SUBJECT: Franklin Care Center,

Petitioner,

Centers for Medicare & Medicaid Services

FINAL DECISION ON REVIEW OF
ADMINISTRATIVE LAW JUDGE DECISION

Franklin Care Center (Franklin) appealed the April 4, 2003 decision of Administrative Law Judge (ALJ) Alfonso J. Montano sustaining the determination of the Centers for Medicare & Medicaid Services (CMS) to impose a civil money penalty (CMP) on Franklin of $5,000 per day for the period April 8 through April 19, 1999. Franklin Care Center, DAB CR1023 (2003) (ALJ Decision). CMS had imposed the CMP based on two surveys by the New Jersey Department of Health and Senior Services (State agency) which found that Franklin was not in substantial compliance with Medicare participation requirements. The ALJ rejected CMS's position that Franklin had not substantially complied with the requirements at 42 C.F.R. §§ 483.13(c)(2), (3), and (4) but upheld the CMP based on his finding that Franklin had not substantially complied with the requirement at 42 C.F.R. § 483.25(m)(2). That section states that the facility "must ensure that . . . [r]esidents are free of any significant medication errors." As discussed in detail below, we sustain the ALJ's decision that Franklin was not in substantial compliance with section 483.25(m)(2) and that the amount of the CMP was reasonable.

Legal Background

Franklin is a long-term care facility that participates in the Medicare program. The regulatory requirements for long-term care facilities participating in Medicare are set forth at 42 C.F.R. Part 483. Section 483.25(m) provides:

Medication Errors. The facility must ensure that-
(1) It is free of medication error rates of five percent or greater; and
(2) Residents are free of any significant medication errors.

Compliance with the participation requirements is determined through the survey and certification process, set out at 42 C.F.R. Part 488, Subpart E. Surveys are generally conducted by a state survey agency under an agreement with CMS. A survey's findings are presented in a Statement of Deficiencies (SOD), which identifies, using an appropriate "F tag" number, each failure to meet a participation requirement. See CMS State Operations Manual (SOM) Appendix P, Chap. IV.

A facility becomes subject to remedial action when it is not in "substantial compliance" with one or more participation requirements. See 42 C.F.R. § 488.400. A facility is not in substantial compliance with a participation requirement if a deficiency results in actual harm to a resident or poses a risk to resident health and safety greater than the potential for causing minimal harm. 42 C.F.R. § 488.301.

If a survey reveals that a facility is not in substantial compliance, CMS may either terminate its provider agreement or allow it the opportunity to correct the deficiencies pursuant to a plan of correction. 42 C.F.R. §§ 488.402(d), 488.408(f), 488.412. To encourage facilities to implement a plan of correction, CMS may impose a CMP for the days in which the facility remains in a state of noncompliance. (Under the regulations, "noncompliance" means "any deficiency that causes a facility to not be in substantial compliance." 42 C.F.R. § 488.301.)

A CMP in the range of $50 - $3,000 per day may be imposed for deficiencies that do not constitute immediate jeopardy but that either cause actual harm or create the potential for more than minimal harm. For deficiencies that constitute immediate jeopardy, a CMP in the range of $3,050 - $10,000 per day of noncompliance may be imposed. 42 C.F.R. § 488.438(a)(1)(i) and (ii). "Immediate jeopardy" is defined as -

a situation in which the provider's noncompliance with one or more requirements of participation has caused, or is likely to cause, serious injury, harm, impairment, or death to a resident.

42 C.F.R. § 488.301.

A CMP continues until either "(1) The facility has achieved substantial compliance, as determined by CMS or the State based upon a revisit or after an examination of credible written evidence that it can verify without an on-site visit" or "(2) CMS or the State terminates the provider agreement." 42 C.F.R. § 488.454(a); see also 42 C.F.R. § 488.440(h).

An ALJ may not "[c]onsider any factors in reviewing the amount of a [civil money] penalty other than those specified in paragraph (f) of" 42 C.F.R. § 488.438. 42 C.F.R. § 488.438(e)(3). The factors in paragraph (f) are --

(1) The facility's history of noncompliance, including repeated deficiencies.
(2) The facility's financial condition.
(3) The factors specified in § 488.404.
(4) The facility's degree of culpability.
"Culpability" for purposes of this paragraph includes, but is not limited to, neglect, indifference, or disregard for resident care, comfort or safety. The absence of culpability is not a mitigating circumstance in reducing the amount of the penalty.

