Greenville Post-Acute, DAB CR6248 (2023)

DECISION

The issue before me involves a long-term care facility’s responsibility to protect residents from misappropriation of property in accordance with the Federal Regulations and its own nursing home policies.

Petitioner, Greenville Post-Acute (Petitioner or facility) is a skilled nursing facility (SNF) in Greenville, South Carolina that participates in the Medicare program.  On May 22, 2020, the South Carolina Department of Health and Environmental Control (SCDHEC or Surveyor), a contractor for the Centers for Medicare & Medicaid Services (CMS), completed a survey and found that the facility was not in substantial compliance with Medicare participation requirements.¹  The Surveyor found that facility conditions

Page 2

constituted immediate jeopardy to residents’ health and safety and that substandard quality of care existed from April 26, 2020, until May 22, 2020.  CMS Exhibit (Ex.) 2 at 1.

I.    Procedural Background

In a notice dated August 7, 2020, CMS confirmed the Surveyor’s findings that the facility was not in substantial compliance with the Medicare participation requirements and that the facility conditions constituted immediate jeopardy to residents’ health and safety from April 26, 2020, until May 22, 2020.  CMS acknowledged that while corrective action taken by the facility removed the immediate jeopardy deficiency finding on May 22, 2020, conditions in the facility remained out of substantial compliance with participation requirements.  CMS Ex. 2 at 1. 

The August 7, 2020 notice confirmed that based on the May 22, 2020 survey, the facility’s Medicare participation would terminate effective November 22, 2020.²  Furthermore, CMS would impose a per‑instance civil money penalty (CMP) in the amount of $21,393.00 for the noncompliance cited for two deficiencies; a per‑instance CMP of $16,288.00 for the deficiency designated as F602, cited at scope and severity level “J” (F602J), and a per‑instance CMP of $5,105.00 for the deficiency designated as F610, cited at scope and severity level “D” (F610D).  CMS Ex. 2 at 2.  The Surveyor found that the deficiency designated as F602J was based on the facility’s misappropriation of controlled medications for two of three residents who were reviewed for misappropriation of property.  The deficiency designation of F610D was based on the facility’s failure to investigate and report misappropriation in accordance with regulatory requirements.³  CMS Ex. 1 at 6-25, 30-37. 

On October 7, 2020, Petitioner timely requested a hearing (RFH) before an Administrative Law Judge (ALJ).  In the RFH, Petitioner outlined a series of exchanges between the Surveyor and CMS after Petitioner implemented a plan of correction and the immediate jeopardy finding was lifted.  While Petitioner discussed the various decisional

Page 3

documents issued by the Surveyor and CMS during the period between the survey and September 30, 2020, Petitioner acknowledges that the issue for its RFH involves the sole remaining J-level citation (F602), which was the basis for CMS finding immediate jeopardy.  Petitioner acknowledges “the Resident’s pain medication went missing when the Resident was moved from one unit to another due to COVID-19 considerations” and that “the Resident missed several doses between April 26 and April 29, 2020.”  Petitioner contends, however, that “the missed doses did not result in any ‘serious injury, serious harm, serious impairment or death’ as required in order to cite immediate jeopardy.”  RFH at 3.  Petitioner thus asserts that the circumstances surrounding the resident did not meet the criteria for imposing any immediate jeopardy level citation.  RFH at 4.

On October 8, 2020, the presiding ALJ⁴  issued an acknowledgment and receipt of Petitioner’s October 7, 2020 RFH.  Departmental Appeals Board Electronic Filing System (E-File) Entry 2.  The ALJ also issued an order (Order) establishing deadlines for pre-hearing briefs and proposed exhibits.  The Order specified that an in-person hearing to cross-examine witnesses would only be necessary if a party files admissible, written direct testimony, and the opposing party asks to cross‑examine the witness(es).  The Order further directed that absent an explicit request for cross-examination of a particular witness, the ALJ would not afford an opportunity for cross-examination.  Order at 9.

