Ascension St John Urgent Care - Utica

Summary Statement of Deficiencies D0000 The recertification survey was performed on 05/11/2023. The laboratory was found in compliance with standard-level deficiencies cited. The findings were reviewed with the laboratory director, technical consultant #1, technical consultant #2, nurse supervisor, Utica team lead, and the clinical educator during an exit conference performed at the conclusion of the survey. 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 a review of records and interview with technical consultant #1, the laboratory failed to ensure a proficiency testing attestation statement had been maintained for one of ten events reviewed during 2021, 2022, and to date in 2023. Findings include: (1) A review of 2021, 2022, and 2023 proficiency testing records identified the following for one of ten events: (a) First 2022 Chemistry Core Event - The attestation statement had not been maintained. (2) The findings were reviewed with technical consultant #1 who stated on 05/11/2023 at 11:30 am, the attestation statement had not been maintained as stated above. 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 -- D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on observation and interview with technical consultant #1, the laboratory failed to ensure expired supplies were not available for use. Findings include: (1) Observation of the laboratory on 05/11/2023 at 09:15 am, identified the following expired collection supplies that appeared to be available for use: (a) BD Affirm VPIII Ambient Temperature Transport System - Nine of lot #B01C3 with an expiration date of 04/30/2022 and ten of lot #B01D096M with an expiration date of 07/31/2022; (b) Holigic Aptima Unisex Swab Specimen Collection Kit - 15 of lot #303725HA with an expiration date of 01/31/2023. (2) Interview with technical consultant #1 on 05/11 /2023 at 09:25 am confirmed the collection supplies were used to collect patient samples to send to the reference laboratory for testing and were available for use. 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 a review of records and interview with technical consultant #1, the laboratory failed to demonstrate the performance specifications for one of one replacement analyzer. Findings include: (1) On 05/11/2023 at 09:20 am, technical consultant #1 stated the following: (a) The laboratory performed Sodium, Potassium, Chloride, CO2, Ionized Calcium, Glucose, BUN, and Creatinine testing using the iSTAT 1 analyzer and the Chem 8+ cartridge; (b) The laboratory began using iSTAT 1 (serial number 399412) to replace iSTAT 1 (serial number 322246) on 03/06/2023. (2) A review of records in 2023 identified no evidence the performance specifications (i.e., accuracy, precision, reportable range) had been demonstrated for the replacement iSTAT 1 analyzer; (3) The findings were reviewed with technical consultant #1 who stated on 05/11/2023 at 11:40 am, the laboratory had not demonstrated the performance specifications for the replacement analyzer. 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) -- 2 of 4 -- -- (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 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 a review of records and interview with technical consultant #1, the laboratory failed to perform calibration verification procedures at least once every six months for one of one test system during the review period of July 2021 through the current date. Findings include: (1) On 05/11/2023 at 09:20 am, technical consultant #1 stated the laboratory performed Sodium, Potassium, Chloride, CO2, Ionized Calcium, Glucose, BUN, and Creatinine testing using the iSTAT 1 analyzer and the Chem 8+ cartridge; (2) A review of records from July 2021 through the current date identified no evidence calibration verification had been performed at least once every six months during the review period; (3) The records were reviewed with technical consultant #1 who stated on 05/11/2023 at 12:15 pm, calibration verification procedures had not been performed every six months. 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 a review of records and interview with technical consultant #1, the laboratory failed to follow their policy for monitoring the effectiveness of their QCP (Quality Control Plan) for one of one test system during the review period of July 2021 through the current date. Findings include: (1) On 05/11/2023 at 09:20 am, technical consultant #1 stated the following: (a) The laboratory performed Sodium, Potassium, Chloride, CO2, Ionized Calcium, Glucose, BUN, and Creatinine testing using the iSTAT 1 analyzer and the Chem 8+ cartridge; (b) An IQCP (Individualized Quality Control Plans) had been developed for the test system. (2) A review of the IQCP for the test system identified that QA (Quality Assessment) reviews of the QCP (Quality Control Plan) were to be performed on an annual basis; (3) A review of records for the test system from July 2021 through the current date identified no documentation that annual QA reviews had been performed during the review period; (4) The records were reviewed with technical consultant #1 who stated on 05/11/2023 -- 3 