SUBJECT:

Vijay Sakhuja, M.D.,

Petitioner,

Centers for Medicare & Medicaid Services.

DECISION

Vijay Sakhuja, M.D. (Petitioner) challenges the Centers for Medicare & Medicaid Services' (CMS's) determination to revoke his physician laboratory's certificate that was issued under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. § 263a et seq. and to cancel its approval to receive Medicare or Medicaid payments for its services. For the reasons set forth below, I sustain CMS's decision to revoke Petitioner's laboratory's CLIA certificate.

I. Background

Petitioner maintained a physician's office laboratory in Jamaica, New York. The New York State Department of Health (NYSDOH) performed a biannual recertification survey of Petitioner's laboratory on September 28, 2001 (September 2001 Survey). CMS Ex. 2 at 1. The NYSDOH had advised Petitioner 18 days previously that it would be conducting the survey. The NYSDOH also advised Petitioner what documents it expected to review at the time of the survey. CMS Ex. 4.

Based on the surveyor's observations during the September 2001 Survey, the CMS Regional Office determined that a second substantiating visit to Petitioner's office should be made. The NYSDOH surveyor and a supervisor attempted to return to the laboratory on October 26, 2001, but Petitioner's office in Jamaica was closed. The two surveyors contacted Petitioner and met with him at his Manhattan office. Tr. 147-48.

Several days later, on October 29, 2001, two NYSDOH surveyors returned to Petitioner's laboratory to collect additional documentation and complete the survey (Oxtober 2001 Survey). The surveyors determined that Petitioner's laboratory failed to comply with a number of CLIA requirements. Based on the October 2001 Survey, the NYSDOH determined that Petitioner failed to ensure accurate and reliable patient test results to the extent that those results constituted an immediate jeopardy to patient health and safety. CMS Ex. 1.

Based on the information it received from the NYSDOH, CMS agreed that Petitioner's laboratory presented immediate jeopardy. By letter dated November 7, 2001, CMS notified Petitioner that it intended to suspend Petitioner's CLIA certificate and cancel Medicare payments on November 16, 2001. CMS advised Petitioner that his CLIA certificate would be revoked effective January 16, 2002. CMS notified Petitioner he had five days from receipt of CMS's November 7^th letter to submit a credible allegation of compliance to CMS and that he had 60 days to request a hearing before an administrative law judge (ALJ). CMS Ex. 1.

On December 28, 2001, the NYSDOH received some materials from Petitioner but did not find the materials to constitute an adequate plan of correction. Tr. 38-40; CMS Ex. 22. On January 3, 2002, Petitioner timely filed a request for hearing. Thereafter, on January 4, 2002, CMS informed Petitioner that the effective date of revocation of his CLIA certificate would be delayed to January 23, 2002 if he hired a consultant to assist him in preparing a plan of correction. CMS Ex. 29.

On January 14, 2002, Petitioner notified the NYSDOH that he had hired a technical consultant to help with a plan of correction. CMS Ex. 26. The revised plan of correction was received on January 16, 2002. CMS Ex. 25. The NYSDOH determined that the revised plan was also insufficient. Tr. 44-45; CMS Ex. 26. The revised plan stated that Petitioner would provide the requested documentation for NYSDOH's review by February 13, 2002. Id. Petitioner requested an extension of time to complete a plan of correction, which was denied by CMS. CMS Ex. 31.

A hearing was held in this case on February 11 and 12, 2003, in New York, New York. Testifying for CMS were: Colleen Flood, the Associate Director of the Physician Office Laboratory Evaluation Program for the NYSDOH; Constance Maitland, the NYSDOH surveyor; and Daria Gregg, the NYSDOH surveyor. CMS submitted exhibits marked CMS Exs. 1-39. These were admitted into the record.

Petitioner did not testify and called only one witness, Edward Maziarz, supervising clinical laboratory consultant for the Physician Office Laboratory Evaluation Program of the NYSDOH. ⁽¹⁾ Petitioner initially submitted exhibits marked P. Exs. 1-37. During the course of the hearing, Petitioner also offered exhibits marked P. Exs. 38, 39, 40, 41, 42, 58, 61, 91, and 92. ⁽²⁾ These were admitted into the record. Petitioner also offered P. Ex. 46 which I rejected as irrelevant. Tr. 431-32.

Both parties were given an opportunity to submit post-hearing briefs. CMS did so. Petitioner did not. My decision is based on the testimony, the exhibits of record, the parties' arguments, and the law and regulations relating to CLIA.

II. Applicable law

A. CLIA

CLIA establishes requirements for all laboratories that perform clinical diagnostic tests on human specimens and provides for federal certification of such laboratories. Pub. L. No. 100-578, amending section 353 of the Public Health Service Act, codified at 42 U.S.C. § 263a et seq. The purpose of CLIA is to ensure the accuracy and reliability of laboratory tests and hence the public health of all Americans. See H.R. Rep. No. 899, 100^th Cong. 2d Sess. 8, 18 (1988), reprinted in 1988 U.S.C.C.A.N. 3829, 3839.

CLIA requires, among other things, that the Secretary of Health and Human Services (Secretary) establish certification requirements for any laboratory that performs tests on human specimens and certify, through the issuance of a certificate, that a laboratory meets certification requirements. 42 U.S.C. § 263a.

The Secretary has exercised his authority under 42 U.S.C. § 263a(f) and issued regulations implementing CLIA. See 42 C.F.R. Part 493. The regulations specify the specific conditions of certification that a laboratory must meet to achieve compliance. The regulations confer broad authority on CMS to ensure that laboratories perform as Congress intended, including the authority to inspect and sanction laboratories that fail to comply with the regulatory requirements. Pursuant to CLIA, the Secretary delegated to CMS the authority to suspend, limit, or revoke the CLIA certificate of a laboratory that is out of compliance with one or more CLIA conditions and to impose alternative sanctions, such as a directed plan of correction or monitoring by a state. 42 C.F.R. 493.1806.

The regulations establish both conditions and standards for participation under CLIA. Conditions of participation are set forth as broadly stated general requirements which must be met in order for a laboratory to qualify under CLIA. Standards of participation are set forth as specific quality requirements which must be met by a laboratory in order to meet the more general requirements of conditions of participation. Thus, standards are subparts of the more broadly stated conditions. A failure by a laboratory to comply with one or more standards may be so serious as to constitute a failure to comply with the condition of which the standards are part.

