W J Mangold Memorial Hospital Lab

Summary Statement of Deficiencies D5551 IMMUNOHEMATOLOGY CFR(s): 493.1271(a)(f) (a) Patient testing. (a)(1) The laboratory must perform ABO grouping, D (Rho) typing, unexpected antibody detection, antibody identification, and compatibility testing by following the manufacturer's instructions, if provided, and as applicable, 21 CFR 606.151(a) through (e). (a)(2) The laboratory must determine ABO group by concurrently testing unknown red cells with, at a minimum, anti-A and anti-B grouping reagents. For confirmation of ABO group, the unknown serum must be tested with known A1 and B red cells. (a)(3) The laboratory must determine the D (Rho) type by testing unknown red cells with anti-D (anti-Rho) blood typing reagent. (f) Documentation. The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based upon review of manufacturer's instructions, quality control records, transfusion service records and interview of facility personnel, the laboratory failed to perform quality control procedures for ABO and D typing on 4 of 689 days between January 1, 2023 and November 20, 2024 using the MTS A/B/D Monoclonal Grouping Card. The findings included: 1. Review of the Micro Typing Systems MTS A/B/D Monoclonal Grouping Card instructions for use found on page 6 under the heading quality control: "To confirm the reactivity and specificity of the microtubes containing Anti-A and Anti-B, it is recommended that each lot of cards be tested each day of use with antigen positive and antigen negative red blood cells. To confirm the reactivity and specificity of the microtubes containing Anti-D, it is recommended that each lot of gel cards be tested on each day of use with D-positive or weak D-positive and D-negative red blood cells." 2. Review of quality control records found no quality control procedures documented on the following dates when donor units were typed for crossmatch: 01/17/2023 01/20/2023 09/23/2023 10/31/2024 3. Review of transfusion service logs found the following units typed for crossmatch on the following dates: 01 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 -- /17/2023 - Units W041523001308 and W041523000339 01/20/2023 - Units W041523000005 and W041523000312 09/23/2023 - Unit W041523028772 10/31 /2024 - Unit W04152403255600 4. During interview of the Technical Consultant conducted November 20, 2024 at 10:46 AM she confirmed that the laboratory did not test quality control materials each day of patient testing. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A recerticiation survey was completed on August 26, 2021. The laboratory was found out of compliance with the CLIA regulations. The conditions not met were: D2000 - 42 C.F.R. 493.801 Enrollment And Testing Of Samples 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 pre survey paperwork, proficiency testing records, interview, and test volumes, the laboratory failed to ensure they were enrolled in proficiency testing (PT) for Rheumatoid Factor (RF). Findings follow. A. Review of the pre-survey paperwork titled Listing of Tests Performed in the Facility showed the laboratory was performing Rheumatoid Factor. B. Review of the American Proficiency Institute (API) records from the 1st, 2nd, and 3rd events of 2020 and the 1st event of 2021 showed the laboratory was not enrolled in PT for RF. C. Interview with the technical consultant #2 on August 23, 2021 at 1140 hours confirmed the laboratory was not enrolled in PT for RF and had never done PT for that. D. Email from technical consultant #2 on August 26, 2021 acknowledged the laboratory performed 81 RF tests annually. D2007 TESTING OF PROFICIENCY TESTING SAMPLES 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 -- CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on review of pre-survey paperwork, proficiency testing records, and interview the laboratory failed to ensure one of 5 testing personnel participated in proficiency testing (PT). Findings follow. A. Review of the pre-survey paperwork titled Laboratory Personnel showed testing personnel #5 was performing routine chemistry, Complete Blood Count (CBCs), urine drug screens, and serum pregnancy testing in the laboratory. B. Review of the American Proficiency Institute (API) records from the 1st, 2nd, and 3rd events of 2020 and the 1st event of 2021 showed only testing personnel #1-4 rotated for the respective PT. C. Interview with the technical consultant #2 on August 23, 2021 at 1140 hours acknowledged the laboratory had MTs (Medical Technologists), and rotated PT among the MTs in the lab, and confirmed testing personnel #5 was the only person not rotated in for PT. D5305 TEST REQUEST CFR(s): 493.1241(c) The