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401 EAST SPRUCE

GARDEN CITY, KS 67846

CONTENT OF RECORD: ORDERS DATED & SIGNED

Tag No.: A0454

28996

Based on record review and staff interview, the hospital failed to implement a system that ensured that each person signed, dated and/or timed all orders, including verbal orders, for 18 of 25 sampled records (#'s 1, 2, 3, 5, 6, 7, 8, 9, 10, 11, 13, 14, 16, 17, 18, 19, 20 and 22).

Findings included:

- Review of Medical Staff By-Laws Rules and Regulations revised August 2009 revealed the following: section 4.1 Written/Verbal Orders directs "...All orders will include date and time...".

- Patient #5's medical record revealed 34 physician orders, written 4/10/10 to 4/18/10, lacked date and/or time when authenticated (signed).

- Patient #6's medical record revealed 23 orders, written 4/9/10 to 4/15/10, lacked a date and/or time when authenticated.

- Patient #7's medical record revealed 6 orders, written 4/12/10 to 4/15/10, lacked a date and/or time when authenticated.

- On 4/19/10 at 2:30pm Staff C acknowledged medical staff failed to date and time signatures on orders.

- This deficient practice also affected patient #'s 1, 2, 3, 8, 9, 10, 11, 13, 14, 16, 17, 18, 19, 20 and 22.

PHARMACIST RESPONSIBILITIES

Tag No.: A0492

Based on observation, document review and interview, the Pharmacy Director failed to supervise the activities of the hospital's pharmacy services and implement practices to keep all medications secure and/or locked, haveonly medications within date available for patients, and have all medications appropriately labeled. Concerns were identified in one of one C-section room on the Maternal/Child Unit where multiple unsecured, unlocked and appropriately labeled medications within date were found.

Findings included:

- Review on 4/26/10 of the hospital policy titled "Medication Storage" updated 9/2009 directed "...Purpose...Minimize the risk of drug diversion (security)...Policy. Storing medications in unauthorized areas of the hospital is prohibited. III. Only authorized persons may access medications...Procedure IV. Medication rooms and carts are secured when not attended...".

- Observation on 4/20/10 at 11:25am revealed an unlocked and unattended anesthesia cart in the C-section room on the Maternal/Child Unit that contained the following medications:

Three 20 ml (milliliter) vials of Propofol 200mg (milligrams) per ml.(used to sedate a patient)
One vial Sodium Bicarbonate 50ml (an electrolyte supplement)
Three 30ml vials of lidocaine 2% with epinephrine (a numbing agent)
Two 5ml vials of lidocaine 2% (a numbing agent)
One 10ml vial of lidocaine 2% with epinephrine (a numbing agent)
Three 3ml vials of 10% dextrose (used to treat low blood sugar)
One 2ml vial of Ephedrine 50mg per ml (a stimulant)
One 5ml vial of Rocuronium Bromide (used when a breathing tube is placed in the throat)
Six 1ml vials of oxytocin 10 units per ml (used to produce uterine contractions)
Four 2ml vials of Tetracaine 1% (a numbing agent)
Five vials of Epinephrine 1:1000 1mg per 1ml (a stimulant)
Two vials of Labetalol Hydrochloride 20mg per 4ml (used to treat high-blood pressure)
One vial of Cefazolin 1 gram (an antibiotic)
One open vial of Ketamine 500mg per 10ml approximately 1/2 full (used to tranquilize
patients during surgery)
One 30ml vial of Narapin 0.5% 5mg per ml (a numbing agent)

The top drawer of an unlocked and unattended anesthesia cart contained two 250ml bottles of Sevoflurane and one 100ml bottle of Forane both inhalation anesthetics.

- Review of the hospital policy on 4/26/10 for labeling of medications approved 3/2008 directed "...Procedures: 1. At a minimum all medication labels include: a. Drug name, strength and amount. b. expiration date, when not used within 24 hours. c. Expiration time, if expiration date is less than 24 hours. d. For all compounded IV admixtures, the date prepared and diluent...4. Anytime medication are prepared but are not administered immediately, the medication container must be appropriately labeled...".

