Brooke Knoll Village, DAB CR6019 (2022)

DECISION

In a terrible accident involving a Hoyer lift transfer, a resident at Brooke Knoll Village (Petitioner or facility) fell three feet to the ground after half of the sling's straps suddenly split apart.  The resident suffered multiple fractures and wounds, including one to the head, and died a week later.  Based on this accident, the Centers for Medicare & Medicaid Services (CMS) found that Petitioner was not in substantial compliance with the Medicare requirement for skilled nursing facilities at 42 C.F.R. § 483.25(d) (accidents) and imposed an $18,370 per-instance civil monetary penalty (CMP).

In its defense, Petitioner mainly argues that the accident was unforeseeable as its staff had inspected the lift before attempting the transfer.  Petitioner also argues that it did not know, and had no reason to know, that the manufacturer recommended replacing the sling every six months, which it did not do.

As explained below, contrary to Petitioner's argument, the weight of the evidence supports that the sling's straps, which had been in use for 11 months, had exhibited signs of excessive wear before the accident.  Staff should have, but did not, recognize those signs and thus failed to ensure the sling was safe to use before attempting the transfer.  Further, the facility failed to follow the manufacturer's recommendations for maintaining the lift, including the replacement of the sling every six months and for a qualified

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technician to inspect the lift monthly.  Therefore, I conclude that CMS met its burden of showing a prima facie case that Petitioner was not in substantial compliance with 42 C.F.R. § 483.25(d) and Petitioner failed to show that it was in substantial compliance with that requirement.  Further, I conclude that the CMP amount that CMS imposed was appropriate under relevant statutory and regulatory factors.

I.  Legal Framework

The Medicare program "provides basic protection against the costs of . . . related post-hospital . . . care" for individuals over the age of 65 who are eligible for Social Security retirement benefits and for individuals under 65 who meet other criteria.  42 U.S.C. § 1395c.  Post-hospital care includes extended care services provided at a skilled nursing facility (SNF).  42 U.S.C. §§ 1395f(a)(2)(B), 1395x(h)-(i).

For Medicare program purposes, an SNF is an institution that is primarily engaged in providing skilled nursing care and/or rehabilitation services for its residents but is not primarily engaged in the care and treatment of mental diseases.  42 U.S.C. §§ 1395x(j), 1395i-3(a)(1).  Because an SNF is a "provider of services" in the Medicare program, each SNF that participates in the program must file a provider agreement with the Secretary of Health and Human Services (Secretary).  42 U.S.C. §§ 1395cc(a), 1395x(u).

In addition to complying with the terms of the provider agreement, a participating SNF must meet a variety of ongoing statutory requirements related to how it provides services, maintains the rights of its residents, and administers its facility.  42 U.S.C. § 1395i-3(a)(3), (b)-(d).  Further, SNFs must comply with "such other requirements relating to the health, safety, and well-being of residents or relating to the physical facilities thereof as the Secretary may find necessary."1   42 U.S.C. § 1395i-3(d)(4)(B); see 42 U.S.C. § 1395i-3(c)(1)(xi), (f).  The Secretary has promulgated regulations to establish those additional requirements.  See 42 C.F.R. pt. 483, subpt. B.2

When an SNF fails to meet a statutory or regulatory participation requirement, then the SNF has a "deficiency."  42 C.F.R. § 488.301; see 42 U.S.C. § 1395i-3(h)(1).  "Noncompliance" means "any deficiency that causes a facility to not be in substantial compliance."  42 C.F.R. § 488.301.  To maintain "substantial compliance," an SNF's

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deficiencies may "pose no greater risk to resident health or safety than the potential for causing minimal harm."  42 C.F.R. § 488.301.

Broadly, noncompliance that subjects an SNF to enforcement remedies is divided into two levels.  One level is comprised of deficiencies that immediately jeopardize the health or safety of residents and the other level is composed of deficiencies that do not.  42 U.S.C. § 1395i-3(h)(1).  "Immediate jeopardy" exists when "the provider's noncompliance with one or more requirements of participation has caused, or is likely to cause, serious injury, harm, impairment, or death to a resident."  42 C.F.R. § 488.301.

The Secretary has the duty to enforce the statutory and regulatory participation requirements for SNFs.  42 U.S.C. § 1395i-3(f)(1).  To do so, the Secretary contracts with state agencies to conduct surveys to determine whether SNFs are in substantial compliance.  42 U.S.C. §§ 1395aa(a), 1395i-3(g); 42 C.F.R. § 488.10.  Standard surveys are unannounced and occur at least once every 15 months.  42 U.S.C. § 1395i-3(g)(2)(A)(i), (iii)(I).  State agencies also conduct investigations into complaints against SNFs.  42 U.S.C. § 1395i-3(g)(1)(C), (4).  When the results of a survey show that an SNF is not in substantial compliance with program participation requirements, the Secretary may impose enforcement remedies on the SNF.  42 U.S.C. § 1395i-3(h)(2); 42 C.F.R. § 488.406.  When CMS selects an enforcement remedy to impose on an SNF, it determines the scope (i.e., the number of residents affected or potentially affected) and severity (i.e., the degree of harm or potential harm) for each deficiency.  See 42 C.F.R. § 488.404(a)-(b).

