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Based on record review and interview the hospital failed to:

A. Ensure daily operations of the drug room were provided under the supervision of a qualified staff who had documented education, training and competency in the field of pharmacy and within the scope of his/her license.(Refer to A-0492)

B. Ensure a registered pharmacist developed, supervised, and coordinated all activities of the pharmacy. (Refer to A-0492)

C. Ensure only authorized personnel had access to medication. (A-0504)

D. Ensure policies and procedures were developed and implemented to ensure safe and efficient monitoring, storage, control and distribution of all medications ordered, administered or distributed within the hospital. (Refer to A-0500, A-0502, A-0506)

This failed practice had the potential to negatively impact all patients receiving medications in the hospital, increased the risk of misappropriation and/or tampering with medications by nursing staff and the possibility of unauthorized personnel entering secure areas of the hospital.

Based on record review and interview, the hospital failed to recognize the difference between a complaint and a grievance, and provide resolution of grievances in 3 of 5 Occurrence Report Summaries (Occurrence Report #2, 4 and 5) reviewed.

Findings:

A document titled "Occurrence Report Summary" did not distinguish between a grievance and a complaint. There was no documentation of the steps taken to resolve the grievance or steps taken to prevent the occurrence from repeating. There was no documentation of letters to the patients explaining the investigation process and resolution.

Occurrence Report #2 documented a patient grievance regarding care received in the emergency room. The documentation of the investigation included "...my guess is that he got his bill today and is upset...PCP is (doctor in another town)...we seem to not be able to please these patients regardless of what we do..." There was no indication a letter was sent to the patient of the resolution of the grievance.

Occurrence Report #4 documented a patient grievance regarding care provided to a child through the emergency room. There was no documentation of an investigation. There was no indication a letter was sent to the patient of the resolution of the grievance.

Occurrence Report #5 documented a patient grievance regarding a possible HIPAA violation. There was no documentation of an investigation; there was mention a new procedure would be implemented but no mention of when this procedure would begin. There was no indication a letter was sent to the patient of the resolution of the grievance.

On 01/10/18 at 10:00 am, Staff A and J discussed the occurrence reporting system utilized by the hospital. They stated they could not distinguish between a complaint and grievance in the system, and was not able to show an investigation conducted or a resolution to the grievances had been provided. Both stated they did not recognize and document occurrences as a grievance, and that caused resolutions to not be reported to patients. Staff A and J were referred to Appendix A for additional information.

Based on record review and interview, the Governing Body and Medical Staff failed to provide oversight over the Quality Improvement Performance Improvement (QAPI) Program and ensure QAPI activities:

* had established quality indicators that were measured at a designated frequency, analyzed, and evaluated for effectiveness.

* were determined, designed, and prioritized annually.

* were defined with clear, specific safety expectations and included the establishment of goals or benchmarks in order to measure sustained improvement at a desired level.

* had a documented reasons for being conducted, were designed for safety and quality, and measurable progress was achieved.

These failed practices had the potential for the Governing Body, who has full responsibility for hospital operations, to miss key safety and quality improvement opportunities, and to misinterpret what the data being gathered represented.

Findings:

A review of the document titled, "Quality Management Plan (signed August-September 2017)" defined the program's philosophy, philosophical goals and objectives, functions, leadership responsibilities, quality model, and general program review, but failed to designate the specific QAPI indicators for 2017 and to prioritize and design the indicators, including determining the frequency and details for data collection.

A review of QAPI Meeting Minutes for 01/17 through 12/13/17 showed tasks instead of initiative PI projects, initiatives not specific and measurable, incomplete data that was not dated as to timeframe it reflected, months without data, and minimal action plans. The minutes did not contain any infection control initiatives or hand hygiene surveillance data or action plans. The hand hygiene discussion for 07/17- 11/17 was documented as "ongoing and continue to monitor" and no data submitted.

A review of QAPI Meeting Minutes 01/17 through 12/13/17 showed the following, but was not limited to:
*07/17 Pharmacy Initiative: listed a 'narcotic sheet compliance", but failed to define "compliance", what was being measured, and showed rates listed "91.1%, 87.1%, 80 %" with no explanation as to the time periods the data reflected.

