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Based on observation, interview and record review, the governing body failed to ensure staff were properly trained in terminal cleaning to prevent the spread of infection. This had the potential to affect all patients receiving services. The facility performed 61 procedures in the last 30 days. The current census was four.

See A0049

Based on observation, interview and record review, the facility failed to ensure humidity levels were maintained between 20 percent and 60 percent in the operating rooms (K701); and failed to meet the requirements for life safety, specifically Chapter 18 and 19 of the applicable provisions of the 2012 new and existing editions of the Life Safety Code of the National Fire Protection Association. At this survey, The Medical Center at Elizabeth Place was found not in substantial compliance with the 2012 edition of the National Fire Protection Association (NFPA) 101, Life Safety Code (LSC) Chapter 18, New Healthcare and Chapter 19, Existing Healthcare (K709). This has the potential to affect all patients receiving services in this facility. The facility performed 61 procedures in the last 30 days. The census was four.

Based on observation, record review and interview, the facility failed to ensure staff were trained in terminal cleaning; failed to ensure the operating rooms were appropriately terminally cleaned; and failed to ensure equipment was properly maintained to ensure proper cleaning;and failed to ensure sterile packaging were maintained and disposed of when expired (A0749). The cumulative effects of these systemic practices resulted in the facility's inability to promote and ensure a sanitary environment to minimize infections.

The failure to ensure staff had training in terminal cleaning for the inpatient and operating rooms resulted in a determination of immediate jeopardy. The facility performed 61 procedures in the last 30 days. The census was four.

Based on record review and interview, the governing body failed to ensure staff were properly trained on the procedures for terminal cleaning to prevent the spread of infection.. This has the potential to affect all patients receiving services at the facility. The facility performed 61 procedures in the last 30 days. The current census was four.

Six personnel files were reviewed. Staff A, Director of Nursing; Staff E, Director of Surgical Services, Staff D, a floor nurse, and Staff M, a surgical technician, did not have evidence of training for terminal cleaning of operating rooms and patient rooms.

Interview with the Director of Human Resources on 04/24/19 at 4:34 P.M. revealed the above staff did not have training on terminal cleaning.

Review of the Governing Body Meeting Minutes dated 03/28/19 revealed documentation of discussions on training of staff for the terminal cleaning processes.

Based on observation, record review and interview, the facility failed to ensure all patients were given information on how to file a complaint with the Ohio Department of Health. This affected all patients, staff, and visitors entering the medical center. The hospital active census was four.

Findings include:

Observation of the registration area included the "Notice of Privacy Practice" signage that included the patient health information rights. It included information that stated, " If you believe your privacy rights have been violated, you may file a complaint with the facility by the process outlined in the facility's Patient Rights documentation. You may also file a complaint with the Secretary of the Department of Health and Human Services. All complaints must be submitted in writing." The signage contained no contact information to file a complaint with the listed entities. There was no notice on how to contact the Ohio Department of Health.

Review of the admission packet given to all patients included the same "Notice of Privacy Practice" that was posted in the registration area. The packet contained no information on how to contact the Ohio Department of Health.

During interview on 04/22/19 at 12:59 P.M. with Registration Staff Z it was confirmed all patients admitted to the hospital receive the admission packet that lacks information on how to file a complaint with the Ohio Department of Health.

Based on record review and interview, the facility failed to ensure patient's pain was assessed within one hour of receiving pain medication. This affected five (Patients #1, #2, #6, #11 and #13) of five patients reviewed for pain management. The sample was 30 patients. The census was four.

Findings include:

1. Medical record review revealed Patient #1 was admitted to the inpatient unit on 04/12/19. The diagnosis was revision of the right hip.

On 04/12/19 at 11:08 P.M. the patient was given Ultram, two 50 milligrams (mg) tablets for right hip pain. The pain was not reassessed until 12:43 A.M. with partial relief.

On 04/13/19 at 2:44 A.M. the patient was given Ultram, two 50 mg tablets, for pain. The follow up reassessment was not done until 6:43 A.M. and there was no reassessment of the patient's pain level.

During interview on 04/23/19 at 4:35 P.M., Staff A stated the patient's pain was not reassessed timely.

