturer's expiration date of 03/19;

-50 1.8 mL syringes of Articaine HCL 4% with Epinepherine 1:200,000 (a medication used for local, infiltrative, or conductive anesthesia in both simple and complex dental procedures) with a manufacturer's expiration date of 04/19.

3. At the time of the finding, Staff #501, #502, and #503 confirmed the expired medications and removed them from the cart. Staff #502 and #503 stated that the medications were brought into the OR by the dentist. Staff #502 and #503 stated that the OR staff, not the Pharmacy, inspected the medications on the "Dental Cart" and that they had informed the dentist's staff of upcoming medication expirations.

4. On 05/14/19 at 2:00 PM, during an interview with Surveyor #5, the Pharmacy Director (Staff #505) and the Pharmacy Manager (Staff #506) stated that they were unaware that a dentist had been bringing in medications from his personal office and stated that Pharmacy did not inspect the "Dental Cart."

5. On 05/29/19 at 10:20 AM, Surveyor #8 visited the emergency room (ER) with the Charge Nurse (Staff #815) to view the Dental Tray which was currently stored behind the nurses' desk. The following observations were found:

-Two partially used containers of temporary cement powder, without an open date.

-A product called COE periodontal paste was open, undated and had a sticky unclean tip from previous uses. The item was not ready for next use.

-The Bosworth Hydroxide paste, opened and undated, had a sticky substance remaining from previous uses. The item was not ready for next use.

-The Catalyst 90gr, undated, no expiration date, half empty with a sticky residue substance around the cap. The item was not ready for next patient use.

6. Surveyor #8 requested the policy for the dental procedures in the ER, the Charge Nurse reported that there was no policy.

7. On 05/29/19 at 3:30 PM, in an interview with the Pharmacist, (Staff #818) regarding unusable dental supplies. The Pharmacist confirmed the medications/dental supplies should come under pharmaceutical services and have a policy for their care and use.

8. On 05/30/19 at 9:15 AM, Surveyor #8 toured the operating room with the Charge Nurse (Staff #814) during the tour of OR #3's anesthesia cart, the following observations were made:

-A partially used tube a 30 ml tube of Lidocaine hydrochloride with no initial or date. The label read to discard unused portion.

-A tube of Lubri-fresh ophthalmic ointment with no initial or date. The label indicated it was a single use ointment.

-The Charge nurse removed a partially used tube of Bacitracin ointment that was in the same cart. She verbalized that she thought everything was previously pulled that was not supposed to be in the carts.

Item #2 Monthly Pharmacy Inspection

1. Document review of the hospital's policy titled, "Medication Inspection Policy," policy number 1002.153, reviewed 08/09/18, showed that pharmacy will inspect all medication areas monthly to assure appropriate storage, security, removal of expired or other unusable medications, identification of hazardous conditions, and labeling.

2. On 05/13/19 at 10:45 AM, Surveyor #5, the Chief Medical Officer (CMO) (Staff #501), the Operating Room Nurse Manager (Staff #502), and the Operating Room Charge Nurse (Staff #503) inspected a "Dental Cart" located in the sub-sterile room between Operating Room (OR) #1 and #2. Surveyor #5 observed medications, expired medications, and irrigation solutions stored on the cart.

3. At the time of the finding, Staff #502 and #503 stated that the medications were brought into the OR by the dentist. Staff #502 and #503 stated that the OR staff, not the Pharmacy, inspected the medications on the "Dental Cart" and that they had informed the dentist's staff of upcoming medication expirations.

4. On 05/14/19 at 2:00 PM, during interview with Surveyor #5, the Pharmacy Director (Staff #505) and the Pharmacy Manager (Staff #506) stated that the Pharmacy had not conducted monthly inspections of this area as they were unaware that a Dentist had been bringing in medications from his personal office.

5. On 05/15/19 at 1:50 PM, Surveyor #5 and the Dialysis Nurse Manager (Staff #512) inspected an emergency cart located in the hospital's Outpatient Dialysis Center. Surveyor #5 asked Staff #512 to open the emergency cart. Surveyor #5 observed that the breakaway security lock was stretched out and Staff #512 was able to remove the metal slide and open the emergency cart without breaking the security lock. Surveyor #5 reviewed the monthly checklist and noted that staff did not verify the security lock number. Surveyor #5 reviewed the monthly pharmacy audit sheet and observed that pharmacy did not include review of the emergency cart in the monthly audit.

6. At the time of the observation, Staff #512 confirmed the finding.

7. On 05/29/19 at 1:10 PM, during interview with Surveyor #5, the Pharmacy Director (Staff #505) confirmed that Pharmacy had not checked the emergency cart located at the Dialysis Center, as the Pharmacy was unaware staff were storing Heparin in the cart.

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VIOLATION: GOVERNING BODY Tag No: A0043
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Based on observation, interview, record review, and review of hospital policies and procedures and Governing Body bylaws, the Governing Body failed to develop and maintain effective systems that ensured that patients received high quality health care in a safe environment.

Failure to ensure patients are provided with care that meets acceptable standard of practice and meets the patient's healthcare needs in a safe environment risks poor health care outcomes, injury, and death.

Observations, interviews, record reviews, and review of hospital policies and procedures, showed the following:

Failure to develop a coordinated process to oversee the performance of all patient care services and departments;

Cross-reference: A0049

Failure to ensure that pharmaceutical services were delivered according to regulatory requirements and accepted standards of practice;

Cross-reference: A0489

Failure to maintain a safe and sanitary patient care environment;

Cross-reference: A0700

Failure to develop and implement an effective infection prevention and control program that ensures appropriately cleaned, disinfected, or sterilized instruments, a sanitary environment, and use of effective patient care supplies;

Cross-reference: A0747

Failure to ensure that surgical services were delivered according to regulatory requirements and acceptable standards of practice.

Cross-reference: A0940

Due to the scope and severity of deficiencies detailed under 42 CFR 482.12 Conditions of Participation for Governing Body, 42 CFR 482.25 Pharmaceutical Services, 42 CFR 482.41 Physical Environment, 42 CFR 482.42 Infection Control, and 42 CFR 482.51 Surgical Services, the Condition of Participation for Governing Body was NOT MET.

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VIOLATION: CONTRACTED SERVICES Tag No: A0084
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Based on interview, document review, and review of the hospital's quality and performance improvement program, the Governing Body failed to ensure that contracted patient care services were provided to patients in a safe and effective manner (3 of 8 contracts).

Failure to develop a coordinated process to oversee the performance of all patient care services and departments risks provision of improper or inadequate care and adverse patient outcomes.

Findings included:

1. Document review of the hospital's document titled, Quality and Patient Safety Plan Acute Care Hospital 2018-2019," showed that the hospital's plan is designed to assess, monitor, and improve the delivery of exceptional and safe care for patients. Data is collected and used to evaluate the quality of care, safety, and experience for relevant stakeholders, identify opportunities for improvement, and relevant action steps and to determine if improvement has been achieved.

The PeaceHealth Board holds the authority, fiduciary responsibility, and accountability for ensuring PeaceHealth implements and maintains an effective Quality Management System at both the system and Medical Center level. The Community Health Board is a sub-committee of the PeaceHealth Board and is responsible to ensure medical staff is accountable for the quality of care provided to patients.

2. On 05/16/19, Surveyor #5 and the hospital's Quality Committee members including Quality Manager (Staff #512) and Quality Manager (Staff #525) reviewed the Hospitals Quality Program. Surveyor #5 observed:

The hospital failed to perform a contract evaluation for 2 of 4 clinical contracts reviewed.

