HospitalInspections.org

Based on record review and interview, the hospital failed to meet the requirements for the Condition of Participation for Radiological Services as evidenced by failing to ensure a qualified full-time, part-time or consulting radiologist supervised the ionizing radiology services (see findings in tag A-0546).

Based on observations, interviews and record reviews the Hospital failed to meet the requirements of the Condition of Participation in Infection Control as evidenced by:

1) failing to ensure that the designated Infection Control Officer was qualified through experience, ongoing education and/or training to be responsible for the development and implementation of the hospital's Infection Control Program. (see A-0748)
2) failing to maintain an ongoing Infection Control Program designed to prevent, control, and investigate infection control practices that included: data collection and analysis of infection control practices/breaches through monitoring and active surveillance of all the services of the hospital for infection control practices to identify infection control breaches with associated corrective actions to prevent and control infections, monitoring compliance with all infection control policies, procedures, protocols and other infection control program requirements that were implemented by the facility. This failed practice was evidenced by observations of multiple infection control breaches, no documentation of a hospital-wide active surveillance program, no documentation of infection control data analysis to identify trends/patterns with implementation of corrective actions/measures and no documented evidence that the hospital's Infection Control Program was comprehensive and maintained as an ongoing program. (see A-0749)

Based on record reviews, observations, and interviews, the hospital failed to meet the Conditions of Participation for Surgical Services by failing to ensure the hospital followed acceptable professional standards of practice governing surgical services and infection control as evidenced by:

1) failing to ensure that surgical instruments were available in a quantity that was commensurate with the hospital ' s expected daily procedure volume, as evidenced by the hospital ' s routine use of IUSS (Immediate Use Steam Sterilization) of surgical instruments for surgical procedures,

2) failing to ensure that staff adhered to acceptable standards of professional practice in surgical attire in the restricted areas as evidenced by multiple observations of surgical attire breaches,

3) failing to ensure that staff followed MFU (Manufacturer Directions for Use) for HLD (High Level Disinfectant) processing as evidenced by not adhering to the MFU instructions for temperature monitoring of the HLD solution prior to use, and

4) failing to ensure that the hospital processed/sterilized surgical supplies according to MFU for the processing and sterilization of surgical items in paper-plastic peel pouches as evidenced by failing to have a policy in place with the MFU for processing/sterilizing surgical items in double paper-plastic peel pouches. (see A-0951)

Based on record reviews and interview, the hospital's governing body failed to ensure there was a mechanism in place to evaluate the quality of each contracted service to ensure that each contracted service was provided in a safe and effective manner. This deficient practice was evidenced by the hospital's governing body's failure to include contracted services in the hospital-wide QAPI (Quality Assurance Performance Improvement) program.

Findings:

Review of a list of the hospital's contracted services revealed 93 contracted services listed.

Review of the hospital's QAPI data revealed no documented data for contracted services utilized by the hospital.

In an interview on 6/22/16 at 10:00 a.m. with S2DON, she verified contracted services were not reviewed in the QAPI program.

Based on record reviews, observations and interviews, the hospital failed to ensure the registered nurse supervised and evaluated the nursing care of each patient. This deficient practice is evidenced by failing to assign qualified staff to continuously monitor telemetry patients and failing to run and place a telemetry strip in the patients chart every 6 hours as per policy for 1 (#20) of 1 current patient on telemetry monitoring.

Findings:

Review of the hospital policy titled Telemetry, Policy number CP-16, revealed in part:
4. The patient will have continuous qualified monitoring.
7. A six-second (minimum) telemetry strip will be run at least every 6 hours and placed in the chart in the space provided. In addition, a strip will be run any time dysrhythmias are noted and /or whenever the patient has chest pain.

Review of the medical record for Patient #20 revealed an order dated 6/20/16 at 6:45 p.m. for telemetry monitoring.

In an observation on 6/21/16 at 1:30 p.m. there was no person in the nursing station monitoring Patient #20 on telemetry.

An observation on 6/22/16 from 8:00 a.m. until 8:10 a.m. revealed no staff member was watching the telemetry monitor for Patient #20 in the nurse's station. Further observation revealed S5WardClerk then entered the nurse's station and sat in front of the telemetry monitor and began performing other tasks.

Review of the medical record for Patient #20 on 6/22/16 at 10:00 a.m. revealed she only had one telemetry strip in her medical record since telemetry had been ordered on 6/20/16 at 6:45 p.m.

In an interview on 6/22/16 at 9:00 a.m. with S2DON, she said S5WardClerk was responsible for watching the telemetry monitor for Patient #20. S2DON verified S5WardClerk was not trained to interpret telemetry strips and did not continuously monitor the telemetry screen at all times. S2DON said S5WardClerk depended on the computer alarm to alert her as to when she needed to notify a nurse. S2DON also verified Patient #20 only had 1 telemetry strip in her medical record but should have had a rhythm strip placed into the chart every 6 hours.

