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Based on interview and record review, the facility failed to ensure the informed consent (IC, the process in which a health care provider educates a patient about the risks, benefits, and alternatives of a given procedure or intervention) was completed without using abbreviations in describing the procedure for one of 30 sampled patients (Patient 11), in accordance with the facility's policy and procedure regarding consents.

This deficient practice had the potential for Patient 11 not to understand the meaning in the abbreviated context and violated Patient 11's Right (Patient rights are fundamental human rights that allow patients to demand respectful and ethical treatment from healthcare providers. These rights are based on legal and professional obligations to uphold confidentiality, informed consent, and quality care) to be informed of the procedure in order to make "informed" decision.

Findings:

During a review of Patient 11's History and Physical (H&P, the most formal and complete assessment of the patient and the problem), dated 8/9/2024, the H&P indicated, on 8/9/2024, Patient 11 was transferred to the facility for expedited liver transplant (a surgical procedure that replaces a diseased or damaged liver with a healthy liver from a donor) evaluation. The H&P further indicated, Patient 11 had past medical history (PMH, records information about the patient's medical, personal and family history that might be relevant to the presenting illness) of severe alcohol abuse disorder, renal failure (RF, a condition in which the kidneys stop working and are not able to remove waste and extra water from the blood or keep body chemicals in balance) and was on a ventilator (a machine or device used medically to support or replace the breathing of a person who is ill).

During a concurrent interview and record review on 8/21/2024 at 9:42 a.m. with assistant nurse manager (ANM 4), Patient 11's medical record (MR) titled, "Informed Consent for Continuous Renal Replacement Therapy (techniques that manage solute [a substance dissolved in a solution] removal and fluid balance over 24 hours)," was reviewed. The MR indicated, the anatomical location (vascular access site, a surgically created opening in the skin and a blood vessel that allows access to the bloodstream) was documented as follows: "R IJ Perma Cath." The ANM 4 stated, "R IJ Perma Cath" is an abbreviated terminology for "right internal jugular (vein) permanent catheter (a flexible tube that is inserted into a blood vessel in the neck vein)." The ANM 4 then reviewed the policy titled, "Consents: Obtaining and Verifying," dated 5/23/2024, and stated, per the facility's policy, no abbreviations should be used in describing the procedure on the informed consent form because patients may not understand them.

During a review of the facility's policy and procedure (P&P) titled, "Consents: Obtaining and Verifying," dated 5/23/2024, the P&P indicated, 'It is the responsibility of the provider to obtain and document informed consent. The medical terminology describing the procedure should be entered into the space provided on the form. No abbreviations should be used in describing the operation or procedure. A description of the operation or procedure in lay terminology (simple, everyday terms that are used to communicate with laypeople, who are people who are not part of a particular profession) should be entered by the provider in the space provided."

Based on interview and record review, the facility failed to ensure that a comprehensive care plan (provides a framework for evaluating and providing patient care needs related to the nursing process) addressing pain was developed upon admission for one of thirty (30) sampled patients (Patient 9).

This deficient practice had the potential to result in the delayed provision of care to Patient 9 by not identifying patient's needs and risks, which may result in worsening pain for Patient 9.

Findings:

During a review of Patient 9's History and Physical (H&P, the most formal and complete assessment of the patient and the problem), dated 8/19/2024, the H&P indicated, Patient 9 was admitted to the facility on 8/19/2024 due to leakage from a previous surgical wound. The H&P further indicated, Patient 9 required to undergo wound dehiscence (a partial or total separation of previously approximated wound edges, due to a failure of proper wound healing) repair.

During a review of Patient 9's medical record (MR) titled, "Informed Consent (a process in which a healthcare provider educates a patient about a medical procedure, treatment, or intervention, and the patient then decides whether to undergo it)," dated 8/20/2024, the MR indicated, on 8/20/2024, Patient 9 underwent posterior (the back of a structure) cervical (relating to the neck) wound revision with possible duraplasty (a medical procedure that involves repairing or expanding the dura, the outer covering of the brain, when it has been cut during surgery), and possible lumbar (refers to the lower spine) drain (a small, flexible tube that's inserted into the lower back to drain cerebrospinal fluid [CSF, a watery colorless liquid that protects and nourishes the brain and the spinal cord] from the spinal column).