3. On 05/16/19 at 11:20 AM, Staff #512 confirmed the finding and stated they were "missed."

4. On 05/30/19, Surveyor #5 reviewed 4 clinical contracts. Surveyor #5 observed:

The hospital failed to perform a contract evaluation for 1 of 4 clinical contracts reviewed. The hospital failed to define measurable performance requirements for 3 of 4 contracts reviewed.

5. On 05/30/19 at 5:00 PM the Network Quality Director (Staff #526), confirmed the observation and stated the hospital had identified a "gap."
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VIOLATION: Condition of Participation: Pharmaceutical Se Tag No: A0489
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Based on observation, interview, and document review, the hospital failed to ensure that pharmaceutical services were delivered according to regulatory requirements and accepted standards of practice.

Failure to ensure controlled substance accountability standards, diversion-monitoring audits, and pharmacist review of medication orders risks patient safety, theft, and diversion of controlled substances.

Observations, interviews, record reviews, and review of hospital policies and procedures, showed the following:

1. Failure to ensure that pharmaceutical services were acquired, controlled, distributed, inspected, and labelled according to according to applicable standards of practice and hospital policy;

Cross-reference: A0500

2. Failure to ensure medication syringes were labelled according to standards of practice and hospital policy;

Cross-reference: A0501

3. Failure to ensure medications were kept secure;

Cross-reference: A0502

4. Failure to ensure that unusable or expired medications were not available for patient administration.

Cross-reference: A0505

Due to the scope of the deficiencies cited under 42 CFR 482.25, the Condition of Participation for Pharmaceutical Services was NOT MET.

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VIOLATION: DELIVERY OF DRUGS Tag No: A0500
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Based on observation, interview and document review, the hospital failed to ensure drugs were acquired, controlled, and distributed in accordance with applicable standards of practice.

Failure to implement processes for medication control, distribution, inspection, and preparation in a safe and timely manner risks patient safety.

Reference:

INVEGA SUSTENNA (paliperidone palmitate) Extended-Release Injectable Suspension Package Insert (Janssen Pharmaceuticals, Inc. 2018) Invega Sustenna is a prescription medicine given by injection by a healthcare professional.

Findings included:

1. Document review of the hospital's policy titled, "Procurement of Pharmaceuticals and Supplies Procedure," policy number 100.2.178, reviewed on 11/07/18, showed that only trained and authorized pharmacy personnel may perform ordering and order processing for pharmacy medications and supplies. Upon receipt of drug supplies, pharmacy purchasing will verify the product integrity, verify quantities received match quantities ordered, notify the hospital or clinic requesting the product for immediate distribution, identify and assess for short expiration dated product, stock the product in the designated location and in the appropriate storage environment.

For emergency needs, Pharmacy Purchasing will coordinate the acquisition of medication from an alternate supplier and a record of all purchases will be made. A hospital employee may be used to pick up the supplies locally. The pharmacist or intern doing the procuring must initial all documents including delivery charges accompanying the material. The paperwork is to be given to pharmacy.

2. On 05/13/19 at 10:45 AM, Surveyor #5, the Chief Medical Officer (CMO) (Staff #501), the Operating Room Nurse Manager (Staff #502), and the Operating Room Charge Nurse (Staff #503) inspected a "Dental Cart" located in the sub-sterile room located between Operating Room (OR) #1 and #2. Surveyor #5 observed:

-50 1.8 mL syringes of Mepicaine HCL 3% (local injectable anesthetic agent);

-50 1.8 mL syringes of Articaine HCL 4% with Epinepherine 1:200,000 (a medication used for local, infiltrative, or conductive anesthesia in both simple and complex dental procedures);

-72 1.8 mL syringes of Orabloc (Articaine HCL 4% with Epinepherine 1:200,000) a medication used for local, infiltrative, or conductive anesthesia in both simple and complex dental procedures);

-28 1.8 mL syringes of Vivacaine (Bupivacaine HCl 0.5% and Epinephrine 1:200,000 Injection) (local injectable dental anesthetic agent);

-57 1.7 mL syringes of Lidocaine HCL 2% (dental anesthetic).

3. At the time of the inspection, Staff #502 and #503 stated that the OR was not responsible for the dental cart or procedures. The Dentist brought his own assistants to assist him during surgery, but that the hospital did provide a circulating nurse and the operating room. They stated that the medications were not stocked by pharmacy, but instead the Dentist (Staff #504) brought in his own medications. Staff #502 and #503 stated that the OR staff had told the Dentist's staff in that there were medications expiring in the dental cart in April.

4. On 05/14/19 at 2:00 PM, during interview with Surveyor #5, the Pharmacy Director (Staff #505) and the Pharmacy Manager (Staff #506) stated that they were unaware that a Dentist had been bringing in medications from his personal office and stated that it was the hospital policy that all medications must be acquired and distributed by the hospital's pharmacy.

5. On 05/15/19 at 2:35 PM, Surveyor #5, the Director of Behavioral Health (Staff #507), the Behavioral Health Manager (Staff #508), and a Registered Nurse (Staff #509) inspected the Behavioral Health medication storage area. Surveyor #5 observed a box of Invega Sustenna 234 mg extended release injectable (an antipsychotic drug used to treat schizophrenia) labeled with "Fred Meyer" Pharmacy located on a table with other patient medications.

6. At this time, Surveyor #5 asked Staff #507, #508, and #509 why a hospital administered medication would have a label from a different outpatient pharmacy. The Registered Nurse (Staff #509) stated that the patient had gotten the medication from the Fred Meyer Pharmacy and brought it to the Behavioral Health Clinic. She stated that patients acquiring prescription medications from another pharmacy was not the hospital policy, but sometimes patients are able to purchase the medications cheaper by using discount offers from the medication companies through other pharmacies rather than use the hospital's pharmacy. Staff #509 verified that only a healthcare professional can administer this medication.

7. On 05/29/19 at 1:10 PM, during interview with Surveyor #5, the Pharmacy Director (Staff #505) confirmed the observation and stated that it was not hospital policy for patients to obtain and bring their medications for administration.

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VIOLATION: PHYSICAL ENVIRONMENT Tag No: A0700
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Based on observation, interview, and document review, the hospital failed to maintain the physical environment to ensure sanitary conditions for storage of patient care supplies.

Failure to maintain a safe and sanitary environment risks substandard patient care due to contaminated patient care supplies.

Observations, interviews, record reviews, and review of hospital policies and procedures, showed the following:

The hospital failed to maintain a safe and sanitary patient care environment that included the following:

1. Failure to conduct maintenance inspections to identify areas in need of repair.

Cross Reference: A-0701

2. Failure to maintain ceiling tiles to prevent contamination of stored medications.

Cross Reference: A-0701

3. Failure to complete permanent repairs to a leaking water line in patient care supplies storage room.

Cross Reference: A-0724


Due to the scope and severity of deficiencies cited under 42 CFR 482.41, the Condition of Participation for Physical Environment was NOT MET.

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VIOLATION: MAINTENANCE OF PHYSICAL PLANT Tag No: A0701
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Based on observation, interview, and document review, the hospital failed to maintain the facility in a safe and sanitary condition as evidenced by temporary repairs to a plumbing leak (Item #1), the hospital failed to maintain clean and cleanable surfaces (Item #2), and the hospital failed to ensure patient care supplies are stored in a manner that protects against damage or contamination (Item #3).

Failure to maintain the physical plant in a safe and sanitary condition increases the risk of infection to patients, staff, and visitors.

