Urology Group, Pa

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 the Procedure Manual (PM), lack of Quality control verification (QVC) records and interview with the General Supervisor (GS), the laboratory failed to follow the PM for "New Quality Control (QC) Lot Verification Procedures"" from 8/12/21 to 10/23/24. The finding includes: 1. The PM stated: a) "Run sample of new delivery QC lot and document the results" b) " Run the new lot for three times on three separate days prior to instituting the new lot" c) "Document the results for each analytes low medium and high. Compare the results to the value in the insert" 2. There was no documented evidence that the aforementioned procedures were performed. 3. The GS confirmed on 10/23/24 at 12:00 pm the laboratory did not follow the PM. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (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. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other 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 -- materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

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 surveyor review of the Proficiency Testing (PT) records and interview with the Technical Consultant (TC), the laboratory failed to enroll in an approved PT program for Gram Stain and Antibiotic Susceptibility tests from 2/22/19 to the date of survey. The TC confirmed on 8/12/21 at 2:40 pm the laboratory was not enrolled in PT for the above test.. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on surveyor review of the Proficiency Testing (PT) records and interview with the Technical Consultant (TC), the laboratory failed to review and evaluate coded PT results obtained with the American Association of Bioanalysts (AAB) Chemistry tests 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 -- in the calendar year 2020 and 2021. The findings include: 1. The laboratory did not evaluate the asterisk (*) (out of grading range or incorrect response) for Urine Sediment Educational in event Q3 - 2020 and Q1 - 2021. 2. The TC confirmed on 8/12 /21 at 2:30 pm that the laboratory failed to evaluate coded results for PT events above. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on surveyor review of the Procedure Manual and interview with the Laboratory Director (LD), the laboratory failed to establish a detailed procedure for Biannual Assessment (BA) from 2/22/19 to the date of survey. The findings include: 1. The BA procedure did not include the name of the referring pathologist or how discrepancies will be documented. 2. The laboratory included the diagnosis when sending out the slides for review but the diagnosis is part of the BA. 2. The LD confirmed on 8/12/21 at 3:15 pm that the BA procedure was not in detail. 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: Based on surveyor review of the Manufacturers Package Insert (MPI), Microbiology work records and interview with the General Supervisor (GS), the laboratory failed to follow the MPI for BD BBL Sensi-Disc Antimicrobial Susceptibility Test Discs used for Urine Culture Sensitivity tests from 2/22/19 to the date of the survey. The finding includes: 1. The MPI stated to perform a Gram Stain before plating organism but there was no documented evidence Gram Stains on Gram Negative organisms were performed. 2. The TP #3 listed on CMS form 209 confirmed on 3/14/19 at 2:10 pm the laboratory did not follow the MPI. . D5477 CONTROL PROCEDURES CFR(s): 493.1256(e)(4)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (4) Before, or concurrent with the initial use-- (e)(4)(i) Check each batch of media for sterility if sterility is required for testing; (e)(4)(ii) Check each batch of media for its ability to support growth and, as appropriate, select or inhibit specific organisms or produce a biochemical response; and (e)(4)(iii) Document the physical characteristics of the media when compromised and report any deterioration in the media to the manufacturer. (g) The laboratory must document all control procedures performed. -- 2 of 4 -- This STANDARD is not met as evidenced by: Based on the lack of Quality Control (QC) records and interview with the General Supervisor (GS), the laboratory failed to check each new lot number and shipment of Mueller Hinton Agar, MacConkey/Blood Agar plates and Uricults for sterility, ability to support growth and select or inhibit organisms from 2/22/19 to the date of the survey. The GS confirmed on 8/12/21 at 1:50 pm the laboratory did not perform the above QC. D5629 CYTOLOGY CFR(s): 493.1274(c)(5) (c) Control procedures. The laboratory must establish and follow written policies and procedures for a program designed to detect errors in the performance of cytologic examinations and the reporting of results. The program must include the following: (c) (5) An annual statistical laboratory evaluation of the number of - (c)(5)(i) Cytology cases examined; (c)(5)(ii) Specimens processed by specimen type; (c)(5)(iii) Patient cases reported by diagnosis (including the number reported as unsatisfactory for diagnostic interpretation); (c)(5)(iv) Gynecologic cases with a diagnosis of HSIL, adenocarcinoma, or other malignant neoplasm for which histology results were available for comparison; (c)(5)(v) Gynecologic cases where cytology and histology are discrepant; and (c)(5)(vi) Gynecologic cases where any rescreen of a normal or negative specimen results in reclassification as low-grade squamous intraepithelial lesion (LSIL), HSIL, adenocarcinoma, or other malignant neoplasms. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, lack of laboratory records and interview with the Laboratory Director (LD), the laboratory failed to establish written policies and procedures for the evaluation and comparison of three of three required statistics for nongynecologic cytology from 2/22/19 to the date of the survey. Findings include: 1. The laboratory failed to provide written policies and procedures for an annual statistical evaluation of three required statistics for nongynecologic specimens. 2. The laboratory failed to provide an evaluation of three of three required statistics. Statistics include: a. The number of cytology cases examined; b. The number of specimens processed by specimen type; c. The number of patient cases reported by diagnosis to include unsatisfactory. 3. The LD confirmed on 8/12/21 at 2:50 pm the laboratory did not have the above procedure. This was cited on the previous survey performed on 2/22/21. D5643 CYTOLOGY CFR(s): 493.1274(d)(2)(iii) (d) Workload limits. The laboratory must establish and follow written policies and procedures that ensure the following: (d)(2)(iii) Nongynecologic slide preparations made using liquid-based slide preparatory techniques that result in cell dispersion over one-half or less of the total available slide may be counted as one-half slide; and (d)(2) (iv) Technical supervisors who perform primary screening are not required to include tissue pathology slides and previously examined cytology slides (gynecologic and nongynecologic) in the 100 slide workload limit. This STANDARD is not met as evidenced by: -- 3 of 4 -- Based on surveyor review of the Procedure Manual (PM) and interview with the Laboratory Director (LD), the laboratory failed to establish workload limits for personnel reading nongynecology slides from 2/22/19 to the day of the survey. The LD confirmed on 8/12/21 at 3:00 pm that workload limits were not established. D5645 CYTOLOGY CFR(s): 493.1274(d)(3) (d) Workload limits. The laboratory must establish and follow written policies and procedures that ensure the following: (d)(3) The laboratory must maintain records of the total number of slides examined by each individual during each 24-hour period and the number of hours spent examining slides in the 24-hour period irrespective of the site or laboratory. This STANDARD is not met as evidenced by: Based on surveyor review of the Procedure Manual and interview with the Laboratory Director (LD), the laboratory failed to establish a procedure for maintaining records of the total number of slides reviewed in 24 hours from 2/22/19 to the date of the survey. The LD confirmed on 8/12/21 at 3:05 pm that the above mentioned procedure was not established. This was cited on the previous survey performed on 2/22/21. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on surveyor review of the Individual Quality Control Plan (IQCP), Quality Control (QC) records and interview with the General Supervisor (GS), the laboratory failed to follow written procedures for QC performed on the Remel Rapid One System from 2/22/19 to the date of survey. The findings include: 1. The IQCP stated QC was to be performed with each new lot number and monthly there after but the laboratory performed QC once on each new lot number. 2. The GS confirmed on 8/12 /21 at 2:45 pm that the laboratory did not follow written procedures. D6088 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4) The laboratory director must ensure that the laboratory is enrolled in an HHS- approved proficiency testing program for the testing performed. This STANDARD is not met as evidenced by: Based on surveyor review of the Proficiency Testing (PT) records and interview with the Technical Consultant (TC), the Laboratory Director (LD) failed to ensure that PT samples were tested for Gram Stain and Antibiotic Sensitivity tests from 2/22/19 to the date of the survey. The TC confirmed on 8/12/21 at 2:35 pm that the LD did not ensure PT samples were tested for all tests performed in the laboratory. -- 4 of 4 --

Summary Statement of Deficiencies D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on surveyor review of the Proficiency Testing (PT) records and interview with the Clinical Consultant (CC), the laboratory failed to maintain attestation statements for PT provided by the American Associations of Bioanalysts (AAB) for Q2 NonChemistry and Q3 Chemistry 2018. The CC confirmed on 2/20/19 at 10:30 am that the above attestation statements were not maintained. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES 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: 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 -- Based on surveyor review of the Competency Assessment (CA) records and interview with the Clinical Consultant (CC), the laboratory failed to perform CA correctly on one of three Testing Personnel and the General Supervisor (GS) from 3/8/17 to the date of survey. The finding includes: 1. The CA did not include how assessment was done and what records were reviewed. 2. The CC confirmed on 2/20/19 at 10:00 am that CA was not done correctly. D5629 CYTOLOGY CFR(s): 493.1274(c)(5) (c) Control procedures. The laboratory must establish and follow written policies and procedures for a program designed to detect errors in the performance of cytologic examinations and the reporting of results. The program must include the following: (c) (5) An annual statistical laboratory evaluation of the number of - (c)(5)(i) Cytology cases examined; (c)(5)(ii) Specimens processed by specimen type; (c)(5)(iii) Patient cases reported by diagnosis (including the number reported as unsatisfactory for diagnostic interpretation); (c)(5)(iv) Gynecologic cases with a diagnosis of HSIL, adenocarcinoma, or other malignant neoplasm for which histology results were available for comparison; (c)(5)(v) Gynecologic cases where cytology and histology are discrepant; and (c)(5)(vi) Gynecologic cases where any rescreen of a normal or negative specimen results in reclassification as low-grade squamous intraepithelial