(Italics in original.) Section 488.404, captioned "Factors to be considered in selecting remedies," lists "the seriousness of the deficiencies" (i.e., their scope and severity) as one factor. Section 488.404(a) and (b). Section 488.404(c) provides for consideration of:

(1) The relationship of the one deficiency to other deficiencies resulting in noncompliance.
(2) The facility's prior history of noncompliance in general and specifically with reference to the cited deficiencies.

A facility may appeal a certification of noncompliance leading to an enforcement remedy. 42 C.F.R. § 488.408(g). A determination with respect to the level of noncompliance may be appealed if a successful challenge on this issue would affect the range of CMP amounts that CMS could collect. 42 C.F.R. §§ 498.3(b)(13)(i) and 498.3(d)(10)(i). ⁽¹⁾ CMS's determination as to the level of noncompliance "must be upheld unless it is clearly erroneous." 42 C.F.R. § 498.60(c)(2). This includes CMS's finding of immediate jeopardy. Woodstock Care Center, DAB No. 1726, at 9, 38 (2000), aff'd, No. 01-3889 (6^th Cir. Nov. 17, 2003).

Standard of review

The standard of review on a disputed issue of law is whether the ALJ decision is erroneous. The standard of review on a disputed factual issue is whether the ALJ decision is supported by substantial evidence in the record as a whole. Guidelines for Appellate Review of Decisions of Administrative Law Judges Affecting a Provider's Participation in the Medicare and Medicaid Programs (at http://www.hhs.gov/dab/guidelines/); see, e.g., Fairfax Nursing Home, Inc., DAB No. 1794 (2001), aff'd, Fairfax Nursing Home v. Dep't of Health & Human Srvcs., 300 F.3d 835 (7th Cir. 2002), cert. denied, 2003 WL 98478 (Jan. 13, 2003).

The ALJ Decision

The ALJ made five findings of fact and conclusions of law (FFCL). FFCL 1 states that "Petitioner failed to comply substantially with 42 C.F.R. § 483.25(m)(2)." In the text following this finding, the ALJ stated specifically:

I find that Petitioner failed to comply with 42 C.F.R. § 483.30(m)(2) [sic] because Residents #1, #2, and #3 suffered serious medication errors which can only be described as significant. After an investigation, it was determined that on the morning of March 27, 1999, Nurse Ramos inadvertently injected Residents #1 and #2 with insulin instead of the prescribed heparin. As a result the residents suffered hypoglycemia reactions. Both residents were rushed to the hospital emergency room. After some difficulty, the residents['] blood sugar levels were stabilized. Without prompt intervention, Residents #1 and #2 would have died. Tr. at 39. Similarly, Resident #3's serious Digoxin overdose led to his hospitalization.

ALJ Decision at 9 (footnote omitted).

The digoxin overdose referred to above was described by the ALJ as--

. . . caused by a transcription error by a Franklin Care Center nurse other than Nurse Ramos. The physician's order for the medication was not correctly placed on the medication administration record. As a result, the resident did not receive the appropriate dose of medication as ordered for nine days, from April 1, 1999 through April 9, 1999. Tr. 62; [CMS] Ex. 15.

Id.

Based on the incidents with these three residents, the ALJ stated:

I find that CMS established a prima facie case that Petitioner failed to comply with 42 C.F.R. § 483.25(m)(2) in that Petitioner failed to ensure that residents are free of any significant medication errors. I also find that Petitioner did not rebut CMS's prima facie case by a preponderance of the evidence. The residents suffered serious actual harm as a result of Petitioner's significant medication errors. Therefore, I sustain CMS's deficiency finding on participation requirement 42 C.F.R. § 483.25(m)(2); (F 333) at the immediate jeopardy level.

Id. at 10.

In FFCLs 2, 3, and 4, the ALJ found that, contrary to what CMS argued, Franklin was in substantial compliance with the requirements of sections 483.13(c)(2), (3), and (4). The FFCLs read as follows:

2. Petitioner was in substantial compliance with 42 C.F.R. § 483.13(c)(2),(3), and (4).

3. Petitioner timely and properly reported to the authorities medication errors relating to Residents #1 and #2 pursuant to 42 C.F.R. § 483.13(c)(2).

4. Petitioner did not neglect the other residents in the facility, nor did it fail to conduct a thorough investigation, or safeguard the residents in the sub-acute unit during the investigation.

Id. at 10, 12, 14.

FFCL 5 states:

5. A civil money penalty at the immediate jeopardy level of $5,000 for each day of non-compliance is reasonable. The total amount of civil money penalty is $60,000.