Findings included:

Item #1 Plumbing Leak

1. Document review of the hospital's document titled, "Safety Management System 2019 Plan," approved 02/12/19, showed that Environment of Care (EOC) Inspections are conducted to identify compliance and risks throughout the facilities. EOC inspections are scheduled and announced; department/area managers are responsible for completing follow-up for deficiencies noted on the EOC inspection checklist.

2. On 05/14/19 from 9:30 AM until 10:30 AM, Surveyor #5, the Director of Facilities (Staff #522), a Facilities Engineer (Staff #523), and the Inventory Control Coordinator (Staff #524) inspected a ceiling leak in the hospitals central supply storage area. Surveyor #5 observed a leak diverter system on the top shelf of Central Supply Cart #8. The leak diverter system consisted of a plastic jug (approximately 2-gallon volume) and a flexible hose extending from the jug through a fitted lid to a hose fitting protruding from a ceiling tile approximately 18-inches overhead. The ceiling tile was discolored by a brown stain of approximately 6-inch radius around the hose fitting. The collection jug contained approximately 2-inches of clear liquid. Clean patient care supplies abutted the leak diverter system.

3. At the time of the observation, during an interview with Surveyor #5, the Inventory Control Coordinator (Staff #524) stated that the leak had been there for more than 6 months, but she was not sure of the exact date. Surveyor #5 asked why the leak had not been repaired and if the walls and ceiling had been assessed for mold growth. Staff #524 stated that she did not know and we would need to contact the facilities department.

4. On 05/14/19 at 10:11 AM, during interview with Surveyor #5, the Director of Facilities (Staff #522) and the Facilities Engineer (Staff #523) stated that a pipe in the ceiling had been leaking for more than 6 months and that it was a major pipe that had leaked in multiple locations including the supply room and across the hallway. Staff #523 stated that replacement of the pipe was a major repair that would affect central supply function during the repair process.

5. On 05/28/19 at 10:15 AM, Surveyor #6 interviewed the Network Safety Coordinator (Staff #622), the Network Safety Manager (Staff #628) and the Facility Manager (Staff #629) about hospital procedures related to facility maintenance. Staff #628 stated that Environment of Care (EOC) Inspections are scheduled for all areas of the hospital - at least once per year in non-clinical areas, and at least twice per year in clinical areas. EOC Inspection reports are reviewed monthly by the EOC Committee. Copies of the inspection are released to department managers, who are expected to follow up on any identified concerns in their department.

The Network Safety Coordinator (Staff #622) described the work order process for repairs: Work order requests can be submitted by any staff member by completing a request on the hospital's intranet; then Facilities decides whether a repair can be completed immediately by staff, or whether the repair should become a project (requiring administrative approval).

6. On 05/28/19 at 4:00 PM, Surveyor #6 reviewed the most recent EOC inspection report for Materials Management/Central Supply/Receiving. The report showed:

a. An EOC Inspection on 10/24/17 included the following comment from Facilities: "Stained ceiling tiles in Central Supply must be replaced. Please cc Safety and IP when placing a work order for replacement." An undated Follow Up Comment stated, "Ceiling tiles have been replaced."

The inspection included the following comment from EVS (Environmental Services): "Stained ceiling tiles in Central Supply." An undated Follow Up Comment stated, "corrected."

b. The inspection report was released (to the department manager) on 12/11/17.

c. The inspection report was closed (any identified issues were resolved) on 01/03/18.

7. On 05/28/19 at 4:10 PM, during an interview with Surveyor #6, the Network Safety Manager (Staff #628) stated that hospital records show that the Central Supply storage room has not had an EOC Inspection since 10/24/17.

8. On 05/28/19 at 4:15 PM, Surveyor #6 requested copies of any work orders resulting from the 10/24/17 EOC Inspection report. The Facility Manager (Staff #629) stated that there was no record of a work order from that inspection report. He stated that it is common for staff to make simple repairs, such as replacement of a ceiling tile, without completing a work order.

9. On 05/29/19 at 10:20 AM, Surveyor #6 interviewed the Network Safety Coordinator (Staff #622), the Facility Manager (Staff# 629), the Inventory Control Coordinator (Staff #630), and the Central Supply Assistant Lead (Staff #631) about the ceiling leak repair in the Central Supply storage room. Staff #631 stated that sometime in September 2018 she noticed a ceiling tile above Supply Cart #8 was sagging and appeared wet. Staff #630 stated that a work order request was entered into the hospital's electronic system. Staff #629 stated that facilities staff identified a drip from a hot water supply pipe and created a temporary fix to capture and collect the leaking water. He stated that the permanent repair was sent out for bids sometime late 2018.

10. At the time of the interview, Surveyor #6 inspected the plumbing leak in the Central Supply storage room. The observation showed that the leak had been repaired. The hot water supply had been diverted and the leaking pipe was capped off. The plenum space (area above a dropped ceiling) appeared dry with no obvious evidence of mold. A new, clean ceiling tile had been installed.

11. On 05/29/19 at 11:00 AM, Surveyor #6 and the Facility Manager (Staff #629) reviewed Work Order # 2: Leak in ceiling in back corner of supply room in Central. The Work Order showed:

a. Actual Start data entry: 09/11/18; Actual Finish data entry 11/01/18. Staff #629 stated that the finish date entry is an error. The project is still open but the work was completed 05/17/19.

b. Log entry: 09/11/18 - Central Supply has leak in ceiling; 11/01/18 - pipe leak, (technician) handling it and has work order

12. On 05/29/19 at 3:00 PM, Surveyor #6 reviewed the following documents to determine a timeline of activity to repair the ceiling leak in the Central Supply storage room:

a. A work quote from an engineering and construction company, dated 02/21/19;

b. A time report from an industrial general construction company, dated 03/07/19;

c. A time report from the same industrial general construction company, dated 05/17/19

13. On 05/29/19 at 3:30 PM, Surveyor #6 reviewed EOC Committee Meeting Minutes from 09/11/18 through 05/14/19. The review showed the following:

a. 09/11/18: EOC rounds included Ceiling Tiles among the "Top 5 Unsatisfactory Items" for April and May (no year specified);

b. 10/09/18: EOC rounds included Ceiling Tiles among the "Top 5 Unsatisfactory Items" for May (no year specified);

c. 02/12/19: EOC rounds included Ceiling Tiles among the "Top 5 Unsatisfactory Items" for August 2018;

d. The Central Supply storage room leak was not specifically addressed in any of the 9 months of EOC Committee Meeting Minutes reviewed.

Item #2 Uncleanable Surfaces

Reference: Association of periOperative Registered Nurses (AORN) Guideline for Positioning the Patient, (2019) - "Recommendation IV.c. Perioperative team members should verify cleanliness, surface integrity, and correct function of positioning equipment, devices, and support surfaces before use. ... Loss of surface integrity can create a reservoir for the collection of dirt and debris that may be difficult or impossible to remove ... lead to bacterial growth. IV.c.1. Soiled, damaged or defective surfaces, devices, and equipment should be removed from service and cleaned, repaired, or replaced."

AORN Guideline for Design and Maintenance, (2019) - "Recommendation XII.a. The integrity of structural surfaces (e.g., doors, floors, walls, ceilings, cabinets) should be maintained, and surfaces should be repaired when damaged. ...XII.a.1. ...Damaged structural surfaces may create a reservoir for the collection of dirt and debris that cannot be removed during cleaning."

The United States Pharmacopeia Convention (2008), "(797) Pharmaceutical Compounding - Sterile Preparations, ... the surfaces of ceilings, walls, floors, fixtures, shelving, counters, and cabinets in the buffer area shall be smooth, impervious, free from cracks and crevices, and nonshedding, thereby promoting cleanability and minimizing spaces in which microorganisms and other contaminants may accumulate."

