Midwest Urological Group

Summary Statement of Deficiencies 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 CASPER Report 0155D and interview with a American Proficiency Institute (API) representative; the laboratory failed to successfully participate in proficiency testing (PT) for the routine chemistry analyte total bilirubin during events 3 of 2020 and event 2 of 2021. See D2096. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in two 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 -- 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 CASPER Report 0155D and interview with a American Proficiency Institute (API) representative; the laboratory failed to successfully participate in proficiency testing (PT) for the routine chemistry analyte total bilirubin during events 3 of 2020 and event 2 of 2021. Findings include: 1. Review of the CASPER Report 0155D on 08/02/2021 at 10:15 AM, identified the initial unsuccessful PT performance for the specialty of chemistry for the analyte as indicated below. CHEMISTRY Bilirubin, total - EVENT-3, 2020 = 40% - Unsatisfactory Bilirubin, total - EVENT-2, 2021 = 40% - Unsatisfactory 2. A phone interview with the API PT representative on 08/02/2020, at 1:10 PM, confirmed the unsatisfactory PT scores for total bilirum for PT event 3 of 2020 and event 2 of 2021. -- 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 direct observation, review of laboratory records, and interview with testing personnel (TP) #1; the laboratory failed to retain quality control print-outs for urinalysis testing on the Clinitek Advantus analyzer in 2019. Findings Include: 1. During tour of the laboratory facility on 01-21-2020, the surveyor observed patients' specimens being tested on the Clinitek Advantus analyzer. 2. Interview with TP#1, at 9:50 AM, confirmed the Clinitek Advantus analyzer, used for dipstick urinalysis testing, was not interfaced with the laboratory information system (LIS). 3. Review of patient test results for dipstick urinalysis testing on the Clinitek Advantus analyzer found instrument print-outs for quality control testing failed to be retained by the laboratory for 1 of 3 patient test dates reviewed. Patient Identification - P10, Test Date: 07-08-2019 4. Review of quality control records for the Clinitek Advantus for 06-21-2019 through 7-10-2019 revealed the laboratory failed to retain quality control print-outs for 8 of 12 days when quality controls were performed. 5. Interview with TP#1 on 01-21-2020, at 4:07 pm, confirmed the laboratory failed to retain instrument print-outs for quality control testing on the Clinitek Advantus analyzer for 8 of 12 dates reviewed. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at 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 -- least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on direct observation, review of laboratory records, and interview with testing personnel (TP) #1; the laboratory failed to perform and document preventative maintenance for urinalysis testing on the Clinitek Advantus analyzer in January of 2020. Findings Include: 1. During tour of the laboratory facility on 01-21-2020, the surveyor observed patients' specimens being tested on the Clinitek Advantus analyzer. 2. Review of the Clinitek Advantus operator's manual, on page 37, revealed the laboratory should clean the push bar, fixed platform, moving table, reagent strip holddown plate, and display screen each day of use. 3. Review of preventative maintenance documentation found no daily preventative maintenance was documented in January for 2020 for the Clinitek Advantus. 4. Review of the quality control log identified 14 days of testing in January of 2020 when daily preventative maintenance was not documented. 5. On survey date 01-21-2020, at 4:07 pm, the surveyor's findings were confirmed by TP#1. D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must establish a maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. The laboratory must perform and document the maintenance activities specified in paragraph (b)(1)(i) of this section. This STANDARD is not met as evidenced by: Based on direct observation, review of laboratory records, and interview with testing personnel (TP) #1; the laboratory failed to perform maintenance activities as outlined by the laboratory to ensure accurate and reliable test performance for chemistry and hematology testing. Findings Include: 1. Direct observation on 01-21-2020, at 9:50 AM, identified a PSS Select microscope (Serial #200017475) used for semen analysis testing and a Horizon mini-E (Serial # 520804-z61) centrifuge used to centrifuge patients specimens for hematology and chemistry testing. 2. Review of the laboratory's policy and procedure manual identified the policy "Annual Equipment Maintenance Verification" which stated the microscope will be cleaned and checked annually by a service tech and the centrifuge will be routinely cleaned and tached annually by the technical consultant. 3. Review of preventative maintenance records revealed the laboratory microscope failed to have annual maintenance documented by a service tech in 2018 and 2019 and the centrifuge failed to have a documented tachometer check in 2019 by the technical consultant. 