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Based on record review, interviews and observations, the hospital failed to ensure that the RN supervised and evaluated the nursing care of each patient as evidenced by failing to ensure staff assigned to monitor telemetry patients was continuously monitoring the inpatients on telemetry monitoring.

Findings:

Review of the hospital policy titled, "Telemetry Monitoring", revealed in part the following: Telemetry monitoring is available on the medical and surgical nursing unit. Continuous telemetry monitoring is performed on the Medical-Surgical Unit at both campuses.

Review of the personnel record for S48LPNTele and S39LPNTele revealed a job competency that was titled "Unit Secretary/Monitor Tech" The competency included the following competencies: application, set up, and basic EKG interpretation, answering the telephone, complete charges, and maintain log book.

On 02/06/17 at 2:00 p.m., an observation was made on the Med-Surg Unit at the Main Campus. S48LPNTele was observed in the nurse's station seated at the desk where the cardiac monitor screen was located. S48LPNTele was observed to be talking on the telephone, looking away from the cardiac monitor screen. S48LPNTele was also observed to be working on a record at the desk, looking away from the cardiac monitor screen. S48LPNTele stated her duties included monitoring the cardiac rhythms for telemetry patients, answering the telephone, answering the patient call lights, checking the chart for new orders, and answering questions when people come to the desk. S48LPNTele stated she filed x-ray and lab results into the record also.

An observation on 02/07/17 at 5:30 p.m. was made on the Med-Surg Unit at the Off-Site Campus. S39LPN/Tele was observed in the nurse's station seated at the desk where the cardiac monitor screen was located. S39LPN/Tele was observed talking on the telephone and looking away from the cardiac monitor screen several times. S39LPN/Tele was also observed moving over to the chair by the computer at the desk (angled to the left of the telemetry monitors) and was observed working on a medical record at the desk and was no longer sitting in front of the cardiac monitor screen.

In an interview on 02/07/17 at 5:45 p.m. with S39LPN/Tele she indicated that her duties included in part: monitoring the cardiac monitors for telemetry patients, answering the telephone, answering the patient call lights, checking the chart for new orders, faxing new medication orders to pharmacy, placing nursing orders into the computer, placing patient meal orders in the computer, placing consult orders in the computer, and filing x-ray and lab results into the medical record. She indicated that she functioned as a telemetry monitor technician and a unit clerk simultaneously.

In an interview on 02/07/17 at 5:45 p.m. with S38RN on the Med-Surg unit, she indicated that the telemetry monitor technicians also functioned as unit clerks while they were performing telemetry monitoring duties.

In the exit conference on 02/08/17 at 2:15 p.m. with S2CNO she indicated that the telemetry monitor technician's main responsibility was to monitor the cardiac monitors and not perform other unit clerk duties.




30172

26351


Based on observation, record review and interview, the hospital failed to ensure a RN assigned the care of each patient to nursing staff in accordance with the patients' needs and competence of the nursing staff as evidenced by assigning patients in the ED with a physician's emergency certificate (PEC) to be monitored 1:1 by sitters without training in crisis prevention interventions for 3 (#13, #21, #22) out of 4 (#13, #20, #21, #22) ED patients reviewed with 1:1 observation.

Findings:

In an interview on 02/06/17 at 1:00 p.m. during a tour of the ED, S3ADON stated the staff provides 1:1 observation of all PEC patients to ensure safety since there were multiple ligature points and hazards in the exam rooms. S3ADON stated the staff that provided the 1:1 observation had CPI training.


Patient #13
On 02/07/17 at 1:20 p.m., Patient #13 was observed in the ED in an exam room with S11ED Sitter seated in the room with the patient. S11ED Sitter was observed documenting every 15 minute observations of Patient #13.

In an interview on 02/07/17 at 1:20 p.m., S47RNSup confirmed Patient #13 was a PEC patient and stated S11ED Sitter was providing 1:1 observation of Patient #13.

Review of the ED record for Patient #13 revealed the patient was a 14 year old that presented to the ED on 02/06/17 at 6:43 p.m. by ambulance after purchasing items to kill his father. The record revealed the patient was under a PEC dated/timed 02/06/17 at 8:50 p.m. due to Homicidal, dangerous to others, gravely disabled and unwilling/unable to seek voluntary admission. Review of the record revealed the Suicide/Elopement Precaution Checklist dated 02/06/17 revealed S11ED Sitter documented every 15 minute observations of Patient #13 from 8:45 p.m. to 11:00 p.m. Review of the Suicide/Elopement Precaution Checklist dated 02/07/17 revealed S11ED Sitter documented every 15 minute observations from 7:15 a.m. to 2:00 p.m.

