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                              Claremore Nursing Home, DAB CR5243 (2019)
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Claremore Nursing Home, DAB CR5243 (2019)








  
  
    

  
      
Department of Health and Human Services 
    DEPARTMENTAL APPEALS BOARD
          Civil Remedies Division





Claremore Nursing Home,
	(CCN: 375375),
	Petitioner,
v.
Centers for Medicare & Medicaid Services
Docket No. C-16-594Decision No. CR5243February 4, 2019

        
              
    

      DECISION
Petitioner, Claremore Nursing Home, is a long-term care facility located in Claremore, Oklahoma, that participates in the Medicare program.  After one of its residents fell and suffered a serious injury, facility staff revised her care plan in order to prevent additional falls.  Yet, when a state surveyor visited the resident’s room, she saw that the care plan’s interventions were not in place.
Based on this and multiple other deficiencies, the Centers for Medicare & Medicaid Services (CMS) determined that the facility was not in substantial compliance with Medicare program requirements and that its deficiencies posed immediate jeopardy to resident health and safety.  CMS imposed civil money penalties (CMPs) of $5,700 per day for two days of immediate jeopardy and $1,250 per day for 34 days of substantial noncompliance that did not pose immediate jeopardy.  Petitioner appealed the one deficiency cited at the immediate jeopardy level, as well as the immediate jeopardy determination itself.
For the reasons set forth below, I find that, from February 16 through March 22, 2016, the facility was not in substantial compliance with Medicare program requirements; that,
Page 2
on February 16 and 17, its deficiencies posed immediate jeopardy to resident health and safety; and that the penalties imposed are reasonable.
Background
The Social Security Act (Act) sets forth requirements for nursing facilities to participate in the Medicare program and authorizes the Secretary of Health and Human Services to promulgate regulations implementing those statutory provisions.  Act § 1819.  The Secretary’s regulations are found at 42 C.F.R. Part 483.  To participate in the Medicare program, a nursing facility must maintain substantial compliance with program requirements.  To be in substantial compliance, a facility’s deficiencies may pose no greater risk to resident health and safety than “the potential for causing minimal harm.”  42 C.F.R. § 488.301.
The Secretary contracts with state survey agencies to conduct periodic surveys to determine whether skilled nursing facilities are in substantial compliance.  Act § 1864(a); 42 C.F.R. § 488.20.  Each facility must be surveyed annually, with no more than fifteen months elapsing between surveys.  Facilities must be surveyed more often, if necessary, to ensure that identified deficiencies are corrected.  Act § 1819(g)(2)(A); 42 C.F.R. §§ 488.20(a), 488.308.  The state agency must also investigate all complaints.  Act § 1819(g)(4).
Here, the Oklahoma State Department of Health (state agency) completed a recertification survey on February 18, 2016.  CMS Ex. 3.  Based on the survey findings, CMS determined that the facility was not in substantial compliance with multiple Medicare participation requirements:
42 C.F.R. § 483.10(k), (*l*) (Tag F174 – resident rights:  telephone and personal property) cited at scope and severity level E (pattern of noncompliance that causes no actual harm with the potential for more than minimal harm);
	42 C.F.R. § 483.13(c)(1)(ii)-(iii), (c)(2)-(4) (Tag F225 – staff treatment of residents:  investigating and reporting abuse and neglect) cited at scope and severity level E;
