HospitalInspections.org

Based on observation, review of facility documents, and staff interviews, it was determined that the facility failed to ensure that patient care is provided in a safe setting.

Findings include:

1. The facility failed to ensure that patients with suicidal ideation receive care in an environment that meets the needs of the patient (Cross refer to Tag A-144).

2. The facility failed to ensure that written consent is obtained prior to administering medical treatment or medications (Cross refer to Tag A-131).

3. The facility failed to ensure that its policy and procedure regarding restraint management, is implemented (Cross refer to Tag A-175).

Based on medical record review, review of facility documents, and staff interviews, it was determined that the facility failed to ensure that its policy and procedure for obtaining consent is implemented.

Findings include:

Reference #1: Facility policy, "Consent" states, "... At the completion of the registration in-take process, the Admission and Registration representative will have properly identified the person or legal guardian authorized to provide consent. ... if written consent cannot be obtained because of the patient's medical condition... witnessed oral consent should be obtained. Thereafter, written consent should be obtained as soon as possible. ... ."

1. Review of Medical Record #21 on 10/9/19 revealed the following:

a. The patient was admitted to the ICU (Intensive Care Unit) on 10/7/19.

b. The Consent for Medical Treatment form was not signed.

c. On the line marked "Signature of Patient," the following was hand written: "Pt [patient] is unable to sign."

d. There was no evidence that an oral consent was obtained.

2. Staff #63 confirmed the above finding.


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Reference #2: Facility policy, "Medication Documentation" states, "... Medication Consent... Parent shall sign a consent form for administration of medication and prescriptions. Medication will not be administered without consent. The Consent shall be obtained upon explanation of prescription prescribed by either program psychiatrist or nurse. ... ."

1. During a tour of the facility's off-site Partial Hospitalization Program, on 10/9/19, the following was revealed:

a. In the medication cabinet, a medication bottle labeled with minor Patient #40's name was observed.

(i) The label on the medication bottle stated, "Methylphenidate 5 MG [milligram], Gen. (generic) for Ritalin 5 MG."

b. The Psychotropic Medication Authorization form states, "... Medication: Concerta (methylphenidate), Dosage: 18 MG - 54 MG."

c. There was no evidence that a Psychotropic Medication Authorization form for Methylphenidate 5 MG was signed by Patient #40's parents. Upon interview, Staff #126 stated, "I don't have a template for that medication."

2. Review of the Psychotropic Medication Authorization form for minor Patient #41 revealed the following:

a. The Psychotropic Medication Authorization form for Zyprexa was incomplete.

(i) Line one (1) of the form states, "I, ________, hereby give the physician permission... ." The name of the parent/legal guardian was left blank.

(ii) The box authorizing the prescribers to prescribe medications was not checked.

(iii) The box authorizing the administration of the medication during program hours was not checked. The medication was available for use.

3. Staff #126 confirmed the above findings.

Based on observation, medical record review, review of facility documents, and staff interview, it was determined that the facility failed to ensure that patients receive care in a safe setting.

Findings include:

Reference #1: Facility document, "Suicidal Awareness and Suicidal Precautions" states, "... if a child reports suicidal ideation during his or her stay, the child's therapist will be informed. The therapist will assess any intent by the child. The therapist will review the patient safety plan with the child. If they think it is necessary, the therapist will complete an updated suicide risk assessment form."

Reference #2: Facility document, "Treatment Plan" states, "The [name of facility] adheres to the following treatment planning requirements... Plan Development... The initial plan is developed from the initial assessment and is refined as further clinical information becomes available. ...Treatment Plan Updates: a. Reflect changes in individual needs and patient response to treatment, including updates to problem statements, goals, objectives and treatment services. ... ."

1. During a tour of the off-site Partial Hospitalization Program on 10/9/19, the following was observed:

a. The male and female restrooms were identified with the following un-mitigated ligature risks:

(i) The door hinges and door knobs

(ii) The toilet and sink plumbing

(iii) The grab rails in the handicap stalls

(iv) The receptacle to dispose of feminine hygiene products that adhered to the wall

b. Plastic garbage bags, which present a suffocation risk, were observed in the following patient care areas:

(i) The male restroom

(ii) The female restroom

(iii) Room #122 and Room #123

c. Two metal detectors were hanging from a hook in the hallway near Room #126.

2. Review of Medical Record #40 on 10/9/19 revealed the following:

a. Documentation revealed that on 9/25/19 at 12:18 PM, Patient #40 began hitting him/herself and banging his/her head and repeatedly indicated that he/she wanted to kill him/herself.

b. A Treatment Plan Update/Family Session note dated 9/25/19 at 2:30 PM - 3:00 PM failed to include interventions/goals to maintain patient safety while attending the partial hospitalization program.

c. There was no evidence that Patient #40 was assessed for the need to complete a suicide risk assessment.

3. Staff #125 confirmed the above findings.

4. On 10/10/19 at 4:27 PM, Staff #1 was notified that the above findings resulted in an Immediate Jeopardy (IJ) and a copy of the completed IJ template was provided. An acceptable IJ removal plan was received from the facility on 10/11/19. On 11/13/19, an onsite visit was conducted and revealed that the removal plan was implemented and the IJ was removed.

Based on review of facility documents, medical record review, and staff interview, it was determined that the facility failed to ensure that its policy regarding the management of restraints, is implemented.

Findings include:

Reference: Facility policy, "Restraint Management: Medical-Surgical, Non-Behavioral" states, "... E. Monitoring/Care of the Patient While in Restraint... 2. Assessment and monitoring of care will be completed by trained registered nurses [RNs] or LIPs [Licensed Independent Practitioners] 3. Every 2 hours the staff shall offer or provide the following as appropriate and document the interventions in the medical record: a) assess clinical status and re-evaluation of need for restraints b) Toileting c) Release the restraints in order to reposition and perform skin care as needed and to allow individual to perform skin care as needed and to allow individual to perform range of motion for staff to provide passive range of motion for a minimum of five minutes per limb (unless clinically contraindicated) d) Hygiene needs, including assistance with bathing once a day documented in the medical record... 4. Visual observation will be made at a minimum every 2 hours by an RN. The clinical condition of the patient will be evaluated by the RN and documented at least every 2 hours. This evaluation includes: a) Respiratory status b) Circulatory status c) Skin integrity d) Need for continued restraint based on risk and behaviors... 5. The RN will assess the patient to determine if criteria for early termination have been met... Criteria includes... iv. The patient no longer exhibits behavior that put him/her at risk for harm... ."