Id. at 15.

Franklin took exception to FFCLs 1 and 5. We discuss Franklin's arguments with respect to these FFCLs in turn below. Since Franklin did not take exception to FFCLs 2, 3 or 4, we adopt and affirm those FFCLs without further discussion. ⁽²⁾

Procedural History

The following summarizes the procedural background of the case, as reflected in the ALJ Decision and the record before the ALJ.

On April 7, 1999, Franklin notified the State agency that medication errors had occurred at its facility on March 27, 1999. As a result of this notification, the State agency conducted a complaint survey at Franklin on April 8, 1999. At the conclusion of the survey, the State agency cited Franklin for failure to substantially comply with two participation requirements identified in the SOD as Tag F333 - corresponding to 42 C.F.R. § 483.25(m)(2), and Tag F225 - corresponding to 42 C.F.R. § 483.13(c)(1)(2). The SOD indicates that each of these deficiencies was at a scope and severity level of "J," meaning that the deficiency was isolated but posed actual harm that was immediate jeopardy. CMS Ex. 2; SOM § 7400.

On April 9, 1999, Franklin notified the State agency that another medication error involving a third resident had occurred at its facility.

On April 14, 1999, the State agency conducted another survey at Franklin. CMS Ex. 14. The surveyor reviewed Franklin's Plan of Correction, which alleged compliance with the participation requirements as of April 14 and requested an addendum. CMS Exs. 2, 14. Franklin submitted a "Revised Addendum to Plan of Correction" dated April 15, 1999. CMS Ex. 16.

On April 20, 1999, the State agency conducted a revisit survey and found that Franklin had achieved substantial compliance. CMS Exs. 3, 13.

CMS sent two letters to Franklin regarding these matters. On April 21, 1999, CMS notified Franklin, that, based on the State agency findings, its Medicare provider agreement would be terminated on April 30, 1999 if immediate jeopardy was not removed. CMS stated that in addition, it would impose a CMP in the amount of $5,000 per day, commencing on April 8, 1999, and a denial of payment for new admissions, effective May 6, 1999. CMS also stated that the CMP would continue to accrue until all deficiencies were corrected and the facility was found to be in substantial compliance, or the provider agreement was terminated. CMS Ex. 1. Then, on June 24, 1999, CMS notified Franklin that, based on the April 20, 1999 revisit survey, Franklin was found to have achieved substantial compliance on April 20, 1999. CMS stated that it would therefore impose a CMP "in the amount of $5,000 per day, from April 8, 1999 through April 19, 1999, a period [of] 12 days of noncompliance which constituted immediate jeopardy." CMS Ex. 4. ⁽³⁾

1. The ALJ's finding that Franklin was not in substantial compliance with section 483.25(m)(2) was not erroneous and was supported by substantial evidence.

Franklin did not dispute that medication errors were made with respect to Residents 1, 2 and 3. Nor did Franklin dispute that, "[w]ithout prompt intervention, Resident #1 and #2 would have died" as a result of those errors, while the error as to Resident 3 "led to his hospitalization." ALJ Decision at 9. Franklin nevertheless argued that the ALJ's finding that it was not in substantial compliance with section 483.25(m)(2) was erroneous and was not supported by substantial evidence. According to Franklin, the "test . . . is not whether a resident was harmed, but whether the harm resulted from an identified deficiency." Franklin asserted that there was no proof of an identified deficiency here since "[n]o testimony or argument was presented that indicated that [Franklin] acted improperly or failed to act prudently in protecting residents from harm." ⁽⁴⁾ Thus, Franklin argued, the ALJ improperly held it to a strict liability standard when he found a deficiency under section 483.25(m)(2) based on "accidents" that were "isolated." Franklin Br. at 13-14.

Contrary to what Franklin's arguments suggest, however, the ALJ did not need to find specifically that Franklin engaged in improper acts or failed to act prudently or that there was a pattern of medication errors at the facility in order to conclude that Franklin failed to substantially comply with section 483.25(m)(2). The preamble to the final regulation makes clear that a facility's compliance with section 483.25(m)(2) turns solely on whether it made a medication error or errors that were "significant" and that a single medication error can be "significant." The preamble states in pertinent part:

Since medication errors vary in their significance (e.g., from significant errors such as a double dose of a potent cardiac drug like digoxin to a small error in the dose of an antacid like milk of magnesia), we have based sanctions on two different criteria. First, if a facility has a significant medication error, then it is sanctioned. This policy satisfies consumers, who maintain that a five percent tolerance in medication errors is too lenient and that one medication error could be disastrous for a resident. Second, a facility is sanctioned if it has an error rate of five percent or greater. This satisfies providers who maintain that there must be some tolerance of errors because all systems have some errors. . . .

