HospitalInspections.org

Based on review of records and interview, the facility governing body failed to ensure that the policies pertaining to a critical access hospital (CAH) were reviewed and subsequently scheduled to be reviewed every two years by members of the hospital's professional healthcare staff, including one or more doctors of medicine or osteopathy and one or more physician assistants, nurse practitioners, or clinical nurse specialists on staff. Reviews of 17 out of 25 policies showed that the policies had not either been reviewed within the past two years or had a next scheduled review date greater than 2 years.

Findings included:

The following 17 policies were provided by the facility as current policies in use:

POLICY #1
"Title: Nurse Staffing Effectiveness
Maintained by: Patient Care Services
Effective date: (blank)
Next review date: (blank)

REVISION SUMMARY
Date: 2019; Referenced Section(s): (blank); Change: Policy formatted to new template.
Date: 02/2017; Referenced Section(s): (blank), Change: (blank)

SCOPE
Applicable to: CHI St. Luke's Health Memorial - Lufkin, Livingston, San Augustine

REFERENCE(S)
Federal regulations (42CFR 482.23(b) Staffing and delivery of care. (this referenced regulation was part of the Conditions of Participation for an acute care hospital and not a critical access hospital)"

POLICY #2
"Title: Nurse Staffing Plan
Maintained by: Patient Care Services
Effective date: (blank)
Next review date: (blank)

REVISION SUMMARY
Date: 2019; Referenced Section(s): (blank); Change: Formatted to new template.
Date: 09/2008; Referenced Section(s): (blank); Change: Revised
Date: 07/2007; Referenced Section(s): (blank); Change: (blank)
SCOPE
Applicable to: CHI St. Luke's Health Memorial - Lufkin, Livingston, San Augustine

REFERENCE(S)
Federal regulations (42CFR 482.23(b) Staffing and delivery of care. (this referenced regulation was part of the Conditions of Participation for an acute care hospital and not a critical access hospital)"

POLICY #3
"Title: Patient Rights and Responsibilities (Division)
Maintained by: Division VP of Quality
Reviewed by: Regional Corporate Responsibility Officer; Director Risk Management Operations-Texas Division; Corporate Counsel-Texas Division
Approved by: Senior Vice President and Chief Medical Officer Chief Nursing Officer
Effective date: December 2020
Next review date: December 2023

REVISION SUMMARY
Date: March 2016 ...
Date: December 2020; Referenced Section(s): All, Change: Made to be CHI St Luke's Division Policy

SCOPE
Applicable to: CHI St. Luke's Health- Brazosport Medical Center; CHI St. Luke's Health-Baylor St. Luke's Medical Center; CHI St. Luke's Health- Patient Medical Center; CHI St. Luke's Health- Sugar Land Hospital; CHI St. Luke's Health- Lakeside Hospital; CHI St. Luke's Health at The Vintage Hospital; CHI St. Luke's Health- The Woodlands Hospital, Springwoods Village; CHI St. Luke's Health Memorial Market - Lufkin, Livingston, San Augustine; CHI St. Joseph Health System - Regional, College Station, Burleson, Madison, Grimes

Department(s): All Departments

POLICY
A. It is the policy of CHI St. Luke's to respect, protect, and promote each patient's rights in accordance with regulatory and accreditation standards. This policy should not be construed as a complete notation of patient rights and responsibilities. There may be additional rights and responsibilities pertaining to identified patient populations that are not contained in this policy.

-Code of Federal Regulation (42CFR Part 482), CMS Conditions of Participation, Appendix A" (this referenced regulation pertained to the Conditions of Participation for an acute care hospital and not 42CFR Part 485 Subpart F Conditions of Participation for a critical access hospital)

POLICY #4
"Subject: Refrigerator and Freezer Temperatures
Reference # V-3
Department: Dietary
Approved By: (Staff #1, Staff #17)
Effective: March 2011
Revised: March 2011"
(no review dates or scope listed)

POLICY #5
"Title: Safety Precautions
Maintained by: (Staff #17)
Approved by: (Staff #17)
Effective Date: 12/12/2020
Next review date: 12/12/2020

SCOPE
Applicable to: CHI St. Luke's Health Memorial
Department(s): Dietary

POLICY #6
"Subject: Hazardous Materials/Substances: Waste Disposal
Pharmacy Policy No. 19-09
Effective Date: 1/88 To be reviewed every three years by the Pharmacy and Therapeutics Committee
Reviewed: 7/92 11/86, 11/99, 11/02, 1/06, 10/08, 1/11, 1/16
Review By: 1/19

Document Metadata
Document Name: Hazardous Materials & Substances - Waste Disposal.doc
Original Location: /10. CHI St. Luke's Health Memorial/San Augustine/Pharmacy
Created on: 06/18/2020
Published on : 06/18/2020
Last Review on: 02/17/2020
Next Review on 02/17/2023"

POLICY #7
"Subject: Waste Storage Rooms
Reference # A-033
Department: Environmental Services (Housekeeping)
Approved By: (blank)
Effective: 3/1/2021

Document Metadata
Document Name: Waste Storage Rooms.pdf
Original Location: /10. CHI St. Luke's Health Memorial/San Augustine/EVS
Created on: 06/19/2020
Published on : 06/19/2020
Last Review on: 02/17/2020
Next Review on 02/17/2023"

POLICY #8
"Subject: Dietary Department Staffing
Reference #1-5
Department: Dietary
Approved By: Administrator (signature blank) Dietician (Staff #17)
Effective: March 2011
Revised: May 2019

