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Based on the manner and degree of the standard level deficiency referenced to the Condition, it was determined the Condition of Participation §485.608 Compliance with Federal, State, & Local Laws was out of compliance.

C-0812 (a) The CAH is in compliance with applicable Federal laws and regulations related to the health and safety of patients. Based on interviews and document review, the facility failed to ensure federal and state laws were followed. Specifically, the facility failed to ensure applicants showed compliance with Colorado Adult Protective Services Data Systems (CAPS check) prior to hiring staff who provided direct care to at-risk adults in four of four providers hired after January 1, 2019.

Based on interviews and document review, the facility failed to ensure federal and state laws were followed. Specifically, the facility failed to ensure applicants showed compliance with Colorado Adult Protective Services Data Systems (CAPS check) prior to hiring staff who provided direct care to at-risk adults in four of four providers reviewed who were hired after January 1, 2019.

Findings include:

Reference:

2020 Colorado Revised Statutes Title 26 - Human Services Code Article 3.1. Protective Services for Adults at Risk of Mistreatment or Self-neglect Section 26-3.1-111. Access to CAPS - employment checks read, (1) The general assembly finds and declares that individuals receiving care and services from persons employed in programs or facilities described in subsection (7) of this section are vulnerable to mistreatment, including abuse, neglect, and exploitation. It is the intent of the general assembly to minimize the potential for employment of persons with a history of mistreatment of at-risk adults in positions that would allow those persons unsupervised access to these adults. As a result, the general assembly finds it necessary to strengthen protections for vulnerable adults by requiring certain employers to request a CAPS check by the state department to determine if a person who will provide direct care to an at-risk adult has been substantiated in a case of mistreatment of an at-risk adult.

Subsection six read, (6) (a) (I) On and after January 1, 2019, prior to hiring or contracting with an employee who will provide direct care to an at-risk adult, an employer described in subsection (7) of this section shall request a CAPS check by the state department pursuant to this section to determine if the person is substantiated in a case of mistreatment of an at-risk adult.

Subsection seven read, (7) The following employers shall request a CAPS check pursuant to this section: (a) A health facility licensed pursuant to section 25-1.5-103, including those wholly owned and operated by any governmental unit.

1. The facility failed to ensure all staff employed after January 1, 2019 received a CAPS check prior to working with at-risk adults.

a. Review of credential files revealed a lack of a CAPS check being completed. Examples include:

i. Review of the credential file for Certified Registered Nurse Anesthetists (CRNA) #7 revealed her hire date was 2/16/20 and did not reveal any documentation a CAPS check had been completed.

ii. Review of credential file for Provider (MD) #8 revealed his hire date was 7/21/19. There was no evidence a CAPS check had been completed.

iii. Review of credential file for Provider (MD) #9 revealed her hire date was 2/21/21 and did not contain any documentation a CAPS check had been completed.

iv. Review of credential file for CRNA #10 revealed no evidence of his hire date or appointment letter along with no evidence of completion of a CAPS check.

b. On 8/25/22 at 1:42 p.m., an interview was conducted with the Credentialing and Administrative Assistant (Assistant) #11. Assistant #11 stated she was unaware of what CAPS checks were and was unaware the checks were required to be completed.

c. On 8/31/22 at 11:54 a.m., an interview was conducted with the Human Resources Director (Director) #12. Director #12 stated CAPS checks were to be conducted on staff members who had the potential to work with at risk adults. Director #12 stated she believed the facility's corporation was conducting the CAPS checks for providers.

The facility was unable to provide evidence CAPS checks were completed on the above providers prior to exit of the survey.

Based on the manner and degree of the standard level deficiency referenced to the Condition, it was determined the Condition of Participation: § 485.618 Emergency services, was out of compliance.

C-0884 Equipment, supplies, and medication used in treating emergency cases are kept at the CAH and are readily available for treating emergency cases. Based on observations, interviews and document review, the facility failed to ensure emergency equipment was available in emergency situations. Specifically, the facility failed to ensure expired emergency equipment and medications were removed and replaced to provide usable equipment in an emergency situation in three of three code carts (carts stocked with emergency medications and supplies) and two of two emergency department patient bays observed.

Based on observations, interviews and document review, the facility failed to ensure emergency equipment was available in emergency situations. Specifically, the facility failed to ensure expired emergency equipment and medications were removed and replaced to provide usable equipment in an emergency situation in three of three code carts (carts stocked with emergency medications and supplies) and two of two emergency department patient bays observed.

Findings include:

Facility policies

According to the Code Carts - Location, Cleaning, Inspection policy, the Code Carts are cleaned and checked monthly for outdated medications and supplies. Any outdated medications or supplies are to be removed from the cart at the time it is checked. The staff member that finds the outdates, is to give the items to the House Coordinator or Staff RN and request replenishment. b. The House Coordinator or Staff RN puts the outdated medications in the pharmacy outdate box and retrieves new stock to replace the outdate.

According to the Emergency Equipment and Supplies policy, nursing is responsible for the crash carts, the monthly checks, Pars and for out-dates and after each use to ensure the appropriate equipment and medications supplies are stocked on the cart in the ER and on the PCU.

1. The facility failed to ensure medical supplies and medications used in emergencies were ready for use in patients and were not beyond their expiration dates.

a. On 8/22/22 at 4:05 p.m., observations were conducted of the code cart in the patient care unit and revealed a medication vial of romazicon 0.5 mg/mL (a medication used to wake a patient up after a sedative was given for a surgery or medical procedure) with the expiration date of 7/22.

On 8/22/22 at 4:35 p.m., observations were conducted of the emergency department bays one and two. Observations of the code cart revealed an expired vial of Dobutamine (a medication used to treat severe heart failure) 250 mg/20 mL with the expiration date of 5/22. Additionally, a pediatric ambu bag (a bag used in an emergency to provide ventilation to the person not breathing normally) with the expiration date of 11/20/10 and a package of cardiac electrodes (a device that conducts electricity and was used to monitor the heart) with the expiration date of 8/10/22 were found on the boom (a structure suspended from the ceiling designed to organize and support hospital services such as electricity, oxygen and suction) next to the code cart.

On 8/24/22 at 3:10 p.m., observations were conducted of the code cart in the perioperative unit and revealed a vial of Methylprednisolone 80 mg/mL (a medication used to treat severe allergic reactions) with the expiration date of 5/22.

b. On 8/24/22 at 4:59 p.m., an interview was conducted with the director of nursing (DON) #1. DON #1 stated almost all packages had an expiration date printed on them. She further stated prior to the end of each month, the staff was expected to go through the code carts and check for expired medications and supplies. DON #1 further explained expired medications and supplies were expected to be removed and replaced with current medications and supplies. DON #1 stated the staff were expected to check for expired items in the patient and supply room cupboards and drawers in the patient care unit, emergency room bays, Pyxis (an automated medication dispensing system) and obstetrical room.

DON #1 then stated the Dobutamine vial was known to be expired, but the facility physicians requested that it remain in the emergency department code cart due to the medication being on national backorder. DON #1 stated the manufacturer or the facility pharmacist were not consulted about the decision or whether it would have been acceptable to use the medication past the expiration date.

