HospitalInspections.org

Based on record review and interview, the Governing Body failed to ensure that the hospital's QAPI program reflected the hospital's organization and services as evidenced by not having all hospital departments and services, including those services furnished under contract, involved in the QAPI Program. The governing body failed to ensure the QAPI program included monitoring of any of the contracted services except contracted linen services. The governing body also failed to ensure all departments were included in the QAPI program. Findings:.

Review of the Quality Improvement Plan and the Performance Improvement Indicators for 2015 revealed documented evidence that the only contracted service included in QA indicators was that of the contracted linen service. Further review revealed respiratory services and Business Office/Admissions services were not incorporated into QA.

In an interview 10/13/15 at 12:15 p.m. S3QAICDP reported that contracted services were not incorporated into the QA program. S3QAICDP reported that only the contracted linen services were evaluated and included in the program. S3QAICDP reported that the QA program did not include all of the departments and services of the hospital. S3QAICDP verified that the Respiratory department, Anesthesia Department, and Admissions/Business Office Services were not included in the QA program and did not have indicators.

Based on record review and interview the hospital failed to insure that a properly executed informed consent for procedures and treatments were included in the medical record of each patient, as per hospital policy and procedure. This failed practice was evidenced by consents for surgery/procedures with blank areas such as the patient's condition for which the procedure is indicated, the material risks, and any additional risks particular to the patient because of a complicating medical condition, and the name of the authorized physician. This failed practice was evidenced in 5 of 5 (#6, #7, #10, #12, #18) medical records reviewed for properly executed consents of a total sample of 30.
Findings:



Review of Hospital Policy #NURS-23.1.27, titled "Informed Consent", provided as current, revealed the following, in part:
Requirements for Informed Consent ...a description of the proposed procedure...the indications for the proposed procedure; material risks and benefits for the patient... treatment alternatives, the probable consequences of declining recommended or alternative therapies; who will conduct the surgical intervention... Documentation according to Section 4 of this policy should be in the medical record as evidence that consent has been obtained.
Section 4. A properly executed informed consent much contain at least the following: i. the name of the hospital, ...iii the name, nature and purpose of the surgical or medical procedure; iv. A statement that the procedure, surgery or treatment, including the anticipated benefits, material risks and alternative therapies, was explained to the patient... v. Name(s) of the attending physician(s) performing or supervising the surgery, procedure, or treatment requiring informed consent;..

Patient #6
Review of the medical record for Patient #6 revealed she had a Left Total Hip Arthroplasty performed 6/16/15. Further review revealed documentation of an Informed Consent with area #4: Material Risks of Treatment Procedure (a) and (b) were blank. Further review revealed , under Acknowledgement, Authorization, and Consent, (e) Authorized Physician was blank.

Patient #7
Review of the medical record for Patient #7 revealed she had a C 4-6 Anterior Cervical Discectomy and Fusion, performed 08/26/15. Further review revealed documentation of an Informed Consent with area, under Acknowledgement, Authorization, and Consent, (e) Authorized Physician was blank. A Sales Rep/Observer Consent was noted to be completely blank with the exception of the patient's signature and date (08/26/15) and the signature of a witness. The form failed to include the name of the additional person and the reason for him/her to be in the operating room during Patient #7's surgery, or what services he/she would provide.


Patient #10
Review of the medical record for Patient #10 revealed he had a Left Carpal Tunnel Release performed 10/08/15. Further review revealed documentation of an Informed Consent with area #4: Material Risks of Treatment Procedure (a) and (b) were blank. Further review revealed , under Acknowledgement, Authorization, and Consent, (e) Authorized Physician was blank.


Patient #11
Review of the medical record for Patient #11 revealed she had a Right Carpal Tunnel release with right trigger-thumb release performed 10/08/15. Further review revealed documentation of an Informed Consent with area #4: Material Risks of Treatment Procedure (a) and (b) were blank. Further review revealed , under Acknowledgement, Authorization, and Consent, (e) Authorized Physician was blank.

Patient #12
Review of the medical record for Patient #12 revealed he had a left foot hardware removal with open reduction, internal fixation performed 10/08/15. Further review revealed documentation of an Informed Consent with area #4: Material Risks of Treatment Procedure (a) and (b) were blank. Further review revealed , under Acknowledgement, Authorization, and Consent, (e) Authorized Physician was blank.

Patient #18
Review of the medical record for Patient #18 revealed she had a a direct lateral fusion with instrumentation at L4-5 performed 08/27/15. Further review revealed documentation of an Informed Consent with area (#3) Patient Condition: Patient's diagnosis and description of the nature of the condition or ailment for which the medical treatment ...is indicated and recommended was blank. Further review revealed a patient consent for a Sales Rep/Observer. The observer was named, as was the observers company for neuromonitoring. The rest of the consent was blank as to the reason for the person's presence in the procedure. Listed in the possible reasons were observation only, assist surgeon, product demonstration/orientation (with the name of the product to be specified)
Equipment demonstration/orientation, with the name/type/nature of the equipment to be specified, product use requires rep/vendor involvement with a blank for an explanation, equipment use requires sale rep/vendor involvement ( rental/trial/other. If other, explain)
and "other". A statement just above the patient's ( or patient representative's) read " I understand that the above-named individual(s) will be present in the operating room during my procedure at the request of my surgeon for the reason(s) listed above. No area of the reason for the monitor was documented; the entire area was blank.

In an interview 10/13/15 at 10:20 a.m. S12Nurse reported that the Informed Consents are usually signed by the physician and patient at the physician's office, then sent to the hospital to be put on the chart for the day of surgery. She reported that the nurses do not get the consents signed, but check that they are signed. S12Nurse reported that she did not look at the consent to make sure all blanks were filled or marked through.

