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PERRY COUNTY MEMORIAL HOSPITAL 434 NORTH WEST STREET PERRYVILLE, MO 63775 May 21, 2014
VIOLATION: POLICIES - DRUG MANAGEMENT Tag No: C0276
Based on observation, interviews and record reviews the facility failed to establish and maintain policies and procedures:
- To ensure drug storage inside and outside the main Pharmacy was secure and sufficient to protect against loss (diversion or theft) of drugs;
- To direct Pharmacy quality assessment/performance improvement (QA/PI) studies that identified security breaches in processes and procedures used during the movement of drugs through the facility including security of drug dispensing equipment (Omnicels);
- To ensure an identified drug theft or potential drug theft was reviewed, by appropriate staff (other than the accused), so effective measures could be placed to prevent future theft or attempts.

The lack of policies and procedures directing security measures for non-controlled drugs; lack of QA/PI study and lack of remedial actions from past drug thefts had the potential to cause an adverse subsequent delay in drug therapy for patients (delayed drug therapy caused by an undetected theft from the Pharmacy). The facility stored approximately 2200 drugs in the main Pharmacy. The facility census was 16.

Findings included:

1. Record review of an undated American Society of Health-System Pharmacists' (ASHP) position paper titled, "ASHP Statement on the Roles and Responsibilities of the Pharmacy Executive" showed one of the responsibilities of the Pharmacy Executive was supply chain management. Supply chain management included responsibility for receiving; security; inventory control; diversion (theft) prevention and distribution policies.

2. Record review of the facility's undated position description/performance review form for Staff G, Director of Pharmacy showed two of the essential job responsibilities included supervision of medication storage areas in the facility and strict control and accountability for all medications (drugs).

3. Record review of the facility's policy titled, "Director of Pharmacy," dated 07/11 showed the director was responsible for the following:
- All activities related to the pharmacy;
- Drug storage and distribution which included establishing a system for ordering, controlling and distributing drugs;
- Maintaining accurate records of drugs dispensed.

4. Record review of the National Library of Medicine, Pub Med Health web site showed Tramadol was an opium-like pain reliever that may become habit forming and showed Ultracet was a combination of Tramadol and acetaminophen (Tylenol); that provided better pain relief than either drug alone; and pain relief could be attained by a lower dose.

5. During an interview on 05/20/14 at 8:49 AM, Staff A, Chief Executive Officer (CEO), stated the following:
- Staff J, the Vice President, Operations (VP-O) was organizationally in charge of the Pharmacy Services.
- He knew Staff J had completed an investigation of an allegation of drug theft from the facility pharmacy by Staff G, Director of Pharmacy;
- Staff G and all other Pharmacy staff were drug screened immediately after the accusation and the drug screen results were evaluated by an offsite physician (Medical Review Officer or MRO).
- Drug screen results showed levels (positive test) of Tramadol for Staff G.
- Staff G, who tested positive for Tramadol had a prescription for the drug.
- Per the MRO's report, Staff G had a drug level within the expected therapeutic level for a person prescribed Tramadol.

6. During a telephone interview on 05/20/14 from 2:00 PM through 2:30 PM, Staff J confirmed the following:
- He investigated two incidents involving accusations of drug thefts from the Pharmacy.
-The first report of Tramadol theft was in 07/13. The report from Staff H, Pharmacy Technician (PT) was that she and Staff Q, Pharmacist had noted Staff G exhibited suspicious behavior when he was near the bins of Tramadol.
- Staff G had mentioned to them that he was prescribed Tramadol for knee pain.
- Staff H and Staff Q were concerned and started a systematic count (monitor) of the number of doses of Tramadol in the Pharmacy bin.
- They reviewed the number of doses purchased from the wholesaler; subtracted out the number of doses dispensed to patients and compared their results to the number of doses left in the bin on the shelf.
- Their running totals showed unexplained losses of 100 doses over a three month period from 04/19/13 through 07/08/13 (when they reported their suspicions to Administration).
- Staff J immediately directed all Pharmacy staff to submit to urine drug screening. Samples were sent to an offsite laboratory. Two of five Pharmacy staff tested positive for Tramadol. The laboratory results were then sent to an offsite MRO who interpreted that the drug levels were appropriate for persons on the prescribed levels documented on their medication profiles. Both staff with positive results had documented prescriptions for Tramadol.
- Other actions taken by Staff J, VP-O included directing that the Tramadol inventory be moved to the controlled substance cabinet (for routine counting/monitoring) and installation of a video camera monitoring system in 08/13.
- A second report of drug theft was filed in 02/14 with a Board member.
- The Board member informed the CEO who told the VP-O;
- Through her medication "counts" and observations of Staff G's suspicious behaviors, Staff H determined that there was loss of 40 doses of Ultracet between 12/27/13 and 02/21/14.
- After receiving the report of theft of Ultracet, Staff J conducted an investigation and viewed a video of suspicious behaviors by Staff G.
- Staff J reported Staff G had moved packets of Ultracet from a bin to an inappropriate place in the pharmacy.
- Staff J confirmed that no punitive personnel actions were taken against Staff G after the suspicious behavior viewed on video (recording from the video camera monitoring system installed in 08/13) and the mishandling of Ultracet.