1. Review of Medical Record #42 on 10/9/19 revealed the following:

a. Documentation on the Restraint Reassessment/Monitoring form indicated that Patient #42 was in soft bilateral wrist restraints to his/her upper extremities on 10/9/19 at 5:00 AM.

(i) From 5:00 AM to 8:00 AM, there was no evidence that a trained RN or LIP assessed the patient's clinical status and re-evaluated the patient's need for restraints.

(ii) From 5:00 AM to 8:00 AM, there was no evidence that staff offered or assisted the patient with toileting and other hygiene needs.

(iii) From 5:00 AM to 8:00 AM, there was no evidence that staff released the patient's restraints for repositioning, to perform skin care, and/or to allow for range of motion exercises.

(iv) From 5:00 AM to 8:00 AM, there was no evidence that the patient was visually observed every two (2) hours by an RN.

2. Staff #110, Staff #112 and Staff #131 confirmed the above findings.

Based on medical record review, review of facility policy and procedure, and staff interviews, it was determined that the facility failed to ensure that its policy and procedure regarding pain management, is implemented.

Findings include:

Reference: Facility policy, "Pain Management" states, "... Patients have the right to pain management... Guidelines for pain intensity... Mild 1-3 ... Moderate 4-6 ... Severe 7-10 ... Reassess the patient... The goals of pain management are... To accept, respect, and treat the patient's report of pain. ...When pain is identified, the criteria for assessment of pain are... pain frequency... pain duration... patient's responses to treatment... If pain is assessed and identified as positive, a pain treatment plan including pain management goals need to be developed, implemented and documented in the medical record. ... ."

1. Review of Medical Record #3 on 10/10/19 revealed the following:

a. On 10/08/19 at 11:22 AM, the patient reported pain in the right knee with a pain intensity score of four (4).

b. The pain assessment did not include pain frequency and pain duration.

c. There was no evidence that a pain treatment plan was developed, implemented, or documented.

d. There was no evidence that the patient's pain was treated.

2. Review of Medical Record #26 on 10/10/19 revealed the following:

a. On 10/10/19 at 7:35 AM, the patient reported pain in the right ear with a pain intensity score of six (6).

b. There was no evidence that a pain treatment plan was developed, implemented, or documented.

c. There was no evidence that the patient's pain was treated.

3. Review of Medical Record #27 on 10/10/19 revealed the following:

a. On 10/10/19 at 8:19 AM, the patient reported abdominal pain with a pain intensity score of seven (7).

b. At 8:46 AM, the patient received Toradol 30 mg (milligrams) IV (intravenous).

c. At 10:34 AM, there was no evidence that the patient's pain had been reassessed.

d. At 10:34 AM, there was no evidence of the patient's response to treatment.

4. Staff #6 and Staff #65 confirmed the above findings.

Based on medical record review, review of facility documents, and staff interviews, it was determined that the facility failed to ensure that policies and procedures addressing the accountability and control of all scheduled drugs, are implemented.

Findings include:

Reference #1: Facility policy, "Medication Distribution and Storage" states, "... IV. Procedure: ...VI. Automated Dispensing Cabinet System... b. The pharmacy will monitor the use of the Automated Dispensing Cabinets to ensure all medications are properly accounted for."

Reference #2: Facility policy, "Controlled Substances... The Maintenance and Distribution of" states, "...6.0 Wasting of Controlled Substances... 6.1. When controlled substances are accidentally dropped, spilled, etc. the following is required... 6.1.1 Documentation in the Narcvault must be made. 6.1.2 This entry should include reason for waste. 6.1.3 Documentation of the waste should be witnessed and initialed by a second pharmacist. 6.2 Controlled substances which are being wasted within the pharmacy must be witnessed by a second pharmacist, documented, and signed off by both pharmacists."

1. Review of the Anesthesia Record for Patient #44, dated 6/11/19, indicated that he/she was administered a total of 350 mcg (micrograms) of Fentanyl.

a. The corresponding Automated Dispensing Cabinet report for Patient #44 indicated that only one (1) ampule of Fentanyl 100 mcg/2 ml (milliliter) was removed. The records do not reconcile.

2. Review of the Anesthesia Record for Patient #45, dated 10/7/19, indicated that the patient was administered a total of 80 mg of Ketamine. Staff #5 stated that the total Ketamine administration is unclear since the documentation on the anesthesia record is illegible.

a. The corresponding Automated Dispensing Cabinet report for Patient #45 indicated that one (1) vial of Ketamine 500 mg/ 10 ml was removed and 250 mg was wasted on 10/7/19. The records do not reconcile.

3. Review of the main pharmacy narcotic waste logs revealed the following:

a. On 8/7/19, two (2) Fentanyl-NS(Normal Saline) 25 ml products were wasted. It was not documented that a second pharmacist signed off the witnessing of the controlled substance wasted.

b. On 8/7/19, two (2) Midazolam-NS premix 25 ml syringes were wasted. It was not documented that a second pharmacist signed off the witnessing of the controlled substance wasted.

c. On 8/7/19, one (1) Midazolam-NS 100 ml product was wasted. It was not documented that a second pharmacist signed off the witnessing of the controlled substance wasted.

d. On 10/2/19, one (1) Fentanyl-NS premix 25 ml product was wasted. It was not documented that a second pharmacist signed off the witnessing of the controlled substance wasted.

e. On 10/2/19, one (1) Hydromorphone PCEA (patient-controlled epidural analgesia) product was wasted. It was not documented that a second pharmacist signed off the witnessing of the controlled substance wasted.

f. On 10/2/19, one (1) Fentanyl-NS premix 25 ml product was wasted. It was not documented that a second pharmacist signed off the witnessing of the controlled substance wasted.

g. In all instances of the main pharmacy narcotic wastages, the reason for waste was not documented.

