Sierra View Homes, DAB CR6182 (2022)

DECISION

I sustain the determination of the Centers for Medicare & Medicaid Services (CMS) to impose per-instance civil money penalties of $12,500 and $5,000 against Petitioner, Sierra View Homes, a skilled nursing facility.¹

I. Background

This case emanates from a survey that was conducted at Petitioner’s facility by surveyors from the California Department of Public Health, completed on April 21, 2021.  Based on the survey findings, CMS determined that Petitioner failed to comply with regulatory requirements at 42 C.F.R. §§ 483.25(h) and 483.80.²  CMS determined to impose civil money penalties as remedies for these noncompliance findings.

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Petitioner appealed.  On July 21, 2022, I held an in-person hearing for the purposes of receiving documentary evidence and the cross-examination and redirect testimony of witnesses whose affidavits or declarations were in evidence.  I received exhibits from CMS, identified as CMS Ex. 1-CMS Ex. 5, CMS Ex. 27, and CMS Ex. 33-CMS Ex. 51.  I received exhibits from Petitioner, identified as P. Ex. 1-P. Ex. 10.³  The parties filed post-hearing briefs.

II. Issues, Findings of Fact and Conclusions of Law

A. Issues

The issues are whether Petitioner failed to comply substantially with Medicare participation requirements and, if so, whether the civil money penalty amounts imposed are reasonable.

B. Findings of Fact and Conclusions of Law

1. Noncompliance with the requirements of 42 C.F.R. § 483.25.

The relevant regulation requires that a skilled nursing facility provide each of its residents with the necessary care and services to allow that resident to attain or maintain the highest practicable physical, mental, and psychosocial well-being, in accordance with the resident’s comprehensive assessment and plan of care.  The regulation provides additionally that a skilled nursing facility must administer parenteral fluids: “consistent with professional standards of practice and in accordance with physician orders, the comprehensive person-centered care plan, and the resident’s goals and preferences.”  42 C.F.R. § 483.25(h).

CMS alleges that Petitioner failed to comply with this requirement because it did not assure that its staff properly managed a medical device known as a “PICC line.”  A PICC line is a long intravenous tube or catheter that is inserted into a patient’s peripheral vein (often, the patient’s arm) and threaded to a larger vein in the resident’s chest, near the heart.  CMS Ex. 46 at 5 (¶ 9).  The purpose of a PICC line is to administer parenteral medications to a patient, which may include antibiotics.  A PICC line may be implanted in a patient for an extended period – days or weeks – while therapeutic medications are provided through it.

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There are known risks associated with implantation and management of a PICC line.  Among these is a risk of infection associated with the possible introduction of bacteria into a patient’s body.  That might occur if the exterior of the line is contaminated or because a contaminated substance is introduced via the line.  Consequently, it is imperative that sterile procedures be employed in administering the line.  CMS Ex. 46 at 5-6 (¶¶ 13-14).

CMS premises its noncompliance allegations on the PICC line care that Petitioner’s staff provided to a resident who is identified as Resident 32.  Petitioner admitted this resident on March 19, 2021, immediately after her discharge from a hospital.  CMS Ex. 27 at 1, 11-17.  She came to Petitioner’s facility with a newly implanted PICC line with its tip in a major vein close to the interior of her heart.  Id. at 14.  The PICC line had been implanted to facilitate the administration of parenteral antibiotics to the resident.  The antibiotics – which were to be administered over a period of eight weeks – were prescribed to treat an epidural abscess, an infection between the resident’s skull and the lining of her brain.  Id. at 16.

Petitioner’s medication administration record documented that Resident 32 received through her PICC line an antibiotic, Rocephin, in the amount of 2 grams daily mixed with 50 ml of saline solution.  Id. at 31-32, 36.

CMS alleges that Petitioner’s staff committed a series of errors in managing Resident 32’s PICC line.  I find that several of these allegations are supported by the evidence offered by CMS and are not rebutted by Petitioner.

