Preferred Care at Old Bridge, LLC, DAB CR6859 (2026)

DECISION

Based on a recertification survey completed on March 11, 2021 by the New Jersey Department of Health (state agency), the Centers for Medicare & Medicaid Services (CMS) determined that Petitioner, Preferred Care at Old Bridge, LLC, was not in substantial compliance with Medicare participation requirements at 42 C.F.R. § 483.25(k) (Pain Management) due to several alleged violations pertaining to one resident.  As a result, CMS imposed a per-instance civil money penalty (PICMP) of $11,300 against Petitioner.  Petitioner timely appealed.

For the reasons explained in this decision, I reverse CMS’s determination that Petitioner was not in substantial compliance with Medicare participation requirements arising from the complaint investigation completed by the state agency on March 11, 2021.  While Petitioner had a single violation of 42 C.F.R. § 483.25(k), the violation did not pose a risk for more than minimal harm.  Therefore, Petitioner was in substantial compliance with Medicare participation requirements at that time, and CMS is not authorized to impose remedies based on the March 2021 complaint investigation.

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I.  Background and Procedural History

Petitioner is a skilled nursing facility (SNF) located in Old Bridge, New Jersey.  CMS Exhibit (Ex.) 1 at 1.  The state agency conducted a recertification survey of Petitioner’s facility that ended on March 11, 2021.  Id.  The state agency determined that Petitioner was not in substantial compliance with five Medicare participation requirements:

• 42 C.F.R. § 483.21(b)(3)(i) (Tag F658) (Comprehensive Care Plans), Scope and Severity (S/S) level E (a deficiency that involves no actual harm, but has the potential for more than minimal harm that does not amount to immediate jeopardy)1;
• 42 C.F.R. § 483.25(c)(1)-(3) (Tag F688) (Mobility), S/S level E (a deficiency that involves no actual harm, but has the potential for more than minimal harm that does not amount to immediate jeopardy);
• 42 C.F.R. § 483.25(k) (Tag F697) (Pain Management), S/S level G (a deficiency that involves actual harm that is not immediate jeopardy);
• 42 C.F.R. § 483.45(a), (b)(1)-(3) (Tag F755) (Pharmacy Services), S/S level D (a deficiency that involves no actual harm, but has the potential for more than minimal harm that does not amount to immediate jeopardy);
• 42 C.F.R. § 483.45(c) (Tag F756) (Pharmacy Services, Drug Regimen Review), S/S level E (a deficiency that involves no actual harm, but has the potential for more than minimal harm that does not amount to immediate jeopardy).

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CMS Ex. 1 at 1, 21, 36, 69, 78.

On June 1, 2021, CMS issued an initial determination informing Petitioner that CMS is solely imposing a PICMP of $11,300.00 based on the Substandard Quality of Care deficiency cited at 42 C.F.R. § 483.25(k) (Tag F697 Pain Management) with a S/S level of G from the recertification survey completed on March 11, 2021.  CMS Ex. 2 at 1.  CMS also imposed a prohibition against the provision of a Nurse Aide Training and Competency Evaluation Program (NATCEP) effective March 11, 2021, through June 1, 2023.  Id. at 5.  CMS further stated that an April 22, 2021 revisit conducted by the state agency found that Petitioner had returned to substantial compliance as of March 24, 2021.  Id. at 1.

The Surveyor alleged in a statement of deficiencies (SOD) that Petitioner was noncompliant with 42 C.F.R. § 483.25(k) (Tag F697) based on Petitioner’s failure to ensure that pain management was provided to a resident who required such services, consistent with professional standards of practice, the comprehensive person-centered care plan, and the residents' goals and preferences.  Specifically, surveyors cited three examples to support the allegation of noncompliance under Tag F697:

• Failure to “administer breakthrough pain medication in a timely manner when a resident visually and verbally exhibited signs of unmanaged pain during movement.”
• Failure to ensure the same resident was appropriately assessed and pre-medicated for breakthrough pain prior to performing wound care and activities of daily living.
• Failure to place a pressure-relieving gel seat cushion to the chair when out of bed to offload pressure and reduce pain associated with the resident's full thickness tissue loss pressure ulcer.

CMS Ex. 1 at 36.

On July 30, 2021, Petitioner timely requested a hearing to challenge the initial determination.  Only the alleged noncompliance with the participation requirement at 42 C.F.R. § 483.25(k) (Tag F697) is before me for consideration.

In a July 30, 2021 notice, CMS directed Petitioner to pay a $7,345 CMP into an escrow account pending final administrative decision.  CMS Ex. 3 at 1.  CMS later amended the notice by letter dated October 29, 2021, indicating that it had incorrectly applied a 35% CMP reduction for waiver of appeal rights and that the correct CMP amount is $11,300.

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CMS Ex. 3 at 4. 2  The notice further advised Petitioner that the duration of the NATCEP prohibition would be in effect from March 11, 2021, through March 10, 2023.  Id. 

The Civil Remedies Division acknowledged receipt of the hearing request and assigned the case to me.  On August 18, 2021, I issued my Standing Prehearing Order (SPO).  In accordance with the SPO, on January 27, 2022, CMS filed a prehearing brief (CMS Prh. Br.) and 29 exhibits (CMS Exs. 1-29).  CMS proposed one witness, Laura Sagaard, R.N., whose written direct testimony was submitted as Exhibit 6.  On March 10, 2022, Petitioner filed a prehearing exchange consisting of a prehearing brief (P. Prh. Br.) and sixteen exhibits (P. Exs. 1-16).  Petitioner proposed six witnesses, whose written direct testimonies were submitted as P. Exs. 10-15.  On March 23, 2022, CMS filed its Reply to Petitioner’s brief, along with two additional exhibits (CMS Exs. 30 and 31) and an amended version of CMS Ex. 6.  On May 5, 2022, the parties filed their Joint Statement of Issues Presented, Joint Stipulation of Undisputed Facts, and a Joint Statement in which the parties requested an oral hearing.

On January 16 and 29, 2024, the parties participated in a hearing convened by video teleconference, which was later transcribed.  CMS Exhibits 1-31 were admitted as evidence.  Transcript (Tr.) 14, 313.  Petitioner Exhibits 1-16 were admitted as evidence.  Tr. 10, 16, 74, 162, 215, 450.

CMS called the following witness: Surveyor Laura Sagaard, RN.  Petitioner called the following witnesses: Albanerys Ortiz, CNA; Emily Sawyer, LPN; Kimberlie Silva, RN, Petitioners Director of Nursing (DON); Gail Rader, RN; and Adowa Tetteh, CNA.

On April 15, 2024, I established a post-hearing briefing schedule directing the parties to file post-hearing briefs, reply briefs, proposed findings of fact and conclusions of law, and a list of errata to the transcript.

The parties filed post-hearing briefs (CMS Br. and P. Br., respectively), proposed findings of fact and conclusions of law, and lists of errata to the transcript on August 23, 2024.  CMS filed a post-hearing reply on September 24, 2024 (CMS Reply).  By letter dated September 25, 2024, Petitioner indicated it would not be filing a post-hearing reply brief.

II.  Issues

The issues in this case at present are:

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Whether Petitioner was in substantial compliance of the Medicare participation requirements at 42 C.F.R. § 483.25(k) (Pain Management); and

If Petitioner was not in substantial compliance, whether the PICMP imposed on Petitioner is reasonable.3

III.  Jurisdiction

I have jurisdiction to hear and decide this case.  Social Security Act (Act) §§ 1128A(c)(2), 1819(h)(2)(B)(ii) (codified at 42 U.S.C. §§ 1320a-7a(c)(2), 1395i-3(h)(2)(B)(ii)); 42 C.F.R. §§ 488.408(g), 488.434(a)(2)(viii), 498.3(b)(13).

IV.  Applicable Legal Authority

The Act establishes requirements for SNFs to participate in the Medicare program and authorizes the Secretary of Health and Human Services (Secretary) to promulgate regulations implementing those statutory provisions.  Act § 1819 (42 U.S.C. § 1395i-3).  The Secretary’s regulations are found at 42 C.F.R. pts. 483 and 488.

To participate in the Medicare program, a SNF must maintain substantial compliance with program requirements.  To be in substantial compliance, a facility’s deficiencies may “pose no greater risk to resident health or safety than the potential for causing minimal harm.”  42 C.F.R. § 488.301.  “Noncompliance” means “any deficiency that causes a facility to not be in substantial compliance.”  Id.  A deficiency is a violation of a participation requirement specified in the Act or in 42 C.F.R. pt. 483, subpt. B.  Id.  The term “noncompliance” refers to any deficiency (statutory or regulatory violation) that causes a facility not to be in substantial compliance; that is, a deficiency that poses a risk for more than minimal harm.  42 C.F.R. § 488.301.  Therefore, even if a facility violates a statutory or regulatory requirement, CMS may not impose enforcement remedies if the deficiency does not pose a risk for more than minimal harm.