Based on observations and interviews, the facility failed to ensure preventive maintenance (PM) for automated enzymatic solution (cleaner that helps break down bacteria on instruments used during surgery and on instruments used to visualize the inside of the body) dispensers occurred in accordance with manufacturer's instructions in two out of three dispensers observed.

Findings include:

References:

According to Steris (2022) Acu-sInQ Enzymatic Dosing System, retrieved from:
https://shop.steris.com/en/ca/manual-washing-dosing-systems/acu-sinq-enzymatic-dosing-system?fetchFacets=true#facet:&productBeginIndex:0&facetLimit:&orderBy:&pageView:EPP&minPrice:&maxPrice:&pageSize:&, the Equipment Considerations read, Steris's Acu-sInQ Enzymatic Dosing System is a manual washing dosing system requiring two preventive maintenance inspections annually with Inspection 1 requiring parts replacement.

According to the Equipment Management Plan (2022), all non-facility owned equipment is subject to the same requirements as any facility owned equipment and must either have appropriate service documentation provided by the entity providing the equipment, which could include the incoming inspection by that entity, or it must undergo an incoming inspection similar to the initial inspections performed on facility owned equipment.

After completing PM inspections on a device, Field Service Technicians attach a 'PM Due Date' sticker indicating the month and year when the next PM inspection for that device is due.

Any device found to have a due date sticker with a past due date will promptly be brought to the attention of the Field Service Technician so the issue can be resolved. The device should not be used until the issue is resolved except in the case of an emergency, and then the device should be monitored for proper operation.

1. The facility was unable to provide evidence that Steris Acu-sInQ Enzymatic Dosing Systems in the perioperative department were regularly maintenanced to ensure proper functioning.

a. During an observation of the soiled utility room in the perioperative department on 8/23/22 at 10:24 a.m., an interview was conducted with Certified Scrub Technician (CST) #17. CST #17 stated she did not know how to determine if the Steris Acu-sInQ Enzymatic Dosing System was functioning properly. CST #17 stated when a button was pressed, the machine dispensed a set amount of enzymatic solution into the sink where the dirty surgical instruments were soaked.

b. On 8/31/22 at 12:43 p.m., an observation occurred in the operating room's soiled utility room. No PM sticker was visualized on the Acu-sInQ Dosing System.

On 8/31/22 at 12:49 p.m., an observation occurred in the endoscope (instrument used to visualize inside the body) cleaning room. No PM sticker was visualized on the Acu-sInQ Dosing System.

This was in contrast with the Equipment Management Plan which read, after PM was completed, a PM Due Date sticker would be placed on the equipment that indicated the month and year when the next PM inspection was due.

c. On 8/31/22 at 5:02 p.m., an interview was conducted with Vice President of Surgical Services (VP) #19. VP #19 stated he was unable to locate the manufacturer's instructions for use (IFU) or any record that PM had been completed on either of the Acu-sInQ Dosing Systems. This was in contrast to Steris's Acu-sInQ Dosing System Equipment Considerations, which read the systems required two PM inspections yearly, with Inspection 1 requiring parts replacement.

This was also in contrast to the Equipment Management Plan, which read all non-facility owned equipment was subject to the same requirements as any facility owned equipment and must have the appropriate service documentation provided. Furthermore, the Equipment Management Plan read, any device in which the PM was past due should not be used until the issue was resolved except in the case of an emergency, and then the device should be monitored for proper operation.

Based on the manner and degree of the standard level deficiency referenced to the Condition, it was determined the Condition of Participation §485.627 Organizational Structure, was out of compliance.

C-0962 §485.627(a) Standard: Governing Body or Responsible Individual The CAH has a governing body or an individual that assumes full legal responsibility for determining, implementing and monitoring policies governing the CAH'S total operation and for ensuring that those policies are administered so as to provide quality health care in a safe environment. Based on observations, interviews, and document review, the governing body failed to ensure patient care services were provided in a safe manner and in accordance with professional standards of practice. Specifically the governing body failed to provide oversight in the following areas: quality assurance and performance improvement (QAPI), surgical services, credentialing and granting privileges to qualified providers and pharmaceutical services.

Based on observations, interviews, and document review, the governing body failed to ensure patient care services were provided in a safe manner and in accordance with professional standards of practice. Specifically the governing body failed to provide oversight in the following areas: quality assurance and performance improvement (QAPI), surgical services, credentialing and granting privileges to qualified providers and pharmaceutical services (Cross-reference C-0331, C-0336, C-1140, C-1144, C-1016).

Findings include:

Facility documents:

The Bylaws of the Board of Directors read, the day-to-day business and other affairs of the District and the Hospital shall be managed by the Chief Executive Officer, who shall serve at the direction of the board. The board shall have full power and authority to adopt policies and procedures for the operation of the Hospital. Additional duties and powers of the board include to determine which categories of health care practitioners are entitled to join the Hospital's Medical Staff and/or to exercise clinical privileges and to remove and approve medical staff appointments and reappointments and granting privileges to providers.

The board shall establish and maintain a quality management program for the hospital the provides for quality assurance and risk management activities. The quality management program shall be submitted to and approved by the board.

Facility policies:

The Quality and Regulatory Affairs Scope of Service read, the quality and regulatory affairs department is responsible for: Quality Improvement initiatives, activities, Council Meetings, oversight of data submission to various reporting agencies.

1. The governing board failed to provide oversight of the facility's QAPI program.

a. The facility was unable to provide evidence incident reports were evaluated and incorporated into the quality assurance program quality measures.

2. The governing board failed to ensure leadership oversight for the surgical services department.

a. Review of the facility's Organizational Chart, dated August of 2022, revealed the director of surgical services was a registered nurse. There was no further evidence on the Organizational Chart of a physician acting as director of the surgical services department.

b. Interviews with the director of surgical services (Director) #4 were conducted on 8/23/22 at 10:41 a.m. and 8/30/2022 at 2:27 p.m. Director #4 stated she began the role as director of surgical services in August of 2022. She explained the role included building up the surgery center in order to increase the number of surgeries performed, organize the processes and procedure of the department, and verify that equipment was functioning properly.

c. On 8/31/22 at 9:52 a.m., an interview with the vice president of surgical services (VP) #19 was conducted. VP #19 stated he also acted as the facility's chief financial officer (CFO). VP #19 verified that Director #4 was the current director of surgical services and explained that she reported to him. VP #19 stated he provided oversight of surgical services, however he did not have a history of a clinical background and relied on others for clinical information.

3. The governing board failed to ensure patients were provided care by qualified practitioners who were credentialed and appointed privileges.

a. Surgeon #16's credential file was reviewed and revealed Surgeon #16 had not been appointed privileges (the assessment and confirmation of the medical provider's qualifications) to perform surgery.

b. The credential file for Certified Registered Nurse Anesthetist (CRNA) #10 was reviewed and revealed CRNA #10 was not credentialed or appointed privileges at the facility.

c. Medical record reviews revealed several patients had surgery performed by Surgeon #16 and anesthesia administered by CRNA #10. Examples include:

i. On 5/24/22 Patient #16 had surgery performed. The surgery was performed by Surgeon #16 and anesthesia was administered to Patient #16 by CRNA #10.

ii. Patient #21 had surgery performed by Surgeon #16 on 8/23/22.

iii. On 6/16/22 CRNA #10 administered anesthesia to Patient #31 during surgery.

