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 interview with the laboratory director on 11/3/2020, and record review of the Centers for Medicare and Medicaid Services (CMS) CASPER 96D report, the laboratory failed to enroll in an Health and Human Services (HHS) approved proficiency testing (PT) program that meets the criteria in 42 C.F.R. part 493 subpart I for each of the specialties and subspecialties in Hematology, Chemistry, and Endocrinology for which it seeks certification. In accordance with 42 C.F.R. part 493. 1236(c)(1), for those tests not included in subpart I, the laboratory failed to, (at least twice annually) verify the accuracy of any test or procedure it performs. The findings include: 1. The laboratory performs complete blood counts (CBC) on a PocH 100i Hematology analyzer, and Free Thyroxine (FT4), Thyroid-stimulating hormone (TSH), Vitamin D, Prostate-specific antigen (PSA), and Testosterone on a NanoEnTek FREND System. 2. The NanoEnTek FREND System and the PocH 100i are classified by the Food and Drug Administration (FDA) as moderate complexity testing platform. The CBC analytes and the FT4, TSH are regulated analytes listed in 42 C.F.R. part 493 subpart I requiring PT enrollment with an HHS approved PT program. 3. In accordance with 42 C.F.R. part 493 subpart I, the laboratory failed to enroll in an HHS approved PT program for the regulated analytes FT4, TSH, and Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 8 -- White Blood Cell differential counts (WBC), Erythrocyte (RBC) counts, Hemoglobin, Hematocrit and Platelets counts. 4. The laboratory failed to perform twice annual verification for accuracy or to enroll in an HHS approved PT program for the four non- regulated analytes FT4, TSH, Vitamin D, and Testosterone. 5. The laboratory has been open and testing patients analytes since January 2020. 6. The laboratory director confirmed by interview on 11/3/2020 at 9:10 a.m., that the laboratory did not enroll in an HHS approved PT program for the regulated analytes in accordance with 42 C.F.R. part 493.801 subpart I, and the laboratory did not perform verification of accuracy twice annually for the unregulated analytes that are not listed within 42 C.F.R. part 493 subpart I. 6. The laboratory records indicate that the laboratory performs 30,950 moderate complexity patient specimens annually. 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 quality control (QC) record review and interview with the laboratory director (LD) and the office manager (OM) on 11/3/2020, the laboratory failed to retain quality control and patient test records (including instrument printouts) for at least 2 years. The findings included: 1. The laboratory performs complete blood counts on the PocH 110i hematology analyzer. During interview with the LD and the OM regarding QC records during a random review of patients records from January 1, 2020 through October 31, 2020, the laboratory did not have QC records from January 2020 through July 6, 2020. 2. The OM stated by interview on 11/3/2020 that the hematology analyzer QC records were misfiled in the transition from the original facility location to this facility location and the records prior to July were not available. 3. The laboratory does not have an integrated laboratory information system (LIS) and enters the patients laboratory results into the electronic health record (EHR) manually. The LD stated that patient analyzer test printouts are not saved, but shredded once the results are manually entered into the laboratory's EHR. 4. The laboratory director and office manager confirmed by interview on 11/3/2020 at 11:40 a.m. that the laboratory does not retain for two years patient printouts from the hematology analyzer, and that the laboratory did not have QC records from January 2020 through June 2020 available at the time of survey. 5. The laboratory reports performing 6000 CBC patient specimens annually. 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 personnel training and competency records, the Centers for Medicare and Medicaid Services (CMS) 209 personnel form, and interview with the laboratory's office manager (OM) on 11/03/20, the laboratory failed to establish and follow written -- 2 of 8 -- policies and procedures to assess employee and, if applicable, consultant competency. The findings includes: 1. The laboratory's CMS-209 form identifies six (6) testing personnel performing moderate and waived complexity testing procedures. Four (4) of the (6) identified testing personnel did not have documentation of initial training and competency. Personnel Start Dates (1) MA 05-25-2020 (2) MA 08-26-2020 (3) MA 10-01-2020 (4) MA no training start date 2. For two (2) of six (6) testing personnel listed on the CMS-209, the laboratory did not have adequate documentation of competency which included the six parameters as listed in 493.1413(b)(8) for biannual and annual competency requirements and did not establish policies or procedures to monitor each testing individual for competency. 3. The laboratory has one technical consultant (TC) listed on the CMS-209, the laboratory had no documentation of competency for this individual. 4. The laboratory director and office manager confirmed by interview on 11/3/2020 that the laboratory does not have policies and procedures for initial training and competency assessments, biannual and annual competency assessment, in accordance with 42 C.F.R. 493.1413(b)(8). 5. The laboratory reports performing 1040 waived and 6,250 non-waived patient specimens annually. 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 record review and interview with the laboratory director on 11/3/2020 , the laboratory failed to 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. The findings include: 1. The laboratory has no written policies or procedures for an ongoing mechanism to monitor, asses and when indicated identify general laboraory systems requiremenst such as training and competency assessments; See D5209, 2. The laboratory has no written policies or procedures for monitoring of maintanance and quality control performance; See D5421, D5403. 3. The laboratory does not have policies or procedures to ensure that patient testing records and printouts are maintained for two (2) years. See D3031. 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)