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The Critical Access Hospital (CAH) reported a census of 24 acute and swing bed patients, and 10 Special Care Unit patients. Based on document review and staff interview the CAH failed to assure staff appropriately assessed a patient in restraints for one of one patient in restraints (patient #33). The CAH failed to assure staff appropriately dispensed medications for one of three patients discharged from the Emergency Department (ED) (patient #12). The CAH failed to assure the physician performed a complete history and physical before the scheduled surgical procedure for one of five surgical clinical records reviewed (patient #24), failed to store irrigation solutions as recommended by the manufactures in one of two warming cabinets observed, failed to develop and implement a policy and procedure that directed staff to report adverse drug reactions to the physician and a process to report serious adverse drug reactions to the Food and Drug Administration (FDA) and the infection control officer failed to develop an active infection control system to identify, report, investigate, monitor, and implement infection control practices for two of two observed cleaning of a discharged patient room, six of six emergency room/outpatient room observations, three of three operating rooms/endoscopy room, one of one preop/postop rooms, and one of one observed dressing change.

Findings include:

- The CAH failed to provide care according to written policies. See further evidence at C-271, 42 CFR 485.635(a).

- The CAH failed to properly store irrigation fluids. See further evidence at C-276, 42 CFR 485.635(a)(iv).

- The CAH failed to develop and implement policies and procedures for the reporting of adverse drug reactions. See further evidence at C-277, 42 CFR 485.635(a)(3)(v).

- The CAH failed to assure the infection control coordinator developed an active infection control system to identify, report, investigate, monitor, and implement infection control practices. See further evidence at C-278, 42 CFR 485.635(a)(3)(vi).

The Critical Access Hospital (CAH) reported a census of 24 acute and swing bed patients, and 10 Special Care Unit patients. Based on document review and staff interview the CAH failed to assure staff appropriately assessed a patient in restraints for one of one patient in restraints (patient #33). The CAH failed to assure staff appropriately dispensed medications for one of three patients discharged from the Emergency Department (ED) (patient #12). The CAH failed to assure the physician performed a complete history and physical before the scheduled surgical procedure for one of five surgical clinical records reviewed (patient #24).

Findings include:

- The CAH's policy titled " Restraints " reviewed on 10/3/12 at 4:35pm directed, "...the use of restraints will be based on the patient's assessed needs ...patients in restraints will be monitored and reassessed at appropriate intervals with supporting documentation in the medical record ...evaluate patient's condition regarding need for continued restraint every shift ..."

- Patient #33's clinical record reviewed on 10/3/12 at 10:15am revealed an admission date of 9/28/12 with diagnoses of pneumonia and dementia. Observation on 10/3/12 at 11:30am of patient #3 in their room, revealed the patient sitting up in bed resting with eyes closed. Patient #3 responded to the nurse in the room when the nurse called their name. The patient had soft wrist restraints on both wrists. Patient #33's clinical record revealed staff placed the patient in soft wrist restraints per physician orders on 10/1/12 at 11:15am because the patient continued to pull oxygen off of his face and pull on the intravenous tubing. The clinical record lacked evidence staff assessed the patient's needs and need for the restraints before placing the patient in restraints. Patient #33's clinical record revealed on 10/1/12 between 8:00pm to 8:13am and on 10/2/12 between 7:00pm to 8:00am the clinical record lacked evidence the Registered Nurse (RN) reassessed the patient for the use of restraints. The CAH failed to assure the RN staff followed the restraint policy.

Administrative staff I and J interviewed on 10/3/12 at 10:30am acknowledged the staff failed to assess patient #3 for the use of restraints before placing patient #3 in restraints and failed to reassess the patient according to the CAH's policy for the use of restraints.

- The CAH's policy, titled "Medications Sent Home From the Emergency Room That A Nurse May Provide Without A Physician Presence Policy", reviewed on 10/4/12 at 8:30am, directs "The patient...must present to the ER (Emergency Room) for the prescription to be released". The policy also directs staff to log the medication given to a patient through the ED to be logged in the ED Pharmacy Record Book.