One such remedy is a CMP.  42 U.S.C. § 1395i-3(h)(2)(B)(ii).  CMS may impose a per‑instance CMP for each instance of the SNF's noncompliance or a per‑day CMP for the number of days an SNF is not in substantial compliance.  42 U.S.C.  § 1395i‑3(h)(2)(A), (h)(2)(B)(ii)(I); 42 C.F.R. § 488.430(a).  For CMPs assessed on or after October 11, 2018, and for deficiencies that occurred after November 2, 2015, the CMP amounts may range as follows:  $2,140 to $21,393 for per-instance CMPs; $107 to $6,418 per day for less serious noncompliance; or $6,524 to $21,393 per day for noncompliance that poses immediate jeopardy to the health and safety of residents.  45 C.F.R. § 102.3 (2018); 83 Fed. Reg. 51,369, 51,380 (Oct. 11, 2018); see 42 C.F.R. § 488.438(a)(1) (providing original CMP amounts before statutory inflation adjustments).

If CMS imposes a CMP based on a finding of substantial noncompliance, then the SNF may request a hearing before an administrative law judge (ALJ) to challenge CMS's initial determination of noncompliance that led to the imposition of an enforcement remedy and/or the level of noncompliance (if a successful challenge to the level would affect the range of CMP amounts imposed on the SNF).  42 U.S.C. §§ 1320a-7a(c)(2), 1395i‑3(h)(2)(B)(ii); 42 C.F.R. §§ 488.330(e)(3)(ii), 488.408(g)(1), 488.434(a)(2)(viii), 498.3(b)(13)-(14), (d)(10); see also 5 U.S.C. §§ 554, 556.  However, CMS's choice of remedies is not reviewable.  42 C.F.R. §§ 488.438(e)(2), 488.408(g)(2), 498.3(b)(13).

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If an SNF challenges the existence of a deficiency, CMS must make a prima facie case that the SNF failed to substantially comply with federal participation requirements and, if such a showing is made, the SNF must then prove substantial compliance by a preponderance of the evidence.  Hillman Rehabilitation Ctr., DAB No. 1611 at 8 (1997); see Batavia Nursing & Convalescent Inn, DAB No. 1911 (2004); Batavia Nursing & Convalescent Ctr., DAB No. 1904 (2004), aff'd, Batavia Nursing & Convalescent Ctr. v. Thompson, 129 F. App'x 181 (6th Cir. 2005); Emerald Oaks, DAB No. 1800 (2001).  If an SNF challenges CMS's determination as to the level of noncompliance, CMS's determination must be upheld unless it is clearly erroneous.  42 C.F.R. § 498.60(c)(2).

If an ALJ concludes that there was a basis for imposing a CMP on an SNF, then the SNF may dispute the amount of the CMP.  The ALJ's review of the CMP amount is limited to considering the statutory and regulatory factors for setting a CMP amount.  42 C.F.R. § 488.438(e)(3); see 42 U.S.C. §§ 1320a-7a(d), 1395i-3(h)(2)(B)(ii)(I); 42 C.F.R. § 488.438(f).  The ALJ may not reduce a CMP to zero.  42 C.F.R. § 488.438(e)(1).

Either the SNF or CMS may request Departmental Appeals Board (DAB) review of an ALJ's decision.  42 C.F.R. § 498.80.

II.  Background and Procedural History

Petitioner is an SNF that operates in Avon, Indiana.  In response to various complaints at the facility, surveyors from the Indiana State Department of Health (state agency) conducted a survey at Petitioner's facility that ended on August 5, 2019.  CMS Ex. 2 at 1.  The state agency subsequently issued a Statement of Deficiencies indicating the facility was not in substantial compliance with 42 C.F.R. § 483.25(d)(1)-(2) (Tag F689) (i.e., accident prevention and adequate supervision) at a scope and severity level of "J" (i.e., isolated deficiency posing immediate jeopardy to resident health or safety).  CMS Ex. 2.  On August 14, 2019, the state agency issued an initial determination in which it recommended that CMS impose a CMP on Petitioner based on the deficiency found during the survey.  CMS Ex. 1 at 1-2.  The initial determination also indicated that Petitioner was prohibited from offering a Nurse Aid Training and Competency Evaluation Program (NATCEP) for two years because the state agency had conducted an extended survey based on a finding of substandard quality of care.  CMS Ex. 1 at 3.

On September 6, 2019, CMS issued an initial determination adopting the state agency's survey findings and imposing an $18,370 per-instance CMP on Petitioner.  DAB E-File Document No. 1a at 2-3.  Further, CMS agreed with the state agency that Petitioner's NATCEP was prohibited for two years because Petitioner was subject to a partial extended survey based on substandard quality of care at the facility, but also indicated that a CMP in any amount over $10,697 was another reason that the NATCEP would be statutorily prohibited.  DAB E-File Document No. 1a at 2-4.

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Petitioner requested a hearing before an ALJ to dispute CMS's September 6, 2019 initial determination.  The Civil Remedies Division acknowledged receipt of the hearing request and issued my Standing Prehearing Order (SPO).

In compliance with the SPO, CMS submitted a prehearing exchange that included a prehearing brief and motion for summary judgment as well as 29 proposed exhibits (CMS Exs. 1-29).  Two of CMS's proposed exhibits (CMS Exs. 28-29) were written direct testimony from witnesses.  Petitioner filed a prehearing exchange that included a prehearing brief both opposing summary judgment for CMS and moving for summary judgment in Petitioner's favor as well as 16 proposed exhibits (P. Exs. 1-16).3  Eleven of Petitioner's exhibits (P. Exs. 1-8, 10, 13-14) were written direct testimony from witnesses.  CMS filed a reply brief and response to Petitioner's summary judgment motion.  Petitioner submitted a rebuttal (P. Rebuttal) to CMS's reply brief.

Both parties objected to some of the opposing party's proposed exhibits, and Petitioner responded to CMS's objections.  CMS requested to cross-examine five of Petitioner's witnesses.  Petitioner requested to cross-examine both of CMS's witnesses.

