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Based on record review and interview, the hospital failed to ensure the Quality Assurance (QA) Program tracked medical errors and implemented preventive actions. This was evidenced by the failure to measure, analyze and track medications errors. Findings:

Review of the occurrence reports revealed in April 2015, two medication errors were identified. On 04/08/15 and 04/09/15 S14RN withheld insulin with no documentation of the reason, and on 04/09/15 S20RN did not administer blood products as ordered by the physician. Review of the QA data revealed there failed to be documented evidence the medication errors were reviewed and preventive actions implemented.

According to interview with S2DON on 08/25/15 at 2:20 p.m. an occurrence report was completed for medication errors and sent to pharmacy and herself. When asked if medication errors were analyzed, S2DON replied she did not know.

Review of 2 of 10 medical records (#2, #24) revealed the following medication administration errors were identified.

Review of the medical record for patient #2 revealed the Medication Administration Record (MAR) dated 8/24/15 revealed the following medications had been circled by the nurse to indicate they had not been given: Glucophage 500mg (circled at 10:05 p.m. with "held for glucose 131" noted) and Trandate 200mg (circled at 9:58 p.m. with "hold for low blood pressure" noted).

Review of the MAR dated 8/25/15 revealed the following medications had been circled by the nurse to indicate they had not been given: Diabeta 5mg (circled at 9:26 p.m. with "patient blood glucose 116" noted) and Trandate 200mg (circled at 9:00 p.m. with "hold for low blood pressure" noted).

Further review medical record revealed no documented evidence that the physician had been notified of the above held medications that were ordered for the patient.

Review of the MAR for Patient #24 dated 8/25/15 revealed the following medication had been circled by the nurse to indicate they had not been given: Levemir 100u/mL 20 units every night at bedtime (circled at 10:10 p.m. with "hold-patient not eat" noted). There was no documented evidence in the medical record that the physician had been notified of the held medication.

In an interview on 8/26/15 at 11:00 a.m. with S2DON, she stated that medications should not be held without a physician order. S2DON reviewed the medical records of patient #2 and patient #24 and confirmed that there was no documented evidence that their physician was notified of the medications not being given as ordered.

Further interview with S2DON revealed the 11:00 p.m. to 7:00 a.m. nurse audits the patient's medical record for errors. When asked if the medications that were with held for patients #2 and #24 should have been identified, S2DON replied "yes".

Based upon record review and interview, the hospital failed to conduct performance improvement projects. This was evidenced by the failure to conduct annually distinct improvements projects related to the scope of services furnished at the hospital for 2014 and 2015. Findings:

Review of the Quality Assurance Program data revealed there failed to be documented evidence the hospital developed distinct Quality Assurance Improvement Projects for 2014 and 2015.

Interview on 8/25/15 at 2:30 p.m. with S3QA revealed no hospital wide QA projects had been implemented for 2014 and 2015.

Based on record reviews and interviews, the hospital failed to ensure that the contract staff's clinical activities were evaluated by a hospital-employed RN (Registered Nurse) at least once a year as evidenced by 2 of 2 (S11RN, S48RN) contract Cath Lab RN's, who perform conscious sedation in the Cath Lab, not having a conscious sedation competency skills evaluation performed by the supervising RN in 5 years.

Findings:
A review of the hospital's contact employee files for S11RN and S48RN, reviewed for conscious sedation skills competency, revealed no documented evidence of a conscious sedation competency skills evaluation in 5 years for the 2 contract employees.

In an interview on 08/25/15 at 11:30 a.m. with S9RN she indicated that she was the Director of Surgical Services and had taken that position a month ago. S9RN indicated that the 2 Cath Lab RN's, S11RN and S48RN, were the contract RNs who were contracted to work in the Cath Lab. S9RN indicated that the Cath Lab performed most procedures under conscious sedation. S9RN further indicated that she was the supervising RN for the Cath Lab contract RN's and that she was responsible for their performance evaluations and annual competencies. S9RN was asked for the evaluations of their conscious sedation skills competency checklists. S9RN indicated that she had not performed any conscious sedation skills competency checklists for the 2 Cath Lab RNs since she became the Director of Surgical Services and that it may have been performed by S31RN, the prior Director of Surgical Services.
In an interview on 08/27/15 at 12:00 p.m. with S11RN and S48RN they indicated that they were the contract RNs who worked in the Cath Lab and had been working contract in the Cath Lab for the last 5 years. S11RN and S48RN indicated that many Cath Lab procedures were performed under conscious sedation. S11RN and S48RN indicated that they did not remember if they had a conscious sedation competency skills checklist evaluation during those 5 years, unless it was evaluated during their annual performance evaluations, by S31RN, the prior Director of Surgical Services..
In an interview on 08/27/15 at 12:30 p.m. with S31RN she indicated that she was the prior Director of Surgical Services. S31RN indicated that she was the supervising RN for the Cath Lab contract nurses, S11RN and S48RN, when she was the Director of Surgical Services. S31RN indicated that during those 5 years she only completed annual performance evaluations on S11RN and S48RN and she did not evaluate conscious sedation competency skills. S31RN further indicated that she did not do conscious sedation herself and would not consider herself competent to evaluate conscious sedation competency skills in other RNs. S31RN indicated that she remembered S11RN and S48RN had presented conscious sedation competency skills from a prior hospital where they worked prior to doing contract at the hospital 5 years ago.

