HospitalInspections.org

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Based on observation, document review, interview and review of hospital policy and procedures, the hospital failed to ensure that pharmaceutical services including sterile compounding, controlled substance accountability, and supervision and coordination of programs and activities were delivered.

Failure to deliver and maintain pharmaceutical services at acceptable standards of practice risks poor patient outcomes, harm, and death.

Findings included:

1. Failure to ensure staff supervision of safe sterile compounding practices, controlled substance accountability and coordinating pharmacy activities to ensure patient own medications or unusable mediations are not available for use.

Cross-reference: A0491

2. Failure to maintain accurate records for controlled substance accountability and destruction.

Cross-reference: A0494

3. Failure to ensure sterile compounding services meet professional practice standards in compliance with United States Pharmacopeia Chapter 797 standards.

Cross-reference: A0501

4. Failure to perform monthly unit inspections of clinical areas to ensure outdated or unusable medications are not available for patient use.

Cross-reference: A0505

Due to the scope of the deficiencies cited under 42 CFR 482.25, the Condition of Participation for Pharmaceutical Services was NOT MET.
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Based on observation, document review, interview, and review of hospital policy and procedure, the hospital failed to ensure pharmacist leadership responsibilities were conducted according to regulatory requirements and accepted standards of practice.

Failure to ensure staff supervision of safe sterile compounding practices risks patient safety.

Findings included:

1. Document review of the hospital policy and procedure titled, "Procurement of Medications," policy number P042, last reviewed 12/19/19, showed that the selection, distribution, and safe and effective use of medications at the hospital shall be established by the effort of the Pharmacy Department Director, Pharmacy Department, medical staff, and hospital administration. The Pharmacy Director and staff pharmacists should be responsible for the maintenance, supply, and assuring that drugs are properly stored and labeled.

2. Document review of Simplifi 797 task sheet dated 03/30/21 showed 15 grossly overdue tasks from November 2020 to present without resolution. At the time of the review, a pharmacy technician (Staff #301) did not know who was responsible for overseeing and ensuring all assigned tasks were completed or resolved.

3. Document review of the hospital's Compounding Aseptic Isolator (CAI) on-site certification reports for the period October 2019 to October 2020 showed that the viable biological sample report dated 10/14/20 showed growth found in the segregated compounding room for two cultures including mold, a highly pathogenic organism.

4. On 03/30/21 between 1:30 PM and 2:30 PM, Investigator #1 and #3 interviewed a staff pharmacist (Staff #307) about the hospital sterile compounding program. When asked by the investigators who was responsibile for the overall oversight of the program, Staff #307 stated currently, no one is directly responsible. Staff #307 stated that previously, he was in charge of the program, but the previous Director assumed those responsibilities soon after his hire. Investigator #3 asked Staff #307 who reviewed the Simplifi 797 tasks dashboard to ensure items are completed. Staff #307 again stated that no one is specifically responsible but acknowledge that he received alerts when tasks were not completed.

Investigator #3 asked Staff #307 if he was aware of any positive growth cultures in the segregated room from October 20. Staff #307 stated that he was unaware of the positive culture and did not know if any investigation or remediation such as extra cleaning was performed.

5. On 03/31/21 at 11:45 AM, Investigator #1 and #3 interviewed the Director of Pharmacy (Staff #305) about pharmacy operations and management. Staff #305 stated that he assumed interim responsibilities as pharmacy director last month with the demise of the previous director. Previously, Staff #305 had worked at the hospital as a staff pharmacist. When asked by the investigator who was responsible for the sterile compounding program, Staff #305 stated he was currently responsible. When asked it he was aware of the positive culture for mold in the segregated compounding room, Staff #305 stated he had not heard anything.
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Based on document review, interview, and review of hospital policy and procedure, the hospital failed to follow its policy for controlled substance management and accountability.

Failure to maintain accurate records for controlled substances distribution and accountability risks medication errors and potential diversion.

