Ochsner Lsu Health Shreveport Ambulatory Care

Summary Statement of Deficiencies D0000 A Recertification survey was performed at Ochsner LSU Health Shreveport Ambulatory Care, CLIA ID 19D2207753, on June 14, 2024. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(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-- (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 review of the laboratory's Individualized Quality Control Plan (IQCP), quality control records, patient logs and interview with personnel, the laboratory failed to perform quality control (QC) for Chem 8 testing on the I-Stat analyzer every thirty (31) days of use for one (1) of eighteen (18) months reviewed in 2023 and 2024. Findings: 1. Review of the laboratory's Individualized Quality Control Plan (IQCP) revealed QC will include: 2 levels of external QC performed per lot/shipment and 2 levels of external QC performed at least once every 31 days. 2. Review of the laboratory's quality control (QC) records from January 2023 through June 14, 2024 revealed the laboratory did not perform external QC every thirty-one (31) days for the following one (1) of eighteen (18) months reviewed: a) September 2023: QC performed August 3, 2023; due September 4, 2023; not performed until October 6, 2023 3. Review of the patient test logs revealed the laboratory reported the following Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 7 -- three hundred seventy four (374) patients for Chem 8 testing without the performance of external quality control (QC) per the laboratory's IQCP: a) September 5, 2023 at 09: 43 am: Patient ID 362567755 b) September 5, 2023 at 10:04 am: Patient ID 365661236 c) September 6, 2023 at 13:29 pm: Patient ID 358353304 d) September 8, 2023 at 07:56 am: Patient ID 362521417 e) September 8, 2023 at 08:03 am: Patient ID 365793616 f) September 8, 2023 at 08:11 am: Patient ID 364173772 g) September 8, 2023 at 08:18 am: Patient ID 366446645 h) September 8, 2023 at 08:38 am: Patient ID 362608637 i) September 8, 2023 at 09:17 am: Patient ID 361303761 j) September 8, 2023 at 09:26 am: Patient ID 356489109 k) September 8, 2023 at 09:45 am: Patient ID 366940011 l) September 8, 2023 at 10:52 am: Patient ID 302880955 m) September 8, 2023 at 10:58 am: Patient ID 366829217 n) September 11, 2023 at 08:26 am: Patient ID 358272584 o) September 11, 2023 at 08:30 am: Patient ID 363776913 p) September 11, 2023 at 08:34 am: Patient ID 358136329 q) September 11, 2023 at 08: 47 am: Patient ID 368034864 r) September 11, 2023 at 09:38 am: Patient ID 362595762 s) September 11, 2023 at 09:43 am: Patient ID 362595284 t) September 11, 2023 at 10:44 am: Patient ID 368741694 u) September 11, 2023 at 10:51 am: Patient ID 360431575 v) September 11, 2023 at 11:00 am: Patient ID 358776147 w) September 11, 2023 at 11:08 am: Patient ID 351676316 x) September 11, 2023 at 11: 49 am: Patient ID 362596465 y) September 11, 2023 at 13:13 pm: Patient ID 368285995 z) September 11, 2023 at 13:20 pm: Patient ID 368695045 aa) September 11, 2023 at 15:33 pm: Patient ID 368283552 bb) September 12, 2023 at 08:11 am: Patient ID 358099107 cc) September 12, 2023 at 09:15 am: Patient ID 363207437 dd) September 12, 2023 at 09:19 am: Patient ID 368078482 ee) September 12, 2023 at 09: 44 am: Patient ID 367541036 ff) September 12, 2023 at 10:27 am: Patient ID 365694385 gg) September 12, 2023 at 11:08 am: Patient ID 336068066 hh) September 12, 2023 at 12:25 pm: Patient ID 342064940 ii) September 12, 2023 at 12: 35 pm: Patient ID 320791449 jj) September 12, 2023 at 13:30 pm: Patient ID 336038552 kk) September 12, 2023 at 13:34 pm: Patient ID 336020827 ll) September 12, 2023 at 13:38 pm: Patient ID 336015427 mm) September 12, 2023 at 13:44 pm: Patient ID 347142058 nn) September 12, 2023 at 13:50 pm: Patient ID 336045763 oo) September 12, 2023 at 13:55 pm: Patient ID 368225338 pp) September 12, 2023 at 13: 59 pm: Patient ID 336064550 qq) September 12, 2023 at 14:03 pm: Patient ID 357367787 rr) September 12, 2023 at 14:07 pm: Patient ID 352074794 ss) September 12, 2023 at 14:11 pm: Patient ID 357367497 tt) September 12, 2023 at 14:15 pm: Patient ID 352111333 uu) September 12, 2023 at 14:22 pm: Patient ID 360165360 vv) September 12, 2023 at 14:30 pm: Patient ID 352059212 ww) September 12, 2023 at 14:58 pm: Patient ID 360730788 xx) September 12, 2023 at 15:03 pm: Patient ID 358237033 yy) September 12, 2023 at 15:07 pm: Patient ID 366844357 zz) September 12, 2023 at 15:30 pm: Patient ID 362780977 aaa) September 12, 2023 at 15:49 pm: Patient ID 361308473 bbb) September 12, 2023 at 16:01 pm: Patient ID 363259376 ccc) September 12, 2023 at 16:05 pm: Patient ID 363243957 ddd) September 13, 2023 at 07:56 am: Patient ID 326388958 eee) September 13, 2023 at 08:00 am: Patient ID 369228553 fff) September 13, 2023 at 08:23 am: Patient ID 321824829 ggg) September 13, 2023 at 08:47 am: Patient ID 336202808 hhh) September 13, 2023 at 09:01 am: Patient ID 368433606 iii) September 13, 2023 at 09: 10 am: Patient ID 362607664 