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Based on observation, interview, and record review, the facility failed to ensure the mobile magnetic resonance imaging (MRI - procedure that uses magnetism, radio waves, and a computer to create pictures of areas inside the body) trailer and generator power source were maintained in safe operating condition, inspected, and licensed.

This failure had the potential to lead to harm from equipment malfunction, fire, or hazardous conditions, for inpatients, outpatients undergoing MRI procedures as well as employees.

Findings:

On 2/28/17, at 8:40 a.m., the mobile MRI trailer was observed onsite in the east parking lot outside the emergency department (ED). The mobile MRI trailer was powered by a portable diesel generator. A cable bundle from the generator to the unit was unprotected on the ground of the parking lot and in the travel pathway of cars.

During an interview on 2/28/17 at 9:51 a.m., the radiology technician (RT) in the trailer indicated they would be using the trailer until 6 p.m. RT indicated the mobile MRI trailer is used for both outpatients and inpatients.

During a tour of the outpatient ED, and concurrent interview with the Director of Emergency Services (ADM 4), on 2/28/17, at 11:07 a.m., an MRI trailer without a covered awning was observed outside the ED glass doors. ADM 4 indicated patients were taken directly from the facility to the MRI trailer for MRI procedures.

On 2/28/17, at 3:15 p.m., the facility was requested to provide documentation from the Office of Statewide Health Planning and Development (OSHPD) and the California Department of Public Health Licensing and Certification (CDPH - L&C), for approval of the MRI trailer. Radiology Director (ADM 5) showed a sticker from the State of California Department of Housing and Community Development on the circuit breaker inside the trailer which stated "A department insignia shall not have its fire and life safety, plumbing, electrical, or mechanical equipment or installations, altered or converted unless approval is first obtained by the department." No OSHPD or CDPH - L&C approval documents were provided.

During an interview on 2/28/17, at 3:16 p.m., ADM 5, indicated the MRI trailer is onsite on Tuesdays and Fridays.

During an interview with the Director of Nursing (DON), on 3/1/17, at 10:10 a.m., the DON indicated the MRI trailer has it's own monitoring equipment.

On 3/1/17, at 11:25 a.m., hospital administrator (ADM 44) indicated having no records of MRI licensure.

During an interview with license nurse (RN 1), on 3/1/17, at 1:20 p.m., RN 1 indicated that ICU and telemetry patients had not been cardiac monitored in the MRI trailer during MRI procedures.

During an interview with the Radiology Director (ADM 5), on 3/1/17, at 1:35 p.m., ADM 5 indicated the MRI trailer was used for about 60 patients per month.

During an interview with the Radiology Supervisor (RAD), on 3/1/17, at 1:36 p.m., RAD indicated there had been at least three different MRI trailers used at the facility since the 1990's. If it was raining, an umbrella was held over patients to protect them from the weather. The facility did not have an MRI-safe ventilator, or an MRI-safe intravenous infusion (IV) pole. The facility was not able to monitor cardiac ICU and telemetry patients during the procedure.

The facility policy and procedure entitled "MRI Safety, Transport & Screening Guidelines" dated 2/26/14, indicated, "If a patient requires continuous mechanical ventilation, a MRI compatible ventilator is available and is housed in the physiology department...All patients requiring constant monitoring will be monitored by the radiology/MRI Monitor system by a trained nurse. The patient will be attached to the (MRI safe) monitor prior to entering the scan room"

Based on staff interview, review of administrative records, policies and procedures, the hospital governing body failed to govern the operation of the facility so as to provide safe patient care, as evidenced by the following:

1. Based on staff interview, review of administrative records, policies and procedures, and infection control/periodic evaluation, and quality assurance review documentation, it was determined the critical access hospital's governing body had failed to assume full responsibility for determining, implementing, and monitoring policies covering the facility's total operation, and for ensuring that these policies were administered so as to provide quality healthcare in a safe environment.

*The governing body failed to ensure periodic evaluation and quality assurance review reflected the hospital's services and involved all departments, including Nursing and Surgery (Refer to C-0330).

*The governing body failed to ensure the disinfection of equipment was done according to the manufacturer's recommendations; due to the potential for harm an immediate jeopardy was called on 2/27/17 at 2:50 p.m. (Refer to C-0278, C320 and C 321).

*The governing body failed to ensure the nurse staffing ratios required by the State of California were met; due to the potential for harm an immediate jeopardy was called on 2/28/17 at 2:20 p.m. (Refer to C-0272 and C-0294).

*The governing body failed to ensure on-site mobile units were licensed by the California Department of Public Health Licensing and Certification; due to the potential for harm, an immediate jeopardy was called on 3/1/17 at 11:25 a.m. (Refer to C-0222 and C-0272).

2. The hospital administrator (ADM 44) and Chief Executive Officer (CEO), responsible for determining, implementing and monitoring the policies governing the Critical Access Hospital (CAH), failed to ensure those policies were administered in a way that provided safe care to patients. This failure placed patients of the CAH at significant risk for physical and psychosocial harm (Refer to C241):

* For patients restrained using Posey hand-control mitten restraints without a physician order, indicated assessments, or documentation; this failure had the potential to result in serious psychosocial harm and physical harm.(See C294)

* For patients receiving procedures in an unlicensed mobile magnetic resonance imagery (MRI) trailer, this failure had the potential to result in serious harm from equipment failure, or hazardous conditions. (See C222.)

* For Patient 1 receiving care from a physician assistant (PA), with inadequate medical staff supervision; this lack of oversight resulted in Patient 1 not being referred to specialist care in a timely manner, and has the potential to lead to substandard patient care and could put patients at risk of poor outcomes. (See C264.)

* For surgery patients, post-anesthesia care (also known as recovery), was provided in a space which did not comply with state law or with acceptable standards of practice. Access was not limited to authorized personnel. This failure places surgical patients at risk for post-surgical infection. (See C320 and 321).

* For patients with orders for telemetry monitoring, continuous cardiac monitoring was not provided. For Patients 11,12,13,and 14, this failure had the potential to result in serious harm in the event of a cardiac event (heart attack) or arrhythmia (abnormal rate and rhythm of the heartbeat) going unnoticed by staff. (See C294.)

On 2/28/17, at 2:20 p.m., an IJ was declared due to the intensive care unit (ICU) being staffed by two registered nurses assigned to ICU patient care and also assigned the responsibility to monitor patients with physician's orders for continuous telemetry (device that transmits electrical activity from the heart) monitoring. The monitoring relays problems/changes in the hearts rhythm. When both ICU nurses are giving patient care to their assigned patients, telemetry patients are not being continuously monitored. (C-294)

On 2/28/17, at 3:45 p.m., the IJ was abated after an acceptable action plan was presented that an appropriately trained RN or monitoring technician will continuously monitor all patients on heart telemetry devices ordered by their physicians.

On 2/27/17, at 2:50 p.m., an Immediate Jeopardy (IJ - a situation in which the provider's non-compliance with one or more requirements of participation has caused, or is likely to cause, serious injury, harm, impairment, or death to a resident) was declared for not following Association of Perioperative Nurses (AORN) standards for precleaning, cleaning, and processing surgical instruments through sterile processing when:

a. A major and minor surgical set was opened, more than half of the instruments contained brown stains, tape used to identify the instrument was chipping off, there was etching on the instruments.

b. Hinged instruments remained closed during sterile processing.

c. Instruments were not scrubbed prior to cleaning.

d. Cleaning time of instruments was not monitored.

e. Use of a non-approved chemical to polish surgical instruments.

f. A disinfectant being used on surgical instruments was not approved for human use.

g. The decontamination door was open to the area used for scrubbing prior to surgery.

h. There was no barrier between sterile processing to operating rooms (OR's).

On 3/1/17, at 5:10 p.m., IJ was abated after an acceptable action plan was presented of discontinuing utilization of the surgical suites. Sterile processing and decontamination ceased. No invasive procedures requiring reusable instruments to be done. Elective surgeries canceled. Patients coming to the emergency department requiring surgery will be transferred to the closest available facility. The cumulative effects resulted in the hospitals inability to provide effective infection control for patient care in a safe manner in accordance with the Condition of Participation for Infection Control Services.

The cumulative effect of these systemic problems resulted in the hospitals inability to provide safe, quality patient care in a safe environment.

Based on interview, and record review, Administrative staff responsible for determining, implementing and monitoring the policies governing the Critical Access Hospital (CAH), failed to ensure those policies were administered in a way that provided safe care to patients.

Findings:

The facility policy and procedure titled "Policies: Procedures and Document Control, Development, Approval, Distribution" dated 2/12/17, indicated, "All policies and procedures shall be consistent with current local, state and federal regulations and other standards and guidelines including, but not limited to: State regulations (Title XXII, Cal-OSHA), Federal regulations (CMS Conditions of Participation), Accreditation standards, Professional organization standard of practice guidelines."

During a review of facility policies and concurrent interview with administrative staff, on 2/27/17, at 11:05 a.m., Administrative staff stated facility policy and procedures were "developed at our sister facility (name of sister facility) in Ventura California, 17 miles away, which is not a CAH)." Both facilities "combine" and "share policy and procedures." The DON was unable to locate the facility policy and procedure for basic care of an ICU patient.

During an interview with Senior management on 3/6/17, at 10:45 a.m., the senior management indicated annual reviews of policy and procedure were done at the "other sister hospital." The chief medical officer "is over both (name of sister facility) and Ojai Valley Community Hospital." The current system was the Chief Nursing Officer from (name of sister facility-ADM 7) "signs off" on all policies. The Chief Medical Officer is over both facilities. Policies and procedures are to be approved by the CAH Medical executive committee for use at the CAH.

During an interview with the human resources manager (HR Manager) and review of "Job Description" for Chief Nursing Officer, on 3/6/17, at 3:40 p.m., she indicated the Chief Nursing Officer from (name of sister facility-ADM 7) "renders," reviews, and signs all policies related to nursing for both hospitals. All the senior management, including the Chief Nursing Officer and Chief Medical Officer, were shared by both facilities, but the number of hours at each hospital was not defined.

1. The facility policy and procedure titled "Restraint Management", dated 12/15/17, had been approved by Chief Nursing Officer (ADM 7), and applied to both (name of sister facility) and the CAH. The policy did not comply with state regulations (California Title 22: section 70059 and Section 72319).

2. The facility policy and procedure titled "MRI Safety, Transport & Screening" dated 2/26/14, had not completed the approval process. The policy included equipment not available at the CAH, but only at (name of sister facility). Further, the MRI had not been inspected and licensed as required by the department. The facility policy and procedure titled "Transport of Mechanically Ventilated Patient to MRI" dated 11/18/16, had not completed the approval process. The policy included equipment not available at the CAH, but only at another facility, (name of sister facility).

3. The facility policy and procedure titled "Cardiac Monitoring Continuous and Intermittent" was dated 3/12/13, and the last reviewed date was back in 10/2007. Review of state law, California Title XXII, section 70203(c), indicated "The following shall be available to all patients in the hospital: (4) cardiac monitoring capability." The facility was utilizing ICU nurses with patient care assignments to also monitor telemetry patients. The facility policy and procedure titled "Cardiac Telemetry Admission, Transfer / Discharge and Triage Criteria" dated 3/12/13, had not completed the approval process. The policy included equipment not available at the CAH, but only at another facility, (name of sister facility).

During an interview with Chief Nursing Officer from (name of sister facility-ADM 7), on 3/6/17, at 3:55 p.m., she indicated the current policy on restraints had not been reviewed by committee at the CAH. The telemetry policy had not been approved by committee for use at the CAH. The MRI (magnetic resonance imagery) policy had not gone through the approval process.

Based on interview with facility staff and review of documents the facility failed to ensure all clinic physician assistants participated with a physician in a periodic review of the patients' health records. For two of two physician assistants there was incomplete documentation of health record review by supervising physicians according to facility policy.

The failure resulted in physician assistants work not being reviewed by a doctor of medicine or osteopathy in February of 2016.

Findings:

The facility document titled "Delegation of Services Agreement for Physician Assistant," approved by the Interdisciplinary Practice Committee (IPC) in February 2016, stated for outpatient services the supervising physicians were to review a percentage of the physician assistants' cases. Review of the tracking documents provided by the facility showed the number of the physician assistants' cases reviewed since IPC approval of the agreement did not consistently meet the percentage required. In an interview on 3/1/2017 at 3 p.m. ADM 27 agreed there was no documentation that supervising physician review of outpatient records for the first months of 2016 met the percentage required by the agreement.

