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Based on observation and interviews with facility staff, the facility failed to ensure that supplies used in treating emergency cases were properly maintained as expired supplies were found in the emergency department available for use in patient care which potentially could cause unsafe or ineffective supplies to be used.

The findings were:

During a tour of the emergency department, the following expired supplies were found available for use: In the trauma room: McGrath Disposable Laryngoscope Blades, partial box of 50, expired 6/19; In the decontamination room: Hebiclens, 8 oz. bottle, expired 7/18.

In an interview with the DON, staff #16 during the tour on the afternoon of 9/9/19, staff #16 agreed that the above listed supplies were expired.

Based on observation and interview with facility staff, the facility failed to maintain the facility to ensure the safety of patients as there were several instances of inadequate maintenance of the physical environment observed. The facility failed to properly maintain patient care equipment and supplies as equipment in the Rehab Department was not maintained and expired supplies were found in patient care areas available for use. The facility failed to properly store drugs as expired medications were found in patient care areas available for use. Unsecured and improperly labeled medication was found in the Rehab Department.

Cross refer to:

C 221, CFR 485.623(a), Construction
C 222, CFR 485.623(b)(1), Maintenance
C 224, CFR 485.623(b)(3), Drug Storage

Based on observation and interviews with facility staff, the facility failed to maintain the facility to ensure the safety of patients as there were several instances of inadequate maintenance of the physical environment observed.

The findings were:

During a tour of the facility on the afternoon of 9/9/19, the following observations were made.

In the Emergency Department:

An approximately 1' x 2' area of the sheet vinyl flooring outside the Clean Linen Room was buckled with multiple cracks and holes in the vinyl flooring which created a trip hazard and could not be properly cleaned. The emergency call cords were wrapped around the grab bars rendering them inoperable if pulled in the rest rooms located near the ambulance entrance and near the procedure recovery area. These findings were confirmed by the DON, staff #16 during the tour on the afternoon of 9/9/19.

In the REHAB area:

A hole (approximately the size of a quarter) was observed in the floor covering of the hydrotherapy room.

In the CENTRAL SUPPLY STORAGE area:

Two of the four ceiling mounted fluorescent light fixtures were observed to have what appeared to be numerous dead insects contained within the light fixture. In an interview on 9/09/2019 with staff member #2 (who had accompanied the surveyor on the tour) confirmed the above findings in the rehab and central supply storage areas.

In the men's restroom across from LABORATORY DRAW station:
Observation in the men's restroom located across from the laboratory draw station on the afternoon of 9/09/2019 revealed an area on the floor (approximately 30 inches in length) where the material between the rows of floor tiles was missing, this area was such that it could potentially become a reservoir for moisture/bacterial growth.

In an interview on 9/09/2019 with staff members #1 and #2 who were with the surveyor during the tour confirmed the findings.

Based on observation, review of documentation and interview it was determined that the hospital failed to ensure that patient care equipment and supplies were maintained. The hospital failed to ensure that expired supplies were properly disposed of.

Findings were:
The patient care equipment and supplies were not maintained. During a tour of the hospital on the afternoon of 9/9/2019 the following issues were observed:

In the REHAB area:

Unidentified matter was observed in the bottom of the liquid wax in the paraffin bath. When the surveyor asked staff member #3 if the liquid wax were cleaned? The response was yes that it is cleaned once a week and that the matter in the bottom of the liquid wax was from paper towels. When the surveyor asked if there was a log documenting the cleaning of the paraffin bath, the response from staff #3 was that there was no log.

Review of hospital policy entitled: "Interdepartmental Care of Equipment" with a reviewed date of 08-2018 stated: "Paraffin Unit 1. Most paraffin baths should be sterilized once a month depending on usage. Clean regularly to remove moisture and sediment that collects at the bottom."

In the hydrotherapy room a cloth covered chair was observed which was dirty and stained in appearance. The surveyor was told by staff #4 that patients sit in this chair during shoulder therapy.

Expired supplies were found and thus potentially available for use. During a tour of the hospital on the afternoon of 9/8/2019 the following expired supplies were found.

In the REHAB area:

In an over sink cabinet in the hydrotherapy room there were two each valutrode neutrostimualtor electrodes, each had an expiration date of 07-2017.

4 each mediquip TENS, EMS, NMS electrodes, each had an expiration date of 2015-07.

In the soiled closet there was a one-gallon container of Oxivir Five 16 Concentrate One step disinfectant cleaner, the expiration date was 08/2019.

