The information below comes from the statement of deficiencies compiled by health inspectors and provided to AHCJ by the Centers for Medicare and Medicaid Services. It does not include the steps the hospital plans to take to fix the problem, known as a plan of correction. For that information, you should contact the hospital, your state health department or CMS. Accessing the document may require you to file a Freedom of Information Request. Information on doing so is available here.

PEACHEALTH ST JOHN MEDICAL CENTER 1615 DELAWARE STREET LONGVIEW, WA 98632 June 20, 2016
VIOLATION: PHARMACEUTICAL SERVICES Tag No: A0490
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Based on observation, interviews and document review, the hospital failed to ensure patient safety related to the quality of pharmaceutical services.

Failure to do so creates risk to patient safety and protection from harm.

Findings:

As evidenced by deficiencies identified A0490, A0493, A0501, A0502 and A0508 in this report, the cumulative effects demonstrated that the hospital failed to ensure patient safety by implementation of timely corrections in pharmacy facility sites and clinical operations within the facility sites over a period of 20 months.

Due to the scope and severity of deficiencies cited under 42 CFR 482.25, the Conditions of Participation for Pharmaceutical Services are NOT MET.
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VIOLATION: PHARMACY PERSONNEL Tag No: A0493
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Based on facility document review and interview, the facility failed to demonstrate that the number of pharmacists-in-charge and scope of authority was adequate and that there were adequately stable reporting relationships to act on addressing needs.

Failure to do so creates risk that quality and safety measures, including for those emergency services, are not adequately provided or ensured as provided.

Findings:

1. In review of facility job description titled "Director Pharmacy Services" (Modified 4/25/2016) it stated that s/he reported to the System Vice President for Quality. On the system organizational chart dated 2/11/2016 there was not a job title of System Vice President for Quality. Additionally, the first sentence of the job summary stated, "Directs, controls and is accountable for Pharmacy." The job description further identified accountabilities including, but not limited to, those for patient safety. The job description did not specifically include actions through participation in the Pharmacy and Therapeutics Committee.

2. a. On 6/15/2016 at 10:30 AM Surveyor #1 and Technical Advisor #1 interviewed the Director of Pharmacy (Staff Member #5). During the interview the Director stated that s/he was not aware of the direct reporting relationship s/he had to the (Interim) Vice President of Professional Services (Staff Member #12) per the organizational chart provided and dated 6/13/2016. Furthermore, s/he stated s/he had not been kept up-to-date about past changes in reporting relationships.

At 11:00 AM that day s/he related that s/he was aware that the organization was non-compliant with USP 797 and that she had worked consistently with different administrators since 2014 (including an emergency capital budget request in the fall of 2014) to try to secure compliance. The funding for the remodel was approved based on the business plan dated June 11, 2015 that the Director of Pharmacy developed. (In 2015, s/he wrote 2 other business plans that included remodeling of pharmaceutical compounding area.)

In a subsequent interview on 6/17/2015 at 11:15 AM, s/he was asked about how many different individuals she reported to since January 2014. S/he identified 6 different individuals. Four of the six had since left the organization. S/he also stated that over time and regularly s/he attempted to communicate the seriousness of the need for compliance to various administrators. She also attempted to be informed of updates and timelines and noted that s/he had been omitted from inclusion in some key decision making and information gathering processes.

Additionally, s/he stated that s/he was the Pharmacist-in-Charge (while operating as the Director of Pharmacy) for pharmaceutical services at 2 hospitals (including the one being surveyed) located 45 minutes apart by vehicle. S/he related that the physical distance posed challenges for day-to-day supervision of onsite services.

b. On 6/17/2015 at 10:00 AM in an interview with the Chief Administrative Officer (Staff Member #13), s/he verified that as of June 30, 2015, the Pharmacy remodel at the hospital and the Outpatient Infusion Center (hazardous drug compounding area [HDC]) remodel were approved for funding. They were rank ordered #1 and #2, respectively in a document dated June 30th titled, "PeaceHealth Columbia Network FY15 Capital" (Approved as of 7/2/2015).

