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Based on observation, interviews and revies of documents, the hospital did not meet the Condition of Participation for Governing Body by failing to:

1. Develop, implement and maintain an effective performance improvement program to ensure safe, sterile procedures and practices in the satellite pharmacies and in the intravenous additive. The hospital failed to develop, implement and maintain an effective performance improvement program to ensure safe surgical, practices in the hospital. The hospital failed develop, implement and maintain an effective performance improvement program to ensure safe cleaning practices and personal protective equipment by its staff performing these duties. (Refer to A 0263)

2. Ensure a safe and effective sterile (germ-free) compounding process (a process of making sterile intravenous medications) that meets the needs of all patients requiring intravenous (IV, route of administration through a vein) medications. (Refer to A 0490)

3. Ensure an effective, active system-wide infection control program for prevention, control, and investigation of infections and communicable diseases. The infection control program did not meet the needs of all patients receiving pharmaceutical services and supportive healthcare in the hospital. The hospital's Infection Control Program failed to provide aseptic technique education to pharmaceutical staff who performed compounding.
(Refer to A 0747)

4. Provide surgical services in a well-organized manner and in accordance with acceptable standards of practice. The hospital failed to ensure they had an effective, active and a systematic infection control surveillance program in place for identifying, investigating, and controlling infections in their operating room department. There was no evidence of daily terminal cleaning (Infection Prevention process performed by the Environment of Care staff) in 24 of 24 operating rooms, and one decontamination room. There was no evidence that surgical service staff received education regarding the cleaning agents used in surgical services. (Refer to A 0940)

The cumulative effects of these systemic problems resulted in failure of the hospital's Governing Body to ensure provision of quality health care in a safe environment.

Based on interviews, a tour of the facility, and a review of documents supplied by the hospital, the hospital failed to develop, implement and maintain an effective performance improvement program to ensure safe, sterile procedures and practices in the satellite pharmacies and in the intravenous additive. The hospital failed to develop, implement and maintain an effective performance improvement program to ensure safe surgical, practices in the hospital. The hospital failed develop, implement and maintain an effective performance improvement program to ensure safe cleaning practices and personal protective equipment by its staff performing these duties as follows:

1. The hospital failed to measure, analyze and track aspects of performance in the satellite pharmacies and in the intravenous additive departments. Refer to A0501, A0748, A0749

2. The hospital failed to ensure the program for Quality Assurance and Performance Improvement program reflected the complexity of the surgical services department when it failed to ensure oversight for daily terminal cleaning of surgical suites. Refer to A0748.

3. The hospital's governing body failed to ensure an ongoing program for quality improvement and patient safety had been designed, implemented, and maintained to improve patient safety. See A0273, A0308

4. The hospital governing body failed to ensure ongoing program to promote staff and patient safety. Refer to A0308

5. The hospital's governing body failed to provide adequate resources to ensure daily terminal cleaning of each operating room. Refer to A0308, A0749

6. The hospital's governing body failed to ensure, by means of adequate Quality Assurance and Performance Improvement plans, adequate oversight had been provided to ensure safe sterile pharmaceutical conditions existed when airflow readings in the intravenous additive service were out of range. See A0273, A0308, A0501, A0749

The cumulative effects of these systemic problems resulted in failure of the hospital and the Quality Assurance Performance Improvement program to provide patient care in a safe environment.

On 12/7/2016, at approximately 12:15 p.m., through observations, interviews and a review of selected documents, an Immediate Jeopardy was declared by the survey team.

Based on interviews, a tour of the hospital and a review of documents supplied by the hospital, the Quality Assurance Committee failed to develop a plan to assess, implement a corrective action plan or to provide a plan for action when air flow within the intravenous additive pharmacy (IVAS) was out of compliance and out of range. This could lead to unsafe, unsterile preparation of intravenous medication in the pharmacy.

Findings:

Interviews conducted on 12/7/2016 at 1315 hours, with Director of Quality Assurance, Performance Improvement (QAPI), Infectious Disease Director and Epidemiologist. When interviewed they agreed there was no hospital wide program to observe, evaluate or develop a program for Quality Assurance in the management of sterile processing when airflow in the IVAS department fell below range. When interviewed, the QAPI committee were unaware of eight occurrences between November, 2015 and December, 2016 when air pressure in the IVAS fell below standards required to ensure sterile preparation practices. (Refer to A0501)

Based on interviews, a tour of the hospital and observations, the Quality Assurance Performance program failed to focus on high-risk, high volume, problem prone areas in the hospital to improve patient safety. This could lead to unsafe practices in the hospital.

Findings:

1. A tour of the hospital was conducted at approximately 1030 hours on 12/6/2016. Present on the tour were CMO, CNO, and MD OR Director. Operating room 16 was inspected during the tour. Dust and dirt were noted on the top of the anesthesia cart and dirt covered the oxygen tanks on the rear of the anesthesia machine. 8 uncovered single use surgical clamps were found on the anesthesia cart. Residual tape was found on the operating room table, which impairs disinfection of the table. Dirt was noted in the tubing of the anesthesia mattress. The operating room table base demonstrated residual dark matter in the metal seams.
2. When interviewed on 12/7/2016 at approximately 1:30 p.m., the QAPI committee stated environmental rounds were made on a regular basis, however, the interior of the surgical rooms were not always directly inspected.
3. Interviews with the QAPI committee on 12/7/2016 revealed there was no direct oversight or observations made of cleaning techniques or personal protective equipment worn by the staff performing these duties.
4. There was no direct oversight by the QAPI committee to ensure sterile preparations in the satellite pharmacies or in the intravenous access room.
5. There was no direct oversight of the QAPI committee to ensure surgical instruments had been processed and remained stain free, in accordance with nationally recognized standards such as the AORN(Association of Operating Room Nurses). The QAPI committee failed to establish a plan for oversight of ice machines, to ensure foreign debris was not present. The Ice Machine in the surgical area was used for direct patient care equipment.
6. The QAPI committee failed to establish and maintain a system to ensure all personnel working in sterile areas had been trained and observed to ensure appropriate disinfection of all non-porous surfaces and that personnel were acquainted with the time required for these surfaces to remain in direct contact with disinfecting agents.

Based on interviews and a review of selected documents supplied by the hospital, the hospital's governing body failed to ensure all hospital departments had established, implemented, and maintained a program of Quality Assessment and Performance Improvement for quality of care and patient safety. This could lead to unsafe surgical practices within the hospital.

Findings:

1. Interviews were conducted with the Manager of Services Officer on 12/7/2016 at approximately 10:20 am. When interviewed, it was discovered that four of 28 surgical suites had not received terminal cleaning on a daily basis. The manager stated surgical procedures were performed in such great numbers, it was not possible to clear the surgical suite on a daily basis to provide terminal cleaning. A log of cleaning was presented for review. This revealed that Room 16, a surgical suite used for liver transplant procedures, had received a terminal cleaning (cleaning from top of walls to floors, with all equipment removed from the operating room), on 11/9/2016, but had not been terminally cleaned until 12/6/2016, during the survey.
2. There was no plan to observe, evaluate or assess whether hospital staff who performed surgical suite cleaning, observed appropriate Personal Protective Equipment practices. There was no documented evidence that the cleaning staff received education regarding the cleaning agents used in the operating rooms.
3. The hospital's governing body failed to ensure, by means of adequate Quality Assurance and Performance Improvement plans, adequate oversight had been provided to ensure safe sterile pharmaceutical conditions existed when airflow readings were out of range.

