HospitalInspections.org

Based on observation and staff interview, the Critical Access Hospital (CAH) failed to ensure all patient care equipment was maintained in safe operating condition as evidenced by failing to ensure the functionality of a nurse call button located on the handrails of the beds on the in-patient unit. Findings:

On 01/19/16 from 12:05 a.m. to 12:45 p.m. an observation was made of the inpatient unit with S2DON. A nurse call button was noted to be on the handrail of the beds in rooms 103 beds A and B, 104, 108, 109 B bed, 110, 111 A bed, and 112 beds A and B. The button was noted to be non- functional as it failed to activate any type of nurse call system. S2DON was interviewed at the time of the observation and confirmed the nurse call button located on the handrails of the patient beds was not functioning when pressed. S2DON indicated that they have a nurse call system which included a cord with a button and reported that patients are instructed to use this call system. When asked if it would be possible for a patient who may be confused or sedated to press the nurse call button on the handrail of the bed thinking they are calling for assistance without the nursing staffs' knowledge due to the call button not working, S2DON confirmed that was possible.

In an interview on 01/22/16 at 10:20 a.m., S5ADON provided a list of inpatient beds that had non-functioning nurse call buttons in the handrails of the bed. Review of the list revealed 14 of the 17 patient beds currently available for use on the inpatient unit had non-functioning call buttons in the handrails.

Based on record review and interview, the Governing Body failed to ensure policies were monitored and implemented to provide quality health care in a safe environment as evidenced by the Governing Body failing to appoint members to the medical staff in accordance with medical staff bylaws. The Governing Body appointed members to the medical staff without specific privileges delineated for 2 (S32MD, S37APRN) of 7 sampled credentialing files reviewed. Findings:

Review of the Medical Staff Bylaws, Rules & Regulations, revised date of April, 2014 revealed in part the following: Allied Health Professionals shall be appointed, reappointed, and privileged using the same procedures as members of the Medical Staff. Appointment process: The Medical Executive Committee shall recommend the application to the Board of Commissioners. Board of Commissioners shall review applications and may decide to grant appointment and clinical privileges as requested of specifically delineated. Each application for appointment and reappointment to the Medical Staff must contain a request for the specific clinical privileges desired by the applicant.

S32MD
On 01/19/16 at 11:30 a.m., S7ED Mgr. stated S32MD was the Medical Director of the ED and he also worked shifts as the ED physician.

Review of the credentialing file for S32MD revealed the physician was a family practice physician and was reappointed to the medical staff for 06/23/14 to 06/23/16 as active medical staff. Review of the Clinical Delineation Form revealed the form listed only Medicine Privileges. There was no documented evidence of a request or approval of emergency department privileges or specific procedures the physician could perform.

In an interview on 01/21/16 at 10:55 a.m., S6HIM confirmed she was responsible for medical staff credentialing and confirmed there were no specific privileges or procedures related to the emergency department requested or approved for S32MD. S6HIM confirmed S32MD was the Medical Director of the ED.


S37APRN
In an interview on 01/20/16 at 12:45 p.m., S6HIM indicated S37APRN was a psychiatric nurse practitioner in the hospital's IOP clinic.

In an interview on 01/21/16 at 1:20 p.m., S18IOP Director indicated S37APRN was a psychiatric nurse practitioner and did the psychiatric evaluations, participated in treatment team, and provided psychiatric nurse practitioner services to the clinic. S18IOP Director confirmed S37APRN did not conduct medical history & physicals or perform medical services for the clinic.

Review of the credentialing file for S37APRN revealed the nurse practitioner was psychiatric nurse practitioner reappointed to the medical staff on 10/26/15 by the Governing Body. Review of the delineation of privileges dated 08/22/15 revealed the only privileges requested and approved were for medical privileges. There was no documented evidence of any specific privileges related to psychiatric services requested or approved.

In an interview on 01/21/16 at 4:00 p.m., S6HIM confirmed the delineation of privileges for S37APRN were only medical nurse practitioner privileges. S6HIM stated psychiatric privileges were delineated on the initial appointment in 2009, but were not done on the reappointments.

Based on record reviews, observations and interviews, the CAH (Critical Access Hospital) failed to meet the Conditions of Participation for Provision of Services as evidenced by:

I.

1) failing to ensure safe and effective care was provided to patients presenting to the hospital's ED who were a potential threat to themselves or others as set forth per hospital policy. This deficient practice was evidenced by failing to ensure PEC patients were observed continuously 1:1 by an attendant and not locked in the seclusion room for staff convenience to ensure the patient's safety for 1 of 1 current patients with suicidal ideations PEC'd in the ED (#14), and 3 of 3 (#3, #4, #5) closed actively suicidal patients that had been PEC'd in the ED out a total sample of 22 patients and failing to remove all hazards from patient and patient care area according to hospital policy for 1 of 1 (#14) current sampled PEC'd ED patient reviewed.



2) failing to ensure ED patients were triaged by the Registered Nurse prior to being registered by the ED Clerk (see findings in C-0271).


II.

1) failing to maintain a comprehensive and ongoing Infection Control Program designed to prevent, control, and investigate infection control practices that included: data collection, tracking, trending and analysis of infection control practices/breaches through monitoring and surveillance of all the services of the CAH, active surveillance of infection control practices to identify infection control breaches with implementation of corrective actions to prevent and control infections, monitoring of compliance with all infection control policies, procedures, protocols and other infection control program requirements that were implemented by the CAH;

2) failing to ensure that the CAH followed acceptable professional standards of practice and acceptable infection control practices for sterilization, failed to ensure that staff adhered to acceptable decontamination protocols and workflow patterns for the decontamination of soiled instruments, and failed to ensure that the Central Supply Director was qualified by training and/or experience in sterilization recommended practices; and

3) failing to ensure a safe and sanitary environment was maintained as evidenced by observations of infection control breaches/issues (see findings in C-0278).

Based on record review, observations and interviews, the CAH (Critical Access Hospital) failed to ensure health care services were furnished in accordance with written policies as evidenced by:

1) failing to ensure safe and effective care was provided to patients presenting to the hospital's ED who were a potential threat to themselves or others as set forth per hospital policy. This deficient practice was evidenced by failing to ensure PEC patients were observed continuously 1:1 by an attendant and not locked in the seclusion room for staff convenience to ensure the patient's safety for 1 of 1 current patients with suicidal ideations PEC'd in the ED (#14), and 3 of 3 (#3, #4, #5) closed actively suicidal patients that had been PEC'd in the ED out a total sample of 22 patients and failing to remove all hazards from patient and patient care area according to hospital policy for 1 of 1 (#14) current sampled PEC'd ED patient reviewed.

2) failing to ensure ED patients were triaged by the Registered Nurse prior to being registered by the ED Clerk.

3) failing to ensure the hospital policy for withholding life support was implemented by failing to obtain physician's orders for a no code directive, and failing to ensure the decision to withhold life support was supported by documentation in the physician progress notes for 1 (#16) of 2 (#15, #16) sampled deceased patient records reviewed out of a total sample of 22.


Findings:

1) failing to ensure safe and effective care was provided to patients presenting to the hospital's ED who were a potential threat to themselves or others as set forth per hospital policy. This deficient practice was evidenced by failing to ensure PEC patients were observed continuously 1:1 by an attendant and not locked in the seclusion room for staff convenience to ensure the patient's safety for 1 of 1 current patients with suicidal ideations PEC'd in the ED (#14), and 3 of 3 (#3, #4, #5) closed actively suicidal patients that had been PEC'd in the ED out a total sample of 22 patients and failing to remove all hazards from patient and patient care area according to hospital policy for 1 of 1 (#14) current sampled PEC'd ED patient reviewed.

Review of the hospital policy titled, "Emergency Department Psychiatric Care", policy number 1206A, provided by S2DON as current, revealed in part the following:
2. PEC: Proper placement of the psychiatric patient in ER: Once triaged, and medically stable, the individual will be placed in a treatment area. The patient must be observed continuously 1:1 by an attendant (law enforcement, if available or hospital employee) while in an exam room or in a 5 bed ER suite as long as staff can remain present to observe the patient continuously. a. All cabinets must be locked and equipment/access to sharps removed from area. b. The patient is to be placed in a hospital gown. c. Valuables are collected as per policy. d. If the patient becomes violent and/or displays threatening behavior, ER staff is to request assistance from law enforcement officers. e. If ER staff can't provide a safe environment due to volume of patients in ER; assistance can be requested from the inpatient unit to help monitor the safety of all patients. f. Violent and/or threatening patients may require restraints. Restraints are used to prevent the patient from injuring himself or others only. Restraints are not to be used for convenience, punishment, or discipline of the patient. There must be a physician's order for restraints.

