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Based on observation, interview, and document review the Critical Access Hospital (CAH) failed to ensure policies were reviewed annually by a group of professional personnel including at least one doctor of medicine or osteopathy, one midlevel practitioner (Advanced Registered Nurse Practitioner or Physician Assistant) and one non staff to ensure the quality of patient care. The CAH failed to ensure outdated drugs and biologicals were not available for patient use in one of one clot box (a kit used during a life threatening emergency involving a blocked artery) and one of one fluid warming cabinet containing outdated/unusable drugs and/or biologicals. The infection control coordinator failed to ensure two staff members followed infection control policies and acceptable standards of practices when they provided care to three of 21 sampled patients (#'s 8, 10, and 21). The infection control coordinator failed to ensure staff followed acceptable standards of practices, hospital policy for hand hygiene and cleaning of equipment while cleaning one room of a discharged patient room and one of the operating room. The infection control coordinator failed to ensure the Critical Access Hospital (CAH) followed the infection control surveillance plan for environmental compliance for eight of eight observed unoccupied patient beds (in room #'s 102A, 102B, 109, 112A, 114, 116, 118, and 120) and one of three physical therapy treatment tables.

Findings include:

- The CAH failed to ensure policies were review annually by a group of professional personnel including at least one doctor of medicine or osteopathy, one midlevel practitioner (Advanced Registered Nurse Practitioner or Physician Assistant) and one non staff member at the CAH to ensure the quality of patient care. See further evidence at CFR 485.635(a)(2), C-0272.

- The CAH failed to ensure that outdated drugs and biologicals were not available for patient use in one of one observed clot box (a kit used during a life threatening emergency involving a blocked artery) and one of one observed fluid warming cabinet containing outdated/unusable drugs and/or biologicals. See further evidence at CFR 485.635(a)(3)(vi), C-0276.

- The CAH infection control coordinator failed to ensure two staff members followed infection control policies and acceptable standards of practices when they provided care to three of 21 sampled patients (#'s 8, 10, and 21). The infection control coordinator failed to ensure staff followed acceptable standards of practices, hospital policy for hand hygiene and cleaning of equipment for one of one observed cleaning of a discharged patient room and one of one observed cleaning of the operating room. The infection control coordinator failed to ensure the Critical Access Hospital (CAH) follow the infection control surveillance plan for environmental compliance for eight of eight observed unoccupied patient beds (in room #'s 102A, 102B, 109, 112A, 114, 116, 118, and 120) and one of three physical therapy treatment tables. See further evidence at CFR 485.635(a)(3)(vi), C-0278.

Based on document review and interview the Critical Access Hospital (CAH) failed to ensure policies were review by a group of professional personnel including at least one doctor of medicine or osteopathy, one midlevel practitioner (Advanced Registered Nurse Practitioner or Physician Assistant) and one non staff member on an annual basis to ensure quality patient care. This deficient practice had the potential to affect patient care provided at the CAH.

Findings include:

- Review on 11/17/10 at 5:30pm of the Administrative Policy Manuel revealed a policy titled "Annual Review of Policies" directed " ...3. The CAH policies will be reviewed annually by a group of professional personnel including but not limited to the CEO (Chief Executive Officer), a member of the medical staff and a member of the network facility: CAH support hospital ... "

- Review of the policy and procedure manuals provided during the survey between 11/15/10 and 11/18/10 lacked evidence the documents were review annually by a group of professional personnel that included at least one doctor of medicine or osteopathy, at least one midlevel practitioner, and at least one member that is not on staff at the CAH.

Administrative staff A on 11/17/10 at 1:30pm acknowledged the CAH failed to have a method to ensure policies are reviewed annually.

Based on observation, document review and staff interview the Critical Access Hospital (CAH) failed to ensure that outdated drugs and biologicals were not available for patient use in one of one observed clot box (a kit used during a life threatening emergency involving a blocked artery) and one of one observed fluid warming cabinet containing outdated/unusable drugs and/or biologicals.