jjj) September 13, 2023 at 09:29 am: Patient ID 362109483 kkk) September 13, 2023 at 09:35 am: Patient ID 358324689 lll) September 13, 2023 at 09:39 am: Patient ID 362596397 mmm) September 13, 2023 at 09:56 am: Patient ID 352977079 nnn) September 13, 2023 at 10:05 am: Patient ID 336884839 ooo) September 13, 2023 at 10:27 am: Patient ID 360429365 ppp) September 13, 2023 at 10:57 am: Patient ID 362603818 qqq) September 13, 2023 at 11:34 am: Patient ID 364644754 rrr) September 13, 2023 at 12:46 pm: Patient ID 368747726 sss) September 13, 2023 at 12:56 pm: Patient ID 362169307 ttt) -- 2 of 7 -- September 13, 2023 at 13:05 pm: Patient ID 363625792 uuu) September 13, 2023 at 13:14 pm: Patient ID 368036883 vvv) September 13, 2023 at 13:28 pm: Patient ID 355942182 www) September 13, 2023 at 13:32 pm: Patient ID 362604329 xxx) September 13, 2023 at 13:37 pm: Patient ID 363638897 yyy) September 13, 2023 at 13:45 pm: Patient ID 368764761 zzz) September 13, 2023 at 13:57 pm: Patient ID 336267169 aaaa) September 13, 2023 at 14:04 pm: Patient ID 362600311 bbbb) September 13, 2023 at 14:12 pm: Patient ID 364706647 cccc) September 13, 2023 at 14:26 pm: Patient ID 366509826 dddd) September 13, 2023 at 14:37 pm: Patient ID 363476425 eeee) September 13, 2023 at 14:46 pm: Patient ID 368432766 ffff) September 13, 2023 at 14:52 pm: Patient ID 365108828 gggg) September 13, 2023 at 14:58 pm: Patient ID 363405031 hhhh) September 13, 2023 at 15:04 pm: Patient ID 353581321 iiii) September 13, 2023 at 15:09 pm: Patient ID 366446435 jjjj) September 13, 2023 at 15:15 pm: Patient ID 366510815 kkkk) September 13, 2023 at 15:31 pm: Patient ID 365843886 llll) September 13, 2023 at 15:39 pm: Patient ID 353536354 mmmm) September 14, 2023 at 08:16 am: Patient ID 336374877 nnnn) September 14, 2023 at 09:06 am: Patient ID 362615356 oooo) September 14, 2023 at 09:13 am: Patient ID 369672764 pppp) September 14, 2023 at 09:23 am: Patient ID 353575409 qqqq) September 14, 2023 at 09:49 am: Patient ID 327619629 rrrr) September 14, 2023 at 10:26 am: Patient ID 368357399 ssss) September 14, 2023 at 10:41 am: Patient ID 362616000 tttt) September 14, 2023 at 10:59 am: Patient ID 353535660 uuuu) September 14, 2023 at 11:23 am: Patient ID 365759557 vvvv) September 14, 2023 at 11:31 am: Patient ID 359878869 wwww) September 14, 2023 at 12:46 pm: Patient ID 368830977 xxxx) September 14, 2023 at 12:53 pm: Patient ID 368660204 yyyy) September 14, 2023 at 15:02 pm: Patient ID 368289540 zzzz) September 15, 2023 at 07:53 am: Patient ID 368775755 1) September 15, 2023 at 08: 09 am: Patient ID 303907552 2) September 15, 2023 at 08:20 am: Patient ID 363758348 3) September 15, 2023 at 08:28 am: Patient ID 368557143 4) September 15, 2023 at 08:37 am: Patient ID 363793921 5) September 15, 2023 at 09:10 am: Patient ID 368797668 6) September 15, 2023 at 09:42 am: Patient ID 365027591 7) September 15, 2023 at 09:46 am: Patient ID 363793921 8) September 15, 2023 at 09: 56 am: Patient ID 359495079 9) September 15, 2023 at 10:06 am: Patient ID 326854781 10) September 15, 2023 at 10:40 am: Patient ID 359694069 11) September 15, 2023 at 10:51 am: Patient ID 303190182 12) September 15, 2023 at 11: 21 am: Patient ID 359387056 13) September 15, 2023 at 11:29 am: Patient ID 369944250 14) September 18, 2023 at 08:12 am: Patient ID 370097939 15) September 18, 2023 at 08:21 am: Patient ID 365029381 16) September 18, 2023 at 09: 08 am: Patient ID 368072718 17) September 18, 2023 at 09:20 am: Patient ID 365107034 18) September 18, 2023 at 10:07 am: Patient ID 369750478 19) September 18, 2023 at 10:12 am: Patient ID 362620169 20) September 18, 2023 at 13: 24 pm: Patient ID 368790623 21) September 18, 2023 at 14:12 pm: Patient ID 370102719 22) September 18, 2023 at 14:36 pm: Patient ID 368879047 23) September 18, 2023 at 14:45 pm: Patient ID 368376102 24) September 19, 2023 at 08: 02 am: Patient ID 364860318 25) September 19, 2023 at 10:35 am: Patient ID 369412891 26) September 19, 2023 at 12:40 pm: Patient ID 332501524 27) September 19, 2023 at 12:56 pm: Patient ID 337281547 28) September 19, 2023 at 13: 14 pm: Patient ID 366771680 29) September 19, 2023 at 13:25 pm: Patient ID 370633899 30) September 19, 2023 at 13:30 pm: Patient ID 359479016 31) September 19, 2023 at 13:36 pm: Patient ID 337321812 32) September 19, 2023 at 13: 42 pm: Patient ID 363086973 33) September 19, 2023 at 13:49 pm: Patient ID 343345156 34) September 19, 2023 at 14:08 pm: Patient ID 353335730 35) September 19, 2023 at 14:39 pm: Patient ID 362823660 36) September 19, 2023 at 14: 51 pm: Patient ID 363287217 37) September 19, 2023 at 15:23 pm: Patient ID 353364976 38) September 19, 2023 at 15:30 pm: Patient ID 363193801 39) -- 3 of 7 -- September 19, 2023 at 15:37 pm: Patient ID 364179963 40) September 19, 2023 at 15: 46 pm: Patient ID 364653298 41) September 20, 2023 at 08:33 am: Patient ID 353507357 42) September 20, 2023 at 08:49 am: Patient ID 337409260 43) September 20, 2023 at 08:56 am: Patient ID 367366139 44) September 20, 2023 