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Based on interview, personnel file and policy review, the facility failed to ensure:

1. Monitoring of physician vaccinations required to ensure safe patient care by an adequate number of physicians in the event of an infectious outbreak (refer to A 049);

2. Monitoring and tracking of staff to ensure an effective immunization program to ensure an adequate number of staff were immunized in the event of an outbreak in the community (refer to A747 and A749);

3. Monitoring to ensure an adequate supply of infection control supplies (PPE or personal protective equipment such as face masks) were available in the event of an outbreak (refer to A747 and A749);

4. Training of adequate number of staff to ensure the proper use of protective infection control equipment (N95 masks and Powered Air Purifying Respirators -PAPR) to care for patients with infectious diseases or during a potential outbreak. (An N95 mask is a snug-fitting respiratory protective device which, when fitted correctly, filters out 95 percent of particulate matter in the air. A PAPR is a hooded, battery operated piece of equipment that consists of a half or full facepiece, breathing tube, battery-operated blower, and particulate filters. Contaminated air is blown through the filter which removes any infectious agents or contaminants in the air. Both devices are used to prevent the transmission of infectious agents.) (refer to A747 and A749);

5. Staff followed facility policies and procedures for infection control practices and there was effective monitoring of those practices to ensure staff were trained according to policies and procedures (refer to A747 and A749);

6. Written plans of care were initiated for patients regarding isolation precautions or open wounds prone to infection in order to ensure continuity of care for control and treatment of infections. (refer to A747 and A749).

The cumulative effect of these systemic problems resulted in the hospital's inability to provide the necessary oversight and accountability to implement and maintain an effective infection control program.

Based on interview and personnel file and policy review, the governing body failed to ensure adequacy of coverage and quality of care when seven of 17 physicians (Physicians 2,3,5,10,11,12,13) did not have vaccinations required to provide care, if required, in the event of an outbreak of a communicable disease such as measles or chicken pox in the hospital or community. This failure had the potential to effect the quality of care to patients and community.

Findings:

During a medical staff personnel file record review and interview, on 5/21/15 at 10:25 a.m., Unlicensed Staff L stated "about a year and a half ago", physicians were required to have documentation of MMR (measles, mumps, rubella) vaccination, varicella (chicken pox), pertussis (whooping cough), and hepatitis (viral infection that caused inflammation of the liver) vaccinations. Unlicensed Staff L stated medical staff were informed if they refused the vaccinations and there was an outbreak, they would be unable to work for 21 days or until they provided the facility with either a blood titer (blood test that checks immune status or ability to resist infection) or documentation of vaccination.

On 5/21/15, a review of medical staff personnel files indicated seven of 17 physician files reviewed (Physicians 2,3,5,10,11,12,13) were missing information on vaccinations.

During an interview, on 5/26/15 at 3 p.m., Unlicensed Staff L stated results were misplaced and on 5/22/15, some physicians signed declinations until results could be obtained or found.

Review of Physician Health Screening Documents dated, 5/26/15, supplied by Unlicensed Staff L, on 5/26/15, indicated after it was discovered the documentation of vaccinations were missing on 5/21/15, of the seven physicians who were missing the immunizations such as MMR, varicella, pertussis and Hepatitis B, four physicians (Physician 2,5,11,13) filled out a declination form and one physician was still missing pertussis (physician 10). Two physicians provided documentation or had titers done (Physician 12 and 3).

During an interview, on 5/26/15 at 4:50 p.m., Administrative Staff A stated there was a "gap" in how the facility monitored Physician vaccinations. Administrative Staff A stated medical staff personnel were supposed to review to confirm the vaccinations were done. The plan was at every reappointment, they would check for vaccination of the physicians. Administrative Staff A stated the facility should have had the vaccination process in place for the physicians and agreed ensuring physicians were vaccinated was vital to ensure patient care was provided.

During an interview, on 5/27/15 at 8:30 a.m., Management Staff F stated the problem initially occurred when the physicians did not have the vaccination documentation available during appointment or reappointment, and then they did not come up for reappointment for two years so it was missed. Management Staff F stated the recently signed declination (refusal of vaccination) forms were just a "hold over" until the physician obtained their vaccinations and was "not a long term fix." Management Staff F stated the physicians should follow the policy and procedures for obtaining the vaccinations.

On 5/27/15, review of the policy titled, Health Screening and Immunizations for Medical Staff, reviewed 8/20/14, indicated in order to prevent the transmission of infectious diseases by healthcare professionals to susceptible patients, coworkers and visitors, immunity to certain communicable diseases was required of all staff and that medical staff were required to submit valid documentation of immunity for measles, mumps, rubella, varicella, pertussis and hepatitis B. The Policy indicated that Medical Staff who could not provide evidence of immunity to the above diseases must either submit to lab testing, vaccination, or sign a declination for each refused vaccine.

