Rio Grande Urology Pa

Summary Statement of Deficiencies 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 review of laboratory procedures, Alternative proficiency testing records, and staff interview, the laboratory failed to have documentation of performing accuracy assessment twice annually in 2019 and 2020 for the gross analysis of histology specimens. The findings included: 1. Review of the laboratory's procedure titled Alternative Proficiency Testing (Procedure Number QA-2) found " Twice a year a slide set must be prepared by the lab& staff using protocols consistent with all SOPs. The first set will be from tissue received and processed in the lab between January 1 and June 30. The second set will be prepared from tissue received and processed in the laboratory between July 1 and December 31. Each set must be submitted within 60 days of the sampling window closing. Samples cannot be sent for evaluations that have been prepared by another laboratory. Each slide set will include: 1 H&E stained slide from patient material processed within the previous 6 month period. 1 slide stained with a special stain from the special stain menu from the previous 6 month period- special stains chosen for submission will not be repeated until all stains have been part of a previous alternative proficiency submission. 1 slide with stained with and immunhistochemical (IHC) stain from the Lab stain menu from the previous 6 month -period- IHCstains chosen for submission will not be repeated until all stains have been part of a previous alternative proficiency submission." 2. Review of the 2020 Alternative Proficiency testing Score sheets found two of two histotechnicians performing gross analysis of tissue specimens prepared the slides for the alternative proficiency testing. 3. A request for semi annual accuracy assessment of gross analysis of tissue specimens was requested but not provided. 4. Interview of general supervisor 2 listed on the CMS report 209 conducted on February 25, 2021 at 10:54 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 -- AM confirmed that the alternative proficiency testing assessed the accuracy of the slide preparation and staining only. She also confirmed that the laboratory had no other means to assess the accuracy of gross analysis of tissue specimens at least twice each year. D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Review of package inserts, prepared specimen slides and interview of facility personnel found the laboratory failed to follow the manufacturer's instructions for including positive tissue controls on the same slide as the patient tissue, when using the Universal DAB Detection kit in preparation of tissues stained on the Ventana Immunostainer. The findings included: 1. Review of the manufacturer's instructions for the ultraView Universal DAB Detection kit (used to identify targets by immunohistochemistry (IHC) in sections of formalin-fixed, paraffin- embedded and frozen tissue) found on page 2 under Positive Tissue Control "Optimal laboratory practice is to include a positive control section on the same slide as the patient tissue. When this practice is employed, identification of a failure to apply primary antibody or other critical reagent to the patient test slide is easily detected. Additionally, positive controls should be selected on the basis of expression of the antigen. Low levels of antigen expression are suggested to prevent false negative results due to insufficient sensitivity. A tissue with weak positive staining is more suitable for optimal quality control and for detecting minor levels of reagent degradation. A positive tissue control must be run with every staining procedure performed. Optimal laboratory practice is to include a positive control section on the same slide as the patient tissue. This practice helps to identify a failure to apply primary antibody or other critical reagent to the patient test slide. a tissue with weak positive staining is more suitable for optimal quality control. The positive tissue components are used to confirm that the antibody was applied and the instrument functioned properly. The tissue may contain both positive and negative staining cells or tissue components and serve as both the positive and negative control tissue. Control tissues should be fresh autopsy, biopsy, or surgical specimens prepared or fixed as soon as possible in a manner identical to the test sections. Such tissues may monitor all steps of the procedure from tissue preparation through staining. Use of a tissue specimen will provide control for all reagents and method steps except fixation and tissue processing. 2. Review of prepared specimen slides from five cases in 2019, 2020 and 2021 found the laboratory did not include a positive tissue control on the patient test slides. 3. Interview of general supervisor 2 on the CMS report 209 conducted on February 25, 2021 at 11:49 AM confirmed the laboratory did not include a positive tissue control on patient test slides. She went on to say the laboratory prepared "a single control slide with each run instead because the pathologist doesn't want it". -- 2 of 2 --

Summary Statement of Deficiencies D0000 The laboratory was surveyed and failed to meet the following conditions of the CLIA regulations found at CFR 42 493.1 through 493.1780: 493.1441 Condition: Laboratories Performing High Complexity Testing; laboratory director 493.1487 Condition: Laboratories Performing High Complexity Testing; testing personnel D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on review of the laboratory's personnel records, and staff interview, the laboratory director failed to ensure that all testing personnel held the appropriate education prior to performing gross analysis of patient tissue specimens (See to D 6102) D6102 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(12) The laboratory director must ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: Review of personnel records and interview of facility personnel found that the Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- laboratory director failed to ensure that one of one testing personnel had the appropriate education prior to performing gross analysis of patient specimens for Histopathology. (See D 6171) D6127 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) The technical supervisor is responsible for evaluating and documenting the performance of individuals responsible for high complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on a review of the laboratory's personnel records and interview of facility personnel, the technical supervisor failed to perform and document semiannual competency evaluations for one of one testing personnel performing high complexity testing during the first year of patient testing. Findings included: 1. A review of the facility's personnel files found no documentation of semiannual competency assessments for one of one testing personnel performing gross analysis of patient specimens in Histopathology. Testing person one was hired September 5, 2018. One competency assessment dated August 23, 2018 was labeled as a 6 month competency assessment. No other competency assessments were available for review. 