During further review of Patient 9's MR titled, "Medication Administration Record (MAR)," dated 8/21/2024, the MR indicated, on 8/21/2024, Patient 9 had two documented complaints of severe pain, for which Patient 9 was treated with hydromorphone (narcotic analgesic, that acts on the central nervous system to relieve pain) administration.

During a concurrent interview and record review on 8/21/2024 at 10:00 a.m. with the assistant nurse manager (ANM 4), Patient 9's MR titled, "Interprofessional Plans of Care," dated 8/20/2024, was reviewed. The MR contained no documentation of nursing care plan developed to address Patient 9's pain. The ANM stated, nursing care plans are developed to address patient's needs and is initiated to establish a plan of care to address identified patient's needs. The ANM stated, nursing staff did not develop a care plan to guide nurses in addressing Patient 9's post-operative (after surgical procedure) pain.

During a review of the facility's policy and procedure (P&P) titled, "Interprofessional Plan of Care (IPOC) Guidelines for Completion and Use," dated 7/12/2022, the P&P indicated, "All members of the interprofessional team involved in the care of the patient are responsible for contributing to the IPOC throughout the continuum of care. The IPOC is individualized and based upon actual or potential problems, anticipated length of stay, assessed needs, policies, patient care standards, cultural issues, available resources and will be consistent with other therapies and/or disciplines. Expected patient outcomes and/or goals will be realistic and measurable. The IPOC, including problems, interventions, and outcomes will be reviewed at least every 24 hours and updated as patient progress indicates."

Based on observation, interview and record review, the facility failed to:

1. Ensure that during an invasive surgical procedure (a medical procedure that invades [enters] the body, usually by cutting or puncturing the skin or by inserting instruments into the body) all stages of the counting process of sharps, soft goods, instruments, and surgical items used during two (2) of 30 sampled patients (Patient 1 and Patient 18) were documented in accordance with the facility policy and procedure regarding counts.

This deficient practice had the potential to result in incorrect assessments of counts that were carried out during the procedures, which can cause confusion and incorrect counting of surgical items, endangering patient safety as well as the general effectiveness of surgical procedures.

2. Ensure patients' health safety requirements are met when the isolation sign (placed outside the doors of hospital patient rooms to indicate that the patient is under isolation precautions) was not placed outside one of 30 sampled patients (Patient 6) room to indicate that Patient 6 was in contact isolation precautions (germs can be spread through direct or indirect contact with the patient or their environment) in accordance with the facility's policy and procedure regarding isolation precautions.

This deficient practice had the potential for staff to spread germs to other patients, visitors, and healthcare workers not knowing that Patient 6 was in isolation room and not knowing what type of isolation precautions (different types of isolation precautions protect against different types of germs) to implement.

Findings:

1. a. During a review of Patient 1's "History and Physical (H&P, the most formal and complete assessment of the patient and the problem)," dated 10/10/2023, the "H&P" indicated that Patient 1 was admitted to the facility after RHC (Right Heart Catheterization, pulmonary artery catheterization, an invasive procedure that can provide direct measurement of pressures in the heart)." The H&P further indicated, "On baseline (an initial measurement of a condition that is taken at an early time point and used for comparison over time to look for changes), the patient says his exercise tolerance has worsened over the past several months." The H&P indicated under assessment and plan: "Now undergoing advanced therapy evaluation."

During a review of Patient 1's "Disclosure Note," dated 11/9/2023, the note indicated that Patient 1 "underwent LVAD (left ventricular assist device is implanted in the chest, helps pump blood from the lower left heart chamber to the rest of the body) placement yesterday. As the operation was nearing conclusion, we noted that our lap sponge count was off by one. We immediately called for a chest x-ray (diagnostic using energy beams to produce images), and upon review of the film by (Surgeon 1 name), we decided to reopen the chest to retrieve what appeared to be one of the lap sponges used during LVAD implantation to appropriately position the heart. Shortly after opening the sternum (a long flat bone that forms the center front of the chest wall), we discovered the lap sponge behind the heart and removed it prior to closing the chest again."