On April 16, 2021, I issued an Amended Notice of Hearing in which I denied the parties' motions for summary judgment and set this case for hearing.  In the Amended Notice of Hearing, I ruled on the evidentiary objections raised by the parties and excluded Petitioner Exhibits 1, 2, 3, 6, 8, 9, 10, 15, and 16 as duplicative and unnecessary.  I also admitted the following exhibits into the record:

• CMS Exhibits 1 through 29; and
• Petitioner Exhibits 1A, 2A, 3A, 4, 5, 6A, 7, 8A, 9A, 10A, and 11 through 14.

In the Amended Notice of Hearing, I also indicated that all of the exhibits that included written direct testimony for witnesses were only provisionally admitted into the record.  I noted that each of those exhibits would be considered fully admitted once each witness was either cross-examined or the request to cross-examine the witness was withdrawn.

Before the date of the hearing, the parties filed a joint withdrawal of their requests to cross-examine witnesses and requested a decision based on the written record.  I granted the joint motion and issue this decision based on the written record.  42 C.F.R. § 498.66.

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III.  Issues

1) Whether Petitioner was in substantial compliance with the Medicare requirement at 42 C.F.R. § 483.25(d)(1), (2) (Tag F-689);

2) If Petitioner was not in substantial compliance, whether the amount of the CMP imposed on Petitioner is appropriate under the factors in 42 U.S.C. § 1320a-7a(d) and 42 C.F.R. § 488.438(f).4

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

My findings of fact and conclusions of law are in bold and italics.

1. As of July 3, 2019, Resident G weighed approximately 231 pounds, and due to her condition and various diagnoses, she required transfer assistance from one surface to another daily.

In July 2019, Resident G was 88 years old and had been a resident at the facility for just over three years.  CMS Ex. 6 at 1.  She had been receiving hospice care since September 2018 with a primary diagnosis of stage four chronic kidney disease (CKD).  CMS Ex. 6 at 117, 145.  Her other diagnoses included atrial fibrillation, osteoarthritis, osteoporosis, and gout.  CMS Ex. 6 at 2, 117, 145.  Notably, she needed transfer assistance.  Her care plan lists that her transfer-related functional and cognitive challenges included cerebrovascular accident (CVA), CKD, pain, peripheral vascular disease, non-ambulatory, Hoyer [lift] transfers,5 and opioid use.  CMS Ex. 6 at 44.  Her care plan, initiated in October 2018, required two staff members to assist her with transfers from one surface to another daily.  CMS Ex. 6 at 44; see CMS Ex. 6 at 145; see also CMS Ex. 6 at 42 (noting the resident's need for assistance to transfer from bed).  As of July 2019,

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Resident G weighed approximately 231 pounds.  CMS Ex. 6 at 74 (also showing the resident's weight was as high as 242 pounds four months earlier, in March 2019).

2. On July 26, 2019, Resident G fell backward during a Hoyer lift transfer when four of the eight straps of the sling holding her up suddenly split apart.  Resident G's head hit the legs of the Hoyer lift.

In the afternoon of July 26, 2019, CNA Erica E. Hughley and CNA Mionne Combs attempted to use a Hoyer lift to transfer Resident G from a recliner chair to her bed, a distance of "approximately six to eight feet."  P. Ex. 1A ¶ 7; P. Ex. 2A ¶ 7; see CMS Ex. 10 at 2-3.  At that time, only the resident and the two CNAs were in Resident G's room.  P. Ex. 1A ¶ 7; P. Ex. 2A ¶ 7.

CNAs Hughley and Combs testified that they inspected the lift and ensured that the straps of the sling were properly attached to the lift.  P. Ex. 1A ¶ 9; P. Ex. 2A ¶ 9; see CMS Ex. 10 at 2-3.  They also testified that the straps were properly attached and that the resident was successfully lifted approximately three inches from her recliner prior to proceeding further with the transfer.  P. Ex. 1A ¶ 10(a); P. Ex. 2A ¶ 10(a).

After suspending Resident G in the air, CNA Hughley began moving the lift's legs towards the resident's bed.  CMS Ex. 10 at 2-3.  But while she was moving the lift, four of the eight straps suddenly split and Resident G fell to the floor.  P. Ex. 1A ¶ 10(b)-(c); P. Ex. 2A ¶ 10(b)-(c); CMS Ex. 10 at 2-3; see also P. Ex. 4 at 1, 3, 5, 7 (three photographs of the sling taken "at approximately 4:15 p.m. on July 26, 2019.").

There is no dispute that the resident fell after the straps split.  P. Br. at 11. (citing P. Ex. 1A ¶ 14; P. Ex. 2A ¶ 14); CMS Ex. 6 at 71 (Per LPN statement, CNAs told LPN that fall occurred during transfer when Hoyer straps broke.).  The resident fell from a height of "about three feet," and she hit her head on the legs of the Hoyer lift on the way down.  CMS Ex. 6 at 92.  As the CNAs both described the fall in their testimony:

When each and all of the Applicable Straps split into two pieces, none of Applicable Straps provided any support for the Applicable Sling.  Consequently, the Applicable Sling itself completely failed and the Applicable Resident fell backwards (essentially with the back of her head first) from and out of the Applicable Sling.

P. Ex 1A ¶ 11; P. Ex. 2A ¶ 11.

The CNAs realized that the straps had split apart while they called for help.  Each of the broken straps had split in two with one piece still attached to the lift and the other completely detached.  P. Ex. 1A ¶ 10(c); P. Ex. 2A ¶ 10(c).

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3. Resident G suffered multiple fractures (including fractures to two cervical vertebrae) and lacerations requiring stiches (including a laceration to the scalp).  Resident G had significant pain and died a week after the fall.

