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Based on record review and interview, the hospital failed to develop and implement a hospital-wide Quality Assessment and Performance Improvement Program. The hospital failed to ensure data was collected, measured and analyzed.

The hospital opened in July 2017, and monthly QAPI minutes began in June 2017. The QA Plan was approved through the QA/IC Committee; however the Plan had no listed PI projects or quality areas for review, such as National Healthcare Safety Network (NHSN) data collection, reporting and analysis from the infection control program, or medication error reporting from the P&T Committee. The QA Plan was not approved through the Governing Body.


Refer to A-273, A-283, A-297 and A-309.

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

1. Ensure the daily operation of the drug room was provided under the supervision of a documented trained and competent Drug Room Supervisor. (Refer to A-0492)

2. Ensure medications were properly labeled in the drug room. (Refer to A-500)

3. Ensure drug administration errors, adverse drug reactions or dosing issues were reported to the hospital's QA/PI program (Refer to A-508)

The hospital established a drug room in lieu of a pharmacy with the day-to-day operations assigned to a Drug Room Supervisor. The facility contracts with a pharmacist to provide services to the hospital consistent with statutory requirements, practice and operation of a licensed drug room.

The consulting pharmacist is at the facility approximately two hours per week. The consulting pharmacist stated she had always been a staff pharmacist and this is her first time to manage a drug room; she was unaware of the responsibilities associated with a hospital's drug room.

Based on record review and interview, the hospital failed to establish a Utilization Review plan for:

1. Admissions to the institution;
2. The duration of stays; and
3. Professional services furnished including drugs and biologicals.


This failed practice had the potential to cause patients to receive medically unnecessary care and higher costs associated with care.

Findings:

A review of Governing Body minutes and QAPI program meeting minutes showed no documentation of Utilization Review plans, record reviews, or recommendations.

On 10/05/17 at 10:10 am, Staff A and Staff E stated there was no established Utilization Review committee or plan, and no documentation of reviews for medical necessity could be provided for review.

Based on observation, record review, and interview, the hospital failed to provide an active infection prevention program as evidenced by:


1. Failure to ensure a hospital-wide active surveillance program was in place. There was no indication a surveillance program had been developed or utilized since the opening of the hospital in July 2017.

2. Failure to maintain a sterile operating room environment by allowing patients to be taken directly into the sterile operating room from the medical/surgical floor. AORN (Association of periOperative Registered Nurses) guidelines state that the restricted area of the operating room is accessible only through a semi-restricted access area. The medical/surgical floor is an unrestricted access area.

3. Failure to control air flow within the operating room by allowing uncontrolled opening of the operating room doors during procedures performed in the operating room. AORN guidelines state when the doors are open, the HVAC system is unable to maintain critical environmental control parameters in the sterile environment.

Refer to Tag A-0749

Based on record review and interview, the hospital failed to ensure patients were informed of their rights for 20 (Patients #1-20) of 20 records reviewed.

Findings:

During a review of patient records (Patients #1-20), showed no documentation patients were informed of their rights on admission.

On 10/05/17 at 10:10 am, Staff A stated there was no documentation of patient rights in the records because the hospital had not given patients copies of their rights.

Based on record review and interview the hospital failed to provide documentation of written notice to the patient reporting the grievance resolution for 1 of 1 grievances reviewed.

Findings:

Document titled "Grievance Policy" states a patient grievance is a formal or informal written or verbal complaint that is made to the hospital and that a written response will be provided to the grievant.

A grievance submitted on 08/08/17 contained documentation of the investigation of the grievance; however, there was no resolution letter sent to the complainant explaining the investigation findings.

On 10/05/17 at 9:25 am, Staff A and Staff F stated there was no documentation the resolution letter with findings was sent to the patient.

Based on record review and interview, the hospital failed to measure, analyze, and document the quality indicator data.

Findings:

Documents titled "Sayre Community Hospital QA/IC Meeting" dated June, July, August, and September 2017 were reviewed. The minutes did not reflect what data was collected or analysis of data showing a measurable improvement with evidence of how this will improve health outcomes.