The Secretary contracts with state agencies to conduct periodic surveys to determine whether SNFs are in substantial compliance with the participation requirements.  Act § 1864(a) (42 U.S.C. § 1395aa(a)); 42 C.F.R. §§ 488.10, 488.20.  The Act and its

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implementing regulations require that facilities be surveyed on average every twelve months, and more often, if necessary, to ensure that identified deficiencies are corrected. Act § 1819(g)(2)(A) (42 U.S.C. § 1395i-3(g)(2)(A)); 42 C.F.R. §§ 488.20(a), 488.308.  The state agency must also investigate all complaints.  Act § 1819(g)(4) (42 U.S.C. § 1395i-3(g)(4)).

The regulations specify the enforcement remedies that CMS may impose if a facility is not in substantial compliance with Medicare requirements.  42 C.F.R. § 488.406.  Among other remedies, CMS is authorized to impose a per-day CMP for the number of days a facility is not in substantial compliance or a PICMP for each instance of the facility’s noncompliance.  42 C.F.R. § 488.430(a).  In this case, CMS imposed a PICMP.  The regulations specify that PICMPs fall into a single range of penalties between $2,233 and $22,320.  42 C.F.R. §§ 488.408, 488.438; 45 C.F.R. § 102.3 (Table) (2020).4

Furthermore, pursuant to 42 C.F.R. § 483.151(b)(2) and (f), a state may not approve and must withdraw any prior approval of a NATCEP offered by a SNF or nursing facility that has been:  (1) subject to an extended or partial extended survey under sections 1819(g)(2)(B)(i) or 1919(g)(2)(B)(i) of the Act; (2) assessed a CMP of not less than $10,697 (45 C.F.R. § 102.3 (Table) (2018)); or (3) subject to termination of its participation agreement, a DPNA, or the appointment of temporary management.  Ineligibility or withdrawal of approval to conduct a NATCEP is mandatory if one of the conditions is satisfied; it is not a remedy that the state agency or CMS may decline to impose.  See 42 C.F.R. § 488.406.

If CMS imposes a remedy, such as a PICMP, based on a noncompliance determination, then the facility may request a hearing before an administrative law judge (ALJ) to determine whether there was a basis for the deficiency findings that led to the imposition of the remedy, and whether the CMP imposed was reasonable.  Act §§ 1128A(c)(2), 1819(h)(2)(B)(ii) (42 U.S.C. §§ 1320a-7a(c)(2), 1395i-3(h)(2)(B)(ii)); 42 C.F.R. §§ 488.408(g), 488.434(a)(2)(viii), 498.3(b)(13).  However, the facility may not appeal CMS’s choice of remedies, or the factors CMS considered in selecting remedies.  42 C.F.R. § 488.408(g)(2).

A facility may only challenge CMS’s determination as to the scope and severity of noncompliance if a successful challenge would affect the range of the CMP that may be imposed or there is a finding of substandard quality of care that resulted in the loss of approval of a SNF’s NATCEP.  42 C.F.R. § 498.3(b)(14), (d)(10)(i).  CMS’s determination as to the level of noncompliance, including the finding of immediate

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jeopardy, “must be upheld unless it is clearly erroneous.”  42 C.F.R. § 498.60(c)(2); Woodstock Care Ctr., DAB No. 1726 at 9, 39 (2000), aff’d, Woodstock Care Ctr. v. Thompson, 363 F.3d 583 (6th Cir. 2003).

At sole issue here are the alleged deficiencies in Petitioner’s compliance with the quality-of-care regulation, 42 C.F.R. § 483.25, which states generally that, “[b]ased on the comprehensive assessment of a resident, the facility must ensure that residents receive treatment and care in accordance with professional standards of practice, the comprehensive person-centered care plan, and the resident’s choices . . . .”  With respect to pain management, section 483.25(k) imposes the following obligations upon a facility:

(k) Pain Management.  The facility must ensure that pain management is provided to residents who require such services, consistent with professional standards of practice, the comprehensive person-centered care plan, and the residents' goals and preferences.

42 C.F.R. § 483.25(k).5

V.  Findings of Fact, Conclusions of Law, and Analysis

I discuss in this decision the credible evidence given the greatest weight in my decision-making.  I also discuss any evidence that I find is not credible or worthy of weight.  The fact that evidence is not specifically discussed should not be considered sufficient to rebut the presumption that I considered all the evidence and assigned such weight or probative value to the credible evidence that I determined appropriate within my discretion as an ALJ.  There is no requirement for me to discuss the weight given every piece of evidence considered in this case, nor would it be consistent with notions of judicial economy to do so.

1. Petitioner was in substantial compliance with 42 C.F.R. § 483.25(k), because even though CMS made a prima facie showing that Petitioner violated 42 C.F.R. § 483.25(k), the singular violation did not pose a risk for more than minimal harm.  

I find that, with the exception of a single instance, the preponderance of the evidence in the record demonstrates that Petitioner did not violate 42 C.F.R. § 483.25(k) as Petitioner provided care and services that were consistent with professional standards of care, the resident’s comprehensive person-centered care plan, and the resident’s goals and

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preferences.  Specifically, I find that the alleged deficiencies associated with R25’s wound care performed on March 9, 2021, all the care provided to R25 on March 10, 2021 with the exception of failing to have a nurse assess R25’s pain associated with a bed transfer, and the resident’s comprehensive person-centered care plan did not violate 42 C.F.R. § 483.25(k).

I find that Petitioner solely violated 42 C.F.R. § 483.25(k), because the CNAs continuance of R25’s bed transfer on March 10, 2021 without having a nurse assess R25’s pain after R25 demonstrated signs and symptoms of possible pain was contrary to the applicable professional standard of care as articulated by both parties at the hearing.  Petitioner, however, has proven that the violation did not pose a risk of more than minimal harm, and therefore Petitioner had remained in substantial compliance with the participation requirement established by 42 C.F.R. § 483.25(k).

In reaching this conclusion, I address below the allegations of noncompliance with section 483.25(k) documented in the SOD and raised by CMS in its briefs.  

a.  Facts

Resident 25 (R25), an 87-year-old female, was initially admitted to Petitioner’s facility on January 29, 2009.  CMS Ex. 12.

R25’s diagnoses included: idiopathic gout; anemia; altered mental status; dysphagia; abnormalities of gait and mobility; abdominal aortic aneurysm, without rupture; lack of coordination; COVID-19; unspecified atrial fibrillation; generalized muscle weakness; difficulty in walking; acute embolism and thrombosis of unspecified deep veins lower extremity; hypothyroidism; morbid obesity; anxiety disorder; muscle wasting and atrophy; acute cystitis without hematuria; edema; urinary tract infection; pure hypercholesterolemia; chronic embolism and thrombosis of unspecified deep veins of left lower leg; chronic kidney disease, stage 3; age-related osteoporosis without current pathological fracture; pulmonary embolism without acute cor pulmonale; chronic diastolic heart failure; insomnia; atherosclerotic heart disease of native coronary artery without angina pectoris; essential hypertension; gastro-esophageal reflux disease without esophagitis; and major depressive disorder with anxiety.  CMS Ex. 12 at 2.  At the time of the March 2021 survey, R25 also had a Stage III pressure ulcer on her sacrum, which was healing.  Jt. Stip. at ¶ 17.

R25 required pain management.  Jt. Stip. ¶ 16.  Petitioner’s pain management policy provides that, “[t]he facility must ensure that pain management is provided to residents who require such services, consistent with professional standards of practice, the comprehensive person-centered care plan, and the residents’ goals and preferences.”  CMS Ex. 25 at 1.  The policy establishes a systematic approach for pain management consisting of:

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1) Recognition:  evaluating the resident for pain; the policy provides a non-exhaustive list of signs or symptoms that may suggest the presence of pain.

2) Pain Assessment:  assessment by the IDT which may include the residents’ self-reporting of pain, review of factors that may be causing or contributing to pain, identifying key characteristics/descriptors of pain, determining factors that make the pain better or worse, review of prescribed medications and treatments, and the residents’ goals and preferences.

3) Treatment:  collaboration between the IDT and the resident to arrive at pertinent, realistic and measurable goals for treatment, including both pharmacological and non-pharmacological interventions.

4) Monitoring:  regularly reassessing residents with pain and revising pain management regimen and plan of care as indicated if pain is not adequately controlled.

See CMS Ex. 25.

Petitioner’s interdisciplinary care plan team (IDT) met on multiple occasions to discuss R25’s plan of care.  The IDT progress notes reflect that R25 had been ordered various medications for pain management, required weekly wound care for a sacrum wound, and was routinely seen by a psychiatrist and psychologist.  P. Ex. 8.  A December 2, 2020 IDT progress note shows that the IDT additionally recommended, among other things, that R25 “be out of the bed to a wheelchair as much as tolerated (up to 3 hours) and ha[ve] a ROHO cushion in place.”  P. Ex. 8 at 2.

