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

1. Properly identify complaints that required the grievance process to be followed (Refer to A118);

2. Ensure the Governing Body took responsibility for the effective operation of the grievance process (Refer to A119);

3. Review, investigate, and respond to grievances in a timely manner (Refer to A122 and A123);

4. Adequately inform patients about their medical care prior to making decisions and giving consent for treatment (Refer to A131);

5. Properly identify restraints that required the restraint process to be followed (Refer to A159);

6. Ensure patient care plans were updated when restraints were applied (Refer to A166);

7. Ensure restraints were applied and continued in accordance with physician's orders (Refer to A168 and A171);

8. Assess, reassess, and monitor patients in restraints to ensure their use was necessary, safe, and effective (Refer to A175 and A179); and,

9. Provide adequate education to staff using a bed with a canopy and mattress system that acted as a restraint to keep the patient from getting out of bed (Refer to A194).

The cumulative effect of these systemic problems resulted in failure to ensure patient's rights were protected and promoted at all times.

Based on interview and record review, the facility failed to ensure their policy and procedure was implemented, and their process accurately reflected the federal regulations for the definition of a grievance. This resulted in the facility not recognizing complaints as grievances, not responding to the complaints as grievances, and not informing the complainants in writing of the resolution to their grievances.

Findings:

During an interview on August 15, 2017, at 9:30 a.m., the Risk Manager (RM), stated the facility treated written complaints and complaints by insurance carriers as grievances. The RM stated complaints received verbally, in person, or via a telephone call (including complaints received after the patient was discharged from the facility) were treated as "concerns" not grievances, unless the individual specifically stated they wanted to file a "grievance." The RM stated these concerns were investigated, but the complainant did not receive a written response to their "grievance." In addition, the RM stated the Grievance Log only contained the written and insurance carrier grievances, not the verbal "concerns."

On August 15, 2017, the facility presented a Grievance Log which was reviewed.

The following complaints were received via telephone calls, to the Patient Relations Department, were not treated as grievances, and were not included on the "Grievance Log:"

- On May 30, 2017, from Patient 4's family member, a complaint regarding the staff's attitude during a clinic visit on May 12, 2017.

- On July 6, 2017, from Patient 5, a complaint regarding the patient's privacy and lack of respect during a procedure which was performed
on July 13, 2016.

- On July 10, 2017, from Patient 6, a complaint regarding Patient 6's care, nurse's attitude, and communication in the Emergency Department (ED) on May 30, 2017.

- On June 1, 2017, from Patient 7's responsible party, a complaint regarding Patient 7's admission to the facility on February 17, 2017.

During an interview with Patient Relations Representative (PRR) 1, on August 15, 2017, at 1:50 p.m., she stated the facility did not consider the telephone calls grievances, and the patient's did not receive a written response to their grievances.

The facility policy and procedure titled, "Patient/Family Grievances and Conflict," last reviewed by the facility on June 16, 2017, revealed, "Grievance Defined: A formal written or verbal grievance that is filed by a patient or their family, when the issue cannot be resolved promptly by staff present ..."

The facility policy and procedure titled, "Patient/Family/Visitor Grievance Mechanism," last reviewed by the facility on March 2015, revealed "... Upon notification of a patient grievance, the Patient Representative will: Complete a (name of event reporting documentation system) report which includes the patient's name, date of receipt, nature of the problem, date and resolution or disposition of the grievance. ... An acknowledgment letter will be sent to the patient/grievant within 7 days, including final resolution, if all information is available. ... If the grievance involves additional review or investigation and will take longer than 7 days to resolve, the letter will include an expected date of resolution which should be no longer than 21 days. ..."

Based on interview and record review, the facility failed to ensure the facility's Governing Body (GB) approved and was responsible for the effective operation of the grievance process or the GB delegated, in writing, the responsibility for the effective operation of the grievance process, to include review and resolution of grievances, to a committee. This failed practice resulted in an ineffective grievance process to go unrecognized and uncorrected.

Findings:

On August 15, 2017, the facility policies and procedures regarding the facility's grievance process were reviewed.

On August 15, 2017, the facility Governing Body By-Laws were reviewed.

There was no documented indication the grievances were being reviewed by the GB, or the grievance process had been delegated to a committee.

There was no documented indication in either the GB By-Laws or the facility's policies and procedures that the GB was responsible for reviewing the grievances, or that they had delegated the grievance process to a committee.

During an interview with the Director Nursing Operations and Clinical Practice (DNOCP), on August 16, 2017, at 12 p.m., she reviewed the facility GB By-Laws and the facility's policies and procedures for the grievance process and was unable to find documentation of the grievance process being delegated, in writing, by the GB to a committee. The DNOCP stated when the facility policies and procedures had been reviewed/revised the delegation of the grievance process had been removed from the facility's policies and procedures.

Based on interview and record review, the facility failed to ensure verbal grievances were reviewed, investigated, and resolved in a timely manner for two of six grievances reviewed (Patients 6 and 7). This failed practice resulted in a delayed investigation and response to the patients grievances.

Findings:

On August 15, 2017, at 1:50 p.m., facility grievance packets were reviewed with Patient Relations Representative (PRR) 1.

a. Patient 6 made a telephone call to the Patient Relations Department, on June 10, 2017, regarding nursing attitude, care received, and communication which occurred during the patient's Emergency Department (ED) visit on May 30, 2017.

The grievance was referred to the ED Director on June 10, 2017, and the ED Director spoke with Patient 6 on July 26, 2017 (46 days after the grievance was filed with the Patient Relations Department).

There was no documentation to indicate the steps taken to investigate the grievance, the results of the grievance process, or the date the grievance process was completed, and sent to Patient 6.

b. Patient 7's responsible party made a telephone call to the Patient Relations Department on June 1, 2017, regarding physician communication, the patient's diagnosis, and the need to admit Patient 7 to the facility during an ED visit on February 17, 2017.

The grievance was referred to the ED Physician on June 1, 2017.

The Patient Relations Department received a second telephone call from Patient 7's responsible party on June 27, 2017 (26 days after the grievance was filed with the facility), who indicated no one had responded to her grievance.

The ED Physician spoke with Patient 7's responsible party on June 28, 2017, and the grievance was forwarded to the Admitting Team Representative.

There was no documentation to indicate a written notice of the steps taken to investigate the grievance, the results of the grievance process, or the date the grievance process was completed, was sent to Patient 7's responsible party.

During a concurrent interview with PRR 1, she stated the facility did not consider telephone complaints after discharge as grievances. PRR 1 stated the patients' grievances were investigated and should have been resolved timely. PRR 1 stated the patient's grievance was forwarded to the individual responsible for the department where the event occurred. The individual responsible should respond to the patient's grievance in a timely manner. PRR 1 stated the event reporting documentation system did track the department's response to the grievance, and sometimes a second notice to respond to the grievance was needed.

The facility policy and procedure titled, "Patient/Family Grievances and Conflict," last reviewed by the facility on June 16, 2017, revealed, "Grievance Defined: A formal written or verbal grievance that is filed by a patient or their family, when the issue cannot be resolved promptly by staff present ..."

The facility policy and procedure titled, "Patient/Family/Visitor Grievance Mechanism," last reviewed by the facility on March 2015, revealed, "... Upon notification of a patient grievance, the Patient Representative will: Complete a (name of event reporting documentation system) report which includes the patient's name, date of receipt, nature of the problem, date and resolution or disposition of the grievance. ... An acknowledgment letter will be sent to the patient/grievant within 7 days, including final resolution, if all information is available. ... If the grievance involves additional review or investigation and will take longer than 7 days to resolve, the letter will include an expected date of resolution which should be no longer than 21 days. ..."

Based on interview and record review, the facility failed to ensure a written notice of the facility's decision was provided to the patient/patient's responsible party for four of six grievances reviewed (Patients 4, 5, 6, and 7). This failed practice resulted in the patients/patients' responsible party not receiving written notice of the steps taken to investigate the grievance, the results of the grievance process, or the date the grievance process was completed.

Findings:

On August 15, 2017, at 1:50 p.m., facility grievance packets were reviewed with Patient Relations Representative (PRR) 1.

a. Patient 4's family member made a telephone call to the Patient Relations Department, on May 30, 2017, regarding a clinic staff's attitude during Patient 4's visit to the clinic on May 12, 2017.

The grievance was referred to the Director of the clinic service, who contacted Patient 4's family member on June 13, 2017.

There was no documented indication a written notice, of the steps taken to investigate the grievance, the results of the grievance process, or the date the grievance process was completed, was sent to Patient 4 or Patient 4's family member.

b. Patient 5 made a telephone call to the Patient Relations Department, on July 6, 2017, regarding her concern that her privacy had been violated and the staff were laughing at her during a procedure performed on July 13, 2016.

The grievance was referred to the Director of the service, who contacted Patient 5 on July 6, 2017.

There was no documented indication a written notice, of the steps taken to investigate the grievance, the results of the grievance process, or the date the grievance process was completed, was sent to Patient 5.

c. Patient 6 made a telephone call to the Patient Relations Department, on June 10, 2017, regarding nursing attitude, care received, and communication which occurred during the patient's Emergency Department (ED) visit on May 30, 2017.

The grievance was referred to the ED Director on June 10, 2017, and the ED Director spoke with Patient 6 on July 26, 2017 (46 days after the grievance was filed with the Patient Relations Department).

There was no documented indication a written notice, of the steps taken to investigate the grievance, the results of the grievance process, or the date the grievance process was completed, was sent to Patient 6.

d. Patient 7's responsible party made a telephone call to the Patient Relations Department on June 1, 2017, regarding physician communication, the patient's diagnosis, and the need to admit Patient 7 to the facility during an ED visit on February 17, 2017.

The grievance was referred to the ED Physician on June 1, 2017.

The Patient Relations Department received a second telephone call from Patient 7's responsible party on June 27, 2017 (26 days after the grievance was filed with the facility) who indicated no one had responded to her grievance.

The ED Physician spoke with Patient 7's responsible party on June 28, 2017, and the grievance was forwarded to the Admitting Team Representative.

There was no documented indication a written notice, of the steps taken to investigate the grievance, the results of the grievance process, or the date the grievance process was completed, was sent to Patient 7's responsible party.

During a concurrent interview with PRR 1, she stated the facility did not consider telephone complaints after discharge as grievances. PRR 1 stated the patients' grievances were investigated and should have been resolved timely. PRR 1 stated based on the federal regulations, Patients 4, 5, 6, and 7, or their responsible parties', should have received written notice of its decision that contained the name of the facility contact person, the steps taken on behalf of the patient to investigate the grievance, the results of the grievance process, and the date of completion.

The facility policy and procedure titled, "Patient/Family Grievances and Conflict," last reviewed by the facility on June 16, 2017, revealed, "Grievance Defined: A formal written or verbal grievance that is filed by a patient or their family, when the issue cannot be resolved promptly by staff present ..."

The facility policy and procedure titled, "Patient/Family/Visitor Grievance Mechanism," last reviewed by the facility on March 2015, revealed, "... Upon notification of a patient grievance, the Patient Representative will: Complete a (name of event reporting documentation system) report which includes the patient's name, date of receipt, nature of the problem, date and resolution or disposition of the grievance. ... An acknowledgment letter will be sent to the patient/grievant within 7 days, including final resolution, if all information is available. ... If the grievance involves additional review or investigation and will take longer than 7 days to resolve, the letter will include an expected date of resolution which should be no longer than 21 days. ..."

Based on observation, interview, and record review, the facility failed to ensure two consents signed by one patient's (Patient 34's), responsible party were signed on consent documents written in the language the responsible party could read and understand, (Spanish).

Together these failures may negatively impact the right of Patient 34 to make informed decisions regarding their medical care.

Findings:

An observation of Patient 34 was conducted on August 17, 2017, at 11:15 a.m. Patient 34's eyes were open, the patient was non verbal. The patients parents were at her bedside, speaking in Spanish.

A review of Patient 34's record was conducted. Patient 34 was admitted to the facility on July 21, 2017. Patient 34 was born with an arteriovenous malformation (AVM, per the Mayo Clinic, 2017, is a tangle of abnormal blood vessels connecting arteries and veins in the brain). The patient had a recent intraventricular hemorrhage (bleeding into the fluid filled areas of the brain containing the cerebral spinal fluid (per Stanford Children's Health, 2017).

The following authorization and consent dated August 4, 2017, at 12:05 p.m. was reviewed for Patient 34. An esophagogastroduodenoscopy (EGD - procedure in which a thin scope with a light is used to look inside the upper digestive tract, per WebMD, 2017), with sedation; and, a percutaneous endoscopic gastrostomy (PEG) with possible biopsy (PEG - a medical procedure in which a tube is passed into a patient's stomach through the abdominal wall, most commonly to provide a means of feeding when oral intake is not adequate, per MedicineNet, 2017). The consent was signed by Patient 34's responsible party. The consent form was written in English.

A review of an authorization and consent to have a left frontal ventriculostomy, dated July 21, 2017, at 8:05 a.m., was conducted. (ventriculostomy, a neurosurgical procedure that involves creating a hole within a cerebral ventricle for drainage, by surgically penetrating the skull, (Webster Medical Dictionary, 2017.) The consent was signed by Patient 34's responsible party. The consent form was written in English.

An interview was conducted with the Charge Nurse, (CN) 1, on August 17, 2017, at 12:15 p.m. CN 1 stated she could speak Spanish and English. CN 1 proceeded to call Patient 34's responsible party, who told CN 1, in Spanish, that she couldn't write or read English, but she signed both consents which were written in English.

