Elkader Care Center, DAB CR5950 (2021)

DECISION

The Centers for Medicare & Medicaid Services (CMS) determined that Elkader Care Center (Petitioner or facility), a skilled nursing facility (SNF) participating in the Medicare program, was in substantial noncompliance with Medicare requirements by failing to ensure the personal privacy of a resident and to provide care to that resident.  The only evidence for these deficiencies is numerous minute-long video clips taken from March 10 through 13, 2017, by a motion-activated camera hidden in a clock in the resident’s room.  The privacy deficiency is based on video clips showing the resident unclothed below the waist in her room and facility staff leaving the room door open, exposing the resident to individuals who may walk by the room.  The lack of care deficiency is based on a review of all the video clips cumulatively, which do not show facility staff checking on the resident, sometimes for many hours, or providing necessary medication and food.

I sustain the deficiency relating to privacy because the video clips establish that such incidents occurred.  However, I reduce the civil money penalty (CMP) imposed on

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Petitioner for this deficiency to $2,097, which is the minimum amount permitted under the regulations.  None of the video clips show other residents or facility visitors in the corridor looking into the resident’s room, and the video clips establish that a person would have to take at least one step into the resident’s room to see her.

I do not uphold the deficiency concerning the failure to provide care to the resident.  CMS’s evidence for this deficiency is negative, i.e., there is a lack of video evidence that care was timely and appropriately provided.  CMS has no evidence to show that the hidden camera always made a recording when there was motion in the resident’s room and has no way of knowing if it is in possession of all of the video clips recorded by the hidden camera.  Indeed, CMS never had possession of the hidden camera to evaluate it or the original data files for the video clips to determine whether all of the video clips were provided.  Further, the video clips were provided months after they were originally recorded and provided by the daughter of the resident, who was also an employee of the facility at the time.  The daughter had a fractious relationship with the facility.  Further, the daughter had daily access to the resident’s room and the capability to turn the hidden camera on and off.

Based on the unreliable nature of the video clip evidence to substantiate that care was not provided, along with significant facility documentation showing that appropriate care was timely provided to the resident from March 10 through 13, 2017, I conclude that Petitioner showed that it was in substantial compliance with the requirement to provide care to residents.  Therefore, no CMP is warranted for this deficiency.

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 an 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).  Further, a participating SNF must meet a variety of ongoing requirements related to how it provides

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services, maintains the rights of its residents, and administers its facility.  42 U.S.C. § 1395i-3(a)(3), (b)-(d); 42 C.F.R. pt. 483, subpt. B.All citations to the Code of Federal Regulations are to the version in effect at the time of the survey unless otherwise indicated.

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 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 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.  These surveys can be unannounced surveys that occur at least once every 15 months or can be in response to a complaint.  42 U.S.C. § 1395i-3(g).  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); see also 42 U.S.C. § 1395i‑3(h)(2)(B)(ii)(III)(bb).

One such enforcement 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 February 3, 2017, and for deficiencies that occurred after November 2, 2015, the CMP amounts may range as follows:  $2,097 to $20,965 for per-instance CMPs; $105 to $6,289 per day for less serious noncompliance; or $6,394 to $20,965 per day for more serious noncompliance that poses immediate jeopardy to the health and safety of residents.  45 C.F.R. § 102.3 (2017); 82 Fed. Reg. 9,174, 9,175, 9,182-83 (Feb. 3, 2017); see 42 C.F.R. § 488.438(a)(1) (original CMP amounts before inflation adjustments).

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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).

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 this occurs, the SNF must then prove substantial compliance by a preponderance of the evidence.  Hillman Rehab. 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 participating in the Medicare program.  The Iowa Department of Inspections and Appeals (IDIA) conducted a survey at Petitioner’s facility that ended on June 28, 2017.  P. Ex. 1.  IDIA issued a Statement of Deficiencies (SOD) detailing a variety of deficiencies, the most serious of which involved a violation of the personal privacy of a resident (designated as Resident 2) under Tag F-164 (42 C.F.R. §§ 483.10(h)(1)(3)(i), 483.70(i)(2)) with a scope and severity level of “G” and a violation involving the failure to provide care and services to bring the highest well-being to Resident 2 under Tag F-309 (42 C.F.R. §§ 483.24, 483.25(k)(l)) with a scope and severity level of “J.”CMS designated a scope and severity level of “G” to be a deficiency that resulted in actual harm to a person but that did not immediately jeopardize the health and safety of the person, while a level of “J” indicated that the deficiency is isolated noncompliance that posed immediate jeopardy to resident health and safety. See State Operations Manual (SOM), Chap. 7, § 7400.5.1 (rev. 161, eff. Sept. 23, 2016).  CMS Ex. 1.  The deficiencies were based on video recordings, made in 59

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second increments by a hidden camera in Resident 2’s room from 5:48 p.m. on March 10, 2017 through March 13, 2017 at 2:32 p.m.  The SOD stated that the instructions for the hidden camera indicated that it would record for one-minute increments when motion was detected.  CMS Ex. 1 at 4, 9-10.

Petitioner requested Informal Dispute Resolution (IDR) to dispute the deficiency at Tag F-309 (42 C.F.R. §§ 483.24, 483.25(k)(l)) as well as another deficiency in the SOD, but not Tag F-164 (42 C.F.R. §§ 483.10(h)(1)(3)(i), 483.70(i)(2)).  P. Ex. 3.  An IDIA Independent Reviewer conducted an IDR conference on August 16, 2017.  The Independent Reviewer recommended the dismissal of the two disputed tags, including Tag F-309.  P. Ex. 3 at 2.

In an August 29, 2017 letter, CMS rejected the IDR recommendation.  CMS Ex. 11.

In evaluating the deficiencies, the Independent Reviewer stated that IDIA had not shared the video evidence from the survey with the Independent Reviewer or Petitioner.  The Independent Reviewer also stated that IDIA had pitted the video evidence against Petitioner’s documentation, which showed that it had provided needed care to Resident 2.  The Independent Reviewer found Petitioner’s evidence more persuasive than video clips with “an unknown origin, an unknown chain of custody, and technical specifications/ timestamps that were modified at best, and malicious at worst.”  P. Ex. 3 at 2.

On October 25, 2017, CMS issued an initial determination based on the results of the IDIA survey.  CMS imposed two per-instance CMPs as follows:

• $13,505 for a March 10, 2017 deficiency involving 42 C.F.R. §§ 483.24 and 483.25(k)(l) (Provide Care/Services for Highest Well Being) (Tag F-309, scope and severity level “J”)
• $11,000 for a March 12, 2017 deficiency involving 42 C.F.R. § 483.10(h) (Personal Privacy) (Tag F-164, scope and severity level “G”)

CMS Ex. 10.

Petitioner requested Independent Informal Dispute Resolution (IIDR) of Tags F-309 and F-164.  An IIDR Independent Reviewer conducted the dispute resolution and indicated that, while Petitioner did not have access to the video evidence IDIA and CMS relied on, the IIDR Reviewer did have such access.  P. Ex. 2 at 2.  On November 20, 2017, the IIDR Reviewer recommended the removal of Tag F-309 because the facility had shown that its records of medical care provided to Resident 2 were reliable but that the video

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evidence, which could not be authenticated and did not include footage for the entire period of time in question, was insufficient to overcome Petitioner’s evidence.  P. Ex. 2 at 5.  Regarding Tag F-164, the IIDR Reviewer recommended upholding the deficiency, but at a reduced scope and severity level of “D,”A “D” scope and severity level indicates isolated noncompliance that caused no actual harm with the potential for more than minimal harm that is not immediate jeopardy. SOM, Chap. 7, § 7400.5.1 (rev. 161, eff. Sept. 23, 2016). and eliminating the CMP imposed for the deficiency.  Finally, the IIDR Reviewer recommended certain factual amendments to the SOD.  P. Ex. 2 at 5-6.

In December 2017, IDIA amended the SOD’s factual findings as recommended by the IIDR Reviewer, but IDIA did not accept the IIDR’s recommendations concerning Tags F-309 and F-164.  P. Ex. 1 at 1.

