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Based on observation, document review, and staff interview, it was determined that the facility failed to protect and promote the rights of each patient.

Findings include:

1. The facility failed to ensure that the patients were not provided the right to receive care in a safe setting. (Refer to Tag A 144)

2. The facility failed to protect the right of confidentiality of patient records. (Refer to Tag A 146)

3. The facility failed to ensure that a physician's order was in place for patients in restraints. (Refer to Tag A 168)

4. The facility failed to ensure that staff adhered to an order for restraints used for the management of violent or self-destructive behavior for an adult. (Refer to Tag A 171)

5. The facility failed to ensure that patients in restraints were monitored and assessed per facility policy. (Refer to Tag A 175)

6. The facility failed to ensure that the 1-hour face-to-face medical and behavioral evaluation was completed in patients with restraints. (Refer to Tag A 184)

Based on tours of two patient care units, review of facility policies and procedures, and interviews with administrative staff, it was determined that the facility failed to ensure that patients are provided care in a safe setting.

Findings include:

Reference #1: Policy and Procedure titled, "Hot Water Temperature" states: " ..... REFERENCE:
New Jersey Department of Health Licensure Standards
PURPOSE: To provide the guidelines under which hot water temperatures will be controlled within the Hospital.
POLICY: In accordance with the above referenced New Jersey Department of Health Licensure Standards, the maximum permissible hot water temperature for general use is 120 (degrees) F (Fahrenheit) ....."

Reference #2: Policy and procedure titled, "Code Cart Exchange" states: " ..... Nursing: .....10. Patient care units are responsible for checking the integrity of all equipments/supplies [sic] on top of the cart.
a. All Code carts must be checked once per day. ....."

Reference #3: Policy and procedure titled, "NEEDLE / SYRINGE CONTROL" states: "POLICY: To maintain reasonable control of needles and syringes
PROCEDURE:
1) Needles and Syringes [sic] will be kept locked at all times. ....."

Reference #4: Policy and procedure titled, "PRECISION XCEED PRO QUALITY CONTROL TESTING" states: "POLICY
Quality control testing will be performed daily prior to patient testing, and the following times: .....7.0 If the precision Xceed Pro meter is not used daily, quality control will be performed prior to testing.
PROCEDURE .....
2.0 Follow the Precision Xceed Pro Testing Procedure for each control.
2.1 Prior to testing the controls verify that the reagents are in-date and have not expired.
2.1.1 When a new control is opened the expiration date is changed to 90 days.
The vial must be labeled with (Expiration Date) label. ....."

1. A tour of the Emergency Department (ED) on 4/9/19, accompanied by Administrators #15 and #16, revealed:

a. Hallway:

(i) A Workstation on Wheels (WoW) was observed to have an accumulation of dust in a recessed section containing medical supplies.

(ii) A stretcher mattress had a circular tear exposing the foam.

b. Nurses Station West:

(i) A cabinet under the sink had a heavy accumulation of dust and grit on the base and door hinges and a black substance around the interior sides and corners of the base.

(ii) A printer on the cabinet next to the sink had heavy dust atop it, and heavy dust, grit, a white powdery substance, and paper scraps beneath and behind it.

(iii) The ledge of the splash guard behind the sink and the printer had a heavy accumulation of dust on it.

(iv) A yellow stacking bin on the counter next to a copy machine contained three (3) Excyte ESR (Erythrocyte Sedimentation Rate) Vacuum tubes with an expiration date of 1/10/19.

(v) A printer on the counter next to the sink had a heavy coat of dust, clumps of dust, grit, and paper scraps beneath and behind it.

(vi) The "Portable BP (Blood Pressure) Cuffs" drawer under the counter had dust, grit, paper scraps, and hair at the bottom.

(vii) The water temperature of the hot water tap in the sink was tested with a calibrated thermometer and was found to be 126 (degrees) F.

(viii) Under the countertop, beneath wooden cabinet doors, in the charting area, was heavy dust, a dried roll of surgical tape, a dried piece of chewed gum, saw dust, grit, wrappers, paper scraps, one (1) individually packaged tablet of 500mg (milligram) Kepra which had an expiration date in 2009 and one (1) BD 3ml. (milliliter) syringe. There was heavy dust on the floor under the counter.

(ix) There was heavy dust and grit beneath and behind the Shred-it box.

(x) An unlocked drawer under the counter contained one (1) 3ml. BD syringe, one (1) cup of 650mg/20.3ml Acetaminophen Oral Solution, and one (1) prefilled syringe of Naloxone Hydrochloride 1mg/ml.

(xi) An unlocked drawer under the counter, across from Room #23, contained one (1) BD SafetyGlide 1ml 25G (gauge) x 5/8 needle, one (1) BD 3ml syringe, one (1) BD SafetyGlide 18G x 1 1/2 needle, one (1) vial of Ceftriaxone for injection, one (1) 25mg/1 ml Diltiazam Hydrochloride injection vial, one (1) bottle of Nitrostat 0.4mg/tablet, one (1) tube of Bacitracin Ophthalmic Ointment, one (1) Albuterol Sulfate Inhalation Solution 0.083% 2.5mg/3ml individual package, one (1) Ipratroprium Bromide 0.5mg and Albuterol Sulfate 3mg individual package. The bottom of the drawer had grit, hair, paper scraps, and tape residue on it.

(xii) On the floor under the counter with the patient monitors was one (1) vial of Famotidine Injection 20mg/20ml. The floor had heavy dust, grit, paper scraps, dust clumps, a throat lozenge, needle caps, old wristband printing cartridges, a bobby pin, a used lollipop stick, and other refuse.

(xiii) The unlocked top drawer under the counter in front of the chart rack contained two (2) tablets of Bisacodyl 5mg enteric coated tablets.

(xiv) There was a heavy coat of dust on the counter behind the On Call binder, Scheduling binder, Physician Phone number binder, and other binders.

(xv) The top drawer near the entrance to the inner area of the Nurses Station had dirty gauze taped to the top of the drawer with dirty surgical tape.

(xvi) The top drawer under the counter in front of the chart rack contained a plastic bag with a prescription bottle containing one (1) 50mg tablet of Metoprolol Succinate. The prescription bottle and the patient identification sticker on the plastic bag indicated that the medication belonged to Patient #24. Administrator #15 stated that the patient had been discharged from the ED on 1/19/19.

c. Pantry:

(i) Two cases of bottled water were stored in the cabinet under the sink. Administrator #15 stated that there should be no storage under the sink.

(ii) The water temperature of the hot water tap in the sink was tested with a calibrated thermometer and was found to be 124 (degrees) F.

(iii) The drawer under the cabinet next to the sink had crumbs at the bottom of it.

(iv) The top cabinet above the counter contained one (1) quart container of 1.2Cal (calorie) Specialized Nutrition for Enhanced Glycemic Control with an expiration date of 12/31/2018.

d. The middle desk had an approximately 48 inch piece of dirty surgical tape along the wooden edge of the counter and dirty surgical tape on the drawers.

e. Room #20 (Patient Room):

(i) A drawer divided into four sections had dust at the bottom of all four sections.

(ii) The bed mattress had a small hole and the foam was exposed.

f. Medication Room:

(i) There was heavy dust atop the Pyxis machine.

(ii) The floor beneath the bins on wheels had an accumulation of cellophane wrappers, vial caps, and paper scraps.

(iii) The Hi and Lo Glucose, and Ketone Control Solution bottles in the glucometer kit had stickers with an expiration date of 1/1/19.

