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PATIENT RIGHTS: INFORMED CONSENT

Tag No.: A0131

Based on interview, review of medical record documentation for 2 of 2 hospital encounters for Patient 1 that included surgical procedures, review of policies and procedures and review of other documentation, it was determined the hospital failed to fully develop and enforce policies and procedures to ensure patients' rights were recognized, protected and promoted as follows:
* The hospital failed to develop and implement policies and procedures that addressed situations when non-English speaking patients needed an interpreter and interpreter services were unavailable.
* Interpreters used during provision of informed consent for surgical procedures were not evaluated and determined qualified in accordance with hospital policies and procedures.
* Non-English speaking patients were not afforded the right to fully participate in their plan of care using a qualified interpreter in accordance with hospital policies and procedures in the following areas:
- PCA education.
- Limb immobilizer education.
- Oxycodone administration and education.

Findings include:

1. The following P&Ps were reviewed and failed to include a process for addressing situations when non-English speaking patients needed an interpreter and interpreter services were unavailable:

2. A document titled, "Patient Rights and Responsibilities" dated "07292024" was reviewed and reflected:
* "To discuss and participate in your health care decisions ... You have the right to discuss, ask questions about, and make decisions regarding your care ... And, to help ensure you understand the care being given or proposed, interpreter services are available at no cost to you."
* "To communicate about your care ... You are encouraged to learn and ask questions about the treatment you are receiving. If necessary, our staff will obtain an interpreter at no cost to you or provide other means for you to fully understand the care being given to you or proposed."

The document did not address the steps the hospital would take when a qualified interpreter was unavailable.

3. A 2-page document titled, "Interpreter Decision Tree," dated "2.16.18" was reviewed and reflected:
* The document contained an algorithm titled, "Spoken Language Interpreter Selection Decision Tree."
* At the bottom of pages 1 and 2, written in red lettering: "Remember: [underlined] -DO NOT use patient's family members or friends to interpret. -If patient declines interpreter, use scripting tool."
* The scripting tool, as described by the LAM/CRC, the "Interpreter Decision Tree," did not contain any references to instances when it was appropriate to use family members or friends for interpretation. Refer to Finding 15, interview with the LAM/CRC.

The document did not address the steps the hospital would take when a qualified interpreter was unavailable.

4. The P&P titled "Interpreter Services For Patients - Spoken Language Interpreter Services," dated "Effective 10/2021" reflected:
* "It is the policy of PHSOR to meet the Civil Rights Act of 1964 Title VI requirements, Section 1557 of the Patient Protection and Affordable Care Act (ACA) mandate, and the Joint Commission standards for interpretation and patient access and any other applicable federal, state or local regulatory mandates. PHSOR utilizes video remote interpreting (VRI), telephonic interpretation and contracted interpreter vendors to provide spoken language services. Based upon the population served some ministries may employ spoken language interpreters."
* "... Caregivers may not require, suggest or encourage a LEP or NES patient and/or companion to use friends or family members as interpreters as this may compromise the effectiveness of providing medical care ... If a patient and/or companion needs an in-person interpreter and DECLINES the service, caregivers should ensure that the patient and/or companion understand that ... Interpreter services are available free of charge ... Qualified in-person, VRI, or telephonic interpreters are offered at every clinical encounter for patient safety ... A patient can decline an interpreter, however, providers and caregivers are required to use an interpreter modality to facilitate communication."
* "Ad hoc interpreters (e.g., family members, friends, and caregivers) can interpret non-medical information, such as demographic information and provide social conversation."
* "If a patient presents with a life-threatening condition, the temporary use of an ad hoc interpreter is permitted, until a qualified interpreter arrives or is accessed through VRI."
* "Caregivers with second language proficiency will not provide medical interpretation or care in a language other than English unless they are ... Employed by PHSOR as interpreters, telephonic or video interpretation is the preferred method to include anticipated need is less than 30 minutes ... Formally assessed and qualified to provide care in a language other than English and providing care specifically within their scope of work."
* "... PHSOR endeavors to provide the highest quality interpreter service to patients and companions. Interpreter vendor agreements include contractual language about the expectations for agency interpreters ... "
* "For any concerns that involve interpreters ... Complete an event report ... Contact regional language access manager."

"Contact regional language access manager" was the only next step described in the document and it was unclear which types of "concerns that involve interpreters" were to be addressed by the regional language manager. For example, it was unclear what other the steps the hospital would take when a qualified interpreter was unavailable, what would occur once the language access manager was contacted, or whether an interpreter would be immediately available for a patient once the regional manager had been contacted.

5. A 2-page document titled, "Patient Refusal of Interpreter Services - Scripting Tool" dated "March 12, 2018" was reviewed and reflected:
* "In the event a patient refuses interpreter services for any reason, Providence caregivers still have an obligation to ensure that effective communication is taking place, which includes any/all caregivers understanding the patients as well as any conversations between a patient and their family members who may be involved with the patients' care."
* "There are occasions when a patient may refuse interpreter services ... In these instances, caregivers should advise patients of the following: 1. Assure patients that interpreters keep patient information private and confidential ... If a patient is concerned about the in-person interpreter being of the opposite gender, we can offer telephonic interpreter services ... InDemand [sic] units also have a 'privacy screen' which allows the patient and the interpreter to hear one another without them seeing one another on the screen ... Assure patients that interpreter services are offered by Providence at no charge to the patient ... If a patient insists on using a family or friend to interpret, caregivers should use the following statement: 'We understand that having your [son, daughter, friend, etc.] interpret for you makes you more comfortable. While your [son, daughter, friend, etc.] is interpreting for you, we will use an interpreter for the [doctor, nurse, etc.].'"