A number of the regulatory provisions regarding conditions and standards have been revised. The effective date for most of the amended regulations was April 24, 2003. 68 Fed. Reg. 3640-01 (January 24, 2003). The revisions relate primarily to the form and structure of the regulations rather than their substance. See, e.g., 42 C.F.R. Part 493, Subparts J and K. Id. ⁽³⁾ Neither the preamble, nor the comments to the amendments, nor the amended regulations suggest the amendments are to be retroactive. Id. Therefore, the proper regulations for deciding this case are those that were in effect at the time of the survey when the challenged deficiencies were cited. There is a presumption that administrative rules should not be applied retroactively unless their language specifically requires that application. See Bowen v. Georgetown Univ. Hosp., 488 U.S. 204, 208 (1988); Comprehensive Mental Health Center of Baton Rouge, DAB No. 1774 (2001); Lakewood Plaza Nursing Center, DAB No. 1767 (2001).

No injustice will accrue to Petitioner by applying the regulations in effect at the time of the survey. Although, Petitioner would possibly not have been cited for as many condition-level deficiencies under the new regulations, due to the absence of a separate condition for Quality Assurance, the deficiencies supported by the record herein would be deficiencies under the new regulations as well and would fully support CMS's imposed sanctions. ⁽⁴⁾

Both the statute and regulations provide for the imposition of principal sanctions (including suspension, limitation, or revocation of a laboratory's CLIA certificate and cancellation of all Medicare payments for services performed by the laboratory. See 42 U.S.C. § 263a(i); 42 C.F.R. §§ 493.1806(a), 493.1807(a), 493.1840, and 493.1842. CMS can also impose alternative sanctions including a civil money penalty against laboratories found to be noncompliant with the CLIA requirements. See 42 U.S.C. § 263a(h); 42 C.F.R. §§ 493.1806(c) and 493.1834. In addition, CLIA provides that when a laboratory's CLIA certificate is revoked, its owner(s) and operator(s), including the Director, are prohibited from owning, operating, or directing a laboratory for at least two years from the date of revocation. 42 U.S.C. § 263a(i)(3); 42 C.F.R. §§ 493.2, 493.1840(a)(8).

The burden of proof in an appeal of CMS's sanctions is governed by the decision in Hillman Rehabilitation Center, DAB No. 1611 (1997). CMS has the burden of providing evidence that is sufficient to establish a prima facie case. Petitioner then has the burden of coming forward with evidence sufficient to establish by a preponderance of the evidence the elements of its defense or affirmative arguments. In CLIA cases, the finding of even one condition-level deficiency authorizes revocation of a laboratory's CLIA certificate. Medical Services Laboratories, DAB CR936 (2002).

III. Issue

The issue in this case is whether CMS's action of suspension and revocation of Petitioner's CLIA certificate and cancellation of Medicare and Medicaid payments for laboratory services furnished by Petitioner is authorized under the applicable CLIA statute and regulations as set forth in 42 U.S.C. § 263a and 42 C.F.R. Part 493.

IV. Findings of Fact and Conclusions of Law

I make Findings of Fact and Conclusions of Law (Findings) to support my decision in this case. I set forth each Finding in bold face as a separate heading.

A. Petitioner failed to comply with the CLIA "condition" of patient test management.

During the applicable time period, section 493, Subpart J, of 42 C.F.R. set forth the regulatory requirements for the "condition" of patient test management. Pursuant to these regulations, "each laboratory performing moderate complexity . . . testing . . . must employ and maintain a system that provides for proper patient preparation; proper specimen collection, identification, preservation, transportation, and processing; and accurate result reporting." Any such system must assure optimum patient specimen integrity and positive identification throughout the preanalytic (pretesting), analytic (testing), and postanalytic (posttesting) processes and must meet the standards as they apply to the testing performed. 42 C.F.R. § 493.1101. There were several "standards" that formed part of the "condition" of patient test management.

1. Petitioner failed to meet the CLIA patient test management "standard" requiring a laboratory to have written policies and procedures.

One of the patient test management "standards" under CLIA requires a laboratory to have available and follow written policies and procedures for each of the following, if applicable: methods used for the preparation of patients; specimen collection; specimen labeling; specimen preservation; conditions for specimen transportation and processing. Such policies and procedures had to assure positive identification and optimum integrity of the patient specimen from the time the specimen(s) was collected until testing had been completed and the results reported. 42 C.F.R. § 493.1103(a). ⁽⁵⁾

Petitioner advertised his physician offices as being an "international medical office specialising [sic] in medical clearance for legalization in America on behalf of Immigration and Naturalization Services." ⁽⁶⁾ CMS Ex. 6. Petitioner had two physician offices: one in Manhattan and one in Jamaica, Queens. He had a laboratory only at the Jamaica, Queens, office. Petitioner did only two types of tests, HIV and syphilis screening, in his office laboratory. Tr. 22. Regardless of the laboratory size, CLIA requires laboratories to have written procedures. ⁽⁷⁾

A procedure is a step by step outline of all the steps that are taken to achieve a certain part of patient test management. For example, with respect to specimen identification, the physician should have a written system to show the steps he uses in his laboratory to ensure that the specimens are accurately identified when the specimen is collected. Tr. 22-23. As another example, even though there are often manufacturer's instructions that come with a test kit, a laboratory must have its own written procedures for how the laboratory will do a particular test. Tr. 23-24.

A number of times during the survey at issue the NYSDOH requested Petitioner to provide his written policies and procedures. He was unable to do so. On Surveyor Maitland's September 2001 visit to Petitioner's laboratory, she asked to see his written laboratory procedures. He did not have the procedures. He could not even produce the manufacturers' package inserts for test kits indicating how specific tests were to be performed. Tr. 145, 149; CMS Ex. 4, at 11-14.

Further, Petitioner had no written procedures to show the surveyors at the time of their October 29, 2001 visit to Petitioner's laboratory. Tr. 30. Petitioner's inability to produce such documentation on two occasions confirms the conclusion that Petitioner had no written procedures for patient preparation, for collecting blood specimens for the HIV and syphilis testing that he did, or for transporting specimens from his Manhattan office to his Jamaica, Queens, laboratory. See, also, Tr. 148, 161.

In Petitioner's first submission of an alleged plan of correction, he submitted a purported procedures manual with some copied text, but the text did not refer to Petitioner's laboratory in particular. Nor did the text match up with Petitioner's cited deficiencies. Tr. 39-40; CMS Exs. 15, 22.