Findings included:

1. Document review of the hospital policy and procedure titled, "Controlled Substances-Purchasing and Distribution," policy number P052, last revised 12/20/19, showed that accounting of controlled drugs will be done in accordance with all federal and state laws and standards of professional practice. A transaction record for all controlled substances will be maintained by the hospital.

2. On 04/01/21 between 9:00 AM and 10:30 AM, Investigators #1 and #3 toured and inspected the East Campus Pharmacy with a staff pharmacist (Staff #304). The observation showed:

a. The pharmacy had a controlled drug inventory record binder and a separate transaction "ledger style" book for controlled substances. At the time of the observation, Investigator #3 asked Staff #304 why there were two binder/books for controlled substances. Staff #304 stated she was unsure why, but the ledger style book primarily was used to record delivery and removal/receipt of controlled substances to and from the inpatient chemical dependency unit.

b. Investigator #3 observed an unmarked box which contained twenty 2 mg injectable lorazepam and 92 tablets of diazepam 5 mg tablets with an associated controlled substance inventory destruction sheet.

c. Investigator #3 observed a box marked "Expired Meds (Controlled Substances)" which contained 212 suboxone 8 mg tablets and 226 suboxone 2 mg tablets. There was no associated substance inventory destruction sheet located within the box.

3. A review of the controlled substance inventory destruction sheet balance showed that 92 diazepam 5 mg tablets were transferred from the current available inventory on 02/22/21. The current available controlled substance inventory sheet for diazepam 5mg tablets showed that the transfer occurred on 05/01/20 (8 months and 21 days earlier than recorded on the inventory destruction sheet).

4. A review of the current available controlled substance inventory sheet for suboxone 8 mg showed that 212 were pulled for destruction on 03/05/21. Similarly, the current available controlled substance inventory sheet for suboxone 2 mg tablets showed that 226 tablets were pulled for destruction on 03/05/21.

5. At the time of the review, Investigator #3 interviewed the staff pharmacist (Staff #304) about the controlled substance items awaiting destruction. Staff #304 was unaware and had no explanation for the discrepancy in documenting the dates of transfer for the diazepam. The staff pharmacist did not know why the controlled substance inventory destruction sheet for the two dosage forms of Suboxone had not been prepared yet.

6. On 03/31/21 between 1:50 PM and 2:30 PM, Investigators #1 and #3 interviewed the Director of Pharmacy (Staff #305) about controlled substances management. Staff #305 stated there is a perpetual inventory of the controlled substance in the main pharmacy and that once a week a separate inventory count of all controlled substances is conducted with two staff.

7. Document review of the main pharmacy "CII Safe Inventory" signature sheet showed that for the week of 02/11/21, no weekly inventory count was recorded. The week of 04/01/21 showed only one set of initials recorded.

8. On 04/02/21 between 10:00 and 11:00 AM, Investigator #1 and #3 interviewed the pharmacy buyer (Staff #306) about the controlled substance procurement, accountability, and discrepancy reporting processes. Staff #306 stated that she frequently assists in the weekly CII Safe inventory. When asked about the absence of initials on 02/11/21, Staff #306 stated she was off that week and did not know why the weekly inventory count was not documented. Staff #306 stated that she had forgot to document her initials for the week inventory of 04/01/21 but it had been completed.
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Item #1 - Antiseptic Hand Hygiene & Protective Wear for Sterile Compounding Activities

Based on observation, interview, and review of hospital policy and procedures, the hospital failed to ensure staff performed antiseptic hand hygiene and correct garbing practices in the preparation of sterile intravenous medications for 2 of 2 observations.

Failure to perform proper hand hygiene and garbing when preparing sterile intravenous medications risks contamination of the products and possible transmission of infectious diseases to patients.