	42 C.F.R. § 483.20(g)-(j) (Tag F278 – resident assessment:  accuracy, coordination, certification) cited at scope and severity level E;
	42 C.F.R. § 483.20(d), (k)(1) (Tag F279 – resident assessment:  comprehensive care plans) cited at scope and severity level E;
	42 C.F.R. §§ 483.20(d)(3) and 483.10(k)(2) (Tag F280 – resident assessment:  coordination and comprehensive care plans) cited at scope and severity level E;Page 3
42 C.F.R. § 483.20(k)(3)(ii) (Tag F282 – resident assessment:  services to be provided by qualified persons and in accordance with care plan) cited at scope and severity level E;
	42 C.F.R. § 483.25 (Tag F309 – quality of care) cited at scope and severity level H (pattern of noncompliance that causes actual harm that is not immediate jeopardy);
	42 C.F.R. § 483.25(a)(3) (Tag F312 – quality of care:  nutrition, grooming, personal and oral hygiene) cited at scope and severity level E;
	42 C.F.R. § 483.25(c) (Tag F314 – quality of care:  prevention of pressure sores) cited at scope and severity level H;
	42 C.F.R. § 483.25(g)(2) (Tag F322 – quality of care:  appropriate treatment for naso-gastric tubes) cited at scope and severity level E;
	**42 C.F.R. §** **483.25(h) (Tag F323 – quality of care:  accident prevention) cited at scope and severity level K (pattern of noncompliance that poses immediate jeopardy to resident health and safety);1**
	42 C.F.R. § 483.25(i) (Tag F325 – quality of care:  nutrition) cited at scope and severity level H;
	42 C.F.R. § 483.25(*l*) (Tag F329 – quality of care:  unnecessary drugs) cited at scope and severity level E;
	42 C.F.R. § 483.35(c) (Tag F363 – dietary services:  menus and nutritional adequacy) cited at scope and severity level E;
	42 C.F.R. § 483.35(d)(1) and (2) (Tag F364 – dietary services:  food preparation) cited at scope and severity level E;
	42 C.F.R. § 483.75(*l*)(1) (Tag F514 – administration:  clinical records) cited at scope and severity level E; and
	42 C.F.R. § 483.75(o)(1) (Tag F520 – administration:  quality assessment and assurance) cited at scope and severity level E.Page 4
CMS Exhibits (CMS Exs.) 1, 3.2
Thereafter, CMS determined that the facility returned to substantial compliance on March 23, 2016.  CMS Ex. 2.
CMS has imposed against the facility CMPs of $5,700 per day for two days of immediate jeopardy (February 16-17, 2016) and $1,250 per day for 34 days of substantial noncompliance that did not pose immediate jeopardy (February 18 – March 22, 2016), for a total penalty of $53,900.  CMS Ex. 2.
Petitioner challenges just one of the deficiencies cited:  42 C.F.R. § 483.25(h) (Tag F323), as well as the immediate jeopardy determination.  On July 25, 2018, I convened a hearing, via telephone, from the offices of the Departmental Appeals Board in Washington, D.C.  Mr. Neel Gandhi and Ms. Jennifer Mendola appeared from Dallas, Texas, on behalf of CMS.  Transcript (Tr.) 4.  Ms. Gina Cheatham appeared from Oklahoma City, Oklahoma, on behalf of Petitioner.  Tr. 4.  The witness, Surveyor Teresa Pritchett, appeared from Muscovite, Oklahoma.  Tr. 5.
The parties have filed pre-hearing briefs (CMS Br.; P. Br.) and post-hearing briefs (CMS post-hrg. Br.; P. post-hrg. Br.).  I have admitted into evidence CMS Exs. 1-25 and P. Exs. 1-2.  Order Summarizing Pre-Hearing Conference at 2 (June 25, 2018); Tr. 7.
Issues
As noted above, Petitioner challenges just one of the 17 deficiencies cited.  Based on the deficiencies Petitioner has not appealed, I find that, from February 16 through March 22, 2016, Petitioner was not in substantial compliance with Medicare program requirements, and I sustain a CMP of at least $1,250 per day.  Tr. 6.