Based on record review and interview, the hospital:
1) failed to ensure drugs and biologicals were administered in accordance with acceptable standards of practice by the physician failing to include the specific drug name in a medication order for 4 (#6, #9, #10, #18) of 20 patients sampled; and
2) failed to ensure drugs and biological were administered per standards of practice per 1 out 1 patients (Patient # 4) reviewed for administration of Digoxin.

Findings:

1) Failing to ensure drugs and biologicals were administered in accordance with acceptable standards of practice.

Patient #6
Review of the medical record for Patient #6 revealed the following physician ' s orders:
Written on 6/20/16 at 2:48 p.m. for Laxative of Choice 1 each PRN daily and Antacid of Choice 1 each PRN daily.

Patient #9
Review of the medical record for Patient #9 revealed the following physician ' s orders:
Written on 6/20/16 at 10:28 a.m. for Laxative of Choice PRN daily.

Patient #10
Review of the medical record for Patient #10 revealed the following physician ' s orders:
Written on 5/23/16 at 1:25 p.m. for Laxative of choice 1 each PRN daily and Antacid of Choice 1 each PRN daily.

Patient #18
Review of the medical record for Patient #18 revealed the following physician ' s orders:
Written on 5/23/16 at 7:17 p.m. for Laxative of choice 1 each PRN daily and Antacid of Choice 1 each PRN daily

In an interview on 6/22/16 at 10:30 a.m. with S6Pharmacy, he verified the above mentioned medication orders did not have a drug name.

2) Failing to ensure drugs and biological were administered per standards of practice.

Review of Patient #4's medical record revealed he was admitted to the hospital on 6/18/16 for COPD (Chronic Obstructive Pulmonary Disease) and Pneumonia.

Review of the physician's orders reviewed an order for Digoxin .125 mg po daily on 6/20/16 at 13:45 (1:45 p.m.).

Review of Patient #4's Medication Administration Record revealed he was administered Digoxin on 6/20/16 at 14:06 (2:06 p.m.) and on 6/21/16 at 8:28 a.m. With further review of Patient #4 revealed his pulse was taken at 06/20/16 at 12 p.m. (2 hours before the Digoxin was administered) and on 6/21/16 the patient's pulse was taken 6:00 a.m. (2.5 hours before the Digoxin was administered. There was not documented pulse taken prior to the administration of Digoxin.

Review of the reference book, Nursing 2016 Drug Handbook, used by the nurses as a reference book according to S6Pharmacy, revealed in part, Digoxin, Before giving drug take apical-radial pulse for 1 minute.

An interview was conducted with S2DON on 6/21/16 at 1:15 p.m. She reported the nurses are taking the patients' pulses prior to administration of the Digoxin, but failing to document the patient's pulse on electronic medical records. She further reported there used to be an area to add the patient's pulse to the MAR on the electronic medical record, but with the last update of the EMR, it was no longer available.





30364

Based on record review, observation and interview, the hospital failed to ensure all patient medical records were properly stored in secure locations where they were protected from fire, water damage and other threats. This deficient practice was evidenced by the storage of all patients' medical records being stored on open shelving in 2 rooms in the Medical Records Department. Findings:
Review of the hospital policy titled, Storage and Retrieval, Policy #21, revealed in part, Fire and other damage, the medical records manager and the administrative team will determine what recovery mechanisms are feasible based on age and type of records.
An observation was conducted with S4MR Dir on 6/20/16 at 3:15 p.m. of the Medical Records Department. All medical records were filed on open shelving in 2 rooms and were not protected from potential water and fire damage.
An interview was conducted with S4MR Dir on 6/20/16 on 6/20/16 at 3:15 p.m. She reported some of the medical records were scanned and some were not scanned. She confirmed all the medical records were not protected from water and fire damage.

Based on record review and interview, the hospital failed to ensure errors in medication administration were documented in the medical record for 2 (#10, #18) of 2 patients reviewed for known medication errors.

Findings:

Review of the hospital's policy titled "Medication Variance Reporting" revealed in part:
Objective: To establish a policy and procedure in defining and reporting medication variances (errors).
1. When a medication variance is noticed (whether or not injury had been sustained) the incident must be reported verbally to the physician and documented on a Medication Variance Report form which is filed with the Risk Manager/DON. Record occurrence in the Nurse's Notes.

Patient #10
Review of an incident report for Patient #10 revealed she had received 10 mg of Atorvastatin on 5/23/16 and 5/24/16 instead of the ordered 20 mg.

Review of the medical record for Patient #10 revealed no documentation of the above mentioned medical error.