Findings included:

1. Document review of the hospital policy and procedure titled, "Pharmaceutical Compounding: Accessing Hand Hygiene and Garbing Related Practices of Compounding and Personnel Metrics," policy number P085A, last reviewed 10/09/17, showed that staff will wash hands up to the elbow with soap and warm water for at least 30 seconds. Hand hygiene includes removing debris under the fingernails and drying hands thoroughly with a wipe. After drying hands, staff must apply an antimicrobial rub with persistent activity. The product AVAGARDD will be used. Staff will not wear cosmetics, makeup or jewelry on their hands, neck or head.

2. On 03/30/21 between 9:50 and 10:30 AM, Investigators #1, #3, and #12 observed a Pharmacy Technician (Staff #301) perform antiseptic hand hygiene and the garbing process prior to preparing a sterile intravenous medication. The observation showed:

a. Staff #301 was wearing a metal necklace.

b. Staff #301 did not perform hand hygiene for the minimum 30 second period required.

c. Staff #301 did not attempt to remove any debris from under her fingernails as the hand hygiene sink did not have nail picks available for the staff member to use.

d. Staff #301 did not apply the antimicrobial rub AVAGARDD after drying her hands.

e. Staff #301 did not disinfect her hands after touching the door handle to enter the segregated sterile compounding room.

f. Staff #301, upon entering the segregated sterile compounding room, put on a white lint free jacket hanging on a hook. Investigator #3 observed there were 2 additional white lint-free jackets hanging on hooks and 5 additional white lint free white jackets hanging inside a closet within the segregated sterile compounding room.

3. On 03/30/21 between 9:50 AM and 10:30 AM, Investigator #3 interviewed Staff #301 about the number of white lint free jackets within the segregated sterile compounding room. Staff #301 stated that the white jackets hanging on the hooks were pharmacy staff personnel and the jackets hanging in the closet were the housekeeping staff. Investigator #3 asked Staff #301 when the jackets should be changed? Staff #301 stated that the white lint-free jackets could be reused during their duty shift but then should be disposed of at the end of the work shift. When asked why there were so many additional used white jackets, Staff #301 did not know why.

4. On 03/30/21 between 3:25 PM and 3:45 PM, Investigators #1 and #3 observed a Pharmacy Technician (Staff #302) perform antiseptic hand hygiene and garbing prior to preparing a sterile intravenous medication. The observation showed:

a. Staff #302 did not perform hand hygiene for the minimum 30 second period required.

b. Staff #302 did not attempt to remove any debris from under her fingernails as the hand hygiene sink did not have nail picks available for the staff member to use.

c. Staff #302 did not apply the antimicrobial rub AVAGARDD after drying her hands.

Item #2 - Aseptic Compounding Technique

Based on observation, interview, and review of hospital policy and procedures, the hospital failed to ensure staff maintain aseptic manipulation skills while performing sterile compounding for 2 of 2 observations.

Failure to maintain aseptic technique while preparing sterile intravenous medications risks contamination of the products and possible transmission of infectious diseases to patients.

Findings included:

1. Document review of the hospital policy and procedure titled, "Sterile Compounding," policy number P085A, last revised 10/30/20, showed that compounding personnel are adequately skilled and trained to maintain or achieve sterility of compounded products in primary engineer control devices and protect compounding environments from contamination.

2. On 03/30/21 between 9:50 AM and 10:30 AM, Investigators #3, and #12 observed a Pharmacy Technician (Staff #301) prepare a sterile intravenous medication. The observation showed:

a. Staff #301 did not gather and place the required items (needles, syringes, medication vial) for the preparation of the sterile intravenous product in the ante chamber and close the ante chamber door before moving the items into the main mixing area with the laminar flow air. Instead, the pharmacy technician removed the packaging and assembled the items (needle, syringe, medication vial cover) in the Compounding Aseptic Isolator (CAI) ante chamber while the ante chamber door remained open to the outside air.

b. Staff #301, while wearing sterile gloves, placed her hands in the CAI sleeve gauntlet which had "non-sterile gloves" attached to it in the main mixing chamber instead of sterile gloves as required by USP 797.

c. After moving the assembled items into the main mixing chamber, Staff #301 "dabbed" the top of the medication vial with an alcohol swab instead of allowing an adequate contact time for disinfection prior to accessing the vial contents.

d. During the accessing of the medication vial, Staff #301 partially blocked the flow of the laminar flow air with their hand.

e. At the time of the observation, Investigator #3 asked Staff #301 about the direction of laminar air flow in the main mixing chamber. Staff #301 stated the air was flowing directly toward her instead of the actual flow which was flowing from the ceiling downward.

