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Based on observation, staff interview and review of maintenance records on August 1 to August 2, 2022, the Orthopaedic Hospital of Wisconsin failed to construct, install, and maintain the building systems to ensure safety of patients.

Findings include:

The facility was found to contain the following deficiencies.

1. K324 - Cooking Facilities
2. K346 - Fire Alarm System - Out of Service
3. K354 - Sprinkler System - Out of Service
4. K374 - Subdivision of Building Spaces - Smoke Barrier Doors
5. K521 - HVAC
6. K919 - Electrical Equipment - Other
7. A701 - Maintenance of Physical Plant
8. A709 - Life Safety from Fire

As a result of these deficiencies, 42 CFR Subpart CFR 482.41 Condition of Participation: Physical environment was NOT MET.

Based on observation, staff interview and review of maintenance records on August 1 to August 2, 2022, the Orthopaedic Hospital of Wisconsin failed to construct, install, and maintain the building systems to ensure safety of patients.

Findings include:

The facility was found to contain the following deficiencies.
1. K324 - Cooking Facilities
2. K346 - Fire Alarm System - Out of Service
3. K354 - Sprinkler System - Out of Service
4. K374 - Subdivision of Building Spaces - Smoke Barrier Doors
5. K521 - HVAC
6. K919 - Electrical Equipment - Other

As a result of these deficiencies, 42 CFR Subpart CFR 482.41(b) Standard: Life safety from fire was NOT MET.

Based on record review, observation, and interview the facility failed to monitor the Anesthesia refrigerator temperatures daily, and failed to notify maintenance when temperatures were out of normal range in 1 of 1 refrigerators located in the Anesthesia department and failed to ensure calibration of it's thermometers in 1 of 1 refrigerator/freezers in the Laboratory in a total of 2 of 11 departments (Anesthesia and Laboratory).

Findings Include:

Review of facility policy titled, "Refrigerator and Freezer Monitoring," last reviewed 12/2020 revealed, "This organization provides for safe storage of food, medication.......by assuring proper operation of all refrigerators and freezers....2. Temperature will be monitored and recorded daily....on refrigerators containing: 2.2 Medication...3. Refrigerator temperature will be maintained 36-41 degrees F. If temperature is unsatisfactory call maintenance for correction."

Review of January to December 2021 refrigerator logs revealed no normal parameters listed and 4 temperature readings above 41 degrees F.

Review of January to July 2022 refrigerator logs revealed no normal parameters listed and 22 temperature readings above 41 degrees F.

Review of January to December 2021 refrigerator logs revealed, January 2021 had 12 days with no recorded temperature, February 2021 had 18 days with no recorded temperature, March 2021 had 10 days with no recorded temperature, April 2021 had 11 days with no recorded temperature, May 2021 had 17 days with no recorded temperature, June 2021 had 9 days with no recorded temperature, July 2021 had 19 days with no recorded temperature, August 2021 had 14 days with no recorded temperature, September 2021 had 15 days with no recorded temperature, October 2021 had 15 days with no recorded temperature, November 2021 had 14 days with no recorded temperature, and December 2021 had 10 days with no recorded temperature. This was confirmed by Vice President of Nursing and Surgery RN B on 08/01/2022 at 2:35 PM.

Review of January to July 2022 refrigerator logs revealed, January 2022 had 10 days with no recorded temperature, February 2022 had 8 days with no recorded temperature, March 2022 had 12 days with no recorded temperature, April 2022 had 9 days with no recorded temperature, May 2022 had 11 days with no recorded temperature, June 2022 had 18 days with no recorded temperature and July had 21 days with no recorded temperature.

On 08/01/2022 at 2:35 PM on a tour of the OR (Operating Room) Department with Vice President of Nursing RN (VP of Nursing) B observed the anesthesia refrigerator to have an incomplete temperature log and no parameters for a normal range noted, this was confirmed by VP of Nursing B.

On 08/01/2022 at 2:35 PM during interview with Anesthesia Tech (AT) N, when asked if the temperature was to be documented each day, AT N stated, "That would be correct, some mornings are hectic and the first person in marks it down." When asked how do you know what a normal range is, AT N stated, "They've never said what its supposed to be, I don't know what the correct temperature range is but I know my resources."

On 08/01/2022 at 2:35 PM during interview with VP of Nursing B, VP of Nursing B, stated, "There should be a range to know when to call.

In an interview on 08/03/2022 at 9:50 AM with VP of Nursing B, when asked for the follow-up that was done when the temperature was outside of normal parameters, VP of Nursing B stated, "No corrective action was taken, staff didn't know the parameters, but the correct log is now on the fridge."




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Record review of policy "Care and Monitoring of Laboratory Environment," #DS310, last reviewed 7/2022, under Procedure, 1.3 revealed "All thermometers and humidistats should be NIST [National Institue of Standards and Technology] traceable."

