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Based on document review, policy review, observation, and staff interview, it was determined the CAH failed to ensure a system to avoid potential transmission of infections and communicable diseases was fully implemented. This had the potential to impact all staff and patients in the CAH. Failure to follow policies, nationally recognized guidelines, and standard precautions had the potential to allow for transmission of infections. Findings include:

1. The CAH's policy "Immediate Use Sterilization Procedures," revised 10/15/13, stated "This policy outlines the procedure for the adequate sterilization of surgical instruments and equipment using an immediate use autoclave in the instance of emergency situations and/or when there is insufficient time to sterilize an item by the preferred prepackaged method and/or manufacturer's recommendation. The use of immediate use sterilization shall be kept at a minimum." The policy referred to AORN guidelines.

The AORN Guidelines for Perioperative Practice 2015, stated "Immediate use steam sterilization (IUSS) should be kept to a minimum and should be used only in selected clinical situations and in a controlled manner." Additionally, the AORN Guidelines stated "Immediate use steam sterilization may be associated with increased risk of infection to patients. Time constraints may result in pressure on personnel to eliminate or modify one or more steps in the cleaning and sterilization process."

The CAH policy and AORN guidelines were not followed.

A tour of the CAH's reprocessing area was conducted with a Surgical Technician beginning at 1:20 PM on 5/11/16. During the tour the Surgical Technician was questioned regarding IUSS. He stated 2 autoclaves, in the OR area, were used for IUSS and the autoclaves were tested daily for proper sterilization temperatures using chemical indicators.

The Surgical Technician stated when instruments were sterilized utilizing IUSS, a control card, for a chemical indicator, was placed in each load. According to the AORN, chemical indicators are used to verify that one or more of the conditions necessary for sterilization were achieved within each package. The control card included patient information, and the instruments sterilized, so the instruments may be tracked to the patient, if an infection or surgical complications were identified.

The IUSS log for May 2016 was reviewed, and included documentation of daily entries for control testing. Additionally, the log included documentation of IUSS, of surgical instruments, from 1 to 7 times a day.

When asked about the frequent utilization of IUSS, the Surgical Technician stated IUSS was frequently used for dropped instruments and there was a locum tenens (a physician who temporarily fills the place of need if a hospital is short staffed) surgeon who brought their own instruments to the CAH and these required sterilization using IUSS.

A request was made for the IUSS log for April 2016. The log was reviewed and included documentation of frequent use by the CAH of IUSS.

IUSS was not used infrequently by the facility. Examples include, but are not limited to, the following:

a. On 4/05/16, 4/21/16, 4/27/16, and 5/04/16, the logs documented 4 IUSS loads

b. On 4/15/16, 4/20/16, 4/26/16, and 4/28/16, the logs documented 5 IUSS loads

c. On 5/02/16, 5/03/16, 5/05/16, and 5/10/16, the logs documented 6 IUSS loads

d. On 4/12/16, 4/14/16, and 5/10/16, the logs documented 7 IUSS loads

For April 2016, instruments were sterilized using IUSS 18 out of 30 days. For May 2016, IUSS was utilized 6 out of 11 days, from 5/01/16 to 5/11/16.

During an interview on 5/11/16 at 1:50 PM, the Surgical Services Director reviewed the IUSS logs and confirmed IUSS was not utilized infrequently. He stated the budget for the upcoming fiscal year included monies for purchasing more instruments.

The CAH failed to follow their policy and nationally recognized guidelines for infrequent utilization of IUSS.

2. An observation of the Medical/Surgical unit was conducted by surveyors on 5/10/16, beginning at 12:50 PM, accompanied by the Medical/Surgical and Mother/Baby Director. An RN was speaking with a physician outside of a patient's room. The RN was holding a urine specimen cup, which contained urine. The RN was not wearing gloves and the urine specimen cup was not contained in a plastic bag for transport of the specimen.

The Medical/Surgical and Mother/Baby Director was questioned about the RN holding the urine specimen cup in her bare hands. He stated he had not observed the RN holding the urine specimen cup, and went to speak with the RN. When he returned to the surveyors, the Director confirmed the RN was holding the urine specimen cup, with urine, without wearing gloves and the cup was not in a plastic bag, used for transport of blood or body fluid specimens. When questioned what the RN had done with the urine specimen, the Director stated she placed the specimen cup inside a glove and placed it on the desk of the Nurse's Station.

