Concord Hospital - Laconia

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 record review and staff interview, the laboratory (lab) failed to enroll in an approved proficiency testing (PT) program for gram stains in 2025. Findings include: 1. Review on 4/29/2025 and 4/30/2025 of PT records for gram stains revealed the lab performed a gram stain on 1 sample for Event 1 of 2025. 2. Interview on 4/30/2025 at 9:40 a.m. with the Microbiology Technical Supervisor confirmed the above finding and revealed the lab had not enrolled in a PT program that included 5 samples per event, 3 events per year. 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 3 -- Based on record review and staff interview, the laboratory (lab) failed to establish and follow written policies and procedures to assess the Technical and General Supervisor competency in 2023 and 2024. Findings include: 1. The lab was not able to provide a policy and procedure used to assess competency of the Technical and General Supervisors upon request by the surveyor on 4/30/2025. 2. Interview on 4/30/2025 at 10:40 a.m. with the Director of Laboratory Services revealed there was no policy and procedure in place to access competency of the Technical and General Supervisors. Interview further revealed competency assessments had not been performed for Technical and General Supervisors in 2023 and in 2024. D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) (b)(2)(i) Define a function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (b)(2)(ii) Perform and document the function checks, including background or baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks must be within the laboratory's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory (lab) failed to perform function checks for equipment used for Immunohematology testing in 2024 and 2025. Findings include: 1. Review on 4/30/2025 of the lab's "Blood Bank Maintenance Log" for 2024 revealed no function checks had been performed in 2024 for 2 refrigerators and 1 freezer used to store blood products and reagents, 1 water bath used to thaw frozen plasma products, 3 centrifuges, an incubator, heating block, and pipettes used for patient testing. Further review revealed certain function checks were scheduled to be done each month. There was no "Blood Bank Maintenance Log" for 2025. 2. Interview on 4/30/2025 at 10:00 a.m. with the Blood Bank Supervisor confirmed the maintenance outlined on the "Blood Bank Maintenance Log" had not been performed in 2024 and 2025 and revealed it was the Supervisor's responsbility to ensure it was completed. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) (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 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 -- 2 of 3 -- reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory (lab) failed to perform calibration verification for routine chemistry and toxicology analytes in 2023 and 2024. Findings include: 1. Review on 4/30/2025 of calibration verification records from 2023 and 2024 revealed calibration verification performed in December 2024 failed to include 26 of 39 routine chemistry and toxicology analytes; calibration verification performed in June 2024 failed to include 13 of 29 routine chemistry and toxicology analytes; calibration verification performed twice in 2023 each failed to include 28 of 39 and 26 of 39 routine chemistry and toxicology analytes. 2. Interview on 4/30/2025 at 12:10 p.m. with the Technical Supervisor confirmed calibration verifications from 2023 and 2024 failed to include all the analytes. D6072 TESTING PERSONNEL RESPONSIBILITIES CFR(s): 493.1425(b)(3) (b)(3) Adhere to the laboratory's quality control policies, document all quality control activities, instrument and procedural calibrations and maintenance performed; This STANDARD is not met as evidenced by: Based on record review and staff interview, testing personnel failed to adhere to the laboratory's (lab) approved control procedure for routine chemistry and toxicology testing in 2025. Findings include: 1. Review on 4/30/2025 of the lab's procedure titled "Laboratory Quality Control Policy Core Laboratory Laconia and Franklin," approved 1/10/2025, revealed quality control (QC) instruction on page 3: "Chemistry assays with 2 or fewer calibrators have three levels of QC run twice a day." 2. Review on 4 /30/2025 of calibration verification records revealed 39 routine chemistry and toxicology analytes with 2 or fewer calibrators. Analytes include: acetaminophen, albumin, alkaline phosphatase, alanine aminotransferase, ammonia, amylase, aspartate transaminase, blood urea nitrogen, calcium, cholesterol, creatine kinase, carbon dioxide, carbamazapine, creatinine, c-reactive protein, direct bilirubin, ethanol, gentamicin, gamma-glutamyl transferase, glucose, high density lipoprotein, high sensitivity c-reactive protein, lactate dehyrdogenase, microalbumin, magnesium, phosphate, phenytoin, salicylate, total bilirubin, tobramycin, total protein, triglyceride, urinary/cerebral total protein, valproic acid, vancomycin, uric acid, sodium, chloride, and potassium. 3. Review on 4/30/2025 of control records from January through April revealed three control materials had been tested once per day from 1/9/2025 to 2/16 /2025 for routine chemistry analytes using the "multi-qual" QC material and from 1/9 /2025 to 2/17/2025 for toxicology analytes using the "IA Plus" QC material. Two routine chemistry controls were run once a day after 2/16/2025, and two toxicology controls were run once a day after 2/27/2025, through 4/30/2025. 4. Interview on 4/30 /2025 at 12:10 p.m. with the Technical Supervisor confirmed the control procedure for the analytes listed above had not been followed. -- 3 of 3 --