c. On 6/16/2016 1:30 PM in an interview with the Executive Vice President and Chief Financial Officer (Staff Member #15) who had been in her/his postion for 3 months, s/he stated that an intent existed to complete the pharmacy remodel but completion of conversion to a new electronic record ("Go Live") was given organizational priority. The electronic record conversion occurred in August 2015 and presented challenges (including general patient safety and pharmacy-specific) related to the conversion.

d. On 6/20/2016 at 11:30 AM during an interview with the System Vice President for Facilities, Safety and Security (Staff Member #14), s/he stated that during participation in a conference call in early January 2016, a system-level administrative decision was made to re-organize the pharmacy remodel process and timeline for compliance with USP 797 to occur at several hospital locations. According to the Director of Pharmacy (Staff Member #5), s/he found out about the timeline change later that month incidentally during a web-based meeting.

3. In review of the Pharmacy and Therapeutics Committee Meeting minutes from October 9, 2014 to May 19, 2016, they reflected busy workflows but did not include discussion of deficiencies from State Pharmacy Inspections in 2015. The content did not include information related to sterile compounding risk and/or possible adverse events related to non-adherence to USP 797. However, a new sterile compounding procedure was mentioned as approved in December 2015.
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VIOLATION: PHARMACIST SUPERVISION OF SERVICES Tag No: A0501
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Based on observation, review of policy and procedure and interview, the facility failed to ensure safe sterile compounding practices and preparation of sterile solutions, including labeling.

Failure to do so creates risk for patient harm including, but not limited to, illness and death.

Reference: United States Pharmacopeia [USP], 39 NF 34-General Chapter 797, Pharmaceutical Compounding - Sterile Preparation, Official from 05/01/2016.

Findings:

A. Antiseptic Hand Hygiene and Protective Wear for Sterile Compounding Activities

1. Per facility policy titled, "Sterile Compounding" (Policy # ANC-2551; Reviewed 12/15/2016) item 1.1.14. stated, "Compounding personnel are adequately skilled, educated, instructed and trained to adequately perform. . .the following activities: Perform antiseptic hand cleansing, Perform disinfection of non-sterile compounding surfaces, Select and don protective garb, Maintain and achieve sterility of compounded sterile preparations in ISO 5 environments . . ."

Item 1.1.6 stated that "personnel working in the IV [intravenous] room may be subject to quarterly quality assurance."

2. Review training records of pharmacy technicians (Staff Members #1, 6 and 7) indicated that staff completed initial training for sterile compounding. However, their compounded work products had not been subjected to ongoing quarterly quality assurance.

3. The following observations of a pharmacy technician (Staff Member #1) were noted by Surveyor #1 and Technical Advisor #1 on 6/16/2016 at 10:30 AM in the anteroom and sterile compounding space of the inpatient pharmacy:

a. Under nail cleaning: the staff member performed hand hygiene at the sink in the anteroom. However, s/he neglected to clean her/his nails first. Unpackaged nail cleaners were noted to be located at the head of the sink in standing water, available for use.

b. Location for donning sterile gloves: the staff member donned sterile gloves used for compounding in the anteroom, not as required in the sterile compounding area

c. Hand hygiene: the staff member did not use an alcohol-based product with persistent antimicrobial activity prior to donning sterile gloves (in the sterile compounding area)

d. Securing hair: the staff member did not ensure that her/his hair was fully secured under her/his hair cover prior to sterile compounding activities

e. Maintaining Sterility of Gloves: the staff member did not protect her/his hands from coming in contact with the hanging plastic barrier strips located between the anteroom and sterile compounding room, thereby potentially cross-contaminating them for use.

3. On 6/20/2106 at 1:45 PM the Pharmacy Manager (Staff Member #2) was informed of the above observation by Surveyor #1 and Technical Advisor #1. S/he acknowledged the observation.