After his proposed plan of correction was rejected by CMS, Petitioner hired a consultant to assist in preparing an acceptable document. A document with written procedures was submitted to CMS but this was also rejected primarily because it referred to procedures Petitioner planned to adopt in the future and the document failed to provide proposed procedures specific to his laboratory. Tr. 44-45; CMS Ex. 25. Petitioner's consultant again attempted to submit written procedures. Again, the information provided was very general and did not apply to Petitioner's laboratory. The submission included copied text about tests that Petitioner historically had not provided in his laboratory. CMS Exs. 28, 39; Tr. 47-48.

2. Petitioner failed to meet the CLIA patient test management "standard" requiring a laboratory to have a record system to ensure reliable identification of patient specimens or to assure that accurate test results are reported.

Another "standard" requirement under the "condition" of patient test management was that the laboratory had to maintain a record system to ensure reliable identification of patient specimens as they are processed and tested to assure that accurate test results are reported. These records must also identify the personnel performing the testing procedure. Records of patient testing, including, if applicable, instrument printouts, must be retained for at least two years. 42 C.F.R. § 493.1107. ⁽⁸⁾

Additionally, the record system must include the patient's name or other unique identifier (see 42 C.F.R. § 493.1105 (a)) and the record system must provide documentation of: the patient identification number, accession number, or other unique identification of the specimen; the date and time of specimen receipt into the laboratory; the condition and disposition of specimens that do not meet the laboratory's criteria for specimen acceptability; and the records and dates of all specimen testing, including the identity of the personnel who performed the test(s), which are necessary to assure proper identification and accurate reporting of test results. 42 C.F.R. § 493.1107(a)-(d). ⁽⁹⁾

As noted above, Petitioner lacked appropriate written procedures for identifying patient specimens for either the syphilis or HIV testing he did. He also lacked appropriate procedures for collecting the specimens and he had no written procedures for collecting, identifying, or reporting his test results. Tr. 30.

Moreover, Petitioner's records were in complete disarray. When Surveyor Maitland arrived at the laboratory to begin the September 2001 Survey, she saw many papers around the office, some in accordion folders and others in boxes. Tr. 142. Although Petitioner reported to Surveyor Maitland that he had a confirmed positive HIV test in the past, he could not produce any documentation concerning the test. Tr. 145-146.

When Surveyor Maitland returned in October with Surveyor Gregg to resume the survey, Petitioner's business office was still in disarray. Tr. 310. Surveyor Maitland asked to see Petitioner's patient records, in particular, his accession logs with the accordion file where his patient records were stored. CMS Ex. 16. (An accession log is used to record specimens seriatim to aid in identification of specimens. Tr. 148-149.) In her contemporaneous memorandum of the survey visit, Surveyor Gregg described what happened next:

The doctor responded that he did not know where these records were. He could not find them. After reminding the doctor [Surveyor Maitland] had seen them on her initial visit/survey and rewording the request several times, the doctor still responding (sic) that he could not find these records.

After [another] interaction, Dr. Sakhuja decided to cooperate with us and pulled the accordion file from underneath a sheet and gave us what patient records he had available. He remarked he had been in this office most of the night trying to organize things for our visit. He could only find limited laboratory testing accession logs. We made copies of these log sheets. [see CMS Ex. 16]. An example of a patient report and the immigration form were copied also. Immigration sheet copies were filed in a separate accordion file.

CMS Ex. 5, at 1.

The surveyors took the records Petitioner showed them and copied them at a public copier about a block and one-half away from the laboratory. Tr. 149, 313.

Other than a form of accession log, Petitioner had no patient records such as patient charts. Tr. 150, 313. Petitioner's patient records consisted of INS forms with his laboratory findings written on them. Normally, in a physician's office laboratory, the surveyor will find manilla envelopes with each patient's records in an envelope which will be clearly labeled with the patient's name. Petitioner only had a piece of paper from the INS that had Petitioner's findings for the INS. Tr. 314. Laboratory results were written on the back of the INS sheet. The sheet did not contain the date the specimen was collected or the date of testing, nor the name and address of the laboratory that did the test. Tr. 316. See CMS Ex. 16, at 7. Petitioner was also unable to produce patients' signatures confirming that all of his patients for whom he had given an HIV test had received counseling prior to having the test, a New York State requirement. Tr. 151; CMS Ex. 5, at 3.

Surveyor Gregg looked at Petitioner's accordion file for 2001 and noted:

I looked at all the patient records with last names starting with the letter A. Two of approximately 20 records were not signed by the patient as having received HIV counseling and did not have the date of service. Looking at the patients with last names starting with S, there were about 40. Also some were missing the patient's signature and date of service. All patient records now had their HIV and RPR [syphilis] results on the back of the sheet. The doctor said he had done this since [Surveyor Maitland's] original visit.

CMS Ex. 5, at 3.

Surveyor Gregg also noted that:

While waiting in the printing store down the block to copy his records for our office, I asked the doctor what percentage of his patients were seeing him for his internal medicine/lung specialist business. He said around 30%. These patient charts, if different from the immigration clients, were not available during our visit.

CMS Ex. 5, at 4.

CMS has shown that Petitioner was unable to produce patient laboratory records or written laboratory procedures as requested. Tr. 145, 179; CMS Ex. 4, at 11-14. Further, the testing records that Petitioner did produce were missing information that a complete record would contain. See CMS Ex. 16. He failed to fill in the date of testing, the test that was ordered, the date and time of the report, or the specimen type. Tr. 152. This information is necessary so that one can determine, for example, how long a specimen was stored in a refrigerator prior to testing. Other information that is important for complete record-keeping is some form of specimen identifier in addition to the patient's name as people from the same family could have the same name and the specimens could be confused. Tr. 82, 153-55. Moreover, if a specimen has been sent to a reference laboratory, the record should state when and where the specimen was sent and when the information was returned from the reference laboratory. Tr. 154.

Petitioner had some computer records that he made available to the surveyors, but Petitioner's hand-written accession logs did not match his computer reports. Tr. at 155, 159. ⁽¹⁰⁾ Computer printouts of testing dates did not correspond to the dates on the accession logs. The accession logs were labeled only with the month of service. The computer records Petitioner produced contained the date of testing but not the date of specimen collection. CMS Ex. 16, at 15-16.