On 10/05/17 at 9:25 am, Staff A and Staff E stated, the minutes did not reflect any data collection, tracking or analyzing; there was no documentation of evidence of data collection.

Based on record review and interview, the hospital failed to develop performance improvement activities.

Documents titled "Sayre Community Hospital QA/IC Meeting" dated June, July, August, and September 2017 were reviewed. The minutes did not reflect the hospital developed or set priorities for any performance improvement activities. There was no documentation of developed performance improvement activities.

Document titled "QA Plan" did not define priorities or performance improvement activities.

On 10/05/17 at 9:25 am, Staff E stated the hospital would develop and prioritize performance improvement activities, update the Quality Plan and report results through the QA/IC Meeting and Governing Body.

Based on record review and interview, the hospital failed to conduct performance improvement projects.

Findings:

Documents titled "Sayre Community Hospital QA/IC Meeting" dated June, July, August, and September 2017 were reviewed. The minutes did not reflect performance improvement projects were developed.

On 10/05/17 at 9:25 am, Staff E stated the hospital would document performance improvement activities and report results through the QA/IC Meeting and the Governing Body.

Based on record review and interview, the hospital's governing body failed to ensure a quality improvement program was established.

Findings:

Documents titled "Sayre Community Hospital QA/IC Meeting" dated June, July, August, and September 2017 were reviewed. The minutes did not reflect quality improvement activities were being collected or analyzed.

Documents titled "Governing Board Minutes" dated monthly from March through August 2017 were reviewed. There was no documentation of quality improvement activities.

On 10/05/17 at 9:25 am, Staff E stated the hospital would develop quality improvement activities and report results through the QA/IC Meeting and the Governing Body.

On 10/05/17 at 11:00 am, Staff D stated he understood the Governing Body's responsibilities and the needed documentation.

Based on record review and interview, the hospital failed to ensure an RN supervised and evaluated care provided to patients for 2 (Patients #12 and 13) of 20 records reviewed.

This failed practice had the potential to result in:

1. Untreated adverse effects of medications and/or deterioration of a skin condition for Patient #12; and

2. Self-inflicted injuries due to psychosis causing tactile hallucinations for Patient #13.


Findings:

Patient #12

The patient presented to the hospital on 09/23/17 for a CT of the abdomen and pelvis. The radiologist report suggested right groin cellulitis. There was no documentation of a physical assessment to include integumentary status, pain level, or any vital signs. A review of the clinical record showed an unsigned order dated 09/23/17 at 8:00 am for Rocephin (an antibiotic) to be given to the patient as an IM injection. There was no documentation a nurse acknowledged the order, verified medication allergies, or administered the medication, and no documentation of education/instructions given to the patient regarding the infection and signs/symptoms to report. The patient was not admitted to the hospital.


Patient #13

A review of the clinical record showed the patient presented to the ER on 09/12/17 at 10:39 am complaining of depression, anxiety, and hallucinations; documentation showed the patient had multiple skin lesions/rashes covered with ointment for mange, in addition to using flea and tick treatment (intended for use on animals) because he/she thought the lesions were caused by insects. The patient was described as "...agitated, having delusions and anxious" and the patient verbalized thoughts of self-harm. At 11:09 am, the patient was placed in a "safe room". Documentation showed no nursing interventions provided, and the patient was not continuously monitored by hospital staff. At 6:40 pm, the physician ordered a transfer to another facility capable of providing behavioral health services. At 10:35 pm, documentation showed the patient was "angry and refusing to go to inpatient facility...getting aggressive..." and complaining of "mites" biting him/her. Documentation showed the patient was not continuously monitored by hospital staff or law enforcement following the aggressive behavior and hallucinations. The patient remained at the hospital until transferred via law enforcement to another facility on 09/13/17 at 12:40 am.


A policy titled "Shift Assessment- Required Documentation" stated nursing care provided would be identified in documentation, including the following:

1. Initial assessments and reassessments;
2. Nursing interventions related to the patient's plan of care;
3. Effectiveness of nursing interventions and patient outcomes; and
4. The evaluation of the data must be done by an RN.