These errors are significant given the risks associated with implantation and management of PICC lines and, in particular, Resident 32’s PICC line.  PICC lines are not simple intravenous lines or catheters.  As I have discussed, they must be managed with extreme care to avoid the possibility of admitting pathogenic bacteria deep within a patient’s body.  Casual or imprecise management of a PICC line can pose grave risks to a patient.  Resident 32’s PICC line, terminating within her body close to the interior of her heart, had to be monitored closely and in exact accord with relevant protocol to protect the resident from a potentially lethal infection.

CMS alleges, and the evidence establishes, that Petitioner did not write and implement a plan of care for management of Resident 32’s PICC line.  In particular, the resident’s plan of care failed to address the placement and management of port caps on the resident’s PICC line connectors.  This is a violation of Petitioner’s own policy governing management of PICC lines.  The policy directs that Petitioner’s staff discard tubing that lacks a sterile cap at its end.  P. Ex. 1 at 5-6.

A plan of care is a road map of the care that a skilled nursing facility intends to provide to a resident.  To be meaningful, the plan must describe exactly what care will be provided.

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Concerning Resident 32, the plan of care should have provided instructions for management of the resident’s PICC line.  Specifically, it ought to have spelled out whether the resident’s PICC line required port caps.  That was necessary to instruct Petitioner’s staff on how to manage the resident’s PICC line.  However, the plan of care for Resident 32 fails to address this issue.  CMS Ex. 27 at 44.

The failure of the plan of care to address the issue of port caps became important in Resident 32’s case because at times her PICC line apparently had needleless connectors that did not require a port cap and at other times it had connectors requiring port caps.  Yet the plan left the staff in the dark as to PICC line management.

There is no dispute that when the California Department of Health surveyors observed the resident on April 21, 2021, the resident’s PICC line lacked port caps.  That meant that Resident 32’s PICC line potentially was unprotected from admission of pathogens through its capless ends.

Petitioner contends that when Resident 32 came to the facility her PICC line had connectors that did not require the placement of port caps.  Petitioner’s post-hearing brief at 8-9.  Thus, according to Petitioner, putting port caps on the resident’s line would have been unnecessary.  However, at some point after the resident’s admission to Petitioner’s facility, the staff changed the needleless connector on the resident’s PICC line to one that required port caps.  Tr. at 118-19.  Even if Resident 32’s PICC line initially had connectors that did not require port caps, Petitioner’s staff should have immediately documented the change to connectors requiring port caps and should have written a care plan addressing that change.  Its failure to do so was a missing element in the plan of care for Resident 32 that put her at risk of infection.

It is unclear from the medical record exactly when Resident 32’s PICC line connectors were changed because Petitioner’s staff did not document that event.  Petitioner’s staff would have had no way of knowing from casual observation of the resident’s PICC line whether missing caps were significant and in violation of Petitioner’s policy.

CMS alleges additionally that Petitioner’s staff failed to change Resident 32’s PICC line dressing timely.  CMS’s post-hearing brief at 8-12.  I find that the record unambiguously supports this allegation.  This failure posed a risk of harm to Resident 32 because providing the resident with sterile and timely changed dressings is a barrier to possible infection.  The Centers for Disease Control and Prevention (CDC) guidelines for dressing changes in conjunction with maintenance of PICC lines specify that dressings should be changed at least every seven days.  CMS Ex. 27 at 87.  Any failure to satisfy these guidelines puts a patient at risk of infection.  This is not some minor hazard for, as I have discussed, infections associated with PICC lines can travel deeply into a patient’s body.  Tr. at 47.

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Petitioner was supposed to change Resident 32’s dressing every seven days, consistent with CDC guidelines.  P. Ex. 7 at 3 (¶ 10).  Dressing changes occurred on Mondays.  The resident was due for a dressing change on Monday, April 5, 2021 (her previous dressing change was on Monday, March 29, 2021).  P. Ex. 2 at 32.  However, staff did not change her dressing until Wednesday, April 7, 2021, nine days after the March 29 change. P Ex. 2 at 24. 