Based on observation, interviews, and record reviews, the hospital failed to ensure a safe and effective sterile (germ-free) compounding process (a process of making sterile intravenous medications) that meets the needs of all patients requiring intravenous (IV, route of administration through a vein) medications, as evidenced by:

1. The hospital failed to ensure the pharmacy personnel in the satellites pharmacies prepared sterile IV medications with proper aseptic technique and garbing requirement, and maintained the sterile compounding areas, following their policies and procedures that were in accordance with acceptable standards of practice. (Refer to 501)

2. The hospital failed to periodically perform glove fingertip sampling (sampling of compounding personnel glove fingertips to evaluate and ensure competency in proper hand hygiene, garbing procedure, and aseptic work practices) to the satellite pharmacy personnel. (Refer to 501)

3. The hospital failed to ensure the air pressure relationships within the IVAS were compliant at all time and failed to investigate non-compliant air pressure relationships that were detected. (Refer to 501)

4. The hospital failed to integrate the monitoring of air pressure relationships inside IVAS into the facility's QAPI program. (Refer to 273)

5. The hospital failed to have a contingency plan for the sterile compounding process in the event of an air pressure excursion within the IVAS that is not readily resolved. (Refer to 273)

The cumulative effects of these systemic problems resulted in the hospital's
inability to provide sterile compounding products in a safe and effective manner in accordance with the Condition of Participation for Pharmaceutical Services.

Based on observations, interviews, and record reviews, the hospital failed to ensure a part of its pharmaceutical services, sterile (germ-free) compounding process (a process of making sterile intravenous medications), was performed in a safe and consistent manner, as evidenced by:
1. The hospital failed to ensure the pharmacy personnel in the six of six satellites pharmacies prepared sterile intravenous (IV) medications with proper aseptic and garbing requirements, and maintained the sterile compounding areas, following their policies and procedures that were in accordance with acceptable minimum standards of practice;

2. The hospital failed to periodically perform glove fingertip sampling (sampling of compounding personnel glove fingertips to evaluate and ensure competency in proper hand hygiene, garbing procedure, and aseptic work practices) to the satellite pharmacy personnel;

3. The hospital failed to ensure the air pressure relationships within the IVAS were compliant at all times and failed to investigate non-compliant air pressure relationships that were detected;

4. The hospital failed to ensure the room designated to compound hazardous (such as chemotherapy) medications did not contain sources of water (such as a sink);

5. The hospital failed to ensure appropriate Beyond-Use Date (BUD, a date by which the compounded medication must be used before it is at risk for chemical degradation or contamination; similar to expiration date) was assigned to a compounded sterile IV stock solution found in the 5th floor satellite pharmacy and two reconstituted (fluid added to the dry powder to form a liquid) single-use vials of antibiotics (CSP, compounded sterile products, or IV medications) based on information provided by the manufacturer, and/or described in a nationally accepted professional standards of practices, such as the chapters in United States Pharmacopeia (USP, published by a scientific non-profit organization that sets standards for the identity, strength, quality, and purity of medicines, ... to help ensure the quality, safety, and benefit of medicines. Adherence to these practice and quality standards allows the hospital to assign BUD to CSPs).

6. The hospital failed to ensure two pre-drawn syringes for sterile compounding had proper label that included the BUD.

These failures had a potential for all patients requiring IV medications be exposed to avoidable contamination that may or may not affect patient safety or health.

Findings:

1. During a tour of the hospital, on 12/5/16 at 9:30 am, Pharm 1 described the hospital's sterile compounding program. Pharm 1 stated that the hospital had sterile (germ free) intravenous (IV, directly into a vein) medications mixed in the satellite pharmacies which were located on floors 2, 4, 5, 6, 7, 8, and the pharmacy in the basement (IVAS, Intravenous Additive Services).
On 12/5/16 at 10:35 am, at the 8th floor pharmacy, Pharm 1 identified the IV compounding area with a laminar airflow hood (IV hood, device to maintain a germ free work area). The area on the floor in front of the IV hood was marked off with red and white stripped tapes. The taped off area resembled a rectangle. There was enough room for a person to stand in the area and work in the IV hood. (See Exhibit 1). Pharm 1 stated the taped area was used as a segregated compounding area (a designated space for sterile IV compounding for low-risk level sterile IV medications with up to a 12-hour beyond-use date, BUD). Pharm 1 also stated that the satellite pharmacies on Floors 2 through 8 had similar floor plans and segregated compounding areas. Pharm 1 further stated pharmacy personnel would mix first doses of IV medication orders for each floor in these areas within the satellite pharmacies and the remaining doses would be mixed in IVAS. During a concurrent inspection of the IV hood, there was a spray bottle of nonsterile alcohol (70% isopropyl alcohol, IPA). Pharm 3 stated pharmacy personnel put on nonsterile gloves, spray their hands with the nonsterile alcohol, and spray the tops of medication vials before the sterile compounding process. There was no evidence that sterile gloves and no personal protection equipment (PPE, shoe covers, hair/facial hair covers, face mask, and gown) were available and used within the satellite.
On 12/5/2016 at 10:56 a.m., during an inspection of the 7th floor satellite pharmacy, Pharm 4 stated pharmacy personnel used the nonsterile alcohol to clean the hood, and as well as during the sterile compound process described by Pharm 3 previously. Concurrently, the Pharmacy Tech (PTech 2) was stepping away from the IV hood. Pharm 4 indicated PTech 2 had just finished compounding an IV medication. PTech 2 was wearing nonsterile gloves and had not donned on PPE. There was no evidence that sterile gloves and no PPE were available and used within the satellite.
On 12/5/2016 at 11:30 a.m., at the 6th floor satellite pharmacy, Pharm 1 described the sterile compounding process occurred in the satellite pharmacies on floors 2, 4, 5, 6, 7, and 8. Pharm 1 stated pharmacy personnel used nonsterile gloves during sterile compounding process. Pharm 1 also confirmed that pharmacy personnel used nonsterile alcohol inside the IV hood for cleaning.
On 12/5/2016 at 11:50 a.m., during an inspection of the 5th floor satellite pharmacy, there was a spray bottle, with "H2O" (water) handwritten on it, inside the IV hood. Pharm 5 indicated the pharmacy personnel would use that bottle of water during the cleaning process of the IV hood. During a concurrent interview, Pharm 1 stated the described practice did not meet the hospital's expectation for IV hood cleaning.
On 12/7/2016 at 10 a.m., a record review of IV medications dispensing report for a randomly selected 7-day period between 11/29/2016 and 12/5/2016 indicated the hospital's pharmaceutical sterile compounding services had dispensed a total of 10,972 doses of IV medications. Of those 10,972 doses, the six satellites combined had prepared and dispensed 3,540 doses and the IVAS had dispensed 7,432 doses. Therefore, the six satellite pharmacies combined roughly accounted for a third of all sterile compounding of the hospital.
A review of the hospital's policy, numbered 6503, titled "Equipment Cleaning: Laminar Airflow Workbench" dated 8/5/2016, indicated "...[IV hood] ... are to be cleaned with sterile 70% Isopropyl Alcohol in the following circumstances ... "
A review of the hospital's policy, numbered 6402, titled "Aseptic Technique Overview", and dated 8/7/2016, indicated the hospital utilize USP Chapter 797 (United States Pharmacopeia chapter, titled Pharmaceutical Compounding - Sterile Preparations, "The objective of this chapter is to describe conditions and practices to prevent harm, including death, to patients that could result from ... microbial contamination (non-sterility), ... excessive bacterial toxins ... " ) as reference. The policy also indicated the equipment and materials for the policy included "approved hand hygiene and garbing equipment and supplies ... Spray bottles containing sterile 70% isopropyl alcohol ... Touch contamination by pharmacy personnel ...is the most common cause of ...contamination. Touch contamination is the result of aseptic technique not being maintained ... [Compounded sterile IV medications] integrity must be maintained and every precaution taken to assure sterility. "
A review of USP 797 Pharmaceutical Compounding-Sterile Preparations, Personnel Cleansing and Garbing, indicated "...Personnel shall don the following PPE, ... shoe covers, head and facial hair covers, ...face masks, hand cleansing procedure, ... gown, ... Sterile gloves shall be the last item donned before compounding begins.