Thus, the regulation infers that a facility has a deficient medication system if there is either a significant medication error or an error rate in excess of the five percent rate determined to be tolerable "because all systems have some errors. . . ."

The preamble describes a "significant medication error" as follows:

A significant medication error is judged by a surveyor, using factors which have been described in interpretive guidelines since May 1984. The three factors are: (1) Drug category. Did the error involve a drug that could result in serious consequences for the resident (2) Resident condition. Was the resident compromised in such a way that he or she could not easily recover from the error (3) Frequency of error. Is there any evidence that the error occurred more than once[.] Using these criteria, an example of a significant medication error might be as follows: A resident received twice the [in]correct dose of digoxin, a potentially toxic drug. The resident already had a slow pulse rate, which the drug would further lower. The error occurred three times last week.

56 Fed. Reg. 48826, at 48853 (Sept. 26, 1991).

The interpretive guidelines referred to in the preamble are found in Appendix N, section VI.A. of the SOM. The guidelines describe the three factors relevant in determining whether an error is "significant" as follows:

1. Patient Condition.-The patient's condition is an important factor to consider. For example, a potent diuretic erroneously administered to a dehydrated patient may have serious consequences but if administered to a patient with a normal fluid balance may not. If the patient's condition requires rigid control, a single missed or wrong dose can be highly significant.

2. Drug Category.-If the drug is from a category that usually requires the patient to be titrated to a specific blood level, a single medication error could alter that level and precipitate a re-occurrence of symptoms or toxicity. This is especially true if the half life of the drug is short. . . .

3. Frequency of Error. If the error is occurring with any frequency, there is more reason to classify the error as significant. For example, if a patient's drug was omitted several times . . . , classifying that error as significant would be in order. This conclusion may be especially valid when taken in concert with the patient's condition and the drug category.

The ALJ's finding that the medication errors made by Franklin with respect to Residents 1, 2 and 3 were significant is fully consistent with the preamble and the SOM. ⁽⁵⁾ In all three cases, the nature of the drug was such that the medication error caused serious consequences to the residents, whose conditions were sufficiently compromised that they required hospitalization in order to recover. In addition, insulin alters an individual's blood sugar level (see Tr. at 35, 37-38), and if inappropriately administered, a single dose can produce adverse symptoms. Thus, the medication errors involving Residents 1 and 2 can each properly be considered a significant medication error based on the drug category alone. Furthermore, since the preamble specifically describes a double dose of digoxin as a significant medication error, Franklin's administration of a similar overdose of digoxin to Resident 3 constitutes a significant medication error. ⁽⁶⁾

Franklin is correct that, in finding that there was a deficiency under section 483.25(m)(2), the ALJ did not address whether the medication errors in question were widespread or the extent of Franklin's culpability, if any. This is not required in order to find that Franklin was not complying with the regulation, however. While medication errors that are not significant are not a basis for imposition of a remedy such as a CMP unless the facility's error rate exceeds five percent, the preamble indicates that there is no tolerance for significant medication errors. Moreover, this case is distinguishable from those where the Board has held that the requirement in section 483.25(h) that a facility "ensure" that each resident receives supervision adequate to prevent accidents "does not amount to strict liability or require absolute success in an obviously difficult task." See, e.g., Woodstock at 27. To "ensure that residents are free of any significant medication errors" as required by section 483.25(m)(2), a facility must administer the "right dose" of the "right med[ication]" by the "right route" to the "right patient" at the "right time" (Tr. at 193). This is not reasonably considered "an obviously difficult task" since, unlike the prevention of accidents such as patient falls, this task does not typically involve any factors outside the facility's control.

We therefore conclude that the ALJ did not err in finding that Franklin failed to comply substantially with section 483.25(m)(2), regardless of the circumstances under which the medication errors occurred.

The ALJ's determination that there was an immediate jeopardy level deficiency under section 483.25(m)(2) for a 12-day period and that a CMP of $5,000 per day was justified was not erroneous.

Franklin argued that the ALJ's findings as to the duration and level of the noncompliance and the amount of the CMP were erroneous. We address each of Franklin's arguments in turn below.

