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Based on observation, interview and record review, it was determined that the hospital governing body failed to ensure:

1. Patient 37 who expressed wishing to die on admission and was not found with a call light cord wrapped around his neck four days later. (Refer to A144)

2. Patients 1, 24, and 25 had physician's orders prior to the use of hand mittens as stated in the hospital's policy. (Refer to A168)

3. The hospital's policies and procedures were implemented to ensure a sanitary environment and avoid sources of transmission of infections and communicable diseases. (Refer to A747)

The cumulative effect of these systemic problems resulted the hospital's inability to ensure the provision of quality health care in a safe environment.

Based on observation, interview, and record review, the facility failed to follow current standards of practice and ensure patient safety. Patient 34 was not wearing a yellow band around the wrist indicating the patient at risk for fall. Patient 37 expressed during admission wishing to die and four days later, the patient was found with a call light cord wrapping around his neck.

The deficient practice had the potential for patients injuries.

Findings:

1. A review of Patient 37's medical record indicated that the patient was admitted to the facility on 11/21/2017. A review of the document titled, 'Emergency Provider Note', dated 11/21/17 at 15:20, included "He (Patient 37), states he wants to die". A review of a nursing document, dated 11/21/2017 at 15:23, titled 'ED suicide/Homicide Risk Screen', indicated, "ED suicide Risk Screen Current Ideation within the last 6 months: No", and Past attempts (at suicide) No."

A review of an addendum, entered into Patient 37's medical record on 11/25/17, at 8 A.M., indicated that Patient 37 was found unresponsive during bedside handoff with the call light cord wrapped around his neck. Code blue initiated. Patient 37 was transferred to intensive care unit (ICU).

A review of a facility's policy and procedure titled, "Suicide risk Assessment and Prevention", dated 10/2017, indicated that all patients are screened for suicide risk on admission. A facility policy addendum dated, 3/2018, titled "Addendum to the Regional Policy for Suicide Risk assessment and Prevention", indicated that "if a patient expresses a wish to die, the caregiver should immediately report this to the supervisor, the patient's nurse, or the patient's physician.



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2. During a tour of one of the facility's medical/surgical units on 9/11/2018 at 8:45 AM, accompanied by the Quality Manager, one of the room for Patient 34 was marked with the notation 'Fall Risk' just outside the doorway to the room. The patient in the room, Patient 34, had a white band with his identifying information (name and patient identifier) on his wrist.

During a conversation with Registered Nurse (RN 1) at that time, RN 1 stated that the sign on the wall outside of the patient's room indicated that the patient had been assessed as having the potential to fall if left unassisted during ambulation or transferring from the bed. RN 1 stated there should be a yellow band around the patient's wrist, indicating the patient was at risk for fall.

A review of the patient census data for Patient 34, dated 9/11/2018, indicated the patient had diagnoses that included: ST segment depression (an abnormality in the heart rhythm that may lead to infarction or obstruction of blood flow to a part of the heart), sepsis (a systemic infection leading to possible destruction of body organs), urinary tract infection, and high blood pressure.

The facility's "Fall Risk Assessment and Prevention" policy indicated that patients at high risk for falls may include those over the age of 85, those with frailty due to a medical condition, patients with history of orthopedic conditions, with bleeding disorders, or those on anti-coagulation therapy.

Based on observation, interview, and record review, the facility failed to provide bathing to Patient 33.

This deficient practice had the potential for the patient to have poor personal hygiene.

Findings:

During a tour of the Medical/Surgical unit in the facility, accompanied by the Quality Manager on 9/11/2018 at 8:45 AM, Patient 33 was sitting in a chair at her bedside. She was in her hospital gown at that time when she stated that she had been in the hospital for ten (10) days and had just undergone a second surgical operation. She further stated that she had her hair washed intermittently but had not had a bath since being admitted to the facility.

When asked at that time, Registered Nurse 1 (RN 1) stated that the nursing record showed that Patient 33 had not had a bath today but that she would make sure she would be bathed today. RN 1 stated the patients were normally given baths daily. She subsequently declared that while there is no specific hospital policy regarding patient hygiene, she referred to printed Certified Nursing Assistant (CNA) day shift and night shift routines.

According to the "CSS4 CNA Routine - Day Shift", one of the CNA's responsibilities is to discuss the plan of the day for the patient as well as communicate when a bath will be given.

According to "CSS4 CNA Routine - Night Shift" indicated some of the CNA's duties incorporate the following: at 24:00 - 04:00 (12 midnight - 4 AM) is to give bath to at least one patient during the night shift to a full care patient. It continues to state that baths are done on full care patients at least one per night shift; this is an expectation, not a courtesy. It is expected that whiteboards (dry erase boards for updating patient care plan in patient rooms) will be updated as to when a bath is given. (There was no indication of bath given at that time.)

Based on observation, interview, and record review, the facility failed to ensure a physician order was obtained, prior to placing hand mittens three of 31 sampled patients (Patients 1, 24 and 25).

This deficient practice had potential for the physician being unaware the bilateral hand mittens had been placed on the patient and place the patients at risk of poor blood circulation and patient injury associated with the use of hand mittens.

Findings:

1. On 9/11/18 at 11:20 a.m., during a tour of the Intensive Care Unit (ICU), Patient 1 was observed lying in bed. The patient was restless, and was muttering unintelligibly. There was a Finger Control Mitt on each of the patient's hands. During an interview at the same time, Registered Nurse 1 (RN 1) stated the patient was confused, and previously had bilateral wrist restraints that were discontinued the prior day, after he was extubated (removal of breathing tube from the airway). When questioned if there was an order for the hand mittens, RN 1 stated an order was not required for hand mittens because the hospital policy indicated that hand mittens were not considered to be a restraint.

A review of the package insert for Posey Finger Control Mitts, indicated "Rx ONLY" (According to Collins Dictionary of Medicine, "Rx" is a symbol used as the heading of a prescription for medicine or a medical appliance. (Collins Dictionary of Medicine © Robert M. Youngson 2004, 2005)

A review of the facility's policy, titled, "Restraint and Seclusion Policy", revised 5/18, stipulated that a physician order is required for restraints, and that the initial order must specify clinical justification for the restraint, the date and time ordered, the type of restraint to be used, and behavior-based criteria for release.


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2. On 9/11/18 at 11 a.m., during facility tour, Patient 24 and 25 were observed wearing hand mittens.

A review of the medical record for Patient 24's indicated the patient was admitted to the facility on 8/31/18 with diagnoses included but not limited to confusion and anxiety.

A review of the medical record for Patient 25's, indicated the patient was admitted to the facility on 9/9/18 diagnoses included but not limited to stroke with left side residual (weakness), unable to provide history, and on a breathing machine. The medical record for Patient 25 indicated that the designated responsible party for Patient 25 was the daughter.

A record review of the "Hand Mitten" manufacturer's instructions indicated a doctor's order was required before the application.

There were no physician's orders for Patient 24 and 25 for the application of the hand mittens.

During an interview on 9/13/18 at 9:50 a.m., Registered Nurse 13 (RN 13) stated, "there is no order for the hand mittens because we don't consider it a restraint". RN 13 stated there was no consent and the family was not notified because, "we do not consider hand mittens a restraint".

During an interview on 9/13/18 at 10:35 a.m., RN 14 confirmed that no doctor's order was obtained for the hand mittens, "because it is not a restraint". RN 14 stated that skin assessments of the patients' wrist/hand should be done every two hours to check area for pulse, temperature and color of skin for blood flow.

During an interview on 9/13/18 at 10:40 a.m., RN 15 stated patient hand mittens are documented as personal protective equipment.

During record review of Patients 24 and 25 charts from 9/1/18 to 9/13/18 at 11 a.m., the Nurse Notes for skin assessment were inconsistent, in terms of, time, frequency, temperature, color and day of.

During an interview on 9/13/18 at 11:15 a.m., after the reviewing of the Nurse Notes for Patient 24 and 25, RN 14 stated the documentation did not include the date that the hand mittens were applied for Patients 24 and 25. The notes for neurological assessment (skin assessment) were inconsistent. RN 14 stated the documentation showed the assessment was completed every 4 hours, but it should be done every 2 hours, and there were multiple days with no skin assessments done. RN 14 stated that there are no specific policies to indicate the frequency for skin assessments, so the staff perform skin assessments every 4 hours as "an unwritten rule. RN 14 stated because we do not consider hand mittens as a restraint.