3. On 03/30/21 between 3:25 PM and 3:45 PM, Investigators #1 and #3 observed a Pharmacy Technician (Staff #302) prepare a sterile intravenous medication. The observation showed that Staff #302 partially blocked the flow of the laminar flow air with their hand while accessing the medication vial in the main mixing chamber. The investigator then asked Staff #301 why non-sterile gloves were attached to the gauntlet sleeve instead of the required sterile gloves. Staff #301 stated the sterile gloves the hospital were using did not stretch over the gauntlet ring, popped off or tore too easily and had to be replaced more often than the nonsterile gloves.

Item #3 - Pharmacy Personnel Training and Competency Assessment of Sterile Compounding

Based on interview and record review, the hospital failed to ensure that pharmacy personnel staff who are involved in sterile compounding receive competency training and skills assessments as evidenced by absence of annual training documentation for 8 of 8 personnel files requested for review (Staff #1201, #1202, #1203, #1204, #1205, #1206, #1207, #1208).

Failure to ensure that staff have the proper training and competency to perform sterile compounding risks contamination of sterile products and possible transmission of infectious diseases to patients.

Reference: United States Pharmacopeia <797> Pharmaceutical Compounding - Sterile Preparations Appendix I. Principal Competencies, Conditions, Practices, and Quality Assurances That are Required in USP Chapter <797> states that "cleaning and disinfecting procedures performed by other support personnel shall be thoroughly trained in proper hand hygiene, and garbing, cleaning, and disinfecting procedures by a qualified aseptic compounding expert. Support personnel shall routinely undergo performance evaluation of proper hand hygiene, garbing, and all applicable cleaning and disinfecting procedures conducted by a qualified compounding expert."

Findings included:

1. Document review of hospital policy titled "Sterile Compounding," policy P085, revised 10/20, showed that the hospital must complete and maintain records of annual competency evaluations of all pharmacists and technicians who prepare and dispense compounded sterile products that include but are not limited to: garbing and gloving, cleaning and disinfecting, and aseptic technique. The policy showed that competency evaluation in proper hand hygiene, garbing, and aseptic practice is performed initially and whenever media fill testing is performed; at least annually. The policy also stated that the sterile compounding services will maintain compliance with United States Pharmacopeia (USP) Chapter <797> Standards.

2. On 03/31/21 at 2:30 PM, Investigator #12 reviewed pharmacy staff training documents with the pharmacy buyer (Staff #1209). Record review showed Staff #1202, #1205, #1206, #1207 and #1208 completed media fill testing in August 2020, Staff #1201 and #1204 completed media fill testing in September 2020, and Staff #1203 completed media fill testing in October 2020. Document review showed that 0 of 8 competency evaluations in hand hygiene, garbing and aseptic practice were performed during media fill testing as required per hospital policy (Staff #1201, #1202, #1203, #1204, #1205, #1206, #1207, and #1208).

3. The investigator interviewed Staff #1209 at the time of the document review. Staff #1209 stated that pharmacy staff use the Simplifi 797 system for education, and they have used the system for over two years. Staff #1209 stated that the pharmacy manager or director assigns the modules to staff as part of their required education. Staff #1209 stated that there are annual competency modules and checklists for aseptic technique, sterile compounding fundamentals, and cleaning and disinfection available on Simplifi, but the manager has never assigned them to the staff.