B. Pharmacy Staff Cleaning and Disinfecting of Sterile Compounding Surfaces

Findings:

1. Per facility policy titled, "Sterile Compounding" (Policy #ANC-2551; Reviewed 12/15/2016) item 5.1.2 under "Biological Safety Cabinet (BSC) or Vertical Flow Hood" it stated, "The inside of the BSC should be cleaned . . . prior to compounding with . . . by pharmacy personnel. . . 5.1.2.3 The inside of the hood will be cleaned using side to side motions starting at the back of the hood working forward towards the front of the hood."

2. The following observation of Staff Member #1 was noted by Surveyor #1 and Technical Advisor #1 on 6/16/2016 at 10:30 AM in the sterile compounding space of the inpatient pharmacy:

The staff member did not clean the entire surface of the compounding deck (table) within the hood prior to and after use for sterile compounding. S/he only cleaned a portion of the table where medication and supply items had direct physical contact with the surface.

3. On 6/20/2016 at 1:45 PM, Surveyor #1 and Technical Advisor #1 informed the Manager of the main pharmacy (Staff Member #2) of the above observation. S/he acknowledged the observation.

C. Specially Trained EVS Staff Cleaning and Disinfecting Sterile Compounding Surfaces

Reference: USP 797, under "Personnel Training and Competency Evaluation of Garbing, Aseptic Work Practices, and Cleaning/Disinfection Procedures, . . . In the event that cleaning and disinfecting procedures are also performed by other support personnel (e.g. institutional environmental services, housekeeping), thorough training of proper hand hygiene, garbing, and cleaning and disinfection procedures shall be done by a qualified aseptic compounding expert. After completion of training, personnel shall routinely undergo performance evaluation of . . . conducted by a qualified aseptic compounding expert."

Findings:

1. On 6/16/2016 at 3:30 PM, Surveyor #1 and Technical Advisor #1 interviewed the Manager of Environmental Services (Staff Member #8) about environmental staff training and activities related to cleaning the pharmacy areas, particularly medication rooms and sterile compounding areas. S/he referenced facility policy titled, "Environmental Services" (Policy #0164; Reviewed 10/13/2015), particularly section 1.6 titled, "Patient discharge and Terminal Clean". The surveyor clarified the relevance of the reference since it did not include specific information about compounding environments and only referenced direct patient care environments.

When asked if there were any specific policies and procedures related to medication room or sterile compounding room cleaning, s/he stated there were not any besides quick reference sheets. S/he stated that environmental services staff were recently trained on donning and doffing personal protective equipment but that the content did not address required actions in pharmacy areas, including work in a hazardous drug environment. Additionally, there had been no training to date by a qualified aseptic compounding expert.

Subsequently, on 6/20/2016 at 12:30 PM the surveyor received 2 documents titled, "Garbing requirement for Clean Room" and "Cleaning By Housekeeping Staff". The documents were not formatted as approved procedures. The second document referenced the IV Ante room and "Monthly Cleaning Procedure Clean Room [compounding area]" which mentioned "Tops of Hoods". In the general information section of the form it stated, "You must wear the appropriate garb for entry into each room". It also stated to clean surfaces in the clean room (no further definition on specific surfaces and specific products) and then surfaces in the ante room then floors in the clean room and then floors in the ante room. It then stated, "Empty all trash".

There was no mention of how to select, handle or discard mop heads in the reference document. There was also not a reference of how to clean hazardous compounding areas compared to non-hazardous compounding areas.


2. On 6/17/2016 at 5:30 PM the surveyor interviewed an environmental services technician (Staff Member #9) who was responsible for cleaning the hazardous drug sterile compounding area and the connected medication room. The surveyor requested that s/he do a mock demonstration of cleaning in the Cancer Center area. The staff member stated that s/he cleaned the floor in the medication room and then (after special garbing) the clean room (hazardous drug compounding area). After ungarbing, s/he stated that s/he discarded waste from the hazardous compounding area in a biohazards waste container. However, s/he also stated that s/he placed the mop head used on the floors (including use in the hazardous drug compounding area) into the laundry for bulk laundering and re-use.