In the physical therapy office there were 95 each sterile acupuncture needles found, the box containing the needles listed the expiration date as 2019-03.

2 each individual packets of Sombra Warm Therapy Natural Pain Relieving Gel, both packets had an expiration date of 07/13.

In an interview on the afternoon of 9/9/2019 with staff members #2 and #3 the above referenced findings of expired supplies in the rehab area were confirmed.

During a tour of the radiology department on the afternoon of 9/9/19, a contrast reaction cart was observed in the CT room which contained in a drawer a laryngoscope handle with a metal laryngoscope blade attached which was not wrapped and there was no evidence that it had been high level disinfected or sterilized. In an interview with the radiology director, staff #24 during the tour on the afternoon of 9/9/19, staff #24 acknowledged that the laryngoscope blade was unwrapped in the drawer.

According to the CDC's Healthcare Infection Control Practices Advisory Committee (HICPAC), laryngoscope blades are "semicritical" items, which are defined as, "Items that directly or indirectly contact mucous membranes of the respiratory tract. They should be sterilized or subjected to high-level disinfection before reuse ...After disinfection, proceed with appropriate rinsing, drying, and packaging, taking care not to contaminate the disinfected items in the process."

Based on observation, review of documentation and interviews with facility staff, the facility failed to properly store drugs as expired medications were found in patient care areas available for use. This was not consistent with facility policy and potentially could have caused unsafe or ineffective medications to be used.
The findings were:

During a tour of the pharmacy on the afternoon of 9/9/19, the following expired medications were found on shelves in the pharmacy.
1. Promethazine, 25 mg/ml, 10 vials, expired 6/18.
2. Ampicillin 1 gm vial, expired 4/19.
3. Nicotine transdermal patch system, 7 mg, expired 5/19.
4. 0.45% Sodium Chloride injection, 1000 ml bag, 4 expired 1/19.
5. Virt-Phos 250, 18 tabs, expired 9/18.
6. Celecoxib 200 mg, 30 caps, expired 8/19.
7. Xarelto 15 mg, 30 tabs, expired 4/19.
8. Meloxicam 15 mg, 4 tabs, expired 12/18.
9. Pedialyte 0.6 oz. packet, 12 boxes of 6 packets, expired 4/19.

In an interview with the DON, staff #16 during the tour on the afternoon of 9/9/19, staff #16 agreed that the above listed medications were expired.

During a tour of the radiology department on the afternoon of 9/9/19, Diphenhydramine 50 mg/ml, expired 8/19 was found in a drawer of the Contrast Reaction Cart. In an interview with the radiology director, staff #21 during the tour on the afternoon of 9/9/19, staff #21 agreed that the medication was expired.

The facility policy entitled "Expired and Destroyed Drugs" dated 8/19 reflected in part "All expired medications will be removed from shelves, Omnicell, crash carts on a monthly basis. Policy: The Pharmacy will assure that out-dated or unusable drugs are properly removed from active stock and either returned to a reversal management company for credit or destruction in an appropriate manner. Procedures: All drugs in the pharmacy, Emergency Rooms, or Physical Therapy will be checked monthly for expiration. 2. Expired medications will include those medications whose expiration date has passed. An indication of month and year will pertain to the last day of the month. Expired medication will be removed from active stock and stored in a secured area."



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Based on observation, review of documentation and interview it was determined that the hospital failed to ensure that medications were properly stored.

Findings were:
Medications were not properly stored.

During a tour of the hospital rehab area on the afternoon of 9/9/2019 it was observed that the door to the physical therapist's office was open with no one in the office (staff member #3 had been obseved leaving the office) and a gray metal narcotics style lockbox (which would typically be found mounted in a cabinet or on a wall) was laying on top of a counter top. This box was not locked and upon opening it the surveyor found a 3ml syringe with a clear liquid in the syringe and no label on the syringe. The box contained several 5ml multidose vials of Dexamethasone Sodium Phosphate. One of the vials had the blue plastic cap removed and there was medication still observed in the vial, no date as when the vial had been opened or the initials of the staff member who had opened it were found on the vial. Numerous blue medication vial caps were lying loose found in the medication box as well as what appeared to be a steak knife. When the surveyor asked staff #3 what the knife was used for? Staff member #3 did not know. Also found in the medication box were personal medications for staff #3. (2 medication containers which had the name of staff #3 on the label of the container).