The issues remaining are:
on February 16 and 17, 2016, was the facility in substantial compliance with 42 C.F.R. § 483.25(h);
	if the facility was not then in substantial compliance with section 483.25(h), did that deficiency pose immediate jeopardy to resident health and safety; and****
	if the facility was not in substantial compliance with section 483.25(h), is the penalty imposed – $5,700 per day – reasonable.Page 5
Order Summarizing Pre-Hearing Conference at 1; Tr. 6.****
Discussion
***1. The facility was not in substantial compliance with 42 C.F.R. § 483.25(h) because its staff did not provide a vulnerable resident with the supervision and assistive devices they determined she needed in order to prevent falls.3***
**Program requirement:  42 C.F.R. §** **483.25(h) (Tag F323)**.  Under the statute and the “quality of care” regulation, each resident must receive, and the facility must provide, the necessary care and services to allow a resident to attain or maintain the highest practicable physical, mental, and psychosocial well-being, in accordance with the resident’s comprehensive assessment and plan of care.  Act § 1819(b); 42 C.F.R. § 483.25.  To achieve this, the regulation mandates, among other requirements, that the facility “ensure” that each resident’s environment remains as free of accident hazards as possible and that each resident receives adequate supervision and assistive devices to prevent accidents.  The facility must therefore eliminate or reduce a known or foreseeable risk of accidents “to the greatest degree practicable.”  *Del Rosa Villa*, DAB No. 2458 at 7 (2012), *aff’d*,*Del Rosa Villa v. Sebelius*, 546 F. App’x 666 (9th Cir. 2013); *Clermont Nursing & Convalescent Ctr.*, DAB No. 1923 at 9-10 (2004), *aff’d*,*Clermont Nursing & Convalescent Ctr. v. Leavitt*, 142 F. App’x. 900 (6th Cir. 2005); *accord*, *Briarwood* *Nursing Ctr.*, DAB No. 2115 at 5 (2007) (holding that the facility must “take all reasonable steps to ensure that a resident receives supervision and assistive devices designed to meet his or her assessed needs and mitigate foreseeable risks of harm from accidents.”).  A facility is permitted the flexibility to choose the methods it uses to prevent accidents, but the chosen methods must constitute an “adequate” level of supervision under all the circumstances.  *Briarwood*, DAB No. 2115 at 5; *Windsor Health Care Ctr.*, DAB No. 1902 at 5 (2003), *aff’d*,*Windsor Health Care Ctr. v. Leavitt*, No. 04-3018 (6th Cir. 2005).
**Facility policies**.  The facility had in place a “fall awareness program.”  Its stated purpose is “to identify those residents who may be at risk for falls and injury.”  CMS Ex. 20 at 1.  The policy requires fall risk assessments for all admissions, re-admissions, falls, and significant changes.  It directs staff to report all falls and changes to the Director of Nursing (DON) and the Quality Manager.  CMS Ex. 20 at 1.  The policy lists risk factors and, for any resident scoring 25 or above on his/her fall risk assessment, directs staff to implement a “fall awareness protocol.”  CMS Ex. 20 at 1-2.  The policy then lists actions
Page 6
staff should take when a resident falls.  In addition to assessing the resident for injuries, they include:  completing an incident report; completing an additional risk assessment tool; developing a new care plan; and assessing for functional decline.  CMS Ex. 20 at 2-3.
The facility also had in place a policy for investigating incidents, including falls.  The policy directs a member of the administrative staff to conduct a “thorough” investigation, which might include:  interviewing relevant staff, residents, and other witnesses; reviewing the resident’s chart; and contacting the resident’s physician.  All information is to be compiled on a standard form.  CMS Ex. 21.
*Resident 9(R9):*  R9 was an 87-year-old woman, suffering from a long list of ailments, including dementia, cerebrovascular disease, heart failure, shortness of breath, dysphagia, urinary tract infection, malnutrition, abnormal weight loss, and anemia.  CMS Exs. 11, 13, 14.  She had a history of falls.  CMS Exs. 11-14.  R9 was incontinent and required extensive to total assistance for bed mobility, ambulation, and activities of daily living.  CMS Ex. 16 at 4-5.
On December 16, 2015, citing R9’s “significant change in status,” the facility completed a new MDS (Minimum Data Set) assessment.  CMS Ex. 16 at 1.  Notwithstanding the policy requiring staff to conduct a fall risk assessment whenever a resident undergoes a significant change, the facility has produced no evidence that it conducted one.  *See* CMS Br. at 4.