A nursing note entered at the time of the fall states that Resident G was "lying flat on back on floor parallel to bed."  CMS Ex. 6 at 66.  The note does not mention a fall or otherwise explain how the resident ended up on the floor.  In any case, it further states that the resident was alert and oriented at baseline, and did not complain of any pain, but that she later stated that her right lower extremity "hurt a little."  CMS Ex. 6 at 66.  An accident and investigation report adds that the resident complained of pain to her right leg and the back of her head; that staff assessed the resident to have a skin tear, a head laceration and hematoma, a left shoulder skin tear that was 7 cm x 9 cm, and a right leg laceration that was 25 cm long and 3 cm deep; and, finally, that staff dressed the resident's right leg and applied pressure and dressed the back of her head.  CMS Ex. 6 at 82-90; see also CMS Ex. 6 at 71.  The resident was sent to the hospital for evaluation based on her son's request.  CMS Ex. 6 at 66; see also CMS Ex. 6 at 91 (indicating resident was sent to hospital even though she was a hospice patient because she might need sutures).

At the hospital, the resident was evaluated and diagnosed with lacerations to her leg and scalp and fractures to her C6 and C7 vertebrae, thoracic spine, two left ribs, and left elbow.  CMS Ex. 6 at 92-93, 95.  The resident needed "6 or 7 staples" for the scalp laceration and 13 stitches for her leg laceration.  CMS Ex. 6 at 94, 146.  The resident's family declined treatment for the fractures in favor of discharging the resident to hospice care for pain management.  CMS Ex. 6 at 93.  After only a few hours at the hospital, the resident returned to the facility.  CMS Ex. 6 at 67-68; CMS Ex. 2 at 7.

The next morning, July 27, a physician evaluated Resident G and noted that the resident "has been in significant pain and morphine has been adjusted."  CMS Ex. 6 at 72; CMS Ex. 6 at 56 (July 28, 2019 order indicates change in scheduled morphine dosage); see also CMS Ex. 6 at 67-68 (facility nursing note listing the resident's injuries as including fractures to the "C-6/C-7" cervical spine, left rib, and left elbow, staples to left side of head for a hematoma, left shoulder laceration, and staples to right leg calf.); CMS Ex. 6 at 82-90 (photos of injuries).

A hospice visit note discusses the resident's decline after her fall:  "Patient is totally bed bound and immobile post fall.  Motivation is poor as patient has severe pain.  Breath sounds are diminished/shallow throughout . . . Patient is refusing all nutrition by mouth and taking limited medication due to pain and anxiety."  CMS Ex. 6 at 145, 175 (July 29 note).  On July 29, the resident's physician ordered daily hospice skilled nursing visits to continue "due to severity of patient's wounds and current overall status."  CMS Ex. 6 at 58.  Resident G continued to decline and eventually passed away on August 2, 2019, one week after the fall.  CMS Ex. 2 at 11; CMS Ex. 26 at 12.

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4. The sling's straps exhibited signs of excessive wear before the attempted transfer; however, facility staff failed to recognize those signs of excessive wear before attempting the transfer. 

The record supports a finding that the sling's straps exhibited signs of excessive wear before the July 26, 2019 transfer.  According to the owner's manual for the Hoyer lift, Petitioner was to "[r]eplace any worn parts immediately" and to "[c]heck entire sling inventory for fraying, tearing or excessive wear of any kind and replace any worn or damaged slings with new Medline slings."  CMS Ex. 20 at 7-8 (emphasis added).

Two state agency surveyors testified that they examined the straps on the lift at issue during the survey and observed the signs of "excessive wear" as the straps had "multiple hardened creases (including at the spot where the sling broke)."  CMS Ex. 28 ¶ 11a; CMS Ex. 29 ¶ 11a.

After having noted the hardened creases on the lift straps, the surveyors tested one of the untorn straps from Resident G's lift and found that it "easily tore with gentle side-side pressure."  CMS Ex. 28 ¶ 11(a); CMS Ex. 29 ¶ 11(a).  Although Petitioner's Regulatory Nurse Consultant, Matthew Brandon Hunt, was not present for the surveyors' test of the strap, his testimony confirms that one of the straps on the lift "had been entirely intact" but was "now torn."  P. Ex. 3A ¶ 4(h).  Mr. Hunt documented the new tear with a photograph.  P. Ex. 3A ¶ 4(i)(i); P. Ex. 3A at 16.

The surveyors and Mr. Hunt performed another test on one of the other remaining straps that had not broken on July 26, 2019.  One of the surveyors and Mr. Hunt pulled from opposite ends.  P. Ex. 3A at 7-8 ¶ 4(j).  The surveyors present both testified that the strap "tore upon being pulled from both ends."  CMS Ex. 28 at 3 ¶ 11a; CMS Ex. 29 at 3 ¶ 11a.  Mr. Hunt testified that the result of the second test was that "one of the loops on that strap broke but a second loop of that strap did not break, thus correctly serving its intended, applicable purpose as safety precaution which secured the applicable strap itself from complete failure."  P. Ex. 3A ¶ 4(j).

A review of the record discloses that Petitioner's witnesses do not expressly deny that the sling straps had the hardened creases identified by the surveyors.  Both Petitioner's Administrator and Petitioner's Housekeeping Manager appended to their written testimony a joint signed statement documenting a meeting they had with the surveyors.  P. Ex. 5 ¶ 4; P. Ex. 6A ¶ 6.  In that statement, they indicate that the surveyors showed them the hardened creases, and the Housekeeping manager, who is responsible for correctly cleaning and looking for damage to sling straps, did not consider creasing of the straps to be damage.  P. Ex. 5 at 4; P. Ex. 6A at 5.