The document did not address the steps the hospital would take when a qualified interpreter was unavailable for the "doctor, nurse, etc."

6. The P&P titled "Document Translation GOP" dated "Effective 12/2023" reflected:
* "This policy describes the process utilized by Providence Oregon in the provision of written translation services for individuals with limited English proficiency (LEP)."
* "Translation of written materials from English (source language) into the patient's target language is a requirement of the Title VI of the Civil Rights Act of 1964 to help improve access to services for persons with limited English proficiency and to assure effective communication."
* "Providence Oregon will provide written translation services as described herein to Eligible Persons at no cost to the Eligible Person. Only translators approved by Language Access Services may translate documents utilized in Providence Oregon's health care programs and services."
* "Definitions ... Limited English Proficiency (LEP): a person with limited English proficiency is one whose primary language for communication is not English and who has a limited ability to speak, read, write or understand the English language."
* "Patients should be asked in what language they prefer a written document, since this may differ from their identified preferred oral (spoken) language. Provide the patient with both English and translated versions, or a bilingual version, to ensure best comprehension by the patient. Patients with vision loss may require large print versions of translated materials, use of an assistive device for magnification, or may need Braille versions, which need to be ordered in advance through the Language Access Program."
* "Providers and staff should never utilize on-line or electronic translation or applications such as Google Translate, Microsoft Translator, etc. to produce on-the-spot translations. They are never completely accurate and may not be confidential as these apps store data in unsecure [sic] locations (and once you use their tool, it becomes their property, and they can use the data as they wish). Machine translation doesn't have proof-reading ability and many English words and terminology do not have 1:1 equivalency, so misinterpretation may occur, which can cause patient harm."
* "Caregivers and Providers who self-identify as bilingual must demonstrate medical proficiency in the target language by completing a medical language assessment before providing language translation (Providence Oregon GOP: Medical Proficiency for Bilingual Caregivers)."
* "In the event translation documents are not available at the time of need, the caregiver will provide an English version of the document to the patient and will read the document to the patient with the assistance of an interpreter. The English version of the document will be sent home with the patient and the translated version will be either emailed or mailed to the patient post discharge once the document is available."
* "Provide eligible persons documents in their primary language when available."
* "Document in EMR when patient has been provided with translated materials and the language version provided."
* "Guidelines for using translated consents ... Document the name of the interpreter who was present on the consent form, if appropriate. NOTE: the interpreter may not be the witness to the signature ... Make a notation in the electronic medical record (EMR) that a translated consent form was provided to the patient."

7. The P&P titled "PSJH-CLIN-1203 Nondiscrimination Policy" dated "Effective 01/2024" reflected:
* "To establish Providence's System-level policy and procedures prohibiting discrimination against individuals accessing any Health Program and/or Activity (defined below) provided by Providence ... "
* "Definitions ... Auxiliary aids and services include:(1) Qualified interpreters on-site or through video remote interpreting (VRI) services ... Caregivers: Refers to all workforce members of Providence ... Limited English Proficiency: Means an individual whose primary language for communication is not English and who has a limited ability to read, write, speak or understand English."
* "Qualified Bilingual/Multilingual Staff: Qualified bilingual/multilingual staff must demonstrate to the covered entity that they are proficient in English and at least one other spoken language, including any necessary specialized vocabulary, terminology, and phraseology, and are able to effectively, accurately and impartially communicate directly with individuals with limited English proficiency in their primary language. An individual who meets the definition of 'qualified bilingual/multilingual staff' does not necessarily qualify to interpret or translate for individuals with limited English proficiency within the meaning of this rule ..."
* "Qualified Interpreter or Translator for an Individual with Limited English Proficiency or non-English speaking: Means an interpreter or translator, who interprets or translates effectively, accurately, and impartially; who via a remote interpreting service or an on-site appearance: Means an interpreter who via a remote interpreting service or an on-site appearance: Adheres to generally accepted interpreter or translator ethics principles, as applicable, including client confidentiality; In the case of an interpreter has demonstrated proficiency in speaking, and in the case of a translator has demonstrated proficiency in writing, and in both cases, demonstrates proficiency in understanding both spoken English and at least one other spoken language; and In the case of an interpreter is able to interpret, and in the case of a translator is able to translate: effectively, accurately, and impartially, both receptively and expressly, to and from such language(s) and English, using any necessary specialized vocabulary, terminology and phraseology."
* "It is also Providence's policy to provide free auxiliary aids and language assistance services to individuals with Disabilities, or Limited English Proficiency, or non-English speaking who are accessing Providence Programs or Activities. Such services may include providing Qualified Bilingual/Multilingual Staff, Qualified Interpreters, and Qualified Translation free of charge as needed or appropriate."

The document did not address the steps the hospital would take when a qualified interpreter was unavailable.