2. On 12/6/2016 at 2:16 p.m. a review of the pharmacy administrative record indicated gloved fingertip sampling (GFS) had been done for pharmacy personnel worked in IVAS; however, there was no evidence that the GFS had been performed to the pharmacy personnel worked in the six satellite pharmacies.
During an interview on 12/7/2016 at 10:30 a.m., the Director of Pharmacy (DOP) confirmed no GFS done on the pharmacy personnel working at the satellite pharmacies.
A review of the hospital's policy, numbered 6607, titled "Gloved Fingertip Sampling", dated 8/7/2016, and reference to the USP 797, indicated "GFS is an integral part of insuring that the employee is aware of the microbiological bioburden on their gloves and that touch contamination is believed to be the primary source of [sterile IV medication] contamination ... "
3. During a tour, interview, and administrative record review, on 12/5/16 at 1:15 p.m., in the IVAS, Pharm 1 identified the sterile IV compounding suite. (See exhibit 4, IVAS floor plan). According to the floor plan and pharmacy personnel, IVAS consisted of five areas, identified as, ante-room (area to prepare for mixing sterile IVs), buffer room (area under negative pressure and limited to activities such as personnel hand hygiene and garbing procedures, preparation and staging of components required), chemo room (area to mix hazardous chemotherapy medications), gene therapy (area to mix other hazardous, high-risk, non-chemo medications), and IV prep (area to mix non-hazardous medications). These areas were separated by walls and centrally connected via doorways to the buffer room. All five areas required proper air pressure differentials to ensure sterile compounding areas could achieve and maintain sterility, minimize potential of contamination of the IV medications. In the ante room, on the wall next to the door leading into the buffer room, there was a panel of four pressure gauges. During a concurrent inspection of those gauges with Pharm 1, Pharm 1 acknowledged that each room was maintaining a correct pressure differential (pressure differences between opposite sides of a door).
During an interview and record review, on 12/5/16 at 3:15 p.m., Pharm 2 and MGR 4 identified the iSensix (pressure monitoring system for IVAS) logs. A concurrent review of the logs showed there were several occasions when the pressure differential between any two IVAS rooms were outside the required standards.
On 12/7/2016 at 9:13 a.m., during an interview with MGR 2 and a concurrent review of the IVAS pressure excursion (incident when the pressure differential was outside the required standard) history report between November 2015 and December 2016, MGR 2 confirmed there were eight occurrences in the past twelve months when the air pressure relationships within IVAS' sterile compounding areas were outside of the required standards. One of those eight occurrences had lasted 25 days. MGR 2 indicated there was no record that the hospital had investigated, and/or acted upon, these occurrences to ensure the environment for the sterile compounding process remained free of contaminants. MGR 2 stated there was no policy or contingency plan of operation when the pressure excursion occurred within the IVAS was not readily resolved. (Cross reference to A0273)
On 12/7/2016 at 10 a.m., during an interview, DOP acknowledged that IVAS dispensed roughly two-thirds of all IV medications for the hospital patient needs and the above mentioned eight pressure excursions without actions. DOP agreed there should be contingency plan.
A review of the hospital's policy, numbered 6602, titled "Airflow Considerations and Pressure Differential Monitoring", dated 8/5/2016, and reference to the USP 797, indicated " ...pressure differentials are monitored daily ...and ensures prompt actions in the event of malfunction."

4. During a tour, interview, and administrative record review, on 12/5/16 at 1:30 p.m., in the IVAS, Pharm 1 identified one of the buffer rooms was used to mix chemo medications. A concurrent inspection of the chemo room with Pharm 1 indicated there was a working sink with foot pedals. Pharm 1 acknowledged that the hazardous buffer room should not have a working sink.
A review of USP chapter 797, Pharmaceutical Compounding-Sterile Preparations, indicated " ...The buffer area shall not contain sources of water (sinks) ... "

5. During a tour, interview, and record review, on 12/5/16 at 10:55 am, in the 7th floor pharmacy, Pharm 1 identified the sterile compounding area. Inside the area, there was an IV hood. Inside the hood there were two vials of Azactam (antibiotic) 1 gm (gram), NDC 0003-2560-16, medication vials. An inspection of the vials showed they had been reconstituted; each vial had handwritten notes "12/12 [seven days]." PTech 2 stated she had just reconstituted and mixed an IV medication with the vials and the handwritten date was when the Azactam expired. Pharm 1 inspected the two Azactam vials and stated they were single dose vials. Pharm 1 further stated single dose vials should have been thrown away after one use.

A review, of USP chapter 797, Pharmaceutical Compounding-Sterile Preparations, indicated for Single-Dose and Multiple-Dose Containers, " ...Opened or needle-punctured single-dose containers, such as bags, bottles, syringes, and vials of sterile products and CSPs shall be used within 1 hour if opened in worse than ISO Class 5 air quality (such as outside of a properly functioning IV hood), and any remaining contents must be discarded. Single-dose vials exposed to ISO Class 5 or cleaner air (such as inside a properly functioning IV hood) may be used up to 6 hours after initial needle puncture. "

On 12/6/2016 at 11:40 a.m., during an inspection of the 5th floor satellite pharmacy, there was a syringe inside the hood. Pharm 5 stated she prepared the syringe as stock solution to be used throughout the day. A concurrent inspection of the label and compounding information of the syringe with Pharm 6 indicated it had a beyond-use date (BUD, a date by which the compounded medication must be used before it is at risk for chemical degradation or contamination; similar to expiration date) of twenty-four hours. Both Pharm 5 and Pharm 6 identified that the compounding area was considered ISO 5 (a categories of air and cleanliness quality).