Patient #18
Review of an incident report for Patient #18 revealed a nitroglycerin patch was not removed at 9:00 p.m. on 5/25/16 as ordered and remained on the patient until discovered the next day.

Review of the medical record for Patient #18 revealed no documentation of the above mentioned medication error.

In an interview on 6/21/16 at 2:17 p.m. with S2DON, she verified the above mentioned medication errors were on incident reports which were not a permanent part of the patient's medical records. S2DON also verified there was no documentation in the patient's medical records of the errors, but should have been.

Based on observation, record review and interview, the hospital failed to ensure a qualified full-time, part-time or consulting radiologist supervised the ionizing radiology services.

Findings:

In an observation on 6/20/16 at 2:45 p.m., the hospital offered Computerized Tomography and general radiologic services.

Review of the hospital's organizational chart revealed no medical director listed for radiologic services.

In an interview on 6/20/16 at 4:30 p.m. with S2DON, she verified there had been no medical director appointed for radiologic services on a full time, part time or consulting basis.

Based on record reviews and interview, the hospital failed to ensure that the designated Infection Control Officer was qualified through experience, ongoing education and/or training to be responsible for the development and implementation of the hospital's Infection Control Program.
Findings:
A review of the Infection Control Officer's employee file (S2DON) revealed that S2DON was the designated Infection Control Officer in her role as the Director of Nursing. S2DON infection control training/experience and/or qualifications, as noted in her employee file included in part: Director of Nursing and Assistant Director of Nursing roles at other facilities that included infection control responsibilities and annual in-services in infection control as required for all employees at the hospital. A further review of S2DON employee file revealed no documented evidence of any infection control training/experience or any current infection control training/experience in the development and implementation of a hospital Infection Control Program.
In an interview on 06/22/16 at 9:30 a.m. with S2DON she indicated that she was the Director of Nursing and the designated Infection Control Officer for the hospital. S2DON indicated that she attended the LHA (Louisiana Hospital Association) management training seminars in 2013, 2014, 2015 that discussed infection control issues. A review of the LHA management brochures for 2013, 2014 and 2015, as provided by S2DON revealed in part; The 2013 LHA management seminar, "The ABC's of The Joint Commission (TJC) Survey Preparation" revealed a 90 minute presentation on TJC Infection Control National Patient Safety Goals; the 2014 LHA (one day) management seminar, "How to Prepare for Licensing and Certification Surveys by State and CMS Surveyors" revealed a 1.0 hour presentation review on 9 (nine) CMS CoPs with one of the nine being in Infection Control; and the 2015 LHA webinar "CMS Hospital CoPs Made Easy" had a 2.0 hour presentation that included a review of the CMS CoPs on Discharge Planning, Infection Control and Post Anesthesia Assessments. A further review of S2DON employee file revealed no documented evidence of any Infection Control Program training on the fundamentals of developing and implementing an active and effective hospital Infection Control Program. S2DON indicated that the management training seminars/webinar presented by LHA constituted her infection control training while employed at the hospital. S2DON was unable to present any documented evidence of infection control training in the development and implementation of a Hospital Infection Control Program.

Based on observations, interviews and record reviews the hospital failed to maintain an ongoing Infection Control Program designed to prevent, control, and investigate infection control practices that included: data collection and analysis of infection control practices/breaches through monitoring and active surveillance of all the services of the hospital for infection control practices to identify infection control breaches with associated corrective actions to prevent and control infections, monitoring compliance with all infection control policies, procedures, protocols and other infection control program requirements that were implemented by the facility. This failed practice was evidenced by observations of multiple infection control breaches, no documentation of a hospital-wide active surveillance program, no documentation of infection control data analysis to identify trends/patterns with implementation of corrective actions/measures and no documented evidence that the hospital's Infection Control Program was comprehensive and maintained as an ongoing program.


Findings:
A review of the hospital policy titled "Infection Prevention and Control Comprehensive Program and Plan", with a hospital review date of 2016 and provided by S2DON as the most current, revealed in part: The Infection Prevention and Control Plan ensures the development, implementation and maintenance of an active hospital-wide program for the prevention, control and investigation of infections and communicable diseases that includes an infection surveillance prevention program, methods to reduce infection control risks, providing ongoing review and daily analysis, developing and implementing a hospital-wide risk assessment addressing the highest priority risks, utilizing evidence-based national guidelines, scope and method of surveillance, initiating action plans and control activities, ensures compliance of hospital infection control policies, maintaining a sanitary environment, mitigate infection control risks, and adherence to national recognized infection prevention and control precautions such as CDC (Centers for Disease Control and Prevention), APIC (Association for Professionals in Infection Control and Epidemiology), AORN (Association of periOperative Registered Nurses), CMS (Centers for Medicare and Medicaid Services). Active surveillance activities of the Infection Control Program include in part; monitoring patients and staff for infections, conducting surveillance on a hospital-wide basis in accordance with acceptable infection control practices, methods for obtaining and reviewing data, methods for monitoring and evaluating practices of asepsis, provisions to monitor compliance with all hospital policies and procedures and other infection control requirements, provisions for program evaluation, measurement and analysis of data to identify any patterns or trends, and implementation of measures to prevent transmission of infections and to reduce the risk of potential infections. The Infection Control Program will provide educational opportunities to all who have direct and indirect contact with patients or medical equipment to include employees, contract staff, physicians and visitors that addresses the principles and practices for preventing transmission of infections