Moreover, the few accession logs and computer reports he was able to produce had problems. Tr. 155; CMS Ex. 16, at 1-2, 5, 8-9, 13-14. On one set of records, Petitioner had recorded a different number of patients than the number of results. On the March 2001 accession log for Petitioner's syphilis testing, 19 results were recorded but only 18 patient names were listed. Tr. 156; CMS Ex. 16, at 14. In some cases, Petitioner was using the back of a form to write down a patient's name and the results of testing. Petitioner's syphilis testing on February 24, 2000 and June 30, 2000 and his HIV testing on February 28, 2000 and June 30, 2000 were recorded on plain paper or on the reverse side of previously used accession logs CMS Ex. 16, at 6-9; Tr. 157-58. In several instances, the date of testing noted on the computer report was several days before the date on the accession log. Compare CMS Ex. 16, at 3-4, with the same exhibit at 6-7. On computer-generated forms titled "Laboratory Reports Year 2000" and "Laboratory Reports Year 2001," the listed dates of testing did not correspond to the dates of testing noted on the laboratory's accession records. CMS Ex. 11; CMS Ex. 16, at 3-4, 15-16. He had also written down test results for different dates on the same sheet of paper. The syphilis test results for January 21, 2000 and January 30, 2000 were recorded on the same sheet of plain paper. CMS Ex. 16, at 11-12; Tr. 157-58.

Surveyor Maitland saw Petitioner's log sheets containing test results for August 1999, July 2001, and August 2001 during her September 2001 visit. During the October revisit, Petitioner was unable to come up with the test log sheets that he had shown Surveyor Maitland in September. Tr. at 158. Nor had he any other records available for review even though the regulations require the retention of such records for two years. Tr. 115, 160, 312.

Petitioner had no written procedures for record-keeping. Thus, Petitioner was unable to submit to either the NYSDOH or CMS a copy of his laboratory's written protocol for record-keeping. Tr. 161. Petitioner failed to have written procedures that included a means of positive specimen identification or adequate directions for maintaining optimum specimen integrity until the final results were reported. Tr. 31; CMS Ex. 15. As a result, Petitioner could not specify how the laboratory assured positive identification or optimum specimen integrity from the time of specimen collection until testing was completed and the final results reported. Tr. 24-28, 75-76; CMS Ex. 14.

Petitioner argued that he collected the specimen and wrote the patient's name on the tube. Because he actually saw the patient and knew the patient's gender and other identifying characteristics, he did not think that anything other than the name on the tube would be required. However, 4 out the 12 specimens that Petitioner submitted to the State's laboratory for testing from April to June 2001 had to be discarded as "ID unsatisfactory" because the patient identification on the blood tube did not match the patient identification on the test requisition. Tr. 28-29. ⁽¹¹⁾

Clearly, if Petitioner ever had a written protocol for record-keeping, he could not find it at the time of the survey visits in September and October 2001, or thereafter. In January of 2002, Petitioner did submit to CMS some material from his consultant that purported to show that he would have a record-keeping system in place by February 13, 2002, but his submission was insufficient to demonstrate to the NYSDOH that he had an adequate record-keeping system in place that would address all of the NYSDOH's concerns. Tr. 44-45; CMS Ex. 25.

Petitioner put forth several arguments to explain why he could not provide the requested records to the surveyors. He contended that he was in the process of having his records computerized and that the person he had hired to do this job had left the job before its completion. Nonetheless, since his computer input was incomplete, Petitioner was required to keep the original records for two years to provide the information CLIA requires. Moreover, Petitioner provided no confirmation concerning the particulars surrounding his attempts to computerize his laboratory records such as when the project was started, the scope of the project, or who was hired to complete the project. He did not even suggest that the person he had hired to do the computer input had Petitioner's original records in his control. Therefore, based on the record evidence, I can only conclude that Petitioner did not have a system for filing and maintaining records in his laboratory that met CLIA's requirements.

3. Petitioner failed to meet the patient test management "standard" requiring a laboratory to produce records confirming that he had referred specimens for testing only to a laboratory that had a valid certificate to perform that test.

Another "standard" requirement under the "condition" of patient test management was that the laboratory must refer specimens for testing only to a laboratory possessing a valid certificate authorizing the performance of testing in the specialty or subspecialty of service for the level of complexity in which the referred test is categorized. 42 C.F.R. § 493.1111. Additionally, the referring laboratory must retain or be able to produce an exact duplicate of each testing laboratory's report. 42 C.F.R. § 493.1111(b). ⁽¹²⁾

During the survey, Petitioner told the surveyors he was using the State Medical Laboratory and Bayside Diagnostics Laboratory for his confirmatory testing for HIV. Neither of these laboratories had a comprehensive permit that would allow them to do confirmatory testing. Although these laboratories were licensed, they were licensed to do only screening tests. If Petitioner had sent tests to either of these laboratories, the laboratories would have had to refer to even other laboratories. At the time of the survey visits, Petitioner had no records documenting any referrals or reports to these laboratories. Tr. 42-43. In fact, the one positive HIV test result report that Petitioner was eventually able to find, i.e., P. Ex. 40, proves that he had sent a specimen for confirmatory testing to Bayside Diagnostics Laboratory on October 4, 1999 and Bayside sent the specimen to Specialty Laboratories for testing. In sum, Petitioner could not produce records confirming he had referred specimens for testing only to a laboratory that had a valid certificate to perform the test, as required by CLIA.

Petitioner did not comply with several "standards" under patient test management and to such an extent that I find that Petitioner did not meet the "condition" requirement for patient test management. The Departmental Appeals Board has previously confirmed that a laboratory can be so pervasively noncompliant with standards as to have failed to have complied with the overall condition. Oakland Medical Group, P.C., DAB No. 1755 (2000).

B. Petitioner failed to meet the CLIA "condition" of quality control.

During the applicable time period, section 493, Subpart K, of 42 C.F.R. set forth the requirements for the "condition" of quality control for moderate and high complexity tests. Subpart K was divided into two sections, one for general quality control and one for specialties and subspecialties. In essence, this "condition" required the laboratory to establish and follow written quality control procedures for monitoring and evaluating the quality of the analytical testing process to assure the accuracy and reliability of patient test results and reports. 42 C.F.R. § 493.1201(b). ⁽¹³⁾

1. Petitioner failed to meet the CLIA quality control "standard" requiring the laboratory to follow the manufacturer's instructions for test system operation and performance and to have a procedures manual describing its process for testing.

One of the "standard" requirements for the "condition" of quality control is that, for tests of moderate complexity using an instrument, kit, or test system cleared by the Food and Drug Administration, the laboratory: must follow the manufacturer's instructions for test system operation and test performance; must have a procedures manual describing the processes for testing and reporting patient test results; perform and document calibration procedures or check calibration at least once every six months; perform and document control procedures using at least two levels of control materials each day of testing; perform and document that remedial action has been taken when problems or errors are identified as specified in 493.1219; and maintain records of all quality control activities for two years. 42 C.F.R. § 493.1202(c)(1)-(7). Each of these requirements is also described as a "standard" requirement within the "condition" of quality control. 42 C.F.R. § 493.1202-493.1221.