2. Medical record review revealed Patient #2 was admitted to the inpatient unit on 04/12/19. The diagnosis was bilateral knee replacement.

On 04/13/19 at 11:12 P.M. Dilaudid, two mg was given for pain. The pain reassessment was not done until 1:20 AM.

During interview on 04/23/19 at 4:35 P.M., Staff A stated the patient's pain was not reassessed timely.

3. Medical record review revealed Patient #6 was admitted to the inpatient unit on 04/15/19. The diagnosis was revision of the right hip.

On 04/16/19 at 1:45 P.M., Oxycodone ten mg was given for right hip pain. The pain reassessment was not done until 6:39 P.M. with partial relief.

During interview on 04/23/19 at 9:30 A.M., Staff D stated the patient's pain was not reassessed timely.

4. Medical record review revealed Patient #11 was admitted to the inpatient unit on 04/17/19. The diagnosis was right total knee arthroplasty tibial component.

On 04/18/19 at 10:13 A.M., Oxycodone ten mg was given. The pain reassessment was no done until 12:00 A.M.

On 04/19/19 at 3:23 P.M., Oxycodone ten mg was given. The pain reassessment was not done until 6:55 P.M.

During interview on 04/24/19 at 2:15 P.M., Staff A stated the patient's pain was not reassessed timely.

5. Medical record review revealed Patient #13 was admitted to the inpatient unit on 04/19/19. The diagnosis was left total hip arthroplasty.

On 04/20/19 at 9:35 P.M., Oxycodone 5 mg was given for pain. There was no follow up pain assessment.

During interview on 04/25/19 at 9:25 A.M., Staff C stated the patient's pain was not reassessed timely

Review of the facility policy and procedure titled "Pain Management", approved April 2018, read "it is the responsibility of all caregiver to monitor patients' pain and take appropriate actions. .....effectiveness of pain intervention is checked one hour after treatment for oral medication. If pain interventions is not effective, the physician is notified."

Based on observation, record review and interview, the facility failed to ensure expired drugs or controls were not available for patient use or equipment testing; and failed to ensure opened medications were discarded within 28 days after opening. This has the potential to affect all patients receiving services at the facility. The facility performed 61 procedures in the last 30 days. The current census was four.

Findings include:

Tour of the Post-Anesthesia Care Unit (PACU)/Pre-operative area on 04/22/19 at 2:00 P.M. revealed in the medication refrigerator there was Tuberculin Purified Protein Derivative (used to test for tuberculosis), Diluted 5 TU/1 mL, opened 2/27/19; Humulin RU-100 (used to control blood sugar levels) 10 mL, 100 units per ML, opened 03/20/19; and I-stat machine controls which stated "education only", expired 12/31/18. In a storage cabinet were two 16 ounce bottles of Hydrogen Peroxide 3% which expired July 2016.

At the time of the observation, Staff E verified the opened medications were beyond 28 days after opening and the expiration of the I-stat machine controls and Hydrogen Peroxide 3%.

Tour of the endoscopy procedure room completed on 04/23/19 at 8:25 AM revealed Epinephrine Injection (medication for allergic reaction 1 mg/10 ml had expired on 03/01/19 in the anesthesia cart. This finding was verified by Staff E at the time of the finding.

Review of the policy titled "Medications Returned to Pharmacy, 3042 "It is the policy of the Medical Center at Elizabeth Place to remove expired medications and other unusable medications from stock to prevent their use and to ensure that they are disposed of safely. Storage areas for expired and unusable medications will be separated from storage areas for active stock."

Based on record review and interview, the facility failed to ensure humidity levels in the operating rooms below or above the identified 20 percent to 60 percent range were addressed before performing surgical procedures. This affected five (Operating Rooms #1, #2, #3, #4 and #5) of five procedure rooms. This had the potential to affect all patients receiving surgical services at the facility. The facility performed 61 procedures in the last 30 days. The census was four.

Findings include:

Temperature and humidity logs were reviewed for Operating Rooms #1, #2, #3, #4 and #5 for the period of January through March 2019. The normal humidity range for all four operating rooms was to be between 20 percent and 60 percent.