Similar findings of patient care administered by non-credentialed medical practitioners were found in the surgical records for Patients #13, #27, #28, #29, and #32.

d. On 8/25/22 at 9:10 a.m., an interview was conducted with Physician #18. Physician #18 stated he participated in the approval process for medical practitioners who applied to become credentialed and appointed privileges at the facility. Physician #18 stated the National Practioner Data Bank (NPDB) was used to check the medical background of all medical practitioners who applied for medical privileges. Physician #18 stated the NPDB listed legal actions and concerns which have occurred against a medical practitioner. Physician #18 stated the training, education and work history of medical practitioners were reviewed during the credentialing and appointment process to ensure the medical practitioner was qualified to provide patient care.

Physician #18 stated patients could experience harm when a medical practitioner cared for a patient and was not granted privileges at the facility.

4. The governing board failed to ensure oversight of pharmaceutical services.

a. On 8/30/22 at 1:02 p.m., an interview was conducted with Pharmacist #14. Pharmacist #14 stated his role was to process controlled medications (medications that may be abused or cause addiction) delivered from the wholesaler. Pharmacist #14 stated he inventoried the medications, put them into a locked cabinet, kept track of how much medication he had, and dispensed the medications to the units.

Additionally, Pharmacist #14 stated he was not responsible for ordering non-controlled medications, creating policies, monitoring antibiotic usage, monitoring for diversion of medications, and overseeing medications in the perioperative department. Pharmacist #14 further stated he was unsure of who verified the medications that were ordered by physicians.

Furthermore, Pharmacist #14 stated he was only responsible for his locked cabinet of controlled medications, and any questions related to other pharmacy services needed to be directed to Director of Nursing (DON) #1.

i. This interview was in contrast with the contractual agreement between Pharmacist #14 and the facility. Review of the Consulting Pharmacist Agreement revealed Pharmacist #14 would provide pharmacy consultation services to the hospital as required in State Board of Pharmacy Other Outlet Regulations. These duties included: Hospital visits as services were needed, call, protocol review, inventoried counts, ordered controlled substances which included appropriate documentation, was a consultant for pharmacy compliance, assisted with medication outdates, recalls, and he was to oversee the hospital's Other Outlet Pharmacies.

b. On 8/31/22 at 10:17 a.m., an interview was conducted with the director of nursing (DON) #1. DON #1 stated her role was also as a pharmacy lead, which would typically be done by a pharmacist or a pharmacy tech. DON #1 stated she was responsible for ordering and stocking medications that were not controlled and managing the formulary (list of medications used by the facility).

Additionally, DON #1 stated she had not been told she was in charge of monitoring for diversion with medications used in the perioperative department, had not signed a job description for the pharmacy lead position, and did not receive training for the role. DON #1 also stated Pharmacist #14 was ultimately responsible for pharmaceutical services.

Based on the manner and degree of the standard level deficiencies referenced to the Condition, it was determined the Condition of Participation: §485.635 Provision of Services was out of compliance.

C-1008 The policies are developed with the advice of members of the CAH's professional healthcare staff, including one or more doctors of medicine or osteopathy and one or more physician assistants, nurse practitioners, or clinical nurse specialists, if they are on staff under the provisions of §485.631(a)(1). These policies are reviewed at least biennially by the group of professional personnel required under paragraph (a)(2) of this section, and reviewed as necessary by the CAH. Based on interviews and document review, the facility failed to ensure policies were reviewed every two years to ensure safe management of patients.


46674

C-1016 Rules for the storage, handling, dispensation, and administration of drugs and biologicals. These rules must provide that there is a drug storage area that is administered in accordance with accepted professional principles, that current and accurate records are kept of the receipt and disposition of all scheduled drugs, and that outdated, mislabeled, or otherwise unusable drugs are not available for patient use. Based on observations, interviews, and record reviews, the facility failed to provide oversight of pharmaceutical services. In addition, the facility failed to ensure medications were handled in a way to prevent drug diversion (using a medication for a purpose other than its intended use). Also, the facility failed to ensure medications labeled as single dose were not being used for multiple dose administrations.

Based on interviews and document review the facility failed to ensure policies were reviewed every two years to ensure safe management of patients.

Findings include:

Facility policy:

The Policies policy read all policies of the hospital shall be reviewed at least annually and revised more frequently when required. Reviews shall be documented in the policy manuals.

1. The facility failed to review and revise policies pertaining to patient care.

a. Review of facility policies revealed numerous outdated policies which had not been reviewed or revised at least every two years. The outdated policies included:

i. The Crash Cart Check and Maintenance of Defibrillator policy was effective 3/2012. There was no date to indicate when the policy was reviewed or revised.

ii. The Incident Reports policy was reviewed last on 2/7/2020

iii. The Suicide Precautions policy was last revised on 12/8/2010.

iv The Care of Isolation Patient and Equipment policy became effective on 7/14/10. There was no date to indicate when the policy was reviewed or revised.

v. The Policies policy was last revised in 2019.

The lack of review of policies was in contrast to the policy which distinguished when policies were to be reviewed and revised. According to the Policies policy, all policies were to be reviewed and revised yearly.

b. On 8/31/22 at 11:32 a.m., an interview was conducted with the Chief Executive Officer (CEO) #6. CEO #6 stated the policies had not been updated and the facility had planned to review all policies by the end of the year.

c. On 8/30/22 at 8:13 a.m., an interview was conducted with the Director of Nursing (DON) #1. DON #1 stated policies were expected to be updated to make sure current processes were followed. DON #1 further stated if policies were not updated, there could be a risk to patients if the processes in the policy were not updated in accordance with best practice.

Based on observations, interviews, and record reviews, the facility failed to provide oversight of pharmaceutical services. In addition, the facility failed to ensure medications were handled in a way to prevent drug diversion (using a medication for a purpose other than its intended use). Also, the facility failed to ensure medications labeled as single dose were not being used for multiple dose administrations.

Findings include:

Facility policies:

The Drug Diversion policy read, the hospital is to stay abreast of trends, good or bad, within the healthcare industry and at the same time ensure patient safety. One of the "bad" areas is the need to monitor for, and identify early on, any drug diversion that is occurring within the facility. It is important to have a policy in place prior to any incidents in order to be proactive and avoid any problems or a delay in action, should an issue occur.

Questions, concerns, and advisement shall be directed to the Drug Diversion Management Team, COPIC, YDHC Legal Counsel and any other agencies that may help and offer direction.

Drugs are checked out to anesthesia as needed in a combination lock box and are written on the anesthesia drug count/waste documentation sheet. These sheets are signed by the CRNA and the RN and kept as part of the narcotic sheet record.

The Drugs, Biologicals, and Intravenous (IV) Medication Guidelines policy read, the hospital is to adhere to all State and Federal guidelines regarding the ordering, preparation, administration, and storage of all drug, biological or intravenous medications. Drugs and biologicals must be prepared and administered in accordance with accepted standards of practice and the manufacturer's recommendations.