Findings include:

- Review on 11/18/10 at 9:00am of the CAH's policy for outdated drugs directed "...To remove all outdated drug products from the shelves for patient safety...Drugs throughout the facility are checked on a monthly basis for dating. Drugs with approaching outdates will be replaced with current dated drugs from the pharmacy..."

- Tour of the Emergency Room on 11/16/10 at 10:00am revealed the following outdated drugs in the clot box;
1. One IV (intravenous) bottle Lidocaine 2gm (grams) (used to treat irregular heartbeats) in 500cc (cubic centimeters) with an expiration date of 4/10,
2. One vial Dopamine 400mg (milligrams) (used to treat heart conditions) with an expiration date of 2/10,
3. One vial Diphenhydramine 50mg (used for allergy-related symptoms) with an expiration date of 7/10,
4, One vial Nitroglycerin 50mg (used in the management of heart pain) with an expiration date of 5/10,
5. One vial Amiodarone 900mg (used to correct abnormal rhythms of the heart with an expiration date of 5/10,
6. One vial Heparin 1,000 units (used to treat blood clots) with an expiration date of 5/10,
7. One IV bag of dextrose 5% 500cc (used to hydrate patients or mix with medications) with an expiration date of 8/10,
8. TNKase 50mg (used to dissolve blood clots) with and expiration date of 9/10,
9. Two Lidocaine injection 50mg with and expiration date of 4/10,
10. One IV bag of dextrose 5% 250cc with an expiration date of 3/1/10 and,
11. One box of chewable aspirin 81mg (used during a heart attack) with 12 tablets with an expiration date of 7/10.

- Staff D on 11/16/10 at 10:00am acknowledged the outdated medications and confirmed the medications were available for patient use.

- Review on 11/18/10 at 10:00am of the manufacture's information sheet for Baxter irrigation and IV solutions directed " ...IV solutions can be warmed to temperatures not exceeding 40 degrees centigrade (104 degrees Fahrenheit) and for a period no longer than 14 days...Irrigation solution can be warmed to temperatures not to exceed 45 degrees centigrade (113 degrees Fahrenheit) for a period no longer than 14 days..."

- Observation in the operating room on 11/17/10 at 8:25am revealed a fluid warming cabinet on the west wall. The temperature of the warming cabinet registered one hash mark below 120 degrees Fahrenheit. The warming cabinet contained the following:
1. Four 1000cc (cubic centimeters) containers of normal saline irrigation solution;
2. Two 1000cc container of Lactated Ringer intravenous (IV) solution; and
3. Seven 1000cc containers of sterile water irrigation solution.

The warmed solutions lacked a date when placed in the warmer or when to be removed from use.

Staff D and staff I on 11/17/10 at 10:55am acknowledged the warmed solutions lacked a date when placed in the warmer or when to be removed from use. Staff D and staff I acknowledged they were not sure how long the fluids had been in the warmer.

Staff B on 11/18/10 at 12:45pm verified, with a thermometer, the temperature in the warming cabinet registered 115 degrees Fahrenheit.

- Based on observation, record review and staff interview, the infection control coordinator failed to ensure two staff members followed infection control policies and acceptable standards of practices when they provided care to three of 21 sampled patients (#'s 8, 10, and 21). The infection control coordinator failed to ensure staff followed acceptable standards of practices, hospital policy for hand hygiene and cleaning of equipment for one of one observed cleaning of a discharged patient room and one of one observed cleaning of the operating room. The infection control coordinator failed to ensure the Critical Access Hospital (CAH) followed the infection control surveillance plan for environmental compliance for eight of eight observed unoccupied patient beds (in room #'s 102A, 102B, 109, 112A, 114, 116, 118, and 120) and one of three physical therapy treatment tables.

Findings include:

- Review on 11/17/10 at 4:30pm of the CAH's infection control plan directed "...The goal of the Infection Control Plan/Program is to prevent and reduce infections through the processes of surveillance, epidemiological analysis, identification, prevention and control. Some of the components of the Infection Control Plan/Program activities include hand washing ...cleaning procedures for disinfecting...The Infection Control Coordinator ...has the authority to institute any surveillance, prevention or control measures ...This authority and responsibility includes ...Develop and implement a preventive and corrective program designed to minimize infectious hazards ...The Infection Control Coordinator in collaboration with the Risk Manager will perform surveillance rounds on a quarterly basis to detect: 1. Good hand washing practices 2. Environmental compliance with infection control practices ..."

