Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD
Civil Remedies Division
Bastrop Lost Pines Nursing and Rehabilitation Center,
Centers for Medicare & Medicaid Services.
Docket No. C-16-776
Decision No. CR5144
Bastrop Lost Pines Nursing and Rehabilitation Center (Petitioner or “the facility”) is a skilled nursing facility (SNF) located in Bastrop, Texas, that participates in the Medicare program. Following a health complaint and incident investigation survey that was completed on May 16, 2016, the Centers for Medicare & Medicaid Services (CMS) determined that the facility was not in substantial compliance with Medicare program requirements and that five cited deficiencies posed immediate jeopardy to resident health and safety. CMS imposed a per-day civil money penalty (CMP) of $7,550 for eight days of immediate jeopardy noncompliance, and a per-day CMP of $1,000 for an additional 31 days of noncompliance, for a total CMP of $91,400.
Petitioner contests the deficiencies cited under 42 C.F.R. § 483.10(b)(11) (Tag F157 (changes in condition)), 42 C.F.R. § 483.13(c) (Tags F224 and F226 (abuse and neglect prevention policies)), 42 C.F.R. § 483.25(m)(2) (Tag F333 (medication errors)), and 42 C.F.R. § 483.60(a) (Tag F425 (pharmaceutical services)), all cited at the “L” level of scope and severity, and also challenges the imposition of a CMP. For the reasons discussed below, I find that there is no genuine dispute as to any material fact, and CMS is entitled to judgment as a matter of law because the facility was not in substantial
compliance with Medicare program requirements, CMS’s immediate jeopardy determination was not clearly erroneous, and the CMP imposed is reasonable.
The Social Security Act (Act) sets requirements for SNF participation in the Medicare program. The Act authorizes the Secretary of the United States Department of Health & Human Services (Secretary) to promulgate regulations implementing those statutory provisions. Act § 1819 (42 U.S.C. § 1395i-3). The Secretary’s regulations are found at 42 C.F.R. part 483.1
A facility must maintain substantial compliance with program requirements in order to participate in the program. To be in substantial compliance, a facility’s deficiencies may pose no greater risk to resident health and safety than “the potential for causing minimal harm.” 42 C.F.R. § 488.301.
The Secretary contracts with state agencies to conduct periodic surveys to determine whether SNFs are in substantial compliance with the participation requirements. Act § 1864(a) (42 U.S.C. § 1395aa(a)); 42 C.F.R. §§ 488.10, 488.20. The Act and its implementing regulations require that facilities be surveyed on average every twelve months, and more often if necessary, to ensure that identified deficiencies are corrected. Act § 1819(g)(2)(A) (42 U.S.C. § 1395i-3(g)(2)(A)); 42 C.F.R. §§ 488.20(a), 488.308.
The Texas Department of Aging and Disability Services (state agency) conducted a health complaint and incident investigation of Petitioner from May 12 through 16, 2016. CMS Exhibit (Ex.) 3 at 1. In a sampling of twelve residents, the state agency cited five deficiencies that collectively involved four of those residents. CMS Ex. 3 at 2, 25, 50, 76, 99. As relevant here, the state agency determined that Petitioner was not in substantial compliance with the five aforementioned regulatory requirements, all at the “L” level of scope and severity.2 CMS Ex. 3. By letter dated June 8, 2016, CMS notified
Petitioner that it concurred with the state agency’s findings that Petitioner was not in substantial compliance with participation requirements, and it informed Petitioner that immediate jeopardy3 to resident health and safety had been identified as of May 9, 2016, and abated as of May 17, 2016. CMS Ex. 1 at 2. CMS imposed a per-day CMP4 of $7,550 based on noncompliance from May 9 through 16, 2016, and a per-day CMP of $1,000 thereafter.5 CMS Ex. 1 at 2. By letter dated July 12, 2016, CMS informed Petitioner that it had achieved substantial compliance, effective June 17, 2016. CMS Ex. 2 at 1.
On July 29, 2016, Petitioner, through counsel, requested a hearing before an administrative law judge (ALJ). Pursuant to my Acknowledgment and Pre-Hearing Order, CMS filed a Pre-Hearing Brief (CMS Br.), along with 42 exhibits (CMS Exs. 1-42), and Petitioner submitted a Pre-Hearing Brief (P. Br.), along with four exhibits (P. Exs. 1-4). CMS thereafter filed a motion for summary judgment (CMS Motion), as permitted by Section 5 of my Pre-Hearing Order, and Petitioner timely filed a response (P. Response).
In the absence of any objections, I admit all submitted exhibits.
The issues are:
- Is summary judgment appropriate;
- Whether Petitioner was in substantial compliance with 42 C.F.R. §§ 483.10(b)(11), 483.13(c), 483.25(m)(2), and 483.60(a);
- If Petitioner was not in substantial compliance, did the deficiencies pose immediate jeopardy to resident health and safety;
- Is the duration of the noncompliance appropriate;
- Is the CMP, totaling $91,400, reasonable?
III. Findings of Fact, Conclusions of Law, and Analysis6
A. Summary judgment is appropriate because the material facts are not in dispute.
Summary judgment is appropriate when there is no genuine dispute as to any issue of material fact for adjudication and/or the moving party is entitled to judgment as a matter of law. Senior Rehab. & Skilled Nursing Ctr., DAB No. 2300 at 19-20 (2010), aff’d, Senior Rehab. & Skilled Nursing Ctr. v. Health & Human Servs.,405 F. App’x 820 (5th Cir. 2010); see Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248 (1986). The moving party must show that there are no genuine issues of material fact requiring an evidentiary hearing and that it is entitled to judgment as a matter of law. Anderson,477 U.S. at 248. If the moving party meets its initial burden, the non-moving party must “come forward with ‘specific facts showing that there is a genuine issue for trial . . . .’” Matsushita Elec. Indus. Co. v. Zenith Radio, 475 U.S. 574, 587 (1986). “To defeat an adequately supported summary judgment motion, the non-moving party may not rely on the denials in its pleadings or briefs, but must furnish evidence of a dispute concerning a material fact – a fact that, if proven, would affect the outcome of the case under governing law.” Senior Rehab., DAB No. 2300 at 3. In determining whether there are genuine issues of material fact for hearing, an ALJ must view the evidence in the light most favorable to the non-moving party, drawing all reasonable inferences in that party’s favor. Id.
After the parties filed their respective briefs and supporting evidence, to include written direct testimony7 (CMS Exs. 38, 39; P. Ex. 4), CMS filed a motion for summary judgment in which it provided a statement of undisputed material facts. CMS Motion at 4-13. In Petitioner’s response, it did not cite to any evidence that raised a dispute with
CMS’s statement of undisputed material facts.8 In fact, Petitioner conceded a number of undisputed material facts, as will be discussed below.
Resident # 1
Petitioner does not dispute the following material facts: It did not transcribe all of Resident # 1’s medications (P. Br. at 12); it “missed” doses of medications (P. Br. at 14); it did not notify Resident # 1’s physician that he requested transfer to a hospital (P. Br. at 11); and, it did notify Resident # 1’s responsible party that he requested a transfer to the hospital. P. Br. at 14. Petitioner also concedes that its nurses’ actions “jeopardized” Resident # 1. P. Br. at 23. Records maintained by or obtained from Petitioner support Petitioner’s factual concessions, as discussed below.
Resident # 1 was 82 years old and had diagnoses of acute respiratory failure, congestive heart failure, and a bacterial infection of his heart valves (enterococcal aortic valve endocarditis). CMS Exs. 10 at 1; 14 at 1.
Resident # 1 was admitted to the facility on May 9, 2016, after his discharge from a hospital.9 CMS Exs. 9 at 1; 10 at 1; 14 at 1.