Based on observation, interview, and record review, the hospital failed to provide patient care services which met the needs of all patients, in compliance with the Condition of Participation for Provision of Services, as evidenced by the following failures:

The facility failed to ensure that the Condition of Participation for Provision of Services was met when:

1. The hospital failed to ensure they had an effective, active and a systematic infection control surveillance program in place for identifying, investigating and controlling infections (Refer to C-0278).

2. The hospital did not have a method for determining the temperature levels in their sterile storage room or decontamination room (Refer to C-0278).

3. The hospital did not have a method for determining the humidity level in their decontamination room or sterile storage room (Refer to C-0278).

4. The processing and sterilization of surgical equipment and devices did not follow nationally accepted standards when the hospital failed to ensure there was no presence of spotting and staining on two of two processed surgical trays (previously cleaned, disinfected and sterilized surgical instruments) (Refer to C-0278).

5. The facility failed to provide and maintain a sanitary environment to avoid sources and transmission of infections, when they failed to ensure their sterile processing area was clearly separate from dirty items (Refer to C-0278).

6. The hospital failed to produce infection control policies which were specifically developed for the hospital's surgical department. (Refer to C-0278).

7. The hospital failed to ensure the surgical department staff used approved cleaning products to clean surgical instruments (Refer to C-0278).

8. The hospital failed to ensure the decontamination room door remained closed at all times (Refer to C-0278).

9. The hospital failed to ensure the decontamination room was equipped to safely clean and disinfect dirty surgical instruments in accordance with infection control standards (Refer to C-0278).

10. The hospital failed to ensure all surgical instruments were in the open position during sterilization, in accordance with infection control standards (Refer to C-0278).

11. The hospital failed to ensure gastrointestinal (GI) scopes were cleaned and high level disinfected in accordance with IC standards and in a manner to prevent cross contamination (Refer to C-0278).

12. The hospital failed to ensure the GI scope cabinet was in compliance with IC standards and in a manner to prevent cross contamination (Refer to C-0278).

13. A surgical coordinator did not wear proper personal protective equipment during cleaning and disinfecting surgical instruments (Refer to C-0278).

14. Sterile supplies were not stored in a climate control area (Refer to C-0278).

15. There was no evidence to demonstrate IC practices and surgical instrumentation processing staff had oversight, to ensure high level disinfecting and sterilization of instrument practices were performed in a manner to prevent cross contamination (Refer to C-0278).

16. There was no evidence to demonstrate the hospital's decontamination room and sterile processing room were terminally cleaned (Refer to C-0278).

17. The accessories/removable parts from the GI scopes were not stored in a manner to prevent cross contamination and in accordance with IC practices (Refer to C-0278).

18. A laryngeal mask airway (LMA) was left in an opened container and soaking overnight in the decontamination room (Refer to C-0278).

19. Brushes used to clean surgical instruments/equipment were left out, uncovered in the decontamination room and the surgical staff were unable to provide evidence to indicate they were reusable and they were unable to provide cleaning guidelines/recommendations for the brushes (Refer to C-0278).

20. Job descriptions for the IC Preventionist (ICP) and a Surgical Coordinator (SC) and did not indicate they were employed by the hospital (Refer to C-0278).

The cumulative effect of these systemic problems had the potential to transmit infectious microorganisms to patients and increased the risk of infections to all patients who received surgical services in a universe of 11. The facility failed to deliver care in a safe setting in their surgical department in order to be in compliance with the Condition of Participation for Provision of Services - § 485.635.

Immediate Jeopardy

On 2/27/17, at 2:50 p.m., an Immediate Jeopardy (IJ) was declared after the team identified, through observations, interviews, and record reviews, a pattern of ineffective infection control practices, in the surgical services department. The hospital failed to protect all patients requiring surgical services from the potential of nosocomial infections and failed to provide surgical services in a well-organized manner and in accordance with acceptable infection control (IC) standards of practice.

Findings:

On 2/27/17, at 9:20 a.m., during a tour of the hospital's surgical services department, the following were observed:

1a) The hospital did not have a method for determining the temperature levels in their sterile storage room or decontamination room.

b) The hospital did not have a method for determining the humidity level in their decontamination room or central sterile room where surgical instrument sterilization/processing was performed.

c) Two of two (one major and one minor) processed surgical trays (previously cleaned, disinfected and sterilized surgical instruments) contained more than half (each tray) surgical instruments with brown spotting and staining that was easily removed when wiped.

d) The sterile processing area was used to sterilize surgical instruments and to wash/process dirty scopes.

e) A surgical coordinator used cleaning supplies which were not meant or approved to be used on any surface or instruments that are introduced directly into the human body.

f) The decontamination room door remained open throughout survey.

g) The decontamination room contained one small sink which was cracked in the inner basin and patched with a product that was peeling.

h) 12 out of 80 surgical instruments which had been previously sterilized, in a major tray, were in an open position during sterilization and 15 out of 69 surgical instruments in a minor tray were in the open position during sterilization.

i) Gastrointestinal (GI) scopes were cleaned and high level disinfected in a operating room (OR 2) which was used to perform GI procedures.

j) The GI scope cabinet, used to store clean scopes was stored in OR 2 during GI procedures and during cleaning of scopes. The cabinet also did not contain a HEPA filter and was not properly vented.

k) The surgical coordinator did not wear proper personal protective equipment during cleaning and disinfecting surgical instruments.

l) Sterile supplies were stored in a non-climate control area (staff office and sterile processing room).

m) It was determined that there was no evidence to demonstrate IC practices and surgical instrumentation processing staff had oversight, to ensure high level disinfecting and sterilization of instrument practices were performed in a manner to prevent cross contamination.

n) There was no evidence to demonstrate the hospital 's decontamination room and sterile processing rooms were terminally cleaned.

o) The accessories/removable parts of the GI scopes were not stored in a manner to prevent cross contamination and were left in an open container on top of a cart used to clean GI scopes.

p) A laryngeal mask airway (LMA-medical device that keeps a patient's airway open during anesthesia or consciousness) was left in an opened container and soaking overnight in the decontamination room.

q) Brushes used to clean surgical instruments/equipment were left out, uncovered in the decontamination room and the surgical staff were unable to provide evidence to indicate they were intended to be reusable and were not able to provide cleaning guidelines/instructions for the brushes.

The cumulative effect of these systemic problems had the potential to transmit infectious microorganisms to patients and increased the risk of infections to all patients who received surgical services. The hospital failed to deliver care in a safe setting and therefore failed to comply with the §485.639 Condition of Participation for Surgical Services.

On 2/27/17, at 4:25 p.m., the hospital's Vice President of Quality and the Chief Administrator Officer (CAO) provided the team an acceptable corrective action plan to lift the immediacy of the IJ. On 3/1/7, at 5:10 p.m., the immediate jeopardy was abated, after the team validated, through observations, interviews, and record reviews, the hospital's directive action plan. The IJ was abated in the presence of the Vice President of Quality and the CAO.

Based on interview and record review, the facility failed to ensure staff adhered to appropriate written policies and procedures consistent with state law:

1. The hospital failed to have a policy and procedure in place or incorporation into the bylaws for the oversight and responsibility of medical residents practicing medicine at the CAH

2. Recovery of patients following surgery was not performed on the PACU (post-anesthesia care unit), but was performed in a corner of the ICU. This failure places surgical patients at risk for post-operative infection.

Findings:

1. Review of state law, California Title XXII, section 70706.
Interdisciplinary Practice and Responsibility for Patient Care, 70706(c), indicated, "The committee on Interdisciplinary Practice shall establish written policies and procedures for the conduct of its business. Policies and procedures shall be included but not limited to:" " (3) Providing for clear lines of responsibility of the nursing service for nursing care of the patients and of the medical staff for medical services in the facility.

Review of state law, California Title XXII, section 70203(b), indicated "The responsibility and accountability of the medical service to the medical staff and administration shall be defined."

Review of state law, California Title XXII, section 70705, indicated patient care provided by residents or interns shall be in accordance with an approved program.

Review of state law, California Title XXII, section 70019, indicated "Defined. Defined means defined in writing."

The policy and procedure provided by the facility did not apply to the Critical Access Hospital (CAH) and did not define responsibilities and accountability of medical residents and staff to administration at the CAH, and did not identify an approved residency program at the CAH. The faciltiy was unable to supply a policy related to the supervision of residents in the CAH.

The policy and procedure titled "Education/Supervision, Medical Students and Residents Manual: (name of sister facility) Department Medical Education Control Number: MD-EDU001. Applies to: (name of sister facility), "Purpose: This policy covers the clinical activities of all medical students and residents Providing clinical services at (name of sister facility). There must be sufficient oversight by attending medical staff to assure that students and residents are appropriately supervised. Attending Physician must closely supervise and assume responsibility for all actions and omissions of student/ resident."

2. Review of California, Title XXII, section 70237 indicated, in part:
"(a)There shall be adequate and appropriate equipment for the delivery of anesthesia and post anesthesia recovery care."

Review of California, Title XXII, section 70239 indicated, "post anesthesia recovery unit" shall meet floor area and equipment requirements.

Review of facility policy and procedure titled "PACU CARE Guidelines - Phase 1 and 2", dated 2/2/16, indicated, in part, "Purpose: To provide guidelines for care of the patient in the post anesthesia care unit. Policy: It is the policy of (name of health system) to provide and document standards of care for patients undergoing the recovery phase of the perioperative experience. These guidelines are based on recommendations by the American Society of Peri Anesthesia Nurses." (AORN)

Review of the American Society of Peri Anesthesia Nurses. (AORN) guidelines, titled "Guidelines for Perioperative Practice", dated 2017, indicated, in part,"Policies and procedures for the provision of a safe environment of care should be developed, reviewed periodically, revised as necessary, and readily available in the practice setting. Policies and procedures assist in the development of patient safety, quality assessment, and performance improvement activities. Policies and procedures establish authority, responsibility, and accountability within the organization. Policies and procedures also serve as operational guidelines that are used to minimize patient risk for injury or complications, to standardize practice, to direct perioperative personnel, and to establish continuous performance improvement programs."

Based on interview and record review, facility policies and procedures were not developed and approved, reviewed annually, and as necessary, by the Critical Access Hospital (CAH) professional healthcare staff. For patients cared for at the CAH, this failure has the potential for serious harm:

Findings:

1. A review of the facility's policy and procedure titled, "Pharmacokinetic Monitoring" indicated "Last Review/Revision Date: 5/6/13." The time frame from the date of last policy review to the date of inspection was calculated to be a duration of approximately three years and nine months.

During an interview on 3/7/17 at 3:05 p.m., the Director of Pharmacy (DOP) and Medication Safety Coordinator (MSC) acknowledged the "Pharmacokinetic Monitoring" policy was last reviewed 5/6/13 and that it had been more than three years since the "Pharmacokinetic Monitoring" policy and procedure had been reviewed.

2. The facility utilized restraints with hand-control mittens without a doctors order, indicated assessments, or documentation.

During an interview with Administrative staff 3/2/17, at 10:05 a.m., they indicated the nurses were not assessing and documenting on the hand-control mittens because the mittens were considered "Activity mittens" and therefore were not considered restraints.

The manufacturers insert for (name of) hand-control mitten restraints, dated 2014, indicated, in part, "...Staff must have on going training and be able to demonstrate competency to use this device in accord with: ... your facility policies and state and federal regulations (Federal Register, Part IV, 42 CFR Part 482.13(e)(5)."

Federal Register, Part IV, 42 CFR Part 482.13(e)(5), indicated, "The use of restraint or seclusion must be in accordance with the order of a physician or other licensed independent
practitioner who is responsible for the care of the patient as specified under § 482.12(c) and authorized to order restraint or seclusion by hospital policy in accordance with State law."

Review of state law, California Code of Regulations, Title 22: Section 70059, indicated, in part, "Restraint means controlling a patient's physical activity in order to protect the patient or others from injury by seclusion or mechanical devices."

Section 72319 indicated, in part, "Restraints shall only be used with a written order of a licensed healthcare practitioner" and include"soft cloth mittens."

During an interview with ADM 7, on 3/6/17, at 3:55 p.m., she indicated the current policy on restraints had not been reviewed by committee at the CAH.


35335

Based on observation, interview, and facility policy review, the facility failed to ensure that emergency medications and supplies were stored in a secured manner as evidenced by:

1. Outpatient clinic emergency crash cart (a cart containing tools and drugs needed to treat a person who may be having a medical/surgical emergency with life support protocols), located in a accessible hallway, containing medications and supplies lacked a locked tight fitting seal.

This failure has the potential for patients not having access to necessary emergency medications and equipment.

2. The facility failure to ensure medications were not stored past their expiration dates. This occurred when one of one expired (name of syrup) was observed stored in the Emergency Department (ED) Medication Room.

This failure had the potential for patients to be administered deteriorated medication.