of 4 -- at 12:18 pm, annual QA reviews had not been documented as performed for the above test system. D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least annually, after the first year. This STANDARD is not met as evidenced by: Based on a review of records and interview with technical consultant #1, the technical consultant failed to ensure personnel performing moderate complexity testing had been evaluated at least annually for one of ten persons during the review period of July 2021 through the current date. Findings include: (1) A review of personnel records for ten persons performing moderate complexity testing during the review period of July 2021 through the current date identified no evidence an annual competency evaluation had been performed for one of ten testing persons as follows: (a) Testing Person #15 - Not performed during the review period. (2) The records were reviewed with technical consultant stated on 03/27/2023 at 02:04 pm, the annual evaluation had not been performed. -- 4 of 4 --

Summary Statement of Deficiencies D0000 The recertification survey was performed on 06/04/2021. The findings were reviewed with technical consultant #1 and the laboratory coordinator at the conclusion of the survey. The laboratory was found out of compliance with the following CLIA regulation: 493.1409; D6033: Technical Consultant D6033 TECHNICAL CONSULTANT-MODERATE COMPEXITY CFR(s): 493.1409 The laboratory must have a technical consultant who meets the qualification requirements of 493.1411 of this subpart and provides technical oversight in accordance with 493.1413 of this subpart. This CONDITION is not met as evidenced by: Based on a review of records and interview with technical consultant #1, the technical consultant failed to provide technical oversight in accordance with 493.1413 of this subpart. Findings include: (1) The technical consultant failed to ensure the individual who performed the duties and responsibilities of the technical consultant, met the qualifications. Refer to D6035. D6035 TECHNICAL CONSULTANT QUALIFICATIONS CFR(s): 493.1411 (a) The technical consultant must be qualified and must possess a current license issued by the State in which the laboratory is located, if such licensing is required. (b) The technical consultant must-- (b)(1)(i) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (b)(1)(ii) Be certified in anatomic or clinical pathology, or both, by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (b)(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of 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 -- podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and (b)(2)(ii) Have at least one year of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible (for example, physicians certified either in hematology or hematology and medical oncology by the American Board of Internal Medicine are qualified to serve as the technical consultant in hematology); or (b)(3)(i) Hold an earned doctoral or master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (b)(3)(ii) Have at least one year of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible; or (b)(4)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (b)(4)(ii) Have at least 2 years of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible. Note: The technical consultant requirements for "laboratory training or experience, or both" in each specialty or subspecialty may be acquired concurrently in more than one of the specialties or subspecialties of service, excluding waived tests. For example, an individual who has a bachelor's degree in biology and additionally has documentation of 2 years of work experience performing tests of moderate complexity in all specialties and subspecialties of service, would be qualified as a technical consultant in a laboratory performing moderate complexity testing in all specialties and subspecialties of service. This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory coordinator, the laboratory failed to ensure the individual who performed the duties and responsibilities of the technical consultant, met the qualifications for 21 of 35 competency evaluations performed and signed 5 of 9 proficiency testing attestation forms. Findings include: COMPETENCY EVALUATION (1) On 06/04/2021, the surveyor reviewed records for 35 persons performing moderate complexity testing in 2019, 2020, and 2021. The records showed the evaluation for 21 of 35 persons had been performed by an individual who did not meet the regulatory qualification requirements of the technical consultant: (a) Testing Person #4 - The 01/19/2021 and 12/10/2019 evaluations had been performed by the laboratory coordinator (this person had earned a bachelors degree in clinical laboratory science but did not have at least 2 years of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible); (b) Testing Person #5 - The 11/04/2020 and 11/15/2019 evaluations had been performed by the laboratory coordinator; (c) Testing Person #7 - The 08/21 /2020 and 08/22/2019 evaluations had been performed by the laboratory coordinator; (d) Testing Person #8 - The 07/13/2020 evaluation had been performed by the laboratory