Petitioner argues that the delay in dressing change occurred because the staff member who was attending to Resident 32 lacked sterile gloves of the appropriate size on April 5, 2021, the date when the dressing change should have occurred.  Tr. at 120-22.  This is no excuse.  By Petitioner’s own account, there were other members of Petitioner’s staff who could have performed a dressing change on April 5.

Petitioner also argues that the resident’s dressing was changed on April 14, 2021, therefore establishing that its staff performed weekly dressing changes as directed.  Petitioner’s post-hearing brief at 7-8.  This argument begs the question because it does not address the delay in changing the resident’s dressing that occurred between March 29 and April 7, 2021.

CMS argues further that Petitioner did not demonstrate that its nursing staff was periodically and systematically evaluated on its ability to provide PICC line care.  CMS’s post-hearing brief at 14-17.  I sustain this allegation.

It is true, as Petitioner asserts, that there is no requirement in law that nurses receive special certification to manage a PICC line.  Petitioner’s post-hearing brief at 3-4.  But that doesn’t gainsay the requirement that every nurse who manages a PICC line must have the requisite competence and skills to do so.  PICC line care isn’t just routine nursing care.  It is critical that any nurse who manages a PICC line be cognizant of, and alert to, the risk for potentially lethal infection that attends mismanagement of one of these lines.

Petitioner’s PICC line management policy recognizes that PICC line management is something that exceeds basic nursing skills.  Under the heading “PRACTICE LEVEL COMPETENCIES,” that policy states: 

Changing the dressing on an uncuffed PICC is considered an advanced nursing skill.

CMS Ex. 27 at 80.  Petitioner’s policy is consistent with professional practice standards.  Nurses who perform infusion therapy – including management of PICC lines – should have the advanced training and experience commensurate with their assigned tasks.  This training may exceed that which nurses obtain in nursing schools.  CMS Ex. 42 at 21.

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Petitioner’s policy mandates annual performance reviews of its nursing staff to assess their clinical skills and competence.  CMS Ex. 41 at 22.  That policy emphasizes that reviews will focus on advanced skills (“higher acuity levels”) of nursing services that include intravenous services and infusion.  Id.  This policy is consistent with CDC guidelines that emphasize the importance of periodic evaluation of nurses’ competence.  The CDC asserts that facilities with PICC line patients should: 

Periodically assess knowledge of and adherence to guidelines for all personnel involved in the insertion and maintenance of intravascular catheters.

CMS Ex. 27 at 85.

However, there is no evidence showing that Petitioner did annual performance reviews of its staff’s competence, and no evidence showing that it assessed periodically its nursing staff’s competence to manage PICC lines.  Petitioner’s records showed only three competence evaluation forms for staff members, none of which is dated after 2019, and none of which addressed PICC line management competence.  CMS Ex. 40.  None of Petitioner’s witnesses testified that Petitioner performed reviews of its staff’s competence to manage PICC lines.  See P. Ex. 7-P. Ex. 10; Tr. at 106-28.

In its defense, Petitioner argues that management of PICC lines is an element of basic registered nursing training, and consequently, a task that all its registered nurses are taught to perform.  As support for this assertion, it offered the testimony of Rebecca Ann Zulim, M.D., a co-medical director of Petitioner’s facility.  P. Ex. 7 at 2-3.  Dr. Zulim testified, additionally, that the nurses that Petitioner assigned to care for Resident 32 had the training and skills necessary to manage the resident’s PICC line.  Id. at 3.

But asserting that registered nurses’ basic education and experience includes PICC line management does not address the fact that PICC line management is an advanced skill that must be measured with competence evaluation.  While Petitioner’s registered nurses may have been trained in PICC line management and may have had experience managing PICC lines, it was nonetheless critically important – given the risks attendant with PICC lines – that Petitioner’s management assure that the registered nurses maintained their skills.  Petitioner failed to do this.