4. On survey date 01-21-2020, at 4:07 PM, TP#1 confirmed the laboratory failed to perform annual microscope maintenance in 2018 and 2019 and centrifuge maintenance in 2019 as outlined in the laboratory policy. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, -- 2 of 4 -- either the patient's name and identification number, or a unique patient identifier and 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: A. Based on review of laboratory records and interview with testing personnel (TP) #1; the laboratory failed to include their name and address on the patients' test reports for 3 of 3 post vasectomy semen analysis patient test reports reviewed. Findings Include: 1. Review of 3 of 3 patient test reports for post vasectomy semen analysis revealed the laboratory failed to indicate the name and address of the laboratory. Patient Identification Test Date P1 10-10-2018 P2 07-08-2019 P3 11-27-2019 2. On survey date 01-21-2020, at 4:07 pm, TP#1 confirmed the above findings. B. Based on review of laboratory records and interview with testing personnel (TP) #1; the laboratory failed to include their address on the patients' test reports for 3 of 3 urinalysis patient test reports reviewed. Findings Include: 1. Review of 3 of 3 patient test reports for urinalysis testing revealed the laboratory failed to indicate the address of the laboratory on the patients' test reports. Patient Identification Test Date P9 02-13- 2019 P10 07-08-2019 P11 01-06-2020 2. On survey date 01-21-2020, at 4:07 pm, TP#1 confirmed the above findings. D6045 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(7) (b) The technical consultant is responsible for-- (b)(7) Identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed; This STANDARD is not met as evidenced by: Based on direct observation, review of laboratory records and interview with laboratory testing personnel (TP) #1; the laboratory technical consultant (TC) failed to address the training needs for 5 of 5 testing personnel performing urinalysis testing on the Clinitek Advantus. Findings Include: 1. Review of laboratory's designation of testing personnel document identified 5 testing personnel who were authorized to perform urinalysis testing. 2. During tour of the laboratory facility on 01-21-2020, the surveyor observed patients' specimens being tested on a Clinitek Advantus analyzer. 3. Review of patient testing on the Clinitek Advantus found for 1 of 3 patient testing dates reviewed the quality control materials in use were expired, 07-08-2019. Quantmetrix Dropper Control Level 1 Lot #44471 - Expired 6-30-2019 Quantmetrix Dropper Control Level 2 Lot #44472 - Expired 6-30-2019 4. Further review of quality control logs for urinalysis testing identified 5 additional testing dates when quality control reagents were expired, 07-01, 07-02, 07-03, 07-09, and 07-10 of 2019. 3. Review of the daily quality control logs and the Quantimetrix Dropper manufacturer's product insert for urinalysis testing found the laboratory failed to identify the correct expected range for the Quantimetrix Dropper level 2 quality control material in use since July of 2019 on the Clinitek Advantus analyzer for glucose, specific gravity, pH, urobilinogen, and nitrite. The laboratory had identified on the manufacturer's product -- 3 of 4 -- insert the ranges for the Siemens Clinitek 50 and 500 rather than analyzer in use, the Clinitek Advantus. Quantimetrix Dropper Control Level 2 - Lot# 44652 Analyte Manufacturer's Insert Values QC Log Values Glucose Trace - >1000 mg/dL TR - 500 Bilirubin Small to Large Sm - Lg Ketones 15 - 80 mg/dL 15 - 80 Specific Gravity 1.005 - 1.020 1.005 - 1.025 Blood Small to Large Sm - Lg pH 7.5 - 9 7.5 - 8.5 Protein 30-300 mg/dL 30-300 Urobilinogen 1.0 - 8.0 E.U./dL 1.4 - 4.0 Nitrite Positive Tr - pos Leukocytes Negative Tr - Lg 4. The laboratory failed to retain daily quality control print-outs for urinalysis testing reviewed on the Clinitek Advantus for 8 of 12 testing dates reviewed in 2019. See D3031. 5. The laboratory failed to document daily maintenance activities in January of 2020. See D5429. 6. On survey date 01-21-2020, at 4:07 pm, TP#1 confirmed the above findings. D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on review of laboratory records and interview with testing personnel (TP) #1; the technical consultant (TC) failed to ensure annual competency assessments were completed by a qualified TC for 5 of 6 testing personnel in 2018 and 2019. Findings Include: 1. Review of competency assessment records for 5 of 6 testing personnel (TP#2, #3, #4, #5, and # 6) found all competency assessments in 2018 and 2019 were performed by TP#1, who failed to meet the qualifications as a technical consultant. 2. On survey date 01-21-2020, at 4:07 pm, TP#1 confirmed the TC failed to perform competency assessments for TP#2, #3, #4, #5, and # 6 in 2018 and 2019. -- 4 of 4 --

