Bringing transparency to federal inspections
Tag No.: A0048
Based on record review and interview the GB (Governing Body) failed to ensure the Medical Staff Bylaws were annually reviewed/approved as evidenced by no documented GB review/approval of the Medical Staff Bylaws since 2019.
Findings:
A review of the GB Bylaws revealed the Medical Staff Bylaws will be reviewed and approved by the GB at their annual meeting in July of each year.
A review of the Medical Staff Bylaws, as provided by administration as the current Medical Staff Bylaws, revealed the Medical Staff Bylaws was last reviewed and approved by the GB in 2019.
A review of the GB meetings in 2022 revealed that April 2022 was the only meeting conducted by the GB in 2022. A review of the GB minutes from April 2022 revealed no documented evidence that the Medical Staff Bylaws were reviewed/approved by the GB.
In an interview on 06/28/22 at 11:10 a.m. Staff A indicated the GB Bylaws stated the GB will conduct 4 (four) meetings each year (July, October, January, April). Staff A indicated the GB only had 1 (one) meeting so far in 2022 in April. Staff A indicated the GB may have reviewed/approved the Medical Staff Bylaws at the April 2022 meeting, but it was not documented.
Tag No.: A0341
Based upon review of physician credential files and interview, the Medical Staff failed to ensure 6 of 6 Emergency Department physician credential files (CC, DD, EE, FF, GG, HH) had current appointments to the medical staff. Findings:
Review of the Emergency Department credential files for physicians CC, DD, EE, FF, GG, and HH revealed an initial appointment of 09/21/21 to 01/01/22 and another appointment dated 01/01/22 to 04/08/22. There failed to be further evidence the Medical Staff examined the Emergency Department Physicians Credentials after 04/08/22.
Interview on 06/28/22 at 1:30 p.m. with Staff A revealed when asked about the Emergency Department Physicians outdated appointments, he replied he was aware there were files that were not up to date.
Tag No.: A0396
Based on record review and interview the hospital failed to ensure the nursing staff developed a nursing care plan for each patient based on assessing all the patient's nursing care needs and not solely those needs related to the admitting diagnosis for 5 of 5 (Patient #1, #3, #4, #5, #6) current inpatients reviewed for nursing care plans.
Findings:
A review of the hospital policy titled, "Nursing Care Plan", provided by administration as a current policy, revealed in part: A Registered Nurse plans, evaluates, and supervises the nursing care for each patient. Nursing care plans are based on assessing the patient's nursing care needs and not solely those needs related to the diagnosis and developing appropriate nursing interventions in response to those needs.
A review of Patient #1 medical record revealed in part: Patient #1 was admitted to the hospital on 06/21/22 by Staff BB with gastritis and pneumonia secondary to Covid 19. A review of the patient's medical history revealed the patient also had a present history of hypertension, iron deficiency, and hypothyroidism. A review of the current care plan revealed the patient only had a documented care plan with goals and treatment plans for anxiety, comfort, injury, nausea, bowel elimination, respiratory status, and discharge planning relating to gastritis and pneumonia. A further review of the nursing care plan revealed no documented evidence that the patient's care plan goals and treatments had nursing care needs for hypertension, iron deficiency, infection, and hypothyroidism.
A review of Patient #3 medical record revealed in part: Patient #3 was admitted to the hospital on 06/25/22 by Staff BB with dehydration, CHF (congestive heart failure), and nausea. A review of the patient's medical history revealed the patient also had a present history of hypertension and CAD (coronary heart disease), and COPD (chronic obstructive pulmonary disease). A review of the current care plan revealed the patient only had a documented care plan with goals and treatment plans for cardiac status, respiratory status, anxiety, comfort, injury, fluid and electrolytes, and discharge planning relating to dehydration, nausea, and CHF. A further review of the nursing care plan revealed no documented evidence that the patient's care plan goals and treatments had nursing care needs for hypertension.
A review of Patient #4 medical record revealed in part: Patient #4 was admitted to the hospital on 06/24/22 by Staff BB with pyelonephritis, UTI (urinary tract infection), dehydration, and diabetes. A review of the patient's medical history revealed the patient also had a present history of hypertension, iron deficiency, and anemia, A review of the current care plan revealed the patient only had a documented care plan with goals and treatment plans for comfort, fluid and electrolytes, bowel elimination, and discharge planning. A further review of the nursing care plan revealed no documented evidence that the patient's care plan goals and treatments had nursing care needs for hypertension, iron deficiency, infection, anemia, or diabetes.