This view, that the hardened creases were of no concern, seems to have been consistent among Petitioner's employees.  The CNAs who inspected the straps on July 26, 2019,

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immediately before lifting Resident G, testified that "there was no visible wear and tear to any of the Applicable Sling's eight (8) straps and those eight (8) straps appeared to be entirely suitable for use in and for the Attempted Transfer."  P. Ex. 1A ¶ 9; P. Ex. 2A ¶ 9.  CNA Hughley further testified that, when she completed a transfer earlier that day, she had inspected the straps, which also revealed "no visible wear or tear" and "appeared to be entirely suitable for use."  P. Ex. 1A ¶ 16.  Mr. Hunt also did not identify the hardened creases as wear and tear.  P. Ex. 3A ¶ 4(i)(iv).

Although Mr. Hunt and the CNAs generally thought there was nothing amiss with the straps due to the creasing, their testimony does not explain why.  Therefore, I give more weight to the observations and conclusions of Surveyor Susan Harmon, who holds three nursing degrees, including a master's degree, and is a registered nurse.  CMS Ex. 28 at 1, 6.  Her observations of "excessive" wear with "multiple hardened creases" was supported by the second surveyor.  They testified:

[T]he sling had multiple hardened creases (including at the spot where the sling broke) that easily tore with gentle side-side pressure, and that also tore upon being pulled from both ends.

CMS Ex. 28 ¶ 11(a); CMS Ex. 29 ¶ 11(a).

Petitioner attempts to discredit the surveyor tests as irrelevant because they were performed five days after the accident.  P. Rebuttal at 8; P. Br. at 20; P. Ex. 3A ¶ 4(v)(i)(ii)-(iii) (Mr. Hunt opining that any testing of the sling following its involvement in the incident was "merely speculative").  Further, Mr. Hunt testified that he told the surveyors that their first test had been irrelevant because "horizontal (at the sides) twisting and turning rather than vertical (up and down) weight" does not properly determine the strength of the straps.  P. Ex. 3A ¶ 4(i)(ii).  Mr. Hunt also sought to discount the second test because, although one loop broke, a second loop did not break, which prevented the strap from complete failure.  P. Ex. 3A ¶ 4(j); P. Br. at 20 n.9.

Petitioner's dispute with the surveyors' tests is insufficient for me to disregard them.  I find that the surveyors tested straps on the Hoyer lift that had not been used or altered since the July 26, 2019 incident.  In its brief, Petitioner acknowledges that the sling at issue had "remained undisturbed from its condition at the time of the fall."  P. Br. at 11.  Mr. Hunt testified that, following the accident, Resident G's daughter informed Petitioner that she wanted to ensure that the sling could be made available for inspection for possible legal action.  P. Ex. 3A ¶ 4(c); see also P. Ex. 3A ¶ 4(h)(v) (the facility had received an email to preserve evidence); P Ex. 3A ¶ 4(d) (stating that, in the morning after the accident, the resident's son also asked that the sling be kept in its current condition).  In addition, Mr. Hunt specifically testified that "[u]ntil the [surveyor test], I am completely confident that the condition of Applicable Sling had continuously

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remained in exactly in the same condition as the Applicable Sling had been immediately after the four straps of the Applicable Sling had separated into parts during the attempted transfer . . . during the afternoon of Friday, July 26, 2019."  P Ex. 3A ¶ 6.  Thus, the record supports that the sling at issue was preserved between the time of the accident and the survey, and that the surveyors' observations at the time of the survey were relevant to the lift's condition at the time of the accident.

Further, I find that the surveyors' ability to tear two of the straps by simply pulling on them is significant.  Although the surveyors' test of a second strap did not completely tear apart, I still find it important that the surveyors were able to tear any part of the strap at all.  This supports the proposition that the sling and straps needed to be replaced.

Therefore, I find that the sling's straps showed signs that they had excessive wear (i.e., hardened creases) before the July 26, 2019, attempt to lift Resident G and that the surveyors' tests showed that the creases compromised the strength of those straps.  I further find that Petitioner's staff thought the creases were unimportant even though those hardened creases would seem to fit the owner's manual requirement for replacement as "any kind" of excessive wear.  CMS Ex. 20 at 8.

5. The sling straps that split apart had been in use for 11 months at the time of the attempted transfer, which was five months beyond the lift manufacturer's recommendation.

It is undisputed that the facility had not replaced the sling for Resident G's Hoyer lift for more than 11 months.  CMS Ex. 26 at 4; CMS Ex. 28 ¶ 11; see CMS Ex. 2 at 10; see also P. Br. at 14 n.8 (acknowledging sling first used in August 2018); P. Ex. 8A at 2 ¶ 7 (Mr. Hunt personally removed the sling from its packaging in August 2018).

Further, the evidence supports that the lift manufacturer, Medline Industries, Inc., recommends replacing the slings at issue in this case every six months.  CMS Ex. 21 at 18; CMS Ex. 22 at 3.

Petitioner disputes the six-month replacement recommendation by arguing that Medline "clarified" its recommendation as follows:

The useful life of a sling will be determined by the customer's compliance with the care instructions outlined on the tag, the proper applicable of usage, and the frequency in which the sling is used.  Replacing slings every six months is a ‘Best Practice' for facilities to consider, but the use and safety of the sling will be at the discretion of the facility since they are ultimately in control of the day-to-day handling and usage –

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provided the instructions and requirements identified above are followed and traceable.  P. Ex. 11; P. Br. at 14.

