Uhmp - Portage Urology

Summary Statement of Deficiencies 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 record review and an interview with the RN Clinical Coordinator (RNCC), the laboratory failed to enroll with a proficiency testing (PT) provider for the urine microscopic tests performed in the subspecialty of Urinalysis. This deficient practice had the potential to affect two out of two patient urine microscopic tests performed in this laboratory from 01/23/2025 through 02/03/2025. Findings Include: 1. Review of the laboratory's "UHPS-CLIN-17.0-Proficiency Testing Policy", unapproved by the Laboratory Director and provided on the date of the complaint investigation, found the following statement: "This Laboratory has implemented and maintains a Proficiency Testing Policy in compliance with CLIA 88 rules and regulations." 2. The Inspector requested the laboratory's 2025 urine microscopic PT documentation from the RNCC. The RNCC confirmed, on 02/03/2025 at 9:52 AM, that the laboratory had not enrolled in urine microscopic proficiency testing in 2025 and was unable to provide the requested documentation on the date of the complaint investigation. The RNCC further confirmed via an electronic mail message on 02/10/2025 at 11:26 AM, the first patient urine microscopic test was conducted on 01/23/2025. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 10 -- CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on record review and an interview with the RN Clinical Coordinator (RNCC), the laboratory failed to follow written policies and procedures to assess the competency of the Testing Personnel (TP) for the moderately complex Provider Performed Microscopy (PPM) testing procedures performed in the specialty of Hematology and the subspecialty of Urinalysis. This deficient practice had the potential to affect 396 out of 396 patient post-vasectomy presence or absence of sperm tests performed between 02/03/2023 through 02/03/2025 and two out of two urine microscopic tests performed between 01/23/2025 through 02/03/2025. Findings Include: 1. Review of the laboratory's Form CMS-209, approved via signature and date by the Laboratory Director on 02/03/2025 and provided on the date of the complaint investigation revealed two qualified and listed individuals as TP to perform PPM testing procedures. 2. Review of the laboratory's "Competency Testing" policy and procedure, unapproved via signature and date by the Laboratory Director and provided on the date of the complaint investigation revealed the following: "1. UHPS requires annual competency to be completed on every lab test, for each site, every January. 1.1. New hire and internal transfers: 1.1.1. Training and initial competency completion in the first 30 days. 1.1.2. Repeat competency 6 months after date of hire 1.1.3. Repeat competency 1 year from date of hire 1.1.4. Follow annual competency 1.2. Current employees follow annual competency 2.0 Ultimately, the lab director is responsible to ensure that all testing personnel are competent and maintain their competency in order to perform and report accurate and reliable test results." 3. Review of the laboratory's "Physician Performed Microscopy (PPM) and CLIA Waived Point-of-Care Testing, CP-118" policy and procedure, unapproved via signature and date by the Laboratory Director and provided on the date of the complaint investigation revealed the following: "...competency is required to be assessed semiannually the first year and annually thereafter for all physicians and practitioners who perform PPM independently." "7.0 Microscopic procedures performed under the CLIA PPM Certificate: 1. Competency: 1. Privileges to perform the specified microscopy procedures are contingent upon annual competency assessments. Clinical departments are responsible for administering and documenting annual competency assessments, which must be available for accrediting agency review. 2. House staff may perform PPM under direct supervision and may perform PPM independently once competency has been demonstrated.... 3. Annual competency assessments are required for all physicians/LIP's who perform Provider Performed Microscopy (PPM)...." 4. Review of the laboratory's "UHPS-Clin-7.0- Laboratory Competency Policy", unapproved by the Laboratory Director via signature and date and provided on the date of the complaint investigation found the following: "UHPS requires annual competency to be completed each January. *A new hire needs initial training and initial competency within the first few weeks of hire. Then 6 months after date of hire competency needs to be performed on every test, then one year from date of hire competency needs performed again. Then the employee can be put into the regular annual competency rotation. *Current employees that transfer to another UH office must be treated like a new hire and follow the new hire competency timeline, regardless of any previous competency at another office. *Employees who work at more than one office (site) regardless of whether it is the same physician -- 2 of 10 -- group must have competency completed at each office (site). *Thereafter; evaluations will be performed annually in accordance with our UH policy." 5. Further review of the laboratory's policy and procedure manual, unapproved via signature and date by the Laboratory Director and provided on the date of the complaint investigation revealed a blank "UHMSO Waived-PPMP Laboratory Testing Form". 6. The Inspector requested the laboratory's 2023, 2024 and 2025 competency assessment documentation for Testing Personnel (TP) #1 and TP#2 from the RNCC. The RNCC confirmed the laboratory did not conduct competency assessments on TP#1 and TP#2 in 2023, 2024 and 2025 and was unable to provide the requested documentation on the date of the complaint investigation. The interview occurred on 02/03/2025 at 9:52 AM. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on record review and an interview with the RN Clinical Coordinator (RNCC), the laboratory failed to establish and conduct blind test accuracy verification (TAV) activities, at least twice annually, for the post-vasectomy presence or absence of sperm testing procedures in the specialty of Hematology. This deficient practice had the potential to affect 396 out of 396 patient post-vasectomy semen specimens tested between 02/03/2023 through 02/03/2025. Findings Include: 1. Review of the laboratory's "UHPS-CLIN-17.0-Proficiency Testing Policy", unapproved by the Laboratory Director and provided on the date of the inspection, did not find any mention of TAV instructions. 2. The Inspector requested the laboratory's TAV policy and procedure and 2023, 2024 and 2025 documentation of blind TAV for the post- vasectomy presence or absence of sperm test procedures performed from the RNCC. The RNCC confirmed the laboratory did not establish a TAV policy and procedure, the laboratory did not enroll in a proficiency testing module or conduct any TAV activities in 2023, 2024 and 2025 to date for the post-vasectomy presence or absence of sperm test procedures and was unable to provide the requested documentation on the date of the inspection. The interview occurred on 02/03/2025 at 9:52 AM. 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 record review and an interview with the RN Clinical Coordinator (RNCC), the laboratory failed to ensure that written post-vasectomy presence or absence of sperm, urine microscopic and microscope and centrifuge maintenance/service policies and procedures were established and available to the laboratory personnel for the testing conducted in the specialty of Hematology and the subspecialty of Urinalysis. This deficient practice had the potential to affect 396 out of 396 patient post- -- 3 of 10 -- vasectomy presence or absence of sperm tests performed between 02/03/2023 through 02/03/2025 and two out of two urine microscopic tests performed between 01/23/2025 through 02/03/2025. Findings Include: 1. Review of the laboratory's policies and procedures provided on the date of the complaint investigation did not find any post- vasectomy presence or absence of sperm, urine microscopic and microscope and centrifuge maintenance/service policies and procedures. 2. The Inspector requested the laboratory's post-vasectomy presence or absence of sperm, urine microscopic and microscope and centrifuge maintenance/service policies and procedures from the RNCC. The RNCC confirmed the laboratory did not establish written post-vasectomy presence or absence of sperm, urine microscopic and microscope and centrifuge maintenance/service policies and procedures and was unable to provide the requested documentation on the date of the complaint investigation. The interview occurred on 02/03/2025 at 9:52 AM. 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 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)