Findings included:

1. On 05/13/19 at 3:20 PM, during a tour of the Imaging Department with the Director of Imaging and Ancillary Services (Staff #601), the Manager of the Imaging Department (Staff #611), and the Imaging Department Supervisor (Staff #612), Surveyor #6 observed an MRI (magnetic resonance imagery) bed in the hallway across from the MRI unit. The observation showed large amounts of tape on all sides of the mattress, on the frame of the bed, and patient positioning pillows.

2. At the time of the observation, Surveyor #6 asked Staff #601, Staff #611, and Staff #612 about the use of tape on these surfaces. Staff #611 stated that the bed was used as a spare and agreed that taped surfaces are not cleanable.

3. On 05/14/19 at 10:30 AM, Surveyor #6 and the Director of Ancillary Services (Staff #601) observed a between case cleaning of Operating Room (OR) #8. The observation showed a rubber strip on one of the double doors leading to the core hallway was torn such that a long strip of rubber swung freely when the doors were opened.

4. On 05/14/19 at 11:10 AM, Surveyor #6 asked Staff #601 about the torn strip of rubber on the doors. Staff #601 stated that it should have been replaced.

5. On 05/14/19 at 4:00 PM, Surveyor #5 and a Pharmacy Tech (Staff #521) inspected the hospital's sterile compounding rooms. Surveyor #5 observed the following:

a. 4 areas of exposed drywall in the Ante Room;

b. Exposed drywall in the anteroom near the nonhazardous compounding room.

Drywall is absorbent and not a cleanable surface.

6. At the time of the observation, Staff #521 confirmed the finding.

7. On 05/14/19 between 5:45 PM and 8:15 PM, Surveyor #6, the Director of Ancillary Services (Staff #601), and the Environmental Services (EVS) evening supervisor (Staff #620) observed the terminal cleaning of Operating Room (OR) #8 by a member of the EVS staff (Staff #621). The observation showed a broken laminate surface on a computer desk that exposed an area of particle board. Particle board is an absorbent material and not a cleanable surface.

The observation showed areas of peeling paint and exposed wall board near the X-ray viewer. Wall board is an absorbent material and not a cleanable surface.

8. On 05/14/19 at 8:20 PM, Surveyor #6 interviewed Staff #621 about hospital procedures for reporting broken or damaged surfaces. Staff #621 stated that the uncleanable surfaces should have been reported to a supervisor.

9. On 05/15/19 at 2:00 PM, during a tour of the Broadway Outpatient Dialysis Center, Surveyor #6 inspected the clean utility storage room with the Columbia Network Safety Coordinator (Staff #622). Surveyor #6 observed 4 storage bins constructed of open-edged corrugated cardboard.

10. At the time of the observation, Surveyor #6 asked Staff #622 about the cleaning and sanitizing process for the cardboard bins. Staff #622 stated that the cardboard bins could not be sanitized properly and would be replaced with cleanable storage bins.

Item #3 Sanitary Storage of Patient Care Supplies

1. Document review of the hospital's policy titled, "Material and Equipment Storage," document number CRL. , reviewed 08/26/17, showed that medical supplies may not be stored in areas where contamination by chemicals, leaking pipes, hazardous waste, etc. could occur.

2. On 05/15/19 between 3:00 PM and 3:15 PM, during a tour of the Broadway Outpatient Behavioral Health, Surveyor #6 observed a sagging ceiling tile directly above patient medications stored on a supply cart in the medication room. The sagging ceiling tile allowed dust and debris to fall directly onto the patient medications.

3. At the time of the observation, the Outpatient Behavioral Health Program Nurse (Staff #623) stated she had not noticed the sagging tile.

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VIOLATION: SURGICAL SERVICES Tag No: A0940
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Based on observation, interview and document review, the hospital failed to ensure that surgical services were delivered according to regulatory requirements and acceptable standards of practice in 7 of 7 surgical patient observations.

Failure to ensure that each patient is provided with the care that meets acceptable standards of practice and meets or exceeds the health and safety of patients risks patient harm or patient death.

Observations, interviews, record reviews, and review of hospital policies and procedures, showed the following:

1. Failure to systematically verify the patient's identity prior to initiating an invasive procedure and to ensure staff members follow hospital policy for procedural attire places patients and staff at risk for developing infections.

Cross reference: A0951

2 . Failure to ensure that information required for clinical decision-making was readily accessible to all providers caring for the patient due to unknown or known co-morbid conditions.

Cross Reference: A0952
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VIOLATION: OPERATING ROOM POLICIES Tag No: A0951
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Based on observation, interview, and document review, the hospital failed to implement its policy and procedure for verification of the patient's identity prior to initiating surgical/invasive procedure, as demonstrated by 4 of 4 patients observed (Patient #504, #505, #802, and #803) (Item #1), the hospital failed to ensure that staff members followed hospital policy and accepted standards of practice for procedural attire in the hospitals Endoscopy Unit for 1 of 1 procedures observed (Patient #505) (Item #2), the hospital failed to disinfect and sterilize dental equipment according to surgical standards of practice (Item #3), and the hospital failed to to adhere to the manufacturer's instructions and national standards for use, disinfection, and storage of semi-critical medical devices (Item #4).

Failure to systematically verify the patient identity prior to initiating an invasive procedure risks medical errors and patient harm and to ensure staff members follow hospital policy for procedural attire places patients and staff at risk for developing infections.

Findings included:

Item #1 Surgical Time-Out

1. Document review of the hospital's policy and procedure titled, "Site Marking, Briefing, Time Out, and Debrief: Verification of Patient, Procedure and Procedure Site(s)," policy number 900.3.150, reviewed 01/22/19, showed that the "Time Out" occurs immediately prior to the start of the invasive procedure in the location where the procedure will be performed. During the "Time Out," each team member must agree to the correct patient using two patient identifiers including the patient's full name and date of birth as listed on the armband. If the armband is not accessible after draping, staff are to verify the armband with a patient sticker label prior to positioning and draping. The matched patient sticker label will be placed somewhere on or near the patient and will be visible to staff during the procedure.

2. On 05/13/19 at 1:00 PM, Surveyor #5 observed the Operating Room (OR) staff perform the "Time Out" prior to the invasive procedure for Patient #504, who was admitted for an exam under anesthesia for acute rectal bleeding. Surveyor #5 observed that after the patient was prepped and draped the staff started the "Time Out" procedure. At that time, the Circulating Nurse (Staff #513) read the patient procedure consent, name, and age from the charting desk in the operating room. The remaining staff in the OR including the anesthesiologist and surgeon verbally agreed. The patient's armband was located on the left wrist and visible (not covered by draping). Staff failed to verify the patient's identification using the patient's armband during the "Time Out" verification process.

3. Immediately following the observation, Surveyor #5 asked the Circulating Nurse (Staff #513) if patient verification was part of the "Time Out" verification process. She stated she had verified the patient in the holding area.

4. On 05/14/19 at 9:42 AM, Surveyor #5 observed the Endoscopy staff (Staff #514, #515, and #516) perform the "Time Out" verification procedure prior to an invasive procedure for Patient #505 who was admitted for a routine colonoscopy. Surveyor #5 observed that after the patient was prepped and draped, the staff started the "Time Out" verification process. At that time, a Registered Nurse (Staff #515) read the patient procedure, verified consent, and stated the patients name, and age. Staff failed to verify the patient's identification using the patient's armband during "Time Out" verification process.