During an interview on 8/20/2024 at 12:27 p.m. with the Director of the Main Operating Room (DOR) in operating room 8, the DOR stated, "If the surgery was an open-heart surgery that requires opening the sternum, there should be four times when counting should be done."

During a concurrent interview and record review on 8/20/24 at 3:00 p.m. with the DOR, Patient 1's intraoperative (occurring or performed during the course of a surgical operation) note titled "Operative (name of facility) Main OR record," dated 11/8/2023, was reviewed. The report indicated, on 11/8/2023, for surgical item counts, there were three times when a count was completed:
The first count was a Baseline/Initial count (initial count preferably performed prior to patient's arrival into the OR but must be performed prior to incision; to establish a baseline of surgical items [soft goods], needles, sharps, instruments, miscellaneous items).
The second count was a Closing Count (a count of all soft goods, needles, sharps, instruments, and miscellaneous items to be performed when wound closure begins), which was documented as "correct (correct number of sponges and/or surgical instruments) and
The Final Count (count of all soft goods, needles, sharps, and miscellaneous items to be performed when the skin is closed and when counted items are no longer being used), which was documented as "Sponges-Incorrect (incorrect number of sponges)." The DOR confirmed that there were three documented times when the count was done: the initial baseline count, the closing count, the first final count that resulted in an incorrect count, and a second final count that was conducted after the patient's chest (and sternum) was reopened to retrieve the missing sponge. The DOR confirmed that there are no other repeated stages of counting (baseline, sternal wires being placed, sternal wires crossed) except for the second final count.

During a concurrent interview and record review on 8/23/2024 at 9:00 a.m. with the DOR and the Chief Surgical and Procedure of Operations (CSPO), the facility's policy and procedure (P&P) titled "Counts: Sharps and Soft Goods/Instruments," dated 8/19/2021, was reviewed. The P&P indicated the following:
Additional times to perform a count: Sternotomies (a procedure to cut through the breastbone to reach the heart during surgery) (sponges only): Four counts are required:
(1) Baseline
(2) Sternal wires being placed
(3) Sternal wires crossed, and
(4) final count
The DOR confirmed all four stages were not documented. The DOR further stated the staff completed the two stages of counting, the sternal wires being placed, and the sternal wires crossing; however, there is no place to document both stages in the electronic intraoperative record. The DOR stated the facility would need to add an area in the electronic system to allow operating room staff to document both stages (sternal wires being placed and the sternal wires crossed).
The policy also indicated, "Additional times to perform a count: reopening of a wound-in the event a surgical site is reopened, the counts must be repeated." The DOR stated, "Only the closing count and the final count will need to be repeated." The CSPO stated, "The word "counts" in the policy is supposed to have a parenthesis around the letter "S (the plural in brackets. Use mostly in the case when the singular and the plural form can be used)" to indicate not all four stages need to be repeated. However, the DOR confirmed that the closing count that was required after the reopening of Patient 1's chest was not documented.

1.b. During a review of Patient 18's "History and Physical (H&P, a formal and complete assessment of the patient and the problem)," dated 11/8/2023, the "H&P" indicated, Patient 18 presented with "progressive shortness of breath. EF (Ejection fraction, a measurement, expressed as a percentage, of how much blood the left ventricle [one of the four chambers of the heart] pumps out with each contraction) 50 percent, severe aortic stenosis (a narrowing of the heart major valve opening or failing heart valve) ...with mild aortic regurgitation (The valve between the lower left heart chamber and the body's main artery doesn't close tightly). Patient (Patient 18) presenting for a bioprosthetic aortic valve repair (surgical removal of the valve and replaces it with a mechanical valve or a valve made from cow, pig or human heart tissue) ..."

During a review of Patient 18's "Operative Report (a report written in a patient's medical record to document the details of a surgery)," dated 11/8/2023, the report indicated, "A midline chest incision was made advanced through the subcutaneous (beneath, or under, all the layers of the skin) tissues and the fascia (made up of sheets of connective tissue that is found below the skin). An oscillating saw (a surgical saw driven by electric (line or battery) power for cutting bones and other hard tissues) was then used to complete the median sternotomy (a vertical inline incision is performed along the sternum providing access for surgical procedures)."