On January 6, 2021, CMS filed its pre-hearing brief (CMS Br.) and submitted 10 proposed exhibits, including the written direct testimony of Surveyor Sharon Ross (CMS Exs. 1-10).  On February 9, 2021, Petitioner filed its pre-hearing brief and submitted five proposed exhibits, including the written direct testimony of Mark Millet, Petitioner’s Regional Director of Operations and Ra Lawrence, Petitioner’s Administrator (P. Exs. 1‑5).  Neither party filed objections to the opposing party exhibits or filed a request to cross‑examine opposing party witnesses.  Accordingly, I receive CMS Exs. 1‑10 and Petitioner Exs. 1-5 into evidence.  Inasmuch as a hearing is unnecessary for the purpose of cross‑examination, I will decide this matter on the written record.

II.    Statutory and Regulatory Background

The Social Security Act (Act) sets forth requirements for SNFs or long-term care (LTC) facilities to participate in the Medicare program and authorizes the Secretary of Health and Human Services (Secretary) to promulgate regulations implementing these statutory provisions.  Act § 1819.  The Secretary’s regulations are found at 42 C.F.R. Part 483.  To participate in Medicare, a LTC facility must be in “substantial compliance” with the participation requirements in 42 C.F.R. Part 483, subpart B.  42 C.F.R. §§ 483.1, 488.400.  A “deficiency” is a “failure to meet a participation requirement.”  Id.; 42 C.F.R.

Page 4

§ 488.301.  A LTC facility is not in “substantial compliance” when it has one or more deficiencies that have the potential for causing more than minimal harm to residents.  Id.

The Secretary contracts with state survey agencies to survey LTC facilities to determine whether they are in substantial compliance with program requirements.  Act § 1864(a); 42 C.F.R. § 488.20.  CMS may impose enforcement remedies based on the survey results, including a per-day or per-instance CMP, on a LTC facility that is not in substantial compliance.  42 C.F.R. §§ 488.400, 488.402(b), (c), 488.406.  CMS determines the amount of a CMP based on multiple factors, which include the “seriousness” of the noncompliance.  42 C.F.R. §§ 488.404(b), 488.438(f).  “Seriousness” is a function of the noncompliance’s scope (whether it is “isolated,” constitutes a “pattern,” or is “widespread”) and severity (whether it has created a “potential for harm,” resulted in “actual harm,” or placed residents in “immediate jeopardy”).  42 C.F.R. § 488.404(b).

III.    Issues

The issues before me are: 

1. Whether the facility was in substantial compliance with 42 C.F.R. § 483.12.
2. If Petitioner did not comply substantially with Medicare participation requirements, then whether CMS’s immediate jeopardy determination was clearly erroneous.
3. Whether the CMP imposed for the non-compliance is reasonable.

IV.    Findings of Fact, Conclusions of Law, and Analysis⁵ 

1. Petitioner was not in substantial compliance with 42 C.F.R. § 483.12.

1. Governing Guidelines and Authority

42 C.F.R. § 483.12(b)(1)⁶  requires a SNF to “develop and implement written policies and procedures that prohibit and prevent abuse, neglect, and exploitation of residents and misappropriation of resident property.”  The regulations define “misappropriation of resident property” as “the deliberate misplacement, exploitation, or wrongful, temporary or permanent use of a resident’s belongings or money without the resident’s consent.”  42 C.F.R. § 488.301.

Page 5

42 C.F.R. § 483.12(c)(2) also provides that in response to allegations of abuse, neglect, exploitation, or mistreatment, including misappropriation of resident property (emphasis added), a facility must have evidence that all alleged violations are thoroughly investigated.  Section 483.12(c)(3) requires that the facility prevent further potential abuse, neglect, exploitation, or mistreatment while the investigation is in progress. Additionally, section 483.12(c)(1) requires that a facility report alleged violations involving misappropriation of resident property no later than 24 hours to the administrator of the facility and to other officials (including the state survey agency in accordance with state law through established procedures).  Section 483.12(c)(4) mandates that the facility report the results of all investigations to the administrator or his or her designated representative and to other officials in accordance with state law, including to the state survey agency, within five working days of the incident, and if the alleged violation is verified, appropriate corrective action must be taken. 