(iv) The "Precision PCx Blood Glucose Monitor Six -Month Maintenance Log" for the months of January, February, March, and April did not include entries to indicate that the monitor was checked on 1/1, 2/24, 2/25, 3/13, 3/17, or 3/24/2019.

2. A tour of Unit 2A, an observation unit, on 4/10/19, accompanied by Administrators #5 and #16, revealed:

a. A March 2019 CODE CART CHECKLIST in a binder on an adult code cart in the hallway near the elevators, did not include entries to indicate that the emergency equipment and contents were checked on the 7A (7:00am) shift on 3/4/19, the 7A shift on 3/5/19, and the 7A shift on 3/8/19. Administrator #5 stated that although the policy states that the code carts be checked once per day, it is expected that they be checked once every shift (twice per day).

b. Pantry:

(i) A cabinet above the sink had spilled coffee and white particulate on a shelf.

(ii) There was heavy dust atop a wall cabinet.

(iii) There were dried brown stains under the Keurig machine.

(iv) A plastic bin in the drawer beneath the counter with the coffee machine had crumbs at the bottom of it.

(v) The refrigerator had a cracked gasket on the top and side of the door and there were food particles and grit on, and inside, of the top gasket. A clear plastic drawer in the refrigerator had a large dried white substance that was broken into pieces. The interior of the refrigerator door had various stains on it. The freezer section of the refrigerator had raised stains of different colors on the base of the interior. The cracked gasket had a black substance, food particles, and grit within the cracked gasket. There was a coat of dust atop the refrigerator.

(vi) The water temperature of the hot water tap in the sink was tested with a calibrated thermometer and was found to be 153 (degrees) F.

(v) The floor beneath and behind the refrigerator had a heavy accumulation of dust, grit, food particles, sugar and salt packets, dried raised stains of varying colors and consistency, medication vial caps, drinking straws, cracker wrappers, a coffee cup lid, an empty individual creamer cup, and other refuse.

c. Hallway:

(i) An unattended WoW (Cart# 2ECART4) was found to contain thirteen (13) BD (Becton Dickinson) 3ml (milliliter) syringes in an unlocked drawer and an insulin pen in a plastic bag with a patient sticker (Patient #28) on the bag.

(ii) An unattended WoW (Cart# 2ACART1) was found to have one (1) Ipratropium Bromide 0.5 and Albuterol Sulfate 3mg single-use packet and one (1) unwrapped white tablet in an open recessed bin.

d. Room #207 (patient room): There was dust atop the two wall light covers.

e. Nurses Station:

(i) The "Precision PCx Blood Glucose Monitor Six -Month Maintenance Log" for the months of January, February, March, and April did not include entries to indicate that the monitor was checked on 2/4, 2/18, 2/19, 3/1, 3/4, 3/5, 3/6, 3/7, 3/14, 3/15, 3/21, 3/22, 3/23, 3/24, 3/28, 4/1, 4/2, or 4/3/2019.

(ii) The top drawer under the counter contained a plastic 7 day pill organizer containing 4 tablets in a plastic bag. The patient identification sticker on the plastic bag indicated that the medications belonged to Patient #26. Administrator #5 stated that Patient #26 was discharged from the ED on 1/5/19.

f. Administrator #5 agreed with the above findings.


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3. On 4/9/19, a tour of the 2E unit was conducted in the presence of Staff #5 and Staff #7. The following was identified:

a. A Mindray Accutor 7 blood pressure and pulse oximetry machine were noted in the hallway between patient Room #230 and #231.

(i) Staff #5 stated that this equipment is used for all patients, including patients on isolation precautions.

(ii) Staff #5 indicated that the process is to clean the equipment in between patient use.

(iii) The machine was noted to have tape residue, dust, and other dried light brown residue on it.

b. A WOW (Workstation on wheels) was noted in the hallway outside of Room #235. The WOW was found to have tape residue, dust, and a yellow brown residue noted in the depression of the shelf that contained other medical equipment on it.

(i) Staff #5 noted that it was responsibility of the nursing staff to keep the workstations clean.

c. Staff #5 confirmed the above findings.

4. On 4/9/19, a tour of the 3E unit was conducted in the presence of Staff #5, Staff #7, and Staff #9. The following was noted:

a. A WOW was located in the hallway in between Room #346 and #347. The WOW was observed to have tape residue, dust, and other residue noted.

5. The above findings were confirmed by Staff #5, Staff #7, and Staff #9.

Based on review of policies and procedures, a tour of two patient care units, and review of staff educational documents, it was determined that the facility failed to ensure that the confidentiality of patient records are maintained.

Findings include:

Reference: Hospital educational document titled, "HIPAA (Health Insurance Portability and Accountability Act) Code of Conduct Education" states:
"Preserving Patient Privacy & Security
In accordance with Federal Health Insurance Portability and Accountability Act ('HIPAA') and applicable state medical privacy laws, Barnabas Health is committed to maintaining the confidentiality and security of our patients' health information.
Protected Health Information ('PHI')
PHI in Public Areas .....
* Keep PHI documents locked and secure
* Use special disposal bins when discarding paper containing PHI .....
Includes, but is not limited to:
* Name
* Medical Record Number
* Address
* Date of Birth
* Phone Numbers
* Insurance ID (identification) Number
* Email Addresses
* Social Security Card ....."

1. A tour of Unit 2A, an observation unit, on 4/10/19, accompanied by Administrators #5 and #16, revealed:

a. A binder atop an adult code cart in the hallway near the elevators contained:

(i) A "Rapid Response Team Call Record" form, dated 3/22/19, including the name, medical record number, date of birth, vital signs, and other medical information regarding Patient #12.

(ii) A "Rapid Response Team Call Record" form, dated 4/8/19, including the name, medical record number, date of birth, vital signs, and other medical information regarding Patient #14.

b. A regular trash bin in the Nurses Station, next to a Shred-it box, contained a "RH (Rahway Hospital) Financial Record" form including the name, medical record number, Social Security number, marital status, admitting diagnosis, address, phone number, insurance policy number, and name, address, and phone numbers of the child of Patient #33.

2. A tour of the Emergency Department on 4/9/19, accompanied by Administrators #15 and #16 revealed:

a. A page of patient identification stickers including the name, medical record number, and date of birth of Patient #29 was found behind a printer on a counter in the Nurses Station. Administrator #15 stated that the patient had been discharged on 3/26/19.

b. A regular trash bin in the Doctor's Station contained:

(i) A Prescription Blank for a physician referral, a Special Chemistry Final Report form, A Comprehensive Metabolic Panel Final Report form, and a Hematology & Coagulation Final Report form including the name, telephone numbers, age, and test results for Patient #31.

(ii) A WORK/SCHOOL/GYM NOTE with the name of Patient #32.

3. Administrator #15 agreed with the above findings.

Based on observation, document review, and staff interview, it was determined that the facility failed to ensure that there are physician orders for patients in restraints.

Findings include:

Reference: Policy titled, "Restraints" states, "... Procedure: 1. NON-VIOLENT AND SELF-DESTRUCTIVE PATIENT RESTRAINT ...11. MD ORDER/DOCUMENTATION 11.1. Any use of restraints requires an MD or other LIP (licensed independent practitioner) to see patient... and place order for restraint in computer system....."

