CMS-Spotsylvania-Regional-Medical-Center

Based on staff interview and document review, it was determined the facility failed to implement its policies and procedures to ensure all staff were fully vaccinated for COVID-19. Ninety four (94) percent of facility staff were fully vaccinated, or exempt from receiving the COVID-19 vaccine and the facility was unable to provide completed medical exemption forms for review.

The findings include:

On 3/7/2022, Staff Member (SM) #2 provided documentation that 619 staff members subject to the vaccine requirements. Five-hundred seventy nine (579) out of 619 applicable staff members (approximately 94 percent (94%)) were fully vaccinated or exempt. The facility maintained no listing for staff temporarily delayed. Approximately six (6) percent of, or forty (40) staff members, were documented as having partial vaccination, unverified documentation, no record, or missing documentation.

During an interview on 3/8/2022 at 10:35 a.m., SM #2 stated that if Human Resources (HR) does not have record or documentation of vaccination, exemption, or delay for a staff member, then HR has been reaching out to the staff's director for the staff member to comply.

During an interview on 3/9/2022, SM #2 stated that Human Resources (HR) does not have access to the medical exemption forms completed for staff members. SM #2 stated that there is no mechanism to sort between medical and religious exemptions and that HR does not have access to the exemption forms uploaded by the staff member. SM #2 stated that the exemption request process is that the staff member uploads the completed request form, then the form is verified by Parallon Service Center, Division of HCA, who then confidentially maintains that documentation. The surveyor was unable to review completed medical exemption forms for any staff member to confirm compliance with the facility's policy and the regulation.

The facility's policy titled, COVID-19 Vaccination Requirements for Employees and Staff of HCA CMS Mandate Facilities, states in part:

Purpose: To ensure that Staff of the HCA CMS Mandate Facilities are Fully Vaccinated against COVID-19, and that HCA CMS Mandate Facilities take steps to ensure that all Staff are Fully Vaccinated for COVID-19.

...Procedure:

1. Vaccination Required.

Each HCA CMS mandate facility shall track Staff vaccination to ensure that all staff specified in this policy, except for those staff who have pending requests for, or who have been granted, exemptions to the vaccination requirements of this policy as provided before, or those staff for whom COVID-19 vaccination must be temporarily delayed, as recommended by the CDC due to clinical precautions and considerations, have received, at a minimum:

a. a single dose COVID-19 vaccine, or the first dose of the primary vaccination series for a multi-dose COVID-19 vaccine prior to the later of January 27, 2022 or the first date such staff provided any care, treatment, or other services for an HCA CMS mandate facility and/or its patients.

b. a single-dose of COVID-19 vaccine, or both doses for a multi-dose COVID-19 vaccine prior to the later of February 28, 2022 or the first date such Staff provide any care, treatment, or other services for the HCA CMS Mandate Facility and/or its patients.

c. Staff newly hired or engaged at or for an HCA CMS Mandate Facility on or after January 27, 2022 will meet these requirements prior to the first date such Staff provide any care, treatment, or other services for the HCA CMS Mandate Facility and/or its patients.

...3. Exemption Requests. Staff may request an exemption form the COVID-19 vaccination requirements in this policy based on an applicable federal law.

...e. The HR [Human Resources] function for each HCA CMS Mandate Facility, as applicable, shall be responsible to track and securely document and maintain exemption requests, information provided in furtherance of such exemption requests, and the response to such exemption request...

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Based on clinical record review and facility document review, the facility staff failed to monitor two (2) of two (2) patients receiving a blood transfusion.

The findings include:

On 1/12/2021 the surveyor reviewed the clinical record for Patient #4. Patient #4 received a blood transfusion on 1/9/2021 and on 1/10/2021. The record contained documentation that on 1/9/2021 vital signs were taken at 1818 (6:18 p.m.) and the transfusion began at 1828 (6:28 p.m.). Vital signs were taken again at 1845 (6:45 p.m.), 1941 (7:41 p.m.), 2045 (8:45 p.m.), and 2203 (10:03 p.m.). The blood transfusion ended at 2205 (10:05 p.m.). On 1/10/2021 vital signs were taken at 1121 (11:21 a.m.) and the transfusion began at 1145 (11:45 a.m.). Vital signs were taken again at 1204 (12:04 p.m.) and 1456 (2:56 p.m.). The blood transfusion ended at 1508 (3:08 p.m.). The vital signs taken each time were temperature, pulse, respiratory rate, blood pressure, and oxygen saturation.

On 1/12/2021 the surveyor reviewed the clinical record for Patient #5. Patient #5 received a blood transfusion on 1/10/21. The record contained documentation that on 1/10/2021 vital signs were taken at 1539 (3:39 p.m.) and the transfusion began at 1541 (3:41 p.m.). Vital signs were taken again at 1556 (3:56 p.m.), 1634 (4:34 p.m.), and 1727 (5:27 p.m.). The blood transfusion ended at 1836 (6:36 p.m.). The vital signs taken each time were temperature, pulse, respiratory rate, blood pressure, and oxygen saturation.

On 1/12/2021, a review of the facility's document titled, Blood/Blood Product Ordering and Administration, was conducted. The policy reads in part: Patient monitoring & Documentation...B. Vital signs: blood pressure, temperature, pulse, respirations, pulse oximetry; 1. At initiation of transfusion (pre transfusion), 2. Every 15 minutes x2, then again in 30 minutes, 3. Hourly from the start of the transfusion until completion of transfusion...

At the exit conference on 1/12/2021 at 3:15 p.m., the surveyor discussed the findings with Staff Members #1 (Chief Nursing Officer), #2 (Vice President, Quality), #3 (Infection Preventionist), #4 (Chief Executive Officer), and #8 (Chief Financial Officer).

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Based on interviews, document review, and during the course of an investigation it was determined that the facility failed to allow the participation of patients in the development and implementation of the plan of care for one (1) out of ten (10) patients, including the findings of a cardiac catheterization test (Patient #1).

The findings are:

In the afternoon of 02/18/20, Staff Member #2 assisted in the review of the Medication Administration Record (MAR) of Patient #1. Review of catheterization report from Staff Member #30 (cardiologist) electronically signed on 09/23/19 at 9:55 PM reveals Patient #1 had right heart catheterization procedure. Documentation note includes date of procedure, procedure performed, indication, technique, and plan. Provider note, however, does not mention if results were communicated with patient and family. Other clinician notes written on 09/23/19, 09/24/19, and 09/25/19 do not mention any communication of results of the cardiac catheterization procedure to patient or family. Interview conducted on 02/12/20 at 12:50 PM with Staff Member #31 (Director of Cardiovascular Department). Staff Member #31 states it is both the expectation and responsibility of the provider to meet and discuss directly the results of the cardiac procedure, and answer any questions related to the procedure in a timely manner, followed by documentation of the encounter.

A review of the provider notes related to the cardiac catheterization procedure do not notate any communication with the patient or family of the procedural results. Interview with facility staff reveal it is the direct responsibility of the physician or advanced practitioner to give procedural results to patient and family, and to document said communication. The surveyor asked Staff Member #31 if a task is not documented on a medical record, is it assumed not to have been done? Staff Member #31 answered that a task is not considered to have taken place if no documentation of that task is noted in chart.

The above findings were discussed with the management team for a final time on 02/20/20 at 2:00 PM. No further evidence was provided to the survey team.

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**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on interviews, document review, and during the course of an investigation it was determined the facility failed to implement restraints in a safe manner, including insufficient restraint order and not being included in the plan of care for one (1) out of ten (10) patients (Patient #3).

The findings are:

In the afternoon of 02/13/20, Staff Member #2 assisted with the review of the restraint documentation of Patient #3. Restraint documentation reveals restraints were ordered on [DATE] at 7:35 PM for agitation. Nursing progress note written by Staff Member #33 writes restraint order discontinued at 7:54 PM. Bilateral upper extremities restraint ordered by Staff Member #27 as late entry on 05/13/2019, without indication of time order written. Restraint order written five (5) days following restraint use, and four (4) day following inpatient death of Patient #3. Order did not include clinical justification for the restraint use, the duration of use, as well as the behavior base criteria for release, as mandated by facility policy.

A review of the facility policy titled, Patient Restraint/Seclusion (with last revision date of 11/2018) reads, The [restraint] order must specify clinical justification for the restraint or seclusion, the date and time ordered, the duration of use, the type of restraint to be used and the behavior-based criteria for release.