Resident # 1’s hospital discharge instructions included the following:
- Bilateral positive airway pressure (BiPAP) administration set at 10/5 with a rate of 8 “for sleep and [as needed]: if available”;
- “Titrate [oxygen] . . . to keep sat[uration] above 92% . . . presently on 3 liters”;
- Intravenous administration of ampicillin sodium, 2000 mg per 100ml, every 4 hours;
- Intravenous administration of gentamycin sulfate, 80 mg, every 18 hours;
- Atorvastatin (Lipitor), 10 mg, at bedtime;
- Bisacodyl (Dulcolax), 10 mg, administered rectally at bedtime;
- Digoxin (Digitex), .125 mg, daily;
- Furosemide (Lasix), 40 mg, daily;
- Ipratropium bromide (Atrovent .02% nebulizer solution), .5 mg, by inhalation three times daily;
- Ipratropium bromide (Atrovent .02% nebulizer solution), .5 mg, every 4 hours as needed;
- Metoprolol tartrate (Lopressor), 12.5 mg, three times daily;
- Polyethylene glycol (Miralax), 17 grams, daily;
- Rivaroxaban (Xarelto), 20 mg, with dinner.
(P. Ex. 1 at 1; CMS Ex. 10 at 3). Ms. Stephanie Jasik, a physician’s assistant affiliated with Petitioner’s in-house medical clinic, evaluated Resident # 1 at 9:33 am on May 10, 2016. P. Ex. 1 at 6-10. Ms. Jasik observed that Resident # 1 had frequent wheezing and shortness of breath (reported as dyspnea) at rest, and that his current problems included respiratory failure, chronic bronchitis, and dependence on supplemental oxygen.10 P. Ex. 1 at 6-7. Ms. Jasik ordered that Resident # 1 continue use of BiPAP equipment, that he receive continuous supplemental oxygen, and that he receive Atrovent nebulizer treatments three times per day. P. Ex. 1 at 3, 5, 8. Ms. Jasik reported that Resident # 1 had the following “current medications”:
- Allopurinol, one 100 mg tablet daily;
- Megace ES, 125 mg/1ml oral suspension 6 ml daily;
- Digoxin, one 125 mcg tablet daily;
- Ampicillin sodium, 2 grams powder for injection through IV every four hours;
- Dulcolax, two 5 mg tablets daily;
- Furosemide, one 40 mg tablet daily;
- Gentamycin sulfate, 80 mg intravenously every 18 hours for six weeks;
- Ipratropium bromide .02% solution for inhalation (nebulizer) three times daily;
- Lipitor, one 10 mg tablet at bedtime;
- Metoprolol tartrate (Lopressor), 25 mg, one half tablet three times daily;
- Miralax powder for oral solution, 17 grams in 4 ounces of water daily;
- Xarelto, one 20 mg tablet with dinner.
P. Ex. 1 at 7-8. With respect to the intravenous antibiotics, Ms. Jasik directed that Resident # 1 should “[c]omplete [a] course of IV Gentamycin and Ampicillin [for] 6 weeks.” P. Ex. 1 at 8.
Petitioner’s “eMar Administration Record” (herein “e-MAR”) for Resident # 1 contains, as relevant here, the following transcriptions11 of prescribed treatments and medications:
- BiPAP [at bedtime]12 CMS Ex. 14 at 16-17);
- Oxygen continuous at 3 liters per minute per nasal cannula (CMS Ex. 14 at 12);
- Lipitor, 10 mg tablet, at bedtime13 (CMS Ex. 14 at 1, 2, 4);
- Bisacodyl (Dulcolax), 10 mg, administered rectally at bedtime (CMS Ex. 14 at 14-15);
- Digoxin (Digitex), .125 mg, daily (CMS Ex. 14 at 1, 2, 4, and 5);
- Furosemide, 40 mg, daily (CMS Ex. 14 at 1, 2, 4, and 5)
- “IPRATROPIUM [bromide] .5 MG (ATROVENT .02% NEB SOLU) THREE TIMES DAILY” (CMS Ex. 14 at 16);
- “IPRAT[ropium bromide]-ALBUT[erol sulfate]14 .5-3(2.5) MG/3 ML” three times daily (CMS Ex. 14 at 17);
- “IPRAT[ropium bromide]-ALBUT[erol sulfate] .5-3(2.5) MG/3 ML” every four hours as needed (CMS Ex. 14 at 7);
- Metoprolol tartrate (Lopressor), 12.5 mg, three times daily (CMS Ex. 14 at 3);
- Polyethylene glycol (Miralax), 17 grams, daily (CMS Ex. 14 at 1, 2, 4, 5);
- Xarelto 20 mg tablet (CMS Ex. 14 at 15).
Petitioner acknowledged that it did not transcribe all of Resident # 1’s medications, and it conceded that “Nurse Z did not accurately transcribe the hospital discharge orders to the facility’s medical records system.”15 P. Br. at 12. In fact, Resident # 1’s eMAR does not include transcriptions for several medications, specifically allopurinol, Megace ES, ampicillin sodium, and gentamycin sulfate.16
Likewise, being that Petitioner did not transcribe all of Resident # 1’s medications, it is not unexpected that Petitioner did not administer all of Resident # 1’s medications. Petitioner concedes that medication doses for Resident # 1 “were missed,” but contends that the missed doses “did not represent an immediate risk to the resident’s health and safety . . . .” P. Br at 14. Petitioner’s records reveal that Petitioner administered only a portion of Resident # 1’s prescribed medications, in that Petitioner’s records indicate the administration of only the following:
- Ipratropium [bromide] .5 mg (Atrovent .02% nebulizer solution) at 6:00 am on May 10, 2016 (CMS Ex. 14 at 16)
- Ipratropium [bromide]-albuterol [sulfate] via inhalation17 at 5:00 pm on May 10, 2016 (CMS Ex. 14 at 17-18)
- Metoprolol tartrate (12.5 mg) at 6:00 am, 3:00 pm, and 9:00 pm (CMS Ex. 14 at 3, 6)
- Supplemental oxygen, beginning at 2:00 pm on May 10, 2016 (CMS Ex. 14 at 12)
- Ampicillin sodium, at 2:00 am on March 10, 2016 (CMS Ex. 12 at 4)
- Gentamycin sulfate, at 4:00 am on March 10, 2016 (CMS Ex. 12 at 4)
Although Resident # 1’s eMAR documents that he was due to receive Lipitor, digoxin, furosemide, Xarelto, and Miralax, the eMAR and other facility records do not document that it administered any of these medications on either May 9 or 10, 2016. Further, the record does not support that Petitioner administered two medications that were not transcribed, allopurinol and Megace ES. And with respect to the prescription for intravenous ampicillin sodium that was not transcribed in the eMAR, Petitioner’s records reflect that only a single dose of ampicillin sodium was administered at 2:00 am on May 10, 2016, even though it should have been administered every four hours.18 CMS Ex. 12 at 4.
Resident # 1’s hospital discharge orders indicate that he should have been provided BiPAP equipment at bedtime if available, and Petitioner transcribed this order as “BiPAP [at bedtime]” into Resident # 1’s eMAR without any qualification regarding the availability of BiPAP equipment. P. Ex. 1 at 1; CMS Ex. 14 at 16. While Petitioner argues that the facility canceled this order on May 10, 2016 (P. Br. at 10, citing P. Ex. 1 at 3), it does not address, much less provide evidentiary support, that it provided the prescribed BiPAP equipment on May 9, 2016, prior to the discontinuation of the order.
In addition to not receiving BiPAP therapy at bedtime on May 9, 2016, the record does not evidence that Resident # 1 received any medications by inhalation following his hospital discharge until he complained of shortness of breath at 5:30 am on May 10, 2016.19 CMS Ex. 12 at 3. At that time, Resident # 1 reported that he felt the same way he did prior to his previous hospitalization and asked to be transferred to the hospital.20 CMS Ex. 12 at 3. Petitioner did not transfer Resident # 1 to the hospital, nor did it consult Resident # 1’s physician, based on its purported application of the Interventions to Reduce Acute Care Transfers (INTERACT) “care path” protocol for shortness of breath.21 P. Br. at 11; P. Ex. 4 at 4-5; see P. Ex. 1 at 4.