In an interview 10/13/15 at 1:50 p.m. S2QAICDP reviewed the informed consents reviewed by surveyors and verified the findings. She confirmed that by leaving blanks on the consents they could potentially have information filled in that the patient had not been provided and/or did not consent to. S2QAICDP verified the informed consents of Patients ##6, #7, #10, #12, #18 were not completed as per hospital policy and procedure,.

Based on observation, interviews and record reviews the hospital failed to ensure that staff involved in radiological procedures were provided with a radiation monitoring badge to monitor their exposure to radiation hazards as evidenced by 2 out of 2 staff (S18Nurse and S30CRNA) observed in radiological procedures in the OR not having radiation badges.
Findings:
A review of the hospital policy titled, "Surgical Services- Radiation Safety in the O.R." , provided by S2DON as the most current, revealed in part: Radiation monitoring badges will be utilized consistently and should be worn on the outside of the leaded apron to monitor staff's exposure to radiation hazards.
A review of the dates of hire for S18Nurse and S30 CRNA with S9HR revealed that S18Nurse was hired on 09/14/15 and that S30CRNA was contract and began working at the hospital on 07/29/14.
An observation on 10/12/15 at 2:35 p.m. was made of S18Nurse and S30CRNA in a radiological surgical procedure with leaded aprons on and no evidence of a radiation monitoring badge attached to their leaded apron.
In an interview on 10/12/15 at 2:40 p.m. with S18Nurse and S30CRNA, they indicated that they had not been provided with a radiation monitoring badge by the hospital.
In an interview on 10/12/15 at 2:50 p.m. with S3Rad he indicated that he was responsible for ordering radiation monitoring badges for all employees and contract staff. S3Rad further indicated that radiation monitoring badges are usually received in about 2 (two) weeks after they are ordered. S3Rad indicated that he had not ordered radiation monitoring badges for S18Nurse and S30CRNA.

Based on record review and interview the hospital failed to ensure that radiological personnel were evaluated to be currently competent as evidenced by no current competency evaluations for 1 of 1 (S3Rad) Radiology Technicians reveiwed for competency from a total of 4 Radiology employee names provided.
Findings:


Review of the personnel file for S3Rad revealed a date of hire of 10/19/09. Further review revealed no current competency evaluation for radiology skills since 10/2012.

In an interview 10/12/15 at 3:10 p.m. S9HR, after reviewing personnel records with surveyors, verified that S3Rad did not have any current skill competencies in his personnel file.

In an interview 10/13/15 at 10:00 a.m. S3Rad and S32Rad reported that they did not have annual evaluations for competency of their job performances in radiology. S3Rad confirmed that he performed the CT studies and he was the one that started the IV and injected the contrast material. He reported he learned to do that in Radiology Technician school.

Based on record review and staff interview, the hospital failed to have a current agreement with a qualified dietitian.
Findings:

Reviewed of the Independent Contractor Agreement with S5RD revealed the agreement expired on 05/09/12.

In an interview on 10/12/15 at 10:31 a.m., S3QAICDP confirmed the hospital did not have a current agreement with a qualified dietitian.

Based on observations, interviews and record reviews, the hospital's Infection Control Program failed to ensure the system for preventing and controlling infections and infectious diseases was followed, maintained and monitored as evidenced by:
1) failing to ensure that surgical instrument trays were processed according to acceptable and preferred methods of sterilization, as evidenced by the hospital's frequent use of IUSS of surgical instrument trays for patient's surgical procedures,

2) failing to ensure that staff in the perioperative surgical suite's restricted and semi-restricted areas followed acceptable professional standards of practice and acceptable infection control practices and hospital policy as evidenced by: a) observation of non-scrubbed surgical staff not wearing a long sleeved buttoned up warm up jacket during surgical procedures, b) observations of surgical staff wearing T-shirts under their scrub attire that were not completely covered by their surgical attire, c) observations of surgical staff wearing skull caps (surgeon caps) that did not completely cover all their hair (head and facial beard hair), d) observations of surgical staff wearing home laundered cloth hats that were not completely covered by a disposable surgical bouffant hat, e) observations of surgical staff wearing surgical masks around their necks or having surgical masks in their pockets, f) observations of staff wearing stethoscopes around their neck, g) observations of staff in the decontamination instrument room not wearing appropriate PPE when decontaminating surgical instruments, h) observations of staff not wearing masks when scrubbed persons were present, i) observations of improper packaging of sterile supplies, and j) observations of sterile supplies being stored in opened shelved equipment carts, located in the hallway, and sterile supplies stored on top of the non-sterile equipment or wedged between the non-sterile equipment on the equipment carts in the hallway.
3) failing to ensure that staff adhered to the MFU for a HLD solution used for items that were high level disinfected by the hospital, and

4) failing to ensure that ophthalmology instruments used in ophthalmology surgical procedures were decontaminated according to MFU prior to reprocessing them for future patient use in surgical procedures.