1. On 4/9/19 at 12:24 PM, a tour of the CCU (Critical Care Unit) was conducted in the presence of Staff #5, Staff #6, and Staff #11.

a. Patient #10 was observed at 12:34 PM to have bilateral soft wrist restraints in place.

b. On 4/10/19, a review of the medical record for Patient #10 was completed in the presence of Staff #5 and Staff #23. The medical record review revealed that the last documentation on the restraint flowsheet by an RN for the assessment of the patient was noted to be on 4/9/19 at 2:00 PM. Patient #10 was identified through the documentation to have still been in restraints on 4/9/19 at 2:00 PM.

(i) An order was identified in the medical record that indicated the medical restraints had a stop date and time of 4/9/19 at 10:56 AM.

(ii) The medical record of Patient #10 lacked evidence of when the restraints were removed.

c. Patient #10 was determined to have restraints in place without an active order from 10:56 AM to 2:00 PM.

2. The above findings were confirmed by Staff #23.

Based on a review of the medical records of 5 (five) adult patients who were physically restrained for behavior management, review of policy and procedure, and interview with administrative staff, it was determined that the facility failed to ensure that each order for restraint use for the management of violent or self-destructive behavior that jeopardizes the immediate physical safety of the patient, a staff member, or others is limited to 4 (four) hours.

Findings include:

Reference: Policy and procedure titled, "Restraints" states: "..... Procedure: .....
23. VIOLENT OR SELF-DESTRUCTIVE PATIENT RESTRAINT
23.1. Clinical Justifications .....
23.1.7. Use of restraints must be in accordance with the order of an MD (Medical Doctor) or other LIP (Licensed Independent Practitioner) who is responsible for the care of the patient and authorized to order restraint. .....
28. MD ORDER/DOCUMENTATION
28.1. Use of restraints requires the order of MD or other LIP who has authority to order restraints. This order must be obtained immediately. Order is placed in computer system [sic]
28.2 Any use of restraints for the management of violent or self-destructive behavior requires patient to be seen face to face within one hour after initiation of the intervention by an MD or other LIP or PA (Physician Assistant) who has been trained in management of restraints.
.....
28.4. Each order for restraints used for the management of violent or self-destruction behavior must be renewed in accordance with the following limits for up to a total of 24 hours.
28.4.1. 4 hours for adults 18 years of age or older. ....."

1. Review of the medical record of Patient #13 revealed:

a. A "Restraints Assessment & Care RH (Rahway Hospital)" note dated 2/4/19 at 18:00 (6:00 PM) indicated that the patient was placed in 4-point physical restraints.

b. An Emergency Department Physician Note entry dated 2/7/19 at 19:20 (7:20 PM) stated that the patient was examined face-to-face at 18:17 (6:17 PM) by a physician.

c. A physician order for 4-point restraints was entered at 18:18 (6:18 PM). The order was time limited to four hours.

(i) Since the patient had already been in 4-point physical restraints when the physician entered the order, the order became an order for 4 hours and 18 minutes - 18 minutes longer than the 4 hour limit.

2. Review of the medical record of Patient #37 revealed:

a. A "Restraints Assessment & Care RH" note dated 3/4/19 at 18:15 (6:15 PM) indicated that the patient was placed in 4-point physical restraints.

b. Physician orders for 4-point restraints was entered at 18:30 (6:30 PM). The orders were time limited to four hours.

(i) Since the patient had already been in 4-point physical restraints when the physician entered the orders, the orders became orders for 4 hours and 15 minutes - 15 minutes longer than the 4 hour limit.

3. Administrator #1 agreed with the findings.

Based on a review of policy and procedure and review of the medical records of five of five patients who were physically restrained for management of violent or self-destructive behavior, it was determined that the facility failed to ensure that the condition of the patient is monitored by trained staff at an interval determined by facility policy.

Findings include:

Reference: Policy and procedure titled, "Restraints" states: "..... Procedure: .....
23. VIOLENT OR SELF-DESTRUCTIVE PATIENT RESTRAINT
23.1. Clinical Justifications .....
23.1.7. Use of restraint must be in accordance with the order of an MD (Medical Doctor) or other LIP (Licensed Independent Practioner) who is responsible for the care of the patient and authorized to order restraint.
23.1.8. Patient must have continuous in person observation for duration of restraint (CO) when restraint is used in Violent or Self-Destructive patient. .....
31. ASSESSMENT AND INTERVENTIONS FOR PATIENTS WITH RESTRAINTS
31.1. Patient will remain with continuous observation while maintained in restraints for violent/self-destruction behaviors. Safety rounds are documented every 15 minutes to ensure patient remains safe while restraint is in use.
31.2. RN to assess patient's clinical status and re-evaluate need for restraint every two hours. .....
31.13 Ongoing assessment and interventions are documented on the electronic restraint flow sheet. ....."

1. Review of the medical record of Patient #13 revealed:

a. An order dated 2/4/19 at 18:18 (6:18 PM) stated:
"Reason for Restraints: To Control Violent and/or Destructive Behavior: Dangerousness to Self [sic] Others [sic] Environment, Device: Four Point Hard Limb, Duration: 4 hours.
Protocol: Restraints used for Violent and Aggressive Behavior that poses danger to patients, others, or environment, require FACE to FACE evaluation within ONE HOUR of emergent restraint application and every 8 hours for continued orders up to 24 hours. Sitter REQUIRED. Vital signs required every 15 minutes. ....."

b. "Restraint Assessment & Care RH (Rahway Hospital)" nursing note indicated that the patient was restrained between 18:00 (6:00 PM) and 22:00 (10:00 PM).

c. The "Assessment" section of a "Restraint Assessment & Care RH" nursing note at 18:00 (6:00 PM) stated: "..... Toileting: urethral catheter."

(i) There was no flow sheet in the medical record to indicate that the patient had continuous in person observation or that safety rounds were documented every 15 minutes.

(ii) "Restraint Assessment & Care RH" nursing notes were entered at 18:00 (6:00 PM), 18:54 (6:54 PM), 20:00 (8:00 PM), 21:00 (9:00 PM), and 22:00 (10:00 PM) and none indicated that the patient's clinical status was assessed or that the need for restraints was re-evaluated at any time.

(iii) The only documented vital signs in the medical record while the patient was in restraints were entered at 18:35 (6:35 PM), 19:36 (7:36 PM), and 20:37 (8:37 PM) and not every 15 minutes in accordance with facility policy.

(iv) There was no written physician order for the use of a urethral catheter. Additionally, there was no documentation that the patient was toileted, or offered toileting during the four hours in restraints.

2. Review of the medical record of Patient #34 revealed:

a. An order dated 2/17/19 at 03:47 (3:47 AM) stated: "Reason for Restraints: To Control Violent and/or Destructive Behavior: Dangerousness to Self [sic] Others [sic] Environment, Device: Four Point Hard Limb, Duration: 4 hours.
Protocol: Restraints used for Violent and Aggressive Behavior that poses danger to patients, others, or environment, require FACE to FACE evaluation within ONE HOUR of emergent restraint application and every 8 hours for continued orders up to 24 hours. Sitter REQUIRED. ....."

b. The "Reason" section of a "Restraint Assessment & Care RH" nursing note at 03:45 (3:45 AM) stated: "..... Restraint Device Used: soft limb holders right wrist left wrist right ankle left ankle"

(i) There was no restraint flow sheet in the medical record to indicate that the patient had continuous in person observation or that safety rounds were documented every 15 minutes.

(ii) Although the order was for Four Point Hard Limb restraints, the patient was placed in 4-point soft limb holders.