Additionally, documentation of Patient #3's medical record did not include restraints as part of plan of care. Facility Patient Restraint/Seclusion policy requires the plan of care for Patient #3 to clearly reflect a loop of assessment, intervention, and evaluation for restraint... Staff Member #2 confirms this information is not included in the plan of care of Patient #3 despite having restraints applied on 05/08/19 in the Emergency Department.

The above findings were discussed with the management team for a final time on 02/20/20 at 2:00 PM. No further evidence was provided to the survey team.

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Based on interviews and review of hospital documents it was determined hospital staff failed to break down aggregated data for restraints allowing for comparison of units implementing restraints.

The findings are:

On 2/18/20 in order to facilitate a review of restraint use in the hospital, the survey team asked to be provided with the log of patients who had been restrained in the last year. The survey team was provided a list of patient names. The surveyor asked Staff Member (SM) #2 to provide information as to whether the restraint were violent or non-violent. SM #2 stated the only way to do that would be to open each individual restraint episode to look at it. The morning of 2/19/20 the survey team was provided with a list of patient names, the location of the patient and the type of restraint. The surveyor was told this information had been collected manually.

The surveyor asked SM #1 if restraint information was trended. SM #1 told the surveyor that he/she reviewed restraint information each morning and would be aware of trends if they occurred. SM #1 stated he/she was not aware of any trends related to restraints. The surveyor noted the information provided did not include restraints implemented in the Emergency Department. The surveyor was aware of a restraint implemented on an Emergency Department patient through chart review. The surveyor asked SM #1 if the restraint information could be further broken down into subsets i.e. location: emergency department, ICU, med/surg, behavioral health. For behavioral health restraints where did the restraint occur i.e. common area, hallway, nurses station, etc. SM #1 was able to provide evidence that more detailed restraint documentation was occurring but agreed with the surveyor that the information was not trended except in the memory of staff present during the review of restraints each day. Only the number of restraint episodes is trended and presented during quality review.

The surveyor and SM #1 discussed the importance of being able to breakdown into subsets the information related to restraint implementation. The surveyor discussed the risk involved with the implementation of restraints and the need to examine restraint episodes carefully even though restraint use is infrequent in this hospital.

The above information was shared with SM #1 and SM #2 during the course of the survey and with the management team prior to exit. No further evidence was provided to the survey team.

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Based on interviews, document review, and during the course of an investigation it was determined the facility failed to administer blood products in accordance with facility policy and procedures by not maintaining vital signs monitoring for one (1) out of ten (10) patients (Patient #2).

The findings are:

In the morning of 02/12/20, Staff Member #2 assisted in the review of six blood transfusions for Patient #2. Blood transfusion records of Patient #2 reveal vital signs were not taken in accordance with facility guidelines for six (6) of six (6) blood transfusions.

One of six blood transfusions for Patient #2 initiate it on 01/23/20 at 1:17 PM did not include thirty (30) minutes vital signs. Two (2) of six (6) blood transfusion initiated on 01/25/20 at 6:58 AM did not include any vital signs after the initiation of the blood transfusion. Three (3) of six (6) blood transfusion initiated on 01/25/ 20 at 3:13 PM and only including initiation vital signs, and fifteen (15) minutes following transfusion start. Four (4) of six (6) vital signs initiated on 01/25/20 at 8:02 PM did not include any vital signs with the exception of the start of the transfusion, as well as 15 minutes following. Blood transfusion five (5) of six (6) initiated on 01/28/20 at 5:38 PM did not include either fifteen (15) minute vital signs, or the thirty-(30)-minute following set. Blood transfusion initiated on 01/30/ 20 at 5:58 AM did not include the fifteen (15) minute vital signs nor the thirty-(30)-minute vital signs. Six (6) of six (6) blood transfusions administered to Patient #2 unsafely without proper close vital signs monitoring, as written by facility policy and procedures.

Facility policy titled, Blood/Blood Product Ordering in Administration (with last revision date of one 2019) states vital signs to include blood pressure, temperature, pulse, respirations, and pulse oximetry to be initiated at the start of the transfusion, every fifteen (15) minutes for two occasions, again thirty (30) minutes following, and hourly until the completion of the transfusion.

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**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on medical record review and interview, it was determined facility staff failed to document in the patients' plan of care (POC) the use of restraints for three (3) out of four (4) patients sampled (Patients #1, 3, 11).

The findings include:

Patient #1 was admitted to the facility on [DATE] with diagnosis including, but not limited to, vomiting clots of bright red blood, diarrhea, and abdominal pain. A review of the medical record revealed an order dated 2/22/19 at 3:28 p.m. for soft BUE (bilateral upper extremity) non-violent restraints, with a time limit of 24 hours. It was discovered restraint use was not documented as part of Patient #1's plan of care.

Nursing restraint documentation revealed that restraints were discontinued at 11:20 a.m. on 2/23/19, after Patient #1 met criteria for restraint release.

An interview was conducted on 2/26/19 at 9:45 a.m. with Staff Member (SM) #9, chart navigator, who stated there is not documentation in the care plan that restraints were on.

Patient #3 was admitted to the facility on [DATE] as a transfer from another facility with medical history including, but not limited to, congestive heart failure, diabetes, chronic kidney disease, and dementia. A review of the medical record revealed that Patient #3 was placed in soft BUE restraints on 2/17/19 at 6:00 a.m. by SM #19, a Registered Nurse (RN), in the intensive care unit (ICU). SM #20, a nursing supervisor, signed off as the second tier reviewer.

The record included documentation that Patient #3 was restrained on 2/17/19, 2/18/19, 2/19/19, 2/20/19, 2/22/19, 2/23/19, and through 2/24/19 at 6:00 a.m.

There was no order for or documentation of when restraints were discontinued. In an interview with SM #9, chart navigator, he/she stated Based on the orders, I don't see when restraints were removed. The 24th would have been when (he/she) was moved to hospice.

The use of restraints were not included in Patient#3's plan of care.

Patient #11 was admitted to the facility on [DATE] with diagnosis including, but not limited to, diabetic ketoacidosis, sepsis, hypotension, hyponatremia, and hyperkalemia. A review of Patient #11's medical record revealed an order for violent restraint written 1/5/19 at 10:47 p.m. for bedrails and soft BUE for a time frame of four (4) hours due to attempt to self harm and attempts to remove device. The order was renewed on 1/6/19 at 2:00 a.m.. On 1/6/19 at 7:11 a.m., the restraint order was modified and changed to non-violent BUE with a 24 hour time limit due to unsafe mobile attempts. The restraints were discontinued on 1/7/19 at 2:00 a.m. Patient #11 was discharged from the facility on 1/9/19.

The plan of care for Patient #11 did not contain documentation of the use of restraints. On 2/25/19 at 1:35 p.m. during an interview, SM #10, a chart navigator, stated there is no care plan for restraints.

Concerns were discussed as noted above, and again with members of administration on 2/28/19 at 10:30 a.m.

The facility's policy and procedure (P&P) entitled Patient Restraint/Seclusion was reviewed, and included the following under the heading ...10. Care of the Patient/Plan of care: a. The plan of care will clearly reflect a loop of assessment, intervention, and evaluation for restraint, seclusion and medications. b. Patients and/or families should be involved in care planning to the extent possible and made aware of changes to the plan of care.... Under the heading ...12. Documentation Requirements: The medical record contains documentation of: ...l. Modifications of the plan of care....

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**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on medical record review and interview, it was determined that facility staff failed to ensure that the restraint order for two (2) of five (5) patients sampled matched restraint documentation for that patient (Patients #9 and 10), and that initial restraint orders were issued for one (1) our of five (5) patients sampled (Patient #3).

(Patient #3).

Findings included:

Patient #9 was admitted to the facility on [DATE] with diagnosis including, but not limited to seizures. The medical record was reviewed, which included documentation that Patient #9 was combative in the rescue squad prior to arrival, and that the EMT (emergency medical technician) advised that the patient was given Versed prior to arrival.

The record included an order dated 2/20/19 at 12:40 p.m. for a physical hold/violent restraint, time limit 15 minutes for combativeness.

At 12:56 p.m. on 2/20/19 a second restraint order was noted for violent restraints, including bedrails, physical holding, and quick release synthetic BUE (bilateral upper extremity) restraints, time limit four (4) hours. Unfortunately, Nursing documentation at 3:18 p.m. on 2/20/19 was that Patient #9 was in 4 point restraints. Additionally, restraint documentation dated 2/20/19 at 2:50 p.m. for discontinuation of violent restraint was for violent restraint device soft, all extremities.