5. On 05/14/19 at 10:55 AM, Surveyor #5 exited the room and discussed the observation with the Endoscopy Nurse Manager (Staff #517). Staff #517 stated that the patient's identity is verified in the pre procedure area and she would need to review the hospital policy.

6. On 05/14/19 at 8:20 AM, Surveyor #8 observed a Dialysis Tech (Staff #810) prepare to initiate dialysis for patient #802. The tech asked the patient to state her name and date of birth to validate her identity prior to dialysis. The technician failed to check the information against the patient's armband.

7. At the time of the observation, Surveyor #8 interviewed the Dialysis Manager (Staff #811). Staff #811 acknowledged the finding.

8. On 05/28/19 at 2:44 PM, Surveyor #8 observed the lumbar injection procedure for Patient #803. The observation showed that after the patient was prepped and draped Staff #816 stated the patient's identity, allergies and the name of the procedure. The remaining staff verbally agreed. The staff failed to verify the patient's identity using the patient's arm band during the verification process.

9. Surveyor #8 interviewed the Charge Nurse (Staff #812) following the procedure regarding the time out observation. Staff #812 confirmed that the staff were not following hospital policy.

Item #2 Attire

1. Document review of the hospital's document titled, "Clinical Skills Endoscopic Therapy-CE," Elsevier Performance Manager Clinical Skills, copyright 2019, showed that all assistants will wear personal protective equipment including eye protection, nonsterile gloves and barrier gowns.

Document review of the hospitals policy and procedure titled, "Surgical Attire Policy," policy number 900.2.146, no effective date/review date, showed that personnel in semi-restricted areas will cover the head, hair, and facial hair with a surgical head cover. Surgical masks cover the mouth and nose and must be worn in combination with eye protection devices whenever splashes, spray, spatter, or droplets of blood, body fluids, or other potentially infections materials may be generated.

2. On 03/14/19 at 10:40 AM, Surveyor #5 observed Endoscopic Colonoscopy procedure (endoscopic examination of the large bowel and the distal part of the small bowel with a camera on a flexible tube passed through the anus) for Patient #505. Surveyor #5 observed the following:

a. The Registered Nurse (RN) (Staff #516) assisting in the procedure wore her mask under her chin with her mouth and nose exposed. Staff #516 did not wear a barrier gown or head covering.

b. The physician (Staff #514) performing the procedure did not wear a mask, head covering, or barrier gown.

3. On 03/14/19 at 10:50 AM, during interview with Surveyor #5, the Endoscopy Manager (Staff #517) stated that the nurse should have worn her mask over her nose mouth. Staff #517 stated that staff in the Endoscopy unit wore hospital scrubs during procedures not barrier gowns. During further discussion, Staff #517 stated that the hospital followed The Society of Gastroenterology Nurses and Associates (SGNA) for their policies and procedures to guide practice in the Endoscopy Unit. At this time, Surveyor #5 asked for the hospitals policy and procedures related to attire. Surveyor #5 was only provided a document for clinical skills by Elsevier.

Item #3 Equipment Disinfection and Sterilization

Reference:
Centers for Disease Control CDC), "Infection Prevention & Control Guidelines and Recommendations: Summary of Infection Prevention Practices in Dental Settings: Basic Expectations for Safe Care" (Published 10/16): "Reprocess heat-sensitive critical and semi-critical instruments by using FDA-cleared sterilant/high-level disinfectants or an FDA-cleared low-temperature sterilization method (e.g., ethylene oxide). Follow manufacturer's instructions for use of chemical sterilants/high-level disinfectants

1. Document review of the hospital's policy and procedure titled, "Loaner Instrumentation," policy number, 402.30.27, reviewed 10/16/14, showed that all loaner instruments, instruments not owned by or stored in the facility must be received, inspected, recorded, decontaminated, and sterilized in the Sterile Processing Department (SPD) and returned to SPD following the procedure for decontamination and cleaning,

2. On 05/13/19 at 10:45 AM, Surveyor #5, the Chief Medical Officer (CMO) (Staff #501), the Operating Room Nurse Manager (Staff #502), and the Operating Room Charge Nurse (Staff #503) inspected a "Dental Cart" located in the sub-sterile room located between Operating Room (OR) #1 and #2. Surveyor #5 observed:

-1 dental drill head in a cardboard box;
-1 unpackaged dental dispenser lying in the bottom of a plastic drawer;
-1 unpackaged unknown metal dental tool;
-2 unpackaged metal dental extraction tools with black electrical type tape on the handles that were partially untapped.

3. At the time of the finding, Staff#502 stated that it was hospital policy that all dental tools are reprocessed by the hospital's central sterile and that the Dentist should not be bringing in equipment from his office. She was unable to identify if the dental tools/equipment were clean or if they had been used.

Item #4 Cleaning, Disinfection and Storage of Multiuse Dental Supplies

References:

U.S. Food and Drug Administration, "Multiple-Use Dental Dispenser Devices" (Updated 12/05/17): "Contamination or infection control issues arise for patients when the body or housing of multiple-use dental dispensers comes in contact with a previous patient's cheek or lips, or when the dispenser is handled by a dental practitioner whose gloves have become contaminated with previous patient's blood or saliva. According to the Centers for Disease Control and Prevention (CDC), devices that come in contact with mucous membranes of the mouth are classified as "semi critical" depending on the potential risk for infection associated with their intended use. CDC recommends that once a device in this category (such as a dental dispenser) becomes contaminated, it should be heat sterilized or subjected to immersion in a high-level chemical disinfectant. However, multiple-use dental dispensers cannot be reprocessed using heat sterilization (e.g., steam autoclave) or immersion in high-level disinfectants because this may damage the dispenser or material contained in the dispensers. Also, the FDA does not believe that these devices, once contaminated, can be adequately disinfected by wiping with a chemical disinfecting solution. Therefore, the FDA recommends disposal of contaminated multiple-use dental dispensers in order to avoid the risk of cross-contamination to patients .....DO: Apply disposable barrier sleeves/wraps over multiple-use dental dispensers before use with each patient. (Do) Use new, uncontaminated gloves when handling multiple-use dental dispensers. DO NOT: Reuse the multiple-use dental dispenser if it becomes contaminated. (DO NOT) Reprocess a contaminated multiple-use dental dispenser by using chemical wipes or disinfectants.

Ultradent Product insert: Visostat (astringent hemostatic 15.5% ferric sulfate), (Copyright 2011): 13. All syringe tips and empty syringes are disposable product and for single use only to avoid cross-contamination ... Fill an empty syringe with the amount of materiel needed for the individual patient. Dispose of syringe after use. 14. Prefilled syringes can be used several times, when protected during each use by syringe covers .....Re-cap syringe with the LeuerLock Cap and disinfect syringe with an intermediate level.

Findings included:

1. On 05/13/19 at 10:45 AM, Surveyor #5, the Chief Medical Officer (CMO) (Staff #501), the Operating Room Nurse Manager (Staff #502), and the Operating Room Charge Nurse (Staff #503) inspected a "Dental Cart" located in the sub-sterile room located between Operating Room (OR) #1 and #2. Surveyor #5 observed:

-3 partially filled multi use syringes of Visostat (a medication used for hemostasis) with the applicator tip attached. The syringes with the applicators attached were unpackaged and laying in the bottom of the plastic bin. Surveyor #5 observed the original syringe leurlock cap in the bin with the syringes. Surveyor #5 found no evidence of disposable barrier sleeves or wraps stored in the dental cart for use.