Review of the personnel record for S11ED Sitter revealed no documented evidence of any CPI training.

In an interview on 02/07/17 at 4:55 p.m., SS12ED Director confirmed S11ED Sitter provided 1:1 observation for Patient #13 on 02/06/17 and 02/07/17. SS12ED Director confirmed S11ED Sitter has not had CPI training and stated she was pulled from the Med-Surg floor to observe the patient.



Patient #21
Review of the ED record for Patient #21 revealed she was a 23 year old admitted female to the ED on 02/06/17 with a PEC for Suicidal and Homicidal Ideations. Review of the Suicide/Elopement Precaution Checklist for 02/06/17 revealed 1:1 observations were implemented from 7:30 p.m. to 8:30 p.m. by S11ED Sitter.

Review of S11ED Sitter's personnel record revealed she did not have crisis prevention intervention training.

An interview was conducted with S12ED Director on 02/08/17 at 10:30 a.m. S12ED Director confirmed S11ED Sitter did not have crisis prevention intervention training and she was monitoring a PEC'd patient in the ED. He further reported in the position qualifications for ED Sitter, CPI (a specific type of Crisis Prevention Intervention training) is encouraged, but not mandatory.

Patient #22
Review of the ED record for Patient #22 revealed she was a 21 year old female admitted to the ED on 01/29/17 with a PEC for Suicidal Ideations. Review of the Suicide/Elopement Precaution Checklist for 01/29/17 revealed 1:1 observations were implemented from 6:45 a.m. to 12:45 p.m. by S10ED Sitter.

Review of S10ED Sitter's personnel record revealed he did not have current training in crisis prevention intervention.

An interview was conducted with S12ED Director on 02/08/17 at 10:30 a.m. He confirmed S10ED Sitter did not have current training in crisis prevention interventions.

In an interview on 02/07/17 at 3:00 p.m. with S36RN/ED, at the off-site campus. he indicated that patients who were PEC in the Emergency Department and required 1:1 monitoring were monitored mostly by CNAs. He indicated that they try to assign a CNA who had CPI training. S36RN/ED further indicated that CNAs on the off-site campus were encouraged to have CPI training, but it was not required since the RNs in the Emergency Department were CPI trained





30172

30172

Based on record review, observation and interview the hospital failed to ensure all medical records on the off-site campus were properly stored in secure locations where they were protected from water damage in the event that the sprinkler system in the Medical Record department was activated.

Findings:
A review of the hospital policy titled, "Secure Medical Record Storage", revealed in part: The hospital or facility must store medical records in a way that prevents the loss, destruction, or unauthorized use of such records...Secure Storage Location 1. Medical records must be properly filed and stored in a secure location(s) that safeguard from the following...c. Natural disasters such as floods, forest fire, earthquakes, hurricanes, wind and...

An observation on 02/07/17 at 4:15 p.m. of the off-site hospital Medical Records department revealed a long (over 10 feet) open table cabinet with 2 shelving compartments on each side that contained medical records. A further observation of the Medical Records department revealed 12 cardboard boxes stored on the floor that contained medical records.

In an interview on 02/07/17 at 4:30 p.m. with S13MR she indicated she worked in the Medical Records department at the off-site campus. She was asked about the medical records stored in the long open table cabinet and the medical records stored in the cardboard boxes on the floor. S13MR indicated that those were Emergency Room patient medical records and Outpatient medical records from May 2016 to present. She further indicated that they had not been scanned into the computer system yet and that they were the original patient medical records. S13MR indicated that it was probably over 1000 medical records. S13MR indicated that those medical records were not protected from water damage in the event that the sprinkler system in the Medical Record department was activated.

Based on record review and interview, the hospital failed to ensure that drugs were distributed in accordance with applicable standards of practice for patient safety as evidenced by the failure of the pharmacist to conduct a first dose review of non-emergent medications ordered and administered in the Emergency Department prior to the administration of the first dose for 1 of 1 (#24) patient reviewed for a first dose review by the pharmacist.

Findings:
Review of the hospital's policy titled Medication Management and Administration 13-08 Section 4. Patient Care revised 01/2016 revealed: A pharmacist reviews all prescription or medication orders before dispensing, removal from floor stock, or automated storage unit.