Based on record review and interview, the hospital failed to ensure medications were administered in accordance with the orders of the practitioner responsible for the patient's care. This deficient practice is evidenced by the nursing staff holding patient's ordered medications without a physician's order for 2 (#2, #24) of 10 patients reviewed for medication administration out of a total sample of 30 patients. Findings:

Patient #2
Review of the MAR(Medication Administration Record) for Patient #2 dated 8/24/15 revealed the following medications had been circled by the nurse to indicate they had not been given: Glucophage 500mg (circled at 10:05 p.m. with "held for glucose 131" noted) and Trandate 200mg (circled at 9:58 p.m. with "hold for low blood pressure" noted).

Review of the MAR dated 8/25/15 revealed the following medications had been circled by the nurse to indicate they had not been given: Diabeta 5mg (circled at 9:26 p.m. with "patient blood glucose 116" noted) and Trandate 200mg (circled at 9:00 p.m. with "hold for low blood pressure" noted).

Further review medical record revealed no documented evidence that the physician had been notified of the above held medications that were ordered for the patient.

Patient #24
Review of the MAR for Patient #24 dated 8/25/15 revealed the following medication had been circled by the nurse to indicate they had not been given: Levemir 100u/mL 20 units every night at bedtime (circled at 10:10 p.m. with "hold-patient not eat" noted). There was no documented evidence in the medical record that the physician had been notified of the held medication.

In an interview on 8/26/15 at 11:00 a.m. with S2DON(Director of Nursing), she stated that medications should not be held without a physician order. S2DON reviewed the medical records of patient #2 and patient #24 and confirmed that there was no documented evidence that their physician was notified of the medications not being given as ordered.

Based on record review and interview, the hospital failed to ensure all patients medical record entries were timed by the person responsible for providing or evaluating the service provided for 3 (#2, #3, #24 ) of 3 patients reviewed for the timing of entries entered into the medical record out of a total sample of 30 patients. Findings:

Patient #2
Review of the medical record for Patient #2 revealed S15MD wrote an order dated 08/24/15 to administer the first unit of blood. The order was not timed.

Patient #3
Review of the medical record for Patient #3 revealed S15MD wrote orders for new medications on 08/22/15 and 08/23/15. The orders were not timed by the physician.

Patient #24
Review of the medical record for Patient#24 revealed the physician wrote an order to administer one unit of blood. The order was dated, but not timed.


In an interview on 08/27/15 at 1:45 p.m. with S2DON, she stated that she was aware of the issue with physicians not timing their orders.

Based on record review and interview, the hospital failed to ensure drugs and biologicals were controlled and distributed in accordance with applicable standards of practice, consistent with state law. This deficient practice was evidenced by failing to ensure all medication orders were reviewed by a pharmacist, before the first dose was dispensed, for therapeutic appropriateness, duplication of a medication regimen, appropriateness of the drug and route, appropriateness of the dose and frequency, possible medication interactions, patient allergies and sensitivities, variations in criteria for use, and other contraindications.
Findings:

Review of the hospital pharmacy's policies and procedures revealed no evidence that a pharmacist would review all medication orders prior to the first dose being administered.

On 08/25/15 at 10:55 a.m., interview with S22RN revealed that after the hospital pharmacy closes at 5:30 p.m. every day, all new orders for medications are removed from the automated medication dispensing system (Omnicell). S22RN stated that the pharmacist does not review these medication orders prior to administering the first dose of the medication to the patients.

On 08/27/15 at 1:00 p.m., interview with S19Pharmacist confirmed that there was no hospital policy indicating that first dose reviews were to be performed for all new medications. S19Pharmacist revealed that the pharmacy hours are 7:30 a.m. - 5:30 p.m. (Monday thru Friday) and 8:00 a.m. - 12:00 p.m. (Saturday and Sunday). S19Pharmacist further revealed that if the nurses obtain a physician order for a new medication after pharmacy hours, the nurses will administer the first dose of the medication and a pharmacist will review the medication order that next day.