Petitioner failed to have sufficient written procedures for specimen processing when the HIV and syphilis test specimens could not be tested immediately and when batch testing was done. Tr. 31-32. A laboratory conducts batch testing when it tests a group of patient specimens at the same time for economy and efficiency. Tr. 326. Petitioner's procedures indicated that the specimens were to be stored in the refrigerator in the back of his laboratory, but the procedures did not include information as to how long the specimens could be stored or the temperature at which they must be stored. Tr. 31-32; CMS Ex. 15, at 2.

2. Petitioner failed to meet the CLIA quality control "standard" of providing a laboratory space and environmental conditions necessary for conducting the services offered.

Another "standard" requirement within the "condition" of quality control is that the laboratory must provide the space and environmental conditions necessary for conducting the services offered. The laboratory must be constructed, arranged, and maintained to ensure the space, ventilation, and utilities necessary for all phases of testing. Moreover, safety precautions must be established, posted, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards and biohazardous materials. 42 C.F.R. § 493.1204. ⁽¹⁴⁾

The NYSDOH surveyors' description of Petitioner's laboratory presented an appalling picture of a laboratory used to test human blood samples. Surveyor Maitland testified that when she arrived at Petitioner's laboratory on September 28, 2001, she found used syringes and needles on the floor and in an overflowing bag hanging on the wall. Tr. 142. Medical waste that can cut and puncture should always be in a hard plastic container called a "Sharps" container. Id.; Tr. 119. Petitioner's office was configured in a way that it had no clear separation between the area where he drew blood from patients and the laboratory where he did tests and where surveyors had found used syringes on the floor. Petitioner had no sink for his laboratory and he disposed of his liquid waste in a common bathroom down the hall from the office. ⁽¹⁵⁾ Surveyor Maitland also observed roaches on Petitioner's desk. Tr. 143.

When the surveyors returned for the October 2001 visit, they again found used, uncapped syringes on the floor and an overflowing medical waste container. Petitioner still had no Sharps container. Tr. 310-11, 363. Petitioner did have available some red bags in boxes which can be used for nonpuncturing waste materials but he had them folded up under a table and was not using them. Tr. 173.

Petitioner argued that the medical waste pick-up company he had been using for many years had merged with another company and there was a lag time in their resumption of service. But Petitioner did not at the time of the survey - or thereafter - produce a copy of a contract with any company or any other document confirming the pick-up of medical waste during the applicable 2001 time period. Tr. 131, 144; CMS Ex. 9.

Medical waste companies generally give the laboratory a "manifest" at the time of pick-up and send the laboratory another "manifest" to verify that the medical waste has been properly disposed of. Tr. 144, 363. Petitioner could not produce any of the manifests for the relevant time period to show that any of his medical waste had been picked-up. Id. ⁽¹⁶⁾

Whether or not Petitioner's medical waste pick-up company had merged or he was experiencing some difficulty with pick-up, it was incumbent on Petitioner to store his medical waste materials in a manner that was safe for his patients; i.e., no used, uncapped syringes or laboratory pipettes on the floor.

Petitioner also argued that he had just moved from one office to the adjacent office, had difficulties with his landlord, and this explained the disarray in his office and his inability to come up with the documents the surveyors had requested. Whether or not this would be an acceptable reason for the situation at this laboratory, he did not produce any documentation that would have confirmed when he actually moved from one space to the other.

3. Petitioner failed to meet the CLIA quality control "standard" requiring the laboratory to use testing methods and equipment that provide accurate and reliable test results and test reports and to use laboratory materials in a manner that ensures they are of good quality.

Another "standard" requirement within the "condition" of quality control is that the laboratory must use test methods, equipment, instrumentation, reagents, materials, and supplies that provide accurate and reliable test results and test reports. Further, reagents, solutions, culture media, controls, calibration materials, and other supplies must be prepared, stored, and handled in a manner that ensures they are not used after they have exceeded their expiration dates, have deteriorated, or are of substandard quality. 42 C.F.R. § 493.1205(e). ⁽¹⁷⁾

Petitioner was using a home refrigerator in his laboratory. This refrigerator had limited freezing capacity. Tr. 328; CMS Ex. 16, at 15. Specimens for HIV testing may only be stored in an ordinary home refrigerator for 24 hours. If more than 24 hours are required before the testing can be done, the specimens must be frozen in a freezer that does not have a freeze/thaw cycle, as most home refrigerators have. Tr. 327. Serum samples for syphilis testing should be tested within 72 hours and stored at two to eight degrees Centigrade. If they are stored for longer than five days, they must be kept in a freezer capable of freezing at minus twenty degrees Centigrade. Most home freezers do not freeze at a temperature that low. Tr. 327-28; CMS Ex. 19, at 2. Petitioner told Surveyor Gregg that he stored specimens for HIV and syphilis in his laboratory refrigerator for up to four weeks before testing. Tr. 326.

Petitioner's records for 1999 and 2000 failed to indicate whether and how often Petitioner checked the temperatures of his refrigerator and his laboratory room. Both temperatures must be kept within specific parameters to control the accuracy of testing. Tr. 167. Laboratory temperature records for 1999 and 2000 for the refrigerator used for Petitioner's storage of patient specimens and reagents indicated that the refrigerator was observed only once a month and was, with one exception, noted as four degrees Celsius. Tr. 330. ⁽¹⁸⁾

Room temperatures recorded by Petitioner on 5 of the 13 available log sheet/test result forms were outside of the acceptable range for reliable test results. Tr. 336-37, 396; CMS Ex. 18, at 4; CMS Ex. 19, at 2. Petitioner was asked to submit a copy of two weeks of refrigerator, freezer, and room temperature records but failed to respond to the request.

Petitioner failed to monitor and evaluate adequately the accuracy and reliability of patient test results. For example, Petitioner failed to follow the manufacturer's directions for the type of HIV testing he was doing. CMS Ex. 18. The manufacturer's instructions for the type of HIV testing Petitioner was doing required that he do confirmatory testing of specimens as specified. Tr. 33; CMS Ex. 18, at 6. Confirmatory testing must be done from an approved reference laboratory for all specimens yielding repeat reactive results. Petitioner could not show that the laboratories he used for confirmatory testing were approved for such testing. Tr. 41-43; CMS Ex. 18, at 6. Moreover, Petitioner failed to document the occurrence of the appropriate color reaction in the control zone for each test performed. Tr. 163-66; CMS Ex. 18, at 5-6. Additionally, he failed to document the storage temperature of his HIV test kit components. Tr. 166-67; CMS Ex. 18, at 4. Finally, he failed to document the lot numbers and expiration dates of the test kits he used. Tr. 167-68; CMS Ex. 18, at 4.