3. The facility failure to ensure one of one opened multiple dose vials were stored in accordance with the facility's approved policies and procedures. This occurred when an opened and undated multiple dose vial of the anesthetic (numbing) medication (name of medication) 1% (brand name for the anesthetic lidocaine with vasoconstrictor (narrows the blood vessels) epinephrine) was observed stored in the emergency department (ED) medication room.

This failure had the potential for patients to be administered deteriorated medications.

4. The facility failure to ensure that medications in one of one crash carts were stocked in accordance with the facility's approved policies and procedures. This occurred when the quantity (number) of the anti-arrhythmic (to prevent and treat abnormal heart rhythms) medication adenosine observed inside the adult emergency cart did not match the quantity on the crash cart's contents list posted on the outside of the crash cart.

This failure had the potential for patients not have emergency medications available when needed.

5. The facility failure to ensure that "(name of) Bags" (an intravenous (IV-administered through the patient's vein) solution ordered for alcoholic patients) prepared in ED met criteria for "immediate-use" compounding (mixing) per The United States Pharmacopeia (USP) <797> standards of practice for sterile (germ-free) compounding. This occurred when record review indicated that 28 of 28 ED patients were ordered "(name of) Bags" in the year 2016 which did not meet USP <797> "immediate-use" compounding requirements.

This failure had the potential to expose the patients to increased risk of infections.

6. The facility failure to develop procedures to ensure adequate recovery time is followed after material transfer before and during compounding operations in a CAI (a type of isolator used to compound IV medications) based on USP <797> standards of practice. This occurred when one of one IV vancomycin (an antibiotic medication) that was prepared in a CAI in a segregated compounding area (a space dedicated to mixing medications) was observed labeled with a beyond-use-date of 14 days.

This failure had the potential to expose patients to increased risk of infections.

Findings:

1. During an observation and concurrent interview on 2/27/17, starting at 10:30 a.m., in the out-patient clinic, with the clinic manager (ADM 1), while observing a emergency crash cart located in the clinic hallway, the emergency crash cart was observed to be lacking the supplied red plastic lock. The lock was observed to be in a open position on the floor. ADM 1 stated, "The locks are defective." A license nurse (LVN 1) attempted to put another lock on emergency crash cart, and this lock did not secure the cart drawer. ADM 1 stated, "I am going to call the pharmacy now to see if we can get this fixed."

The facility policy and procedure titled, "Emergency Cart," dated, 1/06, indicated,"Main cart- the integrity of the main cart will be inspected by observing the red numeric seal on the cart is present and tight in it's fitting. If the integrity of the emergency cart is broken, the blue tag lock in the medication drawer will be affixed to the cart and a replacement emergency cart will be called for."


35335


2. During an observation in the ED medication room, and concurrent interview with the Director of Nursing (DON) on 2/27/17 at 10:30 a.m., a bottle of (name of syrup) was observed stored in the medication room listed with an expiration date of 1/17. The bottle of (name of syrup) indicated a National Drug Code "(NDC) 0574-0304-16. The DON acknowledged the bottle of (name of syrup) stored in the ED Medication Room expired 1/17.

The facility policy and procedure titled, "Medication Storage and Medication Preparation Areas" dated 4/22/13, indicated, "Medication will not be kept in storage past their expiration dates."

3. During an observation in the emergency department (ED) medication room and concurrent interview with the DON on 2/27/17 at 10:30 a.m., an opened and undated multiple dose vial of (name of medication) 1 % 20 milliliters (mLs) was observed stored in the medication room next to the sink with no indication of when the vial was opened or when the medication would expire. The DON acknowledged the opened multiple dose vial was undated.

The facility policy and procedure titled, "Medication Storage and Medication Preparation Areas" dated 4/22/13, indicated, "Multiple dose vials should be dated with the last date of use "expiration date" when first entered."

The facility policy and procedure titled, "Medication Administration" dated 3/1/16, indicated, "All other multi-dose vials not listed in Table 3 will be treated as single dose vials and discarded after use on a single patient."

4. During an observation in the medical-surgical nursing unit and concurrent interview with the director of pharmacy (DOP) on 2/27/17 at 11:06 a.m., an inspection of the "Adult # 7 Crash Cart" was conducted. The external contents list posted indicated a quantity of three vials of adenosine 6 milligram (mg)/2 mL. When the crash cart was opened, a quantity of two vials of adenosine 6 mg/2 mL were observed inside the crash cart. During a concurrent interview, the DOP acknowledged the adenosine vials observed inside the crash cart did not match the posted quantity on the external contents list.

The facility policy and procedure titled, "Emergency Cart" dated 3/24/16, indicated, "Adult Emergency Cart Drug List" with a listed quantity of 3 vials of adenosine 6 mg/2 mL were approved by the P&T (Pharmacy and Therapeutics) Committee in 3/16.

5. During an interview on 2/27/17 at 5 p.m., the facility's pharmacist-in-charge (PIC) stated they followed USP <797> standards of practice for sterile compounding.

During an observation in the ED medication room and concurrent interview with license nurse (RN 7) on 2/27/17, at 5:15 p.m., 5 mL vials of injectable multivitamins were observed in the medication room refrigerator and injectable folic acid (a vitamin) vials were observed in the automated dispensed cabinet (ADC-a computerized system for drug storage). The refrigerator contained several little plastic bags individually packaged with two 5 mL injectable multivitamins in each plastic bag. Each plastic bag contained a multivitamin vial with a blue cap and a multivitamin vial with a white cap. Five vials of injectable folic acid were observed stored in the ADC. RN 7 stated the multivitamins and folic acid were used to make "(name of) Bags" when the Pharmacy was closed.

During an observation in the ED medication room and concurrent interview with the medication safety coordinator (MSC), on 2/28/17, at 10:50 a.m., injectable 2 mL vials of thiamine (a vitamin) were observed stored in the ADC. The MSC stated the injectable thiamine vials were used to make "(name of) Bags" when the Pharmacy was not open.

During an interview on 2/28/17, at 1:51 p.m., RN 5 stated she pulls up the medication dose from each injectable vial individually, including the two injectable multivitamins vials, for the preparation of ED "(name of) Bags."

During an interview on 2/28/17 at 4:15 p.m., the MSC acknowledged the preparation of the ED "(name of) Bags" was not low-risk (category based on risk of microbial contamination) level sterile compounding in accordance with USP <797> "immediate-use" sterile compounding requirements.

A review of the ED (name of) Bags ordered from the time period "1/1/16 to 12/31/16" with the injectable medications "folic acid, multivitamins, magnesium sulfate [a supplement], and thiamine" into IV normal saline 1000 mLs indicated 28 (name of) Bags were made outside of the Pharmacy during this time frame.

A review of USP <797> section entitled "IMMEDIATE-USE CSPs (Compounded Sterile Preparations)" indicated "the compounding process involves simple transfer of not more than three commercially manufactured packages of sterile nonhazardous products ...and not more than two entries [punctures] into any one container or package (e.g., bag, vial)..."

The facility policy and procedure titled, "Parenteral Medication - Preparation Outside the Pharmacy" dated 7/22/16, indicated, "The compounding process may involve the simple transfer of not more than three sterile, non-hazardous drugs in the manufacturer's original containers and not more than two entries into any one container."

6. During an observation in the pharmacy refrigerator and concurrent interview with pharmacy technician (Rx Tech 1) on 2/27/17 at 9:45 a.m., an IV antibiotic, vancomycin 1600 mg in a 500 mL normal saline bag was observed in the refrigerator. The IV vancomycin bag was observed to be labeled with a "Compound Date of 2/20/17" and an expiration date of "3/6/17 at 1700." The duration between 2/20/17 to 3/6/17 was calculated to be 14 days. A compounding aseptic isolator (CAI) was observed in the segregated compounding area. Rx Tech 1 stated she prepared the IV Vancomycin in the "glovebox (also known as CAI)" and originally assigned the medication an expiration date of 24 hours. She stated she attempted to deliver the IV vancomycin to the ED, but the Nurse rejected the medication. Rx Tech 1 stated when she returned to Pharmacy, she changed the vancomycin's expiration date to 3/6/17 because it would be stored in the refrigerator for 14 days.

During an interview on 2/27/17, at 5 p.m., the facility's pharmacist-in-charge (PIC) stated they followed USP <797> standards of practice for sterile compounding.

During an interview on 3/6/17, at 9:37 a.m., the PIC and MSC acknowledged there was no documentation to ensure compounding personnel complied with adequate recovery time after material transfer before and during compounding operations to support the observed IV vancomycin's labeled beyond-use-date of more than 12 hours.

A review of a letter from the manufacturer of the CAI, dated 1/17, indicated, "To ensure that not more than 3520 particles (0.5 um -a unit of measurement- and larger) per m3 -a unit of measurement- shall not be counted during material transfer, the recovery rate of 60 seconds must be respected before transferring items from the antechamber and before compounding in the main chamber."

A review of Rx Tech 1's annual competency dated 7/12/16, did not indicate assessment to ensure adequate recovery time is followed after material transfer before and during compounding operations.

A review of USP <797> section entitled "Placement of Primary Engineering Controls (a device that provides an ISO 5-a category of air cleanliness- environment)" indicated "When isolators are used for sterile compounding, the recovery time to achieve ISO [International Organization for Standardization] Class 5 (see Table 1) air quality shall be documented and internal procedures developed to ensure that adequate recovery time is allowed after material transfer before and during compounding operations...If the PEC [Primary Engineering Control] is a CAI...that does not meet the requirements above...then only low-risk level nonhazardous and radiopharmaceutical CSPs pursuant to a physician order for a specific patient may be prepared, and the administration of the CSP shall commence within 12 hours of preparation or as recommended in the manufacturer's package insert, whichever is less."

Based on observation, interview and record review, the hospital failed to provide a functional and sanitary environment when infection control practices were not implemented in accordance with hospital policy and nationally recognized standards. The hospital also failed to ensure they had an effective, active and systematic infection control surveillance program in place for identifying, investigating and controlling infections, in their surgical department. this failure had the potential for patient harm and the spread of infection to patients that require surgical services:

The facility failed to:

1. Failed to provide and maintain a sanitary environment in the surgical department and the decontamination room, in a manner which prevents sources and transmission of infections.

2. Failed to ensure they had an effective, active and a systematic infection control surveillance program in place for identifying, investigating and controlling infections and failed to demonstrate IC practices and surgical instrumentation processing staff had oversight, to ensure high level disinfecting and sterilization of instrument practices were performed in a manner which prevents cross contamination.

3. The cleaning and disinfecting of surgical equipment and devices did not follow nationally accepted infection control standards and failed to ensure the decontamination room was equipped to safely clean and disinfect dirty surgical instruments in accordance with infection control standards and in a manner which prevented the potential of cross contamination.

4. The hospital processing and sterilization of surgical equipment and devices did not follow nationally accepted standards when the hospital failed to safeguard there was no presence of spotting and staining on 2 of 2 processed surgical trays filled with multiple instruments (previously cleaned, disinfected and sterilized surgical instruments) and failed to ensure all surgical instruments were in the open position during sterilization, and in accordance with infection control standards.

5. A laryngeal mask airway (LMA) was left in an opened container, soaking overnight in the decontamination room.

6. The hospital failed to ensure the surgical department staff used approved cleaning products to clean and disinfect surgical instruments.

7. The hospital failed to ensure flexible endoscopes (scopes - optic instruments used to inspect and treat interior portions of the body and digestive tract) scopes were cleaned and high level disinfected in accordance with IC standards and in a manner which prevents cross contamination.

8. The accessories/removable parts from the flexible scopes were not stored in a manner which prevented cross contamination and in accordance with IC practices.

9. The hospital failed to ensure the flexible scope cabinet was in compliance with IC standards and in a manner, which prevents cross contamination.

10. The hospital failed to produce infection control policies specifically developed for the hospital's surgical department practices.

11. There was no evidence to demonstrate the hospital's decontamination room and sterile processing room were terminally cleaned.

12. Brushes used to clean surgical instruments/equipment were left out, uncovered in the decontamination room and the surgical staff were unable to provide evidence to indicate they were reusable and they were unable to provide cleaning guidelines/recommendations for the brushes.

13. Job descriptions for the IC Preventionist and Surgical Coordinator did not indicate they were employed by the hospital.

14. Clean and disinfect a laryngeal mask airway (LMA- a medical device that keeps a patients airway open during anesthesia or unconsciousness), according to the manufacturer's guidelines.

15. Ensure annual competency validation of the surgical coordinator (SC). During an interview on 02/27/17, at 12 p.m., SC indicated she is responsible for sterile processing and the teaching of sterile processing to other staff.

These failures had the potential to transmit communicable diseases throughout the hospital, which could impact the health and welfare of all patients, visitors and staff in a universe of 11.