During an interview on 9/13/18 at 11:20 a.m., RN 15 stated that the facility did not have a specific policy for peripheral neurological assessment during the use hand mitten.

During an interview on 9/13/18 at 11:55 a.m., the Nurse Educator, RN 16 stated that the facility had no specific policy for skin assessment related to the application of hand mittens.

Based on interviews and medical record reviews, the hospital failed to ensure the nursing staff would follow the policy and procedure for pain assessment and patient monitoring documentation for patient who received fentanyl (a potent opioid) patient controlled analgesia (PCA, a delivery system with which patients self-administer predetermined doses of analgesic medication to relieve their pain).

This deficient practice had the potential of inadequate patient monitoring that might lead to unnecessary pain suffering, increase risk of adverse/side effects, and/or medication errors.

Findings:

Review of Patient 22 medication orders and medication administration records indicated Patient 22 had administered fentanyl PCA between 9/3/2018 and 9/12/2018.

Review of the hospital policy and procedure, Patient Controlled Analgesia (PCA) - Post Epic, indicated monitoring guidelines that includes assess and document vital signs, pain level, and sedation level, upon initiation of PCA and with any dose increase. The guideline indicated assessment be performed at every 30 minutes for two times, then every 1 hour for two times, then every 2 hours during first 12 hours post initiation.

On 9/14/2018 at 3 p.m. during an interview and concurrent review of Patient 22's nursing flowsheet data, the director of nursing education confirmed the flowsheet indicated there were gaps in documentation related to Patient 22's PCA monitoring and assessment.

Based on observation, interview, and record review, the facility failed to ensure medications that were drawn up in a syringe and unlabeled, were not stored in the Anesthesia Cart.

This failure had the potential to result in cross-contamination and adverse effects for patients.

Findings:

On 9/11/18 at approximately 2:45 p.m., during a tour of the C-Section Delivery Room 1 with Clinical Manager 2 (CM 2), two sixty (60) milliliter (ml) syringes with needles attached, and containing a white substance, was observed in the top drawer of the Anesthesia Cart. Immediately following the observation, an anesthesiologist entered the room, stated "They're not mine". When questioned about the contents of the syringes, he stated the syringes contained propofol (a sedative) and Succinylcholine (a medication used for general anesthesia). CM 2 proceeded to discard the syringes in the sharps container. During a concurrent interview, CM 2 stated the syringes should have been immediately discarded after use.




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During an interview on 9/14/2018 at 1:37 p.m., the Director of Pharmacy (DOP) stated that the hospital followed the USP 797 (the sterile compounding standards issued by the United States Pharmacopoeia, USP; the USP 797 describes the guidelines, procedures and compliance requirements for compounding sterile preparations and sets the standards that apply to all settings in which sterile preparations are compounded).

A review of USP 797, under the section "Immediate Use CSPs (Compounded Sterile Products)", USP 797 states, "Immediate-use CSPs are not intended for storage for anticipated needs". In addition, it states, "Administration begins not later than 1 hour following the start of the preparation of the CSP ...Unless immediately and completely administered by the person who prepared it or immediate and complete administration is witnessed by the prepared, the CSP shall bear a label listing patient identification information, the names and amounts of all ingredients, the name or initials of the person who prepared the CSP, and the exact 1-hour BUD and time ...If administration has not begun within 1 hour following the start of preparing the CSP, the CSP shall be promptly, properly, and safely discarded."

Based on observations, interviews, and record reviews, the hospital failed to ensure that pharmacy staff practiced proper face mask placement and proper hand hygiene technique during the compounding of sterile intravenous (IV) medications inside of a compounding aseptic containment isolator (CACI, a form of isolator specifically designed for compounding pharmaceutical preparations. It is designed to maintain an aseptic compounding environment within the isolator and provide worker protection from exposure to undesirable).

This deficient practice had the potential for the patients requiring IV medications be exposed to avoidable contamination that may or may not affect the safety or health of the patients.

Findings:

During an observation on 9/12/2018 at 10:40 a.m., in the segregated compounding area of the main pharmacy, the face mask of the pharmacy technician (PTech 1) was not snugly fit around the nose. The top edge of the mask was below PTech1's nose, exposing both nostrils.

During an interview on 9/12/2018 at 11:03 a.m. PTech 1 stated, "I don't have a bridge (of nose)", as she adjusted her facemask with gloved hands. Then, PTech 1 adjusted her chemo gown and, without disinfecting her gloves, inserted both gloved hands into the sleeves of the CACI.

During an interview on 9/14/2018 at 1:37 p.m., the director of pharmacy (DOP) stated that the hospital followed the USP 797 (the sterile compounding standards issued by the United States Pharmacopoeia, USP; the USP 797 describes the guidelines, procedures and compliance requirements for compounding sterile preparations and sets the standards that apply to all settings in which sterile preparations are compounded) as guidelines for sterile compounding preparation.

During an interview on 9/14/2018 at 1:41 p.m., the pharmacy clinical coordinator (PCC) stated "PTech 1 could have used [isopropyl] alcohol to spray her gloves", which was available for use in the pharmacy compounding area.

A review of the hospital policy and procedures, Pharmacy Sterile Compounding Policy: Quality Control, effective on 4/28/2017, indicated, " ...Procedure ...Disinfection of gloved hands will be done by wiping or rubbing isopropyl alcohol on the contact surface areas and letting gloves dry thoroughly. Disinfection will be performed routinely during the compounding process and after touching non-sterile surfaces ...gloves are replaced if any hole or tear is discovered or if contaminated."

A review of the USP 797 (2012 USP 35 NF 30, the edition provided by the hospital) the section Pharmaceutical Compounding-Sterile Preparations indicated "Personnel Cleansing and Garbing ... gloves become contaminated when they contact nonsterile surfaces during compounding activities. Disinfection of contaminated gloved hands may be accomplished by wiping or rubbing sterile 70% IPA (isopropyl alcohol) to all contact surface areas of the gloves and letting the gloved hands dry thoroughly ..."

Based on observation and record review, the hospital failed to ensure outdated or unusable drugs were not available in the pharmacy inventory for distribution.

This deficient practice had the potential for affecting health and safety of the patients due to outdated or unusable medications that may or may not be at risk for chemical degradation, contamination, and/or ineffectiveness.

Findings:

During an observation on 9/12/2018 at 2:55 p.m., in the pharmacy checking area with the pharmacy clinical coordinator (PCC) and the director of pharmacy (DOP), there were four (4) gentamicin (an antibiotic to be administered intravenously for the treatment of certain infections) 60 milligram (mg) pre-mixed intravenous solution bags inside an active bin without the overwraps. On those 4 unwrapped bags of gentamicin, there were adhesive stickers indicated one of 4 bags was expired on 8/27/18, two bags were expired on 8/28/18, and one bag was expired on 8/30/18, respectively. (see attachment AA)

During another observation in the hospital main pharmacy on 9/12/2018 at 3:35 p.m., in the presence of DOP, there was an "Adult Crash Cart" racks on wheels with various crash cart trays ready for distribution to the units. On the rack, there were multiple containers that contained expired medications. There were three (3) "Transport Boxes" containing three medications each; the content lists attached on those 3 boxes indicated each box contained one item that was expired on "September 1, 2018". Also, there was one "Massive Infusion Tray" containing eight (8) items, in which the attached content list indicated it contained three (3) items that were expired on "August 31, 2018", and one item that was expired on "September 1, 2018". Furthermore, there was one "Respiratory Medications Box" containing five (5) items; the attached content list indicated the box contained two (2) items that were expired at the end of August 2018.

A review of the hospital policy and procedures, Pharmacy, dated 12/17/2015, indicated " ...expired medications shall be removed from stock in the designated areas per standard pharmacy department procedure ...Pharmacy staff shall ...remove all out-dated stock from emergency boxes, and heart cart trays and other storage areas."