Document Metadata
Document Name: Dietary Department Staffing.pdf
Original Location: /10. CHI St. Luke's Health Memorial/San Augustine/Dietary
Created on: 06/17/2020
Published on : 06/17/2020
Last Review on: 02/17/2020
Next Review on : 02/17/2023"

POLICY #9
"Subject: Food Preparation
Reference #11-5
Department: Dietary
Approved By: Administrator (signature blank) Dietician (Staff #17)
Effective: March 2011
Revised: June, 2019

Document Metadata
Document Name: Food Preparation.pdf
Original Location: /10. CHI St. Luke's Health Memorial/San Augustine/Dietary
Created on: 06/17/2020
Published on : 06/17/2020
Last Review on: 02/17/2020
Next Review on : 02/17/2023"

POLICY #10
"Subject: Patient Tray Set Up and Delivery
Reference #111-7
Department: Dietary
Approved By: Administrator (signature blank) Dietician (Staff #17)
Effective: March 2011
Revised: July 2019

Document Metadata
Document Name: Patient Tray Setup and Delivery.pdf
Original Location: /10. CHI St. Luke's Health Memorial/San Augustine/Dietary
Created on: 06/17/2020
Published on : 06/17/2020
Last Review on: 02/17/2020
Next Review on : 02/17/2023"

POLICY #11
"Subject: Dishwasher Temperatures
Reference # V-2
Department: Dietary
Approved By: (Staff #1, Staff #17)
Effective: March 2011
Revised: March 2011"
(no review dates or scope listed)

POLICY #12
"Subject: Diet Orders and Tray Identification
Reference # II-4
Department: Dietary
Approved By: (Staff #1, Staff #17)
Effective: March 2011
Revised: March 2011"
(no review dates or scope listed)

POLICY #13
"Subject: Cleaning Schedules
Reference # V-1
Department: Dietary
Approved By: (Staff #1, Staff #17)
Effective: March 2011
Revised: March 2011"
(no review dates or scope listed)

POLICY #14
"Subject: Infectious Waste
Reference # A-022
Department: Environmental Services (Housekeeping)
Approved By: (blank)
Effective: 3/1/2021

Document Metadata
Document Name: Infectious Waste.pdf
Original Location: /10. CHI St. Luke's Health Memorial/San Augustine/EVS
Created on: 06/19/2020
Published on : 06/19/2020
Last Review on: 02/17/2020
Next Review on 02/17/2023"

POLICY #15
"Title: Autopsy
Maintained by: Patient Care Services
Approved by: Market SVP of Patient Care Services
Effective date: August 2021
Next review date: August 2023

REVISION SUMMARY
Date: (blank); Referenced Section(s): (blank); Change: (blank)

SCOPE
Applicable to: CHI St. Luke's Health Memorial San Augustine Medical Staff
Department(s): Patient Care Services"

POLICY #16
"Title: Blood & Body Fluid Exposure Control Plan
Maintained by: Infection Prevention
Reviewed by: Infection Prevention, Quality, Nursing
Approved by: Market Senior VP of Patient Care Services
Effective date: February 2022
Next review date: February 2023

REVISION SUMMARY
Date: 02-10-22; Referenced Section(s): (blank); Change: Updated to reflect current year and new policy template. Changes made for spelling, formatting, duplications, and continuity

SCOPE
Applicable to: CHI St. Luke's Health Memorial San Augustine
Department(s): All Departments"

POLICY #17
"Title: Hazardous Spill & Exposure Plan
Maintained by: EOC
Reviewed by: Administration, Risk, Quality
Approved by: VP of Operations
Effective date: February 2022
Next review date: February 2025

REVISION SUMMARY
Date: 02-10-22; Referenced Section(s): (blank); Change: Updated to reflect current year and new policy template. Changes made for spelling, formatting, duplications, and continuity

SCOPE
Applicable to: CHI St. Luke's Health Memorial San Augustine
Department(s): All Departments"

An interview was conducted with Staff #1 and Staff #2 regarding the policies not being reviewed at least biennially by members of the critical access hospital's professional healthcare staff, including one or more doctors of medicine or osteopathy and one or more physician assistants, nurse practitioners, or clinical nurse specialists on staff. Staff #1 and Staff #2 confirmed that there was no process for the policies to be reviewed every two years.

Staff #1 stated that the hospital belongs to a system that includes acute care hospitals and critical access hospitals. The system was requiring all policies to be entered into the system's computer program that manages policies and that the computer program established the review dates. Staff #1 stated that the system's accrediting agency for the acute care hospitals within the system only require policies to be reviewed every three years. Staff #1 confirmed that their hospital was designated as a Critical Access Hospital and did not have accreditation through an accrediting organization. Staff #1 stated that the system's plan was to make policies applicable to all hospitals (regardless of designation; critical access or acute care hospital) and only review every three years.

Review of Policy #1, Policy #2, and Policy #3 above showed that the hospital system policies referenced requirements for the Conditions of Participation for Acute Care Hospital but did not include the references for requirements in the Conditions of Participation for Critical Access Hospitals.

Based on observation, document review, and interview the facility failed to ensure that the contracted service for Medical Records was reviewed and complied with all applicable conditions of participation and standards.