Observations on 06/20/16 from 1:00 p.m. to 4:00 p.m., on 06/21/16 from 9:00 a.m. to 11:00 a.m. and on 06/22/16 from 8:00 a.m. to 9:00 a.m. revealed the following infection control breaches;

- the dietary food cart with patient dirty food trays being stored in the clean patient refreshment room,
- the ice machine in the clean patient refreshment room with built-up sediment on the ice machine tray grate,
- opened multiple dose medication vials being stored in the anesthesia carts in the O.R. s and available for use in other surgical patient procedures,
- the laryngoscope blades being stored loosely in the drawers in the anesthesia carts in the O.R.s and not being labeled as to how they were disinfected after use or if they were disinfected after use,
- working sinks located in all the O.R.s and available for staff use and next to where sterile instrument supply carts were located
- staff not adhering to contact precautions for 1 of 1 patient (#17) identified by the hospital on contact precautions by observations of staff and family entering the patient ' s room without donning appropriate PPE (personnel protective equipment)


In an interview on 06/22/16 at 8:00 a.m. with S22NA she indicated that the nursing assistants were responsible for bringing the food trays to all the patients in their rooms for each meal. She indicated that the dirty, used food trays from each meal were placed on the dietary cart located in the patient refreshment room until they were picked up later after each meal.

In an interview on 06/21/16 at 9:45 a.m. with S19InstruTech she indicated that the laryngoscope blades being stored in the drawers in the anesthesia carts in the O.R.s were HLD and were not labeled as such or labeled with the date when they were disinfected and were just stored loosely in the bottom drawers of the anesthesia carts for the CRNAs to use for patients.

In an interview on 06/21/16 at 2:45 p.m. with S16CRNA he indicated that the CRNAs dated the multiple doses vials from the anesthesia carts in the O.R.s when opened and then returned/stored them again to the anesthesia cart in O.R.s for other patient use. He indicated that he was not aware that multiple dose medication vials being stored in the anesthesia carts in the O.R.s had to become single use and discarded after they were opened in a patient care area. S16CRNA was asked about the laryngoscope blades being stored loosely in the drawers in the anesthesia carts in the O.R.s and if they were disinfected after use. S16CRNA indicated that he did not know how the laryngoscope blades were disinfected after use and assumed they were sterile if they were in the anesthesia carts.

In an interview on 06/21/16 at 11:30 a.m. with S3DirOR he indicated that the sinks located in all the O.R.s were working sinks and used by staff during surgical procedures as needed. He indicated that due to limited storage space that sterile supply carts were stored in the O.R.s and some of them were stored next to the sinks.

An observation on 06/22/16 at 8:00 a.m. of Patient #17 ' s room revealed a sign on her door indicating that she was on contact precautions. A PPE supply cart was also noted outside of the patient ' s door. S21RN was observed entering the patient ' s room and not donning any PPE. A further observation revealed the patient ' s family member entering and exiting the patient ' s room without donning PPE.

In an interview on 06/22/16 at 8:15 a.m. with S21RN she was asked about the hospital protocol for contact precautions when entering a patient ' s room who was on contact precautions. She indicated that Patient #17 was on contact precautions for a wound infection and a contact precaution sign was on her door and a PPE supply cart was located right outside her door. S21RN indicated that staff were not required to wear PPE if they were only entering the patient ' s room and not expecting to touch the patient. She further indicated that staff would wear gloves if they were going to touch the patient and would wear gown and gloves if they were going to touch the patient ' s wound area.

In an interview on 06/22/16 at 8:30 a.m. with Patient #17 ' s family member, as he exited the patient ' s room, he indicated that he was not instructed by nursing staff on the wearing PPE and was not donning PPE when he entered the patient ' s room. He further indicated that he was only told to not touch the patient ' s wound. The family member indicated that he had been with Patient #17 constantly since she had been admitted and was also sleeping in the patient ' s room each night.

A review of the Infection Control Program binder and the infection control data, provided by S2DON as the complete infection control data, revealed no documented evidence of a hospital-wide active surveillance program with monitoring of compliance with all policies, procedures, and protocols and no documented evidence of hospital-wide infection control data analysis to identify trends or infection control risks.