coordinator; (e) Testing Person #9 - The 08/27/2020 evaluation had been performed by the laboratory coordinator; (f) Testing Person #10 - The 09/14/2020 evaluation had been performed by the laboratory coordinator; (g) Testing Person #11 - The 10/27/2020 and 11/25/2019 evaluations had been performed by the laboratory coordinator; (h) Testing Person #12 - The 06/02/2021 evaluation had been performed by the laboratory coordinator; (i) Testing Person #14 - The 09/04/2020 and 10/10 /2019 evaluations had been performed by the laboratory coordinator; (j) Testing Person #15 - The 05/18/2020 evaluation had been performed by the laboratory coordinator; (k) Testing Person #17 - The 02/24/2021 and 06/20/2020 evaluations had been performed by the laboratory coordinator; (l) Testing Person #20 - The 05/31 -- 2 of 3 -- /2021 and 04/27/2020 evaluations had been performed by the laboratory coordinator; (m) Testing Person #21 - The 09/02/2020 evaluation had been performed by the laboratory coordinator; (n) Testing Person #23 - The 09/04/2020 evaluation had been performed by the laboratory coordinator; (o) Testing Person #24 - The 10/14/2020 and 11/05/2019 evaluations had been performed by the laboratory coordinator; (p) Testing Person #26 - The 05/08/2020 evaluation had been performed by the laboratory coordinator; (q) Testing Person #29 - The 08/28/2020 evaluation had been performed by the laboratory coordinator; (r) Testing Person #30 - The 05/21/2021 and 05/07 /2020 evaluations had been performed by the laboratory coordinator; (s) Testing Person #31 - The 01/05/2021 evaluation had been performed by the laboratory coordinator; (t) Testing Person #32 - The 05/28/2020 evaluation had been performed by the laboratory coordinator; (u) Testing Person #34 - The 10/15/2020 evaluation had been performed by the laboratory coordinator; 2) The surveyor explained to the laboratory coordinator that all components of the competency evaluations must be performed by a person who qualifies as a technical consultant (an individual with a minimum of a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution, and at least 2 years of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service). The laboratory coordinator stated to the surveyor on 06 /04/20201 at 10:30 am, the evaluations had been performed by an individual who did not meet the years of experience of a technical consultant. PROFICIENCY TESTING ATTESTATION FORMS (1) On 06/04/2021, the surveyor reviewed 2019, 2020, and 2021 proficiency testing records and identified that 5 of 9 attestation statements had been signed by an individual who did not meet the minimal educational qualifications of a technical consultant or designee. The attestation statements had been signed by the laboratory coordinator (an individual with a minimum of a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution, and at least 2 years of laboratory training or experience, or both in non- waived testing, in the designated specialty or subspecialty areas of service). The following attestation statements had been signed by the laboratory coordinator: (a) First 2020 Hematology Event (b) Second 2020 Hematology Event (c) Third 2020 Chemistry Core Event (d) First 2021 Hematology Event (e) First 2021 Chemistry Core Event (2) The surveyor reviewed the records with the laboratory coordinator. On 06/04/2021 at 11:05 am, the laboratory coordinator stated the attestation statements, as indicated above, had been signed and dated by an individual who did not meet the regulatory qualification requirements of a technical consultant or designee. -- 3 of 3 --

Summary Statement of Deficiencies D0000 The recertification survey was performed on 01/29/19. The laboratory was found to be in compliance with standard-level deficiencies cited. The findings were reviewed with the laboratory services manager at the conclusion of the survey. 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 a review of records, manufacturer's instructions, and interview with the laboratory services manager, the laboratory failed to ensure the manufacturer's environmental specifications were met. Findings include: HUMIDITY (1) At the beginning of the survey, the laboratory services manager stated to the surveyor the laboratory performed CBC (Complete Blood Count) testing (e.g. WBC (White Blood Count), RBC (Red Blood Count), Hematocrit, Hemoglobin, Platelet count, etc.) using the Sysmex KX-21N hematology analyzer; (2) The surveyor reviewed the manufacturer's environmental requirements. The manufacturer required a humidity between 30 and 80% for optimal performance; (3) The surveyor then reviewed the laboratory humidity/temperature records from 10 months (January, February, April, May, June, July, August, September, November and December 2018). The surveyor identified on 37 of the 272 days reviewed, the manufacturer's humidity requirement had not been met, or the humidity had not been documented. The specific findings follow: (a) January 2018: On 2 of 31 days, the humidity was unacceptable: (i) 28%: Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- Day 1 (ii) 29%: Day 2 (b) February 2018: On 7 of 28 days, the humidity was unacceptable: (i) 20%: Day 28 (ii) 26%: Day 5 (iii) 27%: Day 7,12 (iv) 29%: Days 3,8,11 (c) April 2018: On 1 of 30 days, the humidity had not been documented: Day 8 (d) May 2018: On 2 of 31 days, the humidity had not been documented: Days 4,29 (e) June 2018: On 2 of 30 days, the humidity had not been documented: Days 1,16 (f) July 2018: On 1 of 31 days, the humidity had not been documented: Day 30 (g) August 2018: The humidity was unacceptable, or had not been documented on 8 of 31 days: (i) 82%: Days 17,25 (ii) 83%: Day 29 (iii) 85%: Days 27,28 (iv) 86%: Day 26 (v) The humidity had not been documented: Days 30,31 (h) September 2018: The humidity was unacceptable, or had not been documented on 13 of 30 days: (i) 72% and 86% after recheck: Day 1 (ii) 82%: Days 19,25 (iii) 83%: Day 13 (iv) 84%: Day 5 (v) 85%: Days 2,3,8,14 (vi) 86%: Day 4 (vii) The humidity had not been documented: Days 7,18,30 (i) December 2018: The humidity had not been documented on 1 of 30 days: Day 20 (4) The surveyor reviewed the findings with the laboratory services manager. The laboratory services manager stated to the surveyor the laboratory failed to ensure the manufacturer's humidity requirement for the Sysmex KX-21N analyzer had been met as listed above. REFRIGERATOR TEMPERATURE (1) The surveyor reviewed temperature records of the Tempure Scientific refrigerator from 9 months (July, August, November, and December 2017; January, March, April, October, and November 2018). The laboratory's acceptable temperature range was 2 to 8 degrees C (Centigrade). The surveyor identified on 52 of the 269 days reviewed, the refrigerator temperature was unacceptable, or had not been documented. The specific findings follow: (a) July 2017: The refrigerator temperature was colder than acceptable on 5 of 31 days: (i) 1.3 C: Day 11 (ii) 1.6 C: Day 9 (iii) 1.8 C: Day 8 (iv) 1.9 C: Days 7,10 (b) August 2017: The refrigerator temperature was colder than acceptable on 6 of 31 days: (i) 0.7 C: Day 12 (ii) 0.8 C: Day 15 (iii) 1.3 C: Days 7,14 (iv) 1.5 C: Day 13 (v) 1.9 C: Day 10 (c) November 2017: The refrigerator temperature was colder than acceptable on 24 of 29 days: (i) 0.1 C: Day 19 (ii) 0.5 C: Day 1 (iii) 0.6 C: Day 2 (iv) 0.8 C: Day 8 (v) 0.9 C: Days 3,4 (vi) 1.0 C: Days 11,16 (vi) 1.1 C: Day 22 (vii) 1.2 C: Day 24 (viii) 1.3 C: Day 17 (ix) 1.5 C: Days 13,25 (x) 1.6 C: Days 9,14,20,21,29,30 (xi) 1.7 C: Days 15,26 (xii) 1.8 C: Days 12,27 (xiii) 1.9 C: Day 10 (d) December 2017: The refrigerator temperature was colder than acceptable on 12 of 30 days: (i) 0.8 C: Day 20 (ii) 1.1 C: Day 6 (iii) 1.2 C: Day 15,19 (iv) 1.4 C: Days 21,27 (v) 1.5 C: Day 14,18 (vi) 1.6 C: Days 8,26 (vii) 1.7 C: Day 13 (viii) 1.8 C: Day 12 (e) January 2018: The refrigerator temperature was colder than acceptable on 3 of 30 days: (i) 0.9 C: Day 13 (ii) 1.4 C: Day 12 (iii) 1.6 C: Day 14 (f) April 2018: The temperature had not been documented on 1 of 29 days (i) Day 29 (g) October 2018: The temperature had not been documented on 1 of 31 days (i) Day 22 (2) The surveyor asked the laboratory services manager what was stored in the refrigerator. The laboratory services manager stated the EightCheck 3WPX-XTRA hematology control materials had been stored in the Tempsure Scientific refrigerator until it was replaced on 12/10 /18 with a new refrigerator; (3) The surveyor then reviewed the manufacturer's instructions for the EightCheck 3WPX-XTRA hematology control materials. The manufacturer required a storage temperature between 2-8 degrees C; (4) The surveyor reviewed the findings with the laboratory services manager who stated to the surveyor the laboratory failed to ensure the manufacturer's storage requirement for the hematology control materials had been met, as listed above. 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 -- 2 of 5 -- least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on a review of records, manufacturer's instructions, and interview with the laboratory services manager, the laboratory failed to perform maintenance procedures as required by the manufacturer. Findings include: (1) At the beginning of the survey, the laboratory services manager stated to the surveyor the laboratory performed CBC's (WBC (White Blood Count), RBC (Red Blood Count), Hemoglobin, Hematocrit, Platelet Count, etc.) using the Sysmex KX-21N hematology analyzer; (2) The surveyor reviewed the manufacturer's maintenance requirement for the analyzer. The manufacturer required the following procedures be performed: (a) Weekly: Clean the SRV (b) Monthly: (i) Clean transducer (ii) Clean waste chamber (3) Maintenance records from 06/01/17 through 12/31/18 were reviewed by the surveyor. The surveyor identified the required maintenance procedures had not performed as follows: (a) Weekly maintenance: Had not been performed: (i) Between 06/01/17 and 06/13/17 (ii) Between 06/08/18 and 06/19/18 (b) Monthly maintenance: Had not been performed during 1 of the 18 months reviewed: (i) Between 05/01/18 and 05/31/18 (4) The findings were reviewed with the laboratory services manager who stated to the surveyor there was no documentation the manufacturer's required weekly and monthly maintenance procedures had been performed as listed above. D5785