During a concurrent interview and record review on 8/22/2024 at 3:05 p.m. with operating room Registered Nurse (RNOR) 3, Patient 18's intraoperative report titled "(name of the facility) Main Operating Room Record," dated 11/8/2023, was reviewed. The report indicated there were three stages of counting documented: the initial/baseline count, closing count, and final count. RNOR 3 stated that there should be a separate place to document the wire counts. RNOR 3 stated, "Before the wire is put in, we count, and once the wire is twisted, we count again, but unfortunately, it is not documented. Everything should be counted and documented across the board." RNOR 3 further stated that the documentation should be reflecting the practice and policy. We will add an area to allow charting of the crosswire count."

During a concurrent interview and record review on 8/23/2024 at 9:00 a.m. with the DOR and the Chief, Surgical and Procedure of Operations (CSPO), the facility's policy and procedure (P&P) titled "Counts: Sharps and Soft Goods/Instruments," dated 8/19/2021, was reviewed. The P&P indicated the following:
Additional times to perform a count: Sternotomies (a procedure to cut through the breastbone to reach the heart during surgery) (sponges only): Four counts are required:
(1) Baseline
(2) Sternal wires being placed
(3) Sternal wires crossed, and
(4) final count
The DOR confirmed all four stages were not documented. The DOR further stated the staff completed the two stages of counting, the sternal wires being placed, and the sternal wires crossing; however, there is no place to document both stages in the electronic intraoperative record. The DOR stated the facility would need to add an area in the electronic system to allow operating room staff to document both stages (sternal wires being placed and the sternal wires crossed).
The policy also indicated, "Additional times to perform a count: reopening of a wound-in the event a surgical site is reopened, the counts must be repeated." The DOR stated, "Only the closing count and the final count will need to be repeated." The CSPO stated, "The word "counts" in the policy is supposed to have a parenthesis around the letter "S" to indicate not all four stages need to be repeated. However, the DOR confirmed that the closing count that was required after the reopening of the patient's chest was not documented.

During a review of the facility's policy and procedure (P&P) titled, "Documentation: Charting Policy," dated 7/23/2024, the P&P indicated, "The purpose of this policy is to outline the organization's standard of care for documentation in the patient medical record ... All Medical Records entries should be made as soon as possible after the care provided, or an event or observation is made. Each communication between healthcare providers addressing patient care-related events will be documented ... All nursing personnel are responsible for documenting (within their scope of practice) in the medical record events that are significant in the course of the patient's illness including: Interventions/actions identified to meet the patient's needs, Nursing care/treatment/procedure performed ..."

2. During a review of Patient 6's History and Physical (H&P, the most formal and complete assessment of the patient and the problem), dated 8/10/2024, the H&P indicated, Patient 6 was admitted to the facility on 8/10/2024 for management of post-operative (the period following a surgical operation) complications (left groin surgical site infection).

During an observation on 8/20/2024 at 3:18 p.m. with charge nurse (CN 3), the entry way leading to Patient 6's room, was observed. The door to Patient 6's room was open, and an isolation cart (storage unit in hospitals that holds medical tools and protective equipment [PPE] for healthcare professionals to use when treating isolated patients to help prevent the spread of infection and keep the hospital environment safe) was observed mounted to the door. No isolation precautions signage was posted outside Patient 6's room. The CN 3 stated, Patient 6 was in isolation for contact precautions due to VRE (Vancomycin Resistant Enterococci, a type of enterococcus bacterium (germ) that has become resistant to antibiotics such as penicillin, gentamicin, and vancomycin), but the isolation sign was not placed outside Patient 6's room. The CN 3 further stated nursing staff were responsible for ensuring the contact isolation sign was posted outside Patient 6's room as per the facility's infection control protocol.

During an interview on 8/21/2024, at 2:47 p.m., with the assistant nurse manager (ANM 4), the ANM 4 stated, the isolation sign should be posted outside patients' rooms to prevent the spread of germs and ensure that anyone entering the room wears personal protective equipment (PPE, equipment worn to minimize exposure to hazards that cause serious workplace injuries and illnesses).