In an interview on 06/22/16 at 10:00 a.m. with S2DON she indicated that she was the designated Infection Control Officer for the hospital. She indicated that the hospital followed the professional standards of practice for AORN (Association of periOperative Registered Nurses), CDC (Centers for Disease Control and Prevention), and APIC (Association for Professionals in Infection Control and Epidemiology). S2DON was asked for the hospital's active surveillance monitoring data analysis component of the Infection Control Program that covered the hospital patients, employees, and the hospital services to include ongoing data collection and analysis with documentations of monitoring/tracking activities and data analysis, the infection control activities of the infection control program, evaluations and any indicated revisions. S2DON indicated that her infection control program activities consisted of hand hygiene monitoring data, medical record review for NHSN (National Healthcare Safety Network) input, monthly surveys from the surgeons to determine any postoperative patient infections, and infection control orientation in-services provided to staff upon hire and annually. S2DON indicated that the hospital department managers collected data and submitted it to her, but she was not analyzing the data for patterns/trends or infection control risks. S2DON indicated that she was in the process of reviewing the SSI (surgical site infections) for 2015 and had no documentation to present at this time. She indicated that she had begun investigating a SSI from 2016 which was still on-going. S2DON further indicated that she only had documentation (no analysis) on the active surveillance program for hand hygiene and that there were no other active surveillance activities being conducted in the Infection Control Program for the monitoring of compliance of hospital policies, procedures, and protocols or the identification of infection control risks or the identification of environmental infection control issues or any mitigation of infection control issues in place to present to the surveyor. S2DON had no other infection control information for the surveyor to review. S2DON was made aware of the above infection control observations and interviews and of the observations on 06/20/16 and 06/21/16 of the surgical services infection control breaches that included: The hospital ' s Surgical Services not following acceptable professional standards of practice governing surgical services and infection control as evidenced by:
- the surgical department ' s routine use of IUSS (Immediate Use Steam Sterilization) of surgical instruments for surgical procedures,
- the surgical staff not adhering to acceptable standards of professional practice in surgical attire in the restricted areas as evidenced by multiple observations of surgical attire breaches,
- the surgical staff not following MFU for use for HLD (High Level Disinfectant) by not adhering to the MFU instructions for temperature monitoring of the HLD solution prior to use, and
- the surgical department not processing surgical supplies in accordance with MFU by failing to have a policy in place with the MFU when sterilizing surgical items in double paper-plastic peel pouches.
S2DON indicated that she was not aware of the above infection control breaches and was not aware that the above observations were infection control breaches. S2DON indicated that she depended upon the hospital department managers to alert her to any infection control issues and/or any infection control risk assessments and to know what constituted an infection control issue in their respective departments. S2DON further indicated that the Infection Control Program was more reactive than proactive and that time management was sometimes an issue in a small hospital.

Based on record reviews, observations, and interviews the hospital failed to ensure the hospital ' s Surgical Services followed acceptable professional standards of practice governing surgical services and infection control as evidenced by:

1) failing to ensure that surgical instruments were available in a quantity that was commensurate with the hospital ' s expected daily procedure volume, as evidenced by the hospital ' s routine use of IUSS (Immediate Use Steam Sterilization) of surgical instruments for surgical procedures,

2) failing to ensure that staff adhered to acceptable standards of professional practice in surgical attire in the restricted areas as evidenced by multiple observations of surgical attire breaches,

3) failing to ensure that staff followed MFU (Manufacturer Directions for Use) for HLD (High Level Disinfectant) processing as evidenced by not adhering to the MFU instructions for temperature monitoring of the HLD solution prior to use, and

4) failing to ensure that the hospital processed/sterilized surgical supplies according to MFU for the processing and sterilization of surgical items in paper-plastic peel pouches as evidenced by failing to have a policy in place with the MFU for processing/sterilizing surgical items in double paper-plastic peel pouches.


Findings:
1) failing to ensure that surgical instruments were available in a quantity that was commensurate with the hospital ' s expected daily procedure volume, as evidenced by the hospital ' s routine use of IUSS (Immediate Use Steam Sterilization) of surgical instruments for surgical procedures,

A review of AORN (Association of periOperative Registered Nurses) Guidelines for Perioperative Practice, 2015 edition - Guideline for Sterilization: Recommendation VII revealed in part; Immediate Use Steam Sterilization (IUSS) should be kept to a minimum and should only be used in selected clinical situations. Immediate use is considered the shortest time possible between a sterilized item ' s removal from the sterilizer and its aseptic transfer to the sterile field. IUSS should only be used when there is insufficient time to process by the preferred wrapped or container method intended for terminal sterilization. IUSS should not be used as a substitute for sufficient inventory. IUSS should not be used for implantable devices.