A review of the facility policy, "Patient Rights and Responsibilities (Reviewed Date: 7/14/2017)," was conducted. The policy indicated, "It is the duty of all hospital associates and physicians on staff to assist the patient in the exercise of his/her rights and responsibilities. F. Informed consent is a basic patient right. Informed consent gives the patient the basis on which to make prudent decisions about health care. The elements of informed consent include: 1. Clear and concise explanation about the patient's condition and diagnosis."

Based on observation, interview, and record review, the facility failed to follow their policy and procedure regarding the use of hand mitts (hand mittens/mittens - hand covering used to restrict the patient's ability to grab, pick, or scratch). This failed practice resulted in the potential for unnecessary and unsafe use of restraints in violation of patient's rights.

Findings:

During a tour of the Cardiac Intensive Care Unit (CICU) on August 14, 2017, at 1:30 p.m., accompanied by the Director of Quality Management (DQM) and the CICU Charge Nurse (CN), the CN stated they did not have any patients in restraints at the time. The CN stated they, "rarely," used restraints because they used mittens instead. The CN stated the nurses were allowed to apply mittens without a physician's order, as they were, "not considered restraints."

During a tour of the Medical/Surgical Unit on August 15, 2017, at 11:15 a.m., with Registered Nurse (RN) 15, the facility's hand mitts were observed. The hand mitts were designed to encase the entire hand of the patient, were closed with a one inch Velcro strap which went around the patient's entire wrist, had bulky padding, and had one small hole at the top of the hand mitt for the middle finger to fit through.

During an interview with the Director Nursing Operations and Clinical Practice (DNOCP), on August 17, 2017, at 10:35 a.m., she stated the facility did not consider hand mitts a restraints and did not include hand mitts in their facility restraint policy.

The facility policy titled, "Restraints," was reviewed on August 15, 2017. The policy listed the various types of restraints used at the facility. The policy indicated the facility followed the Code of Federal Regulations (CFR) 482.13 (e)(1) regarding the definition and use of restraints. Although bulky mittens were used, they were not listed as a restraint in the policy.

Based on interview and record review, the facility failed to ensure the plan of care was initiated, revised, and/or updated when restraints were applied and maintained on four of eight sampled patients (Patients 11, 12, 13, and 19) with restraints. This had the potential to result in lack of clear documentation of the patients' individual needs.

Findings:

1. On August 16, 2017, the record for Patient 11 was reviewed. Patient 11 was admitted to the facility on August 11, 2017, with diagnoses including sepsis (potentially life-threatening complication of an infection), wound cellulitis (an infection of the deeper layers of skin and the underlying tissue), and agitation.

The clinical notes indicated hand mitts (hand mittens/mittens - hand covering used to restrict the patient's ability to grab, pick, or scratch) were placed on Patient 11 on August 11, 2017, at 2:25 p.m., in the Emergency Department, with the indication for use as "pulling at cardiac leads."

The record indicated the following:

- On August 11, 2017, at 3:30 p.m., mittens were in place;

- On August 12, 2017, at 12 a.m., mittens were in place to prevent the patient from pulling out the intravenous line; at 8 a.m., mittens were on and were removed to check Patient 11's skin; and at 11:30 a.m., the mittens were replaced when a dressing was changed;

- On August 13, 2017, no documented indication mittens were being used; and,

- On August 14, 2017, at 8:30 a.m., mittens were on both hands; at 10:33 a.m., the mittens were already in place, a "posey belt" was placed on the patient and the charge nurse was called for a sitter; and at 6:03 p.m., mittens were on, and the posey belt was removed when the sitter arrived.

There was no documented indication Patient 11's plan of care was updated/revised when hand mitts were applied and use was continued for several days.

2. On August 16, 2017, the record for Patient 12 was reviewed. Patient 12 was admitted to the facility on May 1, 2017, with diagnoses including right modified radical mastectomy for cancer, hypertension and diabetes.

The clinical note dated May 2, 2017, at 4:37 a.m., indicated Patient 12 was confused, combative, trying to get out of bed, and all alternatives were unsuccessful. The physician was notified and an order for bilateral soft wrist restraints (cloth restraint device applied around the wrist to limit movement of the arms and/or hands) was obtained.

The clinical note dated May 2, 2017, at 7:54 a.m., indicated Patient 12 was in bilateral soft wrist restraints, bilateral hand mitts, and there was a sitter at the bedside.

There was no documented indication Patient 12's plan of care was initiated/updated/revised when bilateral soft wrist and hand mitt restraints were applied.

3. On August 16, 2017, the record for Patient 13 was reviewed. Patient 13 was admitted to the facility on May 11, 2017, with diagnosis of stroke (a medical condition caused by decrease in blood flow to the brain).

The clinical note dated May 14, 2017, indicated the following:

- At 11 p.m., a right leg restraint was on and the physician was "made aware of the need of restraint;" and,

- At 11:17 p.m., the right leg was placed in a restraint in order to keep the leg straight.

The clinical note dated May 16, 2017, at 8:20 a.m., indicated Patient 13 required a soft ankle (right leg) restraint to prevent the leg from bending, the physician was notified and an order for a right leg soft ankle restraint was obtained.

There was no documented indication Patient 13's plan of care was initiated/updated/revised when a soft right ankle restraint was applied on May 14 and 16, 2017.

During an interview with the Clinical Supervisor of Medical Surgical Services (CSMSS), on August 16, 2017, at 3:15 p.m., she reviewed the records for Patients 11, 12 and 13, and was unable to find documentation of plans of care being initiated/updated/revised when restraints were applied. The CSMSS stated the plan of care for restraints, to include interventions, should have been located in the "Injury Risk" plan of care.

4. On August 16, 2017, at 2:25 p.m., Patient 19's record was reviewed. The record indicated Patient 19 was admitted to the facility January 8, 2017, for weakness, drowsiness, and a history of diabetes.

The record indicated Patient 19 had soft wrist restraints applied on January 10, 2017, at 10:40 p.m. after he pulled out a naso-gastric tube (tube inserted through the nose into the stomach used to suction the stomach contents).

The Nurse's Assessment, dated January 11, 2017, at 7:26 p.m., indicated, "...soft restraints in placed (sic)."

The Nurse's Assessment, dated January 11, 2017, at 10:26 p.m., indicated, "...mittens on for safety..."

Review of the Nursing Care Plan revealed there was no documented evidence Patient 19's nursing care plan was initiated/updated/revised with specific nursing interventions related to the use of restraints.

During an interview with the Director of Nursing Operations and Clinical Practice on August 17, 2017, at 10:38 a.m., she stated when restraints were applied, the expectation was the plan of care would be initiated/revised/updated.

The facility policy and procedure titled, "Patient Plan of Care," last reviewed by the facility on August 9, 2016, revealed, "...The plan will be a continuously evolving document concurrent with the patient's identified needs...The plan of care is assessed, updated, and/or changed daily...Interventions pertinent to the attainment of the expected outcome are outlined..."

The facility policy and procedure titled, "Restraints," last reviewed by the facility on May 4, 2015, revealed, "...Documentation of restraint in the medical record includes the following:...Revisions to the patient's plan of care..."

Based on observation, interview, and record review, the facility failed to ensure restraints were applied in accordance with a physician's order for:

1. Three of three patients placed in bulky mitten restraints for medical reasons (Patients 40, 11, and 19);

2. One of two Emergency Department patients who were placed in hard, locked restraints for behavior (Patient 47); and,

3. One of one patients placed in a right ankle restraint for medical reasons (Patient 13).

These failed practices resulted in the potential for unnecessary and unsafe use of restraints in violation of the patient's rights.

Findings:

1. During a tour of the Cardiac Intensive Care Unit (CICU) on August 14, 2017, at 1:30 p.m., accompanied by the Director of Quality Management (DQM) and the CICU Charge Nurse (CN), the CN stated they did not have any patients in restraints at the time. The CN stated they, "rarely," used restraints because they used mittens instead. The CN stated the nurses were allowed to apply mittens without a physician's order, as they were, "not considered restraints."

During a tour of the Medical/Surgical Unit on August 15, 2017, at 11:15 a.m., with Registered Nurse (RN) 15, the facility's hand mitts (hand mittens/mittens - hand covering used to restrict the patient's ability to grab, pick, or scratch) were observed. The hand mitts were designed to encase the entire hand of the patient, were closed with a one inch Velcro strap which went around the patient's entire wrist, had bulky padding, and had one small hole at the top of the hand mitt for the middle finger to fit through.

During a concurrent interview with RN 15, she stated hand mitts were not considered a restraint because the patient's hands were not tied down. RN 15 stated the hand mitts prevented the patient from grabbing at tubes; scratching self; drinking fluids without assistance; grasping objects; and eating food. RN 15 stated the patient would be unable to remove the hand mitts by themselves because the patient would be unable to grasp the Velcro strap securing the mitt in place.

a. During a tour of ICU 3 on August 15, 2017, at 10:50 a.m., accompanied by the Director of Quality and the ICU 3 CN, the CN stated they did not have any patients in restraints at the time, but they did have two patients with mittens on.

On August 15, 2017, at 10:55 a.m., Patient 40 was observed laying in a bed in ICU 3 with bulky mittens on both hands. The bulky part was located on the palm sides of both hands, and the patient was raising his hand to get the attention of the nurse standing outside of the room. Patient 40 was placing his hands on the siderails of the bed, but was not able to grasp them due to the bulky mittens.

During a concurrent interview, Registered Nurse (RN) 1 (the nurse caring for Patient 40) stated he had just applied the mittens, and they were not considered restraints so he did not need a physician's order. The RN stated he put the mittens on to prevent Patient 40 from pulling his airway tube out. RN 1 stated Patient 40 was alert and oriented, and was compliant with his treatment plan until he dozed off to sleep, then he would, "forget and reach for his tube." RN 1 stated Patient 40 communicated by writing, and he could not write with the mittens on, so the RN would remove them when the patient wanted to write, then reapply them.

The record for Patient 40 was reviewed. Patient 40, a 67 year old male, was admitted to ICU 3 on August 6, 2017, with a mediastinal (chest) mass that was shifting and narrowing his airway. The record indicated the patient was alert and oriented, and was intubated (tube placed into his trachea) to protect and maintain his airway. There was no order for the bulky mittens (restraints). There was no evidence the nurses were monitoring the use of the bulky mittens (restraints).

b. On August 16, 2017, the record for Patient 11 was reviewed. Patient 11 was admitted to the facility on August 11, 2017, with diagnoses including sepsis (potentially life-threatening complication of an infection), wound cellulitus (an infection of the deeper layers of skin and the underlying tissue), and agitation.

The clinical notes indicated mittens were placed on Patient 11, on August 11, 2017, at 2:25 p.m., in the Emergency Department, with the indication for use as "pulling at cardiac leads."

The record indicated the following:

- On August 11, 2017, at 3:30 p.m., mittens were in place;

- On August 12, 2017, at 12 a.m., mittens were in place to prevent the patient from pulling out the intravenous line; at 8 a.m., mittens were on and were removed to check Patient 11's skin; and at 11:30 a.m., the mittens were replaced when a dressing was changed;

- On August 13, 2017, no documented indication mittens were being used; and,

- On August 14, 2017, at 8:30 a.m., mittens were on both hands; at 10:33 a.m., the mittens were already in place, a "posey belt" was placed on the patient and the charge nurse was called for a sitter; at 6:03 p.m., mittens were on, and the posey belt was removed when the sitter arrived.

Patient 11 was discharged from the facility on August 15, 2017, at 8 p.m.

There was no documented evidence a physician's order was obtained when hand mitts were applied to Patient 11, and the use of hand mitts was continued for at least three days.

During an interview with the Clinical Supervisor Medical Surgical Services (CSMSS), on August 16, 2017, at 2:20 p.m., she reviewed the record for Patient 11 and was unable to find documentation of a physician's order for hand mitts.

During an interview with the Director Nursing Operations and Clinical Practice (DNOCP), on August 17, 2017, at 10:38 a.m., she stated the facility had not considered hand mitts as restraints because the patient's hands were not tied down.

c. On August 16, 2017, at 2:25 p.m., Patient 19's record was reviewed with the Clinical Analyst Registered Nurse (CARN). The record indicated Patient 19 was admitted to the facility on January 8, 2017, for symptoms of weakness, drowsiness, and a history of diabetes.

The record indicated Patient 19 had soft wrist restraints (cloth device applied to the wrist to limit movement of the hands or arms) applied on January 10, 2017, after he pulled out a naso-gastric tube (tube inserted through the nose into the stomach used to suction the stomach contents).

The Nurse's Assessment, dated January 11, 2017, at 7:26 p.m., indicated, "...soft restraints in placed (sic)."

The Nurse's Notes, dated January 11, 2017, at 10:26 p.m., indicated, "...mittens on for safety..."

In a concurrent interview, the CARN confirmed there was no documented evidence in Patient 19's record of a Physician's Order with an indication for the use of mittens.

During an interview with the DNOCP, on August 17, 2017, at 10:35 a.m., the DNOCP stated the facility did not include mittens on the facility policy because they did not consider mittens restraints. The DNOCP further stated all patients in restraints required an initial Physician's order.

2. During an interview with the Security Officer in Charge (SOC) on August 15, 2017, at 10:30 a.m., the SOC stated all of the security officers were trained and allowed to apply restraints in the ED. The SOC stated they, "only" applied hard locking restraints, "only" on combative patients, and "only" if the physician ordered them.

The Security Department Log was reviewed on August 15, 2017. The log indicated four security officers responded to the ED on August 6, 2017, at 6:53 a.m., and, "Applied two point restraints on combative patient." The information on the log indicated the restraints were applied on Patient 47.

The record for Patient 47 was reviewed. Patient 47, a 31 year old male, arrived at the ED on August 6, 2017, at 2:07 a.m., after falling off of a bike and sustaining a head injury. The ED physician's report indicated the patient was uncooperative and appeared to be intoxicated.