Findings included:

During a tour of the facility on 2/22/2022 with Staff #5 at 10:40 AM it was noted that the room identified as "Medical Records" was vacant. Staff #5 was asked if there was a medical records department at the facility. Staff #5 replied, "No, there is not one here. That is contracted and the medical records office is located at another location."

An interview was conducted with Staff #19 in the afternoon of 2/22/2022. Staff #19 was asked to provide the contract for the medical records service.

The complete contract was not presented for review. The contract provided for review did not include the involved parties, effective date, expiration date, or signature page with approvals.

Staff #19 stated, "This is a national contract. This was sent to me and I was told this was the only part of the contract that was presented to surveyors for review." After multiple requests, the missing pages, which included the involved parties and signature page was presented for review on 2/24/2022 by Staff #19. The contract in whole was never presented for review.

An interview was conducted with Staff #1 on 2/22/2022 after 1:00 PM. Staff #1 was asked how the contract was evaluated to ensure the services provided met all the conditions of participation. Staff #1 stated, "We do not evaluate this contract. I do not have access to the contract."

Staff #19 was asked how the contract was evaluated at the facility to ensure the contract met the conditions of participation. Staff #19 stated, "This is a national contract. The facilities do not have access to this contract. This contract is evaluated at the national level only. None of the facilities in Texas evaluate this contract."

Staff #1 and Staff #19 confirmed the findings.

Based on review of records and interview, the facility failed to ensure that the designated director over medical records had developed and implemented an effective process to ensure that all documentation/forms required by regulation to be a part of the patient's medical record were completed and a part of the patient's medical record. Seven patients (Patient #6, #11, #13, #14, #17, #18, and #20) out of 11 charts reviewed for required consent to treat upon admission, delivery of patient rights, delivery of the Important Message from Medicare (IM letter), and delivery of the Medicare Outpatient Observation Notice (Moon letter) were found to have one or more pieces of documentation/form missing from the medical record.

Findings Include:


During a tour of the facility on 2/22/2022 with Staff #5 at 10:40 AM it was noted that the room identified as "Medical Records" was vacant. Staff #5 was asked if there was a medical records department at the facility. Staff #5 replied, "No, there is not one here. That is contracted and the medical records office is located at another location."

An interview was conducted with Staff #2 on 2/22/2022 after 12:00 PM. Staff #2 was asked how the medical records department was being managed. Staff #2 stated, "That is a contracted service. We used to have an employee here on-site but the company decided there was not enough work at this location, so they moved her to another location."

An interview was conducted with Staff #23 and Staff #27 on 2/23/2022 at 2:05 PM. Staff #23 was asked how they ensured that all medical records were complete when a patient was discharged. Staff #23 replied, "We do an analysis of each medical record and report delinquencies to each facility." Staff #23 was asked to explain what an analysis entailed. Staff #23 stated, "We look for history and physicals, discharge summaries, operative reports, and signed procedural consents. We don't look at admission paperwork or nursing documentation, that is the responsibility of each department." Staff #27 was asked if the contracted agency required the use of an audit tool to ensure that all the required documents were contained within the medical record at discharge. Staff #27 replied, "No we do not use an audit tool because we only do an analysis of the medical record. We only look for certain documents."

An interview was conducted with Staff #28 on 2/24/2022 after 9:00 AM. Staff #28 was asked how she ensured that all required and completed documents were in the patient's medical record after discharge. Staff #28 stated, "We look at the medical record for each patient, inpatient and outpatient. We complete an analysis of each record. We also send a delinquency report to the CEO of each facility, so they are aware of any delinquent records that need to be corrected or completed." Staff #28 was asked if the document titled, "General Consent on Admission" signed by the patient or the patient's representative was included in the analysis of the medical record. Staff #28 replied, "No, we do not look for that document during our analysis. We only look for an informed consent when there is an Operative Report required. Then, we only make sure that it was signed by the patient. The Admissions Department is responsible for ensuring there is a signed consent to treatment, not the Medical Records Department." Staff #28 was asked if the contracted service for medical records was responsible for a complete medical record for each patient. Staff #28 replied, "I guess I don't understand what you consider a complete medical record. Can you provide me with a list of what is required in a complete medical record?"

Staff #28 confirmed they are the only Medical Records Department for the facility and that all staff working in the Medical Records Department were employed by the contracted company.


A review of the policy titled, "Medical Record Content Policy and Procedures" with a review date of March 2021 and a Department Approval by Staff #28 was as follows:

" ...Purpose:
It is the policy of the Hospital that the medical record shall contain sufficient information to identify the patient, support the diagnosis, to justify the treatment and document the results accurately.

Procedure:
The Admissions Department is responsible for collecting sufficient information to identify the patient. The information is documented on the electronic face sheet, which is a permanent part of the patient's record.
...
There is evidence of informed consent in the patient's medical record ..."


Staff #28 confirmed the policy does require evidence of an informed consent, but does not give clear definition on the type of informed consent, i.e. surgical/invasive procedure consent or general admission consent to treatment.

Staff #23, #27, and #28 confirmed they do not ensure a signed informed consent to treat was in the medical record.