A review of the hospital ' s Surgery Policy and Procedure Manual approved by the Governing Body in January 2016 and provided by S3DirOR as the most current, revealed no policy on IUSS.
A review of the hospital ' s Flash (IUSS) log from 03/01/16 to 05/31/16 (3 months) revealed over 37 pages of instruments that were IUSSed for a total of over 75 elective patient surgical procedures. A review revealed that the most common items IUSSed were the cataract surgical trays, which were IUSSed over 35 times for elective surgical procedures and various orthopedic instruments/trays/drills over 36 times for elective surgical procedures. The review of the IUSS log book revealed no documented evidence indicating that the above items were IUSSed due to an urgent or emergent event or identified the clinical situation present that required the item to be IUSSed. A review further revealed that 5 patient procedures had no patient name listed next to the surgical instruments that were IUSSed identifying the patient(s) who used the IUSSed item(s).
In an interview on 06/21/16 at 10:00 a.m. with S17ST/OR (Surgical Technician Supervisor), in the presence of S3DirOR, she indicated that the hospital did not have cataract instruments and that on eye surgery days (once or twice a month), a medical representative would bring in 5 or 6 cataract instrument trays for the eye surgeon to use for his scheduled (elective) cataract surgeries. S17ST/OR indicated that the eye surgeon scheduled more than 5- 6 cataract surgeries on those days and that cataract trays had to be routinely " flashed " (IUSS) on those days to meet the demand of the scheduled cataract surgeries. S17ST/OR further indicated that since the hospital had a large orthopedic schedule each month that various orthopedic instruments, trays and drills had to be routinely " flashed ' (IUSS) autoclaved since the hospital did not have enough orthopedic instruments to accommodate the orthopedic workload on certain days.
In an interview on 06/21/16 at 10:00 a.m. with S19InstruTech (Central Sterile Lead Technician), in the presence of S3DirOR and S17ST/OR, she (S19InstruTech) indicated that she kept the " flash " autoclave logs. S19InstruTech indicated that she was not documenting on the " flash " logs if IUSS was due to an urgent or emergent event or identifying the clinical situation present that required the item to be IUSSed. She indicated that the O.R. had to IUSS instruments when scheduled elective cases were greater than their available supplies and there was not enough time for the O.R. to sterilize the instruments by the preferred steam sterilization method.
In an interview on 06/21/16 at 10:00 a.m. with S3DirOR, in the presence of S9RN/OR, S17ST/OR and S19InstruTech, he indicated that the hospital had 4 (four) O.R.s and the average number of surgery cases performed each month was around 150 surgical cases. S3DirOR, S9RN/OR, S17ST/OR and S19InstruTech indicated that they were not familiar with the term " IUSS " and was only familiar with the term " flash " and they asked the surveyor to explain the term IUSS. S3DirOR indicated that he did not review the IUSS log formally and he did not document with tracking, trending or analysis the IUSS use in the O.R. He further indicated that the O.R. did not have a present policy in place indicating the specific conditions and clinical situations that should be met and/or required before an item was IUSSed. S3DirOR indicated that he was aware of the above " flashing " process utilized by the staff.

2) failing to ensure that staff adhered to acceptable standards of professional practice in surgical attire in the restricted areas as evidenced by multiple observations of surgical attire breaches,

The AORN Guidelines for Perioperative Practice, 2015 edition - Guideline for Surgical Attire:
Recommendation I revealed in part: All individuals entering the restricted surgical area should wear a surgical mask when scrubbed personnel, sterile supplies and/or sterile equipment are present. A surgical mask protects the patient from transfer of microorganisms. The mask should cover the mouth and nose and be secured in a manner to prevent venting. A mask that is securely tied at the back of the head and behind the neck decreases the risk of staff transmitting nasopharyngeal and respiratory microorganisms to patients. Surgical masks are intended to contain and filter droplets from the nasopharynx. The filter portion of the surgical mask harbors bacteria collected from the nasopharyngeal airway. Surgical masks should be tied securely and discarded after each procedure or when soiled and should not be worn hanging from the neck. Recommendation I further revealed in part: All non-scrubbed personnel should wear a freshly laundered or single use long sleeved warm up jacket snapped closed with the cuffs down to the wrists. Wearing the warm up jacket snapped closed prevents the edges of the front of the jacket from contaminating a skin prep area or the surgical sterile field. Long sleeved attire helps contain skin squames shed from bare arms. When in the restricted area all personal clothing should be completely covered by the surgical attire. Undergarments such as T-shirts with a V-neck, and shirts with sleeves which can be contained underneath the scrub top, may be worn; personal clothing that extends above the scrub top neckline or below the sleeve of the surgical attire should not be worn. Personnel clothing is not laundered by a health care-accredited laundry facility. When wearing a two-piece scrub suit, the top of the scrub suit should be secured at the waist, tucked into the pants, or fit close to the body to prevent skin squames from being dispersed into the environment from the axilla and chest. The major source of bacteria dispersed into the air comes from health care provider ' s skin.
Recommendation II revealed in part: Only facility-approved, clean and freshly laundered surgical attire should be donned daily by all personnel entering or reentering the semi-restricted and restricted surgical areas to decrease the possibility of cross-contamination. Surgical attire should be laundered in a health care-accredited laundry facility either on-site or through a contracted service which incorporate OSHA and CDC guidelines and professional association's recommended practices that follow industry standards through the HLAC (Healthcare Laundry Accreditation Council). Home laundering cannot be monitored for quality, consistency or safety, and laundering may not meet the specified measures necessary to achieve a reduction in microbial levels in soiled surgical attire with measures that involve mechanical, thermal, and chemical components.