*Surgery Initiative: listed "1st surgery patient back in procedure by 0820", but showed no health outcome reason as to why the initiative had been selected and documented no data or action plans from 07/17 to 11/17. The 11/08/17 minutes documented a new initiative for "scopes testing negative the day before surgery". There was no documentation of what test was to be performed or goal determined. The action plan showed the scope would be reprocessed if failed testing, but no discussion that an investigation would be warranted to discover why the scope failed the inital test.

*Lab Initiative: listed the project of looking to find an inexpensive and accurate HbgA1C machine and in 08/17 found one; this is a task and not a QI Project initiative.

*Central Supply Initiative: listed the goal to achieve was 90% compliance with spot checks of inventory. There was no documentation as to what elements were to be measured, no data was documented in minutes from 09/17 and 10/17, and the 08/17 minutes documented "100%, 100%, 90% without what timeframes the values represented.

*Nursing Initiative: listed "follow-up calls within 48 hours of discharge". There was no description of what patient population was to be called, the reason for the initiative, or what information was trying to be ascertained by the calls. The benchmark was set at 90%, but in the minutes for 09/17 showed 06/17 23.5%, 07/17 46%, and 08/17 33% with no action plan implemented.
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A review of the document titled, "Quality Management Plan (signed August-September 2017)" defined the program's philosophy, philosophical goals and objectives, functions, leadership responsibilities, quality model, and general program review, but failed to designate the specific QAPI indicators for 2017, to prioritize and design the indicators, document the rationale for the selection, and determine a desired goal..

A review of QAPI Meeting Minutes for 01/17 through 11/08/17 showed no physician attendance.

A review of the document titled, "Quality Improvement Initiatives (dated 01/17-06/17) " showed 74 QI initiatives and data. Staff A was attempting to provide a comprehensive initiative report for the surveyors, printed this report, and stated he/she did not realize the "SQSS" quality reporting system could produce the summary information.

On 01/10/17 at 1:10 pm, Staff A stated the Governing Body had not approved the QAPI initiatives for 2017 or 2018, and information such as from the comprehensive SQSS (Strategic Quality Support System) QI Initiative Report had not been provided to the Medical Staff or Governing Body for their approval. Staff A stated the Governing Body received the QAPI Meeting Minutes.

On 01/10/17 at 1:10 pm, Staff A stated in 12/17, Staff T, a physician, had been selected to serve as a member of medical staff on the QAPI Committee, and would serve as a liaison with the Medical Staff and Governing Body for QAPI matters.

On 01/10/17 at 1:10 pm, Staff A stated he/she was trying to teach each of the hospital's departments to select meaningful quality indicators, data, and action plans.

Based on record review, interview, and observation, the hospital failed to ensure the pharmacist developed and supervised all pharmaceutical services according to standards of practice as evidenced by failure to:

A. Ensure medications were ordered and dispensed in a safe manner in accordance with standards of practice for pharmacist order verification. (Refer to Tag A-0500)

B. Ensure the drug room was managed by licensed staff who had received education and demonstrated competencies defined by the pharmacist and approved hospital policies and procedures. (Refer to findings below)


C. Ensure the duties and responsibilities were within the scope of the drug room supervisor's scope of practice and licensure. (Refer to findings below)

D. Ensure drug room was accessed only by authorized staff. (Refer to Tag A-0502)

These failed practices had the potential to negatively affect the health outcomes of all patients, who received medications at the hospital.

Findings:

A. Medications Ordering and Dispensing:

Review of hospital policy titled "Interpretation, Verification, and Clarification of Drug Orders" showed medication orders would be reviewed by pharmacy staff on a daily basis for correction and recommend any changes.

On 01/10/18 at 3:00 pm, Staff Q stated pharmacy did not verify medication orders. Staff Q stated the nursing staff were the ones who are responsible for verifying the medication order prior to administering the medication. The electronic medication record (EMR) was not set up for a pharmacist to perform medication order verification. Staff Q stated pharmacy staff were not here twenty-four hours, seven days a week to perform order verification.

On 01/11/18 at 9:00 am, Staff R stated the nurse receiving the order was responsible for verifying the order with the physician. Staff R stated the physician would write the medication orders and if needed he/she would call and clarify any orders. Staff R stated if he/she found any discrepancies in the home medication list provided by the patient and medications ordered by the physician he/she would notify the physician and ask for clarification. Staff R reported he/she had access to drug books, online pharmacy sites and could contact the hospital's pharmacist for any drug related questions.