Based on observations, staff interviews, clinical record review, and document review, the hospital failed to ensure the Infection Control Preventionists provided adequate oversight of the Infection Control Program when:

1. There was an inadequate tracking system for monitoring expiration dates of supplies which resulted in a shortage of N95 masks used by staff to care for patients on infection control precautions or in event of an emergency or disaster. (An N95 mask is a snug-fitting respiratory protective device which, when fitted correctly, filters out 95 percent of particulate matter in the air. It is used to prevent the transmission of infectious agents) (Refer to A 749);

2. All employees with the potential to care for a patient (Patient 1) on aerosol isolation precautions (isolation against airborne infectious agents) were not fitted to a newly-supplied N95 mask and/or trained in the use of a Powered Air Purifying Respirators (PAPR - a hooded, battery operated piece of equipment that consists of a half or full facepiece, breathing tube, battery-operated blower, and particulate filters. Contaminated air is blown through the filter which removes any infectious agents or contaminants in the air). (Refer to A 749);

3. There was an inadequate tracking system for monitoring staff immunization status which resulted in some employees and physicians not being fully immunized (Refer to A 749);

4. Immediate Use Steam Sterilization (IUSS - immediate use sterilization refers to the shortest possible time between a sterilized item's removal from the sterilizer and its sterile transfer to the sterile field) was used in non-emergent situations in contrast to hospital policy. (Refer to A 749);

5. Sterile processing staff did not wipe down all work surfaces with disinfectant at the end of their shift per facility policy and procedure (Refer to A 749);

6. Operating Room (OR) cleaning staff removed a red bag (infectious waste) of trash containing potentially contaminated items from the OR to the dirty utility room without performing hand hygiene following changing of gloves (Refer to A 749);

7. Sterilility of equipment was not maintained when there was an open laryngoscope (a metal instrument which is inserted into a patient's mouth to access the airway) blade and handle and two opened endotracheal (ET) tubes (a plastic tube inserted into a patient's airway for the purpose of supplying air or oxygen) in the anesthesia cart located in the cesarean section operating room (Refer to A 749);

8. There was a sterile package of forceps (a metal instrument used during childbirth to assist in delivery of baby) on a cart in the Obstetrics (OB) clean supply room with lint on the outside of the package, along with several sterile packages that had either no sterilization load sticker on them or the information on the sticker was so faded as to be illegible (Refer to A 749);

9. While caring for a patient in the pre-operative area, an employee wiped her nose several times with her gloved hands without changing her gloves or performing hand hygiene (Refer to A 749);

10. A nurse performing a central line (central venous catheter - a tube inserted through a large vein to administer medications, fluids, nutritions) dressing change in the Intensive Care Unit (ICU) did not follow the manufacturer's specifications, nor facility policy and procedure for disinfection of skin (Refer to A 749);

11. A soiled linen barrel located in the OR hallway immediately adjacent to clean supplies was full, preventing closure of the lid (Refer to Tag A 749);

12. OR cleaning staff touched the floor with a disinfectant-soaked rag while cleaning a piece of equipment and did not discard the contaminated rag before proceeding to clean other pieces of equipment (Refer to A 749);

13. A nurse performing a wound dressing change used non-sterile, non-disinfected, single-use scissors for more than one dressing change over the course of two days. The facility did not have a policy for changing wound dressings (Refer to A 749);

14. A nurse preparing intravenous (IV) medication touched and potentially contaminated the sterile plunger of the syringe with her ungloved fingers, then administered the medication to a patient (Refer to A 749);

15. There were no isolation care plans for patients on isolation precautions for 28 of 30 sampled patients, nor for two patients with open surgical wounds. (Refer to A 749);

16. The Quality Improvement (QI) project of auditing IV, PICC (peripherally inserted central catheter) line, and CVC (central venous catheter) dressing changes did not include actual observation by auditors of the dressing changes to observe for aseptic (sterile) technique and proper disinfectant product use (Refer to A 749); and

17. Infection Control Preventionists did not conduct on-going observation of staff performing patient care, nor provided regular infection control inservices to staff (Refer to A 749).

The cumulative effect of these systemic problems resulted in the inability of the hospital's Infection Control Preventionists to fully mitigate risks associated with hospital-acquired infections, putting staff and patients at risk for infections.