Review of the hospital policy titled, "Restraints or Seclusion", policy number 6040, provided by S2DON as current, revealed in part the following: Seclusion is defined as: The involuntary confinement of a patient alone in a room or area from which the patient is physically prevented from leaving. Seclusion may only be used for the management of violent or self-destructive behavior....
Restraint or seclusion may only be imposed to ensure the immediate physical safety of the patient, a staff member, or others and must be discontinued at the earliest possible time.
Seclusion may only be used for the management of violent or self-destructive behavior that jeopardizes the immediate physical safety of the patient, a staff member or others....
Restraint or seclusion must be used in accordance with the order of a physician or other licensed independent practitioner who is responsible for the care of the patient....


During an observation of the ED on 01/19/16 at 11:30 a.m., S7ED Mgr. indicated Exam Room 3 was used for PEC patients after the cabinets were locked and the equipment and trash cans were removed from the room. S7ED Mgr. stated patients who are PEC'd are placed in Exam Room 3 and the door is locked from the outside. S7ED Mgr. indicated the ED physician orders the door to be locked. S7ED Mgr. stated the staff monitor the patient continuously from a computer screen at the nursing desk. S7ED Mgr. stated the ED was staffed with 1 RN and 1 LPN and further confirmed the staff was not increased when a 1:1 patient was in the ED. She further indicated there was no house supervisor or any other staff to assist the ED when a PEC/1:1 patient was in the ED. Observation of Exam Room 3 revealed an exam light extended from the ceiling of the room that could not be removed and could pose a ligature point. Also observed in the room was a sink faucet and handles that could pose a ligature point. The stretcher in the room was observed to have side rails and an open frame that could pose potential ligature points. S7ED Mgr. stated paper gowns and sheets were used. The counter adjacent to the sink was observed to have a 2 inch area of missing Formica with sharp, rough edges that could be used by patients to harm themselves. S7ED Mgr. confirmed the observations.

On 01/19/16 at 11:50 a.m. an observation was made of the camera view for Exam Room 3. The computer screen at the nurse's desk was observed to only visualize the bed and the left corner of the room. The left far corner of the room, the sink and right side of the room including just inside the door were not visible from the camera view. S7ED Mgr. confirmed the observation.

During an observation of the ED on 01/19/16 at 11:30 a.m., S7ED Mgr. indicated PEC patients used the restroom located at the end of the hallway adjacent to the medication room. S7ED Mgr. indicated PEC patients were allowed to use this restroom and they were allowed to shut the door. S7ED Mgr. confirmed 1:1 observation of the patient was not done while patient used the restroom. Observation of the restroom revealed the following ligature points and hazards:

Entrance door was observed to have 3 separate hinges and a flange type door handle that could be used as ligature points.
Toilet plumbing was observed to have exposed plumbing that could be used as ligature points.
Hand rails affixed to the walls with space between the rail and the wall that could be used as ligature points.
Sink faucet that was curved and flange type faucet handles that could be used as ligature points.
Plastic garbage can liners that could be used to harm themselves were observed in the garbage can. S7ED Mgr. confirmed the garbage cans were not removed when PEC patients used the restroom.
An air conditioning vent with large open slats was observed in the ceiling of the bathroom and could be used as a potential ligature point.
S7ED Mgr. confirmed the above observations.

Patient #14

Review of the ED record for Patient #14 revealed the patient was PEC'd on 01/19/16 at 11:45 p.m. and the patient was currently suicidal. Review of the record revealed the physician documented diagnoses of Suicide Risk and Chronic Depression. Further review of the physician orders revealed at 11:47 p.m. the physician ordered: Elopement precautions, patient to remain under video surveillance, may retain clothing, blanket, and pillow due to low temperature in room. There was no documented evidence of a physician's order for seclusion of Patient #14. Further review of the patient's record revealed there was no documented evidence of any violent/self-destructive behavior that warranted seclusion of the patient.


On 01/20/16 at 9:20 a.m. Patient #14 was observed to be in Exam Room 3 with the door to the room locked from the outside. From a window in the door, the patient was observed to be asleep on the stretcher with her personal clothes on, a linen sheet and blanket on the stretcher, and a sharps container was observed to be affixed to the wall in the far corner of the room. S10RN confirmed Patient #14 was PEC'd and was in Exam Room 3 with the door locked from the outside. Observation of the nurse's desk revealed there were 2 computer monitor screens and neither monitor was on to the camera view of Exam Room 3. S10RN confirmed the above observations and stated the ED physician ok'd the patient leaving her clothes on because the room is cold.

Further observations of Patient #14 revealed the following
9:25 a.m. - No monitoring of the camera view for Exam Room 3.
9:35 a.m. - Patient #14 followed S10RN to the restroom. The patient was observed to have large hoop earrings on and an 18 inch chain/necklace.
9:38 a.m. - Monitor screen changed to camera view of Exam Room 3. Patient #14 observed sitting on edge of stretcher.
9:40 a.m. - Camera view of Exam Room 3 turned off and S10RN observed entering data into EMR.
9:44 a.m. - Camera view of Exam Room 3 remains off.
9:46 a.m. - Camera view of Exam Room 3 turned on briefly and then turned back to EMR screen. Camera view remained off until 10:00 a.m.
There was no observation of 1:1 observation of Patient#14 directly by any staff as directed by hospital policy.

In an interview on 01/20/16 at 10:00 a.m., S10RN confirmed there was no physician's order to lock Patient #14 in Exam Room 3. S10RN stated it was in the hospital's policy. After providing the hospital policy and reviewing the policy, S10RN confirmed there were no provisions in the hospital's policies for locking the patient in the room. S10RN confirmed this was locked seclusion of the patient and it was being used for staff convenience and not due to the patient's behavior. S10RN confirmed she had not monitored the patient by camera/video feed continuously this morning. S10RN also confirmed the ED does not have a dedicated monitor to observe continuously and confirmed she had turned the monitor off to enter data into the EMR. S10RN confirmed the hospital policy had not been followed for 1:1 continuous observation and for the removal of hazards in the patient room.


Patient #3
Review of the ED record for Patient #3 revealed the patient presented to the ED on 10/11/15 at 5:34 p.m. with complaints of suicidal ideation, patient stated she took 12 Ecstasy pills to try to kill herself. Review of the record revealed the patient was PEC'd at 7:10 p.m. on 10/11/15 and the patient was currently suicidal. Review of the record revealed the patient was placed in Exam Room 3.

Review of the nursing documentation revealed at 7:10 p.m. on 10/11/15, "Patient is now PEC'd. "All equipment and items that could be used to harm patient have been removed from room. Patient being monitored by video camera in room...." Further review of the nursing documentation revealed the patient remained in the ED until 10/13/15 at 10:28 a.m. when the patient was transferred to an inpatient psychiatric unit. Review of the nursing documentation from 10/11/15 at 7:10 p.m. to 5:50 a.m. on 10/12/15 revealed the patient was continuously monitored by video camera. Review of the nursing documentation on 10/12/15 from 8:30 a.m. to 10/13/15 at 9:06 a.m. revealed no documented evidence that the patient was monitored continuously by staff.

Further review of the physician's orders revealed no documented evidence of an order to monitor the patient by video camera or to lock the patient in Exam Room 3.


Patient #4
Review of the ED record for Patient #4 revealed the patient presented to the ED on 12/08/15 at 11:34 a.m. with a chief complaint of Auditory Hallucinations. Review of the PEC dated 12/08/15 at 12:51 p.m. revealed the patient was paranoid, had thoughts of suicide and violent behavior. The PEC revealed the patient was dangerous to self and others and was intermittently violent.

Review of the nursing documentation revealed the patient was placed in Exam Room 3. Review of the notes revealed: "12:50 p.m.-PEC effective, precautions are in place, patient being monitored by security camera." There was no documented evidence of continuous 1:1 observation by the staff as directed in the hospital policy.

Further review of the record revealed no documented evidence of any physician's orders for locking the patient in the room, or monitoring by video camera.


Patient #5
Review of the ED record for Patient #5 revealed the patient presented to the ED on 10/25/15 at 2:08 a.m. by ambulance with suicidal ideations. The record revealed the patient was placed in Exam Room 1. The record revealed the patient was PEC'd at 4:17 a.m. on 10/25/15 for dangerous to self and suicidal.
Review of the nursing documentation revealed no documented evidence of 1:1 observation by the staff or any monitoring by video camera. Further review of the record revealed no documented evidence the patient was placed in a gown and clothes were removed. There was no documented evidence any hazards were removed from the room.