A review of the document titled, "AMENDED AND RESTATED MASTER SERVICES AGREEMENT BETWEEN CATHOLIC HEALTH INITIATIVES AND CONIFER REVENUE CYCLE SOLUTIONS, LLC" was as follows:

" ...SECTION 3.0 REVENUE INTEGRITY SERVICES

Conifer shall provide the following:

A. Health Information Management ("HIM")

1. Records Management

i. Capture medical record documents via scanning post discharge, as required;
ii. Process and monitor chat completion;
iii. Prepare, scan, and index electronic medical record ("EMR"), as required;
iv. Record filing and retrieval;
v. Discharge record reconciliation;
vi. Create and submit vital records to the applicable governmental agencies;
vii. Loose filing;
vii. Record purging and offsite tracking;
ix. Record assembly;
x. Record analysis;
xi. Record deficiency tracking;
xii. Review clients master patient index ("MPI"), including the merging of duplicate medical records and recommend appropriate changes to client;
xiii. Perform release of information ("ROI") services, in accordance with clients policies and procedures, and HIPPA compliance standards; and
xiv. Monitor agreed upon quality measures and report to client upon request ..."

Staff #28 confirmed that employees in the Medical Records Department are responsible for ensuring that each patient has a complete medical record.






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Records were reviewed on 2-22-2022 and 2-23-2022 for required documentation of patient consent to treat upon admission, delivery of patient rights, delivery of the Important Message from Medicare if required, and delivery of the Medicare Outpatient Observation Notice if required.

Patient #6

Review of Patient #6's chart showed that he was admitted to the facility on 1-16-2022 at 10:17 PM. He was a Medicare recipient. He had initially been admitted to outpatient observation status requiring the delivery of a Moon letter. He was later changed to an inpatient status requiring the delivery of the IM letter. No record of the delivery of the IM letter or Moon letter was found in the patient's chart. No record was found of the consent to treat or record of delivery of patient rights upon admission.

Patient #11

Review of Patient #6's chart showed that she was admitted to the facility on 1-30-2022 at 1:44 PM. She was a Medicare recipient. She had initially been admitted to outpatient observation status requiring the delivery of a Moon letter. She was later changed to an inpatient status requiring the delivery of the IM letter. No record of the delivery of the IM letter or Moon letter was found in the patient's chart. No record was found of the consent to treat or record of delivery of patient rights upon admission.

Patient #13

Review of Patient #13's chart showed that he was admitted to the facility on 12-25-2021 at 10:58 AM. He was a Medicare recipient. He had been admitted to outpatient observation status requiring the delivery of a Moon letter. No record of the delivery of the Moon letter was found in the patient's chart. No record was found of the consent to treat or record of delivery of patient rights upon admission.

Patient #14

Review of Patient #14's chart showed that she was admitted to the facility on 12-25-2021 at 3:45 PM. She was a Medicare recipient. She had been admitted to outpatient observation status requiring the delivery of a Moon letter. No record of the delivery of the Moon letter was found in the patient's chart. No record was found of the consent to treat or record of delivery of patient rights upon admission.

Patient #17

Review of Patient #17's chart showed that she was admitted to the facility on 8-8-2021 at 3:20 PM and died in the facility on 8-25-2021. She was a Medicare recipient. No record of the delivery of the IM letter upon admission was found. No record was found of the consent to treat or record of delivery of patient rights upon admission.

Patient #18

Review of Patient #18's chart showed that she was admitted to the facility on 9-28-2021 at 10:30 AM and died in the facility on 9-29-2021. She was a Medicare recipient. No record of the delivery of the IM letter upon admission was found. No record was found of the consent to treat or record of delivery of patient rights upon admission.

Patient #20

Review of Patient #20's chart showed that he was admitted to the facility on 12-4-2021 at 12:45 PM and died in the facility the same day. He was a Medicare recipient. No record of the delivery of the IM letter upon admission was found. No record was found of the consent to treat or record of delivery of patient rights upon admission.

During medical record review on 2-22-2022, Staff #23 was asked to assist in locating the documents. Staff #23 was asked why there would be so many required documents missing from the medical records. She stated she did not know why. When asked what the medical records auditing process for medical records was, she stated that it was the Quality Director, Admissions Director, and Nursing Director's responsibility to audit the chart for the missing forms. She stated that Medical records only looks for consents, operation notes, physician notes. When advised that the missing documentation/forms were consent to treat and other required information necessary for patients to give informed consent, she stated that the Director of Admission was responsible for that and that Medical Records Department was not responsible for ensuring all documents were in the charts, just the ones she had previously stated.

Interview was conducted with Staff #1 and Staff #2. Neither were aware that Medical Records did not audit the entire medical record for all documentation/forms required by regulation to be in a patient's chart. Neither were aware that they were being required by the Medical Records Department to audit medical records for completeness to ensure all required forms were in the patient chart.

An interview was conducted with Staff #28 on 2/24/2022 after 9:00 AM. Staff #28 confirmed that the Medical Records Department had staff to review nursing documentation to ensure elements of nursing documentation that were missing were entered into the chart. An example provided was if a nurse gave an injection but failed to identify the site location (arm, abdomen, leg, etc.), nursing would be notified of the element of documentation missing so that a late clarification entry could be made. Staff #28 stated that if forms were missing like the consent to treat, there was nothing she could do about it because she couldn't get the form. She stated this was the reason she wasn't responsible as the Director of Medical Records for auditing for those things; hospital staff were.

Based on review of records and interview, the facility failed to ensure that that 8 (Patient #1, #6, #11, #13, #14, #17, #18, and #20) out of 12 charts reviewed for informed consent contained the required delivery of information necessary for informed consent and/or properly executed informed consent forms. These forms included the required consent to treat upon admission, delivery of patient rights (necessary for patients to make informed decisions about how they wish to proceed with treatment), delivery of the Important Message from Medicare (IM letter-necessary for patients to make informed decisions about their discharge options), and delivery of the Medicare Outpatient Observation Notice (Moon letter-necessary for patients to make informed decisions about outpatient treatment).