8. During an interview with the LAM/CRC, QD and DRA on 02/04/2025, beginning at 0930, the LAM/CRC confirmed Findings 1-7. The following information was provided:
* When asked where a patient's interpretation preference was documented in the EHR. The LAM/CRC responded, "It pops up at the point of contact ... the patient can also answer 'No' that they do not want an interpreter as they may have the intention to use a family [member] or friend."
* When asked whether that was acceptable, the LAM/CRC responded, "No. That is spelled out in the scripting tool." The LAM/CRC was asked to identify the "scripting tool," the LAM/CRC responded that it was the Interpreter "Decision Tree." Refer to Finding 3 above, the Interpreter Decision Tree.
* When asked what should staff do when an interpreter is not available? The LAM/CRC stated if an interpreter was not available, the staff should "Escalate [it] to the manager."
* The LAM/CRC further explained that if the language was "just not available," the LAM/CRC would coach the staff through interactions such as: expected time delays vs an interpreter not being available. The LAM/CRC stated that if patient was insistent on using family & friends for interpreting, they could be allowed to use a support person, but the provider needs to know what's being said to the patient. They stated, "Part of our policy on the sharepoint site, the decision tree, is distributed to nursing units; some are laminated and available at the desk. [It] helps [to] avoid issues regarding abuse or coercion and staff can interject."
* When asked where next steps were outlined in the hospital's P&Ps, the LAM/CRC acknowledged that "Nothing in policy that outlines next steps. We intentionally omitted possible options. The goal has been to not skip steps. We don't want them [caregivers/staff] to skip steps. We want them to escalate [it to the manager] each and every time to troubleshoot."

9.a. Review of a medical record for Patient 1 with admit date 07/11/2023 and discharge date 08/02/2023 included:
* The patient was non-English speaking and spoke Chuukese only.
* A consent form titled "Consent To Operation Administration Of Anesthetics And The Provision Of Other Medical Services" reflected "I am having a procedure performed by (print name): [Names of two physicians] I have authorized my physician and associates and assistant chosen by my physician to perform the following treatment, surgery or other procedures ... Right below-knee amputation". The form was signed by the patient and dated 07/20/2023 at 1423.
* An MD note dated 07/20/2023 at 1455 reflected "-Family and patient has had extensive discussion about BKA, and all agreed to proceed ... Patient is consented for R BKA scheduled for tomorrow."
* The patient underwent a below the knee amputation surgical procedure on 07/21/2023.
There was no documentation that reflected the consent for the below the knee amputation surgical procedure had been translated by an approved translator.

9.b. The medical record in Finding 9.a. was reviewed with DRA, QD and a NM on 01/24/2025 beginning at 1430. An interview was conducted with the NM at the time of the medical record review. In response to whether there was an interpreter for the surgical consent for the below the knee amputation surgical procedure, the NM stated "I don't see a note by the doctor."

9.c. Review of a medical record for Patient 1 with admit date 08/15/2023 and discharge date 08/21/2023 included:
* The patient was non-English speaking and spoke Chuukese only.
* An MD note dated 08/16/2023 at 0603 reflected "Right [below the knee amputation] stump with ischemic necrosis ... I believe there is a high likelihood of complete healing following right above-knee amputation. A PAR-Q conference was held with [the patient's] family who served as the interpreter ..."
* A History and Physical electronically signed by an MD and dated 08/16/2023 at 1059 reflected that the patient had "[hypertension] ... [diabetes mellitus], [peripheral vascular disease], [chronic kidney disease], and chronic diabetic foots [sic] [status post] right [below the knee amputation] on 7/21 ... returning to the [emergency department] from [skilled nursing facility] for ongoing poor wound healing of the right residual limb, which has now progressed to wet gangrene. Given degree of necrosis, the [below the knee amputation] is not salvageable and will need an [sic] right above knee amputation ... After a long discussion with the patient and [their adult family member], they are agreeable to proceed. Patient's biggest concern is if the [above the knee amputation] fails to heal. I discussed that failure to heal is always a risk and that there is always a possibility for the need for further revision. However, we feel that the benefits outweighs [sic] these risk as [the patient's] current residual limb is unsalvageable and if left, could lead to profound sepsis, further limb threat and even death ... Plan to proceed with right above knee amputation today 8/16 - Consent signed and scanned copy located in the chart - Family updated - Vascular surgery to follow ..."
* An Operative Report electronically signed by an MD and dated 08/16/2023 at 1323 reflected that a "Consent was obtained" and the patient underwent a right above the knee amputation on 08/16/2023.
There was no documentation that reflected the consent for the above the knee amputation surgical procedure had been translated by an approved translator, or that the translator's qualifications had been documented.

9.d. Regarding the hospital's failure to ensure interpreters used during provision of informed consent for surgical procedures were evaluated and determined qualified to interpret:
* During an interview with the LAM/CRC, QD and DRA on 02/04/2025, beginning at 0930, the following information was provided:
* When asked whether the consent forms for Patient 1 had been translated into a language the patient could understand by an approved translator, both the QD and the DRA responded, "No."
* When asked whether the interpretation/translation of the consents for surgery on 07/21/2023 and 08/16/2023, had been translated by an approved translator, or whether the translator's qualifications had been documented, both the QD and the DRA responded, "No."