Findings:
1) failing to ensure that surgical instrument trays were available in a quantity that was commensurate with the hospital's expected daily procedure volume, as evidenced by the hospital's frequent use of IUSS of surgical instrument trays (provided by the hospital and/or by contract) for patient's surgical procedures,

A review of the hospital policy, titled "Central Sterile - Immediate Use Sterilization" , provided by S2DON as the most current, revealed in part: Immediate Use should only be used in emergent situations in order to prevent the spread of nosocomial infection and pathogens.
A review of the hospital policy, titled "Surgical Services- Loaning-Borrowing of Supplies, Equipment" , provided by S2DON as the most current, revealed in part: Any instrumentation that is brought into the hospital will be treated as contaminated and will be processed in the Central Sterile Department according to hospital policy
A review of AORN Perioperative Standards and Recommended Practices, 2013 edition - 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.
A review of AORN Perioperative Standards and Recommended Practices, 2013 edition- Care of Instruments: Recommendation III revealed in part: Loaner instruments should be examined, cleaned, and sterilized by the receiving facility before use and according to manufacturer's written instructions. Instruments loaned to the facility may not have been adequately decontaminated. Conditions during storage and transport are not known. The quality of any previous processing has not been verified, and sterile storage conditions have not been maintained during transport.
An observation on 10/12/15 of the surgery schedule revealed that the hospital had 13 (thirteen) cataract surgeries scheduled for S24MD. A further observation of the sterile processing area revealed that the hospital had 4 (four) cataract trays and an additional cataract tray that was provided by the medical representative, S23CST, that morning. S20CST was observed performing IUSS (Immediate Use Steam Sterilization) on the cataract trays and on the loaner cataract tray. IUSS was being performed on the cataract trays from 8:00 a.m. until 10:30 a.m. by S20CST.
In an interview on 10/12/15 at 11:00 a.m. with S23CST, he indicated that he was a contract CST for the hospital. S23CST indicated that the hospital required his loaner cataract tray for use today (10/12/15). S23CST indicated that he keeps an extra unsterile cataract tray in his car whenever the hospital needed an extra cataract tray. S23CST further indicated that he brought the cataract tray in this morning for use in the cataract surgeries today. He indicated that the tray was IUSS'ed before use by S20CST.
In an interview on 10/12/15 at 10:00 a.m. with S20CST she indicated that the hospital only had 4 (four) cataract trays and that S24MD had 13 cataract surgeries scheduled for 10/12/15. S20CST indicated that she had to IUSS cataract trays since the hospital did not have sufficient inventory to process the cataract trays required for the surgery workload that day by the preferred sterilization method. S20CST further indicated that S23CST (contract CST) brought in an unsterile loaner cataract tray that morning that also had to be IUSS'ed prior to use for the cataract procedures.
In an interview on 10/12/15 at 3:00 p.m. with S2DON she indicated that she was the Operating Room Director. She indicated that she was aware the Surgical Services Department was performing IUSS on surgical instruments for patient's surgical procedures since the hospital did not have sufficient inventory to process some instrument trays by the preferred sterilization method for the surgery workload on certain days.

2) failing to ensure that staff in the perioperative surgical suite's restricted and semi-restricted areas followed acceptable professional standards of practice and acceptable infection control practices and hospital policy as evidenced by: a) observation of non-scrubbed surgical staff not wearing a long sleeved buttoned up warm up jacket during surgical procedures, b) observations of surgical staff wearing T-shirts under their scrub attire that were not completely covered by their surgical attire, c) observations of surgical staff wearing skull caps (surgeon caps) that did not completely cover all their hair (head and facial beard hair), d) observations of surgical staff wearing home laundered cloth hats that were not completely covered by a disposable surgical bouffant hat, e) observations of surgical staff wearing surgical masks around their necks or having surgical masks in their pockets, f) observations of staff wearing stethoscopes around their neck, g) observations of staff in the decontamination instrument room not wearing appropriate PPE (personnel protective equipment) when decontaminating surgical instruments, h) observations of staff not wearing masks when scrubbed persons were present, i) observations of improper packaging of sterile supplies, and j) observations of sterile supplies being stored in opened shelved equipment carts, located in the hallway, and sterile supplies stored on top of the non-sterile equipment or wedged between the non-sterile equipment on the equipment carts in the hallway.
A review of the hospital policy, titled "Surgical Services- Dress Code Requirements OR Suite" , provided by S2DON as the most current, revealed in part: Proper OR attire is required in the surgical suite to lessen the risk of infection and to create a safe environment. The surgical hat or hood must confine the hair. Masks must be worn at all times in the OR and other designated areas where open sterile supplies or scrubbed persons may be located. Masks are either on or off and should not be saved by hanging around the neck or tucked into a pocket for future use.
A review of the hospital policy, titled "Central Sterile - Decontamination Procedure", provided by S2DON as the most current, revealed in part: PPE should be worn by personnel when decontaminating instruments prior to sterilization to prevent he spread of pathogens.
A review of the AORN Perioperative Standards and Recommended Practices, 2013 edition- Recommended Practice for Surgical Attire - Recommendation III 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 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. 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.
A review of the AORN Perioperative Standards and Recommended Practices, 2013 edition- Recommended Practice for Surgical Attire - Recommendation IV revealed in part: All personnel should cover head and facial hair, 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 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 covered completely by a disposable surgical bouffant hat.

The AORN Perioperative Standards and Recommended Practices, 2013 edition - Recommended Practices for Surgical Attire, Recommendation VI 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. 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 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.

A review of the AORN Perioperative Standards and Recommended Practices, 2013 edition- Recommended Practices for Surgical Attire, Recommendation II revealed in part: Stethoscopes should be clean and not worn around the neck. Stethoscopes may transmit pathogens such as MRSA by indirect contact, by wearing the stethoscope around the neck and contaminating the skin and surgical attire. Stethoscopes come in direct contact with the skin and could provide an opportunity for transmission of microbes from patient to patient and/or from health care personnel to patients.