A physician's order dated August 6, 2017, at 6:58 a.m., indicated Patient 47 was to be put into, "Hard Restraints (wrist and/or ankle)." The order did not indicate the reason for the restraints or the number of limbs to be restrained.

The ED, "Assessment Report" (nurse's notes for documenting restraint use), indicated Patient 47 was placed in hard restraints on August 6, 2017, at 7:30 a.m., for, "Disrupting equipment." There was no evidence of the number of limbs that were restrained.

The ED Assessment Report further indicated on August 6, 2017, at 7:29 p.m. (11 hours and 59 minutes after hard restraints were applied), Patient 47 was changed to soft restraints. There was no order for the change to soft restraints.

A physician's order dated August 7, 2017, at 8 a.m., indicated Patient 47 was to be in four point (all limbs restrained) soft restraints.

The ED Assessment Report indicated Patient 47 remained in soft restraints until August 8, 2017, when the last evidence of restraint monitoring was documented at 7:23 a.m.



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3. On August 16, 2017, the record for Patient 13 was reviewed. Patient 13 was admitted to the facility on May 11, 2017, with diagnosis of stroke (a medical condition caused by decrease in blood flow to the brain).

The clinical note dated May 14, 2017, at 11 p.m., indicated a right leg restraint was on, and the physician was, "made aware of the need for restraint."

The clinical note dated May 14, 2017, at 11:17 p.m., indicated the right leg was placed in a restraint in order to keep the leg straight.

There was no documentation as to when the soft right ankle restraint was removed.

There was no documented indication an order for the right leg soft ankle restraint was obtained on May 14, 2017, and signed by the physician.

During an interview with the Director Nursing Operations and Clinical Practice (DNOCP), on August 17, 2017, at 10:38 a.m., she reviewed the record and was unable to find documentation of a physician's order for the application of a soft right ankle restraint on May 14, 2017. The DNOCP stated an initial order for the application of a restraint should be obtained from the physician and subsequent orders should be obtained for each 24 hours if the continued use of restraints was required. The DNOCP stated the date/time the restraint was removed/discontinued should be documented in the patient's record.

A review of the facility policy and procedure titled, "Restraints" last reviewed by the facility on May 4, 2015, indicated the following:

A. Except in emergency situations, a physician's order must be obtained prior to the use of restraints;

B. Written orders of the physician for restraint use are time limited to up to twenty-four (24) hours for the first episode and up to 24 hours for each subsequent order; and

C. The physician's order shall include the reason for utilizing the restraints, including specific behaviors.

Based on interview and record review, the facility failed to ensure behavioral restraint orders were renewed by the physician every four hours when one patient (Patient 47) was placed in restraints to manage his behavior for 11 hours and 59 minutes. This failed practice resulted in the potential for unnecessary and unsafe use of restraints in violation of the patient's rights.

Findings:

During an interview with the Security Officer in Charge (SOC) on August 15, 2017, at 10:30 a.m., the SOC stated all of the security officers were trained and allowed to apply restraints in the ED. The SOC stated they, "only" applied hard locking restraints, "only" on combative patients, and "only" if the physician ordered them.

The Security Department Log was reviewed on August 15, 2017. The log indicated four security officers responded to the ED on August 6, 2017, at 6:53 a.m., and, "Applied two point restraints on combative patient." The information on the log indicated the restraints were applied on Patient 47.

The record for Patient 47 was reviewed. Patient 47, a 31 year old male, arrived at the ED on August 6, 2017, at 2:07 a.m., after falling off of a bike and sustaining a head injury. The ED physician's report indicated the patient was uncooperative and appeared to be intoxicated.

A physician's order dated August 6, 2017, at 6:58 a.m., indicated Patient 47 was to be put into, "Hard Restraints (wrist and/or ankle)."

The ED, "Assessment Report" (nurse's notes for documenting restraint use), indicated Patient 47 was placed in hard restraints on August 6, 2017, at 7:30 a.m., for, "Disrupting equipment."

The ED Assessment Report further indicated on August 6, 2017, at 7:29 p.m. (11 hours and 59 minutes after hard restraints were applied), Patient 47 was changed to soft restraints.

There were no additional orders to continue the hard behavioral restraints for the duration of time Patient 47 remained in them.

A review of the facility policy titled, "Restraints," indicated when an adult patient was in restraints to manage their behavior, a written or verbal order must be obtained from the physician every four hours.

Based on interview and record review, the facility failed to ensure visual checks and assessments/reassessments were completed and
documented per facility policy and procedure for three of seven sampled patients (Patients 12, 13, and 20) who had restraints in place for medical/surgical care. This had the potential to result in possible injuries related to the use of restraints to go unrecognized.

Findings:

a. On August 16, 2017, the record for Patient 12 was reviewed. Patient 12 was admitted to the facility on May 1, 2017, with diagnoses including right modified radical mastectomy for cancer, hypertension and diabetes.

The clinical note dated May 2, 2017, at 4:37 a.m., indicated Patient 12 was confused, combative, trying to get out of bed, and all alternatives were unsuccessful. The physician was notified and an order for bilateral soft wrist restraints (cloth restraint device applied around the wrist to limit movement of the arms and/or hands) was obtained.

Restraint assessments were completed on May 2, 2017, at 4:54 a.m. and 6:53 a.m.

The clinical note dated May 2, 2017, at 7:54 a.m., indicated Patient 12 remained in bilateral soft wrist restraints, bilateral hand mitts, and there was a sitter at the bedside.

There was no documented indication visual checks and assessments/reassessments for restraints were completed after May 2, 2017, at 6:53 a.m.

There was no documented indication as to when the bilateral soft wrist restraints were removed.

b. On August 16, 2017, the record for Patient 13 was reviewed. Patient 13 was admitted to the facility on May 11, 2017, with diagnosis of stroke (a medical condition caused by decrease in blood flow to the brain).

The clinical note dated May 14, 2017, indicated the following:

- At 11 p.m., a right leg restraint was on and the physician was "made aware of the need for restraint;" and,

- At 11:17 p.m., the right leg was placed in a restraint in order to keep the leg straight.

The restraint assessments indicated a soft right ankle restraint was initiated on May 14, 2017, at 11 p.m.

Restraint assessments were completed on May 15, 2017, at 3 a.m., 5 a.m., 7 a.m., 9:01 a.m., 1 p.m. (4 hours in between assessments), 3 p.m., 5:01 p.m., and 7:01 p.m.

There was no documented indication visual checks and assessments/reassessments for restraints were completed after May 15, 2017, at 7:01 p.m.

There was no documentation as to when, or if, the soft right ankle restraint was removed.

The clinical note dated May 16, 2017, at 8:20 a.m., indicated Patient 13 required a soft ankle (right leg) restraint to prevent the leg from bending, the physician was notified and an order for a right leg soft ankle restraint was obtained.

There was no documented indication visual checks and assessments/reassessments for restraints were completed.

There was no documentation as to when, or if, the soft right ankle restraint was removed.

During an interview with the Clinical Supervisor Medical Surgical Services (CSMSS), on August 16, 2017, at 3:15 p.m., she reviewed the records for Patients 12 and 13, and was unable to find documentation of visual checks every 15 minutes, or assessments/reassessments being completed and documented every two hours. The CSMSS stated the restraint assessments should have been completed every two hours, and the time indicated on the assessment included the every 15 minute visual checks. In addition, the CSMSS stated the time the restraints were discontinued should be documented in the patient's record.



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c. On August 16, 2017, at 2;45 p.m., Patient 20's record was reviewed with the Clinical Analyst Registered Nurse (CARN). The record indicated Patient 20 was admitted to the facility on January 19, 2017, with diagnoses of confusion and low potassium level.

The Physician's order, dated January 19, 2017, at 11:38 p.m., indicated Patient 20 was to be placed in a, "Safe Enclosure Posey," restraint bed (enclosed hospital bed with an attached net canopy used to restrict patient from getting out of bed). The record further indicated Patient 20 continued to be placed in the restraint bed through January 23, 2017.

The Nurse's Notes, dated January 23, 2017, at 8:22 a.m., indicated, "...Pt (Patient 20) is in a posey bed at this time..."

The Nurse's Restraint Assessment, dated January 23, 2017, at 10:52 a.m., indicated Patient 20 was assessed by the nurse.

The Nurse's Restraint Assessment, dated January 23, 2017, at 8:06 p.m. (nine hours and 16 minutes later), indicated Patient 20 was assessed by the nurse.

In a concurrent interview, the CARN confirmed there was no documented evidence Patient 20 was assessed in the restraint bed, at least every 2 hours, on January 23, 2017, between 10:52 a.m., and 8:06 p.m.

During an interview with the Director Nursing Operations and Clinical Practice (DNOCP), on August 16, 2017, at 3:15 p.m., the DNOCP stated the nurses should do an assessment of the patient in restraints every two hours, "... for patient safety and to make sure the patient is not tangled..." (in the restraints).

During a subsequent interview with the DNOCP, on August 17, 2017, at 10:35 a.m., the DNOCP stated all patients with restraints should be visually checked every 15 minutes, and documentation of nursing assessments should be done every two hours.

The facility policy and procedure, titled, "Restraints," last reviewed by the facility on May 4, 2015, was reviewed. The policy indicated, "...Monitoring and documentation for patients in restraints...Monitoring is accomplished by observation, interaction with the patient, or related direct examination of the patient...Patients who are in restraints...will be monitored as follows...Every two (2) hours or more frequently...will be assessed... and documented..."

Based on interview and record review, the facility failed to ensure a one hour face-to-face assessment was completed by the Emergency Department (ED) physician after initiation of behavioral restraints for two of two ED patients who were placed in hard, locked restraints for behavior (Patients 42 and 47). This failed practice resulted in the potential for unnecessary and unsafe use of restraints in violation of the patient's rights.

Findings:

During an interview with the Security Officer in Charge (SOC) on August 15, 2017, at 10:30 a.m., the SOC stated all of the security officers were trained and allowed to apply restraints in the ED. The SOC stated they, "only" applied hard locking restraints, "only" on combative patients, and "only" if the physician ordered them.

The Security Department Log was reviewed on August 15, 2017. The log indicated the following:

1a. Four security officers responded to the ED on August 6, 2017, at 5:36 p.m., and applied two point restraints (on two limbs) on a combative patient. The information on the log indicated the restraints were applied on Patient 42.

The record for Patient 42 was reviewed. Patient 42, a 27 year old male, arrived at the ED on August 6, 2017, at 4:46 p.m., with a possible drug overdose. The record indicated the patient was combative and uncooperative.

A physician's order dated August 6, 2017, at 5:07 p.m., indicated Patient 42 was to be placed in 2 point hard restraints for behavior.

The nurse's notes indicated Patient 42 had two point hard restraints applied (one to his arm and one to the alternate leg). According to the notes, Patient 42 remained in the hard restraints until 9:34 p.m. (four hours and 27 minutes).

There was no evidence the physician evaluated the patient within one hour of the restraints being applied (or the whole time he was in behavioral restraints) to determine his current condition, his reaction to the use of restraints, or the need to continue or terminate the use of the restraints.

1b. Three security officers responded to the ED at 10:20 p.m., and applied four point (all limbs) restraints on a psychiatric patient. The information on the log indicated the restraints were reapplied on Patient 42.

Further review of Patient 42's record indicated the ED physician ordered four point hard restraints for behavior management at 10:42 p.m.

The nurse's notes indicated Patient 42 was, "placed back in restraints for safety," at 10:42 p.m., due to his behavior. According to the notes, Patient 42 remained in the hard restraints until 42 minutes after midnight (two hours).

There was no evidence the physician evaluated the patient within one hour of the restraints being applied (or the whole time he was in behavioral restraints) to determine his current condition, his reaction to the use of restraints, or the need to continue or terminate the use of the restraints.

2. Four security officers responded to the ED on August 6, 2017, at 6:53 a.m., and, "Applied two point restraints on combative patient." The information on the log indicated the restraints were applied on Patient 47.

The record for Patient 47 was reviewed. Patient 47, a 31 year old male, arrived at the ED on August 6, 2017, at 2:07 a.m., after falling off of a bike and sustaining a head injury. The ED physician's report indicated the patient was uncooperative and appeared to be intoxicated.

A physician's order dated August 6, 2017, at 6:58 a.m., indicated Patient 47 was to be put into, "Hard Restraints (wrist and/or ankle)."

The ED, "Assessment Report" (nurse's notes for documenting restraint use), indicated Patient 47 was placed in hard restraints on August 6, 2017, at 7:30 a.m., for, "Disrupting equipment," and was left in hard restraints for 11 hours and 59 minutes.

There was no evidence the physician evaluated the patient within one hour of the restraints being applied (or the whole time he was in behavioral restraints) to determine his current condition, his reaction to the use of restraints, or the need to continue or terminate the use of the restraints.

A review of the facility policy titled, "Restraints," indicated when restraints were used for behavior management reasons, the physician must see and evaluate the patient within one hour of the initiation of the restraints to determine:

a. An evaluation of the patient's immediate situation;

b. The patient's reaction to the intervention;

c. The patient's medical and behavioral condition; and,

d. The need to continue or terminate the restraint.

Based on interview and record review, the facility failed to ensure the clinical educators utilized the manufacturers manual which had specific guidelines to train staff regarding the safe use of the Posey Bed 8070, (Posey Bed, a hospital bed, canopy and mattress system, a type of physical restraint). This failure could potentially lead to misuse of the bed which may result in patient entrapment, (when a patient is trapped or entangled in a confined space), which can result in serious injury or death from suffocation, or other injuries.