laboratory must ensure the test requisition solicits the following information: (1) The name and address or other suitable identifiers of the authorized person requesting the test and, if appropriate, the individual responsible for using the test results, or the name and address of the laboratory submitting the specimen, including, as applicable, a contact person to enable the reporting of imminently life threatening laboratory results or panic or alert values. (2) The patient's name or unique patient identifier. (3) The sex and age or date of birth of the patient. (4) The test(s) to be performed. (5) The source of the specimen, when appropriate. (6) The date and, if appropriate, time of specimen collection. (7) For Pap smears, the patient's last menstrual period, and indication of whether the patient had a previous abnormal report, treatment, or biopsy. (8) Any additional information relevant and necessary for a specific test to ensure accurate and timely testing and reporting of results, including interpretation, if applicable. This STANDARD is not met as evidenced by: Based on review of the manufacturer's instructions, blood gas test reports, interview, and observation, the laboratory failed to have a mechanism to document the accurate collection and received times for blood gases performed on the OPTI-CCA for 7 of 8 test reports. Findings follow. A. Review of the OPTI-CCA Operator's Manual under Specimen Collection and Handling for OPTI Medical ComfortSamplers stated, "After collection, the ComfortSampler should be caped and transported in a horizontal position to the instrument for analysis within 30 minutes, as with all specimens collected in capillary tubes." B. Review of the blood gas test reports from 04/05/2021 to 08/23/2021 showed 7 of 8 test reports collection and received times were entered incorrectly. 1. MR# 74726 ordered 8/12/2021 at 0338, collected 8/12/2021 at 0359, received 8/12/2021 at 0443, resulted 8/12/2021 at 0446. Review of the instrument print out showed the blood gas was performed on 8/12/2021 at 0342. 2. MR# 77658 ordered 7/22/2021 at 1942, collected 7/22/2021 at 2113, received 7/22/2021 at 2113, resulted 7/22/2021 at 2117. Review of the instrument print out showed the blood gas -- 2 of 3 -- was performed on 7/22/2021 at 2056. 3. MR# 60454 ordered 6/15/2021 at 2221, collected 6/15/2021 at 2251, received 6/16/2021 at 0435, resulted 6/16/2021 at 0436. Review of the instrument print out showed the blood gas was performed on 6/15/2021 at 2236. 4. MR# 79058 ordered 6/08/2021 at 2311, collected 6/09/2021 at 0021, received 6/09/2021 at 0421, resulted 6/09/2021 at 0423. Review of the instrument print out showed the blood gas was performed on 6/09/2021 at 0009. 5. MR# 2352 ordered 5/15/2021 at 2247, collected 5/16/2021 at 0103, received 5/16/2021 at 0103, resulted 5/16/2021 at 0105, Review of the instrument print out showed the blood gas was performed on 5/15/2021 at 2311. 6. MR# 74391 ordered 4/19/2021 at 1854, collected 4/19/2021 at 1855, received 4/20/2021 at 0425, resulted 4/20/2021 at 0420, Review of the instrument print out showed the blood gas was performed on 4/19/2021 at 1839. 7. MR# 100727 ordered 4/05/2021 at 0914, collected 4/05/2021 at 1325, received 4/05/2021 at 1325, resulted 4/05/2021 at 1327, Review of the instrument print out showed the blood gas was performed on 4/05/2021 at 0932. C. Interview with technical consultant #2 on August 23 at 1700 hours in the laboratory acknowledged they received electronic orders in the lab for blood gases and go to the Emergency Room to run the samples. Interview with the technical consultant on August 24 at 0950 hours in the Common Room of the Emergency Room acknowledged the nursing staff drawing the blood gases do not provide the laboratory with the collection time, and after a review of the findings that "they [laboratory] could do a better job with the times." NOTE: On August 24 at 0940 in the Common Room, the surveyor observed the OPTI CCA blood gas analyzer was 6 minutes behind the actual time. D5555 IMMUNOHEMATOLOGY CFR(s): 493.1271(c)(f) (c) Blood and blood products storage. Blood and Blood products must be stored under appropriate conditions that include an adequate temperature alarm system that is regularly inspected. (c)(1) An audible alarm system must monitor proper blood and blood product storage temperature over a 24-hour period. (c)(2) Inspections of the alarm system must be documented. (f) Documentation. 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 the blood banking temperature chart wheels, and interview, the laboratory failed to provide documentation that the blood bank refrigerator was monitored for 16 days over a period of 3 1/2 months. Findings follow. A. Review of the blood bank refrigerator temperature chart wheels from 05/04/2021 - 08/24/2021 showed a gap from 08/06/2021 - 08/17/2021, 07/01/2021 - 07/06/2021, and 05/25 /2021 @ 8am - 05/26/2021 at 12. B. Interview with the technical consultant #2 on August 24, 2021 at 1300 hours confirmed the gaps and confirmed they do not have a certain day of the week that they change the chart and had given the responsibility to the night shift to perform. -- 3 of 3 --