(Refer to Tag A-0500)


B. Education and Competencies

Review of hospital policy titled "Job Descriptions: Consultant Pharmacist" showed the pharmacist was responsible for maintaining competence and quality for drug room staff and staff development and orientation for pharmacy personnel including documentation of training.

Review of hospital contract titled "Contractual Pharmacist Agreement" dated 04/28/14 showed the PIC (pharmacist in charge) was responsible for providing education for the drug room supervisor.

Review of document titled "Oklahoma Pharmacy Law Book 2017" showed the pharmacist was responsible for providing orientation, staff development and in-service training to hospital staff and must provide documentation that should include but not limited to: orientation of new employees to hospital policies and procedures, in-services provided, any specialized training for medications or admixiture services, outline of program content and staff sign-in sheet with staff titles.

Review of hospital policy titled "Continuing Education" showed the pharmacist was responsible for requiring and documentation of pharmacy staff's participation in educational programs. There was no evidence of annual educational requirements for the drug room supervisor.

Review of Staff E personnel file showed no evidence of orientation, education, training, in-services or competency for pharmaceutical principles, practices and drug room responsibilities.

On 01/10/18 at 3:00 pm, Staff Q stated he/she had not provided specific education to the drug room supervisor because he/she had been at the hospital prior to Staff Q being employed. Staff Q stated he/she had provided some competencies to the supervisor such as how to properly stock orders. Staff Q reported education and competencies for the supervisor had not been provided on a regular basis.

On 01/09/18 at 1:00 pm, Staff E stated he/she had received on the job training from the previous drug room supervisor when he/she started in the pharmacy many years ago. Staff E stated he/she had not received any formal pharmacy education, training or competencies.

On 01/10/18 at 3:45 pm, Staff E stated education and training has been provided to staff after P&T committee meetings but they had not kept a sign in sheet for hospital staff to sign. Staff E stated the last in-service he/she provided was on antibiotic stewardship at the last P&T committee meeting.


C. Licensure

A review of the following documents the drug room supervisor was practicing above her license as evidenced by:

Review of the drug room supervisor's personnel file included this hospital document titled "Pharmacy Supervisor". This document showed the drug room supervisor was responsible for the organization and, distributive functions in the department. Other responsibilities include but were not limited to:

1. Resource to pharmacy administration and leadership for solving problems related to drug distribution and profiling.

2. Provides consultation to physicians and hospital staff on pharmacy issues, question and other matters.

3. Provides "clinical consultation and expertise in support of client assessment and care processes by consulting on drug therapy, drug regiment reviews and drug utilitization reviews, consulting on drug storage and control".


Review of document titled "Oklahoma Board of Nursing Practice Act" dated 11/2017 showed licensed practical nurses include but are not limited to:

1. Contributing to assessments

2. Participating in development and modification of care plans

3. Delegating tasks that could be safely performed by others consistent with educational preparation or by advanced unlicensed assistive personnel

4. Teach basic nursing skills and related principles


Review of document titled "Oklahoma Pharmacy Law Book 2017" showed a drug room supervisor responsibilities were to assist "the pharmacist in procuring, receiving, storage, distribution, record keeping, and disposition of drug products and medications".

On 01/10/18 at 3:45 pm, Staff E stated he/she had provided education and training during P&T meetings to nursing staff and physicians and had done consultations when staff had pharmacy related questions. Staff E stated he/she was available for on-call staff consultation regarding medication questions when needed.


D. Accessed by Authorized Staff

Review of hospital policy titled "Security of Medication Areas" showed all drug storage areas when not in use must be locked. Personnel designated by the hospital are those responsible for accessing drugs.

Review of hospital policy titled "Pharmacy Control and Security" showed access to the pharmacy would be limited at all times. Hospital staff would gain access to pharmacy during operating hours from the pharmacy staff. After hours and on weekends hospital staff needing medications would need to contact a charge nurse.

On 01/08/18 at 11:52 am, Staff E stated the drug room should remain locked and only accessible by drug room supervisor during operating hours and after hours charge nurses have a key to access the pharmacy to obtain any needed medications that are not available on the unit.