7. During an interview on 05/20/14 at 2:31 PM Staff S, Associate VP, Support Services (AVP-SS) including Human Resources (HR) stated the following:
- He received information on 07/11/13 from Staff H, PT (the first incident of theft) that she felt there was theft of Tramadol.
- Staff H reported that 136 doses of Tramadol was missing (stolen) between 04/09/13 through 07/08/13.
- Staff H had reported to him that she began counting the doses of Tramadol because she suspected Staff G of theft.
- She reported that Staff G was routinely near the bins of Tramadol and was acting suspiciously just before she counted and found doses of Tramadol were missing.

8. During an interview on 05/20/14 at 3:15 PM Staff P, Governing Board (GB) President stated the following:
- He was informed of a theft of Tramadol in 02/14 and he called the CEO.
- He met with the CEO, VP-O and AVP-SS within two hours of being notified of the theft.
- He had not considered involving the entire Board because of the need to address the accusation as soon as possible.
-The GB had not routinely received reports of Pharmacy thefts.

9. Record review of the facility video recording of the Pharmacy dated 02/21/14 at 6:57 AM through 6:58 AM showed:
- A view of the back of Staff G, standing, facing a number of bins of drugs;
- Staff G's hands were not completely visible however, his right hand extended out to the side to crumple a number of plastic grocery bags and as he started to turn away from the table his left hand extended out to scoop up an unidentifiable object from the table.
- Staff G was seen walking out of view.
- Staff G's actions seemed suspicious and did not clearly identify what he removed from the area.

10. During an interview on 05/21/14 from 7:50 AM through 9:16 AM, Staff G, Director of Pharmacy stated the following:
- He currently worked three days a week in the facility.
- He had been transitioning from full time to part time since approximately 07/13 or 08/13, after an accusation of theft of Tramadol.
- When asked directly, Staff G stated that he had not stolen any Tramadol from the Pharmacy.
- The Tramadol was currently in the "locked cabinet" which required a two staff manual count be done.
- He stated that he knew the chemistry of Tramadol and thought it should be locked up like a controlled substances (even though he knew it was not called a controlled substance in this state).
- He stated that he knew controlled substances should be locked up but also knew there were people who could get around any measure to secure controlled substances.
- When asked about the remedial actions after the Tramadol thefts, he related that video cameras were placed [in the Pharmacy.] He felt the placement of the video cameras was done per his decision but, he could not recall for sure. He felt that it was important to capture a view of the front door and of the controlled substances cabinet.
- He stated that he had never thought of getting an overhead view of the staff persons' hands while they were working at the table in front of the drug bins.
- When asked about his movement of the 20 doses of Ultracet from the bin to an inappropriate place in the pharmacy (Staff G was seen on a surveillance video tape recording moving something), he stated that he did not know about the previous Ultracet losses; but, he knew the Pharmacy seldom dispensed Ultracet to patients.
He stated that he moved the 20 doses of Ultracet from the bin to the top of the boxes of intravenous fluids because he was "startled."
- He stated that the 20 doses of Ultracet were not in the appropriate bin but they were also not removed or stolen out of the pharmacy.
- He stated that he knew it was a stupid thing to do (place the twenty doses on the intravenous fluid boxes and not replace them in the appropriate bin).
- He stated that Ultracet and Tramadol should be "locked up" so they could be monitored (counted).
-When asked about the plastic grocery bags, he stated that he brought in bags so his staff could use them to transport supplies (intravenous fluids and normal saline) to other areas of the hospital.
- When asked if he had ever retaliated against any staff under his supervision, he stated that the transfer of a Pharmacist to the long term care (LTC) side was because that pharmacist was hesitant to contact and question physicians regarding medication orders.
- When asked if he was taking any prescribed medication, he confirmed that he was on prescribed Tramadol for knee problems.
- He stated that he was on a lot of other prescribed medications. On occasion he had forgotten to take (ingest) a dose of his prescribed medication so; he took (removed and ingested) a dose from the pharmacy stock. He further stated that he always "announced" (told other staff present) that he was taking a dose and that there was no approved facility policy against this process.
- When asked if he maintained any policies and procedures to show how he maintained inventory control, (knew the numbers of doses he maintained of any drugs in the Pharmacy), he stated that he had not performed any routine or random spot checks of any drugs inside or outside the pharmacy (except controlled substances in the locked cabinet).
- He stated that he had not developed any policies or procedures nor, had he directed any staff to perform counting or auditing of drugs other than the controlled substances because "this is a small place and we trust everyone."
- He stated that he had not established any policies or procedures for reconciliation of non-controlled drugs that may become habit forming such as Tramadol or Ultracet (contained Tramadol).
- He stated that he had not instituted any policies or procedures to ensure that drug theft or potential drug theft was reviewed and analyzed by appropriate staff (other than the staff accused) so that system-wide practices could be put in place as deterrence.
-When asked to describe what projects or studies he had performed to measure the quality of work (QA/PI or PI), he stated that he had not performed any audits of any of the work of Pharmacy staff.
- He stated that he had not performed QA/PI studies or projects that would demonstrate review of the processes involved in an attempt to improve the safe, secure movement of drugs through the facility especially after the 07/13 theft of Tramadol.
- He stated that he had not performed any QA/PI studies to identify security breaches in processes and procedures used anywhere in the facility that would identify areas of improvement in handling, dispensing or administration of drugs.