Reference:

According to the American Society of health-System Pharmacists (ASHP) (2022) Guidelines on Preventing Diversion of Controlled Substances, retrieved from:
https://www.ashp.org/-/media/assets/policy-guidelines/docs/guidelines/preventing-diversion-of-controlled-substances.pdf?utm_campaign=Breaking%20News&utm_medium=email&_hsmi=2&_hsenc=p2ANqtz--1zrMdze6pXXOl5fPGM2rtiIqnwQmoHQs8E2d6sXJydglMkyyoO_xIH3gEzZbq-aL7s96ZpGlwDSTMq4tVIwIAMDLiQA&utm_content=2&utm_source=hs_email, the Guidelines on Preventing Diversion of Controlled Substances read, the organization's waste handling practices should maintain chain of custody to minimize the risk for diversion. Controlled substances should be wasted immediately or as close to the time of administration as possible.

1. The facility failed to provide oversight of pharmaceutical services.

a. On 8/30/22 at 1:02 p.m., an interview was conducted with Pharmacist #14. Pharmacist #14 stated his role was to process controlled medications (medications that may be abused or cause addiction) delivered from the wholesaler. Pharmacist #14 stated he inventoried the medications, put them into a locked cabinet, kept track of how much medication he had, and dispensed the medications to the units.

Additionally, Pharmacist #14 stated he was not responsible for ordering non-controlled medications, creating policies, monitoring antibiotic usage, monitoring for diversion of medications, and overseeing medications in the perioperative department. Pharmacist #14 further stated he was unsure of who verified the medications that were ordered by physicians.

Furthermore, Pharmacist #14 stated he was only responsible for his locked cabinet of controlled medications, and any questions related to other pharmacy services needed to be directed to Director of Nursing (DON) #1.

i. This interview was in contrast with the contractual agreement between Pharmacist #14 and the facility. Review of the Consulting Pharmacist Agreement revealed Pharmacist #14 would provide pharmacy consultation services to the hospital as required in State Board of Pharmacy Other Outlet Regulations. These duties included: Hospital visits as services were needed, call, protocol review, inventoried counts, ordered controlled substances which included appropriate documentation, was a consultant for pharmacy compliance, assisted with medication outdates, recalls, and he was to oversee the hospital's Other Outlet Pharmacies.

b. On 8/31/22 at 10:17 a.m., an interview was conducted with the director of nursing (DON) #1. DON #1 stated her role was also as a pharmacy lead, which would typically be done by a pharmacist or a pharmacy tech. DON #1 stated she was responsible for ordering and stocking medications that were not controlled and managing the formulary (list of medications used by the facility).

Additionally, DON #1 stated she had not been told she was in charge of monitoring for diversion with medications used in the perioperative department, had not signed a job description for the pharmacy lead position, and did not receive training for the role. DON #1 also stated Pharmacist #14 was ultimately responsible for pharmaceutical services.

2. The facility failed to ensure medications were properly stored, handled, and their usage documented to prevent diversion.

A. Storage

a. On 8/30/22 at 8:49 a.m., an observation occurred in the nurses' station located in the patient care unit (PCU). A cabinet with a code entry lock on the front was observed. Inside the cabinet was two shelves that held multiple cubbies, and each cubby was labeled with a different patient room number.

b. During the observation, Director of Nursing (DON) #1 was interviewed. DON #1 stated the syringes of left-over narcotic medications (medications used for pain relief that can cause addiction), such as Morphine and Hydromorphone (Dilaudid), were placed in the patients' cubby and kept for reuse for the remainder of the nurse's shift, instead of wasting the left-over narcotic at the time of use. DON #1 identified the practice relied on the registered nurses' (RN) ethics and morals to prevent diversion. This was in contrast to national standards of practice.

DON #1 identified this practice was implemented as a cost saving measure and also did not follow along with the manufacturer's instructions for use (IFU) for the medication.

c. On review of the IFU for Dilaudid, the safety instructions read, access to drugs with the potential for abuse such as Dilaudid injection presented an occupational hazard for addiction in the healthcare industry. Routine procedures for handling controlled substances developed to protect the public may not be adequate to protect health care workers. Implementation of more effective accounting procedures and measures to restrict access to drugs of this class may minimize the risk of self-administration by health care providers.

d. The facility was unable to provide any evidence the practice outlined by DON #1 followed the IFU, facility policy related to diversion, and current national standards on prevention of diversion, which read, the organization's waste handling practices should maintain chain of custody to minimize the risk for diversion. Controlled substances should be wasted immediately or as close to the time of administration as possible.

B. Handling and documentation

a. The Drug Diversion policy read, drugs were checked out to anesthesia as needed and documented on the anesthesia drug count/waste documentation sheet. The sheet was to be signed by both the certified registered nurse anesthetist (CRNA) and the registered nurse (RN) and kept as a part of the narcotic sheet record.

b. Review of Anesthesia Narcotic Tracking Forms revealed the requirements for documentation for the tracking and use of narcotics. The form identified an area for usage of drugs and included: date, patient name, the anesthesiologist and RN, and the beginning balance recorded in milliliters. The form required further documentation for each patient, and included the drug name, quantity of the drug and amount of the drug given.

At the bottom of the form was an area which required completion for tracking which included: total amount of medication taken from the vault, amount of medications returned to stock, total amount used for the day, amount added during the day, total waste signed by MD/RN, and ending balance.

c. Review of the Anesthesia Narcotic Tracking Forms revealed controlled medications given by the CRNA were only signed off as wasted by one staff member instead of the two required. Examples included:

i. On 3/22/22, two patients were identified to have received Propofol (medication used for sedation) and/or Fentanyl (medication used for pain relief). There was only one staff signature in one column, and it was unclear what medication or amount was cosigned as wasted or accounted for.

ii. On 4/21/22, one patient was identified to have received Fentanyl, Versed (medication used to decrease anxiety and induce sleepiness), Propofol, and Dilaudid (medication used for pain). There was only one staff signature in one column, and it was unclear what medication or amount was cosigned as wasted or accounted for.

iii. On 5/18/22, three patients were identified to have received Propofol, and one patient was identified to have received Propofol, Fentanyl, and Versed. There was only one staff signature in one column, and it was unclear what medication or amount was cosigned as wasted or accounted for.

iv. On 5/25/22, one patient was identified to have received Fentanyl, Versed, and Propofol. There was only one staff signature, and it was unclear what medication or amount was cosigned as wasted or accounted for.

v. On 6/29/22, four patients were identified to have received Propofol and/or Fentanyl. There was only one staff signature on the sheet. It is unclear what was cosigned as wasted or accounted for.

vi. On 8/10/22, three patients were identified to have received Propofol. There was no documentation of the total amount of medication that had been used for the day, if there was any medication wasted, or how much wasted medication had been signed by the MD or RN. Additionally, there were no signatures located on the form.

vii. On 8/17/22, four patients were identified to have received Propofol. One vial of Fentanyl was documented as checked out to the CRNA, however, there was no documentation of the medication being administered or wasted. Furthermore, there were no staff signatures located on the form.

d. On 8/30/22 at 2:27 p.m., an interview occurred with Interim Director of Surgical Services (Director) #4. Director #4 stated the usual process for wasting medications was to look at the Anesthesia Narcotic Tracking Form to see how much of the medication was given for each patient, and for the RN to waste the medication with the CRNA and document the waste on the form. Director #4 stated she did not see this process happening consistently. Furthermore, Director #4 stated there was no auditing or reconciliation process in effect to monitor for diversion in the perioperative department.

e. On 8/30/22 at 1:02 p.m., and interview occurred with Pharmacist #14. Pharmacist #14 stated he was unaware of how the perioperative department verified what medications had been given and he did not monitor for diversion. Pharmacist #14 also stated he had never overseen medications in the perioperative department.