1. Review of the temperature and humidity logs for Operating Room #1 revealed the relative humidity was below 20 percent on 20 surgery days between 01/01/19 through 03/31/19. The low humidity levels ranged between nine percent and 19 percent.

No corrective action was documented along with follow up readings of the humidity levels and no documentation that procedures were suspended until the humidity levels were within the 20 percent to 60 percent range.

2. Review of the temperature and humidity logs for Operating Room #2 revealed the relative humidity was below 20 percent on 18 of the surgery days between 01/01/19 through 03/31/19. The low humidity levels ranged between five percent and 19 percent.

No corrective action was documented along with follow up readings of the humidity levels and no documentation that procedures were suspended until the humidity levels were within the 20 percent to 60 percent range.

3. Review of the temperature and humidity logs for Operating Room #3 revealed the relative humidity was below 20 percent on 18 of the surgery days between 01/01/19 through 03/31/19. The low humidity levels ranged between eight percent and 18 percent. 8% and 18%.

No corrective action was documented along with follow up readings of the humidity levels and no documentation that procedures were suspended until the humidity levels were within the 20 percent to 60 percent range.

4. Review of the temperature and humidity logs for Operating Room #4 revealed the relative humidity was below 20 percent on 17 of the surgery days between 01/01/19 through 03/31/19. The low humidity levels ranged between seven percent and 19 percent.

No corrective action was documented along with follow up readings of the humidity levels and no documentation that procedures were suspended until the humidity levels were within the 20 percent to 60 percent range.

5. Review of the temperature and humidity logs for Operating Room #5, the endoscopy room, revealed the relative humidity was below 20 percent on 19 of the surgery days between 01/01/19 through 03/31/19. The low humidity levels ranged between eight percent and 18 percent.

No corrective action was documented along with follow up readings of the humidity levels and no documentation that procedures were suspended until the humidity levels were within the 20 percent to 60 percent range.

During interview on 04/24/19 at 9:45 A.M., Staff G stated the person that makes the adjustments to the heating, ventilation and air conditioning system is emailed about the humidity levels but there is no return response of adjustments being completed. Staff G also verified there were no follow up checks completed or documented, no corrective action documented, and procedures are not suspended until humidity is within appropriate range.

Review of the policy titled "Temperature and Humidity (Operating Room and Adjacent Areas)" revealed humidity and airflow in the operating rooms must be maintained within acceptable limits between the range of 20 percent to 60 percent. Upon determination of an out of range reading a second reading will be done as a control. If both readings remain outside the normal values corrective actions will be taken. Procedures for humidity correction include: operating room cases will be evaluated for appropriate management and or acceptability by the Administrator or designee. No cases will be started without review of the situation and/or determination of the appropriateness by the administrator. Notification of the facility plan operations or contracted services for this system so that an evaluation of the situation can begin. Once diagnosed, the situation should be corrected as soon as possible. If the situation cannot be resolved, cases will not be completed in that operating suite/procedure room. If repairs/correction are required, temperature/humidity reading must be re-taken and documented prior to starting cases.

Based on observation, interview, and documentation review, the facility failed to meet the requirements for life safety, specifically Chapter 18 and 19 of the applicable provisions of the 2012 new and existing editions of the Life Safety Code of the National Fire Protection Association. At this survey, The Medical Center at Elizabeth Place was found not in substantial compliance with the 2012 edition of the National Fire Protection Association (NFPA) 101, Life Safety Code (LSC) Chapter 18, New Healthcare and Chapter 19, Existing Healthcare. This has the potential to affect all patients receiving services in this facility. The facility performed 61 procedures in the last 30 days. The census was four.

Findings include: :

1. Refer to K161 building construction and type
2. Refer to K222 egress doors.
3. Refer to K225 stairway enclosures
4. Refer to K271 discharge of exits
5. Refer to K291 emergency lighting.
6. Refer to K311 veritical openings
7. Refer to K321 hazardous areas.
8. Refer to K345 maintenace of fire alarm systems.
9. Refer to K347 smoke detection
10. Refer to K351 installation of sprinkler systems
11. Refer to K353 maintenance of sprinkler systems
12. Refer to K362 construction of corridor walls.
13. Refer to K363 corridor doors.
14. Refer to K372 subdivsion of smoke compartments
15. Refer to K913 wet procedure locations and electrical equipement.
16. Refer to K918 generator equiment maintenance
17. Refer to K920 electrical equipment
18. Refer to K923 cylinder storage of gas equipment.
19. Refer to K933 fire loss protection

Based on observation and interview, the facility failed to ensure equipment was properly maintained. This had the potential to affect all patients receiving services from the facility. The facility performed 61 procedures in the last 30 days. The census was four.