A review of AORN Perioperative Standards and Recommended Practices, 2013 edition-Care of Instruments: Recommendation XVIII revealed in part: Personnel handling contaminated instruments and equipment must wear appropriate PPE (personal protective equipment) to help prevent the employee from exposure to bloodborne pathogens and other infectious materials. The appropriate PPE should include; a fluid-resistant gown, gloves, a mask and face protection. Splashes, splatters and skin contact can be reasonably anticipated when handling contaminated instruments.

A review of AORN Perioperative Standards and Recommended Practices, 2013 edition - Surgical Attire: Recommendation IX revealed in part: Restricted areas in a surgical suite includes the OR 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.

A review of AORN Perioperative Standards and Recommended Practices, 2013 edition-Packaging Systems: Recommendation V revealed in part: Paper-plastic pouch packages (used in packaging surgical items for sterilization) 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. 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.

A review of the AORN Perioperative Standards and Recommended Practices, 2013 edition, Recommended Practices for Selection and Use of Packaging Systems for Sterilization: Recommendation VIII revealed in part: Sterilized items should be considered sterile until an event occurs to compromise the sterility of the sterile item such as, moisture penetration or unacceptable storage conditions, exposure to airborne and other environmental contaminants. The sterility of sterile items is event related and not time related. Events that affected the sterility of sterile packages included in part: multiple handing of the sterile package, compression, moisture penetration to include disinfectant solutions, exposure to airborne and environmental contaminants and storage conditions (improper shelving, temperature, humidity, cleanliness, and traffic), type of packaging materials used, use of sterility maintenance covers and method of sealing.
Observations made of the perioperative area (restricted and semi-restricted areas) on 10/09/15 from 10:00 a.m. to 3:00 p.m. in the presence of S2DON, revealed the following surgical attire and infection control breaches:
-S14MD with his surgical mask hanging around his neck and wearing a surgeon's skull cap that did not completely cover all of his hair and facial beard hair,
-S15CRNA with his surgical mask hanging around his neck, wearing a surgeon's skull cap that did not completely cover all of his hair and facial beard hair, and wearing a T-shirt under his surgical attire that was not completely covered by the surgical attire,
-S16Nurse wearing her stethoscope around her neck,
-S17CST wearing a home laundered cloth cap that was not completely covered by the disposable surgical bouffant,
-S2DON with her surgical mask hanging around her neck and wearing a T-shirt under her surgical attire that was not completely covered by the surgical attire,
-S13Nurse wearing her stethoscope around her neck,
-S19Nurse wearing her stethoscope around her neck,
-S20CST with her surgical mask hanging around her neck and wearing a home laundered cloth cap that was not completely covered by the disposable surgical bouffant,
-S10EVS with his surgical mask hanging around his neck and wearing a T-shirt under his surgical attire that was not completely covered by the surgical attire while cleaning an O.R. room between patient use,
-S22MD with a surgical mask folded in the top pocket of his surgical attire and a surgical mask folded in the back pocket of his surgical attire, wearing a surgeon's skull cap that did not completely cover all of his hair, and wearing a T-shirt under his surgical attire that was not completely covered by the surgical attire.
-Multiple observations of surgical masks not being worn by personnel by the surgical scrub sink areas when scrub personnel were present.
-Sterile surgical supply areas with observations of multiple processed sterile surgical packages that were double peeled pouch packed with the inside peel pouch folded over on more than one side,
-Sterile surgical supplies that were stored on top of open equipment carts and/or wedged between the equipment on the carts,
Observations made of the perioperative area (restricted and semi-restricted areas) on 10/12/15 from 10:00 a.m. to 12:15 p.m. revealed the following surgical attire and infection control breaches:
-S18Nurse not wearing a buttoned down warm up jacket during surgical procedures,
-S17CST only wearing disposable gloves in the decontamination room while decontaminating surgical instruments,
-S24MD with his surgical mask hanging around his neck and wearing a surgeon's skull cap that did not completely cover all of his hair,
-S26CRNA with his surgical mask hanging around his neck and wearing a T-shirt under his surgical attire that was not completely covered by the surgical attire,
-S27MD with his surgical mask hanging around his neck and wearing a surgeon's skull cap that did not completely cover all of his hair,
-S28Nurse with her surgical mask hanging around her neck and wearing a home laundered cloth cap that was not completely covered by the disposable surgical bouffant, and
S30CRNA with her surgical mask hanging around her neck and wearing a home laundered cloth cap that was not completely covered by the disposable surgical bouffant

3) failing to ensure that staff adhered to the MFU for a HLD solution used for items that were high level disinfected by the hospital,

A review of the MFU as noted on the hospital's HLD solution bottle revealed in part: The HLD solution does not require pre-mixing and the HLD solution bottle once opened will expire in 75 days. The HLD solution is a HLD for reprocessing heat sensitive semi-critical devices when used according to the MFU. Manual Processing Instructions: the HLD solution should be at a minimum of 20 degrees C (centigrade) when used or reused as a HLD and at or above its MEC (minimum effective concentration) as determined by the HLD solution test strips. The HLD solution when poured into another sterile container can be used or reused for a maximum of 14 days provided the required condition of the concentration and temperature exist based upon monitoring described in the MFU. Do not rely solely on expiration dates.
A review of AORN Perioperative Standards and Recommended Practices, 2013 edition, Recommended Practice 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. HLD should be used according to MFU.