Patient #24
Review of the medical record for Patient #24 revealed she presented to the Emergency Department (Main Campus) on 02/07/17 at 5:39 p.m. with a chief complaint of left lower quadrant pain, severity mild-moderate, and nausea. Exam at 6:16 p.m. revealed the patient was awake and alert, and in no acute distress; mild abdominal tenderness in the left lower quadrant.

Further review of the medical record for Patient #24 revealed an order at 6:06 p.m. for Zofran 4 mg by mouth once (for nausea). The Zofran was dispensed at 6:09 p.m. The patient was discharged to home at 6:26 p.m.

On 02/08/17 at 10:30 a.m., an interview with S40PharmDir confirmed that the above administration of Zofran would not be considered an emergency situation, and should therefore be subject to first dose review. She further confirmed that no orders for medications administrated in the Emergency Department are reviewed by the pharmacist prior to the first dose.

In an interview on 02/07/17 at 4:45 p.m. with S37RPh, at the off-site campus, he indicated that all patient medication orders were reviewed for a first dose review by a pharmacist unless it is ordered as an emergent medication. S37RPh further indicated that it was not the practice of the pharmacists to do first dose medication reviews for patients in the Emergency Department when ordered by the emergency room physicians, whether the ordered medication was emergent or non-emergent.


30172

Based on observation, record review, and interview, the hospital failed to ensure all equipment was maintained in a manner to ensure an acceptable level of safety and/or quality as evidenced by:
1) Failing to ensure the functionality of a nurse call button located on the handrails of the beds for 21 of 21 beds currently in use at the main campus of the hospital, and;
2) Failing to ensure the facility was maintained as evidenced by missing, crumbling plaster from the walls in patient bathrooms.


Findings:

1) Failing to ensure the functionality of a nurse call button located on the handrails of the beds:

During the entrance conference on 02/06/17 at 11:05 a.m. with S3ADON, she stated the hospital had 64 licensed beds at the main campus and 46 licensed beds at the off-site campus.

Review of the current patient census at the main campus revealed there were 21 current patients.

On 02/06/17 at 1:25 p.m., with S3ADON and S6RNSup, an observation was made of the nurse call button in Room "f" in the ICU. On the siderails of the patient's bed was a white cross inside a red square, indicating a button to press to call for assistance. The button was noted to be non-functional as it failed to activate any type of nurse call system. S6RNSup confirmed the white cross in the red square was a nurse call button, but stated the call button was not functional. S6RNSup indicated that the hospital does have a nurse call system which includes a cord with a button and reported that patients are instructed to use this call system. S3ADON confirmed it would be possible for a patient who may be sedated and/or confused to press the white cross button on the handrail of the bed thinking they are calling for assistance without the nursing staff's knowledge due to the call button not working. S6RNSup stated all the patient beds on the ICU and Medical-Surgical unit had beds with nurse call buttons in the side rails and none of the nurse call buttons were functional. Further observations of unoccupied beds in the ICU revealed Rooms "g" and "h" had patient beds with non-functional nurse call buttons in the side rails of the bed.

On 02/06/17 at 2:00 p.m. an observation was made of the Med-Surg/Telemetry unit with S3ADON and S6RNSup Rooms "b", "i", "j", and "k" were observed to have patient beds that had a nurse call button in the side rails of the beds. The button was noted to be non-functional as it failed to activate any type of nurse call system. S6RNSup confirmed the white cross in the red square was a nurse call button, but stated the call button was not functional.

On 02/06/17 at 2:30 p.m., an observation was made of the Rehabilitation Unit with S3ADON and S7RNRehab (Nurse Manager for Rehab Unit). Rooms "c" and "l" were observed to have patient beds that had a nurse call button in the side rails of the beds. The button was noted to be non-functional as it failed to activate any type of nurse call system. S7RNRehab confirmed the white cross in the red square was a nurse call button, but stated the call button was not functional. S7RNRehab confirmed all 10 beds on the Rehab Unit had nurse call buttons in the side rails of the beds and none of the call buttons were functional. S7RNRehab indicated the nurse call button located on a cord was used as the nurse call system.

In an interview on 02/08/17 at 9:40 a.m., S45DirPlantOps provided a list of all patient beds at both campuses of the hospital. Review of the lists provided revealed there was a total of 102 patient beds at the main campus and 47 beds at the off-site campus. S45DirPlantOps confirmed all the beds at both campuses had a nurse call button located in the side rails of the bed and none of the nurse call buttons were functional.