The INTERACT care path for symptoms of shortness of breath, a copy of which Petitioner provided as P. Ex. 1 at 4, requires that when a resident reports a new complaint of shortness of breath or has difficult or labored breathing that is out of proportion to the level of physical activity, staff should assess vital signs, specifically temperature, blood
pressure, pulse, respirations, oxygen saturation, and fingerstick glucose (if diabetic) prior to determining whether notification of the physician is necessary. Petitioner assessed and recorded Resident # 1’s blood pressure, pulse, and oxygen saturation, but it did not record Resident # 1’s respirations or temperature. CMS Ex. 12 at 3.
After it failed to assess all vitals listed in the INTERACT care path for shortness of breath, Petitioner administered a breathing treatment and Resident # 1 reported that “he felt a little better.” CMS Ex. 12 at 3. Petitioner did not contact Resident # 1’s physician or transfer him to the hospital as he had requested. Further, the facility did not contact Resident # 1’s responsible party. CMS Ex. 12 at 3; see P. Motion at 14. (“The facility did not notify . . . the responsible party that he had requested to go to the hospital (and was not sent) because according to the initial History and Physical the resident was found to be capable of exercising his rights.”).
At 11:15 pm on May 10, 2016, Resident # 1’s daughter informed Petitioner’s nursing staff that she was concerned that Resident # 1 “needs a BiPAP, increased oxygen and [an] increase in morphine.” CMS Ex. 12 at 3 (capitalization omitted). Ms. Hampton, “the 10-6 nurse,” reported that Resident # 1 had complained of shortness of breath and that he had asked to go to the hospital a couple of times. CMS Ex. 12 at 3. At 11:45 pm, Petitioner transferred Resident # 1 to the hospital; a late entry note documents that the ambulance crew assessed that Resident # 1 had shortness of breath and bilateral lower extremity edema. CMS Ex. 12 at 3.
Resident # 2:
Petitioner does not dispute the following material facts: It did not transcribe a medication order for Resident # 2 (P. Br. at 16); it did not administer prescribed medication (P. Br. at 16); and, it did not notify Resident # 2’s physician until several days after it missed doses of medication (P. Br. at 16; citing P. Ex. 2). Petitioner further concedes that its nurses’ actions “jeopardized” Resident # 2. P. Br. at 23. Records maintained by or obtained from Petitioner support its factual concessions regarding Resident # 2.
Resident # 2, age 75 at that time, was admitted to the facility on May 6, 2016. His diagnoses included pneumonia, acute respiratory failure with hypoxia, chronic obstructive pulmonary disease with acute exacerbation, gastronomy-percutaneous endoscopic gastronomy tube, dysphagia, and pulmonary tongue cancer with metastasis to the lung and pharynx. CMS Ex. 17 at 1; see CMS Ex. 20 at 4.
May 6, 2016 physician orders prescribe three separate medication administrations every four hours via inhalation: albuterol sulfate, ipratropium bromide-albuterol sulfate, and Xopenex. CMS Exs. 16 at 2; 17 at 3. On May 11, 2016, Ms. Jasik discontinued the order for albuterol sulfate nebulizer treatments, and she further ordered that Xopenex treatments be reduced in frequency to once every 6 to 8
hours as needed for shortness of breath. CMS Ex. 19 at 1. Ms. Jasik added a new medication, metoprolol succinate, to be administered twice daily. CMS Ex. 19 at 1.
The record does not indicate that Petitioner transcribed the new prescription for metoprolol succinate, in that this medication is entirely absent from Resident # 2’s eMAR. CMS Ex. 21. Further, there is no evidence that Petitioner administered metoprolol succinate as ordered by Ms. Jasik. See CMS Ex. 21; see also P. Br. at 16 (“Petitioner concedes that the failure to transcribe the medication order for Metoprolol was a medication error; however, as soon as the error was identified, the physician was notified as indicated on the Medication Incident Report form.”); P. Response at 15 (“A medication error occurred . . . .”).22 Petitioner concedes that there was an “inadvertent omission of medications” and argues that “[t]he medication errors were not significant in severity because no actual harm was resultant from the non-administered doses.” P. Br. at 19.
Petitioner has not submitted evidence refuting CMS’s allegation that it did not administer scheduled breathing treatments. Medication administration records document that, from May 7 through 12, 2016, Petitioner did not administer more than a dozen albuterol sulfate treatments.23 CMS Ex. 21 at 9-20. Further, Petitioner did not administer numerous Xopenex treatments to Resident # 2.24 CMS Ex. 21 at 21-26. Petitioner has acknowledged an “inconsistent administration of nebulizer treatments.” (P. Br. at 16). Facility records do not document that Petitioner informed Resident # 2’s physician of the numerous missed breathing treatments, nor do records indicate that Petitioner informed the physician that it did not offer treatments during sleep or that the resident was refusing treatments.25 See P. Ex. 2 (Medication Administration Incident Report, stating: “Xopenex held, MD not notified”).
The statement of deficiencies cites an interview with Ms. Jasik, in which she informed the surveyor that “she or Resident # 2’s physician should have been notified of the missed nebulizer treatments.” CMS Ex. 4 at 15. Ms. Jasik also stated that she was unaware of the missed nebulizer treatments and that she had not been notified that Resident # 2 had not been administered the prescribed metoprolol succinate. According to the statement of deficiencies, Ms. Jasik also stated that she had been approached by Resident # 2’s responsible party because the responsible party “was concerned with his breathing and increased need for oral suctioning, and he seemed like he had declined to the point when he was most recently hospitalized . . . .” CMS Ex. 3 at 15. Petitioner does not refute these allegations or present facts that dispute Ms. Jasik’s statements. In fact, Petitioner cited Ms. Jasik’s interview with the surveyor to highlight Ms. Jasik’s opinion that “she could not say the inconsistent administration of nebulizer treatments and/or missed doses of Metoprolol for his blood pressure were the direct cause of Resident No. 2’s decline.” P. Br. at 16-17.
Petitioner explained, without any citation to the evidentiary record, that Resident # 2 “was transferred and admitted to a local hospital for increased lung congestion and tachycardia . . . on May 14, 2016.” P. Br. at 15-16.Petitioner does not dispute the report that Resident # 2’s wife noticed his deterioration and reported it to the Ms. Jasik, nor does Petitioner dispute that either the treating physician or Ms. Jasik were not made aware of the missed breathing treatments. See CMS Ex. 3 at 14-15.
Resident # 3:
Petitioner does not dispute the following material facts: With respect to Resident # 3, it “did not provide a new prescription for IV Rocephin (an antibiotic also known as ceftriaxone sodium) until eight hours after the order was written,” and another medication, Betapace, “was due for administration at [9:00 am], but not in stock.” P. Br. at 20. Records maintained by or obtained from Petitioner support its factual concessions regarding Resident # 3.
Resident # 3, an 85-year-old woman, was admitted to the facility on May 4, 2016, following a hospitalization resulting from a traumatic subdural hematoma due to a fall and a urinary tract infection (UTI) with sepsis. CMS Ex. 24 at 1.
Resident # 3’s eMAR indicates that a five-day course of Rocephin was prescribed on May 12, 2016, and first administered on May 13, 2016. CMS Ex. 22 at 16, 28; see
P. Ex. 3 at 2 (May 13, 2016 physician assistant consultation listing that current medications include “Ceftriaxone Sodium 1g Powder for Injection Give 1gm IV [each day for] 5 days”).26
Petitioner did not administer the initial dose of Rocephin to Resident # 3 until 12:09 am on May 13, 2016; Petitioner obtained that dose from its “E-KIT.”27 CMS Ex. 24 at 3. On May 13, 2016, Ms. Jasik observed Resident # 3 was “now non-responsive” and that she approved “completing course of IV Rocephin for UTI to see if [altered mental state] improves.” P. Ex. 3 at 2.
The eMAR indicates that, on May 4, 2015, Resident # 3 was prescribed Betapace, to be administered twice daily at 9:00 am and 5:00 pm. CMS Ex. 22 at 15. Petitioner acknowledged that, at the time of the 9:00 am dose on May 13, 2016, Resident # 3’s Betapace was “not in stock” and that it had been “ordered from the pharmacy for immediate delivery, and received by 10am.” P. Br. at 20. Petitioner contends that this medication “was held due to resident inability to swallow medications at that time,” but it has not cited to any evidence in support of this allegation. P. Br. at 20. Petitioner
submitted evidence that, later that day,a physician ordered that oral medications should be held if Resident # 3 was not awake. P. Ex. 3 at 2.
