Wi Care Clinical Labs Llc

Summary Statement of Deficiencies D0000 An initial survey was completed on 05/22/2026. Immediate Jeopardy exists for the following condition level deficiencies: 42 C.F.R. 493.801 Condition: Enrollment and Testing of Samples 42 C.F.R. 493.1250 Condition: Analytic Systems 42 C.F.R. 493.1403 Condition: Moderate Complexity Laboratory Director 42 C.F.R. 493.1415 Condition: Clinical Consultant 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 review of policies and procedures for "General SOPS", review of the binder titled "College of American Pathologists (CAP) Accreditation Documents", review of laboratory test records, and an interview with the Laboratory Director (LD), the laboratory failed to enroll in a proficiency testing (PT) program for complete blood count (CBC) testing in the specialty of Hematology. This deficient practice affected one out of one patient tested in the specialty of Hematology from 02/12/2026 through 05/19/2026, with the potential to affect an undetermined number of future patients. Findings include: 1. The laboratory failed to enroll in a PT program for CBC testing performed in the specialty of Hematology. (Refer to D2001) D2001 ENROLLMENT Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 9 -- 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; and This STANDARD is not met as evidenced by: Based on review of policies and procedures for "General SOPS", review of the binder titled "College of American Pathologists (CAP) Accreditation Documents", review of laboratory test records, and an interview with the Laboratory Director (LD), the laboratory failed to enroll in a proficiency testing (PT) program which contained five test specimens in three annual testing events for moderate complex complete blood count (CBC) testing performed in the specialty of Hematology. This deficient practice affected one out of one patient tested in the specialty of Hematology from 02/12/2026 through 05/19/2026, with the potential to affect an undetermined number of future patients. Findings include: 1. A review of the "General SOPS" approved by the LD on 01/23/2026, and provided on the date of the inspection, lacks any mention of PT policies and procedures. 2. Review of the binder titled "College of American Pathologists (CAP) Accreditation Documents" does not contain any enrollment documentation or CAP test event documents. 3. In an interview on 05/19/2026 at 11: 30 AM, the inspector requested the laboratory's 2026 CAP PT documentation of CBC enrollment and testing from the LD. The LD confirmed the laboratory had not enrolled in PT and could not provide the requested documents. 4. Review of the laboratory records revealed one of one patient CBC tested, patient identification number 1164911, in the specialty of Hematology from 02/12/2026 through 05/19 /2026. 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 the review of the policy and procedure titled "Quality Procedure for Validation", review of the Beckman Coulter DXH520 instrument quality control records, review of patient test results, and an interview with the Laboratory Director (LD), the laboratory failed to monitor and evaluate the overall quality of the analytic systems and correct identified problems with the moderate complex complete blood count (CBC) testing procedures in the specialty of Hematology and the waived urine drug screen (UDS) testing procedures in the subspecialty of Toxicology. This deficient practice had the potential to affect one of one patient Hematology testing procedure and one of one patient Toxicology testing procedure from 02/12/2026 through 05/19/2026, and an undetermined number of future patients tested. Findings Include: 1. The laboratory failed to follow written procedures for instrument -- 2 of 9 -- validation. (Refer to D5401) 2. The laboratory lacked documentation for reportable ranges, the ranges for imminent life-threatening test results, and/or the panic or alert value ranges for the test system. (Refer to D5403). 3. The laboratory failed to ensure control materials were not used when they had exceeded their expiration date. (Refer to D5217) D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) (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 the review of the policy and procedure titled "Quality Procedure for Validation", review of patient test results, and an interview with the Laboratory Director (LD), the laboratory failed to follow their policy and procedure for validation of the FormFox Flex test system utilized for urine drug screen (UDS) testing in the subspecialty of Toxicology. This deficient practice had the potential to affect one of one patient Toxicology testing procedure from 02/12/2026 through 05/19/2026 and an undetermined number of future patients tested. Findings Include: 1. Review of the policy and procedure titled "Quality Procedure for Validation", approved via signature and date by the LD on 11/06/2025, and provided the date of the inspection, found the following statements: "1) Develop validation plans using predefined template which contains but not limited to, the following: ...iv. Test scenarios. Testing will be performed in a manner to ensure, in a complete, verifiable manner, the requirements, design, and characteristics of the system and its components. ...viii. System acceptance- Final report. A formal system acceptance document, consisting of review and acceptance of the completed/tested system and validation documentation, will be performed to ensure that the expectations laid out in the plan have been fulfilled." 2. On 05/19/2026 at 12:30 PM, the surveyor requested the validation records for the FormFox Flex urine drug screening instrument from the LD. The LD stated the instrument was not in use, and there were no validation records for the FormFox Flex UDS instrument. 3. Review of patient test reports revealed one "Rapid non-DOT Urine Drug Screen" laboratory test requisition for specimen #CC19715250, with attached test panel results for 6-acetylmorphine, barbiturates, buprenorphine, fentanyl, 3,4-methylenedioxymethamphetamine (MDMA), methamphetamine, oxycodone, amphetamines, benzodiazepines, cocaine metabolites, marijuana metabolite, methadone, opiates, and phencyclidine dated 03/30/2026 at 3:23 PM. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) (b) The procedure manual must include the following when applicable to the test procedure: (b)(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. (b)(2) Microscopic examination, including the detection of inadequately prepared slides. (b)(3) Step-by- step performance of the procedure, including test calculations and interpretation of results. (b)(4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (b)(5) Calibration and calibration verification -- 3 of 9 -- procedures. (b)(6) The reportable range for test results for the test system as established or verified in 493.1253. (b)(7) Control procedures. (b)(8)