11. During an interview on 05/21/14 at 9:52 AM Staff Q, LTC unit Pharmacist stated the following:
- She had worked in the facility for 12 years and had recently been assigned to the LTC pharmacy after about 09/13.
- In 04/13 while working in the Pharmacy, she saw Staff G in the area where the Tramadol was stored. He explained he was "straightening" up. Staff Q stated that she felt that was a suspicious statement following suspicious behaviors (did not match his explanation of what he was doing or what his routine duties as director would have been). Later he made an unprompted statement that he was on prescribed Tramadol.
- She stated that, as a pharmacist, she knew Tramadol had "abuse potential."
- She stated that the facility policy for providing a staff person with personal medication if they forgot their dose was to dispense one dose after a Registered Pharmacist checked the person's medication profile.

12. During an interview on 05/21/14 at 10:32 AM, Staff H, PT stated that:
- In 04/13, after she and Staff Q noticed Staff G was engaged in suspicious behaviors around the bins where Tramadol was stored, she and Staff Q started to monitor (count) the doses of Tramadol on the shelf.
- In 07/13, she decided to report the results of the monitoring (shortages) to Administration.
- The counts showed 20 doses missing on 04/30/13; one missing on 05/17/13; one missing on 05/20/13; 20 missing on 05/21/13; 20 missing on 05/30/13; 30 missing on 06/20/13; 24 missing on 06/28/13 and 20 missing on 07/08/13.
- The shortages totaled 136 doses in eight different occasions over a three month period.
- She reported that the dates on which the Tramadol was missing were also days when Staff G was on duty and had access to the drug.
- Each occasion was after a 100 dose delivery from the wholesaler and without documented prescriptions dispensed to any patients per medication profiles.
- Video cameras were installed on 08/06/13 and the Tramadol was locked up after that date.
- She and Staff Q counted the Tramadol until Staff Q was permanently reassigned to the LTC pharmacy.
- In 02/14 Staff G was again exhibiting suspicious behaviors around the bins where Ultracet (she knew Ultracet was a combination of Tramadol and Tylenol) was kept.
- After counting Ultracet which were not in the controlled substance cabinet, she found 20 doses of Ultracet were missing on 12/31/13 and another 20 were missing on 02/21/14.
- A Board member was informed and the Board member contacted the CEO and the VP-O investigated.
- She stated that on 02/21/14, the 20 missing doses were "found" by the VP-O, after he came into the Pharmacy and located them on top of cases of intravenous fluids.
- She reported the Ultracet was then moved to the controlled substances cabinet for routine counting/monitoring.