R25’s care plan contains two sets of interventions related to pain management.  The first, initiated on September 20, 2019, addressed the resident’s degenerative lumbar spine issues, pain in the lower left abdomen, history of hemorrhoidal pain, and diagnoses of gout, osteoporosis, neuropathy of hands/finer, back pain, and history of incision on the inguinal area with the following interventions:  administer medication as ordered; evaluate and establish level of pain on number scale/evaluation tool; evaluate characteristics and frequency/pattern of pain; evaluate need for bowel management regimen; evaluate need for routinely scheduled medications rather than PRN pain med administration; evaluate what makes the patient’s pain worse; implement the patient’s preferred non-pharmacological pain relief strategies; monitor inguinal area for any signs/symptoms of infection; monitor swelling/pain of joints and notify MD; observe for

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potential medication side effects; and refer to rehab as needed.  CMS Ex. 30 at 5.  The second intervention, initiated on August 19, 2020, addressed the resident’s “acute/chronic pain medical condition/diagnosis” as follows:  avoid pressure on the areas of pain; complete pain assessment; distracting activities; evaluate the effectiveness of pain medications; give pain medications; re-position for comfort.  CMS Ex. 30 at 19.

R25’s medical record also reflects that beginning at the end of November 2020, R25’s response to inquiries regarding pain could be confused or atypical, and R25 would at times make vocalizations that sounded like possible expressions of pain without substantiation.  Progress notes dated November 23, 2020 show that R25 was observed displaying intermittent confusion with forgetfulness, as well as hallucination involving laughing when asked about any pain or discomfort.  CMS Ex. 20 at 38-39.  A November 27, 2020 progress note authored by Dr. Shady Hassan states that “[i]t appears that she has intermittent mood swings, which affects her ability to participate in therapy.  On certain days she displays no signs or symptoms of distress, but other days she complains of pain requiring pain medications.  This is an inconsistent behavior.”  CMS Ex. 20 at 35.  A December 24, 2020 progress note shows that R25 was observed talking to self.  CMS Ex. 20 at 24.

December 5, 2020, January 7, 2021, and February 8, 2021 monthly psychoactive summaries authored by LPN Emily Sawyer note behaviors of screaming/crying out and hallucinations, describing the behavior generally as yelling on and off for no apparent reason.  CMS Ex. 23 at 7-9.  An adult and geriatric psychiatric evaluation was conducted by NLP Behavioral Services, LLC on February 19, 2021, and shows that R25 appeared lethargic during the visit, was cooperative with answering questions, and displayed no signs of depression.  Dr. Prado diagnosed R25 with major depressive disorder in remission and recommended discontinuing Bupropion and Remeron.  CMS Ex. 23 at 3.  A Brief Interview for Mental Status (BIMS) was also conducted and R25 had a BIMs score of 11.  CMS Ex. 13 at 5-7.

Petitioner assessed R25’s pain multiple times a day and summarized the level of pain using either a numerical score or a score obtained from Pain Evaluation in Advanced Dementia (PAINAD).6  P. Ex. 1.  The pain assessments are contained in R25’s Weights and Vitals Summary and in the Electronic Medication Administration Record (EMAR or MAR).7  

Of relevance to the alleged deficiencies in this matter, the following table lists R25’s pain levels as documented by facility staff from March 9, 2021, through March 10, 2021.

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P. Ex. 1 at 1.

At the time of the March 2021 survey, R25 had physician orders for the following pain management medications:

5 mg oxycodone hydrochloride, to be administered every eight hours at 6 am, 2 pm, and 10 pm;

Tramadol HCI, 100 mg. tablet to be administered every eight hours by mouth PRN (as needed), for moderate to severe pain levels of 4-10;

Acetaminophen [Tylenol], two 325 mg tablets (total 650 mg) to be administered every four hours PRN for mild to moderate pain (1-3 on pain scale);

Lidocaine ointment 5% to be administered to the sacral area PRN prior to treatment of sacral area, up to four times daily.

Jt. Stip. ¶ 19; CMS Ex. 15 at 10-11; CMS Ex. 17 at 6, 12, 14, 15.

R25’s medication administration was documented in the MAR.  The following table summarizes R25’s pain medication administration from March 9, 2021, through March 10, 2021.

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CMS Ex. 17 at 6, 12, 14, 15.

On March 9, 2021, at approximately 9:30 – 10:00 a.m., R25 received wound care for her sacral wound.  Tr. at 341, 343.  Around 11:03 a.m., Surveyor Sagaard interviewed an RN and an LPN who were involved with the wound care and the LPN Unit Manager who had observed the wound care.  Id. at 342.

Progress notes show that on March 9, 2021, at 1:50 p.m., R25 was observed as verbally responsive with periods of confusion and was assessed for pain and noted with facial grimacing and yelling during positioning.  CMS Ex. 20 at 3.  On March 10, 2021, at 8:15 a.m., R25 was observed displaying signs or symptoms of pain, manifested by grimacing and vocalizations, during positioning.  Between 8:45 – 8:58 a.m., staff attempted twice to give Tramadol with apple sauce, but R25 spit it out both times and refused the second time.  Jt. Stip. ¶ 21; CMS Ex. 20 at 2.

Progress notes show that around 9:00 a.m. on March 10, 2021, nursing staff spoke with R25’s primary care physician, Dr. Moussa, who ordered a psychiatric evaluation and directed staff to observe R25 for any changes in status.  CMS Ex. 20 at 2.

Later that morning, Surveyor Sagaard observed CNAs Adowa Tetteh and Albanerys Ortiz transfer R25 from her bed to a gerichair using a mechanical lift.  Jt. Stip. ¶ 22.  The bed transfer concluded at approximately 11:38 a.m.  Tr. at 326.

A 12:35 p.m. progress note indicates that R25 had a change of condition, indicating that she had an altered mental status and that R25 was observed to scream in pain during movement, was yelling out even when untouched, screamed in “excruciating pain” during transfer to “geri chair,” was quiet after transfer, but remained with periods of yelling out without any movement.  CMS Ex. 20 at 1.  A 12:50 p.m. progress note shows that R25 had been medicated and was quiet at times but continued to periodically yell out.  Id.  As a result, Petitioner’s nursing staff promptly called Dr. Moussa who said that R25 should be transported to the hospital.  Id.  On March 10, 2021, at approximately 1:30 p.m., R25 was transferred to the “RWJH” hospital and was initially admitted with a diagnosis of altered mental status.  Jt. Stip. ¶ 24; CMS Ex. 20 at 1.  She was later diagnosed with a urinary tract infection (UTI).  Tr. at 431.

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b.  Analysis

1. Petitioner appropriately assessed R25 for pain prior to and during R25’s March 9, 2021 Wound Care and correctly determined that no additional pain medication was necessary.  

CMS alleges noncompliance with section 483.25(k) (Tag F697), in part, based on Petitioner’s failure to assess R25 for pain prior to wound care, or alternatively, to provide pain medication prior to wound care when R25 allegedly expressed pain.  CMS Br. at 12-15.  Surveyor Laura Sagaard, RN, was the team leader of the survey cycle at Petitioner’s facility on March 9 and 10, 2021, and documented the allegations of noncompliance in the SOD.  CMS Ex. 1 at 36-69.  The surveyor alleged an instance of noncompliance based on facts obtained from interviews with Petitioner’s staff concerning R25’s wound care on March 9, 2021.  Id. at 44-47.  The surveyor interviewed three staff members:  LPN Roxsanne Tenia, an “agency” nurse; RN Annaida Cleophat 9; and LPN Emily Sawyer, the unit manager.  CMS Ex. 6 at 12-13; CMS Ex. 10 at 4-6.  Specifically, it appears that Surveyor Sagaard alleged that Petitioner was noncompliant with 42 C.F.R. § 483.25(k) in this instance, because either R25 indicated she had a pain level of 2-3 prior to her wound care (according to 1 out of 3 witnesses) but no acetaminophen was given, or the nurses did not pre-medicate R25 even if R25 did not indicate she was in pain prior to the wound care.  CMS Ex. 1 at 45 (“. . . the RN stated that she asked the resident ‘are you in pain?’ and the resident reported that the pain was a 2-3 out of 10, but she didn't need to give the resident any medication because the resident had already received a dose of Oxycodone HCl at 6 AM.”); 47 (“The RN stated that because the pain medication doses were PRN and not routinely scheduled, and because it didn't look like the resident was in any pain, it wasn't needed.”) 

On March 9, 2021, at approximately 11:03 a.m., the surveyor interviewed LPN Roxsanne Tenia about the wound treatment she had recently performed for R25 between 9:30 and 10:00 a.m.  LPN Tenia stated that she performed the wound care with the assistance of the RN, and that R25 did not complain of pain and that prior to the wound care R25 “did not give her a numeric pain scale number, so she ‘didn’t need the pain meds at the time.’”  Id. at 44-45.  It is unclear from the SOD whether Surveyor Sagaard interpreted LPN

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Tenia’s statement as indicating that LPN Tenia had pre-assessed R25 for pain prior to performing wound care.

