Summary:
Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at PedPlus Urgent Care, LLC on October 18, 2018 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. Specific deficiencies cited are as follows: 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 a review of the laboratory's proficiency testing (PT) records and an interview, the laboratory director (LD) and testing personnel (TP) failed to sign and retain four (4) of five (5) attestation statements reviewed from April 2017 to October 2018. Findings include: 1. Review of the American Proficiency Institute (API) records, which included three (3) events in 2017 and two (2) events in 2018 (a total of 5 events), revealed the the laboratory director and testing personnel failed to sign and retain the attestation statements for the following events: 2017 Hematology /Coagulation Event 2, 2017 Hematology/Coagulation Event 3, 2018 Hematology /Coagulation Event 1, 2018 Hematology/Coagulation Event 2. A total of 4 PT attestations were not signed by the LD and TP. 2. At approximately 9:30 AM the Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 7 -- surveyor requested the attestation statements for the above listed events. No documentation was available for review. 3. In an exit interview at approximately 1:30 PM, the LD confirmed the findings. 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 a review of quality control (QC) records, and interviews, the laboratory failed to retain the Beckman Coulter "4C-ES Plus" manufacturer's assay information inserts documenting Complete Blood Cell (CBC) count QC acceptable ranges for six (6) of eight (8) QC lot numbers utilized from April 2017 until October 2018. Findings include: 1. Review of the laboratory's QC for the Beckman Coulter AcT diff 2 from April 2017 until October 2018 revealed 8 lot numbers of "4C-ES Plus" QC material were utilized to document and evaluate patient testing on the AcT diff 2 analyzer. The following QC lot numbers had no acceptable ranges or manufacturer's package inserts documented: 68800/78800/88000 exp 5/8/17, 69400/79400/89400 exp 7/31/17, 67500 /77500/87500 exp 10/23/17, 68200/78200/88200 exp 1/29/18, 668900/78900/88900 exp 4/23/18, 69500/79500/89500 exp 7/16/18. A total of six "4C-ES Plus" QC lot numbers with no acceptable ranges or manufacturer's package inserts. 2. The surveyor requested to review the package inserts for the 6 lot numbers of QC listed above. The Laboratory Director (LD) stated the laboratory failed to retain the "4C-ES Plus" inserts. No documentation was provided. 3. In an exit interview at approximately 1:30 PM, the LD confirmed the findings. D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years. This STANDARD is not met as evidenced by: Based on a review of the laboratory's proficiency testing (PT) records and interviews, the laboratory failed to retain the PT specimen instrument printouts for five (5) of five (5) PT events reviewed from April 2017 to October 2018. Findings include: 1. Review of the American Proficiency Institute (API) records, which included three (3) events in 2017 and two (2) events in 2018 (a total of 5 events), revealed the the laboratory failed to retain the instrument printouts for the following events: 2017 Hematology /Coagulation Event 1, 2017 Hematology/Coagulation Event 2, 2017 Hematology /Coagulation Event 3, 2018 Hematology/Coagulation Event 1, 2018 Hematology /Coagulation Event 2. A total of 5 PT events where the instrument printouts were not retained by the laboratory. 2. At approximately 9:30 AM the surveyor requested the instrument printouts for the above listed events. No documentation was available for review. 3. In an exit interview at approximately 1:30 PM, the Laboratory Director confirmed the findings. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 -- 2 of 7 -- 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 review of the laboratory's policy manual, quality control (QC) records, quality assessment (QA) records, manufacturer's operator's guide, patient test logs and interviews, the laboratory failed monitor and evaluate the analytic quality by failure to: 1. follow their quality control policy to document 3 levels of quality control within the expected ranges before reporting patients for twenty (20) of seventy-four (74) days while reporting forty-one (41) patients. (Cross Reference D5447), 2. perform and document