Summary Statement of Deficiencies 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: Based on review of the laboratory's competency assessment policy, testing personnel competency assessment records, and interview with facility personnel, the laboratory failed to follow the approved competency assessment policy to have a qualified technical consultant perform the annual competency on 4 of 9 testing personnel in 2018. The findings included: 1. Based on review of the laboratory's policy titled "COMPETENCY POLICY", revision approved by the laboratory director on 2/18 /2016, the policy stated the following: "POLICY: Competency is the ability of personnel to apply their skill, knowledge and experience to perform their laboratory duties correctly. Six procedure are required for each analyte or test platform. These include - 1. Direct Observation 2. Monitoring the recording and reporting of results. 3. Review of intermediate test results or worksheets, QC, proficiency testing records, etc. 4. Direct observation of maintenance. 5. Assessment of test performance with previous run samples or proficiency samples. 6. Assessment of problem solving abilities. Competency is required after orientation, at six months and annually thereafter. Competency will be added to the yearly checklist which is posted in laboratory. The Technical Consultant is responsible for assessing and documenting competency on testing person. Lab Director is responsible for assessing competency of Technical Consultant". 2. Based on a review of testing personnel competency records: The competency of Testing Person 6 was performed on 10/01/2018 The competency of Testing Person 7 was performed on 9/24/2018. The competency of Testing Person 8 was performed on 9/26/2018. The competency of Testing Person 9 was performed on 9/27/2018. Each of the 4 competency assessment documents 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 -- indicate a column "Employee Self-Evaluation" with a check next to each component. The listed components do not contain the 6 required procedures of Direct Observations, Monitoring the recording and reporting of results, Review of intermediate test results or worksheets, QC, proficiency testing records, Direct observation of maintenance, Assessment of test performance with previous run samples or proficiency samples, or Assessment of problem solving abilities. Each of the 4 competency assessment documents was signed by Testing Person 5 in the "Instructor Initials" column. Testing Person 5 does not meet the personnel requirements at 42 CFR 493.1411 Technical Consultant Qualifications. 3. In an interview at 10:30 hours on 1/15/2019 in the conference room, the Technical Consultant stated that she had not performed the competency assessments for Testing Persons 6, 7, 8, and 9 for 2018. 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 least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on review of the Opti-CCA blood gas analyzer operator's manual, laboratory maintenance records, and interview with facility personnel, the laboratory failed to replace the peristaltic pump cartridge annually in 2018. As of the date of survey, January 15, 2019, the laboratory had not documented and replaced the peristaltic pump cartridge for one (1) year, seven (7) months, and fourteen (14) days between June 7, 2017 and January 15, 2019. The findings included: 1. Based on review of the Opti-CCA blood gas analyzer operator's manual (PD7202 Rev. B), on page 25, the operator's manual states the following: "Annually Replace the peristaltic pump cartridge and gas I/O port." 2. Based on a review of laboratory maintenance records, the peristaltic pump cartridge was replaced on June 1, 2017. Based on review of maintenance records for July 2017 through January 15, 2019, the laboratory did not document and replace the peristaltic pump, as required by the manufacturer. 