Patient #10 entered the facility ED via ambulance on 2/25/19 due to drug overdose. A review of Patient #10's medical record revealed the following documentation when the nurse attempted to start a new IV( intravenous) line on 2/25/19 at 11:46 a.m.; patient became combative requiring 6 staff to hold (him/her) while placing new IV. Pt was continuously combative and required restraints for pt and staff safety. Dr. ordered restraint order {sic} and Nursing supp aware. Pt medicated and resting comfortably currently. Pt safe and restraints properly applied....

The physician order for restraints was reviewed and the surveyor noted the following initial order:

Clinical justification: Combative; Level of restraint: Violent/self destructive; Violent restraint device: Bedrails, Quick release synth all ext; Violent restraint time limit 4 hours.

Both the initial nurse restraint assessment on 2/25/19 at 11:37 a.m. and the second tier assessment on 2/25/19 at 11:40 a.m. document that Patient #10 had soft BUE restraints.

The two (2) hour nursing restraint assessment at 1:46 p.m. on 2/25/19 that the patient was in soft BUE, drowsy/sleeping, and that the least restrictive restraint was in use.

BUE restraints were documented as discontinued on 2/25/19 at 3:30 p.m., after Patient #10 met criteria for restraint release.

Patient #3 was admitted to the facility on [DATE] as a transfer from another facility, with medical history including, but not limited to congestive heart failure, diabetes, chronic kidney disease, and dementia.

A review of the medical record revealed that Patient #3 was placed in soft BUE restraints on 2/17/19 at 6:00 a.m. by SM #19, a Registered Nurse (RN) in the intensive care unit (ICU). SM #20, a nursing supervisor, signed off as the second tier reviewer.

The surveyor was unable to find evidence in the record of a physician order for the restraint which documented as placed by SM #19 on 2/17/19 at 6:00 a.m. A discussion was held with SM #9, the chart navigator, between 10:00 a.m. and 10:30 a.m. on 2/26/19 while reviewing restraint documentation for Patient #3. At 10:05 a.m., SM #9 stated You are correct, nursing documentation shows restraints were started at 6:00 a.m. on 2/17/19. At 10:30 a.m., SM #9 stated There was no restraint order until 2/18/19 at 9:47 a.m.; that order was written as a renewal, not an initial restraint order.

Concerns were discussed as noted above, and again with members of administration on 2/28/19 at 10:30 a.m.

The facility's restraint P&P was reviewed, and included the following under ...Procedure: ...4. Second Tier of Review: A member of nursing administration/management (e.g., nursing supervisor/manager, charge nurse, manager/director, CNO, etc.) will review the need for restraint or seclusion with the RN who has determined that the patient requires restraint or seclusion. Renewals of restraint or seclusion orders do not require a second tier of review....

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**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on medical record review and interview, it was determined that patient medical records failed to include documentation of safety check for restrained patients for two (2) of five (5) records sampled (Patient #1 and 3).

The findings include:

The medical record for Patient #1, who was admitted on [DATE], was reviewed and revealed a physician order for violent restraint written 1/5/19 at 10:47 p.m. and renewed on 1/6/19 at 2:00 a.m. On 1/6/19 at 7:11 a.m., the restraint order was modified, and changed to non-violent restraint.

Patient #1's medical record lacked documentation, either on paper or in the EHR, that he/she was monitored during the period between 10:47 p.m. and 7:00 a.m. while in violent restraints, except for the initial assessment at

10:47 p.m., and at the time of the order renewal.

The medical record for Patient #3, who was admitted [DATE], was reviewed and revealed that he/she was restrained with soft bilateral upper extremity restraints (BUE) between 2/17/19 at 6:00 a.m. and sometime on 2/24/19 at or after 6:15 p.m.

The medical record lacked restraint documentation from 12:00 a.m. on 2/19/18 until 8:00 a.m. on 2/19/19.

The record lacked restraint documentation on 2/19/19 after the 6:00 p.m. entry until 11:50 p.m. on 2/19/19.

There was no restraint documentation on 2/21/19 at 6:00 p.m. The last documented restraint documentation was on 2/24/19 at 6:15 p.m. There was no nursing note or other documentation which indicated when restraints were discontinued. On 2/26/19 at 11:15 a.m., Staff Member #9, the chart navigator, stated Based on orders, I don't see when the restraints were removed. The 24th would have been when (he/she) was moved to hospice.

Concerns were discussed as noted above, and again with members of administration on 2/28/19 at 10:30 a.m.

The facility's Policy and Procedure (P&P) entitled Patient Restraint/Seclusion was reviewed. Under the heading ...7. Monitoring the Patient in Restraints or Seclusion the following information was present: ...d. A trained staff member monitors each patient in restraint or seclusion at least three (3) times an hour for safety, and to confirm that the patient's rights and dignity are maintained. This check will be documented in either electronic record or on paper. If a paper checklist is used as a summary, recording time and observation from each of the three (3) times an hour check, may be recorded at the end of the shift and the checklist scanned into the EHR/HPF patient record....

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**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on medical record review and interview, it was determined that facility staff failed to ensure a discharge planning evaluation was completed for one (1) of five (5) patients sampled (Patient #2).

The findings included:

Patient #2 was admitted on [DATE] in transfer from another acute care Emergency Department (ED) after a TDO (Temporary Detaining Order) was obtained. Admitting diagnoses included [DIAGNOSES REDACTED]

The clinical record was reviewed and evidenced the following, in part:

Further review of the clinical record revealed a BH (Behavioral Health) Psychosocial Assessment dated 12/31/18 as 1202 (12:02 p.m.) which also included family support, Living situation, safety concerns, and a Preliminary Discharge Plan which was Patient will dc (discharge) to sisters home and follow-up with (initials of Behavioral Health Authority) PACT.

A BH (Behavioral Health) Recovery Plan/Review was contained in the clinical record dated 1/5/19 and another on 1/12/19. These Behavioral Health Plans documented the patients Problems/alterations and target dates and progress toward meeting the goals. Patient #2's plan had documented on 1/5/19: Problem #1 Thought Processes- Related to: Characterized by impairment or disruption in cognitive operations and activities- As Evidenced By: Altered attention span, impaired judgement, non-reality thinking, periods of confusion with disturbed sensory perception....Problem #2 Mood- Characterized by unstable sustained abnormal emotional tone and symptoms wither depressive or bipolar- as evidenced by: altered attention span, impaired judgement or ability to think, reason and problem solve. Problem #3 Home Maintenance- related to discharge planning and follow up treatment- as evidenced by patient has an appropriate discharge plan that is understood by both the patient and family. Each of the three problems had a target date of 1/17/19 for the short term goals and 1/19/19 for the long term goals. Under the area for Progress toward goal, for each problem, there was no documentation indicating how the patient had been progressing toward meeting any of the goals. The Behavioral Health Plan dated 1/12/19 had the same three problems documented, with the same target dates and under Progress toward goals there was no indication on this plan as to the progress of the patient in meeting the set goals.

The surveyor requested the discharge assessment and any documentation related to the discharge planning for Patient #2 and was told in an interview with Staff Member #13 on 2/26/19 at 12:15 p.m., that All the information should be included in the patient's clinical record. I don't have any additional information. The surveyor was unable to locate a document which evidenced a complete Discharge Planning Assessment or and revisions to an assessment for Patient#2. There was no evidence of any contact made with the patient's family where the patient had been living prior to admission.

The survey team discussed the concerns regarding the discharge with the facility Administration on 2/27/19 at 3:40 p.m.

Review of the facility policy and procedure Case Management Discharge Planning and the Continuum of Care was reviewed and evidenced, in part: Discharge Planning provides for continuing care based upon the patient's assessed needs...Important factors such as functional status, cognitive ability of the patient and family support will be considered...the discharge plan must be thorough, clear, comprehensive and understood... A. 1. RN Case Manager/Social Worker- completes the [DIAGNOSES REDACTED]il assessment and identifies continuum of care and discharge planning needs...c, Case Management: The Case Manager/Social Worker completes a discharge planning assessment, initiates the plan and obtains approval for services...B. 1. Evaluation of a Discharge Plan- The case manager will conduct an ongoing assessment and reassessment of the patient's condition every 3-5 days or as necessary to determine if modifications to the plan are necessary. The plan will be revised as necessary...The case manger/social worker will assess the patient's readiness for discharge by assessing the patient's understanding of their health related condition as it pertains to their post discharge treatment plan, medical regime and follow-up services...