- Observation on 4/20/10 at 11:25am of an unlocked and unattended anesthesia cart in the C-section room on the Maternal/Child Unit revealed a 100 ml (milliliter) bag of Normal Saline 9% with a label that read, Neo-synephrine100mg 3/23/10. The label lacked the initials of the person preparing the medication for administration. This cart also contained a 5cc (cubic centimeter)syringe with a clear solution and an empty vial taped to the syringe labeled as Ephedrine Sulfate 50mg (milligrams) per ml. The prefilled syringe lacked an appropriate label with the name of the medication, expiration date, the date prepared, and the initials of who prefilled the medication.

Staff S on 4/20/10 at 11:25am acknowledged the unlocked anesthesia medication cart and the unlocked anesthesia cart with the unsecured medications and the potentially outdated and/or mislabeled medications.

Administrative staff T on 4/20/10 at 11:45am acknowledged the multiple medications in the unlocked, unattended anesthesia medication cart and the potentially outdated and/or mislabeled medications in the unlocked C-section room, which is across the hall from patient rooms. Staff T verified unauthorized persons could access the area without hospital staff knowledge.

Interview on 4/21/10 at 9:50am with pharmacy staff X and staff Y revealed anesthesia staff were to use a Pyxsis cart (a locked, single medication dispensing device) for medications and they were unaware of the unlocked medication carts in the C-section room or the improperly labeled prefilled syringes or add-mixed medications.

The Pharmacy Director failed to supervise the activities of the hospital's pharmacy services and have knowledge of pharmacy practices in the C-section room on the Maternal/Child Unit.

SECURE STORAGE

Tag No.: A0502

Based on observation and interview, the hospital failed to secure drugs in one of one anesthesia medication cart and one of one anesthesia cart on the Maternal/Child Unit. This deficient practice has the potential to effect all unauthorized persons entering the unlocked room with the intent of drug diversion (illegal drug use).

Findings included:

- Review on 4/26/10 of the hospital policy titled "Medication Storage" updated 9/2009 directed "...Purpose...Minimize the risk of drug diversion (security)...Policy. Storing medications in unauthorized areas of the hospital is prohibited. III. Only authorized persons may access medications...Procedure IV. Medication rooms and carts are secured when not attended...."

- Observation on 4/20/10 at 11:25am revealed an unlocked and unattended anesthesia cart in the C-section room on the Maternal/Child Unit found it contained the following medications:

Three 20 ml (milliliter) vials of Propofol 200mg (milligrams) per ml.(used to sedate a patient)
One vial Sodium Bicarbonate 50ml (an electrolyte supplement)
Three 30ml vials of lidocaine 2% with epinephrine (a numbing agent)
Two 5ml vials of lidocaine 2% (a numbing agent)
One 10ml vial of lidocaine 2% with epinephrine (a numbing agent)
Three 3ml vials of 10% dextrose (used to treat low blood sugar)
One 2ml vial of Ephedrine 50mg per ml (a stimulant)
One 5ml vial of Rocuronium Bromide (used when a breathing tube is placed in the throat)
Six 1ml vials of oxytocin 10 units per ml (used to produce uterine contractions)
Four 2ml vials of Tetracaine 1% (a numbing agent)
Five vials of Epinephrine 1:1000 1mg per 1ml (a stimulant)
Two vials of Labetalol Hydrochloride 20mg per 4ml (used to treat high-blood pressure)
One vial of Cefazolin 1 gram (an antibiotic)
One open vial of Ketamine 500mg per 10ml approximately 1/2 full (used to tranquilize
patients during surgery)
One 30ml vial of Narapin 0.5% 5mg per ml (a numbing agent)

The top drawer of an unlocked and unattended anesthesia cart contained two 250ml bottles of Sevoflurane and one 100ml bottle of Forane (both inhalation anesthetics).

Staff S on 4/20/10 at 11:25am acknowledged the unlocked anesthesia medication cart and the unlocked anesthesia cart with the unsecured medications.

Administrative staff T on 4/20/10 at 11:45am acknowledged the multiple medications in the unlocked, unattended anesthesia medication cart and the anesthesia cart in the unlocked C-section room, which is across the hall from patient rooms. Staff T verified unauthorized persons could access the area without hospital staff knowledge.