10.a. Regarding the hospital's failure to ensure non-English speaking patients were afforded the right to fully participate in their plan of care using a qualified interpreter for PCA education; the P&P titled "Patient Controlled Analgesia: Adult" dated "Effective 11/2022" was reviewed and reflected:
* "Patient controlled analgesia (PCA) offers patients an avenue for pain control that is self-administered. PCA therapy allows the patient an opportunity to be involved in their own pain management plan."
* "Assess the patient's readiness for PCA therapy: ... Patient demonstrates understanding and acceptance of PCA use ... Patient demonstrates ability to self-administer pain medication via PCA pump."
* "Initiation of PCA therapy ... Educate Patient and family about the medication and PCA therapy. Note: This should include risk of over sedation and need to speak up if concern about breathing changes ... Pain assessment using criteria consistent with patient's age, condition, and ability to understand ... Reinforce patient education throughout PCA therapy and document ..."
* "Discontinuation of PCA Therapy ... Teach patient/caregiver about analgesic medication transition from PCA. Review with the patient their individualized plan for comfort promotion including a multi-modal approach ... Document education in Patient Education tab and update progress in the Care Plan."

10.b. A document titled, "Pain Management in the Hospitalized Patient" with an origination date of "07/1996" and last revised "10/2023" was reviewed and reflected:
* "Objectives To provide safe and effective pain care for hospitalized patients based on the following principles:"
* "Education of patients and families regarding their roles in managing pain as well as the potential limitations and side effects will be provided."
* "Pain Screening and Assessment ... The hospital has defined criteria to screen, assess, and reassess pain that are consistent with the patient's age, condition, and ability to understand."
* "Treatment, Monitoring and Referral ... The hospital involves patients in the pain management treatment planning process through the following: 1) Developing realistic expectations and measurable goals that are understood by the patient for the degree, duration, and reduction of pain."

10.c. A document titled, "Pain Management Practice Guideline" with an origination date of "08/2018" and last revised "12/2024" was reviewed and reflected:
* "Education is provided to patients and families regarding their roles in managing pain as well as potential limitations and side effects."
* "Educate patient and family, as appropriate to the setting and situation, on the following ... potential for opioid withdrawal and over-dose, signs and symptoms and associated interventions."

11.a. Review of Patient 1's medical record reflected they were admitted on 07/11/2023, discharged on 08/02/2023, were non-English speaking, and had diagnoses that included cellulitis of left upper limb, cerebrovascular disease, diabetes mellitus with diabetic nephropathy, gangrene of toe right foot, peripheral vascular disease, right lower lung mass, severe protein-calorie malnutrition, and chronic kidney disease.
* The record reflected Dilaudid PCA was initiated on 07/21/2023 and the first dose was administered at 1720.
* An RN note dated 07/21/2023 at 1824 reflected "Assumed care from 0730-1900 ... Alert/Oriented x3, disoriented to place at times. Forgetful. Chuukese speaking, family at bedside to interpret. Pain: PCA started post BKA. Tolerating ... Heart/Vitals: BP elevated, daily BP med given and PCA started to manage pain. MD aware."

There was no documentation that reflected: An assessment of the patient's readiness for PCA therapy, that the patient demonstrated understanding and acceptance of the PCA, and that the patient demonstrated ability to self-administer pain medication via the PCA pump in accordance with the hospital's P&Ps. Additionally, there was no documentation that noted:
* Which family member or members interpreted for the patient, nor that the family was determined qualified to interpret in accordance with the hospital's P&Ps.
* Whether the patient and family were educated about the medication and PCA therapy upon initiation of the PCA, including risk of over sedation and need to speak up if concerned about breathing changes in accordance with the hospital's PCA P&Ps.