On 12/6/2016 at 2:16 p.m., Pharm 1 stated the above mentioned IV syringe should have a BUD of 12 hours.

A review, of USP chapter 797, Pharmaceutical Compounding-Sterile Preparations, indicated that IV medications prepared in an IV hood, with previously described environment, shall have a 12-hour or less BUD.

6. On 12/5/16 at 1:15 p.m., during an inspection in the IV Prep room inside the IVAS, there were two pre-drawn syringes inside the IV hood closest to the entrance. Pharm 1 identified those two syringes were not properly labeled and missing at least the BUD.

A review of the hospital's policy, numbered 6418, titled, "Labeling and Label Accountability of Small Volume Parenterals and other miscellaneous sterile products", dated 8/7/2016, and reference to the USP 797, indicated "all miscellaneous sterile products shall be correctly labeled ... shall contain ...expiration date."



22458


7. On December 6, 2016 at 11:45 a.m., during an inspection of the 2nd floor satellite pharmacy, Pharmacist 7 was observed preparing sterile IV solutions within the laminar hood space, with ungloved hands. There were several medication vials, IV solution bags, and sterile needles in the work area. Pharmacist 7 state that she had washed her hands prior to preparing the medications. She then donned a pair of sterile gloves, and continued to prepare the sterile IV solutions.

On December 7 2016 at 2:15 p.m., another interview was conducted with Pharmacist 7. When questioned why she was not wearing gloves prior to starting the IV compounding the prior day, Pharmacist 7 responded that she was rushed for time. She then stated that sterile gloves were to be worn during the mixing and preparation of sterile IV solutions, in order to prevent risk of contamination.

8. On December 6, 2016 at 11:15 a.m., during an observation for cleaning the laminar hood in the 6th floor satellite pharmacy, Pharm Tech 2 donned a pair of sterile gloves. In the process of applying the right glove, the glove accidentally touched a hole puncher device on the work station. However, Pharmacy Tech 1 did not replace the glove. Pharm Tech 2 sprayed the ceiling, sides, and work surface of the hood with sterile alcohol. He then saturated a lint-free cloth with alcohol, then stated that he had to wait for three minutes after applying the alcohol to the cloth. After three minutes, Pharm Tech 1 wiped the hood surfaces with the cloth. The tech did not re-wet the hood surfaces with alcohol, in order to ensure the surfaces remained wet, in order to provide a five minute dwell time.

9. On December 6, 2016 at 11: 55 a.m., during observation of laminar flow hood cleaning in the 2nd floor satellite pharmacy, Pharm Tech 3 opened a pair of sterile gloves. While donning the gloves, the left hand glove was torn near the wrist area. However, Pharm Tech 3 finished donning the gloves without replacing the torn glove, and proceeded to clean the hood.

On December 7, 2016 at approximately 10 a.m., during an interview, the Director of Pharmacy (DOP) stated that the damaged gloves should have been replaced immediately. She also indicated that the hood surfaces must remain wet for five minutes, prior to being re-wiped.



29359

Based on observation, interview, and document review, the hospital failed to ensure an effective, active system-wide infection control program for prevention, control, and investigation of infections and communicable diseases. The infection control program did not meet the needs of all patients receiving pharmaceutical services and supportive healthcare in the hospital as evidenced by:

1. The hospital failed to ensure their Infection Control Program provided active surveillance in their satellite pharmacies. (Refer to A-0490, A-0748 and A-0749)

2. The hospital's Infection Control Program failed to provide aseptic technique education to pharmaceutical staff who performed compounding. (Refer to A-0490, A-0748 and A-0749)

3. The hospital failed to integrate active hospital-wide infection prevention and control program into the facility's QAPI program. (Refer to A-0748 and A-263)

4. The hospital failed to ensure they had an effective, active and a systematic infection control surveillance program in place for identifying, investigating, and controlling infections in their operating room department. (Refer to A-0749 and A-0951)

5. The processing and sterilization of surgical instruments did not follow nationally accepted standards when the hospital failed to ensure there was no presence of spotting and staining on multiple instruments, in two of two processed surgical trays (a major and a minor, previously cleaned, disinfected and sterilized surgical instruments). (Refer to A-0749 and A-0951)

6. The hospital failed to provide effective infection control monitoring and surveillance of their Surgical Services. (Refer to A-0749 and A-0951)

7. Operating Room (OR) #16, a room which had been cleaned and ready for a patient who required surgical procedures contained multiple items with black, red, and gray matter which could be easily wiped off. (Refer to A-0749 and A-0951)

8. OR # 1, a room which had been cleaned and ready for a patient who required surgical procedures, contained a prep stand (used to hold sterile items during a surgical procedure) with red and brown matter which could be easily wiped off. (Refer to A-0951)

9. Two surgical service staff, (OR Assist 1 and Medical Services Officer (MSO 2), did not know the correct contact time (the length of time a disinfectant's label indicates that it must remain wet on a surface in order to achieve efficacy), for the cleaning agent (Quat A456 II) used in the OR. (Refer to A-0749 and A-0951)


10. OR staff did not wear personal protective equipment (PPE- specialized equipment or clothing for eyes, face, head, body, and extremities) in the operating rooms during surgical procedures, and during cleaning of OR rooms. (Refer to A-0749 A-0951)

11. There was no evidence of daily terminal cleaning (Infection Prevention process performed by the Environment of Care staff) in 24 of 24 operating rooms, and one decontamination room. (Refer to A-0749 and A-0951)


12. There was no evidence that surgical service staff received education regarding the cleaning agents used in surgical services. (Refer to A-0749 and A-0951)

The cumulative effects of these systemic problems resulted in the hospital's inability to provide an effective hospital wide infection control program, which resulted in the hospital's inability to provide patient care in a safe and effective manner, and in accordance with §482.42 Condition of Participation for Infection Control Services. The seriousness of these systemic problems resulted in an Immediate Jeopardy being called regarding the hospital's Pharmaceutical Services, which was identified by the survey team.


28851


On 12/5/16 at 5:10 p.m., an Immediate Jeopardy (IJ) was declared for the widespread pattern of potential ineffective sterile compounding process, a process of making sterile (germ-free) IV medications. Through observations, interviews and record reviews, the survey team identified significant concerns in 6 of 6 satellite pharmacies (located on floors 2, 4, 5, 6, 7, 8) and the intravenous additive service pharmacy (IVAS). The hospital failed to ensure the pharmacy personnel in the satellites pharmacies prepared sterile IV medications with proper aseptic technique and appropriate garb requirement, and maintained the sterile compounding areas, following their policies and procedures that were in accordance with acceptable standards of practice. The hospital also failed to ensure the air pressure relationships within the IVAS were compliant at all times, failed to have a system in place for investigating the air pressure relationships that were detected outside of thresholds, and, failed to have a contingency plan for the sterile compounding process in the event of a prolonged air pressure excursion within IVAS, in order to protect the quality, integrity, and sterility of the IV medications.