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**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on medical review and interview, it was determined the facility staff failed to ensure a patients' discharge plan was reassessed when the patient continued to demonstrate behavioral health issues which were present throughout the hospital stay and effected the appropriateness of the discharge plan for one (1) of five (5) patients sampled (Patient #2).

The findings included:

Patient #2 was admitted on [DATE] in transfer from another acute care Emergency Department (ED) after a TDO (Temporary Detaining Order) was obtained. Admitting diagnoses included, but were not limited to: Schizoaffective Disorder-Bipolar Subtype, PTSD (Post Traumatic Stress Disorder), hypertension and diabetes mellitus (by history).

Patient #2 was admitted to the Behavioral Health Unit with significant psychiatric concerns and behaviors which continued throughout the more than two (2) week hospital stay. The patient was discharged on [DATE] to PACT and had to be immediately taken to another facility for an ECO (Emergency Custody Order) and subsequent TDO (Temporary Detaining Order) due to aggressive, paranoid, and delusional behaviors.

The clinical record was reviewed and evidenced the following, in part:

Behavioral Health Initial Assessment - Date of Service: 12/30/2018...admitted to Spotsylvania Regional Medical Center's Behavioral Health Unit on a temporary detaining order...(Name of Patient # 2) apparently has a fairly long-standing psychiatric history. (He/She) has been ascribed a diagnosis of schizoaffective disorder, although (his/her) records also indicate schizophrenia....(He/She) is an open case with (name of service)...(he/she) has fallen out of adherence with (his/her) psychotropic medication. (He/She) apparently does quite well from a symptomatic standpoint when (he/she) is medication adherent. However, with medication nonadherence, (he/she) has developed acute symptoms including paranoid ideations, mood liability, disorganized through processing and persecutory delusions. (He/She) was taken to (Name of Hospital ED). Subsequent to medical clearance, (he/she) was evaluated by local Community Mental Health Center. (He/She) was placed on a detention order and then transferred to this facility for further evaluation and treatment. Mental Status Exam: The patient was hyper alert, pressured, irritable demeanor. Thought processing loose and tangential. Paranoid themes were prominent....no current thoughts of harm to self or others, although acute agitation with the emergency medications noteworthy within the past 24 hours. Judgement and insight are grossly impaired...Initial Treatment Plan: The patient's safety will be closely monitored. (His/Her) psychosocial supports will be assessed. Psychotropic medication will be instituted and modified as warranted...The importance of medication adherence will be emphasized to the patient. (He/She) will be encouraged to actively participate in group and milieu therapy. Assets and Strengths: (He/She) has a history of improved functionality when on medication. Family is concerned about (his/her) condition...

An Initial Nurse Assessment dated 12/30/18 at 1844 (6:44 p.m.) documented, in part: Pt (patient) arrived on the unit by transport and police officer and was in a wheelchair. Pt initially refused to get out of the wheelchair and to let staff take (his/her) vital signs, after a few minutes pt allowed staff to get vitals and moved out of the wheelchair...pt refused to complete safety search with staff...security came to room to assist and patient was still uncooperative. Pt was escorted by several staff members to the quiet room to do the safety search. Pt had no clothing under (his/her) hospital gown and had (blood) between (his/her) legs. Pt appeared unkempt with poor hygiene...posturing with staff and making fists as well as cracking (his/her) knuckles....when escorted to (his/her) room (he/she) willingly took injections to help (him/her) calm down. Pt then layed (sic) down on the bed and has been in (his/her) room for the past several hours. Pt refused assessment question. Prescreen stated that pt was found wondering (sic) in the middle of the road and refusing to speak with anyone...at the hospital pt reports a delusion that (he/she) was raped, is pregnant and was having a miscarriage. A pregnancy test was done which was negative, along with the fact the pt has a birth control implant. Pt is exhibiting paranoia, delusions and is very guarded...

1/15/19 0851 (8:51 a.m.) Social Worker's Notes: ...1140 (11:40 a.m.) Patient discharged today in care of (Behavioral Health Authority) PACT team. Patient was eager to discharge and treatment team agreed patient was at baseline and ready for today's discharge. Met PACT team outside the unit as they were transporting patient to Crisis Stab (Stabilization)...PACT team noted that patient was not at 100% (one-hundred percent) baseline...

On 2/26/19 at 11:30 a.m., the surveyor interviewed Other Interviewee A (OI-A) who stated, The patient was unstable at the time of discharge. If you speak with the PACT team they will tell you that they had to immediately seek help for inpatient hospitalization . The hospital had contacted us prior to the patient's discharge to see if we would emergently admit (him/her) but they were told we do not do emergent admissions. We can only admit under a TDO (temporary detaining order) and the patient was already hospitalized at that time. After the PACT team picked the patient up at the hospital, they saw (he/she- Patient #2) was unstable and tried to get them to reconsider the discharge but they refused. We ended up getting the patient after (he/she) was again TDO'd to our facility....this is the information I was given regarding the patient on admission to our facility...it is my understanding, from the records, that the patient expressed homicidal ideations, was in an angry mood and had soiled (him/herself) twice when they picked (him/her) up at the hospital when discharged . The hospital refused to reconsider the discharge. According to the pre-screening, the patient was manic, expressed suicidal and homicidal ideations , was agitated, paranoid and delusional...

On 2/26/19 at 11:40 a.m., the surveyor interviewed Other Interviewee B (OI-B). OI-B was a Licensed Clinical Social Worker (LCSW) for the Behavioral Health Authority in the City to which the patient was transported after being discharged from the hospital. OI-B stated, My only interaction was as the pre-screener. When I saw the patient, (he/she) was not in a situation that (he/she) should have been discharged . (He/She) was not stable... The patient after being transported here, was immediately ECO'd (Emergency Custody Order) and transported to the emergency room (ER) of (name of hospital). The patient had soiled (him/herself) prior to being discharged and was incoherent. The patient stated that (he/she) wanted to kill someone and had suicidal ideation, but no plan. (He/She) was manic and with the history of assault on police officers, and the inability to protect (him/herself) from harm and meet basic needs. (He/She) was oriented X3 (times three) but was manic, paranoid, restless, agitated and requested not to talk to anymore and then refused to continue to speak to me. When (he/she) was discharged as an inpatient they (discharging hospital) had said the patient was at (his/her) baseline. When the PACT team arrived, they found the patient not at baseline, had soiled (him/herself) and the hospital refused to reconsider the discharge. Upon return to the community, the patient was immediately ECO'd. The PACT team shared progress notes that I will share with you: 'Client presented soiled, aggressive and irate with staff. When asked about changing clothing the patient stated I'll be fine. When the writer reported this to the hospital staff they stated its all behavioral and the hospital continued to push for the discharge. OI-B continued, The patient presented as bizarre and delusional and had no ability to consent. We have provided services to this client in the past and (he/she) was clearly not at (his/her) baseline. I personally would have not been comfortable transporting the patient...

On 2/26/19 at 3:18 p.m., the surveyor interviewed OI-C (PACT Team Supervisor). OI-C stated, The hospital called us the week prior on Friday. At that time they reported (the patient) was stabbing (him/herself) with needles and throwing chairs on the unit, and they wanted us to come and get (him/her). We explained to them (he/she) was not at (his/her) baseline and that we could not take (him/her) on the CSU (Crisis Stabilization Unit) due to the aggressive behaviors as that unit is not designed to handle those behaviors. I told them to call the police because we cannot take the patient with behaviors like that. They continued to push the discharge and on 1/15 when we got there to assess (him/her) (he/she) had soiled him/herself) was aggressive and irate. My team attempted to advocate for the patient, for them to reconsider the discharge as clearly the patient was not in a good space, but they told the team that all this was behavioral. We tried to explain that the patient was not at baseline and was delusional. We took (the patient) because they refused to reconsider the discharge and they said (he/she) was ready and to take (him/her). We had to call for an ECO immediately when we got back to (city). (He/She) was uncooperative, aggressive, and trying to elope. It was clear the patient did not have capacity. When this patient is at (his/her) baseline, (he/she) is extremely independent, takes (his/her) medications, is not paranoid, can transport (him/herself) to appointments and treatment, and coordinate all (his/her)own ADLs (activities of daily living). I was present during the ECO and I witnessed the behaviors. The pre-screener saw (the patient) at (name of hospital). (He/She - Patient #2) had soiled pants, and didn't respond to (his/her) name. The patient was clearly below (his/her) baseline. The discharging hospital had told the PCT team that all this was behavioral and we are proceeding forward with the discharge. I called the supervisor of the (discharging hospital) Behavioral Health Unit with my concern and I never received a return phone call. I also called (Name) (Region 4) and never received a return phone call....this is not the first time this has happened when we have had a client from this facility that had to be TDO's the same day they were discharged ...This patient (Patient #2) had not been hospitalized in over a year...