UNUSABLE DRUGS NOT USED

Tag No.: A0505

Based on observation and staff interview, the hospital failed to implement a system that ensured that outdated and/or mislabeled medications were unavailable for patient use in two of two fluid warming cabinets in Ambulatory Surgery, one of one warming cabinets in Inpatient Surgery, and the one of one anesthesia medication cart in the C-section room on the Maternal/child Unit. The potentially may effect any patient treated in these areas with medications that may no longer be safe for use or may have changed in their effectiveness.

Findings included:

- Review of the information sheet provided by the hospital on 4/26/10 revealed "...Solutions for injection ...in PVC and CR3 plastic flexible containers....may be warmed at a temperature not to exceed 104 degrees Fahrenheit and for periods no longer than two weeks (14 days)...solutions for irrigation in plastic pour bottles may be warmed up to 104 degrees Fahrenheit and for a period on longer than two weeks (14 days)...."

However, observation on 4/19/10 at 1:00pm revealed a fluid warming cabinet in the sub-sterile area of the Ambulatory Surgery suite between rooms 3 and 4 with five 500cc (cubic centimeters) plastic pour bottles of sterile water for irrigation. Each of the five bottles lacked a date when placed in the warmer or the date the solution/bottles needed to be removed.

Observation on 4/19/10 at 1:25pm revealed a fluid warming cabinet in the sub-sterile area of the Ambulatory Surgery suite between rooms 1 and 2 with eight 500cc plastic pour bottles of sterile water for irrigation. For each, the bottles/solutions lacked a date when placed in the warmer or the date the solution needed to be removed.

Observation on 4/19/10 at 2:55pm revealed a fluid warming cabinet in the core area of the Inpatient Surgery with 1 plastic flexible bag of normal saline IV (intravenous) solution 1000cc. The fluid warming cabinet registered a temperature of 122 degrees Fahrenheit. The IV solution lacked a date when placed in the warmer or a date when the solution needed to be removed.

Administrative staff U on 4/19/10 at 1:00pm 1:25pm and at 2:55pm acknowledged the warmed fluids in the three warming cabinets and the bottles of sterile water for irrigation and the normal saline IV fluids failed to be dated.

- Review of the hospital policy on 4/26/10 for labeling of medications approved 3/2008 directed "Procedures: 1. At a minimum all medication labels include: a. Drug name, strength and amount. b. expiration date, when not used within 24 hours. c. Expiration time, if expiration date is less than 24 hours. d. For all compounded IV admixtures, the date prepared and diluent...4. Anytime medication are prepared but are not administered immediately, the medication container must be appropriately labeled...."

However, observation on 4/20/10 at 11:25am of an unlocked and unattended anesthesia cart in the C-section room on the Maternal/Child Unit revealed a 100 ml (milliliter) bag of Normal Saline 9% with a label that read "Neo-synephrine100mg 3/23/10". The label lacked the initials of the person preparing the medication for administration. This cart also contained a 5cc (cubic centimeter) syringe with a clear solution and an empty vial taped to the syringe labeled as "Ephedrine Sulfate 50mg [milligrams] per ml". The prefilled syringe lacked an appropriate label with the name of the medication, expiration date, the date prepared, and the initials of who prefilled the medication.

Staff S on 4/20/10 at 11:25am acknowledged the unlocked anesthesia cart with the outdated and/or mislabeled medications.

Administrative staff T on 4/20/10 at 11:45am acknowledged the outdated and/or mislabeled medications.

Hospital staff failed to properly label medications when not given immediately, and failed to remove the pre drawn, improperly labeled, and potentially expired medication from the patient care areas.

INFECTION PREVENTION CONTROL ABX STEWARDSHIP

Tag No.: A0747

Based on staff interview, review of policies and procedures and infection control documentation, the hospital failed to develop, consistently implement and maintain an Infection Control program for the prevention, control and investigation of infections and communicable diseases for both patients and staff.

Findings included:

- Although the facility had implemented a program to monthly evaluate infection control practices, observations, staff interviews and review of documents revealed that the hospital's infection control officer failed to develop systems and an active infection control system that ensured all hospital personnel followed basic infection control practices during 10 of 24 observations in patient care and during two of two observations of staff cleaning patient rooms after patients had been discharged. The failure of implementation of a system to minimize the spread of infectious microorganisms potentially can result in the spread of infections from one patient to another and from one discharged patient to a newly admitted patient. See further evidence at CFR 482.42(a)(1), A-0749.

