Uropartners Llc - Riverboat

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 review of laboratory records and interview with testing personnel (TP) #2; the laboratory failed to enroll in proficiency testing challenges in 2017 through 2019 in the sub-specialty of bacteriology for gram staining. Findings Include: 1. Review of the laboratory's policy and procedure manual identified the procedure, "Gram Stain", which outlined the test procedure for the determination of gram negative and/or gram positive organisms. 2. Review of American Proficiency Institute proficiency testing records revealed the laboratory failed to enroll in PT for gram staining. 3. Interview with TP#2, on 9-05-2019, at 3:10 pm, confirmed the laboratory will occasionally performs gram stains as part of the work-up for urine culture testing. 4. Review of test volume records revealed from July of 2018 through July of 2019 that 2,818 urine cultures were performed. 5. During the survey on 9-05-2019 at 4:50 pm, the surveyor's findings were confirmed by TP#2. D5028 HISTOPATHOLOGY CFR(s): 493.1219 If the laboratory provides services in the subspecialty of Histopathology, 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 9 -- laboratory must meet the requirements specified in 493.1230 through 493.1256, 493. 1273, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on review of laboratory records and interview with the laboratory director (LD); the laboratory failed to meet the requirements specified in 493.1230 through 493.1256, 493.1273, and 493.1281 through 493.1299. Findings include: 1. The laboratory failed to perform bi-annual method accuracy evaluations for histopathology testing. See D5217, part A. D5032 CYTOLOGY CFR(s): 493.1221 If the laboratory provides services in the subspecialty of Cytology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1274, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on review of laboratory records and interview with the laboratory director (LD); the laboratory failed to meet the requirements specified in 493.1230 through 493.1256, 493.1274, and 493.1281 through 493.1299. Findings include: 1. The laboratory failed to perform bi-annual method accuracy evaluations for urine cytology testing. See D5217, part B. 2. The laboratory failed to have a procedure in place for identifying nongynecologic specimens that have a high potential for cross- contamination and the staining of those samples separately. See D5619. 3. The laboratory failed to establish and follow procedures to evaluate annual statistics for the number of cytology cases examined by specimen type and by diagnosis, including the number of cases reported as unsatisfactory for diagnostic interpretation. See D5629. 4. The laboratory failed to establish and follow procedures to evaluate 4 of 4 testing personnel who performed cytologic examinations against the laboratory's overall statistics. See D5631. 5. The laboratory failed to maintain cytology workload records for the total number of slides examined by each individual during each 24 hour period and the total number of hours spent examining those slides in a 24 hour period irrespective of the site or laboratory for 19 of 23 dates reviewed and failed to document workloads all together from 11-17-2018 to 11-30-2018. See D5645. D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on review of laboratory records and interview with testing personnel (TP) #2; the laboratory failed to verify the accuracy of urine culture identification and microscopic urinalysis analyte performance, which does not reflect the performance of the laboratory for proficiency testing (PT) event 1 of 2019. Findings Include: 1. -- 2 of 9 -- Proficiency testing records for 2017 through 2019 were reviewed. 2. Review of American Proficiency Institute (API) Hematology/Coagulation PT documentation for event 1 of 2019 revealed the laboratory's performance was not graded for 1 of 2 urine sediment sample, sample US-02. 3. Review of the performance summary documentation for Hematology/Coagulation PT event 1 of 2019 revealed the laboratory failed to evaluate the accuracy of urine sediment PT performance. 4. Review of American Proficiency Institute (API) Microbiology PT documentation for event 1 of 2019 revealed the laboratory's performance was not graded for 1 of 5 urine culture identification samples, sample UR-03. 5. Review of the performance summary documentation for Microbiology PT event 1 of 2019 revealed the laboratory failed to evaluate the accuracy of urine culture identification PT performance. 6. On survey date 09-05-2019, at 4:50 pm, TP#2 confirmed the laboratory fail to verify the accuracy of urine sediment and bacteriology PT scores for event 1 of 2019. 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: A. Based on review of laboratory records and interview with the laboratory director (LD); the laboratory failed to perform bi-annual method accuracy evaluations for histopathology testing in 2017 through 2019. Findings Include: 1. Proficiency testing records for 2017 through 2019 were reviewed. 2. Review of the laboratory's proficiency testing records revealed the laboratory failed to evaluate the accuracy of histopathology testing performed by the laboratory in 2017 through the date of survey (9-5-2019) in 2019. 3. Review of the test volume worksheet for July of 2018 through July of 2019 indicated 6,499 specimen blocks were tested for histopathology. 4. Interview with the LD on 9-05-2018, at 11:57 am confirmed the laboratory failed to perform the bi-annual method accuracy evaluations for histopathology slide evaluations in 2017 through 2019. B. Based on review of laboratory records and interview with the laboratory director (LD); the laboratory failed to perform bi-annual method accuracy evaluations for urine cytology testing in 2017 through 2019. Findings Include: 1. Proficiency testing records for 2017 through 2019 were reviewed. 2. Review of the laboratory's proficiency testing records revealed the laboratory failed to evaluate the accuracy of urine cytology testing performed by the laboratory in 2017 through the date of survey (9-5-2019) in 2019. 