During a review of the facility's policy and procedure (P&P), titled, "Isolation Precautions Protocols: Transmission Based Precautions," dated 10/19/2023, the P&P indicated, "Patients assessed to have an infectious disease, whether diagnosed or suspected, shall be placed in a protective environment that commensurate with the infection or condition's mode of transmission. All patients shall be maintained in Standard Precautions and an additional category of isolation/precautions depending upon the patient's clinical situation. Patient with an active infection or a history of Vancomycin Resistant Enteroccocus (VRE) shall be placed on contact isolation precaution upon diagnosis until discharged."

Based on interview and record review, the facility failed to ensure two (2) of two (2) sampled policies (Policy 2021 and Policy 2024) for the operating room are written with clarity:

1.a. In Policy 2021's titled "Counts: Sharps and Soft Goods/Instruments," dated 8/19/2021, the definition of one of the four stages of counting, "Cavity Count," did not have a consistent description throughout the policy.

This deficient practice places patients receiving surgical procedures in the facility at risk of retaining foreign objects, such as sponges or instruments, within the body. If the cavity count stage is not clearly defined and consistently applied, surgical staff may misinterpret the policy and fail to perform counts at all stages, increasing the likelihood that items may be unintentionally left behind. The policy's lack of a clear definition of a cavity count may also cause surgical teams to interpret the counting process differently. This inconsistency can lead to variation in practice across different procedures and teams, increasing the risk of errors.

1.b. The Policy 2021's titled, "Counts: Sharps and Soft Goods/Instruments," dated 8/19/2021, also have a grammatical error with singular and pleural under subtitled "Additional times to perform a count," the sentence that indicates, "reopening of a wound-in the event a surgical site is reopened, the counts must be repeated." The policy written with the word "counts" indicated all four stages of counts must be repeated. However, during an interview on 8/23/2024 at 9:00 a.m. with the Chief, Surgical and Procedure of Operations (CSPO) confirmed that the word "counts" in the policy is supposed to have a parenthesis around the letter "S (the plural in brackets. Use mostly in the case when the singular and the plural form can be used)" to indicate not all four stages need to be repeated.

This grammatical error can lead to ambiguity that is likely to cause misinterpretation. This confusion can impact consistency in the counting process and the reliability of the operating room staff's counting process, jeopardizing patient safety.

1.c. The Policy 2021's titled, "Counts: Sharps and Soft Goods/Instruments," dated 8/19/2021, guideline for counting during sternotomies procedure does not reflects the facility' s electronic medical charting capability. The electronic intraoperative report lacks specific field for staff to document the counting stages (Sternal wires being placed, and Sternal wires crossed) that was described in the policy.

This deficient practice of the mismatch between facility policy and the facility's electronic medical charting can jeopardize patient safety. Inadequate documentation increase risk of miscommunication that can lead to risk for retained surgical items. When the electronic charting system does not reflect the policy, it becomes challenging to track compliance and identify areas for improvement hindering effective audits and quality assurance.

2. Policy 2024's titled, "Counts: Sharps and Soft Goods/Instruments," dated 7/18/2024, there is an error in omission of the definition for "Cavity Count," which is one of the four stages of the counting process.

This deficient practice can lead to ambiguity that is likely to cause misinterpretation. This confusion can impact consistency in the counting process and the reliability of the operating room staff's counting process, jeopardizing patient safety.

Findings:

1.a. During an interview on 8/21/2024 at 11:48 p.m. with Surgical Technician (ST) 2, ST 2 stated the facility policy indicating "Cavity Count," meaning to count when there is a "cavity within a cavity, such as when the heart is open."

During a concurrent interview and record review on 8/23/2024 at 9:00 a.m. with the Chief, Surgical and Procedure of Operations (CSPO) and the Director of Operating Room (DOR), the facility's policy and procedure (P&P) titled, "Counts: Sharps and Soft Goods/Instruments," dated 8/19/2021 was reviewed. The P&P on page 1 of 15 indicated, the definition of a "Cavity Count -a count of all soft goods, needles, sharps, miscellaneous items to be performed prior to closure of a cavity within a cavity of all soft goods and needles (e.g., Uterus)." However, on page 4 of 15 indicated, "When to Perform Surgical Counts: Cavity Count: Performed to reconcile with the baseline count at the beginning of a cavity closure. Staff members performing the count must announce the start of the cavity closure count and the surgical team is to minimize interruptions until the cavity closure count is complete." After reviewing the definition for cavity count on page 4 of 15, the CSPO stated the facility will add the definition to reflect the definition of the first page which is defined as a "Cavity within a cavity."