2. The Facility’s Policies Concerning Resident Property

At the time of the survey, the facility had two policies that dealt with misappropriation of resident property.  The policy entitled “Inventory Control of Controlled Substances” and revised on January 1, 2013, required that the facility ensure that at the change of each shift or at least once daily, the incoming and outgoing nurses count all Schedule II controlled substances and other medications with a risk of abuse or diversion and document the results on the “Controlled Substance Count Verification/Shift Count Sheet.”  The policy required the reconciliation of the total number of controlled medications on hand, addition of newly received medications to the inventory, and removal of medications that were completed or discontinued from the inventory.  CMS Ex. 1 at 8.

A second facility policy captioned as “Abuse Prevention Program” and dated December 2016, provided that the facility’s residents have the right to be free from abuse, neglect, misappropriation of resident property, and exploitation.  The policy required the facility to develop and implement policies and procedures to aid in preventing abuse, neglect, or mistreatment of residents.  CMS Ex. 1 at 7.

The facility policy provided that if a resident did not have a pain medication, the nurses should contact the physician and get the medication for the resident.  CMS Ex. 1 at 42.

3. Factual Background

CMS alleges that there were two instances of drug diversion involving two residents between April 26, 2020, and May 2, 2020, for which the facility failed to comply with its own nursing home policies.  CMS Br. at 7-10. 

Page 6

1. Resident 1

Resident 1 was admitted to the facility on January 7, 2020, with diagnoses of wedge compression fractures to the first and second lumbar vertebra and chronic pain syndrome.  CMS Ex. 1 at 3.  On January 15, 2020, the physician ordered the resident to receive Percocet 7.5/325 milligrams (mg) every six hours for pain.  CMS Ex. 1 at 4.  The resident’s Medical Administration Record (MAR) dated April 26, 2020 through April 29, 2020 indicates that Resident 1 was to receive pain medications at 2:00 AM, 8:00 AM, 2:00 PM, and 8:00 PM.  CMS Ex. 1 at 4.

When the Surveyor visited the facility on May 21, 2020, Resident 1 told the Surveyor that he had not received his pain medications for several days at the end of April 2020.  Resident 1 told the Surveyor that although he had asked the staff why he was not receiving the pain medications, the staff did not explain.  CMS Ex. 1 at 17.  Resident 1 also confirmed that the staff had not asked him any questions related to the pain medications.  CMS Ex. 1 at 5.  The Surveyor noted in the Statement of Deficiencies (SOD) that the resident’s mental assessment of January 14, 2020, confirmed that the resident was cognitively intact for daily decision making.  CMS Ex. 1 at 3.

On April 1, 2020, a pharmacy order of 120 dosages of Percocet was delivered to the facility and added to the medication cart for Resident 1 on April 2, 2020.  The order contained four medication cards containing 30 tablets each.  CMS Ex. 1 at 9; CMS Ex. 5.  From April 2 to April 25, Resident 1 received a total of 90 Percocet tablets.  On April 26, 2020, however, the nurse administering medications found the Percocet for Resident 1 depleted.  CMS Ex. 5.  The nurse informed the nurse practitioner that Resident 1’s pain medication was depleted.  CMS Ex. 1 at 8-9, 11.  Because there should have been 30 Percocet dosages remaining from the April 1 pharmacy delivery, the pharmacy refused to refill the prescription.  CMS Ex. 1 at 11, 14.  The Director of Nursing (DON) and the Assistant Director of Nursing (ADON) were not notified that Resident 1’s pain medication was missing until April 29.  Although there was a search of the facility, the missing 30 Percocet dosages were not found.  CMS Ex. 1 at 15-16.  There is no dispute that Resident 1 did not receive the routine four daily dosages of Percocet for three days from April 26 until April 29, when oxycodone was ordered to replace the missing Percocet.  CMS Ex. 1 at 20.  The Surveyor noted that from 8:00 AM on April 26, 2020, until April 29, 2020, at 2:00 PM, Resident 1 missed at least 14 doses of the prescribed pain medication.  Further, a review of the Progress Notes dated April 27, 2020, through April 29, 2020, contained no documentation that the physician or the resident had been notified that Resident 1 had not received the ordered Percocet.⁷  CMS Ex. 1 at 4.  Furthermore, the physician confirmed on May 22, 2020, that there had been no notification that the resident was without medication.  CMS Ex. 1 at 6.  The ADON acknowledged on May 22, 2020, that the facility’s policy on physician notification would

Page 7

have required the physician to be notified every day until the resident had medication.  CMS Ex. 1 at 5.