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 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 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 record review and staff interview, the laboratory's pathology and cytology slide examination reports failed to include the name and/or the location of the laboratory (Lab A) performing the testing in April, May, and June 2021. Findings include: 1) Review on 6/16/2021 of a pathology report from 4/30/2021 revealed Lab A's name and location was not included on the report. Instead, a different laboratory (Lab B) name and address was documented as performing the professional services. Lab B does not have a CLIA certificate. 2) Review on 6/16/2021 of two cytology reports from May 2021 revealed the laboratory's name (Lab A) was not included on the reports, instead, the name of a different laboratory (Lab B) was listed as performing the slide examination at Lab A's physical location. Lab B does not have a CLIA certificate located at Lab A's location. 3) Interview with the laboratory director (LD) on 6/16/2021 at 9:00 a.m. revealed the pathology slides from finding 1 above were examined under Lab A's CLIA certificate remotely (in accordance with memo QSO-20-21-CLIA) at the location on the report and the cytology slides were examined onsite under Lab A's CLIA certificate. The LD further revealed that 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 -- pathology and cytology slides have been examined at both locations since April 2021. 4) Review on 6/16/2021 of the laboratory's test list revealed the laboratory performs 10,144 pathology and cytology tests annually. -- 2 of 2 --

Summary Statement of Deficiencies D5821 TEST REPORT CFR(s): 493.1291(k) When errors in the reported patient test results are detected, the laboratory must do the following: (k)(1) Promptly notify the authorized person ordering the test and, if applicable, the individual using the test results of reporting errors. (k)(2) Issue corrected reports promptly to the authorized person ordering the test and, if applicable, the individual using the test results. (k)(3) Maintain duplicates of the original report, as well as the corrected report. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to promptly notify the authorized person ordering the test or the individual using the test results of reporting errors for chemistry tests in 2019. Findings include: 1) Review on 5/8/2019 of corrected reports from January through March 2019 revealed results for a comprehensive metabolic profile (CMP) (includes chemistry analytes: glucose, creatinine, calcium, sodium, potassium, chloride, carbon dioxide, alkaline phosphatase, total bilirubin, albumin, total protein, alanine aminotransferase, and aspartate aminotransferase) was first reported on 12/1/2018. This report had been corrected on 3/8/2019 at 9:13 a.m. by personnel in the IT department. The correction to the report included changes to the normal reference ranges and result flags (low, normal, high) for the CMP analytes. There was no documentation that the personnel from IT had notified someone of the correction (e.g. the ordering provider, personnel responsible for providing care to the patient, or the laboratory). 2) Interview with the General Supervisor (GS) on 5/8/2019 at 8:30 a.m. confirmed the above finding. The GS revealed the corrected report was due to the correction of either the gender or date of birth entered during the registration process which resulted in changes to the CMP analytes' normal reference ranges and the result flags. D6063 LABORATORY TESTING PERSONNEL 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 -- 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 record review and staff interview, the laboratory failed to obtain documentation of qualifications for 2 of 4 testing personnel performing moderately complex chemistry and hematology testing in 2017, 2018, and 2019. Refer to tag 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: Based on record review and staff interview, the laboratory failed ensure 2 of 4 testing personnel met qualification requirements prior to performing moderately complex chemistry and hematology testing in 2017, 2018 and 2019. Findings include: 1) Review on 5/7/2019 of 4 personnel records for testing personnel performing moderately complex chemistry and hematology testing revealed 2 of 4 of testing personnel files had no documentation of educational qualifications. 2) Interview with the General Supervisor and human resources personnel on 5/7/2019 at 1:00 p.m. confirmed the personnel records for 2 of the 4 testing personnel did not include educational qualifications. D6103 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(13) The laboratory director must ensure that policies and procedures are established for 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 record review and staff interview, the laboratory director failed to ensure -- 2 of 4 -- policies and procedures used by the information technology (IT) personnel to correct patient test reports were corrected promptly and proficiently in 2019. Findings include: 1) Review on 5/8/2019 of corrected reports from January through March 2019 revealed results for a comprehensive metabolic profile (CMP) (includes chemistry analytes: glucose, creatinine, calcium, sodium, potassium, chloride, carbon dioxide, alkaline phosphatase, total bilirubin, albumin, total protein, alanine aminotransferase, and aspartate aminotransferase) was first reported on 12/1/2018. This report had been corrected on 3/8/2019 at 9:13 a.m. by personnel in the IT department. The correction to the report included changes to the normal reference ranges and result flags (low, normal, high) for the CMP analytes. There was no documentation that the personnel from IT had notified someone of the correction (e.g. the ordering provider, personnel responsible for providing care to the patient, or the laboratory). Further review revealed on 3/8/2019 at 10:20 a.m. the laboratory's information system (LIS) changed the reference ranges (and result flags) back to what had originally reported on 12/1/2019. 