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12.a. Patient 1 was was admitted to the hospital on 07/11/2023 and discharged 08/02/2023. Regarding patient education and involvement in plan of care, and the use of interpreters; a review of Patient 1's medical record following their R BKA on 07/21/2023, reflected the following with regard to designated interpreters/translators:
* On 07/22/2023, a physician noted, "Family requests updates to [adult family member 1], or [their spouse] as other family members have not been able to communicate information well." Electronically signed by MD at 1234.
* On 07/23/2023, a physician noted, "Family requests updates to [adult family member 1], or [their spouse] as other family members have not been able to communicate information well." Electronically signed by MD at 1331.
* On 07/24/2023, a physician noted, "Family requests updates to [adult family member 1], or [their spouse] as other family members have not been able to communicate information well." Electronically signed by MD at 1431.
* On 07/25/2023, a physician noted, "Family requests updates to [adult family member 1], or [their spouse] as other family members have not been able to communicate information well." Electronically signed by MD at 1728.
* On 7/26/2023, a physician noted, "Family requests updates to [adult family member 1], or [their spouse] as other family members have not been able to communicate information well. [Adult family member 1] updated 7/25 and 26 in detail at bedside." Electronically signed by MD at 1447.
* On 07/27/2023, a physician noted, "Family requests updates to ... [adult family member 1], or [their spouse] only, as other family members have not been able to communicate information well (and do not serve as reliable translators). [Adult family member 1] notes that [spouse] ... is the designated NOK in family but defers medical information oftentimes to [adult family member 1] since [adult family member 1] works in medical field ... [adult family member 1] updated 7/27 via phone: We had a lengthier discussion regarding patient's background and mental health history. Patient has a long history of mental health issues ... recent trauma and bereavement ... [adult family member 1] ... notes that there is 'lots of mental health issues' throughout the family ..." Electronically signed by MD at 1122.
* On 07/28/2023, a physician noted, "Family requests updates to ... [adult family member 1], or [their spouse] only, as other family members have not been able to communicate information well (and do not serve as reliable translators). [Adult family member 1] notes that [spouse] ... is the designated NOK in family but defers medical information oftentimes to [adult family member 1] since [adult family member 1] works in medical field ... " Electronically signed by MD at 2036.
* On 7/30/2023, a physician noted, "Family requests updates to ... [adult family member 1], or [their spouse] only, as other family members have not been able to communicate information well (and do not serve as reliable translators). [Adult family member 1] notes that [spouse] ... is the designated decision maker in family but defers medical information often times to [adult family member 1] since [adult family member 1] works in medical field ..." Electronically signed by MD at 2211.
* On 07/31/2023, a physician noted, "Family requests updates to ... [adult family member 1], or [their spouse] as other family members have not been able to communicate information well (and do not serve as reliable translators). [Adult family member 1] notes that [spouse] ... is the designated decision maker in family but defers medical information often times to [adult family member 1] since [adult family member 1] works in medical field ... MD ... 8:18 AM PDT."
* On 08/01/2023, a physician noted, "Family requests updates to ... [adult family member 1], or [their spouse] only, as other family members have not been able to communicate information well (and do not serve as reliable translators). [Adult family member 1] notes that [spouse] ... is the designated decision maker in family but defers medical information often times to [adult family member 1] since [adult family member 1] works in medical field ... MD ... 8:38 AM PDT."
* On 8/2/2023, a physician noted, "Family requests updates to ... [adult family member 1], or [their spouse] only, as other family members have not been able to communicate information well (and do not serve as reliable translators) [sic] [Adult family member 1] notes that [spouse] ... is the designated decision maker in family but defers medical information often times to [adult family member 1] since [adult family member 1] works in medical field ..." Electronic Signature, MD at 0755.

Beginning on day 11 of Patient 1's 23-day hospital admittance, an MD noted 11 times that Patient 1's family members "do not serve as reliable translators" nor did they "communicate information well." Additionally, six times, an MD noted, "Family requests updates to ..." specific family members; specifically to "[adult family member 1] since [adult family member 1] works in medical field," and their "spouse." However, P&P "Interpreter Services For Patients - Spoken Language Interpreter Services" reflected, "Caregivers with second language proficiency will not provide medical interpretation ... unless they are ... Employed by PHSOR as interpreters ... [and] Formally assessed and qualified to provide care in a language other than English and providing care specifically within their scope of work." Refer to Finding 4 above, the hospital's P&P on interpretive services. There was no documentation that reflected the interpretation provided was evaluated against hospital P&Ps and whether it had been determined that family members identified as providing interpreter services were qualified to perform those services for Patient 1 when interpreter services were not available. Refer also to Finding 4 above, the hospital's P&P on interpretive services which reflected, "... Caregivers may not require, suggest or encourage a LEP or NES patient and/or companion to use friends or family members as interpreters as this may compromise the effectiveness of providing medical care ..."

12.b. Regarding Patient 1's BKA after care and use of immobilizer education following their 07/21/2023 surgery, a review of the Patient 1's orders and MD notes regarding weight bearing and care following their R BKA on 07/21/2023 reflected the following:
* "Weight Bearing NWB entire limb Order ... at 07/21/23 1328 Weight Bearing Locations RLE ... "
* "Orientation [-] disoriented to; place ... at 07/21/23 1408 ... "
* "Memory Deficit [-] forgetful per patients [sic] [adult child] ... at 07/21/23 1408 ..."
* "Family Member/Support Person(s) [adult child] ... at 07/21/23 1408 ... [and adult child] ... at 07/21/23 2347 ..."
* "Involvement in Care at bedside ... at 07/21/23 1408 ... [and] at bedside ... at 7/21/23 2347."
* "Nursing communication ... Electronically signed by: ... MD on 08/07/23 1705 ... Order comments: Wound care for R BKA: Please keep it dry, apply Iodine 4 times daily, use a chuck instead of kerlix, followed by knee immobilizer and rooke boot."
* "Continue offloading, wound protection and knee immobilizer ..." Electronically signed by MD on 08/09/2023 at 1626.
* " INTERVAL EVENTS AND SUBJECTIVE ...
- Re-engaged for concerns about wound healing in the R BKA
- Patient has not been using knee immobilizer due to discomfort ...
- Will continue to observe BKA site for now
- Keep wound dry ... Plan for povidine-iodine swabs 4x/day, chux on top with knee immobilizer and Rooke boot." Electronically signed by the MD at 08/09/2023 at 1239 with a co-signer MD on 08/11/2023 at 0941.
* "Given the contracture of [their] right knee it would be best if PT could see [them] and assess. A knee immobilizer would be of value however I am concerned that [they] will develop pressure wounds with the knee immobilizer ..." Signed by MD on 08/10/2021 at 0723.