4. Staff #5, Director of Pharmacy and Staff #136, Pharmacy Manager, confirmed the above findings.

A. Based on observation, review of facility documents, and staff interviews, it was determined that the facility failed to ensure that policies and procedures addressing the maintenance of the vaccine cold chain is implemented in accordance with the Centers for Disease Control and Prevention guidelines.

Findings include:

Reference: The Centers for Disease Control and Prevention website states, "Vaccines that will be used at an off-site or satellite facility should be delivered directly to that facility. If that is not possible, transport of vaccines should be done using a portable vaccine refrigerator with a temperature monitoring device placed with the vaccines. If this is not available, qualified containers and pack-outs can be used with a temperature monitoring device."

1. During an observation in the main pharmacy department on 10/9/19 at 10:20 AM, vaccines were observed in the medication refrigerators.

a. Upon interview, Staff #5 stated that the main pharmacy provides vaccines to the outpatient clinic.

b. When questioned about the facility's practice for transporting vaccines to the outpatient clinic, Staff #139 stated that a pharmacy staff member packs the vaccines with ice packs in a Styrofoam container and transports the vaccines to the outpatient clinic.

c. Staff #139 stated that there is no temperature monitoring when vaccines are transported to the outpatient clinic.

2. Upon request, Staff #5 was unable to provide policies and procedures addressing the transport of vaccines and maintaining the vaccine cold chain. He/she stated that the facility did not have policies and procedures addressing this.

3. Staff #1, Staff #5, Staff #136, and Staff #139 confirmed the above findings.

B. Based on observation, review of facility documents, and staff interview, it was determined that the facility failed to ensure that policies and procedures addressing the use of the patient's own medications, is implemented.

Findings include:

Reference: Facility policy, "Patients Personal Medications" states, "...V. Delivery of a Patient's Own Medication To/From the Pharmacy... B. A "Patient's Own Medication Log" is used to document the patient's name, location, medication name, and quantity. Pharmacy and nursing personnel will sign and date the log. ... F. Upon discharge, a member of the nursing unit will retrieve the patient's own medication from the pharmacy. ... G. The "Patient's Own Medication Log" is used to inventory remaining medication from the pharmacy and document return of the medication to the patient, via the nurse."

1. In the main pharmacy department on 10/9/19, a retail pharmacy prescription bottle containing white colored tablets was found in a zip lock bag.

a. On the zip lock bag, an undated label was present that stated, "[Patient's Own Meds][Pt was discharged without meds-will be picked up on Monday]."

b. Upon interview, Staff #5 and Staff #136 stated that they did not know when this note was written. Staff #5 and Staff #136 confirmed that the tablets should have been disposed.

2. Upon request, Staff #5 was unable to provide a "Patient's Own Medication Log" for Patient #46, the patient identified on the prescription bottle.

a. Review of the facility policy referenced above did not include the procedures for final disposition of medications and recording in pharmacy records.

3. Staff #5 and Staff #136 confirmed the above finding.

C. Based on observation, review of facility documents, and staff interviews, it was determined that the facility failed to ensure that policies and procedures addressing medications supplied to the outpatient infusion center, are implemented.

Findings include:

Reference: Facility policy, "Medications Supplied to Infusion Centers states, "... Procedure... 2. Medications will be delivered to patients which insures the safety of both employees, visitors, and patients. 3. Hazardous drugs will be packaged for transport insuring the safety of those transporting medications. ... 5. Documentation of the dispensing, delivery, and of administration of controlled substances will be done according to federal and local [sic] regulation."

1. During an observation in the main pharmacy department on 10/9/19, the following was revealed:

a. Staff #138 was observed grabbing two zip lock bags that contained compounded, hazardous drugs. The zip lock bags contained a biohazard label.

(i) Staff #138 then placed the two zip lock bags in a red shopping bag for a driver to transport the compounded products to the outpatient infusion center.

(ii) The red shopping bag used for transporting hazardous drugs did not have a mechanism to secure the medications and minimize breakage.

(iii) There was no evidence that the reused transport bag was cleaned and disinfected between uses.

b. Upon interview, Staff #5 stated that the driver did not have training to handle hazardous medications. He/she stated that there was no record keeping to ensure that medications were properly transported to the outpatient locations.

2. Staff #5 and Staff #136 confirmed the above findings.

Based on observation, review of facility documents, and staff interviews, it was determined that the facility failed to ensure that outdated, mislabeled, or otherwise unusable drugs are not available for patient use.

Findings include:

Reference #1: Facility policy, "Single-dose/Single-use and Multiple-dose Vials" states, "Procedure... B. Multi-dose vials-If use of a multi-dose vial is necessary... 5. Once a multiple-dose vial is punctured, it should be assigned a "beyond-use" (expiration) date. The beyond-use date for an opened or entered (e.g., needle-punctured) multiple-dose container with antimicrobial preservatives is 28 days, unless otherwise specified by the manufacturer."

Reference #2: Facility policy, "Medication Administration" states, "... Storage/Preparation... 2. Drugs in single dose or single use packages which are open or have had their seal broken, drugs in containers missing identification, and expired medication should be returned to the pharmacy for disposal."

1. On 10/8/19, during an observation in the anesthesia medication room located in the Operating Room Suite, one (1) opened and needle-punctured, multi-dose vial of Labetalol 100 mg (milligram)/20 ml (milliliter) was found in the medication cabinet. There was no evidence of a beyond use date on the vial.

2. On 10/8/19, in the anesthesia medication room located in the Operating Room Suite, one (1) opened single dose vial of calcium gluconate 1,000 mg/10 ml was found in the medication cabinet and available for patient use.

3. Upon interview, Staff #140 and Staff #141 confirmed that the vials should have been discarded.

4. Staff #5, Staff #140, and Staff #141 confirmed the above findings.



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Reference #3: Facility policy, "Alternate Source Medications During Program Hours" states, "... Upon discharge medication which is not retrieved by a parent/guardian, will be destroyed after documenting date, time, type and quantity of medication destroyed."