The CDC website, accessed 5/23/16, defined standard precautions as "A set of precautions designed to prevent transmission of HIV, Hepatitis B virus (HBV), and other blood borne pathogens when providing first aid or health care. Under standard precautions, blood and certain body fluids of all patients are considered potentially infectious for HIV, HBV and other blood borne pathogens. Gloves are considered Personal Protective Equipment (PPE) utilized by Health Care Workers to prevent the spread of contaminants. The CDC states gloves should be worn when there is a potential for contact with blood, body fluids, mucous membranes, nonintact skin or contaminated equipment.

The CDC report, "Guideline for Hand Hygiene in Health-Care Settings," dated 10/25/02, stated "CDC has recommended that HCWs [Health Care Workers] wear gloves to 1) reduce the risk of personnel acquiring infections from patients, 2) prevent health-care worker flora from being transmitted to patients, and 3) reduce transient contamination of the hands of personnel by flora that can be transmitted from one patient to another."

The CAH failed to follow nationally recognized and accepted standards of practice for the prevention of the spread of infection.

3. A tour of the CAH's Medical/Surgical unit was conducted on 5/09/16, beginning at approximately 3:00 PM. Along one of the Medical Surgical hallways, and in close proximity to the floor, was a row of cabinets with doors. No latches or locks were found on the cabinets. Some of the cabinet doors were left ajar, exposing clean linens to potential contaminants.

During an interview with the Quality Manager on 5/11/16, at approximately 2:25 PM, she confirmed the cabinets contained clean linens for the Medical Surgical floor, and did not protect clean linens from possible contaminants.

The CAH did not fully implement a process to ensure patients and staff were protected from possible transmission of infections and communicable diseases.

4. A planned Caesarean section was observed in the OR on 5/11/16, beginning at 7:30 AM. Three surgical personnel in the OR were observed wearing articles of clothing that were not fully covered by their CAH provided scrubs. The shirt collars of the clothing were exposed several inches above the neckline of the scrub tops.

The AORN Guidelines for Perioperative Practice 2015, stated "Personal clothing that cannot be contained within the scrub attire either should not be worn or should be laundered in a health care-accredited laundry facility after each daily use and when contaminated." Clothing not laundered by a health care accredited laundry allows for microorganisms to remain on the clothing.

During an interview on 5/12/16 at 1:00 PM, the Director for Surgical Services confirmed surgical staff were wearing articles of clothing under their scrubs. The articles of clothing were not laundered at the hospital and were not completely covered by scrubs provided by the CAH.

The CAH was not following nationally recognized standards for surgical attire, allowing for potential spread of infection in the OR.

Based on record review, policy review, and staff interview, it was determined the CAH failed to ensure nursing services met the needs of 2 of 24 patients (Patient #1 and #21) whose records were reviewed. This resulted in nursing evaluations that were not comprehensive and had the potential to negatively impact the safety of all patients receiving care at the CAH. Findings include:

The CAH's policy "Suicide Precautions," created on 7/16/13, and due for review on 7/16/16, stated "...Nursing may implement the following interventions until the physician can be contacted for orders....Visual observation of the patient...One-to-one staff monitoring...To ensure the continued safety of the patient, anything that the patient can potentially use to harm themselves, such as phones, medical equipment, any type of cord, or sharp object will be removed from the room unless necessary for the treatment...Every attempt will be made to place the patient in a room located close to the nursing station..." The CAH did not ensure this policy and standard of care was met as follows:

1. Patient #21's medical record included a 37 year old male who presented to the ED on 12/02/15, at 2:08 AM. He was later admitted to the ICU on the same day. His diagnoses included encephalopathy, suicide attempt, depression and anxiety. Additionally, a 24 hour physician mental hold was initiated in the ED on 12/02/15.

The H&P for Patient #21 stated he had "a history of methamphetamine use, huffing, prior suicide attempts, as well as depression and anxiety." The H&P stated Patient #21 was found lying face down on the street and was transported to the ED by his mother. The H&P stated Patient #21 presented to the ED with an altered mental status, and while in the ED, "the patient had 2 suicide attempts by going to the bathroom and taking a string from his hoodie and wrapping it around his neck and strangling himself. Nurses reported that he passed out the second time. The patient was then put in 4-point restraints and given Ativan and Haldol. He was then transferred to the ICU for observation." Additionally, the H&P stated "...He was placed on a legal hold due to his suicide attempts. He was felt to be a danger to himself and others..."

