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The Critical Access Hospital (CAH) reported a census of 2 patients with 33 records reviewed. Based on observation, policy review, manufacturer ' s guidelines reviewed, 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 one of one disinfecting solution, two of two endoscopy scopes, one of two Hydroculators, one of two blanket/fluid warmers, rinsing and handling of soiled laundry, and failed to provide personal protective equipment in the soiled utility room and the CAH failed to assure the proper labeling of all medications sent home with Emergency Room (ER) patients.

The cumulative effect of failure to develop and implement an effective Infection Control program, failure to conduct CAH wide surveillance for both patients and personnel working in the hospital placed all patients at risk for healthcare acquired infections and the failure to properly label all medications sent home with ER patients placed all ER patients sent home with medications at risk for medication errors.

Findings include:

- The CAH failed properly label medications sent home with the ER patients. See further evidence at C-276, 42 CFR 485.635(a)(3)(iv).

- The CAH failed to assure the infection control officer 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 2 patients with 33 medical records reviewed. Based on observation, policy review, Kansas State Board of Pharmacy Law, and staff interview the CAH failed to assure the proper labeling of all medications sent home with Emergency Room (ER) patients.

Findings include:

- The " Kansas State Board of Pharmacy Laws, 68-7-11 Medical care facility pharmacy ", reviewed on 8/27/12 at 10:40am directed under " Emergency outpatient services ...an interim supply of prepackaged drugs shall be supplied to an outpatient ...The interim supply shall be labeled with the following information: (i) the name, address, and telephone number of the medical care facility, (ii) the name of the prescriber ...(iii) the full name of the patient, (iv) the identification number assigned to the interim supply of the drug ... (v) the date the interim supply was supplied, (vi) adequate directions for use of the drug, (vii) the beyond-use date of the drug, (viii) the brand name or corresponding generic name of the drug, (ix) the name of the manufacturer or distributor of the drug, (x) the strength of the drug, (xi) the contents in terms of weight, measure or numerical count, and (xii) necessary auxiliary labels and storage instruction if needed."

- The CAH 's policy titled, " Emergency Dispensing ", reviewed on 8/30/12 at 9:05am, directed, " Any medications sent home must be labeled with the appropriate labels attached, name and strength of the medication, and the quantity...each label will include: Name, address and telephone number of facility supplying the drug, Name, quantity, and strength of the drug, Auxiliary labels if needed, Adequate directions for use. A space will be designated for: the patient 's name, the practitioner's name, and the date". The CAH failed to include in their policy, the identification number assigned to the interim supply of drug, the date the CAH dispensed the drug, the beyond-use date of the drug, and the name of the manufacturer or distributor of the drug to be included on the label of the medications sent home with the ER patients.

- Observation in the pharmacy on 8/27/12 at 10:40am revealed a medication label used to label medication containers when medications are dispensed form the Emergency Room (ER) in an emergent situation and/or when retail sources are closed. The label contained the name, address telephone number, and DEA (Drug Enforcement Administration) of the CAH. Staff E , Registered Nurse explained the ER staff write the name of the patient, name of the drug, how to take the medication, and name of the practitioner on the label.

Staff B, pharmacy Registered Nurse (RN) interviewed on 8/28/12 at 8:50am acknowledged they were unaware of the pharmacy regulations and that the labels did not contain all of the information on them as required by the Kansas State Board of Pharmacy.

The Critical Access Hospital (CAH) reported a census of 2 patients with 33 medical records reviewed. Based on observation, policy review, manufacturer's guidelines reviewed, 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 one of one disinfecting solution, two of two endoscopy scopes, one of two Hydroculators, one of two blanket/fluid warmers, rinsing and handling of soiled laundry, and failed to provide personal protective equipment in the soiled utility room.

Findings include:

- Hospital policy titled "Reprocessing Flexible Endoscopes" reviewed on 8/27/12 at 4:20pm directed"...prepare the disinfectant in accordance with the label directions...thoroughly rinse the exterior surface...flush all channels with 70% alcohol to facilitate drying...".