3. An order dated 10/8/18 at 03:01 (3:01 AM) in the medical record of Patient #35 stated:
"Reason for Restraints: To Control Violent and/or Destructive Behavior: Dangerousness to Self [sic] Others [sic] Environment, Device: Four Point Hard Limb, Duration: 4 hours.
Protocol: Restraints used for Violent and Aggressive Behavior that poses danger to patients, others, or environment, require FACE to FACE evaluation within ONE HOUR of emergent restraint application and every 8 hours for continued orders up to 24 hours. Sitter REQUIRED. Vital signs required every 15 minutes. ....."

(i) There was no restraint flow sheet in the medical record to indicate that the patient had continuous in person observation or that safety rounds were documented every 15 minutes.

(ii) There was no documentation in the medical record that the patient's vital signs were taken every 15 minutes while the patient was in restraints.

4. Review of the medical record of Patient #36 revealed:

a. An order dated 1/19/19 at 23:54 (11:54 PM) stated:
"Reason for Restraints: To Control Violent and/or Destructive Behavior: Dangerousness to Self [sic] Others [sic] Environment, Device: Bedrails 4 out of 4. Duration: 4 hours
Protocol: Restraints used for Violent and Aggressive Behavior that poses danger to patients, others, or environment, require FACE to FACE evaluation within ONE HOUR of emergent restraint application and every 8 hours for continued orders up to 24 hours. Sitter REQUIRED. Vital signs required every 15 minutes. ....."

(i) There was no restraint flow sheet in the medical record to indicate that the patient had continuous in person observation or that safety rounds were documented every 15 minutes.

(ii) There was no documentation in the medical record that the patient's vital signs were taken every 15 minutes while the patient was in restraints.

(iii) Although the order was for 4 side rails, the patient was placed in 4-point hard limb restraints.

5. Review of the medical record of Patient #37 revealed:

a. An order dated 3/4/19 at 18:30 (6:30 PM) stated: "Reason for Restraints: To Control Violent and/or Destructive Behavior: Dangerousness to Self [sic] Others [sic] Environment, Device: Soft Limb Bilateral Wrists, Duration: 4 hours.
Protocol: Restraints used for Violent and Aggressive Behavior that poses danger to patients, others, or environment, require FACE to FACE evaluation within ONE HOUR of emergent restraint application and every 8 hours for continued orders up to 24 hours. Sitter REQUIRED. ....."

b. An order dated 3/4/19 at 18:30 (6:30 PM) stated: "Reason for Restraints: To Control Violent and/or Destructive Behavior: Dangerousness to Self [sic] Others [sic] Environment, Device: Soft Limb Bilateral Ankles, Duration: 4 hours.
Protocol: Restraints used for Violent and Aggressive Behavior that poses danger to patients, others, or environment, require FACE to Face evaluation within ONE HOUR of emergent restraint application and every 8 hours for continued orders up to 24 hours. Sitter REQUIRED. ....."

c. The "Assessment" section of "Restraint Assessment & Care RH" nursing notes dated 3/4/19 at 18:15 (6:15 PM), 20:00 (8:00 PM), and 22:00 (10:00 PM) and 3/5/19 at 00:00 (12:00 AM), 02:00 (2:00 AM), 04:00 (4:00 AM), and 06:00 (6:00 AM) included the entry: "..... Toileting: urethral catheter."

(i) There was no restraint flow sheet in the medical record to indicate that the patient had continuous in person observation or that safety rounds were documented every 15 minutes.

(ii) There was no written physician order for the use of a urethral catheter. Additionally, there was no documentation that the patient was toileted, or offered toileting during the four hours in restraints.

Based on a review of facility policy and procedure, review of the medical record of two of five patients who were physically restrained to manage violent or self-destructive behavior, and interview with administrative staff, it was determined that the facility failed to ensure that documentation of a face-to-face is completed within one hour of the application of restraints.

Findings include:

Reference: Policy and procedure titled, "Restraints" states: "..... Procedure: .....
23. VIOLENT OR SELF-DESTRUCTIVE PATIENT RESTRAINT .....
28. MD ORDER/DOCUMENTATION .....
28.2 Any use of restraints for the management of violent or self-destructive behavior requires patient to be seen face to face within one hour after initiation of the intervention by an MD or other LIP (Licensed Independent Practioner) or PA (Physician Assistant) who has been trained in management of restraints. ....."

1. Review of "Restraints Assessment & Care RH (Rahway Hospital)" notes dated 1/19/19 at 18:00 (6:00 PM), 18:28 (6:28 PM), 19:36 (7:36 PM), and 20:00 (8:00 PM) in the medical record of Patient #36 indicated that the patient was physically restrained in hard limb holders. There was no documentation that a physician or an LIP performed a face-to-face evaluation of the patient within one hour of the application of the restraints.

2. Review of "Restraints Assessment & Care RH (Rahway Hospital)" notes dated 2/17/19 at 03:45 (3:45 AM), 04:00 (4:00 AM), 04:15 (4:15 AM), 04:30 (4:30 AM), 04:45 (4:45 AM), 05:00 (5:00 AM), 05:15 (5:15 AM), 05:30 (5:30 AM) and 05:45 (5:45 AM) in the medical record of Patient #34 indicated that the patient was physically restrained. There was no documentation that a physician or an LIP performed a face-to-face evaluation of the patient within one hour of the application of the restraints.

Based on document review and staff interview, it was determined that the facility failed to ensure that daily nurse staffing schedules consistently reflect staffing levels based on the acuity of the patients and the complexity of care with changes in patients' condition during a shift.

Findings include:

Reference: Facility policy titled, "Nurse Staffing guidelines," states, " ...POLICY ...6. Daily assessment of the need for additional nursing staff (licensed und unlicensed personnel) is performed by the leader of the clinical unit ... on each shift ..... The assessment of requirements includes: -Patient case mix, staff input, clinical reports of patient conditions and anticipated nursing requirements. -Increased unit level of complexity of care, i.e., unexpected events and/or changes in clinical status of the patient(s) ... ."

1. The daily assignments sheets for all shifts for the 2E, 2A, 3E, 3C, ED (Emergency Department) and CCU (Critical Care Unit) were reviewed for the dates of 1/20/19 to 1/26/19.

a. The 2E Unit failed to provide evidence of staffing assignments according to acuity levels on the following dates and shifts:

(i) 1/20/19: 7 AM to 7 PM and 7 PM to 7 AM

(ii) 1/24/19: 7 AM to 7 PM and 7 PM to 7 AM

(iii) 1/25/19: 7 AM to 7 PM

(iv) 1/26/10: 7 AM to 7 PM and 7 PM to 7 AM

b. The 3E Unit failed to provide evidence of staffing assignments according to acuity levels on the following dates and shifts:

(i) 1/20/19: 7 AM to 7 PM and 7 PM to 7 AM

(ii) 1/21/19: 7 AM to 7 PM and 7 PM to 7 AM

(iii) 1/22/19: 7 AM to 7 PM and 7 PM to 7 AM

(iv) 1/23/19: 7 AM to 7 PM and 7 PM to 7 AM

(v) 1/24/19: 7 AM to 7 PM and 7 PM to 7 AM

(vi) 1/25/19: 7 AM to 7 PM and 7 PM to 7 AM

(vii) 1/26/10: 7 AM to 7 PM and 7 PM to 7 AM

c. The CCU failed to provide evidence of staffing assignments according to acuity levels on the following dates and shifts:

(i) 1/20/19: 7 AM to 7 PM and 7 PM to 7 AM

(ii) 1/21/19: 7 AM to 7 PM

(iii) 1/23/19: 7 AM to 7 PM and 7 PM to 7 AM

(iv) 1/24/19: 7 PM to 7 AM

(v) 1/26/10: 7 AM to 7 PM and 7 PM to 7 AM

(vi) A review of the daily assignment sheet dated 1/22/19 for the 7 PM to 7 AM shift, lacked evidence of Patient #3 being admitted to the unit, assigned an RN (registered nurse), having a medical code, and expiring within the shift.