On 8/01/2022 at 11:15 AM during tour of the Laboratory with Medical Technical Lead (MT) Y, observed in the laboratory refridgerator, a thermometer held in a clear glass container with an orange sticker, to indicate when the calibration expired, with hand written dates opened "6/18/18" (06/18/2018), expired "3/30/19" (03/30/2019) and in the freezer above, a thermometer held in a clear glass container with an orange sticker with hand written dates opened "6/18/18" (06/18/2018), expired "2/9/19" (02/09/2019). During interview with MT Y, MT Y stated s/he was unsure of how frequently the thermometers should be calibrated.

Record review of "NIST Traceable Calibration Certificate" with "refreg., 6-18-18" hand-written on it, with Calibration Date 03/30/18 and Calibration Due Date of 03/30/2019.

Record review of "NIST Traceable Calibration Certificate" with "freezer., 6-18-18" hand-written on it, with Calibration Date 03/30/18 and Calibration Due Date of 03/30/2019.

On 8/02/2022 at 5:23 PM during interview with Chief Executive Officer (CEO) E, CEO E stated the thermometer calibration unit should be changed out annually and confirmed this "hasn't been done."

Based on record review and interview, the facility failed to demonstrate that the designated infection control officer was appointed by the governing body and qualified by training or experience to develop and maintain a hospital-wide program for infection control and prevention in 1 of 1 infection control programs reviewed.

Findings include:

Record review of the facility policy titled, "Infection Prevention Program and Annual Plan," last reviewed 12/2020, revealed, "The responsibility for management of the program is assigned to a qualified person (s)....shall have received specialized training in infection control."

Record review of Infection Prevention Registered Nurse (IP) W's personnel file revealed no evidence of orientation or training in the Infection Prevention role.

On 08/03/2022 at 07:30 AM during interview with Infection Prevention Registered Nurse W, IP W stated, "I had training with the person in this position before me, but nothing was written down, there is no documentation of orientation or sign off related to infection control."

In an interview with Chief Executive Officer (CEO) E, on 08/03/2022 at 10:15 AM, when asked if the infection control professional responsible for infection control was appointed by the governing board, CEO E stated, "No, this would not go to the governing body and it was not brought to the Medical Executive Committee, I don't have it where they were appointed, we definitely missed that."

Based on observation, interview, and record review, the facility failed to ensure that source control (face masks) for healthcare staff and people entering the facility was adhered to per the Centers for Disease Control (CDC) recommendations for healthcare providers for prevention of the transmission of Coronavirus Disease 2019 (COVID-19) in 1 of 1 infection control programs reviewed and failed to avoid sources of infection by failing to ensure proper hand hygiene during observation of 2 of 3 patient's surgical procedures (Patient #33 & Patient #34) in a total of 1 of 11 departments (Surgical Department).

Findings include:

Record Review

Review of CDC Nationally Recognized Standard for Source Control last updated 02/02/2022 revealed in part "Interim Infection Prevention and Control Recommendations for Healthcare Personnel During COVID-19: CDC's new COVID-19 community levels recommendations do not apply in healthcare settings, such as hospitals and nursing homes. Instead, healthcare settings should continue to use community transmissions rates and continue to follow CDC's infection prevention and control recommendations for healthcare settings. For Healthcare Facilities: COVID-19 Community Levels do not apply in healthcare settings, such as hospitals and nursing homes...1. Recommended routine infection prevention and control (IPC) practices...Implement Source Control Measures. Source control refers to use of respirators or well-fitting facemasks or cloth masks to cover a person's mouth and nose to prevent spread of respiratory secretions when they are breathing, talking, sneezing, or coughing. Source control options for HCP (health care providers) include: A NIOSH-approved N95 or equivalent or higher-level respirator OR A respirator approved standards used in other countries...A well-fitting facemask...While it is generally safest to implement universal use of source control for everyone in a healthcare setting, the following allowances could be considered for individuals who are up to date with all recommended COVID-19 vaccine doses...in healthcare facilities located in counties with low to moderate community transmission...HCP who are up to date with all recommended COVID-19 vaccine doses: Could choose not to wear source control or physically distance when they are in well-defined areas that are restricted from patient access (e.g., staff meeting rooms, kitchen). They should wear source control when they are in areas of the healthcare facility where they could encounter patients (e.g., hospital cafeteria, common halls/corridors)...The safest practice is for patients and visitors to wear source control and physically distance... Visitors should wear source control when around other residents or HCP, regardless of vaccination status."

A review of the CDC's Community Transmission metric for the time period from 08/03/2022 through 08/09/2022 revealed the transmission rate for Milwaukee County, Wisconsin, where the facility is located, was, "High."

Review of facility policy titled, "Infection Prevention Program and Annual Plan," last reviewed 12/2020 revealed, "The Infection Prevention designee shall have the authority to initiate isolation using the C.D.C. (Center for Disease Control) Recommendations and institute control measures where there is felt to be a clear and present danger to patients, staff or visitors; i.e., outbreak control."