2. At the time of the observation, Surveyor #5 asked Staff #502 and #503 if the partially used syringes with attached applicator were clean or dirty and to describe the hospitals procedure for cleaning and storage of the syringes after use. Staff #502 and #503 stated that they did not know. Surveyor #5 asked for a policy to direct staff on how to appropriately clean the syringe after patient use.

3. On 05/14/19 at 4:30 PM, Surveyor #5 asked a Quality Manager (Staff #512) for all policies related to Dental care/surgery the Operating Room. Surveyor #5 was provided with a Staffing Policy.

4. On 05/15/19 at 5:00 PM, Surveyor #5 again asked for the Hospital's policy regarding cleaning and storage of multiuse dental syringes. A Quality Manager (Staff #520) stated that the policies were being reviewed to ensure they were the most recent policies. The hospital did not provide the Surveyor with these policies.


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VIOLATION: HISTORY AND PHYSICAL Tag No: A0952
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

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Based on interview and document review, the hospital staff failed to record a complete history and physical (H&P) in the patient's medical record prior to an invasive dental procedures requiring anesthesia for 3 of 4 patients reviewed (Patient #507, #508, and #509) and failed to ensure that the pre-operative medical history and physical (H&P) was completed prior to the start of the procedure for Patient #803.

Failure to ensure that information required for clinical decision-making was readily accessible to all providers caring for the patient risks poor health outcomes due to unknown or known co-morbid conditions.

Findings included:

Item #1 History and Physical

1. Document review of the hospital's document titled, "Medical Staff Rules and Regulations of Peacehealth St. John Medical Center," approved 06/13/17, showed that a history and physical includes:

History
a. Chief complaint
b. Present illness, including, when appropriate, assessment of emotional behavioral, social status
c. Relevant past medical and surgical history, appropriate to age of patients
d. Medications
e. Allergies
f. Systems Review as pertaining to chief complaint
g. Vital signs

Physical
a. Vital signs
b. HEENT (head, eyes, ears, nose, throat)
c. Heart
d. Lungs
e. Other organ systems assessments pertaining to chief complaint
f. Labs/imaging, if available
g. Working Diagnosis and planned action

The document showed that for patients admitted for dental care in the operation room the History and Physical is a dual responsibility involving the Dental/Oral maxillofacial Surgeon staff member and a privileged Licensed Independent Practitioner (LIP). It is the LIP's responsibility to perform the medical history and physical. However, a dentist who has completed a hospital based General Practice Dental Residency Program may perform the medical history and Physical for patients with no complicating medical conditions.

2. On 05/14/19, Surveyor #5 and an Electronic Health Record Support Specialist (Staff #528) reviewed the medical records for 4 patients who had received dental surgery in the hospital's operating rooms. The record review showed the following:

a. Patient #507 was a [AGE]-year-old developmentally delayed patient who was admitted on [DATE] for the surgical treatment of a dental alveolar abscess, swelling, and edema coming from the oral cavity under general anesthesia. The Dental Surgeon (Staff #529) failed to perform a medical history and physical or identify current medications as directed by hospital policy.

b. Patient #508 was an [AGE]-year-old patient who was admitted on [DATE] for the surgical removal of an impacted tooth under general anesthesia. The Dental Surgeon (Staff #529) failed to perform a medical history and physical or identify current medications as directed by hospital policy.

c. Patient #509 was a [AGE]-year-old patient who was admitted on [DATE] for the surgical treatment of intra oral infection and multiple tooth extractions under general anesthesia. The Dental Surgeon (Staff #529) failed to perform a medical history and physical or identify current medications as directed by hospital policy.

3. At the time of the observation, Staff #528 confirmed the findings.

Item #2 History and Physical Update

1. Document review of the hospital's policy and procedure titled, "Moderate Sedation/Analgesia Procedure," Policy number 900.2.138, effective 6/08/18, showed that a current medical history and physical must be documented prior to the procedure.

Document review of the hospital's policy titled, "Medical Staff Bylaws and Policies of Peacehealth," adopted 6/12/18 showed in Appendix B, that a complete medical history and physical examination must be completed and in the patient's medical record prior to surgery.

2. On 05/28/19 at 2:42 PM, Surveyor #8 observed a L4-5 Lumbar Interlaminar Epidural Steroid Injection with fluoroscopic guidance for Patient #803 a [AGE] year old woman. During the procedure the Registered Nurse (RN) viewing the cardiac monitor stated that the patient was in atrial fibrillation. The Surgeon, (Staff #817) commented to the patient that the atrial fibrillaton was new since the patient's last procedure in March. The patient confirmed and stated she has had [DIAGNOSES REDACTED]on and off since she had heart surgery and that she hasn't been on any medications.

3. On 05/28/19 at 3:06 PM, Surveyor #8 discussed the observations with the Ambulatory Care Unit Manager (ACU) (Staff #812). The ACU manager reviewed the electronic medical record and found no history and physical in the chart. The ACU manager also found no previous history of the cardiac arrhythmia, atrial fibrillation.

4. Surveyor #8 asked the RN (Staff #813) if a preoperative review of the chart is standardly performed so that the previous cardiac history would be known and reviewed prior to surgery. Hospital Staff #813 provided a document titled, "Standard Work: Prescreening and Pre-calls..." revised 01/2018, Item #9 showed that for all patients if an H&P was not done within 30 days and the patient is not to be scheduled for a preoperative appointment then staff are directed to report it.
VIOLATION: FACILITIES, SUPPLIES, EQUIPMENT MAINTENANCE Tag No: A0724
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Based on document review, observation, and interview, the hospital failed to store patient care supplies such that they are protected from contamination.

Failure to provide sanitary storage of patient care supplies places patients at risk of substandard care due to contaminated patient care supplies.

Findings included:

1. Document review of the hospital's policy titled, "Material and Equipment Storage," document number CRL. , reviewed 08/26/17, showed that medical supplies may not be stored in areas where contamination by chemicals, leaking pipes, hazardous waste, etc. could occur.

2. On 05/14/19 from 9:30 AM until 10:30 AM, Surveyor #5, the Director of Facilities (Staff #522), a Facilities Engineer (Staff #523), and the Inventory Control Coordinator (Staff #524) inspected a plumbing leak in the Central Supply storage area. The observation showed clean patient care supplies in contact with a drip collection container on the top shelf of Central Supply Cart #8.

3. At the time of the observation, the Director of Facilities (Staff #522) and the Facilities Engineer (Staff #523) stated that the pipe had been leaking for more than 6 months, and had leaked in multiple locations including the clean linen supply room and across the hallway.

4. On 05/15/19 between 3:00 PM and 3:15 PM, during a tour of the Broadway Outpatient Behavioral Health, Surveyor #6 observed a sagging ceiling tile directly above patient medications stored on a supply cart in the medication room. The sagging ceiling tile allowed dust and debris to fall directly onto the patient medications. The Outpatient Behavioral Health Program Nurse (Staff #623) stated she had not noticed the sagging tile.

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VIOLATION: INFECTION CONTROL Tag No: A0747
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Based on observation, interview, and document review, the hospital failed to develop and implement an effective infection prevention and control program that ensures appropriately cleaned, disinfected, or sterilized instruments, a sanitary environment, and use of effective patient care supplies.

Failure to adhere to an effective infection prevention and control program puts patients, staff, and visitors at risk of illness from communicable diseases.