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Based on observations, staff interviews, clinical record review, and document review, the hospital failed to ensure the Infection Control Preventionists (ICPs) provided adequate oversight of the Infection Control Program when:
1. There was an inadequate tracking system for monitoring expiration dates of supplies which resulted in a shortage of N95 masks (an N95 mask is a snug-fitting respiratory protective device which, when fitted correctly, filters out 95 percent of particulate matter in the air);
2. All employees with the potential to care for a patient (Patient 1) on aerosol isolation precautions (isolation against airborne infectious agents) were not fitted to a newly-supplied N95 mask and/or trained in the use of a Powered Air Purifying Respirators (PAPR) (a hooded, battery operated piece of equipment that consists of a half or full facepiece, breathing tube, battery-operated blower, and particulate filters. Contaminated air is blown through the filter which removes any infectious agents or contaminants in the air);
3. There was an inadequate tracking system for monitoring staff immunization status which resulted in incomplete immunization records for three out of 18 employees and an additional six employees identified during a subsequent hospital audit.
4. Immediate Use Steam Sterilization (IUSS) was being used in non-emergent situations in contrast to policy and procedure. (Immediate use sterilization refers to the shortest possible time between a sterilized item's removal from the sterilizer and its aseptic transfer to the sterile field);
5. Sterile processing staff did not wipe down all work surfaces with disinfectant at the end of their shift per facility policy and procedure;
6. Operating Room (OR) cleaning staff removed a red bag (infectious waste) of trash containing potentially contaminated items from the OR to the dirty utility room without performing hand hygiene following changing of gloves;
7. Sterility of equipment was not maintained when there was an open laryngoscope (a metal instrument which is inserted into a patient's mouth to access the airway) blade and handle and two opened endotracheal (ET - a plastic tube inserted into a patient's airway for the purpose of supplying air or oxygen) tubes in the anesthesia cart (contains medications and equipment used to induce sleep and sedation and control pain and sensation during surgery) located in the cesarean section (a surgical operation for delivering a child by cutting through the wall of the mother's abdomen) operating room;
8. There was a sterile package of forceps (a metal instrument used during childbirth to assist in delivery of baby) on a cart in the Obstetrics (OB) clean supply room with lint on the outside of the package, along with several sterile packages that had either no sterilization load sticker (to provide details regarding the sterilization process) on them or the information on the sticker was so faded as to be illegible;
9. While caring for a patient in the pre-operative area, an employee wiped her nose several times with her gloved hands without changing her gloves or performing hand hygiene;
10. A nurse performing a central line (central venous catheter - a tube inserted through a large vein to administer medications, fluids or nutrition) dressing change in the Intensive Care Unit (ICU) did not follow the manufacturer's specifications, nor facility policy and procedure for the skin disinfectant used for one patient (Patient 30);
11. A soiled linen barrel located in the OR hallway immediately adjacent to clean supplies was full, preventing closure of the lid;
12. OR cleaning staff touched the floor with a disinfectant-soaked rag while cleaning a piece of equipment and did not discard the contaminated rag before proceeding to clean other pieces of equipment;
13. A nurse performing a wound dressing change for one patient (Patient 12) used non-sterile, non-disinfected, single-use scissors for more than one dressing change over the course of two days; the facility did not have a policy for changing wound dressings;
14. A nurse preparing intravenous (IV) medication touched and potentially contaminated the sterile plunger of the syringe with her ungloved fingers then administered the medication to a patient;
15. There were no isolation care plans for patients on isolation precautions (for 28 of 30 sampled patients- Patient 1-16, 18-29), nor for two patients with open surgical wounds (Patients 22 and 26); and
16. The Quality Improvement (QI) project of auditing IV, PICC (peripherally inserted central catheter) line, and CVC (central venous catheter) dressing changes did not include actual observation by auditors of the dressing changes to observe for aseptic (sterile) technique and proper disinfectant product use.
17. Infection Control Preventionists did not conduct on-going observation of staff performing patient care, nor provided regular infection control inservices to staff (Refer to A 749).

These failures had the potential to put patients at risk for acquiring an infection.

Findings:

1. During an interview, on 5/14/15 at 8:55 a.m., Management Staff M was asked why the hospital no longer used the Champak (brand name) "Duckbill" N95 masks (the type of N95 mask that most hospital staff had been fitted to) when caring for airborne isolation patients. She stated at the end of April 2015, it was discovered the Champak masks had expired in October 2014, and Materials Management staff attempted to order more. However, due to a nationwide shortage of N95 masks due to recent Ebola (a rare, deadly infectious disease) precautions, they had difficulty obtaining a further supply in a timely manner. Management Staff M stated the hospital did have a supply of 3M (brand name) N95 masks so those were being used instead. Management Staff M acknowledged the tracking system for outdated supplies was inadequate and the expired masks should have been identified and ordered prior to October 2014.

During an interview, on 5/14/15 at 11:47 a.m., Management Staff O stated an order for new Champak masks was placed by phone to the supplier on either 5/2/15 or 5/4/15. At the time he was informed the hospital should receive the masks "pretty rapidly." However, "a couple of days ago" Management Staff O was informed the supplier would not be able to provide any of the masks to the hospital.

During a tour of the Materials Management Central Supply Room and concurrent interview, on 5/20/15 at 10:20 a.m., Central Store Room Staff P stated in April 2015, the Champak N95 masks were moved from a closed cabinet in the supply room to some open shelving. At that time it was noticed that they had an expiration date of October 2014. She stated she did not think the Champak masks had an expiration date since the 3M masks did not (at the time the 3M masks were placed in the cabinet) and she had not looked at the masks after they were placed in the cabinet. Central Store Room Staff P was asked how she kept track of when supplies would expire. She stated a list was generated manually with that information as well as item number and bin location. She then "pulls" supplies within two months of their expiration date, as well as made "spot checks" for expired supplies on the open shelving. She acknowledged the Champak masks were not on this list.

During an interview, on 5/27/15 at 11:30 a.m., Infection Control Preventionist Q was asked if he ever made rounds in the Central Supply Room to check for expired supplies or to make sure there was enough stock in the event of an emergency or disaster. He stated he had, but did not check the masks.

During an interview, on 5/27/15 at 1:50 p.m., Infection Control Preventionist G was asked if she ever made rounds in the Central Supply Room to check for expired supplies or to make sure there was enough stock in the event of an emergency or disaster. She stated she had, but never checked the masks.

During an interview, on 5/27/15 at 1:50 p.m., Infection Control Preventionist G was asked if she ever made rounds in the Central Supply Room to check for expired supplies. She stated she had, but never checked the masks.

2. Review of Patient 1's record indicated Patient 1 presented to the hospital's Emergency Department on 5/6/15 at 10:37 p.m. and was subsequently admitted to the hospital on 5/7/15 at 2 p.m., with diagnoses including herpes zoster ophthalmicus (herpes eye infection) and disseminated varicella zoster infection (shingles caused by the chickenpox virus and is spread via the respiratory system). Patient 1 was placed on aerosol (airborne) and contact isolation precautions in a negative pressure room (a ventilation system that generates negative pressure to allow air to flow into the isolation room but not escape from the room).