Petitioner timely requested a hearing and the Civil Remedies Division (CRD) docketed the consolidated case under C-18-362.IDIA issued a July 12, 2017 initial determination based on the deficiencies in the SOD. IDIA imposed a Denial of Payment for New Admissions (DPNA) on Petitioner effective July 27, 2017, and recommended that CMS impose additional enforcement remedies. Petitioner requested a hearing to dispute the initial determination, and CRD docketed the case as C-17-1152. On October 25, 2017, CMS issued an initial determination in which CMS stated that the DPNA would not go into effect because Petitioner returned to compliance before the DPNA’s effective date. CMS Ex. 10 at 3. The case docketed under C-17-1152 was consolidated into C-18-362; however, it is now moot.  The ALJ first assigned to the case set dates for the submission of prehearing exchanges.  CMS submitted a prehearing brief along with 182 proposed exhibits.  One of the proposed exhibits (CMS Ex. 182) was the written direct testimony for IDIA surveyor Wendy Kuhse.  CMS submitted CMS Exhibits 12 through 181 on a compact disk.  CMS described the exhibits as one-minute video clips taken with a “Granny Cam.”  Because of the cumulatively large size of the files, as well as the sensitive nature of the videos, CMS did not upload those videos to the DAB E-File System.

Petitioner submitted a prehearing brief, a request to cross-examine CMS’s witness, objections to a number of CMS’s proposed exhibits (including all of the video clips that CMS submitted), and 270 exhibits, which included the written direct testimony for ten witnesses (P. Exs. 20-29).  Petitioner Exhibits 31 through 270 were video clips that Petitioner submitted on a flash drive.

CMS neither objected to any of Petitioner’s proposed exhibits nor requested to cross-examine any of Petitioner’s witnesses.

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Following the prehearing submissions, I was assigned to hear and decide this case.  Petitioner later moved for leave to file new evidence (P. Exs. 271-277), which included written testimony explaining when Petitioner received those documents.

On January 8, 2021, I notified the parties that I would hold a prehearing conference on January 29, 2021, and a hearing on April 12, 2021.  The primary reason for the hearing was to permit Petitioner to cross-examine CMS’s witness.  In that January 8, 2021 notice, I overruled most of Petitioner’s objections and admitted CMS Exhibits 1 through 11 into the record.  Further, I provisionally admitted CMS Exhibit 182, the written direct testimony for CMS’s witness.  I stated that CMS Exhibit 182 would be fully admitted after the witness appeared for the hearing and was cross-examined.  I also admitted Petitioner Exhibits 1 through 30 and granted Petitioner’s request to submit proposed Petitioner Exhibits 271 through 277.  I reserved ruling on the admissibility of the video clips submitted by the parties.

On January 29, 2021, I held the prehearing conference in this case, the substance of which is summarized in my February 4, 2021 Order Following Prehearing Conference.  At the conference, it was ascertained that the video clips submitted by the parties represented all of the video clips that CMS obtained from IDIA.  CMS submitted some of those clips for inclusion in the record and had provided the remaining to Petitioner.  Petitioner, in turn, submitted all of the remaining video clips.  It was also ascertained that the video clips could be uploaded to the DAB E-Filing system and, as a result, I ordered the parties to upload all of the video clips (i.e., CMS Exs. 12-181 and P. Exs. 31-270) to the electronic record in this case.  Because the video clips are images from Resident 2’s room, I directed the parties to indicate in the DAB E-Filing System that all of these clips were filed under seal.  I reserved ruling on the admission of the video clip exhibits until I reviewed them.  However, I admitted Petitioner Exhibits 271 through 277 into the record.

The parties timely filed their respective video exhibits into the DAB E-Filing System and, on March 2, 2021, I ordered CMS Exhibits 12 through 181 and Petitioner Exhibits 31 through 270 sealed.

On April 12, 2021, I held a hearing at which CMS’s witness, Wendy Kuhse, testified.  At the hearing, the parties identified a number of video clip exhibits that were duplicates of other clips and, therefore, did not contain the proper video clips.  Hearing Transcript (Tr.) at 4-8.  Petitioner identified CMS Exhibits 13 through 47 as duplicate video clips of other exhibits.  Tr. at 5-6.  Therefore, I deferred admitting the video clip exhibits until CMS corrected all of its exhibits.  Tr. at 9.  However, I overruled Petitioner’s general objection to the video clips as unreliable and indicated that, under the Administrative Procedure Act, a potential lack of reliability was not a basis for me to exclude the video clips but that the question of reliability must be considered when rendering a decision.  Tr. at 9-10; 5 U.S.C. § 556(d).  CMS counsel agreed to resubmit the correct video clips for CMS Exhibits 13 to 47 while a transcript of the hearing was being produced.  Tr. at 136-138.

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On April 12, 2021, Petitioner submitted an amended Petitioner Exhibit 30.  See Tr. at 79.

On May 13, 2021, I notified the parties that the hearing transcript had been completed and set a post-hearing briefing schedule.  I directed CMS to file the corrected video clip exhibits by May 20, 2021.  On May 20, 2021, CMS submitted amended CMS Exhibit 13, and CMS Exhibits 15 through 47.  By email, CMS indicated that no video clip exists for CMS Exhibit 14; therefore, it is simply a duplicate exhibit.  DAB E-File Document No. 129.

On June 16, 2021, I issued an Order to Show Cause to CMS because CMS did not timely file a post-hearing brief and required that the brief be filed by June 18, 2021.  CMS filed a post-hearing brief (CMS Br.) and a statement as to why CMS was untimely in filing it.  Petitioner timely filed a post-hearing brief (P. Br.).  CMS filed a reply brief (CMS Reply).

After having received all of the video clip exhibits, I admit CMS Exhibits 12-13, and 15 through 181, as well as Petitioner Exhibits 31-270 into the record.  Further, I order that all video clips submitted by the parties be sealed, regardless as to whether they were admitted into the record or are duplicates.  I also admit the amended Petitioner Exhibit 30 in place of the original version of that exhibit.  I exclude CMS Exhibit 14 as duplicative.

III. Issues

1. Whether Petitioner was in substantial compliance with the Medicare requirement for SNFs at 42 C.F.R. § 483.10(h) (Tag F-164) and, if not, whether the $11,000 per-instance civil money penalty (CMP) amount is appropriate under the statutory and regulatory factors in 42 U.S.C. § 1320a-7a(d) and 42 C.F.R. § 488.438(f).
2. Whether Petitioner was in substantial compliance with the Medicare requirements for SNFs at 42 C.F.R. §§ 483.24, 483.25(k) (Tag F-309) and, if not, whether the $13,505 per-instance CMP amount is appropriate under the statutory and regulatory factors in 42 U.S.C. § 1320a-7a(d) and 42 C.F.R. § 488.438(f).

CMS imposed per-instance CMPs based on findings of noncompliance with the requirements cited above.  CMS Ex. 10 at 1.  The SOD indicated there were additional deficiencies.  P. Ex. 1.  However, those deficiencies are not at issue in this case because CMS did not impose an enforcement remedy based on them.  42 C.F.R. §§ 488.330(e)(3)(ii), 488.408(g)(1), 498.3(b)(13).

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IV. Findings of Fact

1. The SOD based its deficiencies on video clips taken in Resident 2’s room.  For the deficiency involving resident privacy, the SOD indicates that video clips show that staff failed to protect Resident 2’s privacy because they left the door open to Resident 2’s room while the lower half of her body was uncovered.  However, for the deficiency involving a failure to provide care, the SOD compared the entries on the Neurological Assessment Flow Sheet and the Medication Administration Record for March 10 through 13, 2017, and concluded that any assessment/dispensing of medicine that was not corroborated by a video clip did not occur.

The first deficiency listed in the SOD involves 42 C.F.R. § 483.10(h) (Tag F-164), which deals with resident privacy. The SOD stated:

Based on observation (via video recording clips), clinical record and policy review, the facility did not always ensure[] personal privacy for residents.  According to video recordings of events occurring in Resident #2’s room on 3-11-17 and 3‑12-17, staff left the door open when providing personal cares to the resident exposing his/her naked body.  A reasonable person would feel degraded, embarrassed and ashamed if exposed during cares.