In an interview on 10/09/15 at 11:10 a.m. with S2DON she indicated that the hospital used a HLD solution for heat sensitive instruments (retina lens). S2DON was asked for the HLD log that contained the monitoring of the HLD solution's temperature and MEC. S2DON indicated that the hospital did not maintain a HLD log when the HLD solution was used and did not monitor the HLD's solution temperature or MEC prior to use. S2DON indicated that the representative told the hospital that they did not have to monitor the HLD solution when used, if they only used it on a single use basis and then discarded the solution. A review of the HLD's MFU was reviewed with S2DON for the verbiage that indicated that the HLD solution did not have to be monitored prior to use if only used as single use. The MFU did not specify that the HLD solution did not have to be monitored prior to use if only used as single use. S2DON contacted the medical representative for clarification and a statement from the HLD company to this effect. No response from the medical representative was obtained prior to the survey exit on 10/13/15.

4) failing to ensure that ophthalmology instruments used in ophthalmology surgical procedures were decontaminated according to MFU prior to reprocessing them for future patient use in surgical procedures.
A review of the hospital's Manufacturer's Policies and Procedures for Equipment and Instruments for the Safe Handling and Sterilization for Ophthalmology Instruments, as provided by S2DON as the guidelines used by the hospital for the handling of ophthalmology instruments revealed in part: ophthalmology instruments should be wiped or rinsed during use and/or immediately after surgery to minimize the accumulated debris and fluids. Instruments should be kept moist until they can be cleaned. Proper cleaning and decontamination is essential for effective sterilization. The reprocessing of the instruments consists of manual cleaning or US cleaning, inspection and lubrication, packaging, sterilization, and storage until next use. Immediately after surgery, rinse all instruments with demineralized water and keep submerged in a basin filled with demineralized water until further cleaning is possible. Clean all instruments, paying particular attention to less accessible areas. Use a syringe with demineralized water to flush items with a lumen. Visibly inspect each instrument for debris and damage. The risk of contamination and infections and infection sources (endotoxin residues, viscoelastic residues, exotoxins) during eye surgery is a real concern and can be a potential source of TASS- Toxic Anterior Segment Syndrome, resulting in toxic damage to intraocular tissues, which is why so much time and effort is invested in cleaning and sterilizing eye surgical instruments.
A review of AORN Perioperative Standards and Recommended Practices, 2013 edition- Care of Instruments: Recommendation XIV revealed in part: Special precautions should be taken for reprocessing ophthalmology surgical instruments. Most cases of TASS appear to result from inadequate instrument cleaning and sterilization. Prevention of TASS requires thorough cleaning and rinsing of surgical instruments.

In a continuous observation on 10/12/15 at 10:30 a.m. of S17CST's manual decontamination process of the ophthalmology instruments used during a patient's surgical procedure, the following observations were made: S17CST used a syringe with demineralized water to flush items with a lumen. S17CST then poured demineralized water over all the remaining ophthalmology instruments on the instrument trays, placed the instrument trays back into its containing and then took the ophthalmology instruments to the sterile processing area to be sterilized. S17CST was not observed cleaning each ophthalmology instrument or visibly inspecting each instrument for debris and damage prior to taking the ophthalmology instruments to the sterile processing area to be sterilized.
In an interview on 10/12/15 at 4:30 p.m. with S2DON she was made aware of the infection control breaches in the Surgical Services Department. She indicated that the hospital followed the professional standards of practice of AORN, CDC, and APIC .
In an interview on 10/13/15 at 11:30 a.m. with S3QA/IC/DP she was made aware of the above infection control breaches. She indicated that the hospital followed the professional standards of practice for AORN , CDC , and APIC. She further indicated that acceptable infection control practices had not been maintained in the above observations and practices.

Based on observations, interviews, and record reviews the hospital failed to ensure the Surgical Services Department followed acceptable professional standards of practice, acceptable infection control practices and/or hospital policy as evidenced by:

1) failing to ensure that surgical instrument trays were available in a quantity that was commensurate with the hospital's expected daily procedure volume, as evidenced by the hospital's frequent use of IUSS of surgical instrument trays (provided by the hospital and/or by contract) for patient's surgical procedures,

2) failing to ensure that staff in the perioperative surgical suite's restricted and semi-restricted areas followed acceptable professional standards of practice and acceptable infection control practices and hospital policy as evidenced by: a) observation of non-scrubbed surgical staff not wearing a long sleeved buttoned up warm up jacket during surgical procedures, b) observations of surgical staff wearing T-shirts under their scrub attire that were not completely covered by their surgical attire, c) observations of surgical staff wearing skull caps (surgeon caps) that did not completely cover all their hair (head and facial beard hair), d) observations of surgical staff wearing home laundered cloth hats that were not completely covered by a disposable surgical bouffant hat, e) observations of surgical staff wearing surgical masks around their necks or having surgical masks in their pockets, f) observations of staff wearing stethoscopes around their neck, g) observations of staff in the decontamination instrument room not wearing appropriate PPE when decontaminating surgical instruments, h) observations of staff not wearing masks when scrubbed persons were present, i) observations of improper packaging of sterile supplies, and j) observations of sterile supplies being stored in opened shelved equipment carts, located in the hallway, and sterile supplies stored on top of the non-sterile equipment or wedged between the non-sterile equipment on the equipment carts in the hallway.
3) failing to ensure that staff adhered to the MFU for a HLD solution used for items that were high level disinfected by the hospital, and

4) failing to ensure that ophthalmology instruments used in ophthalmology surgical procedures were decontaminated according to MFU prior to reprocessing them for future patient use in surgical procedures.