Although the MD notes reflected "offloading," it was not clear whether offloading meant "elevation" of limb. It was also not clear whether an interpreter was present when the MD "Re-engaged for concerns about wound healing in the R BKA." I

PATIENT RIGHTS: FREE FROM ABUSE/HARASSMENT

Tag No.: A0145

Based on interview, review of medical record documentation for 1 of 1 non-English speaking patient (Patient 1), review of event documentation for 7 of 7 patients involved in interpreter service incidents (Patients 2, 3, 4, 5, 6, 7 and 8), review of P&Ps, and review of other documentation, it was determined that the hospital failed to fully develop and enforce P&Ps to ensure patients' rights were recognized, protected and promoted and all components of an effective abuse and neglect prevention program were evident, including thorough and complete investigations and follow up actions of potential abuse or neglect, as defined by CMS, to ensure those incidents did not recur.

The CMS Interpretive Guideline for this requirement at CFR 482.13(c)(3) reflects "Abuse is defined as the willful infliction of injury, unreasonable confinement, intimidation, or punishment, with resulting physical harm, pain, or mental anguish. This includes staff neglect or indifference to infliction of injury or intimidation of one patient by another. Neglect, for the purpose of this requirement, is considered a form of abuse and is defined as the failure to provide goods and services necessary to avoid physical harm, mental anguish, or mental illness."

Further, the CMS Interpretive Guideline reflects that components necessary for effective abuse protection include, but are not limited to:
o Prevent.
o Identify. The hospital creates and maintains a proactive approach to identify events and occurrences that may constitute or contribute to abuse and neglect.
o Protect. The hospital must protect patients from abuse during investigation of any allegations of abuse or neglect or harassment.
o Investigate. The hospital ensures, in a timely and thorough manner, objective investigation of all allegations of abuse, neglect or mistreatment.
o Report/Respond. The hospital must assure that any incidents of abuse, neglect or harassment are reported and analyzed, and the appropriate corrective, remedial or disciplinary action occurs, in accordance with applicable local, State, or Federal law.

Findings include:

1. The P&P titled "PSJH-CLIN-1212 Event Reporting and Response Policy and Procedure" dated "Effective 01/2024" reflected:
* "We encourage reporting of any and all Safety Concerns through our Event Reporting System ... This policy describes the expectations and procedures for identifying and responding to Safety Concerns including reporting, analyzing, tracking, trending, resolving, and following up on events with established committees, boards, and state/federal agencies. The intent of this policy is to reinforce consistent processes and practices with the goal of reducing risks and improving safety for all."
* "While direct entry into the Event Reporting System (ERS) by Workforce Members is ideal, Safety Concerns may be identified through a number of different means (event reporting, huddles, PI committees, compliance hotline). Safety Concerns regardless of how they are discovered and by whom will be entered into the ERS, which serves as the principal data gathering and reporting tool for the Quality Program(s)."
* "Event Reports are investigated, and actions are taken to reduce risk and increase safety. Specific actions may include (but are not limited to) corrective and/or preventative actions and action plans, cause analysis (RCA or ACA), performance improvement and/or tracking and trending."
* "The department's core leader or their designee is responsible for reviewing every Event Report generated within their department to ensure thorough understanding and response to each. Additional reviewers may be assigned to contribute to the investigation and follow-up for events as needed."
* "All events are investigated at the department level by the department core leader or their designee. Events that meet state or regulatory criteria are escalated for investigation by the Quality Team. Unit/department core leaders will request consultation from the Quality Team if additional support is necessary or the investigation uncovers complexities that need further attention and expertise."
* "After the electronic Event Report has been entered, it is assigned to the designated core leader(s) of the unit(s)/department(s) involved for review, investigation, and appropriate follow-up. The department where the incident or near miss occurs will document the investigation and any follow-up actions in the ERS."
* "The Event Report initial investigation is expected to be opened within 72 hours after identification, signed off by core leader in 20 days, and completed by the Quality Team within thirty (30) days ..."
* "Action plans will be developed that address the root cause(s) and contributing factors of the event analyzed with the focus on preventing reoccurrence ... Action plans will be detailed, with clear identification of risk reduction strategies, corrective and/or preventative action steps, responsible parties, targeted due dates, required evidence of timely completion of the actions and a strategy for measuring effectiveness of the actions taken ... Action plans will be informed by the best available evidence as well as self-assessment deficiencies (previous missed opportunities), and shared learning garnered from other ministries."

2. The P&P titled "Document Translation GOP" dated "Effective 12/2023" reflected that "Providers and staff should never utilize on-line or electronic translations or applications such as Google Translate, Microsoft Translator, etc. to produce on-the-spot translations. They are never completely accurate and may not be confidential as these apps store data in unsecure [sic] locations (and once you use their tool, it becomes their property, and they can use the data as they wish). Machine translation doesn't have proof-reading ability and many English words and terminology do not have 1:1 equivalency, so misinterpretation may occur, which can cause patient harm."