Summary Statement of Deficiencies D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on review of laboratory records and interview with testing personnel (TP) #1; the laboratory failed to monitor storage temperatures for urinalysis quality control reagents used for urinalysis testing. 1. Review of the laboratory's preventative maintenance logs found no log documenting the temperature of the refrigerator used to store urinalysis quality control reagents in 2016 through date of survey 06-26-2018. 2. Interview with TP#1 at 2:50 pm on 06-26-2018 confirmed that that temperature of the refrigerator where urinalysis quality control reagents are stored was not currently being monitored. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a 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 -- minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on review laboratory records and interview with laboratory testing personnel (TP) #1; the laboratory failed to conduct calibration verifications as required for all analytes performed on the Roche cobas e411 in 2018. Findings include: 1. Review of calibration verification records found that the most recent calibration verifications were performed in August of 2017 for all analytes on the Roche cobas e411 analyzer. 2. Interview on 06-26-2018, at 3:30 pm, with laboratory TP#1 confirmed that six month calibration verifications had not been completed since August of 2017 resulting in a gap of calibration verifications in 2018. D6022 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 and quality assessment programs are established and maintained to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on review of laboratory records and interview with testing personnel (TP) #1; the laboratory director failed to ensure quality assessment plan was maintained in 2016 through date of survey, 06-26-2018. Findings Include: 1. Review of the laboratory procedure manual identified the policy, "Quality Assurance Program", which stated the following: "A summary of data collected will be reviewed by the Laboratory Director." and "Results of Quality Assurance studies are maintained in the laboratory for a period of not less than two years. Data is stored in such a manner that it is accessible for review and inspection upon request." 2. Review of quality assurance documentations found no summary reviews in 2016 through the date of survey, 06-26-2018. 3. On survey date 06-26-2018, at 3:30 pm, TP#1 confirmed no documented quality assurance documents had been completed and reviewed by the laboratory director. D6045 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(7) -- 2 of 4 -- (b) The technical consultant is responsible for-- (b)(7) Identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed; This STANDARD is not met as evidenced by: Based on review of laboratory records and interview with laboratory testing personnel (TP) #1; the laboratory technical consultant failed to address the training needs for 3 of 8 testing personnel. Findings Include: 1. Review of laboratory personnel records found TP#2 and #3, as identified on the CMS-209, were authorized to perform post vasectomy semen presence/absence and urine culture testing. 2. Review of training documentation found neither TP#2 nor TP#3 had documented training for post vasectomy semen presence/absence and urine culture testing. 3. Review of laboratory personnel records found TP#5, as identified on the CMS-209, was authorized to perform urinalysis testing. 4. Review of training documentation found TP#5 failed to have documented training for urinalysis testing on the Clinitek Advantus. 5. During survey date 06-26-2018, at 3:30 pm, TP#1 confirmed 3 of 8 testing personnel failed to have documented training for testing in which the personnel were authorized to perform. D6063 LABORATORY TESTING PERSONNEL CFR(s): 493.1421 The laboratory must have a sufficient number of individuals who meet the qualification requirements of 493.1423, to perform the functions specified in 493. 1425 for the volume and complexity of tests performed. This CONDITION is not met as evidenced by: Based on review of laboratory records and interview with testing personnel (TP) #1; the laboratory failed to employ testing personnel (TP) who met the qualification requirements of 493.1423. Findings Include: 1. 3 of 8 TP, listed on the CMS-209, failed to meet the qualification requirements for moderate complexity testing. See D6065. D6065 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(b)(1)(2)(3)(4)(i) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy 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; or (b)(2) Have earned an associate degree in a chemical, physical or biological science or medical laboratory technology from an accredited institution; or (b)(3) Be a high school graduate or equivalent and have successfully completed an official military medical laboratory procedures course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); or (b)(4)(i) Have earned a high school diploma or equivalent; and This STANDARD is not met as evidenced by: -- 3 of 4 -- Based on review of laboratory records and interview with testing personnel (TP) #1; 3 of 8 TP failed to meet the qualification requirements of 493.1423. Findings Include: 1. Review of laboratory personnel records found 3 of 8 TP, listed on the CMS-209, failed to qualify as moderate complexity TP. a. TP#2 - No degree or high school diploma b. TP#3 - No degree or high school diploma c. TP#5 - Foreign degree and no United States foreign equivalency documentation. 2. On survey date 06-26-2018, at 3: 30 pm, TP#1 confirmed the laboratory failed to have qualifying documentation for TP#2, TP#3, and TP#5. -- 4 of 4 --