INFECTION CONTROL PROFESSIONAL

Tag No.: A0748

Based on interview and document review, the hospital failed to implement standard polices and procedures to ensure contracted environment cleaning/housekeeping services follow the hospital's approved policies and procedures for infection control. Rather, the contracted housekeeping supervisor was following their corporate policies, not the hospital's policies for housekeeping. This potentially affects all patients, staff, and visitors who enter the hospital.

Findings included:

- Review of the service contract on 4/21/10 revealed a signed agreement between the hospital and an environmental cleaning service dated 10/6/09 to provide housekeeping services.

- On 4/22/10 at 9:10am Staff K, Housekeeping Supervisor from the hospital's contracted environmental cleaning service, provided a copy of the three corporate policy and procedure manuals used to direct the contracted service of housekeeping duties.

At 10:40am, staff K returned with staff L, a representative of the contracted environmental cleaning service, who indicated the manual presented at 9:10am had not been approved by the infection control committee, medical staff or the governing body. Staff L acknowledged the approved polices are "on-line" and available on the computer. The contracted housekeeping supervisor failed to provide the surveyor with the current policy manual for housekeeping practices.

Staff L, on 4/22/10 at 11:15am, indicated the hospital's "Care for the Environment Policy" supercedes the corporate policy manuals for housekeeping practices in the hospital. Staff L presented the current approved corporate housekeeping policy manual to the surveyor. Administrative Staff G confirmed the information provided at 9:10 am as the policies for housekeeping lacked approval by the Governing Body.

The hospital failed to implement standard polices and assure contracted environment services follow the hospital's policies and procedures for infection control.

INFECTION CONTROL PROGRAM

Tag No.: A0749

Based on observation, staff interview and document review, the hospital's infection control officer failed to develop systems and an active infection control system that ensured all hospital personnel followed basic infection control practices during 10 of 24 observations in patient care and during two of two observations of staff cleaning patient rooms after patients had been discharged. The failure of implementation of a system to minimize the spread of infectious microorganisms potentially can result in the spread of infections from one patient to another and from one discharged patient to a newly admitted patient.

Findings included:

- Review of the Infection Control Coordinator's job description directed that this person is, "Responsible for the management of the infection control program, which includes implementation, surveillance, collection of data, analysis, reporting and formulation/review of policies and procedures...collaborates with all disciplines and departments to incorporate infection control principles in current policies and procedures or practices to provide a safe environment for patients, personnel, and visitors...Conducts special studies and selective surveillance issues...to evaluate the of new procedures or equipment of the delivery of care (examples: outbreak investigation and environmental rounds)...."

Staff G on 4/20/10 at 8:30am verified they were responsible for the management of the infection control program. The hospital's Infection Control Committee included a representative from all areas of nursing and the contracted environmental cleaning service. The committee reviews policies and procedures and analyze practices. Monthly "secret shoppers" observe, using a criteria list, for breaches in infection control. Housekeeping is a contracted service and a representative from the cleaning service is a member of the infection control committee. A company representative conducts monthly environmental rounds, which are reported to the Infection Control Coordinator. The infection control committee approves housekeeping products used in the hospital and the Governing Body approves housekeeping policies and procedures.

Although "secret shoppers" and a representative from the contracted housekeeping service conducts monthly conduct round for appropriate infection control practices, observations revealed the following:

1. Observation in the emergency room (ER) on 4/19/10 at 12:15pm revealed a linen cart against the wall. The linen cart lacked a cover with all items/linens exposed to potential contamination.

Interview with staff G on 4/21/10 at 9:15am acknowledged the hospital linens should be stored in a covered linen cart and the potential for linens to be contaminated.

2. Observation on 4/19/10 at 12:35pm of housekeeping staff's cleaning a patient care area in ER revealed staff V removed soiled linens from a gurney and held the linens next to their uniform while they carried the linens to the hamper.

Staff G on 4/21/10 at 9:15am acknowledged linens are not to touch a staff member's uniform and the potential for cross-contamination.