Findings include:

During observation of a surgical procedure and tour of the surgical suite completed on 04/23/19 revealed the electrocautery machine had large rust spots all over the cart, some approximately 4 inches by 4 inches.

The operating table in Operating Room #3 had chipped paint.

During interview on 04/23/19 at 8:00 A.M., Staff E verified the above findings.

Based on observation, record review and interview, the facility failed to ensure staff were trained in terminal cleaning; failed to ensure the operating rooms were appropriately terminally cleaned; failed to ensure equipment was properly maintained to ensure proper cleaning; failed to ensure sterile packaging were maintained and disposed of when expired; and failed to store dry food properly. This had the potential to affect all patients receiving surgical procedures at the facility. Additionally, the facility failed to ensure staff performed proper hand hygiene during a dressing change. This affected two (Patients #8 and #10) of two patients observed for dressing changes. The facility performed 61 procedures in the last 30 days. The census was four.

Findings include:

1. Observation of the crash cart located in the Post Anesthesia Care Unit on 04/22/19 at 2:21 PM revealed a suction catheter with an expiration date of February 2019. The sterile packaging was open and it was connected to the vacuum pump on the crash cart.

During interview on 04/22/19 at 2:21 P.M., Staff E stated the suction catheter sterile packaging was open and attached to the vacuum pump so it is readily available and verified the item had passed the expiration date.

2. During observation of the terminal cleaning of Operating Room #4 on 04/23/19 at 10:44 A.M., Staff F did not spray or wipe down the inside or outside of the electrocautery machine. The operating table was not sprayed or wiped down on the sides, including between the steel bars used to connect equipment. When asked what type of chemical was used on the floor, Staff F replied "FC4".

During interview at the time of the observation, Staff F verified the electrocautery machine and every surface of the operating table were not cleaned.

3. Observation of the manufacturer's label for the "FC4" floor cleaner on 04/23/19 at 1:30 P.M. revealed no information stating the cleaner was a disinfectant. Staff F verified at the time of the observation the floor cleaner did not disinfect.

Interview with Staff E on 04/24/19 at 12:00 P.M. revealed the supplier of the "FC4" cleaner was contacted and confirmed the cleaner was not a disinfectant.

4. Review of the facility policy titled "Cleaning of Peri-Operative Areas", revealed "Terminal Cleaning: A. Terminal cleaning and disinfection of operating or procedures rooms will occur daily when OR suite procedure rooms are being used. C. Clean and disinfect all exposed surfaces, including wheels and casters, of all items with an FDA disinfectant, according to manufacturer's written instructions for use including: Anesthesia carts and equipment; patient monitors; OR beds; OR bed attachments; positioning devices; patient transfer devices; overhead procedure lights; tables; mayo stands; bins; kick buckets; mobile and fixed equipment; storage cabinets; light switches, door handles, and push plates; telephone and mobile communication devices; computer accessories; high touch surfaces areas; trash and linen receptacles; Disinfects all floors using either a wet vacuum or a single-use mop and FDA approved disinfectant, areas under the OR bed and mobile equipment mopping toward the exit of the room."


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5. Review of the medical record for Patient #8 reveled an admission date to the inpatient unit on 04/19/19. The procedure performed was for a computer assisted right total knee arthroplasty.

During observation on 04/22/19 at 11:25 A.M., Staff D changed the dressing to the patient's right knee incision. Staff D washed his/her hands, put on a clean pair of gloves, and loosened the tape to the dirty dressing. Staff D removed the soiled gloves and, without performing hand hygiene, put on a pair of sterile gloves. Staff D proceeded to remove the old dressing and put on a clean dressing without changing gloves. Staff D removed the dirty sterile gloves and initialed and dated the new dressing. Staff D did not perform hand hygiene after completing the dressing change.

