Shoreview Pediatrics Sc

Summary Statement of Deficiencies 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 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 D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on surveyor review of laboratory records and interview with the nurse manager, staff A, the laboratory director did not review and approve the performance specification verification records on the replacement Revogene Group A Strep analyzer prior to reporting patient results. Findings include: 1. Review of the "Revogene Instrument Validation" form showed the laboratory installed a replacement Revogene analyzer on June 26, 2021 and started reporting patients on July 2, 2021. Further review showed the laboratory director reviewed and accepted the validation on August 26, 2021. 2. Review of the daily "Revogene Specimen Log" reports showed ninety patients were run between July 2, 2021 and August 26, 2021. 3. Interview with staff A on April 26, 2022 at 11:15 AM confirmed the laboratory director did not review and approve the performance specification verification records on the replacement Revogene Group A Strep analyzer prior to reporting patient results. This is a repeat deficiency from March 31, 2008. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations 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 -- Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on surveyor review of the Individualized Quality Control Plan (IQCP), quality control (QC) records and interview with the nurse manager, staff A, the laboratory did not perform two levels of quality control on each day of patient testing and had not developed Quality Control Plan (QCP) for the Revogene Group A Strep analyzer. Findings include: 1. Review of IQCP records for the Revogene Group A Strep analyzer showed a risk assessment performed on the analyzer. Further review showed no evidence of a QCP. 2. Review of QC records for the Revogene Group A Strep analyzer showed QC was performed monthly and with each new lot. 3. Interview with staff A on April 26, 2022 at 11:12 AM confirmed the laboratory did not perform two levels of quality control on each day of patient testing and had not developed an IQCP for the Revogene Group A Strep analyzer. 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 Individualized Quality Control Plan (IQCP) and interview with the nurse manager, staff A, the laboratory did not have a written procedure to monitor, assess, and when indicated, correct problems identified for the ongoing monitoring of the effectiveness of their IQCP for the Revogene Group A Strep analyzer. Findings include: 1. Review of IQCP records for the Revogene Group A Strep analyzer showed a risk assessment performed on the analyzer. Further review showed no evidence of a Quality Assessment (QA) plan. 2. Interview with staff A on April 26, 2022 at 11:12 AM confirmed the laboratory did not have a written procedure to monitor, assess, and when indicated, correct problems identified for the ongoing monitoring of the effectiveness of their IQCP for the Revogene Group A Strep analyzer. -- 2 of 2 --

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 surveyor review of laboratory procedures and proficiency testing (PT) records and interview with the laboratory director, the laboratory has not verified the accuracy of the colony count for urine cultures twice annually in 2019 and 2020. Findings include: 1. Review of laboratory procedures show the laboratory evaluates colony counts to report urine culture results: *If the colony count is less than 10,000 colonies / mL (milliliter), the laboratory reports the culture as negative, *The culture result is questionable when the colony count is 10,000 to 100,000 colonies / mL, *The laboratory considers the culture positive when the culture grows greater than 100,000 colonies / mL. 2. Review of PT records showed the PT program only graded the 'growth' or 'no growth' determination for each sample; no evidence of laboratory evaluation of the colony count was present in 2019 or 2020. 3. Interview with the laboratory director on October 6, 2020 at 1:00 PM confirmed the laboratory did not verify the accuracy of the colony count on urine cultures twice annually in 2019 or 2020. D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(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-- At least once a day patient specimens are assayed or examined perform the following for-- Each qualitative procedure, include a negative and positive control material; (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 surveyor review of laboratory records and interview with the laboratory director, the laboratory failed to perform positive and negative external quality control testing each day of patient testing for Pertussis and Mycoplasma testing on the Alethia analyzer, and had not developed an Individualized Quality Control Plan (IQCP). Findings include: 1. Review of laboratory quality control records showed the laboratory did not perform external quality controls each day of patient testing. Review of other laboratory records showed no evidence of an IQCP for testing performed on the Alethia analyzer. 2. Interview with the laboratory director on October 6, 2020 at 1:00 PM confirmed the laboratory did not perform external quality controls each day of patient testing. Further interview confirmed the laboratory had not established an IQCP consistent with the requirements identified at 493.1256 as an equivalent quality control program. This is a repeat deficiency previously cited on April 5, 2018. 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. This STANDARD is not met as evidenced by: Based on surveyor review of quality control records and procedures, and interview with the laboratory director, the laboratory had not checked each batch of Uricult media before or concurrent with the initial use for its ability to support growth and, as appropriate, select or inhibit specific organisms, or produce expected biochemical responses. The laboratory did not have a current Individualized Quality Control Plan (IQCP). Findings include: 1. Review of quality control records for the Uricult test system showed no documentation of evaluation of each batch of media by the laboratory. 2. Review of laboratory procedures showed no evidence of an IQCP for the Uricult test system. 3. Interview with the laboratory director on October 6, 2020 at 1:00 PM confirmed the laboratory did not have an IQCP for the Uricult test system. Further interview confirmed the laboratory did not check each batch of media for its ability to support growth and, as appropriate select or inhibit specific organisms, or produce expected biochemical responses prior or concurrent with the initial use. This is a repeat deficiency previously cited on April 5, 2018. D6030 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(12) 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)(12) Ensure that policies and procedures are established for -- 2 of 3 -- 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 surveyor review of laboratory procedures and interview with the laboratory director, the laboratory had not developed a procedure for the evaluation of competency using the six assessment criteria required at 493.1413(b)(8). Findings include: 1. Review of laboratory procedures showed no evidence of a written policy or procedure for the evaluation of testing personnel competency using the six assessment criteria required at 493.1413(b)(8). 2. Interview with the laboratory director on October 6, 2020 at 1:00 PM confirmed a written policy for evaluation of testing personnel competency had not been developed. This is a repeat deficiency previously cited on April 5, 2018. -- 3 of 3 --