A BH (Behavioral Health) Recovery Plan/Review was contained in the clinical record dated 1/5/19 and another on 1/12/19. These Behavioral Health Plans documented the patients Problems/alterations and target dates and progress toward meeting the goals. Patient #2's plan had documented on 1/5/19: Problem #1 Thought Processes- Related to: Characterized by impairment or disruption in cognitive operations and activities- As Evidenced By: Altered attention span, impaired judgement, non-reality thinking, periods of confusion with disturbed sensory perception....Problem #2 Mood- Characterized by unstable sustained abnormal emotional tone and symptoms wither depressive or bipolar- as evidenced by: altered attention span, impaired judgement or ability to think, reason and problem solve. Problem #3 Home Maintenance- related to discharge planning and follow up treatment- as evidenced by patient has an appropriate discharge plan that is understood by both the patient and family. Each of the three problems had a target date of 1/17/19 for the short term goals and 1/19/19 for the long term goals. Under the area for Progress toward goal, for each problem, there was no documentation indicating how the patient had been progressing toward meeting any of the goals. The Behavioral Health Plan dated 1/12/19 had the same three problems documented, with the same target dates and under Progress toward goals there was no indication on this plan as to the progress of the patient in meeting the set goals.

The surveyor requested the discharge assessment and any documentation related to the discharge planning for Patient #2 and was told in an interview with Staff Member #13 on 2/26/19 at 12:15 p.m., that All the information should be included in the patient's clinical record. I don't have any additional information. The surveyor was unable to locate a document which evidenced a complete Discharge Planning Assessment or/and revisions to an assessment for Patient#2. There was no evidence of any contact made with the patient's family where the patient had been living prior to admission.

The surveyor reviewed the clinical record for Patient #2 from the second facility to which the patient was sent for evaluation after discharge on 1/15/19. The clinical record evidenced the following:

History and Physical dated 1/15/19 at 1433 (2:33 p.m.) (age) (gender) h/o (history of bipolar disorder presents to the ED (Emergency Department) with RPD (Police Department) for medical clearance/ECO (Emergency Custody Order). (He/She) is uncooperative and will not answer questions. Reviewed old records, recently here and admitted to psych and dc'd (discharged ) this morning...1603 (4:03 p.m.) No medical problems identified which would require immediate intervention or which would preclude psychiatric evaluation..pt medicated with 10mg Geodon prior tome assuming care of patient (provider handoff 2035 -8:35 p.m.), (he/she) was throwing things at nursing staff thus an additional 10mg of Geodon ordered. Pt was calmer for a few hours. However, now (he/she) is yelling at the police and nursing staff, (he/she) will not stay in (his/her) room and is becoming an issue for other patients thus haldol and benadryl have been ordered at this time...Disposition request time 1800 1/15/19 - receiving Hospital- Central State- Transfer accepted- Yes- Acceptance time 0200- date 1/16/19...

According to the triage record Patient #2 was brought to the ED at 1427 (2:27 p.m.) under a ECO. Nurses notes revealed the patient, while in the ED was Pacing, yelling, Screaming, throwing blankets, Yelling (he/she) about to deliver a baby.

Medication Administration Records revealed the patient received the following:

Geodon 10mg IM at 1935 (7:35 p.m.)

Geodon 10mg IM at 2033 (8:33 p.m.)

Haldol 5mg IM at 0106 (1:06 a.m.) and

Bendaryl 25mg IM at 0113 (1:13 a.m.)

The clinical record documentation evidences Patient #2's aggressive behaviors and paranoia persisted throughout (his/her) hospitalization requiring multiple doses of PRN (as needed) antipsychotic and antianxiety medications. Behaviors on 1/13/19 (2 days prior to discharge) were documented as extremely liable...calm pleasant one moment then screaming and threatening the next. On 1/14/19, the day prior to discharge, the staff continued to document the patient was labile and irritable and still needing PRN medications. Behaviors were described as intrusive and aggressive, and continuing to curse at staff. It was documented the patient was engaged in treatment however, the clinical record evidences the patient did not participate in any group therapies while hospitalized , had refused medications and staff were concerned the patient was cheeking medications. According to interviews with Staff Member #13 the patient's baseline was mood stabilized, less agitated and thoughts were clearer, however upon discharge and according to the prescreening information at the facility to which the patient was immediately transferred (after an ECO was obtained), the patient was expressing suicidal and homicidal ideations, was manic, restless, and agitated. While in that ED, the patient was uncooperative, will not answer questions, throwing things at nursing staff, yelling and required emergency medications for management of the behaviors.

In interviews with the receiving agency, and upon further review of the clinical record from the receiving facility, the patient was still experiencing aggressive, paranoid and manic behaviors. It was documented in interviews and supporting evidence the patient was incontinent at discharge, which was not a behavior that had been documented during the patient's hospitalization . According to further evidence, the patient was discharged at 11:25 a.m., on 1/15/19 and arrived at the other facility under an ECO at 2:33 p.m. on the same day. The patient required a TDO be obtained and was admitted to another facility for further treatment.

The survey team discussed the concerns regarding the discharge with the facility Administration on 2/27/19 at 3:40 p.m..

Review of the facility policy and procedure Case Management Discharge Planning and the Continuum of Care was reviewed and evidenced, in part: Discharge Planning provides for continuing care based upon the patient's assessed needs...Important factors such as functional status, cognitive ability of the patient and family support will be considered...the discharge plan must be thorough, clear, comprehensive and understood...1. Evaluation of a Discharge Plan- The case manager will conduct an ongoing assessment and reassessment of the patient's condition every 3-5 days or as necessary to determine if modifications to the plan are necessary. The plan will be revised as necessary...The case manager/social worker will assess the patient's readiness for discharge by assessing the patient's understanding of their health related condition as it pertains to their post discharge treatment plan, medical regime and follow-up services...

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Based on interview and document review it was determined the facility staff failed to ensure nine (9) of thirty (30) patients who entered the Emergency Department and were seen by a mid-level provider, had an assessment documented by the mid-level provider. (Patient #1, #3, #4, #11, #12, #21, #22, #24 and #29).

The findings included:

A review of electronic medical records (EMR) was conducted on 06/06/17. For the nine patients, who were seen by mid-level providers in the Rapid Initial Assessment (RIA) area, no evidence was found of an initial assessment by the mid-level provider. This impacted the following patients: Patient #1 (Date of Service (DOS) 02/01/17); Patient #3 (DOS 02/21/17); Patient #4 (DOS 05/28/17); Patient #11 (DOS 05/09/17); Patient #12 (DOS 05/10/17); Patient #21 (DOS 01/02/17); Patient #22 (DOS 02/20/17); Patient #24 (DOS 12/26/16); and Patient #29 (DOS 04/10/17).

The survey team, along with assistance from facility Staff Member #4, Staff Member #6, Staff Member #8 and Staff Member #14, who were navigating the EMR, were unable to locate documentation revealing the initial assessment by the mid-level provider. The survey team requested the policy and procedure related to patient assessments.

An interview was conducted on 06/06/17 at 9:10 a.m. with Staff Member #6 regarding the mid-level provider's assessment documentation. Staff Member #6 stated, There is no template to document the initial greet. There used to be a template. If the provider that is going to see them (patient) and is going to keep them (patient), then they (provider) will start the assessment; otherwise one is not done until the patient is seen by the medical provider. Within the past 4-5 months I (Staff Member #6) noticed there was no template. The medical director and DAC (IT staff who create the document) were made aware.

Staff Member #13 (Vice President of Quality), was interviewed on 06/07/17 at approximately 8:45 a.m. Staff Member #13 reported he/she became aware of the issue with the assessment documentation template when it disappeared around December (2016) or January (2017). Staff Member #13 stated, They are currently working on implementing a correction to this missing documentation and it will be corrected. Staff Member #13 reported the facility's policy and procedures did not emphasize the mid-level providers' initial assessment for patients entering into the ED and being placed in the RIA area.

The survey team discussed the concerns regarding mid-level providers failing to document an initial assessment for patients being seen in the ED with Staff Members #4, #6, #8, #13 and #14 during the EMR review. Concerns were again discussed at the end of the day meeting with the Administrative Team.