Petitioner does not deny that Resident 1 did not receive the pain medication from April 26 until April 29 but argues that there were only 15 missed dosages rather than 30 as referenced by CMS in its brief.  P. Br. at 5.  Petitioner also argues that despite the missed dosages, Resident 1 did not complain of pain to the staff.  P. Br. at 5.

2. Resident 2

Resident 2 was admitted to the facility on January 13, 2020, with a diagnosis of Attention-Deficit/Hyperactivity Disorder (ADHD).  On January 14, 2020, the physician ordered that Resident 2 receive Adderall, 30 mg once per day.  CMS Ex. 1 at 17.  CMS alleges that the facility violated its own Inventory Control of Controlled Substances policy as related to Resident 2’s prescribed Adderall.  CMS Br. at 8.

The facility’s policy contained procedures to be followed by the facility’s staff in tracking the inventory of controlled substances, and specifically targeted the control of Schedule II drugs such as Adderall.  The policy required verification of the controlled medication inventory by two nurses.  CMS Ex. 1 at 7-8.  The incoming nurse and the outgoing nurse for each shift were directed to count all medication cards which contained the dosages of controlled medication.  Further, the nurses were to count the control sheets that listed the controlled medications that had been administered during the previous shift and to document the results on the Controlled Substance Count Verification/Shift Count Sheet.  CMS Ex. 1 at 7-8.

On May 22, 2020, the DON confirmed that when the nurses completed their narcotic count for the beginning of the 7:00 PM shift on May 2, 2020, neither nurse followed the facility’s policy for controlled substance inventory control.  The nurses did not complete a count of medication cards and individual count sheets. CMS Ex. 1 at 19.  While the nurses signed off on the narcotic count sheets and the number of narcotic cards, they did not “document” the number of medication cards.  CMS Ex. 1 at 18-19.

Petitioner asserts that Resident 2 was admitted to the hospital on May 1, 2020, and did not return to the facility until May 5, 2020.  Petitioner acknowledges that on May 3, 2020, during the time that Resident 2 was in the hospital, a card containing seven tablets of Adderall prescribed for Resident 2 was misplaced.  P. Ex. 4 at 1.  In its brief, Petitioner asserts that prior to Resident 2’s return to the facility on May 5, 2020, “the missing medication was discovered” and argues that Resident 2 did not miss any Adderall doses while at the facility.  P. Br. at 5; P. Ex. 4.  I note, however, that Petitioner also states in its brief that the misplaced card was “replaced.”P. Br. at 5; P. Ex. 4.  Furthermore, the facility’s Administrator also testified that the Adderall was “replaced” by May 5, 2020.  P. Ex. 4.  Thus, there is some discrepancy as to whether the original misplaced card of

Page 8

seven doses of Adderall was ever found in the facility or if it was simply replaced with other medication.

4. Discussion

CMS asserts that because of the facility’s noncompliance, Resident 1 failed to receive 30 dosages of Percocet (a controlled narcotic pain reliever) for three days and that Resident 2 failed to receive seven dosages of Adderall, a Schedule II stimulant.  CMS Br. at 1-2.  Petitioner contends, however, that Resident 1 only missed a total of 15 dosages before the physician ordered the oxycodone to replace the missing Percocet.  P. Br. at 4-5.  Petitioner further asserts that Resident 2 did not miss any Adderall dosages because she was hospitalized at the time that the medication was missing.  P. Br. at 5.

Petitioner’s arguments are unpersuasive.  Even if there is a discrepancy as to the total number of missed dosages, the undisputed fact is that a total of 30 dosages of a controlled substance were lost and never found.  As a result, Resident 1 was denied his prescribed pain medication for three days.  Although Resident 2’s hospitalization prevented her from missing her prescribed ADHD medication at the facility, the facility failed to follow its own policies and procedures for monitoring and inventorying this medication.  As a result of the facility’s noncompliance, Resident 2’s prescribed medication was also lost for an undetermined period.  Clearly, the facility acted in violation of not only the regulatory requirements of 42 C.F.R. § 483.12, but also in violation of its own policies.