Resident # 7:
Petitioner does not dispute the following material facts: Resident # 7 “had physician’s orders for nebulizer treatments scheduled four times a day” and Petitioner “held doses on May 5 and 11, 2016.” P. Br. at 21. Records maintained by or obtained from Petitioner support that Petitioner held doses on those dates, as discussed below.
Resident # 7, who was 73 years old, had been admitted to the facility in November 2015 with diagnoses that included chronic obstructive pulmonary disease (COPD) with acute exacerbation, pneumonia, and acute respiratory infection. CMS Ex. 25 at 1-2.
Physician orders indicate that Resident # 7 used supplemental oxygen to relieve hypoxia related to COPD. CMS Ex. 26 at 1-2.
Facility records indicate that on April 28, 2016, Petitioner notified Resident # 7’s responsible party (her son) of changes to her medication regimen, explaining it “stopped one of the [sic] breathing treatments, continued albuterol [every four hours] as needed, also changed scheduled breathing treatment to [6:00 am, 12:00 pm, 6:00 pm, 12:00 am] and to combined [sic] both neb[ulizer] medications.” CMS Ex. 27 at 2 (capitalization omitted); see CMS Ex. 26 at 3 (physician orders for May 2016).
On May 2, 2016, Resident # 7, who a nurse observed “was very short of breath,” reported that “she doesn’t know if she got all her medications last night . . . .” CMS Ex. 27 at 1 (capitalization omitted). At that time, Petitioner “brought in her scheduled breathing treatment that is due at [9:00 am and 9:00 pm] and told her [the nurse] could give her the albuterol after the scheduled breathing treatment if she wants it.”28 CMS Ex. 27 at 1.
A May 5, 2016 note reports that Resident # 7’s 12:00 am treatment “was held” because she was “asleep.” CMS Ex. 27 at 1; see CMS Ex. 28 at 43 (showing 12:00 am treatment not given).
On May 11, 2016, Resident # 7’s son reported that Resident # 7 did not receive her 12:00 am and 6:00 am breathing treatments. CMS Ex. 27 at 1. The facility informed Resident # 7’s son that the midnight treatment “was held due to [the] resident being asleep.” CMS Ex. 27 at 1 (capitalization omitted); see CMS Ex. 28 at 43 (eMAR report
showing no 12:00 am treatment given); see CMS Ex. 28 at 44 (reporting 6:00 am treatment given).
Petitioner’s administrator, Leo Garcia, provided written testimony that he was present when a facility nurse told the surveyor that she did not administer breathing treatments on May 5 and 11, 2016 “because the resident simply did not want to wake up for the treatment on those two occasions.” P. Ex. 4 at 2; see P. Ex. 4 at 14 (“Resident # 7 did miss two doses of albuterol but after being assessed shows no signs or symptoms that the resident had received actual harm from the alleged deficient practice and the staff member that notated the held doses was not given the opportunity to expand on the documentation of ‘resident asleep.’”). Petitioner has not submitted the testimony of the nurse that the resident refused treatments, nor has Petitioner submitted evidence that it documented Resident # 7’s refusal of treatments or that it notified Resident # 7’s physician that she purportedly refused treatments.
B. Petitioner did not provide pharmaceutical services that met the needs of four residents, as required by 42 C.F.R. § 483.60(a), out of a sample of 12 residents.
C. Petitioner was not in substantial compliance with 42 C.F.R. § 483.25(m)(2) because it failed to ensure it was free of significant medication errors.29
Pursuant to 42 C.F.R. § 483.25(m)(2), a facility must ensure that its residents “are free of any significant medication errors.” The Departmental Appeals Board (DAB) has concluded that the language of 42 C.F.R. § 483.25 not only requires skilled nursing facilities to furnish the care and services set forth in a resident’s care plan but also to implement doctors’ orders, monitor and document the resident’s condition, and follow its own policies. See, e.g., Alexandria Place, DAB No. 2245 at 7-8 (2009) (upholding a deficiency when a petitioner did not provide care in accordance with a doctor’s order). As previously discussed, Petitioner’s policies required that it maintain a current list of orders for each resident, to include telephone and verbal orders. CMS Ex. 31. Petitioner’s medication errors policy required that all medication errors be reported to, inter alia, the attending physician. CMS Ex. 33 at 1. The policy addressed “incorrect” and “omitted” medications, along with drug reactions, and required that “[a]ny change in the resident’s condition should be immediately reported to the director of nursing services and attending physician.” CMS Ex. 33 at 1. Pursuant to 42 C.F.R. § 483.60(a), a facility must provide routine and emergency drugs and biologicals to its residents, and it must
provide pharmaceutical services to meet the needs of each resident. The facility has a policy requiring that “[a] current list of orders should be maintained in the clinical record of each resident.” CMS Ex. 31 at 1. Another facility policy directs that “[a]ll medication errors and drug reactions should be promptly reported to the director of nursing services and attending physician,” and that “[r]esidents receiving incorrect or omitted medication or having a drug reaction should be monitored.” CMS Ex. 33 at 1.
The undisputed evidence demonstrates that Petitioner did not comply with its obligation to provide pharmaceuticals that met the needs of Resident # 1, Resident # 2, Resident # 3, and Resident # 7, and that with respect to Resident # 1 and Resident # 2, it did not ensure that these residents were free of significant medication errors. Petitioner concedes that it did not transcribe Resident # 1’s hospital discharge orders. P. Br. at 12 (“Unfortunately, Nurse Z did not accurately transcribe [Resident # 1’s] hospital discharge orders to the facility’s medical records system. Nonetheless, this error perhaps supports a finding of ‘negligence,’ . . . .” P. Br. at 12. Further, Petitioner’s eMAR for Resident # 1 does not contain a transcription for current medications listed by Ms. Jasik, to include allopurinol and Megace ES. The eMAR also does not include two intravenous antibiotics, ampicillin sodium and gentamycin sulfate.
In addition to not transcribing medications, Petitioner does not provide evidence rebutting CMS’s allegations that it did not administer prescribed medications. In fact, Petitioner concedes there were “medication doses that were missed.” P. Br. at 14. There is no evidence that Petitioner provided a BiPAP treatment on May 9, 2016, despite the fact that hospital discharge orders directed BiPAP treatment at bedtime and Petitioner acknowledged this order in the eMAR. P. Ex. 1 at 1; CMS Ex. 14 at 16-17. Similarly, the eMAR does not evidence that Petitioner administered Lipitor, digoxin, furosemide, Miralax, or Xarelto. Moreover, Petitioner has not presented evidence to counter CMS’s allegation that it did not administer prescribed doses of ampicillin sodium, and Petitioner’s own records support that it administered only a single dose of ampicillin sodium. CMS Ex. 12 at 4.
With respect to Resident # 2, although Ms. Jasik ordered that Resident # 2 be given metoprolol succinate twice daily (CMS Ex. 19 at 1), Petitioner did not record the order in the eMAR.30 CMS Ex. 21. Petitioner “concede[d] that the failure to transcribe the
medication order for Metoprolol was medication error. . . .” P. Br. at 16. Petitioner has not refuted evidence that it did not administer metoprolol succinate on multiple occasions; in fact, it cites to a medication administration incident report in which it recognized that it failed to provide twice-daily doses of metoprolol succinate on May 11, 12, and 13, 2016. P. Br. at 16, citing P. Ex. 2 at 1.