Based on record review and interview, the facility failed to ensure drug administration errors were reported immediately to the attending physician and documented in the patient's medical record for 2 of 2 (#17, #18) sampled patients with medication variances reviewed with known medication errors out of a total sample of 30. Findings:

Review of the hospital policy titled Medication and Treatment Variances (review date of 09/05/12) revealed it did not indicate to document drug administration errors in the patients' medical records.

Review of two occurrence reports, provided by S2DON, revealed that patient #17 and patient #18 were administered incorrect medications by the nursing staff. Review of the medical records for patients #17 and #18 revealed no documented evidence that the medication errors or physician notifications of the errors were documented.

In an interview on 08/26/15 at 1:50 p.m., S2DON reviewed the occurrence reports and medical records for Patient #17and Patient #18. S2DON confirmed that the medication errors and physician notification of the errors were not documented in the patient's medical records. Further interview with S2DON confirmed that the errors should have been documented in the medical record, but the hospital policy did not address this.

Based on observations, interviews and record reviews, the Infection Control Officer failed to ensure a system for identifying, reporting, investigating and controlling infections was maintained and monitored as evidenced by: 1) failure of the staff to disinfect the computer on wheels when the computer system was taken into the patient's room, 2) failing to ensure that housekeeping followed acceptable infection control practices when cleaning patient rooms.

Findings:

1) failure of the staff to disinfect the computer on wheels when the computer system was taken into the patient's room:

Observations on 08/27/15 at 11:30 a.m. revealed S26RN was observed rolling the computer on wheels (COW) into patient room #204, exit the room with the COW and entered the nursing station. S26RN then retrieved the COW and returned to room #204, change the IV connection to an IV lock, exit the patient's room with the COW, pushed it to an area (room) behind the nurses station. S26RN at no time disinfected the COW after exiting the patient's room (204), entering nurses station and re-entering the paatient's room(204).

On 08/27/15 at 11:35 a.m., observation revealed a COW located at rhe nurses station and the following was noted: pieces of a green colored substance was on top near the keyboard.

In an interview with S24RN on 08/27/15 at 11:45 a.m., he confirmed that the small pieces of green colored substance were pill fragments. S24RN inidcated that the COWs are pushed in & out of patients' rooms, and are cleaned every shift using disinfectant wipes.

2) failing to ensure that housekeeping followed acceptable infection control practices when cleaning patient rooms.

On 08/26/15 at 9:30 a.m. an observation was made of S38Housekeeper and S39Housekeeper cleaning a patient room. S39Housekeeper was observed cleaning the patient bathroom, using the same gloves to clean the toilet and the surrounding bathroom fixtures. S39Housekeeper was then observed assisting S38Housekeeper in completing the cleaning of the patient room using the same gloves that she used to clean the patient bathroom. S38Housekeeper and S39Housekeeper were further observed bringing a blue plastic carry-on container into the patient room that contained housekeeping supplies. They were observed placing this container on dirty surfaces, then onto the cleaned areas, and then onto the floor during the cleaning process of the patient room. S38Housekeeper returned the container to the top of the housekeeping cart that was located outside the door of the patient room, after she had finished cleaning the patient room.
In an interview on 08/26/15 at 10:15 a.m. with S27EVS (Environmental Services) he was made aware of the infection control breaches during the cleaning of a patient's room. S27EVS indicated that the cleaning of the patient room by S38Housekeeper and S39Housekeeper did not follow acceptable infection control practices.




30172

Based on record review, observation, and interviews, the hospital failed to ensure the Surgical Services Department followed acceptable professional standards of practice as evidenced by:

1) failing to ensure that staff in the surgical suite restricted and semi-restricted areas followed acceptable professional standards of practice by: a) non-scrubbed surgical staff not wearing a long sleeved warm up jacket during surgical procedures, b) observations of surgical staff wearing undergarments that were not completely covered by their surgical attire, c) observations of surgical personnel wearing skull caps (surgeon caps) that did not completely cover all their hair, d) failing to ensure that staff adhered to acceptable standards of professional practice for the wearing of surgical masks and surgical attire in the semi-restricted and restricted areas.
2) failing to ensure that sterile irrigation fluids for patient use were labeled, stored and maintained according to manufacturer's instructions and failing to ensure that sterile surgical prep kits containing antiseptic solutions for patient use were not warmed in the warming cabinet with no manufacturer's recommendation/instructions for the warming of antiseptic solutions,
3) failing to ensure that sterile instruments and sterile supplies for patient use were not compromised by storing sterile and non-sterile instruments/supplies together and/or on top or underneath non-sterile equipment and/or stored in open cabinets, failing to ensure that equipment available for patient use was not torn/taped so as to ensure effective cleaning/disinfecting, failing to ensure that expired supplies were not available for patient use, and failing to ensure that SUD (single use devices) were not reprocessed,
4) failing to ensure that the re-usable blue cloth towels used in the surgical instrument trays to be sterilized were lint-free,
5) failing to ensure that staff adhered to the manufacturer's instructions for the use of the high level disinfectant for semi-critical items and failing to ensure that staff were provided with ETO gas sterilizer monitoring badges when using the ETO (Ethylene Oxide) gas sterilizer, and
6) failing to perform daily wet vacuum terminal cleaning of the ORs after the scheduled procedures were completed each day.