13. Observation on 05/20/14 at approximately 10:00 AM in the facility Pharmacy and record review of drug purchases and medication profiles showed the following:
- Twelve randomly selected drugs were counted and the result compared to purchasing records and medication profiles (a beginning balance from 03/26/12 plus the number of doses purchased from the wholesaler minus the number of doses dispensed to patients as of 05/20/14);
- The review showed unexplained losses for seven of the 12 and unexplained overages (which may indicate poor inventory control or errors in doses dispensed to patients) for five of the 12 drugs.
- The seven drugs counted with unexplained losses were:
- Tramadol had 643 doses missing;
- Ultracet had 280 doses missing;
- Acetaminophen (Tylenol) with codeine (narcotic pain reliever) had 744 doses missing;
- Alprazolam (an antianxiety drug) 0.5 milligram (mg a metric unit of measure) had 145 doses missing;
- Zolpidem (a sedative) had 40 doses missing;
- Hydrocodone (narcotic pain reliever) with Tylenol 7.5/325 (7.5 Hydrocodone with 325 Tylenol) had 31 doses missing and
- Diazepam (habit forming tranquilizer) had 16 doses missing.
- The five drugs counted with unexplained overages were:
- Hydrocodone/Tylenol 5/325 had 10 extra doses on the shelf;
- Hydrocodone/Tylenol 10/325 had 21 extra doses on the shelf;
- Alprazolam 0.25 had 40 extra doses on the shelf;
- Clonazepam (a seizure and panic disorder medication) had nine extra doses on the shelf; and
- Oxazepam (sedative) had 13 extra doses on the shelf.

14. Record review of the facility policy titled,"Pharmacy Performance Improvement (PI) Activities," reviewed 07/11 showed the following direction:
- PI (facility term for Quality Assessment / Performance Improvement or QA/PI) activities focused on functions important to the health and safety of patients.
- Important functions included those that may put patients at risk of serious consequence or deprive them of substantial benefit due to care not provided.
- The Pharmacy shall monitor objective, measurable data that show the presence or absence of critical structures or processes.
- An evaluation of the care provided will include examination of the data for patterns and trends that signal opportunities to improve processes.
- The facility will act on the evaluation and give the highest priority to improve processes with the greatest potential to improve patient care.

Record review of the "Pharmacy Department, Fourth Quarter 2013 PIRM (the facility name for QA/PI was Performance Improvement/Risk Management or PIRM) Report," dated 01/08/14 showed the following:
- Pharmacy staff monitored the accuracy of Omnicel filling; the accuracy of Omnicel machines; the Computer Physician Order Entries; Narcotic Count Accuracy; and Medical Chart Medication Orders.
- Each of the Pharmacy PIRM activities were reported for seven consecutive quarters.
- None of the Pharmacy PIRM activities were reported as low enough to cause concern or remedial action (Omnicel fill threshold was 0% and results were 0.1% and 0.2%; Accuracy of Omnicel machines threshold was 100% and results were 85% and 86%; Narcotic Counts were continuously reported as 100%).
- None of the Pharmacy studies involved review of processes, areas, or systems that could uncover potential drug thefts which could in turn have negative impact on patient care.

15. During an interview on 05/21/14 at approximately 1:30 PM Staff G, Director of Pharmacy again confirmed the following:
-The facility QA/PI program was called PIRM and he was not a member of the PIRM committee.
- He submitted a quarterly Pharmacy PIRM report to his supervisor, Staff J, VP-O, who served as Chairman of the PIRM Committee.
-The Pharmacy PIRM reported on topics selected by Staff G.
- He had selected the study topics three years ago and had not changed them even though the results for the last seven quarters showed no statistically significant problems for him to address.
- No targeted Pharmacy PIRM study for security of drugs stored inside the Pharmacy was undertaken to review and analyze preventative measures even after reported losses of 136 doses of a habit forming drug (Tramadol) in 07/13.
- He had not established and maintained Pharmacy policy that identified any non-controlled drugs that may be habit forming or otherwise be problematic that would cause subsequent targeted random monitoring or counting of those drugs.
- He had not established and maintained policy that directed Pharmacy staff to track the movement of drugs through the facility which would consequently cause monitoring and/or counting of more than controlled substances.
- No Pharmacy policies and procedures were instituted for routine monitoring (counts or audits) of the 2200 drugs in the Pharmacy because counting or auditing "would take too much time."
- No Pharmacy policies or procedures were developed to direct monitoring of even a small sample of the 2200 drugs (such as random, periodic selection of 10-15 drugs to count and monitor for shortages and identification of theft of non-controlled substances).
VIOLATION: POLICIES - NUTRITION Tag No: C0279
Based on observation and interview, facility dietary staff failed to clean and maintain the kitchen floor to preserve a sanitary environment in accordance with the US Food and Drug Administration (FDA) 2013 food code. This deficient practice and failure to follow nationally recognized FDA standards of environmental sanitation for food storage and preparation areas had the potential to initiate and spread of food borne illness to all visitors, staff and patients. The facility census was 16.

