Summary:
Summary Statement of Deficiencies D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on record review and staff interview, proficiency testing (PT) samples were not tested in the same manner as patient samples. Findings include: 1. Record review on 2 /6/19 of the laboratory's 2017 and 2018 College of American Pathologists (CAP) PT records revealed: a. 2 of 4 bacteriology TP did not perform PT testing in 2018. b. PT hematology results were submitted for evaluation in 2017 and 2018 for 1 of 10 TP. The same TP's results were submitted for all events. c. 7 of 10 hematology TP tested the same PT samples as internal blind samples prior to the CAP PT program due date for 2017. d. 4 of 10 hematology TP tested the same PT samples as internal blind samples prior to the CAP PT program due date for 2018. 2. Staff interview with the office manager on 2/6/18 at 11:15 AM confirmed the above findings. 3. The laboratory performs 36,985 hematology tests and 6,738 bacteriology cultures annually. 4. This is a repeat violation. D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 13 -- Based on record review and staff interview, the laboratory failed to attest that proficiency testing (PT) samples were performed in the same manner as patient specimens. Findings include: 1. Record review on 2/6/19 of the laboratory's 2017 College of American Pathologists (CAP) microbiology combination attestation sheets revealed the 2017-Event A PT attestation sheet was not signed by the laboratory director. 2. Staff interview on 2/6/19 at 1:00 PM with the office manager confirmed the above finding. 3. The laboratory performs 6,738 cultures annually in the subspecialty of bacteriology. D2122 HEMATOLOGY CFR(s): 493.851(b) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on record review and staff interview the laboratory failed to achieve a score of at least an 80 on proficiency testing (PT) in the specialty of hematology. Findings include: 1. Record review on 2/6/19 of the laboratory's College of American Pathologist (CAP) PT results revealed the laboratory received an unsatisfactory score of 63 for FH1-A 2018 Hematology Auto Differentials. 2. Staff interview on 2/6/19 at 2:00 PM with the office manager confirmed the above finding. 3. The laboratory performs 36,985 tests annually in the specialty of hematology. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) 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 retain quality control (QC) records at least for two years in the specialty of hematology. Findings include: 1. Record review of the laboratory's hematology quality control records on 2/11/19 revealed the laboratory did not have daily QC records for the Sysmex XP300 (SN B3583) analyzer from 12/16/17 through 4/25/18. 2. Staff interview with the laboratory supervisor (LS) on 2/11/19 at 11:15 AM confirmed the above finding. 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. -- 2 of 13 -- Review on 2/6/19 of the laboratory's competency records revealed: a. The laboratory did not a have policy in place to assess the competency of the technical consultant (TC) or clinical consultant (CC). b. Competency documentation for the TC and CC was not available. 2. Staff interview with the office manager on 2/6/19 confirmed the above findings. 3. This is a repeat violation. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on record review and staff interview the laboratory failed to document review of proficiency test (PT) Scores. Findings include: 1. Record review on 2/6/19 of laboratory's 2017 and 2018 College of American Pathologists (CAP) hematology PT scores revealed: a. FH2-A 2017 i. Specimen FH2-05 MCV was unacceptable. ii. Specimens FH2-01 through FH2-05 had an incorrect response due to failure to provide a valid response code for MCHC and RDW. b. FH2-B 2017 i. Specimens FH2-06 through FH2-10 had an incorrect response due to failure to provide a valid response code for MCHC. c. FH1-A 2018 i. Overall score of 63. ii. Specimen FH1-05 MCV was unacceptable. iii. Specimens FH1-01 through FH1-05 had an incorrect response due to failure to provide a valid response code for RBC, hematocrit and RDW. d. The laboratory failed to investigate and/or evaluate the results obtained. e. The results were signed as reviewed by the laboratory director. 2. Staff interview with the laboratory supervisor (LS) and office manager on 2/6/19 at 1:00 PM confirmed the above findings. The LS stated he/she was unaware results could be checked against the participant summary. 3. The laboratory performs 36,985 tests annually in the specialty of hematology. 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. This CONDITION is not met as evidenced by: Based on surveyor observation, 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, D5411, D5481, D5469, D5775, D5781 and D5791. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) -- 3 of 13 -- 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)