* * * * *

Review of video clip #0056 dated 03-11-2017 revealed two unidentified staff enter Resident #2’s room at 0835 and close the door.  One staff removes the sheet/blanket from the resident’s lower body, exposing Resident #2’s unclothed perineum and legs.  One staff exits the room, leaving Resident #2’s unclothed body exposed, with the door ajar.

Review of video clip #0181 dated 03-12-2017 revealed Staff J [] enter Resident #2’s room at 1422:38.  At the time Resident #2 was in bed, dressed only with a shirt and socks on.  Resident #2’s unclothed naked body was exposed from his/her waist to his/her feet.  Staff J exited Resident #2’s room at 1442:42 leaving the door open to the room showing Resident #2 exposed (including his/her pubic hair and male/female genital area).  Staff J returns to Resident #2’s room at 1423:15 appears to talk to Resident #2 and exits the

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room at 1423:36, again leaving Resident #2’s unclothed lower body completely exposed (including his/her pubic hair and male/female genital area) and uncovered and the door to Resident #2’s room open.

Review of video clip #0218 dated 03-12-2017 revealed Staff G to look [sic] in Resident #2’s room (from the doorway) at 1822:33 and almost immediately leave.  Resident #2 is observed wearing only a blouse, with the lower portion of his/her body completely exposed.  Resident #2 was lying down with feet out of bed.  The staff left the resident exposed in this way, with the door to the room appearing to be wide open.  Subsequently, the resident appeared to be attempting to sit up.  Staff G left Resident #2 exposed (showing his/her pubic hair and male/female genital area) and unattended, with the door to the room open to the hallway.

P. Ex. 1 at 3, 6-7.

The second deficiency listed in the SOD involves 42 C.F.R. §§ 483.24 and 483.25(k) (Tag F-309), which deals with providing care and services for a resident’s highest wellbeing.  The SOD stated:

Based on observation (via video recording clips), clinical record and staff interview, the facility failed to ensure one (1) of seven (7) resident[s] received assessment and interventions after a fall.  The facility staff documented they completed comprehensive assessments and administered Resident #2’s medications when in fact the video recording of events occurring in the resident’s room after he/she sustained a fall on 3-10-17 to 3-13-17 at 2:32 p.m., showed care and treatment were inadequate and had not been provided.  The video clips from 3-11-2017 to 3-12-2017 revealed no nurses entered Resident #2’s room for approximately 17 and ½ hours, however they documented completion of comprehensive assessments and medication administration.  The findings resulted in an Immediate Jeopardy to resident’s health and safety.

P. Ex. 1 at 8-9.  The SOD provided a detailed comparison between the Neurological Assessment Flow Sheet and video clips recorded between March 10 and 13, 2017, taken by the hidden camera in Resident 2’s room.  P. Ex. 1 at 16-21.  Further, the SOD indicated that Resident 2 was prescribed to receive various drugs but that “[r]eview of the

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video clips in their entirety reveal nurses[] did not enter Resident #2’s room on 3-11-17 or 03-12-17 with medications.”  P. Ex. 1 at 22-23.

2. In March 2017, Resident 2 was 82-years old, had resided at the facility since 2014, and had significant cognitive and mobility limitations.  Petitioner established a care plan with interventions for several concerns related to Resident 2.  Resident 2 was prescribed several medications that the facility needed to administer to her.  Following a fall on March 10, 2017, staff was required to make periodic neurological checks for the next several days.

Resident 2 was a female born in 1934 who was originally admitted to the facility in 2014 and, following a short hospital stay, was readmitted in 2015.  CMS Ex. 3 at 1; P. Ex. 20 ¶ 9.  Resident 2’s diagnoses included Parkinson’s Disease, Orthostatic Hypotension, pyoderma, spasmatic torticollis, cardiovascular disease, chronic obstructive pulmonary disease, and chronic fatigue.  CMS Ex. 3 at 1; CMS Ex. 7 at 75.  Resident 2 had limited cognitive abilities and was a fall risk.  CMS Ex. 3 at 3.  Resident 2’s prescribed medications included a Fentanyl patch, Carbidopa-Levodopa, Arginaid, and Lorazepam.  CMS Ex. 3 at 2; P. Ex. 5.

Resident 2’s care plan noted a number of items of concern and interventions to assist Resident 2 to cope with those concerns.  The care plan included the following:

• Resident 2 was at risk for skin breakdown due to immobility and a history of pressure sores.  Interventions included keeping Resident 2 as dry and clean as possible, providing a side rail to assist in mobility and repositioning in bed, and using incontinence products to maintain personal hygiene and dignity.  CMS Ex. 7 at 59.
• Resident 2’s ability to complete activities of daily living (ADLs) had deteriorated.  Interventions included giving Resident 2 extra time to complete ADLs and assisting with morning and night ADLs.  CMS Ex. 7 at 59.
• Resident 2 was at risk for falling due to an unsteady gait, Parkinson’s disease, and impaired cognition.  Interventions included ambulating with a walker and gait belt, and a one-person assist as well as installing bed and chair pressure alarms and lowering the bed to the lowest position when occupied.  CMS Ex. 7 at 59, 61.
• Resident 2 had chronic pain.  Interventions included administration of medications as ordered and monitoring for effectiveness and side effects.  CMS Ex. 7 at 61, 63.
• Resident 2 experienced bladder incontinence.  Interventions included assisting Resident 2 to the toilet and using incontinence products to promote hygiene and dignity.  CMS Ex. 7 at 63. 

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• Resident 2 was resistant to care at times.  Interventions included encouraging participation by resident during cares, giving clear explanation of all care activities prior to and during each contact, as well as giving the resident an opportunity for choice while providing care.  CMS Ex. 7 at 71, 73.
• Resident 2 had a potential for weight loss and fluid deficit due to poor intake of fluids at times and a history of urinary tract infections.  Various interventions were established to increase the likelihood Resident 2 would eat and drink.  CMS Ex. 7 at 73, 75.

On March 10, 2017, facility staff found Resident 2 lying on the floor of her room.  Resident 2 fell while trying to get up from a chair.  Resident 2 received a C-shaped laceration above her left eye.  Staff assessed Resident 2 and assisted her up and back to bed.  Staff cleaned the wound and the on-call physician was made aware of the situation.  Staff was to conduct neurological checks on Resident 2 based on facility protocol.  Staff completed a Neurological Assessment Flow Sheet from March 10 to 14, 2017.  CMS Ex. 7 at 27, 29, 31.

3. J.M., the daughter of Resident 2, was an employee at the facility for most of the time that Resident 2 was at the facility.  J.M. often visited Resident 2 during her work-shift and would remove care plan instituted interventions to protect Resident 2 against falls without reestablishing them before ending her visits.  The facility reprimanded J.M. in 2015 and 2016 regarding her conduct in relation to Resident 2.  J.M. was known by facility staff to dislike/have animosity for facility administrator Kristin Dunlap and facility nurses Nichole Buckley and Heidi Mueller.  J.M. resigned from her position at the facility in July 2017.

The facility hired J.M. as a Resident Care Technician on February 10, 2014, and J.M. resigned from that position on July 13, 2017.  P. Ex. 20 ¶ 30.  J.M.’s work schedule was Monday to Friday from 6:00 a.m. to 4:00 p.m., although J.M. often started work early and would leave early.  P. Ex. 20 ¶ 31.

J.M. was often in Resident 2’s room during her work shift, J.M.’s husband visited Resident 2 nearly every day, and Resident 2’s other daughter, J.C., visited a couple of times a week.  P. Ex. 20 ¶¶ 32-34.

On November 25, 2015, the facility issued a written warning to J.M. because J.M. used her cell phone to take pictures of Resident 2’s pressure ulcer while on duty in violation of facility policy.  P. Ex. 16; P. Ex. 20 ¶ 38.  Further, J.M. took Resident 2 to the whirlpool room without the assistance of a nurse.  The facility informed J.M. that taking pictures of residents with a cell phone violated facility policy if J.M. takes those pictures while on-

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duty.  In addition, the facility was concerned that J.M. removed the wound dressing on Resident 2 before an IDIA surveyor, who was apparently at the facility, could look at it.  P. Ex. 16; P. Ex. 20 ¶ 38.