While Petitioner only appeals the determinations of noncompliance and immediate jeopardy in relation to the violation cited as F602J, I also note that the evidence supports CMS’s citation of F610D for the facility’s failure to investigate/prevent/correct alleged violations.  42 C.F.R. § 483.12(c)(2)-(4).  There is no dispute that because of the actions of the facility’s staff, the prescribed medications for both Resident 1 and Resident 2 were unavailable to the residents and thus misappropriated within the meaning of 42 C.F.R. §§ 483.12 and 483.301.  The fact that Resident 2 may have been temporarily hospitalized during the time that her medication was lost or misplaced does not obviate the facility’s misappropriation of Resident 2’s prescribed medication.  The facility has not demonstrated that these violations were investigated or timely reported to the appropriate state or facility authorities as required under 42 C.F.R. § 483.12(c)(2)-(4).  Further, I note that there is no evidence that the misappropriation of Resident 1’s pain medication was reported to his physician within the required time mandated by the facility’s own policy or that the resident was notified of the missing medication in compliance with 42 C.F.R. § 483.10(g)(14)(i)(C). 

Page 9

2. CMS’s determination that the facility’s substantial noncompliance posed immediate jeopardy to resident health and safety is not clearly erroneous.

Petitioner does not dispute that the facility lost and never found the 30 doses of Percocet that was ordered specifically for Resident 1.  While Resident 2 did not go without her Adderall medication because of her hospitalization, Petitioner does not dispute that the facility lost seven doses of this medication and further admits that the facility staff did not follow the policy and procedures for tracking controlled substances.  Petitioner argues, however, that these violations did not meet the criteria for imposing any immediate jeopardy level citation.  RFH at 4; P. Br. at 7-11.

Immediate jeopardy exists if a facility’s noncompliance has caused or is likely to cause “serious injury, harm, impairment, or death to a resident.”  42 C.F.R. § 488.301.  CMS’s determination as to the level of a facility’s noncompliance (which would include an immediate jeopardy finding) must be upheld unless it is “clearly erroneous.”  42 C.F.R. § 498.60(c).  The Board has observed repeatedly that the “clearly erroneous” standard imposes on facilities a “heavy burden” to show no immediate jeopardy and has sustained determinations of immediate jeopardy where CMS presented evidence “from which ‘[o]ne could reasonably conclude’ that immediate jeopardy exists.”  Florence Park Care Ctr., DAB No. 1931 at 27-28 (2004) (citing Koester Pavilion, DAB No. 1750 (2000)); Daughters of Miriam Ctr., DAB No. 2067 at 7, 9 (2007).  Therefore, a finding of immediate jeopardy is presumed to be correct, and the SNF has the “heavy burden” to overturn it.  Crawford Healthcare & Rehab., DAB No. 2738 at 14-15 (2016).

Petitioner argues that the immediate jeopardy findings should be overturned because they do not meet the criteria specified in CMS’s 2019 memorandum (Guidance Memorandum), identified as QSO-19-09‑ALL (P. Ex. 5).  P. Br. at 6.  Petitioner asserts that this memorandum significantly changed guidance to state agency surveyors and directors regarding the key components required to cite immediate jeopardy.  Petitioner asserts that after the Guidance Memorandum issued, surveyors must determine that:  (1) a SNF’s noncompliance “caused or created a likelihood” that serious injury, harm, impairment, or death to a resident would occur or recur; and (2) immediate action is necessary to prevent the occurrence or recurrence of serious injury, harm, impairment or death to one or more recipients.  Petitioner submits this guidance differs from the prior guidance that only required the surveyor to find a “potential” for injury, harm, impairment, or death.  P. Br. at 6-7.

As an additional argument that CMS used the wrong standard in assessing immediate jeopardy, Petitioner contends that the Surveyor’s only statements in the Immediate Jeopardy (IJ) Template and the SOD relating to the immediate jeopardy citation are that the deficiency had the “potential to cause” injury to Residents 1 and 2 and had the “potential to affect” other facility residents.  P. Br. at 6.