Findings:

1) failing to ensure that staff in the surgical suite restricted and semi-restricted areas followed acceptable professional standards of practice by: a) non-scrubbed surgical staff not wearing a long sleeved warm up jacket during surgical procedures, b) observations of surgical staff wearing undergarments that were not completely covered by their surgical attire, c) observations of surgical personnel wearing skull caps (surgeon caps) that did not completely cover all their hair, d) failing to ensure that staff adhered to acceptable standards of professional practice for the wearing of surgical masks and surgical attire in the semi-restricted and restricted areas.

The AORN (Association of periOperative Registered Nurses) Perioperative Standards and Recommended Practices, 2013 edition - Recommended Practices for Surgical Attire, Recommendation VI revealed in part: All individuals entering the restricted surgical area should wear a surgical mask when scrubbed personnel, sterile supplies and/or sterile equipment were present. A surgical mask protects the patient from transfer of microorganisms. 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.

A review of the AORN Perioperative Standards and Recommended Practices, 2013 edition, - Recommended Practices for Surgical Attire - Recommendation III 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. Recommendation V revealed in part: Surgical attire should be laundered in a health care-accredited laundry facility either on-site or through a contracted service which incorporate OSHA and CDC guidelines and professional association's recommended practices that follow industry standards through the HLAC (Healthcare Laundry Accreditation Council). Home laundering cannot be monitored for quality, consistency or safety, and laundering may not meet the specified measures necessary to achieve a reduction in microbial levels in soiled surgical attire with measures that involve mechanical, thermal, and chemical components.

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.
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 daily in a health care-accredited laundry facility when used.
On 08/25/15 from 1:00 p.m. to 3:00 p.m. the following observations were made in the surgical suite: S32CST, S33Orderly, S34RN, S18FNP and S9RN were all noted to be in different colored scrub attire and all were observed wearing cloth hats. S32CST, S33Orderly, S34RN were not observed to be wearing a warm-up jacket. S30MD was observed wearing a surgeon's cap.
In an interview on 08/25/15 at 3:00 p.m. with S32CST, S33Orderly, S34RN and S9RN they indicated that they could wear their own scrubs or use the hospital provided laundered scrubs. They indicated that they home-laundered their personal scrubs and cloth head coverings for use in the surgical suites. They further indicated that warm-up jackets were optional and were home-laundered and that non-scrubbed personnel were not required to wear warm-up jackets during surgical procedures
On 08/26/15 at 10:30 a.m. the following observation was made in the surgical suite of S35RN with her mask hanging around her neck.
On 08/26/15 at 12:30 p.m. the following observation was made in the surgical suite of S40CRNA with his mask hanging around his neck and wearing a surgeon ' s cap that did not completely cover the hair on his head or his facial hair.
On 08/27/15 at 11:30 a.m. the following observation was made in the surgical suite of S11RN wearing a T-shirt under his scrub attire that was not completed covered by his surgical attire.
In an interview on 08/25/15 at 3:30 p.m. with S9RN she indicated that she was the Director of Surgical Services and that the Surgical Services Department followed AORN (Association of periOperative Registered Nurses) Perioperative Standards and Recommended Practices. S9RN was made aware of the above observations and interviews. S9RN indicated that the hospital had a laundry contract that laundered the surgical scrubs and staff were allowed to buy their own scrubs and launder them at home. S9RN indicated that the surgery staff 's warm-up jackets and cloth hats were not sent to the contract laundry and were home-laundered. S9RN further indicated that the non-scrubbed surgical team members were not required to wear warm-up jackets during surgical procedures. S9RN indicated that male surgical personnel were allowed to wear surgeon's caps (skull caps) in the surgical suite. S9RN indicated that OR staff should not wear their surgical masks around their necks. S9RN had no comment regarding exposed T-shirts under surgical attire.