at 09: 30 am: Patient ID 337417973 45) September 20, 2023 at 09:36 am: Patient ID 336974739 46) September 20, 2023 at 09:51 am: Patient ID 362989451 47) September 20, 2023 at 10:26 am: Patient ID 370246475 48) September 20, 2023 at 10: 31 am: Patient ID 337638933 49) September 20, 2023 at 10:39 am: Patient ID 362991867 50) September 20, 2023 at 10:53 am: Patient ID 337434307 51) September 20, 2023 at 11:18 am: Patient ID 365741622 52) September 20, 2023 at 12: 04 pm: Patient ID 363098652 53) September 20, 2023 at 12:45 pm: Patient ID 365458789 54) September 20, 2023 at 13:07 pm: Patient ID 366466045 55) September 20, 2023 at 13:12 pm: Patient ID 369689260 56) September 20, 2023 at 13: 19 pm: Patient ID 365461607 57) September 20, 2023 at 13:25 pm: Patient ID 366467038 58) September 20, 2023 at 13:35 pm: Patient ID 362624096 59) September 20, 2023 at 13:44 pm: Patient ID 363465849 60) September 20, 2023 at 13: 50 pm: Patient ID 359640776 61) September 20, 2023 at 14:00 pm: Patient ID 367380478 62) September 20, 2023 at 14:35 pm: Patient ID 366164081 63) September 20, 2023 at 14:43 pm: Patient ID 366469171 64) September 20, 2023 at 15: 11 pm: Patient ID 363481395 65) September 20, 2023 at 15:19 pm: Patient ID 371064933 66) September 20, 2023 at 15:36 pm: Patient ID 366497830 67) September 21, 2023 at 07:52 am: Patient ID 348397503 68) September 21, 2023 at 08: 01 am: Patient ID 363102491 69) September 21, 2023 at 08:13 am: Patient ID 369941371 70) September 21, 2023 at 08:49 am: Patient ID 359842414 71) September 21, 2023 at 09:02 am: Patient ID 356103768 72) September 21, 2023 at 09: 06 am: Patient ID 337590374 73) September 21, 2023 at 09:17 am: Patient ID 363101873 74) September 21, 2023 at 09:37 am: Patient ID 370939988 75) September 21, 2023 at 09:42 am: Patient ID 365420503 76) September 21, 2023 at 10: 15 am: Patient ID 353703269 77) September 21, 2023 at 10:27 am: Patient ID 370971877 78) September 21, 2023 at 10:47 am: Patient ID 369311977 79) September 21, 2023 at 11:04 am: Patient ID 357077074 80) September 21, 2023 at 11: 39 am: Patient ID 363088394 81) September 21, 2023 at 12:03 pm: Patient ID 370527417 82) September 21, 2023 at 12:21 pm: Patient ID 328629029 83) September 22, 2023 at 07:47 am: Patient ID 368327396 84) September 22, 2023 at 08: 33 am: Patient ID 368740450 85) September 22, 2023 at 08:42 am: Patient ID 359615594 86) September 22, 2023 at 09:25 am: Patient ID 361282607 87) September 22, 2023 at 10:05 am: Patient ID 337828282 88) September 22, 2023 at 10: 16 am: Patient ID 368341210 89) September 22, 2023 at 10:45 am: Patient ID 369885018 90) September 22, 2023 at 11:13 am: Patient ID 368218068 91) September 22, 2023 at 11:38 am: Patient ID 368323114 92) September 25, 2023 at 08: 05 am: Patient ID 228706232 93) September 25, 2023 at 08:13 am: Patient ID 363607086 94) September 25, 2023 at 08:21 am: Patient ID 338646300 95) September 25, 2023 at 08:33 am: Patient ID 370473433 96) September 25, 2023 at 08: 44 am: Patient ID 362813000 97) September 25, 2023 at 09:11 am: Patient ID 366451790 98) September 25, 2023 at 09:18 am: Patient ID 360374694 99) September 25, 2023 at 09:26 am: Patient ID 365906641 100) September 25, 2023 at 09:53 am: Patient ID 363121770 101) September 25, 2023 at 10:03 am: Patient ID 338535446 102) September 25, 2023 at 10:27 am: Patient ID 368810499 103) September 25, 2023 at 10:40 am: Patient ID 363117308 104) September 25, 2023 at 10:54 am: Patient ID 363111931 105) September 25, 2023 at 11:14 am: Patient ID 366195639 106) September 25, 2023 at 13:08 pm: Patient ID 370518844 107) September 25, 2023 at 14:34 pm: Patient ID 369671154 108) September 25, 2023 at 15:03 pm: Patient ID 370506488 109) September 25, 2023 at 15:49 pm: Patient ID -- 4 of 7 -- 371011798 110) September 26, 2023 at 09:19 am: Patient ID 369521256 111) September 26, 2023 at 12:02 pm: Patient ID 360389911 112) September 26, 2023 at 12:07 pm: Patient ID 369443447 113) September 26, 2023 at 12:11 pm: Patient ID 368102746 114) September 26, 2023 at 12:42 pm: Patient ID 368566394 115) September 26, 2023 at 13:06 pm: Patient ID 338518890 116) September 26, 2023 at 13:14 pm: Patient ID 367179978 117) September 26, 2023 at 13:20 pm: Patient ID 354580286 118) September 26, 2023 at 13:24 pm: Patient ID 370855288 119) September 26, 2023 at 13:28 pm: Patient ID 368214867 120) September 26, 2023 at 13:32 pm: Patient ID 344601183 121) September 26, 2023 at 13:58 pm: Patient ID 364382587 122) September 26, 2023 at 14:04 pm: Patient ID 344606351 123) September 26, 2023 at 14:11 pm: Patient ID 354572789 124) September 26, 2023 at 14:20 pm: Patient ID 354634512 125) September 26, 2023 at 14:30 pm: Patient ID 360773823 126) September 26, 2023 at 14:37 pm: Patient ID 364481997 127) September 26, 2023 at 14:48 pm: Patient ID 349553435 128) September 26, 2023 at 14:53 pm: Patient ID 360781153 129) September 26, 2023 at 14:58 pm: Patient ID 363248267 130) September 26, 2023 at 15:03 pm: Patient ID 365754674 131) September 26, 2023 