2. Staff #1 and Staff #3 confirmed the above findings.

3. Staff #3 indicated in an interview on 4/11/19 that charge RNs and nurse managers have a report sheet each shift that notes patient needs and acuity levels that help determine staffing.

a. Upon request, the facility was unable to provide evidence of the report sheets that reflected patient needs.

Based on document review, medical record review, and staff interview, it was determined that the facility failed to ensure that the evaluation of patient needs is performed accurately and on an ongoing basis.

Findings include:

Reference #1: Facility policy titled, "Triage Acuity" states, "...Clinical Acuity System and Definitions: ...2. LEVEL 2 :EMERGENT: is defined as a patient with a condition of a high risk situation whose can deteriorate rapidly if treatment is delayed... These patients are considered unstable.... EXAMPLES: Chest Pain with stable vital signs... 3. LEVEL 3: URGENT: requires prompt care... The patient is considered stable and may wait up to 1 hour... ."

Reference #2: Facility policy titled, "Restraints" states "...VIOLENT OR SELF-DESTRUCTIVE PATIENT RESTRAINT... 23.1 Clinical Justifications...23.1.3 When all other less restrictive interventions have been determined ineffective restraints may be used to protect the patient, a staff member or others from harm..... 31. ASSESSMENT AND INTERVENTIONS FOR PATIENTS WITH RESTRAINTS 31.1. Patient will remain with continuous observation while maintained in restraints for violent/self-destruction behaviors. Safety rounds are documented every 15 minutes to ensure patient remains safe while restraints are in use. 31.2 RN to assess patient's clinical status and re-evaluate need for restraint every two hours..... 31.13 Ongoing assessment and interventions are documented on the electronic restraint flow sheet....."

1. A review of the Medical Record of Patient #1 revealed that the patient presented to the Emergency Department (ED) on 12/17/18 at 7:14 PM with complaints of chest pain. Vital signs were taken upon ED arrival. Patient #1 was triaged as a level 3 and not as a level 2 per facilty policy.

a. An echocardiogram (EKG) was completed at 7:17 PM indicating an ST elevated Myocardial Infarction (STEMI), and a code MI was called at 7:20 PM.

b. Staff #1 confirmed that the above patient should have been triaged at a "LEVEL 2 Emergent" based on the complaints of chest pain with stable vital signs.

2. A review of the Medical Record of Patient #2 revealed that the patient presented to the ED on 12/17/18 at 9:46 PM with complaints of a head injury associated with projectile vomiting and headache. Vital signs were taken, and a Computed Tomography (CT) Scan was performed.

a. A note written by Staff #40 on 12/18/18 at 2:39 AM indicated that the patient had a steady gait and was tolerating PO (oral) intake upon discharge.

(i) The medical record lacked evidence of a correlating ED nursing note or assessment that indicated when the patient had received PO and what was given.

(ii) The medical record lacked evidence that Patient #2 and Patient #2's caregiver were educated regarding the plan of care in the ED.

3. A review of the Medical Record of Patient #3 revealed that the patient presented to the ED on 1/22/19 and was triaged at 5:14 PM as a level 1. Vital signs were taken, the patient was restrained, and the patient was intubated. Patient #3 was determined to be septic.

a. Patient #3's temperature upon arrival to the ED was noted to be 102.5 degrees Fahrenheit.

(i) The medical record lacked evidence of a reassessment of Patient #3's temperature with subsequent vital sign rechecks in the ED.

(ii) The medical record lacked evidence of interventions provided for an elevated body temperature.

b. The ED record of Patient #3 indicated in a note written by Staff #44 on 1/22/19 at 5:16 PM that the patient had been restrained upon arrival to the ED. An order for Behavioral Restraints was placed on 1/22/19 by Staff #45, an ED physician.

(i) The medical record lacked evidence of a restraint flow sheet, and assessments per the restraint order and policy.

(ii) The medical record lacked evidence of attempted alternatives to restraints.

4. A review of the Medical Record of Patient #6 revealed that the patient presented to the ED on 3/14/19 at 1:25 PM with complaints of chest pain. Vital signs were taken, and EKG was completed. Patient #6 was triaged as a level 3 and not as a level 2 per facility policy.

a. Staff #1 confirmed that Patient #6 should have been triaged at a "LEVEL 2 Emergent" based on the complaints of chest pain with stable vital signs.

5. The above findings were confirmed by Staff #1.

Based on document review and staff interview, it was determined that the facility failed to ensure that the agency nursing staff are qualified for the positions they are assigned.

Findings include:

Reference: Facility policy titled, "Scope of Services Critical Care Unit" states, " ...Management/Care Delivery ... The staff of these units will have successfully completed a Critical care Course which includes Cardiac/Respiratory/Hemodynamic/Endocrine modules ....."

1. A review of the personnel and education files for Staff #39, an agency registered nurse, was conducted in the presence of Staff #21 and Staff #22.

a. Staff #39's education file lacked evidence of competencies required as noted in the scope of services of a CCU (Critical Care Unit) nurse.

(i) A competency checklist provided by the agency for Staff #39 indicated less than proficient (able to perform independently) scores in the categories of cardiovascular, neurology, and age specific proficiencies.

(ii) The agency was unable to provide further evidence of CCU competencies as outlined in the scope of services.

2. Staff #22 indicated that agency nurses would be required to complete a CCU competency profile before beginning work.

a. Staff #39 was noted to have a start date of 10/11/18 as an agency PD (per diem) nurse for the CCU.

(i) The facility was unable to provide evidence that a CCU competency profile, as required by the facility, had been completed by Staff #39.

(ii) An interview with Staff #22 on 4/10/19 indicated that Staff #39 had last worked in the CCU on 1/25/19.

3. Staff #21 and Staff #22 confirmed the above findings.

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

Findings include:

1. The facility failed to ensure that multi-dose vials of medications, that are accessed in the immediate patient treatment area, are discarded immediately after single patient use. (Refer to Tag A 749)

2. The facility failed to ensure the development and implementation of policies and procedures addressing qualification testing for malfunctioning sterilizers. (Refer to Tag A 749)

3. The facility failed to ensure implementation of policies and procedures that written manufacturers' instructions of the devices and instruments are reviewed and followed. (Refer to Tag A 749)

4. The facility failed to ensure a functional and sanitary environment for the provision of surgical services in accordance with acceptable standards of practice. (Refer to Tag A 749)

5. The facility failed to ensure implementation of policies and procedures addressing standard precautions. (Refer to Tag A 749)

6. The facility failed to ensure that a separation between clean and contaminated work areas and activities are established. (Refer to Tag A 749)

7. The facility failed to ensure that rigid sterilization container systems are clean prior to sterilization. (Refer to Tag A 749)

8. The facility failed to ensure proper preparation and assembly of instruments in accordance with acceptable standards of practice. (Refer to Tag A 749)

9. The facility failed to ensure instruments are precleaned immediately following use, sterile items are inspected visually for integrity, and stored in a manner that reduces potential for contamination. (Refer to Tag A 749)

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








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

Findings include:

Reference: Facility document titled "2019 Infection Prevention Plan" states, " ...Structure: A. Infection Prevention Manager Responsibilities: ...Review of preventive surveillance and control relating to the inanimate hospital environment. B. Infection Prevention Committee Responsibilities: ...Supervise Infection Prevention activities in all areas of the hospital, including but not limited to Operating rooms, recovery rooms, special care units, sterilization procedures, prevention of cross-infection by any equipment/apparatus ..."