3. The facility failed to ensure prefilled medication syringes labeled as single dose were not being used for multiple dose administrations.

a. On 8/30/22 at 10:29 a.m., an interview was conducted with Registered Nurse (RN) #13. RN #13 stated when a nurse used a prefilled syringe of Dilaudid or Morphine, a patient label would be placed on the syringe, which was then placed into the patient's cubby inside the locked cabinet located in the patient care unit (PCU). RN #13 also stated the same syringe of medication was used to administer additional doses of medication to the same patient during the nurse's shift.

Furthermore, RN #13 stated it was important not to reuse single dose medications because it was an infection risk that could introduce bacteria into the patient. RN #13 stated patients could die from infection if they developed sepsis (the body's response to an infection that can damage tissues and organs) or if the patient was immunocompromised (had a weakened immune system).

b. On 8/30/22 at 10:58 a.m., an interview was conducted with Registered Nurse (RN) #15. RN #15 stated it was not policy to keep single dose medications to be reused. RN #15 also stated it was the nurse's choice to do so. Additionally, RN #15 stated the integrity of the medication was verified if it remained in the original syringe, and from trust of the staff on the unit not to tamper with the medication while the medication was in the cubby.

Furthermore, RN #15 stated reusing single dose medications could cause a bacterial infection, increased treatment and care for the patient, as well as risk of sepsis and death.

c. On 8/31/22 at 10:17 a.m., an interview was conducted with Director of Nursing (DON) #1. DON #1 stated she was aware of how the prefilled Dilaudid and Morphine syringes were being used by the nurses. DON #1 stated if the patient was still present, the nurse kept the syringe of medication and used it throughout the rest of their shift to administer the medication to the same patient.

Additionally, DON #1 stated if staff were to waste the medication every time they gave 0.5 milliliters, the facility would not have enough of the medication in stock. DON #1 also stated cost and storage were the biggest factors for single use syringes of medications to be used to administer multiple doses.

This was in contrast to the Drugs, Biologicals, and IV Medication Guidelines policy which read, drugs and biologicals must be prepared and administered in accordance with accepted standards of practice and the manufacturer's recommendations.

According to the manufacturer's instructions for use (IFU) for Morphine sulfate and Dilaudid injections used at the facility, the notes section read, these products were for single dose only. The IFU also read not to use the medications if the outer packaging had been damaged.

d. On 8/30/22 at 1:02 p.m., an interview was conducted with Pharmacist #14. Pharmacist #14 stated preservatives (substances added to prevent a decrease in the quality of medications) were not appropriate for single dose medications to be used for multiple administrations.

Based on the manner and degree of the standard level deficiencies referenced to the Condition, it was determined the Condition of Participation: §485.638 Clinical Records was out of compliance.

C-1104 The records are legible, complete, accurately documented, readily accessible, and systematically organized. Based on record review and interviews, the facility failed to ensure handwritten documents in the medical record were accurately documented and legible for four of five surgical medical records reviewed.

Based on record review and interviews, the facility failed to ensure handwritten documents in the medical record were accurately documented and legible for four of five surgical medical records reviewed. (Patient #16, #18, #21, #22).

Findings include:

1. The facility failed to ensure patient history and physical examinations, surgical consents, and physician ordered operative requests were accurately documented and legible.

A. Medical record reviews revealed illegible documentation. Examples included:

a. On 8/24/22 at 3:19 p.m., Patient #22's medical record was reviewed with Registered Nurse (RN) #13. RN #13 was provided with Patient #22's handwritten Operative Request Form (documentation of interventions that needed to be completed in preparation for surgery). RN #13 stated she was unable to determine if the procedure type referenced on the form referred to "left" or "lateral."

RN #13 was also provided with Patient #22's handwritten History and Physical (H & P) Examination form (documentation of a patient's chief complaint, medical history, physical assessment, and identified needs). RN #13 was unable to read the section titled, "Head, Eyes, Ears, Nose, Throat" (HEENT). RN #13 stated she would need to ask the physician to verify what it said.

Additionally, RN #13 was provided with Patient #22's Surgical Consent form. When RN #13 was asked to verify what additional procedures were listed for Patient #22, she stated she was unable to read what it said because it was not legible.

b. Review of Patient #16's medical record revealed the following handwritten documents were illegible: Patient Consent form, Physician Office Clinic Note, medication prescriptions, post operative orders for pain medication and labs, and post operative special instructions.

c. Review of Patient #18's medical record revealed the following handwritten documents were illegible: Operative Request form, H & P Examination form, and Surgical Consent form.

d. Review of Patient #21's medical record revealed the following handwritten documents were illegible: Operative Request form, H & P Examination form, and Surgical Consent form.

B. Interviews

a. On 8/23/22 at 10:54 a.m., an interview was conducted with Interim Director of Surgical Services (Director) #4. Director #4 stated the orders from the surgeon were often unreadable. Director #4 stated staff had difficulty verifying correct surgeries, correct patients, and were often unable to verify the type of anesthesia and medications the surgeon required for use during surgeries.

Furthermore, Director #4 stated patients could be harmed if these documents were not legible. Director #4 stated if staff were not able to correctly read these documents, patients could have surgery performed on the wrong site, surgery could be performed on the wrong patient, or a patient could have the wrong surgery performed. Director #4 also stated a patient could be misdiagnosed (diagnosing a patient with a condition they do not have) if a patient had the wrong area of their body resected (removal of tissue or part of an organ), which could lead to increased risk of infection, inability for a patient to perform activities of daily living (skills required to care for oneself), patients could have disabling mental effects, or patients could be disfigured.

b. On 8/31/22 at 2:48 p.m., Patient #22's medical record was reviewed with Chief Executive Officer (CEO) #6. CEO #6 was provided with Patient #22's Operative Request form. CEO #6 stated it was difficult to read the physician's request and staff were not supposed to interpret it.

CEO #6 was also provided with Patient #22's H & P Examination form. CEO #6 stated the Certified Registered Nurse Anesthetist (CRNA) needed the information in this form to care for the patient. CEO #6 also stated this form would be used by the preoperative and postoperative nurses to help identify assessment needs for patients. Additionally, CEO #6 stated she was not able to read the H & P Examination form.

In addition, CEO #6 was provided with Patient #22's Surgical Consent form. CEO #6 stated she was not able to fully read the form. CEO #6 stated the information on the consent form would be used by operating room staff during their time-out (short pause before the incision to confirm the correct procedure and patient).

Furthermore, CEO #6 stated illegible handwriting had been brought to her attention and having legible handwritten documents was important to be able to verify all care a patient was to receive.

Based on the manner and degree of the standard level deficiency referenced to the Condition, it was determined the Condition of Participation: §485.639 Condition of Participation: Surgical Services was out of compliance.