- Review on 11/16/10 at 4:30pm of the CAH's hand washing policy directed "...Observe (standard) universal precautions or other infection control standards as approved by appropriate facility committee ..." The CAH's standard precautions directed "...Wash hands after touching blood, body fluids, secretions, excretions, and contaminated items, whether or not gloves are worn. Wash hands or use anti-microbial agent immediately after gloves are removed and between patient contact ..."

- The Critical Access Hospital provided an anti-microbial agent at the entry of each patient room for staff and visitor use.

- Staff E on 11/15/10 at 12:10pm entered patient #10's room and administered medications. Patient #10 requested staff E heat their roll. Staff E left patient #10's room without performing hand hygiene, heated the roll in the nutrition room then returned the warmed roll to patient #10's room. Staff E left the room and failed to perform hand hygiene. Staff E returned to their medication cart and set up patient #8's medications without performing hand hygiene. Staff E entered patient #8's room at 12:23pm and administered medications. Staff E touched patient #8's bedside table, IV pump, and water glass. Staff E left the room and failed to perform hand hygiene. Staff E along with staff D checked medications into the medication cart.

- Review on 11/17/10 at 1:55pm of the manufacturer's guidelines for disinfection with "Virex 256" instructed staff to allow surfaces to remain wet for 10 minutes to assure disinfection.

- Review of the manufacturer's guidelines for "Crew Clinging Toilet Bowl Cleaner" on 11/17/10 at 1:55pm instructed the user to remove water from the toilet bowl prior to adding one ounce of toilet cleaner to the bowl.

- Staff C observed on 11/15/10 between 1:10pm and 1:45pm cleaned room #109 after the discharge of a patient. Staff C applied protective gloves and sprayed "Virex 256" disinfectant cleaning solution on the over the bed table, top of the mattress, pillows, recliner, side rails, window curtains and exterior of nightstand. The surfaces remained wet for the required ten minute time. Staff C failed to apply disinfectant to the patient's nurse call light and television control, the underside of the mattress, the bed frame legs, the legs and wheels of the bedside table, the blood pressure equipment, the inside of the windows, window sills, shelves above the closet and trash can as directed in the CAH's policy titled "Patient Room- Unit Cleaning."

Staff C observed 11/15/10 at 1:18pm, wearing the same gloves, exited room #109 and entered room #111 to provide housekeeping services for a patient. Staff C removed trash and cleaned the floor in room #111. Staff C, wearing the same gloves, returned to room #109 at 1:20pm, removed their gloves and applied a new pair of gloves without performing hand hygiene. Staff C, using "Virex 256" cleaning solution, cleaned the underside of the mattress, the head and foot of the bed frame, spot cleaned the walls, the closet door, sink and countertop. The surfaces failed to remain wet for the required ten minutes time for total disinfection.

Staff C, on 11/15/10 at 1:35pm, poured an unmeasured amount of "Crew Clinging Toilet Bowl Cleaner" into the toilet bowl and cleaned the toilet. Staff C failed to follow manufacture's guidelines.

Staff J, interviewed on 11/17/10 at 1:55pm confirmed staff needs to remove the water from the toilet bowl prior to using "Crew Clinging Toilet Bowl Cleaner" toilet cleaning chemical.

- Staff D on 11/17/10 at 7:15am performed an intravenous (IV) start on patient #21. Staff D prior to starting the IV placed the IV supply tray directly on the floor without a protective barrier. Staff D at 7:25am completed the IV start, removed the IV supply tray from the floor and placed the tray on the bedside cabinet. Staff D at 7:35am left patient #21's room and returned the IV supply tray to a cabinet at the nurses station. Staff D failed to clean the contaminated IV supply tray when returning the tray to the nurses station.