The IJ was called in the presence of the Chief Medical Officer (CMO), Director of Infectious Diseases, Assistant Director of Pharmacy Services, Director of Clinical Regulatory Affairs, Administrative COO, and Chief Nursing Executive (CNE), and Chief Nursing Officer (CNO).

On 12/6/16 at 10 am, the CNE and the CMO provided an acceptable corrective action plan to lift the immediacy of the IJ. On 12/7/16, at 6:30 PM, the immediate jeopardy was abated, after the team validated, through observations, interviews, and record reviews, the hospital's directive action plan. The IJ was abated in the presence of the CNE, CMO, COO, Director of Operative Services, Director of Pharmaceutical Services, and Director of Infectious Diseases.


33399

Based on observation, interview and record review, hospital's Infection Control Program failed to provide aseptic technique education to pharmaceutical staff who performed sterile compounding of intravenous (IV- directly into a vein) medications and integrate an active hospital-wide infection prevention and control program into the facility's QAPI program.

Findings:

On 12/5/2016 at 10:35 a.m., during a tour of the hospital's satellite pharmacies and IVAS center, the surveyors, the Chief Medical Officer (CMO) and Pharm 1 observed the following:

a. Pharmacy personnel in six of six satellite pharmacies failed to don sterile gloves and protective personal equipment (such as shoe covers, hair and facial hair covers, face mask, and gowns), prior to the start of any sterile compounding process.

b. Pharmacy personnel used nonsterile alcohol to maintain and clean the sterile compounding areas.

c. The hospital used Isenix (pressure monitoring system) to monitor the air pressure relationships within IVAS. A review of the IVAS pressure excursion history between November 2015 and December 2016, indicated there were eight occurrences in the past twelve months when the air pressure relationships within IVAS' sterile compounding areas were outside of the required standards. One of the eight occurrences lasted for 25 days. There was no evidence that the hospital had investigated these occurrences and acted to ensure the environment for the sterile compounding process within IVAS remained free of contaminants.

On 12/5/16 at 5:10 p.m., an Immediate Jeopardy (IJ) was declared for the widespread pattern of potential ineffective sterile compounding process, a process of making sterile (germ-free) IV medications. Through observations, interviews and record reviews, the survey team identified significant concerns in 6 of 6 satellite pharmacies (located on floors 2, 4, 5, 6, 7, 8) and the intravenous additive service pharmacy (IVAS). The hospital failed to ensure the pharmacy personnel in the satellites pharmacies prepared sterile IV medications with proper aseptic technique and appropriate garb requirement, and maintained the sterile compounding areas, following their policies and procedures that were in accordance with acceptable standards of practice. The hospital also failed to ensure the air pressure relationships within the IVAS were compliant at all times, failed to have a system in place for investigating the air pressure relationships that were detected outside of thresholds, and, failed to have a contingency plan for the sterile compounding process in the event of a prolonged air pressure excursion within IVAS, in order to protect the quality, integrity, and sterility of the IV medications.

The IJ was called in the presence of the Chief Medical Officer (CMO), Director of Infectious Diseases, Assistant Director of Pharmacy Services, Director of Clinical Regulatory Affairs, Administrative COO, and Chief Nursing Executive (CNE), and Chief Nursing Officer (CNO).

On 12/6/16 at 10 am, the CNE and the CMO provided an acceptable corrective action plan to lift the immediacy of the IJ. On 12/7/16, at 6:30 PM, the immediate jeopardy was abated, after the team validated, through observations, interviews, and record reviews, the hospital's directive action plan. The IJ was abated in the presence of the CNE, CMO, COO, Director of Operative Services, Director of Pharmaceutical Services, and Director of Infectious Diseases

Based on interview, review of documents and observation the hospital failed to ensure:
1. There was evidence of daily terminal cleaning (Infection Prevention process performed by the Environment of Care staff) in 24 of 24 operating rooms, and one decontamination room.
2.There was evidence that surgical service staff received education regarding the cleaning agents used in surgical services.
3.Staff member practiced hand hygiene in accordance with facility policy and nationally recognized standards of practice, while caring for a immuno-suppressed (suppression of the immune system and its ability to fight infection) patient (Patient 1). This failure had the potential to result in cross-contamination, and placed the patient at increased risk of infection.
4. Safe sterile pharmaceutical conditions existed when airflow readings in the intravenous additive service were out of range.

Findings:

1. During an interview with MSO III, on 12/7/16 at 10:15 AM, she stated, "The OR department has 24 OR rooms but only 4 rooms per night get terminally cleaned because they can't possibly clean all rooms. They get rotated." A request was made to produce terminal cleaning logs.

An interview with a staff from Environmental Service Department (EVS 1) and a concurrent record review (of a terminal cleaning log), on 12/7/16 at 11:50 AM, was conducted. EVS 1 was asked to explain the hospital's terminal cleaning process (thorough environmental cleaning performed at the end of each day when the area is being used). The following was revealed:

a. There was no evidence that daily terminal cleaning was performed in 24 of 24 operating rooms.

b. EVS 1 stated, after reviewing the terminal cleaning log, that OR 16 had been terminally cleaned on 12/6/17 and prior to that date, it had been cleaned on 11/9/16. The log also revealed that none of the 24 OR rooms were terminally cleaned daily.

c. EVS 1 stated that terminal cleaning is performed on a weekly schedule, not daily.

d. EVS 1 provided a document titled, "Surgical/Invasive Areas and Delivery Rooms - Terminal Weekly Cycle Cleaning ...Note: Either Terminal Cleaning - End of Day or Terminal Cleaning - Weekly Cycle procedures shall be performed daily ..."


During an interview, on 12/7/16 at 3:50 PM, the Administrator Director of EVS was asked to provide evidence and to explain the hospital process for terminal cleaning of their decontamination area. He was unable to provide evidence to show that they performed daily terminal cleaning and stated, "We will be working on making changes to that and to ensure it's getting done."

During a previous interview, on 12/5/16, a hospital infection control personnel (ICP 1), stated that the hospital followed the following nationally recognized infection control guidelines.

a. APIC - Association for Professionals in Infection Control
b. AORN - Association of Perioperative Registered Nurses
c. AAMI - Association for the Advancement of Medical Instrumentation
d. CDC -Centers for Disease Control

According to AORN guidelines, terminal cleaning should be performed:

a. When scheduled procedures are done.
b. Each 24 hours during regular work week.
c. Unused rooms should be terminally cleaned every 24 hours.

According to AORN's "Recommended practices for environmental cleaning in the perioperative setting ...The patient should be provided a clean, safe environment. Maintaining a clean environment for patient care reduces the risk of exposing patients and personnel to potentially infectious microorganisms by removing dust and debris that can accumulate during the day. Cleaning between procedures in combination with terminal cleaning at the end of the scheduled procedures ensures a complete cleaning process and protects everyone from infectious microorganisms."