2) Failing to ensure the facility was maintained as evidenced by missing, crumbling plaster from the walls in patient bathrooms:

During an observation of the Med-Surg unit on 02/06/17 from 2:00 p.m. to 2:30 p.m. with S3ADON and S6RNSup the following observations were made:
Room "i" - the plaster was observed to be missing and crumbling off the lower aspect of the dividing wall in the patient's bathroom.
Room "j" - the plaster was observed to be missing and crumbling off the lower aspect of the dividing wall in the patient's bathroom.
Room "b" - the plaster was observed to be missing and crumbling off the lower aspect of the dividing wall in the patient's bathroom.
The above observations were confirmed by S3ADON and S6RNSup.

26351

Based on observation, interview, and record review the Infection Control Officer: a) failed to maintain a system for identifying, reporting, investigating, and controlling infections and communicable diseases as evidenced by failing to maintain a sanitary hospital environment, b) failed to ensure that staff were familiar with the contact time requirements for the EPA disinfectants used to disinfect patient care equipment between use, c) failed to ensure that multiple-use medication vials opened in patient care areas were designated as single use and not available as multiple-use, and d) failed to ensure the Infection Control Program had active infection control surveillance monitoring activities in all of the hospital's departments to include: OR, Radiology, Dietary, Respiratory, Emergency Room, Cardiac Cath Lab, Pharmacy, and Obstetrical Unit.

Findings:
Sanitary Environment:

An observation was conducted on 02/06/17 at 11:45 p.m. in the ED at the Main Campus in Room "d". On the code cart in the room was a large amount of old adhesive from the removal of tape. The old adhesive left a sticky residue behind making it difficult to be disinfected properly. This observation was confirmed by S3ADON and S12ED Director.

An observation was conducted on 02/06/17 at 12:30 p.m. on the Med/Surg Unit at the Main Campus in Room "a". On the side rails of the bed was a brown and red substance. This observation was confirmed by S6RNSup.

An observation was conducted on 02/06/17 at 12:35 p.m. on the Med/Surg Unit at the Main Campus. The closet door in Room "b" had exposed particle board which made it difficult to disinfect properly. This observation was confirmed by S6RNSup.

An observation was conducted on 02/06/17 at 12:40 p.m. in the Rehab Unit at the Main Campus. The bathroom floor in Room "c" had a brown substance in the crevices of the floor and around the toilet area. There also was a substance on the wall which left a splatter pattern on the walls in the bathroom behind the toilet. These observations were confirmed by S7RNRehab and S8PD.

An observation was conducted on 02/06/17 at 2:30 p.m. in the Rehab Unit at the Main Campus with S3ADON and S7RNRehab. S7RNRehab confirmed Room "l" was ready for patient use and they were receiving a new admission to this room soon. Observation of the overbed table next to the patient bed revealed the vinyl covering was loose and lifted up and there was a large red/brown substance noted between the edge of the vinyl covering and the surface of the overbed table. S3ADON confirmed the overbed table was not suitable for patient use as it was not clean.

On 02/07/17 at 1:15 p.m., an observation of the Soiled Utility Room on the medical surgical unit of the Main Campus revealed it contained dirty items including trash and soiled linens. Observation inside a cabinet in the room labeled "Lost and Found" revealed a stack of about a dozen blue cloth pads. An interview with S41EVS at this time confirmed that these were microfiber cleaning cloths ready for use in cleaning patient care equipment. Further interview with S41EVS and S2CNO confirmed that only trash and soiled items should be stored in the room.

On 02/07/17 at 1:40 p.m., observation of the empty patient room e on the Medical/Surgical Unit of the Main Campus revealed the mattress on bed A had a pinhole tear in the top surface and cracks along the side areas. The bed frame rails underneath the mattress were rusted and the rust was also on the underneath surface of the mattress. Observation of bed B revealed multiple tears and cracks in the top surface of the mattress. The paint on the surface of the bed frame rails underneath the mattress was bubbled up and beginning to peel away. An interview with S5IC at this time confirmed that the hole, tears and cracks in the mattresses could allow bodily fluids to seep into the mattress and harbor bacteria, and that the rusted areas on the bed frame rails was not able to be disinfected.

An observation on 02/06/17 of the OR revealed the following infection control sanitary environment breaches:
- the electrocautery units in the OR revealed that the carts that housed the electrocautery units were observed to have some rusting, pitting and peeling paint on the surfaces, and
- the gel positioning pads (x2) were observed to be torn in places where the gel was exposed.