at 15:09 pm: Patient ID 364445297 132) September 26, 2023 at 15:13 pm: Patient ID 364445297 133) September 26, 2023 at 15:18 pm: Patient ID 367142495 134) September 26, 2023 at 15:29 pm: Patient ID 365768761 135) September 26, 2023 at 15:36 pm: Patient ID 363267137 136) September 26, 2023 at 15:46 pm: Patient ID 361998361 137 September 26, 2023 at 15:57 pm: Patient ID 365786682 138) September 26, 2023 at 16:08 pm: Patient ID 362447803 139) September 27, 2023 at 07:52 am: Patient ID 361171977 140) September 27, 2023 at 08:44 am: Patient ID 363714427 141) September 27, 2023 at 08:48 am: Patient ID 331047898 142) September 27, 2023 at 08:53 am: Patient ID 359635663 143) September 27, 2023 at 09:08 am: Patient ID 369114967 144) September 27, 2023 at 09:16 am: Patient ID 363151306 145) September 27, 2023 at 09:49 am: Patient ID 359592548 146) September 27, 2023 at 10:05 am: Patient ID 363142668 147) September 27, 2023 at 10:10 am: Patient ID 355564353 148) September 27, 2023 at 10:57 am: Patient ID 363147337 149) September 27, 2023 at 12:00 pm: Patient ID 363152689 150) September 27, 2023 at 12:40 pm: Patient ID 366055762 151) September 27, 2023 at 12:57 pm: Patient ID 359770219 152) September 27, 2023 at 13:13 pm: Patient ID 368372958 153) September 27, 2023 at 13:18 pm: Patient ID 368317176 154) September 27, 2023 at 13:24 pm: Patient ID 363152071 155) September 27, 2023 at 13:31 pm: Patient ID 369768417 156) September 27, 2023 at 13:35 pm: Patient ID 365460599 157) September 27, 2023 at 13:40 pm: Patient ID 360662178 158) September 27, 2023 at 13:55 pm: Patient ID 372179130 159) September 27, 2023 at 14:08 pm: Patient ID 366893071 160) September 27, 2023 at 14:13 pm: Patient ID 363145336 161) September 27, 2023 at 14:18 pm: Patient ID 359699233 162) September 27, 2023 at 14:24 pm: Patient ID 371779394 163) September 27, 2023 at 14:34 pm: Patient ID 338891297 164) September 27, 2023 at 14:40 pm: Patient ID 366496406 165) September 27, 2023 at 14:44 pm: Patient ID 371790907 166) September 27, 2023 at 14:54 pm: Patient ID 368389338 167) September 27, 2023 at 15:15 pm: Patient ID 357930414 168) September 27, 2023 at 15:22 pm: Patient ID 357799917 169) September 27, 2023 at 15:48 pm: Patient ID 366505009 170) September 27, 2023 at 15:57 pm: Patient ID 359713603 171) September 28, 2023 at 08:00 am: Patient ID 363715870 172) September 28, 2023 at 08:05 am: Patient ID 367526289 173) September 28, 2023 at 08:10 am: Patient ID 367444107 174) September 28, 2023 at 08:18 am: Patient ID 338815031 175) September 28, 2023 at 08:29 am: Patient ID 354934963 176) September 28, 2023 at 08:46 am: Patient ID 371350207 177) September 28, 2023 at 09:00 am: Patient ID 338844985 178) September 28, 2023 at 09:07 am: Patient ID 371448195 179) September 28, 2023 at 09:16 am: Patient ID 353587179 180) September 28, 2023 at -- 5 of 7 -- 09:44 am: Patient ID 367491509 181) September 28, 2023 at 09:51 am: Patient ID 371185068 182) September 28, 2023 at 10:13 am: Patient ID 369444969 183) September 28, 2023 at 10:28 am: Patient ID 363594874 184) September 28, 2023 at 10:32 am: Patient ID 370065221 185) September 28, 2023 at 10:38 am: Patient ID 359883049 186) September 28, 2023 at 10:44 am: Patient ID 363209372 187) September 28, 2023 at 11:20 am: Patient ID 371433274 188) September 28, 2023 at 13:06 pm: Patient ID 369920887 189) September 28, 2023 at 13:16 pm: Patient ID 371439763 190) September 28, 2023 at 13:23 pm: Patient ID 371461721 191) September 28, 2023 at 13:42 pm: Patient ID 330098932 192) September 28, 2023 at 13:51 pm: Patient ID 329770063 193) September 28, 2023 at 14:01 pm: Patient ID 371455217 194) September 29, 2023 at 08:06 am: Patient ID 368364162 195) September 29, 2023 at 08:18 am: Patient ID 370143505 196) September 29, 2023 at 09:43 am: Patient ID 368738595 197) September 29, 2023 at 10:38 am: Patient ID 368742105 198) October 2, 2023 at 07:57 am: Patient ID 363795777 199) October 2, 2023 at 08:22 am: Patient ID 367467622 200) October 2, 2023 at 09:03 am: Patient ID 370530062 201) October 2, 2023 at 09:14 am: Patient ID 363717551 202) October 2, 2023 at 09:21 am: Patient ID 363716753 203) October 2, 2023 at 10:49 am: Patient ID 371379806 204) October 2, 2023 at 13:40 pm: Patient ID 368781220 205) October 2, 2023 at 13:54 pm: Patient ID 370009591 206) October 3, 2023 at 12:42 pm: Patient ID 307439436 207) October 3, 2023 at 12:54 pm: Patient ID 339717507 208) October 3, 2023 at 13:17 pm: Patient ID 369687183 209) October 3, 2023 at 13:21 pm: Patient ID 370558550 210) October 3, 2023 at 13:25 pm: Patient ID 324170496 211) October 3, 2023 at 13:29 pm: Patient ID 325006762 212) October 3, 2023 at 13:34 pm: Patient ID 325012349 213) October 3, 2023 at 13:41 pm: Patient ID 364198702 214) October 3, 2023 at 13:51 pm: Patient ID 372492617 215) October 3, 2023 at 13:56 pm: Patient ID 307483154 216) October 3, 2023 at 14:03 pm: Patient ID 356253323 217) October 3, 2023 at 14:12 pm: Patient ID 361997534 218) October 3, 2023 at 14:22 pm: Patient