Findings:

1. On 2/27/17, at 9:20 a.m., an observation was conducted of the hospital surgical service department, in the presence of an RN Surgical Coordinator (SC) and the Director of Nurses (DON). A Sterile Processing Manager (SPM) and a Director of Surgical Services (DSS), were also present. The following concerns were identified:

a) The entrance to sterile processing was also the entrance into two (2) operating rooms, 2 scrub sinks (an area where surgical staff perform hand hygiene prior to surgeries), 2 sinks used to process scopes (equipment used for invasive procedures), a scope processor, a staff office and a decontamination room with a non-operating door.

b) Immediately upon entering the room, on the left wall were carts that were used to store clean/sterilized surgical equipment and supplies.

c) Once surveyors entered the room, to the right was a staff office which also contained cabinets that were used to store clean/sterilized surgical equipment and supplies.

d) On the left side of the room was an entrance to a workspace area used to package and sterilize surgical instruments.

e) Directly across and approximately less than three feet from a table, used to package clean surgical instruments to prepare for sterilization, was a scope processor used to clean dirty scopes.

During a concurrent interview with SC, she stated that their surgical service department was small and they had no other space to perform procedures. According to SC, the door to the decontamination room was non-functional and it always remained open but realized that it should not be kept opened. According to SC, there was no method of obtaining humidity or temperature levels in their sterile processing room or the decontamination room. There also was no method of obtaining humidity or temperature levels in the staff office or the hallway where sterile supplies were being stored.

SC further stated they performed high level disinfecting (HLD - complete elimination of all microorganisms in or on an instrument, except for small numbers of bacteria) of dirty flexible scopes in the processor machine that is kept in sterile processing room.

During an interview on 2/27/17 at 10:15 a.m., with the Chief Engineer (CE), he stated they did not have a method for obtaining daily temperatures and humidity levels in the sterile processing room or the decontamination room. He also stated there was no continuous daily monitoring of those rooms or of the hallway and the staff office where the sterile supplies were stored. The only rooms which had a method of viewing the temperature and humidity levels were in the two operating rooms.

During an interview with the SC, she was asked which nationally recognized infection control standards the hospital followed. She stated they followed AORN (Association of Perioperative Nurses), AAMI (Association for the Advancement of Medical Instrumentation - an organization for advancing the development, and safe and effective use of medical technology Association), and Centers for Disease Control (CDC), manufacture recommendations/guidelines.

According to AAMI, Sterility Update 2010, relative humidity should be maintained between 30% and 60% in all work areas. "Because of the need to wear PPE, temperature in the decontamination area should be between 60 degrees Fahrenheit and 65 degrees Fahrenheit."

According to CDC guidelines, sterile supplies should be stored in a manner which prevents contamination, there should be a clear separation of sterile items and dirty items, and there must be separate clean/dirty rooms or the designated utility room must flow from clean to dirty.

According to AORN, Inc; 2013:513-540 Recommended practices for sterilization. In: Perioperative Standards and Recommended Practices. "Sterile items should be stored under environmentally controlled conditions, which mean a temperature of approximately 75 degrees Fahrenheit (24 degrees C), a maximum relative humidity of 70%..."
"Physical Design - There should be a physical separation of where items are decontaminated and where clean items are packaged, sterilized and stored ...a pass-thru window, between the decontamination area and the clean area is recommended to progressively move items from being contaminated to being safe to handle ..."
"Sterile Storage - The recommended temperature for all sterile storage areas is 75 degrees Fahrenheit."

2. On 2/27/17, at 10:20 a.m., interviews were conducted with the SPM and the DSS. They both verified the above findings and stated the building was built many years ago but were aware it was not appropriate.
They were asked how they conduct surveillance/monitoring of the surgical and decontamination areas and provide oversight of staff to ensure they are complying with IC practices and policies. They both stated that they were employed by their "sister facility" (under a separate license and approximately 17 miles away) but did try to go to this hospital to perform surveillance. SPM stated she went to this hospital "maybe once a month" and the DSS stated she tried to go to this hospital about 3 times a month.

There was no documented evidence to demonstrate surveillance and oversight of the surgical department, decontamination room or of staff was being performed.

A review was conducted of a policy titled, "Scope of Services - Surgery/Sterile Processing Departments, reviewed 6/7/2016." The documented stipulated, "The manager of Sterile Processing oversees the hospitals decontamination, assembly and sterilization processes ..."

According to AORN "Guideline for Sterilization (2017), a quality assurance and performance improvement process should be in place to measure patient, process, and system outcome indicators ..."

3. On 2/27/17, multiple observations and concurrent interviews with SC, were conducted at 10:30 a.m. of a SC performing cleaning and disinfecting of dirty surgical instruments that were transported into the decontamination room after a surgical case. The following concerns were identified:

a) The SC hand carried a tray with dirty surgical instruments, from OR 1 (operating room), covered with a towel, across the room (approximately 13 feet) to the opened decontamination room.

b) The SC placed the tray in a one (1) compartment sink (small and approximately 3 feet in length). The sink was also used by staff to perform hand hygiene.

c) Above the sink, hanging from a wall, were three small uncovered wired brushes used for brushing instruments. According to SC, the brushes get cleaned in the same solution that the surgical instruments get soaked in. Also observed above the sink was a syringe. The SC stated that the syringe should not be there and was used to flush surgical equipment ports/channels.

d) SC applied a thin plastic gown, wrist high gloves, (PPE - personal protective equipment) and stepped outside of the decontamination room to obtain protective eye goggles which were stored uncovered, above a surgical hand scrub sink, on a shelf.

e) There were two metal containers on a narrow shelf, adjacent to the sink. One container was uncovered and filled with a brown/red fluid; the lid to the container was placed beside it and on top of an empty metal container. The lid was marked with tape and written on the tape was "(name of solution) 3 oz in 3 gallons."

f) Directly above the shelf was a bottle labeled "(name of) Enzymatic Cleaner".

g) SC uncovered the tray with the dirty instruments and proceeded to soak them in the (name of solution) for three minutes (per SCs interview).

h) SC stated "Only used instruments" receive the bedside pre-cleaning. She was asked to clarify and stated, if instruments did not get used for a procedure, during the case, then they did not receive pre-cleaning.

i) SC proceeded to place a portion (not all fit into the container) of the instruments into the (name of) solution for 10 minutes (according to the SC). A red/brown stained plastic bin was used to soak the instruments. During the observation and as SC placed the instruments in the container to soak, water was splashed onto the floor and outside of the container, dripping onto the shelf.

j) It was noted that many of the dirty instruments contained brown/red staining/spotting.

k) Surveyor did not observe SC scrubbing or rinsing all surgical instruments.

l) SC placed the instruments into a tray, covered with a towel and hand carried them into the sterile processing room.
m) SC used a product called, "(name of product)" in an attempt to "remove rust" and stated the product (cotton like material) can be used on instruments and is "reusable".

Immediately following the observations, DSS and SPM were asked if the methods used by SC to transport dirty surgical instruments and her technique for cleaning and disinfecting the surgical instruments were acceptable. They stated that it was not acceptable but that the space they used was too small.

During a review of a hospital policy titled, "Scope of Services - Surgery/Sterile Processing Departments, reviewed 6/7/2016." The documented stipulated, "The department adhered to standards which are in compliance with Federal, State, hospital regulations and practice standards of professional organizations such as ...AAMI, AORN, APIC among others. The policy also stipulated, " F. The patient will be free from injury due to chemical, physical or electrical hazard ..."

After further review of the hospital policy, it was noted that the policy addressed cleaning and decontamination of instruments which were specific to this hospital's sister facility. There was no evidence to show the policy was developed to guide staff manually wash instruments. The policy addressed using a washer, which this hospital did not have. During an interview with the SPM, she stated they did not have a specific policy for manually washing instruments and the current policy was specific to the sister facility's practice.

According to AORN recommendations, "The final rinse should be performed with treated (eg, distilled, reverse osmosis, filtered) water of a quality that will not stain or cause damage to instruments or contribute to recontamination of the instrument. Untreated water can contain contaminants, including endotoxins, which can be deposited on instruments during the final rinse. Rinsing with treated water can prevent deposits of impurities or contaminants on instruments. Endotoxins are heat stable and may not be destroyed by subsequent steam sterilization. Tissue contaminated with endotoxins can cause severe inflammation. Treated water can prevent spotting, stains, deposits, and corrosion on the surfaces of instruments", Guidelines for Perioperative Practice. Denver, CO: AORN, Inc. ANSI/AAMI ST79: Comprehensive Guide to Steam Sterilization and Sterility Assurance In Health Care Facilities.
According to APIC standards and AAMI's Comprehensive guide to steam sterilization and sterility assurance in health care facilities, any instruments that are opened in the OR whether used or not, should be decontaminated and the instruments should not be decontaminated in a scrub or hand sink. APIC further indicates that sterile processing departments play a significant role in minimizing the risk of surgical site infections. In addition, PPE should include a fluid-resistant face mask.

4. On 2/27/17, at 10:50 a.m.,, two sterilization containers (a major and a minor) filled with multiple previously cleaned and sterilized surgical instruments were inspected, in the presence of the SC, SPM and the DSS. The following concerns were identified:

a) In the major tray, 12 of 80 instrument hinges were in the closed position and approximately half of the instruments contained brown staining that was easily removed.

b) In the minor tray, 15 of 69 instrument hinges were in the closed position and approximately half of the instruments contained brown staining that was easily removed.

c) Multiples surgical instruments were rusted and contained etching not from the manufacture.
Immediately following the observations of the instruments, the SC stated that the brown staining of the instruments was rust because the instruments were "old".

During a review of a hospital policy titled, "Scope of Services - Surgery/Sterile Processing Departments, reviewed 6/7/2016." The documented stipulated, "The department adhered to standards which are in compliance with Federal, State, hospital regulations and practice standards of professional organizations such as ...AAMI, AORN, APIC among others.

A.A.M.I "Standards and Recommended Practice, Safe Handling and Biological Decontamination of Medical Devices in Heath Care Facilities and in Non-Clinical Settings, ANSI/AAMI ST35:2003, keeping in mind this process is in two steps: 1. Complete cleaning and 2. Washing and Sterilization".

During a review of a hospital policy titled, "Decontamination and Processing of Reusable Items, last reviewed/revised on 1/14/13" stipulated, " ...For all reusable medical devices, the first and most important step in decontamination is thorough cleaning and rinsing ..."

5. During an observation on 2/28/2017, at 8:45 a.m., in the decontamination room, an uncovered/exposed LMA was soaking in an open container of fluid.

During a concurrent interview with the Surgical Coordinator (SC), on 2/28/2017, at 8:45 a.m., she stated the LMA had been left soaking in (name of solution-an enzymatic solution) overnight, and that it was not an acceptable practice.

During a review of the (name of solution) manufacturer's instructions for use, the soaking time stipulated to soak a minimum to two to five minutes. After soaking, the item(s) was to be rinsed thoroughly.

During a review of the LMA's manufacturer's instructions for use, it was indicated that failure to properly clean, rinse and dry a device may result in retention of potentially hazardous residues or inadequate sterilization.

6. On 2/28/17, at 8:50 a.m., a review of the manufacture product description for "(name of solution)", the disinfectant used by the hospital, to disinfect all surgical instruments, was provided by the SC and was reviewed. The document stipulated in bold lettering, "Note: This product is not to be used as a sterilant or high level disinfectant on any surface or instrument that (1) is introduced directly into the human body, either into or in contact with the bloodstream or normally sterile areas of the body, or (2) contacts intact mucous membranes but does not ordinarily penetrate the blood barrier of other wise normally sterile areas of the body." The product description also indicated it was to be used to "clean and disinfect all washable hard non-porous environmental surfaces such as floors, walls woodwork, bathroom fixtures, equipment, and furniture..."

An immediate interview was conducted with the SC who stated she did not know the product she used to disinfect the instruments was not meant to be used for human contact. She also stated that the Infection Control Preventionist (ICP) approved the product. She was asked if the "(name of solution)" product she used in an attempt to wipe off the rust on surgical instruments, was approved to be used for that purpose and stated, it was not.

On 3/1/17, at 2 p.m., the ICP was interviewed and stated she did not approve the (name of solution) and did not know they were using it to clean instruments. She also stated the "(name of solution)" used to polish surgical instruments was not approved by her and it was not meant to be used on surgical instruments.

The product description for "(name of solution)" indicated it was to be used for "automotive trim, silverware, cookware, brassware, marineware ..."

During a review of a hospital policy titled, "Scope of Services - Surgery/Sterile Processing Departments, reviewed 6/7/2016." The policy stipulated, " F. The patient will be free from injury due to chemical, physical or electrical hazard ..."