Review of hospital policy entitled: "Storage of drugs and biologicals" with a date of December 19, 2012 stated: "All drugs and biologicals will be stored and disposed of appropriately by Physical Therapy and Pharmacy Department." "Policy and Procedure: Dexamethasone is the only medication obtained from pharmacy to be used in the Physical Therapy Department. It is used for their Iontophoresis ..." "It will be used only by the Physical Therapist. The medication is obtained from the pharmacy, it is locked up into a box out of Patient contact and disposed of in sharp box in the Physical Therapist's office. In rare instance (back orders) Multi-Dose vials may have to be used, in such a case the vial is dated with one month dating and discarded appropriately after said date."

In an interview on 9/09/2019 with staff members #2 and #3 who were with the surveyor the above finding was confirmed.

Based on observation, review of documentation and interviews with facility staff, the facility failed to meet provision of service requirements as the facility failed to hold pharmacy and therapeutics (P & T) meetings in accordance with facility policy. The hospital failed to ensure that dietary services were maintained as sanitation and food handling issues were identified. The facility failed to properly provide laboratory services as a significant amount of expired laboratory supplies were found in the lab available for use in patient care. Glucometer control tests were performed on the nursing unit with expired control solutions. The facility failed to properly store radiopaque contrast according to manufacturer's recommendations.

The findings were:

Cross refer to:

C 277, CFR 485.635(a)(3)(v), Policies - Med Errors & ADR's
C 279, CFR 485.635(a)(3)(vii), Policies - Nutrition
C 282, CFR 485.635(b)(2), Laboratory Services
C 283, CFR 485.635(b)(3), Radiology Services

Based on review of documentation and interviews with facility staff, the facility failed to hold pharmacy and therapeutics (P & T) meetings in accordance with facility policy as the last P & T meeting was held in 10/26/16 resulting a lack of interaction between the pharmacist and the medical staff regarding the reporting of adverse drug reactions and medication errors.

The findings were:

Pharmacy documentation was reviewed on the morning of 9/10/19 with the assistance of pharmacy technician, staff #23. The most recent Pharmacy & Therapeutics meeting minutes were dated 10/26/16. Staff #23 was asked if these were the most recent P & T minutes and staff #23 stated that they were. There were "Pharmacy Services Weekly Review" forms which were signed by the pharmacist, staff #24 available for review for July and August 2019. The forms listed a chart review summary, narcotic administration review summary, QI, DUE, ADR and Antibiotic Review. Staff #23 was asked if the pharmacist met with the medical staff, and staff #23 stated that he did not meet with the medical staff. Staff #23 stated that she gave a verbal report from the Pharmacy Services Weekly Review forms to the medical staff.

The facility policy entitled "Pharmacy and Therapeutics/Drug Usage Review Committee" dated 7/13 reflected in part "Kimble Hospital has a Pharmacy and Therapeutics Committee serves as a liaison between the pharmacy department and the Medical Staff to assure the appropriateness of treatment to the patient ...The committee will be comprised of: two medical staff members (physicians); Director of Pharmacy; Administrator or representative; Director of Nursing or representative ...The committee performs procedures related to the procurement, distribution, usage, safety, utilization review and all matters relating to medication use in the hospital." The facility policy entitled "Pharmacy and Therapeutics Committee By-Laws" reflected in part "4. The P & T committee meets at least quarterly, and more as necessary."

Based on observation, review of documentation and interview it was determined that the hospital failed to ensure that dietary services were maintained as the following issues were found during the onsite survey.

Findings were:

During a tour of the kitchen area on 9/9/2019 the following issues were observed:

A bunt cake pan was found with what appeared to be dried food residue on it. The pan was clean otherwise except for the dried residue and was stored with other clean utensils on a wire rack.

The bottom of one of the clean utensil drawers was sticky and to the touch and appeared to be of need of cleaning.

The top of the ice maker was found to be dusty, when the surveyor ran their hand over the top, visible dust was noted.

In the refrigerator there was a one-gallon container of milk, approximately one quarter of the milk remained, and the container stated: "Best by Sep 08-19C".

On the floor by the ice machine there was an opened one gallon container of "eLiminate Premium Descaler" the top to the container was missing.

On the stainless-steel prep area there was a glass rectangular container with a blue plastic lid, the container was found to contain butter, the plastic lid was cracked and there was no date on the lid as to when the butter had been placed in the container.

A zip lock type bag was found containing rice, the hand-written label on the bag stated that the expiration date was 8-16-19.
In the walk-in pantry there was a plastic container labeled "Flakes" the hand-written expiration date on the container was 8-24-19.
In the freezer there was a frozen bag of meat with no label on it.