P. Br. at 17; P. Ex. 10A at 5; P. Ex. 12 at 1.

Medline's clarification, dated September 9, 2019, ultimately supports CMS's position.  It confirms that replacing slings every six months is a best practice for facilities to consider, and Petitioner has not explained why it was still safe to use the straps for months longer than was recommended.  Exceeding that "Best Practice" timeframe means that Petitioner was responsible to ensure that the straps were still safe for use.

The record shows that Resident G, who was 231 lb. at the time of the fall, used the lift for transfers to get in and out of bed daily.  CMS Ex. 6 at 44, 74.  Therefore, the straps were engaged in regular use to lift a relatively heavy person.

Petitioner further argues that no one at the facility was aware of any recommendations to replace Hoyer slings after any period and that no recommendation was ever communicated to the facility.  P. Br. at 13, 17.  Petitioner specifically notes that there were no product inserts in the lift's original packaging and that the only instructions that came with the lift were contained on the tag affixed to the sling, which did not include any expiration or other time limit for replacing straps.  P. Br. at 12.  Though the tag refers to an owner's manual, which was not included in the lift's original packaging, the manual also did not recommend replacing slings on any schedule.  CMS Ex. 11 at 1-2; P. Ex. 8A at 2 ¶ 7.

Petitioner's alleged ignorance of the recommendation to change sling straps every six-months does not change the fact that Medline made such a recommendation.  Medline provides that recommendation on its website – the same website the facility uses to order other replacement parts.  CMS Ex. 29 ¶ 11a; CMS Ex. 18 at 6 ("This order acknowledgment represents the materials and quantities ordered by the Medline.com user.").  Medline's website stated that reusable U shape slings, like the one used during the accident, "should be replaced every six months."  CMS Ex. 22 at 3; CMS Ex. 7 at 1 (facility investigation identifying sling at issue as a "U-shape sling").  The same recommendation also appears on Medline's website where it provides the online manual for "Safe Patient Handling Slings."  CMS Ex. 21 at 18 (recommendation appears under a section for "Sling Maintenance Best Practices"); CMS Ex. 29 ¶¶ 7, 11a.  In addition, Petitioner could have called the manufacturer directly, as the surveyors did during the survey (and Petitioner apparently did after the survey) to find out how often the slings needed to be replaced.  CMS Ex. 2 at 14 (surveyor spoke with a Medline product support specialist who referred to Medline's website for training materials, such as training videos, best practice guidelines, and downloadable instructions.); see P. Ex. 10A ¶ 5 (testimony that Petitioner received the Sling Maintenance Best Practices document from

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Medline.).  Petitioner does not claim that the maintenance recommendation was somehow unreasonably beyond its reach. 6

6. The facility did not conduct monthly inspections of the Hoyer lift at issue using a qualified technician, as recommended by the lift's manufacturer.

The owner's manual for the lift expressly provides a "Maintenance & Inspection Checking List" which states that "[a]t least once a month, the lift should be thoroughly inspected by a qualified technician to recognize any signs of wear, and/or looseness of bolts or parts."  CMS Ex. 20 at 7; see also CMS Ex. 20 at 8 (instructing users to "[a]lways follow the maintenance and cleaning schedule closely and fully while including any state regulations should they apply" and to "[k]eep a log book of maintenance times and work performed or parts replaced.").  The manual's monthly maintenance schedule provides that, users must, among other things, "[c]heck entire sling inventory for fraying, tearing, or excessive wear of any kind and replace worn or damaged slings with new Medline slings."  CMS Ex. 20 at 8; see also CMS Ex. 20 at 7 (manual instructing users to "[r]eplace any worn parts immediately.").

Petitioner submits no evidence showing that it conducted the inspections monthly with a qualified technician.  There are no logs of such inspections.  See CMS Ex. 15 at 1.  There is no evidence that the CNAs who inspected the lift were properly qualified to inspect the lift and slings properly.  Petitioner's failure to show that it inspected the lift according to the manufacturer's instructions undercuts its defense that the straps on the Hoyer lift's sling were still in a safe condition for the July 26, 2019 lift of Resident G.

7. Petitioner was not in substantial compliance with 42 C.F.R. § 483.25(d) (Tag F689) because it failed to ensure the Hoyer lift was in safe-functioning condition before attempting the transfer and because it failed to maintain the Hoyer lift according to the manufacturer's recommendations.

The Social Security Act requires SNFs to "provide services to attain or maintain the highest practicable physical, mental, and psychosocial well-being of each resident, in accordance with a written plan of care."  42 U.S.C. § 1395i-3(b)(2).  In furtherance of this mandate, the Secretary promulgated the general quality of care regulation at 42 C.F.R. § 483.25, which states that the SNF "must ensure that residents receive treatment and care in accordance with professional standards of practice," based on a comprehensive resident assessment, a comprehensive care plan, and resident choice.

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Subsection 483.25(d) imposes specific obligations upon a facility related to accident hazards and assistance devices to prevent accidents, as follows: 7

The facility must ensure that ˗

(1) The resident environment remains as free of accident hazards as is possible; and
(2) Each resident receives adequate supervision and assistance devices to prevent accidents.