2) failing to ensure that sterile irrigation fluids for patient use were labeled, stored and maintained according to manufacturer's instructions and failing to ensure that sterile surgical prep kits containing antiseptic solutions for patient use were not warmed in the warming cabinet with no manufacturer's recommendation/instructions for the warming of antiseptic solutions,

A review of the AORN Perioperative Standards and Recommended Practices, edition 2013, - Recommended Practice for Safe Environment of Care: Recommendation V revealed in part: Precautions should be taken to avoid thermal injuries related to warming fluids in a warming cabinet. Solution manufacturer's instruction for use should be followed regarding the maximum temperature and length of time solutions should remain in a warming cabinet. Fluids kept in a warming cabinet should be labeled with an expiration date based on the manufacturer's recommendation for storage above room temperature and should be removed from the warming cabinet when the warming expiration date had been reached, and discarded and/or returned to storage according to manufacturer's instructions. After removal from the warming cabinet, a "do not re-warm" label should be applied to the fluid container unless the manufacturer's instructions specifies otherwise. Skin antiseptic solutions should not be warmed unless otherwise directed by the manufacturer's instructions for use

On 08/25/15 from 2:00 p.m. an observation was made of the warming cabinet in the surgical suite. The warming cabinet was set at 120oF and was observed to contain the following items: the top shelf had 2 sterile surgical prep kits containing antiseptic solutions and 10 bottles of 1,000 ml sterile water. The second shelf contained blankets. The third shelf contained 2 bags of 1000 ml normal saline, 3 bags of 500 ml normal saline, and 4 bags of 1000 ml of IV lactated ringers. The fourth and fifth shelves contained blankets. None of the fluids in the warmer were dated as to when they were placed in the warmer or when they would expire.
In an interview on 08/25/15 at 3:00 p.m. with S34RN she indicated that she rotated the surgical solutions stored in the warming cabinet from back to front as needed and did not date the surgical solutions, as to when they were placed in the warmer. S34RN indicated that she was not aware that she had to date the surgical solutions, as long as she was rotating them each time. S34RN further indicated that she was not familiar with the manufacturer's recommendation for surgical fluids or antiseptic solutions stored in a warming cabinet.
In an interview on 08/25/15 at 3:30 p.m. with S9RN she indicated that the Surgical Services Department did not have a policy in place for surgical fluids or antiseptic solutions in the warming cabinet based upon specific manufacturer's recommendations

3) failing to ensure that sterile instruments and sterile supplies for patient use were not compromised by storing sterile and non-sterile instruments/supplies together and/or on top or underneath non-sterile equipment and/or stored in open cabinets, failing to ensure that equipment available for patient use was not torn/taped so as to ensure effective cleaning/disinfecting, failing to ensure that expired supplies were not available for patient use, and failing to ensure that SUD (single use devices) were not reprocessed,

A review of AORN Perioperative Standards and Recommended Practices, 2013 edition, Recommendation for Product Selection in Perioperative Practice Settings: Recommendation II, revealed that the FDA (Food and Drug Administration) requires health care organizations who reprocess single use items/devices (SUD) to have policies in place that listed those single use items that were acceptable for reprocessing and that the reprocessing adhere to the same regulations and guidelines required for the original manufacturer.

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. Sterile items should be stored in closed cabinets and under environmentally controlled conditions

On 08/25/15 from 1:00 p.m. to 3:00 p.m. the following observations were made in the surgical suite:
In OR#3 the following single use sterile items were noted to have been reprocessed by the hospital 's Central Sterile department; bovie cautery cords x 7 and bovie cautery tips x 7.
In the Sterile Supply Room the following single use sterile items were noted to have been reprocessed; suture passers x 2, Jackson Pratt bulb drain x1, penrose drains x4, kitner dissector packs x10, and light handle covers x 2.
In OR#3 a further observations revealed multiple sterile supplies located in open cabinets, sterile supplies stored on the top of equipment and single use iodoform gauze bottles x 2 that had been opened and available for patient use.
In PACU's refrigerator revealed a Humulin R (regular) insulin bottle that was dated 03/31/15 and had expired after 28 days.
In OR#2 (Cath Lab) revealed the following observations: the X-Ray bed in the Cath Lab room was noted to have a 2 inch tear that was taped over with a tegaderm. An open contrast bottle was noted to be half used and was still set up in the contrast syringe push device and available for patient use with the instructions on the contrast bottle indicating that once opened, the contrast must be discard after 4 hours. (There were no Cath Lab procedures scheduled for that day). An alcohol bottle that was opened and was not dated as to when it was opened. A soiled surgeon's cap was noted on the sterile supply shelf. Sterile gloves x3 that had been opened were stored with sterile supplies. A store bought bottled water was noted in the room on the desk area. Multiple cable wires and equipment wires were noted on the floor. Unsterile supplies and sterile supplies were noted to be mixed together in various locations.
On 08/26/15 at 12:30 p.m. an observation of the anesthesia cart in OR#1 revealed 3 single use endotracheal tubes that were noted to have been reprocessed by the hospital 's Central Sterile department.
In an interview on 08/26/15 at 12:30 p.m. with S40CRNA he indicated that 2 of the endotracheal tubes that were reprocessed were opened and were not used and the other endotracheal tube that was reprocessed had been used and re-cleaned and then reprocessed because there was a supply shortage. S40CRNA further indicated that he thought that if a sterile item was opened or dropped and not used on a patient it could be reprocessed.
In an interview on 08/25/15 at 3:30 p.m. with S9RN she indicated that the Surgical Services department reprocessed single use supplies if they were opened and not used on patients. S9RN further indicated that the Surgical Services department did not have policies in place based on FDA guidelines and regulations for reprocessing of SUDs. S9RN indicated that the Cath Lab RN 's were contract, and they were responsible for the Cath Lab supplies and were supposed to follow acceptable professional standards of practice.
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4) failing to ensure that the re-usable blue cloth towels used in the surgical instrument trays to be sterilized were lint-free,