2) Interview with the General Supervisor (GS) on 5/8/2019 at 8:30 a.m. confirmed the above finding. The GS revealed the corrected report was due to the correction of either the gender or date of birth entered during the registration process which resulted in changes to the normal reference ranges and the result flags. The GS could not explain at the time of survey why the IT department and not laboratory personnel changed the results of the normal reference range or why the LIS changed the results back. D6168 TESTING PERSONNEL CFR(s): 493.1487 The laboratory has a sufficient number of individuals who meet the qualification requirements of 493.1489 of this subpart to perform the functions specified in 493. 1495 of this subpart for the volume and complexity of testing performed. This CONDITION is not met as evidenced by: Based on record review and staff interview, the laboratory failed to ensure qualifications were met for 5 of 6 testing personnel performing high complexity hematology, immunohematology, and microbiology testing in 2017, 2018, and 2019. Refer to tag D6171. D6171 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1489(b) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry 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; (b)(2)(i) Have earned an associate degree in a laboratory science, or medical laboratory technology from an accredited institution or-- (b)(2)(ii) Have education and training equivalent to that specified in paragraph (b)(2)(i) of this section that includes-- (b)(2)(ii)(A) At least 60 semester hours, or equivalent, from an accredited institution that, at a minimum, include either-- (b)(2)(ii)(A)(1) 24 semester hours of medical laboratory technology courses; or (b)(2)(ii)(A)(2) 24 semester hours of science courses that include-- (b)(2) (ii)(A)(2)(i) Six semester hours of chemistry; (b)(2)(ii)(A)(2)(ii) Six semester hours of biology; and (b)(2)(ii)(A)(2)(iii) Twelve semester hours of chemistry, biology, or medical laboratory technology in any combination; and (b)(2)(ii)(B) Have laboratory -- 3 of 4 -- training that includes either of the following: (b)(2)(ii)(B)(1) Completion of a clinical laboratory training program approved or accredited by the ABHES, the CAHEA, or other organization approved by HHS. (This training may be included in the 60 semester hours listed in paragraph (b)(2)(ii)(A) of this section.) (b)(2)(ii)(B)(2) At least 3 months documented laboratory training in each specialty in which the individual performs high complexity testing. (b)(3) Have previously qualified or could have qualified as a technologist under 493.1491 on or before February 28, 1992; (b) (4) On or before April 24, 1995 be a high school graduate or equivalent and have either-- (b)(4)(i) Graduated from a medical laboratory or clinical laboratory training program approved or accredited by ABHES, CAHEA, or other organization approved by HHS; or (b)(4)(ii) Successfully completed an official U.S. military medical laboratory procedures training course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); (b)(5)(i) Until September 1, 1997-- (b)(5)(i)(A) Have earned a high school diploma or equivalent; and (b)(5)(i)(B) Have documentation of training appropriate for the testing performed before analyzing patient specimens. Such training must ensure that the individual has-- (b)(5)(i)(B)(1) The skills required for proper specimen collection, including patient preparation, if applicable, labeling, handling, preservation or fixation, processing or preparation, transportation and storage of specimens; (b)(5)(i)(B)(2) The skills required for implementing all standard laboratory procedures; (b)(5)(i)(B)(3) The skills required for performing each test method and for proper instrument use; (b)(5)(i)(B)(4) The skills required for performing preventive maintenance, troubleshooting, and calibration procedures related to each test performed; (b)(5)(i)(B)(5) A working knowledge of reagent stability and storage; (b)(5)(i)(B)(6) The skills required to implement the quality control policies and procedures of the laboratory; (b)(5)(i)(B)(7) An awareness of the factors that influence test results; and (b)(5)(i)(B)(8) The skills required to assess and verify the validity of patient test results through the evaluation of quality control values before reporting patient test results; and (b)(5)(i)(B)(8)(ii) As of September 1, 1997, be qualified under 493.1489(b)(1), (b)(2), or (b)(4), except for those individuals qualified under paragraph (b)(5)(i) of this section who were performing high complexity testing on or before April 24, 1995; (b)(6) For blood gas analysis-- (b)(6) (i) Be qualified under 493.1489(b)(1), (b)(2), (b)(3), (b)(4), or (b)(5); (b)(6)(ii) Have earned a bachelor's degree in respiratory therapy or cardiovascular technology from an accredited institution; or (b)(6)(iii) Have earned an associate degree related to pulmonary function from an accredited institution; or (b)(7) For histopathology, meet the qualifications of 493.1449 (b) or (l) to perform tissue examinations. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed ensure 5 of 6 testing personnel met qualification requirements prior to performing high complexity hematology, immunohematology, and microbiology testing in 2017, 2018 and 2019. Findings include: 1) Review on 5/7/2019 of 6 personnel records for testing personnel performing high complexity hematology, immunohematology, and microbiology testing revealed 5 of 6 testing personnel files had no documentation of educational qualifications. 2) Interview with the General Supervisor and human resources personnel on 5/7/2019 at 1:00 p.m. confirmed the personnel records for 5 of the 6 testing personnel did not include educational qualifications. -- 4 of 4 --