Item #4 - Environmental Services Staff Specialty Training for Cleaning and Disinfecting of Segregated Compounding Area

Based on interview and record review, the hospital failed to ensure that environmental services staff received specialty training and skills assessments for cleaning and disinfecting the segregated compounding area as evidenced by absence of annual training documentation for 3 of 3 personnel files requested for review (Staff #1210, #1211, #1212).

Failure to ensure that staff have the proper training and competency to perform cleaning and disinfecting of the segregated compounding area risks possible transmission of infectious diseases to patients and staff.

Reference: Unites States Pharmacopeia <797> Pharmaceutical Compounding - Sterile Preparations Appendix I. Principal Competencies, Conditions, Practices, and Quality Assurances That are Required in USP Chapter <797> states that "cleaning and disinfecting procedures performed by other support personnel shall be thoroughly trained in proper hand hygiene, and garbing, cleaning, and disinfecting procedures by a qualified aseptic compounding expert. Support personnel shall routinely undergo performance evaluation of proper hand hygiene, garbing, and all applicable cleaning and disinfecting procedures conducted by a qualified compounding expert.

Findings included:

1. Document review of hospital Policy titled "Cleaning of IV Room in Pharmacy," policy number EVS-047, reviewed 10/17, showed that environmental services (EVS) staff will put on hospital issued scrubs and follow proper sanitizing protocol before entering the IV room. Staff will disinfect and mop the pharmacy IV room daily and clean all surfaces monthly. When finished cleaning the IV room, staff will initial the daily cleaning log.

2. Document review of hospital policy titled "Sterile Compounding," policy number P085, revised 10/20, showed that the sterile compounding services will maintain compliance with United States Pharmacopeia (USP) Chapter <797> Standards.

3. On 03/30/21 at 10:30 AM, Investigators #3 and #12 toured the pharmacy's sterile compounding room. Observation showed that the tile floor was visibly soiled, especially in the high traffic areas. Investigator #3 used an antibacterial wipe and easily wiped dark residue off the ground. Upon exiting the sterile compounding room, Investigators #3 and #12 observed a clipboard with a paper titled, "Daily/Monthly Housekeeping IV Room Cleaning Log." Investigator #12 observed that no month or year was written on the document, and there were no initials on the boxes after numbers 29 and 30. Investigator #12 obtained a copy of the document.

4. On 03/30/21 at 1:30 PM, Investigators #3 and #12 interviewed the EVS Manager (Staff #1213) and the EVS staff (Staff #1212) assigned to clean the pharmacy IV room on 03/30/21. When asked to describe her cleaning process for the IV clean room, Staff #1212 was unable to describe the cleaning process and stated that she had cleaned the pharmacy, but she did "not go into the IV room" because she had "not been trained."

5. On 03/31/21 at 11:00 AM, Investigators #3 and #12 returned to the sterile compounding room and observed the "Daily/Monthly Housekeeping IV Room Cleaning Log." The investigators observed that the information for the month and year had been filled out, and Staff #1212 had documented their initials on the 29 and 30, indicating they had donned the appropriate attire, emptied the garbage, and mopped the floor.

6. On 04/02/21 at 8:30 AM, Investigator #12 reviewed personnel records of three EVS staff with the EVS Manager, (Staff #1213). Record review showed that on 12/12/19, Staff #1210 signed the forms titled, "Competency of the Cleaning of Pharmacy" and "<797> Pharmaceutical Compounding - Sterile Preparations Appendix V. Sample Form for Assessing Cleaning and Disinfection Procedures." Document review showed the staff initials "C.S." next to the daily and monthly tasks, but there was no signature, printed name or date for listed as a qualified evaluator. Document review showed that Staff #1211 and #1212 had not signed a competency for cleaning the pharmacy IV room since 2014.

7. Investigator #12 interviewed the EVS Manager during the document review. Staff #1213 stated that all EVS staff were trained to clean the pharmacy IV room and compared it to cleaning a sterile operating room environment. Staff #1213 confirmed the investigator's findings that support personnel cleaning the pharmacy IV room did not undergo routine performance evaluation of proper hand hygiene, garbing, cleaning and disinfecting procedures per hospital policy.