- Patient #12's clinical record, reviewed on 10/2/12 at 2:30pm revealed the minor patient's father arrived at the Emergency Department (ED) to obtain medications ordered by a physician. The patient did not accompany the father to the ED. The ED nurse gave the medication to the father, and the father departed the ED.

Administrative Staff A, interviewed on 10/3/12 at 8:30am, acknowledged the patient's face sheet (initial information collected about the patient) indicates the patient was an ED patient. Staff A confirmed the parent, not the patient, presented to the ED. Staff A acknowledged the patient's father presented to the ED and obtained the medications without the patient being present.

The ED Pharmacy Record Book, reviewed on 10/2/12 at 2:00pm revealed the Pharmacy Record Book lacked an entry indicating the medications were to be administered to patient #12. Pharmacy staff V, interviewed on 10/3/12 at confirmed the log remained incomplete and confirmed they were unsure who had been given the doses of medication from the ED.

Staff A, interviewed on 10/2/12 at 2:30pm, acknowledged the CAH failed to document the medications given to the father of patient #12

The CAH failed to failed to follow their policy to assure patients present to the ED for an assessment before medications are given, and follow their policy for medications given out to ED patients to take home.


- The CAH's Medical Staff Rules and Regulations " reviewed on 10/4/12 at 8:30am directed "...A complete history, the results of physical examination, and provisional diagnosis shall be recorded prior to the initiation of any surgical operation ... "

- Patient #24's clinical record reviewed on 10/3/12 at 2:00pm revealed an admission date of 7/24/12 for an elective surgical procedure (Bilateral Tubal Ligation). Patient #24's clinical record lacked a history and physical. The physician performed the surgical procedure without the history and physical completed.

Administrative staff A interviewed on 10/4/12 at 10:30am acknowledged the physician performed the procedure and the clinical record lacked the patient's history and physical prior to surgery.

The Critical Access Hospital (CAH) reported a census of 24 acute and swing bed patients and 10 Special Care Unit patients. Based on observation, document review and staff interview the CAH failed to store irrigation solutions as recommended by the manufacturer in one of two warming cabinets observed.

Findings include:

- The manufacturer's information sheet for Hospira irrigation solutions reviewed on 10/1/12 at 3:40pm directed " ...solutions for irrigation may be warmed up to temperatures not exceeding 40 degrees centigrade (104 degrees Fahrenheit) and for a period no longer than two weeks (14 days) ... "

- The CAH ' s policy titled " Fluid Warming " reviewed on 10/3/12 at 4:35pm directed " ...All fluids are labeled with the 14 day " expiration " date when they are placed in the warming unit. "

- Observation in the surgical suite on 10/1/12 at 1:30pm revealed a fluid warming cabinet.
The temperature of the warming cabinet that contained the flexible containers of irrigation solutions registered 100 degrees Fahrenheit. The warming cabinet contained the following:
1. One 1000cc (cubic centimeter) container of sterile water irrigation solution with a date of 9/28 written on the container.
2. Two 1500cc containers of Glycine irrigation solution.
3. One 3000cc container of Glycine irrigation solution.
4. Two 3000cc containers of Sodium Chloride 9% irrigation solution.

One container of the warmed solutions exceeded the manufacturer ' s guidelines and the CAH policy that solutions for irrigation will remain in the warming cabinet for a period up to, and no longer than two weeks (14 days).

Five containers of the warmed solutions lacked a date when placed in the warmer and/or when to remove from use.

Staff G, Registered Nurse (RN) interviewed on 10/1/12 at 1:30pm acknowledged the five irrigation solutions lacked a date when placed in the warming cabinet and/or when to remove from use, and the one solution with a date, exceeded the two week (14 day) manufacturer ' s guideline and CAH policy.