- The manufacturer's guidelines for Metricide OPA Plus Solution (a disinfectant) reviewed on 8/27/12 at 4:20pm directs "the solution must be discarded after 14 days even if a ... test strip indicates a concentration above the 0.3minimum recommended concentration...thoroughly rinse...manually flush all lumens with large volumes of water ...repeat the procedure two additional times for a total of three rinses...flush all channels with 70% isopropyl or ethyl alcohol ... "

- Observation of the Cidex OPA log (Cidex and Metricide are both disinfectants) on 8/27/12 at 1:20pm between 8/15/11 to 8/23/12 revealed Metricide OPA Plus Solution was changed on the following days, 8/15/11, 10/03/11, 10/24/11, 11/14/11, 12/12/11, 1/9/12, 2/6/12, 2/27/12, 3/19/12, 4/16/12, 5/14/12, 6/8/12, 7/26/12, and 8/23/12. The staff changed the Metricide OPA solution every 48 days to 20 days and not every 14 days as required.

Staff I, a Licensed Practical Nurse (LPN) interviewed on 8/27/12 at 1:45pm acknowledged they failed to change the Metricide OPA solution every 14 days as required. Staff I explained they failed to rinse the endoscopes three times after disinfection and failed to use 70% alcohol to flush all channels of the endoscopes.

- Observation in the decontamination room on 8/27/12 at 1:00 pm revealed an RTU enzymatic foaming Z-Sponge (an enzymatic cleaner) used to clean the outside of the endoscopes and a Pull Thru stubby brush to clean the inside of the endoscopes. The manufacturer's guidelines state each item is for single use only. Staff I, an LPN explained on 8/27/12 at 1:15pm they used the same brush and sponge on all endoscopes receiving cleaning for the day of the procedures creating a potential for cross contamination and the spread of hospital acquired infections.

The CAH failed to assure staff follows the manufacturer's guidelines for cleaning and disinfecting of the endoscopes.

- The manufacturer's guidelines for irrigation and intravenous solutions reviewed on 8/28/12 at 10:30am directs "solutions in ...may be warmed not to exceed 40 degrees centigrade (104 degrees Fahrenheit)...for a period no longer than two weeks (14 days), the manufacturer recommends the use of a controlled temperature warming cabinet that is monitored by a calibrated temperature measurement device. "

- Observation of the blanket/fluid warming cabinet in the central supply closet on 8/29/12 at 9:05am revealed the warming cabinet lacked a thermometer to monitor the temperature of the warming cabinet. The warming cabinet contained a one-liter bottle of water for irrigation and a one-liter bottle of sodium chloride for irrigation. The irrigation bottles lacked the date of placement in the warming cabinet. The warming cabinet contained two intravenous one-liter bags of sodium chloride. The label on the intravenous bags read, "8/6/12 remove 9/12/12". The intravenous bags lacked the correct date of removal from the warming cabinet.

Staff B, a Registered Nurse, interviewed on 8/29/12 at 9:05am acknowledged the CAH failed to follow manufactures guidelines when placing fluids in the warming cabinet.

- The manufacturer's guidelines for maintenance of the "Tropic Heater Heating Units on 8/30/12 at 10:00am directed, "...The tank should also be drained, cleaned and inspected systematically, at minimum intervals of every two weeks."

- Observation of the soiled utility room on 8/29/12 at 8:50am revealed a Hydroculator (a tank with warm water in it to warm special hot packs used on patients with sore muscles) on a metal cart. A log labeled " Hydroculator Clean Q 2 weeks " was on the cart next to the Hydroculator, and revealed the last date the staff cleaned the Hydroculator was 3/27/11.

Staff A, Registered Nurse (RN) interviewed on 8/29/12 at 9:55am acknowledged the CAH stored the clean Hydroculator in the soiled utility room and staff failed to clean the Hydroculator according to the manufacturer's guidelines.

- Observation of cleaning a pair of surgical scissors in the soiled utility room on 8/29/12 at 8:50am revealed staff M entered the soiled utility room with a pair of soiled surgical scissors after removal of a dressing. Staff M, RN placed the scissors in the sink, retrieved a pair of gloves and a "Chlorhexidine" (a disinfectant) scrub brush to clean the scissors from another room. Staff M put gloves on cleaned the scissors and placed them in a plastic bag. Staff M, RN failed to use a protective garment when cleaning the soiled scissors to prevent possible cross contamination.

Staff M, RN interviewed on 8/29/12 at 8:50am acknowledged the soiled utility room did not have Personal Protective Equipment (PPE) (gloves, protective garments, and masks) in the room and failed to use PPE when cleaning the soiled scissors.