Findings:

An interview was conducted with Charge Nurse (CN) 2 on August 16, 2017, at 2 p.m. CN 2 stated the facility uses the Posey Bed for patients who were impulsive. CN 2 further stated a physician's order was required and the documentation was the same as with any other type of restraint used. CN 2 further stated the staff received annual training regarding the use of the Posey Bed at the same time they received training for all the other types of restraints used in the facility.

An observation of one of the facility's two Posey Beds 8070 was conducted on August 17, 2017, at 1:30 p.m., with the Operations Manager for Materials Management (OMM). The OMM stated there were three parts to the Posey bed, the frame, the mattress, and the top enclosure piece.

The following printed documentation was affixed to the outside of the Posey Bed;
"For at risk patients keep the mattress flat and use the Posey torso cushion to help reduce the risk of entrapment. If the head of the bed is raised for patients at risk for entrapment remove the Posey torso cushion and use the Posey filler cushions to help reduce the entrapment risk. Monitor frequently to ensure the Posey filler cushions stay in place. Before use read assembly instructions, user manual and warnings accompanying this product."

An interview was conducted with the OMM on August 17, 2017, at 1:45 p.m. The OMM stated the facility did not have a copy of the manual for the Posey Bed. The OMM further stated the facility did not have Posey torso cushions or Posey filler cushions to use with the bed.

An interview was conducted with the Director of Clinical Education (DCE) on August 17, 2017, at 9:40 a.m. When asked when the training on the Posey Bed was conducted and what was taught, the DCE stated restraint training was part of the nursing staffs annual training and the educators trained the staff regarding use of the Posey enclosure bed.

When further questioned about when and how the trainers were trained on the safe use of the Posey Bed, the DCE did not know when the trainers were trained, and was unaware that the facility did not have the manufacturer's user manual for the bed.

A review of the Posy Bed 8070 User Manual was conducted on August 17, 2017. The risks indicated, "Improper use of the Posey Bed 8070 may lead to serious injury or death. Patient monitoring should be determined by hospital protocol, a doctor, and the patient care plan... It is important to understand when the Posey Bed 8070 is needed, when it should not be used, and the dangers related to entrapment, suffocation, choking, and falls."

"A Special Note" in the Posey Bed 8070 user manual indicated, "To help reduce the risk of entrapment, adhere to the following guidelines: Keep the mattress flat. If you need to elevate the head or torso of an at risk patient, keep the mattress flat and use a cushion to position the patient. If you must leave the head of the bed up while an at risk patient is alone, use the Posey Filler Cushion. Provide extra monitoring. Avoid stretching the canopy material. The canopy may stretch over time during normal use or by patients who engage in escape behaviors. This could result in pocket areas on the inside of the canopy...DO NOT use any canopy that has tears or shows signs of damage."

Indicated in the "Warnings and Precautions" section of the Posey Bed 8070 user manual, "Canopy gaps present an entrapment risk for certain at risk patients. Raising the head of the Posey Bed creates gaps or pockets between the head of the bed and the canopy. These areas pose an extreme risk of serious injury or death from entrapment for certain at risk patients."

A review of the annual facility wide restraint training indicated the educators failed to address entrapment or other risks specific to the Posey enclosure bed.

Based on interview and record review, the facility failed to ensure safe and effective use of restraints (Refer to A159, A166, A168, A171, A175, A179, and A194), and identify these failures through their quality assessment performance improvement process, by failing to:

1. Monitor and assess patient physical safety and effective implementation of the restraint process, on an on going basis; and,

2. Initiate improvement actions, after data collected in May 2017, identified opportunities for improvement in the safe and effective use of restraints.

The cumulative effect of these systemic problems resulted in the failure to ensure quality care was delivered in a safe and effective manner.

Findings:

1. The facility, "2015-2018 PERFORMANCE IMPROVEMENT PLAN," was reviewed on August 17, 2017. The plan indicated, "Performance Improvement (PI) is a continous process. It involves measuring the functioning of the important processes and services, and when indicated identifying changes that enhance performance. These changes are incorporated into new or existing work processes, products or services, and performance is monitored to ensure that the improvements are sustained." The plan's primary objectives included, measuring performance through data collection, assessing current performance, and improving and sustaining performance.

The "2017 PERFORMANCE IMPROVEMENT REPORT," indicated "PI Indicator #2: To reduce the number of Restraints (Patients in a Limb or Vest restraint)...1st Qtr 2017 (January-March) 0.00..." The report indicated there was no data being collected, reported, or analyzed for safe application, appropriate monitoring, or effective use of restraint.

During the Quality Meeting conducted on August 17, 2017, at 1 p.m., the Director of Quality Management (DQM) stated, they were doing a "prevalence study" (type of observational study that analyzes data collected from a specific point in time) on restraints. The 1st Qtr 2017 result of 0.00 indicating, at the time the data was collected, there were no patients on limb or vest restraint. The DQM stated "Behavioral restraints are not being looked at yet."

The DQM stated the facility had not been monitoring quality data on restraints.

The DQM stated the facility had not identified that bulky mittens were considered restraints.

2. On August 15, 2017, the facility restraint log for 2017 was reviewed. The log included a document titled, "Non-Violent Restraint Audit January 1, 2017 - May 30, 2017." The document indicated charts were reviewed and the following was identified:

a. Initial orders were not obtained prior to or within 1 hour of restraint initiation 22% of the time (39 compliant charts out of 50 charts reviewed);

b. The original orders were not authenticated (date/time/signed) within 24 hours by the physician for telephone orders 72% of the time (9 compliant charts out of 32 charts reviewed);

c. Renewal orders were not completed within 24 hours of the original or previous order for restraints lasting more than 24 hours 41% of the time (20 compliant charts out of 34 charts reviewed);

d. Renewal orders were not authenticated (date/time/signed) by the physician 24% of the time (26 compliant charts out of 34 charts reviewed);

e. Renewal orders made via telephone were not authenticated (date/time/signed) by the physician within 24 hours 67% of the time (4 compliant charts out of 12 charts reviewed), and;

f. Daily (24 hour) flowsheets (used by nurses for monitoring patients in restraints) were not completed 86% of the time (7 compliant charts out of 50 charts reviewed).

During the Quality Meeting conducted on August 17, 2017, at 1 p.m., the Director of Nursing Operations and Clinical Practice (DNO) stated the "Non-Violent Restraint Audit January 1, 2017 - May 30, 2017," was data collected from record reviews completed in May of 2017. The DNO and DQM stated the data identified various opportunities for improvement in the restraint process documentation. The DNO and DQM stated there were no action plans or changes initiated as a result of the data collected and indicated on the, "Non-Violent Restraint Audit January 1, 2017 - May 30, 2017."

Based on observation, interview, and document review, the hospital failed to ensure they had an effective, active system wide infection control program for the prevention, control, and investigation of infections and communicable diseases. The infection control program did not meet the needs of all patients, as evidenced by:

1. The hospital failed to provide effective infection control monitoring and surveillance for their Surgical Service Department (Refer to A-0951 Finding 2)

2. In the hospital sterile processing department, 2 of 2 autoclaves (machines used to sterilize surgical instruments) had exposed insulation and large amounts of brown staining within the chambers (Refer to A-0749 finding 1 and A-0951 Finding 1).

3. The processing and sterilization of surgical instruments did not follow nationally accepted standards when the hospital failed to ensure there was no presence of spotting, etching and staining on multiple instruments in 3 of 3 processed surgical trays (a major, a minor and a long, previously cleaned, disinfected and sterilized surgical trays which contained surgical instruments) {Refer to A -0749 finding 2 and A-0951 finding 2}

4. An ice machine, located in the hospital basement, contained black substance that was easily wiped off (Refer to A-0749 Finding 5 and A-0951 finding 5).

5. No evidence was provided to demonstrate the hospitals sterile processing, and one sub-sterile room ((a restricted area where staff must wear proper attire and street clothes are not permitted and is used to clean and disinfect soiled patient equipment and instruments, located in OR 12), were routinely and terminally cleaned (a cleaning method used in healthcare environments to control the spread of infections) or organized in a manner, which prevented the potential for cross contamination (Refer to A-0749 Finding 9)

6. Multiple sterile items were not stored according to event related sterility standards (a sterile storage practice the hospital followed) (Refer to A-0749 finding 3 and A-0951 Finding 3).

7. The hospital failed to provide documentation to demonstrate they had an active infection control surveillance program to ensure all staff were provided oversight and ensure all hospital practices were performed in a manner which prevented cross contamination (Refer to A-0951 Finding 8).

8. There was no evidence to show the tubing attached to the SARNS machine (a dual cooler-heater machine used during a CABG procedure) and the Myocardial Protection System (MPS: a heart-lung machine used to deliver whole blood and / or cardioplegia {intentional and temporary cessation of cardiac activity} solutions to the heart during open heart surgery), used for CABG surgeries, were changed per manufacturer recommendations or that the surgical equipment used for CABG procedures were cleaned on a daily/regular basis (Refer to A-0749 and A-0951 Findings 4 {a}).

9. The hospital did not have policies or systems in place to guide or provide staff directions on daily cleaning/maintenance of surgical equipment used for CABG procedures (Refer to A-0749 Finding 4 {b}).

10. A sub-sterile room located adjacent to OR 12, contained clean and dirty items, did not have a clear demarcation separating clean from dirty items and was not climate controlled (Refer to A-0749 & A-0951 Findings 6).

11. A clean utility room, located in labor and delivery, which contained sterile items was not climate controlled (Refer to A-0749 Finding 7).

12. 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 (Refer to A-0749 Finding 8 and A-0951 Finding 7).

13. There was no evidence to show that a Perfusionist (a certified medical technician responsible for extracorporeal oxygenation of the blood during open-heart surgery and for the operation and maintenance of equipment, such as a heart-lung machine) received competencies to demonstrate he knew how to clean and maintain the CABG (Coronary Artery Bypass Graft - open heart surgery) equipment (SARNS - a dual cooler-heater machine used during a CABG procedure & MPS - Myocardial Protection System: a heart-lung machine used to deliver whole blood (from any arterial source) and / or cardioplegia {intentional and temporary cessation of cardiac activity} solutions to the heart during open heart surgery), used for CABG procedures (Refer to A-0941 Finding 1).

14. No evidence was provided to demonstrate the hospitals sterile processing, and one sub-sterile room ((a restricted area where staff must wear proper attire and street clothes are not permitted and is used to clean and disinfect soiled patient equipment and instruments, located in OR 12), were routinely and terminally cleaned (a cleaning method used in healthcare environments to control the spread of infections) or organized in a manner, which prevented the potential for cross contamination (Refer to A-0749 and A-0951 Findings 9).

15. Three of three outpatient imaging staff were unable to demonstrate and verbalize understanding of the manufacturer's wet contact time for the disinfectant used for turnover cleaning (Refer to A0749 Finding 10).

16. The facility policy for contact precautions (precautions used to prevent the spread of infections) was not implemented for one patient on contact isolation (Patient 2), when Registered Nurse (RN) 14 entered and left Patient 2's room without putting on a gown, changing gloves, or washing his hands (Refer to A0749 Finding 11).

17. No handwashing sink or hand hygiene gel stations were provided for Environmental Services (EVS) Staff who handled soiled trash and linen bags on the basement floor (Refer to A0749 Finding 12).

18. A staff member at the Women's Center was unable to verbalize understanding of the manufacturer's wet contact time for the disinfectant used for cleaning equipment (Refer to A0749 Finding 13).

The cumulative effects of these systemic problems resulted in the hospital's inability to provide an effective hospital wide infection control program. Resulting in the hospitals inability to provide patient care in a safe and effective manner and in accordance with §482.42 Condition of Participation for Infection Control Services. The seriousness of which, resulted in Immediate Jeopardy, which was identified by the survey team.

Based on observation, interview, and record review, the facility failed to ensure a system was in place for identifying, investigating, and controlling infections and communicable diseases in accordance with internal policies and procedures, as well as nationally recognized infection control practices, guidelines, and regulations.

The facility's infection control program had the following failures:

1. In the hospital sterile processing department, 2 of 2 autoclaves (machines used to sterilize surgical instruments) had exposed fibrous material, torn silver material and large amounts of brown staining on the interior of the chambers.

2. The processing and sterilization of surgical instruments did not follow nationally accepted standards when the hospital failed to ensure there was no presence of spotting, etching and staining on multiple instruments in two of two processed surgical trays (a major, and a minor, previously cleaned, disinfected and sterilized surgical trays which contained surgical instruments).

3. Multiple sterile items were not stored according to event related sterility standards (a sterile storage practice the hospital followed).

4(a). There was no evidence to show the tubing attached to the SARNS machine (a dual cooler-heater machine used during a CABG procedure) and the Myocardial Protection System (MPS: a heart-lung machine used to deliver whole blood and / or cardioplegia {intentional and temporary cessation of cardiac activity} solutions to the heart during open heart surgery), used for CABG surgeries, were changed per manufacturer recommendations or that the surgical equipment used for CABG procedures were cleaned on a daily/regular basis.

4(b). The hospital did not have policies or systems in place to guide or provide staff directions on daily cleaning/maintenance of surgical equipment used for CABG procedures.

5. An ice machine, located in the hospital basement, contained black substance that was easily wiped off.

6. A sub-sterile room located adjacent to OR 12, contained clean and dirty items, did not have a clear demarcation separating clean from dirty items and was not climate controlled.

7. A clean utility room, located in labor and delivery, which contained sterile items was not climate controlled.

8. The cleaning and disinfecting of surgical equipment and devices did not follow nationally accepted infection control standards and failed to ensure the decontamination room (a restricted area where staff must wear proper attire and street clothes are not permitted and is used to clean and disinfect soiled patient equipment and instruments), was maintained 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.