Observations, interviews, record reviews, and review of hospital policies and procedures, showed the following:

The hospital failed to monitor and implement an effective infection prevention program that included the following:

1. Failure to receive, inspect, inventory, decontaminate, sterilize, and reprocess medical devices;

Cross Reference: A0749

2. Failure to implement effective hand hygiene infection control;

Cross Reference: A0749

3. Failure to maintain the facility in a safe and sanitary condition and protect patient care supplies from sources of contamination;

Cross Reference: A0724, A0701

4. Failure to implement a quality control system to prevent use of expired patient care supplies.

Cross Reference: A0749

Due to the scope and severity of deficiencies cited under 42 CFR 482.42, the Condition of Participation for Infection Control was NOT MET.

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VIOLATION: INFECTION CONTROL OFFICER RESPONSIBILITIES Tag No: A0749
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Based on observation, document review, and interview, the hospital failed to receive, inspect record, decontaminate, sterilize, and reprocess medical devices according to hospital policy (Item #1), failed to adhere to the manufacturer's instructions and national standards for use, disinfection, and storage of semi-critical medical devices (Item #2), failed to ensure that hospital staff performed hand hygiene (HH) according to hospital procedure and accepted standards of practice (Item #3), failed to develop and implement a quality control system to prevent the use of patient care supplies that exceeded the manufacturer's expiration date (Item #4), and failed to provide a sanitary environment to protect patient care supplies from sources of contamination (Item #5).

Failure to follow national standards of practice, manufacturer's instructions, and the hospital's policy and procedure instructions for cleaning medical devices, and reusing multiple use supplies, failure to ensure staff performs hand hygiene, and failure to ensure patient care supplies are sanitary and not expired risks ineffective patient care and treatment, and potential patient harm.

Findings included:

Item #1 Sterilization and Decontamination of Dental Equipment

Reference:

Centers for Disease Control CDC), "Infection Prevention & Control Guidelines and Recommendations: Summary of Infection Prevention Practices in Dental Settings: Basic Expectations for Safe Care" (Published 10/16): "Reprocess heat-sensitive critical and semi-critical instruments by using FDA-cleared sterilant/high-level disinfectants or an FDA-cleared low-temperature sterilization method (e.g., ethylene oxide). Follow manufacturer's instructions for use of chemical sterilants/high-level disinfectants.

1. Document review of the hospital's policy and procedure titled, "Loaner Instrumentation," policy number, 402.30.27, reviewed 10/16/14, showed that all loaner instruments, instruments not owned by or stored in the facility must be received, inspected, recorded, decontaminated, and sterilized in the Sterile Processing Department (SPD) and returned to SPD following the procedure for decontamination and cleaning.

2. On 05/13/19 at 10:45 AM, Surveyor #5, the Chief Medical Officer (CMO) (Staff #501), the Operating Room Nurse Manager (Staff #502), and the Operating Room Charge Nurse (Staff #503) inspected a dental cart located in the sub-sterile room between Operating Room (OR) #1 and #2. Surveyor #5 observed:

-1 dental drill head in a cardboard box;

-1 unpackaged dental dispenser lying in the bottom of a plastic drawer;

-1 unpackaged metal dental tool (name and use unknown);

-2 unpackaged metal dental extraction tools with black electrical type tape on the handles that were partially un-taped.

3. At the time of the observation, Staff #502 stated that it was hospital policy that all dental tools are reprocessed by the hospital's central sterile and that the dentist should not be bringing equipment from his office. She was unable to identify if the dental tools/equipment were clean or if they had been used.

Item #2 Cleaning, Disinfection and Storage of Multiuse Dental Supplies

References:

U.S. Food and Drug Administration, "Multiple-Use Dental Dispenser Devices" (Updated 12/05/17): "Contamination or infection control issues arise for patients when the body or housing of multiple-use dental dispensers comes in contact with a previous patient's cheek or lips, or when the dispenser is handled by a dental practitioner whose gloves have become contaminated with previous patient's blood or saliva. According to the Centers for Disease Control and Prevention (CDC), devices that come in contact with mucous membranes of the mouth are classified as "semi critical" depending on the potential risk for infection associated with their intended use. CDC recommends that once a device in this category (such as a dental dispenser) becomes contaminated, it should be heat sterilized or subjected to immersion in a high-level chemical disinfectant. However, multiple-use dental dispensers cannot be reprocessed using heat sterilization (e.g., steam autoclave) or immersion in high-level disinfectants because this may damage the dispenser or material contained in the dispensers. Also, the FDA does not believe that these devices, once contaminated, can be adequately disinfected by wiping with a chemical disinfecting solution. Therefore, the FDA recommends disposal of contaminated multiple-use dental dispensers in order to avoid the risk of cross-contamination to patients .....DO: Apply disposable barrier sleeves/wraps over multiple-use dental dispensers before use with each patient. (Do) Use new, uncontaminated gloves when handling multiple-use dental dispensers. DO NOT: Reuse the multiple-use dental dispenser if it becomes contaminated. (DO NOT) Reprocess a contaminated multiple-use dental dispenser by using chemical wipes or disinfectants."

Ultradent Product insert: Visostat (astringent hemostatic 15.5% ferric sulfate), (Copyright 2011): 13. All syringe tips and empty syringes are disposable product and for single use only to avoid cross-contamination ... Fill an empty syringe with the amount of materiel needed for the individual patient. Dispose of syringe after use. 14. Prefilled syringes can be used several times, when protected during each use by syringe covers .....Re-cap syringe with the LeuerLock Cap and disinfect syringe with an intermediate level.

1. On 05/13/19 at 10:45 AM, Surveyor #5, the Chief Medical Officer (CMO) (Staff #501), the Operating Room Nurse Manager (Staff #502), and the Operating Room Charge Nurse (Staff #503) inspected a "Dental Cart" located in the sub-sterile room between Operating Room (OR) #1 and #2. Surveyor #5 observed:

-3 partially filled multi use syringes of Visostat (a medication used for hemostasis) with the applicator tip attached. The syringes with the applicators attached were unpackaged and laying in the bottom of the plastic bin. Surveyor #5 observed the original syringe leurlock cap in the bin with the syringes. Surveyor #5 found no evidence of disposable barrier sleeves or wraps stored in the dental cart for use.

2. At the time of the observation, Surveyor #5 asked Staff #502 and #503 if the partially used syringes with attached applicator were clean or dirty and to describe the hospitals procedure for cleaning and storage of the syringes after use. Staff #502 and #503 stated that they did not know. Surveyor #5 asked for a policy to direct staff on how to appropriately clean the syringe after patient use.

3. On 05/14/19 at 4:30 PM, Surveyor #5 asked a Quality Manager (Staff #512) for all policies related to Dental care/surgery in the Operating Room. Surveyor #5 was provided with a Staffing Policy.

4. On 05/15/19 at 5:00 PM, Surveyor #5 asked again for the Hospital's policy regarding cleaning and storage of multiuse dental syringes. A Quality Manager (Staff #520) stated that the policies were being reviewed to ensure they were the most recent policies. The hospital did not provide the Surveyor with these policies.

Item #3 Hand Hygiene

1. Review of the hospital's document titled, "Isolation Procedure," procedure number 900.3.135, reviewed 09/18, showed that isolation procedures describe precautionary measures, including hand hygiene, to protect patients, caregivers, and others from exposure to potentially pathogenic microorganisms. Indications for hand hygiene include the following:

a. Before and after patient contact;

b. Upon entering and leaving a patient room or area;

c. Before donning gloves;

d. After removing gloves;

e. After contact with objects and surfaces in the patient areas.

