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Based on tours of the Pharmacy conducted on 3/1/13 and 3/2/13 and interviews, it was determined that this Condition was not met because:
1.) The Pharmacy physical environment was not being managed in a manner to minimize the risks of drug contamination, drug dispensing errors, drug diversion and staff exposure to chemotherapy agents. See Tag A 491 and Tag A 500.
2.) Medications, including sterile products, were not being consistently prepared in a clean and uncluttered environment. See Tag A 500.
3.) Medication storage was not consistently being monitored to ensure that unusable medications were not available for patient use. See Tag A 505.

Based on tours of the Pharmacy conducted on 3/1/13 and 3/2/13 and interviews, it was determined that the Pharmacy physical environment was not being maintained and cleaned in a manner to minimize the risks of drug contamination, drug dispensing errors and drug diversion. Dust, splatters and debris in medication storage and preparation areas presented risk for drug contamination, clutter, disorganization and old shelf labeling in medication storage, preparation and dispensing areas presented risk for drug dispensing errors and staff's personal clothing and belongings in the Pharmacy presented opportunity for drug diversion.

Findings include:

A tour of the Pharmacy conducted from 11:50 A.M. to 1:05 P.M. on 3/1/13 identified the following physical environment issues [please note - capitalized words indicate where within the Pharmacy room the findings were observed]:
1.) Twelve reference books on the floor by the doorway to the Break Room. The books and surrounding floor were dusty.
2.) The central processing units of 2 computers located at the Service Window and 2 computers located in the Order Processing Area were covered with a thick layer of dust.
3.) The counter located at the Service Window was cluttered with extra storage bins, papers and small, empty cardboard boxes.
4.) A fan located on a shelf below the counter at the Service Window was dusty.
5.) The top of the file cabinet on which a mannitol (a drug) warmer was located was dusty and littered with a light yellow granular substance.
6.) The outside of the glass doors on the MEDICATION REFRIGERATORS were heavily splattered with sticky and dried substances of many colors.
7.) A small refrigerator located near the medication refrigerators contained food. The Surveyor interviewed the Director and the Clinical Coordinator of the Pharmacy during the tour. The Director and the Clinical Coordinator said the refrigerator was an overflow food refrigerator for Pharmacy staff. The outside of the refrigerator was dusty. The inside of the refrigerator was splattered with dried substances.
8.) IN THE ORDER PROCESSING AREA: a.) the counters were cluttered with papers, small empty cardboard boxes and a pocketbook, b.) a chair was covered with a coat and scarf, c.) another chair was covered with a sweatshirt, d.) a metal desk-top file located on the floor was dusty, e.) a large file cabinet was dusty and filled with old papers, office supplies and coffee cups and f.) there was paper debris located between the lightbulb and the suspended ceiling light cover.
9.) A cardboard box, book, empty metal filing box and a plastic bag were located under a round table used for filling and checking code cart drug drawers. The boxes, book, plastic bag and surrounding floor were dusty.
10.) A bottle of Prolink Cream Cleaner and the bottom of a cabinet located under the counter to the left of the under-sink cabinets were splattered with a dark-brown dried substance.
11.) The floors in the SERVICE WINDOW, ORDER PROCESSING and TECHNICIAN PACKAGING AREAS were splattered with dried substances and littered with debris and dust bunnies.
12.) IN THE "OLD VAULT": a.) the floor was splattered with dried substances and littered with dust bunnies and debris, b.) a large bag of demonstration vials (vials for practicing admixture) were located on the floor, c.) there were 3 cardboard boxes on the floor, d.) a large stack of Interoffice Envelopes were covered with a thick layer of dust and e.) the shelving and storage bins were covered with a thick layer of dust and littered with debris.
13.) IN THE ADMIXTURE ANTE-ROOM: the floor was splattered with dried substances and littered with debris.
14.) IN THE MEDICATION ISLES/ROLLING RACKS: there was debris on the floor.
15.) IN THE AREA ACROSS FROM THE MEDICATION ISLES/ROLLING RACKS: 2 canisters of Dispatch (a cleaner) were on the floor.