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2. On December 5, 2016 at 1:35 p.m, during an observation of the 7th Floor (Liver Transplant/Heart Transplant Unit), RN 1 was in Patient 1's room making the bed, but did not sanitize her hands after she finished. She then touched her hair, and again without sanitizing her hands, moved several items on the over bed table closer to the patient, who was sitting up in the chair. RN 1 then sanitized her hands.

In an interview with RN 1 immediately following the observation, she stated she should have sanitized her hands immediately after touching her hair, in order to prevent cross-contamination.



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3. The hospital used Isenix (pressure monitoring system) to monitor the air pressure relationships within IVAS. A review of the IVAS pressure excursion history between November 2015 and December 2016, indicated there were eight occurrences in the past twelve months when the air pressure relationships within IVAS' sterile compounding areas were outside of the required standards. One of the eight occurrences lasted for 25 days. There was no evidence that the hospital had investigated these occurrences and acted to ensure the environment for the sterile compounding process within IVAS remained free of contaminants.

Based on observations, interviews, and record reviews, the hospital failed to provide surgical services in a well-organized manner and in accordance with acceptable standards of practice. The hospital failed to comply with the §482.51 Condition of Participation for Surgical Services when:

1. The hospital failed to ensure they had an effective, active and a systematic infection control surveillance program in place for identifying, investigating, and controlling infections in their operating room department (Refer to A-0951).


2. The processing and sterilization of surgical instruments did not follow nationally accepted standards when the hospital failed to ensure there was no presence of spotting and staining on multiple instruments, in 2 of 2 processed surgical trays (a major and a minor, previously cleaned, disinfected and sterilized surgical instruments) (Refer to A-0951).


3. The hospital failed to provide effective infection control monitoring and surveillance of their Surgical Services (Refer to A-0951).

4. Operating Room (OR) #16, a room which had been cleaned and ready for a patient who required surgical procedures contained multiple items with black, red, and gray matter which could be easily wiped off (Refer to A-0951).


5. OR # 1, a room which had been cleaned and ready for a patient who required surgical procedures, contained a prep stand (used to hold sterile items during a surgical procedure) with red and brown matter which could be easily wiped off (Refer to A-0951).

6. Four (4) of 4 surgical service staff, (OR Assist 1, OR Charge 1, OR Assist 2 and MSO 2), did not know the correct contact time (the length of time a disinfectant's label indicates that it must remain wet on a surface in order to achieve efficacy), for the cleaning agent (A456 II) used in OR (Refer to A-0951).

7. Interviews with the QAPI committee on 12/7/2016 revealed there was no direct oversight or observations made of cleaning techniques or personal protective equipment worn by the staff performing these duties.


8. There was no evidence of daily terminal cleaning (thorough environmental cleaning performed at the end of each day when the area is being used) in 24 of 24 operating rooms and one decontamination room (Refer to A-0749 and A-0951)


9. There was no evidence that surgical service staff received education regarding the cleaning agents used in surgical services (Refer to A-0951).


The cumulative effect of these systemic problems had the potential to transmit infectious microorganisms to patients and increased the risk of infections to all patients who received care. The hospital failed to deliver care in a safe setting and therefore failed to comply with the §482.51 Condition of Participation for Surgical Services.

On 12/7/16 at 12:15 P.M., an Immediate Jeopardy (IJ) situation was declared in the presence of the facility Administrators, who were verbally notified, after the team identified, through observations, interviews, and record reviews, a pattern of ineffective infection control practices, in the surgical services department. The hospital failed to protect all patients requiring surgical services from the potential of nosocomial infections and failed to provide surgical services in a well-organized manner and in accordance with acceptable standards of practice. These failures had the potential to affect the health and safety of all patients, requiring surgical services.

On 12/7/16 at 6:30 PM, the Immediate Jeopardy Situation was lifted, in the presence of the hospital Chief Nurse Executive (CNE), the Chief Medical Officer (CMO), the Chief Operating Officer (COO) and other senior leadership. The CNE, CMO, and COO were informed that the hospital's corrective action plan was approved by the team, after observation interview and record review confirmed the facility's immediate situation was corrected. The corrective action plan included the following components:

1. Inspection and assessment of all available operating room environments were completed on 12/7/16. All equipment was evaluated, and removed, refurbished and or replaced, if necessary.

2. Effective immediately terminal cleaning occurred in all operating rooms (OR). The standard of practice will reflect terminal cleaning to occur in all ORs, daily.

3. Staff who performed OR cleaning were re-educated in relation to the quaternary (disinfectant cleaner ECOLAB A-456II), dwell time, and the appropriate use of PPE. In addition staff were educated regarding the use of secondary containers with appropriate chemical labeling.

4. A room readiness checklist was developed and was in practice.

5. A thorough review of perioperative environmental cleaning and infection prevention policies was performed to ensure all policies and procedures met regulatory requirements and AORN (Association of Perioperative Registered Nurses) guidelines.

6. An education program regarding OR cleaning policies and procedures was performed on 12/7/16 and further education was designed in partnership with Environmental Services (EVS) Supervisors to assure detailed room cleaning was in compliant with internal, AORN guidelines and regulatory policies. The Infection Control Medical Director and Specialists, with surgical services leadership, were trained from EVS to assure the quality of regular inspection of the physical environment.

7. Monitoring to be done at least weekly and reported to hospital leadership via Infection Control and Clinical Excellence Committees. A surveillance checklist was drafted and implemented on 12/7/16 to maintain a safe, clean patient environment.

Based on observation, interview, and document review, the hospital failed to ensure an effective, active system wide infection control program for prevention, control, and investigation of infections and communicable diseases in their surgical services department. The hospital also failed to ensure hospital operating room policies were followed to assure surgical services were performed in accordance with acceptable standards of care and practice when: The infection control program did not meet the needs of all patients receiving surgical care in the hospital as evidenced by:

1. The processing and sterilization of surgical instruments did not follow nationally accepted standards when the hospital failed to ensure there was no presence of spotting and staining on multiple instruments in 2 of 2 processed surgical trays (a major and a minor tray which contained previously cleaned, disinfected and sterilized surgical instruments).

2. For Operating Room (OR) #16, the hospital failed to appropriately clean and disinfect the OR suite between surgical cases and was not completed according to facility infection control standards and manufacturer's guidelines.

3. For OR # 1, the hospital failed to appropriately clean and disinfect the OR suite between surgical cases and was not completed according to facility infection control standards and manufacturer's guidelines.

4. Four (4) of 4 surgical service staff, (OR Assist 1, OR Charge 1, OR Assist 2 and MSO 2), did not know the correct contact time (the length of time a disinfectant's label indicates that it must remain wet on a surface in order to achieve efficacy), for the cleaning agent (A456 II) used in OR.