Reference #4: Facility policy, "Destroying Medication, Sharps, Blood, Body Fluid, Paper" states, "... Any and all unused medication will be returned to the family or pharmacy as applicable... ."

1. During a tour of the Acute Partial Hospitalization Program on 10/9/19, the following was revealed:

a. In the Nurses Office, a medication bottled labeled with Patient #41's name was stored in the medication cabinet on a shelf.

(i) The medication bottle was labeled "Zyprexa Zydis 5 MG" and contained medication.

(ii) Staff #128 reviewed Patient #41's medical record and confirmed that Patient #41 was discharged on 7/18/19.

2. Staff #124, Staff #125, and Staff #128 confirmed the above findings.

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

Findings include:

1. Upon request on 10/8/19, the facility was unable to provide a policy that addressed the need to report possible or confirmed Controlled Dangerous Substances (CDS) losses to the appropriate authorities.

2. Upon interview, Staff #5 could not provide the list of authorities the facility is required to report suspected or actual CDS losses to.

3. Staff #5 and Staff #143 confirmed the above findings.

Based on review of temperature logs and staff interview, it was determined that the facility failed to ensure that its policy and procedure regarding temperature monitoring for the contrast for Computed Tomography (CT), is implemented.

Findings include:

Reference: Facility policy, "Warming Contrast in CT" states, "...The temperature of the warmer it [sic] to be checked and recorded daily in the temperature log book by the first day shift technologist. ... ."

1. During record review in the Radiology Department on 10/8/19 at 10:57 AM, the following was noted:

a. On the Contrast Warmer Log, for dates 10/5/19 and 10/6/19, the lines indicating the temperature of the warmer were blank.

(i) There was no evidence that the temperature was checked on 10/5/19 and 10/6/19.

2. Staff #114 confirmed the above finding.

Based on observation, review of facility documents, and staff interviews, it was determined that the facility failed to ensure that specific food and dietetic service organization requirements are met and facility failed to comply with the requirements of Chapter XII of the New Jersey State Sanitary Code, "Sanitation in Retail Food Establishments and Food and Beverage Vending Machines" (N.J.A.C. 8:24).

Findings include:

Reference #1: Job Description, "Director, Culinary & Nutrition Services" states, "... 1. Plans, directs, supervises and monitors all activities related to patient meal service... 2. Has oversight accountability for development, i,implementation and monitoring of work flow using established department policies, systems and procedures to maintain standards...4. Coordinates the activities of the patient services area so as to comply with NJ State Department of Health and Joint Commission standards. 8. Performs other duties as required... ."

Reference #2: N.J.A.C. 8:24-6.5(a) states, "The physical facilities shall be maintained in good repair."

Reference #3: N.J.A.C. 8:24-6.5(b) states, "The physical facilities shall be cleaned as often as necessary to keep them clean."

Reference #4: N.J.A.C. 8:24-4.5(a) states, "The Equipment and equipment components shall be maintained in a state of repair and condition that meets the requirements specified under N.J.A.C. 8:24-4.1 and 4.2."

Reference #5: N.J.A.C. 8:24-4.11(2) states, "Clean equipment and utensils shall be stored... (i) In a self-draining position that allows air drying... and (ii) Covered or inverted."

Reference #6: N.J.A.C. 8:24-6.5(i), states, "... (i) maintenance tools such as brooms, mops, vacuum cleaners, and similar items shall be stored... 2. In an orderly manner that facilitates cleaning the area used for storing the maintenance tools."

Reference #7: Facility document, "FOOD STORAGE TIMELINES - QUICK REFERENCE" states, "FOOD ITEM... Dry items (rice, sugar etc) USE BY... 90 days after opening or by expiration date if unopened... Date everything on date it was made and for cold production patient items, date on 'use by' date."

1. During a tour of the main kitchen on 10/8/19 at 10:35 AM, in the presence of Staff #10, Staff #11, and Staff #24, the following observations were made:

a. The following equipment was not clean and maintained in good repair:

(i) The ice machine in the main kitchen was out of order (Refer to Reference #4).

(ii) Two (2) Food Warming units, placed next to the meal service tray-line, had gaskets that were torn (Refer to Reference #2).

(iii) Refrigerator #2 had gaskets that were torn with brown-gray grime (Refer to Reference #2 and #3).

(iv) The reach-in double door refrigerator in the catering area had gaskets that were torn and contained black debris (Refer to Reference #2 and #3).

(v) A small freezer had torn entry sweeps and gaskets with gray-brown grime (Refer to Reference #2 and #3).

(vi) The patient refrigerator on the Pediatrics unit failed to have a thermometer (Refer to Reference #1).

(vii) The microwave in the Pediatric unit pantry area had visible debris on the inside of the door and the roof of the microwave (Refer to Reference #3).

(viii) Refrigerator (#211.030), in the cafeteria kitchen, had a loose metal part at the bottom of the door (Refer to Reference #2).

b. A rack of wet pots, pans and lids were stacked on top of one another after being washed in the pot washing area (Refer to Reference #5).

c. Used mops were placed in various areas of the kitchen were stored directly on the floor. They were not stored in a manner which allowed them to air dry without soiling walls, equipment, or supplies (Refer to Reference #3 and #6).

d. The following food items failed to have a label:

(i) Bins with rice, flour and bread crumbs failed to have a 'filled on' or 'use by' label (Refer to Reference #7).

(ii) A food cart filled with pans of Jamaican Beef Patties failed to have a 'prepared on' or 'use by' date (Refer to Reference #7).

(iii) A rack of trays filled with bacon strips, french toast and six (6) pans of breaded chicken failed to have a 'prepared on' or 'use by' date (Refer to Reference #7).

(iv) Individual frozen ethnic food dinners failed to have a 'use by' date (Refer to Reference #7).

2. Staff #10 and Staff #24 confirmed the above findings on 10/9/19 at 1:00 PM.

Based on observation, review of facility documents, and staff interviews, it was determined that the facility failed to ensure that it was constructed, arranged, and maintained to ensure the safety of the patients, visitors, and staff.