Review of document titled "[Facility] COVID-19 Resource Document: Definitions," not dated, under PPE (personal protective equipment) use revealed "Population or Universal Masking is required within the facility... the CDC recommends healthcare facilities/clinics should consider implementing policies requiring everyone entering the facility to wear a face mask/covering (if tolerated) while in the building, regardless of symptoms."

Review of document title "Mask Guidance" dated 03/07/2022 under Patients revealed "All patients... are required to be masked... Visitors... are required to be masked... Employed and Physician Staff "are required to wear a mask while providing care. Patient-facing is defined as inside six feet for more than 15 minutes cumulatively with the same patient... Any staff in common areas of care or transtioning from one floor to another... are encourged to be masked... Cafeteria staff are required to be masked while preparing or serving food. d. Registration staff are required to be masked during all patient-facing encounters." Vendors and other sales staff "are required to be masked at all times."

Review of facility memo, sent to facility staff, from Chief Executive Officer (CEO) E and Medical Staff President BB, dated, March 30, 2022, Subject: 2022 Incident Command Update #9 revealed, "While SE (southeast) Wisconsin (and the nation) is experiencing a surge in the number of COVID+ patients, [this facility] has reestablished Incident Command on a regular basis in response to this latest surge." Under Situation Update - NEW revealed "Burden Rate fell to 'moderately high'." Under Timeline - NEW revealed Information in this update is valid beginning April 4, 2022." Screening-New: Staff are no longer required to use the symptom screening app every day they are at work unless they are experiencing active signs and symptoms of COVID-19 and directed by their leader....standard questions related to signs and symptoms of COVID-19 as well as previous infections will be asked of all patients and visitors at registration points only. The process of actively screening at main entrances will be discontinued.....Visitors will self-screen and attest that by entering [facility], they are symptom free from COVID-19."

Review of document titled "Masking Guidance" dated 05/01/2022 revealed, "Masking for all Persons: All persons entering [facility] showing any signs of illness are required to be masked at all times, all persons entering [facility] that are unable to maintain 6 feet of social distancing are required to be masked... All staff members, physicians, contracted workers, and vendors/reps that are asked by a patient to wear a mask are required to comply with the request.."

On 08/03/2022 at 8:30 AM during a tour of the entire 3rd floor nursing unit, Post-Operative Unit, public waiting areas, and Pre-Operative Unit, and concurrent interview with Infection Preventionist (IP) W, no signs were present instructing patients/visitors to wear masks or not to visit if ill, no signs were posted listing symptoms of COVID, and these findings were confirmed by Infection Prevent Staff W. When asked how patients/visitors know what the symptoms of COVID were, and how and when to report them, IP W stated, "We do a passive screening, we don't actively screen people that enter at the door and patients are screened at registration." When asked why the only masking sign was at the front entrance, IP W stated, "I thought we had more."



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Observations

On 08/01/2022 at 9:00 AM during an observation at the facility main entrance revealed a sign that said, "For your safety maintain 6 feet of distance between people, wash your hands frequently, supplement with hand sanitizer, masks required, must be worn at all times. Visitor restrictions please ask about visitor limitations." No other signs were present in the lobby or the main waiting area.

On 08/01/2022 at 9:00 AM observed Security Information Officer CC with mask pulled down under his/her nose.

On 08/01/2022 at 10:20 AM, during a tour of the facility and concurrent interview with Vice President (VP) of Nursing B observed Housekeeper M cleaning a bathroom in the Phase 2 unit. Housekeeper M had his/her facemask pulled down, exposing his/her nose and upper lip. VP of Nursing B stated Housekeeper M, "Should be wearing [his/her] mask over the nose."

On 08/01/2022 at 10:24 AM, during a tour of the facility and concurrent interview with VP of Nursing B , observed a total of 6 individuals in the 3rd floor conference room, identified by VP of Nursing B as a combination of hospital staff and vendor representatives. The individuals were observed to be sitting less than 6 feet apart. 4 of the 6 individuals were observed to be not wearing facemasks or had their facemasks pulled down below the chin, exposing the nose and mouth. VP of Nursing B stated the individuals should be wearing facemasks appropriately.

On 08/01/2022 at 10:26 AM, during a tour of the 3rd floor inpatient unit and concurrent interview with VP of Nursing B , observed Health Unit Clerk S sitting at the nurse's station with his/her facemask pulled down around his/her chin, exposing his/her nose and mouth. VP of Nursing B stated Health Unit Clerk S should be wearing his/her mask appropriately.

On 08/01/2022 at 11:00 AM, observed Chef Y serving food to 3 separate hospital staff in the dining room. Chef Y was observed to be wearing his/her facemask pulled down around his/her chin, exposing his/her nose and mouth.

On 08/01/2022 at 2:35 PM during a tour of the Anesthesia Office with Vice President of Nursing Staff B, observed Staff N with his/her mask worn below the nose.