Page 10

Citing the SOD and the IJ Template, Petitioner submits that there is not any discussion of any adverse outcome occurring or the likelihood of an adverse outcome occurring.  P. Br. at 6.  Petitioner maintains that the Surveyor’s statement that “there is a potential for further drug diversion resulting in potential serious harm from pain to a resident” would not qualify as immediate jeopardy under the CMS Guidance Memorandum.  P. Br. at 7. 

In a recent case, a SNF challenging an immediate jeopardy finding raised a similar argument and argued that the immediate jeopardy finding did not meet the criteria of an existing CMS memorandum.  Copperas Cove LTC Partners, Inc., DAB No. 3049 at 40 (2021).  The Board cited its earlier decision in Pinecrest Nursing and Rehab. Ctr., DAB No. 2446 at 18 (2012) in rejecting this argument.  The Board pointed out that the CMS memorandum’s purpose was to guide surveyors in applying a regulatory standard, and not to define that standard.  Copperas Cove, DAB No. 3049 at 40 (citing Pinecrest, DAB No. 2446 at 18).  Citing Pinecrest, the Board explained that the applicable standard is found in 42 C.F.R. § 488.301, which defines immediate jeopardy as a situation in which a deficiency caused or was likely to cause serious harm, injury, or death to a resident.  Copperas Cove, DAB No. 3049 at 40 (citing Pinecrest, DAB No. 2446 at 19).  Furthermore, the Board pointed out that it is not CMS’s burden to show that the violations met the regulatory criteria for an immediate jeopardy finding.  Rather, it was Petitioner’s burden to demonstrate that CMS’s immediate jeopardy findings were clearly erroneous.  Copperas Cove, DAB No. 3049 at 40-41 (citing 42 C.F.R. § 498.60(c)(2); Miss. Care Ctr. of Greenville, DAB No. 2450 at 15 (2012), aff’d, Miss. Care Ctr. of Greenville v. U.S. Dept. of Health & Human Svcs.,517 F. App’x 209 (5th Cir. 2013)).

Petitioner fully admits that two medication inventory issues occurred.  While Petitioner acknowledges that there was “no excuse for the issues,” Petitioner submits that it is appropriate to consider the environment in April and May of 2020 when the facility was deeply involved in the initial fight against COVID-19.  P. Br. at 9-10.  Petitioner further contends that neither of those issues resulted in an adverse outcome or was likely to result in an adverse outcome.  P. Br. at 9.  

Contrary to Petitioner’s argument that its actions failed to cause an adverse outcome, the regulation does not require that a resident be harmed.  Lakeport Skilled Nursing Ctr., DAB No. 2435 at 8 (2012) (emphasis added).  Furthermore, as of May 21, 2020, the Resident Census and Conditions of Residents form reflected that there were 50 residents on a pain management program.  CMS Ex. 4 at 2.  Although Resident 2 was not deprived of her medication for ADHD because of her hospitalization, other residents were identified as receiving psychoactive, antipsychotic, antianxiety, antidepressant, or hypnotic medications as of May 21, 2020.  CMS Ex. 4 at 1-2.  While the record does not confirm which of these medications must also be treated as a controlled substance and subject to the facility’s specific inventory and tracking procedures and how many residents may have been taking both antidepressants and anxiety medications, the facility identified 27 residents receiving opioids.  P. Ex. 3 at 5.  Thus, the facility’s failure to

Page 11

follow its own procedure to inventory and monitor controlled substances posed a threat to far more residents than the two who were identified in the survey.  Clearly, the facility’s deficiencies and noncompliance from April 26, 2020, until May 22, 2020, were likely to cause harm for residents who were dependent on controlled substances as a part of their medication regime. 

Thus, Petitioner has not demonstrated that CMS’s finding of immediate jeopardy is clearly erroneous.

3. There is a basis for the imposition of a CMP and the amount of the CMP imposed by CMS is reasonable.

Regarding the amount of the CMP, I must examine whether a CMP is reasonable by applying the factors listed in 42 C.F.R. § 488.438(f):  1) the facility’s history of noncompliance; 2) the facility’s financial condition; 3) the factors specified in 42 C.F.R. § 488.404; and 4) the facility’s degree of culpability, which includes neglect, indifference, or disregard for resident care, comfort, or safety.  The absence of culpability is not a mitigating factor.  42 C.F.R. § 488.438(f)(4).  The factors listed in 42 C.F.R. § 488.404 include:  1) the scope and severity of the deficiency; 2) the relationship of the deficiency to other deficiencies resulting in noncompliance; and 3) the facility’s prior history of noncompliance in general and specifically with reference to the cited deficiencies.