1.b. During a review of Patient 1's "History and Physical (H&P, a formal and complete assessment of the patient and the problem)," dated 10/10/23, the "H&P" indicated, Patient 1 was admitted to the facility after RHC (Pulmonary artery catheterization [Swan-Ganz or right heart catheterization] an invasive procedure that can provide direct measurement of pressures in the heart), found Patient 1 to have low CO (cardiac output, the quantity of blood pumped by the heart in a given period of time) and elevated filling pressures ( the main physiologic consequence of when the lower heart chambers don't relax as they should). The H&P further indicated, "On baseline (an initial measurement of a condition that is taken at an early time point and used for comparison over time to look for changes) patient says his exercise tolerance has worsened over the past several months." The H&P indicated under assessment and plan: "Now undergoing advanced therapies evaluation."

During a review of Patient 1's "Disclosure Note," dated 11/9/2023, the note indicated, Patient 1 "underwent LVAD (left ventricular assist device is implanted in the chest. It helps pump blood from the lower left heart chamber to the rest of the body) placement yesterday. As the operation was nearing conclusion, we noted that our lap sponge count was off by one. We immediately called for chest x ray and upon review of the film by (Surgeon 1 name) we decided to reopen the chest to retrieve what appeared to be one of the lap sponges used during LVAD implantation to appropriately position the heart. Shortly after opening the sternum (a long flat bone that forms the center front of the chest wall) we discovered the lap sponge behind the heart and removed it prior to closing the chest again."

During a concurrent interview and record review on 8/20/2024 at 3:00 p.m. with the DOR, Patient 1's intraoperative (occurring or performed during the course of a surgical operation) note titled "Operative (name of facility) Main OR record," dated 11/8/2023 was reviewed. The report indicated, on 11/8/2023, for surgical item counts, there were three times when a count was completed:
The first count was a Baseline/Initial Count (initial count preferably performed prior to patient's arrival into the OR but must be performed prior to incision; to establish a baseline of surgical items (soft goods, needles, sharps, instruments, miscellaneous items),
The second count was a Closing Count (a count of all soft goods, needles, sharps, instruments, miscellaneous items to be performed when wound closure begins), which was documented as "correct (correct number of sponges and/or surgical instruments)," and
The Final Count (count of all soft goods, needles, sharps, miscellaneous items to be performed when the skin is closed and when counted items are no longer being used), which was documented as "Sponges -Incorrect (incorrect number of sponges)." The DOR confirmed that there were three documented time when count was done which were at the Initial Baseline Count, Closing Count, and the first Final Count that resulted in an incorrect count and a second Final count that was conducted after Patient 1's chest (and sternum) was reopened to retrieve the missing sponge. The DOR confirmed that there are no other repeated stages of counting (Base line, Sternal wires being placed, Sternal wires crossed) except for the second Final Count that was documented.

During a concurrent interview and record review on 8/23/2024 at 9:00 a.m. with the Chief, Surgical and Procedure of Operations (CSPO) and the Director of Operating Room (DOR), the facility's policy and procedure (P&P) titled, "Counts: Sharps and Soft Goods/Instruments," dated 8/19/2021 was reviewed. The P&P indicated the following:
g. Additional times to perform a count:
i. At the request of any surgical team member, if his/her judgment indicates a need for a count.
Ii. Cavity within a cavity - perform an additional count. (i.e. uterus within the abdomen).
Iii. Sternotomies (sponges only) - Four counts are required:
(1) Baseline
(2) Sternal wires being placed
(3) Sternal wires crossed, and
(4) Final Count
Iv. Reopening of a wound - in the event a surgical site is reopened, the counts must be repeated.
The CSPO stated, "The word "counts" in the policy is supposed to have a parenthesis around the letter "S" to indicate not all four stages need to be repeated, plural was not meant to be plural." The DOR stated, "The count is to be repeated for only Closing Count and Final Count." The DOR stated the baseline/initial Count and the Sternal wires being placed and the sternal wires crossed counts does not need to be repeated. DOR stated the error is in the added "s," after the word count.