The surveyors observed the pharmacy door open and unsecured on several occasions 01/08/18 at 1152 am, 01/09/18 at 1:00 pm, and 01/12/18 at 9:05 am.

(Refer to Tag A-0502)

Based on record review and interview the hospital failed to ensure medications were ordered, verified and dispensed in a safe manner in accordance with standards of practice for pharmacist order verification.

This failed practice had the potential for increased adverse reactions and negative health outcomes for all patients with medication orders secondary to the inappropriateness of medication orders including but not limited to drug selection, dose, frequency and/or route; allergies/sensitivities; contraindications; and interactions such as foods, labs and alternative medications/treatments.

Findings:

Review of hospital policy titled "Interpretation, Verification, and Clarification of Drug Orders" showed medication orders would be reviewed by pharmacy staff on a daily basis for correction and recommend any changes.

On 01/10/18 at 3:00 pm, Staff Q stated pharmacy did not verify medication orders. Staff Q stated the nursing staff were the ones who are responsible for verifying the medication order prior to administering the medication. The electronic medication record (EMR) was not set up for a pharmacist to perform medication order verification. Staff Q stated pharmacy staff were not here twenty-four hours, seven days a week to perform order verification.

On 01/11/18 at 9:00 am, Staff R stated the nurse receiving the order was responsible for verifying the order with the physician. Staff R stated the physician would write the medication orders and if needed he/she would call and clarify any orders. Staff R stated if he/she found any discrepancies in the home medication list provided by the patient and medications ordered by the physician he/she would notify the physician and ask for clarification. Staff R reported he/she had access to drug books, online pharmacy sites and could contact the hospital's pharmacist for any drug related questions.

Based on record review, interview and observation the hospital failed to provide secure storage for drugs and biologicals to prevent access by unauthorized individuals. This failed practice had the potential for increased risk of misappropriation and tampering of medications.

Findings:

Review of hospital policy titled "Security of Medication Areas" showed all drug storage areas when not in use must be locked. Personnel designated by the hospital are those responsible for accessing drugs.

Review of hospital policy titled "Pharmacy Control and Security" showed access to the pharmacy would be limited at all times. Hospital staff would gain access to pharmacy during operating hours from the pharmacy staff. After hours and on weekends hospital staff needing medications would need to contact a charge nurse.

On 01/08/18 at 11:52 am, Staff E stated the drug room should remain locked and only accessible by drug room supervisor during operating hours and after hours charge nurses have a key to access the pharmacy to obtain any needed medications that are not available on the unit.

The surveyors observed the pharmacy door open and unsecured on several occasions 01/08/18 at 1152 am, 01/09/18 at 1:00 pm, and 01/12/18 at 9:05 am.

Based on record review, interview, and observation, the hospital failed to ensure only authorized personnel had access to medication. This failed practice increased the risk for potential unauthorized persons to gain access to secure areas.

Review of hospital policy titled "Job Descriptions: Consultant Pharmacist" showed the pharmacist was responsible for development, supervision and coordination of activities within the pharmacy department.

Review of hospital contract titled "Contractual Pharmacist Agreement" dated 04/28/14 showed the PIC (pharmacist in charge) was responsible for safe and efficient monitoring, control and distribution of all medications administered or distributed within the hospital.

On 01/10/18 at 3:00 pm, Staff Q stated he/she was unaware a hospital volunteer was working in the drug room and had access to the drug room and medications.

On 01/10/18 at 3:45 pm, Staff E stated Staff S was a volunteer who assisted in the drug room and had access to the drug room during operating hours.

On 01/09/18 at 9:50 am, surveyors observed Staff S an unauthorized, unlicensed hospital staff member in the emergency department drug room checking the medication stock. Surveyors asked Staff S what task he/she was performing. Staff S stated he/she was stocking each of the medication drawers for pharmacy. Staff S reported he/she was a volunteer for the hospital and had not received any orientation or training from the pharmacist regarding the drug room or distribution of medication. Staff S stated he/she had made "notebooks" in order to keep up with the process.

Based on record review, interview and observation the hospital failed to ensure drugs were removed from the pharmacy or storage area only by designated personnel.

This failed practice resulted in numerous medications to be removed from the pharmacy by nursing staff and had the potential to increase medication errors and diversion of scheduled medications.