Based on observation, interviews and record reviews, the hospital Food and Nutrition Services failed to ensure staff was competent with respect to washing produce to ensure it is clean and free from debris. Dietetic Staff 1 (DS1) did not follow hospital policy of rinsing produce.

This failure had the potential to result in fruits and vegetable not being washing adequately and result in food borne illness in a medically vulnerable patient population of 174 patient, staff and visitors who were served the food.

Findings:

During and observation of the cold food production area in the kitchen on September 12, 2018, at 11 AM, Dietary Staff 1 (DS1) was preparing sandwiches and salads. DS1 was slicing strawberries to include in the sandwich or salad.

During a concurrent observation and interview, DS1 demonstrated how she rinsed the strawberries before cutting. She took two strawberries in her hand and held it under the running water very quickly and returned to her work station for cutting. DS1 stated that she did not like to wash all of the fruits at the same time, she washed one berry at a time. DS1 further stated when washing fruits with rough skin such as cantaloupe, she rinses the outer skin then proceeds to peeling then cutting the cantaloupe. She also said that she does not use a brush to wash the cantaloupe.

During a concurrent interview with Director of Food and Nutrition Services (DFNS), he stated we do not use produce wash sanitizer and most of our vegetables such as lettuce comes precut and washed.

A review of hospital policy titled "Food Handling - Food Safety policy No. FS-FH-07" (revised 09/17) indicated, "Rinse produce twice in a clean water wash, before serving, cutting or cooking" it further indicates "To properly set up the produce washing sink: place the unwashed produce to the left of the left sink, place a properly cleaned and sanitized colander in the let sink, fill the right sink with water that is 10 degrees Fahrenheit warmer that the produce, place a second sanitized colander on the countertop to the right of the sink, after trimming and removing debris, rinse produce in the left sink under cold running water, use a vegetable brush if appropriate, move produce to the right sink basin, immerse and vigorously agitate, place produce in the second colander to drain ...the produce in now ready to be placed into storage, production or service."

According to the 2017 U.S. Food and Drug Administration Food Code, pathogenic microorganisms (bacteria, virus or fungus too small for the unaided human eye to see), such as salmonella and chemicals such as pesticides, may be present on the exterior surfaces of raw fruits and vegetables. It has been assumed that washing removes the majority of organisms and or chemicals present; all fresh produce, except commercially washed, pre-cut, and bagged produce, must be thoroughly washed under running, potable water or with chemicals or both, before eating, cutting or cooking. Even if you plan to peel or otherwise alter the form of the produce, it is still important to remove soil and debris first. It further indicates, infiltration of microorganisms can occur through stem scars, cuts or bruises in fruits and vegetables during washing. Once internalized, bacterial pathogens cannot be removed by further washing or the use of sanitizing solutions. To reduce the likelihood of infiltration, wash water temperature should be maintained at 10 degrees Fahrenheit warmer that the pulp temperature of any produce being washed.

Based on observation, interviews and record reviews, the hospital failed to ensure all patient diets, including Nutritional Supplements were ordered by the practitioner responsible for the care of the patients. According to the California Business and Professions code, RDs (RD- food and nutrition experts who can translate the science of nutrition into practical solutions for healthy living) may not prescribe dietary treatments. Electronic orders for nutritional supplements, entered by the Registered Dietitian was carried out by the Food and Nutrition Services, for 2 of 4 medical records (Patients 13 and 15).

Findings:

1. During an observation of trayline service for lunch (Patient meal tray assembly) on September 12, 2018, between 11:45 AM and 12:30 PM, two patient meal trays included a nutritional supplement.

A concurrent review of the hospitals diet list (a list of patients and their diet orders) indicated that there was no order for a nutritional supplement.

During medical record review of 4 patients who received nutritional supplements, it was noted that 2 of the medical records indicated there was no physician order for the supplements.

2. A review of physician orders for Patient 13 on September 13, 2018, at 9:15AM, records indicated:

9/6/18 diet general; dysphagia mechanical; sodium restricted 2gm
9/8/18 diet general; sodium restricted 2 gm
9/12/18 Nutrition supplement Boost plus TID between meals

A review of the nutritional assessment dated 9/7/18 for Patient 13 indicated Boost will be sent TID.

A review of nutritional assessment dated 9/10/2018 indicated patient is receiving Boost plus TID with meals.

A review of nutritional supplement order record for the week starting 9/9/18, indicated Patient 13 received boost plus starting 9/9/18 -9/12/18.

During an interview with the clinical Nutrition Manger (CNM) on September 13, 2018, at 9:15AM, she stated that Patient 13 has been receiving nutritional supplement Boost plus without physician order.

3. A review of physician orders for Patient 15 on September 13, 2018, at 10 AM, records indicated:
9/4/18 diet order is NPO (Nothing by mouth is a medical instruction meaning to withhold food and fluids.)
9/7/18 diet order is general, nectar thick, fat and cholesterol modified no straw.
9/9/18 Nutritional supplement Benefiber 2 teaspoons with 4-8oz of beverage daily.
9/9/18 Diet general; thin liquids allowed; fat and cholesterol modified; no straw.
9/9/18 diet order NPO effective midnight 12:01 AM except ice chips and sips with medications.
9/10/18 diet general; dental soft; thin liquids allowed; fat and cholesterol modified; no straw.
9/11/18 diet NPO; strict NPO; effective now.
9/12/18 diet general.

A review of nutritional assessment dated 9/5/18 for Patient 15 indicated RD interventions include start boost plus with lunch.

A review of nutritional supplement order record for the week of 9/9/18 indicated Patient 15 was receiving boost plus with lunch every day starting 9/9/18-9/12/18.

During a concurrent interview with clinical nutrition manager (CNM), she stated that Patient 15 received nutritional supplement boost plus without physician order. She further stated that she does not know why RD's order or recommendations for supplements are carried out by Food and Nutrition Services department without physician order.

A review of the hospital policy titled "Nutrition Care Orders, policy No 4.0" (revised 6/2018) indicated, "Nutrition Care orders should be written by approved medical staff, and communicated appropriately to the Food and Nutrition Department."

A review of the hospital policy titled "Receiving Nutrition Care Orders, Policy No 5.0" (revised 5/2018) indicated, "Nutrition Care order is accepted upon the electronic order of a physician or professional granted privilege from the medical staff. The order remains in effect until a nutrition care order change is received." In further indicates, "Nutrition care orders are communicated to the food and nutrition department via the electronic health record, the nutrition office staff verifies the nutrition care order. Nutrition office staff processing the nutrition care order must check each order as processed."

According to the California Business and Professions Code 2586(a) (1) Notwithstanding any other law, a registered dietitian, or other nutritional professional meeting the qualifications set forth in subdivision (e) of Section 2585 may, upon referral by a health care provider authorized to prescribe dietary treatments, provide nutritional and dietary counseling, conduct nutritional and dietary assessments, and develop and recommend nutritional and dietary treatments, including therapeutic diets, for individuals or groups of patients in licensed institutional facilities or in private office settings.

Based on observation and interview, the facility failed to maintain the physical plant in a manner that assured the safety and well-being of patients.

The failure to ensure maintenance of the physical environment may compromise the medical status of patients and the ability for staff to care for patients.

Findings:

On 9/11/18 between 9 am and 2:40 p.m. the following conditions existed at the facility.

Outpatient Child Family

1. The evaluator observed that in the Outpatient Child Family area, there were signs of water damage on ceiling tiles that included inner black circles surrounded by an outer brown circular staining. The ceiling staining was at ceiling tiles located at the corridors by rooms 116 and 125.

During an interview at the same time as the observation, the Facilities Manager acknowledged the signs of water damage, and stated that the staining was usually caused by condensation lines backing up. During a second interview after touching one of the ceiling tiles the Facilities Manager stated that one of the tiles was wet.


On 9/12/18 between 8:30 a.m. and 3 p.m. the following conditions existed at the facility.

Operating Rooms (OR)

2. The evaluator observed that the faucets at three scrub sinks located by OR 2, OR 4 and OR 7, had a trickle of water instead of a steady flow.

During an interview at the same time as the observation, the Facilities Manager acknowledged the trickling water at the faucets and stated that it looked like the cartridges were plugged.