The Director and the Clinical Coordinator of the Pharmacy could not explain the above listed Pharmacy physical environment issues identified during the 3/1/13 tour of the Pharmacy. The Director and the Clinical Coordinator of the Pharmacy could not provide any Pharmacy cleaning policies or procedures and deferred to Environmental Services (ES).

The ES procedure titled "Pharmacy" was a generic procedure that had not been edited to assign ES and Pharmacy staff responsibilities. The procedure referred to an "Environmental Cleaning Task List and Schedule for Departmental Staff" that could not be located.

The Surveyor interviewed the Director of the Pharmacy during a tour of the Pharmacy conducted from 10:15 to 11:20 A.M. on 3/2/13. The Director of the Pharmacy said Pharmacy and Environmental Services personnel were working on developing a comprehensive Pharmacy cleaning program.

The 3/2/13 tour of the Pharmacy identified that old, no longer necessary labels including medication location location labels were located on shelving throughout the Pharmacy.

Tours of the Hospital's Outpatient Unit, Pain Clinic, Emergency Department, Critical Care Unit, Kitchen, Transitional Care Unit, Dialysis Unit, Medical/Surgical Unit #1 and Medical/Surgical Unit #2 conducted on 2/27/13, 3/1/13 or 3/2/13 did not identify any physical environment issues.

The Surveyor interviewed the ES Operations Manager at 12:30 P.M. on 3/2/13. The ES Operations Manager said he was newly employed at the Hospital. The ES Operations Manager said a 3:00 P.M.-11:00 P.M. shift Housekeeper (Housekeeper #1) was assigned to clean the Pharmacy. The ES Operations Manager said that due to budget and staffing cuts made a couple of years earlier, Housekeeper #1 was also assigned to clean the Laboratory and the Outpatient Department. The ES Operations Manager said it was determined that it was not possible for one housekeeper to thoroughly clean the Pharmacy, Laboratory and Outpatient Department, so another housekeeper (Housekeeper #2) was hired. The ES Operations Manager said Housekeeper #2 started the week of 2/18/13 and was still in orientation.

The ES Operations Manager said Hospital-specific Pharmacy cleaning policies and procedures needed to be developed. The ES Operations Manager also said ES Supervisors perform periodic environmental inspections, but the inspections are focused on patient care and public areas. The ES Operations Manager said some Pharmacy inspections were completed, but the inspections were not documented.

The Surveyor interviewed the Manager of Environmental Safety at 10:30 A.M. on 3/2/13. The Manager of Environmental Safety said Environment of Care Surveillance Tracers are conducted in all Hospital areas, at least every 6 to 12 months. The Manager of Environmental Safety said full Hospital surveys including an assessment of the physical environment are conducted by the Hospital's Insurance Company's Loss Control Manager twice/year.

The last Pharmacy Environment of Care Surveillance Tracer that could be located by the Manager of Environmental Safety was dated 7/19/11. The Summary associated with the 7/19/11 Environment of Care Surveillance Tracer indicated the Tracer identified general clutter and dust on the Pharmacy countertops. Documentation on the Tracer Summary indicated the Summary was sent to an Interim Director of Pharmacy for follow-up and written follow-up was to be sent to the Manager of Environmental Safety within 2 weeks. The Manager of Environmental Safety could not locate the written follow-up to the Pharmacy's 7/19/11 Environment of Care Surveillance Tracer.

A review of the reports related to the Hospital's Insurance Company's 8/13/12 and 12/17/12 Hospital-wide Surveys did not identify concerns regarding the Pharmacy physical environment.

Based on tours of the Pharmacy conducted on 3/1/13 and 3/2/13 and interviews, it was determined that sterile products were not being consistently prepared in a suitable environment and medication storage areas were not consistently being inspected to ensure correct medication storage to ensure patient safety.