On 10/04/17 at 2:10 pm, Staff A and E stated they did not know what was meant by "safe room" and the hospital rooms contain all the same equipment (call lights with cords, hospital beds with wheels and cords, etc.); the hospital practice is to commit one staff member to continuously observe a patient with psychiatric problems including self-harmful intent.


On 10/05/17 at 9:55 am, Staff A stated all orders and nursing notes should be in the electronic record, including paper records; and the hospital did not have a system of checking charts periodically to ensure care is provided as ordered.

Based on record review and interview, the facility failed to provide competent supervision of the drug room.

The hospital established a drug room in lieu of a pharmacy with the day-to-day operations assigned to a Drug Room Supervisor.

A review of the Drug Room Supervisor's employee records did not contain evidence of training, education or competency as a drug room supervisor.

On 10/04/17 at 10:49 am, Staff L (a contracted pharmacist) stated she did not realize the competency training had to be documented.

Based on observation, document review, and interview, the facility failed to identify mislabeled medications in the drug room.

During a tour of the drug room on 10/03/17, the surveyors observed a bin labeled "IV heparin 50 units/10 ml" contained heparin 500 units/10 ml and a bin labeled "Torsemide 10 mg" contained Torsemide 20 mg.


Documents titled "Consulting Pharmacist's Weekly Report" dated 6/23/17 to 10/02/17 noted discrepancies in labeling of vitamin D3 5000 unit in bin labeled "vitamin D3 50,000 unit".


Documents titled "P&T Meeting" dated 06/23/17, 08/18/17 and 09/15/17 contained no information regarding the mislabeling of bins.


On 10/04/17 at 10:49 am, Staff L (a contracted pharmacist) stated medication errors, including the mislabeling of bins, were not reported to the P&T Committee.

Based on record review and interview the hospital failed to report drug administration errors, adverse drug reactions, or dosing issues to the hospital quality assessment and performance improvement (QI/PI) program.


Document titled "Occurrence Reports" dated 07/10/17 through 10/03/17, indicates under "Medication Event" 15 occurrences including medication given but not charted, administered wrong medication, administered at wrong time and medication given after it was discontinued.


Policy titled "Medication Error Reduction" states that all data regarding medication error/near misses are collected and reported to the Quality Management Committee.


Documents titled "P&T Committee", "QA/IC Meeting" and "Governing Body" did not reflect any of the medication event occurrences were reported or that medication processes were reviewed to prevent further occurrences.


On 10/05/17 at 9:25 am, Staff A and Staff E stated medication occurrences were reported to the physicians, but were not reviewed through the QA/PI program.

Based on observation, document review, and interview, the hospital failed to develop an infection control program.

The failed practice increased the risk of infections by:

1. Failing to ensure active surveillance of the hospital was performed; no surveillance activity was documented in meeting minutes including QA/IC and Governing Body.

A document titled "Infection Control Purpose and Scope" states the infection control committee will review data, analyze surveillance data, and assess the effectiveness of the Infection Control Program.

A review of documents labeled "Sayre Community Hospital QA/IC Meeting" dated June, July, August and September 2017 contained no documentation to indicate data was collected, reviewed, analyzed or assessed for effectiveness.

On 10/05/17 at 10:45 am, Staff E stated hospital-wide surveillance had not been done. On 10/05/17 at 9:45 am, Staff E stated the meeting minutes did not indicate data was collected, reviewed, analyzed or assessed.


2. Failing to maintain a sterile environment by bringing patients directly into the operating room from the medical/surgical floor. AORN guidelines state the operating room suite should be divided into three designated areas:

a. Unrestricted area: which may include locker rooms, break rooms, offices, waiting rooms, the preoperative admission area, Phase I and Phase II post-anesthesia care units (PACUs), and access to procedure rooms (e.g., endoscopy rooms, laser treatment rooms). Street clothes are permitted in this area.

b. Semi-restricted area: The peripheral support areas of the surgical suite. This area includes the preoperative admission area, the PACU, and sterile processing. This area is entered directly from the unrestricted area past a nurses' station or from other areas.

c. Restricted area: A designated space contained within the semi-restricted area and accessible only through a semi-restricted area. The restricted area includes the operating and other rooms in which operative or other invasive procedures are performed.