7. On 2/28/17, at 9:15 a.m., an observation was made of SC's process for cleaning and disinfecting a flexible scope. The following concerns were identified:

a) The cleaning occurred in the same room (OR 2) where procedures were performed.

b) There was no running water in the room.

c) A container was placed on top of a cart, taken out of the room across a restricted area and to a closet to fill with water. The closet was a room where housekeeping kept supplies. The closet contained a sink with black, brown particles and staining and the closet floor contained black, brown, and white particles and staining.

d) The cart was taken back into OR 2 and SC proceeded to perform a leak test on the scope. The leak test equipment was on top of a cart that also contained a container filled with multiple clean scope adapters/accessories. The dirty scope was also placed on top of the cart during the leak testing.

e) The scope was then placed into a bin filled with water and SC proceeded to wipe and clean the scope. It was noted that not all channels/valves (biopsy valve) of the scope were flushed.

f) SC proceeded to take the scope into sterile processing where a scope processor machine is kept.

g) Also identified during the procedure was an opened scope storage cabinet.

The SC stated they have no other areas in the hospital where they can perform cleaning and disinfection of scopes.
A review of a hospital policy titled, "Cleaning, Disinfection and Sterilization of Flexible Endoscope Equipment, revised 11/5/15" was conducted. The policy stipulated the following: "Endoscopy instruments are taken to the sub sterile/cleaning room via water proof containers and disassembled and cleaned as soon as possible after use ..." "Flush an enzymatic cleaner/detergent through the channels and repeat several times ..." "Thoroughly clean the internal channels, valves, and biopsy caps with an endoscopic cleaning brush ..."

According to an earlier interview with SC, on 2/27/17, she stated the hospital followed infection control standard guidelines from AORN Association of periOperative Registered Nurses - the leader in advocating for excellence in perioperative practice and healthcare), AAMI (Association for the Advancement of Medical Instrumentation - an organization for advancing the development, and safe and effective use of medical equipment), CDC (Centers for Disease Control and Prevention - the leading national public health institute of the United States) and manufacture guidelines.

According to CDC guidelines for cleaning and disinfection of scopes, indicates to immerse endoscope in high-level disinfectant (or chemical sterilant) and perfuse (eliminates air pockets and ensures contact of the germicide with the internal channels) disinfectant into all accessible channels, such as the suction/biopsy channel and air/water channel ...

8. On 2/28/17, at 9:15 a.m., during an observation of SC's process for cleaning and disinfecting a flexible scope. The following concern was identified:

The leak test equipment was on top of a cart that also contained a container filled with multiple clean scope adapters/accessories. The dirty scope was also placed on top of the cart during the leak testing.

During an immediate interview, SC stated the clean accessories are stored in the box on top of the cart where leak testing of dirty scopes is performed. SC also stated they will relocate them because there is a potential for cross contamination.

A review of the flexible scope's manufacture manual, provided by the hospital, stipulated, " CAUTION: Store the endoscope and accessories in an endoscope storage cabinet which also protects the equipment from physical damage..."

According to AORN guidelines, flexible endoscopes should be stored with all valves open and removable parts detached and stored with the endoscope. The endoscope should be clearly identifiable clearly identifiable as processed and ready for use with a distinct visual cue.

9. On 2/28/17, at 9:15 a.m., an observation in OR 2, while SC was cleaning a scope, it was noted that an opened flexible storage cabinet (with a rolling top door) was located in a room where patient procedures are performed and is also used for cleaning and disinfecting dirty flexible scopes. There were approximately 6 scopes stored without the accessories
.
An immediate interview with SC was conducted who stated, the cabinet was not a drying cabinet and did not provide high-efficiency particulate arrestance (HEPA) filtered air. SC stated the cabinet was supposed to remain closed.

Also observed were black particles at the bottom of the storage cabinet.
SC stated they cleaned the cabinet when needed but they did not have a regular cleaning schedule or documentation to show when it was cleaned. The scopes did not contain labels or written documentation to indicate if they were cleaned.

According to SC, they were all cleaned and the scopes that had not been used in some time would get reprocessed (no evidence was provided to validate the statement). In addition, she stated they did not need to be labeled because she knew when they were cleaned or needed to be reprocessed.

A review of the flexible scope's manufacture manual, provided by the hospital, stipulated,"WARNING: Proper storage procedures are as important as proper reprocessing procedures in maintaining good infection control practices. Be sure that the endoscope storage cabinet is properly maintained, clean dry and well ventilated ...Keep the cabinet doors closed to protect the equipment from environmental contaminants and accidental contact. Limit access to stored equipment by unauthorized personnel ..."

According to an earlier interview with SC, on 2/27/17, she stated the hospital followed infection control standard guidelines from AORN, AAMI, CDC and manufacture guidelines.

According to AORN, storage of flexible endoscopes should be stored in a manner that minimizes their contamination and protects them from damage. Personnel should store the endoscope in a closed cabinet with high-efficiency particulate arrestance (HEPA) filtered air that provides positive pressure and allows air circulation.

According to AORN guidelines, flexible endoscopes should be stored with all valves open and removable parts detached and stored with the endoscope. The endoscope should be clearly identifiable clearly identifiable as processed and ready for use with a distinct visual cue.

10. During a review of 4 of 4 hospital policies from 2/27/17 to 3/1/17, it was identified the policies did not pertain to the hospital practices. The following concerns were identified:

a) A policy titled, " Cleaning, Disinfection and Sterilization of Flexible Endoscope Equipment, revised on 11/5/15," indicated the endoscopes are cleaned in a "sub sterile/cleaning room" however; the hospital cleans the endoscopes in a patient procedure room.

b) A policy titled, "Decontamination and processing of Reusable Items, revised on 1/14/13," indicated, "The work flow in the Sterile Processing Department is designed to separate dirty and clean areas to limit environment contamination and bioburden on items to be sterilized."

During an observation, it was noted that the hospital sterile processing area also contained a scope processor for cleaning scopes.

The same policy also indicated, "The Decontamination area is separated from other areas of the Sterile Processing Department ..." However, during observation, it was identified that the decontamination room was within the same proximity as OR rooms and sterile processing.

During a review of a hospital policy titled, "Scope of Services - Surgery/Sterile Processing Departments, reviewed 6/7/2016. "The hospital policy indicated, that cleaning and decontamination of instruments were specific to this hospital's sister facility. There was no evidence to show the policy was developed to guide staff manually wash instruments. The policy addressed using a washer, which this hospital did not have.

A review of policy, "Environmental Cleaning of the Surgical Practice Areas, revised on 7/21/11," showed no documented evidence to indicate it was developed for the hospital.

During multiple interviews throughout the survey, from 2/2717 to 3/1/17 with the SPM, she stated they did not have a specific policy for manually washing instruments (this facility's practice) and the current policy was specific to the sister facility's practice. She also indicated all the policies were general policies, developed for the "system" (which included another hospital under a separate license).

11. During multiple observations, of the hospital decontamination room and sterile processing areas, from 2/27/17 to 3/1/17, after various conditions were observed in the decontamination room, the SC and SPM were asked to produce documented evidence of terminal cleaning being performed in the decontamination room and sterile processing areas.

On 3/1/17 at approximately 2 p.m., the SPM was reminded that evidence of terminal cleaning being performed in sterile processing department was not provided. SPM stated they did not have a policy and had no logs to show terminal cleaning was being performed.

AORN, infection control standards the hospital followed, defines terminal cleaning as "thorough environmental cleaning that is performed at the end of each day when the area is being used." Both AORN and AAMI (Association for the Advancement of Medical Instrumentation) ST79 recommend that sterile processing be terminally cleaned the same as the operating, delivery, and invasive procedure rooms. AAMI ST79 (Section 3.4) states that the best practice is to provide separate housekeeping facilities for the decontamination and clean areas to avoid transferring contaminates from "dirty to clean" areas. AORN recommends that terminal cleaning and disinfection of the sterile processing areas "be performed daily when the areas are being used."

According to AORN's "Recommended practices for environmental cleaning in the perioperative setting ...The patient should be provided a clean, safe environment. Maintaining a clean environment for patient care reduces the risk of exposing patients and personnel to potentially infectious microorganisms by removing dust and debris that can accumulate during the day. Cleaning between procedures in combination with terminal cleaning at the end of the scheduled procedures ensures a complete cleaning process and protects everyone from infectious microorganisms."

12. During observations on 2/27/17 and 2/28/17, wired brushes and one plastic brush were observed hanging from a wall above a sink used for cleaning dirty surgical instruments. One wired brush contained a piece of brown particle matter. The SC did not know what the matter was. A request was made to produce a policy or manufacture guidelines on the cleaning of the brushes and to verify if the brushes were reusable.
After multiple requests, the hospital was unable to produce documented evidence that the brushes used to clean patient surgical instruments/equipment were reusable.

13. During a review on 2/28/17, at 10:10 a.m., of the SC's and the ICP's employee files, it was identified that their job descriptions did not contain the name of the hospital being surveyed. The employer name on the job descriptions was of a "System" organization.

During an immediate interview with the HR Manager, she stated the hospital's name does not appear on their files because they are employed by the hospital's "system" who also have authority over a "sister" hospital under a separate license. According to the HR Manager, there were no other files.

14. During an observation on 2/28/17, at 8:45 a.m., in the decontamination room, an LMA was left soaking in an uncovered container of fluid.

During a concurrent interview, on 2/28/17, at 8:45 a.m., SC indicated the LMA had been soaking in (name of solution-an enzymatic solution) overnight, and this was not her usual practice. She was uncertain how long it had been soaking.

During a review of the LMA manufacturer's instructions for use, on 2/28/2017, the soaking time was a minimum of 2 to 5 minutes. After soaking, the LMA was supposed to be rinsed thoroughly.

During a review of the LMA's manufacturer's instructions for use, on 03/02/17, it was indicated that failure to properly clean, rinse and dry a device may result in retention of potentially hazardous residues or inadequate sterilization.

According to SC, no policy was developed for the cleaning of the LMA.

15. Review of the employee personnel f

Based on observation, interview, and record review, the facility failed to ensure patient needs were met when:

1. Continuous cardiac monitoring by qualified staff was not provided as ordered for four of four patients (Patients 11, 12, 13, and 14) with physician's order for telemetry (monitoring done using a device worn by a patient which transmits the heart's electrical activity waveform to a monitoring station screen where healthcare worker at the station constantly checks the information looking for problems or changes in how the heart is beating).

2. Patient 28 was placed in (name of) hand-control mitten restraints (device which restricts movement) without a physician order, and indicated restraint assessments were not documented.


3. RASS (Richmond Agitation Sedation Scale, assessment used to evaluate level of sedation and titrate sedative infusions such as propofol) assessment and documentation was not provided as indicated, for Patient 28.

Thus not meeting the immediate needs of the patients under the care of hospital staff.

Findings:

1. The facility policy and procedure titled "Cardiac Monitoring Continuous and Intermittent", dated 3/12/13, indicated, in part, "Cardiac monitoring allows observation of the heart's electrical activity in patients with symptomatic arrhythmias or any cardiac abnormality that might lead to arrhythmias. It can also be used to evaluate effects of therapy. Telemetry monitoring allows continuous cardiac monitoring of an ambulatory patient by a small transmitter worn by the patient that sends cardiac impulses to a monitoring screen by radio waves."

The facility policy and procedure titled "Cardiac Telemetry Admission, Transfer/Discharge and Triage Criteria" dated 3/12/13, indicated, "The Cardiac Telemetry Unit requires the following patient monitoring capabilities: Continuous cardiac monitoring."

During an observation of the ICU (Intensive Care Unit) department, on 2/27/17, at 10:10 a.m., both nurses on duty were in patient rooms and there was no staff at the cardiac monitor station.

During an observation and concurrent interview with the licensed nurse (RN 2), in the ICU (Intensive Care Unit) department, on 2/28/17, at 9:40 a.m., four patients were observed to be in the ICU with two nurses, there were eight cardiac rhythms visible on the monitor screen. No staff was observed near the cardiac monitor screen. Yards of paper rhythm strips (strips which print automatically when the monitor alarm is triggered) were piled on the station desk beside the printer. RN 2 indicated she was assigned care of two patients, but had to watch eight patients on the monitor.

During an interview with a licensed nurse (RN 2), on 2/28/17, at 9:40 a.m., she indicated that on the night shift, the facility had two nurses on duty with no monitor technician. The ICU nurses were responsible for both their own ICU patient's care and the continuous cardiac monitoring of telemetry patients admitted to the medical/ surgical unit.