A review of Patient #5 medical record revealed in part: Patient #5 was admitted to the hospital on 06/23/22 by Staff BB with Covid 19, dehydration, UTI, COPD, and dyspnea. A review of the patient's medical history revealed the patient also had a present history of dementia and hypothyroidism. A review of the current care plan revealed the patient only had a documented care plan with goals and treatment plans for respiratory status, infection, dementia, mobility impairment, and discharge planning. A further review of the nursing care plan revealed no documented evidence that the patient's care plan goals and treatments had nursing care needs for dehydration and hypothyroidism.
A review of Patient #6 medical record revealed in part: Patient #6 was admitted to the hospital on 06/27/22 by Staff BB with pneumonia and dyspnea secondary to Covid 19, obesity, and dermatitis. A review of the patient's medical history revealed the patient also had a present history of arteriosclerotic vascular disease. A review of the current care plan revealed the patient only had a documented care plan with goals and treatment plans for anxiety, comfort, injury, respiratory status, fluid and electrolytes, infection, cardiac status related to edema, and discharge planning. A further review of the nursing care plan revealed no documented evidence that the patient's care plan goals and treatments had nursing care needs for arteriosclerotic vascular disease.
In an interview on 06/28/22 at 3:45 p.m. Staff E indicated that the nurses developed the patients care plans based on the admitting diagnoses and the care plans were not based on any current diagnoses.
Tag No.: A0397
Based on record review and interview the hospital failed to ensure that nursing services were provided in accordance with acceptable professional standards of nursing practice as evidenced by:
a) failing to ensure that an orientation program was conducted and documented for 5 of 5 new staff (Staff L, P, W, X, II) upon hire during 2021 and 2022,
b) failing to ensure that an annual competency skills checklist was performed annually for 13 of 13 staff (Staff D, E, G, H, L, M, N, P, W, X, Z, II, JJ) to assure that the staff had appropriate qualifications/skills for the patient care tasks they performed and;
c) failing to ensure that annual performance evaluations were performed for 9 of 9 staff (Staff D, E, G, H, N, M, O, Z, JJ).
Findings:
A review of 14 current employee files with Staff C revealed 5 employee files (Staff L, P, W, X, II) of staff hired in 2021 and 2022 had no documented evidence of an orientation upon hire; 13 staff files (Staff D, E, G, H, L, M, N, P, W, X, Z, II, JJ) revealed no documented evidence of any prior or current annual competency skills checklist; and 9 staff files (Staff D, E, G, H, N, M, O, Z, JJ) revealed no documented evidence of an annual performance evaluation from 2016 to present.
A review of the hospital policy titled, "Orientation", as provided by administration as a current policy, revealed in part: All employees will be required to complete an orientation packet that will be maintained in their employee file in Human Resources. The orientation packet will be completed prior to independent patient care assignments. The orientation period will vary among employees and will be based on experience and skill level of each employee individually.
A review of the hospital policy titled, "Nursing Evaluations", as provided by administration as a current policy, revealed in part: A 90-day performance evaluation will be completed on all staff with annual evaluations completed annually thereafter.
In an interview on 06/29/22 at 11:30 a.m. Staff C indicated that she was responsible for maintaining the employee files and assuring that the employee files were complete, to include in part: completed orientation packets, annual skills competency checklists, and annual performance evaluations. Staff C indicated that the employee files for Staff L, P, W, X, II had no documented evidence of a completed orientation packet; the employee files for Staff D, E, G, H, L, M, N, P, W, X, Z, II, JJ had no documented evidence of prior or current annual competency skills checklists; and the employee files for Staff D, E, G, H, N, M, O, Z, JJ had no documented evidence of current performance evaluations from 2016 to present. She indicated the directors of each department were responsible for completing the annual competency skills checklists for their staff and the administrator decided on when the performance evaluations were to be performed each year. Staff C indicated the hospital had skills competency forms and performance evaluation forms that used to be completed and maintained in each employee file.
In an interview on 06/29/22 at 4:00 p.m. Staff E indicated that all employees, upon hire, should complete an orientation packet. Staff E further indicated that all employees should have a documented annual skills competency checklist and an annual performance evaluation in their employee files. Staff E indicated she was very new to her position and she assumed the prior director had completed the necessary skills competency checklists and annual performance evaluations on the staff each year. Staff E was unable to locate any skills competency checklists or annual performance evaluations from the prior director's files.