Outpatient Hip and Pelvis

3. The evaluator observed that in the Outpatient Hip and Pelvis Institute in X-Ray room 1, there was a positioning wedge that had it outer coating worn off exposing the cloth and foam beneath.

During an interview at the same time as the observation the Hip and Pelvis Institute Manager acknowledged the worn positioning wedge and stated that the wedge was used to position patients.

3rd Floor Orthopedics (Ortho)

4. The evaluator observed that in the 3rd floor Ortho unit there was an electrical receptacle near nurses' station 3B with marks of arcing.

During an interview at the same time as the observations, the Facilities Manager acknowledged the arcing marks at the receptacle.


On 9/13/18 between 9 a.m. and 1:30 p.m. the following conditions existed at the facility.

2nd Floor ICU- CCU (Intensive Care Unit -Critical Care Unit).

5. The evaluator observed that in the 2nd floor ICU CCU, there was a sign of water damage that included a one foot section of paint peeling away from the hard lid ceiling at the end of the corridor by room 2284.

During an interview at the same time as the observation, the Facility Manager acknowledged the sign of water damage, and stated that it looked like the coping was failing.

1st Floor Medical Surgical

6. The evaluator observed that in the 1st Floor Medical Surgical unit equipment storage room across from room 2115, there was a sign of water damage at ceiling tile that included an inner black circle surrounded by an outer brown circular staining.

During an interview at the same time as the observation the Facilities Manager acknowledged the sign of water damage.

Based on observation, interview and document review the facility failed to ensure that the life safety from fire requirements were met.

The deficiency had the potential to not provide the minimum requirements of the Life Safety Code and referenced Codes and Standards.

Findings:

On 9/11/18 between 9 am and 2:40 p.m. the following conditions existed at the facility.

Outpatient Child Family

1. The evaluator observed that in the Outpatient Child Family there was a penetration through the concrete block wall around a copper water line separating a fire panel room from Classroom B storage room.

During an interview at the same time as the observation the Facilities Manager acknowledged the penetration through the wall.

2. The evaluator observed that in the Outpatient Child Family there was a penetration through the concrete block wall around a copper water line separating Classroom C from the chase above the entrance to Classroom C.

During an interview at the same time as the observation the Facilities Manager acknowledged the penetration through the wall.

3. The evaluator observed that in the Outpatient Child Family there were two penetrations through the concrete wall separating medical records storage room and the elevator machine room.

During an interview at the same time as the observation the Facilities Manager acknowledged the penetrations through the wall.

4. The evaluator observed that in the Outpatient Child Family Pediatric Playroom, the exit door was obstructed from fully opening by a tumbling mat that obstructed the door from fully opening.

During an interview at the same time as the observation the Facilities Manager acknowledged that the exit door was obstructed from fully opening.

5. The evaluator observed that in the Outpatient Child Family Pediatric Playroom, the exit door had a slide bolt installed at a height greater than 48 inches (4 feet) above the finished floor at the exit door.

During an interview at the same time as the observation the Facilities Manager acknowledged that the slide bolt was installed at 5 1/2 feet (66 inches) above the finished floor.

6. The evaluator observed that in the Outpatient Child Family Classroom B, the rear exit door was obstructed by a children's chair and couch.

During an interview at the same time as the observation the Facilities Manager acknowledged that the exit door was obstructed.

7. In the Outpatient Child Family, 17 of 17 fire extinguishers observed by the evaluator did not have the monthly check for August 2018. Closer observation revealed the annual service was done on 6/4/18.

The fire extinguishers missing the August 2018 monthly check included;

Fire extinguisher across from room 110.
Fire extinguisher in the kitchen.
Fire extinguishers in 3 fire hose cabinets.
Fire extinguisher in break room.
Fire extinguisher near viewing room of classroom B.
Fire extinguisher in classroom B.
Fire extinguisher in classroom C.
Fire extinguisher in classroom E.
Fire extinguisher in classroom F.
Fire extinguisher in the basement communication room.
Fire extinguisher in the basement cage.
4 fire extinguishers in the basement medical records storage room.

During an interview at the same time as the observation, the Facility Manager acknowledged the missing August 2018 checks of the fire extinguishers and stated that it looks like rounds were not made for August 2018.

8. The evaluator observed that in the Outpatient Child Family that office room 211's corridor door had a plastic toy on the floor in front of the door holding the door fully open and obstructing it from closing.

During an interview at the same time as the observation the Facilities Manager acknowledged the obstruction to closing the corridor door.

9. The evaluator observed that in the Outpatient Child Family lobby area the light of a fish tank was connected to a two prong household tap type extension cord that was connected to a wall receptacle.

During an interview at the same time as the observation the Facilities Manager stated that when he came to the facility six years ago the extension cord had already been in use connecting the light to the electrical receptacle.

10. The evaluator observed that in the Outpatient Child Family, there was an extension cord connected to to an electrical receptacle behind a wall anchored bookcase.

During an interview at the same time as the observation the Facilities Manager acknowledged the extension cords use as permanent wiring, and stated that the extension cord was connected at an angle to the wall receptacle.

11. The evaluator observed that in the Outpatient Child Family Psychology Intern Room 213 there was a power strip connected to an extension cord that in turn was connected to a wall receptacle.

During an interview at the same time as the observation the Facilities Manager acknowledged the daisy chaining of the power strip and extension cord.


On 9/12/18 between 8:30 a.m. and 3 p.m. the following conditions existed at the facility.

Outpatient Hip and Pelvis

12. The evaluator observed that in the Outpatient Hip and Pelvis Institute, an office exit door was obstructed from fully opening by a bookcase.

During an interview at the same time as the observation the Facilities Manager acknowledged that the exit door was obstructed from fully opening.

Outpatient Services Laboratory

13. The evaluator observed that in the Outpatient Laboratory, there was a fire extinguisher that did not have eight monthly checks, including January, February, March, April, May, June, July, and August of 2018. Closer observation revealed the annual service was done on 1/4/18.

During an interview at the same time as the observation, the Facility Manager acknowledged the 8 missing checks.

4th floor Oncology

14. The evaluator observed that in the 4th floor Oncology unit the corridor door of patient room 2416 had a folded pillow case over the top of the door that obstructed he door from closing.

During an interview at the same time as the observations the Facilities Manager acknowledged the obstruction to the door closing and stated he would remove the pillow case from the door.

3rd Floor Orthopedics (Ortho)

15. The evaluator observed that in the 3rd floor Ortho unit the corridor doors of patient rooms 2312, 2336, 2342 and 2374 failed to hold closed when shut.

During an interview at the same time as the observations the Facilities Manager acknowledged the four corridor doors not holding closed.


On 9/13/18 between 9 a.m. and 1:30 p.m. the following conditions existed at the facility.

2nd Floor ICU CCU (Intensive Care Unit Critical Care Unit)

15. The evaluator observed that in the 2nd floor ICU CCU , there was a fire extinguisher that did not have the monthly check for August of 2018. Closer observation revealed the annual service was done on 6/4/18.

During an interview at the same time as the observation, the Facility Manager acknowledged the missing August of 2018 check.

1st Floor Medical Surgical (Med Surg)

16. The evaluator observed that in the 1st Floor Med Surg unit the corridor doors of patient rooms 2112 and 2174 failed to hold closed when shut.

During an interview at the same time as the observation the Facilities Manager acknowledged the two corridor doors not holding closed.

17. The evaluator noted that in the 1st floor Med Surge unit Biohazard Room a trash chute access door was propped open by overflowing bags of trash in the chute.

During a interviews at the same time as the observation the Facility Manager and the Environmental Services Director acknowledged propped open chute door.

1st Floor Cardio Thoracic

18. The evaluator observed that at 1st Floor Cardio Thoracic unit in front of room eight there was a full e-cylinder stored unsecured standing on the floor.

During an interview at the same time as the observation the Facilities Manager acknowledged the cylinder was full and unsecured.

Central Plant

19. The evaluator observed that at Central Plant in front of an eye wash station there was a an oxygen cylinder stored unsecured standing on the floor.

During an interview at the same time as the observation the Facilities Manager acknowledged the cylinder was unsecured.