3. The P&P titled "Interpreter Services For Patients - Spoken Language Interpreter Services" dated "Effective 10/2021" reflected:
* "It is the policy of PHSOR to meet the Civil Rights Act of 1964 Title VI requirements, Section 1557 of the Patient Protection and Affordable Care Act (ACA) mandate, and the Joint Commission standards for interpretation and patient access and any other applicable federal, state or local regulatory mandates. PHSOR utilizes video remote interpreting (VRI), telephonic interpretation and contracted interpreter vendors to provide spoken language services. Based upon the population served some ministries may employ spoken language interpreters."
* "... Caregivers may not require, suggest or encourage a LEP or NES patient and/or companion to use friends or family members as interpreters as this may compromise the effectiveness of providing medical care ..."
* "... PHSOR endeavors to provide the highest quality interpreter service to patients and companions. Interpreter vendor agreements include contractual language about the expectations for agency interpreters ... For any concerns that involve interpreters: 1. Complete an event report 2. Contact regional language access manager."

4.a. Regarding Patient 3, event documentation reflected that on 10/30/2024 "RNCM and Care Management Social Worker have tried to reach a Chuukese interpreter several times over the last few days without success. Interpretation services have been requested through Cyracom and Linguava. We have tried to schedule the service in advance and have also tried the on-demand option. The lack of interpreter has impacted patient care as we are not able to adequately communicate with the patient."
* The "Initial Report" section reflected:
- The event type was documented as "Incident - event that reached the patient."
- The event was categorized as "Lack of Chuukese interpretation services."
- "Initial impression of extent of harm at time of event" was followed by "No evident harm."
* The "Manager Review" section reflected:
- "Please describe information collected as part of your review of the event (consider SBAR format).
Include if there were any deviations in Generally Accepted Practice Standards (GAPS) that contributed to this event." This was followed by "This is a known issue and is being addressed by [LAM/CRC]."
- "What actions were taken to prevent recurrence? This issue is being addressed by [LAM/CRC]."
- "Is there an immediate threat that could happen elsewhere in the organization?" This was followed by a blank space.
- "Are there adverse trends related to this event?" This was followed by a blank space.
* The "Harm Review section reflected:
- "Select the Safety Event Classification ... Not a Safety Event."
- "Not a safety event because: Not a patient concern."

4.b. An email from LAM/CRC dated 10/31/2024 at 1121 reflected "... we've assessed several options outside of our existing contracts to try to cover this language. This is something our language access leaders across all Oregon and Washington health care systems are collaborating on to trying to secure coverage ... Our hope is to continue to see improvement in coverage for this language ... For now, scheduling in-person or virtual visits ... as far in advance as possible, is the best option we have, or taking our chances on the availability of telephonic interpreters, which may not be available at the exact moment we need them."

4.c. An email from LAM/CRC dated 02/07/2025 at 1546 reflected "The incident was reported via Teams message on October 30 - there was no investigation as this is a known deficiency for the language. Providence has partnered with vendors to on board additional remote interpreters for this language and has also agreed to pay 3 [hour] minimums to in-person and scheduled virtual visits in an effort to prioritize Providence requests over other healthcare systems in Oregon."

4.d. The documentation lacked a thorough and timely investigation. For example:
* The documentation reflected, "The lack of interpreter has impacted patient care as we are not able to adequately communicate with the patient" and the initial impression was that there was "No evident harm." However, there was no further investigation regarding the patient's hospitalization, how the patient was impacted including but not limited whether any procedures were performed that may have required an interpreter for informed consent.
* It was not clear whether there was any harm identified after the initial impression.
* The documentation reflected staff attempted to schedule interpreter services in advance but there was no investigation about how far in advance and whether it aligned with expected timeframes.
* There was no documentation that reflected the event was evaluated against hospital P&Ps and determined those had been fully developed and implemented and addressed situations when interpreter services were not available.
* There was no documentation that reflected abuse and neglect had been ruled out.
There was no documentation of further investigation or follow up actions.

5.a. Regarding Patient 2, event documentation reflected that on 09/16/2024 an "RN requested Dari interpreter utilizing Cryacom interpreter services. Persion [sic] interpreter services reached instead without RN aware. [Patient's] spouse notified RN and provider that incorrect services were utilized. Utilized Cryacom to reach Dari interpreter correctly and consents were signed using correct interpreter."
* The "Manager Review" section reflected:
- "What actions were taken to prevent recurrence? Assigned to [LAM/CRC] for follow up and tracking."
- "Is there an immediate threat that could happen elsewhere in the organization?" This was followed by a blank space.
- "Are there adverse trends related to this event?" This was followed by a blank space.

5.b. During an interview on 02/04/2025 beginning at 0930 regarding Patient 2, LAM/CRC stated "The [event] report that came to me doesn't identify the [interpreter] vendor that was used so my response was to ask what vendor was used." The LAM/CRC stated they were not able to view the manager's response on the event report that identified the vendor. Regarding whether follow up actions were taken related to the event, the LAM/CRC stated "No, not from me."

5.c. An email from LAM/CRC dated 02/07/2025 at 1546 reflected "Post event review indicated Cyracom call logs for this service revealed six (6) voice calls assigned to this patient using Dari over the course of Sept 15-17 totaling 169 minutes. Using the same call log, there is no indication that any Cyracom calls logged Farsi/Persian during the same time frame. Two possibilities could be 1) Cyracom interpreter could have been multi-lingual covering both Farsi/Persian and Dari/Afghanistan and patient/family recognized interpreter may not have been a native Dari-speaker or 2) it's possible the care team accessed a telephonic interpreter from the other vendor. There's no follow-up as the team corrected action by connecting with the correct language. At the time of the report, interpreter details were not provided; HRP event was entered two days after the event, and I have no communication via teams or email at the time of the occurrence."