1.c. During a review of Patient 18's "History and Physical (H&P, a formal and complete assessment of the patient and the problem)," dated 11/8/2023, the "H&P" indicated, Patient 18 presented with "progressive shortness of breath. EF (Ejection fraction, a measurement, expressed as a percentage, of how much blood the left ventricle pumps out with each contraction) 50 percent, severe aortic stenosis (a narrowing of the heart major valve opening or failing heart valve) ...with mild aortic regurgitation (The valve between the lower left heart chamber and the body's main artery doesn't close tightly). Patient (Patient 18) presenting for a bioprosthetic aortic valve repair (surgical removal of the valve and replaces it with a mechanical valve or a valve made from cow, pig or human heart tissue) ..."

During a review of Patient 18's "Operative Report (a report written in a patient's medical record to document the details of a surgery)," dated 11/8/2023, the report indicated, "A midline chest incision was made advanced through the subcutaneous (beneath, or under, all the layers of the skin) tissues and the fascia (made up of sheets of connective tissue that is found below the skin). An oscillating saw (a surgical saw driven by electric (line or battery) power for cutting bones and other hard tissues) was then used to complete the median sternotomy (a vertical inline incision is performed along the sternum providing access for surgical procedures)."

During a concurrent interview and record review on 8/22/2024 at 3:05 p.m. with operating room Registered Nurse (RNOR) 3, Patient 18's intraoperative report titled, "(name of the facility) Main Operating Room Record" dated 11/8/2023 was reviewed. The report indicated, there was three stages of counting documented: the Initial/baseline count, closing count, and final count. RNOR 3 stated there should be a separate place to document the wire counts. RNOR 3 stated, "Before the wire is put in, we count and once the wire is twisted, we count again but unfortunately it is not documented. Everything should be counted and documented across the board." RNOR 3 further stated, the documentation should be reflecting the practice and policy. We will add an area to allow charting of the crosswire count."

2. During a concurrent interview and record review on 8/23/2024 at 9:00 a.m. with the Chief, Surgical and Procedure of Operations (CSPO) and the Director of Operating Room (DOR), the facility's policy and procedure (P&P) titled "Counts: Sharps and Soft Goods/Instruments," dated 7/18/2024, was reviewed. The P&P indicated, "Definitions: Cavity Count: performed to reconcile with the baseline count at the time of a cavity closure and must consist of counting all soft goods, needles, sharps, and miscellaneous items." The CSPO stated, "We need to add the definition, "cavity within a cavity." The DOR stated the definition "cavity within a cavity count" is the correct term because it is not required for staff to count during open cavity."

During a review of the facility's policy and procedure (P&P) titled, "Policies and Procedures: Development, Review, and Revision," dated 4/23/2024, the P&P indicated as follows:
To provide direction for the development and revision of policies that are congruent with (name of the facilities) hereinafter referred to as the "hospitals" mission, goals, and objectives, and ensure conformance with regulatory requirements. To define the processes to ensure periodic review, revision, and appropriate approval of all policies. To provide a common format to be used for all policies within the hospitals ... The hospitals will maintain a standardized and systematic process of developing, reviewing, and revising ... All clinical policies should include Levels of Evidence. The levels are as follows:
a. Level A-Meta-analysis of multiple controlled studies or meta-synthesis of qualitative studies with
results that consistently support a specific action, intervention or treatment
b. Level B -Well designed controlled studies, both randomized and nonrandomized, with results that
consistently support a specific action, intervention, or treatment
c. Level C -Quality studies, descriptive or correlational studies, integrative reviews, systematic reviews, or randomized controlled trials with inconsistent results
d. Level D -Peer-reviewed professional organizational standards, wiLe iple case reports
f. Level M -Manufacturers' recommendations only
6. Procedures shall be approved by Administration and Medical Staff where such is appropriate.
7. The hospitals shall utilize a Policy Committee to coordinate development and review of policies. The committee shall be multidisciplinary.