Basement

20. The evaluator noted that in the Keck basement trash chute room the trash chute's discharge door was obstructed from closing by a bin over filled with bags of trash directly under and abutting the open chute door and bags of trash backed up into the chute.

During a interviews at the same time as the observation the Facility Manager and the Environmental Services Director acknowledged obstructed chute door and identified the chute as the chute serving the Keck building.

21. The evaluator noted that in the basement trash chute room serving the building housing the Med Surge unit, the trash chute's discharge door was obstructed from closing by a bin over filled with bags of trash directly under and abutting the open chute door and bags of trash backed up into the chute.

During a interviews at the same time as the observation the Facility Manager and the Environmental Services Director acknowledged obstructed chute door and identified the chute as the chute serving the 1st floor Med Surge unit where earlier that morning a trash chute access door was observed to be propped open by overflowing trash bags.

22. The evaluator noted that in the basement soiled linen chute room across from Pharmacy, the soiled linen chute room's self-closing 1 1/2 hour fire rated corridor door was held fully open by a linen bin and was obstructed from closing by bags of soiled linen on the floor in the path of swing of the door.

During an interviews at the same time as the observation the Environmental Services Director acknowledged the obstructed corridor door and stated that the doors should be unobstructed to self-close.

Based on observation, interview, and record review the facility failed to provide sufficient personal protective equipment (PPE, equipment worn to minimize exposure to hazards that can cause illness and may include masks, eye protection, gowns, and gloves) for use in facility rooms where patients with suspected pathogens (organisms that can cause disease) reside.

Findings:

During a tour of the facility's Medical/Surgical unit on 9/11/2018 at 9:10 AM, the supply carts outside patient rooms numbered 2136 and 2142. The signage on the outside of those 2 rooms indicated that 'Contact Precautions' (use of standard practices and PPE designed to minimize the transmission of pathogens through direct or indirect contact with an infected person or environment) were to be taken when entering those rooms. The cart outside room 2136 contained one half full box of face masks, one half full box of medium size latex gloves, and no gowns. The cart in front of room 2142 contained no gloves, one box of medium size latex gloves, and one gown.

The Quality Manager, at that time, acknowledged the lack of supplies in those two carts.

Centers for Disease Control and Prevention (CDC) recommends that, in all areas of healthcare provision, supplies and equipment necessary to maintain observance of Standard Precautions (those based on a risk assessment making use of PPE and best practices that protect healthcare providers from the spread of infection) including hand hygiene products and PPE, should be available [Recommendation I.B.8 - Guideline for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Settings (2007)].

Based on observation, interview and record review, it was determined that the hospital failed to implement its policies and procedures to ensure a sanitary environment and avoid sources of transmission of infections and communicable diseases by failing to:

1 Ensure intravenous (IV) insertion sites were signed and dated, per professional guidelines and nationally accepted standards of practice for Patients, 3, 4, 6, 9, 28, 33, and 34. (Refer to A749)

2. Ensure sharps containers were discarded prior to becoming full, in order to prevent potential injury and unauthorized access to medications left in syringes. (Refer to A749)

3. Segregate patient equipment and supplies from hazardous material in the 'Biohazard' room in the Intensive Care Unit (ICU) so as to reduce cross contamination and patient infection. (Refer to A749)

4. Ensure the main operating room door in OR 2 closed in a timely manner during a surgical procedure. (Refer to A749)

5. Place Patients 23, 29 and 30 on contact isolation for Clostridium Difficile (C-diff is an intestinal bacteria that causes infectious diarrhea). (Refer to A749)

6. Assure medical staff had Hepatitis B status, Flu vaccine and PPD status, monitor and document variance and corrections when OR temperature was out of acceptable range temperature and humidity; follow acceptable standards of infection control for the care of urine bag; and assure OR mattresses did not have any tears. (Refer to A749)

7. Ensure infection control practices were followed in Food and Nutrition Services when: Two pans of sliced turkey ready to eat food were not monitored for the date they were thawed to ensure there was a system in place to discard expired food after its use by date. A box of cookies and a box of brie cheese appetizer were stored in the freezer open to the air, not covered or sealed to prevent freezer burn and cross-contamination. Raw shelled eggs and container of pooled liquid eggs were stored on top shelf above a tray of ready to eat food. A tray of muffins and a bag of previously cooked turkey sausage was stored on the same shelf next to a large piece of meat thawing in the refrigerator. The can opener blade had dried brownish residue, was worn and nicked with the potential to harbor harmful bacteria. The use of a food safe chemical sanitizer for the cleaning of the Neonatal Intensive Care Unit (NICU) infant formula preparation area. (Refer to A749)

The cumulative effect of these systemic problems resulted the hospital's inability to ensure the provision of quality health care in a safe environment.

Based on observation, interview, and record review, the facility failed to:

1. Ensure intravenous (IV) insertion sites were signed and dated, per professional guidelines and nationally accepted standards of practice for Patients, 3, 4, 6, 9, 28, 33, and 34.

2. Ensure expired gloves were removed from the patient care area

3. Ensure sharps containers were discarded prior to becoming full, in order to prevent potential injury and unauthorized access to medications left in syringes.

4. Segregate patient equipment and supplies from hazardous material in the 'Biohazard' room in the Intensive Care Unit (ICU) so as to reduce cross contamination and patient infection.

5. Maintain clean faucet heads in Operating Room (OR) scrub sinks.

6. Ensure the main operating room door in OR 2 closed in a timely manner during a surgical procedure.

7. Place Patients 23, 29 and 30 on contact isolation for Clostridium Difficile (C-diff is an intestinal bacteria that causes infectious diarrhea).

8. Provide appropriate equipment for two post-surgical patients (Patient 26, 28)

9. Assure medical staff had Hepatitis B, Flu and PPD, monitor and document variance and corrections when OR temperature was out of acceptable range temperature and humidity; follow acceptable standards of infection control for the care of urine bag; and assure OR mattresses did not have any tears.

10. Ensure infection control practices were followed in Food and Nutrition Services when: Two pans of sliced turkey ready to eat food were not monitored for the date they were thawed to ensure there was a system in place to discard expired food after its use by date. A box of cookies and a box of brie cheese appetizer were stored in the freezer open to the air, not covered or sealed to prevent freezer burn and cross-contamination. Raw shelled eggs and container of pooled liquid eggs were stored on top shelf above a tray of ready to eat food. A tray of muffins and a bag of previously cooked turkey sausage was stored on the same shelf next to a large piece of meat thawing in the refrigerator. The can opener blade had dried brownish residue, was worn and nicked with the potential to harbor harmful bacteria. The use of a food safe chemical sanitizer for the cleaning of the Neonatal Intensive Care Unit (NICU) infant formula preparation area.

These deficient practices had the potential for the hospital's inability to control infections and communicable disease of patients and personal.

Findings:

On 9/11/18 between 10:45 a.m. and 11:15 a.m., during a tour of the First Floor Medical Surgical Unit, the following was observed:

1a) Patient 2 lying in bed, and was awake and alert. A solution of D5 0.45 normal saline was infusing at 100 milliliters (ml) per hour through an IV insertion site in the patient's left arm. The insertion site dressing was not initialed, dated or timed. During a concurrent interview with RN 2, she stated the dressing should have been signed and dated by the staff member who started the IV.

1b) Patient 3 was sitting up in bed. There was a heparin lock (a small tube attached to a catheter that is inserted into the arm in order to administer drugs and fluids) in the patient's right antecubital (area between the upper and lower arm), and one in the left hand. There were no staff initials/signature, or date and time. Upon questioning, During a concurrent interview with RN 4, she stated that the IV sites should have been initialed, with date and time when the IV catheters were inserted.

1c) Patient 4 was observed a heparin lock in his left hand. The dressing was not signed or dated. During a concurrent interview with Nursing Manager 1, he stated the dressing should be initialed and dated.

1d) During a tour of the Tele Post Critical Care unit (PCCU), Patient 6 was observed with a heparin lock in his left hand. The dressing was dated, but there was no indication who started the IV. During a concurrent interview, RN 5 stated the site should also be initialed and timed.