In an interview on 02/06/17 at 2:00 p.m. with S14ORDir he indicated that the housing carts for the electrocautery units were sometimes a challenge to maintain due to the frequent disinfecting and that they had to be sanded and painted often. S14ORDir indicated that the gel positioning pads were torn and should be replaced.


EPA disinfectant contact times
On 02/07/17 at 1:20 p.m., an interview with S41EVS on the Main Campus revealed she uses the cleaning product Vyrex to clean the surfaces of patient care equipment (beds,mattresses, bed rails, tables, chairs, etc). She stated she sprays the surfaces and allows the product to sit for 10-15 minutes to disinfect before wiping the surface with a dry cloth.

On 02/07/17 at 1:35 p.m., an interview with S43RN Medical/Surgical Charge Nurse on the Main Campus revealed she uses the "orange top sanitizer" to disinfect surfaces by spraying the surface and wiping of after about 1 minute or maybe 3 minutes.

On 02/07/17 at 1:50 p.m., an interview with S44RN ICU Nurse on the Main Campus revealed she disinfects with PDI by spraying it on the soiled surface and allowing it to sit for 5 minutes before wiping off.

On 02/07/17 at 1:55 p.m., an interview with S2CNO confirmed that all staff have been inserviced on the use of the disinfecting product and should be able to know how to locate the information for the cleaning product and procedure for use.

Review of the product label on the bottle of PDI (orange top) revealed that the product should be allowed to sit for at least 4 minutes to ensure disinfection of the surface onto which it is applied.


A review of the PDI sani-cloth MFU revealed the item being treated must remain visibly wet for 3 minutes (contact time).

A review of the Vyrex MFU revealed the item being treated must remain visibly wet for 10 minutes (contact time).

An observation on 02/07/17 at 9:30 a.m. was made of S46Hk/OR and S22Hk/OR using Vyrex to disinfect an OR room between patient procedures. They indicated that the contact time for the Vyrex was 10 minutes and it was not necessary for the items being treated to remain visibly wet for the 10 minutes.

In an interview on 02/07/17 at 11:10 a.m. with S27CRNA he indicated that the CRNAs use the PDI sani-cloth to disinfectant their equipment between surgical procedures and that it is supposed to set for 3 minutes. He indicated that it did not have to stay visibly wet for the 3 minutes.

In an interview on 02/07/17 at 5:45 p.m. with S38RN on the Med-Surg unit she indicated that the nurses use the PDI sani-cloth to disinfect patient care equipment between use. She indicated that the contact time was 3 minutes where you let it dry for at least 3 minutes.


Multiple-use medication vials:

An observation of the anesthesia medication drug kits used by the CRNAs at the Main Campus for anesthesia during a patient's surgical procedure revealed that they contained multiple-use medication vials (Dexamethasone 5ml vial, Labetalol 20ml vial, Lidocaine 20ml vial, Neostigmine vial, Rocuronium vial). An observation further revealed opened multiple-use medication vials (Dexamethasone 5ml vial, Lidocaine 20ml vial, Rocuronium vial) in an anesthesia medication drug kit that was labeled as ready for the next patient's use.

In an interview on 02/06/17 at 2:30 p.m. with S16CRNA she indicated that she was the lead CRNA at the Main Campus. S16CRNA indicated that an anesthesia medication drug kit was brought into the OR for a patient's surgical procedure and if a multiple-use medication vial was opened and used for the patient, it was dated and initialed and returned to the anesthesia medication drug kit and then to pharmacy. She indicated that the pharmacist would charge the patient for the medications used and any opened multiple-use medication vials would be returned to the anesthesia medication drug kit and returned to the OR and stored in an anesthesia locked area in the OR for other patient's procedures. S16CRNA indicated that multiple-use medication vials opened in the OR (patient care areas) were not designated as single-use after being opened and were returned to the kits for use in other patient's surgical procedures.


Infection control surveillance monitoring activities not in all departments:

A review of the I.C. officer's (S5IC) infection control binder revealed no documented active infection control surveillance monitoring activities for the following hospital departments: OR, Radiology, Dietary, Respiratory, Emergency Room, Cardiac Cath Lab, Pharmacy, and Obstetrical Unit.

