Cnd Life Sciences, Inc

Summary Statement of Deficiencies D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on lack of accuracy verification documentation for review and interview with the facility personnel, the laboratory failed to verify the accuracy of testing performed under the sub-specialty of Histopathology at least twice annually during 2019 and 2020. Findings include: 1. No documentation was presented for review during the survey to indicate the laboratory verified the accuracy of diagnostic neurology testing at least twice annually during 2019 and 2020. 2. The facility personnel confirmed that the laboratory failed to verify the accuracy of diagnostic neurology testing at least twice annually during 2019 and 2020. 3. The laboratory's approximate annual test volume under the sub-specialty of Histopathology is 1,800. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on lack of written Quality Assessment policies and procedures and interview with the facility personnel, the laboratory failed to establish policies related to accuracy verification for histopathology testing performed by the laboratory. Findings Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- include: 1. The laboratory performs diagnostic biopsy interpretation for Neurology testing under the sub-specialty of Histopathology, with an approximate annual test volume of 1,800. 2. No documentation was presented for review during the survey to indicate the laboratory had an established policy related to the verification of accuracy process for the testing indicated above, including but not limited to, information specific to the frequency of the review, number of cases reviewed, individual or laboratory performing the review and a remedial action plan in the event of a noted discrepancy. 3. The facility personnel confirmed that the laboratory failed to have an established written policy in place at the time of the survey conducted on October 14, 2021, specific to the verification of accuracy process for histopathology testing performed by the laboratory. D5391 PREANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1249(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the preanalytic systems specified at 493.1241 through 493.1242. This STANDARD is not met as evidenced by: Based on review of patient slides and interview with the facility personnel, the laboratory failed to identify and correct issues found with labeling patient slides with the incorrect date. Findings include: 1. The laboratory performs testing in the specialty of Pathology with an approximate annual test volume of 1,800. The laboratory receives 3 separate punch biopsy specimens from each patient which are processed, stained and mounted on labeled slides for interpretation by the Neurologist. 2. It is the practice of the laboratory to label the patient slides with the unique accession number, the specimen source code and stain code, patient last name and date. 3. Review of the pathology report for case# 1061 indicated the following dates: Biopsy Date as 10/16 /2019; Date Received as 10/17/2019; and Date Reported as 11/01/2019. 4. Review of the corresponding slides for case #1061 revealed the slides were labeled with the date, 01/10/2020, which was after the final report date of 11/01/19. 5. No

Summary Statement of Deficiencies D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on review of the laboratory's policy and procedure manual presented for review during the survey and interview with the facility personnel, the laboratory failed to have a procedure manual that was approved, signed, and dated by the current laboratory director. Findings include: 1. The laboratory's procedure manual presented for review during the survey conducted on August 6, 2019 failed to include the approval, signature and date of the laboratory director. 2. The facility personnel acknowledged that the procedure manual was not signed and dated by the laboratory director at the time of the survey. 3. The laboratory began patient testing in the sub- specialty of Histopathology in March 2019, with an approximate annual test volume of 1,000. D5473 CONTROL PROCEDURES CFR(s): 493.1256(e)(2)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (2) Each day of use (unless otherwise specified in this subpart), test staining materials for intended reactivity to ensure predictable staining characteristics. Control materials for both positive and negative reactivity must be included, as appropriate. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on lack of Quality Control (QC) documentation and interview with the facility Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- personnel, the laboratory failed to document the acceptability of staining materials used for testing performed in the sub-specialty of histopathology. Findings include: 1. The laboratory began patient testing in March 2019, with an approximate annual test volume is 1,000. 2. No documentation of the H & E stain and Congo Red stain acceptability was presented for review for testing that occurred on 07/23/19 for case ID# 00001021. 3. The facility personnel confirmed that the laboratory failed to document the stain acceptability for the two stains performed on the specimen indicated above. -- 2 of 2 --