This finding was confirmed with Staff A on on 04/25/19 at 4:00 PM.

6. Review of the medical record for Patient #10 revealed the patient was admitted to the inpatient unit on 04/22/19. The procedure performed was a left total hip arthroplasty.

During observation on 04/24/19 at 2:00 P.M., Staff H changed the dressing to Patient #10's left hip. Staff H washed his/her hands with soap and water and then put on a clean pair of gloves. Staff H removed the old dressing and without changing gloves, opened a pack of sterile gloves, two packs of chlorapreps, two island dressings with gauze and self adhesive tape, pack of sterile two by two's with surrounding sterile dressing then opened two packs of gauze. Staff H proceeded to remove the old dressing which was stained with a moderate amount of red drainage. Staff H removed his/her gloves and without doing hand hygiene, put on a clean pair of sterile gloves. Staff H pulled the drain tube from the hip area and again, without doing hand hygiene, applied the clean dressings to the incision site. Staff H put all of the dirty dressings into a small red biohazard bag that was sitting on the patient's bed. Staff H proceeded to put another clean dressing on the left outer hip, then removed his/her gloves and placed them in the red biohazard bag. Staff H covered the patient with blankets that were on the bed, touched the call light, bedside table and then picked up an ice pack and gave it to the patient. The patient touched the ice pack. Staff H used alcohol hand gel prior to leaving the patient's room.

This finding was confirmed with Staff A on 04/25/19 at 4:00 PM.

7. Review of the policy and procedure titled "Hand Hygiene, 6007A", revised April 2018, read "the purpose to provide guidelines for effective hand hygiene, in order to prevent the transmission of bacteria, germs and infections. It is the policy of the hospital that all personnel will use CDC guidelines regarding hand-hygiene techniques, including when to use non-antimicrobial soap and water, an antimicrobial soap and water or an alcohol-based hand rub as set forth in the following procedure and in the following instances: after working on a contaminated body site and then moving to a clean body site on the same patient, after coming in contact with bodily fluids, and dressings and always after removing gloves. Use antimicrobial soap and water or non-antimicrobial soap and water when hands are visibly soiled or contaminated. Use an alcohol-based hand rub when hands are not visibly soiled and for routine decontamination in all other clinical situation. Always follow standard precautions, change gloves when moving from a contaminated body site to a clean body site on the same patient."


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8. During observation on 04/22/19 at 1:45 P.M., Staff Nurse Y used a syringe to draw medication from a vial. Staff Nurse Y failed to wipe the septum of the vial with an alcohol swab prior to piercing the vial with the needle.

This finding was discussed with Staff A on 04/22/19 at 2:23 P.M. who provided evidence-based safe practice guidelines for intravenous push medications that staff are expected to use.

Review of "Nursing 2019 October 2016, Volume Number 10", pp. 38-44 states to "use sterile technique when preparing and administering intravenous push medications, flush/locking solutions, and parental solutions administered by direct intravenous injection. Sterile technique includes disinfection of the medication access diaphragm on a vial or neck of an ampule before accessing the medication or solution."

9. Observation was made with Staff A, B, and I on 04/23/19 at 9:45 A.M. of the dry food storage area. There was a box of lentils that was opened on 04/19/19 and to use by 09/13/19, white cake mix opened on 04/19/19 and use by 07/25/19 and dry macaroni opened 04/02/19 and use by 10/02/19. All of these items were open to air and not covered in an air tight container.

Interview with Staff I on 04/23/19 at 10:00 AM confirmed the dry storage items should be kept in an air tight container after opening.

Review of the "Food Storage Guidelines" provided by the facility read for grocery items was including cake mixes, and dry pasta. The guidelines did not specify how to store the cake mixes, but it did specify to keep the dry pasta airtight after opening and that the cake mixes and dry pasta could be stored for one year.

Based on record review and interview, the facility failed to ensure a time out was performed at the start of a second procedure on a different body part in the operating room. This affected two (Patients #2 and #15) of two patients who underwent total arthroplasty of both knees during one scheduled operating room visit. The sample was 30 patients. The patient census was four.