In an interview on 02/08/17 at 12:00 p.m. with S5IC she indicated that she only performed active surveillance hand hygiene monitoring activities in the above departments. She indicated that most departments collected data relating to infection control but that information was not reported to her and it probably went to Quality Assurance for review (tracking, trending, and analyzing). S5IC indicated that she tracks, trends, and analyzes infection control data for NHSN requirements. S5IC further indicated that she conducts environmental rounds and issues are handled mostly in "real time" and not tracked, trended, or analyzed over time. S5IC was made aware of the infection control breaches identified by the surveyors. She indicated that she did not have prior knowledge of these infection control breaches. S5IC indicated that she would begin to include the infection control activities presently being conducted within all the departments and review them for accuracy and compliance and incorporate them into a more hospital-wide infection control program approach so infection control breaches can be identified, investigated, and controlled.





20310




17091

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 staff adhered to acceptable standards of professional practice in surgical attire in the restricted and semi-restricted areas in the Operating Rooms and in the Cardiac Catheterization Lab as evidenced by multiple observations of surgical attire breaches,

2) failing to ensure that the hospital processed/sterilized surgical supplies according to acceptable surgical practice in the processing and sterilization of surgical items in paper-plastic peel pouches as evidenced by the hospital sterilizing heavy surgical instruments in paper-plastic peel pouches,

3) failing to ensure that single use items (single use disposable orthopedic tourniquet cuffs) were not available for other patient's surgical procedures and failing to ensure that single use towels were not laundered and used in the Central Sterile reprocessing area to dry instruments,

4) failing to ensure that surgical hand scrubs, prior to surgical procedures, when using alcohol based surgical hand disinfectants followed MFU,

5) failing to ensure the reprocessed endoscopy scopes (at both campuses) were stored in a storage cabinet that had a drying system that circulated HEPA-filtered air through the cabinet and failing to ensure that the one-room design endoscopy reprocessing room (at the off-site campus) maintained a minimum of 3 (three) feet between the decontamination area and the clean work area or a separating wall or barrier to separate the soiled work area from clean work area.

Findings:
1) failing to ensure that staff adhered to acceptable standards of professional practice in surgical attire in the restricted and semi-restricted areas in the Operating Rooms and in the Cardiac Catheterization Lab as evidenced by multiple observations of surgical attire breaches:

A review of the hospital policy titled "Surgical Attire" as provided by S14ORDir as the most current, revealed in part: These practices serve as guidelines for surgical attire within the Surgical Services Department. Compliance will lessen the risk for the spread of infection. These practices apply to all that enter the semi-restricted and restricted areas. The OR Director and the I.C. practitioner are responsible for assuring compliance with this policy. All re-usable attire is laundered after each use by the Contract Laundry Services. OR attire design and composition should minimize bacterial shedding. Masks will have facial compliance to prevent venting. Masks shall be either on or off and should not be saved by hanging around the neck.

The AORN Guidelines for Perioperative Practice, 2016 edition - Guideline for Surgical Attire:
Recommendation I revealed in part: All individuals entering the restricted surgical area (OR suite) 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. Surgical masks should not be worn hanging down from the neck. 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 and should not be worn hanging from the neck. Surgical masks should be tied securely and discarded after each procedure or when soiled. Masks with ear loops may not have been designed and intended for use as a surgical mask and may not provide a secure facial fit that prevents venting at the side of the masks. 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. Recommendation I further revealed in part: When in the semi-restricted or restricted surgical areas, all non-scrubbed personnel should wear a freshly laundered or single use long sleeved scrub top or jacket snapped closed with the cuffs down to the wrists. Wearing the long-sleeved 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. All personal clothing, not laundered by a health care-accredited laundry facility, 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 or should be laundered in a health-care-accredited laundry facility after each daily use.
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. 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

Observations on 02/06/17 from 1:00 p.m. to 2:30 p.m. at the main campus's OR and on 02/07/17 from 8:30 a.m. to 11:30 a.m. at the off-site's campus's OR and Cardiac Cath Lab revealed the following surgical attire breaches in the semi-restricted and restricted surgical suite areas:

S29RN/Cath with facial hair (beard) that was not completely covered by his surgical mask and beard mask.