3. Observation in the emergency room on 4/19/10 at 2:50pm revealed staff V using a spray bottle identified as A-456 II applied a light mist of disinfectant to a patient gurney and pillow. Staff V immediately dried the gurney and pillow with a cloth. The disinfectant remained in contact with the surfaces for approximately 45 seconds. The bottle with disinfectant lacked information directing staff in the proper use of the solution, including the required contact (wet) time to provide disinfection.

However, review of the "Product Specification Document" provided by the hospital on 4/21/10 at 10:00am revealed the "treated surface must remain wet for 10 minutes".

Staff E, on 4/19/10 at 3:30pm, acknowledged the spray bottles of disinfectant lack information to direct staff on the required 10 minute contact (wet) time.

4. Observation in the emergency room on 4/19/10 at 3:50pm with staff E revealed a wheelchair labeled "ER3ER" with a six-inch tear in the seam of the seat. Wheelchair ER3ER and a second chair evidenced white tape wrapped multiple times on the attached telescoping poles.

Staff E on 4/19/10 at 3:50pm acknowledged the non-cleanable surfaces with the potential for cross-contamination.

5. Observation on 4/19/10 between 12:30pm to 2:00pm on the Ambulatory Surgery Unit revealed multiple areas with infection control concerns, a sampling of which included:

a. Operating Room 1 and 2 with the vinyl covering on mattresses and arm boards cracked, leaving a pathway to the inside foam rendering the areas uncleanable with the potential for cross contamination.
b. Endoscope Room 4 with a metal cabinet against the back wall with rust across the bottom and spots of rust on the door rendering the areas uncleanable.
c. Operating Room 3 with a large area on the back wall with gouges in the drywall with chipped paint, which exposed the porous surface, and made the wall uncleanable. Chips of paint lay on the floor below the damaged wall.

Administrative staff U on 4/19/10 between 12:30pm and 2:00pm acknowledged the cracked open areas on the mattresses and arm boards, the rusted areas on the metal cabinet and the damaged wall with paint chips on the floor. Staff U acknowledged the uncleanable surfaces and the potential for cross contamination.

6. Observation on 4/19/10 between 2:20pm to 3:40pm on the Inpatient Surgery Unit revealed two areas with infection control concerns, which included:

a. Urology Room, a room used for sterile procedures, with windows covered by cloth curtains.
b. Orthopedic Room 4 with the vinyl covering on an arm board cracked, leaving a pathway to the inside foam rendering the area uncleanable with the potential for cross contamination.

Administrative staff U on 4/19/10 between 2:20pm and 3:40pm acknowledged the cracked open areas on the arm board. Staff U acknowledged uncleanable surfaces and the potential for cross contamination. Staff U reported the uses of a laser in the Urology room required the windows to be blocked of light and the curtains were not washed after each surgery.

7. Observation on 4/19/10 at 2:55pm on the medical unit revealed staff H pulling a bag of clean cloths down the hall and on to the elevator. The bag was in continuous contact with the floor. Administrative staff D stopped staff H and instructed the housekeeper not to allow the clean cloths to touch the floor.

Staff D on 4/19/10 at 2:55pm acknowledged staff H failed to follow basic infection control practices by allowing the bag of clean cloths to touch the floor.

8. Observation on 4/19/10 at 2:20pm in the Medical Intensive Care Unit revealed Staff I provided nasal tracheal suction to patient #6. Staff I opened sterile gloves and applied the gloves without maintaining sterile technique. Staff I then walked to the foot of the bed and used their sterile gloved hand to move a non-sterile object on the bed, and then adjusted the non-sterile oxygen meter with the other sterile gloved hand. Staff I then preceded with suctioning the patient. Staff I failed to maintain sterile technique during nasal tracheal suctioning.

Review of clinical practice guidelines by the American Association for Respiratory Care (AARC) revealed nasal tracheal suctioning requires sterile technique.

Administrative staff C acknowledged staff I failed to follow basic infection control practices and failed to maintain sterile technique.

9. Observation on 4/20/10 at 9:15am in the wound care center revealed a hyperbaric chamber. Staff N on 4/20/10 at 9:15am cleaned the hyperbaric chamber with "A-456 II" which remained wet for less than one minute not the required 10 minutes.