4. Petitioner failed to meet the CLIA quality control "standard" of having a written procedures manual for the performance of all analytical methods used by the laboratory.

A further "standard" requirement within the condition of quality control is that the laboratory must have a written procedures manual for the performance of all analytical methods used by the laboratory. The manual must be readily available and followed in the testing. Among other things, the manual must include: requirements for specimen collection and processing and criteria for specimen rejection; step-by-step performance of the procedure, including test calculations and interpretation of results; calibration and calibration verification procedures; control procedures; appropriate criteria for specimen storage and preservation to ensure specimen integrity until testing is completed. While manufacturer's inserts can be used to meet these requirements, any required information not provided in the insert must be provided by the laboratory. The procedures in the manual must be approved, signed, and dated by the laboratory director. 42 C.F.R. § 493.1211. ⁽¹⁹⁾

At the time of the survey visits, Petitioner could not produce for the surveyors a written procedures manual and could not even produce the manufacturers' inserts for the test kits he was using. Tr. 30-32, 145, 161.

5. Petitioner failed to meet the CLIA quality control "standard" requiring the laboratory to document and maintain records of all quality control activities for at least two years.

Another "standard" requirement within the "condition" of quality control has been that the laboratory must document and maintain records of all quality control activities for at least two years. 42 C.F.R. § 493.1221. ⁽²⁰⁾

Petitioner had no established quality control procedures for remedial action for HIV and syphilis testing problems that might occur. Tr. 174. For example, temperatures that are incorrect or specimens that are stored for too long under inappropriate conditions may result in false positives or false negatives. Tr. 342-43. Petitioner had no remedial action documented on the five worksheets he provided surveyors on which temperatures outside the acceptable ranges were noted. Petitioner was asked to provide a copy of the laboratory's written remedial action procedures but he failed to do so. Tr. 336-37, 396; CMS Exs. 16; 18, at 4; and 19, at 2.

6. Petitioner failed to meet the CLIA quality control requirement for syphilis serology that a laboratory's equipment, controls, and techniques conform to manufacturers' specifications.

For syphilis serology testing, another requirement within the "condition" of quality control is that the equipment, glassware, reagents, controls, and techniques for tests for syphilis must conform to manufacturers' specifications. 42 C.F.R. § 493.1239. ⁽²¹⁾

For his syphilis testing, Petitioner failed to follow the manufacturer's package insert instructions. ⁽²²⁾ Petitioner did not perform accuracy checks on the needle he used for the screening. Tr. 171, 320. When Surveyor Gregg observed Petitioner perform a syphilis test, she noticed that the needle he used to dispense the reagent was bent when it should have been straight. Tr. 318-19. The manufacturer requires the drop of reagent to be a particular size. A bend in the needle could change the size of the drop and could change the reaction the testing person would observe to determine if the patient is positive for syphilis. Tr. 319-20; CMS Ex. 19, at 1. Additionally, the needle must be rinsed in distilled or deionized water after use. Tr. 319; CMS Ex. 19, at 1. Rinsing must be done to prevent particles of charcoal in the reagent from obstructing the test the next time it is performed. Tr. 322-23. Petitioner failed to rinse the needle when Surveyor Gregg was watching him perform the test. He told her he was unaware that rinsing was required. Tr. 319, 323.

The package insert for the syphilis test kit used by Petitioner also required that the automatic rotator speed used to rotate the test cards should be evaluated. The manufacturer requires the speed of the rotator be set at one hundred plus or minus five revolutions per minute. Tr. 171-72; CMS Ex. 19, at 2. Petitioner could not produce any documentation of his rotator speed and indicated to the surveyor that he was unaware of the requirement to check the rotator speed. Tr. 172, 324, 343-44; CMS Exs. 12, at 2; 16, at 9.

Further, with respect to his syphilis testing, Petitioner did not have a humidity cover on his rotator. The package insert required the use of a humidity cover to keep the sample from drying and producing false results. Tr. 172; CMS Ex. 19, at 2. When questioned by the surveyor, Petitioner responded that he did not use a humidity cover and did not have one in his office. Tr. 172.

CMS has shown that Petitioner failed to follow the manufacturer's directions for syphilis testing from August 25, 1999 through September 28, 2001. Petitioner did not perform and document a needle dispense check when each new kit was opened. Tr. 171, 318-20; CMS Ex. 19, at 1. Petitioner did not check and record the speed of his laboratory's rotator. Tr. 172, 324, 343-44; CMS Exs. 19, at 2; 12, at 2; 16, at 9. On 5 of the 13 testing days for which records were available, the temperature of the laboratory space was outside the acceptable limits for obtaining reliable test results. Tr. 336-37; CMS Ex. 19, at 2. Additionally, Petitioner did not use a humidity cover for the rotator while he was using it to test patient specimens and controls. Tr. 172; CMS Ex. 19, at 2. The test kit's package insertion for the kit Petitioner was using specifically states "in order to obtain reliable and consistent results, the instructions in the package insert must be strictly followed. Do not modify the handling and storage conditions for reagents or samples." CMS Ex. 19, at 1. Petitioner could not show that he had a manufacturer's package insert available at the time of the surveyor's visits. Tr. 170.

As explained by Ms. Flood at the hearing-

Again, the laboratory most basically needs to follow the manufacturers' instructions . . . to insure specimen integrity. There are various accuracy checks, equipment checks, that need to be done each day of patient testing to insure that the equipment is working properly to be sure that you are producing accurate results.

Tr. 35.

Petitioner failed to meet a number of "standards" within the "condition" of quality control and to such an extent that Petitioner had a "condition" level deficiency with respect to quality control. See Oakland Medical Group, P.C., DAB No. 1755 (2000).

C. Petitioner failed to meet the CLIA Laboratory Director "condition" requiring the laboratory to have a director who ensures the laboratory's compliance with CLIA requirements.

Pursuant to 42 C.F.R. § 493.1403, Laboratory Director - moderate complexity testing, a laboratory must have a director who meets the qualifications requirements of 42 C.F.R. § 493.1405 and provides overall management and direction in accordance with 42 C.F.R. § 493.1407.

