Valley Urology Inc

Summary Statement of Deficiencies D0000 A proficiency testing desk review survey as performed on 07/17/2025, the laboratory was found not in compliance with the following CONDITION LEVEL DEFICIENCIES D2016 - 42 C.F.R. 493.803 Condition: Successful [proficiency testing] participation; and D6000 - 42 C.F.R. 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director. D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on review of the Certification and Survey Provider Enhanced Reporting (CASPER) - 0155D and AAB-Medical Laboratory evaluation records (2025-1 and 2025-2), the laboratory failed to successfully participate in a proficiency testing 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 -- program approved by HHS for each specialty, subspecialty and analyte or test in which the laboratory is certified under CLIA, the laboratory failed to successfully participate in the proficiency testing specialty - Bacteriology. See D2028. D2028 BACTERIOLOGY CFR(s): 493.823(e) (e) Failure to achieve an overall testing event score of satisfactory performance for two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D Individual Laboratory Profile and AAB-Medical Laboratory Evaluation (AAB) report, the laboratory failed to achieve satisfactory performance for two of three consecutive events (2025-1 and 2025-2) for the specialty Bacteriology. The finding include: Bacteriology 63% - 2025 first testing event; Bacteriology 66% - 2025 second testing event. A review of the 2025 scores from AAB confirmed the above findings. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on a proficiency testing desk review of the CASPER 0155D report and AAB records for 2025-1 and 2025-2 events, the laboratory director failed to provide overall management and direction of the laboratory services. Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) (e)(4)(i) The proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on a proficiency testing desk review of the CASPER 0155D report and AAB records for 2025-1 and 2025-2 events, the laboratory director failed to ensure successful participation in an HHS proficiency testing program. Refer to D2028 . -- 2 of 2 --

Summary Statement of Deficiencies D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on Surveyor review of laboratory's quality control (QC) records for SHBG test and interview with the laboratory technical consultant on March 15, 2022, at 12:34 pm, the laboratory failed to provide any verification or establishment records of acceptability criteria for the QC lot # 189405. The findings include: See D5469. D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(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-- Establish or verify the criteria for acceptability of all control materials. (i) When control materials providing quantitative results are used, statistical parameters (for example, mean and standard deviation) for each batch and lot number of control materials must be defined and available. (ii) The laboratory may use the stated value of a commercially assayed control material provided the stated value is for the methodology and instrumentation employed by the laboratory and is verified by the laboratory. (iii) Statistical parameters for unassayed control materials must be established over time by the laboratory through concurrent testing of control materials having previously determined statistical parameters. (g) The laboratory must document all control procedures performed. 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 -- This STANDARD is not met as evidenced by: Based on Surveyor review of laboratory's quality control (QC) records for SHBG test and interview with the laboratory technical consultant on March 15, 2022, at 12:34 pm, the laboratory failed to provide any documentation showing that it had established or verified the mean and standard deviation of the QC used. The findings include: 1. The laboratory used Beckman Access automated instrument to test SHBG. The instrument input record showed that the laboratory used the mean value for QC1, 9.7 and QC2, 95, respectively. Though, for the same lot # 189405, the QC manufacturer's record showed the mean value of QC1, 9.56 and QC2, 102, respectively. The technical consultant said that the laboratory had established the QC values by running 20 times and input into the instrument. However, the laboratory could not provide any documentation showing that it had established the QC values by running 20 times. Therefore, the accuracy of the used QC acceptability criteria could not be assured and might had been negatively impacted on patient results. 2. The laboratory technical consultant on March 15, 2022, at 12:34 pm, affirmed that the laboratory did not have the establishment record of QC means used. 3. The laboratory's testing declaration form, signed by the laboratory director on 3/21/2022, stated that the laboratory performs approximately 2,263 SHBG tests, annually. D6020 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) 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)(5) Ensure that the quality control program is established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on Surveyor review of laboratory's quality control (QC) records for SHBG test and interview with the laboratory technical consultant on March 15, 2022, at 12:34 pm, the laboratory director failed to ensure that the quality control programs are established for the SHBG test. The findings include: See D5469. -- 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 proficiency testing (PT) record review and laboratory personnel interview on July 16, 2019, the laboratory failed to maintain documentation to indicate that the laboratory director attested to the routine integration of samples into the laboratory's patient workload using the laboratory's routine methods. The findings included: a. For the subspecialty of bacteriology, the laboratory participates annually in American Association of Bioanalysts (AAB) PT. b. Although the laboratory maintained copies of the PT attestation statements that were provided for the AAB 3rd bacteriology PT event of 2018 and 2nd bacteriology PT event of 2019, the copy of the attestation statement maintained by the laboratory was not signed by the laboratory director. c. The laboratory reported performing approximately 5,663 bacteriological patient tests annually. D5471 CONTROL PROCEDURES CFR(s): 493.1256(e)(1)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e)(i) Check each batch (prepared in-house), lot number (commercially prepared) and shipment of reagents, disks, stains, antisera, (except those specifically referenced in 493.1261 (a)(3)) and identification systems (systems using two or more substrates or two or more reagents, or a combination) when prepared or opened for positive and negative reactivity, as well as graded reactivity, if applicable. (g) The laboratory must document all control procedures performed. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- This STANDARD is not met as evidenced by: Based on review of the laboratory's urine culture quality control (QC) testing log (January 2018) and interview with the technical supervisor on July 16, 2019, the laboratory failed to document all control procedures performed. The findings included: a. The laboratory performs urine cultures for bacterial identification and antimicrobial sensitivity on commercially prepared culture media and biochemical selective reagents utilizing commercially prepared control organisms. b. On the day of survey (7/16/19), the laboratory control logs provided, indicated the biochemicals being tested for the appropriate QC organisms, but did not include the lot numbers and expiration dates for the organisms, the reagents and the culture media. c. The laboratory did not document the lot number and expiration date of the antimicrobial (novobiocin) disk used in urine culture testing on the QC log. d. A review of nine (9) randomly sampled patient test records and urine culture worksheets from 8/29/17 to 7 /2/19 determined that 9 out of 9 urine culture QC tests did not have complete documentation. e. The technical supervisor stated by interview on 7/16/19 at 10.15 a. m. that the laboratory did not document the lot numbers and expiration dates on the QC logs. f. The laboratory reported performing 5,663 patient urine culture and microbial identification tests annually. D5601 HISTOPATHOLOGY CFR(s): 493.1273(a)(f) (a) As specified in 493.1256(e)(3), fluorescent and immunohistochemical stains must be checked for positive and negative reactivity each time of use. For all other differential or special stains, a control slide of known reactivity must be stained with each patient slide or group of patient slides. Reactions of the control slide with each special stain must be documented. (f) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on review of the laboratory's histopathology grossing log and interview with the technical supervisor on 7/16/19, the laboratory failed to document all differential or special stain control slides stained with each patient slide or group of patient slides. The findings included: a. The laboratory performs urology histopathology differential staining for identification of prostatic and urogenital cancer. b. On the day of survey (7 /16/19), the laboratory's histopathology patient logs reviewed from 7/1/17 to 5/9/19 revealed that ten (10) out 10 randomly selected patient samples did not include an evaluation of the staining quality of the differential stains (H & E). c. The technical supervisor and histology technician stated by interview on 7/16/19 at 11.25 a.m. that the laboratory did not document the quality of staining for the histology slides performed. d. The laboratory reported performing 1,974 histology slide reviews annually. D6064 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(a) Each individual performing moderte complexity testing must possess a current license issued by the State in which the laboratory is located, if such licensing is required. -- 2 of 3 -- This STANDARD is not met as evidenced by: a. The laboratory performs prostate-specific antigen (PSA) and testosterone testing on patient plasma specimens on an automated chemistry analyzer (Beckman Access 2). b. On the day of survey (7/16/19) the technical supervisor stated that the testing personnel who performs quality control testing), calibration and maintenance procedures for the automated chemistry analyzer (Beckman Access 2), is an unlicensed medical assistant. c. The laboratory failed to provide documentation of high school diploma or initial training and competency for the laboratory assistant performing moderate complexity testing on the day of survey. d. The technical supervisor confirmed by interview on 7/17/19 at approximately 1.45 p.m. that the laboratory did not maintain the documentation for the testing personnel performing moderate complexity testing on the automated chemistry analyzer. e. The laboratory reports performing approximately 7,775 PSA and testosterone patient tests annually. D6103 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(13) The laboratory director must ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills. This STANDARD is not met as evidenced by: Based on laboratory personnel competency assessment record review and interview with the technical supervisor on July 16, 2019, the laboratory director failed to ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills. The findings included: a. The laboratory performs high complexity testing in bacteriology and histology, and moderate complexity testing in chemistry. The technical supervisor is testing personnel for bacteriology high complexity testing. Two (2) unlicensed personnel perform testing; one (1) for histology high complexity testing and one (1) moderate complexity testing in chemistry. b. The laboratory failed to include records documenting that the direct observation component of the six required CLIA competency assessment procedures had been performed pursuant to 42 C.F.R. 493.1451 (b)(8) when assessing testing personnel competency for 2018. c. The technical supervisor, who performs routine testing of patient specimens, did not have annual competencies assessed by the laboratory director. d. The technical supervisor affirmed by interview on 7/16/19 at 1.10 p.m. that direct observation had not been performed for the two (2) unlicensed personnel and that the laboratory director had not assessed the TS annual competencies. e. The laboratory reports performing approximately 14,498 patient tests annually. -- 3 of 3 --