On 08/02/2022 at 8:45 AM during a tour of the soiled utility room in the operating room suite with Vice President of Nursing (VP) B, observed 2 staff without masks in the hallway less than 3 feet apart. VP B was asked what the masking policy was, Staff B stated, "They should be masking when they are within 6 feet of another."

On 08/02/2022 at 9:05 AM in the front lobby, observed 2 staff sitting at the information desk, less than 3 feet apart, 1 staff was wearing his/her mask at the chin level exposing his/her nose and mouth.

On 08/02/2022 at 9:05 AM during a tour of the medical records department with Chief Financial Officer D, observed 3 staff present within 6 feet of each other, 1 staff member wearing a mask under his/her nose.

On 08/02/2022 at 10:30 AM, observed nursing staff sitting at the 3rd floor nurse's station, less than 6 feet apart. Observed one nursing staff with no facemask, and 2 nursing staff with their facemasks pulled down around the chin, exposing the nose and mouth.

On 08/02/2022 at 12:00 PM at the 3rd floor nurses station, observed a CNA (Certified Nursing Assistant) sitting at the nurses station wearing his/her mask around their chin, less than 6 feet apart from from 2 other staff at the nurses station.

On 08/02/2022 at 1:30 PM in the cafeteria, observed 2 staff wearing masks under their chins and 1 staff not wearing a mask in the kitchen where food is prepared and served. All 3 kitchen staff were within 6 feet of each other.

On 08/03/2022 at 08:15 AM during a tour of the post operative unit observed a registered nurse speaking on the phone, not wearing a mask.

On 08/03/2022 at 8:30 AM during a tour of the 3rd floor nursing unit and concurrent interview with Infection Preventionist Staff W, observed a staff member with no mask, and 2 other staff, within 6 feet, at the nurses station. There were no signs present instructing patients/visitors to wear masks on the entire 3rd floor Nursing Unit, Post Operative (Post-Op) Unit, public waiting areas, or Pre-Operative (Pre-Op) Unit.




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Interviews

In an interview on 08/02/2022 at 10:30 AM with Registered Nurse (RN) U, when asked what is the expectation with masking, RN U stated, "We mask at all times unless eating and drinking or greater than 6 feet apart."

On 08/02/2022 at 2:15 PM, in an interview with Infection Preventionist V, when asked what nationally recognized standards are followed, Infection Preventionist V stated, "Hospital Policy is to follow the CDC." When asked why the CDC recommendations for screening and masking aren't being followed, Infection Preventionist V said, "Infection Prevention provides recommendations based on CDC guidelines and incident command decides on facility guidance."

On 08/02/2022 at 2:30 PM, in an interview with CEO E, when asked why the CDC recommendations for screening and masking weren't being followed, CEO E stated, "Obviously we deviate in areas, we've never taken care of Covid patients and don't have sick people here, we weren't seeing covid in our facility and screening of patients was anti-patient friendly. We asked patients questions and were getting no for answers. The medical executive committee made the recommendation based on community transmission." When asked about the facility infection control policy and following CDC guidelines, CEO E stated, "Not necessarily all of our infection prevention policies follow the CDC. We developed a playbook that is specific to our hospital, as we are a unique model, rather than globally applied. This hospital is different than others, we've tracked staff, we are physician owned and most of our physicians are well read and well researched and aware of the current literature. The Medical Executive Committee made this decision with patient safety in mind, patient satisfaction and staff satisfaction, if staff are within 6 feet of another they need to wear a mask." When told of the recomendations made by the CDC in managing the spread of Covid 19, CEO E stated, "I'm aware of the CDC and the guidance."

Hand hygiene

In an interview on 08/02/2022 at 10:00 AM with Infection Prevention RN V, when asked what nationally recognized infection control standards are followed by this facility, RN V stated, "We follow the CDC (Centers for Disease Control) Guidelines and AORN (Association of Operating Room Nurses)."

Record review on 8/10/2022, CDC website Hand Hygiene Guidelines revealed "Use an Alcohol-Based Hand Sanitizer Immediately before touching a patient, Before performing an aseptic task (e.g., placing an indwelling device), After touching a patient or the patient's immediate environment."

Association of periOperative Registered Nurses (AORN) Guidelines for perioperative Practice 2019 Edition, page 298 revealed "Perioperative team members should perform hand hygiene... before and after patient contact, before performing a clean or sterile task including inserting an invasive device... accessing a vasular device... administering or preparing medications."

Record review of policy titled "Hand Hygiene," #AD707, last reviewed 12/2020, section 1.6 Surgical Hand Hygiene/Antisepsis, #2 Indications for Hand Hygiene, Alcohol-Based Hand Rub, revealed "before and after touching any patient, Before and after any invasive procedure such as administering injections, After removing gloves, After touching anything in the patient's environment."