Petitioner was both the laboratory director and the testing person for his laboratory. As the laboratory director, Petitioner was responsible for the test results that were being produced by his laboratory. Tr. 36. Petitioner failed to ensure the laboratory's compliance with federal CLIA requirements for patient test management and failed to monitor adequately the quality of the laboratory's HIV and syphilis testing to assure accuracy and reliability of patient test results.

ALJ Kessel stated in a prior DAB case:

The laboratory director is the individual who bears responsibility for assuring that a clinical laboratory meets the quality control standards that are at the heart of CLIA requirements. Ultimately, the laboratory director is the person who assures that a clinical laboratory does a competent job testing patients' specimens. It is no exaggeration to say that the success or failure of a laboratory director in discharging his or her responsibilities may have life or death consequences for many patients who rely on a laboratory to perform clinical testing of their specimens.

RNA Laboratories, Inc., and Ter-Zakarian Medical Clinic, DAB CR829 (2001), aff'd, DAB No. 1820 (2002).

The cumulative effect of Petitioner's failure to have readily available documentation, written quality assurance procedures, to perform testing according to manufacturers' instructions all resulted in Petitioner's failure, as laboratory director, to assure the accuracy and reliability of patient test results. Findings A.1-3; B.1-6, above.

D. Petitioner failed to meet the CLIA Quality Assurance "condition" requiring the laboratory to have a quality assurance program.

The CLIA condition that was stated at 42 C.F.R. § 493.1701 required a laboratory performing moderate or high complexity testing to establish and follow written policies and procedures for a comprehensive quality assurance program designed to monitor and evaluate the ongoing and overall quality of the laboratory's total testing process. The quality assurance program must: evaluate the effectiveness of a laboratory's policies and procedures; identify and correct problems; assure the accurate, reliable, and prompt reporting of test results; and, assure the adequacy and competency of staff. A laboratory must revise policies and procedures, as may be necessary, based on the results of its evaluation.

Petitioner failed to have a written comprehensive quality assurance program that included procedures for patient test management, quality control, performance of proficiency testing, and remedial action to be taken in circumstances affecting patient test results, as required by the regulations. Findings A.1-3; B.1-6, above. As a result, Petitioner failed to meet the condition of quality assurance.

E. I have no authority to overturn CMS's determination that Petitioner's noncompliance with CLIA requirements presented immediate jeopardy to his patients.

A laboratory that has been found to be posing immediate jeopardy to patients may appeal the findings of deficiencies that are the basis for the imposition of remedies against that laboratory. But, the laboratory may not appeal CMS's determination that the deficiencies pose immediate jeopardy to patients. 42 C.F.R. § 493.1844(c)(6). I have found that CMS proved by a preponderance of the evidence that Petitioner's laboratory had condition-level deficiencies. I cannot consider the correctness of CMS's immediate jeopardy determination.

F. The surveyors' procedures did not invalidate the deficiencies found during the survey of Petitioner's laboratory.

Petitioner made several references to the survey procedures that he apparently felt distorted the survey results. For example, Petitioner suggested that Surveyor Maitland was under stress during her September 2001 visit and rushed through the process as a result. Tr. 178. Indeed, Surveyor Maitland may have experienced some frustration because Petitioner did not have the information available that she needed to review for the survey. Petitioner had been afforded 18 days prior notice to gather the requested materials for Ms. Maitland's first visit and yet he did not have the materials available. CMS Ex. 4.

During the hearing, Petitioner suggested that 18 days was insufficient notice because he had just moved from the space next door, he had been robbed several times, and he had a problem with his landlord. Tr. 180. In spite of these issues, Petitioner should have been able to provide the requested records at some point during the survey and negotiation process. More importantly, none of Petitioner's alluded-to calamities have evidentiary support in the record. He provided no evidence of when he actually moved, when the alleged robberies took place, and what was taken, or even the nature of his problems with his landlord.

Petitioner also suggested that Surveyor Maitland was biased because her husband worked for another laboratory. Tr. 193. Surveyor Maitland testified at the hearing that her husband did not work at another laboratory. Rather, he was retired but had previously worked as a public health advisor to assist recently released prisoners into housing and/or substance abuse treatment programs. Tr. 193. Petitioner provided no evidence whatsoever that Surveyor Maitland was biased against him or had a conflict of interest in surveying his laboratory.

Petitioner's cross-examination of CMS witnesses also suggested Petitioner felt he had been singled out by the surveyors in that other physicians are not asked by surveyors to perform on-the-spot tests in front of the surveyors. Tr. 364-65. Petitioner provided no evidence that on-the-spot testing is not required of other laboratories during recertification surveys. More importantly, the CLIA regulations specifically permit a surveyor to request a laboratory to test samples. 42 C.F.R. § 493.1773(b)(1).

Petitioner has several times contended that the surveyors should have allowed him to speak to an attorney before they copied his records on October 28, 2001. Tr. 402. The CLIA regulations, however, require a laboratory to maintain certain records and to provide them to surveyors when they are requested. Participation as a CLIA-certified laboratory requires the laboratory to cooperate with inspectors. 42 C.F.R. §§ 493.1771 and 493.1773. Given the notice provided Petitioner - both before the first visit and between the first and second visits - Petitioner had ample time to gather the requested records and to consult an attorney about the survey.

Petitioner also expressed concern that he was not provided an exit interview at the end of the first visit so he did not know what problems had been discovered or how to correct them. Tr. 444. There is no provision in the regulations governing laboratories that compels CMS or its designee, the State agency, to conduct an exit conference with a laboratory at the completion of a survey of that laboratory. See 42 C.F.R. § 493.1773.

Petitioner also suggested that it should not have taken 30 days between September 26, 2001 and October 28, 2001 for the second visit to his laboratory by the surveyors. Tr. 60. On the other hand, Petitioner also apparently wanted additional time between the first and second survey visits to gather documentation. Tr. 70. His contentions are contradictory and unpersuasive.

Petitioner's biggest apparent complaint is that the NYSDOH and CMS refused to cooperate with him to give him time to finish his plan of correction. He suggests the following:

•He should have been given an extension for the first survey visit. Tr. 185. Yet, there is no record evidence that he actually asked for an extension.

•He should have been given an extension to respond to the statement of deficiencies. Tr. 215-16. In fact, he was given an extension but was unable to show that he could resolve the deficiencies the surveyors had found in his laboratory.