The Critical Access Hospital (CAH) reported a census of 24 acute and swing bed patients and 10 Special Care Unit patients. Based on document review and staff interview the Critical Access Hospital (CAH) failed to develop and implement a policy and procedure that directed staff to report adverse drug reactions to the physician and a process to report serious adverse drug reactions to the Food and Drug Administration (FDA).

Findings include:

- The pharmacy policy manual, reviewed on 10/3/12 at 2:00pm, revealed the CAH lacked a policy for reporting adverse drug reactions to the FDA.

- Pharmacy staff U, interviewed on 10/4/12 at 9:30am acknowledged the CAH failed to develop and implement a policy/procedure for reporting adverse drug reactions.

The Critical Access Hospital (CAH) reported a census of 24 acute and swing bed patients, and 10 Special Care Unit patients. Based on observation, document review, and staff interview, the infection control officer failed to develop an active infection control system to identify, report, investigate, monitor, and implement infection control practices for two of two observed cleaning of a discharged patient room, six of six emergency room/outpatient room observations, three of three operating rooms/endoscopy room, one of one preop/postop rooms, and one of one observed dressing change.

Findings include:

- The CAH's Infection Control Plan reviewed on 10/3/12 at 5:00pm directed "...Maintains an organized, effective, hospital wide program for the surveillance, prevention and control of nosocomial and community-acquired infections both in patients and personnel ...responsibility for surveillance activities, data collection and performance improvement activities related to patients to the Infection Control Practitioner..."

- Staff S Infection Control Coordinator interviewed on 12/21/11 at 3:30pm verified they were responsible for the management of the infection control program. The CAH's infection control committee reviews policies and procedures and approves hospital wide cleaning products. Staff S acknowledged they did not have a formal surveillance program with criteria for staff and environmental practices observing breaches in infection control. Staff S's infection control surveillance is based on patient assessment, antibiotic use, and lab reports to track patient infections and monitors staff illness.

- Review of the manufacturer's guidelines for the use of the Virex II 256 One-Step Disinfectant cleaner on 10/3/12 at 10:00am directed, " ...To disinfect ... hard, non-porous environmental surfaces ...all surfaces must remain wet for 10 minutes..."

- Review of the manufacturer's guidelines for use of Sparcling restroom disinfectant cleaner on 10/3/12 at 9:15am directed, "...remove water from toilet bowl, apply 1-2 ounces of solution to surfaces, allow to remain wet at least 2 minutes..."

- Observation of staff C on 10/2/12 between 1:00pm and 1:20pm cleaning room 201, a discharged patient room revealed the following breaches in infection control practices regarding disinfectant wet time per manufacturer's recommendations. For example:

Staff C, wearing gloves, applied Virex II 256 disinfectant cleaner to a blue chair, a multicolored chair, and the patient bed. The surfaces remained wet between five to seven minutes not the required 10 minutes for total disinfection.

Staff C, Certified Nurse Aide interviewed on 10/2/12 at 1:20pm, acknowledged the cleaned surfaces failed to remain wet the required 10 minutes.

- Observation of staff D and staff E on 10/2/12 between 4:20pm and 4:40pm cleaning room 113, a discharged patient room revealed the following breaches in infection control practices regarding disinfectant wet time per manufacturer's recommendations. For example:

Staff D and staff E wearing gloves, applied Virex II 256 disinfectant cleaner to the over bed table, corner table, chair and sofa. The surfaces remained wet between four to six minutes not the required 10 minutes for total disinfection.

- Observation of the mattress in room 113 revealed a tear approximately nine inches with foam exposed.

Staff D, Licensed Nurse and staff E, Certified Nurse Aide interviewed on 10/2/12 at 4:40pm, acknowledged the cleaned surfaces failed to remain wet the required 10 minutes. Staff D and staff E confirmed the tear in the mattress in room 113 and acknowledged the surface of the exposed foam was not cleanable.