During an interview with a licensed nurse (RN 2), on 2/28/17, at 2:25 p.m., she indicated she was alone in the ICU; her co-worker had gone on a break. She was currently responsible to care for four ICU patients as well as three telemetry patients' cardiac monitoring.

During an interview with the house supervisor (RN 7), on 2/28/17, at 2:50 p.m., she confirmed ICU nurses were typically responsible to also provide continuous cardiac monitoring for telemetry patients while providing bedside care to their assigned ICU patients.

During an interview with the Director of Nursing (DON), on 2/28/17, at 10:40 a.m., he indicated the ICU nurses were assigned continuous cardiac monitoring of telemetry patients as well as bedside care for up to two ICU patients each.

2. Review of the manufacturers insert instructions for "(name of) Hand Control Mitts", dated 2014, indicated, in part, "Federal law (USA) restricts this device to sale by or on order of a physician....Staff must have on going training and be able to demonstrate competency to use this device in accord with: (name of) instructions, your facility policies and state and federal regulations (Federal Register, Part IV, 42 CFR Part 482.13(e)(5)."

Federal Register, Part IV, 42 CFR Part 482.13(e)(5), indicated, "The use of restraint or seclusion must be in accordance with the order of a physician or other licensed independent practitioner who is responsiblefor the care of the patient as specifiedunder § 482.12(c) and authorized to order restraint or seclusion by hospital policy in accordance with State law."

During an interview on 3/2/17, at 9:30 a.m., a licensed nurse (RN2) indicated facility nurses are prompted electronically to do a restraint assessment and document in the computer every two hours. A new physician's order was required each day for patients to be restrained. She indicated (name of) hand-control mitten restraints, were called "activity mittens" at the facility, staff were putting the (name of) hand-control mitten restraints on patients without a physician's order with "no need for restraint documentation."

During an interview on 3/2/17, at 9:45 a.m., a licensed nurse (RN 8) indicated (name of) hand-control mitten restraints, called "activity mittens" were used by staff to limit patient's ability to pull at lines. Staff "don't have to do the restraint documentation. No order needed."

The facility policy and procedure titled "Restraint Management" dated 12/15/16, indicated, "Definitions: A restraint is any manual method or physical or mechanical device that immobilizes or reduces the ability of a patient to move his or her arms, legs, body, or head freely or a drug or medication when it is used as a restriction to manage the patient's behavior or restrict the patient's freedom of movement and is not a standard treatment or dosage for the patient's condition."

During an interview with the director of nursing (DON), on 3/2/17, at 10:05 a.m., he indicated the nurses were not assessing and documenting on (name of) hand-control mitten restraints because the (name of health system) which included the sister hospital (name of sister facility) in Ventura, CA policy did not consider them restraints.

During review of the electronic medical record for Patient 28 and concurrent interview with the Infomatics nurse (ADM 6), on 3/2/17, at 11:20 a.m., ADM 6 indicated documentation was incomplete. Restraints were applied in the emergency department (ED), the type of restraint or restraint assessment was not documented during the patient's stay in the ED. On arrival to the ICU the patient was noted to be "anxious, difficulty coping, disassociated thought process." On 1/10/17, the physician ordered vest restraint, but nursing notes indicated both vest and (name of) hand-control mitten restraints were applied.

3. The facility policy and procedure titled "Awakening and Breathing Coordination/Choice of Sedation, Delirium Monitoring/Management, and Early Mobility (ABCDE Bundle) Guidelines" dated 6/4/13, indicated,
"Delirium Monitoring and Management A. Every patient admitted to an adult ICU will undergo routine sedation and delirium assessment using standardized validated assessment tools. "RN will perform and record the results of the Richmond Agitation and Sedation Scale (RASS) every 2 hours with Vital Signs.Documentation: (Meditech or flowsheet)."

Attachment to above policy, dated 3/17/16, indicated "RASS Documentation. Documentaion of the RASS is to be done on ALL sedated ventilated and non-ventilated patients."

Review of the clinical record indicated Patient 28 was admitted to the intensive care unit with multiple medical issues including delirium (temporary mental disturbance state marked by extreme restlessness, confusion, and sometimes hallucinations).

The Medication Orders, dated 1/10/17, indicated, propofol (an intravenous medication used for anesthesia and sedation) intravenous infusion was to be titrated with a target RASS score of two (a RASS score of two indicates light sedation).

Nursing Notes, dated 1/10/17, at 12 noon, indicated Patient 28 was intubated (a breathing tube was placed into her trachea, allowing for mechanical ventilation) and was on a ventilator (respirator) and was sedated with propofol infusion.

Review of the electronic medical record for Patient 28, and concurrent interview with the Director of Nursing (DON) and the Infomatics nurse (ADM 6), on 3/2/17, at 3:10 p.m., revealed RASS assessment was first documented using standardized validated assessment tool, at 1/11/17, at 7 p.m., over twenty-four hours after the propofol infusion was started, and thereafter was not consistently performed and documented every 2 hours per policy.

1. Based on observation, interview, record review, and facility document review, the facility failed implement approved policies and procedures on the insulin (a medication used to treat high blood sugars) administration. This occurred when one of one patient (Patient 13) was observed administered insulin outside of the time frame listed in the policy.

This failure had the potential to result ineffective blood sugar management.

2. Based on interview, clinical record review, facility document review, and facility policy review, the facility failed to implement standards of practice of monitoring for one of one patients (Patient 29) who was administered intravenous (IV-administered through a patient's vein) vancomycin (an antibiotic medication which requires close monitoring to achieve desired therapeutic effects while protecting from adverse health consequences such as drug toxicity) to prevent decline in Patient 29's kidney function when the patient transferred from inpatient (hospital level of care) to swing-bed (skilled nursing level of care). This occurred when the IV vancomycin medication order was continued after transfer without clarification of which health care professional (pharmacy or physician) was monitoring the patient's vancomycin regimen. Patient 29, who had a recent history of acute (condition of patient requires hospitalization) kidney injury was administered IV vancomycin without monitoring the patient's serum creatinine (lab result to assess renal function) for nine days and without monitoring the patient's vancomycin levels (concentration of drug in the body) for 15 days.

This failure resulted in serious disability and harm, including kidney impairment, transfer to a higher level of care to another facility, a procedure to place a catheter (tube inserted into the body) for hemodialysis (process to mimic normal kidney function to filter blood, chemicals, waste, and fluid), and plan for hemodialysis which the patient could not tolerate when started.

Findings:

1. During a medication pass observation and concurrent interview with Registered Nurse 9 (RN 9), the medication regular insulin was observed to be administered to Patient 13 on 2/28/17 at 8:49 a.m. The electronic clinical record indicated the regular insulin was scheduled for 2/28/17 at 7:30 a.m.

When RN 9 was asked why she administered insulin at 8:49 a.m., RN 9 stated "We are running a little late."

During an interview with the Director of Nursing (DON) on 3/2/17, at 4 p.m., the DON acknowledged the insulin was scheduled for 2/28/17 at 7:30 a.m., and was administered to Patient 13 on 2/28/17 at 8:49 a.m.. DON stated the insulin was administered "outside of the time window."

A review of the electronic clinical record indicated the regular insulin was administered on 2/28/17, at 8:49 a.m.

The facility policy and procedure titled, "Medication Administration" dated 3/1/16, indicated, "Time Critical Scheduled Medications: a. Medications for which an early or late administration of greater than 30 minutes might cause harm or have significant negative impact on intended therapeutic or pharmacological effect, such as: insulin" and "The Time Critical Medications listed above must be administered within thirty (30) minutes before or after their scheduled dosing time, for a total window of one (1) hour."

2. Review of Patient 29's History and Physical (initial clinical evaluation of the patient)" for Admit Date 02/21/2016 was completed by Physician 1 and was electronically signed on 2/24/16. The Past Medical History indicated "History of urinary (urine) retention (holding)." The section titled Impression and Plan indicated "Acute on chronic renal (kidney) failure, resolved."

Review of Patient 29's Note Date: 02/23/16 was completed by Physician 1 and was electronically signed on 2/23/16. The section titled Assessment/Plan indicated "Acute kidney injury. A (Assessment) - On admission Cr (creatinine) 1.4 (reference range is 0.6 to 1.3 milligram (mg) per deciliter (dl)). Improved with diuresis (increased urine production)."

Review of Patient 29's History and Physical for Admit Date: 02/28/2016 was completed by Physician 2 and was electronically signed on 3/1/16. The Chief Complaint (initial reason for seeking medical care)"was listed as "skilled nursing admission for IV antibiotics." The History of Present Illness indicated, "This 80 year old white female was admitted to acute care at (name of facility) on 02/21/2016. She presented with to the emergency department with altered mental status (changes with brain function). She was found in the emergency department to have left lower lobe pneumonia (lung infection) and hypokalemia (low potassium levels) with a potassium of 1.7 (normal range is 3.5 to 5.2 millimoles (mmol) per liter (L)) and with a hemoglobin (part of blood that carries oxygen to body) of 7.3 (normal range for females is 12 to 15 grams (g) per deciliter (dL). She has had recent significant bleeding from varicose veins (enlarged blue blood vessels visible through the skin) in her legs requiring blood transfusion (transfer of blood from one person to another) and has had stasis ulcers (wounds) on her legs due to edema (accumulated fluid), due to her diastolic heart failure (heart pumped out to the body is less than normal). She was treated in the hospital and was found to have pneumonia which improved. She also was found to be bacteremic (bacteria in the blood) with Bacteroides (a type of bacteria) and it has been recommended that she have six weeks of IV antibiotics. Therefore, she is being transferred to the skilled nursing for this treatment."

Patient 29' Home Medications included "She is also on vancomycin dosing per pharmacy." The section titled Assessment and Plan indicated "Acute kidney injury. This has improved." The section titled Plan indicated, "We will admit the patient to Swing Bed for six weeks of IV vancomycin therapy with the dosing per pharmacy...I anticipate that she will be in the Swing Bed or Skilled Nursing for her six weeks of IV antibiotics."

Review of Patient 29's Discharge Summary for "Discharge Date: 03/17/2016" was completed by Physician 2 and was electronically signed on 3/24/16. The Admitting Diagnoses indicated "Acute kidney injury which had improved." The Discharge Diagnoses indicated "Acute renal failure likely due cardiorenal (heart and kidney disorder) failure with possible vancomycin toxicity." The section titled Hospital Course indicated "The patient was admitted to the skilled nursing after an episode of acute renal failure and pneumonia...The vancomycin was started during her acute hospitalization and was monitored by pharmacy...Her kidney function which had been improving started to worsen again, and she was found to be retaining fluid...Her kidney function continued to worsen...Because of her worsening failure that was not responding to either diuretics (treatment to improve diuresis) or IV fluids, it was decided to transfer her to (name of local affiliated hospital) for a nephrology (branch of medicine that deals with kidney disease) consult and possible diuresis to treat her vancomycin levels, her oliguria (production of small amounts of urine), and her kidney failure."

Review of Patient 29's Medicine Admission Note was completed by Physician 8 and electronically signed on 3/17/16. The section titled Assessment indicated "AKI (acute kidney injury) with oliguria most likely secondary (resulting from) to cardiorenal syndrome and vancomycin nephrotoxicity (toxicity in the kidney)."

Review of Patient 29's History and Physical - Admitted: 3/17/16 was completed by Physician 8 and was electronically signed 3/18/16. The Chief Complaint was listed as "worsening renal failure and oliguria." The History of Present Illness indicated "creatinine level has been gradually increasing ...she was transferred to (name of local affiliated hospital) for further evaluation and treatment and possible dialysis." The section titled Assessment indicated "acute kidney injury with oliguria most likely secondary to cardiorenal syndrome and vancomycin nephrotoxicity."

Review of Patient 29's Note Date: 03/18/16 was completed by Physician 3 and electronically signed 3/18/16. The section titled Assessment/Plan indicated "1. AKI (acute kidney injury) A (Assessment): WORSE - has baseline CKD (chronic kidney disease) III (moderate kidney damage) - likely secondary to vancomycin toxicity and cardiorenal syndrome - has not responded to Lasix (a diuretic medication) gtt (medical abbreviation for drip) and oliguric at this point with continued anasarca (generalized body swelling...P (Plan): I have consulted (name of Physician 4) from Nephrology."

Review of Patient 29's Consultation Report-Date of Consultation: 3/18/16 was completed by Physician 4 and was electronically signed on 3/19/16. The section titled Assessment/Plan indicated "acute renal failure in this patient with anasarca. Suspect that patient has a vancomycin toxicity in the setting of a probable (likely to be the case) cardiorenal syndrome. Patient remains oliguric despite aggressive diuretic therapy. Although patient is satting (refers to normal blood oxygen levels) fairly well and the electrolytes are stable, likely we will need to initiate dialysis for volume control. I will contact (name of Physician 6) for vascular (blood vessels) access and proceed with dialysis. Likely patient will need daily dialysis until volume status is optimized and renal function is recovered."