Item #5 - Cleaning and Maintenance of Compounding Aseptic Isolator (CAI)

Based on observation, interview, and review of hospital policy and procedure, the hospital failed to followed hospital policy to ensure that the Compounding Aseptic Isolator (CAI) was cleaned and maintained.

Failure to clean and maintain the CAI according to hospital policy risks contamination of sterile products and possible transmission of infectious diseases to patients.

Findings included:

1. Document review of the hospital policy and procedure titled, "Sterile Compounding," policy number P085, last revised 10/30/20, showed that equipment used in the production of sterile products are cleaned, calibrated, and maintained in accordance with the manufacturer's recommendations and USP standards. Pre-filters of the primary engineering control (CAI) are changed monthly or per manufacturer's recommendations to ensure optimum life of the CAI's HEPA filer. Documented maintenance is required.

2. On 03/30/21 between 9:50 AM and 10:30 AM, Investigators #1, #3 and #12 inspected the segregated compounding room and CAI. The observation showed:

a. There was visible dust on top of the CAI.

b. One of the two prefilters located on top of the CAI was markedly covered with a thick layer of gray colored dust.

c. The leg stands of the CAI had visible dust on them with a dried visible liquid material on them.

3. Document review of the Simplifi 797 environmental task log for the CAI prefilter change log for the past year showed that the filter was checked every 3 months with the last filter check completed on 03/13/21.

4. On 03/30/21 at 1:45 PM, Investigator #1 and #3 interviewed a pharmacy technician (Staff #302) about the checking of the CAI's prefilter. Staff #302 stated that the prefilter is checked every month. When asked where she documents that check, she did not know where it was recorded. Investigator #3 asked her who changes out the filter if they are dirty. Staff #302 stated that she is not sure who replaces the filter, that perhaps it was the company that certifies the CAI.

5. On 03/31/21 at 11:30 AM, Investigator #12 interviewed the two biomedical maintenance engineers (Staff #308 and Staff #309) about the CAI. Staff #308 stated they "don't enter the pharmacy, and they're not sure who handles the pharmacy equipment". Staff #309 stated that they don't change the prefilters for the CAI.

6. On 03/31/21 at 2:37 PM, Investigator #12 interviewed a staff pharmacist (Staff #307) about who changes the prefilters on the CAI. Staff #307 stated that biomedical used to change the old filter for the hood but does not know who changes the filter now.
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Item #1 - Patient Owned Medications

Based on observation, interview, and review of hospital policy and procedure, the hospital failed to ensure that patient own medications, medications which are discontinued, outdated, contaminated, improperly stored or labeled drugs were not available for patient administration.

Failure to ensure medication storage areas are devoid of outdated or otherwise unusable medications places patients at risk for receiving medications with compromised sterility, integrity, or stability.

Findings included:

1. Document review of the hospital policy and procedure titled, "Patient's Own Medication," policy number P061, last revised 12/23/19, showed that medication that has been brought in by patients at admission will be sent home with the family. In the event, the medications cannot be sent home, the medications will be placed in a bag labeled with the patient's name and sent to the Pharmacy. Medications will be returned to the patient at discharge.

2. Document review of hospital policy and procedure titled, "Unusable and Outdated Drugs," policy number P096, last revised 09/16/20, showed that all discontinued patient drugs shall be returned to the pharmacy department for proper disposal. Any medication brought in by a patient and not claimed within 30 days after discharge will be returned to the manufacturer or discarded in containers for pickup or destruction.