During an interview, on 5/13/15 at 2 p.m., Licensed Staff S stated most of the hospital staff, including the staff on the medical-surgical floor where Patient 1 was admitted, had been fit-tested to the Champak or "duckbill" N95 masks for use when caring for a patient on airborne isolation precautions. She added only selected hospital staff had been trained in the use of PAPRs, an alternative to N95 masks. With the admission of Patient 1, the facility provided 3M N95 masks which most of the hospital staff had not been fitted to (N95 masks require a "fit test" to ensure a proper seal is achieved). Licensed Staff S stated she had been trained by Employee Health in the use of PAPRs in 2014, but had not used one since then. She stated she had shown staff caring for Patient 1 how to use them. When asked how she knew which staff had been fitted to the 3M mask or to PAPRs, Licensed Staff S stated she relied on staff to tell her what they had been fitted/trained to.

During an interview, on 5/13/15 at 2:30 p.m., Licensed Staff T, a nurse on the medical-surgical floor where Patient 1 was admitted, stated she cared for Patient 1 one time and put on a PAPR, since she had not yet been fitted to the 3M mask. She stated she had been trained in PAPR use in 2014, by a company contracted by the hospital, but that training was a group demonstration only by the company and staff did not actually don/doff (putting on/taking off) the PAPR. Licensed Staff T stated she had never tried on a PAPR prior to wearing one to care for Patient 1 and another nurse on the unit showed her how to use it. She added several nurses were uncomfortable in use of the PAPRs and/or the 3M masks since they had not been trained or fitted to them.

During an interview, on 5/13/15 at 3:07 p.m., Licensed Staff U, a nurse on the medical-surgical floor where Patient 1 was admitted, stated she had not yet been trained in PAPR use or fitted to the 3M mask.

During an interview, on 5/13/15 at 3:30 p.m., Management Staff N stated not all medical-surgical staff had been trained in the use of PAPRs, only break nurses (nurses assigned to cover during staff break time), charge (supervising) nurses, pediatric (children) nurses, and those staff who could not use an N95 mask for some reason. Management Staff N stated it was okay for a nurse to train another nurse in PAPR use as long as the demonstrating nurse had been PAPR trained. When asked how she knew which medical-surgical staff had been fitted to which N95 mask, she stated she did not know as those records were kept by the Employee Health Department.

During an interview, on 5/14/15 at 8:55 a.m., Management Staff M was asked who was allowed to fit-test staff for the N95 masks and train staff in PAPR use. She stated fit-testers needed to be trained in order to fit staff, but anyone who had PAPR training could train other staff. When asked to explain the PAPR training, Management Staff M stated it was, "hands on doing" and part of the process was for staff to put on the respirator and demonstrate how to remove it. She was asked to explain the initial process for fitting/training of medical-surgical staff to the new 3M masks and PAPRs. Management Staff M stated at the time Patient 1 was admitted, only a couple of med-surg staff had been previously fitted to the 3M mask (last fitting occurred September 2014) and the rest of the staff were expected to use the PAPR. She stated Employee Health Staff V went to the medical -surgical (med-surg) unit and, along with Management Staff N, trained staff in its use. Subsequently, the process was for the nurse at the end of his/her shift to train the on-coming nurse if needed. She added staff were told they could contact Employee Health with any questions or if they needed/wanted additional training.

During an interview and policy review on 5/14/15 at 9:20 a.m., Infection Control Preventionist G was asked what she did to make sure all med-surgical staff with the potential to care for Patient 1 were fitted to the 3M N95 mask or trained in use of PAPRs prior. She stated she phoned the Employee Health Department and asked them to take care of that.

The policy titled, "Respiratory Protection Program," approved 12/11/14, was reviewed with Infection Control Preventionist G. It indicated: "Only employees who are in compliance with training and fit-testing will wear respirators. Employees can only wear respirators of specific models and sizes for which they have been trained and fit-tested...Training is required for PAPRs...In the event of shortage Re-donning/Fitting of N95 Respirators will be instituted."

Infection Control Preventionist G was asked if she could provide documentation that the hospital and all medical-surgical staff with the potential to care for Patient 1 were in compliance with this policy. She stated, "No," because she had turned this task over to Employee Health. When asked if she observed staff caring for Patient 1 donning/doffing the Personal Protective Equipment (PPE--gowns, gloves, masks and respirators), Infection Control Preventionist G stated, "No," that she left the unit after making sure the PAPRs were functional in order to assume other duties. Infection Control Preventionist G was asked if she thought the PAPR training should include staff actually donning/doffing the respirator, she stated, "Yes."

During an interview on 5/14/15 at 9:20 a.m., Administrative Staff B was asked why all hospital staff were not trained in PAPR use. She stated the hospital only required it for staff in "high risk" areas such as Emergency Department (ED), Operating Room (OR), Intensive Care Unit (ICU), and Pediatrics, adding that, "we never anticipated a failure mode. We have to anticipate what can go wrong. We didn't anticipate that we wouldn't have N95s." Administrative Staff B acknowledged that this oversight was "my fault."

During an interview, on 5/27/15 at 1:50 p.m., Infection Control Preventionist G was asked if she was trained as a N95 fit-tester and PAPR trained. She stated, "Yes." When asked if she was aware that the Champak N95 masks had expired in October 2014, she stated, "No," adding that she had "rounded" in the supply room in the past, but had not checked the masks.

The policy titled, "Transmission-Based Precautions," revised on 8/26/14, indicated under Airborne Precautions: "Wear a fit tested NIOSH [National Institute for Occupation Safety and Health]-approved N95 or higher level respirator for respiratory protection when entering the room of a patient when the following diseases are suspected or confirmed...chickenpox (varicella)."