Findings include:

1. Review of the medical record for Patient #2 revealed the patient was admitted to the inpatient unit on 04/12/19. The procedure was computer assisted total knee arthroplasty on both the right and left knee. The operative report dated 04/12/19 revealed the time out was at 9:27 A.M. and the procedure was finished at 10:54 A.M. The time out at 9:27 A.M. did not reveal whether the procedure was performed on the right or left knee. At the start of the second total knee arthroplasty, right or left knee unknown, there was no time documented on the operative report for the time out.

This finding was confirmed with Staff A on 04/23/19 at 4:35 P.M. that the second time out was not performed according to the policy and procedure.

2. Review of the medical record for Patient #15 revealed the patient had a computer assisted total knee arthroplasty on both the right and left knee. The operative report date 04/23/19 revealed the left knee procedure was started at 9:51 A.M. and completed at 10:14 A.M. The right knee procedure was started at 10:28 A.M. and completed at 10:48 A.M. The time out for the left knee procedure was marked as 9:50 A.M.; there was no time listed in the time out box at the start of the procedure on the right knee.

This finding was confirmed with Staff A on 04/25/19 at 10:18 A.M.

The time out is including the surgeon, anesthesia, RN circulator, and surgical scrub performed prior to incision and included confirmation of the following: correct patient, correct side and/or site, correct procedure, patient's allergies, no pooling of prep, and antibiotic administration.

Review of the policy and procedure titled "Universal Protocol -Identification of Surgical Sites", revised April 2018, read "surgical site verification ensures that the correct procedure is performed on the correct patient. All staff participate in reducing the potential for errors related to wrong site surgery. The physician/surgeon has the primary responsibility for verification of the patient, surgical site, and procedure to be performed. On page (2 of 3) number (4) was including the circulating registered nurse (RN) will conduct a time out immediately prior to beginning the procedure. The time out will include verification of the patient's name, intended procedure and identification of the surgical side, availability of correct implants or special equipment. Each member of the surgical team including the surgeon, anesthesia provider, RN's and surgical technicians will participate in the time out. The circulating nurse ensures initiation of the time out, participation of all surgical team members and documentation of the time out."

Based on record review and interview, the facility failed to include rules and/or regulations in the medical staff by laws that governed the supervision of a Certified Registered Nurse Anesthetist (CRNA) by the operating physician. This affected all patients receiving anesthesia services within the facility. The facility performed 61 procedures in the last 30 days. The census was four.

Findings include:

Review of the organization of Anesthesia Services revealed the service is organized under the general direction of one individual who is a qualified Doctor of Medicine (MD) or Doctor of Osteopathy (DO). The anesthesia services provides complete anesthesia services that include: general, spinal, epidural, regional, conscious sedation and pain management. The areas where anesthesia services are provided include the operating rooms, GI/Endoscopy Room, and Pre-op/PACU.

The Medical Executive Committee governs the provisions of anesthesia services, including the minimum qualifications for each category of practitioner who is permitted to provide anesthesia services. A CRNA who is supervised by the operating practitioner and/or an anesthesiologist may administer general anesthesia, and monitored anesthesia care including deep sedation/analgesia.

Review of the Anesthesia Service Agreement with Resource Anesthesia, effective 12/01/16, confirmed the CRNA's are a contracted service. The facility was functioning under predominantly an "all CRNA" model.

The physician anesthesiologist and CRNA's are qualified and granted privileges in accordance with the Medical Center's Medical Staff Bylaws, rules and regulations. The operating practitioner is granted authority via the hospital bylaws to supervise anesthesia specific to their service line. The attending surgeon will be responsible for evaluating the patient as to the patient's need for surgery and anesthesia.

Review of the medical staff bylaws revealed they did not include duties and privileges for CRNA's.

Review of the Delineation of Privileges for an operating surgeon was approved on 10/17/18 revealed privileges were approved for orthopedic surgery. The physician noted deferring critical information via monitors to anesthesia. The orthopedic surgeon conducted five procedures within the last thirty days with a CRNA providing anesthesia services.

An interview was conducted with Staff B on 04/25/19 at 4:36 P.M. who confirmed there are no current provisions in the Medical Staff Bylaws that address duties and privileges for CRNA's.