1. A copy of the hospital approved cleaning and disinfecting agents was requested to Staff #1 on 4/10/19.

a. An untitled document without letter head was received that listed ten (10) cleaning and disinfecting agents. There was no evidence provided that these agents had been approved and/or reviewed by the infection control committee and professionals.

2. During an observation of a post-procedure room turnover at 12:39 PM on 4/10/19, Staff #29 was observed wiping down instrument cords using PDI Super Sani Germicidal Disposable wipes. The PDI Super Sani Germicidal Disposable wipes were not listed on the document provided.

a. Staff #29 placed the cleaned cords on an intravenous (IV) pole that had not been cleaned.

b. Upon interview, Staff #29 stated that he/she is responsible for cleaning the anesthesia work station and setting up the workstation, in between cases.

c. Review of Staff #29's personnel file revealed that there were no competencies performed for cleaning of the anesthesia work areas and equipment, in between cases.

d. Upon interview, Staff #33 stated that Staff #29 does not clean, in between cases.

e. At 12:43 PM, Staff #28 was observed mopping a blood-stained floor without moving the cleaned equipment. The dirty mop touched the surfaces of cleaned equipment.

(i) Staff # 28 was observed taking the trash out of the room with gloves on. With the same gloves on, he/she proceeded to touch surfaces of equipment that had already been cleaned.

(ii) Upon interview, Staff #33 stated that there were no competencies performed for the cleaning and disinfecting of the operating room, in between cases for the housekeeping staff.

3. Review of facility document titled "Infection Prevention Council Meeting dated 12/18/18" indicates, "Housekeeping and Food Service: 61 rooms were inspected with a score of 3.4 out of 4."

a. Upon interview, Staff #33 stated that the 61 rooms inspected did not include operating rooms.

4. Upon request, Staff #18 failed to provide evidence of preventive surveillance and control relating to the inanimate hospital environment specific to the cleaning of the operating rooms, in between cases.

5. The above findings were confirmed by Staff #17, Staff #18, and Staff #33.

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

Findings include:

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

1. During an observation in the Post Anesthesia Care Unit (PACU) at 12:52 PM on 4/11/19, one (1) opened and needle punctured multi-dose vial of Humulin R, dated "4/29/19" was found in the medication refrigerator.

a. Upon interview, Staff #38 stated that the practice of this unit is to draw up the medication at the patient's bay and administer the medication with two nurses verifying. Once the medication is administered, the vial is placed back into the medication refrigerator for subsequent patients.

2. Review of the facility policy and procedure titled "Medication Management" failed to address accessing multi-dose containers/vials in the immediate patient treatment area.

3. The above findings were confirmed by Staff #1, Staff #3, Staff #14, and Staff #38.

On April 11, 2019 at 1:29 PM, Staff #1 and Staff #3 were notified that the above finding resulted in an Immediate Jeopardy (IJ) and a copy of the completed IJ template was provided. On April 18, 2019, an onsite revisit was conducted and the Immediate Jeopardy was removed, upon receipt of an acceptable removal plan.

B. Based on observation, staff interviews, and document review, it was determined that the facility failed to ensure the development and implementation of policies and procedures addressing qualification testing for malfunctioning sterilizers.

Findings include:

Reference: AAMI ST 79: 2017 Comprehensive Guide To Steam Sterilization and Sterility Assurance in Health Care Facilities section 13.8 Qualification testing states, "Qualification testing with a BI [biological indicator] PCD [process challenging device] should be performed on all sterilizers after sterilizer installation, relocation, malfunctions, major repairs, sterilization process failures, or changes to the utilities... For dynamic-air-removal sterilizers, three consecutive cycles should be run, one right after the other, with a PCD, yielding negative results from all test BIs and appropriate readings from all physical monitors and CIs [chemical indicators]. In addition, three consecutive Bowie-Dick tests should be run, one right after the other with each test result demonstrating sufficient air removal."

1. Review of the sterilization record log, dated 3/27/19, for the Getinge Sterilizer #1 indicated that on load #3, the "cycle aborted."

2. Review of the Getinge Sterilizer #1 work order on 3/27/19 indicated that "upon inspection found that the chamber temperature reading is bouncing from a good temperature reading to 999.99. Upon further inspection found that the chamber temperature Resistance Temperature Detector (RTD) probe has a loose wire at the connector that plugs into the computer monitor (CM1) board. The wire is barely making contact. Restripped the wires and ensured the connections were making good contact."

3. Upon interview on 4/11/19, Staff #17 and Staff #24 were not aware that the sterilizer had been repaired and serviced recently. When questioned about the process of performing qualification testing's on a malfunctioning sterilizer, Staff #17 and Staff #24 both stated that the qualification testing consisted of performing one (1) Bowie Dick test, followed by three (3) PCDs containing a BI tests.

4. Upon interview on 4/11/19, Staff #24 stated that the facility did not have a policy addressing qualification testing on a malfunctioning sterilizer.

5. The above findings were confirmed by Staff #1, Staff #17, Staff #24, and Staff #3.

On April 11, 2019 at 4:30 PM, Staff #1 and Staff #3 were notified that the above finding resulted in an Immediate Jeopardy (IJ) and a copy of the completed IJ template was provided. On April 18, 2019, an onsite revisit was conducted and the Immediate Jeopardy was removed, upon receipt of an acceptable removal plan.

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

Findings include:

Reference #1: Facility policy titled "Care, handling and transportation of contaminated reusable instruments from the units" states, "Policy: ...The reusable instruments will be cleaned and sterilized following manufacturers' recommendations."

Reference#2: AAMI Sterilization in Health Care Facilities, 2017 edition, section 7.3 states, "Manufacturers' written IFU [Instructions for Use]: The device manufacturer's current written IFU should be accessible, reviewed, and followed. If there are no written IFU in the labeling, then the manufacturer should be contacted and requested to provide a documented method of cleaning. ..."

1. Upon review of the Getinge Steam Sterilizer #2 Sterilization Record logs, dated 4/8/19, the following was noted:

a. In load #2, Biomet instruments were sterilized at a temperature of 275 degrees Fahrenheit and an exposure time of 10 minutes.

(i) The manufacturer's instructions for use for Biomet instruments states, "Recommended Steam Sterilization Parameters: Temperature 270 degrees Fahrenheit and Exposure time 4 minutes."

b. In load #5, an Ortho Tray was sterilized at a temperature of 275 degrees Fahrenheit.

(i) Upon interview, Staff #24 stated that the Ortho Tray consisted of instruments manufacturered by Zimmer.

(ii) The manufacturer's instructions for use for Zimmer Orthopaedic Reusable Devices states, "Recommended Steam Sterilization Parameters: Temperature 270 degrees Fahrenheit."

2. Upon review of the Getinge Steam Sterilizer #1 Sterilization Record logs, dated 4/8/19, the following was noted:

a. In load #5, Stryker Asnis Micro Instruments were sterilized at a temperature of 275 degrees Fahrenheit and a drying time of 30 minutes.