2. On 05/13/19, Surveyor #5 observed the surgical preparation for Patient #504 and observed the following:

a. At 12:44 PM, the Surgeon (Staff #518) removed his gloves and then opened a storage closet and removed foam tape. Staff #518 failed to perform hand hygiene after removing his gloves.

b. At 12:45 PM, Staff #518 used the foam tape to tape the patient's genitals away from the rectum so staff could complete a surgical prep. Staff #518 failed to use gloves during this process.

c. At 12:46 PM, Staff #518 walked to the operating room entrance, collected gloves from a box near the doorway, and donned the pair of gloves. Staff #518 failed to perform hand hygiene after the body positioning prior to donning gloves.

d. At 12:48 PM, Staff #518 removed his gloves, opened the door to the operating room, and exited the room. Staff #518 failed to perform hand hygiene after removing his gloves.

3. On 05/14/19 at 9:30 AM, during a tour of the Sterile Processing Department with the Director of Ancillary Services (Staff #601) and the Nurse Manager of OR (Staff #502), and Sterile Processing (Staff #605), Surveyor 6 observed a Sterile Processing Technician (Staff #606) don latex gloves without performing hand hygiene.

4. At the time of the observation, Surveyor #6 asked Staff #601 and Staff #605 about the hospital's policy regarding hand hygiene. Staff #605 stated that the hospital expected staff to perform hand hygiene prior to donning gloves.

5. On 05/14/19, during observation of an Endoscopy procedure for Patient #505, Surveyor #5 observed the following:

a. At 10:42 AM, the Registered Nurse (Staff #515) removed her gloves and then assembled the patient medication. Staff #515 failed to perform hand hygiene after removing her gloves.

b. At 10:43 AM, Staff #515 donned a pair of gloves and administered the patient medication. Staff #515 failed to perform hand hygiene prior to donning new gloves.

c. At 10:44 AM, the Physician (Staff #514), dropped a cap onto the floor, picked it up, removed his gloves, and donned a new pair. Staff #514 failed to perform hand hygiene between the glove changes.

d. At 10:45 AM, Staff #514 used lubricant to prep the patient's rectum for the procedure, removed his gloves, and immediately donned a new pair. Staff #514 failed to perform hand hygiene between glove changes.

6. At 10:55 AM, Surveyor #5 exited the room and discussed the observation with the Endoscopy Nurse Manager (Staff #517). Staff #517 stated that staff should perform hand hygiene between glove changes.

Item #4 Expired and Unusable Sterile and NonSterile Supplies

1. On 05/13/19 at 10:45 AM, Surveyor #5, the Chief Medical Officer (CMO) (Staff #501), the Operating Room Nurse Manager (Staff #502), and the Operating Room Charge Nurse (Staff #503) inspected a dental cart located in the sub-sterile room between Operating Room (OR) #1 and #2. Surveyor #5 observed expired and unusable supplies including:

Expired Supplies:

-1 partially used box of non-latex Dental Dams with a manufacturer's expiration date of 03/06;

-1 bottle of Supreme Restorative with a manufacturer's expiration date of 06/06;

-1 bottle Supreme Restorative with a manufacturer's expiration date of 08/08;

-1 partially used box of Oral Dental Dams with a manufacturer's expiration date of 04/09;

-1 syringe Dycal Radiopaque composite with a manufacturer's expiration date of 05/09;

-1 partially used box of Oral Dental Dams with a manufacturer's expiration date of 09/09;

-1 partially used box of non-latex Dental Dams with a manufacturer's expiration date of 12/10;

-5 cards of Absorbent Points with a manufacturer's expiration date of 03/11;

-1 partially used box of non-latex Dental Dams with a manufacturer's expiration date of 08/11;

-1 bottle of Opti Bond Adhesive with a manufacturer's expiration date of 01/13;

-1 partially used box of non-latex Dental Dams with a manufacturer's expiration date of 03/14;

-1 package sterile gloves, size 8, with a manufacturer's expiration date of 12/14;

-1 package sterile gloves, size 8, with a manufacturer's expiration date of 02/16;

-1 bottle rubbing alcohol with a manufacturer's expiration date of 08/16;

-1 can tool conditioner with a manufacturer's expiration date of 02/17;

-1 bottle of Opti Bond Adhesive with a manufacturer's expiration date of 03/17;

-2 bottles "ESPE" with a manufacturer's expiration date of 06/17;

-7 red top vacutainers with a manufacturer's expiration date of 11/17;

-1 Helio Molar Syringe with a manufacturer's expiration date of 05/18;

-3 Vacurette tubes with a manufacturer's expiration date of 07/18;

-1 bottle Vitribond 5.5 mL with a manufacturer's expiration date of 08/18;

-1 Gelfoam with a manufacturer's expiration date of 02/19;

-1 Yankaur Suction with a manufacturer's expiration date of 03/19;

-1 Elongation Tip with a manufacturer's expiration date of 03/19;

-3 red top vacutainers with a manufacturer's expiration date of 03/19.

Unusable supplies:

-1 butterfly needle set - package integrity compromised with unknown moist sticky substance;

-Unpackaged Orthodontic - wire laying in the bottom of a plastic drawer that was littered with debris;

-Unpackaged metal fittings - laying in the bottom of a plastic drawer that was littered with debris;

-Composite strips - wet with spilled mouthwash.

3. At the time of the observation, Staff #501, #502 and #503 confirmed the finding. Staff #502 and #503 stated that the OR was not responsible for the dental cart or procedures.

4. On 05/14/19 between 2:30 PM and 3:30 PM, Surveyor #6 toured the Emergency Department (ED) with the Director of Ancillary Services (Staff #601) and the Director of Nursing ICU, Emergency, Trauma (Staff #607). Surveyor #6 observed the following items that had exceeded their manufacturer's expiration date:

-Resource Thicken Up (a dietary thickener), 0.05 oz. packets - approximately 50, expired 04/19;

-Similac Soy Isomil (a baby formula), 2 fluid ounce bottles - 5 expired 05/01/19, 4 expired 01/01/19.

5. At the time of the observations, Staff #607 stated that the expired supplies must have been overlooked during safety rounds.

6. On 05/14/19 between 5:45 PM and 8:20 PM, Surveyor #6, the Director of Ancillary Services (Staff #601) and the Environmental Services (EVS) Evening Supervisor (Staff #608) observed the terminal cleaning of Operating Room (OR) #6. The observation showed an Intravenous (IV) catheter with a manufacturer's expiration date of 01/19 taped to the anesthesia supply cart.

Item #5 Patient Care Supplies Protected from Sources of Contamination

1. Document review of the hospital's policy titled, "Material and Equipment Storage," document number CRL. , reviewed 08/26/17, showed that medical supplies may not be stored in areas where contamination by chemicals, leaking pipes, hazardous waste, etc. could occur.

2. On 05/14/19 from 9:30 AM until 10:30 AM, Surveyor #5, the Director of Facilities (Staff #522), a Facilities Engineer (Staff #523), and the Inventory Control Coordinator (Staff #524) inspected a plumbing leak in the Central Supply storage area. The observation showed clean patient care supplies in contact with a drip collection container on the top shelf of Central Supply Cart #8.

3. At the time of the observation, the Director of Facilities (Staff #522) and the Facilities Engineer (Staff #523) stated that the pipe had been leaking for more than 6 months, and had leaked in multiple locations including the clean linen supply room and across the hallway.

4. On 05/15/19 between 3:00 PM and 3:15 PM, during a tour of the Broadway Outpatient Behavioral Health, Surveyor #6 observed a sagging ceiling tile directly above patient medications stored on a supply cart in the medication room. The sagging ceiling tile allowed dust and debris to fall directly onto the patient medications. The Outpatient Behavioral Health Program Nurse (Staff #623) stated she had not noticed the sagging tile.

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