Recommendation III revealed in part: All personnel should cover head and facial hair, beards, including the sideburns, the ears and the nape of the neck, when in semi-restricted and restricted areas. Human hair can be a site of pathogenic bacteria such as MRSA. Hair acts as a filter when it is uncovered and collects bacteria. A clean, low-lint surgical head covering or hood that confines all hair (including beards) and covers scalp skin and ears should be worn. The head covering or hood should be designed to minimize microbial dispersal. Skull caps (surgeon caps) fail to contain the side hair above and in front of the ears and hair at the nape of the neck and the ears and should not be worn. Reusable head coverings (cloth head coverings) should be laundered in a health care-accredited laundry facility or completely covered by a disposable bouffant hat if home laundered.
Recommendation IX revealed in part: Restricted areas in a surgical suite includes the O.R. (operating room) and procedure rooms, the clean core and the scrub sink areas. People in the restricted areas are required to wear full surgical attire (scrub attire, head coverings, masks, and shoe covers as applicable). The Semi-Restricted areas include the peripheral support areas of the surgical suite, the storage areas, the work areas, and corridors leading to the restricted areas of the surgical suite.

Observations on 06/20/16 from 1:00 p.m. to 4:00 p.m. and on 06/21/16 from 9:00 a.m. to 11:00 a.m. revealed the following surgical attire breaches in the restricted surgical suite area:
Observations of all surgical staff in the restricted surgical suite areas on both days were observed wearing different colored home laundered surgical attire and many were also observed wearing matching home laundered cloth hats that were not covered by a disposable bouffant hat.
Observations were made of surgical staff not wearing surgical masks in the surgery restrictive area when scrub personnel were present at the scrub sinks.
Observations were made of non-scrubbed persons, while opening up sterile supplies onto the sterile field in the O.R. and/or while performing circulating tasks during a patient procedure, not wearing a button down warm-up jackets.
S8MD with facial hair (beard) that was not completely covered by his surgical mask during a patient ' s surgical procedure, and wearing a T-shirt that was not completely covered by the surgical attire,
S11ST/OR, S17ST/OR with a home laundered cloth cap not covered by a disposable bouffant hat and wearing a T-shirt that was not completely covered by the surgical attire
S9RN/OR, S10RN/OR, S18RN/OR with a home laundered cloth cap not covered by a disposable bouffant hat and no warm-up jacket while performing circulating tasks during a patient ' s surgical procedure, and wearing a T-shirt that was not completely covered by the surgical attire
S12CRNA with the surgical mask worn hanging from the necks and wearing a skull cap that did not completely cover all the hair on the head and neck
S16CRNA, S14MD wearing a skull cap that did not completely cover all the hair on the head and neck and wearing a T-shirt that was not completely covered by the surgical attire,
S3DirOR wearing a skull cap that did not completely cover all the hair on the head and neck and wearing a T-shirt that was not completely covered by the surgical attire,
S24MedRep, S15RN/OR, S9RN/OR, S3DirOR with the surgical mask worn hanging from the neck
In an interview on 06/20/16 at 4:00 p.m. with S3DirOR he indicated that surgical staff were required (by hospital policy) to buy their own scrub attire and that staff were allowed to launder their own scrubs, cloth hats and warm-up jackets at home. He indicated that the contract laundry was not contracted to launder the surgery staff or the physician ' s own personal surgical scrub attire and further indicated that the hospital did not provide cloth surgical scrub attire for staff to use. S3DirOR indicated that surgical staff were allowed to wear home laundered surgical attire, cloth hats and warm-up jackets in the restricted surgical area. S3DirOR indicated that non-scrubbed persons were not required to wear button-down warm-up jackets while performing circulating tasks during surgical procedures. S3DirOR further indicated that there was no monitoring system in place to monitor home laundered clothing.