Nevertheless, R9’s care plan identified her as a fall risk and, in entries dated January 4, 2016, it directed staff to:  anticipate and meet the resident’s needs; be sure that her call light is within reach and encourage her to use it; respond promptly to all of her requests for assistance; transfer her using a hoyer lift “at all times” with a two-person assist; keep frequently used items within reach; keep pathways clear, dry, clutter-free, and well-lit; make sure she has appropriate, non-skid footwear; and “position[] bars to bed.”  CMS Ex. 12 at 1-2.
Apparently these interventions (assuming they were implemented) were not effective.  On January 14, 2016, a facility nurse reported finding R9 lying on her back on the floor next to her bed.  R9 told the nurse that she had been trying to get out of bed when she fell.  She complained of knee pain.  Staff gave her pain medications, although they reported that she was not injured.  They returned her to bed, using a hoyer lift, placed a safety mat beside her bed, and a wedge cushion on her bed to prevent her from rolling off.  CMS Ex. 19.  Again, notwithstanding the policy directive, the facility produced no evidence that it conducted another fall assessment following the incident.
Page 7
That day, the facility revised R9’s care plan.  In addition to the interventions already listed, the revised plan directed staff to place a safety floor mat at bed-side and to provide the resident with a wedge cushion while in bed.  CMS Ex. 12 at 1; CMS Ex. 19 at 1.
But, once again, either staff neglected to implement the interventions, or they were ineffective.  On January 31, 2016, R9 reported that she had fallen out of bed the night before and that she was in pain.  Staff noted inflammation of her right knee and, over the course of the day, a bruise appeared on her chin.  Staff administered pain medications and notified the family, who asked about taking an x-ray, which the physician’s assistant ordered.  CMS Exs. 14, 18.  X-rays showed that R9 had suffered an acute distal fracture of her femur.  CMS Ex. 15.  She was sent to the hospital and subsequently underwent surgery.  CMS Ex. 14 at 1; CMS Ex. 24 at 2 (Pritchett Decl.).
The facility’s investigation of the incident leaves a lot to be desired.  Presumably, a staff member found her on the floor – by all accounts, she was not capable of getting herself up and back into bed – yet no one reported it until the following day when the resident herself complained.  The investigative report does not mention this very serious failing.  Nor does it mention whether the care plan’s interventions were in place.  In fact, it does not even indicate that anyone asked staff about the interventions.  CMS Ex. 18 at 2.  Instead, the report suggests that “possibly [R9’s] airloss mattress was set too high and[,] when airing up[,] it causes resident to scoot over in bed.”  CMS Ex. 18 at 2.4
The facility again revised R9’s care plan, adding that staff would be trained to operate correctly R9’s bed.  CMS Ex. 12 at 1; CMS Ex. 14 at 1.
	A subsequent fall risk assessment, dated February 4, 2016, put R9 at high risk for falls.  CMS Ex. 13.  But this fall risk assessment is not consistent with R9’s other records.  It says that she uses no ambulatory aids.  It also says that she is either independent with gait and transfers or immobile/on bed rest.  CMS Ex. 13.  She was neither.  The screening assessment, dated December 16, 2015, indicates that R9 is totally dependent on staff for transfers; that she does not walk, and moves between locations with total assistance.  CMS Ex. 16 at 4.  Her progress notes, dated January 20, 2016, say that she “is only mobile in geri chair when staff moves her about.”  CMS Ex. 14 at 1.
**The surveyor observations**.  From February 8 through 18, 2016, state agency surveyor, Teresa Pritchett, R.N., surveyed the facility.  CMS Ex. 24 at 2 (Pritchett Decl.).  On February 16, she was in R9’s room.  The resident was in bed, and, except for Surveyor Pritchett, alone in her room.  No staff were present there nor in the hallway outside.  No
Page 8
fall mat was beside the resident’s bed; and no wedge cushion was in place to prevent her from falling out of bed.  The wedge cushion was on a chair.  CMS Ex. 23 at 9; CMS Ex. 24 at 2 (Pritchett Decl.); Tr. 18-19.  Surveyor Pritchett also observed a mechanical lift about two feet from R9’s bed – within striking distance, had the resident fallen out of bed.  Her bed had not been lowered and was about three feet above the floor.  Surveyor Pritchett opined, credibly, that, had the resident fallen, she could have been seriously injured by striking the lift and by hitting the unprotected floor.  CMS Ex. 24 at 2 (Pritchett Decl.); Tr. 18-19.