On May 12, 2016, Resident # 3 was prescribed Keflex and Rocephin, both to be administered intravenously. CMS Ex. 23 at 1. Although the available records do not evidence the precise time of the order, a nursing note recording these orders is time-stamped 2:55 pm, at which time the facility had already infused two liters of solution mixed with Keflex and was currently infusing a third liter, which strongly suggests that the order prescribing Keflex and Rocephin was given prior to 2:55 pm. CMS Ex. 23 at 1. Regardless of the precise time of the order prescribing Rocephin on May 12, 2016, the facility did not administer intravenous Rocephin until 12:09 am on May 13, 2016, at which time it was obtained from the facility’s emergency kit. CMS Ex. 24 at 3 (“ROCEPHIN 1GM IN E-KIT INFUSED @ 125 CC/HOUR AT 12:09 AM”). While Petitioner argues the nurse “receiving the order immediately requested the medication from the pharmacy and promptly administered it upon receipt,” it has not presented any supporting evidence of such. P. Br. at 20. Petitioner’s own recordkeeping contradicts this allegation, in that a nurse documented that the initial dose of Rocephin was given from the emergency kit at 12:09 am, rather than from a supply received directly from a pharmacy. CMS Ex. 24 at 3. Even when viewing the evidence in the light most favorable to Petitioner, I nonetheless agree with Petitioner’s assertion that it did not administer the intravenous antibiotic for at least eight hours.
With respect to Resident # 3’s scheduled administration of Betapace, Petitioner acknowledged “the medication was due for administration at [9:00 am] but not in stock.” P. Br. at 20. Because Petitioner had not filled the Betapace prescription for this resident at the time of the scheduled administration, it “was ordered from the pharmacy for immediate delivery . . . .” P. Br. at 20. The fact that, later that evening, a facility physician’s assistant ordered Petitioner to withhold oral medication if the resident was asleep is irrelevant to the question of whether Petitioner failed to have Resident # 3’s medication on hand at the time it was due for administration at 9:00 am. P. Ex. 3 at 2.
With respect to Resident # 7, CMS has submitted evidence, in the form of Petitioner’s own records, that Petitioner did not administer breathing treatments when Resident # 7 was sleeping even though orders directed treatments at 12:00 am and 6:00 am, which are times that Resident # 7 would presumably be sleeping. Petitioner argues that Resident
# 7 “is not a reliable historian,” yet it presents no evidence of such, especially when its contemporaneous records indicate that a nurse informed Resident # 7’s son that a treatment was not administered because she was sleeping and not due to her refusal of the treatment. CMS Ex. 27 at 1 (“I NOTIFIED SON THAT 2400 WAS HELD DUE TO RESIDENT BEING ASLEEP,” and “I EXPLAINED THAT I WAS DOING A 1:1 WITH THE NURSE INSTRUCTING HER TO WAKE HER UP TO ADMINISTER TREATMENT.”). In casting blame on the resident for its own failure, Petitioner attempts to shirk responsibility for its own failure to adhere to orders that it administer medication. Further, Petitioner has not pointed to any evidence that it informed the physician of Resident # 7’s missed administration of medication, despite the facility’s own policy.31 See CMS Ex. 33.
Even when viewing the evidence in the light most favorable to Petitioner, the undisputed evidence shows that Petitioner did not meet the pharmaceutical needs of its residents because it failed to timely transcribe and/or administer prescribed medications. Further, and with respect to Resident # 1 and Resident # 2, the failure to administer numerous medications, to include such medications as an intravenous antibiotic and a blood pressure medication, amounted to significant medication errors. See P. Br. at 16 (“Petitioner concedes that the failure to transcribe the medication order for Metoprolol was a medication error . . . .”); P. Br. at 19 (“This citation is again based on the omission of certain drug doses for Residents No. 1 at 2.”). Therefore, Petitioner failed to ensure compliance with 42 C.F.R. §§ 483.25(m)(2) and 483.60(a).
D. Based on its failure to immediately consult the physician for Resident # 1 and Resident # 2 after each resident had significant alterations in their treatment and changes in their respective conditions, Petitioner failed to provide the necessary care and services required by 42 C.F.R. § 483.10(b)(11).
Pursuant to 42 C.F.R. § 483.10(b)(11), a facility must consult with a resident’s physician when there is a significant change in a resident’s condition (such as a “deterioration in health”), a need to alter treatment significantly, or there is a decision to transfer or discharge a resident from the facility.32 The DAB has explained that such consultation
requires a “dialogue with and a responsive directive from the resident’s physician as to what actions are needed. . . .” Magnolia Estates Skilled Care, DAB No. 2228 at 9 (2009). Petitioner has a medication errors policy that requires physician notification of a medication error. CMS Ex. 33 at 1.
After missing prescribed treatment, Resident # 1 reported shortness of breath and requested that he be transferred to a hospital. In denying Resident # 1’s request for a transfer to the hospital, Petitioner purportedly applied the INTERACT care path to determine it did not need to notify Resident # 1’s physician or transfer him to the hospital.33 P. Br. at 11. However, Petitioner has not presented evidence to support that it adhered to the INTERACT care path, in that it did not obtain the vital signs required by the care path. In particular, in assessing symptoms of shortness of breath, Petitioner did not assess respirations. Shortness of breath to the point that a resident feels he must be hospitalized, when that resident has been “stable” only hours earlier at the time of discharge from the hospital (CMS Ex. 10 at 1), is a change in condition that should have been reported to the physician, particularly in such an instance where Petitioner had not fully assessed the resident’s vital signs and had already failed to comply with a hospital’s discharge orders.
Petitioner admittedly did not administer doses of metoprolol succinate and Xopenex to Resident # 2, and it did not notify the physician that it did not administer the medication until after Resident # 2’s transfer from the facility. P. Ex. 2. Specifically, Petitioner reported in an incident report that metoprolol succinate was “not initiated” and that it had not notified the physician that Xopenex was “held.” P. Ex. 2. Further, Petitioner has not disputed the report in the statement of deficiencies that Ms. Jasik told the surveyor that she was unaware of the missed nebulizer treatments and that she was not made aware that Resident # 2 had not been administered the prescribed metoprolol succinate. CMS Ex. 4 at 15. Petitioner has not challenged Ms. Jasik’s report to the surveyor, as detailed in the statement of deficiencies, that she had been approached by Resident # 2’s responsible party, and not Petitioner, regarding Resident # 2’s apparent decline. CMS Ex. 14 at 15. The report of Resident # 2’s wife to Ms. Jasik was the impetus for Ms. Jasik’s order that Petitioner transfer Resident # 2 to the hospital. CMS Ex. 4 at 15. Petitioner has not disputed these facts but instead focuses on Ms. Jasik’s opinion that “she could not say the inconsistent administration of nebulizer treatments and/or missed doses of Metoprolol for his blood pressure were the direct cause of Resident No. 2’s decline.” P. Br. at 16-17.
Petitioner did not notify the physician when it significantly altered the treatment plan by failing to transcribe and administer medications. Further, it failed to notify a physician of significant changes of condition, with one resident reporting shortness of breath and desiring to go to the hospital and another resident’s decline being brought to the attention of the physician’s assistant by a family member. Even considering the evidence in the light most favorable to Petitioner, I agree with Petitioner’s concession of undisputed material facts and find that Petitioner failed to comply with 42 C.F.R. § 483.10(b)(11).
E. Petitioner was not in compliance with 42 C.F.R. § 483.13(c) because it failed to implement its written policies and procedures to prevent neglect of residents.
Pursuant to 42 C.F.R. § 483.13(c), a facility “must develop and implement written policies and procedures that prohibit mistreatment, neglect, and abuse of residents . . . .” “Neglect” for purposes of the regulation means the “failure to provide goods and services necessary to avoid physical harm, mental anguish, or mental illness.” 42 C.F.R. § 488.301. The DAB has explained that a facility may not comply with section 483.13(c) if it does not develop “policies or procedures adequate to prevent neglect” or fails to implement such policies or procedures. Glenoaks Nursing Ctr., DAB No. 2522 at 14 (2013). The DAB has explained that the failure to implement other policies or procedures can establish noncompliance with section 483.13(c) if those policies or procedures establish the “goods and services” that are “necessary to avoid physical harm.” Heritage Plaza Nursing Ctr., DAB No. 2829 at 5 (2017). One factor considered by the DAB is whether the facility’s actions were contrary to its own care policies. Hanover Hill Health Care Ctr., DAB No. 2507 at 9-10 (2013). The DAB has explained that it is “immaterial” whether a facility had “general anti-neglect and anti-abuse policies and arguably took some steps to implement those particular policies” because “a finding of noncompliance with section 483.13(c) may be based on ‘a facility’s failure to follow’ other policies . . .‘where . . . those other policies determine what the facility deems the ‘goods and services necessary to avoid physical harm.’’” Southpark Meadows, DAB No. 2703 at 9 (2016) (quoting Avalon Place Kirbyville, DAB No. 2569 at 9-10 (2014) (in turn quoting the regulatory definition of “neglect”)). Petitioner had a policy “intended to set out practical guidelines to be followed in an overall effort to prevent or minimize abuse, neglect, or other forms of mistreatment toward nursing home facility residents by any person, and to comply with applicable nursing home regulations as required by law.” CMS Ex. 29 at 2.