A review of the AORN Perioperative Standards and Recommended Practices, 2013 edition- Recommended Practice for Cleaning and Care of Surgical Instruments - Recommendation XII revealed in part: The instrument tray or basket should be lined with an absorbent, lint-free surgical towel. Towels placed within instrument sets should be lint-free, freshly laundered and thoroughly rinsed by a health care-accredited laundry to reduce the risk of leaving chemical residue on the instruments. Lint left on sterile towels may be transferred to the surgical wound and may cause a foreign-body reaction.
An observation on 08/26/15 at 1:40 p.m. of the Central Sterile room revealed blue surgical cloth towels being used in instrument trays and being packaged for sterilization for use in patient surgical procedures.
In an interview on 08/26/2015 at 1:40 p.m. with of S32CST and S42CST they indicated that they used blue surgical cloth towels in all instrument trays. They indicated that the towels came from the contract laundry and that the Surgical Services department did not purchase surgical cloth towels that were already sterile and pre-packaged. They indicated that they (Central Sterile) also packaged and sterilized the surgical cloth towels in separate packs for surgical procedures. S32CST and S42CST were asked if the blue surgical cloth towels were de-linted by the laundry company. They indicated that they did not know, but the cloth towels were re-usable and were washed by the laundry company and returned to them.
In an interview on 08/26/15 at 11:00 a.m. with S9RN she was asked about the blue cloth towels used in the sterile instrument trays and in the sterilized packs and if they were de-linted prior to use each time. S9RN indicated that she did not know. S9RN indicated that the towels were re-usable and were used in surgical procedures and were laundered after each use by the contract laundry. S9RN further indicated that she did not know if they were de-linted at the contract laundry. S9RN indicated that S27EVS probably knew if they were de-linted at the laundry.
In a phone interview on 08/27/15 at 9:30 a.m. with S49Laundry, in the presence of S27EVS, S49Laundry indicated that he was the contracted laundry for the hospital. S49Laundry was asked about the blue cloth towels laundered by the contract laundry. S49 Laundry indicated that he buys the re-usable towels from a medical company and launders them for use in the hospital. S49Laundry was asked if his laundering process included de-linting of the cloth towels prior to returning them to the hospital. S49Laundry indicated that he did not have a process in place to de-lint the cloth towels and that they were not de-linted.
5) failing to ensure that staff adhered to the manufacturer's instructions for the use of the high level disinfectant for semi-critical items and failing to ensure that staff were provided with ETO gas sterilizer monitoring badges when using the ETO gas sterilizer
A review of AORN Perioperative Standards and Recommended Practices, 2013 edition - Sterilization: Recommendation VII revealed in part: Ethylene Oxide sterilization (ETO) is a low-temperature process that may be used for moisture and heat sensitive surgical items. ETO is a known human carcinogen and a chemical that has the potential to cause adverse reproductive effects in humans. OSHA has established exposure limits for ETO in the workplace. Personnel who have the potential for exposure should wear ETO monitoring badges.