3. Review of the test volume worksheet for July of 2018 through July of 2019 indicated 372 urine cytology cases were performed. 4. Interview with the LD on 9-05-2018, at 11:57 am confirmed the laboratory failed to perform the bi-annual method accuracy evaluations for urine cytology evaluations in 2017 through 2019. 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 -- 3 of 9 -- manufacturer. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of laboratory records, direct observations, and interview with testing personnel (TP) #2; the laboratory failed to check each batch of Tryptic Soy Agar (TSA) with 5% Sheep Blood (SB) and Eosin Methylene Blue (EMB) plates for sterility, growth, inhibition, and biochemical response with initial use. Findings include: 1. Direct observation of laboratory testing supplies on 09-05-2019, at 9:43 am, identified Tryptic Soy Agar (TSA) with 5% Sheep Blood (SB) and Eosin Methylene Blue (EMB) plates used for urine culture testing. 2. Review of the test volume worksheet indicated from July 2018 to July 2019 that 2,818 urine cultures were performed with TSA 5% SB and EMB media when no quality controls to check for sterility, growth, inhibition, and biochemical response were performed with the initial use. 3. On survey date 09-05-2019, at 4:50 pm, TP#2 confirmed the laboratory failed to perform and document quality control testing for TSA with 5% SB and EMB plates. D5507 BACTERIOLOGY CFR(s): 493.1261(b)(c) (b) For antimicrobial susceptibility tests, the laboratory must check each batch of media and each lot number and shipment of antimicrobial agent(s) before, or concurrent with, initial use, using approved control organisms. (b)(1) Each day tests are performed, the laboratory must use the appropriate control organism(s) to check the procedure. (b)(2) The laboratory's zone sizes or minimum inhibitory concentration for control organisms must be within established limits before reporting patient results. (c) 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 laboratory records and interview with testing personnel (TP) #2; the laboratory failed to perform quality controls each day tests are performed for antimicrobial susceptibility testing in 2017 through 2019. Findings include: 1. Review of the laboratory policy and procedure manual identified the procedure, "Kirby Bauer Sensitivity Testing", which indicated that quality control testing for Kirby Bauer (KB) sensitivities are performed weekly. 2. Interview with TP#2 on survey date 09-05- 2019, at 9:50 am, confirmed that susceptibility controls are performed weekly, however the laboratory had not implemented an individual quality control plan (IQCP) for the reduced quality control frequency. 3. Review of test volumes records found from July 2018 through July 2019 that 1,286 Kirby Bauer Sensitivities were performed when daily quality control testing was not performed and documented. 4. On survey date 09-05-2019, at 4:50 pm the surveyor's findings were confirmed by TP#2. D5619 CYTOLOGY CFR(s): 493.1274(b)(3) (b) Staining. The laboratory must have available and follow written policies and procedures for each of the following, if applicable: (b)(3) Nongynecologic specimens that have a high potential for cross-contamination must be stained separately from other nongynecologic specimens, and the stains must be filtered or changed following -- 4 of 9 -- staining. This STANDARD is not met as evidenced by: Based on review of laboratory records and interviews with testing personnel (TP) #2 and the laboratory director (LD); the laboratory failed to have a procedure in place for identifying nongynecologic specimens that have a high potential for cross- contamination and the staining of those samples separately. Findings include: 1. Review of the laboratory's policy and procedure manual revealed the laboratory failed to have a procedure to identify nongynecologic specimens with a high potential for cross-contamination and how they will be processed by the laboratory. 2. Interview with the LD on survey date 09-05-2019, at 12:47 pm, confirmed no written procedure was in place to identify and stain separately nongynecologic specimens with a high potential for cross-contamination. 3. Review of test volume records from July of 2018 through July of 2019 found the laboratory performed 372 nongynecological cytology slide examinations. 4. On survey date 09-05-2019, at 4:50 pm the surveyor's findings were confirmed by TP#2. 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 records and interviews with testing personnel (TP) #2 and the laboratory director (LD); the laboratory failed to establish and follow procedures to evaluate annual statistics for the number of cytology cases examined by specimen type and by diagnosis, including the number of cases reported as unsatisfactory for diagnostic interpretation. Findings include: 1. Review of the laboratory's policy and procedure manual revealed the laboratory failed to have a policy in place to evaluate the annual cytology statistics by the number of cytology cases examined by specimen type and by diagnosis, including the number of cases reported as unsatisfactory for diagnostic interpretation. 2. Interview with the LD on survey date 09-05-2019, at 12:47 pm, confirmed no written procedure was established and followed to evaluate the annual cytology statistics by the number of cytology cases examined by specimen type and by diagnosis, including the number of cases reported as unsatisfactory for diagnostic interpretation. 3. Review of test volume records from July of 2018 through July of 2019 found the laboratory performed 372 nongynecological cytology slide examinations. 4. On survey date 09-05-2019, at 4:50 pm the surveyor's findings were confirmed by TP#2. -- 5 of 9 -- D5631 CYTOLOGY CFR(s): 493.1274(c)(6) (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) (6) An evaluation of the case reviews of each individual examining slides against the laboratory's overall statistical values, documentation of any discrepancies, including reasons for the deviation, and, if appropriate,