D. Staff Consent for Reproductive Health Risk Related to Compounding of Hazardous Drugs

Reference: USP 797, under "Hazardous Drugs As CSPs . . . Compounding personnel of reproductive capability shall confirm in writing that they understand the risks of handling hazardous drugs."

Findings:

On 6/16/2016 at 3:00 PM during a review of employee records, the Pharmacy Director (Staff Member #5) indicated to Surveyor #1 and Technical Advisor #1 that eligible compounding staff had not confirmed in writing that they understood the risks of handling hazardous drugs.

E. Air HEPA Filtration in the Controlled Room for Sterile Compounding

Reference: USP 797, under "ISO Class 5 Air Sources, Buffer Areas, and Ante Areas"

1. On 06/16/2016 at 11:00AM, Surveyor #1 and Technical Advisor #1 printed and reviewed facility document titled, "Sterile Compounding" (Policy #ANC-2551; Reviewed 12/15/2016) and found that ISO 7/8 ante areas and ISO 7 buffer areas used for sterile compounding were discussed. However, the policy did not discuss High Efficiency Particulate Air (HEPA) filtered air from the Heating Ventilation and Air Conditioning (HVAC) used to achieve ISO 7 or ISO 8 classification for the controlled room environments used for sterile compounding as is required in USP.

2. On 06/15/2016 at 11:30AM, Surveyor #1 and Technical Advisor #1 made a site visit to the Oncology Infusion Center Pharmacy sterile compounding area. They observed that this area did not have HEPA filtered room air from the HVAC System. On 06/15/2016, at 2:10 PM, Surveyor #1 and Technical Advisor #1 made a site visit to the inpatient pharmacy sterile compounding area. There they observed that this area did not have HEPA filtered room air from the HVAC system.

3. On 06/15/2016 at 10:40 AM, Surveyor #1 and Technical Advisor #1 interviewed the Director of Pharmacy (Staff Member #5) and asked if HEPA filtered air from the HVAC system was present in either the Oncology Infusion Center pharmacy sterile compounding area or the inpatinet pharmacy sterile compounding area. S/he replied that these two areas did not have HEPA filtered air from the HVAC system and that they did not have a policy related to HEPA filtered air for the compounding areas.

On 06/16/2016, at approximately 9:45 AM, during an interview with the Pharmacy Manager (Staff Member #2) by Surveyor #1 and Technical Advisor #1, s/he confirmed the information provided by the Pharmacy Director as noted above.

F. Pressure Differential Monitoring in the Controlled Environments Used for Sterile Compounding

Reference: USP 797, under "PRESSURE DIFFERENTIAL MONITORING"

1. On 06/16/2016 at 11:00 AM, Surveyor #1 and Technical Advisor #1 printed and reviewed facility document titled "Sterile Compounding" (Policy # ANC-2551; Reviewed 12/15/2016) and found that there was not content about pressure differential monitoring, use of devices for pressure differential monitoring or documentation of active pressure differentials in the controlled environments used for sterile compounding.

2. On 06/15/2016 at 11:30 AM, Surveyor #1 and Technical Advisor #1 made a site visit to the Oncology Infusion Center pharmacy sterile compounding area. They observed the area did not have pressure differential monitoring devices or documentation of active pressure differentials in the controlled environments used for sterile compounding.

On 06/15/2016, at 2:10 PM, Surveyor #1 and Technical Advisor #1 made a site visit to the inpatient pharmacy sterile compounding area. They again observed that this area did not have pressure differential monitoring devices or documentation of active pressure differentials in the controlled environments used for sterile compounding.

3. On 06/15/2016, at 10:40 AM, Surveyor #1 and Technical Advisor #1 interviewed the Director of Pharmacy (Staff Member #5) and asked if there was active pressure differential monitoring, pressure differential monitoring devices, or documentation of positive or negative pressure differentials in the controlled environments used for sterile compounding. S/he stated that those two areas did not have pressure differential monitoring devices, did not have documentation of active pressure differentials. S/he also acknowledged that they did not have policies related to pressure differential monitoring.