At 11:15 a.m. on the same day, the surveyor interviewed RN Cleophat, who stated that R25 had expressed pain of 2-3 on a scale of 10, but that she did not give R25 any medication, because R25 had already received a dose of Oxycodone at 6:00 a.m.  Id. at 45.

Shortly thereafter at 11:21 a.m., the surveyor interviewed LPN Sawyer, who stated that she had also been present during R25’s wound treatment that morning, that R25 “‘didn't say a word’ and that the resident was ‘not moaning’”, and that R25 had not been pre-medicated prior to wound treatment.  Id. at 46.  The surveyor added in her written declaration that LPN/UM Sawyer “stated that the resident could not tell staff her pain in numeric numbers so they assessed her using a scale for people who are not able to use numeric numbers.”  CMS Ex. 6 at 13 ¶ 36.

The surveyor testified that, regardless of which version of the events was true, Petitioner violated section 483.25(k), because the facility failed to follow professional standards of practice for pain management, which is to assess pain prior to wound care and to administer pain medication prior to treatment if the resident complains of pain.  Tr. at 348.

As a preliminary matter, I must resolve the issue of which of the two accounts concerning R25’s wound treatment is more likely to be true.  LPN Tenia and LPN Sawyer stated that R25 did not complain of or exhibit any signs of pain prior to or during wound treatment.  RN Cleophat states that R25 expressed pain as a numerical score of 2-3 out of 10.  All agree that R25 was not pre-medicated prior to wound treatment, other than a 6:00 a.m. dose of Oxycodone.  Neither LPN Tenia’s or RN Cleophat’s testimony was provided at the hearing, and LPN Sawyer was not specifically questioned at the hearing regarding the March 9th wound care.  See Tr. at 94-161 (LPN Sawyer cross-examined as to wound care on March 10th and 11th).  The resident’s MAR reflects a 6:00 a.m. dose of Oxycodone but no other medication administration between 9:30 – 10:00 a.m., the approximate time of wound care.  The surveyor’s recorded statements from LPN Tenia, RN Cleophat, and LPN Sawyer are thus consistent with the record on this point.

Based on the documentary evidence and testimony before me, I conclude that the more credible and likely version of events is LPN Tenia’s and LPN/UM Sawyer’s:  R25 was unable to provide a numerical pain rating at that time and did not complain of or show signs or symptoms of pain immediately prior to or during wound treatment on March 9, 2021, which would have rendered R25’s pain a 0 on the PAINAD scale.  Surveyor Sagaard was not aware at that time or at the time of her declaration that Petitioner’s nurses would use the PAINAD scale when R25 was unable to provide a numeric pain rating.  See, e.g., CMS Ex. 6 at 11-12 ¶ 34 (“Despite the fact that it appeared that

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Resident # 25 had a decline in cognition and function since her last MDS assessment, staff continued to rely on the numeric pain scale to assess Resident # 25’s pain.”).  Therefore, after her interviews with the nurses, Surveyor Sagaard mistakenly concluded that R25 was not properly assessed for pain at that time likely because two of the nurses said that R25 was unable to provide a numeric pain rating.  Surveyor Sagaard filed a supplemental declaration on March 22, 2022 and acknowledged that she had not realized the nurses also employed a PAINAD scale where appropriate stating that “at no time during the survey did any of Petitioner’s staff mention that they used the PAINAD scale, in addition to the numeric pain scale. . . ” and that is why she had been mistaken.  See CMS Ex. 31 at 10-11 ¶ 23.

To the contrary, R25’s medical records are replete with examples of R25’s pain being assessed with the PAINAD scale when R25 was unable to provide a numeric rating.  See, e.g., P. Exs. 1 and 9.  Moreover, Surveyor Sagaard remarked in her initial declaration that LPN/UM Sawyer stated with respect to wound care the morning of March 9th, “that the resident could not tell staff her pain in numeric numbers so they assessed her using a scale for people who are not able to use numeric numbers.”  CMS Ex. 6 at 13 ¶ 36.  Therefore, in conjunction with R25’s declining ability to clearly verbally communicate due to her altered mental status on March 9th and March 10th, I find it likely that LPN Tenia and LPN/UM Sawyer assessed/monitored R25 prior to and while performing wound care through observing whether R25 showed signs and symptoms of pain and that R25 did not exhibit any such signs.  While Surveyor Sagaard’s recounting of her interview with RN Cleophat is incongruous with the other two nurses in the pain scale used, Surveyor Sagaard does not state whether she herself believed that RN Cleophat’s account was more accurate or whether she inquired of RN Cleophat whether she had observed R25 display any signs or symptoms of possible pain.  See CMS Exs. 1, 6, and 31.  LPN Sawyer’s statement that R25 did not express pain mirrors and corroborates LPN Tenia’s account of the events.  I find LPN Tenia’s and LPN/UM Sawyer’s version of the events more likely to be accurate and true.  Based on LPN Tenia’s and LPN/UM Sawyer’s account of the events, Petitioner did not fail to assess R25’s pain in this instance and, as such, was in compliance with R25’s care plan and Petitioner’s pain management policy.  CMS Ex. 30 at 5; CMS Ex. 25.

Surveyor Sagaard also indicated in the SOD and at hearing that she believes R25 should have been prophylactically provided pain medication prior to the wound treatment.  See CMS Ex. 1 at 40, 46, 49, 50.  While in some instances it may make sense to do so, CMS failed to prove that was the applicable standard here – especially where the treating physician had ordered acetaminophen, tramadol, and lidocaine to be provided PRN (as needed) rather than prophylactically.  Jt. Stip. ¶ 19; CMS Ex. 15 at 10-11; CMS Ex. 17 at 6, 12, 14, 15.  This makes sense given that R25’s pain management at the time already included 5 mg oxycodone hydrochloride, to be administered every eight hours at 6:00 a.m., 2:00 p.m., and 10:00 p.m.  Jt. Stip. ¶ 19; CMS Ex. 17 at 6.  Consistent with the order, R25 received a 5mg dose of Oxycodone on March 9, 2021, at 6:00 a.m.  CMS Ex.

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17 at 14.  Gail Rader, RN, testified at the hearing on behalf of Petitioner and was qualified as an expert on the standards of practice in nursing.  Tr. at 216.  In response to questioning about R25’s Oxycodone order, RN Rader testified:

[T]hat's an automatic administration. And the purpose of that is that when you have that kind of an order, you build up a therapeutic level for pain management in the body, and oxycodone, obviously drugs have a half-life, and so when they are excreted it, it takes a while for them to excrete through the system. But when you give it on a standing order, it keeps that therapeutic level of pain control, as much as possible, at a steady level . . . There's some carryover . . . .  So what will happen is when you give it every eight hours, you don't get a break and the therapeutic effect doesn't drop.

Tr. at 235.

I find RN Rader’s expert testimony that R25’s order for Oxycodone maintains a baseline therapeutic level of pain control and has a carryover effect to be credible and weighty.  RN Rader was subject to cross-examination by CMS, which did not diminish her testimony.  Tr. at 199-295.  Certainly, even then, a patient may experience break-through pain, at which point the additional pain medication was available for administration based on the degree of pain the patient experienced.

Accordingly, I conclude that, as it pertains to the March 9, 2021 wound care deficiency allegations, Petitioner has demonstrated by a preponderance of the evidence that it did not violate 42 C.F.R. § 483.25(k).

2. March 10, 2021 Bed Transfer to Gerichair
   1. CMS presented a prima facie case that Petitioner was not in substantial compliance with 42 C.F.R. § 483.25(k) (Tag F697) on March 10, 2021. 

CMS also alleges noncompliance with section 483.25(k) based on the facts surrounding R25’s transfer from her bed to a gerichair.10  CMS Br. at 6-12.  There are several discrepancies between Surveyor Sagaard’s account and the two Certified Nurse Assistants (CNAs) who performed the transfer.  Starting with the facts as alleged in the

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SOD, Surveyor Sagaard recorded that at approximately 11:10 a.m., two CNAs11 initiated a bed transfer using a mechanical lift and that during the bed transfer R25 was moaning, appearing tearful, and stating “‘Oww! Oww!’”  CMS Ex. 1 at 58.  The surveyor asked staff whether this was a normal response, and both CNAs stated this was a normal response and that R25 had the ability to say “stop” to cease the transfer.  Id.  At 11:15 a.m., the surveyor additionally asserts she observed CNA # 2 prepare the gerichair for R25 by placing a ROHO gel cushion on the back of the seat.  R25 was then placed in the mechanical lift.  During transfer, R25 yelled out “‘help me, help me!’”  The CNAs stated that R25 may have been anxious while being suspended mid-air.  CMS Ex. 1 at 58.  As the CNAs positioned R25 over the gerichair, Surveyor Sagaard stated she observed R25 yelled out “Ahhhh, my legs, my legs!”  Id.