Summary Statement of Deficiencies D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years. This STANDARD is not met as evidenced by: Based on surveyor review of proficiency testing (PT) records and interview with testing personnel, the laboratory did not retain the laboratory's original test results submitted for the urine culture PT samples for event two in 2017. Findings include: 1. Review of PT records showed no evidence of original urine culture PT test results for the second microbiology event of 2017. 2. Interview with testing personnel (staff A) on April 5, 2018 at 10:15 AM confirmed that original urine culture proficiency testing results were not retained. 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 surveyor review of the manufacturer instructions and laboratory records, and interview with testing personnel, the laboratory does not document the room temperature to ensure storage requirements for the Uricult Cystine Lactose Electrolyte Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- Deficient/Eosin Methylin Blue (CLED/EMB) urine culture media are met. Findings include: 1. The manufacturer's instructions for the Uricult CLED/EMB urine culture media include directions to store the media between 7 - 25 degrees Celsius. 2. Review of laboratory records shows no documented room temperature records for the laboratory. 3. Interview with testing personnel (staff A) on April 5, 2018 at 11:15 AM confirmed room temperatures are not documented in the area where the Uricult CLED /EMB urine culture media are stored. D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(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-- At least once a day patient specimens are assayed or examined perform the following for-- Each qualitative procedure, include a negative and positive control material; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of the laboratory quality control records and interview with testing personnel, the laboratory failed to perform positive and negative quality control materials each day of patient testing for Pertussis, Group A Streptococcus, and Mycoplasma testing performed on the illumigene analyzer, and had not developed an Individualized Quality Control Plan (IQCP). Findings include: 1. Review of quality control records show the laboratory did not perform external quality control each day of patient testing. 2. Interview with testing personnel (staff A) on April 5, 2018 at 10: 00 AM confirms the laboratory failed to perform quality control as required for each day of patient testing. Further interview confirmed the laboratory has not established an individualized quality control program consistent with the requirements identified at 493.1256 to function as an equivalent quality control program. 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. This STANDARD is not met as evidenced by: Based on surveyor review of quality control records and procedures and interview with testing personnel, the laboratory has not checked each batch of Uricult media before or concurrent with the initial use for its ability to support growth and, as appropriate, select or inhibit specific organisms or produce a biochemical response. The laboratory has not developed an Individualized Quality Control Plan (IQCP). Findings include: 1. Review of quality control records for the Uricult test system showed no documentation of on-site evaluation of each batch of the media. 2. Review of laboratory procedures showed no evidence of an IQCP for the Uricult test system. 3. Interview with testing personnel (Staff A) on April 5, 2018 at 11:45 AM confirmed -- 2 of 6 -- an IQCP had not been developed for the Uricult test system and that the laboratory did not check each batch of media for its ability to support growth and, as appropriate, select or inhibit specific organisms or produce a biochemical response prior or concurrent with the initial use. D5785