C-1140 Condition of Participation: Surgical Services. If a CAH provides surgical services, surgical procedures must be performed in a safe manner by qualified practitioners who have been granted clinical privileges by the governing body, or responsible individual, of the CAH in accordance with the designation requirements under paragraph (a) of this section. Based on observations, interviews and document review, the facility failed to ensure state regulations were followed and that the surgical services department was involved in a quality project and review to ensure surgical services were provided in a safe manner. (Cross Reference C-331). In addition, the facility failed to ensure surgical site infections were tracked and monitored. (Cross Reference C-1208)

C-1144 (1) A qualified practitioner, as specified in paragraph (a) of this section, must examine the patient immediately before surgery to evaluate the risk of the procedure to be performed. (2) A qualified practitioner, as specified in paragraph (c) of this section, must examine each patient before surgery to evaluate the risk of anesthesia. (3) Before discharge from the CAH, each patient must be evaluated for proper anesthesia recovery by a qualified practitioner, as specified in paragraph (c) of this section. Based on document review and interviews, the facility failed to ensure patient assessments prior to surgery were completed and conducted by qualified practitioners in eight of 11 surgical patients reviewed.

(C-1140) §485.639 Condition of Participation: Surgical Services. If a CAH provides surgical services, surgical procedures must be performed in a safe manner by qualified practitioners who have been granted clinical privileges by the governing body, or responsible individual, of the CAH in accordance with the designation requirements under paragraph (a) of this section.

Based on observations, interviews and document review, the facility failed to ensure state regulations were followed regarding oversight of the perioperative department. In addition, the facility failed to ensure the surgical services department was involved in a quality project and review to ensure surgical services were provided in a safe manner. (Cross Reference C-331) Also, the facility failed to ensure surgical site infections were tracked and monitored. (Cross Reference C-1208)

Findings include:

References:

According to Chapter 4 of the Department of Public Health and Environment Health Facilities and Emergency Medical Services Division Standards for Hospitals and Health Facilities, Part 24.2 read surgical and recovery services shall be directed by a physician qualified by education, training, competencies, and experience.

According to the National Healthcare Safety Network (NHSN) Surgical Site Infection Event Guidelines (2022) retrieved from: https://www.cdc.gov/nhsn/pdfs/pscmanual/9pscssicurrent.pdf, the following requirements were listed: Perform surveillance for SSI following at least one NHSN operative procedure category (using the associated NHSN operative procedure codes) as indicated in the Patient Safety Monthly Reporting Plan (CDC 57.106). Collect SSI event (numerator) and operative procedure (denominator) data on all procedures included in the selected operative procedure categories indicated on the facility ' s monthly reporting plan. All procedures included in the NHSN monthly surveillance plan are followed for superficial incisional, deep incisional, and organ/space SSI events and the type of SSI reported must reflect the deepest tissue level where SSI criteria are met during the surveillance period. Events meeting SSI criteria are reported to NHSN regardless of noted evidence of infection at time of surgery. An SSI event is attributed to the facility in which the NHSN operative procedure is performed.

1. The facility failed to ensure physician oversight of the surgical services department.

a. Review of the facility's Organizational Chart, dated August of 2022, revealed the director of surgical services was a registered nurse. There was no further evidence on the Organizational Chart of a physician acting as director of the surgical services department.

b. Review of the director of surgical services (Director) #4's personnel file revealed her registered nurse license number and a signed job description dated 7/19/22. There was no evidence in the file of any education or training done for conducting the role of director of surgical services.

c. Interviews with the director of surgical services (Director) #4 were conducted on 8/23/22 at 10:41 a.m. and 8/30/2022 at 2:27 p.m. Director #4 stated she began the role as director of surgical services in August of 2022. She explained the role included building up the surgery center in order to increase the number of surgeries performed, organize the processes and procedures of the department, and verify that equipment was functioning properly.

d. On 8/31/22 at 9:52 a.m., an interview with the vice president of surgical services (VP) #19 was conducted. VP #19 stated he also acted as the facility's chief financial officer (CFO). VP #19 verified that Director #4 was the current director of surgical services and explained that she reported to him. VP #19 stated he provided oversight of surgical services, however he did not have a history of a clinical background and relied on others for clinical information.

2. The facility failed to ensure the surgical services department conducted quality projects and reviews to ensure the safety of patients.

a. Review of the Surgery Team Meeting Minutes on 8/9/22 revealed the director of surgical services reported the surgical department was in need of a quality study. The director reported the department would conduct a study of the start times of the first procedure of the day to determine if there was an issue of doctors arriving late to the facility.

There was no further documentation noted about if the project had started, what the quality indicators were or how the progress of the project was being measured.

b. On 8/31/22 at 3:24 p.m., an interview with the quality director (Director) #5 was conducted. Director #5 stated her responsibilities included running the quality program throughout the facility. Director #5 stated each department was responsible to develop a yearly quality project, which included creating quality indicators and quality measures for each project. Director #5 then stated the surgical services department had not been reporting their quality project process to the quality department since the prior director or surgical services had resigned.

i. The Governing Board meeting minutes documented the director of surgical services had resigned after the board meeting dated 12/6/21.

3. The facility failed to ensure SSI were tracked in patients following surgical procedures.

a. Review of Patient #26's medical record revealed he was admitted to the facility on 5/5/22 for a right total hip replacement surgical procedure due to osteoarthritis (tissues in the joint that break down over time). On 5/6/22 at 7:09 a.m., Patient #26's hip dressing was documented as being clean, dry, and intact. Patient #26 was discharged from the facility on 5/6/22 at 10:12 a.m.

Medical record review also revealed on 5/9/22 at 12:23 p.m., four days after the surgery, a post operative phone call was made to Patient #26 from RN #20. Patient #26's surgical site was documented as being free of redness, swelling, or drainage, and his dressing was documented as being clean, dry, and intact. There was no evidence in the medical record of any further follow up done by the facility.

In addition, record review revealed Patient #26 had a follow up appointment scheduled with his physician on 5/19/22 at 11:45 a.m. On 5/22/22 at 9:10 a.m., Patient #26 was prescribed Bactrim (an antibiotic).

b. An incident report regarding the surgery dated 5/5/22 was reviewed and revealed the facility had been notified by Patient #26's physician that he had a wound infection. Patient #26 had required a wound debridement (removal of damaged tissue), explant (removal) of prosthesis (artificial object placed in the body during surgery), and spacers (device used to maintain space between two parts) had been placed.

c. On 8/23/22 at 10:41 a.m., an interview was conducted with the Interim Director of Surgical Services (Director) #4. Director #4 stated the facility did not have a process in place to track surgical site infections in patients after surgery. Director #4 also stated surgical patients followed up with surgeons in their offices, with their primary care providers, or in the clinic at the facility.

In addition, Director #4 stated the surgical staff at the facility conducted calls to patients the day after surgery and inquired about symptoms such as fever, incision redness, or drainage. Director #4 also stated after this post operative call, she had no way of knowing if a surgical patient had a SSI.

d. On 8/25/22 at 12:20 p.m., an interview was conducted with the infection prevention (IP) registered nurse (RN) #3. RN #3 stated information about patient infections was obtained from patients' providers. RN #3 also stated if staff were concerned about an infection in a patient in the patient care unit (PCU), the staff were trained to email, or call, to notify her or Chief Executive Officer (CEO) #6.

e. On 8/25/22 at 3:03 p.m. an interview was conducted with the Director of Quality and Regulatory (Director) #5. Director #5 stated the facility had not implemented a process for specifically tracking surgical site infections in post-surgical patients.