On 06/16/2016 at 9:45 AM, the Pharmacy Manager (Staff Member #2) was interviewed by Surveyor #1 and Technical Advisor #1 . S/he confirmed the above findings communicated by the Director of Pharmacy.

G. Ante-Room Configuration for Sterile Compounding

Reference: USP 797 under "Facility Design and Environmental Controls", "Additional Personnel Requirements" and "Hazardous Drugs as CSPs"

1. On 06/16/2016 at 11:00 AM, Surveyor #1 and Technical Advisor #1 printed and reviewed the policy document titled, "Sterile Compounding " (Policy # ANC-2551; Reviewed 12/15/2016) and found that it referenced the presence of an "anteroom" in Section 2 titled, "Cleaning by Housekeeping Staff". However, the policy did not contain information describing the physical characteristics of the "anteroom" for sterile compounding.

2. On 06/15/2016, at 11:30 AM, Surveyor #1 and Technical Advisor #1 made a site visit to the Oncology Infusion Center pharmacy sterile compounding area and observed that a room, referred to as an "anteroom" by the staff. The room was a high traffic medication and supply storage room separated from the patient care area by a sealed door. This room also contained, among other things, an Automated Drug Dispensing Device (ADDD), a sink, a file cabinet, 14 boxes of medical supplies in brown cardboard boxes, computer terminals/keyboards, a chair, and a white board. The room did not have HEPA filtered air and it did not have capacity to maintain a pressure differential positive to the adjacent space( including pressure differential monitoring).

Additionally, the entry way between the "Ante-room" and the sterile compounding area did not have a sealed door, but used a plastic strip curtain barrier. It was also observed that the room did not have a line of demarcation to indicate the clean and dirty side of the "Ante-room". This physical layout for compounding would not be considered a Segregated Compounding Area (SCA) per USP.

On 06/15/2016, at 2:10 PM, Surveyor #1 and Technical Advisor #1 made a site visit to the inpatient pharmacy sterile compounding area and viewed a room, referred to as an "anteroom" (low traffic area). However, this space did not have HEPA filtered air and it did not have USP-required positive pressure differential to the adjacent common space or pressure differential monitoring. Additionally, the entry way between this room and the sterile compounding area did not have a sealed door (used a plastic strip curtain barrier). It was also observed that the room did not have a line demarcation to indicate the clean and dirty side of the "Ante-room". (This physical layout would be considered a SCA per USP, and as such, only for low-risk level Compounded Sterile Products (CSPs) with 12-hour or less beyond use date [BUD].)

3. On 06/15/2016 at 10:40 AM, Surveyor #1 and Technical Advisor #1 interviewed the Director of Pharmacy (Staff Member #5) and asked about the ante-room configuration in the Oncology Infusion Center pharmacy sterile compounding area and inpatient pharmacy sterile compounding area. S/he replied that these two areas did not have required ante-room configuration per USP. S/he also stated that they did not have policies related to the requirements of ante-room configurations.

On 06/16/2016, at 9:45 AM, Surveyor #1 and Technical Advisor #1 interviewed the Manager of the inpatient pharmacy (Staff Member #2) about ante-room configuration in the Oncology Infusion Center Pharmacy sterile compounding area and the inpatient pharmacy sterile compounding area. S/he confirmed the above statements provided by the Staff Member #5.