(i) The manufacturer's instructions for use for Stryker Asnis Micro Instruments states, "The following process parameters are validated by Stryker and recommended for sterilization and/or resterilization: Temperature 270 degrees Fahrenheit and Drying Time 35 minutes."

b. Upon interview, Staff #24 stated that Stryker implant devices were also sterilized in load #5 with the sterilization temperature of 275 degrees Fahrenheit and a drying time of 30 minutes.

(i) The corresponding manufacturer's instructions for use for the Stryker implant devices provided states, "The following process parameters are validated by Stryker and recommended for sterilization and/or resterilization: Temperature 270 degrees Fahrenheit and Drying Time 75 minutes."

3. Upon interview, Staff #24 stated that all instruments were sterilized using a universal temperature of 275 degrees Fahrenheit, exposure time of 4 minutes and a drying time of 30 minutes, rather than following the manufacturer's instructions for the devices and instruments.

4. The above findings were confirmed by Staff #16, Staff #17, and Staff #24.

D. Based on observation, staff interviews, and document review, it was determined that the facility failed to ensure a functional and sanitary environment for the provision of surgical services in accordance with acceptable standards of practice.

Findings include:

Reference #1: Association of periOperative Registered Nurses (AORN) Perioperative Standards and Recommended Practices; "RP: Environmental Cleaning" states, "... Recommendation II. A safe environment should be re-established after each surgical procedure. ..."

1. During an observation of a post-procedure room turnover in Operating Room (OR) #3 at 12:39 PM on 4/10/19, in the presence of Staff #17 and Staff #18, the following was observed:

a. Staff #29 wiped down instrument cords and placed the cords on an intravenous (IV) pole, which had not been cleaned.

b. At 12:43 PM, Staff #29 was setting up anesthesia equipment in preparation for the next surgical case. Staff #29 failed to replace the opened packages of the anesthesia equipment and stated that the equipment was not used from the previous case so it can be used for the next surgical case.

c. At 12:43 PM, when questioned if the room had been turned over, Staff #17 stated that housekeeping just came inside to turn the room over and the room is not patient ready yet.

2. The above findings were confirmed by Staff #16, Staff #17, and Staff #18.

Reference #2: Association of periOperative Registered Nurses (AORN) 2017 Edition Guidelines For PeriOperative Practice, Guideline for Environmental Cleaning Recommendation II states, "The patient should be provided with a clean, safe environment... II.h. Mattresses and padded positioning device surfaces (e.g.. OR beds, arm boards, patient transport carts) should be moisture-resistant and intact. Absorbent or nonintact surfaces may become reservoirs for microorganisms and may harbor pathogens."

1. On 4/10/19 at 10:41 AM, in Operating Room #7, Staff #17 stated that the room was patient ready.

a. Arm boards and padded positioning devices had tears in the outer material exposing the inner foam material, which is rendered an uncleanable surface.

2. On 4/10/19 at 11:20 AM, in Operating Room #6, Staff #17 stated that the room was patient ready.

a. Arm boards and padded positioning devices had tears on the outer material, exposing the inner foam material, which is rendered an uncleanable surface.

3. In the Central Processing Department at on 4/11/19 at 10:25 AM, the following was observed:

a. The floors in front of the sterilizer #1 and sterilizer #2 were gouged, scratched and soiled with black residue and stains. The floor surface damage would prevent cleaning.

b. In the decontamination area, the ultrasonic cleaners had rust-like surfaces which precludes cleaning.

Reference #3: CDC [Centers for Disease Control and Prevention] Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008 states, "Ensure that, at a minimum, noncritical patient-care devices are disinfected when visibly soiled and on a regular basis (such as after use on each patient ...) "

1. In the holding area by the surgical unit on 4/10/19 at 10:19 AM, five (5) x-ray aprons were found hanging on a rack, touching the floor.

a. Upon interview, Staff #17 stated that the facility did not have a policy specific to cleaning the x-ray aprons, in between uses and did not know if the x-ray aprons had been cleaned or not.

2. The above findings were confirmed by Staff #17 and Staff #18.

E. Based on observation, staff interview, and document review, it was determined that the facility failed to ensure implementation of policies and procedures addressing standard precautions.

Findings include:

Reference: Facility policy titled "Standard Precautions" states, Procedure: ...1.5 Wash/cleanse hands between patients, paying particular attention to around and under fingernails and between the fingers. Wash/cleanse hands promptly and thoroughly as possible. ...1.5.4 After gloves are removed."

1. During an observation of a post-procedure room turnover at 12:41 PM in Operating Room #3 on 4/10/19, Staff #29 failed to perform hand hygiene in between removing and applying gloves.

2. During an observation of a post-procedure room turnover at 12:17 PM in Operating Room #5 on 4/11/19, Staff #29 failed to perform hand hygiene in between removing and applying gloves.

F. Based on observation, staff interviews and document review, it was determined that the facility failed to ensure that a separation between clean and contaminated work areas and activities are established.

Findings include:

Reference: AAMI (Association for the Advancement of Medical Instrumentation) ST 79: 2017 Comprehensive Guide To Steam Sterilization and Sterility Assurance in Health Care Facilities section 3.2.2, 'Functional workflow patterns' indicates, "The sterile processing department/area should include ... e) systems to contain contaminants and minimize employee exposure to bloodborne and other potentially infectious organisms; ..."

1. In the Decontamination Room on 4/11/19 at 10:16 AM, six (6) decontamination sinks contained torn adhesive labels within the sinks, marking the water levels of water.

a. The adhesive labels had curled edges exposing the adhesive side of the label, preventing proper cleaning.

2. The above finding was confirmed by Staff #17 and Staff #24.

G. Based on observation, staff interviews, and document review, it was determined that the facility failed to ensure that rigid sterilization container systems are clean prior to sterilization.

Findings include:

Reference: Association for the Advancement of Medical Instrumentation (AAMI), ST79: 2017 Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities section 7.5.2.2. Rigid sterilization container systems 7.5.2.2.1 General considerations indicates, "...Rigid sterilization container systems should be cleaned a) before sterilization, either manually or mechanically; ...Rationale: ...Damaged components of container systems could interfere with the sterilization process or allow contamination of the contents..."

1. During an observation in the central sterilization area on 4/11/19 at 11:12 AM, six (6) instrument containers contained tape residue and tape with curled edges, exposing adhesive side of the tape, rendering uncleanable surfaces.

2. Staff #17 and Staff #24 confirmed this finding.

H. Based on observation, staff interviews and document review, it was determined that the facility failed to ensure proper preparation and assembly of instruments in accordance with acceptable standards of practice.

Findings include:

Reference: Association for the Advancement of Medical Instrumentation (AAMI), ST79: 2017 Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities section 8 Preparation and assembly of instruments 8.1 General considerations indicates, "In preparation for sterilization, devices should be a)cleaned; b) dried; c) inspected for cleanliness, flaw, and damage. ..."

1. During an observation in Operating Room #6 at 11:22 AM on 4/10/19, in the presence of Staff #16, Staff #17, and Staff #18, a sterilized instrument tray labeled "Femore Sound" was opened and inspected, and the following was observed:

a. Yellowish residue was observed along the interior lining of the container

b. Tape residue was noted on the outer portion of the container

2. During an observation of the sterile supply room in the surgical unit on 4/10/19 at 12:29 PM, the following was observed:

a. Four (4) peel-pouched sterilized surgical instruments contained brown stains

b. Two (2) peel-pouched sterilized surgical instruments contained dark colored spotting

3. The above findings were confirmed by Staff #16, Staff #17, and Staff #18.

I. Based on observation and staff interviews, it was determined that the facility failed to ensure instruments are precleaned immediately following use, sterile items are inspected visually for integrity, and stored in a manner that reduces potential for contamination.