Facility administrator, Kristin Dunlap, testified in this proceeding that she was involved in reprimanding and/or counseling J.M. regarding her job performance in June 2014, February 2015, December 2015, and May 2016.  P. Ex. 20 ¶ 39.  Further, on September 15, 2016, the facility documented that, when J.M. assists her mother, Resident 2, while on duty at the facility, J.M. “must use two assist with mom at all times for cares and follow care plan for resident to ensure safety.”  P. Ex. 15; P. Ex. 20 ¶ 37.

Ms. Dunlap testified that J.M. blamed Nichole Buckley, RN, for the pressure ulcer that Resident 2 had in 2015 and that staff reported that J.M. stated she was “out to get” Ms. Buckley.  P. Ex. 20 ¶¶ 40-41.  Amber Cole, a CNA at the facility, testified that J.M. made derogatory statements about Nurse Buckley, frequently stating that Ms. Buckley was lazy and did not know how to do her job.  P. Ex. 25 ¶ 6.

A staff member at the facility testified in this proceeding that J.M. also disliked Heidi Mueller, RN.  CNA Maegan Weiss testified that J.M. “was upset with Heidi Mueller, because Heidi had told [J.M.] that she could not come in before her shift and wake up residents early for baths.”  P. Ex. 28 ¶ 8.

J.M. was also known to have animosity for facility administrator Dunlap.  CNA Cole testified that she “also heard [J.M.] state[] that she wished she would get Kristin Dunlap, [Petitioner’s] administrator, fired and stated that she would ‘have the last laugh.’”  P. Ex. 25 ¶ 7.  Catherine Beck, RN, testified that, multiple times, J.M. stated in the break room that Kristin Dunlap was a bad administrator and would call her names.  P. Ex. 23 ¶ 6.

Facility staff also testified that J.M. would leave Resident 2 in an unsafe condition following visits.  CNA Weiss and CNA Kay Schaffer testified that J.M. would visit Resident 2 before J.M.’s shift would start and would raise Resident 2’s bed, although the care plan called for the bed to be left lower to the ground, would move and/or unplug the mat alarm, and would leave Resident 2 sitting on the bed.  P. Ex. 27 ¶ 6; P. Ex. 28 ¶ 9.  Further, Sandy Moser, dietary aid, testified that J.M. would instruct the facility kitchen not to serve breakfast to Resident 2 if Resident 2 were sleeping, but then would question why Resident 2 had not received breakfast.  P. Ex. 26 ¶ 9.

4. Resident 2’s family placed a camera hidden in a clock in Resident 2’s room that would record minute-long videos when motion was detected in the room.  Resident 2’s family provided video clips to IDIA that purport to have been taken from March 10 through 13, 2017.  Resident 2’s family did not provide those videos to IDIA until months later and IDIA only received a copy of the video clips and never inspected or tested the hidden camera or the original

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data files.  J.M. worked at the facility on three of the four days that video clips were purportedly taken and did not notice any change in Resident 2’s condition to warrant J.M. checking the video clips at the time they were taken.  J.M. had the opportunity and ability to turn the clock/camera off and on during the March 10 through 13 period.

On an unknown date, Resident 2’s family surreptitiously placed a video camera hidden in an alarm clock that would start to record when there was motion in Resident 2’s room.  Tr. at 50; CMS Ex. 182 ¶ 13; see CMS Ex. 9.  The family could only see the videos taken by the camera after retrieving the secure digital (SD) card and transferring the data to their computer.  CMS Ex. 182 ¶ 13.  The camera instruction manual stated:

In motion recording mode, The [sic] camera will record video when the motion is detected, All [sic] the videos are in one minute clip [sic]. . . . The system can auto recycle the oldest video for the camera to continue record [sic].

CMS Ex. 9 at 3.  The instructions also provided information on how to reset the hidden camera if it does not “work right.”  CMS Ex. 9 at 3.  Resident 2’s family set the camera to turn on when motion was detected and then the camera would record for a minute.  Tr. at 59.

Petitioner was not aware that J.M. placed a hidden camera in Resident 2’s room until June 14, 2017, when IDIA informed Ms. Dunlap that video recordings were the basis for the finding of deficiencies at the facility.  P. Ex. 20 ¶ 44.  Even after this, the facility did not know that the camera was located in an alarm clock in Resident 2’s room; however, because the alarm clock’s power cord included a spliced and taped rotary power switch, Ms. Dunlap removed the alarm clock as a fire hazard on the advice of the Fire Marshal and returned it to Resident 2’s family.  P. Ex. 9; P. Ex. 20 ¶¶ 45-46; P. Ex. 27 ¶ 7.

The surveyor testified that she did not call the company that made the camera and did not research exactly who created it.  Tr. at 52, 55.  The surveyor admitted that she never took possession of the camera, tested it to see if the camera worked in the dark, or had an expert inspect it.  Tr. at 56-57.  The surveyor was also unaware that the hidden camera used in Resident 2’s room had been modified to include a rotary switch on the cord, and was also unaware who made the modification and whether that person was qualified to do so.  Tr. at 57-58.

The surveyor testified that she did not know how much time elapsed between when the videos were taken, and the time the family removed the SD card from the camera.  The surveyor testified that the family did not see a change in Resident 2’s condition that would indicate a necessity to remove the SD card and review the videos.  Tr. at 66-67.

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The surveyor testified that she never had possession of the original SD card from the camera, did not know where the SD card was located once it was removed from the camera, did not have an expert determine if the SD card was damaged, altered, or had videos deleted from it, did not have possession of the computer used to view the videos, did not know who had access to that computer, did not know how the videos were taken from the SD card and put in the format provided to the surveyor, and did not have the family’s computer reviewed by an expert to determine if any videos had been altered, deleted, or the file names had been renamed.  Tr. at 66-68; see also Tr. at 69-71.

Although the surveyor testified that Resident 2’s family who placed the camera said that they had no knowledge as to how to make adjustments to the recording, the surveyor confirmed that J.M. did change the time on the clock for daylight savings time, which resulted in an inaccurate time because the clock automatically adjusted the time by an hour as well.  Tr. at 61, 63-64.  Further, although the video clips were from March 10 through 13, 2017 and Resident 2’s family did not provide them to IDIA until May 24, 2017, the surveyor did not know how or where the videos were maintained between March and May 2017.  Tr. at 71.  The surveyor also testified that she could not confirm whether all of the videos taken between March 10 and 13, 2017 were given to her or if all of the videos were transferred from the SD card.  Tr. at 71-72.  The surveyor testified that she was not aware of any forensic review of the SD card and stated it was possible that someone either intentionally or inadvertently renamed a video clip.  Tr. at 72.

The surveyor also conceded that she had no firsthand or direct knowledge as to whether the hidden camera worked appropriately and consistently to capture every motion that occurred in Resident 2’s room.  Tr. at 74-75.  She also testified that she had no direct knowledge of how the videos were removed and copied from the SD card.  Tr. at 75.  Finally, the surveyor testified as follows:

Q.  Sure.  Is it fair to say that you have no way to confirm that the videos that were actually captured by that clock video were preserved on the SD card or that they were preserved once the SD card was placed into the computer?

A:  No, I can’t confirm that.

Q:  And is it fair to say that you have no way to confirm that the videos that were captured were preserved on the computer prior to them being delivered to the Department over two months later?

A:  No, I can’t confirm that.

Tr. at 75-76.

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The record also indicates that, during the period of time when the hidden camera was active, J.M. was present and working at the facility on March 10, 12, 13, and 14, 2017.  P. Ex. 17; P. Ex. 20 ¶ 43; Tr. at 73.  The surveyor testified that J.M. would have had access to Resident 2’s room each day that she was at the facility and that the surveyor was unaware that J.M. worked on three out of four days that the video clips were taken.  Tr. at 73.  The surveyor conceded that J.M. could have turned the clock radio/hidden camera off using the rotary switch.  Tr. at 73.  Further, the surveyor testified that J.M. did not report that she observed anything that concerned her during the March 10 through 13, 2017 period and all that J.M. reported was based on the video clips.  Tr. at 74.