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1d. In the mid afternoon on 10/19/11, in the first floor ladies public bathroom, the surveyor observed a nursing staff educator cleaning and disinfecting CPR equipment using the sink plus a plastic tub, sitting on the counter, for disinfecting. There was a jug of bleach present, and the surveyor asked the staff member what strength bleach water she used to disinfect the equipment. She replied she wasn't sure. She said she filled the plastic tub up to about 3/4 full and added an ounce of bleach. No policy for disinfecting CPR equipment was presented.

Based on observations, staff interviews and review of product label information the facility staff failed to ensure

1 a. ice machine in the emergency department had an air gap,

1 b. kitchen staff used the appropriate amount of chemical concentration in the water to clean and disinfect pots, pans and dishes and that pots and pans were not stored stacked and wet and that clean towel and aprons were not stored with dirty mops, brooms and dust pans

1 c. appropriate amount of disinfectant chemicals per recommended water amounts were used to clean surgical instruments.

2. appropriate and recommended bleach to water ratio was used when cleaning instruments used in teaching CPR

The Findings Include:

1a. During the initial tour on 10/18/11 of the facility's Emergency Department (ED), Dietary Services and Surgical Departments with the Senior Leader of Surgical/Outpatient Services the ice machine in the fast track area of the was observed. The drain pipe from the ice machine was observed touching the side of the drain hole. The end of the drain pipe was below the floor level.

The Senior Leader of Facility Services and Environmental Services was called to the area. He observed the ice machine and was asked if it had an air gap. He stated, No but it will shortly.

1b. During the initial tour of the kitchen with the Senior Leader of Surgical/Outpatient Services and the Dietary Manager the 3 part sink was observed. The Dietary Manager was asked how the staff knew how much water was to be placed in the sink with the automatically measured chemical for cleaning. She stated, There should be a mark in the sink so they would know how much water to put in the sink and there is no mark.

Also during the tour of the kitchen a small room was observed the Dietary Manager stated the room was the chemical room. The room held dirty wet mops, mop buckets, brooms, dust pans, cleaning chemicals and a bin of uncovered clean towels and aprons. The Dietary Manager stated, They are bar towels used to wipe off the bars around the food. They probably should not be in here with the wet mops.

1c. On 10/18/11 during the initial tour with the Senior Leader of Surgical/Outpatient Services the decontamination room was observed. The staff member responsible for cleaning instruments was present. The staff member explained the appropriate amount of the cleaning chemical (Prolystica Ultra Concentrate Enzymatic Cleaner) is dispensed when a button on the dispenser is pressed. She was asked how much water was used and she stated, About one gallon. The staff member was asked to show how much a gallon of water was in the large 3 part sink. The staff member pointed and stated, About at the bottom of this wash cloth. A wash cloth was hanging on the dividing wall between two parts of the sink. She was asked to close the sink and measure out 1 gallon of water. She looked around and could not locate an instrument to measure the water with. She located an empty 1 gallon jug, filled it was water and poured it into the closed sink. The water barely covered the bottom of the sink. She stated, That is not enough water.

The enzymatic presoak and cleaner label states in manual/ultrasonic applications to dilute 1/8 to 1/2 fl. oz. per gallon of warm water.

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Based on review of the Governing Body By-laws and Medical Executive Committee meetings and Medical Staff credential files, it was determined that the Governing Body failed to ensure that the mechanism used to review credentials and to delineate individual clinical privileges was effective.

The findings include:

1. The Governing Body By-laws read: 9.3 MEDICAL EXECUTIVE COMMITTEE RECOMMENDATIONS: 9.3.1. The Medical Executive Committee shall be required to make recommendations directly to the Board for its approval. At a minimum, such recommendations shall pertain to the following issues, 9.3.1.2. The mechanism used to review credentials and to delineate individual clinical privileges, 9.3.1.3. Recommendations of individuals for medical staff membership, and 9.3.1.4. Recommendations for delineated clinical privileges for each eligible individual.

2. Review of advanced practice professionals credential files revealed that in the years 2010 and currently in 2011, both physician assistants and nurse practitioners were given appointments and granted clinical privileges by the Board without documented evidence of approval of their protocol and prescriptive authority by the Virginia Board of Medicine and/or the Virginia Board of Nursing and Medicine respectively.

3. Review of the Medical Staff By-laws, and credential files of seven (7) physician assistants, four (4) nurse practitioners and three (3) physicians, and interview with the Medical Staff Coordinator, it was determined that the facility failed to ensure compliance with verification of an approved practice agreement with a supervising physician, including protocol for clinical privileges and prescriptive authority, through the appropriate Board at the Virginia Department of Health Professions for the physician extenders. The facility also failed to ensure compliance with their by-laws for use of temporary privileges with both physicians and physician extenders. The credential files of all practitioners lacked documentation of when the practitioner's file was reviewed and approved by the Medical Executive Committee and the Board of Trustees. There was also no documentation in the credential files of when temporary privileges were granted or when the practitioner began practicing at this facility. The findings included:

A. Review of two physician assistant (PA) credential files from 2010 revealed that in two of the two files there was no documented evidence of submission and approval for clinical privileges protocol, and supervising physician, with prescriptive authority from the Virginia Board of Medicine, when they were granted temporary privileges by the Medical Executive Committee, and full privileges by the Board of Trustees. They both began practicing at the hospital in June 2010. In one PA credential file, the practitioner worked at the hospital emergency department for approximately four months before the practice protocol with supervising physician was submitted to the Virginia Board of Medicine. His protocol was received at the Board of Medicine on September 27, 2010 and approval was granted to him by the Virginia Board of Medicine effective November 3, 2010. In the other PA file reviewed, there was no documented evidence presented that the PA's clinical protocol with supervising physician was ever submitted to the Virginia Board of Medicine.

B. In one Emergency Department PA credential file reviewed for 2011, there was no signature list of alternate supervising physicians present in the file. In interview with the Medical Staff Coordinator, she said the alternate signature list had not yet been completed and submitted to her. She reported the PA had been granted temporary privileges on May 17, 2011 and was currently working in the Emergency Department.

C. Review of four nurse practitioner (NP) credential files from 2010 and 2011 revealed that in four of the four files, there was no documented evidence presented that the practice agreements with their supervising physicians, including protocol, had been submitted to the Virginia Board of Nursing and Medicine and had been approved.

4. In all credential files reviewed, both physician and physician extenders, there was no documentation of when the file was reviewed by the Medical Executive Committee or when appointment and privileges were granted by the Board of Trustees. The meeting minutes of the Medical Executive Committee and Board of Trustees had to be consulted for this information during review of each credential file.

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Based on review of the Governing Body By-laws and the Medical Staff By-laws, and interview with the Vice President of Medical Affairs, it was determined the Medical Executive Committee failed to comply with their Medical Staff By-laws for the use of temporary privileges.

The findings include:

1. The Medical Staff By-laws read: 5.3 TEMPORARY PRIVILEGES - Temporary clinical privileges shall be granted only to individuals defined as practitioners in these Bylaws or to APPs as defined in these Bylaws, to fulfill an important patient care need that cannot be otherwise met by the existing members of the Medical Staff or currently privileged APPs. Therefore, temporary privileges shall be granted only rarely.

2. The Medical Staff By-laws continue: 5.3.2 CONDITIONS AND AUTHORITY FOR GRANTING TEMPORARY PRIVILEGES - All temporary privileges shall be time-limited, as specified for the type of temporary privileges ________Temporary privileges shall automatically terminate at the end of the specific period for which they were granted. 5.3.2.1 Temporary privileges granted under this condition shall not exceed one hundred and twenty (120) consecutive days.

3. Review of the Medical Executive Committee (MEC) meeting minutes for 2010 revealed that temporary privileges were being used frequently for large numbers of medical staff applicants. For example, at the June 21, 2010, Medical Executive Committee meeting, two cardiologists were granted temporary privileges. Seven cardiologists were recommended to the board for full privileges, so there were cardologists on staff. One eICU physician was granted temporary privileges and one recommended for full privileges. Two orthopedic surgeons and one orthopedic PA were granted temporary privileges. At the July 12, 2010, Medical Executive Committee Meeting, four eICU physicians, one otolaryngologist, one hematology/oncologist, one obstetrics/gynecologist, one pain management, one family practice, two hospitalists, one orthopedic, four anesthesiologists, and one pediatric hospitalist were granted temporary privileges.