Petitioner argues that its failure to transcribe and administer orders “perhaps supports a finding of ‘negligence,’ but not of ‘neglect’ . . . . ” P. Br. at 12. Petitioner further argues that its actions did not harm these residents but rather, “merely jeopardized the residents.” P. Br. at 23. As previously discussed at length, Petitioner did not transcribe and administer all medications ordered for Resident # 1 and Resident # 2. Petitioner did not
take seriously Resident # 1’s complaints of shortness of breath and request to be transferred to the hospital, in that it did not assess his vitals in accordance with the INTERACT care path that it purportedly follows prior to notifying a physician. With respect to Resident # 2, Petitioner admitted it withheld breathing treatments and failed to administer prescribed medication, and it failed to observe and report Resident # 2’s decline that precipitated his transfer to a hospital. Both residents were presumably admitted to the facility so that they could receive a level of care that each could not independently provide for himself, and Petitioner deprived these residents of necessary care and services and each resident deteriorated after they did not receive prescribed treatment and services. Even considering the evidence in the light most favorable to Petitioner, the undisputed material facts support that Petitioner failed to implement its policies requiring its staff to receive and record physician orders (CMS Ex. 31) and administer medications (CMS Ex. 33 at 1). Petitioner therefore failed to substantially comply with 42 C.F.R. § 483.13(c).
F. CMS’s determination of immediate jeopardy is not clearly erroneous.
CMS asserts that Petitioner’s deficiencies constituted immediate jeopardy (at the “L” scope and severity level) to resident health and safety from May 9 through 16, 2016. Petitioner argues that any noncompliance does not constitute immediate jeopardy, and if it does, the scope of immediate jeopardy was not widespread.34
Here, CMS’s finding of immediate jeopardy is not “clearly erroneous.” Petitioner argues that its staff did not cause any harm to residents, but “merely jeopardized the residents.” P. Br. at 23. Immediate jeopardy exists if a facility’s noncompliance has caused, or is likely to cause, serious injury, harm, impairment, or death to a resident. 42 C.F.R. § 488.301. Contrary to Petitioner’s flawed understanding of the concept of immediate jeopardy, the regulation does not require that a resident actually be harmed. Lakeport
Skilled Nursing Ctr., DAB No. 2435 at 8 (2012). I must uphold CMS’s determination as to the level of a facility’s substantial noncompliance (which includes an immediate jeopardy finding) unless it is “clearly erroneous.” 42 C.F.R. § 498.60(c). The DAB directs that the “clearly erroneous” standard imposes on a facility a heavy burden to show no immediate jeopardy and has sustained determinations of immediate jeopardy where CMS presented evidence “from which ‘[o]ne could reasonably conclude’ that immediate jeopardy exists.” See, e.g., Barbourville Nursing Home, DAB No. 1962 at 11 (2005) (citing Florence Park Care Ctr., DAB No. 1931 at 27-28 (2004)).
Petitioner failed to transcribe and provide prescribed medications to its residents,35 and it failed to inform physicians of missed doses or condition changes. Moreover, Petitioner failed to inform a physician that a resident had asked to go to the hospital after it did not properly evaluate the resident under its own protocol. Additionally, the condition of two residents, Resident # 1 and Resident # 2, deteriorated after they did not receive care in accordance with orders, and Petitioner ultimately transferred both residents to the hospital. Petitioner admits that it “jeopardized” Resident # 1 and Resident # 2, and based alone on the admitted deficiencies involving these two residents, Petitioner subjected its residents to a likelihood of serious harm. Therefore, the cited deficiencies posed immediate jeopardy to resident health and safety.
G. CMS’s determinations as to the duration of the periods on noncompliance and immediate jeopardy are appropriate.
Petitioner does not dispute the length of noncompliance, as its arguments focus on its mistaken belief that it was in substantial compliance. Substantial compliance means not only that the facility corrected the specific cited instances of substantial noncompliance but also that it implemented a plan of correction designed to assure that no additional incidents would occur in the future. Once a facility is found to be out of substantial compliance, it remains so until it affirmatively demonstrates that it has achieved substantial compliance once again. Premier Living & Rehab. Ctr., DAB No. 2146 at 23 (2008); Lake City Extended Care, DAB No. 1658 at 12-15 (1998). The burden is on the facility to prove that it is compliant with program requirements, and not on CMS to prove that deficiencies continued to exist after they were discovered. Asbury Ctr. at Johnson City, DAB No. 1815 at 19-20 (2002). Noncompliance found during a survey is
“presumed to continue until the facility demonstrates it has achieved substantial compliance.” Taos Living Ctr., DAB No 2293 at 20 (2009). Petitioner has not argued, much less presented evidence, that it abated immediate jeopardy earlier than May 17, 2016, nor has it contended, with supporting evidence, that it returned to compliance prior to June 17, 2016. I therefore sustain CMS’s determination regarding the duration of immediate jeopardy and have no reason to disturb any determination regarding the duration of noncompliance thereafter.
H. The penalty imposed is reasonable.
I examine whether the amount of a CMP is reasonable by applying the factors listed in 42 C.F.R. § 488.438(f): 1) the facility’s history of noncompliance; 2) the facility’s financial condition; 3) the factors specified in 42 C.F.R. § 488.404; and 4) the facility’s degree of culpability, which includes neglect, indifference, or disregard for resident care, comfort, or safety. The absence of culpability is not a mitigating factor. 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.
The regulations specify that a CMP that is imposed against a facility on a per-day basis will fall into one of two ranges.36 42 C.F.R. §§ 488.408; 488.438. The upper range of a CMP, $3,050 per day to $10,000 per day, is reserved for deficiencies that pose immediate jeopardy to a facility’s residents and, in some circumstances, for repeated deficiencies. 42 C.F.R. § 488.438(a)(1)(i), (d)(2). The lower range of CMP, $50 to $3,000 per day, is reserved for deficiencies that do not pose immediate jeopardy, but either cause actual harm to residents, or cause no actual harm but have the potential for causing more than minimal harm. 42 C.F.R. § 488.438(a)(1)(ii). In assessing the reasonableness of a CMP amount, the per-day amount, rather than the total accrued CMP, is at issue. See Kenton Healthcare, LLC, DAB No. 2186 at 28 (2008). Pursuant to 42 C.F.R. § 488.408(g)(2), a facility cannot appeal CMS’s choice of a remedy, and an appeal of a CMP is limited to review based on the regulatory factors set forth at 42 C.F.R. §§ 488.438(f) and 488.404(a)-(c). See, e.g., Senior Rehab., DAB No. 2300 at 19-20.
I must sustain a CMP unless a particular regulatory factor does not support the CMP amount imposed by CMS. Coquina Ctr., DAB No. 1860 at 32 (2002). CMS imposed a $7,550 per-day CMP, and I previously determined that the facility’s substantial noncompliance posed immediate jeopardy for 8 days from May 9 through 16, 2016. The
per-day CMP of $7,550 is at the upper end of the middle range of the $3,050 to $10,000 range for penalties imposed for deficiencies constituting immediate jeopardy. 42 C.F.R. § 488.438(a)(1)(i). Petitioner failed to timely administer medications to four residents out of a sample of 12 residents. Petitioner had multiple significant deficiencies that involved two of its residents, and both of those residents, after not receiving prescribed care, were ultimately transferred to the hospital. Petitioner repeatedly failed to transcribe orders, administer medications, and notify physicians and family members, and I would have sustained a far more severe penalty at the higher end of the range based on the circumstances; the $7,550 per day penalty is entirely reasonable. CMS also imposed a penalty of $1,000 per day effective May 17, 2016 through June 16, 2016. 42 C.F.R. § 488.438(a)(1)(ii); CMS Exs 1, 2. I find that a $1,000 per day CMP, which is at the lower end of that penalty range, is likewise reasonable. 42 C.F.R. § 488.438(a)(1)(ii).
