April 11, 2003 - ASM Comments on QC/Laboratory Director Draft Guidelines

Final Guidelines

Draft Guidelines

Judy Yost, M.A., MT(ASCP)
Director, Division of Laboratory Services
Centers of Medicare and Medicaid Services
7500 Security Boulevard
M.S. S2-12-25
Baltimore, MD 21244

Dear Ms. Yost:

The American Society for Microbiology (ASM) appreciates the opportunity to comment on the draft copy of the revised Interpretive Guidelines, Appendix C of the State Operations Manual, which applies to the CLIA regulations on quality control and laboratory director requirements that were published in the Federal Register on January 24, 2003.The ASM's Public and Scientific Affairs Board's (PSAB) Committee on Professional Affairs reviewed the draft document and would like to submit the following concerns and comments for your consideration in preparation of the final document.

  1. D3015 - What is meant by "separate areas"? Are these separate rooms or only areas within one room?Is environmental monitoring for radioactivity required for Bactec 460 users?
  2. D5311 - 493.1242(a)(6) - If specimen processing is not classified as moderately or highly complex, does that mean that there are no educational requirements for individuals who digest-decontaminate AFB specimens?ASM considers this processing phase to be critical to the ultimate outcome of the culture.
    - 493.1242(a)(6) - Parasitology - fetal should be fecal.
  3. D5313 (b)- Does this apply to facilities where specimens are transported to a laboratory or only to "point of care" testing?
  4. D5407 - What is the rationale for not requiring annual review of procedures by the lab director?Can a cover sheet be used to approve a manual containing many procedures or is a cover sheet required for each procedure as required by CAP accreditation standards?
  5. D5415 (2)- The use of "Frost free" freezers in laboratories should be discouraged. NCCLS Document M2-A8 and M7-A6 recommends the storage of antimicrobial disks and broth dilution susceptibility trays in nonfrost-free freezers.
  6. D5423 - What is meant by modification of the Gram Stain?Does this mean changes in the decolorization step or changing safranin for carbolfuchsin?
  1. D5455 - Is it CMS's intention to say that any molecular amplification test that can be sold with an internal control must be purchased with the internal control?The Roche PCR test for GC and Chlamydia trachomatis as well as the BD Probetec can be purchased with or without the internal control and most labs purchase the test without it.
  2. No tag number (preceeds D5501) - 493.1261(a) -

    - In reference to the statement that begins, "If a laboratory utilizes primary isolation media…," is the intent to require quality control of primary isolation media that is exempt by NCCLS M22-2A when the media is used for presumptive identification of organisms?
    -In reference to the statement that begins, "For bacitracin,…" is there any mechanism currently in place for discs not specifically named in the guidelines, such as lap (leucine aminopeptidase) or hippurate, to be able to fall under the by lot quality control guidelines?
  3. D5511 - It is better to use Mycobacterium fortuitum (rather than M. tuberculosis) as the control organism for checking the processing of AFB cultures.For safety concerns, M. tuberculosis should be used as a control only when absolutely necessary.
  4. D5513 (b)(1) and D5519 (b)(1) - What is required by laboratories to establish acceptable control limits for mycobacterial and mycology susceptibility tests?
  5. D5527 - Regarding the statement that "the regulations do not require use of concentrated and permanent stain techniques to identify fecal parasites," please be advised that a new parasitology Cumitech will be published by ASM Press this summer, which will make performing concentrated and permanent stains the standard of care.In fact, it will state that direct wet mounts should only be performed on stool received by the laboratory within 30 minutes.Futhermore, the CAP accreditation standards (MIC 52100) require that a concentration and permanent stain be performed.Also, NCCLS Document, M28-A, Procedures for the Recovery and Identification of Parasites from the Intestinal Tract, Approved Guideline, includes this information.

    Is it correct that laboratories do not have to perform quality control on the iodine solution when the solution is prepared every two weeks?
  6. D5531- 493.1265(a) Probes - Does this apply only to stool specimens?It is unlikely that C. difficile toxin will be present in other specimens such as blood or sputum.Laboratories should check all cell lines for toxicity to new antiserum or serum.
  7. No tag number - 493.1443 - Laboratory Director Requirements - Please clarify the explanation of who needs to be board certified.The listing of DDSs, DVMs, and DPHs along with MDs and doctoral scientists is confusing.