3. In an interview at 14:10 hours on 1/15/2019 in the conference room, the Technical Consultant and General Supervisor confirmed there was no other documentation of the laboratory changing the peristaltic pump cartridge on the Opti-CCA blood gas analyzer. D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. (g) The laboratory must document all control procedures performed. -- 2 of 4 -- This STANDARD is not met as evidenced by: Based on review of the laboratory Individualized Quality Control Plan (IQCP) for reduced quality control frequency on the Opti-CCA blood gas analyzer, quality control records, and interview with facility personnel, the laboratory failed to monitor, over time, the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance for one (1) year and seven (7) months between June 2017 and January 15, 2019. The findings included: 1. Based on review of the laboratory's Individualized Quality Control Plan (IQCP) for reduced quality control frequency on the Opti-CCA blood gas analyzer, approved by the laboratory director on 4/28/2016, the document states: "Action: Laboratory Personnel will document: Room Temperature (22 - 28 Celsius) Internal Control - SRC done each day of use External Control - With each kit and each month on log sheet Instrument is not moved from the room THB calibration performed every 3 months and documented." The Quality Control Plan (QCP) did not indicate the number and type of controls, criteria for acceptability, actions to take if quality control materials did not meet established acceptability limits (including patient remediation), or a method to monitor, over time, the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. 2. Based on a review of quality control records from June 2017 through January 15, 2019, the laboratory documented the following: June, July, and August of 2017, the laboratory documented "pass" for control levels 1, 2, and 3. September 2017, the laboratory documented "pass" for control levels 1 and 2. There is no level 3 "pass" for September 2017. For October 2017 through December 2018, the laboratory documented "pass" for control levels 1, 2, and 3. 3. In an interview at 14:10 hours on 1 /15/2019 in the conference room, the Technical Consultant stated the laboratory monitored the accuracy and precision of most control materials over time in a software program but the Opti-CCA control materials had not been a part of this program. D5465 CONTROL PROCEDURES CFR(s): 493.1256(d)(8)(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-- Test control materials in the same manner as patient specimens. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of laboratory procedures, Acetest instructions for use, quality control records, patient records, and interview with facility personnel, the laboratory failed to use a control material of a similar matrix to serum for 3 of 3 patients tested between November 2017 and December 2018. The findings included: 1. Based on the laboratory's procedure "ACETEST REAGENT TABLETS", revision approved by the laboratory director on 8/6/2015, under QUALITY CONTROL, the document states: "For best results, performance should be confirmed by testing known negative and positive specimens or controls whenever a new bottle is first opened. Negative and positive specimens or controls may also be randomly hidden in each batch of specimens tested." 2. Based on review of the instructions for use for the Acetest Reagent Tablets, revised (08/10), under SUMMARY AND EXPLANATION, the document states: "ACETEST reagent tablets from Bayer are composed of several -- 3 of 4 -- ingredients, and are primarily used to test for the presence of ketones (acetoacetic acid and acetone) in urine. Serum, plasma or whole blood may also be tested with ACETEST reagent tablets for the presence of ketones." 3. In an interview at 14:45 hours on 1/15/2019 in the laboratory, the General Supervisor stated that quality control was performed each day of patient testing. When the surveyor asked what quality control materials were used, the General Supervisor stated the laboratory used Bio-Rad qUAntify Plus Controls. Based on a review of the Bio-Rad qUAntify Plus Controls instructions for use (Rev 2018/05), under INTENDED USE the document states: "The qUAntify Plus Controls are intended for use as an assayed control material for the precision of urinalysis test procedures for the analytes listed in this package insert." 3. Based on review of quality control and patient records, the laboratory performed quality control with the Bio-Rad qUAntify Plus Controls each day of patient testing for 3 of 3 patients tested on the following dates: Date: 11/27 /2017 Specimen: SPC#1287164 Specimen type: Serum Date: 08/07/2018 Specimen: LAB 35652 Specimen type: Serum Date: 12/29/2018 Specimen: LAB 53520 Specimen type: Serum 4. In an interview at 14:45 hours on 1/15/2019 in the laboratory, the General Supervisor stated that the laboratory did not have a control material of a similar matrix to serum. -- 4 of 4 --