4. Review of the MEC meeting minutes for 2011 revealed that temporary privileges are continuing to be used more than rarely. For example, in the August 18, 2011 MEC meeting minutes , it was documented that temporary privileges were granted to five emergency medicine physicians and one pediatric hospitalist. In interview with the Vice President of Medical Affairs and the Medical Staff Coordinator, they reported that temporary privileges have been used frequently, but will be reduced starting now.

5. Currently there are two physician assistants (PA #6 and &7) who have worked with temporary privileges for 120 days. The temporary privileges have now expired and their credentialing package has not yet gone to the Medical Executive Committee or the Board of Trustees. In interview with the Medical Staff Coordinator, she said PA#7 stopped working September 5, 2011, and PA#6, was to stop working September 17, 2011. Review of the emergency department physician schedule revealed these two PAs are not scheduled to work.

Show Text of Violation

Based on review of Medical Staff By-laws and credential files, and interview with the Vice President of Medical Affairs and the Medical Staff Coordinator, it was determined that the credentialing process for Advanced Practice Professionals was lacking in completeness regarding approval of their practice protocols and prescriptive authority by the Virginia Board of Medicine and/or Virginia Board of Nursing and Medicine. These applicants were granted privileges by the Board of Trustees without this information. Also, temporary privileges are being used frequently and in large numbers while Medical Staff By-laws require that temporary privileges be used rarely.

Findings include:

1. Review of two physician assistant (PA) credential files from 2010 revealed that in two of the two files there was no documented evidence of submission and approval for clinical privileges protocol, and supervising physician, with prescriptive authority from the Virginia Board of Medicine, when they were granted temporary privileges by the Medical Executive Committee, and full privileges by the Board of Trustees. They both began practicing at the hospital in June 2010. In one PA credential file, the practitioner worked at the hospital emergency department for approximately four months before the practice protocol with supervising physician was submitted to the Virginia Board of Medicine. His protocol was received at the Board of Medicine on September 27, 2010 and approval was granted to him by the Virginia Board of Medicine effective November 3, 2010. In the other PA file reviewed, there was no documented evidence presented that the PA's clinical protocol with supervising physician was ever submitted to the Virginia Board of Medicine.

2. In one Emergency Department PA credential file reviewed for 2011, there was no signature list of alternate supervising physicians present in the file. In interview with the Medical Staff Coordinator, she said the alternate signature list had not yet been completed and submitted to her. She reported the PA had been granted temporary privileges on May 17, 2011 and was currently working in the Emergency Department.

3. Review of four nurse practitioner (NP) credential files from 2010 and 2011 revealed that in four of the four files, there was no documented evidence presented that the practice agreements with their supervising physicians, including protocol, had been submitted to the Virginia Board of Nursing and Medicine and had been approved.

4. In all credential files reviewed, both physician and physician extenders, there was no documentation of when the file was reviewed by the Medical Executive Committee or when appointment and privileges were granted by the Board of Trustees. The meeting minutes of the Medical Executive Committee and Board of Trustees had to be consulted for this information during review of each credential file.

5. The Medical Staff By-laws read: 5.3 TEMPORARY PRIVILEGES - Temporary clinical privileges shall be granted only to individuals defined as practitioners in these Bylaws or to APPs as defined in these Bylaws, to fulfill an important patient care need that cannot be otherwise met by the existing members of the Medical Staff or currently privileged APPs. Therefore, temporary privileges shall be granted only rarely.

6. The Medical Staff By-laws continue: 5.3.2 CONDITIONS AND AUTHORITY FOR GRANTING TEMPORARY PRIVILEGES - All temporary privileges shall be time-limited, as specified for the type of temporary privileges ________Temporary privileges shall automatically terminate at the end of the specific period for which they were granted. 5.3.2.1 Temporary privileges granted under this condition shall not exceed one hundred and twenty (120) consecutive days.

7. Review of the Medical Executive Committee (MEC) meeting minutes for 2010 revealed that temporary privileges were being used frequently for large numbers of medical staff applicants. For example, at the June 21, 2010, Medical Executive Committee meeting, two cardiologists were granted temporary privileges. Seven cardiologists were recommended to the board for full privileges, so there were cardologists on staff. One eICU physician was granted temporary privileges and one recommended for full privileges. Two orthopedic surgeons and one orthopedic PA were granted temporary privileges. At the July 12, 2010, Medical Executive Committee Meeting, four eICU physicians, one otolaryngologist, one hematology/oncologist, one obstetrics/gynecologist, one pain management, one family practice, two hospitalists, one orthopedic, four anesthesiologists, and one pediatric hospitalist were granted temporary privileges.

8. Review of the MEC meeting minutes for 2011 revealed that temporary privileges are continuing to be used more than rarely. For example, in the August 18, 2011 MEC meeting minutes , it was documented that temporary privileges were granted to five emergency medicine physicians and one pediatric hospitalist. In interview with the Vice President of Medical Affairs and the Medical Staff Coordinator, they reported that temporary privileges have been used frequently, but will be reduced starting now.

9. Currently there are two physician assistants (PA #6 and &7) who have worked with temporary privileges for 120 days. The temporary privileges have now expired and their credentialing package has not yet gone to the Medical Executive Committee or the Board of Trustees. In interview with the Medical Staff Coordinator, she said PA#7 stopped working September 5, 2011, and PA#6, was to stop working September 17, 2011. Review of the emergency department physician schedule revealed these two PAs are not scheduled to work.

10. Review of the Medical Staff By-laws, credential files and interview with the Medical Staff Coordinator and Vice President of Medical Affairs, the facility failed to comply with their by-laws by ensuring there was documented evidence of Department Chairperson review of all supporting materials for appointment and delineation of clinical privileges for both physicians and Advanced Practice Professionals.

11. The Medical Staff By-laws read: 37.3 APPLICATION PROCESSING - After verification is accomplished and the application is fully complete it shall be reviewed and processed as follows. 3.7.3.1 Department Report: The Medical Staff Services shall make available the application and all supporting materials to the Chairperson of each Department in which the applicant seeks privileges and request the documented evaluation and recommendation as to the staff category, in the case of applicants for Staff membership, the Department to be assigned, the Division to be assigned if appropriate to the applicant's practice, the clinical privileges to be granted, and any concerns regarding the clinical privileges requested. In the event that the applicant is the Department Chairperson, the Chief of Staff or the Department Vice-Chairperson shall make the evaluation and recommendations. Following the Department Chairperson ' s evaluation and recommendations, the report shall then be transmitted to the Medical Executive Committee.

12. The Medical Staff By-laws read for Advanced Practice Professionals, 4.10 ADVANCED PRACTICE PROFESSIONALS - The term, 'Advanced Practice Professional' (APP) refers to individuals other than those defined as a Practitioner, who provide direct patient care services in the Hospital under a defined degree of supervision, exercising judgment within the areas of documented professional competence and consistent with applicable law. Categories/types of APPs eligible for clinical privileges shall be approved by the board and shall be credentialed through the same processes as a Medical Staff Member, as described in Article Three, and shall be granted clinical privileges as either a dependent or independent healthcare professional as defined in State laws and in these By-laws.

13. Review of three physician credential files from 2010 and 2011 revealed no documented evidence of a review, by the Department Chairperson in three of the three physician files reviewed. There was also no documented evidence in the credential files of the dates that the credential packages were reviewed and approved by the Medical Executive Committee and the Board of Trustees.

14. In interview with the Vice President of Medical Affairs and the Medical Staff Coordinator, both reported that, in the past, there was no mechanism for this documentation. They reported that a plan of correction was in process.

Show Text of Violation

Based on review of the Medical Staff By-laws, and credential files of seven (7) physician assistants, four (4) nurse practitioners and three (3) physicians, and interview with the Medical Staff Coordinator, it was determined that the facility failed to ensure compliance with verification of an approved practice agreement with a supervising physician, including protocol for clinical privileges and prescriptive authority, through the appropriate Board at the Virginia Department of Health Professions for the physician extenders. The facility also failed to ensure compliance with their by-laws for use of temporary privileges with both physicians and physician extenders. The credential files of all practitioners lacked documentation of when the practitioner ' s file was reviewed and approved by the Medical Executive Committee and the Board of Trustees. There was also no documentation in the credential files of when temporary privileges were granted or when the practitioner began practicing at this facility.