5. The parties submitted over 400 video clips representing all of the video clips that IDIA obtained during its survey.  However, a review of the video clips in chronological order discloses that either the hidden camera did not record all movement in Resident 2’s room or IDIA did not obtain all of the video clips taken by the hidden camera.  Because IDIA did not obtain and analyze the original hidden camera/data for the video clips, there is no forensic evidence/analysis to explain why there are discrepancies between the video clips.

The parties submitted all of the video clips provided by J.M./Resident 2’s family to IDIA during the survey, which purportedly were taken from March 10, 2017 at 5:26 p.m. through March 13, 2017 at 2:33 p.m.  Each video clip is approximately one minute in length.  See CMS Exs. 12-13, 15-181; P. Exs. 31-270; see also P. Ex. 29 ¶ 10; P. Ex. 30.

At the hearing, the surveyor conceded that the video clips in the record do not cover every minute from March 10 through March 13, 2017, and that the reason for that could be that there was no motion in the room or the hidden camera malfunctioned and did not start recording when there was motion.  Tr. at 80.  Further, a review of the video clips shows that there are several instances where one video clip ends and the next sequential one that starts reveals that items in Resident 2’s room, and sometimes Resident 2 herself, had moved but there is no video clip showing that movement.  See P. Ex. 29 ¶ 13.  Petitioner summarized the evidence as follows:

Numerous video clips were reviewed with [the surveyor] at the hearing, and she had no explanation for why video had not recorded movement that had obviously happened in the room.  Tr. 81:3-84:19 (discussing the twenty minute gap between P. Ex. 31 and CMS Ex. 15, which are videos 121 and 122, and confirming that there is no video recording the clear movement of the resident, a blanket or a remote control on the table); Tr. 84:20-87:3 (discussing four minute gap between P. Ex. 102 and P. Ex. 103, which are videos 36 and

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37, and confirming there is no recording of the staff member’s obvious movements); Tr. 87:4-88:22 (discussing one hour and 17 minute gap between CMS Ex. 102 and CMS Ex. 103, which are videos 145 and 146 from March 12, 2017, and confirming there is no video showing how the blanket got from Resident #2’s shoulders to below her waist); Tr. 88:23-90:9 (discussing 38 minute gap between CMS Ex. 117 and CMS Ex. 118, which are videos 174 and 175, and confirming there is no video showing movement of blanket on Resident #2); Tr. 90:10-91:10 (discussing 15 minute gap between CMS Ex. 118 and CMS Exhibit 119, which are videos 175 and 176, and confirming there is no video showing movement of blanket on Resident #2).  [The surveyor] admitted that based upon this review of the videos, it was possible that the camera did not capture activity that went on in the room.  Tr. 96:10-96:13.  She also agreed that it was possible that the events occurred just as documented in the written record, but either the video did not record the activity or she was not given the videos of such activity.  Tr. 96:14-96:20.  Furthermore, she agreed that there were gaps in the video clips at many of the times in which the neuro checks and other documented cares and thus, the only way to really know what happened was to look at the written records.  97:6-98:8.

In a shining example of CMS’s misplaced reliance on the lack of video regarding Resident #2, [the surveyor] was asked to review the gap in video evidence that she relied upon in the 2567 to claim that no one entered Resident #2’s room for nine hours, despite the written records to the contrary.  P. Ex. 1, p. 29; Tr. 98:14-100:4.  CMS Exhibit 163 (video 220) clearly shows a staff member unknowingly placing a folded sheet or blanket over the granny cam.  Tr. 100:5-101:2.  The next video, which started six minutes later, was a dark or black screen.  CMS Ex. 164 (video 221); Tr. 101:3-101:8.  The next video, which is not until approximately nine hours later, shows Resident #2’s daughter lifting the folded sheet or blanket off of the granny cam.  CMS Ex. 165 (video 222); Tr. 101:9-102:11.  [The surveyor’s] only explanation of her reliance upon gap in video – which was clearly caused by the folded sheet or blanket being placed over it – was that she “can’t say for sure whether it was covered for nine hours.”  Tr. 102:14-102:17.  After admitting that there was only one video showing the sheet or blanket being lifted (CMS Ex.

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165), she tried to escape her obvious erroneous reliance on the lack of video by saying she would have to go “back through every single” video to be sure.  Tr. 102:18-102:25.  No additional review of the video is going to change such an obvious conclusion.  These gaps in numerous portions of the videos submitted clearly calls into question the reliability of the alleged seventeen and a half hour gap of time as well as any other time gaps where the lack of video is relied upon by CMS to assert that no cares were provided – despite written records to the contrary.  Notably, CMS did not attempt to address at the hearing or in its Post-Hearing Brief these significant and damaging reliability issues.  Tr. 116:1-129:5, 133:3-133:24 (redirect examination by CMS counsel); CMS Post-Hearing Brief, pp. 6-7.

P. Br. at 20-21.  In its briefing, CMS did not dispute the discrepancies in the video clip evidence adduced at the hearing or this summary based on the hearing.  See CMS Br. at 6-7; CMS Reply at 1-2.  I find that Petitioner’s summary above of the hearing and record is accurate.

Petitioner’s position concerning the reliability of the video clips is bolstered by the testimony from a forensic digital expert, Douglas G. Elrick, who pointed out the flaws summarized in the quote above.  P. Ex. 29 ¶¶ 14, 19-21.  Mr. Elrick also pointed out additional flaws in some of the other video clips.  P. Ex. 29 ¶¶ 15-18, 22-23.

Mr. Elrick concluded his testimony as follows:

These time gaps could be due to issues with the camera or not all videos were provided.  It is unclear if the video files and the naming convention are in their original state.  This could potentially be determined through analysis of the original media.  The internal data associated with the individual video files did not provide any additional information.

The original storage media or full forensic copy of the original media should be provided for examination in order to make a complete and thorough review.  This is necessary to perform an analysis for file activity, deletion, or manipulation.

P. Ex. 29 ¶¶ 24-25.  I accept Mr. Elrick’s opinion that there are unexplained gaps between the events shown in the video clips, and that this evidences a defect in the hidden camera’s ability to consistently record when movement occurred in Resident 2’s room or that some of the video clips made by the hidden camera were not provided to

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IDIA.  I also accept his opinion that IDIA/CMS ought to have obtained the original data files for the video clips and analyzed them, especially since the video clips are the sole basis for CMS’s allegations that Petitioner failed to provide care to Resident 2 over the course of four days.  I accept Mr. Elrick’s testimony because it is consistent with the record, CMS neither cross-examined him nor submitted evidence to contradict his testimony (which includes a lack of contrary expert testimony), and Mr. Elrick’s lengthy experience (over 25 years in digital forensic investigations) and education (a Master’s degree in digital forensics and three professional certifications).  P. Ex. 29 ¶¶ 2-8; P. Ex. 29 at 7-10.

6. Petitioner submitted documentary evidence showing that it provided Resident 2 with timely and appropriate care from March 10 through March 13, 2017.

Petitioner provided to the surveyor and/or submitted documentation in these proceedings showing that it provided appropriate care to Resident 2 from March 10 through 13, 2017.  This documentation includes:

• Progress Notes for Resident 2 from March 8, 2017 through March 16, 2017.  For the March 10 through 13, 2017 timeframe at issue in this case, the Progress Notes have one entry for March 10 (Resident 2’s fall), three for March 11, one for March 12, and one for March 13, 2017.  CMS Ex. 7 at 29, 31; P. Ex. 6 at 4-5.
• Neurological Assessment Flow Sheet for March 10 to March 14, 2017.  This document was completed by staff due to Resident 2’s fall on March 10.  The Flow Sheet shows 11 checks between 5:45 p.m. and 11:30 p.m. on March 10, six checks throughout March 11, three checks throughout March 12, and three checks throughout March 13.  These checks documented level of consciousness, pupil response, motor functions, pain response, vitals, and additional observations.  CMS Ex. 7 at 27.
• Medication Administration Record for March 2017.  This document shows a check mark (meaning that the medication was administered) and in a limited number of instances, the record shows a number “2” (meaning the medication was refused by Resident 2) for each day from March 10 through March 13, 2017.  In some instances, an “x” appears, which is an undefined symbol.  CMS Ex. 7 at 37, 39, 41, 43, 45, 47, 49, 51, 53, 55, 57.
• Consumption Record for March 10 through March 12, 2017.  This document involves an evaluation by staff of the quantity of food that Resident 2 ate at each meal.  There are notations that Resident 2 ate excellently, poorly, or refused food for each day.  CMS Ex. 7 at 33, 35.