lesion (LSIL), HSIL, adenocarcinoma, or other malignant neoplasms. This STANDARD is not met as evidenced by: Based on surveyor review of the Procedure Manual and interview with the Laboratory Director (LD), the laboratory failed to establish a written procedure which included number of cytology cases examined, specimens processed by type and patient cases reported by diagnosis (including the number reported as unsatisfactory for diagnostic interpretation) from 3/8/17 to the date of the survey. The LD confirmed on 2/20/19 at 10:30 am the laboratory did not have the above procedure. D5633 CYTOLOGY CFR(s): 493.1274(d)(1) (d) Workload limits. The laboratory must establish and follow written policies and procedures that ensure the following: (d)(1) The technical supervisor establishes a maximum workload limit for each individual who performs primary screening. This STANDARD is not met as evidenced by: Based on the surveyor review of the Procedure Manual (PM), review of laboratory records, and interview with the Laboratory Director (LD), the laboratory failed to establish written policies and procedures to ensure that the LD/Technical Supervisor (TS) established a maximum workload limit for two of two Testing Personnel who performed the primary screening of cytology specimens from 3/8/17 to the date of the survey. The LD confirmed on 2/20/19 at 10:45 am that there were no written procedures to establish individual workload limits and no workload limits established by the TS/LD. D5637 CYTOLOGY CFR(s): 493.1274(d)(1)(ii) -- 2 of 4 -- (d) Workload limits. The laboratory must establish and follow written policies and procedures that ensure the following: (d)(1)(ii) Each individual's workload limit is reassessed at least every 6 months and adjusted when necessary. This STANDARD is not met as evidenced by: Based on the surveyor review of the Procedure Manual (PM), review of laboratory records, and interview with the Laboratory Director (LD), the laboratory failed to establish a written procedure to ensure that the workload limit is reassessed at least every 6 months and adjusted when necessary from 3/8/17 to the date of the survey. The LD confirmed on 2/20/19 at 10:40 am the above procedure was not established. D5639 CYTOLOGY CFR(s): 493.1274(d)(2)(i) (d) Workload limits. The laboratory must establish and follow written policies and procedures that ensure the Following: (d)(2) The maximum number of slides examined by an individual in each 24-hour period does not exceed 100 slides (one patient specimen per slide; gynecologic, nongynecologic, or both) irrespective of the site or laboratory. This limit represents an absolute maximum number of slides and must not be employed as an individual's performance target. In addition-- (d)(2)(i) The maximum number of 100 slides is examined in no less than an 8-hour workday; This STANDARD is not met as evidenced by: Based on surveyor review of the Procedure Manual and interview with the Laboratory Director (LD), the laboratory failed to establish a written procedure which ensures the maximum number of slides read in an 8 hour period does not exceed 100 regardless of the location from 2/2/19 to the date of the survey. The LD confirmed on 2/20/19 at 10: 15 am the laboratory did not establish the above procedure. D5645 CYTOLOGY CFR(s): 493.1274(d)(3) (d) Workload limits. The laboratory must establish and follow written policies and procedures that ensure the following: (d)(3) The laboratory must maintain records of the total number of slides examined by each individual during each 24-hour period and the number of hours spent examining slides in the 24-hour period irrespective of the site or laboratory. This STANDARD is not met as evidenced by: Based on surveyor review of the Procedure Manual and interview with the Laboratory Director (LD), the laboratory failed to establish a procedure for maintaining records of the total number of slides reviewed in 24 hours from 3/8/17 to the date of the survey. The LD confirmed on 2/20/19 at 10:50 am that the above mentioned procedure was not established. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and -- 3 of 4 -- identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on surveyor review of the Final Reports (FR) and interview with the Clinical Consultant (CC), the laboratory failed to ensure that the Test Report Date (TRD) was indicated on the FR for Urine Culture and Sensitivity tests from 3/8/17 to the date of survey. The CC confirmed on 2/20/19 at 2:15 pm that the TRD was not on the FR. D5807 TEST REPORT CFR(s): 493.1291(d) Pertinent "reference intervals" or "normal" values, as determined by the laboratory performing the tests, must be available to the authorized person who ordered the tests and, if applicable, the individual responsible for using the test results. This STANDARD is not met as evidenced by: Based on the surveyor review of the Final Reports (FR) and interview with the Clinical Consultant (CC), the laboratory failed to have a Reference Range (RR) for Urine Culture and Sensitivity tests on the FR from 3/8/17 to the date of the survey. The CC confirmed on 2/20/19 at 2:20 pm that the above tests did not have a RR on the FR. D5891 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess and, when indicated, correct problems identified in the postanalytic systems specified in 493.1291. This STANDARD is not met as evidenced by: Based on surveyor review of the Procedure Manual and interview with the Clinical Consultant (CC), the laboratory failed to have a procedure to verify manually entered Urine Culture and Sensitivity test results into the Patient's Medical Record for accuracy from 3/8/17 to the date of the survey. The LD confirmed on 2/20/19 at 2:15 pm that the laboratory did not have the procedure mentioned above. -- 4 of 4 --