Review of the hospital's policy titled "Chamber Cleaning" failed to direct staff regarding the use of the disinfectant and how long the disinfectant must remain in contact with the surface.

Staff A on 4/21/10 at 11:15am acknowledged hospital staff failed to provide proper cleaning of the hyperbaric chamber.

10. Observations on 3-North Medical Unit on 4/20/10 between 2:00pm and 2:35pm of patient rooms 365, 367, 369, 371, 375 and 377 revealed washcloths and other material held in place across the air vents with multiple layers of white tape.

Administrative staff D on 4/20/10 at 2:00pm, lacked knowledge of staff blocking the air vents in patient rooms with materials that had not been cleaned between patient use. Interview with staff K and staff Q on 4/20/10 at 2:35pm confirmed the presence of the uncleaned material covering the air vents. Interview with Housekeeping staff W on 4/21/10 at 2:30pm indicated the material had been present for more than a week. Staff Q confirmed the material covering the air vents in patient rooms had not been cleaned between patient use where at least one patient had been in isolation, potentially allowing bacteria on the uncleaned material to be spread to the next patient who used the room.

11. Review of the "A-456 II" manufacturer's guidelines for disinfection instructed staff to leave " A-456 II" on surfaces for 10 minutes to assure disinfection.

Review of the "QC 91" manufacturer's product specification document identifies the product, as a cleaner for dirt, soap scum, and hard water deposits, but not a disinfectant.

However, observation on 4/20/10 between 1:30pm and 2:00pm of the terminal cleaning of room #375 following the discharge of a patient revealed staff W used the cleaning cloth saturated with the disinfectant A-456 II to clean the sink, cabinet, table, chairs, bed and other flat surfaces. The bed and flat surfaces remained wet for less than one minute, not the required 10 minutes contact time for total disinfection. Staff W swabbed a solution of "QC91" (an acid cleaner, not a disinfectant) in the toilet bowl.

Staff W on 4/20/10 at 2:00pm acknowledged flat surfaces failed to remain wet for the manufacturer's required 10 minutes.

Review of the "SODEXO SHINE" cleaning procedures manual failed to direct staff to disinfect the toilet. Staff L on 4/21/10 at 9:20am acknowledged "QC91" lacked disinfecting properties. Review of the hospital policy titled "Care of the Environment: Daily Room Cleaning" directed staff to "ensure cleaning and disinfecting of ...the environment...High touch [i.e., frequently touched surfaces] are to be cleaned with a hospital approved disinfectant...."

12. Observations on 4/20/10 from 1:50pm to 2:35pm of the terminal cleaning of room #466 following the discharge of a patient revealed staff J used the hospital-approved disinfectant "A-456 II" to clean the room. Staff J used cleaning cloths saturated with the disinfectant to clean the sink, cabinets, table, chairs, bed and other flat surfaces in the room. The bed and flat surfaces remained visibly wet for approximately 5-7 minutes, but not the required 10 minutes for total disinfection. Staff J wiped the toilet seat and flat surfaces of the toilet with "A-456 II" which remain wet for approximately 5 minutes, but not the required 10 minutes for total disinfection. Staff J cleaned the toilet bowl with "QC 91". Staff J dry mopped the floor and then wet mopped the floor with a solution of "A-456 II" which remained wet for a contact time of approximately 4 minutes, but not the required 10 minutes for total disinfection. Staff J used a glass cleaner "QC 52" on the mirror and the paper towel dispenser, this chemical is not a disinfectant.

Staff J on 4/20/10 at 2:30pm acknowledged contact time for "A-456 II" cleaning solution needed to be left on each surface for ten minutes and acknowledged the surfaces in the room did not remain wet for the required 10 minutes.

Staff L, a representative of the contracted environmental cleaning service, on 4/21/10 at 9:20am noted "QC91" as an acid based bowl cleaner used to clean hard water deposits and soil off the toilet bowl and lacked disinfectant properties.

Review on 4/20/10 of the environmental cleaning service checklist after a patient discharge, adopted and approved by the hospital 7/7/2009, found it failed to include a system to evaluate the use of cleaning products for appropriate disinfection and contact (wet) time.