A review of the facility policy, titled, "Peripheral Intravenous Therapy", revised 4/16, stipulated that the IV site will be labeled with date, time, and initials at insertion time and with dressing changes.

2a) On 9/11/18 at 2:45 p.m., during a tour of C-Section Delivery Room 2 with Clinical Manager 2 (CM), the following was observed:

An unopened urinary catheter insertion tray had been placed on top of a Chux absorbent pad, that was on top of a biological waste trash cart. During an interview at the same time, CM 2 stated the urinary catheter tray should not be there, due to contamination risk.

There were eight (8) pairs of disposable sterile gloves with an expiration date of 4/18 in a supply cart. CM 2 stated the gloves should have been discarded when they expired.


2b) On 9/12/18 at 10:30 a.m., during a tour of the Main Operating Room (OR) Heart Room with the Administrative Director of Perioperative, a large blue sharps container located next to the anesthesia machine was observed to be full with discarded syringes, and other sharp items. During a concurrent interview, the Director stated that per facility policy, sharps containers should be replaced when two thirds to three quarters full.

On 9/13/18 at 10:25 a.m., during a tour of the facility's Ambulatory Surgery Center (ASC) OR 4 with the Director of Environmental Services (EVS) Director, a sharps container was observed to be three quarters full. The EVS Director stated the container should have been replaced.

According to the Occupational Safety Health Administration (OSHA) online article, titled, "OSHA Fact Sheet- Protecting Yourself When Handling Contaminated Sharps", and dated 1/2011, indicates that sharps containers must be routinely replaced and not over-filled, which can increase the risk of needle sticks or cuts
(https://www.osha.gov/OshDoc/data_BloodborneFacts/bbfact02.pdf)

2c) On 9/12/18 at 2:35 P.M., during a tour of the Respiratory Department with the Respiratory Supervisor, eighteen (18) expired 8.5 size endotracheal tubes ETT(plastic tubes that are inserted into someone's air passage in order to assist with breathing) had expiration dates of 1/17 and 11/17. The Respiratory Supervisor stated that he should have checked for expiration dates and removed any expired items.







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3. On 9/13/18 at 1:45 p.m., during a review of randomly sampled of 10 medical staff credentialing files, with the Medical Staff director and QIRN1. Ten out of 10 files did not have documentation of Hepatitis B status or Hep B waiver; 10 out of 10 yearly flu vaccination, and eight out of 10 medical staff credentials did not have yearly TB test documented. MD 3 and MD 8 had current TB test attestation.

During a review of Medical Staff credentials with MSC1 on 9/13/18 at 2:15 p.m. indicated there was not a policy and procedure for assessment or screening including required yearly PPD, Flu vaccination and documented Hepatitis B status or waiver for Medical staff. A medical staff credential document provided by MSC1, titled "Processing reapplication for Medical Staff and /or Allied Health Membership and Clinical Privileges" dated 4/30/18 did not include health assessment or screening including required yearly PPD, Flu vaccination and documented Hepatitis B status or waiver for Medical staff.

During an interview with the Infection Control Director (ICD) on 9/13/18 at 3 p.m., he indicated the facility followed CDC guidelines for infection control. ICD indicated there was no Policy requiring medical staff to have yearly PPD, Flu vaccination and documented Hepatitis B status or waiver.

4. During a tour of Labor and Delivery (L&D)/OR#1 on 9/11/18 at 2:40 p.m., with Labor and Delivery Supervisor (RN15) and the CNO and RN10 on 9/11/18 at 2:30 pm. The temperature (T) was at 67 degree Fahrenheit (F) and Humidity (H) was not displayed. When asked RN15 indicated both Humidity and temperature of the delivery rooms were monitored centrally. There were no logs of daily temperature and humidity, variances and correction of variances were not monitored and documented by L&D.

During a Tour of the Operating Room (OR) on 9/12/18 at 9:40 a.m., with Nursing Director of OR, CNO and RN10, Temp of OR observed was 66 degrees F degrees, the humidity was requested, but was not located by DON of OR in the OR room. No humidity device in or room was observed. During an interview with the Director of OR, when asked DON of OR stated there were no logs and no monitoring of temperature and humidity in the OR. During the interview with the DON of OR, there were no daily documentation of: temperature ; humidity; variances; or correction time of variances throughout the day by the RNs in the OR. DON of OR indicated temperature, humidity, variances and monitors correction of variances were monitored by facilities management centrally.

On 9/13/18 at 2:45 p.m. During an interview with the manager of facility management(FM) and MD15 (infection control director), FM indicated the temperature and humidity of the OR is monitored 24 hours a day seven days a week by Facility Management. A log of the out of range temperature and humidity was requested, but did not provide any log and indicated there were none. FM indicated any out of range temperature and humidity was corrected and communicated to MD15. When asked for any logs of communication of any ongoing monitoring or documentation of the temperature and humidity by the OR or alarms of isolation rooms . There were none.

A review of Facility Policy and Procedure dated 9/1/18, titled "Heating Cooling, Relative Humidity and Air Exchange Requirements for Sensitive Areas" indicated for Surgical suites; OR; ASC; L&D, Cath Lab the "relative Humidity range is 30-60%" and".. Surgical/procedural room temperature 68-75 degrees Fahrenheit "

5. During a tour on 9/11/18 at 11:45 a.m. the with RN 10, and Infection Control Prevenstionist (ICP) and Charge Nurse 3, Room 2280 Patient 36 was sitting in a chair by her hospital bed. The indwelling Foley catheter urine collection bag was on the floor. When asked about the Foley bag on the floor, the ICP and charge nurse both replied the Foley bag should not be on the floor and explained due to increased risk of infection.

During an interview with the ICP, on 9/11/18 at 11:25 a.m., she indicated the facility followed; AORN; AAIME; CDC guidelines for infection control.

6. During a tour of the biohazard room on the 2nd floor with RN10, ICP and Charge nurse at 11:15 a.m., a cart of food trays were observed. When asked why the food trays were in the biohazard waste room, Charge Nurse indicated the cart of trays were used to bring up food and would be returned to the kitchen.

7. During a tour of the Operating room on 9/12/18 at 10:40 a.m. with Nursing Director of OR; CNO and RN10, 18 pairs of expired sterile surgical gloves were observed in the or room. During a tour of the Cardiac bypass room, the mattress was observed to have tears.

During an interview with the Director of OR when asked who checks the expiration of products in the rooms indicated materials management checks supplies routinely and EOC does rounds in the OR




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8a. During a tour of the Medical/Surgical unit on 9/11/2018 beginning at 8:45 PM, accompanied by the Quality Manager, Patient 33 had a 'butterfly' (thin gauge IV with bilateral flexible wings) inserted in her left forearm. There was no writing or label over the IV site dressing that indicated when it had been last changed.

At that time, RN 1 stated that a sticker is usually over the site indicating the date of the last IV dressing change and that it is the facility's policy to place a dated sticker over the IV dressing site but sometimes these stickers fall off. She stated that dressing/IV changes are documented on the facility's computerized system.

8b. On 9/11/2018 at 8:50 AM, Patient 34 had an IV in his left arm; there was no dated label over the site.

8c. On 9/11/2018, at 9:15 AM, Patient 9 was observed to have an IV inserted into his left antecubital area (triangular area on the front of the elbow); there was no dated label over the site.

According to the facility's policy 'Peripheral Intravenous Therapy', rigid aseptic technique is to be maintained during all IV activities; the IV site will be labeled with date, time, and initials at insertion site and with dressing changes; IV sites are only changed when clinically indicated; it is recommended that transparent IV dressings be changed every 5 -7 days and (sterile) gauze dressings every 24 hours.

9a. During a tour of the ICU on 9/11/2018 at 9:20 AM, the room labeled 'Biohazard Room' contained a red biohazard can with lid, a yellow sharps container on wheels, and a suction canister. Near the hopper in one corner of the room was a bedside commode. On one side of the room were table tops and recycled compression sleeves. In a wall mounted cabinet on the far wall of the room were two surgical drapes used for marking off the area of the body to be operated.

On the door leading into the 'Biohazard Room' was a sign that indicated the following were not to be put into the room: IV poles, bear huggers, bed alarm, commodes, bedside tables.