In an interview on 01/21/16 at 2:30 p.m., the ED records for Patients #3, #4, and #5 were reviewed with S3QI, acting DON for this day. S3QI confirmed the above findings in the records. S3QI confirmed that locking the patients in the ED room was seclusion and should not have been done. S3QI confirmed the records did not include documentation that the 1:1 observation of PEC patients was done in accordance with the hospital's policy. S3QI confirmed the video camera view of Exam Room 3 does not include all of the room. S3QI confirmed the hospital policy had not been followed for the care and safety of PEC patients.


2) Failing to ensure ED patients were triaged by the Registered Nurse prior to being registered by the ED Clerk:

Review of the hospital policy titled, "Admission of Patients to ED", policy number 1101, provided by S3QI as current policy, revealed in part the following: All patients will be evaluated by the triage nurse prior to being seen by the Emergency Department Registration Clerk.

Review of the hospital policy titled, "Triage", policy number 1202, revealed in part the following: Until the patient is triaged by the Registered Nurse and deemed to have a non-life threatening condition, the Registration Clerk is not to obtain or request any financial or demographic information.

During an observation of the ED on 01/19/16 at 11:20 a.m., the ED entrance was observed to be locked with the following signage affixed to the entrance door: Please see Front Desk Reception from 7:00 a.m. to 4:30 p.m. Push buzzer from 4:30 p.m. to 7:00 a.m.

In an interview on 01/19/16 at 11:25 a.m., S17Operator (at ED Reception desk) confirmed she was the PBX operator at the front desk of the hospital. She stated when ED patients come to the desk, the patient gives their name and she writes the name on a log. S17Operator stated if the patient complains of shortness of breath or has bleeding, she would call the ER nurse and the patient would go to the ER first. The operator indicated that unless the patient is having a heart attack, shortness of breath, or bleeding she had the patient have a seat in the waiting room while she called the admissions clerk, who would let her know when she (the operator) could send the patient to admissions to be registered. After they were registered, the ED nurse would be notified and they would call the patient into the ED.
In an interview on 01/19/16 at 11:55 a.m., S7ED Mgr. stated if a patient rings the buzzer at the ED locked entrance door, the patient is brought to the triage room. She stated if the reception clerk calls and says they have an ED patient, the nurse goes and looks at the patient but there is no documentation until the patient is back in the ED.

In an interview on 01/20/16 at 9:05 a.m. at the front desk where she was working as the PBX Operator, S36PBX Operator reported when patients came into the hospital for ED services she would have them take a seat in the waiting area while she called admissions. She would notify admissions of an ED patient with the need to be registered. If the patient had a complaint of shortness of breath, pain in their left side, chest pain, or severe bleeding she would call the ED nurses to come see the patient without sending them first to admissions to be registered. S36PBX Operator reported that her experience was as a CNA in a nursing home. S36Admit Clerk reported she was not given a list of what complaints should be evaluated by a nurse. S36PBX Operator stated she sometimes worked in admissions as a clerk, where she would verify patients and get them into the EMR system.
In an interview on 01/20/16 at 10:00 a.m., S10RN was asked what the hospital's process was when a patient presented to the ED. S10RN stated the patient goes to the reception desk and then to registration and then the ED is called to notify them they have a patient. She stated if the patient has chest pain or bleeding, the reception clerk calls the ED and the patient goes straight back. She stated if depends on the severity.

In an interview 01/20/16 at 2:10 p.m. S35Admit Coordinator reported that she worked in admissions and sometimes filled in at the front desk as the operator. S35Admit Coordinator indicated when she was working the front desk, and a patient came into the hospital to be seen in the ER, she would ask (the patient), "what they were here for." Unless the patient's complaint was chest pain, bleeding, broken bone(s), or tingling she would send them (the patient) to admissions to "be checked in." Only when a patient presented with one of the above listed complaints did she call a nurse from the ED department to evaluate the patient before they had been through registration to get the patient's name and insurance information.

In an interview on 01/21/16 at 2:30 p.m., S3QI confirmed the initial triage of ED patients presenting to the reception desk was done by the reception clerk and the clerk was not qualified to determine if the patient needed to be seen prior to being registered. S3QI confirmed the hospital's policy for triage of ED patients was not followed.


3) failing to ensure the hospital policy for withholding life support was implemented by failing to obtain physician's orders for a no code directive and failing to ensure the decision to withhold life support was supported by documentation in the physician progress notes:

Review of the hospital policy titled, "Withholding and Withdrawing Life Support", policy number 1106, revealed in part the following:
No Code Orders/DNR (Do Not Resuscitate): CPR will automatically be initiated if there is no signed order for a "No Code/DNR." The "No Code/DNR" order or the order to withdraw life support measures must be written on the physician's order sheet, dated, signed by the physician, and timed....The order to withhold or withdraw life-sustaining treatment must be supported by complete documentation in the progress notes of the circumstances surrounding the decision.

Patient #16
Review of the medical record for Patient #16 revealed the patient was an 83 year old patient admitted to the hospital from a skilled nursing facility on 09/25/15 with diagnoses of Pneumonia, Dehydration, Cellulitis, Dementia and Urinary Tract Infection. Review of the record revealed the patient's son signed a "No Code" form on 09/28/15 and the form was witnessed by S29LPN.

Further review of the physician's orders and the physician's progress notes revealed no documented evidence of a physician's order for the "No Code" status. There was no documented evidence in the physician's progress notes supporting the "No Code" status.

Review of the nursing documentation revealed no documented evidence that the physician was notified of the "No Code" form signed by the patient's son. Review of the nursing notes revealed on 09/29/15 at 7:00 p.m. the patient's son called the nurse to the room and patient was found to have no respirations/pulse/blood pressure. There was no documented evidence that CPR was performed. Further review of the nurse's notes revealed the patient was pronounced dead by the ED physician at 7:05 p.m.

The above findings were confirmed by S8Safety/RM on 01/20/16 at 3:00 p.m. when the EMR was reviewed with S8Safety/RM.

In an interview on 01/21/16 at 2:30 p.m., S3QI reviewed the medical record for Patient #16 and confirmed there was no physician's order for the "No Code" status and no CPR was provided for Patient #16. S3QI confirmed there was no documentation by the physician in the progress notes related to the "No Code" status.

Based on record reviews and interviews, the CAH (Critical Access Hospital) failed to ensure that identified medication errors were documented in the patient's medical record and the notification of the physician of the medication error was documented in the patient's medical record for 3 of 3 (#9, #12, #13) current patient medical records reviewed for medication errors out of 6 current inpatients and a total sample of 22 sampled patients.

Findings:

A review of the CAH's policy titled "Medication Variances", provided by S3QI as the most current, revealed in part: Medication variances will be reported and reviewed. All medication errors will be reported by completing the Hospital Occurrence Report. Medication errors will be reviewed within the QI (Quality Improvement) process and will be evaluated for trends. The nurse shall document in the patient medical record the error and that the physician was notified.

A review of the "Hospital Occurrence Reports" from November - present revealed in part: 16 out of 16 medication error reports were completed by the pharmacist, S19RPh, to include medications errors on current Patients (#9, #12, #13).

A review of the current Patient's (#9, #12, #13) medical records with S5ADON revealed no documented evidence of the medications errors being documented in the medical record or documented evidence that the physician was notified.

In an interview on 01/21/16 at 11:00 a.m. with S19RPh he indicated that he was the Director of Pharmacy. S19RPh was asked about the reporting of patient medication errors. He indicated that he mostly discovered the medication errors when he performed daily medical record reviews. S19RPh indicated that he completes a "Hospital Occurrence Report" and submits them to the Risk Manager, S8Safety/RM. S19RPh was asked how the CAH was tracking and trending medication "near misses". S19RPh indicated that the CAH had no process in place to track or trend "near misses".
In an interview on 01/21/16 at 3:30 p.m. with S8Safety/RM she indicated that she was the Risk Manager and that she received the "Hospital Occurrence Reports" on medication errors. S8Safety/RM indicated that most medication errors were discovered by S19RPh when he performed daily medical record reviews. S8Safety/RM was asked if the nurses were supposed to complete "Hospital Occurrence Reports" on medication errors. She indicated that the nurses were supposed to also complete a "Hospital Occurrence Report" on medication errors and indicate the reason with any actions. S8Safety/RM indicated that the computer software system for medication administration allowed the nurses (through a color coded system cue) to identify medication errors when they reviewed documentation at the end of their shift, but the nurses were not utilizing the color coded system effectively. S8Safety/RM indicated that when she received the medication error reports from S19RPh, she would send a form to the nurse with the medication error listed and the nurse was supposed to complete the form with the reason and any actions. She indicated that the nurses mostly just signed the forms and she would send the signed forms to S2DON, who indicated (in a telephone conversation with S8Safety/RM) that she just filed the signed forms. S8Safety/RM further indicated that the nurses were not documenting medication errors in the patient's medical record and she was not sure if documenting medication errors in the patient's medical record was a risk management concern and therefore this practice was not being enforced. S8Safety/RM further indicated that she filed medication error reports in the physician's folder and the physician would review and sign the next time they were in the facility and return the signed forms to Risk Management. S8Safety/RM indicated that nurses were not documenting in the patient's medical record that the physician was notified and the physician notification was mostly done through the physician's reviewing their designated folders.
In an interview on 01/22/16 at 4:00 p.m. with S3QI she indicated that she received the medication error reports from S8Safety/RM. She further indicated that the QA department was not tracking, trending or analyzing medication errors for opportunities for improvement.