5. OR staff did not wear personal protective equipment (PPE specialized equipment or clothing for eyes, face, head, body, and extremities) in the operating rooms during surgical procedures and during cleaning of OR rooms.

6. There was no evidence of daily terminal cleaning (thorough environmental cleaning performed at the end of each day when the area is being used) in 24 of 24 operating rooms and one decontamination room (an area where surgical instruments are cleaned and disinfected).

7. The hospital failed to provide effective infection control monitoring and surveillance of their Surgical Services.

8. There was no evidence that surgical service staff received education regarding the cleaning agents used in surgical services.

The cumulative effects of this systemic lack of oversight in surgical services and lack of acceptable infection control practices in the operating room had the potential in the facility's inability to perform surgeries in a safe and sanitary manner.

Findings:

1. On 12/5/16 at 11:30 AM, a hospital infection control personnel (ICP 1), stated that the hospital followed the following nationally recognized infection control guidelines.

a. APIC - Association for Professionals in Infection Control
b. AORN - Association of Perioperative Registered Nurses
c. AAMI - Association for the Advancement of Medical Instrumentation
d. CDC -Centers for Disease Control

On 12/7/16 at 11 a.m., an observation was performed of 2 of 2 random processed surgical trays (1 major and 1 minor tray), which were chosen by hospital staff. Both trays combined, contained over 80 surgical instruments. Multiple instruments had brown and white staining. Some of the brown staining was able to be wiped off or scraped off.

During the same observation, a concurrent interview was conducted with Surgical Coordinator 1. The instruments with the staining were shown to Surgical Coordinator 1. She was unable to state what the staining was however she did say that the staining could possibly be due to "overuse of instruments", "detergent" or "hard water" staining. She also stated that the staining was not acceptable and they would remove them from use and or reprocess the instruments. A policy for inspection of surgical instruments was requested.

According to the Association for the Advancement of Medical Instrumentation (AAMI TIR30, Section 5.4.): Medical device manufacturers should be familiar with cleaning, disinfection, and sterilization technologies used in health care facilities and with the kinds of soil and microbial contamination encountered as a result of patient use. Organic soil such as blood, serum, lipids, tissue fragments, and inorganic salts can impede the disinfection or sterilization process if it is not removed during cleaning. Most of these soil components are substrates for the sterilants used for disinfection or sterilization; that is, they are competitors for sterilant action. If these soil components are insufficiently removed, they can also protect microorganisms from inactivation by limiting the
diffusion of the sterilant to the microorganisms' location on the medical device.

AAMI's Technology Information Report (TIR) 30: 2011 5.2.4 specifies:

"Rinsing
Adequate rinsing is necessary to remove all traces of enzymes, detergents, and residual soil. Water quality should be considered when developing and testing cleaning procedures. Water hardness, temperature, and the type of soil can have an impact on the effectiveness of cleaning products and rinsing and, consequently, the efficacy of the cleaning process. Water quality varies from one area to another and from season to season within the same area."

Additionally, AAMI TIR-34 2007 also specifies:

"Patient infection resulting from the use of contaminated devices (e.g., salt or organic deposits from the water used in reprocessing could inactivate the disinfectant or sterilant or could protect microorganisms from the disinfection or sterilization process; a disinfected or sterilized device could transmit an infection if rinsed with water containing unacceptable levels of microorganisms)."

By the completion of the survey, the facility failed to provide a policy regarding the inspection of surgical instruments.


2. On 12/6/16 at 11:35 a.m., during a tour, of the hospital's surgical services department, operating room (OR) 16, a room which had been cleaned and ready for a patient who required surgical procedures, was conducted with OR Charge 1, the following was observed:

a. Gray and white fuzzy matter on top of the anesthesia cart (hospital device used to store tools necessary during surgical procedures that required administration of medications used to subdue a patient's mind and prevent him or her from feeling any pain during a surgical operation).

b. 8 surgical clamps were attached and hanging from the anesthesia cart. An immediate interview was conducted with the OR Charge RN 1, who stated that the clamps were disposable and not meant to be reused. According to OR Charge RN 1, some anesthesiologist will reuse them but they are supposed to be discarded.

c. A two cylindrical tubing attached to the OR bed, had dried red, brown and black matter that was easily removed with a damp wipe.

d. Three (3) of 3 tanks, attached to the anesthesia cart had orange, red, white and brown matter that was easily removed with a damp wipe.

e. Black and brown matter was observed on the bottom of the OR bed, that was easily removed with a damp cloth.

f. Large amounts of black and brown stains and white and gray fuzzy matter was observed on the edges around the floor.

g. The OR bed's mattress was torn and the inner foam was exposed and had yellow and brown discoloration. An immediate interview was conducted with the OR Charge RN 1, who stated that torn items were supposed to be removed from patient use and replaced.

h. 3 of 3 step stools used during surgical procedures had white, black, gray, and red matter of the top surface and the metal portion had red, dried splash marks. During an immediate interview with OR Assist 1, he stated the red marks looked like dried blood.

During an immediate interview following the observations, OR Assist 1 stated after the observations were made in OR 16, that he was the person responsible for cleaning the room on 12/6/16. He also stated, "I do the best that I can and I can only clean as deep as my fingers will allow me" and sometimes the hospital did not have enough staff to help. When asked to verbalize the contact time (the length of time a disinfectant's label indicates that it must remain wet on a surface in order to achieve efficacy) of the cleaning agent (A-456 II Disinfectant Cleaner) that he used to clean OR 16, OR Assist 1 verbalized it had a 5 minute dry time. OR Assist 1 indicated that the 5 minutes contact time, referred to the drying time of the surface cleaned. OR Charge 1 also stated the cleaning agent's contact time was 5 minutes and also stated that the 5 minutes, was the drying time of the surface cleaned.

On 12/6/16, following the interview with OR Assist 1, a review of the A-456 II Disinfectant Cleaner's "Product Specification Document", provided by the hospital, was conducted. The contact time, according to the manufacturer instructions, stipulated, " ...Treated surfaces must remain wet for 10 minutes.

A review of a document, provided by hospital staff, titled, "Between Case Cleaning" stipulated the following, " ...Remove visible organic residue and inorganic salts and damp wipe all medical equipment using an approved disinfectant ...Damp wipe clean soiled spots on walls, ceilings, lights and wall vents ...Damp mop floor using an approved disinfectant by mopping under the procedure table radiating out towards your exit door ...Inspect your work ...

3. On 12/6/16 at 3:25 p.m., an observation was conducted of multiple staff cleaning OR 1, which had been used during a surgical procedure of a patient. During the observation, the surveyor identified brown/red staining on the lower portion of a small table like stand. At the completion of the cleaning, an inspection of the stand was performed.

An immediate interview was conducted with Hospital Assist A, who stated that she cleaned the "prep stand" (a small table used during surgical procedures). When the brown/red staining was shown to her, she wiped it off and stated that she did not know what it was and did not see it when she was cleaning.

On 12/6/16, a review of a hospital document, provided by the hospital staff, stipulated the following, "Between Case Cleaning ...Inspect your work ..."