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• Bowel Movement Record from March 11 through March 17, 2017.  Staff noted on March 12 and 13, 2017, Resident 2 had large bowel movements, one being loose and the other formed/normal.  P. Ex. 7 at 1-2.

Petitioner also provided testimony from staff at the facility indicating that they did not notice any discrepancies with the care provided to Resident 2 from March 10 through 13, 2017.  Maegan Weiss, a CNA at Petitioner’s facility, testified that she worked on March 10, 2017 and provided services to Resident 2, such as checking her bed, repositioning her, and toileting.  P. Ex. 28 ¶¶ 2-3.  Ms. Weiss further testified that she did not notice anything unusual about the care provided to Resident 2 and that “[t]here is also nothing that led me to believe that appropriate care was not being provided to Resident #2 on March 10, 2017 or at any other time.”  P. Ex. 28 ¶ 4.  Julie Bentley, the facility Activity Director, testified that she worked on March 10 and 13, 2017, and did not see anything out of the ordinary regarding Resident 2, and did not see any issues or problems that would lead her to believe that care had not been provided to Resident 2.  P. Ex. 24 ¶ 6.

Further, Petitioner submitted the written direct testimony for Jennifer Clayton, Pharm.D., who is the pharmacist who periodically reviews the prescriptions for Petitioner’s residents.  She reviewed Resident 2’s prescriptions and provided information as to the impact or side effects if those prescribed medications were not provided to Resident 2 for approximately two days, as CMS alleges.  P. Ex. 22 ¶¶ 5-7.  In relevant part, Dr. Clayton testified as follows concerning her analysis:

Arginaid packet – This drug is used for malnutrition/wound healing.  A two day lapse in therapy may increase the risk for a decrease in wound healing and exacerbate any current wound status.

Carbidopa-Levadopa ER 50-200 or 25-100 – This medication, known by its brand name Sinemet, is utilized to treat Parkinson’s disease.  A possible concern with missing such medication is dopamine agonist withdrawal syndrome.  Psychiatric symptoms include anxiety, panic attacks, dysphoria, depression, agitation, irritability, and fatigue.  Autonomic symptoms may include orthostatic hypertension and diaphoresis.  This medication is usually tapered slowing for discontinuation to avoid such symptoms.  Risk associated with withdrawal are directly correlated with the patient’s length of time using the medication, as well as his/her cumulative dopamine dosage.  The half-life of carbidopa-levadopa is very short, which makes it very feasible for such withdrawal symptoms to appear within a two day time period.

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Fentanyl patch 25 mcg/hour – Fentanyl withdrawal symptoms typically occur within 12 to 30 hours from the last dose of the opioid, which would be when the patch change is due.  Withdrawal symptoms include yawning, sweating, restlessness, tearing up, runny nose, chills, backache, stomach cramps, pain in joints and/or muscles, muscle weakness, nausea/vomiting, anorexia, diarrhea, elevated heart rate, hypertension, increase respiratory rate, insomnia, anxiety and pupil dilation.  It takes approximately 48 hours for a Fentanyl patch to reach a steady state, which means that pain relief may be slightly reduced or delayed upon re-initiation of the patch.

* * * * *

Lorazepam .5 mg – Lorazepam is a short acting benzodiazepine, meaning that abrupt withdraw symptoms may occur as early as 1 to 2 days after the last missed dose.  These symptoms may include anxiety, panic, seizures, trouble sleeping, nausea/vomiting, diarrhea, trouble concentrating, hallucinations, blurred vision, decreased appetite, heightened sensory perceptions, mood swings, short-term memory loss, suicidal thoughts and numbness in extremities.  Symptoms should improve after re-initiation of the medication.

* * * * *

Lubiprosone 24 mg – This medication is for constipation.  Missing doses leads to possible increased risk for rebound of constipation.

Senna 3 tabs – This medication is also for constipation.  Missing doses leads to possible increased risk for rebound of constipation.

* * * * *

Midodrine HCl 2.5 mg – This medication is used to treat orthostatic hypotension.  Hypotension can be caused by a neurogenic failure from the patient’s Parkinson’s disease.  Hypotension can result from an abrupt withdrawal of midodrine.  Discontinuation of midodrine should be accompanied by tight blood pressure monitoring.  A patient

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missing this medication would require more assistance due to increased risk for syncope (temporary loss of consciousness) and dizziness.

Entacapone 100mg – This medication is used for severe Parkinson’s, and it is a COMT inhibitor.  It is used to increase levels of dopamine.  An abrupt withdrawal of such medication may result in a significant worsening of Parkinson symptoms.  The likelihood of a worsening of such symptoms would be increased if – as alleged here – the Carbidopa-Levadopa (Sinemet) was also absent from the patient’s drug regimen.

P. Ex. 22 ¶ 9.  I credit Dr. Clayton’s testimony because she is a pharmacist, CMS did not cross-examine her, and her testimony is otherwise unrefuted.

Finally, Petitioner provided testimony from Roxanne Kula, RN, a nurse who works for a long-term care consulting company, who performed an analysis of the medical records for Resident 2 in conjunction with Dr. Clayton’s testimony.  P. Ex. 21.  Ms. Kula testified that assessments and medications are tracked and recorded through written documentation and that the standard is usually “if it is not documented, it was not done.”  P. Ex. 21 ¶ 7.  However, she also noted that “[c]ares – such as assistance with activities of daily living – are documented by exception, meaning that only out of the ordinary or irregular events are documented.”  P. Ex. 21 ¶ 7.

Ms. Kula stated that she reviewed the written documentation related to the medication, assessments, and cares provided to Resident 2 between March 10 to March 14, 2017, (i.e., the Medication Administration Record (P. Ex. 5), a Neurological Assessment Flow Sheet (CMS Ex. 7 at 27), a controlled substance usage count record for Fentanyl patch (P. Ex. 4), Progress Notes (P. Ex. 6), Resident 2’s bowel movement record (P. Ex. 7) as well as information provided by Dr. Clayton (P. Ex. 8) concerning the potential effects on Resident 2 if the facility had not provided multiple doses of Resident 2’s prescribed medications.  P. Ex. 21 ¶¶ 9-11.  Based on that review, Ms. Kula opined that appropriate and consistent care was rendered during March 2017.  P. Ex. 21 ¶ 22.

Ms. Kula elaborated that her conclusion was based on the fact that:  she did not see anything in the records concerning Resident 2 that would indicate the records were not reliable or had been modified to report actions that were not performed or completed; and the records were consistent with industry standards for documenting the provision of medication, assessments, and cares to residents.  P. Ex. 21 ¶¶ 19-21.  Ms. Kula also thought it significant that there was no indication that Resident 2 experienced symptoms related to withdrawal of her Parkinson’s disease medications or worsening of her Parkinson’s disease symptoms, or that Resident 2 showed signs of “rebound”

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constipation from a failure to provide Resident 2’s medicine for constipation, but rather there were large normally formed bowel movements on March 12 through 13 and March 15 through 17.  P. Ex. 21 ¶¶ 12-13.  Finally, Ms. Kula pointed out that Resident 2 was scheduled to have a Fentanyl patch changed every three days and that staff were required to write the date on which the patch was applied to Resident 2.  P. Ex. 21 ¶ 15.  Ms. Kula further testified that:

If the Fentanyl patch was not provided as alleged on either March 9, 2017 or March 12, 2017, the next staff person applying the Fentanyl patch would have seen the date on the patch and such date would have been greater than 3 days before the date they were changing the patch.  Staff would have reported this error as it would indicate that the patch had not been timely changed.  There were no staff reports of any issues with the date on Resident #2’s Fentanyl patch during this time period.