Findings:

A review of a document titled "Administration of Medications" dated 10/2013 showed nursing staff would obtain medications from pharmacy (drug room) when pharmacy staff was not available.

A review of a document titled "Pharmacy Control and Security" showed access to the pharmacy would be limited at all times. Hospital staff would gain access to the pharmacy during operating hours from the pharmacy staff. After hours and on weekends hospital staff needing medications would need to contact a charge nurse.

A review of a document titled "After Hours Entry into the Pharmacy" showed during normal pharmacy hours only the pharmacy supervisor may enter the pharmacy to obtain prepackaged medications. Designated charge nurse would be responsible for obtaining patient medications when it is not available on the nursing unit and a dose must be administered outside of pharmacy operating hourse. The charge nurse would obtain the key inside the West pharmacy door.

A review of a document titled "Medication Sign out Sheet from Pharmacy" dated 12/27/2018 to 01/10/2018 showed 12 employees (6 RNs, 5 LPNs, 1 from CT/Radiology) entered and removed medications from the pharmacy 26 times after normal pharmacy's business hours (including weekends and holidays). During that time period 155 doses of 36 medications were removed, including 1 dose of a Schedule IV medication (Ativan). Zero of the 12 employees were designated as pharmacy staff.

On 01/08/2018 at 11:52 am, Staff E stated the drug room hours were Monday through Friday from 8:00 am to 4:30 pm, and as needed on weekends. Staff E stated only charge nurses had access to the drug room when pharmacy staff were not on site.

On 01/11/2018 at 9:00 am, Staff H stated she currently had the drug room key in her pocket because the LPNs administered the medications and they carried the pharmacy key during their shift.

On 01/11/2018 at 12:00 pm, Staff E stated only the charge nurse was authorized and had the key to gain access to the drug room after hours and on weekends.

Based on record review, interview, and observation, the hospital failed ensure:

A. the soiled utility area of the laundry room was enclosed to allow for negative pressure ventilation, and

B. the soiled utility area of the laundry room's airflow was properly monitored.

This failed practice of not validating negative air flow vented to the outside air in the laundry's soiled utility room had the potential to increase the infection control risk to staff and patients and the hygienically clean textiles contained in an adjacent room.

Findings:

A. Soiled Room Door

During a tour of the laundry area, the surveyors observed two communicating rooms. The first room contained washers and dryers, folding tables, and clean textiles on racks. The second room was the soiled utility room which contained two large uncovered hampers of soil laundry. There was no door separating the two rooms, but had a door jamb and evidence of holes from past door hinges.

On 01/09/18 at 12:05 pm, Staff V stated the door separating the laundry room and soiled utility room had been removed, but did not know when it occurred.


B. Soiled Room Airflow

A review of policy titled, "Storage, Collection, and Transportation of Linens (no date)" documented soiled linen will be stored in a separate, well-ventilated areas in covered hampers or carts.

A review of "OAC 310: 667 Appendix A Ventilation Requirments for Areas Affecting Patient Care in Hospitals and Outpatient Facilities" documented paramenters for a soiled utility was as follows:

*Air movement relative to the adjacent area should be inward.

*There should be six air exchanges of outdoor air per hour.

*All air should be exhaust to the outdoors

On 01/11/18 at 12:29 pm, Staff W stated the laundry's soiled utility airflow had not been evaluated and did not know if the area had negative sirflow and was vented to the outdoors.

Based on observation, record review and interview, the hospital failed to:

A. Track and report the types of infections seen in the facility, hand hygiene surveillance or infection control initiatives

B. Mix IV medications in a room with gloves and hand hygiene capabilities readily available

C. Provide antibiogram data to the members of the Infection Control Committee to track resistance patterns of antimicrobial agents used in the facility

D. Provide trending of infections seen in the facility to the Infection Control (IC) Committee to develop measures to prevent transmission of diseases

E. Provide trending of cultures obtained on patients in the facility to the IC Committee to develop measures to prevent transmission of diseases

F. Provide proper Personal Protective Equipment (PPE) for high risk exposure area within the endoscopy area of the surgical suite


A review of the IC Committee minutes 07/26/17 and 10/25/17 (the most current minutes), showed each meeting documents there were no hospital acquired infections; the tracking tools indicate 12 patients admitted with infections during April 2017, 15 patients in May 2017 and 12 admissions during June 2017. The minutes did not contain discussions of the infections or identify the types of infections, any infection control initiatives or hand hygiene surveillance data. The minutes showed no trending of infections or cultures to track the types of infections being admitted into the hospital or measures taken to prevent the transmission of diseases within the hospital or community.