Findings include:

1. The facility failed to ensure compliance with the 2012 edition of the National Fire Protection Association's Life Safety Code (Cross refer to Tag A-710).

2. The facility failed to ensure that ligature risks within behavioral health units are eliminated (Cross refer to Tag A-701).

3. The facility failed to ensure that equipment is maintained (Cross refer to Tag A-724).

Based on observation, review of facility documents, and staff interviews, it was determined that the facility failed to ensure that the overall hospital environment is maintained to protect the safety and well-being of patients.

Findings include:

1. During a tour of the off-site Partial Hospitalization Program on 10/9/19, the following was revealed:

a. The facility consists of one (1) male and one (one) female patient restroom.

b. Unmitigated ligature risks were identified in the male and female restrooms as follows:

(i) The door hinges and knobs

(ii) The toilet and sink plumbing

(iii) The grab rails in the handicap stalls

(iv) The receptacle for disposal of feminine hygienic products adhered to the wall

c. Plastic garbage bags were in the following patient care areas:

(i) The male restroom

(ii) The female restroom

(iii) Multipurpose Room #122 and Room #123, utilized for dining and group sessions

d. Two metal detectors were hanging from a hook in the hallway near quiet room #126.

2. Review of the "Behavioral Health Risk Assessment" dated 1/22/19 identified fifteen (15) items within the facility that posed ligature risks. The "Behavioral Health Risk Assessment" indicated that fourteen (14) of the fifteen (15) items were mitigated by an "Observer Policy."

a. Upon request, the facility was unable to provide the "Observer Policy."

b. The "Behavioral Health Risk Assessment" indicated that the grab bars located in the handicapped toilet rooms were a ligature risk and would be "investigated."

(i) Upon request, the facility was unable to provide evidence of the investigation and that the finding was corrected.

3. Staff #34, Staff #124, and Staff #125 confirmed the above findings.

4. On 10/10/19 at 4:27 PM, Staff #1 was notified that the above findings resulted in an Immediate Jeopardy (IJ) and a copy of the completed IJ template was provided. An acceptable IJ removal plan was received from the facility on 10/11/19. On 11/13/19, an onsite visit was conducted and revealed that the removal plan was implemented and the IJ was removed.

Based on observation and staff interviews, it was determined that the facility failed to ensure compliance with the 2000 edition of the National Fire Protection Association's Life Safety Code (NFPA).

Findings include:

Reference #1: NFPA 101:28.3.4.5, "Smoke Detection... An approved single-station smoke alarm shall be installed in accordance with 9.6.2.10 in every guest room and every living area and sleeping room within a guest suite."

Reference #2: NFPA 101:28.2.4.6.5, "Carbon monoxide alarms or carbon monoxide detectors shall be provided in accordance with the manufacturer's published instructions in the locations specified as follows... (2) Centrally located within occupiable spaces served by the first supply air register from a permanently installed, fuel burning HVAC system."

Reference #3: NFPA 101:19.7.8 Portable Space-Heating Devices... Portable space-heating devices shall be prohibited in all health care occupancies, unless both of the following criteria are met... (1) Such devices are used only in nonsleeping staff and employee areas. (2) The heating elements of such devices do not exceed 212 degrees Fahrenheit."

Reference #4: 42 CFR 482.41(b)(9), "Buildings must have an outside window or outside door in every sleeping room."

1. On 10/8/19 at 11:10 AM, in the presence of Staff #32, Staff #33, and Staff #35, the following Intensive Care Unit In-patient rooms lacked either a window or a door to the outside (Refer to Reference #4):

a. Room #5001

b. Room #5006

c. Room #5007

d. Room #5012

e. Room #5031

2. On 10/9/19 at 1:15 PM, in the presence of Staff #32, Staff #33, and Staff #34, the Third Floor East Wing was converted into sixteen (16) on-call rooms, which changes the occupancy classification from Health Care to Hotel and Dormitories. These sixteen (16) rooms each consisted of two (2) or more beds that provide sleeping accommodations for more than sixteen (16) persons, and were primarily used by transients for lodging while working within the health care occupancy (Refer to Reference #1).

a. Upon interview on 10/9/19 at 1:20 PM, Staff #32 confirmed the following:

(i) All sixteen (16) sleeping rooms on the Third Floor East Wing lacked smoke detection (Refer to Reference #1).

(ii) The Third Floor East Wing lacked carbon monoxide detectors or alarms (Refer to Reference #2).

3. On 10/9/19 at 10:50 AM, in the presence of Staff #33, Staff #34, and Staff #35, a portable space heater was being utilized by staff in Patient Care Room #583 E (Refer to Reference #3).

Based on observation and staff interview, it was determined that the facility failed to ensure that supplies and equipment are maintained to ensure safety and quality.

Findings include:

1. On 10/10/19 at 11:25 AM, in the presence of Staff #32, the only patient bathroom located in the behavior health Emergency Department "B-Pod" lacked running water to the handwashing sink and shower.

a. Upon interview, Staff #35 confirmed that the patient bathroom had been without running water to the handwashing sink and shower for approximately one (1) week.



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2. During a tour of the Radiology and Respiratory Department on 10/8/19, the following was observed:

a. In the Radiology Department, the cushion on the head holder used for Computed Tomography (CT) Scans contained rips.

b. In the Respiratory Department, the base of an intravenous (IV) pole contained brown rust-like areas.

c. Staff #109, Staff #112, Staff #114, and Staff #122 confirmed the above findings.

3. During a tour of the off-site Partial Hospitalization Program on 10/9/19, the following was observed:

a. In Room #127, the supply cabinet was missing a wheel. A book was placed under the cabinet where the wheel was missing.

4. Staff #124 and Staff #125 confirmed the above findings.

Based on observation, review of facility documents, and staff interviews, it was determined that the facility failed to ensure that a sanitary environment is maintained to avoid the transmission of infections and communicable diseases.

Findings include:

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

2. The facility failed to ensure that policies and procedures regarding high-level disinfection, are implemented (Cross refer to Tag A-748).