Franklin argued first that the ALJ should have reduced the amount of the CMP imposed by CMS because he "rejected 3 out of the 4 deficiency findings." Franklin Br. at 14. As noted above, the ALJ found a deficiency only under section 483.25(m)(2), reversing CMS's findings that Franklin was out of compliance with sections 483.13(c)(2), (3) and (4). ⁽⁷⁾ We conclude that the ALJ did not err in not reducing the amount of the CMP on this basis. The ALJ found that the seriousness of the deficiency under section 483.25(m)(2), together with Franklin's culpability for this deficiency, justified a $5,000 per day CMP. While any additional deficiencies might have been a basis for increasing the CMP amount, the lack of any additional deficiencies was not a basis for reducing it. Moreover, since all of the deficiencies found by the State survey agency were related to the significant medication errors made by Franklin, the number of deficiencies was less important than it might otherwise have been. While the SOD indicated that all of the deficiencies posed immediate jeopardy, there was no actual harm caused by Franklin's alleged failure to report and investigate the medication errors in accordance with section 483.13(c) that was not already caused by the medication errors.

Franklin also argued that the ALJ erred in finding that there was a deficiency at the immediate jeopardy level for 12 days so that a CMP in the upper range was not warranted. Franklin did not dispute that the medication errors initially posed immediate jeopardy. Franklin asserted, however, that its patients were not at risk of serious harm after March 28, 1999, the last day that Nurse Ramos, who made the medication errors with respect to Residents 1 and 2, worked at the facility. ⁽⁸⁾ We do not find Franklin's argument persuasive. It ignores the fact that another significant medication error that caused actual harm (the overdoses of digoxin that resulted in Resident 3's hospitalization) took place from April 1 through April 9, 1999. Thus, the immediate jeopardy continued after Nurse Ramos's departure due to problems that went beyond one individual's mistakes. Indeed, as the Board has observed, the regulatory scheme presumes that there are systemic problems in a facility that give rise to a deficiency, and the regulations thus require that a facility implement a plan of correction and that there be either a revisit or written credible evidence before the facility can be found to be in substantial compliance. See Coquina Center, DAB No. 1860, at 23-26 (2003), citing Regency Gardens Nursing Center, DAB No. 1858 (2002), Barn Hill Care Center, DAB No. 1848 (2002), Lake City Extended Care Center, DAB No. 1658 (1998), and CarePlex of Silver Spring, DAB No. 1683 (1999). Franklin's plan of correction outlined a series of actions to achieve substantial compliance; however, the completion dates extended from April 8 through May 30. Franklin did not identify on appeal any action other than the departure of Nurse Ramos that in its view sufficed to remove the immediate jeopardy. ⁽⁹⁾

Franklin argued further that the ALJ's finding that there was a deficiency at the immediate jeopardy level under section 483.25(m)(2) was inconsistent with his determination, made in connection with his reversal of the deficiency finding under section 483.13(c)(3), that Franklin safeguarded the other residents on the unit during the investigation of the medication errors involving Residents 1 and 2. We see no inconsistency. CMS determined that each of these alleged deficiencies posed immediate jeopardy; thus, the ALJ's finding that there was no deficiency under section 483.13(c)(3) did not directly affect the finding of immediate jeopardy under section 483.25(m)(2). Moreover, in reversing the deficiency finding under section 483.13(c)(3), the ALJ found in effect that Franklin did all that it could reasonably be expected to do before the results of the investigation were known to prevent further medication errors on the unit. In order to remove the immediate jeopardy posed by the deficiency under section 483.25(m)(2), however, Franklin had to address the underlying causes of the medication errors. This it could not even begin to do until after the investigation was completed.

Thus, there is simply no basis upon which we could conclude that the ALJ should have found clearly erroneous CMS's determination that immediate jeopardy continued until the date of the revisit survey.

Finally, Franklin took the position that the ALJ should have reduced the amount of the CMP based on two of the factors in section 488.438(f) which the ALJ may consider in setting the amount of a CMP: the facility's history of noncompliance and the facility's culpability. Franklin argued that the ALJ ignored testimony that Franklin had never been cited for a medication error prior to the incidents in question as well as testimony that Franklin had systems in place that should have been adequate to protect its residents. Franklin Br. at 17, citing Tr. at 192, 316-317. The latter testimony consisted of affirmative responses to counsel's questions whether Franklin "had systems in place to assure proper med passes" and "proper injectables."