Based on record reviews, observations and interviews the CAH

1) failed to maintain a comprehensive and ongoing Infection Control Program designed to prevent, control, and investigate infection control practices that included: data collection, tracking, trending and analysis of infection control practices/breaches through monitoring and surveillance of all the services of the CAH, active surveillance of infection control practices to identify infection control breaches with implementation of corrective actions to prevent and control infections, monitoring of compliance with all infection control policies, procedures, protocols and other infection control program requirements that were implemented by the CAH;

2) failed to ensure that the CAH followed acceptable professional standards of practice and acceptable infection control practices for sterilization, failed to ensure that staff adhered to acceptable decontamination protocols and workflow patterns for the decontamination of soiled instruments, and failed to ensure that the Central Supply Director was qualified by training and/or experience in sterilization recommended practices; and

3) failed to ensure a safe and sanitary environment was maintained as evidenced by observations of infection control breaches/issues.


Findings:

1) failed to maintain a comprehensive and ongoing Infection Control Program designed to prevent, control, and investigate infection control practices that included: data collection, tracking, trending and analysis of infection control practices/breaches through monitoring and surveillance of all the services of the CAH, active surveillance of infection control practices to identify infection control breaches with implementation of corrective actions to prevent and control infections, monitoring of compliance with all infection control policies, procedures, protocols and other infection control program requirements that were implemented by the CAH;

A review of the CAH policy titled "Infection Control Plan" provided by S4IC as the most current, revealed in part: The Infection Control Program will incorporate the following on an ongoing basis; identifying, reporting, investigating and controlling infections through surveillance and addressing potential risks with evaluations and revisions. When problems or opportunities are identified, actions taken/recommended will be documented and forwarded to the Director of Quality Assurance for review and resolution as necessary. Nursing staff are responsible for being familiar with Infection Prevention and Control policies and procedures. There will be collaboration between departments and the Infection Control nurse to identify trends or opportunities to improve outcomes. The review further revealed that the prevention of MRSA (Methicillin Resistant Staph Aureus), in addition to standard precautions that contact precautions will be utilized to include: wearing of gown and gloves when entering all contact precaution patient rooms. The Infection Control Plan indicated that the CAH followed the CDC (Centers for Disease Control and Prevention) Guidelines for Infection Control and Isolation precautions.

OBSERVATIONS on 01/19/16 from 11:00 a.m. and 2:00 p.m.:
S16RN at 1:00 p.m. was observed entering Patient #8's room without donning proper PPE (personnel protective equipment-gown and gloves) when the sign on the patient's door indicated that Patient #8 was on "contact" precautions.
Patient #8's family was observed entering and exiting the patient's room frequently without donning the proper PPE (gown and gloves) when the sign on the patient's door indicated that Patient #8 was on "contact" precautions and that visitors needed to report to the nurse's station before entering the patient's room.
In an interview on 01/22/16 at 9:00 a.m. with S26RN she indicated that staff did not have to don PPE (gown and gloves) for patients on "contact" precautions when staff entered the patient's room if they were not going to have contact with the patient and/or if they were only going to talk to the patient or administer medications. S26RN further indicated that the nursing staff usually did not instruct or enforce the use of PPE for family members of patients on "contact" precautions.
In an interview on 01/19/16 at 2:15 p.m. with S4IC she indicated that patients and family were supposed to be instructed on the use of proper PPE when patients were on "contact" precautions. S4IC further indicated that staff attended annual in-services on isolation precautions. S4IC further indicated that staff were not adhering to the hospital's infection control policy.

In an interview on 01/19/16 at 3:45 p.m. with S4IC she indicated that she was the designated Infection Control Officer for the CAH. A review of the Infection Control Program binder on 01/19/16 at 3:45 p.m. with S4IC revealed data collection activities by the Infection Control Officer, S4IC. There was no evidence of any tracking, trending, and/or analysis of the data with identified opportunities of improvement and/or implementation of corrective actions. S4IC was asked for the documented evidence of the CAH's active surveillance monitoring that included: the data's tracking, trending and analysis of infection control practices/breaches with implementation of any corrective actions and evaluations. S4IC indicated that she was not tracking, trending or analyzing the data she was collecting or implementing corrective actions based on any analysis for any of the identified infection control breaches/issues that she identified in her monthly environmental rounds. S4IC indicated that she conducted monthly environmental rounds and documented her findings on the environmental round sheets and forwarded the data to S3QI in the Quality Assurance Department. She indicated that she had no documentation of any data analysis, tracking, trending or follow-ups that she was currently reporting to QA. S4IC was made aware of the multiple infection control breaches/issues identified by the surveyors through observations in the CAH. S4IC indicated that most of the infection control breaches/issues identified by the surveyors had not been identified by Infection Control. A further review of the Infection Control binder revealed that the CAH followed the guidelines established by the CDC (Centers for Disease Control and Prevention).

In an interview on 01/20/16 at 2:30 p.m. with S3QI, she indicated that she was responsible for the Quality Assurance department. S3QI indicated that the reports submitted to her department by the Infection Control Officer were reported to Medical Executive Committee and to the Governing Board and that no further tracking, trending, or analysis was being performed on the infection control data by her department.


2) failed to ensure that the CAH followed acceptable professional standards of practice and acceptable infection control practices for sterilization, failed to ensure that staff adhered to acceptable decontamination protocols and workflow patterns for the decontamination of soiled instruments, and failed to ensure that the Central Supply Director was qualified by training and/or experience in sterilization recommended practices; and
A review of the CAH policy titled "Central Supply/Purchasing" provided by S23CS as the most current, revealed in part: It is the policy of the CAH that all sterile items for patient use will be maintained using proper sterile technique. Opened, soiled, or expired items will be removed and sent to Central Supply immediately for reprocessing. Items to be sterilized will be packaged appropriately, placing steam chemical indicators in all packages to be sterilized. All items will be identified and labeled with date of autoclaving. An item shall remain sterile unless it has been damaged.
A review of the CAH policy titled "Sterilization Monitoring" provided by S4IC as the most current, revealed in part: A systematic and standardized sterilization process will be followed as referenced by AAMI (Association for the Advancement of Medical Instrumentation) and AORN (Association of periOperative Registered Nurses). An external indicator (heat sensitive tape or a peel pouch with a color heat sensitive dot) will be used for all items to detect color changes to indicate that one of the process parameters of sterilization has been met. It does not indicate sterilization, only that the package has been exposed to heat. An internal chemical indicator will be placed inside of all packages to be sterilized and is a more sensitive indicator than external indicators. A biological indicator shall be run at least weekly in the autoclave to check spore viability.
A review of the CAH policy titled "Cleaning and Disinfecting Guidelines" provided by S4IC as the most current, revealed in part: Cleaning of medical devices (instruments) with enzymatic detergent and mechanical action is essential to sterilization and renders the item safe to handle before the sterilization step and ensures the removal of organic debris, allowing effective sterilization.
A review of AORN (Association of periOperative Registered Nurses) Guidelines for Perioperative Practice, 2015 edition- Guideline for Sterilization-
Recommendation III revealed in part: A controlled environment is intended to facilitate effective decontamination, assembly, sterilization and storage and to minimize environmental contamination and maintain sterility of sterilized items. Functional workflow patterns should be established to create and maintain physical separation between the decontamination and processing and sterilization areas. Room temperature, humidity and ventilation must be controlled and monitored in accordance with established regulations. Controlled conditions reduce the risk of contamination. Functional workflow patterns should be established in the following order: from potentially high contamination areas to clean areas to prevent recontamination. Recommendation III further revealed in part: Items to be sterilized should be cleaned, decontaminated, inspected, sterilized, and stored in a controlled environment. The decontamination area should have a negative airflow with a minimum number of no less than 6 air exchanges (FGI- Facilities Guideline Institute) per hour and a temperature of 60 - 65 degrees F (Fahrenheit) and humidity between 20% - 60%. The preparation/packaging area and the sterilizer loading/unloading area should have a positive airflow with a minimum number of 10 air exchanges and a temperature of 68 - 73 degrees F and humidity between 20% - 60%.
Recommendation VI revealed in part: A quality monitoring program that includes physical monitors (printouts, digital readings, graphs and gauges), chemical indicators, and biological indicators should be used to verify that conditions necessary for steam sterilization have been met. Attention to sterility monitoring to ensure compliance with recommended guidelines is a critical component of quality assurance. Deviation from recommended practices and recommendations can compromise the quality of sterilization processes. Each sterilization cycle should be monitored to verify that parameters required for sterilization have been met. Physical monitors verify cycle parameters are met for every load. External and internal chemical indicators should be used with each package. Chemical indicators should be placed in an area within the package that presents a challenge for air removal and steam contact. Biological indicators should be used to monitor sterilizer efficacy and should be performed at least weekly and preferably daily. Recommendation VI further revealed in part: After steam sterilization, the contents of the sterilizer should be removed from the chamber and left untouched until they are cooled. A period of 30 minutes to 2 hours may be necessary for the cool down. Warm or hot items should not be placed on cool or cold surfaces as moisture may condense from both inside and outside the package. Sterilized packages or containers that have formed condensate should be considered unsterile and the contents should not be used. Moisture can compromise the integrity of the barrier material and the sterility of the contents. Items should be allowed to cool on the autoclave sterilization rack
Recommendation XVII revealed in part: Personnel should receive initial and ongoing education and competency validation for sterilization practices to facilitate the development of knowledge and skills that affect safe patient care.
Recommendation XVIII revealed in part: Every sterilization cycle and modality should be documented to include; contents of each load, load identification, exposure parameters, operator's name/initials, results of physical, chemical and biological monitoring, and the date of sterilization to identify or retrieve items in the event of a sterilizer failure or malfunction. Accurate and complete records are required for process verification and sterilizer function. Documentation demonstrates compliance with regulations and identifies trends and quality improvement opportunities.
A review of the AORN Guidelines for Perioperative Practice, 2015 edition - Guidelines for Packaging Systems - Recommendation IV revealed in part: Towels placed within instrument sets should be lint-free, freshly laundered and thoroughly rinsed by a health care accredited laundry to reduce the risk of leaving chemical residue on the instruments. Lint left on sterile towels may be transferred to the surgical wound and may cause a foreign-body reaction.