The surveyor then asserts she observed the CNAs transfer R25 into the gerichair directly on the seat, because the ROHO cushion that provides pressure relief and required by the care plan was positioned at the back of the gerichair.  Id.  According to Surveyor Sagaard, but disputed by the CNAs, CNA # 3 stated to CNA # 2 that the ROHO cushion needed to be moved up higher on the back, and the CNAs positioned R25 to move the cushion up higher, during which R25 grimaced and called out.  Id. at 59.  At 11:31 a.m., the surveyor states she asked whether R25 should be sitting on the ROHO cushion, as opposed to the cushion being on the back seat.  CNA # 3 stated that the ROHO cushion on the resident’s back must have been for R25 to sit on.  The CNAs subsequently positioned R25 into the mechanical lift again to move the ROHO cushion from the back to the seat of the gerichair.  Id.

Surveyor Sagaard testified regarding her observations.  Her testimony closely mirrors the allegations documented in the SOD.  Her testimony further revealed that she was about two feet from the foot of the bed, CNA # 3 was on one side of the bed, and CNA # 2 was operating the mechanical lift.  Tr. at 319.  She observed R25 grimace and cry out during the transfer and CNA # 2 say “sorry” to R25.  Id. at 320.  CNA # 2 further stated to the surveyor that R25 had been medicated at some point after breakfast.  Id. at 321.  The surveyor additionally testified that based on her observations, R25 was exhibiting signs and symptoms consistent with pain as a result of the transfer.  Id. at 327.  The surveyor further testified that the CNAs did not stop the transfer at any point from 11:05 to 11:38 a.m., that they did not leave the room at any point during the transfer, and that no nurse assessed R25 for pain prior to completion of the transfer.  Id.  The surveyor additionally testified regarding declarations from the two CNAs that the ROHO cushion had been placed directly underneath R25 but slid up as she sat down, and stated that the declarations are not consistent with her observations and that it is unlikely for a ROHO cushion to have slid up from the seat to the back based on the size of the cushion and the

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design which includes non-skid padding.  Id. at 330-31.  Finally, the surveyor testified that the professional standard of practice for CNAs when a resident is exhibiting pain during a transfer is to stop the transfer and immediately find a nurse to assess whether the resident is in pain.  Id. at 334.  The CNAs did not ask R25 whether she was in pain during the transfer and R25 did not ever state that she was not in pain.  Id. at 334-35.  Alternatively, even if the resident were not in pain and merely exhibiting a behavior, the professional standard of practice is to immediately call the physician to determine how to proceed.  Id. at 337-38.

I find that Surveyor Sagaard credibly testified regarding the relevant professional standard of practice and afford her testimony due weight.  Staff should stop a bed transfer if a resident exhibits signs or symptoms consistent with pain and find a nurse to immediately assess the pain or a physician if there are concerns about whether the issue is behavioral.  Petitioner’s pain management policy lists several identifiable characteristics that may be signs or symptoms of pain, including facial expressions like grimacing and sighing, groaning, crying, or breathing heavily.  CMS Ex. 25 at 1.  The surveyor observed R25 grimacing and groaning, which is consistent with the presence of pain, and observed that the CNAs did not stop the transfer to find a nurse or physician to assess R25 for pain.  Therefore, I find that CMS has established a prima facie case of noncompliance with section 483.25(k) based on staff’s failure to provide pain management consistent with professional standards of practice by stopping a bed transfer where R25 exhibited signs or symptoms of pain – even though it may very well be the case here that the signs and symptoms were behavioral and not, in actuality, due to the experience of pain.

I also find that CMS has established its prima facie case based on evidence that staff failed to properly apply a ROHO cushion to R25’s gerichair.  The care plan directs staff to avoid pressure on R25’s areas of pain.  CMS Ex. 30 at 19.  The care plan further instructs that R25 should use a ROHO cushion on wheelchair when out of bed.  Jt. Stip. ¶ 18; CMS Ex. 21.  The surveyor testified that staff did not properly apply the ROHO cushion to the seat of the gerichair until pointed out by the surveyor herself, at which point R25 was placed back into the mechanical lift to move the cushion to the seat.  CMS’s evidence is thus sufficient to meet its prima facie case that Petitioner failed to provide pain management consistent with R25’s care plan in violation of section 483.25(k) based on Surveyor’s testimony.

2. Petitioner rebutted CMS's prima facie case and established by a preponderance of evidence that it was in

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  substantial compliance with 42 C.F.R. § 483.25(k) (Tag F697) on March 10, 2021.12  

Based on the record before me, I conclude that the CNAs failure to stop the transfer of R25 from her bed to the gerichair the morning of March 10th when R25 demonstrated signs and symptoms of possible pain was a violation of the professional standards of care and therefore in violation of 42 C.F.R. § 483.25(k).  However, I find that the facts and circumstances underlying this particular violation did not pose a risk for more than minimal harm, and therefore Petitioner was in substantial compliance with 42 C.F.R. § 483.25(k) (Tag F697) on March 10, 2021.

As a preliminary matter, I must resolve the apparent discrepancies in testimony between surveyor Sagaard and CNAs Ortiz and Tetteh regarding the bed transfer on March 10, 2021.  The testimony between CMS’s witness and Petitioner’s witnesses differs on whether, at approximately 11:00 a.m., staff asked R25 if she was in pain, stopped the bed transfer after potential vocalizations of pain to find a nurse, and placed a ROHO cushion on the seat (as opposed to the back) of the gerichair.

Surveyor Sagaard testified that the CNAs did not stop the transfer at any point from 11:05 to 11:38 a.m., that they did not leave the room at any point during the transfer, and that no nurse assessed R25 for pain prior to completion of the transfer.  Tr. at 327.  The surveyor additionally testified that it was unlikely for a ROHO cushion to have slid up from the seat to the back based on the size of the cushion and the design which includes non-skid padding.  Id. at 330-31.

CNA Ortiz testified that, in response to R25 saying “Ow,” she asked R25 whether she was in pain but that R25 said “I don’t know.  No.  And she never say yes.  Or she say something that made no sense.”  Id. at 35.  She testified on cross-examination that she

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stopped the transfer when R25 said “Ow” and that CNA Tetteh went to get a nurse.  Id. at 54; P. Ex. 10.  She also testified that the ROHO cushion was placed on the seat of the chair but that it slipped toward the back as they placed R25 into the gerichair using the mechanical lift.  Tr. at 31.  I note on cross examination that CNA Ortiz agreed that she did not type her declaration but that she dictated it to the assistant director of nursing, who then typed it out, because CNAs normally do not use the computers.  Id. at 37.  I find this explanation plausible.  I further note that she agreed that her statements at hearing specifically regarding stopping care and asking whether R25 was in pain on March 10th during the transfer are not in her declaration.  Id. at 50.  Ultimately, I find CNA Ortiz’s testimony to be credible, but only afford it weight to the extent that it speaks to what she observed generally on the morning of March 10, 2021, and not as to what occurred at specific points in time that morning.  Her testimony was not specific as to what time she asked R25 whether she was in pain and what time the transfer was stopped.  This is an important distinction, because prior to the 11:05 a.m. transfer the CNAs had started to attempt to position R25 for a transfer earlier in the morning of March 10, a fact not clarified until CNA Tetteh’s testimony on the second day of the hearing, discussed below.  Id. at 454-458.  However, I find her testimony probative as to the placement of the ROHO cushion, her prior experiences with R25’s vocalizations of “ow, ow, ow” in January of 2021, and R25’s vocalizations during the transfer on March 10, 2021 – all of which was corroborated by CNA Tetteh’s testimony.

CNA Tetteh testified that around 8:00 a.m., she asked R25 whether she was in pain and R25 said “no,” after which they repositioned R25 and brought in breakfast.  Tr. at 454.  She stated that she had passed by R25 a couple times in the past and heard R25 say “Ow,” and her coworkers informed her “that’s how she is right now.”  Id. at 456.  At some point in time during the morning shift, she noticed R25 saying “Ow” and asked her if she was in pain; R25 nodded, so she went to get a nurse.  Id. at 457.  CNA Tetteh saw the nurse going into the room, so she then went into another room to assist another patient.  Id.  Given the additional testimony in the record, this is likely when the assigned LPN attempted to give R25 tramadol twice for break-through pain between 8:43 - 9:00 a.m.  CMS Ex. 1 at 51-53.13  After CNA Tetteh finished with the other patient, she returned to R25’s room and the surveyor was in the room.  Tr. at 457-58.  She assumed that the other nurse had given R25 medication and that R25’s vocalizations were behavioral and not pain-related, and so she began the bed transfer later that morning.  Id. at 458.  Importantly, CNA Tetteh testified that she told R25 at this time the plan to transfer her to the gerichair, and R25 nodded in agreement.  Id. at 466.  Surveyor

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Sagaard’s account is not inconsistent on this point; she noted only that R25 “did not verbally respond” to CNA Tetteh after CNA Tetteh explained they were going to transfer her to the gerichair.  CMS Ex. 1 at 57.