Franklin's reliance on the former testimony flies in the face of the clear requirements of the regulations. Section 488.438(e)(3) precludes the ALJ from considering factors not listed in section 488.438(f) (which incorporates by reference the factors in section 488.404). A history of noncompliance is one such factor, but the absence of a history of noncompliance is not. Furthermore, "culpability" is defined in section 488.438(f) as including neglect, which section 488.301 in turn defines as the "failure to provide goods and services necessary to avoid physical harm . . . ." While the ALJ did not discuss culpability in determining whether Franklin was in substantial compliance with section 483.25(m)(2), he found that the question of whether Franklin complied with section 483.13(c) raised a threshold issue of whether Franklin neglected its residents. The ALJ found that the medication errors in question constituted neglect, stating:

The facts in this case establish that Petitioner failed to provide the appropriate medication to Residents #1 and #2, which resulted in physical harm and hospitalization. In addition, Petitioner failed to provide adequate services in the form of proper transcription of a medication order for Resident #3, which resulted in physical harm requiring hospitalization. These medication and transcription errors involving three residents at Petitioner's facility constitute neglect.

ALJ Decision at 12. The testimony that Franklin had systems in place to assure "proper med passes" and "proper injectables" does not undercut this finding of neglect. The mere existence of any such systems was of little value until Franklin took steps, such as training staff about the systems, to assure that the systems would function as intended. There is thus substantial evidence to support the ALJ's determination that Franklin was culpable for the medication errors.

Accordingly, we conclude that the ALJ did not err in concluding that a CMP of $5,000 per day for 12 days was reasonable.

Conclusion

For the reasons stated above, we affirm all of the ALJ's findings of fact and conclusions of law and uphold his determination imposing a CMP in the amount of $5,000 per day for the period April 8 through April 19, 1999.

Cecilia Sparks Ford

Donald F. Garrett

Judith A. Ballard
Presiding Board Member

1. We cite to the regulations as they appeared prior to their amendment in April 2000, when some of the sections were redesignated and amended in ways not relevant here.

2. CMS stated that "it does not concede the correctness of the ALJ's decision" (at FFCL 2) that Franklin was in substantial compliance with section 483.13(c). CMS Br. at 14, n.5. CMS indicated that it nevertheless did not appeal that finding because it "does not impact the amount of the CMP." Id

We note that it is unclear whether section 483.13(c) is even applicable here. The section requires that the facility "must prevent further potential abuse while the investigation" of alleged violations is in progress. (Emphasis added.) CMS contended, and the ALJ found, that the medication errors constituted neglect, not that they constituted abuse.

3. age one of the ALJ Decision identifies the first day of noncompliance as April 9. It appears that the ALJ intended to give April 8 as the date since he subsequently described the CMP as beginning on April 8. ALJ Decision at 2.

4. Franklin did not deny that the nurse who administered the insulin to Residents 1 and 2 acted improperly, however. The Board has consistently held that a facility cannot disavow responsibility for the actions of its employees. See, e.g., Cherrywood Nursing & Living Center, DAB No. 1845 (2002), and decisions cited therein.

5. In imposing the CMP, CMS did not specifically rely on the incident involving Resident 3, which was not reported until after the April 8, 1999 survey. See CMS Exs. 1 and 4. However, neither party questioned whether the ALJ properly relied on this incident either in determining whether there were significant medication errors or in determining the amount of the CMP.

6. The record shows that Resident 3 received digoxin daily instead of on alternate days. CMS Ex. 15.

7. The ALJ found that CMS intended to allege deficiencies under sections 483.13(c)(2), (3), and (4) although the SOD instead cites a deficiency under section 483.13(c)(1)(ii). ALJ Decision at 4-6. Although he then proceeded to find that "Petitioner was in substantial compliance with 42 C.F.R. § 483.13(c)(2),(3), and (4)" (id. at 10 (FFCL 2)), the ALJ specifically discussed only the alleged violations of sections 483.13(c)(2) and (3), not section 483.13(c)(4). Since we would reach the same conclusion whether the ALJ rejected two or three deficiency findings, this omission is not material here.

8. Since the CMP was imposed beginning April 8, 1999, Franklin's argument was that there was no immediate jeopardy during the entire CMP period

9. Before the ALJ, Franklin argued in addition that immediate jeopardy was eliminated on April 14 when "the pharmacy was notified of the similarity of the heparin and insulin bottles and requested special labeling of the insulin." Franklin Post-Hearing Br. at 33. While this action addressed an apparent cause of the medication errors involving Residents 1 and 2, it did not address any underlying cause of the medication error involving Resident 3. Thus, this does not establish that the immediate jeopardy was removed before the date of the revisit survey.