In an interview on 06/30/22 at 2:15 p.m. Staff A indicated that performance evaluations were the responsibility of each department head and should be performed annually. Staff A indicated that he had "dropped the ball" on assuring that annual performance evaluations were performed by the department heads and by himself.
Tag No.: A0505
Based on record review, observation, and interview the hospital failed to ensure medications/supplies were maintained according to acceptable pharmacy standards of practice as evidenced by expired medications/supplies in the OR (operating room) crash cart that were available for patient use.
Findings:
A review of the hospital policy titled, "Crash Cart", provided by administration as a current policy, revealed in part: The Operating Room nurse will check the crash cart once a month to monitor for expired medications/supplies and replace as needed.
An observation on 06/28/22 at 11:00 a.m. with Staff W of the OR crash cart revealed the following expired medications/supplies:
Labetalol 20 ml (milliliters)(x1) expired 05/01/22
Dobutamine 20 ml (x1) expired 05/01/22
Terbutaline 1 ml (x4) expired 05/2022
Narcan 1 ml (x5) expired 05/30/22
Norepinephrine 4 ml (x2) expired 05/31/22
Amiodarone 3 ml (x6) expired 04/2022
Metoprolol tablets 50 mg (milligrams)(x5) expired 04/2022
Endotracheal tubes size 8.0 (x2) expired 05/31/22
In an interview on 06/28/22 at 11:25 a.m. Staff W indicated that she was responsible for checking the outdated medications and supplies in the OR crash cart each month. Staff W indicated she must have overlooked those expired medications/supplies when she checked the crash cart in April 2022 and May 2022.
Tag No.: A0538
Based on record review and interview the hospital failed to ensure that staff who were involved in radiology surgical patient procedures were free from radiation hazards by the use of radiation monitoring devices to detect the amount of radiation exposure as evidenced by 1 (Staff Z) of 6 staff involved in radiology surgical procedures failing to have been assigned a radiation monitoring device.
Findings:
In a review of the hospital policy titled, "Reducing Radiological Exposure", provided by administration as a current policy, revealed in part: Healthcare personnel who are involved in fluoroscopic (radiology) procedures will wear a radiation monitor badge (to detect the amount of radiation exposure during radiology surgical procedures).
In a review of the hospital employee roster, Staff Z was employed to work routinely in the OR. The OR scheduled procedures each month included orthopedic procedures where fluoroscopy was utilized.
In a review of the monthly radiology dosimetry report for 06/26/22, provided by Staff G, Staff Z name was not listed on the dosimetry report.
In an interview on 06/30/22 at 9:15 a.m. Staff G indicated that all radiology staff have radiation monitoring device badges, including all staff who work in the OR due to orthopedic fluoroscopy procedures. Staff G reviewed the June 2022 dosimetry report with the employee list and indicated that Staff Z had never been issued a radiation monitoring badge (x-ray badge) and he must have been overlooked.
Tag No.: A0546
Based on record review and interview the hospital failed to ensure that a qualified Radiologist, appointed by the Governing Body and credentialed by the Medical Staff, supervised the hospital's Radiologic Services to ensure that the radiologic services were provided in accordance with acceptable radiologic professional practice.
Findings:
A review of the Radiology Policy and Procedure Manual, as provided by administration as a current manual, indicated that Staff G was the Radiology Supervisor. She signed the 2021 revision/approval page of the Radiology Policy and Procedure Manual under the "Radiology Supervisor section" as the Radiology Supervisor. Other signatures on the "Policy and Procedure Manual" revision/approval page included the Chief of Staff (Doctor of Osteopathy- Family Practice), the Chief Executive Officer, and the Governing Body Chairman.
A review of the list of medical staff committee chairmen, as provided by administration, revealed Staff BB was the Radiology Department chairman.
In an interview on 06/28/22 at 2:00 p.m. Staff G indicated that she was the Radiology Supervisor and the Director of Radiology and there was no Radiologist who was the supervisor of the Radiology Department. She indicated that Staff BB was not the Radiology Supervisor.
A review of the employee file for Staff G indicated that she was a RRT (Registered Radiology Technician).
A review of the credentialing file for Staff BB revealed that Staff BB was credentialed by the medical staff as a medical doctor with delineation of privileges in family practice. The credential file for Staff BB further revealed no documented evidence that Staff BB was qualified in radiology by education and experience.