On 8/03/2022 at 7:58 AM during observation with Vice President of Nursing & Surgery (VP) B, observed Anesthesiologist AA insert intravenous catheter into Patient #33's left arm, apply tourniquet to right arm, and administer intravenous (anesthesia medication) into intravenous line without changing gloves or cleaning hands in between.

On 8/03/2022 at 9:06 AM during observation with (VP) B, observed Anesthesiologist AA don gloves without cleaning hands, removed a vial of Lidocaine, empty syringe, and needle out of scrub pocket. Anesthesiologist AA then drew up lidocaine (numbing medication) from vial, stuck Patient # 34's left forearm to numb area, and inserted intravenous catheter, without changing gloves or completing hand hygiene.

On 8/03/2022 at 9:25 AM during interview with VP B,when asked what the facilities policy was for hand washing and carrying medication and supplies in pockets, VP B stated that hands should be cleaned after glove removal and medication supplies should not be kept in pockets and stated "[s/he] could have done a better job."

Based on interview, record review and observation facility leadership failed to ensure that Centers for Disease Control (CDC) guidelines were in place and operational to prevent the spread of Covid -19 in the Infection Control Program related to screening of visitors, visual alerts and the use of source control measures.


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Findings include:

Review of CDC Nationally Recognized Standard for Source Control last updated 02/02/2022 revealed in part "Interim Infection Prevention and Control Recommendations for Healthcare Personnel During COVID-19: CDC's new COVID-19 community levels recommendations do not apply in healthcare settings, such as hospitals and nursing homes. Instead, healthcare settings should continue to use community transmissions rates and continue to follow CDC's infection prevention and control recommendations for healthcare settings. For Healthcare Facilities: COVID-19 Community Levels do not apply in healthcare settings, such as hospitals and nursing homes...1. Recommended routine infection prevention and control (IPC) practices...Implement Source Control Measures. Source control refers to use of respirators or well-fitting facemasks or cloth masks to cover a person's mouth and nose to prevent spread of respiratory secretions when they are breathing, talking, sneezing, or coughing. Source control options for HCP (health care providers) include: A NIOSH-approved N95 or equivalent or higher-level respirator OR A respirator approved standards used in other countries...A well-fitting facemask...While it is generally safest to implement universal use of source control for everyone in a healthcare setting, the following allowances could be considered for individuals who are up to date with all recommended COVID-19 vaccine doses...in healthcare facilities located in counties with low to moderate community transmission...HCP who are up to date with all recommended COVID-19 vaccine doses: Could choose not to wear source control or physically distance when they are in well-defined areas that are restricted from patient access (e.g., staff meeting rooms, kitchen). They should wear source control when they are in areas of the healthcare facility where they could encounter patients (e.g., hospital cafeteria, common halls/corridors)...The safest practice is for patients and visitors to wear source control and physically distance... Visitors should wear source control when around other residents or HCP, regardless of vaccination status."

A review of the CDC's Community Transmission metric for the time period from 08/03/2022 through 08/09/2022 revealed the transmission rate for Milwaukee County, Wisconsin, where the facility is located, was, "High."

On 08/01/2022 at 9:00 AM during an observation at the facility main entrance revealed a sign that said, "For your safety maintain 6 feet of distance between people, wash your hands frequently, supplement with hand sanitizer, masks required, must be worn at all times. Visitor restrictions please ask about visitor limitations." No other signs were present in the lobby or the main waiting area.

On 8/01/2022 at 9:00 AM during interview with Security Information Officer CC, Officer CC asked, "Can I help you, do you know where you need to go?" When questioned if there were screening questions to be asked, Officer CC stated, "We aren't asking the screening questions anymore." No questions on COVID contacts or respiratory symptoms were asked on admission to the facility.

Review of facility memo, sent to facility staff, from Chief Executive Officer (CEO) E and Medical Staff President BB, dated, March 30, 2022, Subject: 2022 Incident Command Update #9 revealed, "Screening-New: Staff are no longer required to use the symptom screening app every day they are at work unless they are experiencing active signs and symptoms of COVID-19 and directed by their leader....standard questions related to signs and symptoms of COVID-19 as well as previous infections will be asked of all patients and visitors at registration points only. The process of actively screening at main entrances will be discontinued.....Visitors will self-screen and attest that by entering [facility], they are symptom free from COVID-19."

Review of memo from CEO E and Medical Staff President BB dated 04/28/2022, Subject 2022 Incident Command Update #10, beginning 05/01/2022 revealed "By entering [Facility], staff members attest to being symptom free from COVID-19. All patients will self-screen as well as be actively screened for signs and symptoms of COVID-19 at registration points... Visitors will self-screen and attest that by entering [Facility], they are symptom free from COVID-19."

In an interview on 08/03/2022 at 8:30 AM, with Infection Prevention RN (IP) W, when asked if people are screened for COVID symptoms on admission to the facility, IP W stated "We do a passive screening, we don't actively screen people that enter at the door. Patients are screened at registration." When asked why the only masking sign was at the front entrance or how people know what symptoms to be reported prior to entering the facility to prevent transmission of COVID, IP W stated, "I thought we had more posted in preop, postop and the floor."