9. No evidence was provided to demonstrate the hospitals sterile processing, and one sub-sterile room ((a restricted area where staff must wear proper attire and street clothes are not permitted and is used to clean and disinfect soiled patient equipment and instruments, located in OR 12), were routinely and terminally cleaned (a cleaning method used in healthcare environments to control the spread of infections) or organized in a manner, which prevented the potential for cross contamination.

10. Three of three outpatient imaging staff were unable to demonstrate and verbalize understanding of the manufacturer's wet contact time for the disinfectant used for turnover cleaning.

11. The facility policy for contact precautions (precautions used to prevent the spread of infections) was not implemented for one patient on contact isolation (Patient 2), when Registered Nurse (RN) 14 entered and left Patient 2's room without putting on a gown, changing gloves, or washing his hands.

12. No handwashing sink or hand hygiene gel stations were provided for Environmental Services (EVS) Staff who handled soiled trash and linen bags on the basement floor.

13. A staff member at the Women's Center was unable to verbalize understanding of the manufacturer's wet contact time for the disinfectant used for cleaning equipment.


Immediate Jeopardy

On 8/15/17 at 1:25 PM, the survey team identified significant concerns in the hospital's CABG OR #12. An Immediate Jeopardy (IJ) was declared for failing to maintain an environment to prevent the risk of cross contamination. The IJ was called in the presence of the Vice President of Nursing Services (VPNS) and the Director of Quality (DQ).

In operating room (OR) 12, two (2) machines (SARNS and MPS, contained black particles, floating cloudy matter within the interior portion of the tubing, which was connected to the machine that provided heart and lung support to patients who received CABG procedures (Refer to A-0749 Finding 4a).

The hospital had no processes or policies in place for the cleaning of the SARNS and MPS machines (Refer to A-0749 Finding 4b).

On 8/15/17 at 4:55 PM, the hospital's VPNS and the DQ provided the team an acceptable corrective action plan to lift the IJ. On 8/16/17 at 12:34 PM, 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 VPNS.

Findings:

1. On 8/14/17 at 11:25 AM, a tour was conducted, in the presence of the Sterile Processing Manager (SPM), of the hospital "Sterile Processing Prep & Pack Area". An observation was made of two of two autoclaves (machines used to sterilize surgical instruments) the interior floors and walls of the holding chambers (an area where a cart holding surgical instruments is placed for sterilization) had brown staining. On the exterior of the machine, adjacent to the door, one of the autoclaves had exposed fibrous material and torn silver material.

During an immediate interview with the SPM, he stated that the brown stains were "probably rust and hard water staining." SPM also stated they did not clean the autoclaves on a regular basis and did not have any documentation to show when they had last been cleaned by the users of the machine.

On 8/14/17 at 11:30 AM, an interview was conducted with the Director of Bio Med (DBM). He stated the exposed fibrous material was insulation and should probably be replaced.

A record review, on 8/16/17 at 4 PM, was conducted of the manufacture "Routine and Preventative Maintenance" of the autoclaves. The document stipulated the following:

" ...The customer is responsible for the routine maintenance items ..."

"Recommended intervals for the cleaning of the "exterior surfaces" and the "Chamber Interior" are to be done "Weekly"

"Cleaning the interior of the chamber is necessary to maximize both the transfer of heat during the sterilization cycle and the service life of the sterilizer. The purpose of cleaning is to remove any build-up of minerals, boiler chemicals, pipeline rust, and deposits from liquid loads. The failure to remove such build-up can compromise the stainless passive layer and lead to corrosion of the chamber."

2. During an interview with the Director of Infection Control (ICD), on 8/14/17 at 10:40 AM, she stated that the hospital follows nationally recognized infection control guidelines from AAMI (Association for the Advancement of Medical Instrumentation - an organization for advancing the development, and safe and effective use of medical technology), CDC (Centers for Disease Control), and AORN (Association of perioperative Registered Nurses - leaders in advocating for excellence in perioperative practice and healthcare).

On 8/14/17 at 1:35 PM, during an observation in the SPD, the Manager of Sterile Processing (MSP) was asked to open a major and a minor tray. The following concerns were identified upon observation of the surgical instruments:

- The major tray contained 62 previously sterilized surgical instruments (according to the itemized list of instruments provided by the facility). Approximately 24 instruments contained various concerns such as brown staining (some was removed using white gauze), chipped and peeled surgical instrument identification tape of various colors and etching (not from manufacturer). In addition, 4 hinged instruments were in the closed position.

- The minor tray contained 58 previously sterilized surgical instruments Approximately 26 instruments contained various concerns such as brown staining, chipped or peeled surgical instrument identification tape, of various colors and several hinged instruments were difficult to open.

An interview was conducted with the MPS, immediately following the inspection of the surgical instruments. MPS stated that the instruments should have been inspected prior to being placed in the sterilizer, and any instruments found to be "rusted" or had brown staining and peeled- off tape, should be pulled from use and replaced. MPS also stated that the hinged instruments which were difficult to open could be due to "rust".

- Surveyor requested to observe a third (3) previously processed surgical tray for instrumentation inspection. MSP open a "long instrument set", 10 of 21 instruments also contained brown staining, etching and chipped identification tape.

During an immediate interview, the MSP confirmed the above findings and stated that the hospitals practice was to inspect the instruments prior to packaging and sterilizing. MSP also stated the above instruments should have been pulled and replace.

During the survey, requests were made to provide a hospital policy to address the inspection of surgical instruments however, the document was never produced.

According to AAMI (Association for the Advancement of Medical Instrumentation - an organization for advancing the development, and safe and effective use of medical technology) - "Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities", CDC (Centers for Disease Control) Guidelines, and AORN (Association of perioperative Registered Nurses - leaders in advocating for excellence in perioperative practice and healthcare) guidelines, their recommendations, stipulated the following:

"Instruments should undergo an inspection for proper function and cleanliness...1. Instruments should be inspected for a) cleanliness b) proper functioning and alignment, corrosion, pitting, burrs, nick, and cracks, sharpness of cutting edges c) any other defects... 2. Instruments in disrepair should be labeled and taken out of service until properly repaired or replaced ..."

A record review of a document provided by hospital staff, titled, "Key Surgical Identification Tape", from the identification tape manufacturer, stipulated, "Tape should lay flat without gaps ..." and to replace when tape starts to discolor, chip, crack or flake.

3. During an interview with the Director of Infection Control (ICD), on 8/14/17 at 10:40 AM, she stated that the hospital follows nationally recognized infection control guidelines from AAMI (Association for the Advancement of Medical Instrumentation - an organization for advancing the development, and safe and effective use of medical technology), CDC (Centers for Disease Control), and AORN (Association of perioperative Registered Nurses - leaders in advocating for excellence in perioperative practice and healthcare).

During an observation in a hospital "Storage Room" of various sterile items in peel packs (pouches used for packaging sterile instruments), the following concerns were identified:

-Multiple surgical instruments contained brown staining

-Multiple instruments contained non-manufacture etching

-Multiple instruments contained chipped identification tape
.
-One peel pack contained a brown stain on the exterior side of the pack.

During an interview, with the MSP, who was present during the observations, he stated the hospital followed sterile storage "Event Related Sterility Concept" (an item is considered sterile unless the peel pack is damaged/compromised such as torn, stained or opened).

During a review of a hospital policy titled, "Expiration Dating/Event Related Sterility, reviewed date 5/2017," the document stipulated:
"1. All itemes sterilized in-house wil be considered sterile unless the integrity of the packaging materila used is compromised, or suspected of being compromised, (i.e. torn, seals broken, discolored, wet, stained,etc.) by events which have occurred during the items transportation, handling or storage,..."

AORN's "Recommended Practices for Maintaining a Sterile Field RECOMMENDED PRACTICE III" stipulates, "An event-related sterility system should be used and is based on the concept that "sterility is not altered over time, but may be compromised by certain events or environmental conditions." "Shelf life refers to the time an item may remain on the shelf and still maintain its sterility. Shelf life is influenced by the type of packaging used, storage conditions (e.g., open or closed shelves), humidity, temperature, transport conditions, use of dust covers, and the amount of handling the item receives".

4(a). During an observation of a hospital operating room (OR 12), on 8/15/17 at 10:20 AM, in the presence of the ICD, the Perfusionist, OR Service Manager, OR Supervisor, OR Director and an OR Registered Nurse, the following concerns were identified:

-Multiple patient equipment, including a "stand alone cart", "carbon dioxide tank" and an "Intravenous Pole", used for CABG procedures had brown, black and red matter.

-The SARNS ice chamber, contained stagnant water, black and brown floating matter. At the bottom of the chamber, a square metal filter contained reddish/brown rough matter, and a small round filter contained gray fuzzy matter. The exterior of the machine, contained brown matter.

-The tubing of the SARNS, was filled with stagnant water and contained cloudy floating matter.

-The "stand alone cart", used for the heart-lung machine, contained significant amounts of brown, black and red matter. The cart was wiped with a Sani-Wipe, in the presence of the ICD, the Perfusionist, OR Service Manager, OR Supervisor, OR Director and an OR Registered Nurse, a significant amount of brown, black and red matter were easily wiped off.

-The exterior of the MPS contained brown matter. The tubing attached to the MPS contained stagnant water, black particles, floating cloudy and pink matter within the interior portion of the tubing which was connected to the machine.

During an immediate interview following the observations, the Perfusionist stated, "The vendors of the heart-lung machine come to change the tubing. I change it periodically, when it looks like it needs to be changed." The Perfusionist also stated they did not have policies or procedures in place and no manufacture guidelines were used to address the daily/regular cleaning of the SARNS or the MPS. The Perfusionist was unable to recall the last time the tubing was changed and stated they did not have any documentation or logs.

During the same interview, the Perfusionist stated the reason for the black matter at the bottom of the SARNS, was due to the residue that was left over after the ice has melted.

A record review, on 8/17/17 at 9:20 AM, a document was provided by the Infection Control Preventionist (ICP). The document titled, "Myocardial Protection System Operations Manual," stipulated the following:

"Water Ports, Water hoses connect the water ports on the back of the MPS 2 Console", the tubing which contained the floating matter.

"Disposable Components and Accessories, Description: The MPS 2 console is designed to use a specific line of sterile disposable components ...MPS 2 delivery sets are single use, ..."

"Surface Disinfection, Disinfect the MPS 2 console with any hospital approved disinfecting agent ..."

4(b). The facility did not have any policies or practice in place to address the process of daily/regular cleaning of the SARNS or the MPS and its tubing.

5. On 8/15/17 at 11 AM, an observation was made in the presence of the ICD, ICP, and the Environment Service Supervisor (ESS) of an ice machine located in the hospital basement. According to the staff, the ice machine was used to provide ice to OR 12 for surgical procedures.

During the observation, the following concerns were identified:

-Some of the ice had yellow staining.

-A clean white paper towel was used to wipe the top panel of the ice machine chamber located directly above the ice, after the swipe, the paper contained black matter.

During an immediate interview with the ESS, he stated that it was the environmental staff (EVS) responsibility to clean the ice machine; however they did not have any documentation to indicate that the machine had been cleaned.

The "Installation and User's Manual" for the ice machine, was provided by the ICP, on 8/17/17 at 9:20 AM.
The document stipulated the following:

"Maintenance ...All models require regular sanitation - All models require sensor cleaning ..."

6. During an interview with the Director of Infection Control (ICD), on 8/14/17 at 10:40 AM, she stated that the hospital followed nationally recognized infection control guidelines from AAMI (Association for the Advancement of Medical Instrumentation - an organization for advancing the development, and safe and effective use of medical technology), CDC (Centers for Disease Control), and AORN (Association of perioperative Registered Nurses - leaders in advocating for excellence in perioperative practice and healthcare).

On 8/15/17 at 2:20 PM, an observation was made of OR 12 Sub-Sterile room (a workspace used to process patient equipment), in the presence of the ICD, ICP and an OR RN. The observations revealed the following:

-An ice machine, used to supply ice to the SARNS (a dual cooler-heater machine used during Coronary Artery Bypass Graft procedures (CABG), was located in the sub-sterile room, adjacent to the machine used for cleaning and disinfecting soiled patient Trans-Esophageal Echocardiogram scopes (TEE - used to obtain detailed pictures of the heart and its major blood supply).

According to the ICD and OR RN, the room contained clean and dirty items. The room did not contain a line of demarcation separating clean from dirty items. The room was not equipped to monitor the temperature or humidity inside the room.

During an immediate interview with the ICD, she stated they would be removing the ice machine and would ensure a demarcation line would be installed. ICD also stated the room did not have a method for obtaining temperature and humidity but they would be installing them.

According to AAMI, Sterility Update 2010, relative humidity should be maintained between 30% and 60% in all work areas. "Because of the need to war 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

7. An observation was made on 8/15/17 at 4:10 PM of a labor and delivery "Clean Utility Room" which was used to store sterile instruments. The room contained many sterile instruments and had no method of obtaining and monitoring the temperature and humidity.

During an interview with the Clinical Supervisor of Women's OR and Triage (CSW), at 4:20 PM, she stated the items in the clean utility room were sterile items but they did not monitor temperature or humidity in the room.

A record review was conducted on 8/16/17 at 9:20 PM, of a hospital policy titled, "General Guidelines: Storage of Sterile Supplies, reviewed date 7/2017". The policy stipulated the following:

"Storage: 1. Packaged sterile supplies should be stored in enclosed cupboards with vented shelving or open vented shelving in a closed dust-free room with a humidity not to exceed 70% and constant temperature less than 75 degree Fahrenheit ..."

