Froedtert Hospital - Bluemound Campus

Summary Statement of Deficiencies 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 surveyor review of verification studies and laboratory procedures and interview with a general supervisor (Staff A), the laboratory did not have an approved test procedure for one of one Immunohistochemical (IHC) test performed in the laboratory. Findings include: 1. Review of verification studies completed for MART-1 (MelanA or Melanoma antigen) IHC test showed a technical supervisor (Staff B) evaluated and approved the MART-1 IHC test for use in the laboratory. 2. Review of laboratory procedures showed no evidence of an approved procedure for the MART-1 IHC test. 3. Interview with Staff A on June 28, 2024, at 10:10 AM confirmed the laboratory did not develop and the laboratory director did not approve a standard operating procedure for the performance of MART-1 IHC test. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on surveyor review of supply logs, observation of supplies in the laboratory, 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 -- and communication with a general supervisor (Staff A), the laboratory used expired coverslip film in the laboratory six of the last eight months. Findings include: 1. Review of the laboratory's supply logs showed the laboratory received coverslip film in October 2023 with an expiration date of December 2023. Further review showed the laboratory did not document receipt of any additional coverslip film since October 2023. 2. Observation of the coverslip film in the laboratory on June 28, 2024, at 11:00 AM revealed the laboratory had Tanner Tape coverslip film lot 224264 available for use. The box showed the film expiration date was December 2023. 3. Communication with the general supervisor via email on July 1, 2024, at 7:06 AM confirmed the laboratory used the coverslip film from November 2023 until the date of the survey. -- 2 of 2 --

Summary Statement of Deficiencies D5787 TEST RECORDS CFR(s): 493.1283(a) The laboratory must maintain an information or record system that includes the following: (a)(1) The positive identification of the specimen. (a)(2) The date and time of specimen receipt into the laboratory. (a)(3) The condition and disposition of specimens that do not meet the laboratory's criteria for specimen acceptability. (a)(4) The records and dates of all specimen testing, including the identity of the personnel who performed the test(s). This STANDARD is not met as evidenced by: Based on surveyor review of laboratory records and interview with the general supervisor, the laboratory did not record the time of specimen receipt in the laboratory for twelve of twelve Mohs tissue specimens from six of six randomly reviewed patients. Findings include: 1. Review of laboratory records including patient logs, Mohs maps and patient test reports for six randomly chosen patients showed staff did not record the time of specimen receipt in the laboratory for twelve of twelve Mohs tissue samples from six of six patients. Patient 1: Tissues from three of three stages received. Patient 2: Tissue from one of one stage received. Patient 3: Tissues from two of two stages received. Patient 4: Tissues from four of four stages received. Patient 5: Tissue from one of one stage received. Patient 6: Tissue from one of one stage received. 2. Interview with the general supervisor on March 1, 2023, at 11:40 AM confirmed the laboratory did not record the time of specimen receipt in the laboratory for twelve of twelve Mohs tissue specimens from six of six randomly reviewed patients. 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 --