CMS makes an additional assertion that I find to be unsupported by the evidence.  CMS contends that Petitioner failed to obtain a physician’s order for administration of medications to Resident 32.  CMS’s post-hearing brief at 6-8.  However, the resident’s treatment record plainly shows a prescription by the resident’s physician for the medications and fluids that the staff was to administer.  CMS Ex. 27 at 27-29.

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Finally, CMS alleges that Petitioner’s staff caused Resident 32 to experience pain by wrapping the resident’s PICC line dressing too tightly.  CMS’s post-hearing brief at 12-14.  The undisputed evidence proves that Petitioner used a pressure dressing, Coban.  Tr. at 108.  A surveyor observed the dressing being removed by a member of Petitioner’s staff.  As this was done, the resident complained to the surveyor that her arm hurt.  CMS Ex. 46 at 11 (¶ 33).

I do not find this evidence sufficient to prove that Petitioner’s staff harmed Resident 32 by wrapping a dressing too tightly.  The evidence is insufficient to establish whether the Resident’s pain was caused by the wrapping or by something else.⁴  Nevertheless, the several serious errors that Petitioner and its staff committed in managing Resident 32’s PICC line, and that I have discussed above, are sufficient for me to conclude that Petitioner failed to care for the resident consistent with the requirements of 42 C.F.R. § 483.25(h).

2. Noncompliance with the requirements of 42 C.F.R. § 483.80

The regulation and its subsections require that a skilled nursing facility establish and maintain an infection prevention and control program that is “designed to provide a safe, sanitary, and comfortable environment and to help prevent the development and transmission of communicable diseases and infections.”  CMS cites to several surveyor findings to support its contention that Petitioner failed to comply with this overall regulation and some of its subsections.

CMS asserts that surveyors found that Petitioner’s facility had unsanitary or unsafe features that either contravened regulatory language, Petitioner’s policies, or professionally recognized practice standards governing infection prevention and control.

I find these allegations to be well-supported by the evidence.

 a. Failure to label oxygen tubing

Tubing that is used to supply supplemental oxygen to residents can transmit communicable disease if it is not replaced regularly.  CMS Ex. 48 at 6 (¶ 15).  As a rule, the longer tubing is in place, the greater the opportunity for bacteria to lodge in the tubing and grow.  Id. at 6 (¶ 15).  Petitioner’s policy is to change oxygen tubing weekly.  Id. at 7 (¶ 19).

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The risk of pathogens growing on tubing that is used for too long a period mandates a skilled nursing facility not only to change the tubing regularly but to implement a system for identifying how long tubing has been in use.  Without labeling or otherwise identifying the tubing, staff will not be able to ascertain whether it needs to be replaced.

The undisputed evidence establishes that Petitioner’s staff failed to label or otherwise identify the period that oxygen tubing was in use for one of its residents.  CMS Ex. 48 at 5-7 (¶¶ 10-16).  That failure made it difficult, if not impossible, for staff to ascertain how long tubing was in use and created a risk that infection would spread via contaminated tubing.

Petitioner offered neither evidence nor argument to rebut CMS’s allegations.

b. Failure to disinfect glucometers properly.

I take notice that a glucometer is a device that is used to measure a patient’s blood sugar level.  The glucometer pricks the patient’s skin, producing a small quantity of blood that is then tested.

There is a risk of infection attendant with the use of a glucometer.  According to CDC guidance, if a glucometer is used on more than one individual, all residual blood must be removed, and the glucometer must be disinfected before it is reused.  Improper disinfection of glucometers has been associated with disease transmission via blood-borne pathogens such as Hepatitis B and C.  But even if the glucometer is used on only one individual, it must be disinfected between uses to remove contaminants other than blood-borne pathogens that might accumulate on the instrument’s surface.  CMS Ex. 44 at 2-5.