In an interview on 06/28/22 at 3:15 p.m. Staff A indicated that the hospital did not have a Radiologist supervising the hospital's Radiology Services.
Tag No.: A0750
Based on observation, record review, and interview the hospital failed to maintain a functional and sanitary environment according to acceptable standards of infection control practices as evidenced by observations of infection control breaches.
Findings:
In observations on 06/27/22 from 10:00 a.m. to 1:00 p.m. the following infection control breaches were identified in the OR suite:
a) Used disposable and non-disposable long cover apparel was hanging in the OR dressing room and by the main OR doors.
b) A de-humidifier was present in the OR sterile supply room.
c) The Spill Kit was missing in the OR decontamination room.
In observations on 06/29/22 from 10:00 a.m. to 11:00 a.m. the following infection control breaches were identified in the main CS (Central Supply) room of the hospital:
d) Boxes (more than 20) from the loading dock with hospital supplies in them were kept in the main CS room where sterile/clean supplies were being stored.
e) Cardboard boxes (more than 20) containing sterile/clean supplies were being stored on the floor.
f) Supplies were stored on top shelves in the CS room that were less than 18 inches from the ceiling in a room with a sprinkler system.
A review of the AORN (Association of periOperative Registered Nurses) Standards of Perioperative Practice as developed by AORN using the ANA (American Nurses Association's) scope and standards of practice for nursing and nursing administration: revealed that the perioperative RN (Registered Nurse) should adhere to ANA standards, practice guidelines, and position statements and also adhere to AORN standards, recommended practices, guidelines, and position statements.
In an observation on 06/27/22 at 10:15 a.m. in the OR dressing room and in the main hallway of the OR, revealed disposable and non-disposable long cover apparel hanging in the OR dressing room and by the main OR doors.
A review of AORN Guidelines for Perioperative Practice, 2020 edition; Guidelines for Surgical Attire, revealed in part: If wearing cover apparel (eg, a lab coat, etc.) over scrub attire, make sure that it is clean. Disposable cover apparel is single use and should not be re-worn. Non-disposable cover apparel if worn over home attire should not be re-used again over surgical attire.
In an interview on 06/27/22 at 12:30 p.m. Staff W indicated the disposable and non-disposable long cover apparel were used as cover jackets (lab coats) by OR staff and hospital staff when entering or leaving the OR restricted and semi-restricted areas during the day. The long jackets are hung by the main OR door and in the dressing room for others to use. She was unsure when the non-disposable long jackets were laundered. Staff W indicated the disposable long jackets are re-used and she was not sure how many times they were used before disposing of them.
In an observation on 06/27/22 at 10:30 a.m. of the OR sterile supply room revealed the presence of a de-humidifier.
A review of the AORN Guidelines for Perioperative Practice 2020 edition: Guidelines for Design and Maintenance of the Surgical Suite revealed in part: Do not use free-standing fans, portable humidifiers, air conditioners, and dehumidifiers or other such devices in the OR perioperative areas. These devices all contain a fan that when running can disrupt the planned airflow within the room and may transfer unwanted particles from the floor.
In an interview on 06/27/22 at 11:30 a.m. Staff W and Staff X indicated the de-humidifier had been used on and off in the OR sterile supply room on Friday afternoon, June 24, 2022, starting around 1:00 p.m. when the air conditioning system in the OR areas went out. They indicated the air conditioning system came back on later that Friday around 4:00 p.m. Staff X indicated they were concerned about maintaining the appropriate humidity and temperature ranges in the OR sterile supply room during those times, so a de-humidifier was used. They indicated they were monitoring the humidity and temperature on and off in the sterile supply room on Friday. They indicated they did not document the humidity and temperature during those times and they were unable to provide any monitoring logs to assure the OR sterile supply room had maintained appropriate humidity and temperature ranges. Staff W and Staff X indicated the de-humidifier was left in the OR sterile supply through the weekend and on Monday just in case it was needed again. Staff W indicated she did not have maintenance re-check the positive and negative pressures and the air flows in the OR after this event and she was not aware that this should have been done.
A review of AORN Guidelines for Perioperative Practice, 2020 edition; Guideline for Sterilization revealed in part: The sterility of sterile items is event related and not time related. Positive and negative pressures and the air flows in the OR should be checked periodically or after an event has occurred that may have affected the pressures and air flow cycles.