The Controlled Substance Usage Count Record for Resident #2, which provides the count records for Resident #2’s prescribed Fentanyl patch, shows that the counts for such patch were not incorrect during the time at issue.  [P. Ex. 4].  Some of the counts during that time period were conducted by staff other than the two alleged to have failed to provide the cares in the 2567 (Heidi Mueller, whose signature appears as “HMRN”, and Nichole Buckley, whose signature appears as “NBRN”).  If a Fentanyl patch had not been applied as prescribed, the count record would be off.

P. Ex. 21 ¶¶ 16-17.  I credit Ms. Kula’s testimony and opinion.  It is consistent with the record in this case and CMS did not cross-examine or otherwise discredit her testimony.  Ms. Kula has a nursing degree, is a registered nurse, has previously served as a nurse in an SNF, and has been a nurse consultant and supervisor of nurse consultants working with SNFs for many years.  P. Ex. 19.

Regarding Ms. Kula’s reference to the SOD’s allegations concerning Nurses Nichole Buckley and Heidi Mueller, Administrator Dunlap, Nurse Beck, CNA Weiss, CNA Schaffer, CNA Cole, Activity Director Bentley and dietary aid Moser testified that they had never known Heidi Mueller or Nichole Buckley to document anything that had not occurred and never had any concerns with how Ms. Mueller or Ms. Buckley provided care to residents. CNAs Weiss and Schaffer specifically noted that Ms. Mueller had been

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exceptionally good to Resident 2.The Iowa Board of Nursing declined to take disciplinary action against Nurses Buckley and Dunlap because it found the allegation that they neglected Resident 2 to be unfounded. P. Exs. 271-274.  P. Ex. 20 ¶ 22; P. Ex. 23 ¶¶ 3, 5; P. Ex. 24 ¶¶ 3, 5; P. Ex. 25 ¶¶ 3, 5; P. Ex. 26 ¶¶ 3, 5; P. Ex. 27 ¶¶ 3, 5; P. Ex. 28 ¶¶ 5-7.

7. According to video clips purportedly taken on March 12, 2017, at 2:22 p.m. and 6:22 p.m., facility staff left the door to Resident 2’s room open when, in each instance, Resident 2 was in bed and unclothed/uncovered from the waist down.

Video clip 181, which indicates that it was taken on March 12, 2017, starting at 2:22 p.m., shows Resident 2 lying down in her bed wearing a blouse but otherwise unclothed/uncovered below the waist.  The door is mostly open and the hall is visible through the open doorway.  No one is seen in the hallway during the video.  The head of the bed is within a short distance of the open door.  The video commences when a staff member steps into the room and looks around the end of the door at Resident 2.  The staff member leaves without fully entering the room.  After a short while, the staff member returns and fully enters the room and appears to speak with Resident 2.  The staff member does not cover Resident 2 and leaves without moving the door.  CMS Ex. 124.

Video clip 218, which indicates that it was taken on March 12, 2017, starting at 6:22 p.m., shows Resident 2 lying down in her bed wearing a blouse but otherwise unclothed/uncovered below the waist.  The door is mostly open and the hall is visible through the open doorway.  The video commences when a staff member steps into Resident 2’s doorway and quickly looks at her.  The staff member leaves and is briefly visible in the corridor.  Resident 2 then moves to a sitting position on the edge of the bed.  The door remains open and Resident 2 remains uncovered throughout the video clip.  CMS Ex. 161.

V. Conclusions of Law and Analysis

1. The probative and reliable evidence of record establishes that Petitioner was in substantial compliance with 42 C.F.R. §§ 483.24 and 483.25(k).

The Social Security Act (Act) establishes a variety of requirements for SNFs.  One is that an SNF “must care for its residents in such a manner and in such an environment as will promote maintenance or enhancement of the quality of life of each resident.”  42 U.S.C. § 1395i-3(b)(1)(A).  Further, consistent with all plans of care for the residents, SNFs must provide “nursing services and specialized rehabilitative services to attain or maintain the highest practicable physical, mental, and psychosocial well-being of each

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resident.”  42 U.S.C. § 1395i-3(b)(4)(A)(i).  The Secretary’s regulations implementing these requirements state:

Quality of life is a fundamental principle that applies to all care and services provided to facility residents.  Each resident must receive and the facility must provide the necessary care and services to attain or maintain the highest practicable physical, mental, and psychosocial well-being, consistent with the resident’s comprehensive assessment and plan of care.

42 C.F.R. § 483.24.

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

42 C.F.R § 483.25(k).

CMS’s evidentiary basis for believing that Petitioner failed to meet these requirements from March 10 through 13, 2017, regarding Resident 2, are the video clips provided by Resident 2’s family to IDIA.  More precisely, CMS bases this deficiency on the lack of video clips showing that Petitioner’s staff provided appropriate care and medical administration during the March 10 through 13, 2017 period.

However, as discussed above, it is far from clear that the hidden camera functioned properly and always recorded a video every time there was motion in Resident 2’s room.  Neither IDIA nor CMS obtained and analyzed the original recording equipment and the original data on the SD cards.  Given that Petitioner’s forensic data expert not only raised this concern but also pointed out how the video clips indicate multiple flaws in the hidden camera’s ability to always record when motion in the room occurred, I cannot uphold this deficiency based solely on the omission of video clips showing care and medical administration.

Further, the video clip evidence is problematic because J.M. provided it to IDIA months after it had been taken and there is simply no way of knowing if J.M. provided all the video clips.  J.M. had a lengthy and difficult relationship with Petitioner and multiple managers/nurses at the facility.  She was known among staff to be upset with the nurses who were chiefly involved in this matter.  CMS neither provided written direct testimony from J.M. nor requested a subpoena to compel her testimony at the hearing.  CMS also did not seek a subpoena for J.M. to provide the original hidden camera and the original SD cards.  While I do not conclude that the video clips are entirely unreliable; as a group,

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they are not reliable to prove that Petitioner did not provide care and medicine to Resident 2.

This is especially so because Petitioner has significant records showing that it provided all necessary care and medicine administration.  While the surveyor discounted this evidence, I have accepted the testimony of Ms. Kula that these records appear legitimate and properly kept.  Further, the testimony of Dr. Clayton is important because, had Resident 2 not received any of her medications, there are multiple problems that could have been observed with Resident 2.  Even J.M. did not report any negative effects on Resident 2, and she was present at work for all but one day during the relevant period and would have seen Resident 2.  I have no reason to question the facility’s records.

Although my decision stands on its own, I note that I am not the first person to conclude that the video evidence is insufficient to show that care had not been provided to Resident 2.  The IDR and IIDR reviewers concluded this.  Further, the Iowa Nursing Board found:  “The allegation that [facility nurses Buckley and Mueller] failed to perform necessary cares to [Resident 2] during . . . shifts on 03-10-17 through 03-12-17 is not supported by a preponderance of the evidence.  ‘Nanny cam’ video that purports to show the necessary cares were not provided as documented is not reliable.”  P. Exs. 273-274.

2. Petitioner was not in substantial compliance with 42 C.F.R. § 483.10(h) because Petitioner failed to afford Resident 2 privacy when staff kept Resident 2’s room door open while leaving Resident 2 unclothed and uncovered from the waist down on March 12, 2017.

 The Act affords residents a “right to privacy with regard to accommodations . . . .”  42 U.S.C. § 1395i-3(c)(1)(A)(iii).  The Secretary implemented this provision as follows:

Privacy and confidentiality.  The resident has a right to personal privacy . . . .

(1) Personal privacy includes accommodations, medical treatment, written and telephone communications, personal care, visits, and meetings of family and resident groups, but this does not require the facility to provide a private room for each resident.