An Occurrence/Medication Error Report, for Patient #21, dated 12/02/15 at 3:25 AM, was reviewed. The report stated Patient #21 was instructed to provide a urine sample and was allowed to use a bathroom in the hallway without observation or supervision. The report stated "Pt had made no suicidal statements or actions...found pt unresponsive and head cyanotic in color, pt sat up within 45 seconds of finding on floor...Found pt had wrapped the cord of his hoodie around his neck three times, cord removed and pt able to ambulate back to ED #2 without assist. Security with pt in room and pt again attempted to wrap cord around neck but prevented..."

Patient #21's record included an ED triage note, dated 12/02/15, and signed by an RN. The note stated "pt paranoid, confused, delusional...pt brought in by mother who is worried he will come home and harm her...Pt ambulating, unable to sit still. Pt refused to answer most questions..."

Patient #21 presented with altered mental status, had a history of suicide attempts and attempted suicide in the ED, nursing staff did not place him on one-to-one observation, line of sight observation, and/or suicide precautions until after his initial suicide attempt in the ED.

The Director of the ED/ICU was interviewed on 5/11/16, beginning at approximately 2:15 PM. She reviewed Patient #21's medical record and confirmed the ED nursing staff should have placed Patient #21 on line of sight observation or 1:1 observation immediately after he was assessed in the ED.

ED nurses failed to meet the immediate need of Patient #21.



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2. Patient #1 was a 51 year old female admitted to the CAH on 3/28/16, for a Laparoscopic Nissen Fundoplication (surgical wrapping of the upper stomach around the esophagus to prevent regurgitation). Additional diagnoses included HTN and nonspecific seizure disorder.

Patient #1 was admitted with a history of a known seizure disorder, with documentation of a seizure on 3/27/16, the day prior to her procedure. Patient #4's record included documentation in the nursing assessments of her seizure disorder. However, the documentation did not include specifics related to Patient #4's seizures. Additionally, there was no documentation of seizure precautions or a plan of care for her seizures.

The CAH's Policy "Standards of Practice - General Nursing," dated 10/03/13, stated "The Nursing Services Department of Bingham Memorial Hospital, Inc. shall utilize the American Nurses Association's standards of practice based on the nursing process. The emphasis is based on the process of assessment and problem identification." This policy was not followed.

Patient #1 had 3 documented seizures after her surgical procedure, while in the PACU. There was no documentation of seizure precautions for Patient #1's safety. Additionally, there was no documentation, by the RN, of the type of seizure or the condition of Patient #1 before or after her seizures.

During an interview on 5/12/16, starting at 11:00 AM, the Same Day Surgery Charge Nurse reviewed the surgical record and confirmed the nursing documentation was not complete and nursing did not meet the care needs for Patient #1.

The CAH failed to meet the care and needs for Patient #1.

Based on staff interview, review of CAH personnel files, and review of staff training files, it was determined the CAH failed to verify contracted staff were competent to provide services which met the CAH's requirements. This resulted in the potential for patients of the CAH to receive therapy services from staff which were not qualified or competent to perform the services. Findings include:

A sample of employee personnel files and training files were reviewed duirng the survey. Evidence of competency was not found in the file for the contracted Physical Therapist.

During an interview on 5/12/16 at 10:30 AM, the Manager of Human Resources confirmed she did not have documentation of competency for the contracted Physical Therapist. She stated she was unaware the CAH was required to maintain documentation of compentencies for contracted staff.

The hospital did not verify contracted staff were competent to provide treatment for patients in the CAH.

Based on record review, policy review, and staff interview, it was determined the CAH failed to ensure documentation was complete and/or accurate for 3 of 24 patients (#10, #13, and #19) whose records were reviewed. This resulted in incomplete or inaccurate medical records. It had the potential to interfere with clarity of information related to the course of treatment and completeness of the medical record. Findings include:

1. Medical records were reviewed of patients who had died in the CAH. Documentation related to organ donation was incomplete. Examples include:

a. Patient #10 was a 51 year old female admitted to the ED on 3/24/16 at 10:39 AM, for cardiac arrest. Patient #10 was pronounced dead, by the ED physician, at 10:55 AM on 3/24/16.

Patient #10's record included a form "Record of Death." The form included a section related to organ donation, where staff documented what time the organ donation service was contacted and the person's name to whom hospital staff spoke. The following areas of the organ donation section were incomplete:

- Signature-authorized decision maker

- Relationship to the deceased

- Date and time

During an interview on 5/11/16 at 3:30, the Director of the ED/ICU reviewed the record and confirmed this section was incomplete.

The organ donation section of Patient #10's record was incomplete.

b. Patient #19 was an 88 year old female admitted to the hospital on 10/23/15 at 7:04 AM, for care related to cardiac arrest that occurred in her home. Patient #19's death was pronounced, by the ED physician, at 4:08 PM on 10/23/15.