In an interview on 08/02/2022 at 10:30 AM with Registered Nurse (RN) U, when asked, how are visitors screened, RN U said, "Visitors aren't screened anymore, patients are told not to bring anyone sick with them and that both the patient and visitor need to be masked."

Based on record review and interview the facility failed to follow their contingency plan for staff who are not fully vaccinated for COVID-19 but granted exemptions in 2 of 3 staff who were granted exemptions (Surgical Assistant DD and Registered Nurse EE) in 1 of 1 COVID 19 Mandatory Vaccination policy.

Findings include:

Record review of "COVID Vaccination Religious Exemption Request Form" not dated, under if my exemption request is approved, what will I need to do #3 revealed "Must comply with the current SafeCheck or daily COVID-19 symptom screening process prior to entering" a facility site.

On 8/01/2022 during personnel record review of COVID vaccine status with Quality Coordinator A, Quality Coordinator A indicated Surgical Assistant (SA) DD was hired on 5/31/2022 and was granted a religious exemption and Registered Nurse (RN) EE was hired on 7/11/2022 and was granted a religious exemption .

On 8/02/2022 at 9:20 AM during interview with Quality Coordinator A, Coordinator A stated SA DD and Registered Nurse EE were hired after the staff requirement for daily screening on the app was dropped and they were "not instructed of the mandatory daily reporting" required of staff who received COVID vaccination exemptions. Coordinator A confirmed there was no record that SA DD or RN EE did the required daily screening process prior to entering the facility when they worked.

Based on record review and interview, the facility staff failed to ensure the surgical time out was documented as having been completed prior to the start of the procedure, per facility policy, in 29 of 33 surgical medical records reviewed (Patients #1, 2, 3, 4, 5, 6, 8, 9, 10, 11, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 30, 31, 32), in a total sample of 33 medical records reviewed.

Findings include:

A review of the facility's policy #SS113 titled, "Surgical Site Confirmation Process," last reviewed 04/2020 revealed, "POLICY: The anatomical site and the surgical procedure will be verified with the patient awake, aware, and involved ...A time-out [sic] will be taken immediately prior to starting the procedure to assure correct patient, procedure, surgical site, and any special requirements ...4. Time out will be performed immediately before beginning the procedure and when the operative site is in view. 4.1. The circulating RN [Registered Nurse], anesthesiologist or surgeon is to read the consent aloud after the surgeon is present in the room ...4.3. The patient identification, the planned surgical procedure(s), the operative site(s) and side and the patient positions, allergies and antibiotics will be verbally verified as correct and availability of correct implants and any special equipment will be verbally verified by members of the surgical team. 4.4. The timeout [sic] will be documented on the surgical checklist by the circulating RN ..."

A review of Patient #1's open medical record revealed Patient #1 was admitted to the facility on 08/01/2022 for a left reverse total shoulder arthroplasty (shoulder joint replacement). The "[Facility Name] Surgical Data" form revealed the surgery start time was 2:06 PM. A review of the "Operating Room Nursing Notes" revealed in the "Time Out Complete" box, only the circulating nurse's initials were documented. There was no time documented of when the time out was completed.

A review of Patient #2's open medical record revealed Patient #2 was admitted to the facility on 08/01/2022 for a left total knee arthroplasty (knee joint replacement). The "[Facility Name] Surgical Data" form revealed the surgery start time was 12:35 PM. A review of the "Operating Room Nursing Notes" revealed in the "Time Out Complete" box, only the circulating nurse's initials were documented. There was no time documented of when the time out was completed.

A review of Patient #3's closed medical record revealed Patient #3 was admitted to the facility on 05/03/2022 for a right total hip arthroplasty (hip joint replacement). The "[Facility Name] Surgical Data" form revealed the surgery start time was 12:21 PM. A review of the "Operating Room Nursing Notes" revealed in the "Time Out Complete" box, only the circulating nurse's initials were documented. There was no time documented of when the time out was completed.

A review of Patient #4's closed medical record revealed Patient #4 was admitted to the facility on 05/09/2022 for a left total hip arthroplasty. The "[Facility Name] Surgical Data" form revealed the surgery start time was 7:58 AM. A review of the "Operating Room Nursing Notes" revealed in the "Time Out Complete" box, only the circulating nurse's initials were documented. There was no time documented of when the time out was completed.

A review of Patient #5's closed medical record revealed Patient #5 was admitted to the facility on 05/17/2022 for a left total hip arthroplasty. The "[Facility Name] Surgical Data" form revealed the surgery start time was 7:56 AM. A review of the "Operating Room Nursing Notes" revealed in the "Time Out Complete" box, only the circulating nurse's initials were documented. There was no time documented of when the time out was completed.