Findings include:

A tour of the Pharmacy conducted from 11:50 A.M. to 1:05 P.M. on 3/1/13 identified the following medication storage issues:
1.) The vents of the MEDICATION REFRIGERATORS were dusty.
2.) IN THE TECHNICIAN PACKAGING AREA: the sink and under-counter cabinets and drawers were heavily splattered with wet and dried substances.
3.) IN THE UNDER-COUNTER CABINET located to the left of the under-sink cabinets IN THE TECHNICIAN PACKAGING AREA: a.) a spray bottle of solution was unlabeled and b.) 2 bottles of Lugol's solution (a strong iodine solution) and 1 bottle of Shillings solution were very dusty. The Surveyor interviewed the Director and the Clinical Coordinator of the Pharmacy during the tour. The Director and the Clinical Coordinator of the Pharmacy said they believed the unlabeled spray bottle contained some type of cleaning solution.
4.) IN THE "OLD VAULT": medication and medication kit storage bins were very dusty.
5.) An "empty" TECHNICIAN TRANSPORT CART contained 6 unit-dose tablets of hydrochlorothiazide (a diuretic medication). The tablets were not labeled with a patient's name.
6.) IN THE ADMIXTURE ANTE-ROOM: a.) the sink and surrounding wall were splattered with dried substances, b.) the bottom shelf of the freezer was splattered with a dark-colored substance and c.) the freezer vent was dusty.
7.) IN THE ADMIXTURE (BUFFER) ROOM: a.) the ceiling vent near the door was dusty, b.) the metal shelving was covered with a fine dust, c.) the vents beneath the horizontal flow hoods were dusty, d.) there was debris and 2 dust bunnies on the floor and e.) a spray bottle of solution was unlabeled. The Surveyor interviewed Pharmacy Technician #1 during the tour of the Admixture Room. Pharmacy Technician said the unlabeled spray bottle contained alcohol.
8.) IN THE MEDICATION ISLES/ROLLING RACKS: the medication bins were dusty.
9.) IN THE AREA ACROSS FROM THE MEDICATION ISLES/ROLLING RACKS: plastic vendor storage boxes were dusty and splattered with dried substances.

The Director and the Clinical Coordinator of the Pharmacy could not explain the above listed Pharmacy physical environment or medication storage issues.

The Environmental Services (ES) procedure titled "Pharmacy" was a generic procedure that had not been edited to assign ES and Pharmacy staff responsibilities. The procedure referred to an "Environmental Cleaning Task List and Schedule for Departmental Staff" that could not be located.

The 3/2/13 tour of the Pharmacy identified the following medication storage issues:
1.) Containers of COMMERCIAL CHEMOTHERAPY were stored separately, but not in a manner to prevent personnel exposure.
2.) Old, no longer necessary labels including medication location labels were located on shelving throughout the Pharmacy.

Based on tours of the Pharmacy conducted on 3/1/13 and 3/2/13 and interviews, it was determined medications were not consistently being prepared in a clean and uncluttered area to minimize the possibility of drug contamination and drug errors.

Findings include:

A tour of the Pharmacy conducted from 11:50 A.M. to 1:05 P.M. on 3/1/13 identified the following clutter and cleanliness issues with potential to contribute to drug contamination:
1.) In the Technician Packaging Area: the sink and under-counter cabinets and drawers were heavily splattered with wet and dried substances.
2.) In the under-counter cabinet located to the left of the under-sink cabinets in the Technician Packaging Area: a.) a spray bottle of solution was unlabeled, b.) 2 bottles of Lugol's solution (a strong iodine solution) and 1 bottle of Shillings solution were very dusty and c.) a bottle of Prolink Cream Cleaner and the bottom of the cabinet were splattered with a dark-brown dried substance. The Director and the Clinical Coordinator of the Pharmacy were interviewed during the tour. The Director and the Clinical Coordinator said they believed the spray bottle contained some type of cleaning solution. The Director and the Clinical Coordinator did not know what the Lugol's and Shilling solution were used for or why they were stored in the cabinet.
3.) In the Admixture Ante-Room: a.) the sink and surrounding wall were splattered with dried substances and b.) the bottom shelf of the freezer was splattered with a dark-colored substance.
4.) In the Admixture (Buffer) Room: a.) the ceiling vent near the door was dusty, b.) the metal shelving was covered with a fine dust, c.) the vents beneath the horizontal flow hoods were dusty, and d.) the floor was littered with debris and 2 dust bunnies.