Findings include:

Reference #1: Association for the Advancement of Medical Instrumentation (AAMI) ST 79: 2017 Annex M 2.2.4 Precleaning states, "Instruments should be precleaned immediately following use. Gross debris should be removed, ...The instruments should be maintained in a moist state before cleaning in order to prevent the drying of surgical debris onto or within them."

1. On 4/11/19 at 10:39 AM, in the Decontamination Room in the presence of Staff #17 and Staff #24, the following was observed:

a. Staff #39 was observed transporting a metal-like transport cart containing soiled surgical instruments and devices. The soiled surgical instruments contained red and brown substances and the instruments appeared dry.

b. Upon interview, Staff #24 stated that the surgical instruments were covered with blood and betadine solution.

c. Staff #24 confirmed that the instruments were not precleaned and sprayed with an enzymatic at point of use.

2. The above finding was confirmed by Staff #17 and Staff #24.

Reference #2: AAMI (Association for the Advancement of Medical Instrumentation) Sterilization in Health Care Facilities, 2017 edition, ST 79, section 11.1.1 Storage facilities states, "Sterile items should be stored under environmentally controlled conditions in a manner that reduces the potential for contamination. ...Sterile items should be ...4)positioned so that packaging is not crushed, bent, compressed, or punctured and so that their sterility is not otherwise compromised. ...section 12.2.1 Handling and Inspection, Packaging should be thoroughly inspected visually for integrity..."

1. During an observation in the hallway of the surgical corridor on 4/10/19 at 10:46 AM, sterile supplies and sterilized instruments were found on top of a case cart in the hallway uncovered, adjacent to the soiled utility room.

a. Storing sterile items in an uncontrolled environment condition can increase the potential for contamination.

2. During an observation in the Operating Room #6 on 4/10/19 at 11:30 AM, multiple instruments in sterile packages were placed in drawers and bins that were too small and narrow, causing the sterile packages to bend, crush and fold.

3. The following was observed in the sterile supply room in the surgical unit on 4/10/19 at 12:30 PM:

a. Multiple sterile blue-wrapped packages and peel packs were stored crammed within their designated storage areas/bins, causing the sterile packages to bend, crush and fold.

(i) In the supply cabinet, fifteen (15) peel-pouched sterilized surgical instruments were forced into a bin and were crushed, bent and compressed which can compromise the integrity of the packaging.

(ii) In the supply cabinet, three (3) peel-pouched sterilized surgical instruments were stacked together with a rubber band. The packaging was crushed, yellowed, and peeling.

b. An opened box containing non-sterile supplies was placed on top of wrapped sterilized instruments.

c. Three (3) peel-pouched sterilized surgical instruments had brown and yellow stains on the paper side of the packaging.

4. The above findings were confirmed by Staff #17 and Staff #18.



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J. Based on observation, document review, and staff interview, it was determined that the facility failed to ensure staff compliance with infection control policies and procedures.

Findings include:

Reference #1: Facility policy titled, "Hand Hygiene" states, "...POLICY: ...The policy incorporates the philosophy of "clean in and clean out" for every patient encounter. A. All Staff 1. All personnel shall follow the hand hygiene policy..... PROCEDURE: HANDWASHING AND HAND ANTISEPSIS: 1. a. Wash hands with either non-antimicrobial or antimicrobial soap and water in the following clinical care situations: ...-When there is a significant build-up of waterless hand sanitizer. - If hands are visibly soiled or contaminated with blood or bodily fluids 2. If hands are not visibly soiled, use an alcohol-based hand rub (preferentially) or use antimicrobial soap or non-antimicrobial soap and water (alternatively) for routinely decontaminating hands for the following clinical situations: a. Upon entering and leaving a patient room of environment. b. When carrying supplies or transporting a patient into or out of a room, hand hygiene is required as soon as hands are free. c. Between patient contacts d. Before donning and after removing gloves or other personal protective equipment... ."

Reference #2: Facility policy titled, "Standard and Isolation Precautions for Inpatients and Outpatients," states, "...POLICY: It is the intent if the [facility] to use standard precautions for all inpatients... and apply appropriate isolation precautions as outlined to decrease the risk of transmission of infectious agents to patients, visitors and staff..... PROCEDURE: ...3. Place sign on door. Appropriate signs which denote isolation/precautions contain necessary instruction for staff and visitors... 4. Handwashing a) Follow "Clean In Clean Out" protocol which means clean hands on entering and exiting patient rooms..... d) Use waterless alcohol based antiseptic if hands are not visibly soiled....."

1. On 4/9/19, a tour of the 2E unit was conducted in the presences of Staff #5 and Staff #7. The following was identified:

a. At 11:33 AM, a visitor was observed sitting in the room of Patient #7. Patient #7 was on contact precautions.

(i) The visitor was noted to not be wearing gloves, and the gown was draped around his/her neck.

(ii) At 11:35 AM, Staff #5 told Staff #8, the patient's nurse, about the improper use of PPE (Personal Protective Equipment) and at 11:40 AM, it was noted in an interview with Staff #5 that Staff #8 removed the contact precautions sign and stated to Staff #5 that the patient was no longer on contact precautions.

(iii) At 3:30 PM, a review of the medical record of Patient #7 was completed in the presence of Staff #23, and it revealed that the patient still had an active order to be on contact precautions.

b. Staff #5 confirmed the above finding.

2. On 4/9/19, a tour of the 3E unit was conducted in the presence of Staff #5, Staff #7, and Staff #9. The following was noted:

a. At 12:05 PM, it was observed that Staff #35 entered Room #341 without performing hand hygiene, wearing gloves, or donning a gown. Staff #35 was observed speaking with the patient, and then exiting the room and returned to the nurses station without performing hand hygiene. The patient in Room #341 was noted to be on contact precautions.

(i) At 12:06 PM, Staff #5 notified Staff #35 of the need to perform hand hygiene and to observe the guidelines of contact precautions. Staff #35 then proceeded to re-enter Room #341, and wash his/her hands in the patient's bathroom.

b. The above findings were confirmed by Staff #5, Staff #7, and Staff #9.

3. At 12:24 PM, a tour of the CCU (Critical Care Unit) was conducted in the presence of Staff #5, Staff #6, and Staff #11. The following was noted:

a. At 12:26 PM, Staff #12, a nurse, was observed leaving patient Room #6 and walked down the hallway without performing hand hygiene.

(i) A contact isolation precaution sign was posted to denote that the patient in Room #6 was on contact isolation precautions.

b. Staff #12 was observed at 12:43 PM exiting patient Room #1. He/She walked through the hallway and entered patient Room #3. Staff #12 then exited the room and went to the nurse's station and began to type on the computer keyboard.

(i) Staff #12 did not perform hand hygiene upon exiting Room #1, entering Room #3, and exiting Room #3.

c. Staff #43, a food service worker, was observed at 12:48 PM entering and exiting patient Room #6 without performing hand hygiene or adhering to the guidelines of the posted contact precautions.

d. The above findings were confirmed by Staff #5, Staff #6, and Staff #11.