Patient #19's record included a form "Record of Death." The form included a section related to organ donation, where staff documented what time the organ donation service was contacted and the person's name to whom hospital staff spoke. The following areas of the organ donation section were incomplete:

- Signature-authorized decision maker

- Relationship to the deceased

- Date and time

The Quality Manager was interviewed on 5/11/16, beginning at 8:20 AM. She reviewed Patient #19's medical record and confirmed the organ donation section of the "Record of Death" form was incomplete.

The organ donation section of Patient #19's record was incomplete.

2. Patient #13 was a 78 year old male admitted to the ED on 3/09/16 at 8:47 AM, for care related to a choking episode. He was brought in by private auto from another facility for psychiatric patients, where he was an inpatient.

Patient #13 was accompanied by staff from the psychiatric facility, who stated he was eating breakfast when he started choking. Patient #13 was complaining he felt food stuck in his throat. His record included a physician verbal order for an esophagram (a series of X-ray images of the esophagus after ingesting a solution which coats and outlines the esophagus). However, the verbal order did not include a date. Additionally, the verbal order was not dated or timed by the physician.

During an interview on 5/11/16 at 3:30 PM, the Director for the ED/ICU reviewed the record and confirmed the verbal order did not include a date or time by the physician and was not dated by the nurse who took the order.

Patient #13's verbal order was not dated or timed by the physician.

Based on record review, policy review and staff interviews, it was determined the CAH failed to maintain records which included all pertinent information for 2 of 5 patients (Patient #1 and #4 ) whose surgical records were reviewed. This resulted in patient records which did not accurately document the patients' condition and/or treatment provided. Findings include:

1. Patient #1 was a 51 year old female admitted to the CAH on 3/28/16, for a Laparoscopic Nissen Fundoplication (surgical wrapping of the upper stomach around the esophagus to prevent regurgitation). Additional diagnoses included HTN and nonspecific seizure disorder.

Patient #1's surgical record was incomplete. Examples include:

a. The CAH's policy "Charting in the PACU," stated "PACU personnel are responsible for correctly completing the PACU nurses record to include all pertinent information regarding the patient's condition and events that occurred in the PACU in Clinical Care Station."

The Lippincott Manual of Nursing Practice, dated 2006, gives specific criteria to document a patient's seizure activity. The criteria included patient condition prior to and after the seizure, and the type of seizure.

Patient #1's record included a form "PACU Record," dated 3/28/16, and signed by an RN. The record stated Patient #1 arrived in the PACU at 2:46 PM, following her surgery. The form documented Patient #1 had seizures at the following times:

- 3:10 PM to 3:13 PM

- 3:27 PM to 3:28 PM

- 3:41 PM to 3:42 PM

Patient #1's record included a "Post-Procedure Assessment Report." The RN documented, at 3:10 PM, "Pt believed to be having a seizure, anesthesia present; V/S [vital signs] stable; O2 [oxygen] wnl [within normal limits]; no meds given." However, her record did not include documentation of her condition prior to and after the seizure, or the type of seizure. There was no documentation interventions were provided by staff. Additionally, there was no documentation related to the two subsequent seizures.

During an interview on 5/12/16, starting at 11:00 AM, the Same Day Surgery Charge Nurse reviewed Patient #1's record and confirmed there was incomplete documentation regarding her seizures in the PACU.

b. Patient #1's record did not include documentation of preoperative instructions.

During an interview on 5/12/16, starting at 11:00 AM, the Same Day Surgery Charge Nurse stated surgical patients received a preoperative phone call prior to the day of the surgery. However, she stated the preoperative phone calls are not documented in the patient record. She stated patients are given preoperative instructions during the phone call. The Same Day Surgery Charge Nurse confirmed the preoperative instructions given to Patient #1 were not documented in her record.

Patient #1's surgical record was incomplete.

2. Patient #4 was a 2 year old female admitted to same day surgery on 11/16/15, as an outpatient for dental care under anesthesia.

Patient #4's record included "Admission Orders for Routine Surgery Inpatient/Outpatient/Same Day," dated 11/11/15, and signed by the Dentist who performed the procedure. The orders stated 1000 ml LR to be infused at 100 ml per hour through an 18 or 20 gauge IV catheter. The documentation regarding the IV was inconsistent and unclear.

a. Patient #4's record included a MAR. The MAR, dated 11/16/15, included documentation 1000 ml NS was given to Patient #4. However, it did not include the rate of infusion, the route or a start time.

b. Patient #4's record included an "Anesthesia Record" dated 11/16/15. The form stated a 22 gauge IV was inserted into Patient #4's left hand. Additionally, it documented 130 ml of LR was infused during the surgery.

c. Patient #4's record included a PACU order form, dated 11/16/15. The IV fluids section included a check mark next to continue intraoperative fluids. However, the line for the type of IV fluid to be infused, was left blank.