Review of the Infection Prevention "Exposure Control Plan," revised 7/15/10, indicated Infection Prevention responsibilities included: "In collaboration with Materials Management, provide appropriate types and supplies of protective equipment (gloves, goggles, masks, gowns and ventilation devices for Cardio Pulmonary Resuscitation [CPR]). Instruct and monitor compliance with personnel use of appropriate personal protective equipment.

3. During personnel file and immunization documentation review, and concurrent interviews with Management Staff M and Employee Health Staff V, on 5/21/15 at 9 a.m., the following immunization omissions were found (3 of 18 sampled records):
Employee 1: Mumps and Rubeola (Measles)
Employee 10: Mumps
Employee 15: Hepatitis B

Regarding Employee 15, Management Staff M stated her Hepatitis B series was completed in 12/28/12 and at that time a phone call was made to the employee to come to Employee Health to pick up her lab slip for a Hepatitis B titer (blood level to confirm immunity). Management Staff M stated there was never any follow up to this since the paperwork was returned to the employee file rather than being placed in the "vaccine book" and it was forgotten. Management Staff M stated in January 2015, during an audit of the employee file, this omission was identified. Management Staff M stated on 1/13/15, the employee was contacted via email to notify her a lab slip had been sent to the employee lab and she was to get the labwork done. As of 5/21/15, Management Staff M stated the employee had still not complied with the requests and acknowledged, "a break in the system" even since the January audit.

Regarding Employee 15, Employee Health Staff V stated she did not realize until 5/21/15 that the employee had not complied with earlier requests to get her blood titer drawn. She stated, "It got missed. Fell through the cracks." When asked what role the two Infection Control Preventionists had in the employee immunization program, Employee Health Staff V stated, "Even though we partner with them, it's not on their radar because Employee Health handles this." She added the Infection Control Preventionists were not really involved in the oversight of the program even though they were aware of the Health Screening policy and procedure. Employee Health Staff V acknowledged the Infection Control Preventionists had not ensured the policy was followed.

Employee Health Staff V stated an action plan for updating the current immunization database to the employee files was formulated in October 2014 as some discrepancies were noted. She stated the audit was implemented in January 2015, with approximately five to ten employee files being reviewed per month.

During an interview, on 5/21/15 at 9 a.m., Management Staff M acknowledged the policy titled, "Health Screening of Employees and Volunteers," revised 8/8/14 had not been followed.

Review of the Employee Health Chart Audits for immunization status, conducted by Employee Health staff after identification of immunization omissions on 5/21/15, indicated:

Employee 19--received Measles Mumps Rubella (MMR) #1 on 5/29/07 and MMR #2 on 2/19/15 (According to the Center for Disease Control (CDC), the second dose should be one month later than the first).

Employee 20--received Varicella vaccine #1 on 1/23/15 and as of 5/25/15, had not received #2. (The CDC recommends to get two doses 4 weeks apart.)

Employee 21--received MMR vaccine #1 on 12/24/14 and as of 5/25/15, had not received #2.

Employee 22--Hepatitis titer (blood level), drawn on 4/2/15 and found to be negative (was not immune); letter sent to employee on 4/8/15 and as of 5/25/15, had no response from employee.

Employee 23--received Varicella vaccine #1 on 2/20/15 and as of 5/25/15, had not received #2.

Employee 24--Hepatitis titer drawn on 12/22/14 and found to be negative; letter sent to employee on 1/9/15 and as of 5/25/15, had no response from employee.

Review of the policy titled, "Health Screening of Employees and Volunteers," revised 8/8/14, indicated: Screening policy shall be consistent with CDC recommendations and meet the requirements of California State Title 22. The section under "Requirements," indicated screening would be conducted on all employees for the following infections: Tuberculosis, Rubella, Rubeola (Measles), Mumps, Varicella (chickenpox), Hepatitis B, Pertussis (vaccination with Tdap [tetanus, diptheria, and pertussis]), and Influenza..."Employees who cannot provide evidence of immunity to the above diseases must submit to lab serology [blood] testing, be vaccinated (free of charge) or sign a declination for each refused vaccine."

4. During an interview, on 5/19/15 at 4:02 p.m., Management Staff E was asked about the use of Immediate Use Steam Sterilization (IUSS). He stated, in addition to being used when an instrument was accidentally dropped on the floor or when the sterility of instruments was accidentally compromised, it was used when they had "back to back" same-type cases due to a limited supply of instruments (i.e. Ears, Nose, and Throat [ENT], and prostate cases). He added that process of sterilization was also used when Physician W operated because he "refuses" to bring his two custom-made instruments in to the OR the day before scheduled cases for regular sterilization.

During an interview and concurrent review of IUSS sterilization records, on 5/26/15 at 2:15 p.m., Management Staff X explained the various reasons for the use of IUSS. He stated, in addition to being used when an instrument was accidentally dropped on the floor or when the sterility of instruments was accidentally compromised, it was used when a sterile instrument was not available, i.e., when a "loaner" instrument was brought in and there was not at least two hours before the case to sterilize in the regular manner; an instrument was used in a prior case; or use of personal instruments. Management Staff X stated IUSS was most commonly used for shoulder, prostate, and ENT instruments.

During an interview, on 5/26/15 at 3:05 p.m., Management Staff E stated the use of IUSS has increased primarily due to another orthopedic surgeon practicing at the hospital and an increase in volume of ENT cases.