•He stopped doing laboratory testing to negotiate the plan of correction but negotiations were not forthcoming. Tr. 236. CMS is not obligated to accept as credible a laboratory's allegation of compliance. The determination to accept or not accept a noncompliant laboratory's allegation of compliance is a matter of discretion for CMS to exercise.

•The regulations are confusing. He was trying to conform to the regulations but he did not know how. Tr. 379, 410. Running a laboratory, however, requires that the laboratory director can understand and implement the regulations.

•Neither the NYSDOH nor CMS would recommend a particular consultant for him to assist him in preparing his plan of correction. As explained by Colleen Flood at the hearing, however, it would be highly improper for a government agency to recommend a particular consultant. Tr. 53. Morever, Petitioner could have asked any prospective consultant about his or her experience in this area and asked for references.

•The NYSDOH was purposefully trying to make it difficult for him to correct the laboratory's deficiencies. Tr. 94. On the contrary, the evidence as a whole shows that both the State agency and CMS attempted to work with Petitioner and extended his CLIA revocation date to allow him to submit appropriate written procedures and manuals for his laboratory.

G. Petitioner's other arguments are also unavailing to him in this case.

Petitioner suggested that he had no problems with his previous recertification surveys - certainly not to the extent of the survey at issue in this case. Tr. 181. Further, he contended his proficiency testing had always been acceptable. Tr. 390. He also contended that CMS could not show that any patient was harmed as a result of Petitioner's laboratory testing. Tr. 75. Even if Petitioner's suggestions were found to be true, such facts would not be relevant to this case. The issue presented herein is whether Petitioner was in compliance with CLIA requirements at the time of the 2001 recertification survey. CMS has presented sufficient evidence to show Petitioner was not in compliance and Petitioner failed to rebut that evidence.

V. Conclusion

Petitioner's failure to comply with more than one condition-level CLIA requirement fully supports CMS's determination to revoke Petitioner's CLIA certificate and to cancel Petitioner's ability to receive Medicare or Medicaid payments for laboratory services.

Anne E. Blair

Administrative Law Judge

1. Petitioner made numerous arguments in the nature of testimony as part of his cross-examination of CMS's witnesses. As he was not sworn and presented little confirming documentary evidence, his arguments have no evidentiary value. Nonetheless, as he appeared pro se, I will refer to his arguments in this decision.

2. Petitioner offered a number of proposed exhibits that were not numbered sequentially. In order to prevent further confusion, I decided to admit exhibits 58, 61, 91, and 92 as marked by Petitioner.

3. As stated in the comments, the Secretary has determined that:

This regulation contains revisions to Part 493 of Title 42 of the CFR. We have renamed, reorganized, and consolidated similar requirements into one section, deleted duplicate requirements, and reworded numerous requirements to maintain and/or clarify their original intent, making the revised regulation easier to read and understand. In addition to specific changes to subparts I, J, K, M, and P, applicable technical and conforming changes were also made to other subparts. The organization of this regulation now reflects the flow of a patient specimen through the laboratory, that is, from receipt of the specimen with the test request through test performance and test result reporting. In addition, this final rule more accurately describes the testing requirements and laboratory assessment activities.

4. Throughout this Decision, I refer in footnotes to the applicable revised sections of the regulations to make clear that the requirements at issue are still in place.

5. See 42 C.F.R. §§ 493.1200(a), 493.1207, 493.1232 of the revised regulations.

6. The United States Department of Justice Immigration and Naturalization Service will hereafter be referred to as INS.

7. CLIA was amended in 1988 inter alia to eliminate the prior exemption of small laboratories from CLIA regulation. H.R. Rep. 100 - 899, 1988 U.S.C.C.A.N 3828.

8. See 42 C.F.R. §§ 493.1101(e), 493.1105 of the revised regulations.

9. See 42 C.F.R. § 493.1283 of the revised regulations.

10. Petitioner was able to produce the computer reports only for February 2000 and March and April of 2001. CMS Exs. 11, 16.

11. There was testimony at the hearing surrounding the issue of whether Petitioner had any HIV test results that were positive during the two-year period after his prior recertification survey. A positive screening HIV result requires the laboratory to refer the specimen to another laboratory for confirmation. At the time of the survey, Petitioner could provide no evidence that he had referred any specimens to other laboratories for confirmatory testing. Ms. Flood, however, who had experience with the NYSDOH HIV laboratory, said she had determined that Petitioner had referred a number of specimens to that laboratory for confirmatory testing and, thus, should have had records of these positive findings. Tr. 25-27. Petitioner suggested, and Ms. Flood conceded, that anyone could send tests to the State HIV laboratory to be screened in the first instance, and simply because he had made such referrals did not mean that he should have had additional records of positive HIV findings. Tr. 113. This controversy seems a red herring for both parties. The issue is whether Petitioner could provide records for the tests he had sent to the NYSDOH HIV laboratory for initial screening and for the one positive HIV test that he admitted he had confirmed. Eventually, he did find the lone positive HIV test result document and submitted it as an exhibit in this proceeding. Tr. 414-15; P. Ex. 40.

12. See 42 C.F.R. §§ 493.1242(c) and 493.1291 of the revised regulations.

13. See 42 C.F.R. §§ 493.1200, 493.1207, 493.1250-493.1252 of the revised regulations.

14. See 42 C.F.R. § 493.1101 of the revised regulations.

15. Petitioner had no sink at the time of the survey visits, but an operational sink was apparently installed in Petitioner's laboratory by January 10, 2002. CMS Ex. 25, at 9. A sink is important for a laboratory to have because it allows convenient handwashing and disposal of liquid material. Tr. 142.

16. Petitioner did produce a piece of paper that indicated he had been offered one free month of service for medical waste pick-up. He could not, however, provide any confirmation when he had last had a pick-up of his laboratory's medical waste. Tr. 363.

17. See 42 C.F.R. § 493.1252 of the revised regulations.

18. Petitioner suggested that a NYSDOH employee had told him previously that he only had to check and record temperatures monthly. The evidence indicates that Petitioner in 1997 had submitted to NYSDOH a plan of correction for deficiencies found during a recertification survey in that time period. His plan of correction set forth that he would check and record temperatures monthly. Petitioner submitted no evidence that this part of his plan of correction was accepted. CMS Ex. 13.

19. See 42 C.F.R. § 493.1251 of the revised regulations.

20. See 42 C.F.R. §§ 493.1105(a)(3), 493.1239, 493.1282, 493.1289, 493.1299 of the revised regulations.

21. See 42 C.F.R. § 493.1252 of the revised regulations.

22. A syphilis test is also called an RPR test. Tr. 170.