- The 2003 " Guidelines for Environmental Infection Control in Health-Care Facilities" reviewed on 8/30/12 at 10:17am directed under, " G-3. Collecting, Transporting and Sorting Contaminated Textiles and Fabrics...Sorting or rinsing contaminated laundry at the location where contamination occurred is prohibited by OSHA.967 "

- Observation of the soiled utility room on 8/29/12 at 9:00am revealed a hopper (a large flush sink) without a splash guard. Staff M, Registered Nurse explained they use the hopper to rinse fecal material, blood, and other fluids and debris from the grossly soiled laundry before putting it in the plastic bags to send to the laundry.

Staff A, RN interviewed on 8/29/12 at 9:55am lacked knowledge of the OSHA regulation regarding the no rinsing of contaminated laundry.

The Critical Access Hospital (CAH) reported a census of 2 patients with 33 medical records reviewed. Based on medical record review, Medical Staff Rules and Regulations, policy review and staff interview the CAH failed to assure providers date/and or time all authenticated (signed) entries in the medical record for 25 of 33 patient medical records reviewed (patient ' s #1, 2, 4, 5, 10, 12, 13, 14, 15, 16, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, and 33).

Findings include:

- The Medical Staff's Rules and Regulations reviewed on 8/30/12 at 12:00pm directs, " All clinical entries in the patient's medical record shall be accurately dated and authenticated by legible initial or signature." The Medical Staff Rules and Regulations failed to include the timing of all entries in the patient's medical record.

- The CAH's policy titled, " General Policies Regarding Content of All Medical Records" reviewed on 8/30/12 at 9:45am directs, "...All entries in the record must be dated and authenticated." The CAH's policy failed to include the timing of all entries in the patient's medical record.

- Patient #12's medical record reviewed on 8/27/12 at 1:00pm revealed an admission date of 6/18/12 with a diagnosis of fractured tibia and fibula from a fall. Patient #12's medical record revealed between 6/18/12 to 8/21/12, five dictated progress notes lacked a date and time when signed, one history and physical lacked a date and time when signed, one order written by the provider lacked a time when signed, and seven telephone/verbal orders lacked a date and time when signed by the provider.

- Patient #13's medical record reviewed on 8/27/12 at 1:35pm revealed an admission date of 8/25/12 with diagnoses of chronic renal failure and diabetes type II. Patient #13's medical record revealed between 8/25/12 to 8/27/12, one progress note lacked a time when signed, and six telephone/and or verbal orders lacked a date and time when signed by the provider.

- Patient #14's closed medical record reviewed on 8/29/12 at 8:40am revealed an admission date of 7/3/12 with diagnoses of chronic obstructive pulmonary disease and congestive heart failure. Patient #14 expired on 7/6/12. Patient #14's medical record revealed between 7/3/12 to 7/6/12, one history and physical lacked a date and time when signed, five telephone and/or verbal orders lacked a date and time when signed, and four orders written by the physician assistant and co-signed by the physician lacked a date and time when the physician co-signed the orders.

Staff J, medical record's staff interviewed on 8/28/12 at 12:30pm acknowledged the medical records lacked the date and time when signed by the providers. Staff J confirmed it is a problem and have discussed the issue with the medical staff.

This deficient practice also affected patient #'s 1, 2, 4, 5, 10, 15, 16, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, and 33.

The Critical Access Hospital (CAH) reported a census of 2 patients with 33 medical records reviewed. Based on observation and staff interview the CAH failed to protect patient's medical records from destruction when stored in the annex of the CAH and in the medical records department.

Findings include:

- Observation on 8/28/12 at 2:40pm of the medical record storage area in the annex building of the CAH revealed 21 stacked boxes of patient's medical records stored in a locked area of a large storage room, with five boxes stored directly on the floor. Floor storage of medical records creates a potential for water damage or damage/destruction from bugs or rodents.

- Observation on 8/29/12 at 9:30am of the medical record area of the CAH revealed two boxes of patient's medical records stored directly on the floor.

- Staff K, Chief Executive Officer, interviewed on 8/28/12 at 4:30pm acknowledged the boxes of medical records stored directly on the floor. The CAH failed to take adequate precautions to prevent damage and/or destruction of patient ' s medical records.