Review of the Surgical Services Performance Improvement report regarding "Sterilization for Immediate Use" from June 2014 through April 2015 indicated the following:
June 2014--8 items sterilized out of 460 cases (rate 2%)
July 2014--8 out of 481 (rate 2%)
August 2014--8 out of 510 (rate 2%)
September 2014--3 out of 466 (rate 1%)
October 2014--11 out of 495 (rate 2%)
November 2014--5 out of 412 (rate 1%)
December 2014--7 out of 493 (rate 1%)
January 2015--10 out of 480 (rate 2%)
February 2015--14 out of 414 (rate 3%)
March 2015--10 out of 494 (rate 2%)
April 2015--10 out of 463 (rate 2%)

The policy titled, "Sterilization for Immediate Use in Flash Pak Mobile Sterilization Container System," revised 11/4/14, indicated: "Immediate use sterilization is limited to only emergency situations where a replacement sterile instrument is not available."

According to the Association of peri-Operative Registered Nurses (AORN), "Guidelines for Perioperative Practice" (2015), Section I, Guidelines for Perioperative Nursing, Sterilization and Disinfection, Guideline for Sterilization, Recommendation VII a: "Immediate use steam sterilization should not be use as a substitute for sufficient instrument inventory."

5. During a tour of the Sterile Processing Department, on 5/19/15 at 2:20 p.m., dirty instruments were being cleaned in the decontamination area. In a concurrent interview, Management Staff H was asked about the disinfection process of the contaminated steel sink and counter at the end of the day. He stated Sterile Processing staff did not clean those areas at the end of their shift, but they did disinfect the clean areas of the department at the end of their shift with Sani-Wipes [disinfectant wipes]. Management Staff H added that the housekeeping department cleaned the floor at the end of the day.

During an interview on 5/20/15 at 1:45 p.m., Management Staff FF stated environmental staff terminally cleaned and disinfected the stainless steel sinks and mopped the floors in the dirty instrument processing area in the evening.

During an interview, on 5/27/15 at 11:30 a.m., Infection Control Preventionist Q stated he was not aware Sterile Processing staff were not disinfecting the contamination area at the end of their shift nor that this required process was included in the Sterile Processing Department's policy and procedure titled, "Housekeeping Practices," revised 10/30/14.

Review of the policy titled, "Housekeeping Practices," revised 10/30/14, indicated: "The Central Sterile Aide assigned to the Decontamination Room is responsible for the following cleaning tasks at the close of the shift: Daily cleaning of all work surfaces."

According to the Association of peri-Operative Registered Nurses (AORN), "Guidelines for Perioperative Practice" (2015), Section I, Guidelines for Perioperative Nursing, Aseptic Practice, Guideline for Environmental Cleaning, Recommendation IV e: "...Sterile processing areas where decontamination occurs have some of the highest risks for environmental contamination of all perioperative areas. Environmental cleaning in sterile processing areas is critical for reducing the risk of disease transmission from reservoirs of bloodborne pathogens and microorganisms in the decontamination environment."

6. During an observation, on 5/19/15 at 3:35 p.m., Unlicensed Staff K cleaned Operating Room 7 and wore gloves. Unlicensed Staff K stated, as she handled a red bag, the red bag was used for blood soiled trash. Unlicensed Staff K put a red bag in a large rolling covered trash container and took it to the trash disposal room. Unlicensed Staff K opened the door to the room with the gloves that she handled the red trash with, opened a drawer in the room, pulled out a container of a solidifying agent and put it in the suction fluid container that she brought in the room. She wore the same gloves when she left the trash room and disposed of the gloves in a trash container in the hallway. She did not wash her hands before returning to operating room, and then put on another pair of gloves and continued to clean the room.

During an interview, on 5/19/15 at 4 p.m., Unlicensed Staff K stated staff should wash their hands when they leave patient rooms, between tasks, between glove changes, after taking out garbage, or changing linen. Unlicensed Staff K stated she was "nervous" and forgot to wash her hands earlier when she took the garbage out and took off her gloves.

Review of the facility policy, "Hand Hygiene and artificial nails," revised 9/24/15, indicated staff should wash hands or use hand sanitizer after contact with equipment and items within the immediate vicinity of the patient, after removal of gloves, and before donning gloves.

7. During an observation and concurrent interview, on 5/19/15 at 11:53 a.m., a drawer of the anesthesia cart located in the cesarean section operating room contained one unwrapped laryngoscope blade connected to an unwrapped handle, along with two opened sleeves containing ET tubes, which compromised their sterility. When asked if this was an acceptable practice, Administrative Staff B stated, "No."

Review of the policy titled, "Care and Maintenance of Laryngoscope Blades and Handles," revised 10/26/12 indicated: "Laryngoscope blades and handles will be sterilized according to manufacturer's guidelines."

8. During an observation, on 5/19/15 at 11:20 a.m., in the C-Section (Caesarian Section) sterile supply room, there was a wrapped package of delivery forceps that had been sterilized and was missing the label which had the sterilizer load number (the identification of the load of instruments that was run in the sterilizer that day) or date of the sterilization. The package wrapper was frayed and partially covered with lint and fuzz. Another wrapped package contained obstetrical forceps with a faded, illegible sterilization load sticker (label with the load number and date). The date and load number was not readable. A third package contained a Balfour (abdominal surgical retractor blade) with a faded, illegible sterilization sticker.