During a tour of the sterile processing and decontamination areas on December 6, 2016 at 4:00 pm, when asked about terminal cleaning (a comprehensive and thorough cleaning method used in healthcare environments to control the spread of infections) of these areas, Manager 1 (MGR 1) stated that he did not know when it was performed but it probably was done after he was off duty in the early evening. MGR 1 also stated that it was the environmental services department's responsibilities to perform these cleanings. However, he was unable to produce a document that demonstrated that these areas were terminally cleaned on a daily basis.
No policy was provided upon request that addressed the daily terminal cleaning of the decontamination and sterile processing areas.
According to AORN Guidelines for Perioperative Practice, Guideline for Environmental Cleaning, Recommendation IV.a. Terminal cleaning and disinfection of perioperative areas, including sterile processing areas, should be performed daily when the areas are being used.

4. During interviews conducted from 12/6/16 to 12/7/16 at various times throughout the survey, four (4) of 4 surgical service staff, (OR Assist 1, OR Charge 1, OR Assist 2 and MSO 2), did not know the correct contact time for the cleaning agent (A456 II) used in OR department. The interviews with staff revealed the following:

a. OR Assist 1 indicated that the 5 minutes contact time, referred to the drying time of the surface cleaned.

b. OR Charge 1 stated the cleaning agent's contact time was 5 minutes and also stated that the 5 minutes, was the drying time of the surface cleaned.

c. OR Assist 2 stated the cleaning agent's contact time was 5 minutes and also stated that the 5 minutes, was the drying time of the surface cleaned.

d. MSO III, stated the cleaning agent's contact time was 5 minutes and stated that they had to assure the product dried within 5 min. She also stated that she was responsible for training new staff about the use of the disinfectant/cleaner.


On 12/6/16, a review of the A-456 II Disinfectant Cleaner's "Product Specification Document", provided by the hospital, was conducted. The contact time, according to the manufacturer instructions, stipulated, " ...Treated surfaces must remain wet for 10 minutes.


5. Interviews with the QAPI committee on 12/7/2016 revealed there was no direct oversight or observations made of cleaning techniques or personal protective equipment worn by the staff performing these duties.


6. During an interview with MSO III, on 12/7/16 at 10:15 AM, she stated, "The OR department has 24 OR rooms but only 4 rooms per night get terminally cleaned because they can't possibly clean all rooms. They get rotated." A request was made to produce terminal cleaning logs.

An interview with a staff from Environmental Service Department (EVS 1) and a concurrent record review (of a terminal cleaning log), on 12/7/16 at 11:50 AM, was conducted. EVS 1 was asked to explain the hospital's terminal cleaning process (thorough environmental cleaning performed at the end of each day when the area is being used). The following was revealed:

a. There was no evidence that daily terminal cleaning was performed in 24 of 24 operating rooms.
b. EVS 1 stated, after reviewing the terminal cleaning log, that OR 16 had been terminally cleaned on 12/6/17 and prior to that date, it had been cleaned on 11/9/16. The log also revealed that none of the 24 OR rooms were terminally cleaned daily.
c. EVS 1 stated that terminal cleaning is performed on a weekly schedule, not daily.
d. EVS 1 provided a document titled, " Surgical/Invasive Areas and Delivery Rooms - Terminal Weekly Cycle Cleaning ...Note: Either Terminal Cleaning - End of Day or Terminal Cleaning - Weekly Cycle procedures shall be performed daily ... "


During an interview, on 12/7/16 at 3:50 PM, the Administrator Director of EVS was asked to provide evidence and to explain the hospital process for terminal cleaning of their decontamination area. He was unable to provide evidence to show that they performed daily terminal cleaning and stated, "We will be working on making changes to that and to ensure it ' s getting done."

During a previous interview, on 12/5/16, a hospital infection control personnel (ICP 1), stated that the hospital followed the following nationally recognized infection control guidelines.

a. APIC - Association for Professionals in Infection Control
b. AORN - Association of Perioperative Registered Nurses
c. AAMI - Association for the Advancement of Medical Instrumentation
d. CDC -Centers for Disease Control

According to AORN guidelines, terminal cleaning should be performed:

a. When scheduled procedures are done.
b. Each 24 hours during regular work week.
c. Unused rooms should be terminally cleaned every 24 hours.

According to AORN's "Recommended practices for environmental cleaning in the perioperative setting ...The patient should be provided a clean, safe environment. Maintaining a clean environment for patient care reduces the risk of exposing patients and personnel to potentially infectious microorganisms by removing dust and debris that can accumulate during the day. Cleaning between procedures in combination with terminal cleaning at the end of the scheduled procedures ensures a complete cleaning process and protects everyone from infectious microorganisms."


7. During an interview with MSO III, on 12/7/16 at 10:15 AM, she stated that she was responsible for training the newly hire employees on their cleaning and disinfecting process of the OR rooms, in between cases. She also stated that "seasoned" staff also provided a mentorship/shadowing of the newly hired employees.

MSO III was unable to provide documented evidence to show staff were trained or educated regarding the use of their cleaning and disinfecting of OR rooms in between cases. She was also unable to provide evidence that staff were monitored or that active surveillance was performed by hospital staff. In addition, MSO III stated she thought that their EVS Department also provided instruction to all staff who use the cleaning and disinfecting agents.

During an interview, on 12/7/16 at 11:15 AM with ICP 1, she stated the Infection Control Department did not provide training to OR staff and it was the responsibility of OR supervisors and managers to provide training to OR employees.

During an interview with an Administrator Director of EVS Department, on 12/7/16 at 11:50 AM, he stated that EVS staff did not provide training to all staff, including OR staff and only provide training to employees who work in the EVS Department.

On 12/7/16 at 2:35 PM, a concurrent interview with MSO III and a record review of two (2) of 2 employee files (OR Assist 1 and Hospital Assistant A), were reviewed with MSO III. There was no documented evidence in the files to demonstrate they received training in the use of their cleaning agents or in the cleaning of the OR. MSO III verified the findings and stated they did not have evidence to show their staff were trained.

During the course of the survey from 12/5/16 to 12/7/16, multiple requests were made from the above personnel to provide policies regarding staff being trained/educated about the cleaning and disinfectants used in the OR Department. No policies were provided.


8. During an interview with MSO III, on 12/7/16 at 10:15 AM, she stated that she was responsible for training the newly hire employees on their cleaning and disinfecting process of the OR rooms, in between cases. In addition, MSO III stated that she did not provide active surveillance to ensure staff cleaned the operating rooms in accordance with acceptable standard of practices and tries to check on them when she has time.

MSO III was unable to provide documented evidence to demonstrate active surveillance was performed of staff that cleaned the OR.

During an interview, on 12/7/16 at 11:15 AM with ICP 1, she stated the Infection Control Department did not provide training to OR staff regarding the use of the cleaning agents used in OR. ICP 1 was also unable to provide documented evidence to demonstrate active surveillance was performed of staff that cleaned the OR. ICP 1 stated that she did not conduct daily active surveillance in the OR.


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