Review of Patient 29's Consultation Report-Date of Consultation: 3/18/16 was completed and electronically signed by Physicians 6 and 7 on 3/19/16. The section titled Assessment/Plan indicated "1. Acute renal failure with anasarca and oliguria...The patient's acute renal failure is considered likely secondary to the vancomycin, with possible additional cardiorenal etiology (cause) contributing. Nephrology has been consulted and the patient will likely require hemodialysis."

Review of Patient 29's "Operation" was completed by Physician 6 and electronically signed on 3/19/16. The "Pre-Operative Diagnosis" was listed as "AKI (acute kidney injury)" and "Procedure Performed ...5. RIJ [right internal jugular vein] temporary hemodialysis catheter placement."

Review of Patient 29's Note Date: 3/19/16 was Physician 7 dictating for Physician 6 who electronically signed the note on 3/19/16. The section titled Assessment/Plan indicated "A (Assessment): AKI (acute kidney injury)...patient requires HD (hemodialysis) access...will place temporary rather than tunneled HD catheter...P (Plan): temporary hemodialysis catheter placement to right IJ this AM (morning) in cath (catheterization) lab...okay to use for dialysis."

Review of Patient 29's "Note: 3/19/16" was completed by Physician 4 and was electronically signed on 3/19/16. The section titled "Assessment/Plan" indicated "AKI (acute kidney injury). A (Assessment): Due to Vanco toxicity in the setting of probable cardiorenal syndrome. BUN (blood urea nitrogen-test to measure kidney function by measuring waste products) and Cr (creatinine) stable from yesterday but remains oliguric despite IV Lasix. P (Plan): Will start HD as previously discussed."

Review of Patient 29's "Note Date: 3/19/16" was completed by Physician 3 and electronically signed on 3/19/16. The "Assessment/Plan" indicated "AKI (acute kidney injury). A(Assessment): WORSE - has baseline CKD III - likely secondary vancomycin toxicity and cardiorenal syndrome - has not responded to lasix gtt and oliguric at this point with continued anasarca - HD catheter Right IJ 3/19 by (name of Physician 6) ...P(Plan): starting HD today 3/19-(name of Physician 4) from Nephrology is following."

Review of Patient 29's "Note Date: 3/20/16" was Physician 7 dictating for Physician 6 who electronically signed the note on 3/20/16. The section titled "Assessment/Plan" indicated "1. AKI (acute kidney injury). A (Assessment): s/p (status post - condition after) R IJ temporary HD catheter placement on 3/19/16 ...P (Plan): ok to use for dialysis."

Review of Patient 29's "Note Date: 3/20/16" was completed by Physician 3 and electronically signed on 3/20/16. The "Assessment/Plan" indicated "1. AKI (acute kidney injury). A(Assessment): WORSE - REQUIRES HD ...has baseline CKD III - likely secondary to vancomycin toxicity and cardiorenal syndrome - has not responded to Lasix gtt and oliguric at this point with continued anasarca - HD catheter Right IJ 3/19 by (name of Physician 6) - started HD night of 3/19 but it was stopped after 23 minutes given symptomatic bradycardia (low heart rate) and hypotension (low blood pressure). P (Plan): will attempt HD again today - if patient cannot tolerate HD then may consider hospice...(name of Physician 4) from Nephrology following...13. P (Plan)-patient is very scared to die ..."

Review of Patient 29's "Notation - Hospital Day 3" was completed by Physician 3 and electronically signed on 3/20/16. The "Notation" indicated "Comfort care as prognosis is dismal ...I (Physician 3) do believe patient is actively dying at this point."

Review of Patient 29's "Notation - Hospital Day 4" was completed by Physician 5 and electronically signed on/21/16. The "Notation" indicated "Called by RN (Registered Nurse) that patient died at 9:10 AM."

A review of the (name of local affiliated hospital)'s "Release of Body" form dated 3/21/16 at 9:10 a.m. indicated "Diagnosis: Vanco (vancomycin) toxicity."

Review of Patient 29's "Discharge Summary" was completed by Physician 3 and was electronically signed on 4/17/16. The "Causes of Death" were listed "1. Cardiovascular collapse; 2. Multisystem organ failure; 3. Acute on chronic kidney disease, presumed cardiorenal syndrome; 4. Systolic congestive heart failure, chronic; 5. Pulmonary hypertension, chronic." The section titled "Brief Hospital Summary" indicated, "This 80-year old female was transferred from (name of facility) on 3/17/16 secondary to worsening renal failure and oliguria. She was seen in consultation by (name of Physician 4) and we were to pursue dialysis. Unfortunately, patient had episodes of bradycardia and hypotension, though at times spontaneously resolve. Unfortunately, she could not tolerate dialysis. Ultimately, she was transitioned to comfort care and patient passed away the morning of March 21st."

Review of the package insert (approved document on the safe use of the medication) obtained from the facility for vancomycin dated 8/14, indicated "ADVERSE REACTIONS ...Nephrotoxicity - Renal failure, principally manifested by increased serum creatinine or BUN concentrations... Most of these have occurred in patients who were given aminoglycosides (a type of antibiotic) concomitantly (at the same time) or who had preexisting kidney dysfunction." The section titled "Patients with Impaired Renal Function and Elderly Patients" indicated, "Dosage adjustment must be made in patients with impaired renal function. In the elderly, greater dosage reductions than expected may be necessary because of decreased renal function. Measurement of the vancomycin serum concentrations can be helpful in optimizing therapy, especially in seriously ill patients with changing renal function."

Review of the "Therapeutic Monitoring of Vancomycin in Adult Patients: A Consensus of the American Society of Health-System Pharmacists, the Infectious Disease Society of America, and the Society of Infectious Diseases Pharmacists" dated 2009, in the section titled "Vancomycin Toxicity" indicated on page 602, "A patient should be identified as having experienced vancomycin-induced nephrotoxicity if multiple (at least two or three consecutive) high serum creatinine concentrations (increase of 0.5 milligram (mg) per deciliter (dL) or >= 50% increase from baseline, whichever is greater) are documented after several days of vancomycin therapy in the absence of an alternative explanation." On page 596, it indicated, "Monitoring is also recommended for patients with unstable (i.e., deteriorating or significantly improving) renal function and those receiving prolonged courses of therapy (more than three to five days) ...Once-weekly monitoring is recommended for hemodynamically [stable blood flow and circulation] stable patients. More frequent or daily trough [lowest concentration of medication in the blood] monitoring is advisable in patients who are hemodynamically unstable."

Review of the "ASHP (American Society of Health-System Pharmacy) Guidelines: Minimum Standard for Pharmacies in Hospital" dated 2013, on page 523 in the section titled "Continuity of Care" indicated "Pharmacists should assume responsibility for continuity of care patients' medication therapy. Pharmacists and pharmacy departments should take a leadership role in developing and implementing policies and procedures for admissions, discharges, and transfers sot that patients' medication therapy is well managed regardless of patient transitions across care settings ..."

The facility policy and procedure titled, "Pharmacokinetic (evaluation of how the specified medication(s) is absorbed, distributed, metabolized, and excreted in the patient's body) Monitoring" dated 5/6/13, indicated "POLICY ...The Pharmacy will assist in the determination of a proper dosing regimen with the final decision being that of the physician."

During an interview on 1/31/17, at 2:35 p.m.,with the Clinical Informatics Manager (ADM 7) and Vice President Quality (ADM 27), ADM 7 stated "the error primarily was when physician wrote order but not for pharmacy to dose and check level from 2/28 to 3/11/16." ADM 7 and ADM 27 acknowledged that there were no labs for Patient 29 between 3/2 to 3/9/16.

During electronic clinical record review and concurrent interview on 3/6/17 at 8:15 a.m. with the Director of Pharmacy (DOP), the facility's Pharmacist-In-Charge (PIC), and the Medication Safety Coordinator (MSC), Patient 29's vancomycin regimen was reviewed. The clinical record indicated the patient was admitted to inpatient status on 2/21/16. For the inpatient admission, the clinical record indicated on 2/23/16 at 2:54 p.m., Physician 1 ordered IV vancomycin "pharmacy to dose." The clinical record indicated the patient was discharged from inpatient status and was admitted to swing-bed care on 2/28/16. For the swing-bed admission, the clinical record indicated on 2/28/16, at 9:30 a.m., Physician 1 ordered IV vancomycin 1 gram every 24 hours until 4/7/16. The clinical record indicated the patient was discharged from swing-bed care on 3/17/16, and transferred to a local affiliated hospital for a higher level of care. The electronic clinical record indicated the following measured serum creatinine while the patient was in swing-bed care: 3/1/16 = 0.8 mg/dl; 3/10/16 = 1.5 mg/dl; 3/12/16 = 1.7; 3/13/16 at 5:30 a.m. = 1.8 mg/dl; 3/13/16 at 12:30 p.m. = 1.9 mg/dl; 3/14/16 = 1.8 mg/dl; 3/15/16 = 1.9 mg/dl; 3/16/16 = 2 mg/dl; and 3/17/16 = 2.1 mg/dl. While the patient was in swing-bed care, the time period calculated between first (3/1/16) and second (3/10/16) measured serum creatinine was 9 days. The electronic clinical record indicated the followed measured vancomycin trough levels (target reference range is 10 - 20 mg/liter (L)) while the patient was in the facility: 2/26/16 = 14 mg/L; 3/12/16 = 41 mg/L; 3/13/16 = 43 mg/L; and 3/17/16 = 32 mg/L. The time period calculated between the first (2/26/16) and second (3/12/16) measured vancomycin troughs was 15 days. When the PIC was asked how the patient's renal function was evaluated while on vancomycin regimen, the PIC stated "through the serum creatinine." The PIC acknowledged there was no serum creatinine measured from 3/2/16 to 3/9/16. When asked about the time period between 2/26/16 to 3/12/16 measured vancomycin troughs, the PIC stated "14 - 15 days." The PIC stated there was no "pharmacy to dose" vancomycin order when the patient transferred to swing-bed care. She acknowledged the 2/28/16 vancomycin order from Physician 1 when the patient transferred from inpatient to swing-bed care, it was not clear if it was Pharmacy or the Physician following the vancomycin regimen. When asked "what are risk factors for vancomycin toxicity?" the PIC stated "renal function problems." She acknowledged the "PK (Pharmacokinetic) Monitoring Sheet (facility document to evaluate Patient 29's vancomycin dosing, frequency, renal function, and vancomycin levels)" was being filled out by Pharmacist 2 and the PIC while the patient was under the facility's care. She acknowledged that Pharmacist 2 and the PIC could visualize on the "PK Monitoring Sheet" when the last serum creatinine was collected when completing the "PK Monitoring Sheet."

During an interview on 3/6/17, at 11:20 a.m., with the PIC, the PIC was asked, "What do you think about continuity of care as described in ASHP Guidelines: Minimum Standard for Pharmacies in Hospital?" the PIC stated, "I agree. Pharmacy should be involved in the transitions of care." The PIC stated for patient safety, it should be clarified who is responsible for vancomycin regimen.

During a group interview on 3/6/17, at 1:37 p.m., with Physician 2, she stated she was "under the assumption that Pharmacy was managing" vancomycin regimen when Patient 29 transferred to swing-bed care.

During an interview on 3/6/17, at 3:30 p.m., with the DOP, PIC, and MSC, the group was asked "What is your understanding about the risk of nephrotoxicity with respect to patients on vancomycin as described in the vancomycin package insert?" the DOP stated there is higher possibility if renal function is compromised to start.

Based on record review and interview, the facility failed to ensure care plans were developed for three sampled patients (Patient's 7, 20, and 21) undergoing outpatient surgical procedures.

Failure to develop care plans may result in patients not receiving comprehensive care, further compromising medical status.

Findings:

The facility policy and procedure titled, "Nursing Documentation - Including Admission, Shift, Plan of Care, and Discharge", dated 5/11/2015, indicated, "All patients who receive care at (name of facility) Health System are assessed by qualified individuals to determine patient's immediate and emerging needs...Collection of data will be systematic, continuous, and include assessments and reassessments by various professional disciplines. Problem statements or Nursing Diagnosis, Patient Outcomes (Goals) and Nursing Interventions are developed by this documentation and incorporated into the Plan of Care...A registered nurse plans the patient's nursing care and nursing goals. The plan of care is individualized and personalized to meet the needs of the patient...the admitting RN is responsible for interpreting the data collected, identifying patient care needs, initiating the individualized Plan of Care, including referral to other disciplines as needed for further assessment."