Petitioner argues that the “CMP imposed for the period prior to the survey exit does not appear to serve any remedial purpose as it cannot be viewed as an inducement to correct its deficiencies . . . .” P. Br. at 23. Petitioner has not submitted any evidence that its financial condition renders it unable to pay the CMP, and absent any evidence of such, I need not further address this unsupported argument.37
For the reasons discussed above, I find that CMS imposed reasonable penalties for Petitioner’s substantial noncompliance with Medicare requirements.
Leslie C. Rogall Administrative Law Judge
1. Federal long-term care facility regulations substantially changed beginning on November 28, 2016. 81 Fed. Reg. 68,688 (Oct. 4, 2016). Based on the date of the survey, which preceded the regulatory revisions, I refer to the regulations that were in effect at the time of the survey.
- back to note 1 2. Scope and severity levels are used by CMS and state survey agencies when selecting remedies. The scope and severity level is designated by letters A through L. Pub. 100-7, State Operations Manual, § 7400.5.1 (Factors That Must be Considered When Selecting Remedies), “Assessment Factors Used to Determine the Seriousness of Deficiencies Matrix” (table), https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/som107c07.pdf (last visited July 20, 2018); see 42 C.F.R. § 488.408. As relevant here, a scope and severity level of “L” indicates a widespread deficiency that posed immediate jeopardy to resident health or safety.
- back to note 2 3. 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.” See 42 C.F.R. § 488.301.
- back to note 3 4. The Act authorizes the imposition of enforcement remedies against SNFs that are not in substantial compliance with program participation requirements, and the regulations specify the enforcement remedies that can be imposed. 42 U.S.C. § 1395i-3(h)(2); 42 C.F.R. § 488.406. Among other enforcement remedies, CMS may impose a per-day CMP for the number of days an SNF is not in substantial compliance or a per-instance CMP for each instance of the SNF’s noncompliance. 42 C.F.R. § 488.430(a).
- back to note 4 5. CMS also imposed a denial of payment for new admissions (DPNA) that went into effect on June 15, 2016, and was rescinded on June 17, 2016. CMS Exs. 2 at 1; 3 at 1. Petitioner does not dispute the imposition of the two-day DPNA.
- back to note 5 6. Findings of fact and conclusions of law are in bold and italics.
- back to note 6 7. Because I have granted CMS’s motion for summary judgment, a hearing for the purpose of cross-examination of these witnesses is unnecessary.
- back to note 7 8. The first five pages of Petitioner’s 20-page response to CMS’s motion for summary judgment are essentially a regurgitation of the first five pages of its brief. The next five pages appear to be a boilerplate discussion that lacks any reference to specific facts of this case. Petitioner’s sole citations to the evidentiary record are limited to CMS Exs. 1 and 2, which are letters from CMS informing Petitioner that it was not in substantial noncompliance with program requirements and that certain remedies had been imposed.
- back to note 8 9. There are several copies of Resident # 1’s discharge instructions (CMS Ex. 10 at 2-3; CMS Ex. 11), and the most recent version of the discharge instructions bears a time stamp of 2:22 pm. CMS Ex. 10 at 2-3. The 2:22 pm version of the discharge instructions indicates that the hospital administered intravenous ampicillin sodium at 2:10 pm on May 9, 2016. CMS Ex. 10 at 3. In addition to the discharge instructions, the hospital provided a discharge “order record,” which bears a time stamp of 1:59 pm. P. Ex. 1 at 1-2. Despite this evidence that Resident # 1 was discharged from the hospital shortly after 2:00 pm on May 9, 2016, Petitioner documented on a “face sheet” that it admitted Resident # 1 at 9:46 pm on May 9, 2016. CMS Ex. 9 at 1. There is no evidence indicating whether Resident # 1 received his prescribed medications during this nearly eight-hour period.
- back to note 9 10. As will be discussed later in this decision, Resident # 1 had reported shortness of breath and requested that Petitioner return him to the hospital at approximately 5:30 am on May 10, 2016. CMS Ex. 12 at 3; P. Ex. 1 at 17. A nurse, Ms. Hampton, did not document this encounter until more than 24 hours later, and as a result, this information was not included in Petitioner’s computerized records at the time Resident # 1 visited Petitioner’s in-house health clinic.
- back to note 10 11. At 1:48 pm on May 10, 2016, Petitioner commented in the eMAR that it was “awaiting clarification” regarding the orders for Digoxin, furosemide, Lipitor, and Miralax powder. It is unclear why Petitioner was awaiting clarification at that time, because its in-house physician’s assistant had already evaluated Resident # 1 at 9:33 am that same day and prescribed orders. P. Ex. 1 at 6.
- back to note 11 12. Petitioner points out, citing P. Ex. 1 at 1, that the hospital discharge orders prescribed BiPAP treatment “if available.” P. Br. at 10. Contemporaneous facility records do not indicate that a BiPAP was unavailable; on May 10, 2016, a physician’s assistant affiliated with Petitioner’s in-house clinic ordered that Resident # 1 “[c]ontinue BIPAP” at bedtime. P. Ex. 1 at 1. Further, an order dated May 10, 2016, and signed on May 31, 2016, directed discontinuance of BiPAP therapy at bedtime, which naturally supports that there had been a previous order for use of BiPAP equipment. P. Ex. 1 at 3. Likewise, Petitioner’s records document that use of a BiPAP had been ordered. CMS Ex. 14 at 16. Petitioner’s records do not support that it furnished BiPAP equipment to Resident # 1 at bedtime on May 9, 2016.
- back to note 12 13. Even though Lipitor was ordered to be taken at bedtime, the scheduled administration time in the eMAR is in the morning hours (listed separately as 8:00 am and 9:00 am). CMS Ex. 14 at 1, 2, and 4.
- back to note 13 14. Despite Petitioner’s transcription of an order for ipratropium bromide-albuterol sulfate, the record does not contain a prescription for ipratropium bromide-albuterol sulfate. Rather, both the hospital and Ms. Jasik prescribed ipratropium bromide (Atrovent) alone and not in combination with any other medications. CMS Ex. 10 at 3; P. Ex. 1 at 7.
- back to note 14 15. I observe that both the hospital and Ms. Jasik directed that Resident # 1 receive ipratropium bromide, which is otherwise known as Atrovent, via inhalation; Petitioner erroneously transcribed that Resident # 1 should receive ipratropium bromide in combination with albuterol sulfate, both of which it administered at 5:00 pm on May 10, 2016, despite lacking an order to administer albuterol sulfate. CMS Ex. 14 at 17-18.
- back to note 15 16. Petitioner’s eMAR does not reference the two intravenous antibiotics, ampicillin sodium and gentamycin sulfate. Nursing notes document that Petitioner administered a single dose of each antibiotic in the early morning hours of May 10, 2016. CMS Ex. 12 at 4.
- back to note 16 17. I reiterate there is no prescription for ipratropium bromide-albuterol sulfate.
- back to note 17 18. CMS argued that 600 ml of medication should have been dispensed if it had been dispensed every four hours, but that only 300 ml of ampicillin sodium “had been removed.” CMS Motion at 5; see CMS Exs. 4 at 7; 10 at 2. Petitioner vaguely argues that Resident # 1 “was given his scheduled IV antibiotics,” but Petitioner has offered no evidence that it administered ampicillin sodium intravenously at any time other than at 2:00 am or that it had administered the 300 ml of ampicillin sodium that CMS alleges it did not administer. See P. Br. at 11. Further, Petitioner did not address this allegation in its response to CMS’s motion for summary judgment.