8. During an interview with the Director of Infection Control (ICD), on 8/14/17 at 10:40 AM, she stated that the hospital follows nationally recognized infection control guidelines from AAMI (Association for the Advancement of Medical Instrumentation - an organization for advancing the development, and safe and effective use of medical technology), CDC (Centers for Disease Control), and AORN (Association of perioperative Registered Nurses - leaders in advocating for excellence in perioperative practice and healthcare).

On 8/16/17 at 10 AM a tour of the hospital decontamination room (a restricted area where staff must wear proper attire and street clothes are not permitted and is used to clean and disinfect soiled patient equipment and instruments) was conducted in the presence of the IPD, ICD, MSP, and a sterile processing technician (SPD 1), concerns identified included:

-An observation of SPD 1 cleaning two (2) trays filed with soiled instruments.

-Soiled surgical instruments were not pre-cleaned according to infection control standards and hospital policy

-SPD 1 scrubbed 3 to 4 instruments at a time.

-SPD 1 scrubbed instruments above water.

-SPD 1 placed the tubing, which automatically dispensed the enzymatic solution into the tray filled with soiled instruments (the water contained red discoloration).

-SPD 1 obtained a clean packaged brush from a clean area while the gloves were wet and as he was scrubbing soiled instruments.

-SPD 1 did not change gloves after he completed cleaning the instruments and proceeded to touch clean areas within the decontamination room.

-SPD 1 stated he did not clean the area after he completed cleaning the surgical instruments.

-Directly above the sink, on a wall, were red splash marks, the red marks were identified prior to SPD 1 cleaning the instruments.

-Two exposed areas measuring approximately 4 inches by 4 inches were identified beneath the sinks. MSP stated the gaps were exposed areas from floor pedals that had been removed and not replaced.

-Above a washer were gray/white fuzzy matter and two (2) plastic tubing's.

-On the floor adjacent to the washer was a large area with brown/red discoloration. MSP stated it was "rust"
.
-On the wall adjacent to the washer were multiple brown/red handprints.

-A trash can was over filled with trash.

Immediately following the observations, the IPD, ICP, and MSP were asked if they identified any concerns with SPD 1's cleaning technique. They stated some of their concerns included risk of cross contamination due to not changing the gloves.
IPD, ICP and MSP were also asked if the tubing which was placed in the soiled water, that dispensed the enzymatic solution was supposed to be left in the soiled water. They confirmed the findings and stated that the tubing should have not been left in the soiled water.

During a concurrent interview with MSP the surveyor shared the concerns identified during the observations of the decontamination room. MSP stated they did not have written documentation or logs to show the room was terminally daily by the environmental service (EVS) department or regularly cleaned by staff.

AORN, one of the nationally recognized infection control guidelines 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, further stipulates, "Scheduled cleaning is a cleaning schedule that defines areas and equipment that should be cleaned on a regular (e.g., weekly, monthly) basis. AORN recommends that terminal cleaning and disinfection of the sterile processing areas "be performed daily when the areas are being used." Terminal cleaning should not be performed when personnel are actively de-contaminating instruments. Cleaning should progress from cleanest to dirtiest areas. AORN recommends (Recommendation V) a schedule for cleaning the following:
clean and soiled storage areas, storage cabinets, sterile storage area, aerators on faucets should be cleaned and disinfected on a routine basis? ...

AAMI ST79 states:
"Walls, storage shelves, and air intake and return ducts should be cleaned on a regularly scheduled basis and more often if needed. Stained ceiling tiles should be replaced, and any leaks causing the stains should be repaired. Lighting fixtures or covers should be cleaned at least once every 6 months ..."

9. During an interview with the Director of Infection Control (ICD), on 8/14/17 at 10:40 AM, she stated that the hospital follows nationally recognized infection control guidelines from AAMI (Association for the Advancement of Medical Instrumentation - an organization for advancing the development, and safe and effective use of medical technology), CDC (Centers for Disease Control), and AORN (Association of perioperative Registered Nurses - leaders in advocating for excellence in perioperative practice and healthcare).

On 8/14/17 to 8/15/17 during multiple observations of the hospital sterile processing room (SPD) and a sub-sterile room located in OR 12 and multiple findings shared with the hospital IPD, ICP, MSP, and DSS requests were made to provide evidence of to show daily/regular cleaning and terminal cleaning were done.

Immediate interviews with MSP and DSS were conducted. MSP and DSS indicated they had no documentation to show terminal cleaning or regular cleaning was done in the SPD or the Sub-sterile OR 12.

A record review was conducted on 8/17/17 at 10 AM of a hospital policy titled, "Cleaning Surgical and Procedural Areas, reviewed 3/16." The policy stipulated, "Sub-Sterile Cleanings - Cleanings will be done daily and throughout the day as needed ..."

AORN, one of the nationally recognized infection control guidelines 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 further stipulates, "Scheduled cleaning is a cleaning schedule that defines areas and equipment that should be cleaned on a regular (e.g., weekly, monthly) basis. AORN recommends that terminal cleaning and disinfection of the sterile processing? areas "be performed daily when the areas are? being used." Terminal cleaning should not be? performed when personnel are actively de-?contaminating instruments. Cleaning should progress from cleanest to dirtiest areas. AORN recommends (Recommendation V) a schedule for cleaning the following: clean and soiled storage areas, storage cabinets, sterile storage area, aerators on faucets should be cleaned and disinfected on a routine basis ...

AAMI ST79 states:
"Walls, storage shelves, and air intake and return ducts should be cleaned on a regularly scheduled basis and more often if needed. Stained ceiling tiles should be replaced, and any leaks causing the stains should be repaired. Lighting fixtures or covers should be cleaned at least once every 6 months ..."



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These failures increased the risk for transmission of infections to patients, staff, and visitors.

Findings:

10 a. On August 16, 2017, at 2 p.m., a tour of Outpatient Imaging Facility 1 was conducted. Imaging Staff (IS) 1 was interviewed about the disinfection process when turning over an examination room for the next patient. IS 1 stated she used the the disinfectant "sani-wipes" with the green top to clean all areas of the patient room that might be touched, such as the bed, equipment, table, etc. IS 1 stated she left the disinfectant on the surfaces for 10 minutes. IS 1 stated she did not rewipe the treated surfaces if the disinfectant dried up before 10 minutes.

b. On August 16, 2017, at 3:30 p.m., a tour of Outpatient Imaging Facility 2 was conducted. IS 2 and IS 3 were observed preparing a used transvaginal probe (ultrasound probe placed inside the vagina to look at a woman's uterus, ovaries, tubes, cervix and pelvic area) for high level disinfection. IS 2 and IS 3 were asked how they cleaned and disinfected the bed, table, and other equipment in the examination rooms. IS 2 and IS 3 stated they used the "sani cloth" with the green top.

IS 2 stated he wiped the surfaces with the "sani wipes" and left the surface to dry for 10 minutes. IS 2 stated his understanding was that once the surface was wiped, "We don't use it for 10 minutes." IS 2 stated he did not know anything about the surface needing to remain wet for any period of time, just that he had to wait for ten minutes after he cleaned something before he could use it.

IS 3 stated the contact time for the "sani wipes" with green top was "30 seconds."

The label for "Sani-Cloth HB" (the sani-wipes used in the outpatient imaging facilities) was reviewed. The label indicated, "TO DISINFECT:...Unfold a clean wipe and thoroughly wet surface. Treated surface must remain visibly wet for a full ten (10) minutes. Use additional wipe(s) if needed to assure continuous 10 minute wet contact time..."



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11. During a tour of the medical/surgical unit on August 14, 2017, at 11:15 a.m., Patient 2 was observed laying in bed with a Foley catheter in place (catheter inserted into the bladder to drain urine into a collection bag). A sign was observed on Patient 15's door. The sign indicated, "Contact Precautions...wash your hands before entering and leaving the room...wear gown when entering patient room...wear gloves when entering patient room...remove gloves before leaving patient room..."

Registered Nurse (RN) 14 was observed entering Patient 2's room wearing a pair of disposable gloves. RN 14 was observed re-positioning Patient 2's Foley catheter tubing with the gloves on. RN 14 was observed leaving Patient 2's room and going to the isolation cart (cart with supply of clean gowns and gloves used for contact precautions). RN 14 was then observed opening the cart drawer, pulling out a clean gown, and carrying the gown into Patient 2's room with the used gloves on.

On August 14, 2017, at 11:30 a.m., RN 14 was interviewed. RN 14 stated when a patient was on contact precautions, the nurse should wash their hands and put on a clean gown and clean gloves from the isolation cart before entering the patient's room. RN 14 then stated the nurse should throw the gown and gloves away in the room and wash their hands again before leaving the patient's room.

The facility policy and procedure, titled, "Contact Precautions, " with a review date of July 2017, was reviewed. The policy indicated,"...Purpose: To prevent the transmission of disease...wear gloves when entering the room...Remove gloves before leaving the patient's room...All health care personnel...perform a 15 second hand wash...after patient contact, after handling equipment...wear a gown...Remove the gown before leaving the patient's environment..."

12. A tour and observation of the trash and soiled linen disposal chute areas, Room BB01, located on the basement level, was conducted on August 14, 2017, at 2:25 p.m.

EVS Staff 1 was observed transferring multiple full, clear plastic trash bags into a large wheeled trash bin. Multiple trash bags were observed to contain an unknown white liquid that dripped from the bags onto the trash bins and floor as they were moved by EVS Staff 1.

In a concurrent interview, EVS Staff 1 stated his job was to remove trash bags and full bags of soiled linen from the trash and laundry chutes throughout the day. EVS Staff 1 stated he emptied the chutes at least 5 times daily. EVS Staff 1 stated the small wheeled bins used to collect the trash from the chute got cleaned every few days. EVS Staff 1 stated the large wheeled trash bins used to move and store the trash were cleaned, "whenever they get a chance."

When asked where EVS staff washed or sanitized their hands after handling the trash and soiled linen bags, EVS Staff 1 s

Based on observation, interview, and record review, the hospital failed to provide surgical services in a well-organized manner and in accordance with acceptable standards of practice. The hospital failed to comply with the §482.51 Condition of Participation for Surgical Services 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 in their surgical service department (Refer to A-0951 Finding 8).

2. In the hospital sterile processing department, two of two autoclaves (machines used to sterilize surgical instruments) had exposed insulation and large amounts of brown staining within the chambers (Refer to A-0951 finding 1).

3. The processing and sterilization of surgical instruments did not follow nationally accepted standards when the hospital failed to ensure there was no presence of spotting, etching and staining on multiple instruments in two of two processed surgical trays (a major and a minor, previously cleaned, disinfected and sterilized surgical trays which contained surgical instruments) {Refer to A-0951 finding 2}

4. An ice machine, located in the hospital basement, contained black substance that was easily wiped off (Refer to A-0951 Finding 5).

5. No evidence was provided to demonstrate the hospitals sterile processing, and one sub-sterile room ((a restricted area where staff must wear proper attire and street clothes are not permitted and is used to clean and disinfect soiled patient equipment and instruments, located in OR 12), were routinely and terminally cleaned (a cleaning method used in healthcare environments to control the spread of infections) or organized in a manner, which prevented the potential for cross contamination (Refer to A-0951 Finding 9)

6. Multiple sterile items were not stored according to event related sterility standards (a sterile storage practice the hospital followed) (Refer to A-0951 Finding 3).

7. The hospital failed to provide documentation to demonstrate they had an active infection control surveillance program to ensure all staff were provided oversight and ensure all hospital practices were performed in a manner which prevented cross contamination (Refer to A-0951 Finding 8).

8. There was no evidence to show the tubing attached to the SARNS machine (a dual cooler-heater machine used during a CABG procedure) and the Myocardial Protection System (MPS: a heart-lung machine used to deliver whole blood and / or cardioplegia {intentional and temporary cessation of cardiac activity} solutions to the heart during open heart surgery), used for CABG surgeries, were changed per manufacturer recommendations or that the surgical equipment used for CABG procedures were cleaned on a daily/regular basis (Refer to A-0951 Finding 4 {a}).

9. The hospital did not have policies or systems in place to guide or provide staff directions on daily cleaning/maintenance of surgical equipment used for CABG procedures (Refer to A-0951 Finding 4 {b}).

10. A sub-sterile room located adjacent to OR 12, contained clean and dirty items, did not have a clear demarcation separating clean from dirty items and was not climate controlled (Refer to A-0951 Finding 6).

11. 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 (Refer to A-0951 Finding 7).

12. There was no evidence to show that a Perfusionist (a certified medical technician responsible for extracorporeal oxygenation of the blood during open-heart surgery and for the operation and maintenance of equipment, such as a heart-lung machine) received competencies to demonstrate he knew how to clean and maintain the CABG (Coronary Artery Bypass Graft - open heart surgery) equipment (SARNS - a dual cooler-heater machine used during a CABG procedure & MPS - Myocardial Protection System: a heart-lung machine used to deliver whole blood (from any arterial source) and / or cardioplegia {intentional and temporary cessation of cardiac activity} solutions to the heart during open heart surgery), used for CABG procedures (Refer to A-0941 Finding 1).

13. One patient (Patient 39), who underwent multiple complex procedures in the Cardiac Catheterization Laboratory (CCL), was not positioned to relieve pressure to his skin and bony prominences in accordance with accepted standards of practice, resulting in redness and bruising in both elbows, and a deep tissue injury on his buttock

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 care. The hospital failed to deliver care in a safe setting and therefore failed to comply with the §482.51 Condition of Participation for Surgical Services.


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Findings:

During a tour of the Cardiac Intensive Care Unit (CICU) on August 14, 2017, at 1:30 p.m., accompanied by the Charge Nurse (CN), the CN stated there was one patient in the unit with a pressure sore (Patient 39), acquired after undergoing a nine hour procedure in the CCL.