During the transfer, CNA Tetteh testified on direct examination that R25 vocalized throughout the lift “ow, ow, ow”:

Q.  Did she yell or scream when she was in the Hoyer lift, being moved from the bed into the chair?
A.  She was still doing this ow, ow -- 
Q.  Okay.
A. -- throughout the whole process.
Q.  Did you hear her say anything such as my legs hurt, ow, I’m going to die?
A.  No, sir.  All she say is ow, ow, ow, ow.

Tr. at 463.  CNA Tetteh further testified that she did not stop the transfer, because it was her understanding both that R25 had recently received medicine (not knowing that R25 had spit out the tramadol), and because R25 had developed a behavior or “language” of vocalizing “ow, ow, ow” when not in pain and in response to the slightest of touches or movements of the bed:

Q.  All right.  You already testified that when she said ow earlier, you asked her if she had pain, she nodded her head yes.  When you went back in this third time so that you could give her this out of bed care with Alba [CNA Ortiz], and she continued to say ow, why didn’t you stop?  
A.  Because I was told before that that’s how the patient is right now, that whatever you do, if you pass by, you touch a little bit, she will say ow, ow. Ow, ow has become, like, her language now, because this time she cannot able to talk to you much like what I knew her before, that she would interact with you.  Yeah, so for me, I know that I went to the nurse, I told the nurse the patient says she’s in pain, I saw the nurse going into the room with her cart, so I assumed the nurse has given her pain medicine already.  So when I went to take care of her, even though she was saying this ow, ow again, and because I know previously that that’s how she is, so we just go ahead and put her in the chair, knowing that it’s good for her health.  Because if a patient is in the -- in bed all the time, it’s not good for her lungs.  She has to sit in the chair.  It’s good for her to get out from the room.  So we, me and Alba, we are doing all that to, you know, for the patient’s comfort.  It’s good for her health that we are doing it.  We don’t want her to be in bed, you know, 24/7

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without, you know, moving her out.  So even though she was still saying ow, ow, but I know that that’s how she has become, so we just go ahead and put her in the chair.  
Q.  While you were doing that, putting her in the chair, using the Hoyer lift and a sling, did she ever say to you no?  
A.  No, she didn’t say no.  She – 
Q.  While you were -- 
A.  -- did not say no.  
Q.  While you were doing that, putting her into the chair, using the lift, did she ever say stop?  
A.  She didn’t say stop.  
Q.  And you’re sure she didn’t cry?  
A.  No, she didn’t cry.  All she said was just ow, ow, ow.

Id. at 463-465.  To the point, earlier in the morning of March 10, when CNA Tetteh positioned R25 for breakfast, she testified that R25 vocalized “ow, ow, ow,” and when CNA Tetteh asked whether she was in pain, R25 told her “no.”  Id. at 454.  CNA Ortiz similarly testified: “When I have her in the period that I have, she alone, she speak to me.  I asked a question.  I talked to her.  She talked to me, and then was morning care and feeding sometime.  And she don’t make noise with me.  I mean, like, she was comfortable.  I, I know, and sometimes she say ow, but it’s like not, not make sense.  Like I ask her, you Okay?  Yes.  Oh.  Why you say ow?  I don’t know.  That’s it.”  Id. at 32.

Regarding positioning R25 onto the gerichair, CNA Tetteh testified that:

when we were putting her in the chair, the geri – the therapy has bring a new geri chair, kind of bubble -- I don’t know how to describe it.  But I ask before we put the patient in the chair.  When I realized that the therapy has brought that small geri chair -- geri foam, I don’t know how to call it, in the chair.  So I went and asked the therapy that – if they will come in, because most of the time, if they introduce a new thing, they will do us orientation for us to know how to use it.  So I went and asked one of the therapy that this is what the patient is using now, how do we use it, and they say oh, it’s easy.  Just put the patient -- the cushion have to sit on it.  So I said okay.  So we came -- I came back in, and we positioned everything, and we put the patient on it.14 

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Id. at 460.

The CNAs then placed R25 onto the gerichair with the ROHO cushion on the seat.  Id.  
However, because she was at the front of the gerichair, she did not see that the ROHO cushion had moved up during transfer to the back.  The CNAs then placed R25 on the mechanical lift again to place the ROHO cushion on the seat and subsequently completed the bed transfer.  Id. at 460-61.  The CNAs did not stop the transfer after R25 said “Ow” and did not ask R25 whether she was in pain during the transfer, because they had recently called the nurse for a pain assessment and CNA Tetteh saw the nurse go in R25’s room with the medication cart, they knew from their own experiences and had heard from other nurses that R25 now frequently uttered such exclamations, and they believed R25 could say if she did not want to be transferred.  Id. at 490, 501-502.

I find the CNAs’ testimony to be credible as well, and I must ultimately determine which version of the events is more likely to have occurred based on the facts and evidence before me.  Preliminarily, I find both CNAs sincere in their recollection of the events that occurred on March 10, 2021, and, more fundamentally, that they had genuine care and concern for patient R25 and wanted what was best for her.  In particular, CNA Tetteh had cared for R25 for 8+ years and continued to visit her to say hello after CNA Tetteh was transferred to another unit at Petitioner.  Tr. at 450-452.  She was visibly moved when she testified to witnessing R25’s decline and caring for her the morning of March 10, 2021:

So everything that I was doing, I was doing with care and compassion.  I know this patient.  We talk and, you know, I know the patient very well.  So to see her in that condition, Your Honor, I was really touched.  So everything I was doing for her, honestly, I was doing with compassion and care, because I care for her so much.  This last time I would buy her something.  I buy her blankets, and she was using for a very long time.  She would use it, and she’ll even tell everybody else Adowa get me this, Adowa get me this.  Most of the time she says you are a daughter to me because I was so much, you know, I care for her.  I’ll give her a shower, I’ll do everything for her.  So to see her in that condition, Your Honor, honestly, I was doing everything with care and compassion.  That’s the only thing.

Id. at 502-503.

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As to the sequence and occurrence of events of March 10, 2021, I find as follows.  That at 7:06 a.m., R25 was observed with signs and symptoms of pain and was subsequently treated with breakthrough pain medication which was noted as effective.  CMS Ex. 20 at 3.  At around 8:00 a.m., CNA Tetteh asked R25 whether she was in pain and R25 said “no” (despite having vocalized “ow, ow, ow”) after which staff repositioned her and brought in breakfast.  Tr. at 454.  At 8:15 a.m., R25 was observed displaying potential signs or symptoms of pain, manifested by grimacing and vocalizations, during positioning.  Jt. Stip. ¶ 21; CMS Ex. 20 at 2.  CNA Tetteh asked R25 if she was in pain, and this time R25 confirmed she was experiencing pain, so CNA Tetteh went to find a nurse to address the pain.  Tr. at 457.  It is more likely than not, CNA Ortiz was in the room with CNA Tetteh at that time and that is when she witnesses CNA Tetteh go get the nurse.  Tr. at 54.  Between 8:45 – 8:58 a.m., the assigned LPN attempted twice to give Tramadol with apple sauce, but R25 spit it out the first time and refused the second time.  Tr. at 405.  At 9:00 a.m., the LPN contacted R25’s primary care physician who advised that R25 should be monitored for changes in status and recommended a psychiatric evaluation.  CMS Ex. 20 at 2.  Notably, the physician did not recommend the provision of additional pain medication despite the fact that the physician knew R25 was showing signs and symptoms of possible pain and the administration of tramadol was ineffective.

At 10:50 a.m., Staff assessed R25 for pain and documented it as a “0” on the PAINAD scale.  P. Ex. 1.  Prior to 11:00 a.m. it is unclear from the record when CNA Ortiz entered the room, but she was in the room prior to when Surveyor Sagaard or CNA Tetteh returned.  See Tr. at 491.  CNAs Ortiz and Tetteh initiated R25’s bed transfer at around 11:00 a.m.; they did not stop the transfer at any point from 11:05 to 11:38 a.m., did not leave the room at any point during the transfer, and no nurse assessed R25 for pain prior to completion of the transfer in that time window.  Id. at 327.  During the transfer, the ROHO cushion slid up from the seat to the back of the gerichair.15  R25 was later administered Acetaminophen at 12:12 p.m.  CMS Ex. 20 at 1.  At approximately 12:35 p.m., staff spoke with R25’s treating physician again, and the physician stated that R25 should be sent to the hospital.  Id.  At approximately 1:30 p.m., R25 was transferred to the “RWJH” hospital and was admitted with a diagnosis of altered mental status.  Jt. Stip. ¶ 24; CMS Ex. 20 at 1.  She was later also diagnosed with a urinary tract infection (UTI).  Tr. at 183, 431.

Based on the foregoing testimony and the facts and evidence discussed within this decision, I conclude that a preponderance of the evidence demonstrates Petitioner was in substantial compliance with section 483.25(k).  Specifically, I find that while the CNAs continuing with the March 10, 2021 at 11:05 a.m. transfer of R25 after she made sounds

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that could have been indicative of pain without asking R25 whether she was in pain and without getting a nurse was a violation of the professional standard of practice, and therefore a violation of section 483.25(k), the violation did not pose a risk for more than minimal harm given the particular facts and circumstances of this case.  In all other respects, I find that the record before me establishes more likely than not that Petitioner provided pain management to R25 consistent with professional standards of practice, the comprehensive person-centered care plan, and the residents' goals and preferences.