3. On 04/01/21 at 9:28 AM, Investigator #12 and the Director of Risk and Regulatory Compliance (Staff #1218) toured the hospital's East Campus chemical dependency inpatient unit medication room with the charge nurse (Staff #1219). During the tour, the investigator observed two bottles of Vivitrol 380 mg suspension in the locked medication refrigerator. The observation showed:

a. The first bottle of Vivitrol 380 mg suspension belonged to Patient #1201. Patient #1201 was admitted to the facility on 01/07/21 and discharged to a residential treatment facility on 01/17/21. The medication was not returned to the pharmacy for proper storage or disposal per hospital policy.

b. The second vial of Vivitrol 380 mg suspension was labeled for Patient #1202. Patient #1202 was admitted to the facility on 03/17/21 and left the hospital against medical advice on 03/19/21. The medication was not returned to the pharmacy for proper storage or disposal per hospital policy.

3. The investigator interviewed the charge nurse at the time of the observation. Staff #1219 stated that since the patients were tribal members, the hospital did not return the medications to them, but instead the pharmacy would send the medication back to the tribal pharmacy. When asked how this occurred, Staff #1219 was unable to describe the process.

4. On 04/01/21 between 10:30 AM and 11:00 AM, Investigators #1 and #3 inspected the chemical dependency inpatient unit's medication room with the charge nurse (Staff #303). Investigator #3 asked Staff #303 about where patient own medications are stored. Staff #303 stated that they are sent home with the patient's family or sent to the pharmacy except for "suboxone" (a controlled substance used to treat substance abuse) which is kept on the unit because the pharmacy won't take it. Staff #303 showed the investigators a locked cabinet in which there were five prescription labeled containers of Suboxone. Staff #303 confirmed that none of the five containers of suboxone were for current patients admitted on the unit.

Item #2 - Monthly Unit Inspections

Based on observation, interview, and document review, the hospital failed to ensure that pharmacy personnel perform monthly unit inspections of all drug storage areas in the hospital and hospital associated clinics.

Failure to conduct medication storage area inspections places patients at risk for receiving medications with compromised sterility, integrity, or stability.

Findings included:

1. Document review of the hospital policy and procedure titled, "Unit Inspection," policy number P024, revised 12/2019, showed that pharmacy personnel will conduct monthly inspections of all drug storage areas in the hospital and hospital pharmacy associated clinics.

2. Review of the Pharmacy Floor Inspections dated November 2020 to March 2021 showed:

a. Emergency Department - missing 11/20, 12/20, 01/21, 02/21, 03/21

b. Materials Management - missing 11/20, 12/20, 01/21, 02/21

c. Imaging - missing 01/21, 02/21

d. Chemical Dependency Unit - missing 11/20, 12/20, 01/21, 02/21

e. Wound Clinic - missing 11/20, 12/20, 01/21, 02/21

f. Hoquiam Clinic - missing 11/20, 12/20, 01/21, 02/21

g. Family Medicine & Peds - missing 11/20, 12/20, 01/21, 02/21

h. Internal Medicine - missing 11/20, 12/20, 01/21, 02/21

i. Montesano - missing 11/20, 12/20, 01/21, 02/21

3. On 03/31/21 at 2:26 PM, Investigator #12 reviewed the Pharmacy Floor Inspections book with the Pharmacy Buyer (Staff #1209). Staff #1209 stated that the pharmacy technicians were all assigned units to inspect, but one staff member had been out on medical leave for several months, and their units had not been reassigned to others until recently. Staff #1209 confirmed the Investigator's findings that the monthly inspections were missed for the areas identified above.

4. On 04/01/21 at 9:00 AM, Investigators #3 and #12 reviewed the East Campus Pharmacy monthly self-inspection sheets with Staff Pharmacist (Staff #304). A review of the monthly self-inspection sheets showed one sheet dated 03/29/21 with the next sheet dated 12/14. When asked by the investigators where the most recent sheets were located, Staff #304 could not find them but suggested they may have been sent to the main campus of the hospital.

5. On 04/01/21 between 9:00 AM and 10:30 AM, Investigator #3 and #12 inspected the East Campus Pharmacy for expired medications. The investigators found nine 50 ml intravenous bags of normal saline with an expiration date of 06/20.
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