Petitioner’s policy for disinfecting glucometers is consistent with CDC guidance, requiring that glucometers be cleaned and disinfected after each use.  CMS Ex. 41 at 2; CMS Ex. 43 at 7.

Evidence establishes that Petitioner’s staff were not trained adequately in glucometer disinfection techniques.  There is no evidence to show that Petitioner conducted such training or that it gave precise instructions to its staff about disinfection.

Petitioner’s staff were left to use their own judgment about disinfection techniques.  Unsurprisingly, staff members used varying techniques.  See Tr. at 122.  Staff could not offer any informed assurance that the techniques that they were using were appropriate.  When asked, staff gave conflicting answers as to the length of time that the surface of the glucometers should be moist with disinfectant (“dwell time”) ranging from one to ten minutes.  CMS Ex. 47 at 9-10 (¶¶ 24-27, 29).  One staff member did not know what the expression “dwell time” meant.  Id. at 9 (¶ 26).

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The risks associated with inconsistent and possibly improper disinfection are obvious.  Petitioner had multiple residents with blood sugar issues who were being monitored via glucometers.  CMS Ex. 51 at 4-5.  The fact that possibly contaminated glucometers were in use put residents at risk for harm.

Petitioner argues that the glucometers that its staff used were all dedicated to individual residents.  Petitioner’s post-hearing brief at 15; P. Ex. 8 at 9 (¶ 42).  It asserts that the evidence offered by CMS as to disinfection is “largely irrelevant” because there was no risk that residents could be infected by contaminated glucometers, as glucometers were not shared.  Petitioner’s post-hearing brief at 15.

However, Petitioner has not offered proof showing that there was no risk that a glucometer designated for one resident’s use could not be inadvertently used on a second resident.  In a skilled nursing facility with numerous residents – many of whom have blood sugar issues – there is an ongoing risk that equipment might be used inadvertently on more than a single resident.  Proper disinfection of glucometers after each use was necessary even if those glucometers were dedicated to individual residents.

Petitioner asserts that there is no regulatory requirement that glucometers that are not shared by residents be cleaned after each use.  Petitioner’s post-hearing brief at 15.  But Petitioner’s policy expressly required that all glucometers be disinfected after each use.  If Petitioner wanted to modify that policy to reflect some change in the way its staff used glucometers, it should have done so in writing and not allow its staff to make ad hoc decisions about disinfection.

Moreover, there is a risk of indirect contact transmission from an improperly sanitized glucometer.  Blood remaining on an improperly sanitized glucometer might be transferred to other residents by staff when they handle the glucometer and then subsequently draw blood.  CMS Ex. 44 at 3.

 c. Failure to assure that pill cutters were cleaned properly

I take notice that a pill cutter is a mechanical device that is used to divide pills.  In a skilled nursing facility, it is important to clean a pill cutter after it is used because, if not cleaned, medication residue from the cutting process might mix with other contraindicated medications.  CMS Ex. 47 at 7 (¶ 18).

A surveyor observed several pill cutters on two of Petitioner’s medication carts that were contaminated with visible medication residue.  CMS Ex. 47 at 6 (¶¶ 13, 15).  Petitioner’s director of nursing rebutted this finding by denying that there was more than one pill cutter and by asserting that only one medication cart contained a pill cutter.  P. Ex. 8 at 8 (¶ 40); Tr. at 112.  I find the surveyor’s testimony to be credible, this rebuttal notwithstanding, because she personally observed the medication carts.  By contrast, the

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director of nursing’s testimony did not recite personal observation of the carts during the survey.

The failure by staff to clean the pill cutters after use posed a hazard of cross-contamination for residents of Petitioner’s facility.

