Ibrahim S Elsheikh Md (Pediatric Care

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 an interview with the Laboratory Director, the laboratory failed to enroll in a proficiency testing (PT) program for the sub-specialty of General Immunology. All patient Immunology testing performed in this laboratory from 11/19 /2019 to 01/21/2020 had the potential to be affected by this deficient practice. Findings Include: 1. The laboratory failed to enroll in a proficiency testing (PT) program for the regulated analyte immunoglobulin E (IgE); allergy testing. (Refer to D2001) D2001 ENROLLMENT CFR(s): 493.801(a)(1)(2)(i) The laboratory must-- (1) Notify HHS of the approved program or programs in which it chooses to participate to meet proficiency testing requirements of this subpart. (2)(i) Designate the program(s) to be used for each specialty, subspecialty, and analyte or test to determine compliance with this subpart if the laboratory participates in more than one proficiency testing program approved by CMS; Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 15 -- This STANDARD is not met as evidenced by: Based on record review and an interview with the Laboratory Director, the laboratory failed to enroll in a proficiency testing (PT) program for the regulated analyte immunoglobulin E (IgE); allergy testing. All patient immunology testing performed in this laboratory from 11/19/2019 to 01/21/2020 had the potential to be affected by this deficient practice. Findings Include: 1. Review of the laboratory's Wisconsin State Laboratory Hygiene (WSLH) PT enrollment document did not find verification of enrollment for the analyte IgE which appears on Subpart I. 2. The Inspector requested the laboratory's PT enrollment records for IgE from the Laboratory Director. The Laboratory Director confirmed that the laboratory was not enrolled with a PT provider for IgE and was unable to provide the requested documentation on the date of the inspection. The interview occurred on 01/21/2020 at 9:55 AM. D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on record review and an interview with the Laboratory Director, the laboratory failed to establish a policy and procedure for documenting the handling, preparation, processing, examination and each step in the testing and reporting of proficiency testing (PT) results. All patient testing performed in this laboratory had the potential to be affected by this deficient practice. Findings Include: 1. Review of the laboratory's policies and procedures, provided on the date of the inspection, did not find mention of any PT policies and procedures. 2. The Inspector requested the laboratory's PT policy and procedure from the Laboratory Director. The Laboratory Director confirmed the laboratory did not have an established PT policy and procedure for documenting the handling, preparation, processing, examination and each step in the testing and reporting of PT results and was unable to provide the requested documentation on the date of the inspection. The interview occurred on 01 /21/2020 at 9:55 AM. 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: -- 2 of 15 -- Based on record review and an interview with testing personnel (TP) #2, the laboratory failed to retain all analytic system activity records for the Medonic MSeries Hematology complete blood count (CBC) with five part automated differential (auto diff) test system. All patient CBC with auto diff testing from 10/31/2019 to 12/28 /2019 were affected by this deficient practice. Findings Include: 1. TP#2 stated the laboratory's procedures in which the Medonic MSeries instrument printouts for patient CBC with auto diff test results were scanned into the patients electronic medical record (EMR) and the daily background checks and quality control (QC) printouts were kept in a three-ringed binder. No QC records were found for the following dates of laboratory operation: 2019 November 7, 14, 16, 19, 21 December 5, 7, 12, 14, 17, 19, 21, 23, 24, 26, 27, 28 2020 January 2, 4, 9, 16, 18, 21 2. Direct observation of the laboratory, on 01/21/2020 at 12:15 PM, did not find any instrument maintenance and reagent lot number activities recorded and retained from 10/31/2019 to 01/21/2020. 3. Review of the laboratory's Medonic MSeries Hematology on-board instrument records, provided on the date of the inspection, revealed records of maintenance, a reagent log, calibration, QC and patient test results; however all records where missing from the date of instrument implementation on 10/31/2019 to 12/28/2019. 4. The Inspector requested the laboratory's 2019 and 2020 Medonic MSeries activity records for all maintenance, reagent logs, calibrations, QC and patient testing from TP#2. TP#2 confirmed that the laboratory did not record and retain any manual logs, other than what was held in the analyzer which indicated any activity with maintenance and reagent lot number/expiration dates. TP#2 unsuccessfully attempted to locate the requested information from 10/31/2019 to 01/21/2020 on the analyzer and was unable to provide the requested documentation on the date of the inspection. The interview occurred on 01/21/2020 at 12:15 PM. 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 an interview with the Laboratory Director, the laboratory failed to establish and follow written policies and procedures to assess the competency of testing personnel (TP). All patient Endocrinology, Immunology and Hematology testing performed in this laboratory from 10/31/2019 to 01/21/2020 had the potential to be affected by this deficient practice. Findings Include: 1. Review of the laboratory's policies and procedures, provided on the date of the inspection, did not find any instructions for assessing the competency of TP. 2. Review of the laboratory's Form CMS-209, approved, signed and dated by the Laboratory Director on 01/20/2020 and provided on the date of the inspection, revealed two TP including the Laboratory Director. 3. The Inspector requested the laboratory's competency assessment policy and procedure and all competency assessment documentation for TP#2 from the Laboratory Director. The Laboratory Director confirmed that the laboratory did not establish a competency assessment policy and procedure, TP#2 was not assessed for competency on the moderately complex Endocrinology, Immunology and Hematology testing performed from 10/31/2019 to 01/21/2020 and was unable to provide the requested documentation on the date of the inspection. The interview occurred on 01/21/2020 at 9:42 AM. -- 3 of 15 -- D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on record review and an interview with the Laboratory Director, the laboratory failed to have written policies and procedures available to the laboratory personnel for the thyroid stimulating hormone (TSH), Vitamin D (VitD), Immunoglobulin E (IgE) and complete blood count (CBC) with five part automated differential (auto diff) testing procedures. All patient testing performed in this laboratory from 10/31/2019 to 01/21/2020 had the potential to be affected by this deficient practice. Findings Include: 1. Review of the laboratory's policy and procedure packet titled "Ibrahim S Elsheikh MD, Inc Laboratory Manual", provided on the date of the inspection, found it to be comprised of 12, one-sided pages that included general information of all specimen collection, labeling, handling, processing and send out protocols, all nine waived tests performed as well as the mention of the moderately complex TSH, VitD, IgE, and CBC with auto diff testing procedures performed. 2. Further review of the laboratory's policy and procedure packet revealed the following example of one out of four of the moderately complex testing protocols in total: "IgE allergy Test (Hitachi) - See manufacturer procedural manual Venous sample is obtained from the patient. Then specimen is centrifuged for 10 minutes to separate serum. Procedural manual is followed to analyze patient's sample. Prior to run patient's sample, control is run first. Quality assurance measure Control is run prior to testing patients' samples. Result of control must be within acceptable parameter before analyzing patients' data. See procedural manual. Proficiency Testing Hitachi Reference Lab" 3. The Inspector requested the laboratory's TSH, VitD, IgE and CBC with auto diff testing policies and procedures from the Laboratory Director. The Laboratory Director confirmed the packet provided was the laboratory's only written policies and procedures and referenced the manufacturer's manual as needed and was unable to provide the requested documentation on the date of the inspection. The interview occurred on 01 /21/2020 at 9:25 AM. 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)