9b. During a tour of the surgical suite on 9/11/2018 at 11 AM, accompanied by the Surgery Manager, a minor set (surgical instrument tray containing instruments for procedures not considered life threatening) was opened and the contents examined. The Surgery Manager explained that the try consisted of approximately 45 hinged instruments including "Kelly clamps, mosquito clamps, Alice clamps, retractors, and scissors".

The Surgery Manager stated at that time 22 of the approximate 45 hinged instruments were in the closed position, i.e., with the jaw end of the instrument closed thus not allowing steam to reach those surfaces during the sterilizing process.

An orthopedic tray was opened in the presence of the SPD Manager on the same day at 11:17 AM. In the tray, as described by the SPD Manager, were "criles, thoracic clamps, Jorgensen scissors". Of the approximate 60 instruments in the tray, the vast majority of them were in the closed position as described above; the SPD Manager acknowledged this observation.

According to the Association for the Advancement of Medical Instrumentation (AAMI), using stringers to keep instruments open during the sterilization is supported in ANSI/AAMI ST79. Instruments that are to be sterilized should be in the open position; ratcheted instruments and devices with handles with handles such as scissors and forceps should be kept open by the use of stringers, racks, and pins to allow the effective contact of steam with all surfaces of medical devices. (Loading mechanical cleaning and disinfection equipment. © 2017 Association for the Advancement of Medical Instrumentation. ANSI/AAMI ST79:2017.

10. While touring the facility's Operating Rooms on 9/11/2018 at 10:44 AM, accompanied by the SPD Manager, there were white deposits on the two aerated faucet heads in the scrub sink in front of Operating Room 8.

When asked how faucet heads are normally cleaned in the Operating Room Suite, the SPD Manager stated that they are cleaned with steel wool pads and the appropriate cleaner.

While there are no readily discernible recommendations for general cleaning of shower heads or faucet heads, there is guidance from the Centers for Disease Control and Prevention (CDC) for areas in facilities who are immunocompromised. Specifically, to ward off infection by Legionella spp it is recommended that shower heads and tap aerators be removed and cleaned using a chlorine based, United States Environmental Protection Agency (EPA) registered product. If the approved product is not available, substitute a chlorine bleach solution. [MMWR Recommendations and Reports, June 6, 2003/52(RR10); 1-42]

11. During a tour of the facility's Ambulatory Surgery Center (ASC) on 9/13/2018 at 10:45 AM, accompanied by the Nurse Clinical Supervisor, there was a surgical procedure in progress in Operating Room 2 (OR 2). The doors into OR 2 was seen to be open for 18 seconds, as timed by the surveyor's watch, before it finally closed. A nurse had just entered OR 2. The doorway into the operating room consists of 2 swinging doors. A few minutes later, another surgical team member entered OR 2 by entering through only 1 of the 2 doors; it only took approximately 5 seconds to close.

At that time, the Nurse Clinical Supervisor stated that the door into the OR is usually only open that long when a large piece of equipment or patient gurney enters or exits the room and that personnel usually use just one door to enter any given operating room.

According to the CDC's Guidelines for Environmental Infection Control in Health-Care Facilities, infection control and ventilation requirements for operating rooms include maintaining a positive pressure ventilation with respect to corridors and nearby areas, maintaining appropriate air exchange rates, and keeping OR doors closed except for passing of equipment, personnel, and patients; limit entry into the room to essential personnel. (MMWR Recommendations and Reports, June 6, 2003/52(RR10); 1-42)

As stated earlier, positive pressure in the OR describes the room pressure relative to adjoining areas. This ensures that pathogens do not enter from outside compartments and potentiate infection. Self-closing doors are mandatory for these areas to maintain as much as possible the correct pressure differential. [CDC - Guidelines for Environmental Infection Control in Health-Care Facilities (2003)]



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12a. On 9/11/18, an unannounced visit was initiated at the facility for a Validation Survey. During a tour of the facility, Patient 23 had a sign outside her room, which specified "Contact Isolation" (separation precautions to create barriers between people and germs).

According to Patient 23's chart, he was admitted to the facility on 9/29/18, diagnoses included but not limited to, small bowel obstruction (SBO) with several incidents of loose stool, abdominal pain and nausea. Laboratory results dated 9/9/18 at 10:30 p.m., confirmed a positive result for C-diff.

On 9/11/18 at 11:10 a.m., during this observation Charge Nurse 11 (CN 11) exited Patient 23's room without washing her hands.

On 9/11/18 at 11:12 a.m., during an interview with CN 11 she stated, "We wash our hands at the sink in the nurse station".

12b. On 9/11/18 at 3:06 p.m., Patient 30 had a sign outside her room which specified "Contact Isolation". According to Patient 30's chart, she was admitted to the facility on 9/29/18, diagnoses included but not limited to, severe cognitive distress, recurrent C-diff, loose stool and a positive laboratory results three months ago for C-diff.

On 9/11/18 at 2:30 p.m., during this observation Registered Nurse 11 (RN 11) exited Patient 30's room without washing her hands.

On 9/11/18 at 2:40 p.m., during an interview with Certified Nursing Assistant 11 (CNA 11) she stated, after taking her gloves off in the room "I walk across to nurse station to wash my hands".

On 9/11/18 at 2:43 p.m., with RN 11 she stated she washed her hands at the sink around the corner.

12c. On 9/12/18 at 3:06 p.m., Patient 29 had a sign outside her room, which specified "Contact Isolation". According to Patient 29's chart, she was admitted to the facility on 9/12/18, diagnoses included but not limited to, history of colitis (inflammatory bowel disease), history of E.coli (bacteria found in the intestine) and recent recurrence of C-diff.

On 9/12/18 at 3:07 p.m., during this observation in the emergency room, Medical Doctor 7 (MD 7) exited Patient 29's room after she took off both gown and gloves in the room. However, after exiting Patient 29's room, she carried both gown and gloves to the nurse station and placed both items in the trashcan. Patient 29 did not have a separate isolation precaution trashcan in her room. In addition, MD 7 exited Patient 29' room without washing her hands.

On 9/12/18 at 2:40 p.m., during an interview with Administrator of Critical Care Services 1 (ACCS 1) she stated, all staff should wash their hands inside the room.

On 9/13/18 at 3:15 p.m., with the Infection Prevention MD (MD 8) he indicated "we do not encourage our staff to wash their hands in the room", we want them to walk outside the room and walk to the closest sink in the nurse's station. In addition, there are no guidelines or policy indicating where staff should wash their hands.

A record review of a facility's Policy and Procedure titled, "Isolation Precautions" dated 8/20/17 indicated prevent and reduce the risk for acquiring and /or transmitting epidemiological microorganisms to staff, visitors, and patients. Visitors should use precautions for healthcare workers outlined in this policy and wash hands before leaving the patients room. Staff protective and personal equipment remove gloves and gowns before leaving the patient's room and perform hand hygiene immediately.

A record review of a facility Policy and Procedure titled "Hand Hygiene" dated 08/08 indicated prevent cross contamination by effective removal of transient microorganism from the hands, before and after each patient contact and after contact with nonliving objects, such as, medical equipment in the immediate area of the patient after removing gloves.

13a. On 9/11/18 at 2:48 p.m., while touring the facility Patient 26 was seated next to her bedside with both her legs elevated and supported on a trashcan.

According to Patient 26's chart, she was admitted to the facility on 9/6/18, diagnoses included but not limited to, history of C-diff and a recent surgery for her left knee.

A review of the Operative Report dated 9/6/18 indicated Patient 26 had a left partial knee replacement on 9/6/18.

During an interview on 9/11/18 at 2:49 p.m., according to RN 11 "we don't have anything else, she's short so we don't have anything to elevate her legs on". In addition, RN 11 stated we use the trashcan or the biohazard bin (a red bin with contents that pose a threat to all) to elevate her legs.

A record review of a facility Policy and Procedure titled "393 SSI Reduction Policy" dated 05/18 indicated written guidelines to prevent surgical site infection (SSIs), educate staff involved in the prevention of post-operative wound infections.