S18CRNA and S17MD with the surgical mask worn hanging from the neck,

S20ST and S21CRNA wearing a surgical mask not tied properly to prevent venting,

S14ORDir, S16CRNA, S17MD, S19MD, S24ST, S25CRNA, S27CRNA, S28CathDir, S29RN/Cath, and S30RN/Cath wearing a T-shirt that was not completely covered by the surgical attire,

S34MD wearing a home laundered surgical scrub attire,

S22Hk/OR, S26RN/OR, and S25CRNA wearing a long-sleeved scrub jacket that was not buttoned down the front,

S46Hk/OR, S23CSP, S28CathDir, S29RN/Cath, S30RN/Cath, S31ST/Cath, S32ST/Cath and S33ST/Cath not wearing a long-sleeved scrub jacket buttoned down the front,

S28CathDir, S29RN/Cath, S30RN/Cath, S31ST/Cath, S32ST/Cath and S33ST/Cath wearing loop surgical masks

In an interview on 02/07/17 at 12:00 p.m. with S14ORDir and S28CathDir, S14ORDir indicated that he was the OR Director for both of the hospital's campuses. He indicated that the hospital had a policy on the wearing of surgical attire which should be followed by all staff in surgical areas. S28CathDir indicated that she was the Cardiac Cath Lab Director. She indicated that the Cardiac Cath Lab followed the OR's surgical attire policy. S14ORDir indicated that the surgical services areas followed the AORN Guidelines.


2) failing to ensure that the hospital processed/sterilized surgical supplies according to acceptable surgical practice in the processing and sterilization of surgical items in paper-plastic peel pouches as evidenced by the hospital sterilizing heavy surgical instruments in paper-plastic peel pouches:

A review of the AORN Guidelines for Perioperative Practice, 2016 edition- Guideline for Packaging Systems: Recommendation III revealed in part: Sterilized items should be considered sterile until an event occurs to compromise the sterility of the sterile item. The sterility of sterile items is event related and not time related. Recommendation VII revealed in part: Paper-plastic pouch packages should be used only for small, lightweight, low-profile items. Paper-plastic pouch packaging may be used to facilitate containment of multiple small items to be sterilized.

An observation of the Central Sterile Supply Rooms revealed that several sterile paper-plastic peel pouches contained heavy surgical instruments where visible stress was noted to the sealed edges causing the sealed edges to begin to separate and compromising the integrity of the sterile package.

In an interview on 02/06/17 at 2:00 p.m. with S14ORDir he indicated that some heavy surgical instruments were sterilized in paper-plastic peel pouches and in observing some of the heavy sterile packages with S14ORDir he indicated that some of the instruments were probably too heavy to be peel-packed and were causing noticeable stress along the sealed edges and compromising the integrity of the sterile package.


3) failing to ensure that single use items (single use disposable orthopedic tourniquet cuffs) were not available for other patient's surgical procedures and failing to ensure that single use towels were not laundered and used in the Central Sterile reprocessing area to dry instruments:

A review of AORN Guidelines for Perioperative Practice, 2016 edition- Guideline for Product Selection, Recommendation II revealed that single use items should not be re-used, re-processed or re-sterilized, but discarded.

An observation on 02/07/17 at 2:20 p.m. of the Central Sterile reprocessing area revealed a stack of unsterile blue surgical towels on a shelf next to the washer/sanitizer.

An observation on 02/06/17 at 2:30 p.m. of the OR's tourniquet machine and attached storage basket revealed 8 single use tourniquets cuffs that had been opened and were being stored in the attached storage basket.

In an interview on 02/07/17 at 2:30 p.m. with S14ORDir he indicated that the hospital did not reuse or reprocess single use items. S14ORDir indicated that the tourniquets cuffs used in the OR were single use only and discarded after opened and that the tourniquets cuffs being stored in the tourniquet machine storage basket should have been discarded after they were opened or used. S14ORDir indicated that the hospital used single use sterile blue towels and they were discarded after use. He indicated that the blue towels observed in the Central Sterile reprocessing area on the shelf next to the washer/sanitizer were used to dry the surgical instruments after they came out of the washer/sanitizer. He indicated that they were washed by the contract laundry and returned to the hospital. He further indicated he did not know where the laundry originally obtained the blue towels and that the hospital did not buy reusable unsterile blue surgical towels for the contract laundry. S14ORDir was unable to assure that the blue towels were not the used single use sterile blue towels from patient's surgical procedures that had been throw in the laundry and sent to the laundry along with the hospital's laundry to be washed.


4) failing to ensure that surgical hand scrubs, prior to surgical procedures, when using alcohol based surgical hand disinfectants followed MFU:

A review of the hospital policy titled "Surgical Hand Scrub" as provided by S14ORDir as the most current, revealed in part: Alcohol Based Surgical Hand Disinfectant - may be used after an initial 5 minute hand scrub. See Manufacturer's guidelines on use of surgical hand disinfectant.