The IC Committee minutes showed no reporting of antibiogram data; there was no discussion of indications of antibiotic resistance in the facility. The ICP stated she and Pharmacist may discuss but the information was not presented to the IC Committee.

The IC Committee minutes showed no documentation of recommendations or education provided to staff for the care and treatment of patients with infections admitted into the facility, including the need for proper hand hygiene.

01/08/18 at 8:30 am, Staff B stated only abdominal surgeries are being tracked for surgical site infections; the ICP was notified by the surgery manager if a patient returned to the operating room with a diagnosed infection. There was no tracking of other surgeries performed although the facility routinely performed colonoscopies, general surgery and cataract surgery.

01/10/18 at 8:30 am, Staff B stated he/she did not provide recommendations or education to staff for the care and treatment of patients with infections admitted into the facility, and did not communicate with physicians regarding infections or possible infections of their patients. Staff B stated he/she did not provide education to staff regarding hand hygiene.

Staff B states each department was surveyed quarterly for infection control compliance, to include hand hygiene observations, and when any problems were noted, a recommendation for correction was made to the department by the IC Committee. The IC Committee minutes contained no documentation of hand hygiene observations, or if any recommendations were made to a department, if the recommendations were followed, another plan of correction was made or if corrections were not made.

On 01/11/18 at 11:00 am, Staff E stated that the process for mixing IV medications was to perform hand hygiene, don gloves, clean the top of the cart with alcohol and mix the drug on the top of the medication cart. On a tour of the IV medication mixing room, surveyor observed gloves and hand hygiene capabilities were not available.

On 01/09/18 at 1:00 pm, surveyor observed expired (12/16) Clorox wipes in the physical therapy (PT) department; wipes were replaced by PT staff while surveyor in department.

On 01/11/18 in the endoscopy disinfection room, surveyor observed:

1. A secondary container (a basin that is filled with chemicals from a larger container) was incorrectly labeled as Metricide (a glutaraldehyde containing solution with a minimum effective concentration of 1.5%) and actually contained Medricide OPA Plus (a glutaraldehyde free solution with a minimum recommended concentration of 6.3%).

2. Chemicals were being strip tested (a monitoring of the chemical efficacy) only once each morning instead of before each cycle as recommended by the manufacturer of Metricide OPA Plus.

3. QC Test (a monitoring test of the concentration of the chemical) was not being performed on newly opened bottles of chemicals (Metricide OPA Plus).as recommended by the manufacturer of Metricide OPA Plus.


The Metricide and Metricide OPA Plus manufacturers' instructions were reviewed and stated the following:

1. Metricide requires an immersion time of at least 45 minutes; Metricide OPA Plus requires an immersion time of 12 minutes.

2. Use of a test strip is recommended by the manufacturer before each reprocessing cycle to ensure that the disinfectant has not been compromised by excessive reuse ...inadequate equipment cleaning ...dilution or misuse of the product.

3. Testing of positive and negative controls must be performed on each newly opened bottle


The hospital's policy regarding the disinfection of endoscopes titled High Level of Disinfection of Endoscopes (Metricide) provides information for a chemical that was not used to process endoscopes.

On 01/11/18 at 1020, Staff L and K stated the chemical in the container labeled "Metricide" was actually Metricide OPA Plus, and the test strips were not used according to manufacturer's guidelines.

Based on record review and interview, the hospital failed to ensure a discharge planning evaluation was completed in a timely basis on 2 (Patients #2 and 3) of the 3 current inpatients.

Findings:

A review of the current inpatient records showed the written discharge evaluation was not completed within 48 hours according to hospital policy.

A policy titled "Patient Discharge Planning" states the discharge assessment will be initiated on the day of admission with the written evaluation in the record within 48 hours.

Patient #2 was admitted on 01/05/18 and the discharge written evaluation was completed on 01/08/18.

Patient #3 was admitted on 01/02/18 and the discharge written evaluation was completed on 01/10/18.

