Summit Pain Management

Summary Statement of Deficiencies D0000 A offsite revisit survey was completed on March 14, 2025 for all previous deficiencies cited on February 25, 2025. All deficiencies have been corrected, and no new noncompliance was found. The laboratory is in compliance with 42 C.F.R. 493, Requirements for laboratories. 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 patient record review, Hematology proficiency testing record review and staff interview, the laboratory failed to enroll in an approved Proficiency Testing (PT) program for the specialty of Hematology and the analyte cell identification (manual differential). The laboratory director and Hematology technical supervisor confirmed on February 25, 2025, at 8:45 am, the laboratory was performing cell identification/ manual differential testing in January 2025 and did not enroll in an approved proficiency testing program for 2025. 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 D6084 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(2) The laboratory director must ensure that the physical plant and environmental conditions provide a safe environment in which employees are protected from physical, chemical, and biological hazards. This STANDARD is not met as evidenced by: Based on observation, record review, and interview the laboratory director failed to ensure four of four hazardous waste/toxic chemicals ("2-Propanol", "Acetonitrile LC MS Grade", "Formic Acid, 99+%", "Methanol LC MS Grade") were not being disposed of down a sink where an eyewash was mounted for one of one eyewash observed in the laboratory. Findings include: 1. During tour the laboratory on 7/17 /2023 at 1:34 pm, the following was observed: a) An eye wash station was attached to a faucet in a sink where tubing was running from the "LCM5 Sysmex" into the sink. b) The list of chemicals being drained into the sink from the "LCMS5 Sysmex" are as follows: - "2-Propanol" - "Acetonitrile LC MS Grade" - "Formic Acid, 99+%" - "Methanol LC MS Grade" 2. On 7/17/2023 at 1:34 pm, SP4 (testing personnel) confirmed chemicals used in processing chemistry analytes are disposed of in the sink with the eye wash. 3. Review of Material Safety Data sheets (MSDS) for each chemical indicates the following for the eye: a) "2-Propanol," Section 2, page 2 of 8 reads, "Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. If eye irritation persists: Get medical advice /attention." b) "Acetonitrile LC-MS Grade," Section 4, page 3 of 11 reads; "Rinse out with plenty of water. Call in ophthalmologist. Remove contact lenses." c) "Formic Acid 99+%," Section 4 page 3 of 9 reads; "Rinse immediately with plenty of water, also under the eyelids, for several 15 minutes. Immediate medical attention is required." d) "Methanol LC-MS Grade," Section 4 page 3 of 12 reads; "Rinse out with plenty of water. Call in ophthalmologist. Remove contact lenses". e) "2-Propanol (HPLC)," Section titled "Safety and Handling" (not paginated) "Rinse immediately 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 -- with plenty of water, also under the eyelids for at least 15 minutes. Obtain medical attention." 4. Annual test volume for Chemistry is 768,534. -- 2 of 2 --

Summary Statement of Deficiencies 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 interview, the laboratory failed to ensure proficiency testing (PT) attestation statements were signed by the individual performing the testing during four of four PT events reviewed (event 1, 2018; event 2, 2018; event 3, 2018; and event 1, 2019). Findings included: 1. Review of policy/procedure titled: "Proficiency Testing," last revised 7-8-2016, did not require PT attestation statements to be signed by the individual performing the testing. 2. Review of PT records indicated the following: a. Attestation statements were not signed by the individual performing PT in the speciality of hematology for testing event 2, 2018; event 3, 2018; and event 1, 2019. b. Attestation statements were not signed by the individual performing PT in the subspecialty of routine chemistry for testing event 1, 2018; event 2, 2018; and event 3, 2018. 3. In interview on 5-16-2019 at 2:15 PM, SP1 acknowledged PT attestation statements had not been signed for the hematology testing event 2, 2018; event 3, 2018; and event 1, 2019. SP1 further acknowledged PT attestation statements had not been signed for the routine chemistry testing event 2, 2018; event 2, 2018; and event 3, 2018. 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 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 -- 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 document review and interview, the laboratory failed to: 1) perform calibration verification at least once every 6 months, and when a critical part was replaced for one of three analyzers reviewed (refer to D5439); and 2) take