3. The facility failed to ensure that endoscope reprocessing is implemented in accordance with Society of Gastroenterology Nurses and Associates (SGNA) standards (Cross refer to Tag A-748).

4. The facility failed to ensure that cleaning supplies are used in accordance with the manufacturer's written instructions for use (Cross refer to Tag A-749).

5. The facility failed to ensure that the environment is cleaned in accordance with acceptable standards of practice (Cross refer to Tag A-749).

6. The facility failed to maintain a sanitary environment to prevent and control infections and communicable diseases (Cross refer to Tag A-749).

7. The facility failed to ensure that proper hand hygiene practices are maintained for the prevention of infections and communicable diseases (Cross refer to Tag A-749).

8. The facility failed to ensure that masks are removed prior to leaving the Operating Room (Cross refer to Tag A-749).

9. The facility failed to ensure that the storage and maintenance of lead aprons is maintained (Cross refer to Tag A-749).

A. Based on observation, staff interviews, and review of facility policies and procedures, it was determined that the facility failed to ensure that its infection control policies are implemented in accordance with nationally recognized standards.

Findings include:

Reference: Facility policy, "Safe Use of Cidex OPA (Ortho-Phthalaldehyde) Solution" states, "Policy... 6. To ensure that the effective concentration of the disinfectant is present, Cidex OPA Solution will be tested for the MEC (Minimum Effective Concentration) prior to each use. ... 10. The temperature of the Cidex OPA Solution must be checked and documented prior to each use to ensure that the solution meets or exceeds the minimum temperature of 68 degrees F (Fahrenheit)... ."

1. On 10/9/19 at 12:45 PM, Staff #9 confirmed that the Sterile Processing Department (SPD) follows the Association for the Advancement of Medical Instrumentation (AAMI) guidelines and recommendations.

2. On 10/9/19 at 10:32 AM, in the Evo-Tech Room, in the presence of Staff #9, Staff #71, Staff #72 and Staff #73, the following was observed:

a. A blue rectangular bin that contained two neonatal laryngoscope blades were observed soaking in a solution. The label on the outside of the container stated, "Cidex-OPA 14 Day Solution Mixing Date: 10/02/2019 Expiration Date: 10/15/2019."

b. The Cidex-OPA Log was requested and reviewed. The log contained the following columns: "Ultrasound probe/Item # & Model #, Date, Cidex Temp. (Temperature) Must be > or = 68 degrees F (Fahrenheit), Time In, Time Out, Test Strip pass/fail, Expiration date test strips, Expiration date Cidex OPA, and Initials."

(i) All of the columns were blank. Staff were unable to determine when the laryngoscope blades were placed in the Cidex OPA solution or if the temperature and the MEC of the solution were checked prior to placing the laryngoscope blades in the solution.

3. Staff #9, Staff #72 and Staff #73 confirmed the above findings at 10:37 AM.

B. Based on observation, staff interviews, and review of facility documents, it was determined that the facility failed to ensure that endoscope reprocessing is implemented in accordance with Society of Gastroenterology Nurses and Associates (SGNA) standards.

Findings include:

Reference: SGNA Standards of Infection Prevention in Reprocessing Flexible Gastrointestinal Endoscopes 2018 states, "... Endoscope Reprocessing Protocol... 9. Storage... Key considerations in storage include... d. Each facility should determine a method of documentation and traceability to the endoscope and reusable accessories. Traceability to the endoscope involves documentation which includes patient, date, type of procedure, person performing reprocessing or sterilization, and medical record, if applicable. ... ."

1. On 10/9/19 at 12:45 PM, Staff #9 confirmed that the Endoscopy Unit follows SGNA guidelines and recommendations.

2. On 10/9/19 at 11:22 AM, on the Endoscopy Unit, an observation of the "Mass" Endoscope storage cabinet was conducted.

a. Endoscopes were observed to be stored without the accessories.

(i) Upon interview, Staff #78 confirmed that the facility uses re-useable accessories. The accessories are stored together in a separate bin, rather than stored with the endoscope as a unique identifier for traceability.

3. The facility policy, "Cleaning of Flexible Endoscopes" was reviewed and failed to address tracking and storage of endoscope accessories, in accordance with SGNA Standards.

A. Based on observation, review of facility documents, and staff interviews, it was determined that the facility failed to ensure that policies and procedures regarding the use of multi-dose medication vials in immediate patient care areas, are implemented.

Findings include:

Reference: Facility policy, "Single-dose/Single-use and Multiple-dose Vials" states, "Policy... 5. For insulin's dispensed in vials, the vial may be returned to the patient specific drawer for that patient's use only. Insulin vials must have a "Not Use Beyond Use Date" sticker affixed to the bottle. 6. In patient care areas that do not utilize patient specific medication drawers, multiple-dose vials must be discarded following administration of the medication. IE: insulin vials in pre-op, procedural or OR areas."

1. During an observation on 10/8/19, the following opened and needle punctured multi-dose vials were found in the medication refrigerator:

a. In the Pre-Operative medication room, one (1) vial of Humalog insulin

b. In the Post Anesthesia Care Unit medication room, one (1) vial of Humalog insulin

c. In the Emergency Department medication room, one (1) vial of Humalog insulin and one (1) vial of Humulin R insulin

d. Upon interview, Staff #14, Staff #141, and Staff #142 confirmed that the facility's practice is to carry out the insulin vial, bring the vial to the patient's bedside and scan the barcode on the vial, prepare the medication at the bedside, then administer the medication to the patient. Once the medication is administered, the vial is placed back into the medication refrigerator for patient use.

2. Staff #5, Staff #140, and Staff #141 confirmed the above findings.

3. On 10/9/19 at 2:48 PM, Staff #1 was notified that the above finding resulted in an Immediate Jeopardy (IJ) and a copy of the completed IJ template was provided. An acceptable IJ removal plan was received from the facility on 10/11/19. On 11/13/19, an onsite visit was conducted and revealed that the removal plan was implemented and the IJ was removed.