Findings:
1) failing to ensure that surgical instrument trays were available in a quantity that was commensurate with the hospital's expected daily procedure volume, as evidenced by the hospital's frequent use of IUSS of surgical instrument trays (provided by the hospital and/or by contract) for patient's surgical procedures,

A review of the hospital policy, titled "Central Sterile - Immediate Use Sterilization" , provided by S2DON as the most current, revealed in part: Immediate Use should only be used in emergent situations in order to prevent the spread of nosocomial infection and pathogens.
A review of the hospital policy, titled "Surgical Services- Loaning-Borrowing of Supplies, Equipment" , provided by S2DON as the most current, revealed in part: Any instrumentation that is brought into the hospital will be treated as contaminated and will be processed in the Central Sterile Department according to hospital policy
A review of AORN Perioperative Standards and Recommended Practices, 2013 edition - Sterilization: Recommendation VII revealed in part; Immediate Use Steam Sterilization 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.
A review of AORN Perioperative Standards and Recommended Practices, 2013 edition- Care of Instruments: Recommendation III revealed in part: Loaner instruments should be examined, cleaned, and sterilized by the receiving facility before use and according to manufacturer's written instructions. Instruments loaned to the facility may not have been adequately decontaminated. Conditions during storage and transport are not known. The quality of any previous processing has not been verified, and sterile storage conditions have not been maintained during transport.
An observation on 10/12/15 of the surgery schedule revealed that the hospital had 13 (thirteen) cataract surgeries scheduled for S24MD. A further observation of the sterile processing area revealed that the hospital had 4 (four) cataract trays and an additional cataract tray that was provided by the medical representative, S23CST, that morning. S20CST was observed performing IUSS on the cataract trays and on the loaned cataract tray. IUSS was being performed on the cataract trays from 8:00 a.m. until 10:30 a.m. by S20CST.
In an interview on 10/12/15 at 11:00 a.m. with S23CST, he indicated that he was a contract CST for the hospital. S23CST indicated that the hospital required his loaner cataract tray for use today (10/12/15). S23CST indicated that he keeps an extra unsterile cataract tray in his car whenever the hospital needed an extra cataract tray. S23CST further indicated that he brought the cataract tray in this morning for use in the cataract surgeries today. He indicated that the tray was IUSS'ed before use by S20CST.
In an interview on 10/12/15 at 10:00 a.m. with S20CST she indicated that the hospital only had 4 (four) cataract trays and that S24MD had 13 cataract surgeries scheduled for 10/12/15. S20CST indicated that she had to use IUSS cataract trays since the hospital did not have sufficient inventory to process the cataract trays required for the surgery workload that day by the preferred sterilization method. S20CST further indicated that S23CST (contract CST) brought in an unsterile loaner cataract tray that morning that also had to be IUSS'ed prior to use for the cataract procedures.
In an interview on 10/12/15 at 3:00 p.m. with S2DON she indicated that she was the Operating Room Director. She indicated that she was aware the Surgical Services Department was performing IUSS on surgical instruments for patient's surgical procedures since the hospital did not have sufficient inventory to process some instrument trays by the preferred sterilization method for the surgery workload on certain days.

2) failing to ensure that staff in the perioperative surgical suite's restricted and semi-restricted areas followed acceptable professional standards of practice and acceptable infection control practices and hospital policy as evidenced by: a) observation of non-scrubbed surgical staff not wearing a long sleeved buttoned up warm up jacket during surgical procedures, b) observations of surgical staff wearing T-shirts under their scrub attire that were not completely covered by their surgical attire, c) observations of surgical staff wearing skull caps (surgeon caps) that did not completely cover all their hair (head and facial beard hair), d) observations of surgical staff wearing home laundered cloth hats that were not completely covered by a disposable surgical bouffant hat, e) observations of surgical staff wearing surgical masks around their necks or having surgical masks in their pockets, f) observations of staff wearing stethoscopes around their neck, g) observations of staff in the decontamination instrument room not wearing appropriate PPE when decontaminating surgical instruments, h) observations of staff not wearing masks when scrubbed persons were present, i) observations of improper packaging of sterile supplies, and j) observations of sterile supplies being stored in opened shelved equipment carts, located in the hallway, and sterile supplies stored on top of the non-sterile equipment or wedged between the non-sterile equipment on the equipment carts in the hallway.
A review of the hospital policy, titled "Surgical Services- Dress Code Requirements OR Suite" , provided by S2DON as the most current, revealed in part: Proper OR attire is required in the surgical suite to lessen the risk of infection and to create a safe environment. The surgical hat or hood must confine the hair. Masks must be worn at all times in the OR and other designated areas where open sterile supplies or scrubbed persons may be located. Masks are either on or off and should not be saved by hanging around the neck or tucked into a pocket for future use.
A review of the hospital policy, titled "Central Sterile - Decontamination Procedure", provided by S2DON as the most current, revealed in part: PPE should be worn by personnel when decontaminating instruments prior to sterilization to prevent he spread of pathogens.
A review of the AORN Perioperative Standards and Recommended Practices, 2013 edition- Recommended Practice for Surgical Attire - Recommendation III 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 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. 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.
A review of the AORN Perioperative Standards and Recommended Practices, 2013 edition- Recommended Practice for Surgical Attire - Recommendation IV revealed in part: All personnel should cover head and facial hair, 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 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 covered completely by a disposable surgical bouffant hat.

The AORN Perioperative Standards and Recommended Practices, 2013 edition - Recommended Practices for Surgical Attire, Recommendation VI 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. 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 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.

A review of the AORN Perioperative Standards and Recommended Practices, 2013 edition- Recommended Practices for Surgical Attire, Recommendation II revealed in part: Stethoscopes should be clean and not worn around the neck. Stethoscopes may transmit pathogens such as MRSA by indirect contact, by wearing the stethoscope around the neck and contaminating the skin and surgical attire. Stethoscopes come in direct contact with the skin and could provide an opportunity for transmission of microbes from patient to patient and/or from health care personnel to patients.