- Observation of staff F on 10/2/12 between 4:40pm and 5:00pm cleaning the bathroom in room 113, a discharged patient room revealed the following breaches in infection control practices regarding disinfectant wet time per manufacturer's recommendations. For example:

Staff F, wearing gloves, applied Virex II 256 disinfectant cleaner to the sink, shower stall walls, grab bars, faucet, and shower chair. The surfaces remained wet between five to seven minutes not the required 10 minutes for total disinfection.

Staff F, using Sparcling toilet bowl cleaner, poured an unmeasured amount in the toilet bowl without removing the water from the bowl as directed by the manufacturer.

Staff F, Housekeeper interviewed on 10/2/12 at 5:00pm, acknowledged the cleaned surfaces failed to remain wet the required 10 minutes and they failed to remove the water from the toilet bowl prior to cleaning the toilet bowl as directed by the manufacturer.

- The Association of Operating Room Nurses (AORN) recommendation chapter XI for " Endoscope Cleaning and Processing " reviewed on 10/2/12 at 9:30am directed, " Flexible endoscopes should be decontaminated in an area physically separated from locations where clean items are handled and patient care activities are performed. "

- Observation on 10/1/12 at 1:30pm of the endoscopy procedure room revealed equipment to perform endoscopy procedures, cabinets a large sink, counter space with an empty large gray pan placed on the counter. Staff G explained after the endoscopy procedure the staff cleans the endoscopes in the large gray pan with " Empower " (an enzymatic cleaner) then transports the endoscopes to the reprocessor (Steris washer).

Staff G, RN interviewed on 10/1/12 at 1:30pm acknowledged the staff clean the scopes in the same room they perform the scope procedures, and lacked knowledge the scopes need to be cleaned in a separate room from were the procedure is performed.

- Observation of the pre/post surgical area, endoscopy room, surgery room #2 and surgery room #3 on 1/1/12 at 12:55pm revealed the following:
1. Eight open Yankauer suction tips (rigid hollow tube made of disposable plastic with a curve at the distal end used to remove thick secretions during oral Pharyngeal suctioning) in the pre/post operative area.
2. One open Yankauer suction tip in the endoscopy room.
3. One openYankauer suction tip in operating room #2.
4. One open Yankauer suction tip in operating room #3.

- The Emergency Department/Out-Patient Treatment area, observed on 10/1/12 at 2:30pm, revealed six Yaunker suction tips packages opened and connected to the tubing.
The Yankauer package label states, " sterile unless opened or damaged. "

Staff G, RN interviewed on 10/1/12 at 12:55pm acknowledged the open Yankauer suction tips. Staff G lacked knowledge of the Yankauer package label that states " sterile unless opened or damaged. "

The Critical Access Hospital (CAH) reported 24 patients acute and swing bed patients and 10 Special Care Unit patients. Based on document review and staff interview, the CAH failed to assure clinical records are complete and accurately documented for 11 of 15 records more than 30 days after the patient's discharge (patient #'s 7, 8, 9, 11, 12, 13, 14, 15, 24, 25 and 27).

Findings include:

- Patient #7's clinical record, reviewed on 10/5/12 at 8:20am, revealed an emergency room (ER) visit on 7/27/12 with complaints of breathing problems. A physician examined the patient and determined the patient required a higher level of care. The patient was transferred to another hospital. The clinical record lacked evidence of the physicians notes and orders for the the care of the patient.

Administrative staff A, interviewed on 10/4/12 at 9:30am, acknowledged the clinical record lacked signed physician's orders and a record of the physician's examination and findings.

- Patient #8's clinical record, reviewed on 10/5/12 at 9:30am, revealed an ER visit on 4/13/12 with complaints of abdominal pain. A physician examined the patient and determined the patient required immediate surgery. The clinical record lacked evidence of signed physician's orders for the patient's care.

Staff A, interviewed on 10/4/12 at 9:30am, acknowledge the clinical record lacked evidence of physician's orders for the care of the patient.

- Patient #9's clinical record, reviewed on 10/4/12 at 10:30am, revealed an ER visit on 3/30/12 in cardiac arrest (a medical emergency). A physician was present during patient care. The clinical record lacked evidence of the physician's examination results and the outcome of the care provided.