- back to note 18 19. Although oxygen had been prescribed (P. Ex. 1 at 1, 8), there is no evidence Resident # 1 was given continuous oxygen prior to 2:00 pm on May 10, 2016. See CMS Ex. 14 at 12.
- back to note 19 20. Despite Resident # 1’s report of shortness of breath that he felt necessitated hospitalization, Petitioner did not document this complaint until nearly 24 hours later, which it recorded as a “later [sic] entry” following Resident # 1’s transfer to the hospital.
- back to note 20 21. Remarkably, Petitioner’s staff’s purported use of the INTERACT care path is not documented in any nursing notes or contemporaneous facility records. In fact, the nurse who reported the request, Amber Hampton, GVN, did not reference use of the INTERACT protocol in her late entry note the following day. CMS Ex. 12 at 3. Rather, the only evidence pertaining to Petitioner’s use of the INTERACT care path is contained in the written testimony of its administrator (incorporating a copy of Petitioner’s request for informal dispute resolution). P. Ex. 4 at 4-5.
- back to note 21 22. The incident report, which was completed during the ongoing survey, reports that Petitioner did not notify Resident # 2’s physician until May 13, 2016, at which time the resident had already been transferred to a hospital. P. Ex. 2.
- back to note 22 23. Petitioner does not dispute CMS’s argument that Petitioner did not administer five treatments when Resident # 2 was asleep, and that Resident # 2 refused the remainder of the treatments. See CMS Br. at 8, citing CMS Ex. 3 at 14.
- back to note 23 24. Petitioner does not dispute CMS’s argument that Petitioner did not administer Xopenex five times because Resident # 2 refused and another three times because Resident # 2 was asleep. CMS Br. at 8, citing CMS Exs. 3 at 14; 21 at 4.
- back to note 24 25. If the physician had received timely notification of these missed treatments, the physician could have altered the medication administration schedule or addressed the issue with the resident and his responsible party.
- back to note 25 26. A May 12, 2016 late entry note documents that on May 11, 2016, a nurse practitioner issued “new orders” for “Rocephin 1 [gram] [intramuscular for 3] days for [treatment] of UTI.” CMS Ex. 23 at 1. The nurse practitioner also ordered a 7-day course of another antibiotic, Macrobid. CMS Ex. 23 at 1. There is no evidence that Petitioner transcribed this order to the eMAR or administered these antibiotic medications.
- back to note 26 27. Petitioner’s reference to an “E-KIT” is to an emergency kit. The parties both apparently misstate the facts regarding the administration of Rocephin on May 13, 2016. CMS Br. at 10; P. Br. at 20. CMS, citing the statement of deficiencies and not referencing elsewhere in the evidentiary record, argued that “[a]lthough Bastrop maintains Rocephin IV in its E-Kit, staff members were unaware the drug was readily available in its facility.” CMS Br. at 10. Likewise, Petitioner argued that “[t]he statement of deficiencies fails to recite any standard requiring the availability of Rocephin in emergency supplies, nor does it state a requirement to use medications from a facility’s emergency supply, if so available, in a non-emergency scenario.” P. Br. at 20. Both parties fail to recognize that, according to a facility record authored by the same nurse who later discussed this same issue with the surveyor (see CMS Ex. 3 at 110), Petitioner did administer the initial dose of Rocephin from its emergency kit. CMS Ex. 24 at 3 (reporting 12:09 am dose of Rocephin was obtained from the emergency kit). Further, I note that while Petitioner protests that there is no requirement for it to use supplies from its emergency kit, it actually did so on both May 11, 2016, when it obtained Keflex (CMS Ex. 23 at 1) and on May 13, 2016, when it obtained Rocephin. CMS Ex. 24 at 3. Regardless of the source of the initial dose of Rocephin, Petitioner does not dispute that it did not administer the initial dose until at least eight hours after it was first prescribed.
- back to note 27 28. Resident # 7 had prescriptions for albuterol sulfate every four hours as needed, Brovana and Pulmicort together every twelve hours, and ipratropium bromide-albuterol sulfate every six hours. CMS Ex. 26 at 1-3.
- back to note 28 29. In addressing each deficiency, I limit my discussion to the residents addressed for each deficiency in the statement of deficiencies. Therefore, for this deficiency and the remaining deficiencies discussed below, I focus on the evidence pertaining to only Resident # 1 and Resident # 2.
- back to note 29 30. To the extent that Petitioner raises an unsupported factual dispute regarding the administration of Xopenex breathing treatments, I need not rely on this separate basis in determining that Petitioner failed to provide pharmaceutical services that met Resident # 2’s needs or committed a significant medication error. Petitioner implies in its brief that Resident # 2 refused breathing treatments when he was asleep, but has not come forward with evidence of such; to the contrary, Petitioner recognized that Ms. Jasik considered whether “the inconsistent administration of nebulizer treatments and/or missed doses of Metoprolol for his blood pressure” caused Resident # 2’s “decline” but determined she could not make such a determination. P. Br. at 16-17. Further, the eMAR and other records do not evidence that Resident # 2 refused treatments when he was sleeping.
- back to note 30 31. Had Petitioner notified the physician that the order directing administration of a breathing treatment at midnight was problematic, then the physician could have determined whether a different administration schedule should be employed.
- back to note 31 32. While I need not address other facets of this regulation, I point out that the regulation requires notification of “an interested family member.” 42 C.F.R. § 483.10(b)(11). Petitioner argued it was unnecessary to notify Resident # 1’s daughter of the incident because “the resident was found to be capable of exercising his rights.” Petitioner is mistaken; Resident # 1’s daughter is clearly an interested family member, regardless of Resident # 1’s capabilities.
- back to note 32 33. In its response to CMS’s motion for summary judgment, Petitioner presents a wholly unsupported allegation that Resident # 1’s “request to go to the hospital was a de facto refusal of care.” P. Response at 13. Thus, yet again, Petitioner attempts to discredit its own resident in an effort to shift blame from itself.
- back to note 33 34. I need not make specific findings regarding the scope of the immediate jeopardy level deficiencies because a change in the scope of the deficiencies would have no bearing on the penalty range of between $3,050 and $10,000 per day. See 42 C.F.R. § 488.438; see also Wisteria Care Ctr., DAB No. 1892 (2003) (“Having properly determined (based on uncontested evidence) that [a facility] was not in substantial compliance during the relevant periods, the ALJ was not required to make findings regarding the scope and severity of each of the non-immediate jeopardy level deficiency identified by the surveyors. Such findings would not have affected the range of penalty amounts that CMS could collect.”). Nonetheless, I point out that the deficiencies each involved between two and four residents out of a small sample size of 12 residents; even though a relatively small number of residents were referenced in the statement of deficiencies, the percentage of the sample size that is the subject of a cited deficiency is considerable.
- back to note 34 35. Withholding medications can have serious consequences. In addition to causing a medical condition to be untreated or undertreated, the abrupt cessation of medication, itself, can potentially cause adverse effects. See, e.g., CMS Ex. 4 at 4 (prescribing information for metoprolol tartrate (Lopressor), advising that, “[f]ollowing abrupt cessation of therapy with certain beta-blocking agents, exacerbation of angina pectoris, and in some cases, myocardial infarction have occurred,” and cautioning that the dosage should gradually be reduced over a period of one-to-two weeks prior to discontinuation of therapy).
- back to note 35 36. CMP amounts increased, beginning August 1, 2016, for deficiencies cited after November 2, 2015. See 81 Fed. Reg. 61,538 (Sept. 6, 2016). I apply the CMP amounts that were in effect at the time of the survey in May 2016.
- back to note 36 37. In a rather baffling argument, Petitioner asserts that CMS “has failed to, and cannot, present undisputed facts regarding its purported review of the financial information” and that “review and consideration of the facility’s financial status remains a disputed matter for review and weighing of the evidence by the ALJ at hearing.” P. Br. at 17. If Petitioner feels there is evidence regarding its financial condition that is relevant to my review of the CMP, then Petitioner should have submitted that evidence with its pre-hearing exchange, if not sooner. It is entirely unclear how Petitioner expects CMS to be aware of its financial condition absent the submission of evidence by Petitioner.
- back to note 37