The findings include:

1. Review of two physician assistant (PA) credential files from 2010 revealed that in two of the two files there was no documented evidence of submission and approval for clinical privileges protocol, and supervising physician, with prescriptive authority from the Virginia Board of Medicine, when they were granted temporary privileges by the Medical Executive Committee, and full privileges by the Board of Trustees. They both began practicing at the hospital in June 2010. In one PA credential file, the practitioner worked at the hospital emergency department for approximately four months before the practice protocol with supervising physician was submitted to the Virginia Board of Medicine. His protocol was received at the Board of Medicine on September 27, 2010 and approval was granted to him by the Virginia Board of Medicine effective November 3, 2010. In the other PA file reviewed, there was no documented evidence presented that the PA ' s clinical protocol with supervising physician was ever submitted to the Virginia Board of Medicine.

2. In one Emergency Department PA credential file reviewed for 2011, there was no signature list of alternate supervising physicians present in the file. In interview with the Medical Staff Coordinator, she said the alternate signature list had not yet been completed and submitted to her. She reported the PA had been granted temporary privileges on May 17, 2011 and was currently working in the Emergency Department.

3. Review of four nurse practitioner (NP) credential files from 2010 and 2011 revealed that in four of the four files, there was no documented evidence presented that the practice agreements with their supervising physicians, including protocol, had been submitted to the Virginia Board of Nursing and Medicine and had been approved.

4. In all credential files reviewed, both physician and physician extenders, there was no documentation of when the file was reviewed by the Medical Executive Committee or when appointment and privileges were granted by the Board of Trustees. The meeting minutes of the Medical Executive Committee and Board of Trustees had to be consulted for this information during review of each credential file.

5. Regarding physician medical staff members - Cross-reference to A0353 and A0357.

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Based on review of the Medical Staff By-laws and interview with the Vice President of Medical Affairs and the Medical Staff Coordinator, it was determined the facility failed to follow their by-laws regarding infrequent or rare use of temporary privileges for physicians and advanced practice professionals.

The findings include:

1. The Medical Staff By-laws read: 5.3 TEMPORARY PRIVILEGES - Temporary clinical privileges shall be granted only to individuals defined as practitioners in these Bylaws or to APPs as defined in these Bylaws, to fulfill an important patient care need that cannot be otherwise met by the existing members of the Medical Staff or currently privileged APPs. Therefore, temporary privileges shall be granted only rarely.

2. The Medical Staff By-laws continue: 5.3.2 CONDITIONS AND AUTHORITY FOR GRANTING TEMPORARY PRIVILEGES - All temporary privileges shall be time-limited, as specified for the type of temporary privileges ________Temporary privileges shall automatically terminate at the end of the specific period for which they were granted. 5.3.2.1 Temporary privileges granted under this condition shall not exceed one hundred and twenty (120) consecutive days.

3. Review of the Medical Executive Committee (MEC) meeting minutes for 2010 revealed that temporary privileges were being used frequently for large numbers of medical staff applicants. For example, at the June 21, 2010, Medical Executive Committee meeting, two cardiologists were granted temporary privileges. Seven cardiologists were recommended to the board for full privileges, so there were cardologists on staff. One eICU physician was granted temporary privileges and one recommended for full privileges. Two orthopedic surgeons and one orthopedic PA were granted temporary privileges. At the July 12, 2010, Medical Executive Committee Meeting, four eICU physicians, one otolaryngologist, one hematology/oncologist, one obstetrics/gynecologist, one pain management, one family practice, two hospitalists, one orthopedic, four anesthesiologists, and one pediatric hospitalist were granted temporary privileges.

4. Review of the MEC meeting minutes for 2011 revealed that temporary privileges are continuing to be used more than rarely. For example, in the August 18, 2011 MEC meeting minutes , it was documented that temporary privileges were granted to five emergency medicine physicians and one pediatric hospitalist. In interview with the Vice President of Medical Affairs and the Medical Staff Coordinator, they reported that temporary privileges have been used frequently, but will be reduced starting now.

5. Currently there are two physician assistants (PA #6 and &7) who have worked with temporary privileges for 120 days. The temporary privileges have now expired and their credentialing package has not yet gone to the Medical Executive Committee or the Board of Trustees. In interview with the Medical Staff Coordinator, she said PA#7 stopped working September 5, 2011, and PA#6, was to stop working September 17, 2011. Review of the emergency department physician schedule revealed these two PAs are not scheduled to work.

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Based on review of the Medical Staff By-laws, credential files and interview with the Medical Staff Coordinator and Vice President of Medical Affairs, the facility failed to comply with their by-laws by ensuring there was documented evidence of Department Chairperson review of all supporting materials for appointment and delineation of clinical privileges for both physicians and Advanced Practice Professionals.

The findings include:

1. The Medical Staff By-laws read: 37.3 APPLICATION PROCESSING - After verification is accomplished and the application is fully complete it shall be reviewed and processed as follows. 3.7.3.1 Department Report: The Medical Staff Services shall make available the application and all supporting materials to the Chairperson of each Department in which the applicant seeks privileges and request the documented evaluation and recommendation as to the staff category, in the case of applicants for Staff membership, the Department to be assigned, the Division to be assigned if appropriate to the applicant ' s practice, the clinical privileges to be granted, and any concerns regarding the clinical privileges requested. In the event that the applicant is the Department Chairperson, the Chief of Staff or the Department Vice-Chairperson shall make the evaluation and recommendations. Following the Department Chairperson ' s evaluation and recommendations, the report shall then be transmitted to the Medical Executive Committee.

2. The Medical Staff By-laws read for Advanced Practice Professionals, 4.10 ADVANCED PRACTICE PROFESSIONALS - The term, ' Advanced Practice Professional ' (APP) refers to individuals other than those defined as a Practitioner, who provide direct patient care services in the Hospital under a defined degree of supervision, exercising judgment within the areas of documented professional competence and consistent with applicable law. Categories/types of APPs eligible for clinical privileges shall be approved by the board and shall be credentialed through the same processes as a Medical Staff Member, as described in Article Three, and shall be granted clinical privileges as either a dependent or independent healthcare professional as defined in State laws and in these By-laws.

3. Review of three physician credential files from 2010 and 2011 revealed no documented evidence of a review, by the Department Chairperson in three of the three physician files reviewed. There was also no documented evidence in the credential files of the dates that the credential packages were reviewed and approved by the Medical Executive Committee and the Board of Trustees.

4. In interview with the Vice President of Medical Affairs and the Medical Staff Coordinator, both reported that, in the past, there was no mechanism for this documentation. They reported that a plan of correction was in process.

5. For Advanced Practice Professionals - cross reference to A0341.

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Spotsylvania Regional Medical Center

24 CMS Violations since 2011-09-15

Non Immediate Jeopardy Violations

Violation Name: PATIENT RIGHTS: RESTRAINT OR SECLUSION(A-0175)

Violation Name: COVID-19 Vaccination of Facility Staff(A-0792)

Violation Name: BLOOD TRANSFUSIONS AND IV MEDICATIONS(A-0410)

Violation Name: PATIENT RIGHTS:PARTICIPATION IN CARE PLANNING(A-0130)

Violation Name: PATIENT RIGHTS: RESTRAINT OR SECLUSION(A-0166)

Violation Name: DATA COLLECTION & ANALYSIS(A-0273)

Violation Name: QAPI EXECUTIVE RESPONSIBILITIES(A-0309)

Violation Name: ADMINISTRATION OF DRUGS(A-0405)

Violation Name: ORDERS FOR DRUGS AND BIOLOGICALS(A-0409)

Violation Name: PATIENT RIGHTS: RESTRAINT OR SECLUSION(A-0166)

Violation Name: PATIENT RIGHTS: RESTRAINT OR SECLUSION(A-0168)

Violation Name: PATIENT RIGHTS: RESTRAINT OR SECLUSION(A-0175)

Violation Name: PATIENT RIGHTS: RESTRAINT OR SECLUSION(A-0176)

Violation Name: DISCHARGE PLANNING EVALUATION(A-0806)

Violation Name: REASSESSMENT OF A DISCHARGE PLAN(A-0821)

Violation Name: CONTENT OF RECORD(A-0449)

Violation Name: INFECTION CONTROL PROGRAM(A-0749)

Violation Name: GOVERNING BODY(A-0043)

Violation Name: MEDICAL STAFF - APPOINTMENTS(A-0046)

Violation Name: MEDICAL STAFF - BYLAWS AND RULES(A-0048)

Violation Name: MEDICAL STAFF(A-0338)

Violation Name: MEDICAL STAFF CREDENTIALING(A-0341)

Violation Name: MEDICAL STAFF BYLAWS(A-0353)

Violation Name: MEDICAL STAFF QUALIFICATIONS(A-0357)