In this case, CMS imposed a total CMP of $21,393.00, including a per‑instance CMP of $16,288.00 for the F602J deficiency and a per‑instance CMP of $5,105.00 for the F610D deficiency.  CMS Ex. 2 at 2.  

Petitioner does not specifically argue that any regulatory factor supports a reduction of the CMP amounts proposed by CMS.  For that reason alone, I could conclude the CMPs are reasonable.  See Coquina Ctr., DAB No. 1860 at 32 (2002).  However, even applying the regulatory factors, I find that the CMP is reasonable.

With respect to regulatory factors in assessing the reasonableness of the CMP, I note that CMS presented no evidence of the facility’s history of noncompliance.  I also note, however, that Petitioner has not raised its financial condition as a factor in analyzing the reasonableness of the CMP.  Furthermore, I find the facility’s noncompliance to be quite serious.  There is no dispute that the facility’s failure to track medications in accordance with regulatory guidance and its own policies deprived a resident of his prescribed pain medication for three days.  Equally concerning is the fact that the staff completely lost 30 doses of a controlled substance within its facility and the medication was never found.

On May 3, 2020, and while Resident 2 was hospitalized, the medication card containing her prescribed Adderall was discovered to be missing.  Petitioner asserts that the

Page 12

medication card was replaced before Resident 2 returned from the hospital on May 5.  P. Ex. 4.  Certainly, had Resident 2 returned from the hospital earlier or had not required hospitalization, she may also have been without her prescribed medication.  As noted above, there is also a question as to whether the seven missing doses of Adderall prescribed for Resident 2 were ever found or simply replaced as the facility replaced Resident 1’s missing Percocet. 

There is no dispute that over the course of a week, the facility failed to follow its own protocol and policy for monitoring and inventorying controlled medication as related to two of its residents.  Clearly, the facility’s actions raise concerns about the likelihood of harm to the 27 residents with prescribed opioids, and as well as to any other of the 50 residents who were prescribed pain medications at this time. 

V. Conclusion

For the reasons set forth above, I affirm CMS’s decision and find that the evidence establishes that the facility’s deficiency posed immediate jeopardy to resident health and safety.  The penalty imposed—­­per-instance CMPs totaling $21,393.00—is reasonable.

---

Endnotes

¹   Specifically, the Surveyor cited the facility with six instances of noncompliance which included:  (1) 42 C.F.R. § 483.10(g)(14), Notification of Changes; (2) 42 C.F.R. § 483.12, Free from Misappropriation/Exploitation; (3) 42 C.F.R. § 483.12(c)(1)(4), Reporting of Alleged Violations; (4) 42 C.F.R. § 483.12(c)(2)-(4), Investigate/Prevent/Correct Alleged Violations; (5) 42 C.F.R. § 483.25(k), Pain Management; and (6) 42 C.F.R. § 483.45(a)(b)(1)-(3), Pharmacy Services/Procedures/Pharmacist/Records.  CMS Ex. 9 at 1-2.

²   In its pre-hearing brief (P. Br.), Petitioner references an October 12, 2020 SCDHEC notice that states “[t]he state agency does not need anything else from [Petitioner] . . . The facility is already back into compliance from this survey.”  P. Br. at 4.  Therefore, it appears the mandatory termination did not go into effect. 

³   42 C.F.R. § 483.12(c)(2)-(4).  See also 42 C.F.R. § 483.10(g)(14)(i)(C) that requires a facility to immediately notify the resident and the resident’s representative and to consult with the resident’s physician concerning a change in the form of treatment. 

⁴   The case was initially assigned to a different ALJ and later transferred to the undersigned.

⁵   My findings of fact and conclusions of law appear as headings in bold italic type.

⁶   This regulation was formerly found at 42 C.F.R. § 483.13(c).

⁷   Supra footnote 3.