OBSERVATIONS on 01/19/16 from 3:30 p.m. to 4:30 p.m.:
An observation of a large plastic pan filled halfway with a solution (not dated and not labeled) in the emergency department's dirty utility room
An observation of 15 out of 29 sterile peel packaged instruments in the emergency department cabinet with no evidence of a chemical indicator located within the sterile packs, and 2 out of 29 sterile peel packaged instruments in the emergency room cabinet with water stains noted on the packages and compromised sterility. The 29 sterile peel packed instruments in the emergency department cabinet further revealed no documentation of a load number, a sterilizer number or the sterilization date identified on the sterile packages.
An observation of the hall decontamination room revealed soiled and processed/packaged instruments ready for sterilization located in the same room. The cabinet in the decontamination room contained over 50 laundered green and blue cloth towels that were torn, frayed and faded with visible signs of lint. An assortment of extra clean instruments and sterilization processing supplies were also noted in the cabinets above the decontamination sink. The decontamination room had a plastic bin on a rolling cart that contained processed/packaged instrument pans that were ready to be sterilized. There was no evidence of any enzymatic cleaner/solution in the emergency department soiled utility room or the hall decontamination room. The workflow pattern in the hall decontamination room revealed that it went from dirty to clean to dirty. The room contained only one door for both entering and exiting

OBSERVATIONS on 01/20/16 from 12:15 p.m. to 12:45 p.m.:
An observation of the autoclave room where instruments for patient use were sterilized revealed a table top gravity displaced autoclave. There were no processing supplies noted in the room to package and process instruments after they were decontaminated. The observation further revealed a solid metal table next to the table top gravity autoclave sterilizer.
In an interview on 01/19/16 at 3:45 p.m. with S23CS she indicated that she was the Director of Central Supply/Purchasing and that she was responsible for the decontamination, processing, packaging and sterilization of instruments. S23CS was asked about the soiled utility room in the emergency department, the decontamination room in the hallway, and the autoclave sterilization room. She indicated that she was responsible for those areas. S23CS was made aware of the infection control and sterilization observations in those areas. She indicated that the soaking pan in the emergency department contained a disinfectant solution and indicated that she does not label or date it. She further indicated that she did not use an enzymatic solution/cleaner when decontaminating instruments prior to sterilization and only used an EPA disinfectant solution for decontamination of the instruments. A review of the manufacturer's directions for use on the EPA disinfectant, with S23CS, revealed no indication for use in instrument decontamination. She indicated that she used the cloth towels located in the cabinet in the hall decontamination room to dry instruments and to reprocess in sterile towel packs and to place in the sterile instruments trays used by the physicians when draping patients for sterile procedures in the emergency department. She indicated they were laundered and reused and further acknowledged that they were worn and linty. S23CS did not know where the towels originally came from or if they were originally single use only or reusable. S23CS indicated that she did not always place chemical indicators in the packages prior to sterilization and thought the external indicators were sufficient. S23CS further indicated that she did not know that she was supposed to identify each sterilized item with the autoclave number, the load number and the date the item was sterilized. S23CS indicated that she used the hall decontamination room as both a decontamination area and an area to process and package instruments and supplies prior to taking them to the autoclave room to be sterilized. She indicated that the autoclave room was small and hot at times when the autoclave was being used, so she did not store the sterilization packaging supplies used for sterilization in that room, and stored them instead in the hall decontamination room. She further indicated that after items were sterilized, they were removed from the autoclave and the sterile items were placed directly onto the metal table in the autoclave room until they were cooled. S23CS indicated that she had no prior experience or training in Central Supply decontamination, instrument processing/packaging and sterilization and indicated that she was self-taught. She further indicated that she was not familiar with AAMI or AORN.
In an interview on 01/20/16 at 2:30 p.m. with S4IC, who was present during the tour and the observations in the decontamination and autoclave rooms on 01/19/16 and 01/20/16 with S23CS, indicated that she was not very familiar with sterilization practices.
In an interview on 01/21/16 at 3:45 p.m. with S24Main he was asked about the temperature/humidity monitoring and the air exchanges in the hall decontamination room and in the Central Sterile autoclave room. He indicated that the hall decontamination room used to be the pharmacy department and the autoclave room was a prior janitor closet. S24Main indicated that he was not monitoring those rooms for temperature/humidity and/or air exchanges.

3) failed to ensure a safe and sanitary environment was maintained as evidenced by observations of infection control breaches/issues.
Observations during a tour of the hospital 01/19/16 from 11:30 a.m. until 2:30 p.m. revealed the following:
Emergency Department:
11:30 a.m. - In exam room 3, a 2 inch area of missing Formica with rough exposed particle board was observed on the edge of the counter adjacent to the sink. S7Ed Mgr. confirmed the counter could not be properly disinfected where the Formica was missing.

12:05 p.m. - In a soiled utility room in the ED (Emergency Department) were 2 bedside commodes, 2 plastic spine boards stored. S7ED Mgr. indicated that the equipment was clean and should not have been stored in the soiled utility room. In the same soiled utility room was a red plastic bin, labeled with a biohazard label but with no content or date and time of liquid change or discard date on the container. The container was filled approximately ½ full with a clear liquid with a strong noxious odor when lid was removed. S7ED Mgr. reported this was a solution the ED staff used to soak soiled instruments until the person from Central Sterile would come and pick up the contaminated instruments. S7ED Mgr. reported that she did not know what solution was in the red container.

Inpatient Unit
12:50 p.m. - On IP (Inpatient) unit, in a patient room that was being used as a storage room: the light switch was noted to have a large amount of a sticky substance. The defibrillator/monitor was noted to have tan drip marks in several places, and tape adhesive residue that was discolored with a light brown color. A sticky substance was also observed on an overbed table in the room. S2DON joined surveyors on the tour and verified all findings.

Room 104 - S16RN reported that patient Room 104 had been cleaned and was ready for a patient. Areas of dark brown dried liquid on floor near sink and by bed, easily removed with a Sani-cloth wipe. Formica missing from around nightstand top, leaving rough and sharp edges with fiberboard exposed. This presented an absorbable surface that could not be properly disinfected. The floor had debris on it. The over-bed table surface was noted to have areas of a dried substance on it.