A review of AORN Perioperative Standards and Recommended Practices, 2013 edition-Care of Instruments: Recommendation XVIII revealed in part: Personnel handling contaminated instruments and equipment must wear appropriate PPE to help prevent the employee from exposure to bloodborne pathogens and other infectious materials. The appropriate PPE should include; a fluid-resistant gown, gloves, a mask and face protection. Splashes, splatters and skin contact can be reasonably anticipated when handling contaminated instruments.

A review of AORN Perioperative Standards and Recommended Practices, 2013 edition - Surgical Attire: Recommendation IX revealed in part: Restricted areas in a surgical suite includes the OR 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.

A review of AORN Perioperative Standards and Recommended Practices, 2013 edition-Packaging Systems: Recommendation V revealed in part: Paper-plastic pouch packages (used in packaging surgical items for sterilization) 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. 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.

A review of the AORN Perioperative Standards and Recommended Practices, 2013 edition, Recommended Practices for Selection and Use of Packaging Systems for Sterilization: Recommendation VIII revealed in part: Sterilized items should be considered sterile until an event occurs to compromise the sterility of the sterile item such as, moisture penetration or unacceptable storage conditions, exposure to airborne and other environmental contaminants. The sterility of sterile items is event related and not time related. Events that affected the sterility of sterile packages included in part: multiple handing of the sterile package, compression, moisture penetration to include disinfectant solutions, exposure to airborne and environmental contaminants and storage conditions (improper shelving, temperature, humidity, cleanliness, and traffic), type of packaging materials used, use of sterility maintenance covers and method of sealing.
Observations made of the perioperative area (restricted and semi-restricted areas) on 10/09/15 from 10:00 a.m. to 3:00 p.m. in the presence of S2DON, revealed the following surgical attire and infection control breaches:
-S14MD with his surgical mask hanging around his neck and wearing a surgeon's skull cap that did not completely cover all of his hair and facial beard hair,
-S15CRNA with his surgical mask hanging around his neck, wearing a surgeon's skull cap that did not completely cover all of his hair and facial beard hair, and wearing a T-shirt under his surgical attire that was not completely covered by the surgical attire,
-S16Nurse wearing her stethoscope around her neck,
-S17CST wearing a home laundered cloth cap that was not completely covered by the disposable surgical bouffant,
-S2DON with her surgical mask hanging around her neck and wearing a T-shirt under her surgical attire that was not completely covered by the surgical attire,
-S13Nurse wearing her stethoscope around her neck,
-S19Nurse wearing her stethoscope around her neck,
-S20CST with her surgical mask hanging around her neck and wearing a home laundered cloth cap that was not completely covered by the disposable surgical bouffant,
-S10EVS with his surgical mask hanging around his neck and wearing a T-shirt under his surgical attire that was not completely covered by the surgical attire while cleaning an O.R. room between patient use,
-S22MD with a surgical mask folded in the top pocket of his surgical attire and a surgical mask folded in the back pocket of his surgical attire, wearing a surgeon's skull cap that did not completely cover all of his hair, and wearing a T-shirt under his surgical attire that was not completely covered by the surgical attire.
-Multiple observations of surgical masks not being worn by personnel by the surgical scrub sink areas when scrub personnel were present.
-Sterile surgical supply areas with observations of multiple processed sterile surgical packages that were double peeled pouch packed with the inside peel pouch folded over on more than one side,
-Sterile surgical supplies that were stored on top of open equipment carts and/or wedged between the equipment on the carts,
Observations made of the perioperative area (restricted and semi-restricted areas) on 10/12/15 from 10:00 a.m. to 12:15 p.m. revealed the following surgical attire and infection control breaches:
-S18Nurse not wearing a buttoned down warm up jacket during surgical procedures,
-S17CST only wearing disposable gloves in the decontamination room while decontaminating surgical instruments,
-S24MD with his surgical mask hanging around his neck and wearing a surgeon's skull cap that did not completely cover all of his hair,
-S26CRNA with his surgical mask hanging around his neck and wearing a T-shirt under his surgical attire that was not completely covered by the surgical attire,
-S27MD with his surgical mask hanging around his neck and wearing a surgeon's skull cap that did not completely cover all of his hair,
-S28Nurse with her surgical mask hanging around her neck and wearing a home laundered cloth cap that was not completely covered by the disposable surgical bouffant, and
S30CRNA with her surgical mask hanging around her neck and wearing a home laundered cloth cap that was not completely covered by the disposable surgical bouffant

3) failing to ensure that staff adhered to the MFU for a HLD solution used for items that were high level disinfected by the hospital,

A review of the MFU as noted on the hospital's HLD solution bottle revealed in part: The HLD solution does not require pre-mixing and the HLD solution bottle once opened will expire in 75 days. The HLD solution is a HLD for reprocessing heat sensitive semi-critical devices when used according to the MFU. Manual Processing Instructions: the HLD solution should be at a minimum of 20 degrees C (centigrade) when used or reused as a HLD and at or above its MEC (minimum effective concentration) as determined by the HLD solution test strips. The HLD solution when poured into another sterile container can be used or reused for a maximum of 14 days provided the required condition of the concentration and temperature exist based upon monitoring described in the MFU. Do not rely solely on expiration dates.
A review of AORN Perioperative Standards and Recommended Practices, 2013 edition, Recommended Practice 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. HLD should be used according to MFU.