A review of Patient #6's closed medical record revealed Patient #6 was admitted to the facility on 05/24/2022 for a lumbar (back) fusion. The "[Facility Name] Surgical Data" form revealed the surgery start time was 8:00 AM. A review of the "Operating Room Nursing Notes" revealed in the "Time Out Complete" box, only the circulating nurse's initials were documented. There was no time documented of when the time out was completed.

A review of Patient #8's closed medical record revealed Patient #8 was admitted to the facility on 06/14/2022 for a right total hip arthroplasty. The "[Facility Name] Surgical Data" form revealed the surgery start time was 10:39 AM. A review of the "Operating Room Nursing Notes" revealed in the "Time Out Complete" box, only the circulating nurse's initials were documented. There was no time documented of when the time out was completed.

A review of Patient #9's closed medical record revealed Patient #9 was admitted to the facility on 06/27/2022 for a left total hip arthroplasty. The "[Facility Name] Surgical Data" form revealed the surgery start time was 2:30 PM. A review of the "Operating Room Nursing Notes" revealed in the "Time Out Complete" box, only the circulating nurse's initials were documented. There was no time documented of when the time out was completed.

A review of Patient #10's closed medical record revealed Patient #10 was admitted to the facility on 07/06/2022 for a left total knee arthroplasty. The "[Facility Name] Surgical Data" form revealed the surgery start time was 9:39 AM. A review of the "Operating Room Nursing Notes" revealed in the "Time Out Complete" box, only the circulating nurse's initials were documented. There was no time documented of when the time out was completed.

A review of Patient #11's closed medical record revealed Patient #11 was admitted to the facility on 07/18/2022 for a left total shoulder arthroplasty revision. The "[Facility Name] Surgical Data" form revealed the surgery start time was 12:52 PM. A review of the "Operating Room Nursing Notes" revealed the "Time Out Complete" box was blank.

A review of Patient #13's closed medical record revealed Patient #13 was admitted to the facility on 06/06/2022 for a left total shoulder arthroplasty and repair of a humerus (upper arm bone) fracture. The "[Facility Name] Surgical Data" form revealed the surgery start time was 9:25 AM. A review of the "Operating Room Nursing Notes" revealed in the "Time Out Complete" box, only the circulating nurse's initials were documented. There was no time documented of when the time out was completed.

A review of Patient #14's closed medical record revealed Patient #14 was admitted to the facility on 06/14/2022 for an incision and drainage of a right total hip arthroplasty with polyethylene (component) exchange. The "[Facility Name] Surgical Data" form revealed the surgery start time was 11:58 AM. A review of the "Operating Room Nursing Notes" revealed in the "Time Out Complete" box, only the circulating nurse's initials were documented. There was no time documented of when the time out was completed.

A review of Patient #15's closed medical record revealed Patient #15 was admitted to the facility on 06/15/2022 for an incision and drainage of a left total knee arthroplasty with polyethylene (component) exchange. The "[Facility Name] Surgical Data" form revealed the surgery start time was 2:39 PM. A review of the "Operating Room Nursing Notes" revealed in the "Time Out Complete" box, only the circulating nurse's initials were documented. There was no time documented of when the time out was completed.

A review of Patient #16's closed medical record revealed Patient #16 was admitted to the facility on 06/29/2022 for a lumbar decompression and fusion with instrumentation. The "[Facility Name] Surgical Data" form revealed the surgery start time was 8:21 AM. A review of the "Operating Room Nursing Notes" revealed in the "Time Out Complete" box, only the circulating nurse's initials were documented. There was no time documented of when the time out was completed.

A review of Patient #17's closed medical record revealed Patient #17 was admitted to the facility on 07/25/2022 for a right total shoulder arthroplasty. The "[Facility Name] Surgical Data" form revealed the surgery start time was 3:05 PM. A review of the "Operating Room Nursing Notes" revealed in the "Time Out Complete" box, only the circulating nurse's initials were documented. There was no time documented of when the time out was completed.

A review of Patient #18's closed medical record revealed Patient #18 was admitted to the facility on 05/10/2022 for a lumbar decompression and fusion with instrumentation. The "[Facility Name] Surgical Data" form revealed the surgery start time was 10:21 AM. A review of the "Operating Room Nursing Notes" revealed in the "Time Out Complete" box, only the circulating nurse's initials were documented. There was no time documented of when the time out was completed.

A review of Patient #19's closed medical record revealed Patient #19 was admitted to the facility on 06/28/2022 for a right total knee arthroplasty revision. The "[Facility Name] Surgical Data" form revealed the surgery start time was 7:54 AM. A review of the "Operating Room Nursing Notes" revealed in the "Time Out Complete" box, only the circulating nurse's initials were documented. There was no time documented of when the time out was completed.

A review of Patient #20's closed medical record revealed Patient #20 was admitted to the facility on 07/08/2022 for an incision and drainage of a right total knee arthroplasty with polyethylene (component) exchange. The "[Facility Name] Surgical Data" form revealed the surgery start time was 5:19 PM. A review of the "Operating Room Nursing Notes" revealed in the "Time Out Complete" box, only the circulating nurse's initials were documented. There was no time documented of when the time out was completed.