ID 372108215 219) October 3, 2023 at 14:27 pm: Patient ID 345838754 220) October 3, 2023 at 14:37 pm: Patient ID 364569100 221) October 3, 2023 at 14:42 pm: Patient ID 365113974 222) October 3, 2023 at 14:46 pm: Patient ID 366246666 223) October 3, 2023 at 14:54 pm: Patient ID 361991755 224) October 3, 2023 at 15:03 pm: Patient ID 361991755 225) October 3, 2023 at 15:10 pm: Patient ID 367181978 226) October 3, 2023 at 15:15 pm: Patient ID 366050993 227) October 3, 2023 at 15:20 pm: Patient ID 361940657 228) October 3, 2023 at 15:27 pm: Patient ID 368893756 229) October 3, 2023 at 15:37 pm: Patient ID 368120480 230) October 3, 2023 at 15:45 pm: Patient ID 368751273 231) October 4, 2023 at 09:45 am: Patient ID 371211316 232) October 4, 2023 at 09:54 am: Patient ID 373451036 233) October 4, 2023 at 10:01 am: Patient ID 340115202 234) October 4, 2023 at 10:08 am: Patient ID 360549597 235) October 4, 2023 at 10:20 am: Patient ID 366009839 236) October 4, 2023 at 10:59 am: Patient ID 371046983 237) October 4, 2023 at 11:08 am: Patient ID 356293425 238) October 4, 2023 at 12:37 pm: Patient ID 366786935 239) October 4, 2023 at 12:46 pm: Patient ID 356069373 240) October 4, 2023 at 12:53 pm: Patient ID 362172035 241) October 4, 2023 at 13:00 pm: Patient ID 362150259 242) October 4, 2023 at 13:09 pm: Patient ID 356116798 243) October 4, 2023 at 13:32 pm: Patient ID 370849868 244) October 4, 2023 at 13:39 pm: Patient ID 373289257 245) October 4, 2023 at 13:43 pm: Patient ID 367394478 246) October 4, 2023 at 13:53 pm: Patient ID 363916935 247) October 4, 2023 at 14:03 pm: Patient ID 366506686 248) October 4, 2023 at 14:14 pm: Patient ID 362185786 249) October 4, 2023 at 14:18 pm: Patient ID 373412478 250) October 4, 2023 at 14:22 pm: Patient ID 338893027 251) October 4, 2023 at 14:29 pm: Patient ID 362176276 252) October 4, 2023 at 14:34 pm: Patient ID 338931334 253) October 4, 2023 at 14:39 pm: Patient ID 362178802 254) October 4, 2023 at 15:21 pm: Patient ID 367335088 255) October 4, 2023 at 16:07 pm: Patient ID 373345905 256) October 5, 2023 at 08:20 am: Patient ID 325376069 257) October 5, 2023 at 08:39 am: Patient -- 6 of 7 -- ID 363919976 258) October 5, 2023 at 09:07 am: Patient ID 330535232 259) October 5, 2023 at 09:37 am: Patient ID 363916171 260) October 5, 2023 at 09:45 am: Patient ID 363916578 261) October 5, 2023 at 09:52 am: Patient ID 340213959 262) October 5, 2023 at 10:01 am: Patient ID 373249511 263) October 5, 2023 at 10:25 am: Patient ID 340866011 264) October 5, 2023 at 10:33 am: Patient ID 362354321 265) October 5, 2023 at 10:52 am: Patient ID 341141995 266) October 5, 2023 at 11:52 am: Patient ID 372712204 267) October 5, 2023 at 13:25 pm: Patient ID 373052743 268) October 5, 2023 at 13:39 pm: Patient ID 373048767 269) October 5, 2023 at 14:04 pm: Patient ID 373027028 270) October 5, 2023 at 15:06 pm: Patient ID 371045406 4. In interview on June 14, 2024 at10:40 am, the Technical Consultant stated a change of personnel oversight was in progress and the QC was not performed as required. The Technical Consultant confirmed the laboratory did not perform external QC every thirty (30) days per the IQCP. D6020 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 program is established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on review of the laboratory's Individualized Quality Control Plan (IQCP), quality control records and interview with personnel, the Laboratory Director failed to ensure the quality control program was followed to assure the quality of testing in the laboratory. Refer to D5445. D6042 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(4) (b) The technical consultant is responsible for-- (b)(4) Establishing a quality control program appropriate for the testing performed and establishing the parameters for acceptable levels of analytic performance and ensuring that these levels are maintained throughout the entire testing process from the initial receipt of the specimen, through sample analysis and reporting of test results; This STANDARD is not met as evidenced by: Based on review of the laboratory's Individualized Quality Control Plan (IQCP), quality control records and interview with personnel, the Technical Consultant failed to ensure the quality control program was followed to assure quality of laboratory testing. Refer to D5445. -- 7 of 7 --