Petitioner argues that a pill cutter was used to divide medication for only one resident in its facility.  Petitioner’s post-hearing brief at 14; P. Ex. 8 at 8 (¶ 40); Tr. at 85.  Therefore, according to Petitioner, there could be no risk of cross-contamination of medication.  I find Petitioner’s evidence and argument to be unpersuasive.  As I have discussed, the credible evidence is that the surveyors observed multiple pill cutters on two medication carts.  The inescapable inference is that the pill cutters were being used on more than one resident.

Petitioner asserts that pill cutters were stored in appropriate compartments, each labeled with the name of the resident for whom the pill cutter was intended.  Petitioner’s post-hearing brief at 14; P. Ex. 6.  However, the surveyors found pill cutters on the facility’s medication carts rather than in the “cubbies” where the residents’ medication was stored.

Finally, Petitioner asserts that the surveyor did not observe the pill cutters in actual use.  Petitioner’s post-hearing brief at 14.  That may be true, but the surveyor did observe the pill cutters to be contaminated with medication residue.  The finding of residue on the pill cutters leads to the inference that these devices were in actual use.

d. Presence of an unclean ice machine in Petitioner’s dining room

There is no dispute that surveyors observed an ice machine in Petitioner’s dining room that was visibly dirty, manifesting gray jelly-like substances, black fuzzy spots on top, a soiled covering for the drip tray, and a soiled drain tray.  CMS Ex. 1 at 70-71.  Nor is there any dispute that there were residents at Petitioner’s facility, using the dining room, that suffered from medical conditions that made them vulnerable to harm resulting from ingesting contaminated ice.  CMS Ex. 51.

Petitioner’s defense is to argue that the ice machine was not in use.  Petitioner’s post-hearing brief at 13.  Petitioner contends that ice provided to its residents came from an ice machine in Petitioner’s kitchen rather than from the machine in the dining room.  Id.  As alleged corroboration for this assertion, Petitioner contends that its ice machine cleaning log establishes that the dining room ice machine had not been used since April 2020.  Petitioner’s post-hearing brief at 13; see CMS Ex. 34.

Petitioner’s principal support for its contention that the dining room ice machine was not in use is the testimony of its director of nursing.  P. Ex. 8 at 9 (¶ 44).  Her testimony

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consists of a blanket assertion rather than personal observation.  See Id.  She did not aver that she was in the dining room on the date of the survey and that she personally observed the dining room ice machine not to be functioning on that date.

I find that a surveyor’s personal observation of the ice machine is more credible evidence of its status.  The surveyor testified that she observed the dining room ice machine in use and supplying ice directly to residents.  Tr. at 71, 74.

As for the entries in the cleaning log, the maintenance employee was not called as a witness, and he did not testify about his personal observation of the machine.  There is no evidence that the maintenance employee personally observed the dining room ice machine on the date of the survey.  I conclude that the cleaning log does not rebut the surveyor’s in-person observation because at best it reflects the maintenance employee’s determinations about whether the machine was in use and does not document any personal observation made on the date of the survey.

3. Remedies

There are two remedies at issue in this case:  a $17,320 per-instance civil money penalty that CMS imposed to address Petitioner’s noncompliance with 42 C.F.R. § 483.25, and a $5,000 per-instance civil money penalty that CMS imposed to address Petitioner’s noncompliance with 42 C.F.R. § 483.80.  Both penalties fall within the permissible range for per-instance civil money penalty amounts.  42 C.F.R. § 488.438(a)(2); 45 C.F.R. Part 102 (2020).

a. The $17,320 per-instance civil money penalty

Whether a civil money penalty amount is reasonable depends on evidence relating to one or more factors, including the seriousness of a facility’s noncompliance.  42 C.F.R. §§ 488.438(f)(1)-(4), 488.404 (incorporated by reference into 42 C.F.R. § 488.438(f)(3)).  I find that the magnitude of the potential harm to Resident 32 resulting from Petitioner’s failure to properly manage that resident’s PICC line amply justifies a per-instance penalty that CMS determined to impose. However, and as I explain, the amount of $17,320 is too high given that the evidence does not sustain  all of the allegations of PICC line mismanagement made by CMS.