An observation on 08/26/15 at 1:05 p.m. of the decontamination instrument room revealed that the high level disinfectant instructions on the bottle indicated that the solution could be used undiluted for up to 21 days after a test strip was performed each day to indicate that the high level disinfectant was still active. The high level disinfectant instructions further indicated that the water temperature should be 20oC prior to use. An observation of the high level disinfectant pan that contained the high level disinfectant solution was not observed to have a temperature probe in it.
In an observation on 08/26/15 at 1:40 p.m. of the Central Sterile processing room, an observation was made of an ETO (ethylene oxide) gas sterilizer present in the Central Sterile department
In an interview on 08/26/15 at 1:05 p.m. with S32CST and S42CST they indicated that they were responsible for the decontamination room and the Central Sterile processing room. The high level disinfectant instructions on the bottle were reviewed with S32CST and S42CST. They indicated that they did not check the temperature of the high level disinfectant solution prior to use and indicated that they were not aware that they had to check the solution temperature. S32CST and S42CST indicated that they were also responsible for the ETO (ethylene oxide) gas sterilizer. S32CST and S42CST were asked if they had ETO detection monitoring badges. They indicated that they were not given any ETO detection badges to wear that monitored their exposure to the ETO in the gas sterilizers prior to working with the ETO gas sterilizers. They indicated that they did not know that they needed them.
In an interview on 08/26/15 at 1:30 p.m. with S9RN she was asked if ETO detection monitoring badges were available for staff working with the ETO gas sterilizers. S9RN indicated that they did not have badges and she did not know that they needed them.

6) failing to perform daily wet vacuum terminal cleaning of the ORs after the scheduled procedures were completed each day
A review of the AORN Perioperative Standards and Recommended Practices, 2013 edition, - Recommended Practices for Environmental Cleaning in the Perioperative Setting: Recommendation IV revealed in part: Surgical and Invasive Procedure Rooms and scrub/utility areas should be terminally cleaned daily. Terminal cleaning and disinfection of the perioperative environment decreases the number of pathogens, dust, and debris that is created during the day. Terminal cleaning and disinfection of operating and invasive rooms should be done when the scheduled procedures are completed for the day, and each 24 hour period during the regular work week. Unused rooms should be cleaned once during each 24 hour period during the regular scheduled work week. Floors should be wet-vacuumed with an EPA-registered disinfectant after scheduled cases are completed.

In an interview on 08/25/15 at 3:30 p.m. with S9RN she indicated that the Surgical Services department had a dedicated housekeeping personnel (S41Housekeeper) who assisted in cleaning/disinfecting the surgical suites between cases and at the end of the surgery schedule each day. S9RN indicated that she did not think that S41Housekeeper routinely wet-vacuum the surgical suites each day.
In an interview on 08/26/15 at 1:00 p.m. with S41Housekeeper she indicated that she was the housekeeper assigned to the surgical suites area. S41Housekeeper indicated that she assisted with the cleaning of the rooms between the surgical procedures and cleaned the surgical suites at the end of the day. S41Housekeeper indicated that she did not wet-vacuum the floors. S41Housekeeper further indicated that S27EVS assigned a housekeeper to wet-vacuum the surgical suites on a monthly basis.
In an interview on 08/27/2015 at 9:30 a.m. with S27EVS he was asked about the wet-vacuum terminal cleaning in surgery. S27EVS indicated that the wet-vacuum terminal cleaning in surgery was scheduled once a month and was not performed on a daily basis.

Based on record review and interview, the hospital failed to ensure that an updated examination, that included any changes in the patient's condition, was completed and documented immediately prior to and before the patient's surgical procedure and/or procedure requiring anesthesia services as evidenced by no documentation of an updated examination for 5 of 5 (Patients #19, #20, #21, #22, #23) patient medical records reviewed for updated examinations prior to their surgery/procedure out of a total sample of 30.
Findings:
Patient #19
A review of the patient's medical record on 08/27/15 revealed the patient was admitted on 08/26/15 for an Endoscopic procedure under anesthesia with S50MD on 08/26/15. A further review of Patient #19's medical record revealed no documented evidence of an updated examination prior to her procedure.

Patient #20
A review of the patient's medical record on 08/27/15 revealed the patient was admitted on 08/26/15 for an FNA (Fine Needle Aspiration) surgical procedure of the left breast with S30MD on 08/26/15. A further review of Patient #20's medical record revealed no documented evidence of an updated examination prior to her surgical procedure.

Patient #21
A review of the patient's medical record on 08/27/15 revealed the patient was admitted on 08/26/15 for an Umbilical Hernia Repair with anesthesia with S30MD on 08/26/15. A further review of Patient #21's medical record revealed no documented evidence of an updated examination prior to his surgical procedure.

Patient #22
A review of the patient's medical record on 08/27/15 revealed the patient was admitted on 08/26/15 for an Excision of a Back Mass with anesthesia with S30MD on 08/26/15. A further review of Patient #22's medical record revealed no documented evidence of an updated examination prior to his surgical procedure.

Patient #23
A review of the patient's medical record on 08/27/15 revealed the patient was admitted on 08/26/15 for a Laparoscopic Cholecystectomy with anesthesia with S30MD on 08/26/15. A further review of Patient #23's medical record revealed no documented evidence of an updated examination prior to her surgical procedure.