This was in contrast to the National Healthcare Safety Network Surgical Site Infection Event Guidelines which read the facility was to collect SSI event data on all procedures included in the selected operative procedure categories indicated on the facility's monthly reporting plan.

Based on document review and interviews, the facility failed to ensure patient assessments prior to surgery were completed and conducted by qualified practitioners in eight of 11 surgical patients reviewed. (Patients #13, #16, #21, #27, #28, #29, #31 and #32)

Findings include:

References:

The Scope of Surgical Services read that patients can expect appropriate procedures, treatments, interventions and care based on patient assessments, re-assessments, and desired outcomes.

The Bylaws of the Medical Staff read, Medical Staff privileges shall be extended to professionally competent physicians and advanced practice nurses who meet the qualifications, standards, and requirements set forth in these Bylaws and Medical Staff Documents. Clinical privileges shall be granted in accordance with prior and continuing education, training, experience, and demonstrated current competence and judgment. Continued Medical Staff privileges, appointments and credentials are dependent upon continuously meeting the qualifications, standards, and requirements set forth in the Medical Staff Bylaws and Medical Staff Documents.

1. The facility failed to ensure pre-operative patient assessments were performed immediately before surgery to evaluate the risk of the surgical procedure performed.

a. Review of Patient #16's medical record revealed on 5/24/22 at 10:02 a.m., Patient #16 underwent a left lower leg incision and drainage (I&D) conducted by Surgeon #16. There was no evidence that Surgeon #16 had physically examined or evaluated Patient #16 immediately prior to surgery.

b. Review of Patient 21's record revealed on 8/23/22 at 9:00 a.m., Patient #21 had a lesion excised (the surgical removal of abnormal tissue) on his upper left arm conducted by Surgeon #16. There was no evidence a physical examination had been performed by Surgeon #16 immediately prior to the surgical procedure.

c. An interview was conducted on 8/24/22 at 3:19 p.m. with Registered Nurse (RN) #13. RN # 13 stated she provided care to patients in the Operating Room (OR). RN #13 stated patients were physically expected to be assessed by the surgeon prior to surgery. RN #13 further stated that patient assessments were performed to ensure the patient was safe to proceed with surgery and to ensure any medical conditions were reviewed. RN #13 stated patients were at risk for harm when patients were not assessed by the surgeon prior to surgery.

d. On 8/23/22 at 10:41 a.m., an interview was conducted with Interim Director of Surgical Services (Director #4). Director #4 stated she was aware that patient assessments were absent, incomplete, illegible or not reviewed and updated on the day of surgery in some medical records. Director #4 stated patient harm could occur when patients had unassessed pre-existing medical conditions. Director #4 stated unassessed medical conditions would affect the surgical course and treatment for the patient.

2. The facility failed to ensure the medical practitioners who conducted patient assessments prior to surgical procedures were credentialed, appointed privileges, and deemed qualified medical practitioners.

a. Surgeon #16's credential file was reviewed and revealed Surgeon #16 had not been appointed privileges (the assessment and confirmation of the medical provider's qualifications) to perform surgery.

b. The credential file for Certified Registered Nurse Anesthetist (CRNA) #10 was reviewed and revealed CRNA #10 was not credentialed or appointed privileges at the facility.

c. Medical record reviews revealed several patients had surgery performed by Surgeon #16 and anesthesia administered by CRNA #10. Examples include:

i. On 5/24/22 Patient #16 had surgery performed. The surgery was performed by Surgeon #16 and anesthesia was administered to Patient #16 by CRNA #10.

ii. Patient #21 had surgery performed by Surgeon #16 on 8/23/22.

iii. On 6/16/22 CRNA #10 administered anesthesia to Patient #31 during surgery.

Similar findings of patient care administered by non-credentialed medical practitioners were found in the surgical records for Patients #13, #27, #28, #29, and #32.

d. On 8/25/22 at 9:10 a.m., an interview was conducted with Physician #18. Physician #18 stated he participated in the approval process for medical practitioners who applied to become credentialed and appointed privileges at the facility. Physician #18 stated the National Practioner Data Bank (NPDB) was used to check the medical background of all medical practitioners who applied for medical privileges. Physician #18 stated the NPDB listed legal actions and concerns which have occurred against a medical practitioner. Physician #18 stated the training, education and work history of medical practitioners were reviewed during the credentialing and appointment process to ensure the medical practitioner was qualified to provide patient care.

Physician #18 stated patients could experience harm when a medical practitioner cared for a patient and was not granted privileges at the facility.

e. On 8/25/22 at 2:39 p.m., an interview was conducted with Director of Quality and Regulatory (Director) #5. Director #5 stated medical practitioners were responsible for the care and treatment of patients at the facility. Director #5 stated medical practitioners were required to apply for medical privileges and credentials to provide patient care and perform medical procedures. Director #5 stated medical practitioners were credentialed and deemed qualified to provide patient care after the practitioner's training, education and experience were verified. Director #5 stated the credential and appointment process ensured medical practitioners provided safe and competent patient care. Director #5 stated patients were at risk for loss of life and limb when provided care by non-credentialed medical practitioners.

Based on the manner and degree of the standard level deficiency referenced to the Condition, it was determined the Condition of Participation: §485.640 Infection Prevention and Control and Antibiotic Stewardship Programs, was out of compliance.

C-1208 §485.640(a)(3) The infection prevention and control includes surveillance, prevention, and control of HAIs, including maintaining a clean and sanitary environment to avoid sources and transmission of infection, and that the program also addresses any infection control issues identified by public health authorities. Based on observation, interview, and document review, the facility failed to ensure nationally recognized infection prevention and control guidelines were implemented to control and monitor the transmission of healthcare acquired infections (HAIs). Specifically, the facility failed to evaluate surgical procedures for post-operative surgical site infections (SSI) and healthcare acquired infections (HAIs) according to nationally recognized infection prevention and control guidelines. Additionally, the facility failed to ensure opened suction equipment was disposed of after each patient encounter in suction devices observed in two of two emergency department patient bays.

Based on observation, interview, and document review, the facility failed to ensure nationally recognized infection prevention and control guidelines were implemented to control and monitor the transmission of healthcare acquired infections (HAIs). Specifically, the facility failed to evaluate surgical procedures for post-operative surgical site infections (SSI) and healthcare acquired infections (HAIs) according to nationally recognized infection prevention and control guidelines. Additionally, the facility failed to ensure opened suction equipment was disposed of after each patient encounter in suction devices observed in two of two emergency department patient bays.

Findings include:

References:

According to the National Healthcare Safety Network (NHSN) Surgical Site Infection Event Guidelines (2022) retrieved from: https://www.cdc.gov/nhsn/pdfs/pscmanual/9pscssicurrent.pdf, the following requirements were listed: Perform surveillance for SSI following at least one NHSN operative procedure category (using the associated NHSN operative procedure codes) as indicated in the Patient Safety Monthly Reporting Plan (CDC 57.106). Collect SSI event (numerator) and operative procedure (denominator) data on all procedures included in the selected operative procedure categories indicated on the facility's monthly reporting plan. All procedures included in the NHSN monthly surveillance plan are followed for superficial incisional, deep incisional, and organ/space SSI events and the type of SSI reported must reflect the deepest tissue level where SSI criteria are met during the surveillance period. Events meeting SSI criteria are reported to NHSN regardless of noted evidence of infection at time of surgery. An SSI event is attributed to the facility in which the NHSN operative procedure is performed.

