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Based on observation, staff interview, hospital policy/ procedure review and manufacturers guidelines, the Critical Access Hospital (CAH) failed to date Cidex test strips when opening in the Radiology and Surgical departments. The radiology department had a census of 125 cases a month and the surgical department had 42 cases a month requiring the use of a scope.

Failure to date Cidex test strips when opened could result in harm if the equipment is not properly disinfected with an adequate strength of disinfectant.

Findings include:

1. During an observation on 5/31/11 at 1:00 PM with Staff K, Registered Nurse revealed 1 opened bottle of Cidex test strips located in a drawer in the endoscope cleaning room. The Cidex test strip bottle lacked a date when opened.

During an interview on 5/31/11 at 2:00 PM, Staff K said staff failed to date the Cidex test strip bottle when opened. Staff need to date the bottle when opening it.

2. During an observation on 6/1/11 at 8:35 AM with Staff L, Ultrasound Technician revealed 1 opened bottle of Cidex test strips in a drawer under the Cidex test solution. Staff failed to date the bottle when opening it.

During an interview on 6/1/11 at 8:35 AM, Staff L said the Cidex test strips should be dated by staff when opening the bottle.

Review of the CAH policy titled Ultrasound Infection Control, revised 8/09 showed the policy lacked information instructing staff to date Cidex test strips when opening a new bottle.

Review of the CAH policy titled CS High Level Disinfection, revised 7/10 showed the policy lacked information instructing staff to date Cidex test strips when opening a new bottle.

Review of the manufacturers guidelines for Cidex test strips revealed the following, in part, do not use any remaining strips 90 days after opening the bottle. Improper storage or use of test strips may result in false readings.

Based on review of practitioner credentialing files, Medical Staff Bylaws, and staff interviews, the CAH (Critical Access Hospital) failed to complete 2 (Practitioner A and B) of 13 NPDB (National Practitioner Data Bank) queries for practitioners re-appointment to the medical staff. The CAH identified a census of 7 patients.

Failure to complete the required NPDB query for practitioner's re-appointment could potentially result in sub-standard patient care.

Findings include:

Review of the Medical Staff credentialing files on 6/6/11 at 1:30 PM, with Staff D, Administrative Assistant/Medical Staff Credentialing, revealed a lack of the NPDB, for the current re-appointment period, for 2 of 13 files reviewed, Practitioners A and B.

Review of the Medical Staff Bylaws, approved on 6/2/10 by the governing body, and presented on 6/7/11, stated in part ..."Article V: Procedure for Appointment and Reappointment ....References will be requested from the applicant. Each application shall be submitted to the National Practitioner Data Bank (NPDB) for verification ..."

During an interview on 6/6/11 at 1:50 PM, Staff D verified that the credential files for Practitioners A and B lacked a NPDB for the current re-appointment period. Staff D added that he/she had never completed the NPDB for Practitioner A and B. Staff D reported that Practitioners A and B were 2 of the 10 CRNA's (Certified Registered Nurse Anesthetists) that provide services to patients of the CAH, and confirmed that he/she had not completed a NPDB for any of the 10 CRNAs.

Based on review of defibrillator daily check sheets, policy and procedure review, and staff interview, the CAH (Critical Access Hospital) staff failed to conduct daily checks on 3 of 3 defibrillators available for patient use in the surgery department, acute care, and emergency department. The CAH identified a census of 7 inpatients.

Failure to perform daily defibrillator checks could potentially result in equipment failure in a crisis.

Findings include:

Review of the May 2011 Defibrillator daily checks in the Surgery Department revealed 4 days (5/02, 5/12, 5/26, and 5/30) that surgery staff failed to document they conducted the daily defibrillator checks.

Review of the May 2011 Defibrillator daily checks in the Acute Care unit revealed 5 days (5/06, 5/24, 5/29, 5/30, and 5/31) that acute care staff failed to document they conducted the daily defibrillator checks.