In an interview on 08/26/15 at 2:15 p.m. with S44RN, she indicated that she worked in the Outpatient Department and was responsible for ensuring that patients' Surgical Checklist was completed prior to the patients having their surgery/procedure. S44RN was asked about the documentation of the updated examinations for Patients #19, #20, #21, #22, #23 prior to and before the patient's surgical procedure and/or procedure. S44RN indicated that she did not think the physicians documented an updated examination for patients prior to patients' surgery/procedure on the patients' medical record. S44RN further indicated that she was not aware if the hospital even had a form for the physicians to use to document an updated examination prior to the patients' surgical procedure.

In an interview on 08/27/15 at 1:10 p.m. with S30MD, he was asked about documentation of the updated examinations for Patients #20, #21, #22, #23 prior to and before the patient's surgical procedure and/or procedure. S30MD indicated that he did not know he was supposed to document updated examinations for patients prior to and before the patient's surgical procedure and/or procedure and further indicated that he did not document an updated examination for Patients #20, #21, #22, and #23.

Based on record review and interview, the hospital failed to meet the Condition of Participation for Anesthesia Services by:

Failing to have the Anesthesia Services under the direction of a qualified doctor of medicine (MD) or doctor of osteopathy (DO) who was responsible for all anesthesia administered in the hospital as evidenced by the Anesthesia Services being directed and supervised by a CRNA (Certified Registered Nurse Anesthetist).

Findings:
A review of the credentialing files and the governing body minutes revealed no documented evidence of a doctor of medicine (MD) or doctor of osteopathy (DO) recommended by the medical staff and appointed/approved by the hospital's governing body as the director of the hospital's Anesthesia Services who was responsible for all anesthesia administered in the hospital.

In an interview on 08/26/15 at 12:30 p.m. with S40CRNA (Certified Registered Nurse Anesthetist), he was asked about the Director of Anesthesia Services. S40CRNA indicated that the CRNAs were contract staff and they did not have a contract Anesthesiologist or medical MD on staff. S40CRNA further indicated that since the hospital did not have a hospital MD as the Director of Anesthesia Services that he (S40CRNA) was asked by the hospital to be the Director of Anesthesia Services.

In an interview on 08/27/15 at 10:00 a.m. with S1CEO (Chief Executive Officer) and S29MD they were asked about the hospital's Director of Anesthesia Services. S29MD indicated that he was the Medical Director for the hospital and that the medical staff had not appointed a doctor of medicine (MD) or doctor of osteopathy (DO) to be responsible for all anesthesia administered in the hospital. S1CEO indicated that he was a member of the hospital's governing body and indicated that the governing body had no doctor of medicine (MD) or doctor of osteopathy (DO) appointed /approved by the governing body to be responsible for all anesthesia administered in the hospital. S1CEO indicated that S40CRNA was the Director of Anesthesia Services for the hospital.

Based on record reviews and interviews, the hospital failed to ensure that patients rights and responsibilities were communicated/provided to patients prior to or upon admission to Swing Bed. This was evidenced by 4 of 4 (#3, #4, #5, & #6) patients reviewed for Swing Bed out of a sample size of 30.
Findings:

Review of the medical record for Patient #3 revealed he was admitted to Swing Bed on 08/21/15. There was no documented evidence that indicated Patient #3 was informed of his rights and responsibilities prior to or upon admission to Swing Bed.

Review of the medical record for Patient #4 revealed she was admitted to Swing Bed on 04/26/15 and discharged on 07/09/15. There was no documented evidence that indicated Patient #4 was informed of her rights and responsibilities prior to or upon admission to Swing Bed.

Review of the medical record for Patient #5 revealed he was admitted to Swing Bed on 08/06/15. There was no documented evidence that indicated Patient #5 was informed of his rights and responsibilities prior to or upon admission to Swing Bed.

Review of the medical record for Patient #6 revealed she was admitted to Swing Bed on 07/31/15. There was no documented evidence that indicated Patient #6 was informed of her rights and responsibilities prior to or upon admission to Swing Bed.

In an interview on 08/26/15 at 11:35 a.m., Patient #3's wife indicated that they were not aware of his rights/responsibilities while in Swing Bed. She indicated that the hospital did not provide Patient #3 with information on his rights/responsibilities prior to and or upon admission to Swing Bed.
In an interview on 08/26/15 at 11:40 a.m., S27RN indicated she was the nurse in charge of the hospital's Swing Bed. S27RN indicated the hospital did not provide patients and/or family members with Patient Rights and Responsibilities prior to or upon admission to Swing Bed. S27RN confirmed the above medical records had no documented evidence that patient #3, patient #4, patient #5, and patient #6 were provided with Patient Rights and Responsibilities for Swing Bed Patients.