Findings included:

Records were reviewed on 2-22-2022 and 2-23-2022 for required documentation of patient consent to treat upon admission, delivery of patient rights, delivery of the Important Message from Medicare if required, and delivery of the Medicare Outpatient Observation Notice if required.

Patient #6

Review of Patient #6's chart showed that he was admitted to the facility on 1-16-2022 at 10:17 PM. He was a Medicare recipient. He had initially been admitted to outpatient observation status requiring the delivery of a Moon letter. He was later changed to an inpatient status requiring the delivery of the IM letter. No record of the delivery of the IM letter or Moon letter was found in the patient's chart. No record was found of the consent to treat or record of delivery of patient rights upon admission.

Patient #11

Review of Patient #6's chart showed that she was admitted to the facility on 1-30-2022 at 1:44 PM. She was a Medicare recipient. She had initially been admitted to outpatient observation status requiring the delivery of a Moon letter. She was later changed to an inpatient status requiring the delivery of the IM letter. No record of the delivery of the IM letter or Moon letter was found in the patient's chart. No record was found of the consent to treat or record of delivery of patient rights upon admission.

Patient #13

Review of Patient #13's chart showed that he was admitted to the facility on 12-25-2021 at 10:58 AM. He was a Medicare recipient. He had been admitted to outpatient observation status requiring the delivery of a Moon letter. No record of the delivery of the Moon letter was found in the patient's chart. No record was found of the consent to treat or record of delivery of patient rights upon admission.

Patient #14

Review of Patient #14's chart showed that she was admitted to the facility on 12-25-2021 at 3:45 PM. She was a Medicare recipient. She had been admitted to outpatient observation status requiring the delivery of a Moon letter. No record of the delivery of the Moon letter was found in the patient's chart. No record was found of the consent to treat or record of delivery of patient rights upon admission.

Patient #17

Review of Patient #17's chart showed that she was admitted to the facility on 8-8-2021 at 3:20 PM and died in the facility on 8-25-2021. She was a Medicare recipient. No record of the delivery of the IM letter upon admission was found. No record was found of the consent to treat or record of delivery of patient rights upon admission.

Patient #18

Review of Patient #18's chart showed that she was admitted to the facility on 9-28-2021 at 10:30 AM and died in the facility on 9-29-2021. She was a Medicare recipient. No record of the delivery of the IM letter upon admission was found. No record was found of the consent to treat or record of delivery of patient rights upon admission.

Patient #20

Review of Patient #20's chart showed that he was admitted to the facility on 12-4-2021 at 12:45 PM and died in the facility the same day. He was a Medicare recipient. No record of the delivery of the IM letter upon admission was found. No record was found of the consent to treat or record of delivery of patient rights upon admission.

Interview was conducted with Staff #24 on the afternoon of 2-23-2022. Staff #24 stated that if the family is present, they would have the family sign if the patient was unable. If the forms could not be signed, the admission clerk would annotate why. Staff #24 stated that they did not follow up on paperwork after the patient was admitted. Staff #24 stated that Admissions Staff was responsible for obtaining the initial consent to treat, delivery of patient rights, delivery of the Important Message from Medicare, and delivery of the Medicare Outpatient Observation Notice.

On 2-24-2020, Staff #22 was interviewed with Staff #19 present. Staff #22 stated that she only provided patients with the MOON letter when the patient had been admitted as inpatient and was changed to observation. Staff #22 stated that registration was responsible for giving patients MOON letters and IM letters. Staff #22 stated that letters were only given to patients who had traditional Medicare and not patients who were enrolled in Medicare Advantage Plans (commercial insurance carriers).

Staff #22 stated that if for some reason the patient or representative have given consent by telephone, it would be annotated on the form. No other steps such as mailing a copy to the patient or representative were provided during interview or in hospital policy.

Review of the Medicare Claims Processing Manual Chapter 30 - Financial Liability Protections for delivery of the IM letter was as follows:

200.3.1 - Delivery of the Important Message from Medicare
Hospitals must follow the procedures listed below in delivering the Important Message from Medicare (IM). ...

Delivery Timeframe. Hospitals must deliver the original copy of the IM at or near admission, but no later than 2 calendar days following the date of the beneficiary's admission to the hospital. ...

In-Person Delivery. The IM must be delivered to the beneficiary in person. However, if the beneficiary is not able to comprehend the notice, it must be delivered to and signed by the beneficiary's representative.

Notice Delivery to Representatives. CMS requires that notification of a beneficiary who is not competent be made to a representative of the beneficiary. A representative is an individual who, under State or other applicable law, may make health care decisions on a beneficiary's behalf (e.g., the beneficiary's legal guardian ,or someone appointed in accordance with a properly executed "durable medical power of attorney").

Otherwise, a person (typically, a family member or close friend) whom the beneficiary has indicated may act for him or her, but who has not been named in any legally binding document may be a representative for purpose of receiving the notices described in this section. Such representatives should have the beneficiary's best interests at heart and must act in a manner that is protective of the beneficiary and the beneficiary's rights. ...

Notification to the representative may be problematic because that person may not be available in person to acknowledge receipt of the required notification. Hospitals are required to develop procedures to use when the beneficiary is incapable of receiving or incompetent to receive the notice, and the hospital cannot obtain the signature of the beneficiary's representative through direct personal contact.