In an interview on 06/27/22 at 1:00 p.m. Staff J indicated he was going to have the contract company re-check the positive and negative pressures and the air flows in the OR today and prior to surgery on Tuesday. He indicated there were no surgery scheduled on Monday (today). He further indicated he was unaware that the pressures and air flows needed to be re-checked after an event occurred that may have disrupted pressures and air flows.
An observation on 06/27/22 at 12:30 p.m. in the decontamination room revealed an area on the back wall where a Spill Kit was supposed to be located. There was no observed Spill Kit present.
A review of the AORN Guidelines for Perioperative Practice 2020 edition: Guidelines for High Level Disinfection revealed in part: Chemical spill kits must be stored in close proximity to areas where chemicals or other hazardous materials are stored or used.
In an interview on 06/27/22 at 12:30 p.m. Staff W indicated she did not know where a Spill Kit should be located in the OR and had not really noticed that a Spill Kit was supposed to be present and that it was missing.
In an interview on 06/27/22 at 10:15 a.m. Staff W indicated she was responsible for the OR suites and the perioperative areas. She indicated the hospital followed the AORN Standards of Perioperative Practice.
In an observation on 06/29/22 at 10:15 a.m. of the CS (Central Supply) room revealed hospital sterile/clean supplies still in the loading dock boxes being stored on the floor in the CS room.
A review of the AORN Guidelines for Perioperative Practice 2020 edition: Guidelines for Design and Maintenance, revealed in part: Items should be removed from external shipping containers and web-edged (ie, corrugated) boxes in a breakout area adjacent to clean storage areas because dust, debris, and insects may enter the container or boxes during shipment.
In an observation on 06/29/22 at 10:15 a.m. of the CS room revealed hospital sterile/clean supplies in boxes being stored on the floor in the CS room and supplies stored on the top shelves in the CS room that were less than 18 inches from the ceiling.
A review of the AORN Guidelines for Perioperative Practice 2020 edition: Guidelines for Sterile/Clean storage revealed in part: To comply with fire code regulations and reduce the risk of contamination, sterile/clean supplies should be stored at least 18 inches from the ceiling, and at least 2 inches from outside walls. Fire codes specify minimum distances below the ceiling to ensure the effectiveness of sprinkler systems.
In an interview on 06/29/22 at 10:15 a.m. Staff F indicated he was responsible for the CS room. He indicated that limited space in the CS room was an ongoing problem. Staff F indicated he was not aware that loading dock boxes could not be stored in the CS room and that supplies should be removed from the loading dock boxes and loading dock boxes should not enter the CS room.
In an interview on 06/30/22 at 9:30 a.m. Staff Y indicated she was the Infection Control Consultant for the hospital. She was made aware of the above identified infection control breaches. Staff Y indicated that she had previously identified the infection control breaches in the CS room in her surveillance rounds and had addressed those issues in prior visits. She indicated she depended on the expertise of the OR Supervisor to help identify infection control issues in the OR suites. She further indicated that the hospital followed national accepted infection control guidelines.
Tag No.: A0940
The Hospital failed to meet the CoP (Condition of Participation) in Surgical Services by:
Failing to ensure the OR (operating room) and Surgical Services was supervised by an experienced RN (Registered Nurse) with demonstrated education, experience, and knowledge in surgical services as evidenced by the OR Supervisor having only 6 (six) months of OR experience in Surgical Services. (See Tag A-0942)
Tag No.: A0942
Based on record review and interview the hospital failed to ensure the OR (operating room) and Surgical Services was supervised by an experienced RN (Registered Nurse) with demonstrated education, experience, and knowledge in surgical services as evidenced by the OR Supervisor having only 6 (six) months of OR experience in Surgical Services.
Findings:
A review of the hospital's Key Personnel revealed that Staff W was listed as the OR Supervisor and was responsible for the hospital's Surgical Services.
A review of the employee file for Staff W, with Staff C, revealed that Staff W's prior nursing experience was Emergency Room. Staff W had been in the OR supervisor position for 6 (six) months. There was no documented evidence that Staff W had OR experience or training other than her 6 months experience working in the hospital's OR as a supervisor. A further review of Staff W's employee file revealed no other documented qualifications, certificates, education, training, or background working in surgical services nor any specialized training in the provision of surgical services/management and surgical services operations.
A review of the OR Supervisor job description revealed only a general requirement to have a current RN license. Specific qualifications were not addressed on the job description.