A review of Patient #21's closed medical record revealed Patient #21 was admitted to the facility on 06/20/2022 for a left total shoulder arthroplasty. The "[Facility Name] Surgical Data" form revealed the surgery start time was 11:04 AM. A review of the "Operating Room Nursing Notes" revealed in the "Time Out Complete" box, only the circulating nurse's initials were documented. There was no time documented of when the time out was completed.

A review of Patient #22's closed medical record revealed Patient #22 was admitted to the facility on 06/21/2022 for a left total knee arthroplasty. The "[Facility Name] Surgical Data" form revealed the surgery start time was 10:37 AM. A review of the "Operating Room Nursing Notes" revealed in the "Time Out Complete" box, only the circulating nurse's initials were documented. There was no time documented of when the time out was completed.

A review of Patient #23's closed medical record revealed Patient #23 was admitted to the facility on 06/30/2022 for a right total hip arthroplasty. The "[Facility Name] Surgical Data" form revealed the surgery start time was 11:26 AM. A review of the "Operating Room Nursing Notes" revealed in the "Time Out Complete" box, only the circulating nurse's initials were documented. There was no time documented of when the time out was completed.

A review of Patient #24's closed medical record revealed Patient #24 was admitted to the facility on 07/05/2022 for a left total knee arthroplasty. The "[Facility Name] Surgical Data" form revealed the surgery start time was 8:07 AM. A review of the "Operating Room Nursing Notes" revealed in the "Time Out Complete" box, only the circulating nurse's initials were documented. There was no time documented of when the time out was completed.

A review of Patient #25's closed medical record revealed Patient #25 was admitted to the facility on 06/29/2022 for a right total knee arthroplasty. The "[Facility Name] Surgical Data" form revealed the surgery start time was 3:27 PM. A review of the "Operating Room Nursing Notes" revealed in the "Time Out Complete" box, only the circulating nurse's initials were documented. There was no time documented of when the time out was completed.

A review of Patient #26's closed medical record revealed Patient #26 was admitted to the facility on 07/07/2022 for a lumbar fusion. The "[Facility Name] Surgical Data" form revealed the surgery start time was 8:50 AM. A review of the "Operating Room Nursing Notes" revealed in the "Time Out Complete" box, only the circulating nurse's initials were documented. There was no time documented of when the time out was completed.

A review of Patient #27's closed medical record revealed Patient #27 was admitted to the facility on 07/12/2022 for a left total knee arthroplasty. The "[Facility Name] Surgical Data" form revealed the surgery start time was 12:54 PM. A review of the "Operating Room Nursing Notes" revealed in the "Time Out Complete" box, only the circulating nurse's initials were documented. There was no time documented of when the time out was completed.

A review of Patient #28's closed medical record revealed Patient #28 was admitted to the facility on 07/19/2022 for a right total knee arthroplasty. The "[Facility Name] Surgical Data" form revealed the surgery start time was 7:50 AM. A review of the "Operating Room Nursing Notes" revealed in the "Time Out Complete" box, only the circulating nurse's initials were documented. There was no time documented of when the time out was completed.

A review of Patient #30's closed medical record revealed Patient #30 was admitted to the facility on 06/14/2022 for a right total knee arthroplasty. The "[Facility Name] Surgical Data" form revealed the surgery start time was 8:54 AM. A review of the "Operating Room Nursing Notes" revealed in the "Time Out Complete" box, only the circulating nurse's initials were documented. There was no time documented of when the time out was completed.

A review of Patient #31's closed medical record revealed Patient #31 was admitted to the facility on 07/07/2021 for a left thumb ligament repair. The "[Facility Name] Surgical Data" form revealed the surgery start time was 7:54 AM. A review of the "Operating Room Nursing Notes" revealed in the "Time Out Complete" box, only the circulating nurse's initials were documented. There was no time documented of when the time out was completed.

A review of Patient #32's closed medical record revealed Patient #32 was admitted to the facility on 01/25/2022 for a left total knee arthroplasty and left and right hip bursae (fluid-filled sacs) aspiration. The "[Facility Name] Surgical Data" form revealed the surgery start time was 10:18 AM. A review of the "Operating Room Nursing Notes" revealed in the "Time Out Complete" box, only the circulating nurse's initials were documented. There was no time documented of when the time out was completed.

During an interview on 08/03/2022 at 9:53 AM, the medical record review findings were discussed with and confirmed by Vice President (VP) of Nursing B. When asked how it could be verified by the documentation that the time out was completed prior to the start of the procedure, per facility policy, VP of Nursing B stated, "You're right. There's no way to tell when the time out was done," as facility staff were not consistently documenting the time. VP of Nursing B stated, "This will be fixed when we go to the EHR [electronic health record]."