Regardless of the competency of a beneficiary, if the hospital is unable to personally deliver a notice to a representative, then the hospital should telephone the representative to advise him or her of the beneficiary's rights as a hospital patient, including the right to appeal a discharge decision.

The information provided should include the following at a minimum:

The name and telephone number of a contact at the hospital;

The beneficiary's planned discharge date, and the date when the beneficiary's liability begins;

The beneficiary's rights as a hospital patient, including the right to appeal a discharge decision;

How to get a copy of a detailed notice describing why the hospital and physician believe the beneficiary is ready to be discharged;

A description of the steps for filing an appeal;

When (by what time/date) the appeal must be filed to take advantage of the liability protections;

The entity required to receive the appeal, including any applicable name, address, telephone number, fax number or other method of communication the entity requires in order to receive the appeal in a timely fashion;

Direction to the 1-800-MEDICARE number for additional assistance to the representative in further explaining and filing the appeal; and

The date the hospital conveys this information to the representative, whether in writing or by telephone, is the date of receipt of the notice. Confirm the telephone contact by written notice mailed on that same date. Place a dated copy of the notice in the beneficiary's medical file, and document the telephone contact with the beneficiary's representative (as listed above) on either the notice itself, or in a separate entry in the beneficiary's file or attachment to the notice. The documentation should indicate that the staff person told the representative the planned discharge date, the date the beneficiary's financial liability begins, the beneficiary's appeal rights, and how and when to initiate an appeal. The documentation should also include the name of the staff person initiating the contact, the name of the representative contacted by phone, the date and time of the telephone contact, and the telephone number called.

When direct phone contact cannot be made, send the notice to the representative by certified mail, return receipt requested, or other delivery method that requires signed verification of delivery. The date that someone at the representative's address signs (or refuses to sign) the receipt is the date received. Place a copy of the notice in the beneficiary's medical file, and document the attempted telephone contact to the members' representative. The documentation should include: the name of the staff person initiating the contact, the name of the representative you attempted to contact, the date and time of the attempted call, and the telephone number called.
If both the hospital and the representative agree, hospitals may send the notice by fax or email, however, hospitals must meet the HIPAA privacy and security requirements. ...

Beneficiary Signature and Date. The IM must be signed and dated by the beneficiary to indicate that he or she has received the notice and can comprehend its contents, unless an appropriate reason for the lack of signature is recorded on the IM, such as a properly annotated signature refusal (see below).

Refusal to Sign and Annotation. If a beneficiary refuses to sign the notice, hospitals may annotate the notice to indicate the refusal, and the date of refusal is considered the date of receipt of the notice. The annotation may be placed in the unused patient signature line, in the "Additional Information" section on page 2 of the notice or another sheet of paper may be attached to the notice, if necessary. Any insertions on the notice must be easy for the beneficiary to read in order for the notice to be considered valid. See also Section 200.5.6 - Insertions in Blanks.

Notice Delivery and Retention. Hospitals must give the original copy of the signed or annotated notice to the patient. Hospitals must retain a copy of the signed notice and may determine the method of storage that works within their existing processes, for example, storing a copy in the medical record or electronically.

200.3.2 - The Follow-Up Copy of the Signed Important Message from Medicare

A "follow-up" copy of the signed IM must be delivered to the beneficiary using the following guidelines:

Delivery Timeframe. The follow-up copy must be delivered as far in advance of discharge as possible, but no more than 2 calendar days before the planned date of discharge. Thus, when discharge seems likely within 1- 2 calendar days, hospitals should make arrangements to deliver the follow-up copy of the notice, so that the beneficiary has a meaningful opportunity to act on it. However, when discharge cannot be predicted in advance, the follow-up copy may be delivered as late as the day of discharge, if necessary. If the follow-up copy of the notice must be delivered on the day of discharge, hospitals must give beneficiaries who need it at least 4 hours to consider their right to request a QIO review. Beneficiaries may choose to leave prior to that time, however, hospitals must not pressure a beneficiary to leave during that time period. If the hospital delivers the follow-up copy, and the beneficiary status subsequently changes, so that the discharge is beyond the 2-day timeframe, hospitals must deliver another copy of the signed notice again within 2 calendar days of the new planned discharge date. Hospitals may not develop procedures for delivery of the follow up copy routinely on the day of discharge.

Alternative to Delivery of the Signed Copy. A hospital may choose to deliver a new copy of the IM (not a copy of the signed IM) during the required timeframes; however, the hospital must obtain the beneficiary's or representative's signature and date on the notice again at that time.

Exception to Delivery of the Follow-Up Copy. If delivery of the original IM is within 2 calendar days of the date of discharge, no follow-up notice is required. For example, if a beneficiary is admitted on Monday, the IM is delivered on Wednesday and the beneficiary is discharged on Friday, no follow-up notice is required.

If a beneficiary receives and signs the initial copy of the IM as part of the preadmission process, the follow-up copy of the notice must be delivered if delivery of the initial copy occurred more than 2 calendar days prior.
Documentation. Hospitals must document timely delivery of the follow-up copy of the IM in the patient records, when applicable. Hospitals are responsible for demonstrating compliance with this requirement. If hospitals have processes in place to document delivery of other information related to discharge that includes a beneficiary signature and date, hospitals may include the follow-up copy of the notice in those documents. If there are no other existing processes in place, hospitals may use the "Additional Information" section of the IM to document delivery of the follow-up copy, for example, by adding a line for the beneficiary's or representative's initials and date."