A review of the surgery roster revealed the hospital had surgical procedures scheduled at least 1 (one) day a week with an average monthly volume of approximately 15 procedures a month, consisting of ENT (ear, nose, and throat), orthopedics, general laparoscopy, and endoscopy.
In an interview on 06/27/22 at 12:30 p.m. Staff W indicated she was the OR Supervisor and had been in the position for only 6 (six) months. She indicated her nursing experience consisted of experience as an Emergency Room nurse. Staff W indicated she had no prior OR experience, training, or qualifications and had only the 6 (six) months in the OR setting as the OR Supervisor. Staff W further indicated she had not participated in any qualifying webinars, in-services, training, or received any educational credits in surgical services during those 6 months.
In an interview on 06/27/22 at 1:00 p.m. Staff E indicated she was not aware of Staff W lack of experience in Surgical Services. Staff E further indicated she had been in the interim nursing supervisory position for only a few weeks.
Tag No.: A0945
Based on record review and interview the hospital failed to ensure the surgical services department maintained a roster of practitioners specifying the surgical privileges of each practitioner as evidenced by no current roster being made available in the surgical suite and accessible to the OR staff.
Findings:
A review of the surgical services department revealed no knowledge by staff of a current roster in the surgical suite which listed each practitioner's delineation of surgical privileges.
In an interview on 06/27/22 at 12:10 p.m. Staff W indicated she was not aware of any roster (hard copy or computer based) in the surgical suite which listed each practitioner's delineation of surgical privileges. She further indicated she did not know where such a roster could be found and she would probably have to call someone in the Medical Staff Department. Staff W indicated she assumed each practitioner had the appropriate delineation of privileges to perform surgery.
Tag No.: A0951
Based on observation, record review, and interview the hospital failed to ensure the hospital's Surgical Services followed acceptable professional standards of practice governing surgical services and acceptable infection control practices as evidenced by:
1) failing to ensure that staff processed/sterilized surgical items according to acceptable professional guidelines and manufacturer IFU (instructions for use) for the processing and sterilization of surgical items in paper-plastic peel pouches,
2) failing to perform terminal cleaning in the operating room each day the OR room was used, and
3) failing to ensure that reprocessed endoscopes were stored and handled according to acceptable professional standards of practice as evidenced by 2 of 4 reprocessed endoscopes touching the floor of the storage cabinets, failing to ensure the reprocessed endoscopes were stored in a HEPA (high efficiency particulate air) filtered cabinet, and failing to ensure that scope accessories were scope specific in order to effectively track any infection control outbreaks.
Findings:
A review of the AORN Standards of Perioperative Practice as developed by AORN using the ANA (American Nurses Association's) scope and standards of practice for nursing and nursing administration revealed in part: The perioperative RN (Registered Nurse) should adhere to ANA standards, practice guidelines, and position statements and also adhere to AORN standards, recommended practices, guidelines, and position statements.
1) failing to ensure that staff processed/sterilized surgical items according to acceptable professional guidelines and manufacturer IFU (instructions for use) for the processing and sterilization of surgical items in paper-plastic peel pouches
An observation on 06/27/22 at 11:50 a.m. of the OR Sterile Supply Room revealed several sterile surgical items processed in double paper-plastic peel pouches. A further observation revealed that many of the sterile items processed in paper-plastic peel pouches were not light weight and low profile.
A review of the AORN Guidelines for Perioperative Practice 2020 edition: Guidelines for Packaging Systems revealed in part: Use peel pouches (ie, paper-plastic, polyethylene material, polyester film) according to the manufacturer IFU for sterilization methods and cycles that have been validated by the manufacturer. Use peel pouches only for small, lightweight, low-profile items. Do not use double pouching (ie, placing the item within one pouch and then placing this pouch inside another) unless the pouch manufacturer IFU allow this practice. Folding the sealed inner pouch may entrap air and inhibit sterilant contact and can lead to polyethylene material seal failure at the fold. The plastic side of the pouch is impervious to sterilant penetration. The paper side of the pouch permits sterilant penetration.
In an interview on 06/27/22 at 11:50 a.m. Staff W and Staff X indicated they had both been employed at the hospital for only 6 (six) months. Staff X indicated she was employed as the surgical technician and was the person mainly responsible for the decontamination room and the sterile processing room. Staff X was aware that sterile items should not be processed in double paper-plastic peel pouches, but she indicated she had not had the time to re-process all the double paper-plastic peel pouches that were present in the sterile supply room prior to her employment. Staff X indicated that she was not aware that paper-plastic peel pouches had to be light weight and low profile. Staff W indicated she was new to OR nursing and she was not very familiar with paper-plastic peel pouch processing.