During an interview on 5/12/16, starting at 11:00 AM, the Same Day Surgery Charge Nurse confirmed Patient #4's record did not clearly document the IV fluid given and the amount given.

Patient #4's record included inconsistent documentation related to her IV and IV fluids administered.

Based on review of policies, review of administrative documents, and staff interview, it was determined the CAH failed to ensure an effective QA program to evaluate the quality and appropriateness of Respiratory services furnished in the CAH, including services provided under agreement, were evaluated. This prevented the CAH from assessing its therapy services in order to identify potential areas of concern and take corrective action. Findings include:

The Director of Respiratory Therapy was interviewed on 5/10/16 beginning at 1:00 PM. He stated his department included employees of the CAH, as well as, contracted staff. The Director of Respiratory Therapy stated he was having difficulties with the contracted service provider. He stated he had received several complaints regarding the services provided from patients, as well as, staff. The Director of Respiratory Therapy stated the complaints he received related to the timeliness of services and the satisfaction of patients with services received from the contracted provider. When asked to review the documentation related to the complaints the Director stated there was no documentation to review. He stated the complaints were received verbally and he did not document the conversations.

When asked whether the Director was tracking complaints about the contracted provider, he stated he was not. The Director stated because he did not document the complaints received he was not able to track and trend whether complaints were related to a particular staff, a specific unit, or warranted escalation of the complaint to a grievance for further investigation and resolution.

The Quality Manager was present during the interview. She confirmed the data related to the contracted provider was not submitted for quality monitoring.

The CAH failed to ensure contracted services were included in their quality program.

Based on contract review, policy review, and staff interview, it was determined the facility failed to ensure the family of each potential donor was approached by a designated requester in accordance with their contracts. This had the potential to prevent identification and possible donation of viable organs by patients. Findings include:

During an interview on 5/10/16 beginning at 9:45 AM, the Director of the ED/ICU and the Quality Manager were questioned about the process for Tissue and Organ Donation. The Director for the ED/ICU stated a social worker or nurse trained as a designated requester by the OPO would approach family regarding possible donation. She stated she was trained as a designated requester by the contracted OPO "a couple of years ago," but was unable to recall when the training had taken place.

The Quality Manager, who was present during the interview, stated only staff who had attended the training were allowed to speak with family members regarding donation of tissues and organs. She stated, in previous years, staff in the social services department were trained by the OPO. However, the Quality Manager was not aware whether current social services staff had been trained in the process. When asked who in Administration was responsible for oversight of the OPO program, the Quality Manager stated there was no one in Administration who had direct oversight. She stated it was under her responsibility, as part of an overall quality program.

A CAH policy "Pronouncement of Death, Postmortem Procedures, Autopsy, and Organ Donation," revised 6/02/15, stated "The designated requester provided by [name of OPO] will assess patients and families wishes regarding organ, tissue, and eye donation. The designated requester provided by [name of OPO] will assure families of potential organ donors are made aware of the option of organ, tissue or eye donation and their option to decline."

The CAH contracts for OPO services, both dated 7/17/14, were reviewed. The contract "Tissue Donation Cooperation Agreement" stated, under the section Responsibilities of the Hospital, "The individual designated to initiate the request for tissue and eye donation to the family/authorized decision maker must be a designated requester. A designated requester is an [name of OPO] tissue donation staff member who has successfully completed a course offered and/or approved by [name of OPO]." Additionally, at the end of the contract there were two choices for which entity provided the designated requesters, either the CAH or the OPO. The box marked for the OPO to provide the requesters was checked.

The contract "Organ Donation Cooperation Agreement," stated "[name of OPO] staff are trained designated requesters and are available on a 24/7/365 basis to speak to the families/authorized decision makers of potential donors. [name of OPO] organ donation coordinators will conduct the approach for donation and the informed consent."

During an interview on 5/11/16 at 2:40 PM, the CNO was asked about the OPO program. She stated the Quality department oversees the data from organ and tissue donations. The CNO stated no specific Administrator was responsible for oversight of the program. She confirmed the CAH policy and both contracts stated families and authorized decision makers were to be approached by the OPO requesters, not employees.

The CAH failed to ensure a trained designated requester approached families/authorized decision makers regarding possible donation.