On 01/10/18 at 11:45 am, Staff A stated she understood the importance of the discharge evaluation being in the record in a timely manner to prepare for discharge of the patient.

Based on record review and interview, the hospital failed to ensure two (Staff C and Staff U) of three surgical staff were qualified to perform proper endoscope disinfection and three (Staff C, Staff K, and Staff U) of three surgical staff trained in the use of high level disinfectant according to manufacturers' guidelines.

This failed practice potentially increased the infection risk for all patients receiving endoscopic care.

Findings:

A review of document titled, "Surgical Services offered at Share Medical Center" documented endoscopy services were provided by the hospital.

A review of the personnel files for Two (Staff C and Staff U) of three surgical staff showed no evidence of competency to perform high level disinfection on endoscopes.

A review of the personnel files for three (Staff C, Staff K, and Staff U) of three surgical staff showed no evidence of competency use of the high level disinfectant, Metricide OPA Plus used to disinfect the hospital's endoscopes.

01/11/18 at 2:25 pm, Staff K identified himself/herself, Staff C, and Staff U as staff responsible for disinfecting endoscopes as part of their job duties.

On 01/10/18 at 9:49 am, the surveyor observed the following deficiencies in the endoscopy disinfection room:
* A secondary container was labeled Metricide, but contained Medricide OPA Plus. (The container was not properly labeled with manufacturer's safety information. Metricide and Metricide OPA Plus had different instrument exposure times and a different number of estimated days for efficacy.)

*On 01/10/18 at 9:49 am, Staff U stated Meticide OPA Plus container (used to disinfect endoscopes) was being tested for efficacy once each morning and not prior to each endoscope reprocessing as instructed by the manufacturer.

*On 01/10/18 at 9:49 am, Staff U stated the manufacturer's instructions for the quality control of Meticide OPA Plus efficacy testing strips was not being performed on newly opened bottles.

Based on record review, interview, and observation, the hospital failed to:

A. have a policy regarding surgical fire risk assessments,

B. direct staff to conduct these assessments prior to the initiation of both surgical and endoscopic procedures for 5 (Patient #4, 5, 6, 7, and 8) of 5 surgical/ endoscopic patients out of a total sample of 20 patients.

C. have a correct humidity parameters in the policy for the two operating rooms (OR) air quality.


This failed practice resulted in decreased staff fire safety awareness and increased the fire risk for patients, whose surgeries / procedures required the presence of ignition and fuel sources and oxygen to be available in the OR suite.


Findings:

A. & B. Surgical Fire Risk Assessment

A review of Food and Drug Administration article titled, "Preventing Surgical Fires: FDA Safety Communication" dated 10/13/11 recommended to reduce the risk of surgical fires by conducting a fire risk assessment at the beginning of each procedure amongst other interventions.

A review of policy titled, "Oxygen Enriched Atmosphere Safety in the Operating Room (date none)" showed general information, prevention, and safety tips, but failed to address surgical fire risk assessments, including, but not limited to when to perform the assessments, elements of the assessment, and staff training requirements.

A review of 5 (Patient #4, 5, 6, 7, and 8) of 5 surgical/ endoscopic patients failed to have documentation of a fire risk assessment being conducted prior to surgery/procedure.

A review of the personnel files of 3 (Staff C, D, and K) of 3 surgical staff showed no evidence of fire risk assessment training.

On 01/11/18 at 2:24 pm, Staff K, Operating Room (OR) Manager stated the hospital provided surgical and endoscopic services, and had no policy for conducting fire risk assessment prior to each surgery or invasive procedure.

On 01/11/18 at 8:58 am, the surveyor observed the presence of the element of fire such as oxygen, alcohol [fuel], and cautery [ignition] within the surgical suites, and no fire risk assessment was performed prior to the endoscopic procedure of Patient #4.


C. OR Humidity

A review of policy titled, "Humidity Control and Temperature Documentation (11/13)" showed the relative humidity parameters for the operating room suite to be 35-60%.

A review of "OAC 310: 667 Appendix A Ventilation Requirments for Areas Affecting Patient Care in Hospitals and Outpatient Facilities" documented paramenters for relative humidity percent in the Operating / surgical cystoscopic room was 30-60%.

On 01/10/18 at 10:00 am, Staff U stated he/she contacted maintenance when the OR out of the range of 35-60%.