Summary Statement of Deficiencies D0000 A Validation survey was performed at Ochsner LSU Health Shreveport Ambulatory Care Clinic, CLIA # 19D2207753, on December 21, 2022. Ochsner LSU Health Shreveport Ambulatory Care Clinic was found not in compliance with the following CONDITION LEVEL DEFICIENCIES: 42 CFR 493.1403 CONDITION: Laboratories performing moderate complexity testing; Laboratory Director 42 CFR 493.1409 CONDITION: Laboratories performing moderate complexity testing; Technical Consultant 42 CFR 493.1421 CONDITION: Laboratories performing moderate complexity testing; Testing Personnel 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 review of the laboratory's policy and procedure, proficiency testing records and interview with personnel, the laboratory failed to retain proficiency testing records for one (1) of five (5) events reviewed for 2021 and 2022. Findings: 1. Review of the laboratory's "POC Proficiency Testing Surveys" policy revealed the following: a) Under "Preparation and Performing Procedure" - "The testing personnel sign the Attestation form acknowledging participation in the survey meeting COM. 01400 PT Attestation Statement. The area and individual who performed the test may be noted on the answer form. The POCT technologist generally will sign the testing personnel area." b) Under "POCT Supervisory Personnel" - "The Attestation statement is signed by the laboratory director or qualified designee and all individuals involved in the testing process fulfilling COM.01400." 2. Review of the laboratory's College of American Pathologists (CAP) proficiency testing (PT) records for 2021 and 2022 revealed the laboratory did not retain the following attestation statement for one (1) of five (5) events reviewed: a) CAP AQI - A 2022 Critical Care Aqueous Blood Gas 3. In interview on December 21, 2022 at 11:00 am, Technical Consultant 1 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 7 -- confirmed the laboratory did not have the attestation statemennt for the identified PT event. 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 CMS 209 (Laboratory Personnel Report) form, policy and procedures, personnel records, and interview with personnel, the laboratory failed to perform competency assessments as required for eleven (11) of fourteen (14) testing personnel who perform point of care moderate complexity testing. Findings: 1. Review of the CMS 209 form provided to surveyor revealed the laboratory employed the following fourteen (14) testing personnel who performs point of care moderate complexity testing in the specialty of Chemistry: a) Personnel 1 b) Personnel 2 c) Personnel 3 d) Personnel 7 e) Personnel 8 f) Personnel 9 g) Personnel 11 h) Personnel 12 i) Personnel 13 j) Personnel 14 k) Personnel 15 l) Personnel 16 m) Personnel 17 n) Personnel 18 2. Review of the laboratory's "Training, Competency, and Performance Assessment of Laboratory Personnel Policy" revealed the following: "For nonwaived testing, competency must be assessed at the following frequency: * During the first year of an individual's duties, competency must be assessed at least semiannually. * After an individual has performed his/her duties for one year, competency must be assessed at least annually. * Retraining and reassessment of competency must also occur when problems are identified with an individual's performance." 3. Review of personnel records from 2021 and 2022 revealed the laboratory did not have documentation of initial, 6 month, or annual competency assessments for the following eleven (11) of fourteen (14) testing personnel: a) Personnel 7 b) Personnel 8 c) Personnel 9 d) Personnel 11 e) Personnel 12 f) Personnel 13 g) Personnel 14 h) Personnel 15 i) Personnel 16 j) Personnel 17 k) Personnel 18 4. In interview on December 21, 2022 at 11:00 am, Technical Consultant 1 confirmed the laboratory did not perform competency assessments for the identified testing personnel. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on observation by surveyors, review of laboratory policy and records, and interview with personnel, the Laboratory Director failed to provide overall management and direction for the laboratory. Findings: 1. The Laboratory Director failed to ensure proficiency samples were tested as required by qualified testing personnel. Refer to D6016. 2. The Laboratory Director failed to ensure the laboratory employed testing personnel that met the licensure and educational requirements. Refer to D6028. 3. The Laboratory Director failed to ensure testing personnel had appropriate training documentation prior to patient testing. Refer to D6029. 4. The -- 2 of 7 -- Laboratory Director failed to ensure policies and procedures for assessing personnel competency were maintained. Refer to D6030. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) 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)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on review of the CMS-209 (Laboratory Personnel Report), personnel records, proficiency testing records and interview with personnel, the Laboratory Director failed to ensure proficiency samples were tested as required by qualified testing personnel. Findings: 1. Review of the CMS 209 personnel form provided to surveyor revealed the laboratory employs the following fourteen testing personnel for moderate complexity testing in the specialty of Chemistry: * Personnel 1 * Personnel 2 * Personnel 3 * Personnel 7 * Personnel 8 * Personnel 9 * Personnel 11 * Personnel 12 * Personnel 13 * Personnel 14 * Personnel 15 * Personnel 16 * Personnel 17 * Personnel 18 2. Review of the laboratory's personnel records revealed the