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42 C.F.R. § 483.10(h)(1).The Secretary revised part 483 regulations concerning SNF conditions of participation in 2016, including 42 C.F.R. § 483.10. 81 Fed. Reg. 68,688 (Oct. 4, 2016); 82 Fed. Reg. 32,256 (Jul. 13, 2017) (technical corrections). The regulation concerning resident privacy rights was originally located in paragraph (e) of § 483.10. It was moved, with substantive changes to paragraph (h). In assessing compliance under § 483.25(h) in this case, I consider case decisions analyzing the former § 483.25(e)  Therefore, this regulation interprets the statute to ensure each resident’s right to personal privacy in their accommodations, medical treatment, and personal care.

As described above in the seventh finding of fact, there were two instances on March 12, 2017, in which Resident 2’s room door was mostly open and Resident 2 was unclothed and uncovered from the waist down.The SOD also discussed video clip 56 taken on March 11, 2017, regarding this deficiency. I do not rely on the video clip in upholding this deficiency because staff only left Resident 2’s door slightly open. CMS Ex. 12.  Staff were seen checking on Resident 2 from the doorway, indicating that she was visible from either the hallway or by stepping one foot into the room.

Petitioner asserts it was in substantial compliance with the privacy requirement for residents.  Ms. Dunlap testified that Resident 2 was at risk for skin breakdown and, as a result, sleeps unclothed from the waist down.  P. Ex. 20 ¶¶ 10-11.  Ms. Dunlap also testified that it would be almost impossible to see Resident 2 from the hallway “even if the door was cracked or partially open.”  P. Ex. 20 ¶ 12.  Finally, Ms. Dunlap testified that because Resident 2 is a fall risk, her door must remain open.  P. Ex. 20 ¶ 13.Although I have significant concerns as to whether the hidden camera recorded all motion in Resident 2’s room or, in the alternative, that J.M. provided IDIA with all of the video clips made by the hidden camera, I do not extend my concerns to the content of the two video clips relevant to this deficiency. Petitioner provided testimony from several witnesses who work at the facility and none of them indicated that the video clips inaccurately show Resident 2’s room layout or how widely open staff keep Resident 2’s door. In fact, Ms. Dunlap’s testimony corroborates that Resident 2 sleeps without being clothed on her lower body and that staff leave her door open.

Further, Petitioner argued the following:

A review of the videos shows that no one – other than staff members – saw Resident #2 in a state of undress or that there was any violation of Resident #2’s privacy.  Tr. 113:22-114:1.  A staff member seeing Resident #2 is not a privacy

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violation, because the staff member has to see Resident #2 in order to complete his/her job duties.  Tr. 114:2-114:4.  The videos also show that it would have been very difficult if not impossible for anyone in the hallway to see Resident #2 – even with the door open or partially open – due to the position of the bed in the room.  CMS Ex. 12 (video 56); CMS Ex. 124 (video 181); CMS Ex. 14 (video 218); Tr. 108:8-108:11 (describing position of bed in videos).  [The surveyor] admitted that with regard to CMS Ex. 12, which is video 56, in order to see Resident #2, someone would have had to stick their head through the door and look around the door or “peek in” in order to see Resident #2 in her bed.  Tr. 107:21-108:7.  With regard to CMS Ex. 124 (video 181), [the surveyor] admitted that she “could not say for sure” whether anyone would be able to see in Resident #2’s room if they were coming from one direction down the hallway, and she admitted they would “probably not” be able to see Resident #2 without sticking their head into the room if they were coming from the other direction.  Tr. 109:22-109:18.

P. Br. at 26-27.

Petitioner’s arguments are not availing.  Petitioner’s resolution to Resident 2’s situation (i.e., needing to protect her skin and needing to monitor her as a fall risk) cannot be to leave the door open so that anyone stepping one foot into the room can see Resident 2.  Neither nurse in the videos had much difficulty looking in to assess that Resident 2 was alright; therefore, it was easy to see Resident 2.  Keeping the door open so wide along with the bed positioned so closely to the doorway required an additional effort to protect Resident 2’s privacy.

In a previous case, the DAB upheld a privacy deficiency because the facility failed to have staff await permission from residents to enter their rooms and for failing to properly cover residents during the provision of care.  It stated:

The Statement of Deficiencies stated that Price Hill failed to afford residents the right to personal privacy . . . .  The surveyors interviewed four residents who complained that staff knocked on the closed doors to their rooms but then entered without waiting for the resident to state that they may come in.  In addition, on September 24, the surveyors observed two residents, Resident 4 and Resident 31, who were receiving personal care in their rooms without being properly covered or draped when the curtain was only

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partially pulled or not pulled at all.  The surveyors noted that other staff entered these residents’ rooms during this time without waiting for a response from the staff providing the care. . . .  Thus, there is substantial evidence to support the ALJ’s finding of a deficiency.

Price Hill Nursing Home, DAB 1781 at 10 (2001).

In another case, the DAB affirmed an ALJ who “conclude[d] that the evidence shows that [the resident’s] body was exposed to view from the hallway and that Petitioner’s staff did not take steps to ensure [the resident’s] privacy by closing the privacy curtain or door or otherwise covering [the resident].”  Ivy Woods Health Care & Rehab. Ctr., DAB CR1093 at 11 (2003) aff’d, DAB No. 1933 (2004).  The United States Court of Appeals for the Sixth Circuit also affirmed, noting that “[a]s we read it, however, the surveyor’s observation supporting the violation plainly pointed to the failure to just close the door.”  Ivy Woods Healthcare & Rehab. Ctr. v. Thompson, 156 F. App’x 775, 777 (6th Cir. 2005).  Therefore, there must be a sufficient barrier between a resident who is unclothed/covered from individuals who may pass by in the hall and look in the resident’s room.

I conclude that there was the potential for more than minimal harm to Resident 2 based on her normal practice of sleeping unclothed from the waist down and uncovered and staff’s decision to leave her door mostly open without taking any other steps to ensure her privacy.

3. The $11,000 per-instance CMP for the deficiency at 42 C.F.R. § 483.10(h) is not reasonable under the statutory and regulatory factors for setting the amount of a CMP.  Based on those factors, a $2,097 per-instance CMP is appropriate.

CMS imposed an $11,000 per-instance CMP on Petitioner for the deficiency under 42 C.F.R. § 483.10(h).

CMS simply asserts that Petitioner’s deficiency caused actual harm and that is sufficient to show the $11,000 penalty is reasonable.  CMS Br. at 8.

Petitioner asserts that there was no actual harm in this case, thus necessitating a reduction in the CMP amount.  P. Br. at 32.  Previously, Petitioner had argued that it has no history of non-compliance since 2014.  P. Prehearing Br. at 21.

When determining whether a CMP amount is appropriate, 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,

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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 sections 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).

Facility’s History of Non-Compliance:  CMS makes no representation that Petitioner has a history of non-compliance and Petitioner submitted evidence that it had no deficiency findings for years prior to the survey in this case.  P. Exs. 10-12.  Therefore, this is not a factor that supports a moderately high CMP amount.

Scope and Severity of Deficiencies and Relationship Between Deficiencies:  CMS concluded that the deficiency in this case involved actual harm.  Because the CMP imposed was a per-instance CMP, Petitioner has no right to dispute the scope and severity level of the deficiency.  However, for purposes of the CMP amount analysis, I note that the record does not support actual harm occurred, although there was certainly a potential for more than minimal harm.  Therefore, I do not weigh this factor heavily.

Culpability:  Neither party discussed this factor; however, the record does not support significant culpability given that health and safety considerations were the basis for Resident 2 to be unclothed from the waist down and her door left partially open.

Financial Condition of the Facility:  Petitioner presents no evidence of its financial condition.  Therefore, this is not a factor requiring further consideration.

CMP Amount:  I conclude that a mid-range CMP is excessive based on the factors considered in this case.  A minimal CMP of $2,097 is sufficient.

VI. Conclusion

For the reasons set forth above, I conclude that:

1. Petitioner was in substantial compliance with 42 C.F.R. §§ 483.24 and 483.25(k);

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2. Petitioner was not in substantial compliance with 42 C.F.R. § 483.10(h);
3. CMS’s imposition of a per-instance CMP in the amount of $11,000 is excessive given the limited factors and circumstances in favor of such a high amount, and a CMP of $2,097 is appropriate.