Baker Direct Medical Care

Summary Statement of Deficiencies D0000 An Initial Certification Survey was conducted on 04/15/2024. The facility was found not to be in compliance with the laboratory requirements of 42 CFR Part 493 with deficiencies cited. 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: Based on document review and confirmed in staff interview; the facility failed to ensure attestation statements were signed and dated for 3 (03/2023, 07/2023, and 10 /2023) of 4 proficiency testing (PT) events reviewed. Findings included: A review of "WSLH [Wisconsin Laboratory of Hygiene] Proficiency Testing" laboratory proficiency testing records for chemistry/endocrinology PT events administered in March 2023 (with a due date of 03/10/2023), July 2023 (with a due date of 07/07 /2023), and October 2023 (with a due date of 10/20/2023) revealed the attestation forms for these events were not signed. During an interview on 04/15/2024 at 12:20 PM, the Technical Consultant acknowledged the attestation forms were not signed as required. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on record review, observation, and staff interview on 07/09/2018, the laboratory failed to monitor and document temperatures for the storage of the drugs of abuse testing reagents and storage of urine specimens prior to testing. Findings include: Manufacturer's Instructions for the storage of testing reagents is 2-8 degrees Centigrade. The laboratory failed to document refrigerator temperatures from 02/06 /2018 when the instrument was installed. Based on observation, the laboratory stored urine samples in the freezer prior to testing. There was no documentation of temperatures for the freezer from when the laboratory started patient testing 02/12 /2018. Interviews with the Laboratory Director and testing personnel at 2:00 PM on 07 /09/2018, revealed the laboratory failed to have a system in place to ensure refrigerator and freezer temperatures were monitored and documented daily. D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- At least once a day patient specimens are assayed or examined perform the following Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- for-- Each qualitative procedure, include a negative and positive control material; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on record review and staff interview on 07/09/2018, the laboratory failed to include a positive and negative control material for the Buprenorphine drug of abuse for six of six days of patient testing. Findings include: Record review revealed Buprenorphine results were reported on 02/27/2018, 03/29/2018, 04/27/2018, 05/24 /2018, 06/19/2018, and 06/26/2018. There was no evidence of positive and negative control materials tested on these days. An interview with the testing personnel at 2:00 PM 07/09/2018, revealed the laboratory failed to have a system in place to ensure positive and negative control materials were run and documented on all days of patient testing. D6015 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4) Ensure that the laboratory is enrolled in an HHS approved proficiency testing program for the testing performed. This STANDARD is not met as evidenced by: Based on record review and staff interview on 07/13/2018, the laboratory director failed to enroll the laboratory with an approved proficiency testing agency for toxicology samples. Findings include: Record review failed to reveal confirmation of enrollment for proficiency testing samples for drugs of abuse. Interview with the laboratory director at 2:00 PM on 07/09/2018, revealed the laboratory was not enrolled in proficiency testing for nine drugs of abuse being tested on patients. -- 2 of 2 --