Therefore, subsection 483.25(d)(1) requires that a facility address foreseeable risks of harm from accidents "by identifying and removing hazards, where possible, or, where the hazard is unavoidable because of other resident needs, managing the hazard by reducing the risk of accident to the extent possible."  Maine Veterans' Home - Scarborough, DAB No. 1975 at 10 (2005) (explaining the inherent standard of care in section 483.25(h)(1)).  The provisions of section 483.25(d) "come into play when there are conditions in a facility that pose a known or foreseeable risk of accidental harm."  Meridian Nursing Ctr., DAB No. 2265 at 10 (2009), aff'd sub. nom. Fal‑Meridian, Inc. v. U.S. Dep't of Health & Human Servs., 604 F.3d 445 (7th Cir. 2010).  Further, subsection 483.25(d)(2) requires that a facility take "all reasonable steps to ensure that a resident receives supervision and assistance devices that meet his or her assessed needs and mitigate foreseeable risks of harm from accidents."  Briarwood Nursing Ctr., DAB No. 2115 at 11 (2007) (citing Woodstock Care Ctr. v. Thompson, 363 F.3d 583, 590 (6th Cir. 2003) (facility must take "all reasonable precautions against residents' accidents"), aff'g Woodstock Care Ctr., DAB No. 1726 (2000)).  Facilities are given "the flexibility to choose the methods" they use to provide supervision or assistive devices to prevent accidents, so long as the chosen methods "constitute an ‘adequate' level of supervision" for a particular resident's needs.  Windsor Health Care Ctr., DAB No. 1902 at 5 (2003), aff'd sub. nom. Windsor Health Ctr. v. Leavitt, 127 F. App'x 843 (6th Cir. 2005).

As discussed above, the facility failed to ensure the Hoyer lift was in safe-functioning condition before attempting to transfer Resident G and failed to maintain the lift properly according to the manufacturer's recommendations.  These failures put the facility out of substantial compliance with the requirement to ensure that the resident environment remained as free of accident hazards as possible.

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In addition to the signs of wear, the facility also failed to follow the manufacturer's recommendations for maintaining the lift, namely replacing straps every six months and inspecting the lift monthly using qualified technicians.  There can be no real dispute that using a lift that has not been properly maintained carries an increased risk of accident.  Indeed, Medicare guidelines explain that devices for resident care, such as assistive devices, may be hazardous when they are defective, disabled, or improperly used, i.e., used in a manner that is not per manufacturer's recommendations or current professional standards of practice.  State Operations Manual, CMS Pub. 100-07, Appendix PP – Guidance to Surveyors for Long Term Care Facilities (SOM Appendix PP) at 293 (Rev. 173, eff. Nov. 22, 2017).  The guidelines add that there are risks associated with the use of assistive devices and equipment, such as a Hoyer lift, particularly "if or when they are not properly maintained."8   SOM Appendix PP at 300.

Petitioner's attempts to avoid responsibility are unavailing.  P. Br. at 12, 14.  Petitioner, as a health care facility, should have greater expertise for important and potentially dangerous pieces of equipment like a lift.  Even if the facility did not have actual notice that it ought to replace the sling every six months, 42 C.F.R. § 483.25(d) requires facilities to contemplate potential accident hazards in a resident's environment and then remove them where possible.  Maine Veterans' Home - Scarborough, DAB No. 1975 at 10 (2005).  Here, even if there were no instructions on the lift itself or in its original packaging, the facility was still obligated to consider the risks with using the Hoyer lift and minimize those risks to the extent possible.  The facility should have known to replace the sling after six months because that recommendation was on the same website the facility uses to order replacement parts for the lift.  It is difficult to accept the facility's position that it did not know how often each sling needed to be replaced.

In addition to its failure to replace the straps as recommended, the facility also failed to inspect the lift monthly with a qualified technician as recommended by the manufacturer.  Such inspections may have resulted in the replacement of the old straps that broke, which caused Resident G's terrible fall.

Overall, I cannot accept Petitioner's attempt to cast the accident as completely unforeseeable.  See P. Br. at 10.  The weight of the evidence shows that staff failed to recognize the signs of wear on the straps before attempting the transfer and that the facility failed to follow key maintenance recommendations from the lift's manufacturer.  Together, these failures increased the risk and foreseeability of an accident, putting the facility out of substantial compliance with section 483.25(d).9

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8. A per-instance CMP of $18,370 is a reasonable CMP amount for Petitioner's substantial noncompliance with 42 C.F.R. § 483.25(d).

CMS imposed a single per‑instance CMP in the amount of $18,370 as a result of Petitioner's noncompliance.

When determining whether a CMP amount 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) 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.  See 42 U.S.C. §§ 1320a-7a(d)(2), 1395i-3(h)(2)(B)(ii)(I).  The absence of culpability is not a mitigating factor.  42 C.F.R. § 488.438(f).  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.  See 42 U.S.C. §§ 1320a-7a(d)(1), (3), 1395i-3(h)(2)(B)(ii)(I).

The regulations leave the decision regarding the choice of remedy to CMS, and the amount of the remedy to CMS and the ALJ, requiring only that the regulatory factors at §§ 488.438(f) and 488.404 be considered when determining the amount of a CMP within a particular range.  42 C.F.R. §§ 488.408, 488.408(g)(2), 498.3(d)(11); see also 42 C.F.R. § 488.438(e)(2) and (3); Alexandria Place, DAB No. 2245 at 27 (2009); Kenton Healthcare, LLC, DAB No. 2186 at 28-29 (2008).  However, unless a facility contends that a particular regulatory factor does not support the CMP amount, an ALJ must sustain it.  Coquina Ctr., DAB No. 1860 (2002).

Petitioner does not argue that the CMP is unreasonable based on the regulatory factors.  Coquina Ctr., DAB No. 1860 (2002).  However, for completeness, I briefly discuss the factors below.

Facility's History of Non-Compliance:  CMS argued that Petitioner has a history of noncompliance, and CMS submitted a document titled "AEM Nursing Home Enforcement History" showing that Petitioner had been cited in March 2017 for a G-level deficiency that resulted in a $3,332 CMP.  CMS Br. at 13; CMS Ex. 3 at 2.  Notably, the document also shows that the deficiency was cited under Tag F-323, which was the prior F-Tag number associated with the requirement to prevent accidents.  Petitioner's

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noncompliance with the same regulation, which caused actual harm to a resident less than a year and a half earlier, lends significant support for the CMP amount in this case.