Findings included:

1. Record review of the US Department of Health and Human Services, Public Health Service, Food and Drug Administration, 2013 Food Code directed the following:
- Chapter 4-601.11(C) Nonfood contact surfaces of equipment shall be kept free of an accumulation of dust, dirt, food residue and other debris.
- Chapter 4-602.13 Nonfood contact surfaces of equipment shall be cleaned at a frequency necessary to preclude accumulation of soil residues.
- Chapter 6.201.11 Floors, floor coverings, walls, wall coverings and ceilings shall be designed constructed and installed so they are smooth and easily cleanable.

2. Review of the document titled Cleaning Procedure for Floors in Dietary Department, last reviewed on 07/13, gave a procedure for dust and wet mop with a sanitizing solution, and stated that housekeeping was "responsible for shower scrubbing the floor and waxing it."

3. Review of an undated document titled Daily Dishroom Checklist showed the kitchen floors were to be scrubbed daily.

4. Observation in the facility kitchen on 05/20/14 at 2:00 PM through 05/21/14 at 9:00 AM showed the vinyl floor to be stained from rubber mats and heavy use, with soils accumulated in corners, along cove base, around footing of equipment and floor-mounted electrical outlet boxes, indentations from wheel marks and numerous scarred, pockmarked areas where heavy equipment once sat. Specific examples and locations are as follows:
- Seven of nine heat weld seams (plastic seal between the edges of vinyl flooring) were split in several places and caused cracks in the contiguous floor surface where food crumbs and debris had accumulated.
- Dark yellow-stained floor in the dishwasher room, more stained under the large rubber floor mat.
- Splashed food debris from the pre-wash sink accumulated under the drain tray and three basin sink had blackened the floor and corners around the perimeter of the room.
-Dark yellow and brown stains under the toe kick of two immovable (fixed) cabinets used for food prep and equipment (tray) storage.
- Yellow stain on the floor around water treatment cylinder.
- Round yellow and black ring stains from foot pads of relocated equipment.
- Black and yellow stains around footing of all door jambs, corners, cooking equipment and food preparation tables.
- Brown stain around the base of a stainless steel drain box where tilt skillet and soup urn were located.
- Brown stains on and around the bases of floor-mounted quad electrical outlet boxes located under two of the prep tables and the griddles, and behind the stack ovens in the center of the kitchen.

5. During an interview on 05/20/14 at 2:00 PM, Staff U, Registered Dietician/ Food Service Director stated that housekeepers were assigned to shower-scrub (scrub machine that washes and dries floor in one pass) and wax the floor, but they had not done so in a long time. She stated that dietary staff cleaned the floor each evening after the last meal was served. She stated that her documents showed the last time housekeepers shower scrubbed the kitchen floor was 11/23/12.

6. During an interview on 05/21/14 at 3:00 PM, Staff V, Housekeeping Director, confirmed that the kitchen floor were assigned as a housekeeping responsibility, however they had not been in there for some time. She stated that Dietary staff have been cleaning it themselves because usually there are no housekeepers on site when the kitchen is not functioning. She stated that her staff of housekeepers were responsible for cleaning offices in seven other medical buildings daily, so they don't spend a lot of time at the hospital and were usually gone to the other buildings by the time the kitchen had finished serving food.
VIOLATION: AGREEMENTS - LIST OF SERVICES Tag No: C0291
Based on record review and interviews the facility failed to ensure a complete list of services provided under contract or agreement and failed to include the nature and scope of those services provided for seven of seven contracts listed. This deficient practice places the safety of all staff and patients at risk. The facility census was 16.

Findings included:

1. Review of the facility list of contracts showed seven contracts or service agreements. There was no indication of the nature or scope of those services provided for seven of seven contractors.

2. Review of 12 service agreements and contract files showed three agreements for Telemedicine (use of medical information exchanged from one site to another via electronic communications) related services, one agreement for audiology (studies of hearing, balance, and related disorders) service and one agreement for reference laboratory (laboratory owned and operated by an organization outside the facility or physician practice) services not included on the facility contract list.

3. During an interview on 05/20/14 at approximately 2:00 PM, Staff BB, Administrative Assistant, stated that the facility list of contracts she provided was the only list of contracts the facility maintained.

4. Review of the hand written list of clinical contractors provided by Staff A, Chief Executive Officer (CEO), showed seven clinical contractors and included additional agreements for Pathology (study of disease) and Physician services not included on the facility maintained list.

5. During an interview 05/21/14 at approximately 11:45 AM, Staff A, CEO, stated that the list of contracts provided by Staff BB was the only list of contracts and service agreements maintained by the facility. He stated that the list was not all inclusive and that the facility had a lot more patient service related contracts they had not thought to include on the list. Staff A stated he did not know exactly how many patient service contracts the facility had.