laboratory did not have documentation to support the state licensure and/or education requirements for the following fourteen (14) of fourteen (14) testing personnel: * Personnel 1 - no education documented * Personnel 2 - no education documented * Personnel 3 no education documented * Personnel 7 - no state licensure and education documented * Personnel 8 - no state licensure and education documented * Personnel 9 - no state licensure and education documented * Personnel 11 - no state licensure and education documented * Personnel 12 - no state licensure and education documented * Personnel 13 - no state licensure and education documented * Personnel 14 - no state licensure and education documented * Personnel 15 - no state licensure and education documented * Personnel 16 - no state licensure and education documented * Personnel 17 - no state licensure and education documented * Personnel 18 - no state licensure and education documented 3. Review of the laboratory's CAP proficiency testing records for 2021 and 2022 revealed the following proficiency testing samples were performed by testing personnel who did not meet the licensure and/or education requirements for four (4) of five (5) events reviewed: a) CAP AQI - B 2021 Critical Care Aqueous Blood Gas * Personnel 17 performed samples 06 and 09 * Personnel 18 performed samples 07 and 08 b) CAP AQI - C 2021 Critical Care Aqueous Blood Gas * Personnel 16 performed samples 11 and 12 * Personnel 17 performed samples 13 and 15 * Personnel 15 performed samples 14 c) CAP AQI - B 2022 Critical Care Aqueous Blood Gas * Personnel 13 performed samples 06, 07, and 08 * Personnel 14 performed samples 09 and 10 d) CAP AQI - C 2022 Critical Care Aqueous Blood Gas * Five (5) different Testing Personnel signed attestation statement; however, the testing personnel did not identify the samples which they tested 4. In interview on December 21, 2022 at 11:00 am, Technical Consultant 1 confirmed the above identified proficiency testing events were tested by unqualified testing personnel. D6028 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(10) -- 3 of 7 -- 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)(10) Employ a sufficient number of laboratory personnel with the appropriate education and either experience or training to provide appropriate consultation, properly supervise and accurately perform tests and report test results in accordance with the personnel responsibilities described in this subpart; This STANDARD is not met as evidenced by: Based on review of laboratory policy, personnel records and interview with personnel, the Laboratory Director failed to ensure the laboratory employed testing personnel that met the licensure and educational requirements. Findings: 1. The laboratory failed to ensure testing personnel met the state of Louisiana licensure requirement for eleven (11) of fourteen (14) testing personnel reviewed. Refer to D6064. 2. The laboratory failed to provide documentation that fourteen (14) of fourteen (14) testing personnel reviewed met the educational qualifications for performing moderate complexity testing. Refer to D6065. D6029 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(11) 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)(11) Ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: Based on review of the laboratory's CMS-209 (Laboratory Personnel Report), personnel records and interview with personnel, the Laboratory Director failed to ensure testing personnel had appropriate training documentation prior to patient testing. Findings: 1. Review of the laboratory's CMS-209 (Laboratory Personnel Report) revealed the following testing personnel performs moderate complexity testing in the specialty of Chemistry: * Personnel 1 * Personnel 2 * Personnel 3 2. Review of the personnel records from 2021 and 2022 revealed the Laboratory Director did not review the initial training for the following three (3) of three (3) testing personnel: a) Personnel 1 - intial training performed 10/04/2022 b) Personnel 2 - intial training performed 02/23/2021 c) Personnel 3 - initial training performed 08/09 /2022 3. In interview on December 21, 2022 at 11:00 am, Technical Consultant 1 confirmed the initial training for the above identified testing personnel was not reviewed by the Laboratory Director. D6030 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(12) The laboratory director is responsible for the overall operation and administration of -- 4 of 7 -- 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 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 review of personnel records and interview with personnel, the Laboratory Director failed to ensure policies and procedures for assessing personnel competency were maintained. Findings: 1. The laboratory failed to perform competency assessments as required for eleven (11) of fourteen (14) testing personnel who perform point of care moderate complexity testing. Refer to D5209. 