The Director and the Clinical Coordinator of the Pharmacy could not explain the Pharmacy physical environment issues identified during the 3/1/13 tour of the Pharmacy. The Director and the Clinical Coordinator of the Pharmacy could not produce Pharmacy cleaning policies or procedures and deferred to Environmental Services (ES).

The ES procedure titled "Pharmacy" was a generic procedure that had not been edited to assign ES and Pharmacy staff responsibilities. The procedure referred to an "Environmental Cleaning Task List and Schedule for Departmental Staff" that could not be located.

On 3/1/13, at approximately 3:00 P.M., the Director of Quality Resources was informed the Admixture Room had to be immediately cleaned and that the Room could not be used until re-inspected by the Surveyor.

The Pharmacy was re-toured at 4:10 PM on 3/1/13. The Admixture Room was inspected and found to be clean and Pharmacy de-cluttering and cleaning activities were observed to be underway.

A tour of the Pharmacy conducted from 10:15 to 11:20 A.M. on 3/2/13 demonstrated that the physical environment issues identified during the 3/1/13 Pharmacy Tour were addressed. The Director of the Pharmacy was interviewed during the tour. The Director of Pharmacy said Pharmacy and Environmental Services personnel were working on developing a comprehensive Pharmacy cleaning program.

The ES Operations Manager was interviewed at 12:30 P.M. on 3/2/13. The ES Operations Manager said he was newly employed at the Hospital. The ES Operations Manager said a 3:00 P.M.-11:00 P.M. shift Housekeeper (Housekeeper #1) was assigned to clean the Pharmacy. The ES Operations Manager said that due to budget and staffing cuts a couple of years earlier, Housekeeper #1 was also assigned to clean the Laboratory and the Outpatient Department. The ES Operations Manager said it was determined that it was not possible for one housekeeper to thoroughly clean the Pharmacy, Laboratory and Outpatient Department, and another housekeeper (Housekeeper #2) was hired. The ES Operations Manager said Housekeeper #2 started the week of 2/18/13 was still in orientation.

The ES Operations Manager said Hospital-specific Pharmacy cleaning policies and procedures needed to be developed.

As of 3/2/13, the following had not been developed and implemented to ensure medication preparation in a clean and uncluttered area and to minimize the possibility of drug contamination and drug errors:
1.) A comprehensive Pharmacy cleaning program including the delineation of ES and Pharmacy staff responsibilities and process and quality monitoring components.
2.) A plan for Pharmacy clutter-control including a quality monitoring component.

Based on a tour of the Pharmacy conducted on 3/1/13 and interviews, it was determined that gaps in temperature logs related to 2 of 3 medication refrigerators made it impossible to determine if the medications were safe for patient use and unlabeled solutions available in the Pharmacy had the potential to be utilized during preparation of patient's medications.

Findings include:

A tour of the Pharmacy conducted from 11:50 A.M. to 1:05 P.M. on 3/1/13 identified the following medication refrigeration and solution labeling issues:
1.) Gaps were noted in 2 of 3 MEDICATION REFRIGERATOR temperature logs.
2.) IN THE ADMIXTURE (BUFFER) ROOM: a spray bottle of solution was unlabeled. The Surveyor interviewed Pharmacy Technician #1 during the tour of the Admixture Room. Pharmacy Technician #1 said the spray bottle contained alcohol.

The Surveyor interviewed the Director and the Clinical Coordinator of the Pharmacy during the 3/1/13 tour of the Pharmacy. The Director and the Clinical Coordinator could not explain the gaps in the medication refrigerator temperature logs or unlabeled solutions identified during the tour.