5.d. The documentation lacked a thorough and timely investigation. For example:
* The documentation was not clear when the post event review in Finding 5.c. was conducted.
* There was no documentation regarding why the LAM/CRC's event report view was limited, and whether that would be remedied to facilitate timely and thorough investigations and follow up actions of future events.
There was no documentation of further investigation or follow up actions.

6.a. Regarding Patient 4, event documentation dated 11/14/2024 reflected:
* "Patient is Chuukese speaking only. Unable to obtain a phone interpreter via Cyracom or Linguava. I have been attempting to obtain interpreter for 2 hours through both services with no success. Attempted to get an in-person interpreter and was told one would arrive at 1230; received a phone call at 1215 stating that an in-person interpreter actually wasn't available for 1-2 weeks. Requested a call back when either in-person or phone interpreter was available and just continue [sic] to receive phone calls from both services stating an interpreter is not available. Received a phone call at approximately 1230 stating 3 phone interpreters were available ... but when I called them back on ipad [sic] they stated there were no interpreters."
* The "Manager Review" section reflected "RN spent several hours attempting to reach an interpreter for Chuukese speaking patient. [They] escalated to charge RN, house supervisor, access services. No approved available interpreter available. RN resorted to using Google translate and patients' family to interpret for cares ... Sent HRP details and action review item to [LAM/CRC] in language service."

6.b. An email from LAM/CRC dated 02/07/2025 at 1546 reflected "Post event review indicated Cyracom call logs for this service revealed eight (8) voices calls on November 14, 2024 total 166 minutes for this language, using the same VRI device, and two calls where the caregiver entered the patient MRN, allowing us to match the calls. I do not have access to this event in HRP, but I can see that it was once assigned to me. It shows in my completed items, so I assume my comments are already posted in the event. I do not see any communication on this case in any of [sic] other communications."

6.c. The documentation lacked a thorough and timely investigation. For example:
* The documentation was not clear when the post event review in Finding 6.b. was conducted.
* There was no investigation that reflected why the LAM/CRC did not have access to the event documentation, and whether this would be remedied to facilitate timely and thorough investigations of future events.
* There was no investigation or follow up actions regarding the RN's use of Google translate and the patients' family to interpret for the patient, or whether the patient experienced harm from this.
* There was no documentation that reflected the event was evaluated against hospital P&Ps with respect to the RN's use of Google translate and the patient's family to interpret.
* There was no investigation that reflected abuse or neglect was ruled out.
There was no documentation of further investigation or follow up actions.

7.a. Refer to the findings under Tag A-131. Those findings reflect Patient 1 was NES, their preferred language was Chuukese, and hospital staff attempted and were unable to obtain Chuukese interpreter services for the patient on multiple occasions throughout four hospital encounters. There was no documentation that reflected an event report was generated or that the regional language access manager was notified as required by hospital's P&Ps. There was no investigation and no follow up actions to those events. There was no documentation that reflected abuse or neglect was ruled out.

7.b. During an interview on 01/28/2025 at 1700 regarding Patient 1, the DRA stated no event reports were completed and the regional language access manager was not notified regarding the lack of Chuukese interpreter services.

8. Similar findings regarding lack of complete and thorough investigations and follow up actions were identified during review of incident documentation involving interpreter services for:
* Patient 5, incident date 11/24/2024
* Patient 6, incident date 11/24/2024
* Patient 7, incident date 12/09/2024
* Patient 8, incident date 01/02/2025

9. Refer to the P&P titled "Document Translation GOP" dated "Effective 12/2023" in Finding 2 in this tag that reflects staff should never utilize applications such as Google Translate as they may not be confidential and "misinterpretation may occur, which can cause patient harm."

10. Refer to the P&P titled "Interpreter Services For Patients - Spoken Language Interpreter Services" dated "Effective 10/2021" in Finding 3 that reflects "... Caregivers may not require, suggest or encourage a LEP or NES patient and/or companion to use friends or family members as interpreters as this may compromise the effectiveness of providing medical care ..."

11. During interview with hospital staff that included DRA and QD on 01/28/2025 at 1700, they stated the hospital had not developed P&Ps that described what staff should do if a patient needed an interpreter and interpreter services were not available.

RN SUPERVISION OF NURSING CARE

Tag No.: A0395

Based on interviews, review of medical record documentation for 2 of 2 hospital encounters for Patient 1 that included surgical procedures, review of policies and procedures, and other documentation, it was determined the hospital failed to ensure that nursing services adequately assessed Patient 1's understanding of the nursing education provided that met the patient's learning needs, including understanding the use of equipment for medication delivery and rehabilitation needs, medications and pain relief, and consents for surgical procedures.

Findings include:

1. Refer to Findings under Tag A-131, the hospital's failure to provide Patient's 1 right to be involved, and educated in their Plan of Care in a language that the patient could understand.