3. Failing to control the air flow within the operating room. An automatic door opener in the operating room was located next to the anesthesia cart; standing near the cart allowed an uncontrolled opening of the doors into the operating room causing a disturbance in the air flow into the sterile environment increasing the risk for infection. AORN guidelines recommend the following:

a. Doors to the operating or invasive procedure room should be kept closed except during the entry and exit of patients and personnel. Several studies all support keeping the doors closed during the surgical procedure except when opening is required for a procedure-related reason.

b. When the doors are open, the HVAC system is unable to maintain critical environmental control parameters. The ventilation system in the OR is designed to administer air pressure that is greater than the pressure in the semi-restricted area


On 10/05/17 at 9:45 am, Staff H stated she was not sure why a patient room on the medical/surgical floor was utilized as the preoperative area and the patient brought directly into the operating room. Stated she understood a patient could not be brought from contaminated area directly into the sterile environment; she also understood the doors to the operating room could not have uncontrolled opening during a surgery or procedure. The hospital does follow AORN guidelines. Pain management procedures are the only procedures currently being performed; future plans include ophthalmic procedures and colonoscopies.


On 10/05/17 at 9:25 am, Staff A and Staff E discussed bringing patients into a sterile environment from the medical/surgical floor; both unaware how practice started. Both also stated they would rearrange the operating room slightly to move the anesthesia machine away from the door opening sensor. Staff A stated that Staff E and Staff H would collaborate on a resolution.

Based on record review and interview, the hospital failed to identify patients in need of assistance after discharge for 2 (Patients #4 and 7) of 20 records reviewed.

This failed practice resulted in compromised safety for Patient #4 and a decline in health for Patient #7 from lack of identification and/or utilization of resources for tobacco cessation and management of COPD.

Findings:

A policy titled "Discharge Planning and Screening Criteria" stated planning should involve the patient, family, social worker, and medical professionals caring for the patient. The policy contains a list of factors to be considered in discharge planning, including:

1. Age 65, lives alone;
2. Inadequate or no known support system;
3. History of readmission within 15 days;
4. Domestic violence; and
5. Chemical or substance abuse.

Patient #4

A form titled "Clinical Report- Nurses" dated 10/02/17 at 5:10 pm stated the patient presented to the facility for treatment of alcohol withdrawal, with the intent to transfer to a rehabilitation facility for alcohol abuse when considered medically stable.

A form titled "Clinical Report- Physicians/Mid Levels" stated the patient had no social support.

On 10/02/17 at 8:00 pm, Staff T documented multiple scabbed wounds and bruises were observed during the initial nursing assessment. The patient reported the injuries were sustained during an incident of domestic violence a month prior. Staff T documented no discharge needs were identified. There was no documentation a discharge planning assessment was done or any hospital staff were notified of the reported abuse.

Patient #7

A form titled "History and Physical" dated 09/23/17 stated the patient was admitted to the hospital from 09/17/17 to 09/23/17, and was now being readmitted the same day for the same problem (acute exacerbation of COPD) following an episode of heavy smoking at home. Documentation showed the patient was 71 years old and lived alone. There was no documentation the patient received a discharge planning assessment to identify potential problems with medical/social/financial needs to ensure needed medications and treatments were available, and arrange for assistance with tobacco cessation.

On 09/24/17 at 11:14 am, Staff S documented "No discharge needs identified." There was no documentation a discharge planning assessment was done.

On 10/04/17 at 2:05 pm, Staff A stated staff should contact him/her if any discharge needs are identified and then the social worker would be asked to do a discharge planning assessment; and no requests for discharge planning had been received. The surveyor discussed Patient #4 briefly and Staff A stated the patient should have received a discharge planning assessment.