Review of the ER (Emergency Room) Defibrillator daily checks for May 2011 revealed 14 days (5/01, 5/02, 5/03, 5/04, 5/05, 5/06, 5/07, 5/08, 5/09, 5/10, 5/13, 5/14, 5/24, and 5/31) that ER staff failed to document they conducted the daily defibrillator checks.

Review of the policy titled, "Defibrillator Check" [for Surgery], revised on 7/10, presented on 5/31/11, stated in part ..."The defibrillator is checked daily in OR (Operating Room) using the protocol according to the manufactures recommendations ..."

Review of the policy titled, "Defibrillator Life Pak 9" [for Acute Care and the Emergency Room], revised on 1/04, presented on 5/31/11, stated in part ..."The defibrillator is checked daily on and off battery using the protocol according to the manufactures' recommendations ..."

During an interview on 5/31/11 at 1:00 PM, Staff E, Supervisor Surgery/Outpatients, acknowledged the surgery staff failed to complete the Defibrillator daily checks. Staff E stated, "The hospital has 3 defibrillators, each of them should to be checked daily."

Based on observation, staff interview and document review the Critical Access Hospital (CAH) off site clinical staff failed to remove outdated medications in 1 of 4 off site clinics (Sioux Center Medical Clinic). The Director of the Medical Clinic reported an average weekly census of approximately 200 clinic visits.

Failure to remove outdated supplies could potentially expose patients to supplies no longer guaranteed sterile or potentially less effective.

Findings included:

1. Observations, during a tour of the Sioux Center Medical Clinic, on 5/31/11 at 1:45 PM revealed the following outdated medications.

A. located in a joint injection tray in the physician's work station cabinet:

a. 1 (of 1) - 110 micrograms (mcg) vial - Asthmanex inhalation powder, expired February 2010.
b. 1 (of 1) - 7.5 millimeter (ml) vial - Infant Concentrated Tylenol, expired July 2009.
c. 1 box - Ayrs Saline Nasal Gel, expired July 2009.
d. 1 (of 1) Providone swabstick, expired July 2006.

e. During an interview, at the time of the observation, the Clinic Nurse Manager acknowledged the expired medications were available for patient use and the clinic nursing staff was responsible for monitoring for expired supplies monthly. The Clinic Nurse Manager further stated, "These expired meds will be disposed of right away." The clinic nurse manager identified approximately 3 patient received joint injections weekly.

B. Located in the patient flow coordinator work station:

a. 1 - 30 ml tube of Lidocaine Hydrochloride Jelly 2%, expired June 2009.
b. 13 (of 13) Providone wipes, expired March 2007. The clinic nurse manager stated, "These [Providone wipes] are used to cleanse the skin before you inject the medication."

C. Located in Room #18:

a. 1 (of 1) vial Thin Prep Paptest (cytological procedure), expired June 24, 2010. The clinic nurse manager identified approximately 40 pap tests monthly.

D. Located in nurses station in the east pod:

1 (of 1) - 30 ml vial Bupivacaine, expired February 1, 2010.

E. Located in procedure room:

a. 30 (of 30) - 1.0 mg Fluorescein Sodium Opthmalic strips, expired February, 2010. The clinic nurse manager identified approximately 6 eye trauma procedures yearly.
b. 70 of 70 Povidone prep pads expired September, 2008. The clinic nurse manager identified approximately 2 procedures daily."

c. During an interview on 5/31/11 at 3:15 PM, the Director of the Medical Clinic acknowledged the expired medications and reported that they did conduct monthly safety checks, which included checking for expired medications and documenting. The most recent check was April 2011 and that documentation showed no expired meds. The Director of the Medical Clinic reiterated that they needed to make sure that everyone understood the process.

2. Review of hospital policy titled "The Medication Guidelines for Clinics" revision date 3/05 revealed in part:..."A designated staff member of each clinic completes monthly inspections of medications stored in the clinic. The monthly inspections will include....Outdated or unusable drugs are identified and disposed according th established policy."...."All expired medications are disposed of with other clinic regulated medical waste. Outdated medications to be disposed should be sequestered from other stock..."