A review of the MFU on the surgical hand scrub used by the OR when performing a surgical hand scrub prior to aseptic gowning and gloving, prior to a patient's surgical procedure, revealed in part: Apply to clean dry hands. Application process takes 90 seconds. A minimum of 6 milliliters is required. Hands should remain moist for entire application time. Place cupped hand under dispenser. Receive dosage and dip fingertips of opposite hand into palm, working the solution under the nails into the cuticles, spread to palm, fingers, back of hand and apply up to forearm. Repeat to opposite hand and forearm. Receive third dosage into hands paying particular attention to the fingers, cuticles and interdigital spaces. Rub antiseptic fully into the hands, avoid returning to the forearm. Be sure to rub hands until dry.

An observation on 02/07/17 at 9:15 a.m. of S20ST during the surgical hand scrub, prior to a patient's surgical procedure, revealed she dispensed three pumps of the surgical hand scrub into her hands and rubbed the surgical scrub over her hands and lower arms simultaneously for less than 30 seconds and then with the hands and arms still visibly wet, she immediately proceeded to the OR to don sterile surgical gown and gloves.

In an interview on 02/07/17 at 9:30 a.m. with S14ORDir (present for the observation) he was made aware of S20ST not following the MFU on the Alcohol Based Surgical Hand Disinfectant. He indicated that staff and surgeons would need further in-services on the proper use of the Alcohol Based Surgical Hand Disinfectant.


5) failing to ensure the reprocessed endoscopy scopes (at both campuses) were stored in a storage cabinet that had a drying system that circulated HEPA-filtered air through the cabinet and failing to ensure that the one-room design endoscopy reprocessing room (at the off-site campus) maintained a minimum of 3 (three) feet between the decontamination area and the clean work area or a separating wall or barrier to separate the soiled work area from clean work area:

A review of AORN Guidelines for Perioperative Practice, 2016 edition - Sterilization and Disinfection: Flexible Endoscopes- Recommendation I revealed in part: An endoscopy processing room with a one-room design should provide a minimum of 3 feet between the decontamination area and the clean work area and either a separating wall or barrier that extends a minimum of 4 feet above the sink rim to separate soiled work areas from clean work areas. Cross contamination can result when soiled items are placed in close proximity to clean items or are placed on surfaces upon which clean items are later placed. Separation of the decontamination area from the clean area minimizes the potential for contamination of clean and processed flexible endoscopes. Separating soiled and clean work areas by a distance of at least 3 feet aligns with the current recommendations from the CDC. Having a wall or physical barrier for separation of the decontamination area provides protection and minimizes the potential for contamination of clean and processed flexible endoscopes.
Recommendation IX revealed in part: Flexible endoscopes and endoscope accessories should be stored in a manner that minimizes contamination and protects the device or item from damage. Flexible endoscopes should be stored in a drying cabinet to facilitate drying, decrease the potential for contamination, and provide protection from environmental contaminants. Drying cabinets are to include a drying system that circulates HEPA-filtered air through the cabinet while filtered air under pressure is forced through the endoscope channels where the endoscopes are continuously dried, suppressing bacterial growth.


An observation on 02/06/17 at 2:30 p.m. and on 02/07/17 at 11:30 a.m. of the endoscope storage cabinets at both campuses, respectively, revealed no evidence of HEPA- filtered air being circulated in the storage cabinets.

An observation on 02/07/17 at 11:30 a.m. of the Endoscopy Processing Room at the off-site campus revealed a one-room design. An observation revealed approximately an 18 inch separation between the decontamination area and the clean work area where the flexible endoscopes were being processed. A further observation revealed no evidence of a wall or barrier that extended a minimum of 4 feet above the sink rim to separate the soiled work area from the clean work area.

In an interview on 02/07/17 at 12:15 p.m. with S14ORDir he indicated that the endoscope storage cabinets at both campuses had no HEPA- filtered air being circulated in the storage cabinets. He further indicated that he heard a couple of years ago that HEPA filtered air was going to be required in endoscopy cabinets, but he did not think that it was required yet. S14ORDir indicated that the endoscopy procedures were presently being performed at the off-site campus due to remodeling of the endoscopy suites at the main campus. He indicated that the endoscopy processing room at the off-site campus was small and was a one-room design. S14ORDir indicated that he was not aware of the one-room design requirements for decontamination and the clean work areas. S14ORDir indicated that the Endoscopy Department followed the AORN Guidelines.