2. The Technical Consultants failed to evaluate competency annually for thirteen (13) of fourteen (14) testing personnel reviewed. Refer to D6046. 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 observation by surveyor, review of laboratory policies, personnel records, and interview with personnel, the Technical Consultant failed to provide technical oversight of the laboratory for moderate complexity testing. Findings: 1. The Technical Consultants failed to evaluate competency annually for thirteen (13) of fourteen (14) testing personnel reviewed. Refer to D6046. 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 personnel records and interview with personnel, the Technical Consultants failed to evaluate competency annually for thirteen (13) of fourteen (14) testing personnel reviewed. Findings: 1. Review of the personnel records for 2021 and 2022 revealed the laboratory did not have documentation of annual competency assessments for testing personnel performing point of care moderate complexity testing for the following thirteen (13) of fourteen (14) personnel reviewed: a) Personnel 1 b) Personnel 3 c) Personnel 7 d) Personnel 8 e) Personnel 9 f) Personnel 11 g) Personnel 12 h) Personnel 13 i) Personnel 14 j) Personnel 15 k) Personnel 16 l) Personnel 17 m) Personnel 18 2. In interview on December 21, 2022 at 11:00 am, -- 5 of 7 -- Technical Consultant 1 stated that she took over the technical consultant/point of care coordinator position in October 2022. Technical Consultant 1 further stated that she could not find all the documentation for competency assessments for the identified testing personnel. Technical Consultant 1 confirmed the laboratory did not perform annual competency assessments for testing personnel in 2021 and 2022. 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 personnel records and interview with personnel, the laboratory failed to provide documentation to ensure all testing personnel met licensure and education requirements. Findings: 1. The laboratory failed to ensure testing personnel met the state of Louisiana licensure requirement for eleven (11) of fourteen (14) testing personnel reviewed. Refer to D6064. 2. The laboratory failed to provide documentation that fourteen (14) of fourteen (14) testing personnel reviewed met the educational qualifications for performing moderate complexity testing. Refer to D6065. D6064 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(a) Each individual performing moderte complexity testing must possess a current license issued by the State in which the laboratory is located, if such licensing is required. This STANDARD is not met as evidenced by: Based on review of the CMS 209 (Laboratory Personnel Report), personnel records, and interview with personnel, the laboratory failed to ensure testing personnel met the state of Louisiana licensure requirement for eleven (11) of fourteen (14) testing personnel reviewed. Findings: 1. Review of the laboratory's CMS 209 (Laboratory Personnel Report) revealed that the following testing personnel performs moderate complexity testing for the specialty of Chemistry: * Personnel 1 * Personnel 2 * Personnel 3 * Personnel 7 * Personnel 8 * Personnel 9 * Personnel 11 * Personnel 12 * Personnel 13 * Personnel 14 * Personnel 15 * Personnel 16 * Personnel 17 * Personnel 18 2. Review of personnel records revealed the laboratory did not include a state license covering moderate complexity testing issued by Louisiana State Board of Medical Examiners (LSBME) for the following eleven (11) of fourteen (14) testing personnel: * Personnel 7 * Personnel 8 * Personnel 9 * Personnel 11 * Personnel 12 * Personnel 13 * Personnel 14 * Personnel 15 * Personnel 16 * Personnel 17 * Personnel 18 3. In interview on December 21, 2021 at 11:00 am, Technical Consultant 1 confirmed the above identified testing personnel did not have a Louisiana State laboratory license to perform moderate complexity testing. 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 -- 6 of 7 -- 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 review of the Laboratory Personnel Report (CMS 209), personnel records and interview with personnel, the laboratory failed to provide documentation that fourteen (14) of fourteen (14) testing personnel reviewed met the educational qualifications for performing moderate complexity testing. Findings: 1. Review of the CMS 209 form provided to surveyor and personnel records revealed the laboratory did not maintain documentation of at least a High School Diploma or equivalent for the following fourteen (14) of fourteen (14) testing personnel: a) Personnel 1 b) Personnel 2 c) Personnel 3 d) Personnel 7 e) Personnel 8 f) Personnel 9 g) Personnel 11 h) Personnel 12 i) Personnel 13 j) Personnel 14 k) Personnel 15 l) Personnel 16 m) Personnel 17 n) Personnel 18 2. In interview on December 2, 2022 at 11:00 am, Technical Consultant 1 confirmed the laboratory did not have documentation of education for the above identified Testing Personnel. -- 7 of 7 --