The record for Patient 39 was reviewed. Patient 39, a 78 year old male, presented to the Emergency Department (ED) on August 11, 2017, at 8:02 p.m., with low blood pressure and complaints of abdominal and back pain. The record indicated the patient had a history of:

1. Severe peripheral arterial disease (blockage of arteries outside of the heart and brain, a medical condition that affects (decreases) blood flow to the tissues);

2. Hypertension (high blood pressure, a medical condition that affects (decreases) blood flow to the tissues);

3. Hyperlipidemia (high fat contents in the blood, a medical condition that affects (decreases) blood flow to the tissues);

4. Cerebrovascular accident (CVA - Stroke, a medical condition caused by decreased blood flow to the tissues); and,

5. Current smoker with Chronic Obstructive Pulmonary Disease (COPD, a medical condition that affects (decreases) blood flow to the tissues).

CAT scan (x-rays taken from different angles) results indicated Patient 39 had:

a. A symptomatic contained rupture of an abdominal aortic aneurysm (bleeding from a bulge in the largest artery in the body, a life threatening emergency and a medical condition that affects (decreases) blood flow to the tissues);

b. Total occlusion of his right external iliac and common femoral arteries (blocked arteries in the right leg, a condition that affects (decreases) blood flow to the tissues); and,

c. Total occlusion of his left common femoral and internal iliac arteries (blocked arteries in the left leg, a condition that affects (decreases) blood flow to the tissues).

The record indicated Patient 39 was taken to the CCL by a cardiovascular surgeon, and had the following procedures performed under general anesthesia (making him unable to move during the procedure):

A. Endovascular (through the vessels) repair of the abdominal aortic aneurysm;

B. Endovascular repair of the right common iliac artery;

C. Endovascular repair of the left common iliac artery;

D. Endovascular repair and bypass of the right femoral artery; and,

E. Removal of the left iliac/femoral thrombus (clot).

The CCL record indicated Patient 34 was placed on the procedure table at 1:21 a.m., and was taken off the table at 8:46 a.m. (a seven hour and 25 minute procedure with inability to move and decreased blood flow to his tissues).

[According to the National Pressure Ulcer Advisory Panel (NPUAP), decreased mobility and decreased perfusion (bloodflow) to the tissues increase the risk of developing pressure sores]

There was no evidence any interventions were implemented to relieve pressure on the patient's skin and bony prominences during the procedure.

The record indicated Patient 34 was admitted directly to CICU from the CCL.

The CICU nursing admission assessment indicated Patient 34 had a reddened right elbow and forearm, ecchymosis (multiple small spots of bleeding under the skin) on his left forearm, redness on his lower back, and a deep tissue injury on his buttock (a pressure related tissue injury under intact skin).

The wound care assessment, completed August 14, 2017, indicated the pressure related injuries had progressed to bruising with ecchymosis and a skin tear on his left forearm, bruising with ecchymosis on his lower back, and a Stage 2 pressure sore on his buttock (partial-thickness loss of the skin).

During a tour of the CCL on August 15, 2017, at 11:05 a.m., accompanied by the CCL supervisor, one procedure table was observed with a mattress covering the length of the solid table, approximately two inches thick.

In a concurrent interview, the supervisor stated all of the tables had the same mattress on them. The supervisor stated they did not have or use any special mattresses or padding for cases that they anticipated would last for a long period of time.

During a tour of the Operating Room (OR) on August 17, 2017, at 9:20 a.m., accompanied by the OR Nurse Manager (ORNM), the ORNM stated they used a gelmat (a mattress pad made of a combination of gel and foam) under the patient and mepilex pads (foam pads designed to cover bony prominences) on the bony prominences (elbows, coccyx [tailbone/buttock area]) for all cardiac surgery cases performed in the operating room. She stated they were long procedures, and the patients had compromised blood flow and immobility for long periods of time, so they used the extra padding to prevent pressure sores from developing.

According to the Association of periOperative Nurses (AORN - a nationally recognized professional organization that identifies standards of practice for perioperative nurses), their guidelines are recommended for various practice settings where operative and other invasive procedures are performed, including the CCL.

The Guidelines for Positioning the Patient include:

Recommendation VII:
Perioperative team members should position patients on surfaces that reduce the potential for pressure injury;

Recommendation VII.e:
Perioperative patients identified as being high risk for pressure injury should be positioned on foam surfaces, if possible; and,

Recommendation VII.f:
Perioperative personnel should use additional pressure-redistributing padding to support the patient and redistribute pressure from bony prominences and other pressure points.

The AORN standards of practice were being followed in the operating room, but not in the CCL.

Based on observations, interviews and record reviews, the hospital failed to ensure they provided evidence to show a Perfusionist received training on cleaning and maintaining two (2 ) machines he used and operated for surgical procedures performed in the hospital. This failure had the potential of cross contamination between patients who received Coronary Artery Bypass Graft procedures in the hospital operating room.

There was no evidence to show that a Perfusionist (a certified medical technician responsible for extracorporeal oxygenation of the blood during open-heart surgery and for the operation and maintenance of equipment, such as a heart-lung machine) received competencies to demonstrate he knew how to clean and maintain the CABG (Coronary Artery Bypass Graft - open heart surgery) equipment (SARNS - a dual cooler-heater machine used during a CABG procedure & MPS - Myocardial Protection System: a heart-lung machine used to deliver whole blood (from any arterial source) and /or cardioplegia {intentional and temporary cessation of cardiac activity} solutions to the heart during open heart surgery), used for CABG procedures.


Findings:

During an observation of a hospital operating room (OR 12), on 8/15/17 at 10:20 AM, in the presence of the ICD, the Perfusionist, OR Service Manager, OR Supervisor, OR Director and an OR Registered Nurse, the following concerns were identified:

-Multiple patient equipment, including a "stand alone cart", "carbon dioxide tank" and an "Intravenous Pole", used for CABG procedures had brown, black and red matter.

-The SARNS ice chamber, contained stagnant water, black and brown floating matter. At the bottom of the chamber, a square metal filter contained reddish/brown rough matter, and a small round filter contained gray fuzzy matter. The exterior of the machine, contained brown matter.

-The tubing of the SARNS, was filled with stagnant water and contained cloudy floating matter.

-The "stand alone cart", used for the heart-lung machine, contained significant amounts of brown, black and red matter. The cart was wiped with a Sani-Wipe, in the presence of the ICD, the Perfusionist, OR Service Manager, OR Supervisor, OR Director and an OR Registered Nurse, a significant amount of brown, black and red matter were easily wiped off.

-The exterior of the MPS contained brown matter. The tubing attached to the MPS contained stagnant water, black particles, floating cloudy and pink matter within the interior portion of the tubing which was connected to the machine.

During an immediate interview following the observations, the Perfusionist stated, "The vendors of the heart-lung machine come to change the tubing. I change it periodically, when it looks like it needs to be changed." The Perfusionist also stated they did not have policies or procedures in place and no manufacture guidelines were used to address the daily/regular cleaning of the SARNS or the MPS. The Perfusionist was unable to recall the last time the tubing was changed and stated they did not have any documentation or logs.

During the same interview, the Perfusionist stated the reason for the black matter at the bottom of the SARNS, was due to the residue that was left over after the ice has melted.

A record review, on 8/17/17 at 9:20 AM, a document was provided by the Infection Control Preventionist (ICP). The document titled, "Myocardial Protection System Operations Manual," stipulated the following:

"Water Ports, Water hoses connect the water ports on the back of the MPS 2 Console", the tubing which contained the floating matter.

"Disposable Components and Accessories, Description: The MPS 2 console is designed to use a specific line of sterile disposable components ...MPS 2 delivery sets are single use, ..."

"Surface Disinfection, Disinfect the MPS 2 console with any hospital approved disinfecting agent ..."

The facility did not have any policies or practice in place to address the process of daily/regular cleaning of the SARNS or the MPS and its tubing

A record review was conducted on 8/17/17 at 11:25 AM, of the Perfusionist's employee file. There was no documented evidence to show that he received training regarding cleaning and maintenance of the SARNS or the MPS machines he used during CABG procedures.
During a concurrent interview with the DSS, she stated they had no documentation to show he was trained because he was not an employee of the hospital and was a contracted employee of the heart surgeons.

Based on observation, interview, and record review, the hospital failed to implement a system for evaluating and implementing a hospital wide infection control prevention program and failed to ensure their hospital infection control program had a system in place for the surveillance, prevention, and control of infections, as evidence by:

1. In the hospital sterile processing department, 2 of 2 autoclaves (machines used to sterilize surgical instruments) had exposed insulation and large amounts of brown staining within the chambers.

2. The processing and sterilization of surgical instruments did not follow nationally accepted standards when the hospital failed to ensure there was no presence of spotting, etching and staining on multiple instruments in two of two processed surgical trays (a major, and a minor, previously cleaned, disinfected and sterilized surgical trays which contained surgical instruments).

3. Multiple sterile items were not stored according to event related sterility standards (a sterile storage practice the hospital followed).

4 (a). There was no evidence to show the tubing attached to the SARNS machine (a dual cooler-heater machine used during a CABG procedure) and the Myocardial Protection System (MPS: a heart-lung machine used to deliver whole blood and / or cardioplegia {intentional and temporary cessation of cardiac activity} solutions to the heart during open heart surgery), used for CABG surgeries, were changed per manufacturer recommendations or that the surgical equipment used for CABG procedures were cleaned on a daily/regular basis.

4 (b). The hospital did not have policies or systems in place to guide or provide staff directions on daily cleaning/maintenance of surgical equipment used for CABG procedures.

5. An ice machine, located in the hospital basement, contained black substance that was easily wiped off.

6. A sub-sterile room located adjacent to OR 12, contained clean and dirty items, did not have a clear demarcation separating clean from dirty items and was not climate controlled.

7. 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.

8. The hospital failed to provide documentation to demonstrate they had an active infection control surveillance program to ensure all staff were provided oversight and ensure all hospital practices were performed in a manner which prevented cross contamination.

9. No evidence was provided to demonstrate the hospitals sterile processing, and one sub-sterile room ((a restricted area where staff must wear proper attire and street clothes are not permitted and is used to clean and disinfect soiled patient equipment and instruments, located in OR 12), were routinely and terminally cleaned (a cleaning method used in healthcare environments to control the spread of infections) or organized in a manner, which prevented the potential for cross contamination.


Findings:


1. On 8/14/17 at 11:25 AM, a tour was conducted, in the presence of the Sterile Processing Manager (SPM), of the hospital "Sterile Processing Prep & Pack Area". An observation was made of 2 of 2 autoclaves (machines used to sterilize surgical instruments) the interior floors and walls of the holding chambers (an area where a cart holding surgical instruments is placed for sterilization) had brown staining. On the exterior of the machine, adjacent to the door, one of the autoclaves had exposed fibrous material and torn silver material.
During an immediate interview with the SPM, he stated that the brown stains were "probably rust and hard water staining." SPM also stated they did not clean the autoclaves on a regular basis and did not have any documentation to show when they had last been cleaned by the users of the machine.

On 8/14/17 at 11:30 AM, an interview was conducted with the Director of Bio Med (DBM). He stated that the exposed fibrous material was insulation and should probably be replaced.

A record review, on 8/16/17 at 4 PM, was conducted of the manufacture "Routine and Preventative Maintenance" of the autoclaves. The document stipulated the following:

" ...The customer is responsible for the routine maintenance items ..."

"Recommended intervals for the cleaning of the "exterior surfaces" and the "Chamber Interior" are to be done "Weekly"

"Cleaning the interior of the chamber is necessary to maximize both the transfer of heat during the sterilization cycle and the service life of the sterilizer. The purpose of cleaning is to remove any build-up of minerals, boiler chemicals, pipeline rust, and deposits from liquid loads. The failure to remove such build-up can compromise the stainless passive layer and lead to corrosion of the chamber."

2. During an interview with the Director of Infection Control (ICD), on 8/14/17 at 10:40 AM, she stated that the hospital follows nationally recognized infection control guidelines from AAMI (Association for the Advancement of Medical Instrumentation - an organization for advancing the development, and safe and effective use of medical technology), CDC (Centers for Disease Control), and AORN (Association of perioperative Registered Nurses - leaders in advocating for excellence in perioperative practice and healthcare).

On 8/14/17 at 1:35 PM, during an observation in the SPD, the Manager of Sterile Processing (MSP) was asked to open a major and a minor tray. The following concerns were identified upon observation of the surgical instruments:

- The major tray contained 62 previously sterilized surgical instruments (according to the itemized list of instruments provided by the facility). Approximately 24 instruments contained various concerns such as brown staining (some was removed using white gauze), chipped and peeled surgical instrument identification tape of various colors and etching (not from manufacturer). In addition, 4 hinged instruments were in the closed position.

- The minor tray contained 58 previously sterilized surgical instruments Approximately 26 instruments contained various concerns such as brown staining, chipped or peeled surgical instrument identification tape, of various colors and several hinged instruments were difficult to open.

An interview was conducted with the MPS, immediately following the inspection of the surgical instruments. MPS stated that the instruments should have been inspected prior to being placed in the sterilizer, and any instruments found to be "rusted" or had brown staining and peeled- off tape, should be pulled from use and replaced. MPS also stated that the hinged instruments which were difficult to open could be due to "rust".

- Surveyor requested to observe a third (3) previously processed surgical tray for instrumentation inspection. MSP open a "long instrument set", 10 of 21 instruments also contained brown staining, etching and chipped identification tape.

During an immediate interview, the MSP confirmed the above findings and stated that the hospitals practice was to inspect the instruments prior to packaging and sterilizing. MSP also stated the above instruments should have been pulled and replace.

During the survey, requests were made to provide a hospital policy to address the inspection of surgical instruments however, the document was never produced.