This process was found to be outlined in CHI St. Luke's Health Policy and Procedures, Title: Notification of Hospital Discharge Appeals (Important Message from Medicare) Effective Date: December 2020.

Interview with Staff #22 and Staff #19 confirmed that there was not a monitoring process that had been put in place for the facility to ensure that policy was being followed.

Staff #19 was interviewed regarding a policy for the deliver of the MOON Letter. No policy was provided that contained the requirements and procedures for the delivery of the MOON letter as outlined in the Medicare Claims Processing Manual Chapter 30 - Financial Liability Protections, 400 - Part A Medicare Outpatient Observation Notice.

Review of the MOON letter showed that Observation affects other treatments the patient may or may not be able to access at a later time. This was information necessary for informed consent for treatment. Information from the form necessary for patients to make informed decisions about treatment consent included:

"Observation services may affect coverage and payment of your care after you leave the hospital:
If you need skilled nursing facility (SNF) care after you leave the hospital, Medicare Part A will only cover SNF care if you've had a 3-day minimum, medically necessary, inpatient hospital stay for a related illness or injury. An inpatient hospital stay begins the day the hospital admits you as an inpatient based on a doctor's order and doesn't include the day you're discharged.
If you have Medicaid, a Medicare Advantage plan or other health plan, Medicaid or the plan may have different rules for SNF coverage after you leave the hospital. Check with Medicaid or your plan."


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Findings for improperly documented informed consent included:

During a review of the medical record with Staff #2 on 2/24/2022 after 9:00 AM the following was found:

Patient #1 was admitted to the facility on 4/23/2021 in the Emergency Department. A review of the document titled, "General Consent on Admission" was as follows:

" ...1. Consent for Treatment
...

The signature line of the Patient or Legal Representative read as follows:

Patient Medically Unable to sign DUE TO PT LEGU (sic) BLIND. No date or time was documented.
...

Representation/Signature: My signature below indicates that I have read fully and understand the document or have had it read to me and that I (As the patients Legal Representative, or Guardian) hereby accept and agree to the terms of this Conditions on Admission.

__ I have received a copy of the Rights & Responsibilities of Patients.

The signature line of the Patient or Legal Representative read as follows:

Patient Medically Unable to sign DUE TO PT LEGU (sic) BLIND. No date or time was documented ..."

No witness signature was on the document.

Along the outer side of the document titled, "General Consent on Admission" was an electronic statement that read:

"04/23/2021 08:55 - SIGNATURE OPT OUT- Staff #29."

During the medical record review on of Patient #1 on 2/24/2022, Staff #2 confirmed no documentation was found in the medical record of Patient #1 that the consent for treatment was verbally explained. Also, no documentation was in the medical record confirming the patient received a printed copy of the document titled, "Rights and Responsibilities of Patients".

A review of the policy titled, "Medical Record Content Policy and Procedures" with a review date of March 2021 and a Department Approval by Staff #28 was as follows:

" ...Purpose:
It is the policy of the Hospital that the medical record shall contain sufficient information to identify the patient, support the diagnosis, to justify the treatment and document the results accurately.
Procedure:
The Admissions Department is responsible for collecting sufficient information to identify the patient. The information is documented on the electronic face sheet, which is a permanent part of the patient's record.
...
There is evidence of informed consent in the patient's medical record ..."


Staff #2 confirmed the findings.

Based on review of records and interview, the facility failed to ensure that all current employees had a properly documented negative Tuberculosis (TB) test result in their employee health files for 3 staff members (Staff #1, #18, #26) out of 9 employee files reviewed. Failure to have an accurately documented test in the file could result in the potential spread of TB in the facility to other staff members and patients.

Findings included:

On the afternoon of 2-23-2022 and morning of 2-24-2022, employee health records were reviewed with the employee health nurse.

Records for Staff #1, #18, and #26 contained results for the Purified Protein Derivative (PPD) test used to detect latent TB. Latent TB would not be contagious. However, a person with latent TB would have the potential to develop active TB and become contagious, requiring more frequent screening.

Review of the forms in the employee health files showed that the times for administration and reading of PPD test were not documented. Without this information it could not be determined if the test had been read too early or too late to be valid since this was a time-sensitive test.

The forms did not contain the Manufacturer/Lot Number/expiration date of the PPD used. Without this information, it could not be determined if the PPD used was not compromised by either recall or expiration.

The measurement of the induration (thickening of skin due to swelling/reaction to PPD - not redness) left at the injection site was not recorded. Without this information, it could not be determined if the induration left by the PPD test was within the measurements for a negative test.

The Employee Health Nurse and Staff #19 confirmed the information was missing and that staff did not have documentation of a negative Interferon Gama Release Assay (IGRA blood test) in their employee health file.

Review of information from https://medlineplus.gov/ency/article/003839.htm was as follows:


"The PPD skin test is a method used to diagnose silent (latent) tuberculosis (TB) infection. PPD stands for purified protein derivative.

How the Test is Performed

You will need two visits to your health care provider's office for this test.

At the first visit, the provider will clean an area of your skin, usually the inside of your forearm. You will get a small shot (injection) that contains PPD. The needle is gently placed under the top layer of skin, causing a bump (welt) to form. This bump usually goes away in a few hours as the material is absorbed.

After 48 to 72 hours, you must return to your provider's office. Your provider will check the area to see if you have had a strong reaction to the test."