In an interview on 10/09/15 at 11:10 a.m. with S2DON she indicated that the hospital used a HLD solution for heat sensitive instruments (retina lens). S2DON was asked for the HLD log that contained the monitoring of the HLD solution's temperature and MEC. S2DON indicated that the hospital did not maintain a HLD log when the HLD solution was used and did not monitor the HLD's solution temperature or MEC prior to use. S2DON indicated that the representative told the hospital that they did not have to monitor the HLD solution when used, if they only used it on a single use basis and then discarded the solution. A review of the HLD's MFU was reviewed with S2DON for the verbiage that indicated that the HLD solution did not have to be monitored prior to use if only used as single use. The MFU did not specify that the HLD solution did not have to be monitored prior to use if only used as single use. S2DON contacted the medical representative for clarification and a statement from the HLD company to this effect. No response from the medical representative was obtained prior to the survey exit on 10/13/15.

4) failing to ensure that ophthalmology instruments used in ophthalmology surgical procedures were decontaminated according to MFU prior to reprocessing them for future patient use in surgical procedures.
A review of the hospital's Manufacturer's Policies and Procedures for Equipment and Instruments for the Safe Handling and Sterilization for Ophthalmology Instruments, as provided by S2DON as the guidelines used by the hospital for the handling of ophthalmology instruments revealed in part: ophthalmology instruments should be wiped or rinsed during use and/or immediately after surgery to minimize the accumulated debris and fluids. Instruments should be kept moist until they can be cleaned. Proper cleaning and decontamination is essential for effective sterilization. The reprocessing of the instruments consists of manual cleaning or Ultrasonic cleaning, inspection and lubrication, packaging, sterilization, and storage until next use. Immediately after surgery, rinse all instruments with demineralized water and keep submerged in a basin filled with demineralized water until further cleaning is possible. Clean all instruments, paying particular attention to less accessible areas. Use a syringe with demineralized water to flush items with a lumen. Visibly inspect each instrument for debris and damage. The risk of contamination and infections and infection sources (endotoxin residues, viscoelastic residues, exotoxins) during eye surgery is a real concern and can be a potential source of TASS- Toxic Anterior Segment Syndrome, resulting in toxic damage to intraocular tissues, which is why so much time and effort is invested in cleaning and sterilizing eye surgical instruments.
A review of AORN Perioperative Standards and Recommended Practices, 2013 edition- Care of Instruments: Recommendation XIV revealed in part: Special precautions should be taken for reprocessing ophthalmology surgical instruments. Most cases of TASS appear to result from inadequate instrument cleaning and sterilization. Prevention of TASS requires thorough cleaning and rinsing of surgical instruments.

In a continuous observation on 10/12/15 at 10:30 a.m. of S17CST's manual decontamination process of the ophthalmology instruments used during a patient's surgical procedure, the following observations were made: S17CST used a syringe with demineralized water to flush items with a lumen. S17CST then poured demineralized water over all the remaining ophthalmology instruments on the instrument trays, placed the instrument trays back into its containing and then brought the ophthalmology instruments to the sterile processing area to be sterilized. S17CST was not observed cleaning each ophthalmology instrument or visibly inspecting each instrument for debris and damage prior to bringing the ophthalmology instruments to the sterile processing area to be sterilized.
In an interview on 10/12/15 at 4:30 p.m. with S2DON she was made aware of the infection control breaches in the Surgical Services Department. She indicated that the hospital followed the professional standards of practice of AORN , CDC , and APIC.
In an interview on 10/13/15 at 11:30 a.m. with S3QA/IC/DP she was made aware of the above infection control breaches. She indicated that the hospital followed the professional standards of practice for AORN, CDC, and APIC. She further indicated that acceptable infection control practices had not been maintained in the above observations and practices.

Based on record review and interview the hospital failed to ensure qualified personnel performed specific respiratory treatments and procedures, as per their Respiratory Policies and Procedures. This failed practice was evidenced by no documented competencies in personnel records for 6 of 6 (S2DON, S6Nurse, S18Nurse, S11Nurse, S12Nurse,S13Nurse) nurses that provide direct patient care that could include respiratory treatments from a total of 33 nurses employed for direct patient care.
Findings:


Review of hospital policy #PC-23.2.20, titled, Respiratory Care, Provision of Care, provided by S1ADM as current, revealed, in part, the policy as "It will be the policy that all nurses by educated to give respiratory treatments.

Review of hospital policy (no number) titled, "Respiratory Therapy Services", provided by S1ADM as current, revealed the following, in part: "Only competent care givers ...will be allowed to care for patients who need respiratory therapy." The skill level the policy applied to was documented as RN, LPN, Respiratory Therapist.

Review of the personnel files for S2DON, S6Nurse, S18Nurse, S11Nurse, S12Nurse, and S13Nurse revealed no competencies for providing respiratory treatments.

In an interview 10/12/15 at 3:10 p.m., during personnel record reviews, S9HR verified that there were no skills competencies, for the above noted nurses, for respiratory treatments.

In an interview 10/13/15 at 10:05 a.m. S6Nurse and S12Nurse verified that they had not had their skills evaluated for competency in respiratory treatments.

In an interview 10/13/15 at 1:50 p.m. S3QAICDP reported that the nurses provided most of the respiratory treatments. S3QAICDP reported that the respiratory therapist was called in if there was a patient with a medical history that indicated the patient might need extra respiratory support. This was determined prior to the patient's admission, otherwise the nurses provided respiratory treatments. S3QAICDP confirmed there were respiratory treatment competencies of nurses documented.

No documentation of respiratory therapy competencies for nurses was provided.