In summary, the two sterile compounding areas (Inpatient Pharmacy and Oncology Infusion Center Pharmacy) do not have true ante-areas (ante-rooms) as evidenced by the absence of (not all inclusive): a sealed door between the ante-areas and buffer-areas permitting a defined pressure differential between these two spaces; pressure monitoring devices indicating the presence of appropriate pressure differentials between the unclassified environments, ante-areas, and buffer-areas; HEPA filtered air introduced through the ceiling; required air changes per hour (ACPH) of HEPA filtered air; line of demarcation between the ante-areas and buffer-areas.
As such, and in part, these two compounding areas would be categorized as segregated compounding areas (SCA's) and were therefore limited to Low Risk Level CSP's with 12-hour or less BUD. The USP does not permit this category of compounding to be used for hazardous drugs.
Also the high volume oncology infusion center pharmacy (core business) utilizes a BSC in a non-ISO 7 space that was not negative in pressure to an adjacent positive pressure ISO 7 ante-area and lacked the pressure differential monitoring devices required by USP. As such, the oncology infusion center pharmacy was not in compliance with USP as it relates to the compounding of hazardous drugs.

H. Compounding Hazardous Drug (HD) Activity in a Non-Compliant Area (per USP)

Reference: USP 797, under "HAZARDOUS DRUGS AS CSPS"

1. On 06/16/2016 at 11:00 AM, Surveyor #1 and Technical Advisor #1 printed and reviewed the policy titled "Sterile Compounding" and found that as it related to HDs, said policy only referenced in part, the areas of transport, storage, aseptic technique and cleaning. It did not address the USP requirements of the primary and secondary engineering controls required when compounding HDs.

2. On 06/15/2016, at approximately 11:30 AM, Surveyor #1 and Technical Advisor #1 made a site visit to the Oncology Infusion Center pharmacy sterile compounding area and observed that the sterile compounding area did not meet the requirements of the USP for compounding HDs. It was observed that while an externally vented biological safety cabinet (BSC) was being used to compound HDs, it was not placed within a negative pressure ISO 7 buffer room adjacent to an ISO 7 positive pressure ante-room (to provide inward airflow to contain airborne drug as is required per USP). In addition, a pressure indicator has not been installed that could be readily monitored for correct room pressurization.

I. Sterile Compounding of Non-Hazardous Drugs in a Hazardous Drug (HD) Compounding Area

Reference: USP 797, under "HAZARDOUS DRUGS AS CSPS"

1. Upon review of facility policy titled, "Sterile Compounding" it did not reference the compounding of non-hazardous sterile products in the HD sterile compounding area.

2. On 06/15/2016, at 11:30 AM, Surveyor #1 and Technical Advisor #1 made a site visit to the Oncology Infusion Center pharmacy sterile compounding area used for compounding sterile HDs. Observation was made that non-hazardous sterile compounding was being performed in the HD sterile compounding area. More specifically, intravenous iron and intravenous dexamethasone (two non-hazardous compounded sterile products) were discovered in the refrigerator located in the HD sterile compounding area.

3. On 06/20/2016, at 1:30 PM, Surveyor #1 and Technical Advisor #1 interviewed Director of Pharmacy (Staff Member #5) and asked if the intravenous iron and intravenous dexamethasone had been compounded in the Oncology Infusion Center Pharmacy HD sterile compounding area or the inpatient pharmacy. The Director of Pharmacy (Staff Member #5) reviewed the label information on the two products and stated that the aforementioned products had been compounded in the Oncology Infusion Center pharmacy (HD sterile compounding area). S/he further stated that they did not have a policy related to this practice, however these or any other non-hazardous products should not have been compounded in the Oncology Infusion Center pharmacy HD sterile compounding area.

J. Quality Assurance Program for Sterile Compounding

Findings:

Reference: USP 797, under "Quality Assurance (QA) Program, A provider of CSPs shall have in place a formal QA program intended to provide a mechanism for monitoring, evaluating, correcting and improving the activities and processes described in this chapter . . . the selection of indicators and the effectiveness of the overall QA program is reassessed on an annual basis."

1. In review of facility Pharmacy policy titled, "Quality Assurance Plan" (Policy # MC-ANC; Approved 12/22/2014), it described the quality improvement responsibilities within the department. Sterile compounding practices were not included among the 10 areas of focus.

2. On 6/15/2016 at 1:00 PM, Surveyor #1 and Technical Advisor #1 interviewed the Director of Pharmacy (Staff Member #5) about quality improvement indicators for the Pharmacy. S/he discussed some items. However, s/he did not mention indicators for ensuring quality standards for sterile compounding practices.