RN Rader testified that the professional standards of care are to obtain a nurse to assess whether a resident is in pain, and that breakthrough pain medications are only provided based upon a contemporaneous assessment for pain and whether the assessment matches the physician’s orders.  Tr. at 292.  LPN Sawyer testified regarding the specific standard of care at Petitioner’s facility, which is that CNAs are trained to stop a transfer if there are signs of pain during the transfer and to ask for a nurse to come in and assist the patient.  Id. at 144.  Surveyor Sagaard testified to a similar professional standard of care.  Id. at 334.  And both CNA's similarly agreed that they are to stop care and find a nurse if a patient exhibits signs or symptoms indicative of pain.  Id. at 27; 469.  Based on the witnesses’ qualifications and the overall consensus, I afford significant weight to their testimony regarding the relevant professional standards of care for pain management in this situation.  The evidence demonstrates that staff failed to adhere to the professional standard of care as articulated by the parties’ witnesses in violation of section 483.25(k), because the CNAs did not stop the 11:05 a.m. bed transfer despite R25’s vocalizations of “Ow” which were potentially indicative of pain.  Id. at 327, 490, 501.  However, a preponderance of the evidence shows that this did not pose a risk for more than minimal harm under the circumstances.  The record establishes that R25 received Oxycodone on March 10, 2021, at 6:00 a.m.  CMS Ex. 17 at 6.  Then at 7:06 a.m., R25 was observed with signs and symptoms of pain and was subsequently treated with breakthrough pain medication which was noted as effective.  CMS Ex. 20 at 3.  Despite the successful administration of Oxycodone at 6:00 a.m. and acetaminophen at 7:06 a.m., R25 was later observed at 8:15 a.m. displaying potential signs or symptoms of pain manifested by grimacing and vocalizations.  To address R25’s potential pain, staff attempted twice to give Tramadol, but R25 either refused or was unable to swallow the medication.  Tr. at 157.  After the failed attempt of tramadol, the nurse spoke with R25’s physician, and rather than order additional pain medication to be delivered via an alternate route, the physician ordered a psychological evaluation.  CMS Ex. 20 at 2.  As such, the physician was concerned that the signs and symptoms R25 was exhibiting may have been behavioral and not indicative of pain.

Despite R25’s earlier signs of potential breakthrough pain and failed administration of Tramadol, staff ultimately assessed R25 for pain and documented it as a “0” on the PAINAD scale at 10:50 a.m., no more than 15-20 minutes prior to the bed transfer at around 11:10 a.m.  P. Ex. 1; CMS Ex. 1 at 58.  Thus, the facts reasonably establish the possibility that R25 was not experiencing much, if any, pain at the time of the bed

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transfer and that any vocalizations were more likely a behavior that had been consistently observed by staff in the months preceding the survey.  See, e.g., Tr. at 56 (LPN Ortiz agreeing that she had treated R25 eight times in the past two months and that she would say “ow” even it not being touched), 456 (“that’s how she is right now.”).  At times during the transfer, it appears that R25 yelled out due to a fear of falling, rather than due to any perceived pain.  Id. at 321.

The likelihood of this possibility is further substantiated by progress notes dated November 23, 2020 showing that R25 was observed displaying intermittent confusion with forgetfulness, as well as hallucination involving laughing when asked about any pain or discomfort.  CMS Ex. 20 at 38-39.  A November 27, 2020 progress note authored by Dr. Shady Hassan noted that “[o]n certain days she displays no signs or symptoms of distress, but other day she complains of pain requiring pain medications.  This is an inconsistent behavior.”  CMS Ex. 20 at 35.  December 15, 2020, January 7, 2021, and February 8, 2021 monthly psychoactive summaries authored by LPN Sawyer additionally note behaviors of screaming/crying out and hallucinations, describing the behavior generally as yelling on and off for no apparent reason.  CMS Ex. 23 at 7-9.  Although LPN Sawyer is not a psychiatrist, she is certainly competent to record her observations, which are largely consistent with those documented by R25’s physicians.  Both CNAs testified to the presence of similar behaviors.  CNA Ortiz testified that she asked R25 whether she was in pain but that R25 said “I don’t know.  No.  And she never say yes.  Or she say something that made no sense.”  Tr. at 35.  CNA Tetteh testified that she had been “told before that that’s how the patient is right now, that whatever you do, if you pass by, you touch a little bit, she will say ow, ow.  Ow, ow has become, like, her language now, because this time she cannot able to talk to you much like what I knew her before[.]”  Id. at 464.  Their testimony is credible, consistent with the other testimony and documentary evidence of record, and consistent with the subsequently discovered fact that a mere two hours later R25 would be admitted to the hospital with diagnoses of altered mental status and a UTI.  Jt. Stip. ¶ 24; CMS Ex. 20 at 1; Tr. at 183, 431.  Altogether, R25’s previously observed behaviors of yelling out without any perceivable reason and then confirming she was not in pain, a pain assessment of “0” only minutes before the CNAs began her transfer to the gerichair, and her later diagnosis of altered mental status and a UTI upon admission to the hospital reasonably indicate any perceived signs or symptoms of pain were more likely than not attributable to a reason other than pain.

On the other hand, had the CNAs stopped care and sought out a nurse, it is hard to see how the outcome would have been significantly altered.  R25 was declining and needed to go to the hospital for additional treatment.  As such, a transfer was inevitable for that reason alone.  Ultimately, when R25 was transferred to the hospital less than 2 hours later, the physician gave no direction to the staff or Surveyor Sagaard, with whom the physician separately spoke, that the patient should be administered additional medication prior to transfer to the hospital.  See CMS 20 at 1; CMS Ex. 8 at 14.

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Lastly, CMS has not offered any qualified expert testimony that R25 actually experienced any pain or harm during the 11:05 a.m. bed transfer.  Surveyor Sagaard testified at the hearing that a physician is best suited to make such a diagnosis or determination.  See Tr. at 136.  CMS also has not offered any qualified expert testimony that R25 was at risk for more than minimal harm due to the CNAs continuing with the bed transfer of R25 without a nurse’s pain assessment in this instance.  To the contrary, the undisputed record evidence demonstrates that Petitioner consulted a physician twice on March 10, 2021 – once before the bed transfer and once after – and under neither circumstance did the physician order additional pain medication for R25 despite her signs and symptoms of possible pain and the inability of Petitioner to administer R25 tramadol. CMS Ex. 20 at 2.  Instead, the physician ordered a psychological assessment first, and the physician later ordered that R25 be transferred to a hospital, which necessitated R25 be transferred from her bed.  Id. at 1.

Thus, while Petitioner’s staff may have contravened the professional standard of care by not stopping the transfer based upon a potential vocalization of pain, such violation presented no more than a risk for minimal harm given R25’s documented medical history and her status at that time.  This is especially the case given Petitioner’s concomitant obligations to provide pain management in accordance with R25’s comprehensive person-centered care plan, as well as her goals and preferences and that R25 had nodded in agreement to the transfer to the gerichair prior to the initiation of the transfer.  Tr. at 466.  Furthermore, IDT progress notes, used in the formulation of R25’s care plan, show that the IDT recommended, among other things, that R25 “be out of the bed to a wheelchair as much as tolerated (up to 3 hours).”  P. Ex. 8 at 2.  To this end, Surveyor Sagaard noted that LPN Sawyer had gotten R25 out of bed the prior evening and “[R25] did very well with that, and she wanted to do it again, to try it again,” which was the reason that staff initiated the bed transfer on March 10th.  Tr. at 421.  The foregoing demonstrates Petitioner’s difficult task of balancing R25’s overall wellbeing (by encouraging her to be out of bed) with providing pain assessment and management in accordance with the professional standard of care.  Staff initiated a bed transfer precisely to facilitate her wellbeing, but did not stop the bed transfer after hearing vocalizations potentially indicative of- but not likely attributable to- pain based on their longstanding familiarity with the resident and information obtained from fellow staff members, which is furthermore corroborated by medical evidence of record.  See Tr. at 22 (“I was familiar with the resident [] about eight times two months before that happened.”); Tr. at 424 (both CNAs indicated a familiarity with R25).  While it is possible that R25 experienced some level of pain during the bed transfer, the regulation does not require that pain be prevented, only that it be managed consistent with the professional standard of care, the resident’s care plan, as well as their goals and preferences.  Based on the facts and evidence before me, I conclude that any risk for harm was no more than minimal harm.