During an interview, on 5/19/15 at 2 p.m., Management Staff H stated it was a problem if the load stickers were missing or faded/illegible because there would be no way to track which instruments were processed in which specific load or when they were sterilized. He stated such packages should be pulled from service and re-sterilized. Management Staff H stated operating room staff were expected to look at the packages for integrity.

During an interview, on 5/19/15 at 4:10 p.m., Management Staff E stated the operating room staff monitored outdates in Obstetrics (OB) and the Operating Room, and they monitored the supply outdates and integrity of the packaging quarterly.

During an interview, on 5/27/15 at 11:30 a.m., Infection Control Preventionist Staff Q stated he was not aware of the packaging integrity problem and he checked the supply carts himself.

A review of the Event Related Sterility policy, revised 1/3/12, indicated a load number label with the date an item was sterilized was placed on each hospital sterilized item. The Policy indicated a package that was torn, or damaged was not to be used and a package with an impaired integrity was to be returned to the Central Sterile Department for reprocessing.

9. During an observation of patient care in the pre-operative area, on 5/19/15 at 10:12 a.m., Unlicensed Staff Y wiped her nose several times with her wrists, forearm, and gloved hands then touched a patient on his left shoulder. She did not change her gloves or perform hand hygiene before touching the patient.

During an interview on 5/19/15 at 10:30 a.m., Unlicensed Staff Y stated she did not realize she had been wiping her nose with her hands and arms and acknowledged she should have changed her gloves and washed her hands.

During an interview, on 5/27/15 at 11:30 a.m., Infection Control Preventionist Staff Q stated he was not aware of this behavior.

Review of the policy titled, "Hand Hygiene and Artificial Nails," revised 9/22/14, indicated under the section, "Indications for Hand Sanitizer or Handwashing:" were after patient clinical care or contact with excretions, feces, blood or body fluids; Contact with mucous membranes, non-intact skin or wound dressings (the lining of the nose is considered to be a mucus membrane).

10. During an observation of a Central Venous Catheter (CVC) dressing change for Patient 30, in the Intensive Care Unit on 5/19/15 at 10:45 a.m., Licensed Staff Z used a circular motion when disinfecting the insertion site with a ChloraPrep [a disinfectant] swab.

During an interview, on 5/27/15 at 9:15 a.m., Licensed Staff Z acknowledged she incorrectly used a circular motion when disinfecting the CVC site. She stated she had since learned she was supposed to use a back and forth scrubbing motion. When asked if she had ever received an inservice on how to do CVC dressing changes, Licensed Staff Z stated she did receive training at one of the annual Skills Day, but did not recall the year. She added she did remember the training mentioned using a circular motion when disinfecting the site rather than a back and forth scrubbing motion.

During an interview, on 5/27/15 at 11:30 a.m., Infection Control Preventionist Staff Q stated he was not aware of this practice and acknowledged he had not observed staff performing CVC dressing changes.

Review of the policy titled, "Central Venous Catheters," revised 6/10/14, indicated: "Disinfect site with 2% Chlorhexidine: apply liberally to exit site; then apply to a small area of surrounding skin using gentle back and forth scrubbing motion for 30 seconds."

Manufacturer's directions for use for the ChloraPrep Single Swabstick indicated for dry surgical sites: "Use gentile repeated back-and-forth strokes for 30 seconds. Allow the area to air dry for approximately 30 seconds. Do not blot or wipe away."

11. During a tour of the OR department and concurrent interview, on 5/19/15 at 4 p.m., a full soiled laundry barrel with an unsecured lid approximately three inches above the top of the barrel was observed in the area immediately adjacent to a rack of clean supplies. Management Staff E acknowledged the linen should have been emptied sooner so the lid could be closed.

Review of the policy titled, "Soiled Linen, In-House Handling Of," revised 12/2/13, did not address lidded linen barrels only linen bags.

12. During an observation of terminal (end of the day) cleaning in the OR, on 5/19/15 at 3:40 p.m., Unlicensed Staff AA wiped down an instrument stand with a Cavicide-soaked rag (Cavicide is a type of disinfectant). While doing so the rag touched the floor. Unlicensed Staff AA continued cleaning other pieces of equipment with the same rag that had been contaminated by touching the floor. In a concurrent interview, Management Staff Q stated the contaminated rag should have been replaced with a clean one after it touched the floor