K. Handling Medications for Acceptable Future Use

Findings:

1. In review of facility policy titled, "Multi-dose Medication Vial, Handling and Disposal" (Policy #NSG-2259; Review/Revision 2/6/2015) for the Patient Care Department item #3 stated, "MDV [multi-dose vials] may be used up to 28 days of the date of initial entry or the manufacturer's expiration date, whichever occurs first. 3.1 All MDV must be dated with a revised expiration date once opened."

In review of another policy titled, "Medication Inspection and Outdated Medications" Procedure # ANC-3827; Approved 11/11/2015) item 1.2 stated, "The pharmacy technician will remove the following from the medications areas and return to pharmacy: Expired or unusuable medications . . . Stock with illegible or incomplete labels including expiration dates."

2. The following observations were noted by Surveyor #1 and/or Technical Advisor #3:

a. On 6/15/2016 at 11:15 AM at the Cancer Center, a vial of 1% Lidocaine 10 milligrams per milliliter was labelled as "Opened 5-11-16". This medication was not labelled with a beyond use date of 28 days, was expired and available for use.

At that time the Director of Pharmacy (Staff Member #5) acknowledged that the medication was not properly labeled and had expired for patient use.

b. At the same time an inpatient pharmacy-compounded Vancomycin infusion bag (attached to a CADD pump cassette [pump typically used for extended duration infusions on an outpatient basis] was located in the refrigerator of the HD compounding area and labeled to expire on 6/22/2016 (a week later). The Director of Pharmacy (Staff Member #5) stated at that time the facility did not compound medications for a beyond use of greater than 12 hours due to environmental deficiencies in the sterile compounding area.

c. Also at that time and place of the above observation, a vial of docetaxol (a HD drug) was found labelled as "spiked 6-13-2016 10:30". This medication was not properly labeled with the beyond use date.

d. On 6/16/2016 at 3:00 PM Surveyor #1 and Technical Advisor #1 observed a Physician's Assistant (Staff Member #3) in the Emergency Department (ED) access a laceration care supply cart. The staff member opened a vial of "Sensorcaine 0.5% MPF" (manufactured preservative free-usually not multidose) and withdrew medication with a needle and syringe. S/he returned the solution to the cart (available future use), did not label it with a beyond use date or discard it to prevent future use. When asked about labeling, the staff member stated s/he did not label vials at the facility.

When the Surveyor requested that the cart be re-accessed, an opened vial of bupivacaine-lidocaine solution was located that was not labelled with a beyond use date. Then another multidose vial was found in the cart with the metal cuff removed around connection between the rubber septum and glass portion (improperly breached). That vial had not been removed to prevent future use.

L. Preparing Sterile Injections in 1 of 2 Observations

Findings:

1. In review of facility reference document listed under "Nursing Procedures" it provided staff members a reference to "Mosby's Clinical Skills" for procedures not listed. A procedure contained as a Mosby reference (not listed as a hospital procedure) was titled, "Preparing Medication from a Vial Containing a Solution." Item #2 stated, "Firmly and briskly wipe the surface of the rubber seal with an alcohol swab, being sure to apply friction, and allow it to dry."

2. On 6/16/2016 at 3:00 PM Surveyor #1 and Technical Advisor #1 observed a Physician's Assistant (Staff Member #3) in the ED access a laceration care supply cart. The staff member opened a vial of "Sensorcaine 0.5% MPF" (manufactured preservative free) and cleaned the rubber septum with one swipe and did not allow it to dry prior to piercing it with a needle and withdrawing medication into syringe.

Subsequent to the observation, the Director of Pharmacy (Staff Member #5) acknowledged the observation.
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VIOLATION: REPORTING ADVERSE EVENTS Tag No: A0508
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Based on interview, review of policy and procedure and facility records, the facility failed to demonstrate that it determined what circumstances necessitated reporting of medication errors to the quality assessment and performance improvement program.