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I also conclude that Petitioner presented preponderant evidence that staff properly placed the ROHO cushion as required by R25’s care plan.  I find it more likely than not that, during the transfer of an obese resident, a gel cushion could have been inadvertently moved from the seat to the back of the gerichair.  I accord less weight to the surveyor’s testimony than the CNAs regarding the placement of the ROHO cushion, because there is  a reasonable likelihood that certain details, such as the precise placement of a cushion, may have been missed by a single observer when in the heat of the moment during a bed transfer involving three people, one of whom is an elderly, obese resident repeatedly uttering exclamations, and during which certain viewpoints may have been easily obscured.  This is in contrast to the surveyor’s testimony that no one entered or left the room during the transfer, which I found probative, because it is comparatively much easier to accurately observe whether an individual left the room during that time.  I further note that when asked to address the inconsistency between the CNA’s declarations and her observations on this point, Surveyor Sagaard opined that the non-skid backing would make it difficult for the cushion to move during transfer.  However, she did not testify that movement of the cushion would be impossible.  I also find no reason to doubt the credibility of the CNAs’ testimony regarding the placement of the ROHO cushion and credit the consistency in their testimony across the two days of the hearing.  However, even if I were to accord greater weight to the surveyor’s testimony, I would still conclude that Petitioner substantially complied with section 483.25(k), because any alleged violation did not pose a risk for more than minimal harm.  According to the surveyor’s testimony, staff initially incorrectly placed the cushion on the back but quickly corrected this error so the time R25 spent sitting on the gerichair without a ROHO cushion was likely brief and unlikely to have posed a risk for more than minimal harm.

Accordingly, I conclude that Petitioner has rebutted CMS’s prima facie case of noncompliance based on alleged deficiencies occurring on March 10, 2021, and established by a preponderance of evidence that it was in substantial compliance with section 483.25(k).

3. Section 483.25(k) does not impose a legal requirement upon Petitioner as to the specific content of comprehensive person-centered care plans.

CMS further argues that Petitioner violated 42 C.F.R. § 483.25(k) based on a failure to develop a person-centered comprehensive care plan for R25’s pain management.  CMS acknowledges that R25’s care plan identified the presence of pain, need for pain management and monitoring, and established a goal of evaluating what makes the patient’s pain worse.  Nevertheless, CMS contends that R25’s care plan did not satisfy the regulation because it failed to specifically identify precipitating factors of pain, e.g., what made R25’s pain worse, as well as assessing whether R25’s behaviors of yelling and calling out were related to pain.  CMS Br. at 16-18.

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A review of R25’s care plan reveals that, consistent with Petitioner’s pain management policy, it required assessing pain, providing pain medication both as prescribed and as needed, evaluating the efficacy of pain medications, evaluating what makes the resident’s pain worse, and evaluating the characteristics and frequency/pattern of the resident’s pain.  CMS Ex. 30 at 5, 19; see CMS Ex. 25 (pain management policy).  The care plan does not contain specific information concerning R25’s precipitating factors of pain, nor does it direct staff to assess whether R25’s behaviors of yelling and calling out were related to pain.  However, the absence of such information does not constitute noncompliance with 42 C.F.R. § 483.25(k) (Tag F697), because the regulation imposes no such legal requirement.  The plain language of the regulation, titled “Pain Management,” imposes a requirement that pain management be provided consistent with professional standards of practice, the comprehensive person-centered care plan, and the residents' goals and preferences.  While the comprehensive person-centered care plan is one standard by which a facility’s pain management is evaluated for purposes of determining quality of care, nothing in the regulation16 purports to impose specific requirements with respect to the content of person-centered comprehensive care plans –  much less the requirement that a pain management care plan necessarily address precipitating factors of pain, acceptable numeric pain levels, and assessments of behaviors potentially indicative of pain.  Section 483.25(k) therefore cannot be construed to impose a legal requirement upon Petitioner as it pertains to the specific content of comprehensive person-centered care plans as CMS essentially avers.

CMS cites no authority supporting its argument other than a reference to the portion of the State Operations Manual17 (SOM) governing Tag F697.  CMS Br. at 16 (citing CMS Ex. 27 at 1-2).  The SOM is sub-regulatory guidance published by CMS for state surveyors conducting surveys on CMS’s behalf and therefore does not have the force and effect of law.  Nevertheless, a review of the SOM does not reasonably appear to support CMS’s position that failure to address precipitating factors of pain and provide an assessment of behaviors potentially indicative of pain in a resident’s care plan constitutes a violation of section 483.25(k).  The relevant portion of the SOM provides the following guidance:

[i]n order to help a resident attain or maintain his or her highest practicable level of well-being and to prevent or manage pain, the facility, to the extent possible:

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• Recognizes when the resident is experiencing pain and identifies circumstances when pain can be anticipated; 
• Evaluates the existing pain and the cause(s), and 
• Manages or prevents pain, consistent with the comprehensive assessment and plan of care, current professional standards of practice, and the resident’s goals and preferences.

CMS Ex. 27 at 1-2.  While the SOM provides guidance on what a facility should do, to the extent possible, to manage pain, it again imposes no requirements relating to what a care plan must specifically contain with respect to pain management under section 483.25(k).

Such a reading of the regulation is supported by other CMS sub-regulatory guidance, namely CMS Form 20076, titled “Pain Recognition and Management Critical Element Pathway,” which instructs surveyors on how to determine whether and what deficiencies exist when a resident has pain symptoms or can reasonably be expected to experience pain.  CMS Ex. 28.  The guidance instructs surveyors that a failure to “identify, treat, monitor, and manage the resident’s pain to the extent possible in accordance with the comprehensive assessment and care plan, current professional standards of practice, and the resident’s goals and preferences” constitutes a deficiency under Tag F697, whereas a failure to “develop and implement a comprehensive person-centered care plan . . . ” constitutes a deficiency under Tag F656.  CMS Ex. 28 at 3.  Tag F656 is the F-tag designation for the regulatory requirement under 42 C.F.R. § 483.21(b), which specifically addresses the requirements for comprehensive person-centered care plans.  CMS responded to comments concerned about the scope of section 483.21(b) in its final rule which revised various regulations for long-term care facilities.  CMS specifically revised section 483.21(b) to clarify its intention that “facilities must both develop and implement a comprehensive person-centered care plan.”  81 Fed. Reg. 68,688, 68,740 (Oct. 4, 2016) (Emphasis added).  Thus, CMS’s construction of section 483.25(k), one that would require care plans to address precipitating factors of pain and assess behaviors potentially indicative of pain, is undermined by the existence of section 483.21(b), the purpose of which is to govern the development and implementation of comprehensive person-centered care plans.  Otherwise, section 483.21(b) would be mere surplusage.  See Duncan v. Walker, 533 U.S. 167, 174 (2001) (utilizing a canon of construction which gives effect, if possible, to every clause and word of a statute).

CMS could have included noncompliance with section 483.21(b) as a basis for the imposition of enforcement remedies in its notice letter, but expressly chose not to do so here.  Although CMS’s exercise of discretion to impose remedies solely based on noncompliance with section 483.25(k) is unreviewable, CMS cannot now attempt to establish noncompliance with section 483.25(k) based on evidence and argument related

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to the development and implementation of R25’s care plan when the regulation imposes no such legal obligation. 18 

Additionally, my review is limited to the determination of noncompliance that led to the imposition of enforcement remedies.  The hearing rights of a long-term care facility are established by federal regulations at 42 C.F.R. Part 498.  A provider dissatisfied with CMS’ initial determination is entitled to further review, but administrative actions that do not constitute initial determinations are not subject to appeal.  42 C.F.R. § 498.3(d).  A finding of noncompliance that results in the imposition of a remedy specified in 42 C.F.R. § 488.406 is an initial determination for which a facility may request a hearing.  42 C.F.R. § 498.3(b)(13).  Unless the finding of noncompliance results in the actual imposition of a specific remedy, the finding is not an initial determination.  42 C.F.R. § 498.3(d)(10)(ii).  In this case, the finding of noncompliance that resulted in an enforcement remedy involved only section 483.25(k); therefore, I have no authority to review CMS’s allegations of noncompliance with section 483.21(b).  See 42 C.F.R. §§ 488.408(g), 488.434(a)(2)(viii), 498.3(b)(13).

2. There is no basis for the imposition of enforcement remedies.  

On June 1, 2021, CMS issued an initial determination imposing a PICMP of $11,300 and a prohibition against the provision of a NATCEP based on alleged deficiencies with section 483.25(k) during the March 11, 2021 survey.  CMS Ex. 2 at 2, 5.  Petitioner did not have an approved NATCEP at the time.  Jt. Stip. at 3 ¶ 14.  A CMP is among the available remedies specified in 42 C.F.R. § 488.406.  When CMS applies the remedies specified in section 488.406, the remedies are applied on the basis of noncompliance found during surveys conducted by CMS or by the survey agency.  42 C.F.R. § 488.402(b).  I have concluded that Petitioner was in substantial compliance with

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42 C.F.R. § 483.25(k).  Therefore, there is no basis for the imposition of enforcement remedies.

VI.  Conclusion

Petitioner was in substantial compliance with the Medicare participation requirement established by 42 C.F.R. § 483.25(k) (Tag F697) at the time of the survey.  Accordingly, CMS did not have a basis to impose remedies, and CMS’s proposed PICMP of $11,300 is therefore unreasonable.