- Staff F and staff G observed on 11/17/10 between 2:10pm and 3:00pm cleaning the operating room using "Virex 256" solution. Staff F and staff G wet wiped two arm boards, the patient table and base. These areas remained wet for a contact time of less than the required ten minutes for disinfection. Staff F used "Virex 256" solution on the over-head light then immediately dried the surface. The over-head light failed to remain wet the required ten minutes for disinfection. At 2:20pm staff F cleaned the top of the cautery machine (a machine used to stop bleeding) but failed to clean the sides, shelves, or the foot pedal of the cautery machine. During the observation the anesthetic machine and the anesthetic medication cart were not cleaned. At 2:48pm staff F began to wet mopped the floor using "Virex 256" cleaning solution. The floor remained wet for a contact time of only seven minutes not the required ten minutes for disinfection. At 2:51pm staff F cleaned the scrub sinks using the "Virex 256" cleaning solution. The sinks remained wet for eight minutes not the required ten minutes for disinfection.

Staff G on 11/17/10 at 2:25pm acknowledged the housekeeping staff does not clean the anesthetic machine or the anesthetic medication cart. Staff G noted the surgery staff cleans the anesthetic equipment.

Staff G on 11/17/10 at 2:45pm acknowledged housekeeping clean the top of the cautery machine and thought the surgery staff cleaned the sides, shelves and foot pedals of the machine.

Staff F and staff G on 11/17/10 at 2:55pm were aware "Virex 256" cleaner required a contact time of 10 minutes to achieve disinfection. Staff F and staff G acknowledged all surfaces on the equipment, the floor of the operating room, and the scrub sinks failed to remain wet for the 10 minutes required for disinfection. Staff G acknowledged housekeeping did not clean the anesthetic machine that contained a used suction canister and tubing, the anesthetic medication cart or the entire cautery machine.

Surgery staff I on 11/17/10 at 4:20pm acknowledged the surgery staff did not clean the anesthetic machine or the anesthetic medication cart and did not clean the sides, shelves, and foot pedal of the cautery machine. Staff I thought housekeeping cleaned all equipment in the operating room.

- Review on 11/18/10 at 11:05am of the CAH's policy for work orders directed "...When something is wrong with a piece of equipment ...a safety concern or situation that requires correcting by the maintenance department, a work order should be filled out with enough detail to pin point the problem ..."

- Tour of the Physical Therapy Department on 11/16/10 at 7:55am revealed three patient treatment tables. The treatment table in the northeast corner of the department contained a mattress with multiple areas of peeled covering exposing a non-cleanable surface with the potential for exposure to microorganisms to patients and staff.

- Staff K on 11/16/10 at 7:55am acknowledged the worn mattress cover and the non-cleanable porous surface had the potential for cross contamination of microorganisms.

- Observation of eight unoccupied beds, available for patient use, on 11/16/10 at 2:35pm revealed rusted surfaces on the bed frames and under the mattresses. The beds in room 102A, 102B, 109, 112, 114, 116, 118 and 120 revealed areas of approximately 8 inches by 12 inches of rough surface with bare metal exposed in the middle of the bed frame.

Staff B, present during the observation in patient rooms on 11/16/10 at 2:35pm, confirmed the presence of the non-cleanable surfaces on the patient beds. The CAH failed to maintain cleanable patient care surfaces.

- Staff H, Infection Control Coordinator, interview on 11/16/10 at 12:55pm revealed they provided education to staff at orientation and on an annual basis. Staff H revealed they included hand washing and facility rounds as their surveillance for infection control. Staff H noted they do not include observation of housekeeping practices or proper use of cleaning product in the surveillance process. Surveillance included environmental rounds for cleanliness.

- Request for documentation of environmental surveillance and hand washing surveillance Staff H on 11/17/10 at 4:30pm provided check off sheets for environmental surveillance. Review of the environmental rounds failed to include a system to evaluate cleaning of patient care equipment, cleaning of the operating room and patient care practices. Staff H reported they had developed a hand washing surveillance tool about three months ago but had not implemented the hand washing surveillance.

Staff H, Infection Control Coordinator, failed to develop an active infection control system to identify, report, investigate, monitor, and implement infection control practices.