13b. On 9/11/18 at 3:16 p.m., during facility tour, Patient 28 had an IV in her right elbow; the tape used to secure her IV site appeared discolored and midway raised. In addition, Resident 28's IV site was not labeled with date, time, and initials at insertion time according to facility's policy.

According to Patient 28's chart, she was admitted to the facility on 9/9/18 diagnoses included but not limited to, fall with a hip fracture and a recent surgery to repair hip fracture on 9/10/18.

During an interview on 9/11/18 at 3:17 p.m., according to RN 12 "we should have a label there".

A record review of a facility Policy and Procedure titled "Peripheral Intravenous Therapy" dated 05/16 indicated for management of IV site, the IV site will be labeled with date, time, and initials at insertion time and with dressing changes.

On 9/11/18 at 3:16 p.m., during facility tour, Patient 28 had a commode (used as a toilet) at her bedside. The frame used to hold the human waste container appeared brown and /or rusty along the length of frame under the container.

During an interview on 9/11/18 at 3:17 p.m., with Resident 28 she stated she uses the commode at night.

During an interview on 9/11/18 at 3:18 p.m., RN 12 did not have an answer to address the condition of the commode.

A record review of a facility Policy and Procedure titled "Medical Equipment Management Plan 2018" dated 03/18, indicated medical equipment plan is to promote safe and effective use of medical equipment, to assure appropriate use and reduce risk to patients and visitors. Minimization of risk should include inspection, maintenance, monitoring and follow up; provide education and training to staff in the proper use of medical equipment.




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14. During an observation of the kitchen on September 12, 2018, at 9:40 AM, there were two pans of previously cooked sliced turkey in the walk in refrigerator thawing. The label on the turkey pans indicated it was made 9/6/18 and had a use by date of 9/9/18.

During a concurrent interview with the Director of Food and Nutrition Services (DFNS), he stated he did not know why expired two pans of turkey are in the walk in refrigerator.

During an interview with cook on September 12, 2018, at 10 AM the cook stated that he had cooked the turkey on 9/6/18 and stored it in the freezer be used later. He also stated he took it out of the freezer and place it in walk in refrigerator yesterday to thaw. He stated the two pans of previously cooked and frozen turkey had expired labels. During a concurrent interview with (DFNS), he stated the label should have been changed to previously cooked and thawing food item.

A review of Hospital policy titled "Food Handling - Food Safety", policy No.FS-FH-07 (revised 9/27/17) indicated, "After prepared food is fully defrosted, the refrigerated/frozen food label needs to be changed to reflect the use-by-date of two days. Label all foods that are prepared and /or cooked and cooled on site and then frozen with the refrigerated/Frozen Food Label. Discard foods that are not used by the manufacturers "Use By/Best Before" date."

15. During a tour of the kitchen on September 12, 2018, at 10:15 AM, a box of frozen cookies was noted in the walk in freezer. The box was noted to be open with the cookie doughs exposed to the freezer air. There was another box of brie (cheese) appetizer noted to be open and a bagel that was not part of that item inside the box.

During a concurrent interview with the (DFNS), he stated the boxes should be closed and the bagel does not belong in the box of cheese appetizer.

During an observation in the kitchen on September 12, 2018, at 9:40 AM, a breakfast cart with 3 shelves Was noted in the walk in refrigerator. The top shelf held 1 container of pooled eggs (breaking eggs into container and using combined eggs to make egg dishes) and the other container had French toast mix with eggs. There was also a carton of raw shelled eggs. Below the first shelf was cooked bacon and sausages and the lower shelf had pancake mix in two containers.

During a concurrent interview with (DFNS), he stated the breakfast cart was prepared at 5:45 AM for tomorrow's breakfast service in the cafe. He also verified that raw products should be stored on the bottom shelf below the ready to eat cooked products.

During an observation in the walk in refrigerator for meat and poultry on September 12, 2018, at 10:48AM, a tray of muffins and a bag of cooked turkey sausage was noted stored on the same shelf and next to a large piece of raw meat (Round of eye) that is thawing.

During a concurrent interview with (DFNS), he stated muffins should not be stored next to raw meats.

According to the 2017 U.S. Food and Drug Administration Food Code, Food shall be protected from cross contamination by separating raw animal foods during storage, preparation, holding and display from cooked ready-to-eat foods.

A review of hospital policy titled "Location and Equipment - Food Safety", Policy No FS-RS-06 (Revised 6/22/17) indicated, "Pathogenic microorganisms along with physical and chemical contaminants can be introduced into food and cause foodborne illness, injury or allergic reactions when raw foods contaminate ready-to-eat foods and when foods are stored unprotected which can lead to cross-contamination." it further indicates, "after opening, store all foods in a manner that protects the product from outside contamination and make sure packaging is intact and free of rips, cracks, holes or evidence of tampering. "

A review of hospital policy titled "location and Equipment - Food Safety", policy No FS-RS-06 (revised 6/22/17) indicated, "Separate ready to eat foods from raw animal protein in all refrigerated storage area. Use a top to bottom system for storage: top shelf includes prepared/ready to eat foods and washed produce, bottom shelf includes raw whole cuts of meat, poultry and raw shell eggs."

16. During a tour of the kitchen on September 12, 2018, at 10:48 AM, one can opener blade was noted to be covered in brownish residue, was worn and nicked. The blade was not smooth to the touch due to the nicks in the surface of the blade.

During a concurrent interview with the (DFNS), he verified that there is only one can opener in the kitchen and that it needs a new blade, he also stated that the can opener is washed in the dish machine.

According to the 2017 U.S. Food and Drug Administration Food Code, cutting or piercing parts of can openers shall be kept sharp to minimize the creation of metal fragments that can contaminate food when the container is opened. It also indicates food-contact surfaces of equipment shall be smooth, free of breaks, open seams, cracks chips, inclusions, pits, and similar imperfections. Surfaces which have imperfections such as cracks, chips, or pits allow microorganisms to attach and form biofilms (a thin, slimy film of bacteria that adheres to a surface). Once established, these biofilms can release pathogens (disease causing organisms) to food. Biofilms are highly resistant to cleaning and sanitizing efforts.

17. During an observation in the NICU on September 12, 2018, at 3:15 pm, the infant formula preparation area was observed. A container of germicidal disposable wipes AF3 was stored on the counter. The manufacturer's specifications on the wipes container did not indicate that they were food safe.

During a concurrent interview with the NICU RN, she stated that they use germicidal disposable wipes to sanitize the counters then prepare and mix infant formula, fortifiers and breast milk for patients.

During a concurrent interview with the Infection Control Preventionist (ICP), the ICP indicated that the germicidal wipes are used to clean the infant formula and human breast milk preparation counter. The (ICP) further stated that the germicidal wipes are generic wipes used in different departments in the hospital as indicated on the manufactures label such as NICU, ICU and Dialysis.

During an interview with Infection Control Preventionist (ICP) on September 13, 2018, at 3:20 PM he stated that there is no need to use a food safe disinfectant for infant formula preparation area because during the milk or formula preparation, the food product does not touch the sanitizer or counters. If there is any formula or milk spill on the counter, it is not used and it is discarded.

A review of the hospital policy titled "Formula preparation and storage", policy No NB-8 (revised 5/2018) indicated, "work area for feeding preparation: Before infant formula is prepared, all work surfaces must be cleaned using hospital approved antibacterial sanitizing wipes, surfaces are cleaned after an spills during the preparation process and again at the end of the preparation process." The policy did not indicate which wipes to use. The policy further indicated that one of the references used for this policy was American Dietetic Association: infant feedings: Guidelines for preparation of Formula and Breast milk in health care facilities, Robbins S, Meyers R. Ed 2nd Edition. Pediatric Nutrition practice Group, 2011

A review of American Dietetic Association (2011) Guidelines for Preparation of Formula and Breastmilk in Healthcare Facilities. 2nd Edition. S.T. Robbins and Meyers, R. Editors., page 23 states, "Cleaning Supplies: Dishwasher detergent, bleach, sanitizing solutions and other cleaning supplies used in the infant feeding preparation room must be approved for foodservice use by the health care facility's infection control committee." On page 14, it states "Appropriate chemicals are those that are acceptable for food contact surfaces and approved by the facility's infection control committee."