Room 103 - Bedside table: wood laminate torn at corners, leaving fiberboard exposed and top edges sharp. The over-bed table was observed to have rough edges around the top of the tabletop where the laminate was peeling off.

Room 108 - Sticky substance noted on bedside table. This room was reported to be used for respiratory isolation, as it had a Hepa Care air machine in the room with a large metal exhaust tubing to the outside, through the window. Tape residue was noted on the air machine and an accumulation of dust was observed on the exhaust tubing.

Room 110 - (patient occupied) large uncovered foam wedge sitting directly on floor, visible from the hallway. S2DON verified that the wedge should not be on the floor and was now contaminated.

A thick blackish brown buildup was noted along the footboards along the walls in patient rooms and the hallway.

Rehabilitation unit:
Seated elliptical machine had dirt and fine debris in the foot pedals. The bottom rail, on which the seat moved (to adjust for client leg length) was filled with dirt and thick debris. Wadded paper was observed in the tray of the elliptical. The findings were verified by S20Reh.Tech and S9Therapy Director.

A large uncovered foam wedge was sitting on a therapy table. S34PTA indicated that the wedge should not be there.

A Balance Pad was observed to have 3 rips in the pad and multiple holes on the edge of the pad. S9Therapy Director confirmed the Balance Pad could not be disinfected with the multiple rips and holes.

In an interview on 01/19/16 at 1:35 p.m., S20Reh.Tech reported that she had cleaned the elliptical machine that morning. S20Reh.Tech reported that the staff was supposed to clean the equipment at the end of the day.

1:40 p.m. - An observation of the Rehabilitation therapy table revealed dark brown/black markings on one end of the padded table. When asked to wipe the area with a damp cloth, S9Therapy Director wiped the padded patient table with a damp disposable disinfectant wipe, with the wipe being brown after a couple of passes with the wipe. S9Therapy Director agreed that the therapy table was not clean.

A rolling stool in the therapy room was noted to have a rip in the vinyl covering on the side, preventing the stool from being disinfected completely.

Both staff chairs, in the therapy gym by patient equipment, had large tears in the fabric at the top back of the chairs, preventing them from being cleaned and disinfected completely.

Supply closet with a single shoe on the floor, (a prosthetic leg with the matching shoe on it was propped in the closet), paper and debris were noted on the floor, patient supplies and seasonal (Christmas decorations) were noted to be mixed in the closet.

S9Theapy Director verified all observations in the Therapy department.

Based on record review and interview, the hospital failed to ensure that nursing care for each patient was supervised and evaluated by a Registered Nurse for 2 (#12, #13) of 6 (#8, #9, #10, #11, #12, #13) swing-bed patients' records reviewed out of a total sample of 22 records (#1-#22) by failing to ensure unlicensed personnel reported abnormal findings to licensed personnel (#13) and failing to ensure weights were done as ordered by the physician (#12). Findings:

1) failing to ensure unlicensed personnel reported abnormal findings to licensed personnel

Review of a policy and procedure entitled "Vital Signs, Taking of (by unlicensed personnel)," presented by S3QI as current, revealed, in part: "Specifications: CNA will take patient's vital signs as ordered and document appropriately in EMR. CNA will report to charge nurse/primary nurse after vital signs are obtained and entered in EMR."

Review of "C.N.A. Job Description" presented by S3QI as current, revealed, in part: "Takes and records temperatures, pulse, respiration rates...Reports any and all unusual conditions, changes in patient status, or reactions to nurse in charge..."

Patient #13
Review of the medical record for Patient #13 revealed he was a 55-year-old male admitted to the hospital on swing-bed status on 01/04/16. Diagnoses included Debility, Physical Deconditioning; End State Renal Disease, Diabetes Mellitus, Cardiovascular Disease, Hypertension, Atrial Fibrillation. Further review revealed Patient #13 had been ordered digoxin, 0.125 milligrams by mouth every other day to be administered at 9:00 p.m., and to hold the medication if the pulse was less than 60 beats per minute.

Review of the Patient Progress Notes dated 01/14/16 at 8:33 a.m. revealed a radial pulse of 56 beats per minutes was obtained by S28CNA. Further review of Patient #13's medical record revealed S28CNA did not inform the licensed nurse on duty of the patient's low heart rate.

In an interview on 01/22/16 at 1:22 p.m., S28CNA indicated, when asked, she would consider a pulse reading of "40-44 or something like that" as the measurement she considered reportable to the licensed nurse.

In an interview on 01/21/6 at 2:40 p.m., S8Safety/RM reviewed the medical record for Patient #13 and confirmed there was no documentation in the medical record that S28CNA reported the pulse of 56 to the licensed nurse, and agreed the abnormal finding should have been reported by S28CNA to the nurse.


2) failing to ensure weights were done as ordered by the physician

Review of a policy and procedure entitled "Weights" presented by S2DON as current, revealed, in part: "Purpose: . . . to have an accurate weight of a patient upon admission to enable the physician to make comparisons on a day-to-day basis."

Patient #12
Review of the medical record for Patient #12 revealed she was a 60-year-old female admitted to the hospital on swing-bed status on 12/18/15. Diagnoses included Severe Physical Deconditioning, Diabetes Mellitus, Cardiovascular Disease, Hypertension, and Hypothyroidism. Further review revealed an order for daily weights ordered on 12/26/15.

Review of the Patient Progress Notes and the Graphic Intake and Output sheets revealed no daily weights documented for 01/01/16, 01/03/16, 01/07/16, 01/11/16, 01/17/16, and 01/18/16.

In an interview on 01/21/16 at 3:45 p.m., S8Safety/RM reviewed the medical record and confirmed there were no weights recorded for the above-referenced date, and there should have been, as there was no order to discontinue daily weights written by the licensed practitioner.

Based on record review, interview and observation, the CAH failed to meet the Conditions of Participation for Clinical Records as evidenced by:

1) failure to ensure the clinical records system was maintained in accordance with written policies and procedures as evidenced by failure to ensure all medical records were accessible by appropriate medical staff 24 hours a day, 7 days a week, whenever that a medical record may be needed as evidenced by IOP patient medical records being stored and under the supervision of the IOP staff. The IOP was not open 24 hours/day, 7 days/week. (See findings at C-0301)

2) failure to ensure patient medical records were protected against loss or destruction. This failed practice was evidenced by:
a) approximately 100 un-scanned, copied or backed up patient medical records in an open cardboard box unprotected from potential water damage, and all un-scanned medical records from 2004 to February, 2013 filed in the medical record room's open file shelving system covered by a fabric curtain (on a rod at the top of each unit) labeled water resistant and washable in warm water and detergent;
b) electronic patient records backed up only on one onsite server that used tapes, and;
c) IOP outpatient records store at the offsite campus with no sprinkler system to protect files from fire. (See findings at C-0308)

3) failure to to implement policies and procedures that ensured compliance with state regulations in regards to retention of all medical records. This was evidenced when the hospital offsite IOP had , and followed, different policies and procedures for the retention of patient medical records than those of the Medical Record Department. The IOP P&P stated that client records would be destroyed 7 years from the date of a client's death instead of the state required record retention of 10 years. (See findings at C-0311)

Based on record review and interview the CAH failed to ensure a clinical record system, with written policies and procedures, was implemented and maintained in which records could be easily retrieved and readily assessable, as needed. This deficient practice was evidenced by medical records, for outpatients receiving services in the offsite IOP, that were under the custody and supervision of IOP staff, not medical records, and stored at the offsite location, making them not retrievable and readily accessible, if needed during the days and hours the IOP was not open.
Findings:

Review of a hospital policy titled, "Security of Client Records" (Policy #057, issued 8/21/09, revised 11/21/14, and reviewed 12/28/15, Department of Primary Responsibility: Intensive Outpatient Program) revealed , in part, that client records would be kept in a secure setting all all times, in a locked file cabinet, in a locked office. In a life threatening situation, in which written consent could not be obtained, pertinent medical information could be released to the medical staff responsible for the client's care.

In an interview 121/16 at 3:00 p.m. S12HIM Coordinator reported that she did coding for the IOP (offsite) services. In response to a request for IOP patient medical records, S12HIM reported that the medical records department could only provide a face sheet and diagnoses for coding purposes. S6HIM indicated that any service that used the EMR could be accessed for an IOP patient such as laboratory results or radiology results S6HIM, present for the interview indicated that the offsite IOP were responsible for admitting their own patients, making, maintaining, and storing their own medical records at the offsite location. S6HIM verified that the Medical Records department did not have access to the IOP outpatient medical records. The HIM Director indicated that the department only performed the medical coding (for billing) for the IOP patients. When asked how the IOP records could be accessed, S6HIM indicated that S18IOP Director would have to retrieve them. S6HIM verified that the records would not be readily accessible if they were needed by medical staff, when the IOP was not open.