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B. Based on observation, review of manufacturer's Instructions for Use (IFUs), and staff interview, it was determined that the facility failed to ensure that cleaning supplies are used in accordance with the manufacturer's written instructions.

Findings include:

Reference #1: Super Sani-Cloth Germicidal Disposable Wipes - manufacturer's instructions for use (IFU) states, "Cleansing procedure... All blood and other body fluids must be thoroughly cleaned from surfaces and objects before disinfection by the germicidal wipe. ... Contact time... Use second germicidal wipe to thoroughly wet surface. Allow to remain wet two (2) minutes, let air dry. ... ."

Reference #2: Diversey Exposure II 256 Phenolis Disinfectant Cleaner - manufacturer's instructions for use (IFU) states, "Pre-clean if heavily soiled. Thoroughly wet surfaces with the use solution [sic] for 10 minutes. Wipe dry."

1. On 10/8/19 at 12:16 PM, the following was observed during the room turnover cleaning in Operating Room (OR) #4:

a. Staff #42 sprayed Diversey Exposure II 256 Phenolis Disinfectant Cleaner on the OR mattress and mattress roller board and immediately wiped them dry. He/she did not allow the surface to remain wet for ten (10) minutes, in accordance with the disinfectant's IFU.

(i) Upon interview on 10/8/19 at 12:17 PM, Staff #42 was unaware of the contact time for Diversey Exposure II 256 Phenolis Disinfectant Cleaner.

b. On 10/8/19 at 12:22 PM, Staff #45 sprayed Diversey Exposure II 256 Phenolis Disinfectant Cleaner on the OR floor and immediately wiped it dry. He/she did not allow the surface to remain wet for ten (10) minutes, in accordance with the disinfectant's IFU.

(i) Upon interview on 10/8/19 at 12:24 PM, Staff #45 stated the contact time for Diversey Exposure II 256 Phenolis Disinfectant Cleaner was ten (10) minutes, however, Staff #45 did not observe the contact time for the Diversey disinfectant cleaner.

c. On 10/8/19 at 12:29 PM, Staff #47 used Super Sani-Cloth Germicidal Disposable Wipes to wipe the Anesthesia cart. He/she did not allow the surface to remain wet for two (2) minutes, in accordance with the IFU.

(i) Upon interview on 10/8/19 at 12:30 PM, Staff #47 was unaware of the two (2) minute contact time for the Super Sani-Cloth Germicidal Disposable Wipes.

2. On 10/8/19 at 12:36 PM, during an observation of room turnover cleaning in OR #8, Staff #48 was observed spraying Diversey Exposure II 256 Phenolis Disinfectant Cleaner on the OR mattress and the OR Rolling Board.

a. Staff #48, immediately placed the OR Rolling Board on the mattress, then placed the Exposure II 256 Phenolis Disinfectant Cleaner bottle on the OR mattress without allowing the surfaces to remain wet for ten (10) minutes.

3. Staff #9 confirmed the above findings.

4. During a tour of the Radiology Department on 10/8/19, the following was observed:

a. Staff #115 was observed spraying the CT (Computed Tomography) Scan table with Expose II 256 Phenolic Disinfectant Cleaner.

(i) Staff #115 then immediately wiped the table with a dry cloth after spraying it with the disinfectant.

(ii) The instructions for use for Expose II 256 Phenolic Disinfectant Cleaner states, "Apply use solution to hard, non-porous surfaces. Allow to remain wet for 10 minutes. Wipe with a cloth or towel... ."

(iii) Upon interview, Staff #115 stated that he/she was unaware of the contact time.

C. Based on observation, staff interviews and review of Association of PeriOperative Nurses (AORN) Guidelines for Perioperative Practice, it was determined that the facility failed to ensure that the environment is cleaned in accordance with acceptable standards of practice.

Findings include:

Reference #1: AORN (Association of PeriOperative Nurses) Guidelines for Perioperative Practice, 2017 edition, Environmental Cleaning Recommendation VI states, "VI. b. Cleaning and disinfection activities should be performed in a methodical pattern that limits the transmission of microorganisms. Cleaning an area in a methodical pattern establishes a routine for cleaning so that items are not missed during the cleaning process... VI.b.1. Cleaning should progress from clean to dirty areas. VI.b.2. Cleaning should progress from top to bottom areas."

1. On 10/8/19 at 12:16 PM, during an observation of room turnover cleaning in OR #4, Staff #45 used a frayed, plastic bristle broom to sweep the OR floor. Next, he/she proceeded to clean the OR bed, then the overhead lights, without progressing from top to bottom.

2. On 10/8/19 at 12:36 PM, during an observation of room turnover cleaning in OR #8, Staff #46 cleaned the Mayo cart, the intravenous (IV) pole, the OR bed, and the overhead lights, in that order.

3. Staff #9 and Staff #46 confirmed the above findings.

D. Based on observation and staff interviews, it was determined that the facility failed to maintain a sanitary environment to prevent and control infections and communicable diseases.

Findings include:

Reference #1: Facility policy, "Standard and Transmission Based Precautions", states, "... Contact Precautions... Gown... You must wear a gown when entering a room of a patient on Contact Precautions... ."

1. On 10/9/19, in the Intensive Care Unit, Staff #61 was retrieving a tray from a patient who was on contact precautions. He/she was wearing a gown that was not tied in the back, exposing his/her uniform.

2. On 10/10/19, in the Intensive Care Unit, Staff #90 was administering intravenous medication to Patient #30, who was on contact precautions. Staff #90 was wearing a gown that was not tied in the back, exposing his/her uniform.

Reference #2: Contracted hemodialysis provider policy and procedure, "Surface Cleaning in the Hospital Dialysis Setting" states, "... PROCEDURE... 3. Machine surface cleaning... Discard all single-use supplies. Move any reusable supplies to an area where they will be cleaned and disinfected before being stored or returned to the dialysis station or machine. ... ."

1. During an observation on 10/9/19, Patient #44's hemodialysis treatment was completed at the bedside in Room #517. At the completion of the hemodialysis treatment, Staff #104 removed a clipboard he/she used for documentation during the treatment from the patient room. Staff #104 then placed the clipboard on top of clean supplies stored in the hallway outside the patient room.

a. Staff #104 did not clean all surfaces of the clipboard prior to removing it from the patient room and placing it on top of the clean supplies.