CMS initially determined that Petitioner’s noncompliance with 42 C.F.R. § 483.25 was so egregious as to put Resident 32 in a state of immediate jeopardy.⁵  I reach no conclusion whether that determination was clearly erroneous.  That is because a finding

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of immediate jeopardy is not a necessary element of a finding that a per-instance civil money penalty is reasonable.  42 C.F.R. § 488.438(a)(2).

Although the presence or absence of immediate jeopardy is not a factor in determining the reasonableness of a per-instance civil money penalty, seriousness of noncompliance is.  As I have discussed, improper management of a PICC line can cause a patient to experience a serious, even lethal, infection.  The errors committed by Petitioner’s staff in managing Resident 32’s PICC line were certainly serious.  Failure to plan the management of the resident’s PICC line and to ensure that the line’s connectors had port caps – after the line no longer had needleless connectors – posed a serious risk of bacterial contamination via the ports.  Failure to change the resident’s dressing as required posed an additional risk for infection.  Failure to assure that Petitioner’s staff maintained the requisite skills and competence to manage a PICC line created a risk that a resident might be harmed by staff error.

However, not all of the allegations made by CMS concerning Petitioner’s management of Resident 32’s PICC line are supported by the evidence.  CMS asserted that Petitioner failed to obtain a physician’s prescription for administration of medications to Resident 32.  In fact, the record plainly shows the physician’s orders for administration of medication.  CMS alleged additionally that the resident was harmed by a dressing that was too tight.  The evidence is equivocal on that issue.  The consequence of these unestablished allegations is that the level of potential harm to Resident 32 was somewhat less than CMS contended it to be.  For that reason I am reducing the civil money penalty from the $17,320 that CMS determined to impose to $12,500.

Petitioner has not offered evidence or argument to challenge this penalty amount aside from contending that it should be rescinded because Petitioner in fact complied with regulatory requirements.  I have rejected Petitioner’s compliance assertions.

b. The $5,000 per-instance civil money penalty

The $5,000 per-instance penalty is modest, comprising only one-quarter of the permissible maximum of per-instance civil money penalties.  45 C.F.R. Part 102 (2020).  I find it to be reasonable given the relative seriousness of Petitioner’s failures to comply with the infection control requirements of 42 C.F.R. § 483.80.  For example, the failure by Petitioner’s staff to label oxygen tubing plainly posed a risk that residents would use tubing for a prolonged and unsafe period, increasing the risk that these residents might acquire an infection from contaminated tubing.  Similarly, Petitioner’s failure to establish and enforce protocols for cleaning glucometers created a risk of harm to residents.

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As is the case with the $17,320 civil money penalty, Petitioner offers no challenge to the reasonableness of the $5,000 penalty amount aside from contending that it complied with regulatory requirements.

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Endnotes

¹ At the hearing of this case, I stated that the “larger of the two” penalty amounts is “roughly” $10,000.  Tr. at 2-3.  That misstatement does not prejudice Petitioner because CMS consistently put Petitioner on notice and argued that the larger penalty amount is $17,320.

² The California Department of Public Health surveyors alleged numerous additional alleged failures by Petitioner to comply with Medicare participation requirements.  CMS did not make remedy determinations based on these additional allegations.  Consequently, they are not at issue.

³ I also receive P. Ex. 11.  This exhibit was inadvertently omitted from the exhibits received at the hearing.

⁴ CMS also offered evidence that the resident’s arm had non-blanchable areas on it, suggesting that pressure had caused an impairment of circulation to the skin.  I find this evidence to be equivocal.

⁵ “Immediate jeopardy” is defined at 42 C.F.R. § 488.301 to mean noncompliance so egregious as to cause or to be likely to cause a resident to suffer serious injury, harm, impairment, or death.