In an interview 1/21/16 at 3:15 p.m. S18IOP reported that patients receiving services at the offsite IOP were registered at the offsite location where demographic and insurance information was entered into a computer system, enabling the hospital's medical record department to access that information in order to perform coding on those medical records. S18IOP reported that the rest of a patient's record was in paper form (as opposed to EMR) and was stored at the offsite location. S18IOP reported that the IOP had their own policies and procedure for the security of Client Records. The IOP director reported that the offsite IOP location housed approximately 100 records.

Based on observation and interview, the CAH failed to ensure patient medical records were protected against loss or destruction. This failed practice was evidenced by
a) approximately 100 un-scanned, copied or backed up patient medical records in an open cardboard box unprotected from potential water damage, and all un-scanned medical records from 2004 to February, 2013 filed in the medical record room's open file shelving system covered by a fabric curtain (on a rod at the top of each unit) labeled water resistant and washable in warm water and detergent;
b) electronic patient records backed up only on the one onsite server that used tapes, and;
c) IOP outpatient records store at the offsite campus with no sprinkler system to protect files from fire.


Findings:

An observation was made of the hospital's medical records department on 1/19/16 at 11:30 a.m. A room with open storage shelves against 3 walls and in the middle of the room, filled with paper medical records was observed. The shelving units had fabric curtains suspended on a rod, on the front of them. A label on the curtains indicated the curtains were water resistant and washable in warm water and detergent. A cardboard box, containing approximately 100 paper patient charts was observed on a rolling cart with no covering over then. S6HIM reported that the cardboard box containing approximately 100 paper patient records was there to be scanned into the EMR system, then shredded. S6HIM verified the medical records in the cardboard box were not protected from water damage. S6HIM verified the label on the curtains on the front of the shelving units. S6HIM agreed that if the fabric was washable it was not waterproof, and may not protect the paper records waiting to be scanned into the permanent electronic medical record system. S6HIM indicated patient medical records from 2004 to February, 2013 were stored in the open storage shelves.

In an interview 01/19/16 at 11:35 a.m. S6HIM reported that she was not familiar with the back up process for the electronic medical records. S6HIM reported that the hospital started using the EMR systems in 2013. She suggested that surveyors speak with the IT director for information regarding the protection of the EMR.

In an interview 1/20/16 at 11:30 a.m. S33IT Director reported that the hospital only backed up their EMR system on-site. The IT director reported the hospital used a back-up system of tapes. S33IT Director verified that the EMRs could be destroyed by damage from fire or other destructive cause.

In an interview 1/21/16 at 3:15 p.m. S18IOP Director reported the offsite outpatient program had their patient's records separate from the hospital's other records. The IOP director indicated the paper records were kept at the offsite campus in a room that was not sprinkler-equipped. S18IOP Director verified the IOP's approximate 100 patient's medical records were not protected from fire.

Based on record review and interview the CAH failed to implement policies and procedures that ensured compliance with state regulations in regards to retention of all medical records. This was evidenced when the hospital offsite IOP had, and followed, different policies and procedures for the retention of patient medical records than those of the Medical Record Department. The IOP P&P indicated that client records would be destroyed 7 years from the date of a client's death instead of the state required record retention of 10 years.

Findings:


Review of a policy titled, "Security of Client Records" (Policy #057, Department of Responsibility: Intensive Outpatient Program, issued 8/21/09, revised 11/21/14, last reviewed 12/28/15), provided by S18IOP Director as current, revealed client records would be destroyed 7 years from the date of death or 10 years from the date of discharge, whichever came first.

In an interview 01/21/16 S18IOP Director reported the offsite IOP medical records were managed separately from the hospital's other medical records, and the IOP had their own P&P for the program's patient records. The IOP Director reported that it was the (outpatient) IOP program's policy to destroy a patient's record 7 years after their death. If a patient was not deceased the record would be kept for 10 years.

Based on record review and staff interview, the CAH (Critical Access Hospital) failed to ensure an annual evaluation of its total program was conducted. Findings:

Review of the hospital policy titled, "Organizational Performance Improvement Plan", policy number 2100 revealed in part the following: The QI Coordinator annually coordinates an assessment of the objectives, scope, organization and oversight effectiveness of the Quality Improvement Program and makes revisions as necessary. The review specifically addresses the structure of the program, program process, andoutcome of quality management improvement activities.

Review of the Quality Improvement Binders, Reports, and Meeting Minutes revealed no documented evidence of an annual evaluation of the hospital's total program.

In an interview on 01/21/16 at 2:30 p.m., S3QI confirmed she was the QI Coordinator and there was no annual evaluation of the total program.

Based on record reviews and interviews, the CAH (Critical Access Hospital):

1) failed to ensure that an effective QA (Quality Assurance) reporting system and process was in place that proactively identified causative factors that included tracking, trending and analysis with implementation of corrective actions to reduce and/or prevent medication errors and "near misses" as evidenced by no documented evidence of tracking, trending and analysis of medication errors and medication "near misses" in the CAH's QA program;

2) failed to ensure an effective QA process was in place for the CAH's Infection Control program that demonstrated a comprehensive and ongoing Infection Control Program designed to prevent, control, and investigate infection control practices that included: data collection, tracking, trending and analysis of infection control practices/breaches through monitoring and surveillance of all the services of the CAH, active surveillance of infection control practices to identify infection control breaches with implementation of corrective actions to prevent and control infections, monitoring of compliance with all infection control policies, procedures, protocols and other infection control program requirements that were implemented by the facility, and;

3) failed to ensure an effective QA process was in place for all current identified quality indicators that included tracking, trending and analysis of the data collected, and corrective actions for identified problems.


Findings:


1) failed to ensure that an effective QA (Quality Assurance) reporting system and process was in place that proactively identified causative factors that included tracking, trending and analysis with implementation of corrective actions to reduce and/or prevent medication errors and "near misses" as evidenced by no documented evidence of tracking, trending and analysis of medication errors and medication "near misses" in the CAH's QA program and


A review of the hospital's policy titled "Medication Variances", provided by S3QI as the most current, revealed in part: Medication variances will be reported and reviewed. All medication errors will be reported by completing the "Hospital Occurrence Report". Medication errors will be reviewed within the QI (Quality Improvement) process and will be evaluated for trends. The nurse shall document in the patient medical record the medication error and that the physician was notified.

In an interview on 01/21/16 at 3:30 p.m. with S8Safety/RM she indicated that she was the Risk Manager and that she received the "Hospital Occurrence Reports" on medication errors. S8Safety/RM indicated that most medication errors were discovered by S19RPh when he performed daily medical record reviews. S8Safety/RM was asked if the nurses were supposed to complete "Hospital Occurrence Reports" on medication errors. She indicated that the nurses were supposed to also complete a "Hospital Occurrence Report" on medication errors and indicate the reason with any actions. S8Safety/RM indicated that the computer software system for medication administration allowed the nurses (through a color coded system cue) to identify medication errors when they reviewed documentation at the end of their shift, but the nurses were not utilizing the color coded system effectively. S8Safety/RM indicated that when she received the medication error reports from S19RPh, she would send a form to the nurse with the medication error listed and the nurse was supposed to complete the form with the reason and any actions. She indicated that the nurses mostly just signed the forms and she would send the signed forms to S2DON, who indicated (in a telephone conversation with S8Safety/RM) that she just filed the signed forms. S8Safety/RM further indicated that the nurses were not documenting medication errors in the patient's medical record and she was not sure if documenting medication errors in the patient's medical record was a risk management concern and therefore this practice was not being enforced. S8Safety/RM further indicated that she filed medication error reports in the physician's folder and the physician would review and sign the next time they were in the facility and return the signed forms to Risk Management. S8Safety/RM indicated that nurses were not documenting in the patient's medical record that the physician was notified and the physician notification was mostly done through the physician's reviewing their designated folders.
In an interview on 01/22/16 at 4:00 p.m. with S3QI she indicated that she received the medication error reports from S8Safety/RM. She further indicated that the QA department was not tracking, trending or analyzing medication errors for opportunities for improvement.

2) failed to ensure an effective QA process was in place for the CAH's Infection Control program that demonstrated a comprehensive and ongoing Infection Control Program designed to prevent, control, and investigate infection control practices that included: data collection, tracking, trending and analysis of infection control practices/breaches through monitoring and surveillance of all the services of the CAH, active surveillance of infection control practices to identify infection control breaches with implementation of corrective actions to prevent and control infections, monitoring of compliance with all infection control policies, procedures, protocols and other infection control program requirements that were implemented by the facility.