Review of resources from the National Institute of Health's website, https://www.ncbi.nlm.nih.gov/books/NBK556037/ contained the following information:

"Documentation of the injection site, date and time of test administration, person placing the test, product lot number, and the manufacturer should be done. The patient should avoid scratching or rubbing the area and should keep the site uncovered and clean. Since it is possible to have allergic reactions with tuberculin, epinephrine (1 mg/mL) should be available to treat them."

Review of CHI St. Luke's Health Policy and Procedure Title: Employee Tuberculosis Screening (System), Effective August 2020 was a s follows:

"POLICY

It is the policy of CHI Texas Division to comply with Federal and State requirements concerning tuberculosis screening for employees who are healthcare workers, in an effort to reduce the transmission of TB in the environment.

PROCEDURES

...
2. Current Employees
a. Current employees must have a documented history of negative TB results.
b. Current employees with a documented history of a positive TB result will need to complete the TB Program Symptom Survey in Employee Medical Record t (sic) annually. See Positive TB Screening Results."

Based on observation, review of records and interview, the facility failed to ensure that 1 piece of equipment (hydrocollator machine) out of 10 pieces of equipment inspected in the physical therapy room were maintained in a sanitary manner that would prevent the spread of infection.

Findings included:

On the morning of 2-23-2022, a tour of the physical therapy room was made with Staff #18 present. The facility was observed to have a hydrocollator machine in use (A thermostatically controlled hot water tank for warm, moist heated pads). When the hydrocollator machine lid was raised to look inside the tank, it was observed to have a heavy build-up of a dark red, almost black, substance built up around the upper lip where the lid rested on the tank and along the edges of the lid. The build up was easily wiped away with a dry towel.

Review of the equipment temperature and cleaning log showed that the equipment had been cleaned on 2-21-2022, per required schedule. Staff #18, when interviewed, confirmed that she had cleaned the equipment on that date.

Review of CHI St. Luke's Health Policy Title: Equipment Cleaning; Effective Date 3/6/2017 was as follows:

"Hydrocollator Machine
1. Recommended operating temperature is 160-165 degrees Fahrenheit.

...

3. The tank is drained and cleaned at a minimum of every two weeks. Cleaning the tank can included raining the water (sic), removing mineral deposits with a strong solution of vinegar (5%) and water followed by rinsing as indicated (it is acceptable to use a green, blue, or white abrasive scour pad if absolutely necessary to remove deposits), rinsing the tank thoroughly, and refilling with clean water. Exterior cleaning can be completed as necessary with a stainless steel polish and a soft cloth."

Based on review of records and interview, the facility failed to develop a facility wide antibiotic stewardship program that demonstrated coordination among all components of the CAH responsible or antibiotic use and resistance, including, but not limited to, the infection prevention and control program, the QAPI program, the medical staff, nursing services, and pharmacy services.

Findings included:

An interview was conducted with Staff #8 on 2-22-2022. Staff #8 was asked how pharmacy staff from the facility participated in the Antibiotic Stewardship Program Committee and meetings. Staff #8 stated that pharmacy staff from the facility were not part of an Antibiotic Stewardship Program Committee.

On 2-23-2022, Staff #6 was interviewed on how the facility's Antibiotic Stewardship Committee functioned and the Infection Preventionist's role. Staff #6 stated that there was not a facility Antibiotic Stewardship Committee. Staff #6 stated that Antibiotic Stewardship was tracked at the Market level and local hospital staff were not involved.

On 2-23-2022, Staff #2 was interviewed. Staff #2 confirmed that the QAPI program does not include Antibiotic Stewardship information that would be reported through a facility Antibiotic Stewardship Program Committee to the Quality Committee, to the Medical Staff Committee and then up to the Market Committee (Market Committee would include information for all hospitals in the CHI St. Luke's Memorial Market).

Review of the meeting minutes titled Antimicrobial Stewardship Program (ASP) 11/17/2021 showed that the meeting was attended by Market representatives, Lufkin representatives, and Livingston representatives. Some of the data reported in the meeting did not clearly delineate which facility the data was for. No active projects for San Augustine were identified.

Staff #6 was asked about the lack of projects and involvement. Staff #6 stated that she was told that the reason was because they did not do enough cultures and did not do enough surgeries for San Augustine's data to be statistically significant. When asked if a local Antibiotic Stewardship team tracked and trended antibiotics prescribed without cultures being ordered, Staff #6 confirmed there was no such team to look at the antibiotics that were prescribed in the facility's Emergency Department or Inpatient Services.

An interview was completed with Staff #19 on 2-24-2022. Staff #19 confirmed that information for the San Augustine hospital collected and tracked for Market reporting was not being presented, reviewed, and evaluated by a facility Antibiotic Stewardship Program Committee or coordinated with the required facility participants to include, but not limited to, the infection prevention and control program, the QAPI program, the medical staff, nursing services, and pharmacy services.

Based on review and interview the facility failed to have a comprehensive care plans on 4 (#'s 24, 25, 26, and 27) out of 4 patients.

Review of the patient charts revealed the patients in a swing bed had nursing care plans but not comprehensive care plans developed by the interdisciplinary team. This would include nursing, the physician, social work, activities, nurses aides, physician, therapy services, dietary, and any other discipline that would provide care to the patient.

An interview with Staff #2 on 2/23/22 confirmed that there was not an interdisciplinary team meeting or care plans implemented.