Petitioner has not disputed the surveyor observations but presents written declarations from Amber Nowling, R.N., the Director of Clinical Operations for the facility’s parent company, and Chandra Hardy, L.P.N., a nurse consultant.  Neither was in the facility on February 16, and neither observed the resident or her room.  Nevertheless, based on their reviews of the record, both opine that staff were in the process of getting R9 out of bed.  P. Ex. 1 at 3; P. Ex. 2 at 3.  Neither explains how staff were doing so without being physically present in the room or its environs.  No staff member claims to have been in the hallway, the room, or in the process of getting the resident out of bed.
**The facility’s substantial noncompliance**.  Staff may have planned to get the resident out of bed but, after removing the devices in place to keep her safe, they abandoned (at least for a while) the effort and the resident.  This put R9 at a significant risk.  As her history of falls shows – and as her care plan acknowledges – R9 could not safely be left without supervision or assistive devices for *any* period of time.  The Departmental Appeals Board has long held that a facility violates section 483.25(h) if it fails, without justifiable reason, to implement the accident precautions its own staff have determined are necessary to mitigate foreseeable accident risks.  *Good Shepherd Home for the Aged, Inc.*, DAB No. 2858 at 14 (2018),*citing Del Rosa Villa*, DAB No. 2458 at 9, *aff’d*,*Del Rosa Villa v. Sebelius*, 546 F. App’x 666 (9th Cir. 2013); *NHC Healthcare, Athens*, DAB No. 2258 at 13 (2009); *Burton Health Care Ctr*., DAB No. 2051 at 9 (2006).  Because staff were not following the facility’s own plan for keeping R9 safe, the facility was not in substantial compliance with 42 C.F.R. § 483.25(h).
And there were other problems.  Facility policies required staff to complete a fall risk assessment whenever a resident fell or underwent a significant change in condition.  CMS Ex. 20 at 1.  Facility documents confirm that, in December 2015, R9 had undergone a significant change in status; yet staff performed no fall risk assessment.  CMS Ex. 16 at 1.  Nor did staff perform a fall risk assessment following R9’s fall on January 14.
Finally, as discussed above, the facility’s “investigation,” following R9’s January 30 fall, was far from the “thorough” investigation required by the facility’s policy.  CMS Ex. 21.
Failing to investigate an accident can itself evidence inadequate supervision.  If a resident sustains what appear to be accidental injuries, “a reasonable first step” to prevent the
Page 9
harm from recurring would be to ask how or why the injuries occurred and to review existing safeguards to ensure that they were adequate and that they were implemented.  *Lake Park Nursing & Rehab. Ctr.*, DAB No. 2035 at 11 (2006); *Beechwood Sanitarium*, DAB No. 1906 at 106-07 (2004) (affirming a finding of noncompliance with section 483.25(h)(2) based on the facility’s failure to investigate); *see Dumas Nursing & Rehab.*, DAB No. 2347 at 15 (2010) (finding that the facility’s failure to investigate properly means that it could not identify, understand, and correct its deficient practices).
The facility was not ensuring that R9 received adequate supervision and assistive devices to prevent accidents and was therefore not in substantial compliance with 42 C.F.R. § 483.25(h).
***2. CMS’s determination that the facility’s substantial noncompliance posed immediate jeopardy to resident health and safety is not clearly erroneous.***
**Immediate jeopardy**. 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).
That R9 could not safely be left without adequate assistive devices in place is abundantly clear.  She was at high risk for falls, and, as with so many elderly and infirm, a fall was likely to cause her serious injury, harm, impairment, or even death.  She had already sustained one very serious injury as the result of a fall.  CMS’s determination that the facility’s deficiency under section 483.25(h) posed immediate jeopardy to resident health and safety is therefore not clearly erroneous.