1. A review of Patient 7's clinical record revealed Patient 7 was admitted to the acute hospital for an outpatient epidural (procedure to treat spinal nerve irritation that is most often caused by tissues next to the nerve pressing against it) procedure on 2/28/17. Patient 7 received medications before the procedure to cause a state of moderate sedation (the administration of central nervous system depressant drugs and/or analgesics to provide analgesia, relieve anxiety, and/or provide amnesia during surgical, diagnostic, or interventional procedures. Consciousness is depressed, and the patient may fall asleep but is not unresponsive. Over sedation or an adverse patient response to sedation may result in life-threatening complications such as hypotension, loss of airway reflexes, inability to maintain a patent airway, hypoventilation, apnea, or agitation and movement at a critical point in the procedure. Anesthetic monitoring during conscious sedation includes at a minimum monitoring of blood pressure, electrocardiography, and pulse oximetry). There was no care plan found anywhere in Patient 7's clinical record to address any possible post procedure complications.

2. A review of Patient 20's clinical record revealed Patient 20 was admitted to the acute hospital for an outpatient epidural procedure on 2/28/17. Patient 20 received medications before the procedure to cause a state of moderate sedation. There was no care plan found anywhere in Patient 20's clinical record to address possible post procedure complications.

3. A review of Patient 20's clinical record revealed Patient 21 was admitted to the acute hospital for an outpatient epidural procedure on 2/28/17. Patient 20 received medications before the procedure to cause a state of moderate sedation. There was no care plan found anywhere in Patient 20's clinical record to address possible post procedure complications.

In an interview with a licensed nurse (RN 6) on 2/28/17, at 2:30 p.m., RN 6 indicated there were no care plans put in place for any short stay outpatients unless they were staying in the facility overnight. RN 6 confirmed there were no care plans in the clinical records for Patient's 7, 20, and 21. RN 6 agreed care plans should have been put in place since all three patients had received medications which had the potential to affect their airway.

Based on interview and clinical record review, medical staff members failed to review physician assistant (PA) and a terminated physicians patient encounters, to review outstanding medical orders and other medical care referrals provided to one patient (Patient 1) in the outpatient clinic.

This lack of oversight resulted in Patient 1 not being referred to specialist care in a timely manner, and has the potential to lead to substandard patient care and could put patients at risk of poor outcomes.

Findings:

During a concurrent record review and interview with Adm 1 on 2/27/17, at 10:30 a.m., the clinical record of Patient 1 indicated Patient 1 was seen by her primary care physician (PCP) on 7/8/16, her PCP ordered a referral for a sleep study (a study to determine if there is a physiological basis for a sleep disorder) secondary to Patient 1's complaints of anxiety, insomnia and morbid obesity. On this same day, Patient 1's PCP wrote an order for a referral for Patient 1 to be seen by a pulmonologist (a medical doctor who focuses on the respiratory system) due to complaints of shortness of breath at rest. Further record review did not reveal referrals were processed for Patient 1.
Adm 1 stated, "We had problems with this physician and we fired her and we deleted some of the referrals." When asked if another physician or PA had reviewed the referrals prior to deleting them, Adm 1 stated, "Sometimes the physician director did." Adm 1 could not identify if Patient 1's referrals were reviewed by the physician director prior to deleting, stating, "I don't know, I think there would have been some documentation." Further record review of visits for Patient 1 to the clinic after 7/8/16, did not reveal MD or PA clinical review for canceling referrals. There was no documentation indicating Patient 1 had been notified that referrals were no longer being processed. Adm 1 stated, "We just put them (referrals) into a delete file."

Based on observation, interview, and document review, the hospital falied to ensure surgical services met the needs of surgical patients, as evidenced by the following failures:

1. The hospital did not have a method for determining the temperature levels in their sterile storage room or decontamination room (Refer to C-0278)

2. The hospital did not have a method for determining the humidity level in their decontamination room or sterile storage room (Refer to C-0278).

3. The processing and sterilization of surgical equipment and devices did not follow nationally accepted standards when the hospital failed to ensure there was no presence of spotting and staining on two of two processed surgical trays (previously cleaned, disinfected and sterilized surgical instruments) (Refer to C-0278).

4. The facility failed to provide and maintain a sanitary environment to avoid sources and transmission of infections, when they failed to ensure their sterile processing area was clearly separate from dirty items (Refer to C-0278).

5. The hospital failed to produce infection control policies which were specifically developed for the hospital's surgical department. (Refer to C-0278).

6. The hospital failed to ensure the surgical department staff used approved cleaning products to clean surgical instruments (Refer to C-0278).

7. The hospital failed to ensure the decontamination room door remained closed at all times (Refer to C-0278).

8. The hospital failed to ensure the decontamination room was equipped to safely clean and disinfect dirty surgical instruments in accordance with infection control standards (Refer to C - 0278).

9. The hospital failed to ensure all surgical instruments were in the open position during sterilization, in accordance with infection control standards (Refer to C - 0278).

10. The hospital failed to ensure gastrointestinal (GI) scopes were cleaned and high level disinfected in accordance with IC standards and in a manner to prevent cross contamination (Refer to C - 0278).

11. The hospital failed to ensure the GI scope cabinet was in compliance with infection control standards and in a manner to prevent cross contamination (Refer to C - 0278).

12. A surgical coordinator did not wear proper personal protective equipment during cleaning and disinfecting surgical instruments (Refer to C - 0278).

13. Sterile supplies were not stored in a climate control area (Refer to C - 0278).

14. There was no evidence to demonstrate infection control practices and surgical instrumentation processing staff had oversight, to ensure high level disinfecting and sterilization of instrument practices were performed in a manner to prevent cross contamination (Refer to C 0278).

15. There was no evidence to demonstrate the hospital's decontamination room and sterile processing room were terminally cleaned (Refer to C - 0278).

16. The accessories/removable parts from the GI scopes were not stored in a manner to prevent cross contamination and in accordance with IC practices (Refer to C - 0278).

17. A laryngeal mask airway (LMA) was left in an opened container and soaking overnight in the decontamination room (Refer to C -0278).

18. Brushes used to clean surgical instruments/equipment were left out, uncovered in the decontamination room and the surgical staff were unable to provide evidence to indicate they were reusable and they were unable to provide cleaning guidelines/recommendations for the brushes (Refer to C - 0278).

19. Job descriptions for the Infection Control Preventionist (ICP) and a Surgical Coordinator (SC) and did not indicate they were employed by the hospital (Refer to C - 0278).

The cumulative effect of these systemic problems resulted in the inability of the hospital's surgical services to ensure safe care in accordance with acceptable standards of practice, placing surgical patients at risk for post-surgical infections.

Immediate Jeopardy
On 2/27/17, at 2:50 p.m., an Immediate Jeopardy (IJ) was declared after the team identified, through observations, interviews, and record reviews, a pattern of ineffective infection control practices, in the surgical services department. The hospital failed to protect all patients requiring surgical services from the potential of nosocomial infections and failed to provide surgical services in a well-organized manner and in accordance with acceptable infection control (IC) standards of practice.

On 2/27/17, at 4:25 p.m., the hospital's Vice President of Quality and the Chief Administrator Officer (CAO) provided the team an acceptable corrective action plan to lift the immediacy of the IJ. On 3/1/7, at 5:10 p.m, the immediate jeopardy was abated, after the team validated, through observations, interviews, and record reviews, the hospital's directive action plan. The IJ was abated in the presence of the Vice President of Quality and the CAO.

Findings:

On 2/27/17, at 9:20 a.m.., during a tour of the hospital's surgical services department, the following were observed:

a) The hospital did not have a method for determining the temperature levels in their sterile storage room or decontamination room.

b) The hospital did not have a method for determining the humidity level in their decontamination room or central sterile room where surgical instrument sterilization/processing was performed.

c) Two of two (one major and one minor) processed surgical trays (previously cleaned, disinfected and sterilized surgical instruments) contained more than half (each tray) surgical instruments with brown spotting and staining that was easily removed when wiped.

d) The sterile processing area was used to sterilize surgical instruments and to wash/process dirty scopes.

e) A surgical coordinator used cleaning supplies which were not meant or approved to be used on any surface or instruments that are introduced directly into the human body.

f) The decontamination room door remained open throughout survey.

g) The decontamination room contained one small sink which was cracked in the inner basin and patched with a product that was peeling.

h) 12 out of 80 surgical instruments which had been previously sterilized, in a major tray, were in an open position during sterilization and 15 out of 69 surgical instruments in a minor tray were in the open position during sterilization.

i) Gastrointestinal (GI) scopes were cleaned and high level disinfected in a operating room (OR 2) which was used to perform GI procedures.

j) The GI scope cabinet, used to store clean scopes was stored in OR 2 during GI procedures and during cleaning of scopes. The cabinet also did not contain a HEPA filter and was not properly vented.

k) The surgical coordinator did not wear proper personal protective equipment during cleaning and disinfecting surgical instruments.

l) Sterile supplies were stored in a non-climate control area (staff office and sterile processing room).

m) It was determined that there was no evidence to demonstrate infection control practices and surgical instrumentation processing staff had oversight, to ensure high level disinfecting and sterilization of instrument practices were performed in a manner to prevent cross contamination.

n) There was no evidence to demonstrate the hospital 's decontamination room and sterile processing rooms were terminally cleaned.

o) The accessories/removable parts of the GI scopes were not stored in a manner to prevent cross contamination and were left in an open container on top of a cart used to clean GI scopes.

p) A laryngeal mask airway (LMA) was left in an opened container and soaking overnight in the decontamination room.

q) Brushes used to clean surgical instruments/equipment were left out, uncovered in the decontamination room and the surgical staff were unable to provide evidence to indicate they were intended to be reusable and were not able to provide cleaning guidelines/instructions for the brushes.

Based on staff interview and review of administrative records, policies and procedures, contracts, facility logs, inspection records, infection control and quality assurance documentation, it was determined the critical access hospital had failed to develop, implement, and maintain effective, ongoing, data driven, hospital wide periodic evaluation and quality assurance review, that incorporated infection control issues (Refer to C-0278) and patient safety issues (Refer to C-0222, C-0272, and C-0294). The facility policy titled "Quality Management, Performance Improvement and Patient Safety Plan" with a review date of April 2016 stated all departments will be responsible for identifying critical issues within their area. No documentation was available indicating the facility's quality department had considered the infection control issues that resulted in an immediate jeopardy on 02/27/2017 or the nursing issues which resulted in an immediate jeopardy on 2/28/2017. In an interview on 3/07/2017 at 3:30 p.m. ADM 11 and ADM 44 stated they were not aware of the issues prior to the immediate jeopardy being called by CDPH.

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

Based on interview and record review, the facility failed to assure that three patients (Patients 5, 6, and 26), admitted to "swing bed" status, received a comprehensive activities assessment.

This failure has the potential of impeding progress towards reaching the patient's highest practicable level of physical, mental and psychosocial well-being.

Findings:

During an interview with Patient 26, on 3/1/17, at 3 p.m., Patient 26 was asked about the activities program being provided, Patient 26 stated, "Not sure what you are talking about." Patient 26 indicated he was not aware of desired indivulized activities that were discussed.

During an interview with Patient 6, on 3/1/17, at 3:45 p.m., when asked about facility activities, Patient 6 stated, "I was given a calendar to attend, but I haven't felt like it physically." Patient 6 did not recall given other opportunities or being asked.

During a concurrent interview and record review with Adm 3 on 3/1/17, at 2:55 p.m., while reviewing Patient 5, 6, and 26 activities assessments conducted by activities director (Adm 2), the assessments indicated that introductions were made and activities calendar was given. Adm 3 acknowledged documentation did not reflect a comprehensive individualized patient assessment.

During a concurrent policy review and interview with Adm 2, on 3/2/17, at 9:05 a.m., when asked what the process was to do swing bed patients activity assessments, Adm 2 indicated she is stationed at the distinct part skilled nursing facility (DP/SNF) and when she is notified of an admission, she approaches the patient, introduces herself and leaves an activity calendar with the patient, telling the patient they are welcome to come to any of the activities, and that the patient should notify the nursing staff and the nurses will transport the patient to the DP/SNF to attend. Asked if Adm 2 conducts a comprehensive activities assessment of the swing patients, Adm 2 stated, "No, not what I would identify as comprehensive." While concurrently reviewing policy titled, "Activities Program and Scope," last reviewed 2/6/12, the policy indicated it applies only to DP/SNF, Adm 2 acknowledged policy and procedure was not being applied to the swing bed population. Adm 2 stated, "This is used with the SNF (DP/SNF) residents where I have a whole check list and try and really narrow down what the resident's interest are, but I haven't been doing that at the swing beds."