2) failing to perform terminal cleaning in the operating room each day the OR room was used,
A review of the Terminal Cleaning Log for the OR, as provided by administration, revealed in part: OR 1 was terminally cleaned on June 7, 9, 15, 27 of 2022. OR 2 was terminally cleaned on June 2, 9, 15 of 2022.
A review of the AORN Guidelines for Perioperative Practice 2020 edition: Guideline for Environmental Cleaning revealed in part: Terminally clean operating and procedure rooms each day the rooms are used. Clean and disinfect the exposed surfaces, including wheels and casters, of all items. Clean and disinfect the entire floor, including areas under the OR bed and mobile equipment, using either a wet vacuum or mop. Terminally clean the preoperative and postoperative patient care areas each day the areas are used. 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. For terminal cleaning in semi-restricted and restricted areas, a multidisciplinary team should determine the frequency and extent of cleaning required for unused rooms and on weekends. Cleaning of the preoperative, intraoperative, and postoperative areas after each patient has left the area is a regulatory requirement of CDC (Centers for Disease Control and Prevention) and CMS (Centers for Medicare & Medicaid Services).
In an interview on 06/27/22 at 12:10 p.m. Staff W and Staff X indicated that the ORs were used approximately once a week and terminal cleaning was performed at least monthly and not necessarily weekly or on the days the ORs were used. Staff W and Staff X indicated they were not very familiar with the hospital's OR policy on terminal cleaning and indicated they did not think the policy referenced a specific cleaning schedule. Staff W indicated she was not very familiar with the AORN Standards and Guidelines, as she was very new to OR nursing, but the hospital's Surgical Services followed the AORN Standards of Perioperative Practice.
3) failing to ensure that reprocessed endoscopes were stored and handled according to acceptable professional standards of practice as evidenced by 2 of 4 reprocessed endoscopes touching the floor of the storage cabinets, failing to ensure the reprocessed endoscopes were stored in a HEPA (high efficiency particulate air) filtered cabinet, and failing to ensure that scope accessories were scope specific in order to effectively track any infection control outbreaks.
An observation on 06/27/22 at 12:30 p.m., with Staff W and Staff X, was made of the endoscopy storage cabinet. Two of the four endoscopes were observed touching the cabinet floor. The storage cabinet was also not equipped with a HEPA filter system. A further observation observed no scope accessories stored with each of the scopes.
A review of AORN Guidelines for Perioperative Practice, 2020 edition - Flexible Endoscopes revealed in part: Flexible endoscopes and endoscope accessories should be stored in a manner that minimizes contamination and protects the device or item from damage. Flexible endoscopes should be stored in a drying cabinet to facilitate drying, decrease the potential for contamination, and provide protection from environmental contaminants. Drying cabinets are to include a drying system that circulates HEPA-filtered air through the cabinet while filtered air under pressure is forced through the endoscope channels where the endoscopes are continuously dried, suppressing bacterial growth. Drying cabinets should be of sufficient height, width, and depth to allow flexible endoscopes to hang vertically, without coiling and without touching the bottom of the cabinet. Records of flexible endoscope processing enable traceability in the event of a processing failure and in infections and include the identity of the endoscope and the endoscope accessories. Reusable buttons and valves should be reprocessed and stored together with the endoscope as a unique set for tracking purposes.
In an interview on 06/27/22 at 12:30 p.m. Staff W and Staff X indicated they were not aware that processed scopes could not touch the cabinet floor or that a HEPA filtered cabinet was standard protocol. Staff X indicated that since the scope accessories were universal, she was not aware that the scope accessories should be specific to each scope. Staff X indicated that all the accessories for all the scopes were stored together in a metal pan in the reprocessing room.
In an interview on 06/30/22 at 9:30 a.m. Staff Y indicated she was the Infection Control Consultant for the hospital. She was made aware of the above identified infection control breaches in the OR. Staff Y indicated that she depended on the expertise of the OR Supervisor to help identify infection control issues in the OR suites. Staff Y indicated she was not aware that HEPA filters were now standard protocol. She further indicated that the hospital followed national accepted infection control guidelines.