The plastic drain line leading from the container of APM silver shine plus had dark discoloration spots on it (the appearance was that the dark spots were on the inside of the tubing). This drain line emptied into a container where according to staff #5 the silver ware was soaked.

Review of hospital policy number .3.024, entitled: "Food Storage" stated: "Food will be stored in such a manner to prevent food borne illness." The policy was also found to state: "h. All open food/beverage will have the date opened on the label or lid." "i. All food and beverages will be dated when opened. Once items are opened, dietary will monitor to discard within appropriate times."

In an interview with staff members #2 and #5 who accompanied the surveyor on the tour the above findings were confirmed.

In a tour of the nursing unit on the afternoon of 9/9/19, the nourishment refrigerator temperature log for August and September 2019 was observed to have blank boxes where no temperature was recorded for 8/1-7/19, 8/11/19, 8/16/19, 8/21-25/19, 8/30-31/19, 9/5-8-19. In an interview with the DON, staff #16 during the tour on the afternoon of 9/9/19, staff #16 was asked who was responsible for checking the nourishment refrigerator temperature, and staff #16 stated that dietary was. Staff #16 acknowledged that the temperature had not been checked as listed above.

The facility policy entitled "Patient Snack Refrigerator" dated 4/17 reflected in part "Safe storage of patient snack items will be kept separate from other food products and easily accessible for patient use ...The temperature of the refrigerator is monitored by the dietary department and recorded to assure the proper temperature is maintained."

Based on observation, review of documentation, and interviews with facility staff, the facility failed to properly provide laboratory services as a significant amount of expired laboratory supplies were found in the lab available for use in patient care. Glucometer control tests were performed on the nursing unit with expired control solutions.

The findings were:

During a tour of the laboratory on the afternoon of 9/9/19, the following expired supplies were found available for use.

In the lab draw room there was an unopened package of 100 each Blue top BD Vacutainer tubes, the packaging listed the expiration date as 2019-8-31.

In the lab draw room there was an unopened package of 100 each Blue top BD Vacutainer tubes, the packaging listed the expiration date as 2019-7-31.

Also found in lab draw room was a plastic hand carried lab collection kit (phlebotomist tray), this contained three each Blue top BD Vacutainer tubes which were expired, each of the tubes had an expiration date of 2019-04-30.

In a drawer (below directly below where the above phlebotomist tray was stored) was a bag of purple cap RM Scientific Safe T Fill Micro Capillary Blood Collection devices, there were approximately 13 of these devices in the bag and the bag listed the expiration date as 2019-06-30.

In the same drawer was a bag of red cap RM Scientific Safe T Fill Micro Capillary Blood Collection devices, there were approximately 35 of these devices in the bag and the bag listed the expiration date as 2019-08-31.

Also found in the same drawer was a bag of green cap RM Scientific Safe T Fill Micro Capillary Blood Collection devices, there were approximately 35 of these devices in the bag and the bag listed the expiration date as 2019-08-31.

In the lab area on a shelf there was a 120ml bottle or RICCA Potassium Hydroxide 10%, with a yellow label affixed to the bottle, handwritten in the label's expiration space was: 5-19.

In the laboratory freezer there was a container with 6 each 1ml vials of MAS Diabetes Liquid Assayed Diabetes Control, the expiration date on each was listed as 2019-06-30.

In the weekend phlebotomist plastic lab collection kit (phlebotomist tray), there was a blue top BD Vacutainer tube with an expiration date of 2019-07-31.

In an open under counter storage area there were two expired BD vacutainers found, one was a green top with an expiration date of 2019-07-31 and the second tube was a yellow top with an expiration date of 2019-06-30.

Review of hospital laboratory services policy entitled: "Service and Policies" stated on page 7 under the "Supplies" section: "Kimble Hospital Laboratory provides certain supplies necessary to collect and submit specimens for analysis by Kimble Hospital Laboratory." "Home Health Agencies and nursing home employees may get their supplies needed for specimen collections." "Such supplies need to be monitored to make sure items are in date. Expired supplies will not be used for testing."

In an interview on the afternoon of 9/9/2019 with staff members #2 and #6 the above referenced findings of expired laboratory supplies were confirmed.

In a tour of the nursing unit on the afternoon of 9/9/19, Stat Strip Level 1 and Level 3 Glucose Control solutions marked "exp 9/1/19" were found in the glucometer box. Review of the glucometer control test log revealed that glucometer control tests were performed 9/2-8/19 using the expired control solutions. In an interview with the DON, staff #16 during the tour on the afternoon of 9/9/19, staff #16 confirmed that the control solutions were expired.