28786

Based on observations, staff interviews, clinical record review, and document review, the hospital failed to ensure the Infection Control Preventionists (ICPs) provided adequate oversight of the Infection Control Program when:
1. There was an inadequate tracking system for monitoring expiration dates of supplies which resulted in a shortage of N95 masks (an N95 mask is a snug-fitting respiratory protective device which, when fitted correctly, filters out 95 percent of particulate matter in the air);
2. All employees with the potential to care for a patient (Patient 1) on aerosol isolation precautions (isolation against airborne infectious agents) were not fitted to a newly-supplied N95 mask and/or trained in the use of a Powered Air Purifying Respirators (PAPR) (a hooded, battery operated piece of equipment that consists of a half or full facepiece, breathing tube, battery-operated blower, and particulate filters. Contaminated air is blown through the filter which removes any infectious agents or contaminants in the air);
3. There was an inadequate tracking system for monitoring staff immunization status which resulted in incomplete immunization records for three out of 18 employees and an additional six employees identified during a subsequent hospital audit.
4. Immediate Use Steam Sterilization (IUSS) was being used in non-emergent situations in contrast to policy and procedure. (Immediate use sterilization refers to the shortest possible time between a sterilized item's removal from the sterilizer and its aseptic transfer to the sterile field);
5. Sterile processing staff did not wipe down all work surfaces with disinfectant at the end of their shift per facility policy and procedure;
6. Operating Room (OR) cleaning staff removed a red bag (infectious waste) of trash containing potentially contaminated items from the OR to the dirty utility room without performing hand hygiene following changing of gloves;
7. Sterility of equipment was not maintained when there was an open laryngoscope (a metal instrument which is inserted into a patient's mouth to access the airway) blade and handle and two opened endotracheal (ET - a plastic tube inserted into a patient's airway for the purpose of supplying air or oxygen) tubes in the anesthesia cart (contains medications and equipment used to induce sleep and sedation and control pain and sensation during surgery) located in the cesarean section (a surgical operation for delivering a child by cutting through the wall of the mother's abdomen) operating room;
8. There was a sterile package of forceps (a metal instrument used during childbirth to assist in delivery of baby) on a cart in the Obstetrics (OB) clean supply room with lint on the outside of the package, along with several sterile packages that had either no sterilization load sticker (to provide details regarding the sterilization process) on them or the information on the sticker was so faded as to be illegible;
9. While caring for a patient in the pre-operative area, an employee wiped her nose several times with her gloved hands without changing her gloves or performing hand hygiene;
10. A nurse performing a central line (central venous catheter - a tube inserted through a large vein to administer medications, fluids or nutrition) dressing change in the Intensive Care Unit (ICU) did not follow the manufacturer's specifications, nor facility policy and procedure for the skin disinfectant used for one patient (Patient 30);
11. A soiled linen barrel located in the OR hallway immediately adjacent to clean supplies was full, preventing closure of the lid;
12. OR cleaning staff touched the floor with a disinfectant-soaked rag while cleaning a piece of equipment and did not discard the contaminated rag before proceeding to clean other pieces of equipment;
13. A nurse performing a wound dressing change for one patient (Patient 12) used non-sterile, non-disinfected, single-use scissors for more than one dressing change over the course of two days; the facility did not have a policy for changing wound dressings;
14. A nurse preparing intravenous (IV) medication touched and potentially contaminated the sterile plunger of the syringe with her ungloved fingers then administered the medication to a patient;
15. There were no isolation care plans for patients on isolation precautions (for 28 of 30 sampled patients- Patient 1-16, 18-29), nor for two patients with open surgical wounds (Patients 22 and 26); and
16. The Quality Improvement (QI) project of auditing IV, PICC (peripherally inserted central catheter) line, and CVC (central venous catheter) dressing changes did not include actual observation by auditors of the dressing changes to observe for aseptic (sterile) technique and proper disinfectant product use.
17. Infection Control Preventionists did not conduct on-going observation of staff performing patient care, nor provided regular infection control inservices to staff (Refer to A 749).

These failures had the potential to put patients at risk for acquiring an infection.

Findings:

1. During an interview, on 5/14/15 at 8:55 a.m., Management Staff M was asked why the hospital no longer used the Champak (brand name) "Duckbill" N95 masks (the type of N95 mask that most hospital staff had been fitted to) when caring for airborne isolation patients. She stated at the end of April 2015, it was discovered the Champak masks had expired in October 2014, and Materials Management staff attempted to order more. However, due to a nationwide shortage of N95 masks due to recent Ebola (a rare, deadly infectious disease) precautions, they had difficulty obtaining a further supply in a timely manner. Management Staff M stated the hospital did have a supply of 3M (brand name) N95 masks so those were being used instead. Management Staff M acknowledged the tracking system for outdated supplies was inadequate and the expired masks should have been identified and ordered prior to October 2014.

During an interview, on 5/14/15 at 11:47 a.m., Management Staff O stated an order for new Champak masks was placed by phone to the supplier on either 5/2/15 or 5/4/15. At the time he was informed the hospital should receive the masks "pretty rapidly." However, "a couple of days ago" Management Staff O was informed the supplier would not be able to provide any of the masks to the hospital.

During a tour of the Materials Management Central Supply Room and concurrent interview, on 5/20/15 at 10:20 a.m., Central Store Room Staff P stated in April 2015, the Champak N95 masks were moved from a closed cabinet in the supply room to some open shelving. At that time it was noticed that they had an expiration date of October 2014. She stated she did not think the Champak masks had an expiration date since the 3M masks did not (at the time the 3M masks were placed in the cabinet) and she had not looked at the masks after they were placed in the cabinet. Central Store Room Staff P was asked how she kept track of when supplies would expire. She stated a list was generated manually with that information as well as item number and bin location. She then "pulls" supplies within two months of their expiration date, as well as made "spot checks" for expired supplies on the open shelving. She acknowledged the Champak masks were not on this list.

During an interview, on 5/27/15 at 11:30 a.m., Infection Control Preventionist Q was asked if he ever made rounds in the Central Supply Room to check for expired supplies or to make sure there was enough stock in the event of an emergency or disaster. He stated he had, but did not check the masks.

During an interview, on 5/27/15 at 1:50 p.m., Infection Control Preventionist G was asked if she ever made rounds in the Central Supply Room to check for expired supplies or to make sure there was enough stock in the event of an emergency or disaster. She stated she had, but never checked the masks.

During an interview, on 5/27/15 at 1:50 p.m., Infection Control Preventionist G was asked if she ever made rounds in the Central Supply Room to check for expired supplies. She stated she had, but never checked the masks