Scope and Severity of Deficiencies and Relationship Between Deficiencies:  CMS argues that the seriousness of the offense supports the penalty amount because the noncompliance not only created a risk for serious harm but in fact resulted in hospitalization and ultimately death.  CMS Br. at 12-13.  I agree with CMS.  Resident G was grievously injured.  At the hospital, the resident was diagnosed with fractures to her C6 and C7 vertebrae, thoracic spine, two left ribs, and left elbow, as well as having lacerations to her leg and scalp.  CMS Ex. 6 at 92-93, 95.  She needed staples for the hematoma on her head and 13 stitches for her right leg.  CMS Ex. 6 at 67-68, 94, 146; see also CMS Ex. 6 at 87-90 (photos of injuries).  After returning from the hospital, she was "in significant pain" and needed to increase her morphine dosage.  CMS Ex. 6 at 56, 72; CMS Ex. 2 at 7.  Finally, the death of Resident G warrants a significant CMP.

Culpability:  Petitioner's culpability is high because, as explained above, facility staff failed to recognize the signs of wear on the straps before attempting the transfer.  Additionally, Petitioner should have, but did not, keep itself informed as to the life expectancy of the lift straps.  The fall occurred after Petitioner had used the straps for 11 months even though the manufacturer recommends replacing straps after six.  Petitioner should have known to follow the recommended replacement schedule for the lift at issue considering how it was aware of the resident's relatively heavy weight and that she needed assistance with transfers from one surface to another daily.  These factors also support a high CMP amount.

Financial Condition of the Facility:  Petitioner does not assert that its financial condition justifies a reduction in the CMP amount.  Therefore, this is not a factor requiring consideration.

CMP Amount:  A per-instance CMP of $18,370 in the upper part of the penalty range is entirely appropriate based on the factors considered above.

V.  Conclusion

For the reasons set forth above, I sustain CMS's initial determination that Petitioner was not in substantial compliance with 42 C.F.R. § 483.25(d) and conclude that an $18,370 per‑instance CMP is appropriate under the relevant statutory and regulatory factors.

1. "It is the duty and responsibility of the Secretary to assure that requirements which govern the provision of care in skilled nursing facilities . . . are adequate to protect the health, safety, welfare, and rights of residents and to promote the effective and efficient use of public monies."  42 U.S.C. § 1395i-3(f)(1).
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2. All citations to the Code of Federal Regulations are to the version in effect at the time of the survey unless otherwise indicated.
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3. Petitioner redacted certain information from Petitioner Exhibits 1, 2, 3, 6, 8, 9, and 10.  However, Petitioner also submitted unredacted versions of those exhibits marked as Petitioner Exhibits 1A, 2A, 3A, 6A, 8A, 9A, 10A.
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4. In the Amended Notice of Hearing, I indicated that, if I reduced the CMP in this case below $10,697, I would review CMS's finding that Petitioner provided substandard quality of care because that led to Petitioner's loss of its NATCEP.  See 42 C.F.R. § 498.3(b)(16).  However, because I uphold a CMP that is greater than $10,697, the loss of the NATCEP is mandatory.  42 U.S.C. § 1395i-3(f)(2)(B)(iii)(I)(b)-(c), (g)(2)(B)(i); 42 C.F.R. § 483.151(b)(2)(iii)(iv), (f)(1); 45 C.F.R. § 102.3.  Therefore, it is unnecessary for me to review the substandard quality of care finding.
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5. "A Hoyer Lift is a device operated by staff to lift a resident by using a hammock-like sling that is placed under the resident and has straps that are attached to the lift during the transfer."  West Texas LTC Partners, Inc., d/b/a Cedar Manor, DAB No. 2652 at 3-4 (2015).
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6. The parties dispute whether the facility's administrator acknowledged during the survey that he was aware that the straps should be changed every three to six months.  CMS Ex. 28 ¶ 11(a); CMS Ex. 29 ¶ 11(a); P. Ex. 13 ¶ 3; P. Ex. 14 ¶ 3.  It is unnecessary to resolve whether the administrator admitted to being aware of the timeline for replacing straps given how the facility should have known about the recommendation.
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7. CMS revised part 483 regulations concerning SNF conditions of participation in 2016, including the quality of care regulation found at 42 C.F.R. § 483.25.  81 Fed. Reg. 68,688 (Oct. 4, 2016); 82 Fed. Reg. 32,256 (Jul. 13, 2017) (technical corrections).  The accident prevention regulation currently promulgated in 42 C.F.R. § 483.25(d) was formerly found in 42 C.F.R. § 483.25(h).  In assessing compliance under section 483.25(d) in this case, I consider case decisions analyzing the former section 483.25(h).
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8. It is ironic that Petitioner provided an assistive device (i.e., the Hoyer lift) under 42 C.F.R. § 483.25(d)(2) to Resident G to prevent an accident.
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9. CMS also contends that Petitioner failed to comply with 42 C.F.R. § 483.25(d) because, during the transfer, one of the CNAs had moved away from the lift before the resident was over the bed.  CMS Br. at 10.  Having found that the facility failed to substantially comply with that regulation based on its failures (1) to ensure the lift was in safe-functioning condition and (2) to follow the manufacturer's maintenance recommendations, I decline to address whether staff provided adequate supervision while transferring the resident because that allegation is not material to the outcome of this case.  See, e.g., Heritage Plaza Nursing Ctr., DAB No. 2829 at 4 n.3 (2017)
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