3) failing to ensure that staff followed MFU (Manufacturer Directions for Use) for HLD (High Level Disinfectant) processing as evidenced by not adhering to the MFU instructions for temperature monitoring of the HLD solution prior to use, and

A review of AORN Guidelines for Perioperative Practice, 2015 edition - Guideline for High-Level Disinfectant, Recommendation IV revealed in part: High-Level Disinfectant (HLD) should occur at appropriate temperatures, contact time, and length of use. Improper use of HLD can cause contamination and lead to outbreaks.
A review of the MFU (manufacturer ' s instruction for use) label for the HLD solution used in the surgery department indicated the temperature should be a minimum of 20 degrees Centigrade prior to each use. A review of the Surgical Services Policy Manual revealed no policy or MFU on HLD use.
A review of the surgery department ' s HLD log for June 2016 to present revealed that the solution ' s temperature monitoring section prior to each use, noted the temperature for the HLD solution was below 68 degrees Fahrenheit for 20 out of 24 times.
In an interview on 06/21/16 at 9:45 a.m. with S19InstruTech she indicated that she was responsible for the HLD reprocessing of surgical instruments in the surgery department. She was asked what 20 degrees Centigrade was equivalent to in Fahrenheit degrees. S19InstruTech indicated that she would have to look it up and that she did not know.
In an interview on 06/21/16 at 9:45 a.m. with S3DirOR and S17ST/OR they indicated that they would have to look up the Fahrenheit equivalent to 20 degrees Centigrade and that they did not know off hand. (NOTE: 20 degrees Centigrade is equivalent to 68 degrees Fahrenheit).

4) failing to ensure that the hospital processed/sterilized surgical supplies according to MFU for the processing and sterilization of surgical items in paper-plastic peel pouches as evidenced by failing to have a policy in place with the MFU for processing/sterilizing surgical items in double paper-plastic peel pouches.

A review of the AORN Guidelines for Perioperative Practice, 2015 edition- Guideline for Packaging Systems:
Recommendation V revealed that paper-plastic peel pouches should not be placed in a container or wrapped set (such as to segregate small items within a set) unless the pouch or container manufacturer has validated this process. Paper-plastic peel pouches within a container or wrapped set may not be able to be positioned in a manner that allows adequate air removal, steam contact or drying.
Recommendation VII revealed in part: Paper-plastic pouch packages should be used according to manufacturer ' s written instructions. Paper-plastic pouch packages should be used only for small, lightweight, low-profile items. Double paper-plastic pouch packaging may be used to facilitate containment of multiple small items to be sterilized according to MFU. Double paper-plastic pouch packages should be used in such a manner to avoid folding the inner package to fit into the outer package. Folding the edges of the inner peel packages may entrap air and inhibit the sterilization process. Hospitals should refer to the use of double peel packaging to the MFU.
An observation of the Central Sterile Supply Room revealed that sterile surgical instruments that were packaged in paper-plastic peel pouches were packaged in double paper-plastic peel packages where the inner paper-plastic peel pouch was folded on multiple sides.
In an interview on 06/21/16 at 10:15 a.m. with S19InstruTech and S17ST/OR they indicated that it was routine procedure for all surgical instruments that were sterilized in paper-plastic peel pouches to be sterilized in double paper-plastic peel pouches with the edges folded over on multiple sides. They indicated that they were not aware that the use of (double) paper-plastic peel pouches in sterilization processing had to follow MFU. They further indicated that the surgery department did not have a MFU policy in place for the use of (double) paper-plastic peel pouches used in the sterilization process.
In an interview on 06/21/16 at 11:30 a.m. with S3DirOR he indicated that the hospital ' s Surgical Services followed AORN (Association of periOperative Registered Nurses) Guidelines. S3DirOR indicated that he was somewhat familiar of the AORN Guideline on home-laundered surgical attire and was familiar with the AORN Guideline that surgical masks should not be worn around the neck. He indicated that he was not aware of or familiar with the AORN Guideline on IUSS, warm-up jackets, skulls caps, beards, t-shirts, cloth hats, HLD use, and paper-plastic peel pouch use. S3DirOR further indicated that the most recent edition of the AORN Guideline used in the Surgical Services was dated 2010. S3DirOR indicated that the current Surgical Services Policy and Procedure Manual was reviewed and revised based upon the 2010 Guidelines and did not address all of the above surgical issues noted above. The current Surgical Services Policy and Procedure Manual was approved by the Governing Body on January 2016.

Based on record reviews and interviews, the hospital failed to ensure a physician was appointed as the Medical Director of the hospital's Respiratory Care services. This deficient practice was evidenced by failure of the hospital's Governing Body to appoint a physician to serve as Medical Director of the hospital's Respiratory Care services. Findings:

Review of the hospital's organizational chart revealed no evidence of a Medical Director being appointed as the Medical Director of Respiratory.

An interview was conducted with S2DON on 6/20/16 at 3:30 p.m. She reported S8MD was the Medical Director of Respiratory Services, but he had not been appointed by the Governing Body.