A review of the CAH policy titled "Infection Control Plan" provided by S4IC as the most current, revealed in part: The Infection Control Program will incorporate the following on an ongoing basis; identifying, reporting, investigating and controlling infections through surveillance and addressing potential risks with evaluations and revisions. When problems or opportunities are identified, actions taken/recommended will be documented and forwarded to the Director of Quality Assurance for review and resolution as necessary. Nursing staff are responsible for being familiar with Infection Prevention and Control policies and procedures. There will be collaboration between departments and the Infection Control nurse to identify trends or opportunities to improve outcomes.

In an interview on 01/19/16 at 3:45 p.m. with S4IC she indicated that she was the designated Infection Control Officer for the CAH. A review of the Infection Control Program binder on 01/19/16 at 3:45 p.m. with S4IC revealed data collection activities by the Infection Control Officer, S4IC. There was no evidence of any tracking, trending, and/or analysis of the data with identified opportunities of improvement and/or implementation of corrective actions. S4IC was asked for the documented evidence of the CAH's active surveillance monitoring that included: the data's tracking, trending and analysis of infection control practices/breaches with implementation of any corrective actions and evaluations. S4IC indicated that she was not tracking, trending or analyzing the data she was collecting or implementing corrective actions based on any analysis for any of the identified infection control breaches/issues that she identified in her monthly environmental rounds. S4IC indicated that she conducted monthly environmental rounds and documented her findings on the environmental round sheets and forwarded the data to S3QI in the Quality Assurance Department. She indicated that she had no documentation of any data analysis, tracking, trending or follow-ups that she was currently reporting to QA. S4IC was made aware of the multiple infection control breaches/issues identified by the surveyors through observations in the CAH. S4IC indicated that most of the infection control breaches/issues identified by the surveyors had not been identified by Infection Control. A further review of the Infection Control binder revealed that the CAH followed the guidelines established by the CDC (Centers for Disease Control and Prevention).

In an interview on 01/20/16 at 2:30 p.m. with S3QI, she indicated that she was responsible for the Quality Assurance department. S3QI indicated that the reports submitted to her department by the Infection Control Officer were reported to Medical Executive Committee and to the Governing Board and that no further tracking, trending, or analysis was being performed on the infection control data by her department.



3) failed to ensure an effective QA process was in place for all current identified quality indicators that included tracking, trending and analysis of the data collected, and corrective actions for identified problems:

Review of the hospital policy titled, "Organizational Performance Improvement Plan", policy number 2100, revealed the hospital would identify and prioritize opportunities for improvement. Patterns, trends and opportunities for improvement would be identified at both the organizational and departmental level. Data collected through the QI program would be analyzed, presented, prioritized, and acted upon at several multidisciplinary and interdepartmental meetings. The policy revealed the outcome of review performed by all hospital departments would be submitted monthly to the QI Committee for their analysis, action, or referral. Further review of the policy revealed the QI plan encompassed all aspects of care and services, including contracted services.


Review of the critical indicators by department for the year 2015 revealed data was collected and reported by department. Review of the data collected and reported revealed no documented evidence of an analysis of the data, there was no tracking or trending of the data, and there was no documented evidence of any corrective actions implemented for data that was below the threshold for the indicator.

In an interview on 01/21/16 at 1:30 p.m., S3QI confirmed the quality assurance program of the hospital collected data and reported the numbers and percentages of the data collected on the quality indicators. S3QI confirmed there was no tracking, trending or analysis of the data collected and there were no corrective actions plans implemented for quality indicators that did not meet the threshold of compliance. S3QI stated problems identified were addressed with the staff involved, but corrective actions were not implemented hospital wide.

Based on record reviews and interviews, the CAH failed to ensure all patient care services and other services affecting patient health and safety were evaluated by the hospital's QA program as evidenced by failing to include patient grievances, organ procurement, bio medical services, PICC line services, contracted ED patient transportation, and PEC patients in the ED in the QA program.

Findings:

Review of the hospital policy titled, "Organizational Performance Improvement Plan", policy number 2100, revealed the hospital would identify and prioritize opportunities for improvement. Indicators are developed to measure and monitor the performance and stability of the process used in delivering patient care service and the associated outcomes. Data collected through the QI program would be analyzed, presented, prioritized, and acted upon at several multidisciplinary and interdepartmental meetings. The policy revealed the outcome of review performed by all hospital departments would be submitted monthly to the QI Committee for their analysis, action, or referral. Further review of the policy revealed the QI plan encompassed all aspects of care and services, including contracted services.


Review of the Quality Assurance reports for 2015 revealed no documented evidence that quality indicators were developed, tracked, and trended for patient grievances, organ procurement, bio medical services, PICC line services, contracted ED patient transportation, and PEC patients in the ED.

In an interview on 01/21/16 at 2:30 p.m., S3QI confirmed she was the QI Coordinator and confirmed there were no current quality indicators developed, tracked or trended for patient grievances, organ procurement, bio medical services, PICC line services, contracted ED patient transportation, and PEC patients in the ED. S3QI confirmed the quality assurance program did not include all patient care services.

30172

Based on record reviews and interviews the CAH (Critical Access Hospital) failed to ensure that hospital policies were adhered to that incorporated the OPO (Organ Procurement Organization) and the hospital's definition of Clinical Triggers, Imminent Death and Timely Notification in order to identify potential donors as agreed upon by the hospital's OPO contract and in accordance with the Louisiana Uniform Anatomical Gift Act and failure to notify the OPO in the event of a patient's death for 1 (#15) of 2 (#15, #16) sampled records of deceased patients reviewed out of a total sample of 22.

Findings:
A review of the hospital's OPO signed contract, provided by S3QI, as the current contract, revealed in part: By entering into this agreement, the Donor Hospital agrees to meet all the obligations set forth by the Louisiana Uniform Anatomical Gift Act and CMS. Timely referral is defined as within 2 hours or less of when a Donor Hospital identifies a patient that meets the criteria for medically established "Clinical Triggers/Imminent Death" for organ donation evaluation as established by the Donor Hospital's definition of "Clinical Triggers/Imminent Death".

A review of the hospital policy titled, "Organ and Tissue Donation", as provided by S3QI as the most current, revealed in part: The purpose of the policy is to establish criteria for identification of patients who can potentially donate organs and/or tissue to the OPO. The CAH will refer all patients meeting the clinical triggers, established by the CAH, to the OPO. The patient must be referred within one hour of meeting clinical triggers to be defined as a timely referral. The CAH will call in all deaths to the OPO within 2 (two) hours of cardiac death to be defined as a timely referral. The CAH personnel will be responsible for contacting and completing the designated OPO form.

In an interview on 01/21/16 at 12:00 p.m. with S10RN she indicated that she was the charge nurse. S10RN was asked about the hospital's OPO policy and the clinical triggers that identified possible "imminent death" patients and the timeliness of notifying the hospital's OPO of possible "imminent death" patients in regard to potential organ donation. S10RN indicated that she did not remember the hospital's OPO policy on "imminent death" or if the hospital had a policy that defined "imminent death". She further indicated that they (staff) did notify the OPO usually within an hour after a patient had died and was not aware of an OPO agreement/requirement to notify the OPO of a patient's "imminent death". She further indicated that she was not notifying the OPO of a patient ' s imminent death and was not aware of other nursing staff notifying the OPO of a patient ' s imminent death. S10RN indicated that there have been occasions when staff were aware that a patient was declining and death was imminent.

In an interview on 01/21/16 at 12:40 p.m. with S5ADON she was asked about the hospital's OPO policy and the clinical triggers that identified possible "imminent death" patients and the timeliness of notifying the hospital's OPO of possible "imminent death" patients in regard to potential organ donation. S5ADON indicated that the staff were notifying the OPO after the patient had died and that the nursing staff were not notifying the OPO of possible "imminent death" patients in regard to potential organ donation at this time. S5ADON indicated that there have been occasions when they were aware that a patient was declining and that death was imminent and the OPO was not notified. She further indicated that the OPO policy needed to be re-in serviced with staff.


Patient #15
Review of the EMR for Patient #15 on 01/20/16 at 2:18 p.m. with S8Safety/RM revealed the patient expired in the hospital on 08/07/15 at 10:46 a.m. Review of the record revealed no documented evidence that the OPO was notified of the patient's death. S8Safety/RM confirmed she had looked everywhere in the EMR that the OPO notification could have been documented and she did not find it.