2. Staff #104 confirmed the above findings on 10/9/19 at 2:30 PM.

3. Staff #9 confirmed the above findings on 10/9/19 at 2:35 PM.

4. During a tour of the Radiology Department on 10/8/19, the following was observed:

a. The base of the computed tomography (CT) machine contained a layer of dust and dirt.

b. The towel dispenser contained a buildup of a brown and white residue.

c. The Sani Wipe holder affixed to the wall was visibly dirty and contained a buildup of a brown and white residue.

d. The shelves in the storage area contained a buildup of dust.

e. The storage room contained one (1) tub of Sani-Cloth Bleach Germicidal Disposable Wipes, which expired on 7/2018.

f. A blue storage bin contained a buildup of dust.

5. Staff #109, #112, and #114 confirmed the above findings.

6. During a tour of the Operating Room (OR) and Post-Anesthesia Care Unit (PACU) within the Labor & Delivery (L&D) Unit, on 10/8/19, the following was observed:

a. The staff handwashing sink in the PACU had a large crack in the Formica countertop. A portion of the Formica was missing making it an uncleanable surface.

b. In OR #3, there was a crack in the monolithic floor, making it an uncleanable surface.

c. A patient stretcher located in the hallway between the OR and PACU was found to have cracks in the base of the plastic frame, making it an uncleanable surface.

7. During a tour of the Newborn Nursery (NBN) Unit on 10/9/19, the following was observed:

a. Three (3) out of three (3) wood-like cribs in the nursery had deep scratches in the wood-like material around the edges and along the side of the crib. The scratches in the material made the surfaces of the cribs uncleanable.

(i) Three (3) out of three (3) plastic crib bassinets, where the infants are placed while in the unit, were scratched and/or cracked.

(ii) Three (3) out of three (3) crib mattress inserts were torn or ripped, exposing the foam inserts of the infant crib mattress.

b. One (1) crib had six (6) long pieces of clear tape holding the two (2) sides of the wood-like crib together, making this an uncleanable surface.

c. Three (3) out of three (3) newborn cribs had tape residue on the surfaces of the plastic inserts and wood-like material.

d. Three (3) out of three (3) staff clipboards found in a pocket attached to the newborn cribs, were cracked and/or covered with tape residue.

e. Two (2) out of two (2) unoccupied warmer beds had a rust-colored substance observed at the base of the warmer legs.

8. During a tour of the Postpartum (PP) Unit 4D on 10/9/19, the following was observed:

a. In the Medication Room, the medication cart in the room had tape residue on the top surface of the cart, making this an uncleanable surface.

9. Staff #7, Staff #20, and Staff #21 confirmed the above findings.

Reference: AAMI (Association for the Advancement of Medical Instrument), 2017 edition, pg. 72 states, "... Package labeling and expiration dating... Each item or package intended for use as a sterile product should be labeled with a lot control identifier... For items intended to be stored, not used immediately, the labeling should also include the following, as applicable... An expiration date on the product package label... ."

1. During a tour of the Radiology Department on 10/8/19, an expired Arrow OnControl Bone Lesion Biopsy System Tray with an expiration date of 4/5/19, was observed in the storage area. The biopsy tray was readily available for patient use.

2. Staff #114 confirmed the above finding.

E. Based on observation, review of facility documents, and staff interview, it was determined that the facility failed to ensure that proper hand hygiene practices are maintained for the prevention of infections and communicable diseases.

Findings include:

Reference: Facility policy, "Hand Hygiene" states," ... If hands are not visibly soiled, use an alcohol-based hand sanitizer for routinely decontaminating hands... before and after patient contact... before inserting devices that do not require a surgical procedure... after contact with inanimate objects... in the immediate vicinity of the patient... a. Wash hands before and after the care of each patient. ... c. Using plenty of soap, work up a good lather and scrub hands for 15 seconds."

1. On 10/08/19 at 11:54 AM, in the Post Anesthesia Care Unit (PACU), Staff #43 was observed washing his/her hands for five (5) seconds.

a. Staff #9 confirmed the above finding.

2. On 10/10/19, in the Emergency Department (ED), Staff #85 inserted an intravenous (IV) catheter into Patient #26's right arm. Staff #85 donned (put on) gloves, moved the bedside table with his/her gloved hands, and then inserted the IV.

a. Staff #85 failed to perform hand hygiene after touching the bedside table with gloved hands and prior to inserting the patient's IV.

b. Staff #65 confirmed the above findings.

3. On 10/10/19, in the Intensive Care Unit, Staff #90 donned gloves and administered IV medication to Patient #30. Staff #90 did not sanitize his/her hands before donning gloves.

a. Staff #63 confirmed the above finding.

F. Based on observation and staff interview, it was determined that the facility failed to ensure that masks are removed prior to leaving the Operating Room.

Findings include:

Reference: OSHA (Occupational Safety and Health Administration) 29 CFR part 1910.1030(d)(3)(vii) states, "All personal protective equipment shall be removed prior to leaving the work area."

1. On 10/8/19 at 11:42 AM, in the Post Anesthesia Care Unit, Staff #61 was observed with a mask hanging around his/her neck.

2. On 10/8/19 at 1:28 PM, in the Pediatric Emergency Department, Staff #62 was observed exiting Patient #4's room with a mask hanging around his/her neck.

3. Staff #6, Staff #9 and Staff #65 confirmed the above findings.

G. Based on observation, review of facility documents, and staff interview, it was determined that the facility failed to ensure that the storage and maintenance of lead aprons, is maintained.

Findings include:

Reference: Facility policy, "Lead Apron Storage and Cleaning" states, "... 2. Storing the Apron... a. Aprons must be hung by the shoulders, use the straps or place it on an apron hanger."

1. During a tour of Operating Room #8, on 10/8/19 at 12:09 PM, two (2) lead aprons were observed hanging over a chair. The aprons were touching the floor.

2. Staff #9 confirmed the above finding.


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