According to AAMI (Association for the Advancement of Medical Instrumentation - an organization for advancing the development, and safe and effective use of medical technology) - "Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities", CDC (Centers for Disease Control) Guidelines, and AORN (Association of perioperative Registered Nurses - leaders in advocating for excellence in perioperative practice and healthcare) guidelines, their recommendations, stipulated the following:

"Instruments should undergo an inspection for proper function and cleanliness...1. Instruments should be inspected for a) cleanliness b) proper functioning and alignment, corrosion, pitting, burrs, nick, and cracks, sharpness of cutting edges c) any other defects...2. Instruments in disrepair should be labeled and taken out of service until properly repaired or replaced ..."

A record review of a document provided by hospital staff, titled, "Key Surgical Identification Tape", from the identification tape manufacturer, stipulated, "Tape should lay flat without gaps ..." and to replace when tape starts to discolor, chip, crack or flake.

3. During an interview with the Director of Infection Control (ICD), on 8/14/17 at 10:40 AM, she stated that the hospital follows nationally recognized infection control guidelines from AAMI (Association for the Advancement of Medical Instrumentation - an organization for advancing the development, and safe and effective use of medical technology), CDC (Centers for Disease Control), and AORN (Association of perioperative Registered Nurses - leaders in advocating for excellence in perioperative practice and healthcare).

During an observation in a hospital "Storage Room" of various sterile items in peel packs (pouches used for packaging sterile instruments), the following concerns were identified:

-Multiple surgical instruments contained brown staining

-Multiple instruments contained non-manufacture etching

-Multiple instruments contained chipped identification tape

-One peel pack contained a brown stain on the exterior side of the pack

During an interview, with the MSP, who was present during the observations, he stated the hospital followed sterile storage "Event Related Sterility Concept" (an item is considered sterile unless the peel pack is damaged/compromised such as torn, stained or opened).

During the survey, requests were made to provide a hospital policy to address their event related sterility practice however, the document was never produced.

AORN's "Recommended Practices for Maintaining a Sterile Field RECOMMENDED PRACTICE III" stipulates, "An event-related sterility system should be used and is based on the concept that "sterility is not altered over time, but may be compromised by certain events or environmental conditions." "Shelf life refers to the time an item may remain on the shelf and still maintain its sterility. Shelf life is influenced by the type of packaging used, storage conditions (e.g., open or closed shelves), humidity, temperature, transport conditions, use of dust covers, and the amount of handling the item receives".

4(a). During an observation of a hospital operating room (OR 12), on 8/15/17 at 10:20 AM, in the presence of the ICD, the Perfusionist, OR Service Manager, OR Supervisor, OR Director and an OR Registered Nurse, the following concerns were identified:

-Multiple patient equipment, including a "stand alone cart", "carbon dioxide tank" and an "Intravenous Pole", used for CABG procedures had brown, black and red matter.

-The SARNS ice chamber, contained stagnant water, black and brown floating matter. At the bottom of the chamber, a square metal filter contained reddish/brown rough matter, and a small round filter contained gray fuzzy matter. The exterior of the machine, contained brown matter.

-The tubing of the SARNS, was filled with stagnant water and contained cloudy floating matter.

-The "stand alone cart", used for the heart-lung machine, contained significant amounts of brown, black and red matter. The cart was wiped with a Sani-Wipe, in the presence of the ICD, the Perfusionist, OR Service Manager, OR Supervisor, OR Director and an OR Registered Nurse, a significant amount of brown, black and red matter were easily wiped off.

-The exterior of the MPS contained brown matter. The tubing attached to the MPS contained stagnant water, black particles, floating cloudy and pink matter within the interior portion of the tubing which was connected to the machine.

During an immediate interview following the observations, the Perfusionist stated, "The vendors of the heart-lung machine come to change the tubing. I change it periodically, when it looks like it needs to be changed." The Perfusionist also stated they did not have policies or procedures in place and no manufacture guidelines were used to address the daily/regular cleaning of the SARNS or the MPS. The Perfusionist was unable to recall the last time the tubing was changed and stated they did not have any documentation or logs.

During the same interview, the Perfusionist stated the reason for the black matter at the bottom of the SARNS, was due to the residue that was left over after the ice has melted.

A record review, on 8/17/17 at 9:20 AM, a document was provided by the Infection Control Preventionist (ICP). The document titled, "Myocardial Protection System Operations Manual," stipulated the following:

"Water Ports, Water hoses connect the water ports on the back of the MPS 2 Console", the tubing which contained the floating matter
.
"Disposable Components and Accessories, Description: The MPS 2 console is designed to use a specific line of sterile disposable components ...MPS 2 delivery sets are single use, ..."

"Surface Disinfection, Disinfect the MPS 2 console with any hospital approved disinfecting agent ..."

4(b). The facility did not have any policies or practice in place to address the process of daily/regular cleaning of the SARNS or the MPS and its tubing.

5. On 8/15/17 at 11 AM, an observation was made in the presence of the ICD, ICP, and the Environment Service Supervisor (ESS) of an ice machine located in the hospital basement. According to the staff, the ice machine was used to provide ice to OR 12 for surgical procedures. During the observation, the following concerns were identified:

-Some of the ice had yellow staining

-A clean white paper towel was used to wipe the top panel of the ice machine chamber located directly above the ice, after the swipe, the paper contained black matter.

During an immediate interview with the ESS, he stated that it was the environmental staff (EVS) responsibility to clean the ice machine; however they did not have any documentation to indicate that the machine had been cleaned.

The "Installation and User's Manual" for the ice machine, was provided by the ICP, on 8/17/17 at 9:20 AM. The document stipulated the following:

"Maintenance ...All models require regular sanitation - All models require sensor cleaning ..."


6. During an interview with the Director of Infection Control (ICD), on 8/14/17 at 10:40 AM, she stated that the hospital followed nationally recognized infection control guidelines from AAMI (Association for the Advancement of Medical Instrumentation - an organization for advancing the development, and safe and effective use of medical technology), CDC (Centers for Disease Control), and AORN (Association of perioperative Registered Nurses - leaders in advocating for excellence in perioperative practice and healthcare).

On 8/15/17 at 2:20 PM, an observation was made of OR 12 Sub-Sterile room (a workspace used to process patient equipment), in the presence of the ICD, ICP and an OR RN. The observations revealed the following:

"An ice machine, used to supply ice to the SARNS (a dual cooler-heater machine used during Coronary Artery Bypass Graft procedures (CABG), was located in the sub-sterile room, adjacent to the machine used for cleaning and disinfecting soiled patient Trans-Esophageal Echocardiogram scopes (TEE - used to obtain detailed pictures of the heart and its major blood supply).

According to the ICD and OR RN, the room contained clean and dirty items. The room did not contain a line of demarcation separating clean from dirty items.

The room was not equipped to monitor the temperature or humidity inside the room.

During an immediate interview with the ICD, she stated they would be removing the ice machine and would ensure a demarcation line would be installed. ICD also stated the room did not have a method for obtaining temperature and humidity but they would be installing them.

According to AAMI, Sterility Update 2010, relative humidity should be maintained between 30% and 60% in all work areas. "Because of the need to war 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

7. During an interview with the Director of Infection Control (ICD), on 8/14/17 at 10:40 AM, she stated that the hospital follows nationally recognized infection control guidelines from AAMI (Association for the Advancement of Medical Instrumentation - an organization for advancing the development, and safe and effective use of medical technology), CDC (Centers for Disease Control), and AORN (Association of perioperative Registered Nurses - leaders in advocating for excellence in perioperative practice and healthcare).

On 8/16/17 at 10 AM a tour of the hospital decontamination room (a restricted area where staff must wear proper attire and street clothes are not permitted and is used to clean and disinfect soiled patient equipment and instruments) was conducted in the presence of the IPD, ICD, MSP, and a sterile processing technician (SPD 1), concerns identified included:

-An observation of SPD 1 cleaning two (2) trays filed with soiled instruments
.
-Soiled surgical instruments were not pre-cleaned according to infection control standards and hospital policy.

-SPD 1 scrubbed 3 to 4 instruments at a time.

-SPD 1 scrubbed instruments above water.

-SPD 1 placed the tubing, which automatically dispensed the enzymatic solution into the tray filled with soiled instruments (the water contained red discoloration).

-SPD 1 obtained a clean packaged brush from a clean area while the gloves were wet and as he was scrubbing soiled instruments.

-SPD 1 did not change gloves after he completed cleaning the instruments and proceeded to touch clean areas within the decontamination room.

-SPD 1 stated he did not clean the area after he completed cleaning the surgical instruments.

-Directly above the sink, on a wall, were red splash marks, the red marks were identified prior to SPD 1 cleaning the instruments.

-Two exposed areas measuring approximately 4 inches by 4 inches were identified beneath the sinks. MSP stated the gaps were exposed areas from floor pedals that had been removed and not replaced.

-Above a washer were gray/white fuzzy matter and two (2) plastic tubing's.

-On the floor adjacent to the washer was a large area with brown/red discoloration. MSP stated it was "rust".

-On the wall adjacent to the washer were multiple brown/red handprints.

-A trash can was over filled with trash.

Immediately following the observations, the IPD, ICP, and MSP were asked if they identified any concerns with SPD 1's cleaning technique. They stated some of their concerns included risk of cross contamination due to not changing the gloves.
IPD, ICP and MSP were also asked if the tubing which was placed in the soiled water, that dispensed the enzymatic solution was supposed to be left in the soiled water. They confirmed the findings and stated that the tubing should have not been left in the soiled water.
During a concurrent interview with MSP the surveyor shared the concerns identified during the observations of the decontamination room. MSP stated they did not have written documentation or logs to show the room was terminally daily by the environmental service (EVS) department or regularly cleaned by staff.

AORN, one of the nationally recognized infection control guidelines 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 further stipulates, "Scheduled cleaning is a cleaning schedule that defines areas and equipment that should be cleaned on a regular (e.g., weekly, monthly) basis. AORN recommends that terminal cleaning and disinfection of the sterile processing? areas "be performed daily when the areas are? being used." Terminal cleaning should not be? performed when personnel are actively de-?contaminating instruments. Cleaning should progress from cleanest to dirtiest areas. AORN recommends (Recommendation V) a schedule for cleaning the following: ?clean and soiled storage areas, storage cabinets, sterile storage area, aerators on faucets should be cleaned and disinfected on a ?routine basis? ...

AAMI ST79 states:
"Walls, storage shelves, and air intake and return ducts should be cleaned on a ?regularly scheduled basis and more often if needed. Stained ceiling tiles should be replaced, and any leaks causing the stains should ?be repaired. Lighting fixtures or covers should be cleaned at least once every 6 months ..."?

8. During an interview with the Director of Infection Control (ICD), on 8/14/17 at 10:40 AM, she stated that the hospital follows nationally recognized infection control guidelines from AAMI (Association for the Advancement of Medical Instrumentation - an organization for advancing the development, and safe and effective use of medical technology), CDC (Centers for Disease Control), and AORN (Association of perioperative Registered Nurses - leaders in advocating for excellence in perioperative practice and healthcare).

During an interview with ICD, on 8/15/17 at approximately 1 PM, after surveyor discussed the survey finding concerns, ICD was asked how they conducted surveillance/monitoring of the surgical and decontamination areas and provided oversight of staff to ensure they were complying with infection control standard of practices and policies. ICD stated that she did not conduct regular surveillance of the hospital's SPD or of the Surgical Department and only conducted "environmental rounds" two times a year. ICD also stated that the department managers and supervisors, performed oversight of staff, to ensure staff performed their tasks to standards of care.

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

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 ..."


9. During an interview with the Director of Infection Control (ICD), on 8/14/17 at 10:40 AM, she stated that the hospital follows nationally recognized infection control guidelines from AAMI (Association for the Advancement of Medical Instrumentation - an organization for advancing the development, and safe and effective use of medical technology), CDC (Centers for Disease Control), and AORN (Association of perioperative Registered Nurses - leaders in advocating for excellence in perioperative practice and healthcare).

On 8/14/17 to 8/15/17 during multiple observations of the hospital sterile processing room (SPD) and a sub-sterile room located in OR 12 and multiple findings shared with the hospital IPD, ICP, MSP, and DSS requests were made to provide evidence of to show daily/regular cleaning and terminal cleaning were performed.

Immediate interviews with MSP and DSS were conducted. MSP and DSS indicated they had no documentation to show terminal cleaning or regular cleaning was done in the SPD or the Sub-sterile OR 12.

A record review was conducted on 8/17/17 at 10 AM of a hospital policy titled, "Cleaning Surgical and Procedural Areas, reviewed 3/16." The policy stipulated, "Sub-Sterile Cleanings - Cleanings will be done daily and throughout the day as needed ..."

AORN, one of the nationally recognized infection control guidelines 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 further stipulates, "Scheduled cleaning is a cleaning schedule that defines areas and equipment that should be cleaned on a regular (e.g., weekly, monthly) basis. AORN recommends that terminal cleaning and disinfection of the sterile processing? areas "be performed daily when the areas are? being used." Terminal cleaning should not be? performed when personnel are actively de-?contaminating instruments. Cleaning should progress from cleanest to dirtiest areas. AORN recommends (Recommendation V) a schedule for cleaning the following: ?
clean and soiled storage areas, storage cabinets, sterile storage area, aerators on faucets should be cleaned and disinfected on a ?routine basis? ...

AAMI ST79 states:
"Walls, storage shelves, and air intake and return ducts should be cleaned on a ?regularly scheduled basis and more often if needed. Stained ceiling tiles should be replaced, and any leaks causing the stains should ?be repaired. Lighting fixtures or covers should be cleaned at least once every 6 months ..."?