Based on observation, facility document review, and staff interviews, the facility failed to ensure cleanliness of ceiling air vents in the dishwashing area of the kitchen.

Failure to maintain the ceiling air vents in a clean and sanitary manner could potentially result in dust and/or dirt falling on clean dishes increasing the risk of spreading infectious organisms.

Findings include:

Observations during the kitchen environment tour on 6/1/11, at 1:25 P.M. revealed a covering of dust on two of three ceiling air vents, located above the clean dish end of the dishwasher and above the dishwasher itself.

Review of an undated document titled "Chore List" showed dietary staff failed to include the ceiling air vents as part of the routine cleaning tasks.

During an interview on 6/2/11 at 9:05 A.M., Staff A, Manager of Food Services, reported dietary staff cleaned the ceiling vents in the kitchen as needed. The food Services Manager also cleaned the ceiling vents, at times.

Based on observation, policy review, document review and staff interviews, dietary staff failed to:
1. Ensure staff labeled, dated, and protected food from contamination when stored in the walk-in cooler.
2. Hold and/or serve all foods at the appropriate temperatures.
3. Measure all food temperatures prior to service.
4. Maintain a clean and sanitary environment in the kitchen.

Failure to maintain the kitchen in a sanitary condition and ensure that all food is appropriately stored and maintained at safe temperatures prior to and during food service could potentially result in foodborne illness.

Findings include:

1. Observations, during the initial kitchen environment tour, on 5/31/11 at 11:55 P.M., showed dietary staff stored 2 open, undated 5-pound (#) bags of cheese, as well as, the following opened, unsealed and undated products: 8# carton of potato salad, 10# case of sausage links, 10# case of pollock (fish), 20# case of chocolate chunk cookie dough, and 1 case of 72 omelets.

Review of a policy titled "Sanitary Food Storage, dated 7/00 and revised 8/05, revealed the following information, in part. " ...14. Leftover food is stored in covered containers or wrapped carefully and securely. Each item is clearly labeled and dated before being refrigerated ....16. e. Rewrap packages of frozen food which has been opened ....16. g .... Wrap product so it is airtight, label and date."

2. Observation, during supper meal service, on 5/31/11 from 5:29 P.M. to 5:45 P.M. showed Staff C, dietary aide, measured the temperature of the turkey and swiss sandwich at 43.6 degrees Fahrenheit and proceeded to serve the sandwich.

Review of a policy titled "Food Temperatures," dated 7/00 revised 11/07, revealed the following information, in part. " ...foods will be maintained at proper temperature to insure food safety...3. The temperature of potentially hazardous cold foods will be no greater than 40 degrees F when served to residents. 4. The cook is responsible to see that all food is at the proper temperature ...."

3. Observation, during supper meal service, on 5/31/11 from 5:29 P.M. to 5:45 P.M. showed Staff B, dietary aide, failed to measure the temperature of the mashed potatoes, gravy, macaroni and cheese, and tomato soup after removing the food from the hot holding cart (a storage container used to hold cooked hot food at a safe serving temperature until served) and prior to serving the food to CAH patients.

a. Review of the temperature records for the month of May revealed dietary staff only measured and recorded the food temperatures when the food came out of the oven, before placing the food in the hot holding cart. The temperature records lacked documentation that showed dietary staff measured and recorded the food temperatures after they removed the products from the hot holding cart and just prior to service or that dietary staff measured the temperature the optional menu items from the select menu prior to service.

b. Review of a policy titled "Food Temperatures," dated 7/00 revised 11/07, revealed the following information, in part. " ...foods will be maintained at proper temperature to insure food safety ....1. The temperature of hot foods during tray assembly will be a minimum of 140 degrees F. 2. The temperature of hot foods served to the residents will be no less than 140 degrees F. 3. The temperature of potentially hazardous cold foods will be no greater than 40 degrees F when served to residents. 4. The cook is responsible to see that all food is at the proper temperature ...."

