Summary:
Summary Statement of Deficiencies D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on record review and staff interview the laboratory failed to enroll in proficiency testing (PT) in the specialties of Hematology and Microbiology. Findings include: 1. Record review on 3/11/19 of the laboratory test reports revealed the laboratory was performing the following moderate complexity tests. a. Complete blood count (CBC) b. Throat culture by Strep Select Agar. c. Urine culture, uricult 2. Record review of the laboratory's inspection documentation on 3/11/18 revealed the laboratory failed to provide evidence or documentation of PT enrollment for the above tests. 3. Staff interview with the practice manager (PM) on 3/11/18 at 10:30 AM confirmed the above findings. The PM stated the laboratory has been performing bacteriology testing since opening 8 - 10 years ago and hematology testing for approximately 4 years and never enrolled in PT. 4. The laboratory performs 621 cultures annually in the specialty of microbiology and 8,225 tests annually in the specialty of hematology. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 14 -- Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on record review and staff interview the laboratory failed to retain quality control (QC) and instrument maintenance records at least for two years in the specialty of hematology. Findings include: 1. Record review of the laboratory's hematology QC and maintenance records on 3/11/19 revealed the laboratory did not have the daily QC and maintenance records for the Horiba hematology analyzer as indicated below: a. June 2017 b. August 2017 c. October 2017 2. Record review of the laboratory's hematology QC records on 3/11/19 revealed the laboratory did not have daily QC records for the Sysmex XP300 (SN B3577) analyzer from: a. 12/28/17 through 6/6/18. b. 11/27/18 through 2/11/19. 3. Staff interview with the laboratory supervisor (LS) on 3/11/19 at 11:15 AM confirmed the above findings. The LS further stated QC records were inadvertently deleted and not recoverable. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to have a policy in place to assess the competency of all laboratory personnel. Findings include: 1. Review of the laboratory's procedure manual on 3/11/19 revealed the following: a. The laboratory did not have policy in place to assess the competency of the technical consultant (TC) and clinical consultant (CC) until 2019. The new policy was signed by the laboratory director but not dated. 2. Record review on 3/11/19 of the laboratory's testing personnel records revealed: a. Competency assessment documentation for the TC, CC, and laboratory moderate complexity testing personnel was not available, since the laboratory opened 8 - 10 years ago. 3. Staff interview with the practice manager (PM) on 3/11/19 at 11:10 AM confirmed the laboratory did not have a policy in place to assess the competency of the above laboratory personnel until recently and they were not assessed. The PM stated the new policy was put into place approximately a week prior to inspection and although the policy was signed by the laboratory director, it was not dated. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. -- 2 of 14 -- This CONDITION is not met as evidenced by: Based on record review and staff interview, the laboratory failed to monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. The cumulative effect of this lack of oversight resulted in the laboratory's inability to ensure accuracy and reliability of patient test results in the specialty of hematology and the subspecialty of bacteriology. Refer to D5403, D5407, D5413, D5421, D5429, D5469, D5471, D5781, and D5791. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)