***3. The penalties imposed are reasonable.***
To determine whether a CMP is reasonable, I apply 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) 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.  The factors 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
Page 10
history of noncompliance in general and specifically with reference to the cited deficiencies.
I consider whether the evidence supports a finding that the amount of the CMP is at a level reasonably related to an effort to produce corrective action by a provider with the kind of deficiencies found, and in light of the section 488.438(f) factors.  I am neither bound to defer to CMS’s factual assertions nor free to make a wholly independent choice of remedies without regard for CMS’s discretion.  *Barn Hill Care Ctr.*, DAB No. 1848 at 21 (2002); *Cmty. Nursing Home*, DAB No. 1807 at 22 *et seq*. (2002); *Emerald Oaks*, DAB No. 1800 at 9 (2001); *CarePlex of Silver Spring*, DAB No. 1683 at 8 (1999).
Here, CMS imposes a penalty of $5,700 per day for each day of immediate jeopardy, which is at the low-to-mid range for situations of immediate jeopardy ($3,050 to $10,000).  42 C.F.R. §§ 488.408(e)(1)(iii), 488.438(a)(1)(i).  Considering the relevant factors, these penalties are reasonable.
CMS has come forward with evidence establishing that the facility has a less-than-stellar history, and its deficiencies have included multiple quality-of-care citations.  For the ten years prior to this survey, the facility was consistently out of substantial compliance.  CMS Ex. 10.  In surveys completed in August 2012, May 2012, and May 2011, it was out of substantial compliance with section 483.25(h), and, in 2011, that deficiency caused actual harm.  CMS Ex. 10 at 3.  The facility’s history alone thus justifies imposing CMPs that are substantially greater than the minimum, particularly in light of the facility’s erratic compliance with the quality-of-care regulation.  *See* H.R. Rep. No. 100-391(I), 100th Cong., 1st Sess. (1987) (expressing the goal of eliminating the “yo-yo” or “roller coaster” phenomenon); *Florida Agency for Health Care Admin. v. Bayou Shores SNF, LLC*, 2016 WL 3675462 at 19 (11th Cir. July 11, 2016); *Heartland Manor at Carriage Town*, DAB No. 1664 (1998).
Petitioner does not claim that its financial condition affects its ability to pay the CMP.
In addition to the immediate jeopardy deficiency, the facility was not in substantial compliance with multiple other requirements, which were cited at scope and severity levels E and H.  Notably, the H level deficiencies (causing actual harm) were also quality-of-care deficiencies.  And I consider very serious the facility’s failings with respect to R9.  Knowing that she was at risk and had already suffered serious injury from a fall, facility staff disregarded her care plan and the facility’s policies and left her alone, without assistive devices.  For this, the facility is culpable and the penalties imposed are reasonable.
Page 11
Conclusion
For all of these reasons, I find that, from February 16 through March 22, 2016, the facility was not in substantial compliance with Medicare program requirements; on February 16 and 17, its deficiencies posed immediate jeopardy to resident health and safety; and the penalties imposed – $5,700 per day for two days of immediate jeopardy and $1,250 per day for 34 days of substantial noncompliance that was not immediate jeopardy – are reasonable.


          /s/
        Carolyn Cozad Hughes

                      Administrative Law Judge
      1. I highlight, in bold, the sole deficiency that Petitioner has appealed. back to note 1
                      2. I apply these regulations because they were in effect at the time of the survey. Since then, CMS has amended its regulations governing nursing facility participation in the Medicare program. 81 Fed. Reg. 68,688 (October 4, 2016). back to note 2
                      3. My findings of fact/conclusions of law are set forth, in italics and bold, in the discussion captions of this decision. back to note 3
                      4. Wedge cushions are supposed to prevent a resident from rolling off the edge of the mattress. Presumably, if the wedge cushion had been properly in place, it should have prevented R9 from “scooting” so far “over in bed” that she fell out. back to note 4 Back to top
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