2. Interview of the laboratory director listed on the CMS report 209 conducted on September 25, 2018 at 9:57 AM confirmed that no competency assessments for testing person one were available for review. She went on to say that her first visit to the facility was in January 2018. D6168 TESTING PERSONNEL CFR(s): 493.1487 The laboratory has a sufficient number of individuals who meet the qualification requirements of 493.1489 of this subpart to perform the functions specified in 493. 1495 of this subpart for the volume and complexity of testing performed. This CONDITION is not met as evidenced by: Based on a review of the CMS 209 Laboratory Personnel Report, personnel records and staff interview, it was revealed that one of one testing personnel performing high complexity testing (grossing) did not have the appropriate education credentials required to perform high complexity testing. (refer to D6171). D6171 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1489(b) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located or have earned a doctoral, master's or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution; (b)(2)(i) Have earned an associate degree in a laboratory science, or medical laboratory technology from an accredited institution or-- (b)(2)(ii) Have education and training equivalent to that specified in paragraph (b)(2)(i) of this section that includes-- (b)(2)(ii)(A) At least 60 semester hours, or equivalent, from an accredited institution that, at a minimum, -- 2 of 4 -- include either-- (b)(2)(ii)(A)(1) 24 semester hours of medical laboratory technology courses; or (b)(2)(ii)(A)(2) 24 semester hours of science courses that include-- (b)(2) (ii)(A)(2)(i) Six semester hours of chemistry; (b)(2)(ii)(A)(2)(ii) Six semester hours of biology; and (b)(2)(ii)(A)(2)(iii) Twelve semester hours of chemistry, biology, or medical laboratory technology in any combination; and (b)(2)(ii)(B) Have laboratory training that includes either of the following: (b)(2)(ii)(B)(1) Completion of a clinical laboratory training program approved or accredited by the ABHES, the CAHEA, or other organization approved by HHS. (This training may be included in the 60 semester hours listed in paragraph (b)(2)(ii)(A) of this section.) (b)(2)(ii)(B)(2) At least 3 months documented laboratory training in each specialty in which the individual performs high complexity testing. (b)(3) Have previously qualified or could have qualified as a technologist under 493.1491 on or before February 28, 1992; (b) (4) On or before April 24, 1995 be a high school graduate or equivalent and have either-- (b)(4)(i) Graduated from a medical laboratory or clinical laboratory training program approved or accredited by ABHES, CAHEA, or other organization approved by HHS; or (b)(4)(ii) Successfully completed an official U.S. military medical laboratory procedures training course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); (b)(5)(i) Until September 1, 1997-- (b)(5)(i)(A) Have earned a high school diploma or equivalent; and (b)(5)(i)(B) Have documentation of training appropriate for the testing performed before analyzing patient specimens. Such training must ensure that the individual has-- (b)(5)(i)(B)(1) The skills required for proper specimen collection, including patient preparation, if applicable, labeling, handling, preservation or fixation, processing or preparation, transportation and storage of specimens; (b)(5)(i)(B)(2) The skills required for implementing all standard laboratory procedures; (b)(5)(i)(B)(3) The skills required for performing each test method and for proper instrument use; (b)(5)(i)(B)(4) The skills required for performing preventive maintenance, troubleshooting, and calibration procedures related to each test performed; (b)(5)(i)(B)(5) A working knowledge of reagent stability and storage; (b)(5)(i)(B)(6) The skills required to implement the quality control policies and procedures of the laboratory; (b)(5)(i)(B)(7) An awareness of the factors that influence test results; and (b)(5)(i)(B)(8) The skills required to assess and verify the validity of patient test results through the evaluation of quality control values before reporting patient test results; and (b)(5)(i)(B)(8)(ii) As of September 1, 1997, be qualified under 493.1489(b)(1), (b)(2), or (b)(4), except for those individuals qualified under paragraph (b)(5)(i) of this section who were performing high complexity testing on or before April 24, 1995; (b)(6) For blood gas analysis-- (b)(6) (i) Be qualified under 493.1489(b)(1), (b)(2), (b)(3), (b)(4), or (b)(5); (b)(6)(ii) Have earned a bachelor's degree in respiratory therapy or cardiovascular technology from an accredited institution; or (b)(6)(iii) Have earned an associate degree related to pulmonary function from an accredited institution; or (b)(7) For histopathology, meet the qualifications of 493.1449 (b) or (l) to perform tissue examinations. This STANDARD is not met as evidenced by: Review of the CMS report 209 laboratory personnel report, personnel records, patient test logs and interview of facility personnel found that one of one testing personnel performing gross analysis of patient tissue specimens failed to meet the minimum education requirements for performing high complexity testing (gross analysis of patient tissue specimens). The findings included: 1. Review the CMS report 209 laboratory personnel report found one of one testing personnel listed for high complexity testing. 2. Review of personnel files found that testing person one (hire date September 5, 2017) who performed the gross examinations of histopathology -- 3 of 4 -- specimens had no documentation of education available for review. Testing person one and the laboratory director offered two letters of attestation dated September 14, 2018, one letter of attestation dated August 9, 2017 and a HT PRACTICAL EXAMINE PERFORMANCE REPORT for qualification purposes. 3. Review of patient test logs found 788 patient specimens tested since the labortory started testing in September 2017. 4. Interview of testing person one on the CMS report 209 Laboratory Personnel Report conducted on September 25, 2018 at 09:42 AM confirmed that she was hired September 5, 2017. She went on to confirm that she performed gross analysis of tissue specimens and had no education records available for review other than the letters of attestation from former employers and coworkers. -- 4 of 4 --