4. Observations, during the full kitchen environment tour, on 6/1/11 at 1:25 P.M., revealed the following concerns:

a. A brownish black substance on all surfaces of the drainpipes that were located under the sink in the prep counter and continued through the cupboard above the shelf where staff stored skillets and pans used to prepare patient food. Further observation showed the substance wiped off with a paper towel and 1 of the pans stored in the cupboard was touching the pipe and contaminated with the brownish black substance from the pipes.

b. The Emerson microwave had a covering of a white, sticky substance on the inside top of the unit.

c. The white plastic cutting board surface of the sandwich table and 1 (of 1) large teal and 1 (of 1) large tan plastic cutting boards had unsanitizable surfaces due to worn finishes and multiple surface cuts.

5. During an interview on 6/2/11 at 9:05 A.M., Staff A, Manager of Food Services, reported the dietary staff was responsible for measuring and recording all hot food temperatures prior to placing the food in the hot holding cart and again when they removed the food from the hot holding cart, prior to service. According to Staff A, the hot food temperatures, at the time of service, should measure 165 degrees Fahrenheit or above and the cold food temperatures, at the time of service, should measure less than 41 degrees Fahrenheit. Staff A verified the temperatures recorded on the menus for the hot food items were the temperatures staff had obtained when the food finished cooking, prior to placing the food in the hot holding cart. Additionally, Staff A verified dietary staff did not obtain or record temperatures for the optional menu items.

I. Based on observation and staff interview, the Critical Access Hospital (CAH) administrative staff failed to secure all medical records against unauthorized access in 1 (of 1) basement storage area in the offsite nuclear medicine clinic. The CAH Administrative Staff identified approximately 13 nuclear medicine procedures monthly.

Failure to secure medical records against unauthorized access could potentially result in unauthorized disclosure of patient information, including name, date of birth, or social security number.

Findings include:

1. Observations during a tour of the basement storage area on 6/1/11 at 9:40 AM revealed
shelving units with 5 large boxes of nuclear radiology medical records dated from 2006 to 2011. The stored medical records contained patient names, date of birth, and all radiology procedures performed on the patients.

2. During an interview, at the time of the tour, the Nuclear Medicine Director stated maintenance staff, housekeeping staff, and non-hospital personnel went into the basement storage area without nuclear medicine staff present, and stated, "Anyone would have access, which is probably not the best." The Nuclear Medicine Director acknowledged medical records "are locked upstairs ...and should be locked down here."


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II. Based on observation, review of policy and procedures, staff interview, the CAH (Critical Access Hospital) failed to secure patient medical records from unauthorized users in 2 (Physical Therapy and Radiology) of 12 patient care areas. The CAH identified a census of 7 patients.

Failure to secure patient's medical records could potentially result in access to patient information by unauthorized users.

Findings include:

1. During an observation on 6/01/11 at 9:30 AM, with Staff G, Supervisor Physical Therapy (PT), revealed a rolling cart containing approximately 50 patient medical records and 1 drawer containing approximately 500 patient billing statements from 2010-2011. The rolling cart and the drawer lacked a lock to secure the patient medical records. Staff G reported that housekeeping cleaned the PT area that contained unsecured medical records, unattended by PT staff, after hours and they would have access to the unsecured medical records.

Review of the policy titled, "Confidentiality" revised on 8/10, presented on 6/07/11, stated in part ...It is the hospital's responsibility to safeguard both the record and its informational content against loss, defacement, tampering, and from use by unauthorized individuals.

During an interview on 6/06/11 at 4:05 PM, Staff I, Environmental Services, verified that she/he cleaned the Physical Therapy department after all PT staff and patients had left.

2. Observation on 5/31/11 at 4:15 PM, with Staff J, Radiology Technologist revealed 8 radiology patient records located in the break room behind the registration room. The 8 patient records were in a hanging file on the wall.

During an interview on 5/31/11 at 4:15 PM, Staff J said the housekeeping staff clean the break room and registration office after normal working hours and are not supervised by radiology staff. The housekeeping staff would have access to the patient records.