The Stat Strip Control Solution product insert reflected in part "Use only for 3 months after first opening. When you open a new vial of control solution, count forward 3 months and write that date on the label of the control solution vial. Discard any remaining solution after the date you have written on the vial."

Based on observation, review of documentation and interviews with facility staff, the facility failed to properly store radiopaque contrast according to manufacturer's recommendations as Optiray contrast was being stored in a contrast warmer without being dated when it was put in the warmer and it should only be in the warmer for one month.

The findings were:

During a tour of the radiology department on the afternoon of 9/9/19, 16 boxes of Optiray 320 contrast were observed in a contrast warmer which the temperature strip showed a temperature of 104 degrees F. The boxes were not dated as to when they were put in the warmer. In an interview with the radiology director, staff #21 during the tour on the afternoon of 9/9/19, staff #21 acknowledged that the boxes of contrast were not dated.

The Optiray (loversol injection) product insert reflected in part "Store Optiray and Optiray RFID-tagged syringes at 25 degrees C (77 degress F); excursions permitted to 15 to 30 degrees C (59 to 86 degrees F) ...Opitray may be stored up to 40 degrees C (104 degrees F) for up to one month in a contrast media warmer utilizing circulating warm air."

Based on review of documentation and interviews with facility staff, the facility failed to develop a nursing care plan for each inpatient as 2 of 5 inpatient medical records reviewed did not contain a nursing care plan.

The findings were:

Electronic medical records (EMR) were reviewed on 9/10/19 with the assistance of medical record director, staff #27. The electronic medical records of inpatients #3, date of admission 5/14/19 and patient #9, date of admission 5/28/19 did not contain a nursing care plan. The EMR super-user nurse, staff #17 also checked the records of patients #3 and #9 and was not able to find a nursing care plan. In an interview with staff #27 and staff #17 on the afternoon of 9/10/19 in the conference room, staff #27 and #17 confirmed this finding.

The facility policy entitled "Interdisciplinary Care Plans" dated 4/19 reflected in part "1. Each patient shall have an individualized plan of care based on data obtained from the admission and/or daily nursing assessment, practitioner, medical record, family or significant other. Exception: a. Observation patients whose expected hospitalization will be 23 hours or less. 2. The Interdisciplinary care plan shall be initiated within twenty four hours of admission by a registered nurse using the nursing process: nursing diagnosis, interventions and patient goals/outcomes."

Based on review of documentation and interviews with facility staff, the facility failed to ensure the medical records were complete with signatures of staff making entries into the record as in 3 of 5 endoscopy patient records reviewed, the post procedure notes were not signed by the nurse. The facility did not have a policy which required all entries into the medical record be dated and signed.

The findings were:

Electronic medical records (EMR) were reviewed on 9/10/19 with the assistance of medical record director, staff #27. The electronic medical records of endoscopy patients #17, date of procedure 6/13/19, patient #18, date of procedure 7/18/19 and patient #19, date of procedure 7/18/19 contained post procedure notes entered by RN, staff #28 that were in the draft mode and were not electronically signed by staff #28. The EMR super-user nurse, staff #17 also checked the records of patients #17, 18, and 19 and confirmed that the post procedure notes were not signed. In an interview with staff #27 and staff #17 on the afternoon of 9/10/19 in the conference room, staff #27 and #17 confirmed this finding.

Staff #27 was asked if there was a policy that required all entries into the medical record be dated and signed, and after checking, staff #27 stated that there was not.

Based on review of documentation and interview it was determined that the hospital failed to ensure that there was documentation that all staff had participated in fire drills.

Findings were:
No documentation was found that all hospital staff had participated in fire drills.

On the morning of 9/10/2019 the survey team randomly selected the names of staff members #12, #14, #15, #20 and then asked staff member #22 for documentation that these individuals had participated in a recent fire drill. Staff member #22 was unable to provide documentation that the staff members selected had participated in a recent fire drill.

Review of document entitled: "Kimble Hospital And Junction Medical Clinic Fire Response Plan Code Red" stated on page 5 under the "Fire Drills" section: "Fire drills will be conducted at least once per shift, per quarter in all hospital buildings. Non-patient care buildings will conduct at least one fire drill annually. At least 50% of all fire drills will be unannounced. All staff are required to participate in fire drills to the extent of their duties as outlined in this plan."