According to the Cardinal Health manufacturer packaging for yankauers (a suction catheter used in medical procedures), the device was labeled single use only, do not use if package opened or damaged.

1. The facility failed to ensure SSI were tracked in patients following surgical procedures.

a. Review of Patient #26's medical record revealed he was admitted to the facility on 5/5/22 for a right total hip replacement surgical procedure due to osteoarthritis (tissues in the joint that break down over time). On 5/6/22 at 7:09 a.m., Patient #26's hip dressing was documented as being clean, dry, and intact. Patient #26 was discharged from the facility on 5/6/22 at 10:12 a.m.

The medical record also revealed, on 5/9/22 at 12:23 p.m., a post operative phone call was made to Patient #26 from RN #20. Patient #26's surgical site was documented as being free of redness, swelling, or drainage, and his dressing was documented as being clean, dry, and intact. There was no evidence in the medical record of any further follow up done by the facility.

In addition, record review revealed Patient #26 had a follow up appointment scheduled with his physician on 5/19/22 at 11:45 a.m. On 5/22/22 at 9:10 a.m., Patient #26 was prescribed Bactrim (an antibiotic).

b. An incident report dated 5/5/22 at 8:00 a.m. was reviewed and revealed the facility had been notified by Patient #26's physician that he had a wound infection. Patient #26 had required a wound debridement (removal of damaged tissue), explant (removal) of prosthesis (artificial object placed in the body during surgery), and spacers (device used to maintain space between two parts) had been placed.

c. On 8/23/22 at 10:41 a.m., an interview was conducted with the Interim Director of Surgical Services (Director) #4. Director #4 stated the facility did not have a process in place to track surgical site infections in patients after surgery. Director #4 also stated surgical patients followed up with surgeons in their offices, with their primary care providers, or in the clinic at the facility.

In addition, Director #4 stated the surgical staff at the facility conducted calls to patients the day after surgery and inquired about symptoms such as fever, incision redness, or drainage. Director #4 also stated after this post operative call, she had no way of knowing if a surgical patient had a SSI.

d. On 8/25/22 at 12:20 p.m., an interview was conducted with the infection prevention (IP) registered nurse (RN) #3. RN #3 stated information about patient infections was obtained from patients' providers. RN #3 also stated if staff were concerned about an infection in a patient in the patient care unit (PCU), the staff were trained to email, or call to notify her or the Chief Executive Officer (CEO) #6.

e. On 8/25/22 at 3:03 p.m. an interview was conducted with the Director of Quality and Regulatory (Director) #5. Director #5 stated the facility had not implemented a process for specifically tracking surgical site infections in post-surgical patients.

This was in contrast to the National Healthcare Safety Network Surgical Site Infection Event Guidelines which read the facility was to collect SSI event data on all procedures included in the selected operative procedure categories indicated on the facility ' s monthly reporting plan.

2. The facility failed to ensure opened suction equipment was disposed of after each patient encounter.

a. On 8/22/22 at 4:35 p.m., observations were conducted in the emergency department patient bays one and two. Observations revealed yankauers (suction tips) and tubings were attached to suction devices located on the booms (structures suspended from the ceiling designed to organize and support hospital services such as electricity, oxygen and suction) and were outside of their original packaging.

This was in contrast to the manufacturer packaging for yankauers which read the device was single use only and not to be used if the package had been opened or damaged.

b. On 8/24/22 at 4:59 p.m. an interview was conducted with Director of Nursing (DON) #1. DON #1 stated suction tubing was for single-patient use only and not changed out between patients unless it was used on a patient. DON #1 also stated there was a risk of contamination (making something dirty by coming into contact with something unclean) and an infection risk to patients if opened suction devices were not changed between patients.

(C-0330) §485.641 Condition of Participation: Periodic Evaluation and Quality Assurance Review.

Based on the manner and degree of the standard level deficiency referenced to the Condition, it was determined the Condition of Participation §485.641 Periodic Evaluation and Quality Assurance Review was out of compliance.

C-0336 Standard: Quality Assurance. The CAH has an effective quality assurance program to evaluate the quality and appropriateness of the diagnosis and treatment furnished in the CAH and of the treatment outcomes. Based on interviews and record review, the facility failed to establish a quality assurance program to evaluate quality and appropriateness of diagnosis and treatment furnished at the facility. Specifically, the facility failed to ensure reported incidents were evaluated and incorporated into the quality assurance program to improve quality measures in four of four occurrence reports reviewed.

C-0336 §485.641(b) Standard: Quality Assurance The CAH has an effective quality assurance program to evaluate the quality and appropriateness of the diagnosis and treatment furnished in the CAH and of the treatment outcomes.

Based on interviews and record review, the facility failed to establish a quality assurance program to evaluate quality and appropriateness of diagnosis and treatment furnished at the facility. Specifically, the facility failed to ensure reported incidents were evaluated and incorporated into the quality assurance program to improve quality measures in four of four occurrence reports reviewed.

Findings include:

1. The facility failed to ensure incidents were evaluated and incorporated into the quality assurance program quality measures.

A. On 8/25/22 at 2:39 p.m., a review of facility occurrence reports was conducted with the director of quality and regulatory (Director) #5 and revealed a lack of follow up occurred after the incident. For example:

a. Review of an incident report dated 8/25/21 revealed during a colonoscopy procedure (a procedure in which an instrument is used to visualize the inside of the colon), the patient's bowel was perforated. The patient was transferred to a different facility to receive a higher level of care. There was no documentation that the incident report had been reviewed by risk management.

During the review of the occurrence report, Director #5 stated the occurrence was logged only, with no follow-up. Director #5 also stated she did talk to a physician to have the case reviewed, but he did not feel investigation was warranted because perforation was a risk of having a colonoscopy.

b. Review of an incident report dated 8/11/22 revealed an occurrence involving a fall sustaining fractures (break in the bone) to the leg from assisting an unsteady family member without staff assistance.

During the review of the occurrence report, Director #5 reported an incident report was completed with no follow-up documented. Director #5 further stated no process improvements were implemented to ensure the incident did not reoccur.

c. Review of an incident report dated 5/24/22 revealed an occurrence involving intubation (a procedure to insert a tube down into the lungs to help with breathing) and extubation (a procedure to remove a tube from the lungs no longer required to help with breathing) twice after a procedure ultimately leading to a transfer to another facility for a higher level of care.

During the review of the occurrence report, Director #5 stated the occurrence report was logged but there was no investigation or follow-up regarding the occurrence.

d. Review of an occurrence report dated 8/18/21 revealed a patient aspirated (when something enters the airway or lungs by accident) during a colonoscopy.

During the review of the occurrence report, Director #5 reported there was not a process in place to ensure the incident did not happen in the future. Furthermore, Director #5 stated her responsibility included to oversee that occurrences were identified and to identify steps so it would not happen again. Director #5 further stated the surgery department was not tracking occurrences.