- Patient #24 ' s clinical record reviewed on 10/3/12 at 2:00pm revealed an admission date of 7/24/12 for a surgical procedure, Bilateral Tubal Ligation. Patient #24 ' s clinical record revealed one verbal order written on 7/24/12 and one order written on 7/25/12 lacked the physician ' s signature. The physician failed to complete the dismissal clinical record within 30days as required by the Medical Staff Rules and Regulations.

Administrative staff A, interviewed on 10/4/12 at 9:30am, acknowledge the clinical record lacked the physician's examination results and signed orders for the patient's care.

Staff A interviewed on 10/4/12 at 10:30am acknowledged the physician failed to sign the verbal orders.

The deficient practice also affected patient #'s 11, 12, 13, 14,15, 25 and 27.

The Critical Care Hospital (CAH) reported a census of 24 acute and swing bed patients and 10 Special Care Unit patients. Based on document review and staff interview the CAH failed to assure physicians date/and or time all authenticated (signed) entries in the medical record for 8 of 34 patient clinical records reviewed (patient # ' s 17, 21, 23, 24, 25, 27, 28, and 33).

Findings include:

-The CAH ' s policy titled " The Medical Record " reviewed on 10/4/12 at 10:30am directed, " All entries in the medical record are to be timed, dated, and authenticated by the person making the entry. "

- Patient #21 ' s clinical record reviewed on 10/1/12 at 1:00pm revealed an admission date of 9/21/12 for an appendectomy and colectomy (removal of part of the colon) surgical procedures. Patient #21 ' s clinical record revealed between 9/20/12 to 10/2/12, three orders written by the physician lacked a time when signed by the physician, and three progress notes lacked a time when signed by the physician.

- Patient # 25 ' s closed clinical record reviewed on 10/3/12 at 2:40pm revealed an admission date of 6/18/12 for a colonoscopy (examination of the colon with an instrument) and an Esophogogastroduodenoscopy (examination of the esophagus, stomach, and small intestine) procedure. Patient #25 ' s clinical record revealed between 6/15/12 to 6/19/12 four physician progress notes lacked a date and/or time when signed by the physician.

- Patient #28 ' s clinical record reviewed on 10/3/12 at 10:15am revealed an admission date of 9/18/12 with diagnoses of pneumonia and dementia. Patient #28 ' s clinical record revealed between 9/28/12 to 10/3/12 six verbal orders lacked a date and/or time when signed by the physician, three orders written by the physician lacked a time when written by the physician, and six physician progress notes lacked a time when written.

Staff R, Health Information staff interviewed on 10/4/12 at 10:30am acknowledged the clinical records lacked the date and/or time when signed by the physicians.

This deficient practice also affected patient # ' s 17, 23, 24, 27, and 33.

The Critical Access Hospital (CAH) reported 24 patients acute and swing bed patients and 10 Special Care Unit patients. Based on document review, observations and staff interview, the CAH failed to assure all patient care services are included in the CAH's Quality Assurance Performance Improvement (QAPI) program.

Findings include:

- The CAH's Quality Improvement Plan, reviewed on 10/4/12 at 9:00am, directs the CAH to "ensure the delivery of the best care possible for the patients". The plan directs "The Board of Directors of Mitchell County Hospital Health Systems is responsible for establishing, maintaining and supporting the ongoing quality improvement program".

The plan includes the interdisciplinary quality activities including 1. Drug usage including the process of monitoring patient responses and adverse drug reactions. The CAH failed to develop and implement a procedure for reporting adverse drug reactions.

The plan includes interdisciplinary quality activities including surgical case review. The review is to include pre-operative diagnosis and the process is to review 100% of all surgical cases. The CAH failed to assure every surgical patient's clinical record contained the history and physical examination

Administrative staff A, interviewed on 10/3/12 at 3:30pm acknowledged the CAH failed to develop and implement policies to report adverse drug reactions and failed to review all surgical clinical records for completeness.