Failure to do so creates risk that errors and substandard outcomes will not be addressed systematically and therefore may cause patient harm.

Findings:

1. In review of facility policy titled, "Medication: Adverse Drug Reactions and Adverse Drug Events" (Policy #MC-PTC; Approved 11/20/2014) item 1.3 stated, "On a monthly basis, the Medication Safety team will evaluate all ADEs [adverse drug events] in the region and identify possible performance improvement projects and/or educational opportunities."

Review of documentation about the functions of the Pharmacy and Therapeutics Committee, item c stated, "Review all significant untoward drug reactions." (Drug reactions are one type of adverse drug event among other types, and do not always include medication errors.)

In review of Pharmacy policy titled, "Quality Assurance Plan" (Policy #MC-ANC; Reviewed 12/22/2104) item 2.4 stated, "Review of medication errors and improve processes ..." and Item 2.6 stated, "Perform RCA [root cause analysis] on serious medication errors."

2. On 6/20/2016 at 1:30 PM, Surveyor #1 and Technical Advisor #1 interviewed the Manager of the Inpatient Pharmacy (Staff Member #2) who was a member of the Medication Safety Committee. During that time s/he stated that the Medication Safety Committee did not have a mission or charter to direct their work efforts. S/he described that after review of medication errors with another team member, s/he coded the medication errors with pre-determined code numbers. Then s/he selected a few (coded) more serious situations from the group of events to present to the Medication Safety Committee.

When asked if there was an analysis performed after codes were assigned or if data was routinely aggregated for analysis and decision making, s/he stated that it was not analyzed.

In another interview that day at 1:00 PM, the Director of Quality and Patient Safety (Staff Member #11) stated that analysis of identified components of adverse drug events were not incorporated into the hospital quality assessment and performance improvement program.
VIOLATION: GOVERNING BODY Tag No: A0043
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Based on observation, interviews and document review, the hospital failed to ensure patient safety related to the quality of pharmaceutical services.

Failure to do so creates risk to patient safety and protection from harm.

Findings:

As evidenced by deficiencies identified in A0490, A0493, A0501, A0502 and A0508 of this report, the cumulative effects demonstrated that the governing body failed to ensure patient safety by implementation of timely corrections in the pharmacy facility sites and clinical operations within the facility sites over a period of 20 months.

Due to the scope and severity of deficiencies detailed under 42 CFR 482.12, the Conditions of Participation for Governing Body are NOT MET.
VIOLATION: SECURE STORAGE Tag No: A0502
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Based on review of policy and procedure, observation and interview, the facility failed to demonstrate that it ensured the security of medications for emergency use.

Failure to do so creates risk for patient harm including, but not limited to, illness and death.

Findings:

1. In review of facility policy titled, "Code Blue Cart and Defibrillator/AED Checklist" (Reviewed 9/2/2014) item #1 stated, "The charge nurse or designee shall check the Code blue cart and defibrillator/AED a minimum of three times a week." Item 2.4 stated, "Medication drawer is in date. . . If meds or supplies are outdated or approaching expiration date, exchange the cart."

2. On 6/15/2016 at 3:30 PM during a tour of the ED, Surveyor #1 noted that a Code Blue cart was missing documentation of several required checks for the month of May and June 2016. At that time, this finding was acknowledged by the Director of the ED (Staff Member #10).

3. On 6/15/2016 at 3:30 PM during a tour of the ED, Surveyor #1 interviewed the charge nurse (Staff Member #4) of the Emergency Department about the practice of maintaining Code Blue Carts for patient care use. S/he stated that responsibility for Code Blue Cart checks was assigned to the person who covered the block of rooms containing the code carts (whether or not there were patients assigned to those rooms). S/he acknowledged that the checks were not consistently completed a minimum of 3 times a week.

4. In review of documentation of Code Blue Cart checks for the April 2016, it demonstrated that the ED documented completion of the Code Blue Cart checks at a frequency of 24% less than minimally required.
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